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Cochrane Database Syst Rev. 2020; 2020(4): CD011621.
Published online 2020 Apr 15. doi:10.1002/14651858.CD011621.pub4
PMCID: PMC7158881
PMID: 32293717
Monitoring Editor: Cochrane Work Group, Jos H Verbeek,
Blair Rajamaki, Sharea Ijaz, Riitta Sauni, Elaine Toomey, Bronagh Blackwood, Christina Tikka, Jani H Ruotsalainen, and F Selcen Kilinc Balci
Author information Copyright and License information PMC Disclaimer
This article is an update of "Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff" in volume 2019, CD011621.
This article has been updated. "Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff" in volume 2020, CD011621.
Abstract
Background
In epidemics of highly infectious diseases, such as Ebola, severe acute respiratorysyndrome (SARS), or coronavirus (COVID‐19), healthcare workers (HCW) are at muchgreater risk of infection than the general population, due to their contact withpatients' contaminated body fluids. Personal protective equipment (PPE) can reduce therisk by covering exposed body parts. It is unclear which type of PPE protects best,what is the best way to put PPE on (i.e. donning) or to remove PPE (i.e. doffing), andhow to train HCWs to use PPE as instructed.
Objectives
To evaluate which type of full‐body PPE and which method of donning or doffing PPEhave the least risk of contamination or infection for HCW, and which training methodsincrease compliance with PPE protocols.
Search methods
We searched CENTRAL, MEDLINE, Embase and CINAHL to 20 March 2020.
Selection criteria
We included all controlled studies that evaluated the effect of full‐body PPE used byHCW exposed to highly infectious diseases, on the risk of infection, contamination, ornoncompliance with protocols. We also included studies that compared the effect ofvarious ways of donning or doffing PPE, and the effects of training on the sameoutcomes.
Data collection and analysis
Two review authors independently selected studies, extracted data and assessed therisk of bias in included trials. We conducted random‐effects meta‐analyses wereappropriate.
Main results
Earlier versions of this review were published in 2016 and 2019. In this update, weincluded 24 studies with 2278 participants, of which 14 were randomised controlledtrials (RCT), one was a quasi‐RCT and nine had a non‐randomised design.
Eight studies compared types of PPE. Six studies evaluated adapted PPE. Eight studiescompared donning and doffing processes and three studies evaluated types of training.Eighteen studies used simulated exposure with fluorescent markers or harmlessmicrobes. In simulation studies, median contamination rates were 25% for theintervention and 67% for the control groups.
Evidence for all outcomes is of very low certainty unless otherwise stated because itis based on one or two studies, the indirectness of the evidence in simulation studiesand because of risk of bias.
Types of PPE
The use of a powered, air‐purifying respirator with coverall may protect against therisk of contamination better than a N95 mask and gown (risk ratio (RR) 0.27, 95%confidence interval (CI) 0.17 to 0.43) but was more difficult to don (non‐compliance:RR 7.5, 95% CI 1.81 to 31.1). In one RCT (59 participants), people with a long gownhad less contamination than those with a coverall, and coveralls were more difficultto doff (low‐certainty evidence). Gowns may protect better against contamination thanaprons (small patches: mean difference (MD) −10.28, 95% CI −14.77 to −5.79). PPE madeof more breathable material may lead to a similar number of spots on the trunk (MD1.60, 95% CI −0.15 to 3.35) compared to more water‐repellent material but may havegreater user satisfaction (MD −0.46, 95% CI −0.84 to −0.08, scale of 1 to 5).
Modified PPE versus standard PPE
The following modifications to PPE design may lead to less contamination compared tostandard PPE: sealed gown and glove combination (RR 0.27, 95% CI 0.09 to 0.78), abetter fitting gown around the neck, wrists and hands (RR 0.08, 95% CI 0.01 to 0.55),a better cover of the gown‐wrist interface (RR 0.45, 95% CI 0.26 to 0.78,low‐certainty evidence), added tabs to grab to facilitate doffing of masks (RR 0.33,95% CI 0.14 to 0.80) or gloves (RR 0.22, 95% CI 0.15 to 0.31).
Donning and doffing
Using Centers for Disease Control and Prevention (CDC) recommendations for doffingmay lead to less contamination compared to no guidance (small patches: MD −5.44, 95%CI −7.43 to −3.45). One‐step removal of gloves and gown may lead to less bacterialcontamination (RR 0.20, 95% CI 0.05 to 0.77) but not to less fluorescent contamination(RR 0.98, 95% CI 0.75 to 1.28) than separate removal. Double‐gloving may lead to lessviral or bacterial contamination compared to single gloving (RR 0.34, 95% CI 0.17 to0.66) but not to less fluorescent contamination (RR 0.98, 95% CI 0.75 to 1.28).Additional spoken instruction may lead to fewer errors in doffing (MD −0.9, 95% CI−1.4 to −0.4) and to fewer contamination spots (MD −5, 95% CI −8.08 to −1.92). Extrasanitation of gloves before doffing with quaternary ammonium or bleach may decreasecontamination, but not alcohol‐based hand rub.
Training
The use of additional computer simulation may lead to fewer errors in doffing (MD−1.2, 95% CI −1.6 to −0.7). A video lecture on donning PPE may lead to better skillsscores (MD 30.70, 95% CI 20.14 to 41.26) than a traditional lecture. Face‐to‐faceinstruction may reduce noncompliance with doffing guidance more (odds ratio 0.45, 95%CI 0.21 to 0.98) than providing folders or videos only.
Authors' conclusions
We found low‐ to very low‐certainty evidence that covering more parts of the bodyleads to better protection but usually comes at the cost of more difficult donning ordoffing and less user comfort, and may therefore even lead to more contamination. Morebreathable types of PPE may lead to similar contamination but may have greater usersatisfaction. Modifications to PPE design, such as tabs to grab, may decrease the riskof contamination. For donning and doffing procedures, following CDC doffing guidance,a one‐step glove and gown removal, double‐gloving, spoken instructions during doffing,and using glove disinfection may reduce contamination and increase compliance.Face‐to‐face training in PPE use may reduce errors more than folder‐basedtraining.
We still need RCTs of training with long‐term follow‐up. We need simulation studieswith more participants to find out which combinations of PPE and which doffingprocedure protects best. Consensus on simulation of exposure and assessment of outcomeis urgently needed. We also need more real‐life evidence. Therefore, the use of PPE ofHCW exposed to highly infectious diseases should be registered and the HCW should beprospectively followed for their risk of infection.
Plain language summary
Protective clothes and equipment for healthcare workers to prevent them catchingcoronavirus and other highly infectious diseases
Background
Healthcare workers treating patients with infections such as coronavirus (COVID‐19) areat risk of infection themselves. Healthcare workers use personal protective equipment(PPE) to shield themselves from droplets from coughs, sneezes or other body fluids frominfected patients and contaminated surfaces that might infect them. PPE may includeaprons, gowns or coveralls (a one‐piece suit), gloves, masks and breathing equipment(respirators), and goggles. PPE must be put on correctly; it may be uncomfortable towear, and healthcare workers may contaminate themselves when they remove it. Some PPEhas been adapted, for example, by adding tabs to grab to make it easier to remove.Guidance on the correct procedure for putting on and removing PPE is available fromorganisations such as the Centers for Disease Control and Prevention (CDC) in theUSA.
This is the 2020 update of a review first published in 2016 and previously updated in2019.
What did we want to find out?
We wanted to know:
what type of PPE or combination of PPE gives healthcare workers the bestprotection;
whether modifying PPE for easier removal is effective;
whether following guidance on removing PPE reduced contamination;
whether training reduced contamination.
What did we find?
We found 24 relevant studies with 2278 participants that evaluated types of PPE,modified PPE, procedures for putting on and removing PPE, and types of training.Eighteen of the studies did not assess healthcare workers who were treating infectedpatients but simulated the effect of exposure to infection using fluorescent markers orharmless viruses or bacteria. Most of the studies were small, and only one or twostudies addressed each of our questions.
Types of PPE
Covering more of the body leads to better protection. However, as this is usuallyassociated with increased difficulty in putting on and removing PPE, and the PPE is lesscomfortable, it may lead to more contamination. Coveralls are the most difficult PPE toremove but may offer the best protection, followed by long gowns, gowns and aprons.Respirators worn with coveralls may protect better than a mask worn with a gown, but aremore difficult to put on. More breathable types of PPE may lead to similar levels ofcontamination but be more comfortable. Contamination was common in half the studiesdespite improved PPE.
Modified PPE
Gowns that have gloves attached at the cuff, so that gloves and gown are removedtogether and cover the wrist area, and gowns that are modified to fit tightly at theneck may reduce contamination. Also, adding tabs to gloves and face masks may lead toless contamination. However, one study did not find fewer errors in putting on orremoving modified gowns.
Guidance on PPE use
Following CDC guidance for apron or gown removal, or any instructions for removing PPEcompared to an individual’s own preferences may reduce self‐contamination. Removing gownand gloves in one step, using two pairs of gloves, and cleaning gloves with bleach ordisinfectant (but not alcohol) may also reduce contamination.
User training
Face‐to‐face training, computer simulation and video training led to fewer errors inPPE removal than training delivered as written material only or a traditionallecture.
Certainty of the evidence
Our certainty (confidence) in the evidence is limited because the studies simulatedinfection (i.e. it was not real), and they had a small number of participants.
What do we still need to find out?
There were no studies that investigated goggles or face shields. We are unclear aboutthe best way to remove PPE after use and the best type of training in the long term.
Hospitals need to organise more studies, and researchers need to agree on the best wayto simulate exposure to a virus.
In future, simulation studies need to have at least 60 participants each, and useexposure to a harmless virus to assess which type and combination of PPE is mostprotective.
It would be helpful if hospitals could register and record the type of PPE used bytheir workers to provide urgently needed, real‐life information.
Search date
This review includes evidence published up to 20 March 2020.
Summary of findings
Background
Description of the condition
Over 59 million people are employed in the healthcare sector worldwide (WHO 2006). Some of these healthcare workers (HCW) areat risk of developing life‐threatening infectious diseases due to contact with patients’blood or body fluids such as mucus, vomit or exhaled droplets. The risk of infection andits consequences vary, but it is well recognised as an occupational risk (Heptonstall 2010; Sepkowitz 2005). Especially during epidemics, these risks become more visible asthe infection rate among HCW is higher than in the general population. Another risk of HCWinfection is that infected HCWs will infect patients or that they will act as a vector forthe transfer of the disease between patients. In addition, during epidemics, infected HCWwill further diminish the capacity of an already overburdened healthcare system.
The 2013 to 2015 Ebola Virus Disease (EVD) epidemic put HCW at high risk of a diseasewith a very high fatality rate in the epidemic areas (Ebola 2014). According to the World Health Organization (WHO), healthcareworkers were between 21 and 32 times more likely to be infected with Ebola than people inthe general adult population (Forrester 2014;WHO 2015a). According to the statistics from the2013‐2015 West Africa EVD epidemic, there were 1049 registered cases of infected HCW with535 deaths (Kilmarx 2014; WHO 2015b).
Just a decade earlier during the 2002 to 2003 Severe Acute Respiratory Syndrome (SARS)epidemic, 20% of all patients were healthcare workers of whom about 10% lost their lives(WHO 2003).
During the COVID‐19 pandemic, HCW are at higher risk of infection than the generalpopulation, just as during other epidemics. Experts strongly urge the use of properpersonal protective equipment (PPE) for the HCWs' and patients' safety (Adams 2020; Chang2020). In a Chinese case‐series of 138 consecutive patients that werehospitalised in Wuhan, China during the month of January 2020, 30% were HCW, which isconsiderably higher than expected (Wang 2020).Remuzzi 2020 reports that in Lombardy, Italy asof 12 March 2020, 20% of HCW at intensive care units became infected, while Giwa 2020 estimates that at least 10% of HCW in Italywill become infected in spite of using PPE.
HCW may become infected through various routes of transmission, depending on thepathogen. Infection can occur through splashes and droplets of contaminated body fluids onnon‐intact skin, or via needle‐stick injuries through intact skin. Infection can alsooccur when splashes or droplets of contaminated body fluids land on the mucous membranesin the eyes, mouth or nose, or when the same mucous membranes come into contact withcontaminated skin, such as when rubbing the eyes with a hand carrying pathogens aftertouching a patient or contaminated surface (Siegel2019). For EVD, contact transmission is the main route of transmission. For SARS,the highest risk of infection was due to inhalation of aerosols, but the disease was alsotransmitted through droplet and contact infection. For COVID‐19 the main route of exposureis through droplet transmission and contact transmission but other transmission routes arealso possible (Chang 2020; Otter 2016; Peng2020).
Here, we focus on highly infectious diseases, which means that contamination withinfectious material can readily lead to clinical disease. We also focus on thoseinfections that have serious consequences, such as a high case fatality rate, because themotivation of HCW to protect themselves will be different in situations where the risk islow and the consequences are not serious. The term 'high consequence pathogen' is alsoused but the list of what constitutes a high consequence pathogen varies from country tocountry. The European Network for Infectious Diseases defines highly infectious disease asan infectious disease easily transmitted from person to person, causing life‐threateningdisease, presenting a serious hazard in healthcare settings and in the community, andrequiring specific control measures (Brouqui2009).
Description of the intervention
In the occupational health field, the 'hierarchy of controls' is best practice. Thismeans that measures with a general effect such as control of exposure should have priorityover more individual control measures such as PPE. Exposure of HCW can be best controlledby organisational measures that minimise the exposure to contaminated body fluids orinfected patients. The most important preventive measure is the proper organisation of thehospital or healthcare unit to avoid unnecessary contact. Once this has been implemented,the main strategy for reducing physical exposure to highly infectious diseases is throughPPE. Both in the European Union (EU) and in the USA, it is mandatory for employers toprotect their workers against blood‐borne pathogens and other infections at work (OSHA 2012; EU2010).
Coveralls, gowns, hoods, masks, goggles and face shields, among others, are used toprevent skin and mucous membranes from becoming contaminated and respirators are used toprevent inhalation. Depending on the transmission route and the specifics of theinfection, different types of PPE are recommended. PPE in health care are usuallyconsidered as part of what is called transmission‐based precautions. Standard precautionsor universal precautions are based on the principle that all blood, body fluids,secretions, excretions except sweat, non‐intact skin, and mucous membranes may containtransmissible infectious agents. Depending on anticipated exposure, hand hygiene and theuse of PPE such as gloves, gowns, masks, eye protection (i.e. goggles or face shields)should be implemented. When the route(s) of transmission is (are) not completelyinterrupted using standard precautions alone, there are three categories that elaboratethe precautions to be taken: contact precautions, droplet precautions, and airborneprecautions (Siegel 2019).These precautionscontain a number of measures including appropriate PPE to prevent the specific modes oftransmission.
PPE will only be effective if the equipment can form a barrier between the HCW and thecontaminated body fluids. Therefore, standards have been developed that, when compliedwith, ensure that PPE is of sufficient quality to protect against biohazards (Mäkelä 2014; NIOSH2014). Even though the biohazard symbol (Figure 1), iswidely used to indicate the presence of biohazards, it is not a label for protectiveclothing. For biohazards, these standards are based on laboratory tests that evaluate towhat extent the fabric and the seams of protective clothing are leak‐tight, that is, arethey impermeable for liquids, viruses, or both at certain pressure levels. The standardsin the EU and the USA are different. PPE should contain a label that specificallyindicates the standards against which it has been tested.
Technical standards for PPE
Technical standards for PPE are complicated and the categorisation is confusing. In theEU, there is standard EN 14126 for clothing,specifically coveralls that protect workers against biological hazards frommicro‐organisms. Clothing compliant with the standard EN 14126 is further classified according to routes of contamination and thecirc*mstances in which contamination may occur (pressurized contaminated liquid,mechanical contact with substances containing contaminated liquid, contaminated liquidaerosols, contaminated solid particles) based on ISO2004a and ISO 2004b test methods. Thereis a separate standard for surgical gowns, EN13795, but this standard is specifically designed to protect the patient.
In the USA, ANSI/AAMI PB70 2012 standardclassifies surgical and isolation gowns according to their liquid barrier performancewith four levels of protection, with level 4 offering the most protection against viraland liquid penetration but level 1 offering only minimal water resistance. There areseveral differences between ANSI/AAMI PB70 2012and EN 13795 surgical gown classifications.Because the test methods and performance requirements cannot be compared directly, it isdifficult to assign equivalency between surgical gowns classified according to ANSI/AAMI PB70 2012 and EN 13795. There is also US standard NFPA 1999 which was specifically developed toaddress a range of different protective clothing items worn by emergency medical servicefirst responders, and also applies to medical first receivers. NFPA 1999 lists many performance requirements forprotective clothing used by emergency medical personnel, including (but not limited to)viral penetration resistance, tensile strength, liquid integrity, and seam strength.
To summarise, the qualities of protective clothing certified by different standards arenot fully comparable and complex. Nonetheless, they all aim to ensure that protectiveclothing is of a quality that prohibits water and blood‐like fluids with virusparticles, applied under a specified amount of pressure, from passing through. Inaddition, some standards have requirements that the whole piece of clothing, includingthe seams, must be non‐permeable to liquids (NFPA1999).
Clothing that is manufactured according to the standards mentioned above, at theappropriate level of protection, is impermeable to body fluids and viruses and willtechnically prevent skin contamination. However, this review does not deal with thetechnical physical standards of equipment, but rather whether and how its use inpractice will prevent contamination and infection.
Guidelines for choosing proper PPE
In 2014, the WHO developed a guideline for infection prevention and control ofepidemic‐ and pandemic‐prone acute respiratory infections in health care. The guidelinestrongly recommends using appropriate PPE as determined by risk assessment (according tothe procedure and suspected pathogen). Appropriate PPE when providing care to patientspresenting with acute respiratory infection (ARI) syndromes may include a combinationof: medical mask (surgical or procedure mask); gloves; long‐sleeved gowns; and eyeprotection (goggles or face shields). For aerosol‐generating procedures (AGPs) thiscombination including a surgical or a procedural mask or a particulate respirator isconditionally recommended. If splashing with blood or other body fluids is anticipatedand gowns are not fluid‐resistant, a waterproof apron should be worn over the gown(WHO 2014).
For COVID‐19, recommendations for PPE are gloves, masks, goggles or face shields, andlong‐sleeved gowns (WHO 2020a; WHO 2020b) with N95 respirators recommended overmasks for AGPs, consistent with the WHO 2014guideline. Masks are further described as medical mask (flat, pleated or cup‐shaped,affixed to head with a strap). Otherwise there are no quality criteria provided for thePPE parts. This is especially worrying because isolation gowns can have very differentqualities, of which the end users are usually not aware (Kilinc‐Balci 2016). Most isolation gown models alsoleave the neck unprotected, which could be a source of contamination (Zamora 2006). Centers for Disease Control andPrevention (CDC) recommends that non‐sterile, disposable patient isolation gowns, whichare used for routine patient care in healthcare settings, are appropriate for use by HCWwhen caring for patients with suspected or confirmed COVID‐19. Current US guidelines donot require use of gowns that conform to any standards (CDC 2020a). If there is a medium to high risk of contamination, CDC recommendsisolation gowns that claim moderate to high barrier protection (ANSI/AAMI PB70 2012 level 3 or 4; CDC 2020b). For a proper overview of requirementsfor and use of isolation gowns see Kilinc‐Balci2015 and Kilinc‐Balci 2016.
During the EVD epidemic, several guidelines became available for choosing proper PPE(Australian NHMRC 2010; CDC 2014; ECDC2014; WHO 2016). Even though allguidelines propose using similar protective clothing, there are differences. Forexample, ECDC 2014 proposes taping gloves, bootcovers and goggles onto the coveralls to prevent leaving any openings but the otherguidelines do not recommend this. Most guidelines have recently been updated. There arealso recommendations for the technical quality of the PPE to be used with Ebola. Forgowns, WHO 2016 currently recommends EN 13795 high‐performance surgical gowns or ANSI/AAMI PB70 2012 level 3 (option 1), or level 4(option 2), or equivalent. As the first option for coveralls, WHO currently recommendsprotection equivalent to EN 14126, level 3protection against blood level 2 against viruses.
Overprotection can be a problem. Some propose using three layers of gloves, becauseaccording to their experience, this is best practice (Lowe 2014). However, it may make work more difficult, and eventually lead toan increased rather than a decreased risk of infection, especially during doffing (i.e.removing the PPE). For example, the combined use of several respirators probably doesnot lead to more protection, but considerably increases the burden on the worker (Roberge 2008a; Roberge 2008b).
Donning and doffing of PPE
Despite using proper PPE, probably the biggest risk of infection is associated withself‐contamination by HCW inappropriately removing the PPE (Fischer 2014). Some types of PPE make donning anddoffing more difficult, thereby increasing the risk of contamination (Zamora 2006). There is evidence that when doffingPPE, the use of a double pair of gloves decreases the risk of contamination (Casanova 2012). How contamination of PPE occurs hasalso been clearly illustrated with a simulation study about cleaning up vomit (Makison 2014). The results of such simulationstudies should increase HCW's confidence in executing the donning and doffing procedurescorrectly, and thus can also be an incentive for their uptake and compliance with theguidelines. Therefore, specific guidance has been developed for donning and doffing PPE(CDC 2014; WHO 2016).
Compliance with guidance on correct PPE use in health care is historically poor. HCWsometimes distrust infection control, and using PPE is stressful (Zelnick 2013). For respiratory protection such asmasks and respirators, compliance has been reported to be around 50% on many occasions(Nichol 2008). Due to lack of proper fittingand incorrect use, real field conditions almost never match laboratory standards (Coia 2013; Howie2005). Also, reports of hand hygiene show that there is still much room forimprovement, and guidelines recommend education and training in combination with otherimplementation measures (WHO 2009). From reportsof HCW, it is clear that most appropriate PPE is not user‐friendly in tropicalconditions. It prevents heat loss through sweating because it is not made of breathablematerial. A common reason for a breach in the barrier of the PPE is the worker sweatingand then instinctively wiping their face (Cherrie2006).
In this review, we only concentrated on PPE for highly infectious diseases that haveserious consequences for health, such as EVD and COVID‐19. We excluded other highlyinfectious, but less serious viral infections, such as norovirus, as we expected theeffect of PPE to be different. We included SARS as it was highly infectious to HCW,sometimes fatal, and had similar recommendations on PPE use and training toCOVID‐19.
We did not specifically study the effects of hand hygiene or of respiratory protectionto prevent transmission through inhalation. Hand hygiene is also crucial in preventingskin contamination, but this has already been covered in another review (Gould 2010). The protective effect of differenttypes of respiratory protection, and effects of interventions to increase their uptakeare covered in two other reviews (Jefferson2011; Luong Thanh 2016).
How the intervention might work
First, HCW, their supervisors, or occupational health professionals should choose theproper type of PPE, as indicated in the guidance described above. Then, the HCW needs toknow how to don and doff PPE according to the guidelines provided. Next, the HCW needs tocomply with established procedures for correctly using, donning and doffing PPE. Educationand training are used to increase compliance. The emphasis in teaching the correct use ofPPE is on doing everything slowly and carefully to minimise the risk of making a mistake.Often an assistant or buddy, sometimes coupled with a mirror, is used while donning PPE,while a hygienist supervises doffing.
Compliance can be increased by personal supervision and instruction, checklists, auditsof performance, by providing feedback, and by allowing sufficient time for donning anddoffing. Education and training on uptake and compliance with PPE should have an effect inboth the short term and the long term (Northington2007; Ward 2011). Education and trainingcan be seen as one method to increase compliance (Gershon2009; Hon 2008). Compliance with PPE canalso be improved by providing sufficient, comfortable, well‐fitting, and more user‐ andpatient‐friendly PPE. Compliance with guidelines has been studied for hand hygiene. Thereis some evidence that multifaceted interventions and staff involvement are important, butaltogether, there is little evidence that allows firm conclusions (Gould 2010).
Why it is important to do this review
From studies conducted during the SARS epidemic and the EVD epidemic it has become clearthat the use of gloves, gowns and masks each help to reduce the infection rate in HCW(Appendix 1, Verbeek 2016a). More consistent use of gloves, gowns, masks and goggles was eachrelated to fewer infections among HCW. Also, theoretically, protecting the skin and themucous membranes of the mouth nose and eyes will prevent transmission. We have thereforelittle doubt that in a technical sense PPE will help and that the minimum amount of PPEneeded is gloves, gown, and mouth, nose and eye protection, as recommended by WHO and CDC.The guidance does not, however, indicate which type or quality‐level of PPE is mostprotective. In this review, we concentrate on finding out which PPE protects best by onlyincluding studies that compare one type of PPE against an alternative type of PPE, such asgowns against coveralls or goggles against face shields only when used as part of fullPPE. We do not include studies that compare the use of PPE against no PPE, or studiescomparing one type of PPE to another when not used as part of a set of full‐body PPE.
There is still uncertainty about the optimal type, composition, amount, and ways of usingfull‐body PPE to prevent skin and mucous membrane contamination of HCW while treatingpatients infected with highly infectious diseases. This is also reflected in the differentways guidelines for PPE are implemented in Europe (DeIaco 2012), and acknowledged in current WHO guidelines regarding EVD (WHO 2016). WHO realises that a safer, more comfortableand culturally appropriate protective system commensurate with the risk is needed and hasprovided guidance for industry, health workers, engineers, innovators, medical andscientific researchers, and others to re‐think, energise, and innovate for a better PPEsystem for the HCW responding to Ebola virus outbreaks in tropical climates (WHO 2018).
Since full‐body protection has mainly evolved as a direct result of experiences gainedfrom the recent outbreaks of deadly viruses, there are still many types of PPE availablewith varying types of components. The comparative effectiveness of one type againstanother is still unknown. Regarding the equipment, there is uncertainty whether faceshields protect as well as goggles, especially when goggles are combined with a hood.There is uncertainty whether and when double or triple gloves would be more protectivethan single gloves. Regarding suits, it is unclear if gowns are as protective ascoveralls, and how breathable and impermeable for liquids or viruses they should be. Someargue that using more breathable material would decrease the risk of contamination (Kuklane 2015).
When it comes to donning and doffing procedures for EVD, there is uncertainty about theeffect of integrity checks of gloves and other equipment, and whether gloves should bechanged when highly contaminated. With doffing especially, it is unclear if this should bedone in pairs with a helper buddy removing part of the PPE, or if this can be done alone.Another element of the doffing procedure that is uncertain is if spraying with adisinfectant such as chlorine spray is more protective than not using spray. It is notclear which disinfectant is the best antiviral: chlorine solution or alcohol gel, and atwhich concentration.
Also, for COVID‐19, different procedures for donning and doffing PPE are recommended.Giwa 2020 proposes a specific procedure ofdoffing PPE, but the procedure is not consistent with the procedures proposed by CDC(CDC 2020c). Others, including the CDC, haveproposed that gown and gloves should be doffed in a one‐step procedure (Osei‐Bonsu 2019), to minimise self‐contamination.
It is also unclear what are the best ways to train HCW and how to best maintain theskills needed for proper use of PPE.
This review is a timely update of the Verbeek2019 review, the results of which indicated that more research is still needed toanswer the review's questions.
Objectives
To evaluate which type of full‐body PPE and which method of donning or doffing PPE have theleast risk of contamination or infection for HCW, and which training methods increasecompliance with PPE protocols. In particular, we evaluated the effect of:
different types of PPE on contamination and infection rates or on compliance (onetype or component of full‐body protection PPE versus another);
different donning or doffing procedures on contamination and infection rates or oncompliance (one procedure for donning and doffing full‐body PPE versus another);and
different types of education and training aiming to improve compliance withguidelines for full‐body PPE on compliance, contamination and infection rates, (onetype of training versus another).
Methods
Criteria for considering studies for this review
Types of studies
Since the circ*mstances for evaluation studies are difficult during epidemics, weanticipated including a broad range of study designs.
We included any prospective or retrospective controlled field study. Field study hererefers to a study that tests interventions with healthcare staff in a real‐life exposuresituation. This also includes case‐control studies that compare the use of interventionsretrospectively between cases that have become infected and comparable controls that didnot get infected.
We also included randomised as well as non‐randomised prospective controlled studiesthat simulated exposure to contaminated body fluids with the use of marker chemicals orharmless viruses or bacteria.
We excluded studies without a comparison group, but did not exclude studies on thebasis of type of comparison group.
Types of participants
For simulation studies, we included any type of participants (volunteers or HCW) usingPPE designed for EVD or comparable highly infectious diseases with seriousconsequences.
For field studies, we included studies only if they were conducted with HCW orancillary staff exposed to body fluids from patients in the form of splashes, droplets,or aerosols contaminated with particles of highly infectious diseases that have seriousconsequences for health such as EVD, SARS, or COVID‐19.
We excluded studies conducted with laboratory staff because the preventive measures inlabs are more detailed and easier to comply with.
Types of interventions
1. We included studies that evaluated the effectiveness of different types of full‐bodyprotection (PPE), or comparing different types, compositions, or amounts of thefollowing PPE components:
body protection such as gowns, coveralls, or hazardous materials (hazmat)suits;
eye and face protection such as glasses, goggles, face shields or visors, ormasks or hoods that cover the entire head;
hand protection: gloves; and
foot protection: overshoes or boots.
We defined PPE as any of the equipment listed above that is designed or intended toprotect healthcare staff from contamination with infected patients' body fluids.
2. We included studies that evaluated the effectiveness of different PPE parts ordifferent procedures or protocols for donning and doffing of the PPE.
For example, extra assistance during donning and doffing, extra disinfection, or theuse of extra gloves to prevent contamination in comparison to standard protocols.
3. We included studies that evaluated the effectiveness of training to increasecompliance with existing guidance on the selection or use of PPE, including but notlimited to:
education (courses);
practical training;
information only (such as posters, guideline leaflets, etc.);
audit and feedback; or
monetary or organisational incentives.
Types of outcome measures
Primary outcomes
We included all studies that had measured the effectiveness of interventions as:
contamination of skin or clothing, measured with any type of test material tovisualise contamination (e.g. stains made visible with UV light) or harmlessviruses or bacteria;
infection with EVD, another viral haemorrhagic fever, or comparable highlyinfectious disease with serious consequences such as SARS, or COVID‐19;
compliance with guidance on selection of type and use of PPE measured, forexample, with an observation checklist.
Secondary outcomes
User‐reported assessment of comfort and convenience
Costs or resource use
Time to don and doff the PPE
The secondary outcomes were not a criterion for including studies in this review.
Search methods for identification of studies
Electronic searches
We conducted a systematic literature search to identify all published and unpublishedtrials that could be considered eligible for inclusion in this review.We adapted thesearch strategy we developed for Medline through PubMed (see Appendix 2) for use in the other electronicdatabases. The literature search identified potential studies in all languages.
We searched the following electronic databases from inception to the dates presentedunderneath for identifying potential studies (search dates provided below). We searchedwith different interfaces for the various updates. The searches are listed in theappendices for all interfaces. For the 2020 update we did not search OSH‐Update becausethe earlier search yielded so little.
Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 3) via WileyOnline Library (Appendix 3);
MEDLINE (Ovid) (Appendix 2; Appendix 4) until 20 March 2020;
Embase (OVID) (Appendix 5; Appendix 6; Appendix 7) to 20 March 2020;
CINAHL (EBSCOhost) (Appendix 8; Appendix 9) to 20 March 2020;
NIOSHTIC (OSH‐UPDATE) (Appendix 10) to 31December 2018;
NIOSHTIC‐2 (OSH‐UPDATE) to 31 December 2018;
HSELINE (OSH‐UPDATE) to 31 December 2018;
CISDOC (OSH‐UPDATE) to 31 December 2018;
We also conducted a search of ClinicalTrials.gov (www.ClinicalTrials.gov), and the WHO trialsportal (www.who.int/ictrp/en/), whichincludes the Pan African Registry for potential studies on EVD for the 2016 and 2019updates. For the 2020 update we searched the WHO trials portal for COVID 19/SARS‐CoV‐2.We searched all databases from their inception to the present for the first versions ofthe review. We searched from the earliest date of search to the present for updates ofthe review. We did not impose a restriction on language of publication.
Searching other resources
We checked reference lists of all primary studies and reviewed articles for additionalreferences. For the 2016 version of the review, we contacted non‐governmentalorganisations involved in medical relief operations in the high‐risk EVD areas toidentify additional unpublished materials on protection against EVD (Médécins SansFrontières (MSF) and Save the Children). We also used Twitter to ask for unpublishedreports from people in the field. Evidence Aid helped in locating relevant organisationsand in asking them for unpublished reports. We also contacted DuPont, and 3M, PPEmanufacturers, to request unpublished studies.
In addition, we used Google to find any unpublished or grey literature on our questionthat may not be available from the sources listed above by using the following terms:'personal protective equipment ebola'. For the March 2020 update we conducted a searchof Google Scholar using the search phrase ('SARS CoV 2' OR 'COVID' AND 'protectiveequipment' AND 'healthcare worker').
Data collection and analysis
Selection of studies
Pairs of review authors (JV, RS, BR, ET, BB, CT, SI, JR) independently screened titlesand abstracts of all systematic search results to identify studies for inclusion. Thesame review authors coded them as 'retrieve' (eligible or potentially eligible/unclear)or 'do not retrieve'. We retrieved the full‐text study reports/publication and pairs ofreview authors (JV, ET, BR, RS, BB, CT, SI, JR) independently screened the full text,identified studies for inclusion, and identified and recorded reasons for exclusion ofthe ineligible studies. We used the computer programme Covidence for the selection of references and full‐text studies. We resolvedany disagreement through discussion, except in two cases where a third‐person assessment(SI or CT) was needed. We identified and excluded duplicates and collated multiplereports of the same study so that each study rather than each report is the unit ofinterest in the review. We recorded the selection process and completed a PRISMA flowdiagram (Moher 2009), for the search for ouroriginal review (Figure 2), our updated review (Figure 3) and this update (Figure 4). Wealso completed a 'Characteristics of excludedstudies' table.
Data extraction and management
We used Covidence for extracting studycharacteristics and outcome data. Two review authors (JV, BR, BB, ET, CT, RS, SI, JR)independently extracted the following study characteristics from included studies.
Methods: study design, total duration of study, study location, study setting,withdrawals, and date of study
Participants: number, mean age or age range, sex, severity of condition,diagnostic criteria if applicable, inclusion criteria, and exclusion criteria
Interventions: description of intervention, comparison, duration, intensity,content of both intervention and control condition, and co‐interventions
Outcomes: description of primary and secondary outcomes specified and collected,and at which time points reported
Notes: funding for trial, and notable conflicts of interest of trial authors,country where trial was conducted
Pairs of review authors (JV, BR, CT, SI, JR, ME, RS) independently extracted outcomedata from included studies. We noted in the 'Characteristics of included studies' table if outcome data were not reportedin a usable way. We resolved disagreements by consensus so there was no need to involvea third review author. One review author (JV or BR) transferred the data into ReviewManager 5 (Review Manager 2014). Wedouble‐checked that data had been entered correctly by comparing the data presented inthe systematic review with the study reports. A second review author (CT or JV)spot‐checked study characteristics for accuracy against the trial report.
Assessment of risk of bias in included studies
Pairs of tworeview authors (JV, BR, CT, SI, JR, ME, RS) independently assessed risk ofbias for each randomised study using the criteria outlined in theCochrane Handbookfor Systematic Reviews of Interventions(Higgins2017). We resolved any disagreements by discussion so there was no need toinvolve another review author. We assessed the risk of bias according to the followingdomains in all RCTs.
Random sequence generation
Allocation concealment
Blinding of participants and personnel
Blinding of outcome assessment
Incomplete outcome data
Selective outcome reporting, and
Other bias
We rated each potential source of bias as high, low, or unclear and provided a quotefrom the study report or study author together with a justification for our judgment inthe 'Risk of bias' table. We summarised the 'Risk of bias' judgements across differentstudies for each of the domains listed. For compliance, we considered blinding to PPEtype significant for the outcome assessor only. Where information on risk of biasrelates to unpublished data or correspondence with a study author, we noted this in the'Risk of bias' table.
We considered randomised studies to have a low overall risk of bias when we judgedrandom sequence generation and blinded outcome assessment to have a low risk of bias andnone of the other domains to have a high risk of bias.
We used the domains blinding of participants and personnel, blinding of outcomeassessment, incomplete outcome data, selective outcome reporting, and other bias for allnon‐randomised studies. Instead of the domains random sequence generation and allocationconcealment, we used the following items as suggested in the ROBINS‐I tool (Sterne 2016), for the assessment of risk of bias innon‐randomised intervention studies.
Bias due to confounding. We made an overall assessment of risk of bias based onthe following questions if the signalling question, 'Is confounding of the effectof intervention unlikely in this study?' was answered with no.
Did the authors use an appropriate analysis method that adjusted for all thecritically important confounding domains?
Were confounding domains that were adjusted for measured validly and reliablyby the variables available in this study? For this review question, weconsidered baseline differences between compared groups in the followingfactors significant: prior experience with PPE, healthcare qualification, oreducation of HCW, age and sex, ambient temperatures, and stressfulactivities.
Bias due to selection of participants into the study. We made an overallassessment of this risk of bias based on the following questions if the signallingquestions, 'Was selection into the study unrelated to intervention or unrelated tooutcome?, and 'Do start of follow‐up and start of intervention coincide for mostparticipants?' were answered with no.
Were adjustment techniques used that are likely to correct for the presenceof selection biases?
For case‐control studies: were the controls sampled from the population thatgave rise to the cases, or using another method that avoids selectionbias?
We considered the domains of confounding and selection of participants to yield high,low, or unclear risk of bias. For a non‐randomised study as a whole, we considered thestudy to have a low risk of bias if all domains received a judgment of low risk of biascomparable to an RCT. This means receiving a low 'Risk of bias' judgment on the twodomains listed above as well as domains three to seven in the previous section.
When considering treatment effects, we took into account the risk of bias for thestudies that contributed to that outcome.
We judged studies to have a low overall risk of bias if we judged them to have a lowrisk of bias in the following domains: both random allocation and allocationconcealment, or both confounding and selection bias, and incomplete outcome data andselective reporting. We considered the blinding of participants and outcome assessorsless important because the outcomes were objective or we could not imagine thatparticipants would have an interest in a certain type of attire and outcome.
Assessment of bias in conducting the systematic review
We conducted the review according to the published protocol (Verbeek 2015), and where there were deviationsfrom it, we reported these in the 'Differences betweenprotocol and review' section of the systematic review.
Measures of treatment effect
We entered the outcome data for each study into the data tables in Review Manager 2014 to calculate the treatmenteffects. We used risk ratios (RRs) for dichotomous outcomes, and mean differences (MDs)or standardised mean differences (SMDs) for continuous outcomes. When studies reportedonly effect estimates and their 95% confidence intervals or standard errors, we enteredthese data into Review Manager 2014 using thegeneric inverse variance method. When study authors used multivariate analyses, we usedthe most adjusted OR (odds ratios) or RRs. We ensured that higher scores for continuousoutcomes had the same meaning for the particular outcome, explained the direction andreported where the directions were reversed, if this was necessary. If, in futureupdates of this review, we come across studies reporting results that we cannot enter ineither way, we will describe them in the 'Characteristics of included studies' table, or we will enter the data intoadditional tables. For cohort studies that compare an exposed to a non‐exposedpopulation we intended to report both the RR for the intervention versus the control atbaseline and at follow‐up for dichotomous outcomes to indicate the change brought aboutby the intervention but we did not find any such studies.
Unit of analysis issues
If in future updates of this review we come across studies that employ acluster‐randomised design and that report sufficient data to be included in themeta‐analysis but do not make an allowance for the design effect, we will calculate thedesign effect based on a fairly large assumed intra‐cluster correlation of 0.10. Webased this assumption of 0.10 being a realistic estimate by analogy on studies aboutimplementation research (Campbell 2001). We willfollow the methods stated in the Cochrane Handbook for Systematic Reviews ofInterventions (Higgins 2011) for thecalculations.
We intended to take the paired nature of the cross‐over design in the included studiesinto account in our data analysis. However, the included studies did not presentsufficient data to do so and the results presented here are based on the unpaired testthat is implemented in Review Manager 2014 whichresulted in wider confidence intervals than with the use of a paired t‐test.
Dealing with missing data
We contacted investigators to verify key study characteristics and obtain missingnumerical outcome data where possible (e.g. when a study was identified as abstractonly). If in future updates of this review we come across studies where this is notpossible, and the missing data are thought to introduce serious bias, we will explorethe impact of including such studies in the overall assessment of results by asensitivity analysis.
Similarly, if in future updates of this review we come across studies where numericaloutcome data are missing, such as SDs or correlation coefficients and they cannot beobtained from the authors, we will calculate them from other available statistics suchas P values, according to the methods described in the Cochrane Handbook forSystematic Reviews of Interventions (Deeks2017).
Assessment of heterogeneity
We assessed the clinical hom*ogeneity of the results of included studies based onsimilarity of population, intervention, outcome and follow‐up. We considered populationsas similar when they were HCWs directly engaged in patient treatment (nurses, doctors,paramedics) versus those who were not involved in patient therapy directly (cleaning andtransport staff).
We considered interventions as similar when they fell into one of the interventioncategories as stated in Types ofinterventions.
We considered any assessment of contamination of the skin or mucous membranes assimilar enough to combine.
We considered the following follow‐up times as similar: from immediately following aprocedure up until the end of the work shift (short‐term), and any time after theincubation time (long‐term).
If in future updates of this review we come across studies with results that we canpool with meta‐analysis, we will use the I² statistic (Higgins 2003), to measure heterogeneity among the trials in each analysis.Where we identify substantial heterogeneity, we will report it and explore possiblecauses by prespecified subgroup analysis. We will regard an I² value above 50% assubstantial heterogeneity (Deeks 2017).
Assessment of reporting biases
For a future update, if we are able to pool more than five trials in any singlemeta‐analysis, we will create and examine a funnel plot to explore possible small studybiases.
Data synthesis
In future updates of this review we will pool data from studies we judge to beclinically hom*ogeneous using Review Manager software (RevMan Web 2019). If more than one study provides usable data in any singlecomparison, we will perform meta‐analysis. We will use a random‐effects model when I² isabove 40%; otherwise we will use a fixed‐effect model. When I² is higher than 75% wewill not pool results of studies in meta‐analysis. We will include a 95% confidenceinterval (CI) for all estimates (Deeks2017).
We will describe the results in the case of skewed data reported as medians andinterquartile ranges.
Where multiple trial arms are reported in a single trial, we will include only therelevant arms. If two comparisons are combined in the same meta‐analysis, we will halvethe control group to avoid double‐counting.
Subgroup analysis and investigation of heterogeneity
If future updates of this review find a sufficient number of studies, we will carry outthe following subgroup analyses:
high income versus low and middle‐income countries; and
PPE that is certified for biological hazards versus PPE that does not have such acertification.
We will also use our primary outcomes in subgroup analyses, and we will use the Chi²test, as implemented in RevMan Web 2019, to testfor subgroup interactions. At this time, we have not identified enough studies to allowfor such a subgroup analysis.
Sensitivity analysis
If future updates of this review find a sufficient number of studies, we will performsensitivity analyses defined a priori to assess the robustness of our conclusions.Thisinvolves including only studies we judge to have a low risk of bias. At this time wehave not identified enough studies to allow such a sensitivity analysis.
Reaching conclusions
We based our conclusions only on findings from the quantitative or narrativesynthesis of included studies that we judged to have the lowest risk of bias.Consequently, we used findings from non‐randomised studies when we did not findevidence from randomised studies. We avoided making recommendations for practice basedon more than just the evidence, such as values and available resources. Ourimplications for research suggest priorities for future research and outline what theremaining uncertainties are in the area.
Summary of findings and assessment of the certainty of theevidence
Studies used numerous comparisons to measure the effect of PPE and we limited the'Summary of findings' tables to the findings of the comparisons we judged most useful.We created a series of 'Summary of findings' tables to present the primary outcomes fordifferent types of PPE (one type versus another) and donning or doffing procedures (oneprocedure versus another). We used the five GRADE considerations (study limitations,consistency of effect, imprecision, indirectness and publication bias) to assess thecertainty of a body of evidence as it related to the studies that contributed resultsdata for the prespecified outcomes. We used methods and recommendations described inSection 8.5 (Higgins 2017), and Chapter 12(Schünemann 2017), of the Cochrane Handbookfor Systematic Reviews of Interventions, using GRADEpro GDT software. We justified all decisions to down‐ or upgrade thecertainty of evidence using footnotes and we made comments to aid reader's understandingof the review where necessary. With non‐randomised studies, we started at low‐certaintyevidence and with randomised studies at high‐certainty evidence. In future updates ofthis review, if the outcomes are measured in many different ways, we will prioritise thereporting of outcomes as follows: infection rates, contamination rates and compliancerates.
Results
Description of studies
Results of the search
The search to January 2016 resulted in 10,268 references for screening (see Figure 2). From these references we selected 205 articles forfull‐text assessment. Through checking the references of included articles we found 18additional articles. We found another five articles by using Google, and we found onemore through contacting NGOs (Tomas 2015). Ourcontacts with the manufacturers did not yield any responses or data. Most of the studiesthat we located outside our electronic searches were studies of PPE use during the SARSepidemic that did not make reference to any type of PPE in the title or abstract. Forthe same reason we did not locate Nyenswah 2015because there was no reference to PPE. By using Google search, we found one additionalarticle (Bell 2015), that was not indexed in anyof the databases that we searched. Based on a request of one of the peer referees wealso searched the African Index Medicus, which yielded 24 references but no new studiesto include. Contacting PPE manufacturers did not lead to any responses. This added up to205 papers that we checked full‐text for inclusion. Of these, we excluded 196. Thisresulted in nine included studies.
We updated the searches in Embase up to 22 May 2018, in Medline through PubMed up to 15July 2018, in CINAHL up to 31 July 2018, in OSH‐update on 31 December 2018, and inCENTRAL up to 18 June 2019. We did not have access to Embase after May 2018 and usedScopus to update the Embase search up to 18 June 2019. This yielded 1698 new referencesafter de‐duplication. We assessed 68 articles in full‐text and subsequently we excluded58 articles. This resulted in 10 new studies that fulfilled our inclusion criteria (seeFigure 3) of which we could include eight in the review andtwo were awaiting assessment.
For the 2020 update we reran the searches including the search word 'decontamination'and PPE as a MeSH term in Medline. We did not update the OSHupdate search because thisyielded so little for the previous version. We also searched African Index Medicus butit did not add any new articles. Altogether we retrieved 3792 references throughdatabase searching and 17 additional records through searching Google Scholar. Weremoved 1760 duplicates (see Figure 4). Thus, we screened 2049records, which led to 65 full‐text assessments. Of these, we excluded 58 records, mainlybecause the studies did not have a comparison or were already included in the review.The selection process finally resulted in seven new studies included in the review whichincludes the two studies awaiting assessment in the previous version of this review(Andonian 2019; Chughtai 2018; Drews 2019; Hajar 2019; Kpadeh Rogers 2019; Osei‐Bonsu 2019; Suen 2018).
Included studies
We contacted Bell 2015; Casalino 2015; Casanova 2016; Curtis 2018; Drews 2019; Hall2018; Suen 2018 and we got additionalinformation from all but Casanova 2016. Weentered this information in the 'Characteristics ofincluded studies' table.
Study types
We included 24 studies in total. Twenty‐two were simulation studies, of which 18simulated exposure to contaminated body fluids and measured contamination outcomes,and four studies provided alternative PPE or procedures and measured compliance withdonning and doffing procedures.
Of these simulation studies 14 were randomised trials (seven with parallel groups(Andonian 2019; Bell 2015; Curtis2018; Hung 2015; Osei‐Bonsu 2019; Tomas 2016; Wong 2004), seven had across‐over design (Chughtai 2018; Hajar 2019; Guo2014; Mana 2018; Strauch 2016; Suen 2018; Zamora 2006)), and onewas a quasi‐RCT (Gleser 2018).
There were seven non‐randomised controlled studies (five with a cross‐over design((Buianov 2004; Casanova 2012; Drews 2019; Kpadeh Rogers 2019;Hall 2018) and two with parallel groups(Casalino 2015; Casanova 2016)).
In addition, we found two retrospective cohort studies. One study evaluated theeffect of PPE training on SARS infection rates and noncompliance with the doffingprotocol (Shigayeva 2007). In this study, theauthors located all HCW that had been exposed to SARS patients and assessed, byquestionnaire, compliance with PPE guidelines and PPE doffing guidelines. Houlihan 2017 evaluated the risk of EVD infectionaccording to donning and doffing practices and the use of disinfectant in HCW that hadbeen deployed in West Africa during the EVD epidemic.
Participants
In the simulation studies, researchers included 816 intervention and 367 controlparticipants, when we take into account that studies used a cross‐over design and thusall participants were intervention participants. In the cohort studies, there were 863intervention and 232 control participants. Altogether there were 2278participants.
The participants in all studies were healthcare workers with a mixture ofoccupations, but mainly physicians, nurses and respiratory technicians. One studyincluded medical students during their internships (Casalino 2015). No studies included other healthcare staff such as peopleworking in emergency services or cleaning staff.
In the two retrospective cohort studies, exposure of participants was to the SARSepidemic in one study (Shigayeva 2007), and tothe EVD epidemic in another study (Houlihan2017).
In the simulation studies, 12 studies simulated exposure using a fluorescent agent,three studies exposed participants to a harmless virus or microbes, and another threestudies used both ways of exposure simulation. Studies used a wide range of differentfluorescent agents and a range of exposure methods that varied from rubbing 0.5 mL offluorescent agent over the gloved hands to throwing 100 mL of fluorescent agent ontothe torso of the gown (see Table 17). The situation wassimilar in the studies that used viruses or bacteria to simulate exposure. Fourstudies simulated donning and doffing to assess compliance with guidance (Casalino 2015; Curtis 2018; Drews 2019; Hung 2015).
1
Exposure and outcome in simulation studies
| Study ID | Exposure | Outcome | |||||||
| Agent | Name | Solution | Amount | Additions | Exposure method | Detection | Photographs | Measure | |
| Andonian 2019 | Fluorescent fluid/microbeads | Powder (Glitter Bug)/fluorescent 2‐μm polystyrene latex bead (PLSs) | Grape‐seed oil and water (1:6 oil‐to‐water ratio)/in aerosol | 75 mg/mL | ‐ | Pesticide hand sprayer: 5 sweeping passes of sprayer from head to feet onthe front and back of the HCW/4 min of continuous aerosol generation whilethe HCW turned 90° every 60 s | UV‐light/PLS detection was performed by counting via epifluorescentmicroscopy | No | Number of body sites with fluorescent marker/with PLS |
| Bell 2015 | Fluorescent | Glogerm, Tide, Bright Dyes Orange Dye | Water | 100 mL | Oatmeal, chocolate powder, crushed cereal | 100 mL splashed on the front torso of their garment | UV LED black light, Chauvet | Yes | Contaminated yes/no |
| Buianov 2004 | Microbes | ? | 10^8 CFU/m3 | ? | ? | ? | ? | ? | ? |
| Casanova 2012 | Virus | MS2 | 10^5 PFU/5 muL | 25 muL | ? | Shoulder, respirator, eye protection, hand 5 drops of 5 muL | Swabs of face and hands; extraction gloves, scrubs | n/a | Any contamination yes/no; mean Log10 PFU recovered |
| Casanova 2016 | Virus | MS2, Phi6 | 10^8 MS2, 10^7 Phi6/5 muL | 25 muL | ? | Hand, shoulder, face‐shield, boot | Swabs of face and hands; extraction gloves, scrubs | n/a | Any contamination yes/no |
| Chughtai 2018 | Fluorescent | Fluorescent spray: Glitter Bug | ? | 0.5 mL | ? | Rubbed over hands; sprayed on front and sides from 1 m distance | UV light | No | People with contaminated patches |
| Gleser 2018 | Fluorescent | Schulke | ? | 5 mL | No | Distributed equally on the gloves | UV box | No | Hand contamination (yes/no) |
| Guo 2014 | Fluorescent | Glogerm | Oil and water | ? | No | Sprayed 3.8 g of the lotion onto the upper body of the subject at adistance of 60 cm from the participant | UV scan | No | Number of stains |
| Hajar 2019 | Fluorescent | Fluorescent solution (Super Blue Invisible Ink, Black Light World) | ? | 0.5 mL | ? | Rubbed over gloved hands appr 15 s | Black light | no | Sites per person/people with contamination |
| Hall 2018 | Fluorescent | VIOLET‐tool | Water, glycerol | 800 mL (blue UV) | Flour, salt | Manikin vomited, produced diarrhoea, sweat and cough | UV‐A strip lights | Yes | Yes/no and location (n = 12) |
| Kpadeh Rogers 2019 | Bacteria | Bacterial suspension of MSSA/GloGerm Mist liquid | ? | 50 muL each | ? | Rubbed the bacteria/fluorescent marker on their hands | Plated on tryptic soy agar for quantitative culturing. Plates wereincubated overnight. | No | Number of CFUs of K pneumoniae and MSSA were calculated |
| Mana 2018 | Fluorescent | ? | ? | 0.5 mL | No | Rubbed over gloved hands; then contaminated front of the gown | Ultra light UV1 | No | Any contamination yes/no |
| Virus | Phi X174 | 10^8 PFU/0.5 mL | 0.5 mL | ? | Rubbed over de‐gloved hands for 10 sec | Swabs of hands and wrist; swabs of neck and chest | n/a | Any contamination yes/no; mean Log10 PFU recovered | |
| Osei‐Bonsu 2019 | Fluorescent/ bacteria | Glo Germ fluorescent powder/Staphylococcus epidermidis | ? | 1 mL of S epidermidis in a 0.5 McFarland suspension (1.5 108 CFU/mL) | ? | Wedge foam paint brush to coat participants with Glo Germfluorescentpowder on both arms, hands, and the abdomen/dripping droplets over the PPEwith a 1000 uL pipette | Black light/areas of apparent powder transfer were documented andcultured using cotton swabs, inoculated onto blood agar plates, andincubated for 48 h. | No | Number of people with contamination |
| Suen 2018 | Fluorescent | Fluorescent solution (UV GERM Hygiene Spray, Glow TecLtd | ? | 12 times 1.99 g | ? | Solution was sprayed onto the face shield, 2 upper limb/gloves andanterior surfaces of the gown | UV lamp (CheckPoint, 220– 240 V/50 Hz; Glow Tec Ltd., London, England)under dim light | No | Overall average of contaminated body sites |
| Strauch 2016 | Fluorescent | Glogerm | Oil | 25 mL | No | 1. brushed on masks 2. 1 mL on the hands | UV‐A light | Yes | Contaminated yes/no; intensity of UV light reflection |
| Tomas 2016 | Fluorescent | ? | ? | 0.5 mL | No | Rubbed over gloved hands | Ultra light UV1 | No | Contaminated hands/wrist yes/no |
| Virus | MS2 | 10^10 PFU /0.5 mL | 0.5 mL | ? | Gloved hands were inoculated | Swabs of hands and wrist | n/a | Contaminated hands/wrist yes/no; mean log10 PFU recovered | |
| Wong 2004 | Fluorescent | ? | Water | 100 mL | No | Sprayed the exposed part with an atomiser (participants were blindfoldedduring this process) | UV scan | Yes | Number of stains |
| Zamora 2006 | Fluorescent | Detection paste | ? | 100 mL | No | Paste on forearms and palms of the hands | UV lamp | No | Areas measured |
| CFU: colony forming units; HCW: healthcare worker; Kpneumonia: Klebsiella pneumoniae;LED: light‐emitting diode; MS2: harmless virus; MSSA:methicillin‐sensitive Staphylococcus aureus;mL: millilitre; muL: microlitre; n/a: not applicable;PFU: plaque forming units; Phi6: harmless virus;PLS: polystyrene latex bead; UV: ultraviolet | |||||||||
Countries
Twelve studies were performed in the USA, four in China and Hong Kong, two in Canada,two in the UK, one each in Australia, Germany and Russia, and one was performed inthree countries at the same time: France, Mexico and Peru (Casalino 2015). One study in Canada was performedduring the SARS epidemic and one study in the UK was among HCW that had returned fromthe West‐African EVD epidemic.
Time period
All studies were conducted after the year 2000, with six before, and 18 after2015.
Interventions and comparisons
Of the 24 included studies, 17 studies evaluated an intervention and a controlcondition. Four studies (Buianov 2004; Guo 2014; Houlihan 2017; Shigayeva 2007),evaluated two interventions. One study compared three types of PPE (Suen 2018), one study five types (Hall 2018), and one study 10 types (Chughtai 2018).
Fourteen studies compared one type of PPE to one or more other types. Eight studiescompared two or more different ways of donning and doffing. One of these studies namedthe intervention 'enforced training' but we categorised it under different ways ofdoffing because it entailed giving instructions during the donning and doffing processversus not giving instructions (Casalino2015). Three studies evaluated the effect of training.
Comparison of different types or parts of full‐body PPE
Fourteen simulation studies compared different types or parts of full‐body PPEoutfits or compared an adapted design versus a standard design PPE, but all in adifferent way. Only a couple of studies were similar enough to allow us to combinetheir results. None of the included studies used a standardised classification ofthe properties of the PPE that protect against viral penetration such as the EN 14126.
Two simulation studies compared different types of masks or respirators as part offull‐body PPE. Buianov 2004 compared twodifferent types of powered, air‐purifying respirator (PAPR) that were especiallydeveloped for this project in Russia to protect healthcare personnel against Ebolaand similar viruses. Buianov 2004 alsocompared the effect of different airflow rates that varied from 50 L to 300 L perminute. The intervention participants were required to carry out a step test thatlasted for four hours. The study authors did not describe the equipment they testedin sufficient detail for us to be able to judge their technical qualities. Zamora 2006 compared PPE combined with a PAPR inuse at the study hospital with PPE without a PAPR according to CDC recommendationsto prevent respiratory infection at the time of the study, the so‐called EnhancedRespiratory and Contact Precautions (E‐RCP).
Six simulation studies compared different types of gowns and protective clothing.Wong 2004 compared four types of PPEaccording to their material properties. First, they tested the material according tothe American Association of Textile Chemists and Colorists' standards 22 and 127. Weexcluded the surgical‐gowns‐only category since it had no water repellency andinsufficient viral barrier properties. Type A had good water repellency and waterpenetration resistance, but at the cost of poor air permeability. Type B had goodwater repellency and good air permeability, but poor water penetration resistance.Type C was the surgical gown with both poor water repellency and water penetrationresistance. Type D, Barrierman, was made of Tyvek and had good water repellency,poor air permeability and fair water resistance. Bell 2015 compared commercially available PPE, compliant with CDCrecommendations, with locally available clothing, such as rain coats that werethought to be as protective as the commercially available ones. Guo 2014 compared three types of PPE: adisposable water‐resistant, non‐woven gown, a reusable, woven, cotton gown, and adisposable non‐woven plastic apron. The second one was a cotton, water permeablegown, like a surgical gown. We left this arm out of the analysis because surgicalgowns alone are not used for EVD. The study authors tested the fabrics for waterrepellency and liquid penetration according to the American Association of TextileChemists and Colorists' standard 22. The gown and the apron received ratings of 4and 5 respectively on a scale of 0 to 5 for water repellency. One simulation studycompared different full‐body PPE ensembles. Hall2018 compared five different PPE ensembles used in EVD surge units inhospitals, which all met the guidance of the Advisory Committee on DangerousPathogens endorsed by Public Health England (PHE). Three ensembles used gowns whiletwo ensembles used coveralls. Some PPE ensembles were comprised of gowns withsurgical caps and other ensembles of coveralls with hoods. Some PPE comprised bootsonly and others boot covers. Some taped the second pair of gloves whereas others didnot. Suen 2018 compared three types of PPE,which differed with respect to the use of a waterproof gown, isolation gown, orcoverall. Chughtai 2018 compared 10different outfits that complied with guidance given by WHO or in specific countries,including the guidance for donning and doffing.
Modifications to existing PPE
Strauch 2016 compared a N95 filteringface piece respirator (FFR) mask to a modified FFR mask with tabs placed on theelastic band as a doffing aid. The study authors reported having evaluatedcontamination of the hands and head in two different trials but they reportedtheir results in the same article.
Tomas 2016 compared a standard gown to aprototype seamless PPE that consisted of a polyethylene gown with nitrile glovesattached by a contact bond adhesive to enable the removal of the gown and glovesat the same time. Mana 2018 compared astandard polyethylene gown to a modified gown with a double elastic neck closurefor easier removal, more gown coverage on the palm of the hand and smaller thumbholes and elastic wrist bands to create a snugger fit. Hajar 2019 also evaluated a gown with improvedglove gown interface.
One simulation study compared different types of gloves. Gleser 2018 compared a modified glove with asmall tab near the thumb to aid in glove removal without contamination to standardmedical examination gloves. Both types of gloves were made of the same materialfrom the same company. The study authors did not provide any more information.
Studies comparing different types of eye protection or footwear are missing.
Contamination rates are not only determined by the type of PPE but also by thedonning and doffing procedures. All studies had a priori determined donning anddoffing procedures. It should be noted that these studies evaluated the totalityof the type of PPE inclusive of the donning and doffing procedure. We havedescribed the procedures in the 'Characteristicsof included studies' table.
Donning or doffing procedures (one procedure for donning or doffingversus another)
Eight studies compared different donning or doffing procedures.
Extra gloves
Casanova 2012 compared the effect ofwearing two pairs of gloves with wearing one pair of gloves on contaminationrates. We classified the study under methods of doffing because the intention ofthe double‐gloving was to decrease contamination during doffing. Doffing was doneas per CDC recommendation, which describes how to do both single‐gloving anddouble‐gloving. Osei‐Bonsu 2019 alsocompared the CDC procedure for doffing with doffing with double gloves.
Structured procedures versus individual ways of donning anddoffing
One simulation study compared individual's own versus recommended procedures.Guo 2014 compared the effect of doffinga gown or an apron according to an individual's own views versus the procedurerecommended by CDC in the USA in 2007. Participants were given the followinginstructions: "Gown front and sleeves are contaminated! Unfasten neck, then waistties. Remove gown using a peeling motion; pull gown from each shoulder toward thesame hand. Gown will turn inside out. Hold removed gown away from body, roll intoa bundle and discard into waste or linen receptacle".
Alternative procedures versus CDC procedure
One study (Osei‐Bonsu 2019) compared theCDC procedure for doffing with a one‐step procedure in which gloves are doffed atthe same time as the gown.
Extra instruction
Two simulation studies compared the effect of extra assistance during donning ordoffing versus no instructions. Casalino2015 compared standard (unassisted) donning or doffing procedure toreinforced (extra assistance) procedures. The reinforcement consisted of aninstructor saying out loud the next step of donning or doffing. The study authorsused the reinforcement with both basic PPE (impermeable apron without a hood) andenhanced PPE (full‐body suit and hood). Andonian2019 compared training in teamwork to conventional donning anddoffing.
Disinfection procedures
Four simulation studies, and one field study, compared donning or doffingprocedures with extra disinfection during the process. Casanova 2016 compared the self‐contaminationof skin with two surrogate viruses when either an alcohol‐based hand rub orhypochlorite solution was used for the glove hygiene step of a PPE doffingprotocol. Houlihan 2017 intended tocompare the PPE removal with and without chlorine spray and also with and withoutassistance but there was collinearity between these variables and being inclinical work or in laboratory work. All those that were in clinical work reportedhaving used chlorine spray and assistance whereas those in laboratory work didnot. Therefore we could not analyse these data. Kpadeh Rogers 2019 compared the effect of alcohol‐based hand rub,quaternary ammonium or bleach to no glove disinfection. Osei‐Bonsu 2019 compared the recommended CDCprocedure to the same procedure plus extra hand hygiene with alcohol‐based handrub.
Type of training or education (one type of training or educationversus another)
Three studies evaluated different training methods for donning and doffingprocedures.
Hung 2015, a simulation study, compared aconventional training session for donning and doffing procedures to a procedure inwhich the conventional session was complemented with a computer simulationlater.
Shigayeva 2007, a field study, evaluatedthe effect of active and passive training versus no training on compliance rates. Wedefined active training as training that involved any group or face‐to‐faceinteraction. We defined passive training as watching a video or receiving writteninstructions. This allowed us to make an indirect comparison between the effect ofactive and passive training. We calculated the effect of active training compared topassive training by subtracting the OR for passive training from the OR for activetraining, as outlined in the Cochrane Handbook for Systematic Reviews ofInterventions (Higgins 2011). Wecalculated the variance of this indirect comparison by summing the variances of bothdirect comparisons. Then we calculated the standard error by taking the square rootof the combined variance. We used this as input for the generic inverse variancemethod in Review Manager 2014.
Curtis 2018, a simulation study, compared avideo‐based learning session on instructions for PPE use for patient decontaminationas part of a disaster medicine training to a traditional lecture beforeparticipating in a practical exercise.
Outcomes
Infection rates
One study (Houlihan 2017), evaluated theeffect of interventions on infection rates. The study authors measured the level ofimmunoglobulin G (IgG) specific for EVD in an oral fluid sample to assess if therehad been undetected infections in HCW exposed to EVD.
Contamination outcomes
Simulation studies measured contamination either as the proportion of peoplecontaminated, as the number of contaminated spots, or as the area of the bodycontaminated in studies using a fluorescent marker (see Table 17). Study authors measured contamination with the helpof a UV lamp (when using fluorescent marker), or by directly measuring viral ormicrobe presence or viral or microbial load (when using a non‐pathogenic virus ormicrobes). However, across studies, different body locations were contaminated andalso different body locations were measured for the contamination outcome. In thecontrol groups there was a median of 67% of participants contaminated and acrossintervention groups this was 25%. There were two studies in which there wereparticipants that had zero contamination with a specific PPE outfit (Chughtai 2018; Hall 2018).
Compliance with guidance: noncompliance rates with donning anddoffing procedures
Ten studies evaluated the effect of interventions on noncompliance (Casalino 2015; Casanova 2012; Curtis 2018; Drews 2019; Hajar 2019; Hung 2015; Shigayeva 2007; Suen 2018; Zamora 2006)
Four contamination simulation studies (Casanova2012; Drews 2019; Hajar 2019; Zamora 2006), measured non‐compliance as the number of participants thatdid not follow the correct order of the protocol, omitted elements, or did not usethe correct equipment.
Shigayeva 2007 measured noncompliance intheir training study as the number of violations against protocol as recorded frominterviews. There were two different compliance outcomes. One was called consistentadherence and was calculated as the proportion of exposure episodes with fullcompliance with PPE. The other one was called unsafe doffing, measured if one ormore of the elements of the doffing procedure were violated. We recalculatedoutcomes in such a way that they represented the frequency of noncompliance.
Hung 2015 measured compliance as a totalscore on a 16‐item checklist for donning and 20‐item checklist for doffing. To getresults comparable to the other studies we subtracted the mean compliance valuesfrom the maximum score and used these as noncompliance values.
Casalino 2015 measured noncompliance as thenumber of errors per person for donning and for doffing and the number of peoplewith one or more errors as measured by the specialist trainer or instructor, whoalso gave the spoken instructions in case of reinforcement. The study authors alsomeasured critical errors, which were those where there was contact between skin andpotentially contaminated PPE, but we did not consider this a valid measure ofcontamination and disregarded it. We took measurement of the errors at the lasttraining session as the effect of the intervention. We disregarded the errormeasurements at earlier training sessions.
Suen 2018 measured non‐compliance as theaverage of the percentage errors of all items of a checklist.
Curtis 2018 measured compliance as thepercentage of the maximum attainable score that an external evaluator gave on apractical skills test for both donning and doffing PPE.
Secondary and other relevant outcomes
No studies reported on costs or other economic outcomes such as resource use.
Wong 2004 and Lai 2011a measured time, and Wong 2004 and Drews 2019 measured satisfaction. Buianov2004 measured heart rate and body temperature. We chose to report theresults of this outcome as well, as we identified it as an additional outcome thatappeared relevant to the questions being addressed.
Excluded studies
Description of case series or outbreak
One reason for excluding important studies was that the researchers only described acase‐series of HCW cases' use of PPE for EVD (Muyembe‐Tamfum 1999), Marburg Haemorraghic Fever infection (MHF) (Borchert 2007; Colebunders 2004; Jeffs 2007; Kerstiens 1999), Congo Crimean Haemorraghic Fever(CCHF) (Gozel 2013), or for SARS (Christian 2004; Ho 2003; Ofner 2003; Ofner‐Agostini 2006). None of these studiesdescribed the use of PPE by the cases in such detail that they could be replicated. Incombination with the lack of a control condition, it is difficult to conclude how muchPPE, or the lack thereof, contributed to the infection. The only different study of aseries of cases during an outbreak was the study by Dunn 2015 that contained proper descriptions of PPE.
Description of PPE use only
We excluded studies if they only described how and what PPE was used without relationto an outcome (Beam 2016a; Beam 2016b; Franklin 2016; Lee 2017; Lowe 2014; Marklund 2002; Minnich 2003).
One type of PPE only, no comparison
Alraddadi 2016, Delaney 2016, Drew 2016, Elcin 2016, Luo 2011, Kwon2017 and Tomas 2015 evaluated onlyone type of PPE without a comparison in a simulation study. Also for the 2020 updatewe excluded many studies because of the lack of a control group (Abualenain 2018; Casanova 2018; Kogutt 2019; Mumma 2018; Parveen 2018; Williams 2019; Weber 2018).
No infection rates contamination or compliance outcomes
Some studies measured only performance with PPE compared to no PPE use and notinfection rates, contamination or compliance (Castle2009; Coates 2000; Garibaldi 2019; Hendler 2000). Other studies did not measure personal but only environmentalcontamination (Jaffe 2019; Lai 2011; Porteous 2018; Visnovsky 2019).
Comparison with no PPE only
We excluded studies that only compared PPE use with no PPE and not with alternativePPE use (Lu 2006; Schumacher 2010; Teleman 2004).
Studies that evaluated only one type of PPE and not part of full‐bodyPPE
Ogendo 2008 measured eye protection only.Bearman 2007 measured universal glove useonly. Chughtai 2013, Lindsley 2012 and Lindsley 2014 measured masks or face shields only. Even though these studiesyield valuable information, it is unclear how well the results also cover the use ofthese items as part of full‐body protection and therefore we excluded thesestudies.
Participants not exposed to highly infectious diseases with seriousconsequences
Many studies evaluated PPE use for diseases other than EVD and related haemorraghicfevers, such as HIV or other nosocomial infections that were not considered highlyinfectious or having serious consequences, or both, and we excluded these studies(Anderson 2017; Bischoff 2019; Malik 2006; Makovicka 2018; Ransjo 1979; Sorensen 2008). In another study participants were not HCW (Kahveci 2019).
Training or simulation studies without a control group
There were a number of studies that evaluated training but that did not use a controlgroup. This makes it difficult to draw inferences about the effect of one type oftraining compared to another (Abrahamson 2006;Beam 2014; Hon 2008; Northington 2007; Tomas 2015).
Inconsistent use of PPE during the SARS epidemic
After intensive discussion, we excluded 11 studies that measured the use of PPE(mask, gloves, gowns, goggles) during the SARS outbreak and related that to the riskof SARS infection. One line of thinking was that these studies did not fulfil theinclusion criteria because the comparison here was not clearly one type of PPE versusanother type of PPE. Another line of thinking was that the studies compared differenttypes of PPE composition and thus would fulfil the inclusion criteria. We finallydecided to deal with these studies in the discussion section only (Ho 2004; Lau2004; Le 2004; Liu 2009; Loeb2004; Nishiura 2005; Park 2004; Pei2006; Scales 2003; Seto 2003; Teleman 2004).
Risk of bias in included studies
See Figure 5 for an overview of our judgment of the risk of biasper study. Figure 6 gives an overview of risk of bias per domain.Since the figures contain the 'Risk of bias' assessments for both randomised andnon‐randomised studies, not all cells are applicable to both study types and those thatare not applicable remain empty.
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item foreach included study
'Risk of bias' graph: review authors' judgements about each 'Risk of bias' itempresented as percentages across all included studies
Allocation
Allocation was random in 14 studies but only five of them stated adequately what methodthey had used for generating the random sequence and where thus rated as at low risk ofbias for random sequence generation. Five studies reported an appropriate method (Osei‐Bonsu 2019; Suen 2018; Wong 2004; Zamora 2006), and for one we received additionalinformation from the study authors (Mana 2018).One used alternation and we rated it as having a high risk of bias (Gleser 2018). The other studies were rated atunclear risk of bias
Allocation concealment was unclear in all but two of the randomised studies (Mana 2018; Osei‐Bonsu 2019). We judged only these two studies to have a low risk ofselection bias.
Blinding
In the simulation studies, the participants could not be blinded for the type of attirethey were wearing or the type of donning or doffing procedure they were following. It isunclear if they could have contaminated themselves more with attire that they thoughtwas not good, or they did not like, but for the majority of the studies we consideredthis unlikely and assessed the risk of performance bias to be low. For one study, Casalino 2015, we rated the risk of performance biasas high because the instructors who provided the intervention were very much aware ifinstruction was given or not and they were the also the assessors. We also rated therisk of performance bias as high for Drews 2019and Hajar 2019 because the outcomes weresubjective and the participants unblinded. We judged the risk of performance bias as lowin 15 studies.
For the non‐randomised SARS study (Shigayeva2007), we considered the risk of performance bias low because the study wasretrospective and the participants did not know they were part of a study.
The risk of detection bias was unclear in most studies, as they did not report whetheroutcome assessors were blinded. We considered the risk to be high in one study (Casalino 2015), as providers of the interventionwere also the assessors of compliance, and in a second study (Shigayeva 2007), because the intervention and theoutcome were assessed with the same questionnaire at the same time. We judged the riskto be low in four studies because the study authors stated that assessors were blind togroup status (Curtis 2018; Hung 2015; Mana2018; Zamora 2006). We judged the riskof detection bias to be low for Houlihan 2017because they used antibodies against Ebola, an objective outcome, which would not beaffected by assessors' knowledge of treatment. All in all, we judged the risk ofdetection bias as low in eight studies.
Incomplete outcome data
We judged the risk of attrition bias to be low in 14 studies and unclear in 10 studies.All but two studies were short‐term experiments and therefore most had a completefollow‐up of all participants.
Selective reporting
It was difficult for us to judge selective reporting because none of the includedstudies had published a protocol. We judged seven studies (Andonian 2019; Casalino 2015; Casanova 2016; Chughtai 2018; Guo2014; Kpadeh Rogers 2019; Suen 2018), to have a low risk of reporting bias asthe study authors appeared to have reported all relevant data as specified in theirarticles' methods. We judged Bell 2015 to be athigh risk of reporting bias because they did not report outcomes separately for theintervention and the control. We also judged Hung2015 to have a high risk of reporting bias as the study authors did not fullyreport the results of the computer usability questionnaire. In addition, Gleser 2018 and Osei‐Bonsu 2019 did not fully report all results. In total we judged fourstudies to be at high risk of reporting bias.
Other potential sources of bias
We did not consider that any of the included studies were at risk of other sources ofbias except for Gleser 2018, where we consideredthat there was a substantial financial conflict of interest because the first author wasalso the director of the company that produced the gloves that were part of theintervention.
Bias due to confounding (non‐randomised studies)
We judged there to be a low risk of bias due to confounding in six non‐randomisedstudies (Casanova 2012; Casanova 2016; Drews 2019; Hall 2018; Houlihan 2017; Shigayeva 2007), unclear risk in two non‐randomised studies (Casalino 2015; Kpadeh Rogers 2019), and a high risk in one non‐randomised study (Buianov 2004).
Bias due to selection of participants into the study (non‐randomisedstudies)
We judged there to be a low risk of bias due to selection of participants into thestudy for five non‐randomised studies (Buianov2004; Casalino 2015; Casanova 2012; Hall 2018; Shigayeva 2007), andunclear for one study (Casanova 2016). Weconsidered the risk of selection bias to be high in two studies. Houlihan 2017, because they recruited participantsbased on snowball sampling, and Kpadeh Rogers2019, where different HCW performed tests with different bacteria.
Overall risk of bias per study
We judged none of the included studies to be at low risk of bias overall. Accordingto our judgment they were all at either unclear (N = 15) or at high risk of bias (N =9).
Effects of interventions
See: Table 1; Table 2; Table 3; Table 4; Table 5; Table 6; Table 7; Table 8; Table 9; Table 10;Table 11; Table 12; Table 13; Table 14; Table 15; Table 16
Summary of findings 1
Personal protective equipment (PPE) types: powered, air‐purifyingrespirator (PAPR) plus coverall versus N95 mask plus gown
| PAPR versus enhanced respiratory and contact precautions (E‐RCP) attire forpreventing contact with contaminated body fluids in healthcare staff | ||||||
| Patient or population: healthcare staffvolunteers Settings: simulation study Intervention:PPE with PAPR Control: E‐RCP attire according to 2005 CDC recommendation | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| E‐RCP attire | PAPR attire | |||||
| Any contamination: fluorescent marker Follow‐up: post intervention | 960 per 1000 | 259 per 1000 (163 to 413) | RR 0.27 (0.17 to 0.43) | 50 (1 cross‐over RCT) | ⊕⊝⊝⊝ Very low1,2,3 | Analyses presented in this table are unadjusted for the paired nature of thecross‐over design but similar to the results that the study authors presentedwhile taking the cross‐over into account |
| Compliance: noncompliance with donning guidance Follow‐up: post intervention | 40 per 1000 | 300 per 1000 (72 to 1000) | RR 7.5 (1.81 to 31.1) | 50 (1 cross‐over RCT) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Compliance: noncompliance with doffing guidance Follow‐up: post intervention | 240 per 1000 | 120 per 1000 (48 to 295) | RR 0.5 (0.2 to 1.23) | 50 (1 cross‐over RCT) | ⊕⊝⊝⊝ Very low1,2,3 | |
| *The basis for the assumed risk is the control group risk. Thecorresponding risk (and its 95% confidence interval) is based on theassumed risk in the comparison group and the relative effect of theintervention (and its 95% CI). CDC: Centers for Disease Control andPrevention; CI: confidence interval; E‐RCP: enhanced respiratoryand contact precautions; PAPR: powered, air‐purifying respirator;PPE: personal protective equipment; RCT: randomised controlledtrial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Simulation study, downgraded one level forindirectness.
2One cross‐over study with 50 participants,downgraded one level for imprecision.
3HIgh risk of bias, downgradedone level for study limitations.
Summary of findings 2
Personal protective equipment (PPE) types: more protective versus lessprotective
| Three types of PPE attire compared by number of contaminated spots | |||||
| Patient or population: healthcare workervolunteers Settings: simulation study Intervention:more protective attire, not permeable not breathable(A) Comparison: less protective attire: permeable but breathable(B); fairly permeable, not breathable (D) | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | ||||
| Less protective type of PPE (B or D) | Most protective type of PPE attire (A) | ||||
| Number of contaminated spots: trunk Fluorescent marker Follow‐up: post‐intervention | The mean number of contaminated spots in control group Bwas 1.62 spots | The mean number of contaminated spots in the intervention group Awas 1.60lower (3.35 lower to 0.15 higher) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Number of contaminated spots: neck Fluorescent marker Follow‐up: post‐intervention | The mean number of contaminated spots in control group Bwas 0.12 spots | The mean number of contaminated spots in the intervention group Awas 0.7 higher (0.26 lower to 1.66 higher) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Number of contaminated spots: foot Fluorescent marker Follow‐up: post‐intervention | The mean number of contaminated spots in the control group Bwas 2.86 spots | The mean number of contaminated spots in the intervention group Awas 0.96 lower (2.35 lower to 0.43 higher) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Number of contaminated spots: palm Fluorescent marker Follow‐up: post‐intervention | The mean number of contaminated spots in the control group Bwas 17.83 | The mean number of contaminated spots in the intervention group Awas 7.72 lower (15.65 lower to 0.21 higher) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Number of contaminated spots: trunk or neck Fluorescent marker Follow‐up: post‐intervention | The mean number of contaminated spots in the control group Dwas 0 | Because no standard deviations were provided no analysis was possible | |||
| Number of contaminated spots: foot Fluorescent marker Follow‐up: post‐intervention | The mean number of contaminated spots in the control group Dwas 4.96 | The mean number of contaminated spots in the intervention group Awas 4.1 lower (6.94 to 1.26 lower) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Number of contaminated spots: palm Fluorescent marker Follow‐up: post‐intervention | The mean number of contaminated spots in the control group Dwas 20.49 | The mean number of contaminated spots in the intervention group Awas 12.76 lower (21.62 to 3.9 lower) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Usability score Range 1 to 5, higher indicating better | Mean score for group B was 4.02 | The mean score of intervention group A was 0.46 lower (0.84 to 0.08lower) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Compliance with guidance | See comment | See comment | 0 (0 studies) | See comment | No studies evaluated the effect of the interventions on compliance withguidance. |
| *The basis for the assumed risk is the control group risk. Thecorresponding risk (and its 95% confidence interval) is based on theassumed risk in the comparison group. CI: confidence interval;PPE: personal protective equipment | |||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | |||||
1Simulation study, downgraded one level for indirectness.
2One study with 100 participants, 25 participants per arm,downgraded one level for imprecision.
3Unclear risk of bias in thestudy, downgraded one level.
Summary of findings 3
Personal protective equipment (PPE) types: gowns versus aprons
| Gowns versus aprons for preventing highly infectious diseases due to contactwith contaminated body fluids in healthcare workers | |||||
| Patient or population: healthcare workervolunteers Settings: simulation study Intervention:gowns versus aprons | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | ||||
| Aprons | Gowns | ||||
| Contamination with marker: individual type of doffing Follow‐up: post‐intervention | The mean contamination with marker in the control groups was 16.98small spots | The mean contamination with marker in the intervention groups was 10.28lower (14.77 to 5.79 lower) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | Cross‐over study; the analyses were unadjusted for the paired nature of thedata but similar to the analysis of the study authors, who took this intoaccount |
| Contamination with marker: CDC‐recommended doffing Follow‐up: post‐intervention | The mean contamination with marker in the control groups was 1.88small spots | The mean contamination with marker in the intervention groups was 0.62lower (1.75 lower to 0.51 higher) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Compliance with guidance | See comment | See comment | 0 (0 studies) | See comment | No studies evaluated the effect of the interventions on compliance withguidance. |
| *The basis for the assumed risk is the control group risk. Thecorresponding risk (and its 95% confidence interval) is based on theassumed risk in the comparison group. CDC: Centers for DiseaseControl and Prevention; CI: confidence interval | |||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | |||||
1Randomisation method unclear, downgraded onelevel.
2Simulation study, downgraded one level forindirectness.
3Single cross‐over study with 50 participants,downgraded one level for imprecision.
Summary of findings 4
Personal protective equipment (PPE) types: different types of PPEattire
| One type of full‐body PPE compared to another type for preventing highlyinfectious diseases due to exposure to contaminated body fluids in healthcareworkers | ||||
| Patient or population: healthcare workers Setting:simulation study Intervention: one type of full‐bodyPPE Comparison: another type | ||||
| Outcomes | Impact | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments |
| Any contamination | In 1 RCT (59 participants) people with a long gown had less contamination thanthose with a coverall and those with a coverall less than those with anisolation gown. In 1 observational study (11 participants) there were too few events to enablecomparison of contamination rates between 5 types of PPE In 1 observational study (10 participants), out of 10 different ensembles therewere contaminations in only 4, of these 3 used coveralls | 59 participants (1 RCT) 21 participants (2 observational studies) | ⊕⊕⊝⊝ Low1,2 ⊕⊝⊝⊝ Very low3 | |
| Compliance | Isolation gown was easiest to don and doff, coverall was more difficult todoff | 59 participants (1 RCT) | ⊕⊝⊝⊝ Very low1,2 | |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). PPE: personal protectiveequipment; RCT: randomised controlled trial | ||||
| GRADE Working Group grades of evidence High certainty: weare very confident that the true effect lies close to that of the estimate ofthe effect Moderate certainty: we are moderately confident in theeffect estimate: the true effect is likely to be close to the estimate of theeffect, but there is a possibility that it is substantiallydifferent Low certainty: our confidence in the effect estimate islimited: the true effect may be substantially different from the estimate of theeffect Very low certainty: we have very little confidence in theeffect estimate: the true effect is likely to be substantially different fromthe estimate of effect | ||||
1 One study with 59 participants, downgraded by one level because ofimprecision.
2Risk of bias in the study was unclear and so wedowngraded by one level.
3The simulated exposure was very low. Thisresulted in a lack of power to detect differences, We downgraded by one level.
Summary of findings 5
Modified personal protective equipment (PPE): sealed gown‐gloveinterface versus standard gown
| Sealed gown‐glove interface compared to standard gown for preventing highlyinfectious diseases due to exposure to contaminated body fluids in healthcareworkers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: sealed gown‐gloveinterface Comparison: standard gown | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with traditional suit | Risk with sealed suit | |||||
| Contamination: fluorescent lotion | 733 per 1000 | 198 per 1000 (66 to 572) | RR 0.27 (0.09 to 0.78) | 30 (1 RCT) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Contamination: MS2 | 1000 per 1000 | 680 per 1000 (470 to 980) | RR 0.68 (0.47 to 0.98) | 30 (1 RCT) | ⊕⊝⊝⊝ Very low1,2,3 | |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Unclear risk of bias, downgraded by one level.
2This isa simulation study so we downgraded by one level because ofindirectness.
3One study with 30 participants so we downgraded byone level because of imprecision.
Summary of findings 6
Modified personal protective equipment (PPE): gown ‐ easy to doffcompared to standard gown
| Easy‐to‐doff gown compared to standard gown for preventing highly infectiousdiseases due to exposure to contaminated body fluids in healthcare workers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: gown: easy todoff Comparison: standard gown | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with standard gown | Risk with easy‐to‐doff gown | |||||
| Contamination: fluorescent marker | 419 per 1000 | 34 per 1000 (4 to 231) | RR 0.08 (0.01 to 0.55) | 62 (1 RCT) | ⊕⊕⊝⊝ Low1,2 | |
| Contamination: bacteriophage | 613 per 1000 | 325 per 1000 (178 to 576) | RR 0.53 (0.29 to 0.94) | 62 (1 RCT) | ⊕⊕⊝⊝ Low1,2 | |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Simulation study, downgraded by one level.
2One smallstudy, downgraded by one level.
Summary of findings 7
Modified personal protective equipment (PPE): gown with gown‐gloveimprovement compared to standard gown and gloves
| Gown with gown‐glove improvement compared to standard gown and gloves forpreventing highly infectious diseases due to exposure to contaminated bodyfluids in healthcare workers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: gown with gown‐gloveimprovement Comparison: standard gown and gloves | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with standard gown and gloves | Risk with gown with gown‐glove improvement | |||||
| People with contamination | 410 per 1000 | 185 per 1000 (107 to 320) | RR 0.45 (0.26 to 0.78) | 50 (2 RCTs) | ⊕⊕⊝⊝ Low1,2 | Cross‐over study analysed as parallel study |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Study at high risk of performance bias, otherwise unclear risk of bias,downgraded one level.
2Simulation study, downgraded by one level.
Summary of findings 8
Modified personal protective equipment (PPE): gloves with tab versusstandard gloves
| Gloves with tab compared to standard gloves for preventing highly infectiousdiseases due to exposure to contaminated body fluids in healthcare workers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: gloves withtab Comparison: standard gloves | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with standard gloves | Risk with gloves with tab | |||||
| Any contamination of hands | 733 per 1000 | 161 per 1000 (110 to 227) | RR 0.22 (0.15 to 0.31) | 317 (1 RCT) | ⊕⊝⊝⊝ Very low1,2 | |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Clusters of healthcare workers who were present at work were allocated tointervention or control on alternating days and so we downgraded by two levels becauseof study limitations.
2This is a simulation study so we downgraded byone level because of indirectness.
Summary of findings 9
Modified personal protective equipment (PPE): mask plus tabs versusstandard masks
| Mask tabs compared to no mask tabs for preventing highly infectious diseasesdue to exposure to contaminated body fluids in healthcare workers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: mask tabs Comparison:no mask tabs | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with No mask tabs | Risk with Mask tabs | |||||
| Contamination of mask from hands | 1000 per 1000 | 330 per 1000 (140 to 800) | RR 0.33 (0.14 to 0.80) | 20 (1 RCT) | ⊕⊝⊝⊝ Very low1,2,3 | Analyses presented in this table are unadjusted for the paired nature of thecross‐over design but similar to the results that the study authors presentedwhile taking the cross‐over into account. |
| Contamination of head from hands | 867 per 1000 | 832 per 1000 (719 to 971) | RR 0.96 (0.83 to 1.12) | 20 (1 RCT) | ⊕⊝⊝⊝ Very low1,2,3 | Analyses presented in this table are unadjusted for the paired nature of thecross‐over design but similar to the results that the study authors presentedwhile taking the cross‐over into account. |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1The randomisation procedure was unclear and the cross‐over procedure wasunclear so we downgraded by one level because of studylimitations.
2This is a simulation study so we downgraded by onelevel because of indirectness.
3One study only with 20 participantsand so we downgraded by one level because of imprecision.
Summary of findings 10
Procedures: doffing according to Centers for Disease Control andPrevention method versus individual doffing
| Centers for Disease Control and Prevention (CDC) method versus individualdoffing for preventing contact with contaminated body fluids in healthcareworkers | ||||||
| Patient or population: healthcare workervolunteers Settings: simulation study Intervention:CDC method of doffing Control: individual method of doffing | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Individual doffing method | CDC‐recommended doffing method | |||||
| Contamination with fluor marker when using gowns Follow‐up: post‐intervention | The mean contamination with fluor marker in the control group was 6.7small spots | The mean contamination with fluor marker in the intervention groupwas 5.44 lower (7.43 to 3.45 lower) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | Cross‐over study; the analyses were unadjusted for the paired nature of thedata but similar to the analysis of the study authors, who took this intoaccount. | |
| Contamination with fluor marker when using aprons Follow‐up: post‐intervention | The mean contamination with fluor marker in the control groupwas 16.98 small spots | The mean contamination with fluor marker in the intervention groupwas 15.1 lower (19.28 to 10.92 lower) | 50 (1 study) | ⊕⊝⊝⊝ Very low1,2,3 | ||
| *The basis for the assumed risk is the control group risk. Thecorresponding risk (and its 95% confidence interval) is based on theassumed risk in the comparison group. CDC: Centers for DiseaseControl and Prevention; CI: confidence interval | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1The randomisation procedure was unclear and so we downgraded by one leveldue to study limitations.
2This is a simulation study so wedowngraded by one level because of indirectness.
3One cross‐overstudy with 50 participants and so we downgraded by one level due to imprecision.
Summary of findings 11
Procedures: single‐step doffing compared to Centers for Disease Controland Prevention standard
| Single‐step doffing compared to Centers for Disease Control and Prevention(CDC) standard for preventing highly infectious diseases due to exposure tocontaminated body fluids in healthcare workers | ||||||
| Patient or population: preventing highly infectious diseases due toexposure to contaminated body fluids in healthcare workers Setting:simulation study Intervention: single‐stepdoffing Comparison: CDC standard | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with CDC standard | Risk with single‐step doffing | |||||
| Fluorescent contamination | 917 per 1000 | 898 per 1000 (688 to 1000) | RR 0.98 (0.75 to 1.28) | 22 (1 RCT) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Bacterial contamination | 667 per 1000 | 133 per 1000 (33 to 513) | RR 0.20 (0.05 to 0.77) | 27 (1 RCT) | ⊕⊝⊝⊝ Very low1,2,4 | |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CDC: Centers forDisease Control and Prevention; CI: confidence interval; RCT:randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Simulation study, downgraded by one level.
2Largedifference in effects between fluorescent contamination and bacterialcontamination.
3Confidence Interval contains harms andbenefits.
4Confidence interval contains both very large effects andvery small effects.
Summary of findings 12
Procedures: doffing with double gloves compared to doffing with singlegloves
| Doffing with double gloves compared to doffing with single gloves forpreventing highly infectious diseases due to exposure to contaminated bodyfluids in healthcare workers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: doffing with doublegloves Comparison: doffing with single gloves | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with doffing with single gloves | Risk with doffing with double gloves | |||||
| Contamination: virus detected ‐ all body parts | 733 per 1000 | 249 per 1000 (125 to 484) | RR 0.34 (0.17 to 0.66) | 58 (1 RCT, 1 observational study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Contamination: virus detected ‐ face | 17 per 1000 | 73 per 1000 (9 to 606) | RR 4.39 (0.53 to 36.37) | 58 (1 RCT, 1 observational study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Contamination: virus detected ‐ shirt | 567 per 1000 | 572 per 1000 (448 to 731) | RR 1.01 (0.79 to 1.29) | 58 (1 RCT, 1 observational study) | ⊕⊝⊝⊝ Very low1,2,4 | |
| Contamination: virus detected ‐ pants | 611 per 1000 | 556 per 1000 (318 to 966) | RR 0.91 (0.52 to 1.58) | 36 (1 observational study) | ⊕⊝⊝⊝ Very low2,4 | |
| Non‐compliance: any error | 667 per 1000 | 720 per 1000 (467 to 1000) | RR 1.08 (0.70 to 1.67) | 36 (1 observational study) | ⊕⊝⊝⊝ Very low2,4 | |
| Contamination with fluorescent | 917 per 1000 | 898 per 1000 (688 to 1000) | RR 0.98 (0.75 to 1.28) | 22 (1 RCT) | ⊕⊝⊝⊝ Very low1,2,4 | |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Difference in viral/bacterial outcomes and fluorescent marker outcomes,downgraded one level.
2Simulation studies, downgraded onelevel.
3Confidence interval contains both very large and moderateeffects.
4Confidence interval contains both harms and benefits.
Summary of findings 13
Procedures: donning and doffing with instructions compared to withoutinstruction
| Donning and doffing with instructions compared to without instructions forpreventing highly infectious diseases due to exposure to contaminated bodyfluids in healthcare workers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: donning and doffing withinstructions Comparison: without instructions | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with without instructions | Risk with donning and doffing with instructions | |||||
| People with one or more errors | 467 per 1000 | 145 per 1000 (51 to 434) | RR 0.31 (0.11 to 0.93) | 120 (1 observational study) | ⊕⊝⊝⊝ Very low1,2,3 | |
| Mean errors | The mean errors was 1.15 | MD 0.89 lower (1.36 lower to 0.41 lower) | ‐ | 120 (1 observational study) | ⊕⊝⊝⊝ Very low1,2 | |
| Fluorescence contamination | The mean fluorescence contamination was 11 | MD 5 lower (8.08 lower to 1.92 lower) | ‐ | 24 (1 RCT) | ⊕⊕⊝⊝ Low4,5 | |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; MD: mean difference; RCT: randomised controlled trial;RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Unblinded outcome assessors with subjective outcome, downgraded onelevel.
2Simulated donning/doffing, downgraded onelevel.
3Confidence Interval includes very large effect size andsmall effect size.
4Simulation study, downgraded onelevel.
5One small study only, downgraded one level.
Summary of findings 14
Procedures: doffing with extra sanitation of gloves compared tostandard no sanitation
| Doffing with extra sanitation of gloves compared to standard no sanitationfor preventing highly infectious diseases due to exposure to contaminated bodyfluids in healthcare workers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: doffing with extra sanitation ofgloves Comparison: standard no sanitation | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with standard no sanitation | Risk with doffing with extra sanitation of gloves | |||||
| Bacterial contamination: alcohol‐based hand rub | 667 per 1000 | 500 per 1000 (260 to 967) | RR 0.75 (0.39 to 1.45) | 46 (1 RCT, 1 observational study) | ⊕⊕⊝⊝ Low1,2 | In the observational study, bacterial contamination (2.2 CFUs) did notsignificantly reduce compared to no sanitation (2.4 CFUs) |
| Bacterial contamination: quaternary ammonium | 20 (1 observational study) | ⊕⊝⊝⊝ Very low1,3,4 | Bacterial contamination significantly reduced from 2.4 CFUs to 0 CFUs andcompared to 2.2 CFUs without sanitation | |||
| Bacterial contamination: bleach | 20 (2 observational studies) | ⊕⊝⊝⊝ Very low1,3,4 | In one study, bacterial contamination significantly reduced from 2.4 CFUs to 0CFUs and compared to 2.2 CFUs without sanitation. In another study there wascollinearity between PPE use and other variables, which precluded analysis. | |||
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CFU: colony‐formingunit; CI: confidence interval; PPE: personal protective equipment;RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Simulation study, downgraded by one level.
2Confidenceinterval contains both harms and benefits.
3Study at high risk ofselection bias, downgraded one level.
4One small study with 20participants, downgraded one level.
Summary of findings 15
Procedures: doffing with hypochlorite versus doffing with alcohol‐basedglove sanitiser
| Doffing with hypochlorite compared to doffing with alcohol‐based glovesanitiser for preventing highly infectious diseases due to exposure tocontaminated body fluids in healthcare workers | ||||||
| Patient or population: healthcare workers Setting:simulation study Intervention: doffing withhypochlorite Comparison: doffing with alcohol‐based glovesanitiser | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with doffing with alcohol‐based glove sanitiser | Risk with doffing with hypochlorite | |||||
| Contamination: MS2 | Study population | RR 4.00 (0.47 to 34.24) | 15 (1 observational study) | ⊕⊝⊝⊝ Very low1,2,3 | ||
| 100 per 1000 | 400 per 1000 (47 to 1000) | |||||
| Contamination: Ph6 | Study population | Not estimable | 15 (1 observational study) | ‐⊕⊝⊝⊝ Very low1,2,3 | ||
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; RR: Risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1Allocation to intervention was based on belonging to last fiveparticipants, which is an unclear selection procedure and so we downgraded by onelevel because of study limitations.
2This is a simulation study so wedowngraded by one level because of indirectness.
3The study had asmall number of participants and so we downgraded by one level because ofimprecision.
Summary of findings 16
Teaching: video‐based learning versus traditional lecture
| Video‐based learning compared to traditional lecture for preventing highlyinfectious diseases due to exposure to contaminated body fluids in healthcareworkers | ||||||
| Patient or population: healthcare workers Setting:simulation studies Intervention: video‐basedlearning Comparison: traditional lecture | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with traditional lecture | Risk with video‐based learning | |||||
| Skills in PPE donning Assessed with assessment scale. Scalefrom: 0% to 100%; higher is better | The mean skills in PPE donning was 47.4% | MD 30.7% higher (20.14 higher to 41.26 higher) | ‐ | 26 (1 RCT) | ⊕⊝⊝⊝ Very low1,2,3 | |
| *The risk in the intervention group (and its 95% confidence interval) isbased on the assumed risk in the comparison group and the relative effectof the intervention (and its 95% CI). CI: confidenceinterval; MD: mean difference; PPE: personal protective equipment;RCT: randomised controlled trial | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close tothat of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate;the true effect is likely to be close to the estimate of the effect, but thereis a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; thetrue effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effectestimate; the true effect is likely to be substantially different from theestimate of effect. | ||||||
1The randomisation and allocation procedures were unclear and so wedowngraded by one level because of study limitations.
2This is asimulation study so we downgraded by one level because ofindirectness.
3One study with only 26 participants and so wedowngraded by one level because of imprecision.
1. Different types of PPE compared
1a Different types of mouth and nose protection
1.1 Powered air‐purifying respirator (PAPR) versus PPE for enhancedrespiratory and contact precautions (E‐RCP)
Outcome: contamination with fluorescent marker
Zamora 2006 found that the PAPR system inuse in their hospital led to less contamination than using the E‐RCP system (RR0.27, 95% CI 0.17 to 0.43; Analysis 1.1).Other ways of measuring contamination also led to less contamination with the PAPRsystem: contamination more than 1 cm (RR 0.21, 95% CI 0.12 to 0.36). The totalcontaminated area was also less with a mean difference of −81.10 cm² (95% CI−96.07 to −66.13). This was mainly due to a lack of protection of the neck in theE‐RCP system.
Outcomes: compliance with guidance ‐ donning and doffingnoncompliance
Noncompliance with donning guidelines occurred more with the PAPR system as thisconsists of more elements (RR 7.50, 95% CI 1.81 to 31.10; Analysis 1.4; Zamora 2006). Noncompliance with doffing guidelines was more frequentwith the E‐RCP system, but this was not statistically significant (RR 0.50; 95% CI0.20 to 1.23; Analysis 1.5).
Outcomes: donning and doffing time
The donning (MD = 259 seconds) and doffing time (MD = 337 seconds) wereconsiderably longer with the PAPR system (Analysis1.6; Analysis 1.7; Zamora 2006).
1.2 One type of PAPR versus another and different airflowrates
Outcome: contamination with microbial aerosol
Buianov 2004 found that the suit that hadthe hood attached to the suit (СКБ‐I) had a lower 'contamination penetration rate'than the suits that had separate hoods and coveralls with a percentage of8.10‐8 for the suit and 2.10‐1 for the coveralls. However,we could not understand the meaning of the penetration rate and we decided that wewould not use these results for our conclusions (their results are not shown indata tables).
Outcomes: heart rate and body temperature
Buianov 2004 also found thatcontamination stopped beyond the 250 L/minute airflow rates. Body temperature andheart rates were also lower at these airflow rates.
1b Different types of body protection
1.3 Four types of PPE versus another
Wong 2004 compared four types of PPEaccording to their material properties. Type A had good water repellency and waterpenetration resistance but at the cost of poor air permeability. Type B had goodwater repellency and good air permeability but poor water penetration resistance.Type C was the surgical gown with both poor water repellency and water penetrationresistance. Type D, Barrierman, was made of Tyvek and had good water repellency,poor air permeability, and fair water resistance.
Outcomes: contamination, user‐reported assessment of comfort andconvenience ‐ usability, donning and doffing times
There were no considerable differences in contamination (Analysis 2.1) between Type A and Type B forface, neck, trunk, foot, or hand, but Type B scored about 10% higher on usability(MD −0.46, 95% CI −0.84 to −0.08; Analysis2.2); this was due especially to better breathability of the fabric.There were no considerable differences in donning and doffing times (Analysis 2.3; Analysis 2.4).
Analysis
Comparison 2: Four types of PPE attire compared, Outcome 1: A vs B Contamination, meannumber of spots
There were considerable differences in contamination of the foot (MD −4.1 spots,95% CI −6.94 to −1.26) and the hand (MD −12.76 spots, 95% CI −21.62 to −3.9)between Type A and Type D (Analysis 2.5).Donning (MD 33 seconds, Analysis 2.7) anddoffing (MD 17 seconds, Analysis 2.8) timeswere also much worse for Type D. Usability was rated as not considerablydifferently (MD 0.25, 95% CI −0.12 to 0.62; Analysis 2.6).
Analysis
Comparison 2: Four types of PPE attire compared, Outcome 5: A vs D Contamination, meannumber of spots
It was unclear how many participants had no contamination. On average, all typesof PPE had some contamination.
1.4 Formal PPE versus locally available PPE
Outcome: contamination with fluorescent marker
Bell 2015 compared contamination in fourparticipants with formal PPE with four participants with locally availableprotective gear, such as raincoats. They found contamination in one participant inboth study arms. The study was so small that it is difficult to draw conclusions(Analysis 3.1).
1.5 Gown versus apron
Outcome: contamination with fluorescent marker
Guo 2014 compared a gown with an apronand found that the gown left less contamination than an apron, regardless of theway of doffing (Analysis 4.1; Analysis 4.2).
1.6 Five types of PPE attire compared
Outcome: contamination with fluorescent marker
Hall 2018 compared post‐doffingcontamination of five types of PPE ensembles used in different hospital wardsacross the UK. No analysis of contamination rates of the different suits wasavailable since the authors reported the data on contamination sites only and notaccording to type of attire. They argued that the contamination rates were too lowto provide a valid comparison.
1.7 Three different types of PPE attire compared
Outcome: contamination with fluorescent marker
Suen 2018 measured small and largepatches of contamination in three different ensembles with PPE 1, a surgical gownused with EVD with a hood covering the neck, PPE 2, a coverall also used for EVD,and PPE 3, an isolation gown. They reported the median number of patches across 10body sites and four environmental contamination sites. The median number ofcontaminations for small patches was respectively 5, 7 and 7 and for large patchesit was 39, 43 and 47. These differences were reported as being statisticallysignificantly different but there were insufficient data to check this. This wouldmean that a long gown protects better than a coverall and that the commonly usedisolation gown protects least. According to the study authors, the reducedprotection for the isolation gown is especially due to the lack of coverage of theneck, "which resulted in many small or extra‐large patches in the anterior andposterior neck region after spraying of the fluorescent solution onto the faceshield and anterior surfaces of the gown".
Outcomes: compliance with guidance ‐ donning and doffingnoncompliance
Suen 2018 also measured compliance andreported the average percentage of errors across the items measured. For PPE 1,PPE 2 and PPE 3, the averages for donning were 6.1, 6.0 and 3.7 and for doffing3.0, 9.5 and 3.5. This seems to give an indication that coveralls are moredifficult to doff.
Outcomes: time for donning and doffing
Suen 2018 also measured the time neededto don and doff the PPE (Analysis 5.1;Analysis 5.2). PPE 3, the isolation gown,was quickest to don and doff, while the coverall doffing took significantlylonger, with on average more than 10 minutes for doffing. The attire with the longsurgical gown took twice as long as the isolation gown to put on and was alsoslower to doff because more PPE items were used. We were not able to conduct aproper paired analysis because of the lack of detail in the study report. Weanalysed the trial as if it were a two‐group parallel trial, which leads to toowide confidence intervals.
1.8 Ten different types of PPE ensembles compared
Outcome: contamination with fluorescent marker
Chughtai 2018 evaluated 10 different PPEensembles recommended for use with EVD by global and national authorities. Six ofthese used coveralls and four used gowns. There were also differences in the useof a PAPR or a respiratory mask. Each ensemble was tested in total three times bypart of 10 volunteers. There were only four ensembles that led to contamination:the ensemble recommended by WHO, North Carolina authorities, CDC and HealthCanada. The first three consist of coveralls and the last one is a gown.
Outcome: user satisfaction
Chughtai 2018 also asked users to ratethe ease of donning and doffing. The ECDC coverall and protocol was rated highestfor ease of donning and doffing. Since there were only three ratings per ensemble,this has only a limited meaning.
2. Modifications versus standard gear
2.1 Sealed gown‐glove interface versus traditional gown‐gloveinterface
Outcome: contamination
Tomas 2016 found that participants doffinga gown that had continuous coverage of skin from arm to hand (sealed suit) were lesslikely to contaminate themselves with fluorescent lotion than those doffingtraditional PPE of gown and glove (RR 0.27; 95% CI 0.09 to 0.78; Analysis 6.1). The study authors obtained similarresults when they used MS2 bacteriophage as the contaminate (RR 0.68; 95% CI 0.47 to0.98; Analysis 6.2).
Analysis
Comparison 6: Gown sealed gloves versus standard gown, Outcome 1: Contaminationfluorescent lotion
2.2 Easy‐doffing gown versus traditional gown
Outcome: contamination
Mana 2018 compared a gown with modifiedneck and wrist design to facilitate doffing with a traditional gown and found fewerpeople with contamination with both fluorescent marker (RR 0.08, 95% CI 0.01 to0.55; Analysis 7.1) and with harmless virus(RR 0.53, 95% CI 0.29 to 0.94; Analysis 7.2).Even though we received additional information from the study authors we were unableto conduct a proper paired analysis.
Analysis
Comparison 7: Gown easy to doff versus standard gown, Outcome 1: Contamination withfluorescent marker
2.3. Modified gown‐glove interface versus standard gown‐gloveinterface
Outcome: contamination
Hajar 2019 modified the gown‐gloveinterface with more overlap between gown and glove. They evaluated this in twodifferent groups. In one they compared the modified gown to a standard gown and inthe other they added extra education to both intervention and control group. Thisled to considerably less contamination (RR 0.45, 95% CI 0.26 to 0.78, Analysis 8.1) in the meta‐analysis of the twotrials. We could not take into account that the trials had a cross‐over design butanalysed these as if they were parallel trials with twice the number ofparticipants. This may have led to a slight overestimation of the precision.
2.4. Modified‐inside gown versus standard gown
Outcome non‐compliance: errors during donning, doffing,performance
Drews 2019 redesigned the gown based onobserved errors during doffing, donning and performing tasks. They found a similarnumber of people with errors while donning (RR 0.93, 95% CI 0.50 to 1.72; Analysis 9.1), while performing tasks (MD −0.30,95% CI −0.67 to 0.07; Analysis 9.2) and whiledoffing (RR 0.81, 95% CI 0.33 to 2.00; Analysis9.3).
Analysis
Comparison 9: Gown with marked inside versus standard gown, Outcome 1: Noncompliancedonning: people with errors
Analysis
Comparison 9: Gown with marked inside versus standard gown, Outcome 2: Noncompliance:errors during performance
2.5 Gloves with tabs versus gloves without tabs
Outcome: contamination
Gleser 2018 found a decrease in people withcontamination when doffing gloves with tab near thumb and wrist compared to standardgloves (RR 0.22, 95% CI 0.15 to 0.31; Analysis10.1).
2.6 Masks with tabs versus masks without tabs
Outcome: contamination
Strauch 2016 found that contamination fromhands to the head was less when the participant doffed a mask with tabs on the strapengineered as a doffing aid compared to a mask without tabs (RR 0.33, 95% CI 0.14 to0.80; Analysis 11.1). There was no differencein contamination rates when participants doffed a contaminated mask that either had ordid not have tabs (RR 0.96; 95% CI 0.83 to 1.12; Analysis 11.2).
Analysis
Comparison 11: Mask with tabs versus no mask tabs, Outcome 1: Contamination of headfrom hands
3. Changes in donning or doffing procedures
3.1 Double‐gloving versus single‐gloving
Outcome: contamination with MS2 virus
Both Casanova 2012 and Osei‐Bonsu 2019 found that contamination withthe use of double gloves was less than with single gloves. We felt that the studieswere comparable even though the first used harmless virus and the second harmlessbacteria as the simulated exposure. When all contaminated sites were taken togetherthe RR was 0.34 (95% CI 0.17 to 0.66; Analysis12.1). For the specific body parts the reduction was less clear (Analysis 12.1). Also when measured withfluorescent marker, there was no difference between double‐ and single‐gloving (RR0.98, 95% CI 0.75 to 1.28; Analysis12.4).
Analysis
Comparison 12: Doffing with double gloves versus doffing with single gloves, Outcome 1:Contamination: virus detected
Analysis
Comparison 12: Doffing with double gloves versus doffing with single gloves, Outcome 4:Contamination with fluorescent
All participants had some level of contamination. Measured as the quantity of virusfound, the hands were less contaminated after degloving when participants useddouble gloves but due to missing data we could not test this.
Outcome: compliance with guidance ‐ compliance errors
No more errors in compliance occurred with the donning or doffing protocol fordouble‐gloving compared to single gloving (RR 1.08, 95% CI 0.70 to 1.67; Analysis 12.3).
3.2 CDC‐recommended procedure versus individual doffing
Outcome: contamination
Guo 2014 found that the CDC's recommendedway of doffing a gown or an apron led to a different decrease in contaminationcompared to individually chosen doffing. When doffing the gown, there were 5.4 fewersmaller contamination patches (95% CI −7.4 to −3.4) and 5.2 fewer stains in theenvironment (95% CI −7.3 to −3.3), but no difference in small contamination patcheson the hands, shoes or underwear. With doffing the apron, there were fewer smallerstains, stains on the hands, shoes, and environment, but more large stains and asimilar number of stains on the underwear (Analysis13.1; Analysis 13.2).
Analysis
Comparison 13: CDC versus individual doffing, Outcome 1: Gown: contamination with fluormarker
3.3 CDC‐recommended procedure versus single step
Outcome: contamination
Osei‐Bonsu 2019 evaluated doffing gown andgloves in a single step versus the standard gloves first procedure and found nodifference in contamination with fluorescent marker (RR 0.98, 95% CI 0.75 to 1.28;Analysis 14.1) but with bacterialcontamination there was a considerable difference (RR 0.20, 95% CI 0.05 to 0.77;Analysis 14.2). It is unclear what wouldcause this difference in effect between the two outcome measures. We would beinclined to assume that the bacterial simulation is more realistic than thefluorescent powder.
3.4 Doffing with extra disinfection of gloves
a. Alcohol‐based sanitation of gloves versus no extra glovesanitation
Outcome: bacterial contamination
Osei‐Bonsu 2019 compared alcohol‐basedglove sanitation versus no glove sanitation and found no considerable reduction inthe number of people contaminated (RR 0.75, 95% CI 0.39 to 1.45; Analysis 15.1). Kpadeh Rogers 2019 found a non‐significantreduction in bacterial contamination from a median 2.4 colony‐forming units (CFUs)to 2.2 CFUs for both bacteria used when alcohol‐based hand rub was used versus noextra sanitation of gloves.
Analysis
Comparison 15: Doffing with extra sanitation of gloves versus standard no sanitation,Outcome 1: Bacterial contamination
b. Quaternary ammonium versus no extra glove sanitation
Outcome: bacterial contamination
Kpadeh Rogers 2019 found a significantreduction in bacterial contamination from a median 2.4 CFUs to 0 CFUs for bothbacteria used for simulating exposure when quaternary ammonium‐based hand rub wasused versus no extra sanitation of gloves.
c. Bleach versus no extra glove sanitation
Outcome: bacterial contamination
Kpadeh Rogers 2019 found a significantreduction in bacterial contamination from a median 2.4 CFUs to 0 CFUs for bothbacteria used for simulating exposure when bleach‐based hand rub was used versusno extra sanitation of gloves.
d. Hypochlorite sanitation versus alcohol‐based sanitation
Outcome: viral contamination
Casanova 2016 found non‐significantlygreater self‐contamination of bacteriophage MS2 to the hands, face or scrubs whenhypochlorite solution was used for the glove sanitising step of the doffingprotocol compared to the use of an alcohol‐based hand rub (RR 4.00, 95% CI 0.47 to34.24; Analysis 18.1). The study authorsdid not detect contamination of bacteriophage Ph6 when using either alcohol‐basedhand rub or the hypochlorite solution (Analysis18.2).
Analysis
Comparison 18: Doffing with hypochlorite versus doffing with alcohol‐based glovesanitiser, Outcome 1: Contamination MS2
e. Chlorine spray versus no spray
Houlihan 2017 compared the risk of HCWcontracting Ebola when either using or not using a chlorine spray during the doffingof PPE. However, there was no variation in the use of chlorine spray among clinicalworkers. The use only varied between clinical and laboratory workers. Since it isnot possible to disentangle risk of exposure and the use of hypochlorite solution,no conclusions can be drawn from this study with regard to PPE.
3.5 Additional spoken personal instructions versus no suchinstructions
3.5.1. Outcome: compliance with guidance ‐ noncompliance
Casalino 2015 found that there weresubstantially less noncompliance (people with one or more errors) after additionalspoken instruction compared to no instructions with (RR 0.31, 95% CI 0.11 to 0.93)and also that the mean number of errors fell by on average almost one (MD −0.89, 95%CI −1.36 to −0.41) in the group with spoken instructions (Analysis 16.1; Analysis 16.2).
Analysis
Comparison 16: Donning and doffing with instructions versus without instructions,Outcome 1: People with one or more errors
Analysis
Comparison 16: Donning and doffing with instructions versus without instructions,Outcome 2: Non‐compliance: mean errors
Andonian 2019 organised team work betweenthe person with PPE and doffing assistants who guided the donning and doffingprocess and found a decrease in the number of sites contaminated with eitherfluorescent marker or particles (MD −5.00, 95% CI −8.08 to −1.92). We assumed thatthe median reported by the study authors would be roughly equal to the mean and theinterquartile range equalled, 1.35 SD.
3.5.2. Outcome: infection rate
One study compared infection rates between people who had instructions whiledonning and doffing versus rates in those without instructions. Due to the fact thatthe exposure was also different between these two groups, we were unable to drawconclusions about the protective effect of instructions (Houlihan 2017).
4. Training and instructions
4a. Training and instruction for proper and complete PPE use
4a.1 Active training versus passive training
4a.1.1 Outcome: compliance with guidance ‐ noncompliance with PPEguidance
Shigayeva 2007 defined consistentadherence as always wearing gloves, gown, mask, and eye protection. We transformedthis to inconsistent use as being noncompliant with the guidance. The study foundthat active training led to less noncompliance than no training (OR 0.37, 95% CI0.2 to 0.58). For passive training, they found a lower risk of noncompliancecompared to no training (OR 0.58, 95% CI 0.33 to 1.00). For the indirectcomparison, active versus passive training, the OR was 0.63 (95% CI 0.31 to 1.30;Analysis 20.1).
4b. Training and instruction for PPE donning and doffing
4b.1. Active versus passive instruction
4b.1.2. Outcome: compliance with guidance ‐ noncompliance withdoffing procedures
Shigayeva 2007 found no considerableeffect of active (OR 0.70, 95% CI 0.45 to 1.11) or passive training (OR 1.56, 95%CI 0.83 to 2.94) compared to no training on the number of errors in compliancewith the doffing protocol. For the indirect comparison, active versus passivetraining, the OR was 0.45 (95% CI 0.21 to 0.98; Analysis 19.1).
4b.2. Additional computer simulation versus no additional computersimulation
4b.2.1. Outcome: compliance with guidance ‐ noncompliance
Even though the number of errors was already low, Hung 2015 found that adding computersimulation reduced the number of errors with on average half an error for donning(MD, −0.52, 95% CI −0.90 to −0.14; Analysis20.1) and with more than one error for doffing (MD −1.16, 95% CI −1.63 to−0.69; Analysis 20.2).
4b.3 Video‐based learning versus traditional learning
Curtis 2018 compared skills in donning PPEwhen taught with a video‐based learning method versus a traditional lecture. Thosethat participated in the video learning had a higher mean score on the post‐examthan those who attended a traditional lecture. (MD 30.7, 95% CI 20.14 to 41.26;Analysis 21.1).
5. Subgroup and sensitivity analysis
We planned a subgroup analysis of studies conducted in high‐ versus low‐ andmiddle‐income countries. However, there were not enough studies for such a subgroupanalysis to be meaningful.
We also planned a sensitivity analysis including only studies we judged to have a lowrisk of bias. As none of the included studies fulfilled this criterion, we could notperform this analysis.
6. Certainty of the evidence
We judged if there was a reason to downgrade the certainty of the evidence for eachdomain of GRADE. Since we judged all studies to have a high or unclear risk of bias, wedowngraded the evidence for all comparisons by one level. We considered simulationstudies to be indirect evidence, and downgraded the evidence yielded by these studies byone level as well. In addition, when there was only one small study, we downgradedbecause of imprecision. All in all, the certainty of the evidence is low to very low forall comparisons. For the non‐randomised studies, there were no reason to upgrade thecertainty of the evidence.
Discussion
Summary of main results
Almost all findings are based on one or at most two small simulation studies. Therefore,we judged the certainty of the evidence as very low or low.
One type of PPE compared to another
One study found less contamination when a PAPR with hood and coverall was used comparedto a gown and a N95 mask but there were more errors in donning with the PAPR (Table 1).
Three studies compared different types of body protection. One study found that moreprotective gear protected slightly better but was more uncomfortable because of lack ofbreathability (Table 2). Another study found gowns to bebetter than aprons (Table 3). The third study did not providedata.
Three studies compared more recently proposed PPE ensembles according to differentguidelines. One study found too few contamination events to draw conclusions. Anotherstudy found that long gowns protected better than a coverall or isolation gown and thecoverall was difficult to doff (Table 4).
Modifications versus standard attire
Three studies compared changes to gowns especially related to improved doffing andchanged glove‐gown interface and found considerably less contamination (Table 5; Table 6; Table 7). One study modified the inside of the gown and theclosure system but found no difference in errors with donning or doffing or duringperformance.
Two studies evaluated the effect of tabs to improve ease of donning and found lesscontamination with tabs on masks or gloves (Table 8; Table 9).
One type of donning or doffing procedure compared to another
There are eight studies that compared donning and doffing procedures.
Following CDC recommendations for doffing gowns and aprons compared to individuallychosen ways may decrease the risk of contamination (Table 10).Doffing of gloves and gown in one step may also decrease the risk of contamination(Table 11).
For doffing, there is very low‐certainty evidence that double‐gloving as part offull‐body PPE may reduce the risk of contamination and reduce the viral load on thehands without increasing the frequency of noncompliance with the doffing protocol (Table 12). Instructions during doffing may increase compliance(Table 13). Adding extra steps to the process in the form ofglove disinfection may not be effective for alcohol‐based rub but may decrease viral andbacterial contamination when quaternary ammonium or bleach is used (Table 14). There is no difference in contamination between usingalcohol‐based hand rub during doffing and using chlorine based disinfection (Table 15).
One type of training versus another
Three studies compared training models. There is very low‐certainty evidence from oneSARS‐related study and two simulation studies that more active training in PPE usedecreases noncompliance with donning and doffing guidance more than passive training.The active training used in the studies was video or computer simulation or face‐to‐facetraining compared to lectures (passive) only (Table 16).
We found no audit reports or other unpublished reports or data from our contact effortsto manufacturers and other organisations.
Overall completeness and applicability of evidence
Most studies provided sparse descriptions of the level of chemical protection (ISO 2013), or viral protection (EN 14126; ISO2004a), of the PPE they used, or the outfits used varied so much in theircomponents that it was impossible to make uniform comparisons.
For some PPE parts such as face shields and goggles, we found no studies that comparedthe two. There is, however, evidence from studies with viruses that do not have seriousconsequences and from simulation studies with manikins that each protects compared to nointervention (Agah 1987; Lindsley 2014). In a thorough overview of face shieldsfor infection prevention, Roberge 2016 concludesthat even though face shields can considerably reduce droplet contamination of the face,more research is needed into their efficacy. Other technical laboratory studies withoutinvolvement of humans also support the findings of this review. Kahveci 2019 found that double gloving can reducecontamination by reducing the fluid leakages through the glove‐gown interface.
Doffing procedures are fairly easy to evaluate in simulation studies. We found severalstudies that confirmed that it is important to follow procedures. However, all studieswere small and only the comparisons about double‐gloving disinfection procedures andspoken instructions had more than one study. It seems that it would not be difficult toperform more and better simulation studies to find out how important these proceduresare.
Because studies seem feasible and because we searched exhaustively, there must be otherreasons why there is so little evidence available with infection rates as an outcome. Oneof these is probably the highly politicised context in which such a study has to beperformed during an epidemic. However, retrospective cohort and case‐control studies arepossible as has been shown during the SARS epidemic. The studies conducted after the SARSepidemic show that the consistent use of PPE rather than type of PPE was most important(see Appendix 1). At the start of the epidemic,SARS patients were not appropriately diagnosed, and the importance of PPE was notimmediately clear. PPE compliance was higher in the later stages, and infections occurredless frequently (Nishiura 2005). SARS alsoaffected comparatively higher‐income countries such as China, Hong Kong and Canada. Theexperiences from retrospective studies during Ebola epidemics are similar. During the 1995Ebola epidemic in Kikwit in the Democratic Republic of the Congo, a study also reportedthat once PPE and other control measures were used, there were very few HCW infections(Kerstiens 1999). Dunn 2015 is a case study from the Ebola epidemic thatalso provided systematic information on the use of PPE and infection rates. We reanalysedthe excluded study by Dunn 2015 as a cohort studyof exposed HCW (Verbeek 2016a). The risk ratio ofcontracting Ebola infection for HCW using gloves only versus those not using PPE was 0.16(95% CI 0.04 to 0.71) indicating that using gloves already provides a lot of protection.For using gloves or a gown or more compared to no PPE, the RR was 0.03 (95% CI 0.00 to0.57; Verbeek 2016a). This is very similar to thefindings of the SARS studies mentioned above. It is also, to a certain extent, reassuringfor those situations during an epidemic or in low‐ and middle‐ income countries, whensufficient PPE is not available (see Levy 2015),that some PPE decreases the risk of infection considerably. In this version of the reviewwe were able to include one retrospective cohort study from the 2015 West Africa Ebolaepidemic. Unfortunately, the information on PPE was not detailed enough to be able to drawconclusions.
While the included studies show that more active training prevented errors, it is notclear how long the effects of training last. Northington2007 showed that at six months after training, only 14% of participants were ableto correctly don and doff PPE. It is unclear from the included studies, if fit‐testing ofmasks is part of training. This is a commonly accepted prerequisite for proper functioningof respiratory protection.
We included only one study conducted in a low‐ and middle‐income country. Since mostserious haemorrhagic fever epidemics occur in some parts of Africa, this is a seriousdisadvantage of the current evidence. However, in such resource‐poor settings, appropriateresearch is the lowest priority for the local decision makers. Consequently, theinitiative has to come from WHO and international organisations that work in theseepidemics.
Quality of the evidence
We rated the certainty of the evidence as very low or low for all comparisons, mainlybecause our conclusions are based on single studies or two small studies and all theincluded studies had a high or unclear risk of bias. The retrospective cohort studies havea high risk of recall bias because participants had to recall their use of PPE after theepidemic occurred. The simulation studies had small sample sizes or very few events acrosscompared groups.
One of the major problems is that most of the studies did not indicate if the PPE thatthey used complied with one or more of the international standards for protective clothingand whether they used whether they used protective clothing that is constructed with viralresistant fabrics and seams. The lack of attention to the designation of PPE as beingprotective for viruses is also problematic in practice.Also the lack of description of thePPE significantly reduces the ability make clear conclusions.
The many different labels and standards that are in use to designate protection make italmost impossible for a HCW in practice to make the right choice. For EVD, it wasespecially problematic because HCW needed the highest standard of protection. Theconfusing language of infection control has also been reported for isolation practices ingeneral. This is why Landers 2010 called for theadoption of internationally accepted and standardised category terms for isolationprecautions. Others have tried to improve the standardisation by providing HCW with asummary card of the various types of precautions that have to be taken and indicated thatthis increased the implementation of precautionary measures (Russell 2015).
In simulation studies, it is not clear how well the exposure represents real lifeexposure. Some studies used 'high volume exposure to simulate splash' (Bell 2015), whereas other studies only used a powderedfluorescent marker spread in the room (Beam 2011).It is also not clear how well the fluorescent marker can indicate that there is no viralcontamination. Casanova 2008 showed that in spiteof no fluorescent marker being detected, there could still be viral contamination withbacteriophage MS2. On the other hand, Osei‐Bonsu2019 did not find a difference in effect with fluorescent marker as the outcomebut did find a difference with bacterial exposure.
Only one of the case studies that we collected (Dunn2015), properly described the use of PPE. Better description would enable betteranalysis.
Potential biases in the review process
We excluded all studies that evaluated only one piece of PPE, such as goggles or masks.However, none of these excluded studies would have answered the questions that in ourcurrent review remained unanswered. From Casanova2012, it became clear that using double gloves as part of full‐body PPE isimportant, because it facilitates the removal of the other pieces of PPE withoutcontaminating the hands. This shows that it is important to consider the effect of onepiece of PPE as part of full‐body PPE. In addition, seldom is there only one cleartransmission route. Even with SARS, which, as a respiratory infection, was spread bydroplets and aerosols, consistent use of other pieces of PPE besides respiratoryprotection was still important to prevent contact transmission. Therefore, we think thatour strict inclusion criteria did not bias the results of our review.
We assumed that adherence to PPE use and training would work in a similar way betweenSARS, EVD, and simulation studies. However, there is an important difference. At the startof the SARS epidemic, the causal virus and its transmission were unclear and workers wereprobably not instructed well enough to protect themselves. On the other hand, it has beenknown for years that EVD is a highly contagious disease with a very high fatality rate.Thus, compliance and effectiveness of training concerning EVD might be higher than weconcluded from the SARS study. In the SARS studies that we excluded, there was highheterogeneity in the effects of consistently wearing PPE that we could not explain. Theheterogeneity in effect is also underpinned by studies that did not find any SARSinfections in spite of imperfect protection with PPE. This means that at best theeffectiveness of PPE is not fully understood.
Twelve of the included simulation studies are cross‐over studies. But the authors of onlyfour studies analysed the data with tests that took into account the paired nature of thedata: Zamora 2006 used the Mailand‐Gart test;Guo 2014 used repeated measures; and Casanova 2012 and Strauch 2016 the paired t‐test but the methods used in Mana 2018 were unclear. We could not use the resultsof these tests in our analyses in Review Manager2014, which resulted in wider confidence intervals than using a paired analysis.There were insufficient data in the studies to properly adjust for the cross‐over effectin our analyses. However, all results that were reported as being statisticallysignificant were also statistically significant in our analyses. Therefore, we think thatthis has not biased our results.
With the simulation studies the way exposure was simulated is an important element toconsider. This varied highly between the studies. However, most studies used a worst casescenario, spraying fluorescent marker over large parts of the body but some studiesapplied only small amounts. Hall 2018 used asophisticated manikin with an internal mechanism simulating exposure as described by Poller 2018. Future studies urgently need consensusfrom experts in the field on how exposure can be best simulated. This is best possibleunder the auspices of WHO or other internationally recognised bodies.
With the included non‐randomised studies, we assessed risk of bias with a hybrid versionof the Cochrane 'Risk of bias tool' (Higgins 2017)and the recently developed ROBINS‐I tool (Sterne2016). This might not have been the optimal way to assess risk of bias. However,we believe that the limitations of the available studies are profound and a more rigorous'Risk of bias' assessment could not have lowered (or improved) our confidence in theevidence any further.
Agreements and disagreements with other studies or reviews
We found two other reviews that have evaluated the effect of PPE for highly infectiousdiseases with serious consequences in HCW: Hersi2015 and Fischer 2015. Hersi 2015 was commissioned by WHO to underpin the PPEguidelines issued for HCW exposed to EVD. The authors originally included only controlledstudies of interventions to protect HCW against EVD and similar haemorrhagic feverinfections with infection rates as outcomes. During the review process the authors decidedto also include case studies and case series but they were not able to draw conclusionsfrom these studies because the PPE use was not well described. Fischer 2015 took a more pragmatic but unsystematicapproach and included all articles pertaining to filovirus transmission and PPE and inaddition articles that evaluated donning and doffing strategies. They conclude that thereis a lack of evidence but that simulation studies could provide evidence forguidelines.
Heat stress and breathability is an important issue in PPE especially for Ebola. Kuklane 2015 argued that using other materials wouldsubstantially reduce the heat stress but these come at a tenfold higher price. Otherresearchers that have looked into this problem have found inconsistent results. Coca 2015 found that PPE on manikins led to a criticalbody core temperature of 38.4ºC in one hour. On the other hand, Grélot 2015 found that HCW caring for Ebola patientshad only a 0.46ºC rise in core body temperature after being at work for one hour. Of the25 workers studied, only four reached a core body temperature over 38.5ºC.
An independent panel of experts that evaluated the Ebola response concluded, among manyother things, that a coordinated research effort is needed to build a better global systemfor infectious disease outbreak and response (Moon2015). Their recommendation is that research funders should establish a worldwideresearch and development financing facility for outbreak‐relevant drugs, vaccines,diagnostics, and non‐pharmaceutical supplies (such as PPE). This is very much in line withwhat we experienced and found in this review.
Missair 2014 reviewed implications of EVD patientmanagement for anaesthetists based on a literature review of all types of studies on EVD.This is why their inclusion criteria were very broad and non‐specific. Finally the authorsrelied on PPE guidelines as provided by WHO and MSF to make recommendations with noevidence of their comparability. This makes their results difficult to compare toours.
Moore 2005 reviewed all measures to preventhealthcare workers from SARS and other respiratory pathogens in a narrative format, from168 publications. They concluded that a positive safety climate is the most importantfactor for adherence to universal precautions. They recommend using adequate PPE, but theydo not define 'adequate'. Their inclusion criteria were much broader than ours and theirresults are difficult to compare with ours. The same research group formulated valuableadvice about research gaps based on this review but focused only on respiratory protection(Yassi 2005). They corroborate the findings ofJefferson 2011, that N95 respirators may not besuperior, citing the early containment of the SARS epidemic without these in Hanoi.
The Cochrane Review by Jefferson 2008, updated inJefferson 2011, evaluated the effect of physicalinterventions to interrupt the spread of respiratory viruses for all patient and staffpopulations. Even though they only included studies on respiratory infections and any typeof protection for any person at risk, 10 studies in their review are about SARS andprotecting HCW. The authors did not conduct a subgroup or additional analysis of these HCWstudies because the infection risk for HCW is substantially different from the populationsthey protect. The Jefferson 2011 results are notapplicable to HCW.
Authors' conclusions
Implications for practice
In addition to other infection control measures, consistent use of full‐body personalprotective equipment (PPE) can diminish the risk of infection for healthcare workers(HCW). EN (European) and ISO (international) standards for protective clothing andfabric permeability for viruses are helpful to determine which PPE should technicallyprotect sufficiently against highly infectious diseases. However, the risk ofcontamination depends on more than just these technical factors. In simulationstudies, contamination happened in almost all intervention and control arms.
For choosing between PPE types, there is very low‐certainty evidence, based onsingle‐exposure simulation studies. Covering more parts of the body leads to betterprotection but usually comes at the cost of more difficult donning (putting on) ordoffing (taking off) and user comfort, and may therefore even lead to morecontamination. A powered, air‐purifying respirator (PAPR) with a hood may protectbetter than an N95 mask with a gown but is more difficult to don. A long gown may bethe best compromise between protection and ease of doffing. Coveralls may be moredifficult to doff. A more breathable fabric may still lead to similar levels ofcontamination protection to less breathable fabric, and may be preferred by users.
For changes to PPE, there is low‐ to very low‐certainty evidence that adding tabs togloves or masks or closer fit of gowns at the neck or the wrist may decreasecontamination, even though one study could not show a decrease in donning or doffingerrors.
For different procedures of donning and doffing, there is very low‐certainty evidencethat double gloves, as part of PPE and following Centers for Disease Control andPrevention (CDC) guidelines, and providing users with help or spoken instructionsduring donning and doffing may reduce the risk of contamination. Extra disinfection ofgloves with bleach or quaternary ammonium may decrease hand contamination but notalcohol‐based hand rub.
For various training procedures there is very low‐certainty evidence that more activetraining (including video or computer simulation or spoken instructions) may increasecompliance with instructions compared to passive training (lectures or no addedinstructions). No studies compared methods to retain PPE skills needed for properdonning and doffing in the long term.
The certainty of the evidence is low to very low for all comparisons becauseconclusions are based on one or two small studies and a high or unclear risk of biasin studies, indirectness of evidence, and small numbers of participants. This meansthat we are uncertain about the estimates of effects and it is therefore possible thatthe true effects may be substantially different from the ones reported in thisreview.
Implications for research
We concur with the World Health Organization (WHO) that there is a need to carry outa re‐evaluation of how PPE is standardised, designed, and tested (WHO 2018). What is missing is a harmonised set ofPPE standards and a unified design for PPE to be used when taking care of patientswith highly infectious diseases. This holds for PPE as used for preventing contacttransmission as well as other ways of transmission. There is, for example, no unifiedtechnical standard for isolation gowns. There is also a need for a more transparentand uniform labelling of infection control measures, such as droplet precautions, andthe protection level of PPE for HCW. We believe that this is an important prerequisitefor the universal implementation of infection control measures for HCW.
Simulation studies are a feasible and relatively simple way to compare differenttypes of PPE and to find out which protects best against contamination. It is aprerequisite for a reliable answer that methods of simulation studies are standardisedin terms of exposure and outcome measurement. We recommend developing a core outcomeset (COS) in this field that would provide critical outcomes measures to enable bettercomparisons and synthesis across trials. Viral marker bacteriophage MS2 seems to bethe most sensitive marker and we would advocate using this. Studies should havesufficient power. A sample size of 62 would be needed to be able to detect arelatively large risk ratio of 0.5 with a large control group rate of contamination of0.7, assuming α = 0.05 and β = 0.80. In addition, it would help evidence synthesis ifstudy authors would better adhere to the appropriate reporting guidelines (Cheng 2016).
To find out how PPE behaves under real exposure, we need prospective follow‐up of HCWinvolved in the treatment of patients with highly infectious diseases, with carefulregistration of PPE, donning and doffing and risk of infection. Here, the effect sizeswould be smaller and thus the sample size should be bigger than 60.
In addition, case‐control studies comparing PPE use among infected HCW and matchedhealthy controls, using rigorous collection of exposure data, can provide informationabout the effects of PPE on the risk of infection. The sample sizes should be muchbigger than the current case studies because we would like to detect small butimportant differences in effect between various combinations of PPE such as gownsversus coveralls. There is a need for collaboration between organisations servingepidemic areas to carry out this important research in circ*mstances with limitedresources, and during the throes of an outbreak.
We also need more randomised controlled studies of the effects of one type oftraining versus another, to find out which training works best, especially atlong‐term follow‐up of one year or more. Here also, the effect size seems to be quitelarge and thus a sample size of around 60 seems to provide adequate power.
Feedback
Unified design for PPE, September 2019
Summary
We noted the timely and welcome update of the above review by Dr Verbeek and his team.As stated in the introduction, in epidemics of highly infectious diseases such as EbolaVirus Disease (EVD), healthcare workers (HCW) are at much greater risk of infection thanthe general population. Sadly the review comes at a time when this once again is beingproved, with recent (20th July, 2019) data from the Democratic Republic of Congo (DRC)recording that since the beginning of the epidemic, the cumulative number of cases hasbeen 2564 (2470 confirmed and 94 probable) with 1728 deaths (1634 confirmed and 94probable cases). Of those, the cumulative number of confirmed/ probable cases amonghealth workers is 138 (5% of all confirmed/probable cases) including 41 deaths (1). Thiscomes shortly after the World Health Organization declared EVD in DRC a Public HealthEmergency of International Concern (2). With the United Nations also recognising theseriousness of the emergency, by activating the Humanitarian System‐wide Scale‐Up tosupport the EVD response, this increases the possibility of HCW from around the globebeing called upon to provide practical support in country, or travellers to affectedcountries returning with infection, and with it the need for personal protection fromexposure to patients’ contaminated body fluids.
We were pleased that data from our recent research (3) was included in the review. Inour study, we compared five PPE ensembles used in different high consequence infectiousdisease (HCID) units around the UK for examination of a ‘suspected case’, using amedical training manikin to expose HCW wearing the PPE to four different body fluidsimulants, each tagged with different colour fluorochromes, and UV light to visualiseany cross‐contamination during dry doffing. We note and accept the conclusions of theReview that “what is missing is a harmonised set of PPE standards and a unified designfor PPE to be used when taking care of patients with highly infectious diseases”, alsothat the quality of the evidence was low because conclusions were based on singlestudies or on small numbers of participants.
While resources did not allow us to address the ‘small numbers’ issue, we haveaddressed the ‘unified design for PPE’ in a paper which was published after the Reviewliterature search cut‐off date. In this follow‐up work, we presented the outcome of theinitial research to the HCID units and reached a consensus on a unified PPE ensemble forexamination of a suspected HCID case. Again, using HCW volunteers, we tested the unifiedPPE ensemble with fluorochromes as before, the result being no cross contaminationevents from 20 volunteers (4). In subsequent HCW training for one HCID unit, a further40 challenges using 35 volunteers tested the PPE ensemble with only one crosscontamination event through a known deviation from the doffing protocol (unpublisheddata).Therefore, there were 60 challenges with 54 volunteers with one breach. PublicHealth England plan in the near future to make written and video guidance available todemonstrate safe use of this unified PPE ensemble, and similar guidance is alreadyavailable through Health Protection Scotland (5).
While more is needed, we believe this adds to the body of evidence required to ensureHCW can conduct the important business of patient care with confidence that they will beprotected from potential infection.
Brian Crook(a), Anne Tunbridge(b), Bozena Poller(b), Samantha Hall(a), CariadEvans(c) on behalf of the High Consequence Infectious Diseases Project Working GroupUK
(a) Health and Safety Executive, Harpur Hill, Buxton SK17 9JN UK, (b) SheffieldTeaching Hospitals NHS Foundation Trust, Department of Infectious Diseases, RoyalHallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK, (c) Sheffield TeachingHospitals NHS Foundation Trust, Department of Virology, Northern General Hospital,Herries Road, Sheffield, S5 7AU, UK
References
1. DRC Ministry of Health. Epidemiological situation report, Fri 20 Jul 2019. Availableat: https://mailchi.mp/sante.gouv.cd/ebola_kivu_20juil19?e=77c16511ad
2. WHO news release 17th July, 2019. Available at: https://www.who.int/news-room/detail/17-07-2019-ebola-outbreak-in-the-democratic-republic-of-the-congo-declared-a-public-health-emergency-of-international-concern
3. Hall S, Poller B, Bailey C, Gregory S, Clark R, Roberts P, Tunbridge A, Poran V,Evans C, Crook B. Use of ultraviolet‐fluorescence‐based simulation in evaluation ofpersonal protective equipment worn for first assessment and care of a patient withsuspected high‐consequence infectious disease. J Hosp Infect 2018;99: 218‐228
4. Poller B, Tunbridge A, Hall S, Beadsworth M, Jacobs M, Peters E, Schmid ML, Sykes A,Poran V, Gent N, Evans C, Crook B on behalf of the High Consequence Infectious DiseasesProject Working Group. A unified personal protective equipment ensemble for clinicalresponse to possible high consequence infectious diseases: A consensus document onbehalf of Public Health England and the Health and Safety Executive. Journal ofInfection 2018;77:496–502
5. NHS Education for Scotland. Viral Haemorrhagic Fever‐ The correct order for donningand the safe order for removal and disposal of Personal Protection Equipment. Availableat:https://www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/public-health/health-protection/travel-and-international-health/viral-haemorrhagic-fever.aspx
Reply
Thank you for the comments and for supporting the conclusions of our review. It isgreat to see that the use of PPE for highly infectious diseases is becoming standardisedin the UK. Compared to the current diversity in outfits this is certainly animprovement.
We believe that controlled studies form the best evidence in showing the protectivecapabilities of PPE against highly infectious diseases. We have no doubts that PPE helpsin preventing infection. The question remains what the best possible PPE is. Given thatinfections still occur among health care workers and that users are not very satisfiedwith the PPE ensembles currently in use, improvement is still possible. Therefore, weincluded only controlled studies that compared newly designed PPE with existing PPE. The20 test of one type of PPE by 17 volunteers in the Poller 2018 study were anuncontrolled experiment. Unfortunately, the paper did not provide data on the test ofvolunteers but only reported that there were no contaminations. Without knowing furtherdetails of this study, for example how many times the volunteers tested the new PPEensemble, it is difficult to judge the significance of this result.
We also noticed that the agreed PPE ensemble currently does not include tags on glovesand masks or a sealed gown‐glove combination. These are both aspects that are supportedby some evidence in our updated Cochrane review, meaning that these may preventcontamination more than conventional PPE. Therefore, we think that the agreed PPEensemble could still be improved. We also hope that the newly agreed ensemble, and anyfurther improvements upon it, will be tested against the currently used ones in asufficiently large randomised experiment of simulated exposure.
Contributors
Jos H Verbeek, Blair Rajamaki, Sharea Ijaz, Christina Tikka, Jani H Ruotsalainen,Riitta Sauni
Certainty of the evidence, November 2019
Summary
This is a large scale and important review. On the next update, the review may benefitfrom up‐to‐date application of GRADE. Authors should use the term 'certainty' ratherthan 'quality' of evidence. At present, the term 'certainty' features in GRADE tables,but 'quality' throughout the text. Although the authors GRADE all comparisons as verylow certainty, in the abstract the authors present findings using the term 'may', forexample: "may protect better". The accepted plain language for very low certaintyevidence is 'we do not know', and the review may therefore over‐represent the certaintyof evidence. The authors should consider how best to ensure the very low certainty ofevidence is adequately reflected for each result presented.
Paul Hine, Honorary research fellow, Cochrane Infectious Diseases Group
Reply
Thank you very much for your comments on our review and pointing out the inconsistencyin using quality and certainty of the evidence. We will repair this throughout thereview with the next update.
We don't think that the phrase 'may improve' instead of ‘we don't know’ over‐representsthe certainty of the evidence. At the beginning of the abstract we state: 'Evidence forall outcomes is based on single studies and is very low quality'. Recent GRADE guidancesays that very low certainty evidence can be reported as 'may improve but the evidenceis very uncertain'.1 This is also the guidance in the latest version of theCochrane Handbook (Table 15.6.b). We will add the additional "but the evidence is veryuncertain" to the phrase 'may improve' in the review update in line with the most recentGRADE guidance.
1Santesso N, Glenton C, Dahm P, Garner P, Akl E, Alper B, Brignardello‐Petersen R,Carrasco‐Labra A, De Beer H, Hultcrantz M, Kuijpers T, Meerpohl J, Morgan R, MustafaR, Skoetz N, Sultan S, Wiysonge C, Guyatt G, Schünemann HJ, for the GRADE WorkingGroup, GRADE guidelines 26: Informative statements to communicate the findings ofsystematic reviews of interventions, Journal of Clinical Epidemiology (2019)
Contributors
Jos H Verbeek, Blair Rajamaki, Sharea Ijaz, Christina Tikka, Jani H Ruotsalainen,Riitta Sauni
Comparisons, April 2020
Summary
The comparison of PAPR and gown, vs N95 and gown is a poor comparison. And should notbe used as a fair comparison and will likely give HCW the wrong impression. PAPR/CAPRand gown vs N95 and face shield with gown should be the equal comparison arms. Pleaseconsider this as this will give people the wrong messaging as we know face shields arean important component to PPE and we should do a real comparison as to determine whetherone protection is better than another.
Michael Bolaris
Reply
Thank you for comments. We were already quite strict with including only studies thatintended to evaluate full‐body protection. We don't have control over the interventionsand controls that have been evaluated in studies. This specific combination ofintervention and control was evaluated in one trial as a result of the problemsencountered with aerosol generating procedures during the SARS epidemic. We think thatthe results are still very useful for the current COVID‐19 pandemic. The difference incontamination with the two types of PPE was especially caused by contamination of theneck in the PPE that consisted of mask and gown but where the gown did not cover theneck. We doubt that a face‐shield would have made much difference here because it doesnot protect the neck. The current WHO COVIID‐19 guidelines suggest the use of a gownwith face mask and goggles as minimum PPE. This PPE ensemble leaves a part of the bodyuncovered and the trial mentioned above shows that this can easily lead tocontamination
Contributors
Jos H Verbeek, Blair Rajamaki, Sharea Ijaz, Riitta Sauni, Elaine Toomey, BronaghBlackwood, Christina Tikka, Jani H Ruotsalainen, F Selcen Kilinc Balci
What's new
| Date | Event | Description |
|---|---|---|
| 24 April 2020 | Feedback has been incorporated | Feedback about comparisons and author response incorporated |
History
Protocol first published: Issue 4, 2015
Review first published: Issue 4, 2016
| Date | Event | Description |
|---|---|---|
| 30 March 2020 | New citation required and conclusions have changed | Seven new studies incorporated, revised to incorporate COVID‐19 developments,conclusions changed. |
| 30 March 2020 | New search has been performed | All searches updated, new studies incorporated, categorisation ofinterventions slightly changed, background revised to incorporate COVID‐19developments, conclusions changed |
| 5 December 2019 | Feedback has been incorporated | Feedback about the certainty of the evidence and authors' responseincorporated |
| 13 September 2019 | Amended | Feedback updated with more information from latest tests |
| 9 September 2019 | Feedback has been incorporated | Feedback and authors' response added |
| 22 July 2019 | Amended | In summary of findings tables we corrected the number of plusses for thequality of the evidence to match the very low quality evidence |
| 20 June 2019 | New citation required and conclusions have changed | We included eight new studies of which one is a field study and seven aresimulation studies. This extended the evidence to other types of PPE. |
| 18 June 2019 | New search has been performed | Updated the databases:PubMed up to 15 July 2018, CENTRAL up to 18 June 2019,Scopus 18 June 2019, CINAHL 31 July 2018 and OSH‐Update up to 31 December2018 |
Notes
Disclaimer. The findings and conclusions in this Cochrane systematic review are those ofthe authors and do not necessarily represent the official position of the National Institutefor Occupational Safety and Health, Centers for Disease Control and Prevention. Mention ofproduct names does not imply endorsem*nt
Acknowledgements
We thank the Cochrane Editorial Unit for providing financial support to undertake thisreview. For this 2020 update, we thank Ruth Foxlee for updating the searches, Bozena Pollerand Nick Gent for peer referee comments, Euan S Shearer for consumer comments, TobyLasserson, Liz Bickerdike, Anne‐Marie Sephani, Robin Featherstone, and Helen Wakeford foreditorial input, and Denise Mitchell for copy‐editing the review.
We thank Kaisa Neuvonen, Erja Mäkelä and Raluca Mihalache and Michael Edmond for theircontributions as authors to the previous version of this review (Verbeek 2016b). We thank Toby Lasserson, Hannah Ryan,Darrel Singh, Fiona Smaill, Mauriccio Ferri, Annalee Yassi, Nuala Livingstone and JulianHiggins for their comments on the text for the first publication of this review (Verbeek 2016b). We extend a special thankyou to ConsolSerra for her editorial work. We thank Claire Allen from Evidence Aid for her help in tryingto locate unpublished reports. We thank Alexey Pristupa for assessing the studies written inRussian.
Sharea Ijaz's time for this update was supported by the National Institute for HealthResearch (NIHR) Collaboration for Leadership in Applied Health Research and Care West(CLAHRC West) at University Hospitals Bristol NHS Foundation Trust.
Appendices
Appendix 1. Effects of wearing personal protective equipment (PPE)consistently on the risk of SARS infection
Wearing PPE consistently versus wearing PPE inconsistently
During and just after the SARS epidemic a number of studies evaluated the impact of theuse of PPE on SARS infection rates. Six of these studies were case‐control studies andfive were retrospective cohort studies. Since information in these studies was collectedin the same retrospective way by questionnaires and/or interviews we combined theresults of these studies.
There were two studies (Le 2004; Park 2004), one in a single hospital in Vietnam andthe other in multiple hospitals in the USA, that reported no cases in spite ofsufficient exposure to SARS patients. The Vietnamese study claimed that this was becauseof the almost universal use of N95 masks later during the epidemic. The US study couldnot find an explanation because the use of PPE was not optimal in many cases. We couldfind no reasons to explain this result because these studies were similar to the otherstudies included. Also, in another hospital near the one in the Vietnamese study, SARScases did occur among healthcare workers but this was more at the beginning of theepidemic and it was unclear how well PPE had been used (Reynolds 2006).
1 Consistent mask use versus inconsistent use
We were able to combine six studies (Liu2009; Loeb 2004; Nishiura 2005; Scales 2003; Seto 2003; Teleman 2004), in a meta‐analysis that showed abeneficial effect of consistent mask use as part of PPE both in a fixed‐effect (OR0.28, 95% CI 0.17 to 0.46, I² = 42%) and in a random‐effects meta‐analysis model (OR0.27, 95% CI 0.13 to 0.53).
2 Consistent gown/suit use versus inconsistent use
Four studies (Loeb 2004; Nishiura 2005; Pei 2006; Teleman 2004), could becombined and showed that consistent gown use had a preventive effect on SARS infectionboth in a fixed‐ and random‐effects analysis (OR 0.22, 95% 0.10 to 0.50, I² = 53%).The data in Teleman 2004 were reported as OR0.5, 95% CI 0.4 to 6.9 P = 0.6). However, this is an apparent mistake as theconfidence interval does not fit with the OR nor with the P value. We corrected thisto OR 0.5, 95% CI 0.04 to 6.9 which makes the results consistent.
3 Consistent glove use versus inconsistent use
Also consistent glove use in six studies (Loeb2004; Nishiura 2005; Pei 2006; Scales2003; Seto 2003; Teleman 2004), led to a decrease in the risk ofSARS infection both in fixed‐effect meta‐analysis (OR 0.54 95% CI 0.33 to 0.89, I² =0%) and in a random‐effects analysis (OR 0.53, 95% CI 0.28 to 1.01) but this was notstatistically significant.
4 Consistent use of more than one PPE part versus inconsistentuse
Ho 2004, Lau2004, and Scales 2003 measuredconsistent use of more than one PPE part compared to no use at all. The combination ofmore than one PPE had a similar effect on SARS infection risk but this was notstatistically significant, neither in the fixed‐effect analysis (OR 0.36, 95% CI 0.09to 1.39, I² = 35%) nor in the random‐effects analysis (OR 0.37, 95% CI 0.07 to1.98).
Appendix 2. MEDLINE search strategy 15 July 2019
#1
"Protective Clothing"[Mesh] OR gown*[tw] OR coverall*[tw] OR "protective layer"[tw] OR"protective layers"[tw] OR "surgical toga"[tw] OR apron*[tw] OR "smock"[tw] OR"smocks"[tw] OR "hazmat suit"[tw] OR (hazmat[tw] AND suit[tw]) OR "Gloves,Protective"[Mesh] OR "glove"[tw] OR "gloves"[tw] OR "Respiratory Protective Devices"[Mesh]OR "Masks"[Mesh] OR "mask"[tw] OR "masks"[tw] OR "air‐purifying respirator"[tw] OR"PAPR"[tw] OR "enhanced respiratory and contact precautions" OR "E‐RCP"[tw] OR"respiratory protection"[tw] OR "transparent panel"[tw] OR "surgical mask"[tw] OR"surgical masks"[tw] OR "filtering face piece"[tw] OR "filtering facepiece"[tw] OR "EyeProtective Devices"[Mesh] OR goggle*[tw] OR "visor"[tw] OR "facial protectionequipment"[tw] OR "safety glass"[tw] OR "safety glasses"[tw] OR "safety spectacles"[tw] OR"personal protective equipment"[tw] OR "PPE"[tw] OR "protective equipment"[tw] ORovershoe*[tw] OR "shoe cover"[tw] OR "shoe covers"[tw] OR "rubber boot"[tw] OR "rubberboots"[tw] OR "head cover"[tw] OR "head covering"[tw] OR "face shield"[tw] OR "faceshields"[tw] OR "surgical hood"[tw] OR "hood"[tw] OR "Equipment Contamination/preventionand control"[Mesh] OR "Infection Control"[Mesh] OR "infection control"[tiab] OR"gloving"[tw] OR "donning"[tw] OR "doffing"[tw]
#2
"Communicable Diseases"[Mesh] OR "infectious disease"[tiab] OR "infectiousdiseases"[tiab] OR "Disease Transmission, Infectious"[Mesh] OR "disease transmission"[tw]OR "Infectious Disease Transmission, Patient‐to‐Professional"[Mesh] OR "infection controlprecautions"[tw] OR "human‐to‐human transmission"[tw] OR "parenteral transmission"[tw] OR"Virus Diseases/prevention and control"[Mesh] OR "viral disease"[tw] OR "viraldiseases"[tw] OR "Bacterial Infections/prevention and control"[Mesh] OR "bacterialinfection"[tw] OR "filovirus"[tw] OR "Ebolavirus"[Mesh] OR "Hemorrhagic Fever,Ebola"[Mesh] OR "Ebola"[tw] OR "Marburg virus"[tw] OR "Lassa virus"[tw] OR "haemorrhagicfever"[tw] OR "HIV Infections/prevention and control"[Mesh] OR "HIV"[ti] OR "hivinfection"[tiab] OR "hiv transmission"[tw] OR "Influenza, Human/prevention andcontrol"[Mesh] OR "SARS Virus"[Mesh] OR "Severe Acute Respiratory Syndrome Virus"[tw] OR"SARS"[tw] OR "MERS"[tw] OR "respiratory infection"[tw] OR "Influenza, Human/preventionand control"[Mesh] OR "influenza"[tiab] OR "Tuberculosis/prevention and control"[Mesh] OR"tuberculosis"[tiab] OR "Hepatitis A"[Mesh] OR "hepatitis a"[ti] OR "HepatitisB/prevention and control"[Mesh] OR "hepatitis b"[ti] OR "Hepatitis C/transmission"[Mesh]OR "hepatitis c"[ti] OR "bioterrorism"[tw] OR "aerosol‐generating procedure"[tw] OR "CrossInfection"[Mesh] OR "bacterial contamination"[tw] OR "microbial contamination"[tw] OR"self‐contamination"[tw] OR "decontamination"[tw] OR "surface decontamination"[tw] OR"skin decontamination"[tw]
#3
"Health Personnel"[Mesh] OR "Personnel, Hospital"[Mesh] OR "health care worker"[tw] OR"health care workers"[tw] OR "health care personnel"[tw] OR "health personnel"[tw] OR"health‐personnel"[tw] OR "health provider"[tw] OR "health providers"[tw] OR "health careprovider"[tw] OR "health care providers"[tw] OR "medical staff"[tw] OR "medicalpersonnel"[tw]OR "medical professional"[tw] OR "medical worker"[tw] OR "medicalworkers"[tw] OR "dental personnel"[tw] OR "dental staff"[tw] OR "Dentists"[Mesh] OR"dentist"[tw] OR "dentists"[tw] OR "dental assistant"[tw] OR "dental assistants"[tw] OR"Dental Assistants"[Mesh] OR "nursing staff"[tw] OR "Nurses"[Mesh] OR "nurse"[tw] OR"nurses"[tw] OR "nursing assistant"[tw] OR "nursing assistants"[tw] OR "Nurses'Aides"[Mesh] OR "Nurse Midwives"[Mesh] OR "midwife"[tw] OR "midwives"[tw] OR"military‐medical personnel"[tw] OR "Physicians"[Mesh] OR "physician"[tw] OR"physicians"[tw] OR "emergency medical services"[tw] OR "Emergency Medical Services"[MeSH]OR "transporting patients"[tw] OR "patient transport"[tw] OR "Ambulances"[Mesh] OR "AlliedHealth Personnel"[Mesh] OR paramedic[tw] OR paramedics[tw] OR paramedical personnel[tw] OR"Burial"[Mesh] OR burial staff OR cleaning workers[tw] OR cleaner work OR cleaner[tw] ORcleaners[tw]
#4
(#1 AND #2 AND #3)
Appendix 3. CENTRAL search strategy 20 March 2020
#1 MeSH descriptor: [Personal Protective Equipment] explode all trees
#2 MeSH descriptor: [Protective Clothing] explode all trees
#3 MeSH descriptor: [Respiratory Protective Devices] explode all trees
#4 MeSH descriptor: [Masks] explode all trees
#5 MeSH descriptor: [Eye Protective Devices] explode all trees
#6 MeSH descriptor: [Equipment Contamination] explode all trees
#7 MeSH descriptor: [Infection Control] explode all trees and with qualifier(s): [methods‐ MT]
#8 (glove* or gloving):ti,ab,kw
#9 (gown* or coverall* or (protective NEXT layer*) or (surgical NEXT toga*) or apron* orsmock* or (hazmat NEXT suit*)):ti,ab,kw
#10 (mask* or (air NEXT purifying NEXT respirator*) or PAPR or "enhanced respiratory andcontact precautions" or ERCP or "respiratory protection" or (transparent NEXT panel*) or(filtering NEXT face NEXT piece*) or (filtering NEXT facepiece*)):ti,ab,kw
#11 (goggle* or visor* or (safety NEXT glass*) or "safety spectacles" or overshoe* or(shoe NEXT cover*) or (rubber NEXT boot*) or (head NEXT cover*) or (face NEXT shield*) orhood* or "protective equipment" or PPE or donning or doffing):ti,ab,kw
#12 "infection control":ti,ab,kw
#13 {or #1‐#12}
#14 MeSH descriptor: [Health Personnel] explode all trees
#15 MeSH descriptor: [Personnel, Hospital] explode all trees
#16 ((health NEXT care NEXT worker*) or (healthcare NEXT worker*) or "health carepersonnel" or "healthcare personnel" or "health personnel" or (health NEXT provider*) or(health NEXT care NEXT provider*) or "medical staff" or "medical personnel" or (medicalNEXT professional*) or (medical NEXT worker*) or "military‐medical personnel" or "militarymedical personnel"):ti,ab,kw
#17 MeSH descriptor: [Dentists] explode all trees
#18 MeSH descriptor: [Dental Assistants] explode all trees
#19 ("dental personnel" or "dental staff" or dentist* or (dental NEXTassistant*)):ti,ab,kw
#20 MeSH descriptor: [Nurses] explode all trees
#21 MeSH descriptor: [Nursing Assistants] explode all trees
#22 MeSH descriptor: [Nurse Midwives] explode all trees
#23 MeSH descriptor: [Nursing Staff] explode all trees
#24 (nurse or nurses or nursing or midwife OR midwives):ti,ab,kw
#25 MeSH descriptor: [Physicians] explode all trees
#26 physician*:ti,ab,kw
#27 MeSH descriptor: [Emergency Medical Services] explode all trees
#28 MeSH descriptor: [Ambulances] explode all trees
#29 ("emergency medical services" or "transporting patients" or "patient transport" orparamedic* or (ambulance NEXT worker*)):ti,ab,kw
#30 MeSH descriptor: [Allied Health Personnel] explode all trees
#31 MeSH descriptor: [Burial] explode all trees
#32 "burial staff":ti,ab,kw
#33 ("cleaning workers" or cleaner* or janitor*):ti,ab,kw
#34 {or #14‐#33}
#35 MeSH descriptor: [Communicable Diseases] explode all trees
#36 MeSH descriptor: [Disease Transmission, Infectious] explode all trees
#37 MeSH descriptor: [Virus Diseases] explode all trees and with qualifier(s):[prevention & control ‐ PC, transmission ‐ TM]
#38 MeSH descriptor: [Bacterial Infections] explode all trees and with qualifier(s):[prevention & control ‐ PC, transmission ‐ TM]
#39 MeSH descriptor: [Ebolavirus] explode all trees
#40 MeSH descriptor: [Hemorrhagic Fever, Ebola] explode all trees
#41 MeSH descriptor: [Marburg Virus Disease] explode all trees
#42 MeSH descriptor: [Lassa virus] explode all trees
#43 MeSH descriptor: [Influenza, Human] explode all trees and with qualifier(s):[prevention & control ‐ PC, transmission ‐ TM]
#44 MeSH descriptor: [SARS Virus] explode all trees
#45 MeSH descriptor: [Severe Acute Respiratory Syndrome] explode all trees
#46 MeSH descriptor: [Middle East Respiratory Syndrome Coronavirus] explode all trees
#47 MeSH descriptor: [HIV Infections] explode all trees and with qualifier(s):[prevention & control ‐ PC, transmission ‐ TM]
#48 MeSH descriptor: [Tuberculosis] explode all trees and with qualifier(s): [prevention& control ‐ PC]
#49 MeSH descriptor: [Hepatitis A] explode all trees and with qualifier(s): [prevention& control ‐ PC, transmission ‐ TM]
#50 MeSH descriptor: [Hepatitis B] explode all trees and with qualifier(s): [prevention& control ‐ PC, transmission ‐ TM]
#51 MeSH descriptor: [Cross Infection] explode all trees
#52 ((infectious NEXT disease*) or "disease transmission" or "infection controlprecautions" or "human‐to‐human transmission" or "human transmission" or "parenteraltransmission"):ti,ab,kw
#53 ((viral NEXT disease*) or (bacterial NEXT infection*) or filovirus or ebola or"Marburg virus" or "Lassa virus" or "haemorrhagic fever" or "hemorrhagic fever" or (HIVNEAR/3 infection*) or "Severe Acute Respiratory Syndrome Virus" or SARS or "Middle EastRespiratory Syndrome" or MERS or coronavirus* or (corona NEXT virus*) or COVID or "COVID19" or “severe acute respiratory syndrome coronavirus 2” or "SARS CoV 2" or (SARS NEXTCoV*)):ti,ab,kw
#54 ("surface decontamination" or "skin decontamination" or "self contamination" orself‐contamination):ti,ab,kw
#55 {or #35‐#54}
Appendix 4. Medline OVID search strategy 20 March 2020
1 exp Personal Protective Equipment/
2 exp Protective Clothing/
3 exp Respiratory Protective Devices/
4 exp Masks/
5 exp Eye Protective Devices/
6 exp Equipment Contamination/
7 exp Infection Control/mt [Methods]
8 (glove* or gloving).ti,ab.
9 (gown* or coverall* or protective layer* or surgical toga* or apron* or smock* orhazmat suit*).ti,ab.
10 (mask or masks or air purifying respirator* or PAPR or "enhanced respiratory andcontact precautions" or ERCP or "respiratory protection" or transparent panel* orfiltering face piece* or filtering facepiece*).ti,ab.
11 (goggle* or visor* or facial protection equipment or safety glass* or safetyspectacles or overshoe* or shoe cover* or rubber boot* or head cover* or face shield* orhood* or protective equipment or PPE or donning or doffing).ti,ab.
12 infection control.ti.
13 or/1‐12
14 exp Health Personnel/
15 exp Personnel, Hospital/
16 (health care worker* or healthcare worker* or health care personnel or healthpersonnel or health care provider* or health provider* or medical staff or medicalpersonnel or medical professional* or medical worker* or military medicalpersonnel).ti,ab.
17 exp Dentists/
18 exp Dental Assistants/
19 (dental personnel or dental staff or dentist* or dental assistant*).ti,ab.
20 exp Nurses/
21 exp Nursing Assistants/
22 exp Nurse Midwives/
23 exp Nursing Staff/
24 (nurse or nurses or nursing or midwife or midwives).ti,ab.
25 exp Physicians/
26 physician*.ti,ab.
27 exp Emergency Medical Services/
28 exp Ambulances/
29 (emergency medical services or transporting patients or patient transport orparamedic* or ambulance worker*).ti,ab.
30 exp Allied Health Personnel/
31 exp Burial/
32 burial staff.ti,ab.
33 (cleaning worker* or cleaner* or janitor*).ti,ab.
34 or/14‐33
35 exp Communicable Diseases/
36 exp Disease Transmission, Infectious/
37 exp Virus Diseases/
38 exp Bacterial Infections/
39 exp Ebolavirus/
40 exp Hemorrhagic Fever, Ebola/
41 exp Marburg Virus Disease/
42 exp Lassa virus/
43 exp Influenza, Human/
44 exp SARS Virus/
45 exp Severe Acute Respiratory Syndrome/
46 exp Middle East Respiratory Syndrome Coronavirus/
47 exp HIV Infections/pc, tm [Prevention & Control, Transmission]
48 exp Tuberculosis/pc, tm [Prevention & Control, Transmission]
49 exp Hepatitis A/pc, tm [Prevention & Control, Transmission]
50 exp Hepatitis B/pc, tm [Prevention & Control, Transmission]
51 exp Cross Infection/
52 (infectious disease* or disease transmission or infection control precautions or(human* adj3 transmission) or parenteral transmission).ti,ab.
53 (viral disease* or viral infection* or bacterial infection* or filovirus or ebola* orMarburg virus or Lassa virus or h?emorrhagic fever or (HIV adj3 infection*) or SevereAcute Respiratory Syndrome Virus or SARS or Middle East Respiratory Syndrome or MERS orcoronavirus* or corona virus* or COVID or severe acute respiratory syndrome coronavirus orSARS CoV 2 or SARS‐CoV‐2).ti,ab.
54 (skin decontamination or surface decontamination or self contamination).ti,ab.
55 or/35‐54
56 13 and 34 and 55
57 exp animals/ not humans.sh.
Appendix 5. Embase OVID search strategy 20 March 2020
1 exp protective equipment/
2 exp protective clothing/
3 exp mask/
4 exp eye protective device/
5 exp medical device contamination/
6 infection control/pc [Prevention]
7 (glove* or gloving).ti,ab.
8 (gown* or coverall* or protective layer* or surgical toga* or apron* or smock* orhazmat suit*).ti,ab.
9 (mask or masks or air purifying respirator* or PAPR or "enhanced respiratory andcontact precautions" or ERCP or "respiratory protection" or transparent panel* orfiltering face piece* or filtering facepiece*).ti,ab.
10 (goggle* or visor* or facial protection equipment or safety glass* or safetyspectacles or overshoe* or shoe cover* or rubber boot* or head cover* or face shield* orhood* or protective equipment or PPE or donning or doffing).ti,ab.
11 infection control.ti.
12 or/1‐11
13 exp health care personnel/
14 exp hospital personnel/
15 (health care worker* or healthcare worker* or health care personnel or healthpersonnel or health care provider* or health provider* or medical staff or medicalpersonnel or medical professional* or medical worker* or military medicalpersonnel).ti,ab.
16 exp dentist/
17 exp dental assistant/
18 (dental personnel or dental staff or dentist* or dental assistant*).ti,ab.
19 exp nurse/
20 exp nursing assistant/
21 exp nurse midwife/
22 exp nursing staff/
23 (nurse or nurses or nursing or midwife or midwives).ti,ab.
24 exp physician/
25 physician*.ti,ab.
26 exp emergency health service/
27 exp ambulance/
28 (emergency medical services or transporting patients or patient transport orparamedic* or ambulance worker*).ti,ab.
29 exp paramedical personnel/
30 exp burial/
31 burial staff.ti,ab.
32 (cleaning worker* or cleaner* or janitor*).ti,ab.
33 or/13‐32
34 exp communicable disease/
35 exp disease transmission/
36 exp virus infection/
37 exp bacterial infection/
38 exp ebolavirus/
39 exp Ebola hemorrhagic fever/
40 exp Marburg hemorrhagic fever/
41 exp Lassa virus/
42 exp filovirus infection/
43 exp influenza/
44 exp SARS coronavirus/
45 exp severe acute respiratory syndrome/
46 exp Middle East respiratory syndrome coronavirus/
47 exp Human immunodeficiency virus infection/pc [Prevention]
48 exp tuberculosis/pc [Prevention]
49 exp hepatitis/pc [Prevention]
50 exp cross infection/
51 (infectious disease* or disease transmission or infection control precautions or(human* adj3 transmission) or parenteral transmission).ti,ab.
52 (viral disease* or viral infection* or bacterial infection* or filovirus or ebola* orMarburg virus or Lassa virus or h?emorrhagic fever or (HIV adj3 infection*) or SevereAcute Respiratory Syndrome Virus or SARS or Middle East Respiratory Syndrome or MERS orcoronavirus* or corona virus* or COVID or severe acute respiratory syndrome coronavirus orSARS CoV 2 or SARS‐CoV‐2).ti,ab.
53 (skin decontamination or surface decontamination or self contamination).ti,ab.
54 or/34‐53
55 12 and 33 and 54
56 exp experimental organism/
57 animal tissue/
58 exp animal disease/
59 exp carnivore disease/
60 exp bird/
61 exp experimental animal welfare/
62 exp animal husbandry/
63 animal behavior/
64 exp animal cell culture/
65 exp mammalian disease/
66 exp mammal/
67 exp marine species/
68 nonhuman/
69 animal.hw.
70 or/56‐69
71 70 not human/
72 55 not 71
Appendix 6. Scopus search strategy 18 June 2019
#1
"protective clothing" OR gown* OR coverall* OR "protective layer" OR "protective layers"OR "surgical toga" OR apron* OR smock OR smocks OR "hazmat suit" OR glove OR gloves OR"respiratory protective devices" OR mask OR "air‐purifying respirator" OR "PAPR" OR"enhanced respiratory and contact precautions" OR "E‐RCP" OR "respiratory protection" OR"transparent panel" OR "surgical mask" OR "surgical masks" OR "filtering face piece" OR"filtering facepiece" OR "eye protective device" OR goggle* OR visor OR "facial protectionequipment" OR "safety glass" OR "safety glasses" OR "safety spectacles" OR "personalprotective equipment" OR "PPE" OR "protective equipment" OR overshoe* OR "shoe cover" OR"shoe covers" OR "rubber boot" OR "rubber boots" OR "head cover" OR "head covering" OR"face shield" OR "face shields" OR "surgical hood" OR hood OR gloving OR donning ORdoffing)
#2
"health care personnel" OR "hospital personnel" OR "health care worker" OR "health careworkers" OR "health care personnel" OR "health personnel" OR "health‐personnel" OR "healthprovider" OR "health providers" OR "health care provider" OR "health care providers" OR"medical staff" OR "medical personnel" OR "medical professional" OR "medical worker" OR"medical workers" OR "dental personnel" OR "dental staff" OR "dentist" OR "dentists" OR"dental assistant" OR "dental assistants" OR "nursing staff" OR "nurse" OR "nurses" OR"nursing assistant" OR "nursing assistants" OR "midwife" OR "midwives" OR"military‐medical personnel" OR "physician" OR "physicians" OR "emergency medicalservices" OR "transporting patients" OR "patient transport" OR "ambulance" OR "paramedicalpersonnel" OR paramedic OR paramedics OR "burial staff" OR "cleaning workers" OR cleanerOR cleaners
#3
"virus infection" OR "viral disease" OR "filovirus" OR "ebola" OR "marburg virus" OR"lassa virus" OR "haemorrhagic fever" OR "Severe Acute Respiratory Syndrome Virus" OR"SARS" OR "MERS" OR "bioterrorism" OR "bacterial contamination" OR "microbialcontamination" OR "self‐contamination" OR "decontamination" OR "surface decontamination"OR "skin decontamination"
#4
LIMIT‐TO ( PUBYEAR, 2018 )
#5
#1 AND #2 AND #3 AND #4
Appendix 7. Embase search strategy embase.com 15 July 2016
#7
#6 NOT [medline]/lim) (646)
#6
#5 AND [embase]/lim (2,227)
#5
#4 AND [humans]/lim (5,270)
#4
#1 AND #2 AND #3 (5,675)
#3
'communicable disease'/de OR "infectious disease":ab,ti OR 'disease transmission'/de OR"disease transmission" OR "infection control precautions" OR "human‐to‐human transmission"OR "parenteral transmission" OR 'virus infection'/de OR "viral disease":ab,ti OR'bacterial infection'/de OR "bacterial infection":ab,ti OR "filovirus" OR 'ebola virus'/deOR 'hemorrhagic fever ebola'/de OR "ebola" OR "marburg virus" OR "lassa virus" OR"haemorrhagic fever" OR 'sars coronavirus'/de OR "Severe Acute Respiratory Syndrome Virus"OR "SARS" OR "MERS" OR "bioterrorism" OR 'cross infection'/de OR "bacterial contamination"OR "microbial contamination" OR "self‐contamination" OR "decontamination" OR "surfacedecontamination" OR "skin decontamination" (323,524)
#2
'health care personnel'/de OR 'hospital personnel'/de OR "health care worker" OR "healthcare workers" OR "health care personnel" OR "health personnel" OR "health‐personnel" OR"health provider" OR "health providers" OR "health care provider" OR "health careproviders" OR "medical staff" OR "medical personnel" OR "medical professional" OR "medicalworker" OR "medical workers" OR “dental personnel” OR “dental staff” OR "dentist" OR"dentists" OR "dental assistant" OR "dental assistants" OR "nursing staff" OR 'nurses'/deOR "nurse" OR "nurses" OR "nursing assistant" OR "nursing assistants" OR 'nursingassistant'/de OR 'nurse midwife'/de OR "midwife" OR "midwives" OR "military‐medicalpersonnel" OR 'physician'/de OR "physician" OR "physicians" OR "emergency medicalservices" OR “transporting patients” OR “patient transport” OR 'ambulance'/de OR'paramedical personnel'/de OR "paramedical personnel" OR paramedic OR paramedics OR'posthumous care'/de OR "burial staff" OR "cleaning workers" OR "cleaner work" OR cleanerOR cleaners (1,287,399)
#1
'protective clothing'/de OR gown* OR coverall* OR "protective layer" OR "protectivelayers" OR "surgical toga" OR apron* OR smock OR smocks OR "hazmat suit" OR (hazmat ANDsuit) OR glove OR gloves OR 'respiratory protective devices'/de OR 'mask'/de OR mask OR"air‐purifying respirator" OR "PAPR" OR "enhanced respiratory and contact precautions" OR"E‐RCP" OR “respiratory protection” OR "transparent panel" OR "surgical mask" OR "surgicalmasks" OR "filtering face piece" OR "filtering facepiece" OR 'eye protective device'/de ORgoggle* OR visor OR "facial protection equipment" OR "safety glass" OR "safety glasses" OR"safety spectacles" OR "personal protective equipment" OR "PPE" OR "protective equipment"OR overshoe* OR "shoe cover" OR "shoe covers" OR "rubber boot" OR "rubber boots" OR "headcover" OR "head covering" OR "face shield" OR "face shields" OR "surgical hood" OR hood OR'medical device contamination'/de OR 'infection control'/de OR 'infection control':ab,tiOR gloving OR donning OR doffing (160,118)
Appendix 8. CINAHL EBSCO search strategy 20 March 2020
S51 S10 AND S32 AND S50
S50 S33 OR S34 OR S35 OR S36 OR S37 OR S38 OR S39 OR S40 OR S41 OR S42 OR S43 OR S44 ORS45 OR S46 OR S47 OR S48 OR S49
S49 TI ("surface decontamination" OR "skin decontamination") OR AB ("surfacedecontamination" OR "skin decontamination")
S48 AB (“viral disease” OR “viral diseases” OR “viral infection” OR “viral infections” OR“bacterial infection” OR “bacterial infections” OR filovirus OR ebola* OR “Marburg virus”OR “Lassa virus” OR “haemorrhagic fever” OR “hemorrhagic fever” OR “HIV infection” OR “HIVinfections” OR “Severe Acute Respiratory Syndrome Virus” OR SARS OR “Middle EastRespiratory Syndrome” OR MERS OR coronavirus* OR “corona virus” OR “corona viruses” ORCOVID OR “severe acute respiratory syndrome coronavirus” OR “SARS CoV 2” OR“SARS‐CoV‐2”)
S47 TI (“viral disease” OR “viral diseases” OR “viral infection” OR “viral infections” OR“bacterial infection” OR “bacterial infections” OR filovirus OR ebola* OR “Marburg virus”OR “Lassa virus” OR “haemorrhagic fever” OR “hemorrhagic fever” OR “HIV infection” OR “HIVinfections” OR “Severe Acute Respiratory Syndrome Virus” OR SARS OR “Middle EastRespiratory Syndrome” OR MERS OR coronavirus* OR “corona virus” OR “corona viruses” ORCOVID OR “severe acute respiratory syndrome coronavirus” OR “SARS CoV 2” OR“SARS‐CoV‐2”)
S46 TI (“infectious disease” OR “infectious diseases” OR “disease transmission” OR“infection control precautions” OR “human‐to‐human transmission” OR “parenteraltransmission”) OR AB (“infectious disease” OR “infectious diseases” OR “diseasetransmission” OR “infection control precautions” OR “human‐to‐human transmission” OR“parenteral transmission”)
S45 (MH "Cross Infection+")
S44 (MH "Hepatitis B+/PC/TM")
S43 (MH "Hepatitis A/PC/TM")
S42 (MH "Tuberculosis+/PC/TM")
S41 (MH "HIV Infections+/TM/PC")
S40 (MH "Middle East Respiratory Syndrome") OR (MH "Middle East Respiratory SyndromeCoronavirus")
S39 (MH "SARS Virus") OR (MH "Severe Acute Respiratory Syndrome")
S38 (MH "Influenza, Human+")
S37 (MH "Hemorrhagic Fever, Ebola") OR (MH "Ebola Virus")
S36 (MH "Bacterial Infections+")
S35 (MH "Virus Diseases+")
S34 (MH "Disease Transmission, Patient‐to‐Professional") OR (MH "Disease Transmission,Professional‐to‐Patient")
S33 (MH "Communicable Diseases+")
S32 S11 OR S12 OR S13 OR S14 OR S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22 ORS23 OR S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30 OR S31
S31 TI ("cleaning worker" OR "cleaning workers" OR cleaner* or janitor*) OR AB ("cleaningworker" OR "cleaning workers" OR cleaner* or janitor*)
S30 (TI burial) or (AB burial)
S29 (MH "Allied Health Personnel+")
S28 TI (“emergency medical services” OR “transporting patients” OR “patient transport” ORparamedic* OR “ambulance worker” OR “ambulance workers”) OR AB (“emergency medicalservices” OR “transporting patients” OR “patient transport” OR paramedic* OR “ambulanceworker” OR “ambulance workers”)
S27 (MH "Ambulances")
S26 (MH "Emergency Medical Services+")
S25 (TI physician*) OR (AB physician*)
S24 (MH "Physicians+")
S23 AB (nurse OR nurses OR nursing OR midwife OR midwives)
S22 TI (nurse OR nurses OR nursing OR midwife OR midwives)
S21 (MH "Nurse Midwives")
S20 (MH "Nursing Assistants")
S19 (MH "Nurses+")
S18 AB ("dental personnel" OR "dental staff" OR dentist* OR "dental assistant" OR "dentalassistants")
S17 TI ("dental personnel" OR "dental staff" OR dentist* OR "dental assistant" OR "dentalassistants")
S16 (MH "Dental Assistants")
S15 (MH "Dentists+")
S14 AB (“health care worker” OR “health care workers” OR “healthcare worker” OR“healthcare workers” OR “health care personnel” OR “health personnel” OR “health careprovider” OR “health care providers” OR “health provider” OR “health providers” OR“medical staff” OR “medical personnel” OR “medical professional” OR “medicalprofessionals” OR “medical worker” OR “medical workers” OR "military medicalpersonnel")
S13 TI (“health care worker” OR “health care workers” OR “healthcare worker” OR“healthcare workers” OR “health care personnel” OR “health personnel” OR “health careprovider” OR “health care providers” OR “health provider” OR “health providers” OR“medical staff” OR “medical personnel” OR “medical professional” OR “medicalprofessionals” OR “medical worker” OR “medical workers” OR "military medicalpersonnel")
S12 (MH "Personnel, Health Facility+")
S11 (MH "Health Personnel+")
S10 S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 OR S8 OR S9
S9 AB (glove* OR gloving OR gown* OR coverall* OR "protective layer" OR "protectivelayers" OR "surgical toga" OR apron* OR smock* OR "hazmat suit" OR “hazmat suits” OR mask*OR "air‐purifying respirator" OR PAPR OR "enhanced respiratory and contact precautions" ORE‐RCP OR ECPR OR "respiratory protection" OR "transparent panel" OR "surgical mask" OR"surgical masks" OR "filtering face piece" OR "filtering facepiece" OR goggle* OR visor*OR "facial protection equipment" OR "safety glass" OR "safety glasses" OR "safetyspectacles" OR "personal protective equipment" OR PPE OR "protective equipment" ORovershoe* OR "shoe cover" OR "shoe covers" OR "rubber boot" OR "rubber boots" OR "headcover" OR "head covering" OR "face shield" OR "face shields" OR "surgical hood" OR "hood"OR "infection control OR donning OR doffing)
S8 TI (glove* OR gloving OR gown* OR coverall* OR "protective layer" OR "protectivelayers" OR "surgical toga" OR apron* OR smock* OR "hazmat suit" OR “hazmat suits” OR mask*OR "air‐purifying respirator" OR PAPR OR "enhanced respiratory and contact precautions" ORE‐RCP OR ECPR OR "respiratory protection" OR "transparent panel" OR "surgical mask" OR"surgical masks" OR "filtering face piece" OR "filtering facepiece" OR goggle* OR visor*OR "facial protection equipment" OR "safety glass" OR "safety glasses" OR "safetyspectacles" OR "personal protective equipment" OR PPE OR "protective equipment" ORovershoe* OR "shoe cover" OR "shoe covers" OR "rubber boot" OR "rubber boots" OR "headcover" OR "head covering" OR "face shield" OR "face shields" OR "surgical hood" OR "hood"OR "infection control OR donning OR doffing)
S7 (MH "Infection Control+/PC")
S6 (MH "Equipment Contamination/PC")
S5 (MH "Respiratory Protective Devices")
S4 (MH "Gloves")
S3 (MH "Eye Protective Devices")
S2 (MH "Masks")
S1 (MH "Protective Clothing+")
Appendix 9. CINAHL search strategy 31 July 2018
S5 S4 MEDLINE records excluded (878)
S4 (S1 AND S2 AND S3) (2,584)
S3
(MH "Communicable Diseases") OR (TI "infectious disease") OR (AB "infectious disease") OR(MH "Disease Transmission) OR TX "disease transmission" OR (MH "Disease Transmission,Patient‐to‐Professional") OR TX "infection control precautions" OR TX "human‐to‐humantransmission" OR TX "parenteral transmission" OR (MH "Virus Diseases/PC") OR TX "viraldisease" OR TX "viral diseases" OR TX "bacterial infection" OR (MH "Bacterialinfection/PC") OR TX "filovirus" OR TX "ebolavirus" OR (MH "Hemorrhagic Fever, Ebola") ORTX "ebola" OR TX "marburg virus" OR TX "lassa virus" OR TX "haemorrhagic fever" OR (MH"SARS Virus") OR TX "severe acute respiratory syndrome virus" OR TX "SARS" OR TX "MERS" ORTX "respiratory infection" OR TX "bioterrorism" OR TX "aerosol‐generating procedure" OR(MH "Cross Infection") OR TX "bacterial contamination" OR TX "microbial contamination" ORTX "self‐contamination" OR TX "decontamination" OR TX "surface decontamination" OR TX"skin decontamination" (37,937)
S2
(MH Protective Clothing) OR TX gown* OR TX coverall* OR TX "protective layer" OR TX"protective layers" OR TX "surgical toga" OR TX apron* OR TX "smock" OR TX "smocks" OR TX"hazmat suit" OR TX (hazmat AND suit) OR (MH "gloves protective") OR TX glove OR TX glovesOR (MH "Respiratory Protective Devices") OR (MH "Masks") OR TX mask OR TX masks OR TX"air‐purifying respirator" OR TX "PAPR" OR TX "enhanced respiratory and contactprecautions" OR TX "E‐RCP" OR TX "respiratory protection" OR TX "transparent panel" OR TX"surgical mask" OR TX "surgical masks" OR TX "filtering face piece" OR TX "filteringfacepiece" OR (MH "Eye Protective Devices") OR TX goggle* OR TX "visor" OR TX "facialprotection equipment" OR TX "safety glass" OR TX "safety glasses" OR TX "safetyspectacles" OR TX "personal protective equipment" OR TX "PPE" OR TX "protective equipment"OR TX overshoe* OR TX "shoe cover" OR TX "shoe covers" OR TX "rubber boot" OR TX "rubberboots" OR TX "head cover" OR TX "head covering" OR TX "face shield" OR TX "face shields"OR TX "surgical hood" OR TX "hood" OR (MH "Equipment Contamination/PC") OR (MH "InfectionControl") OR (TI "infection control") OR (AB "infection control") OR TX "gloving" OR TX"donning" OR TX “doffing” (28,554)
S1
(MH "Health Personnel") OR TX health care workers OR TX health care personnel OR TXhealth personnel OR TX health‐personnel OR TX health providers OR TX health care providersOR TX medical staff OR TX medical personnel OR TX medical professional OR TX medicalworkers OR TX dental personnel OR TX dental staff OR (MH "Dentists") OR TX dentist OR TXdental assistant OR TX nursing staff OR (MH "Nurses") OR TX nurse OR TX nursing assistantOR (MH "Allied Health Personnel" OR (MH "Midwives") OR TX nurse midwife OR TX nursemidwives OR TX military‐medical personnel OR (MH “Physicians") OR TX physician OR TXemergency medical services OR (MH “Emergency Medical Services”) OR TX transportingpatients OR TX patient transport OR (MH "Ambulance") OR (MH "Allied Health Personnel") ORTX paramedic OR TX paramedical personnel OR (MH "Burial") OR TX burial staff OR TXcleaning worker OR TX cleaner work OR TX cleaner OR TX cleaners (498,394)
Appendix 10. OSH‐update search strategy
| Step: | Hits: | Strategy: | ||
| #1 | 32657 | GW{protective clothing OR gown* OR coverall* OR protective layer* ORsurgical toga* OR apron* OR smock* OR hazmat suit* OR (hazmat AND suit) ORglove* OR respiratory protective device* OR mask OR masks OR air purifyingrespirator* OR 'PAPR' OR 'enhanced respiratory and contact precautions' OR'E‐RCP' OR respiratory protection OR transparent panel* OR surgical mask* ORfiltering face piece OR eye protective device* OR goggle* OR visor OR facialprotective equipment OR safety glass* OR safety spectacles OR personalprotective equipment OR 'PPE' OR protective equipment OR overshoe* OR shoecover* OR rubber boot* OR head cover* OR face shield* OR surgical hood ORhood OR equipment contamination OR infection control OR gloving OR donningOR doffing} | ||
| #2 | 11286 | GW{communicable disease* OR infectious disease* OR disease transmission ORinfection control precautions OR human‐to‐human transmission OR parenteraltransmission OR viral disease* OR bacterial infection* OR filovirus OREbolavirus OR hemorrhagic fever OR Ebola OR Marburg virus OR Lassa virus ORSARS virus OR severe acute respiratory syndrome virus OR 'SARS' OR 'MERS' ORrespiratory infection* OR bioterrorism OR aerosol‐generating procedure ORcross infection* OR bacterial contamination OR microbial contamination ORself‐contamination OR decontamination OR surface decontamination OR skindecontamination} | ||
| #3 | 32599 | GW{health personnel OR health care worker* OR health care personnel ORhealth personnel OR health‐personnel OR health provider* OR health careprovider* OR medical staff OR medical personnel OR medical professional ORmedical worker* OR dental personnel OR dental staff OR dentist* OR dentalassistant* OR nursing staff OR nurse* OR nursing assistant* OR nurses' aidesOR nurse midwife OR nurse midwives OR midwife OR midwives ORmilitary‐medical personnel OR physician* OR emergency medical services ORtransporting patients OR patient transport OR ambulance* OR allied healthpersonnel OR paramedic* OR paramedical personnel OR burial OR burial staffOR cleaning worker* OR cleaner work OR cleaner*} | ||
| #4 | 1250 | #1 AND #2 AND #3 | ||
| #5 | 742476 | DC{OUBIB OR OUCISD OR OUHSEL OR OUISST OR OUNIOC OR OUNIOS OR OURILO} | ||
| #6 | 1103 | #4 AND #5 |
Notes
Edited (no change to conclusions)
Data and analyses
Comparison 1
PAPR versus E‐RCP Attire
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1.1 Any contamination | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.2 Contamination > 1 cm | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.3 Contamination area | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.4 Donning noncompliance | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.5 Doffing noncompliance | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.6 Donning time | 1 | 100 | Mean Difference (IV, Fixed, 95% CI) | Not estimable |
| 1.7 Doffing time | 1 | 100 | Mean Difference (IV, Fixed, 95% CI) | Not estimable |
Comparison 2
Four types of PPE attire compared
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 2.1 A vs B Contamination, mean number ofspots | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.1.1 Face type A vs type B | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.1.2 Trunk type A vs type B | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.1.3 Neck type A vs type B | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.1.4 Foot type A vs type B | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.1.5 Palm type A vs type B | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.2 A vs B Usability score (1‐5) | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.3 A vs B Donning time | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.4 A vs B Doffing time | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.5 A vs D Contamination, mean number ofspots | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.5.1 Face type A vs type D | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.5.2 Trunk type A vs type D | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.5.3 Neck type A vs type D | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.5.4 Foot type A vs type D | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.5.5 Palm type A vs type D | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.6 A vs D Usability score (1‐5) | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.7 A vs D Donning time | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.8 A vs D Doffing time | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected |
Comparison 3
Formal versus local available attire
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 3.1 Contamination | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected |
Comparison 4
Gown versus apron
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 4.1 Contamination with marker; individualdoffing | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.1.1 small patches | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.1.2 large patches | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.1.3 hand | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.1.4 shoe | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.1.5 underwear | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.1.6 environment | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.2 Contamination with marker; CDCdoffing | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.2.1 small patches | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.2.2 large patches | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.2.3 hand | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.2.4 shoe | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.2.5 underwear | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4.2.6 environment | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected |
Comparison 5
Three types of PPE compared
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 5.1 Time for donning | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 5.1.1 PPE 1 vs PPE 3 | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 5.1.2 PPE 2 vs PPE 3 | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 5.2 Time for doffing | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 5.2.1 PPE 2 vs PPE 3 | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 5.2.2 PPE 2 vs PPE 3 | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected |
Comparison 6
Gown sealed gloves versus standard gown
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 6.1 Contamination fluorescent lotion | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 6.2 Contamination MS2 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected |
Comparison 7
Gown easy to doff versus standard gown
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 7.1 Contamination with fluorescent marker | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 7.2 Contamination with bacteriophage | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected |
Comparison 8
Gown with gown‐glove improvement vs standard gown‐gloves
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 8.1 People with contamination | 1 | 200 | Risk Ratio (M‐H, Random, 95% CI) | 0.45 [0.26, 0.78] |
| 8.1.1 Improved vs standard | 1 | 120 | Risk Ratio (M‐H, Random, 95% CI) | 0.50 [0.31, 0.81] |
| 8.1.2 Improved plus education vs standard plus education | 1 | 80 | Risk Ratio (M‐H, Random, 95% CI) | 0.22 [0.05, 0.96] |
Comparison 9
Gown with marked inside versus standard gown
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 9.1 Noncompliance donning: people witherrors | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 9.2 Noncompliance: errors duringperformance | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 9.3 Noncompliance doffing: people witherrors | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected |
Comparison 10
Gloves with tab versus standard gloves
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 10.1 Any contamination of hands | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected |
Comparison 11
Mask with tabs versus no mask tabs
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 11.1 Contamination of head from hands | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 11.2 Contamination of hands from mask | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected |
Comparison 12
Doffing with double gloves versus doffing with single gloves
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 12.1 Contamination: virus detected | 2 | Risk Ratio (M‐H, Fixed, 95% CI) | Subtotals only | |
| 12.1.1 All body parts | 2 | 58 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.34 [0.17, 0.66] |
| 12.1.2 Face | 2 | 58 | Risk Ratio (M‐H, Fixed, 95% CI) | 4.39 [0.53, 36.37] |
| 12.1.3 Shirt | 2 | 58 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.01 [0.79, 1.29] |
| 12.1.4 Pants | 1 | 36 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.91 [0.52, 1.58] |
| 12.2 Contamination: virus quantity | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 12.2.1 Dominant hand | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 12.2.2 Non‐dominant hand | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 12.2.3 Face | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 12.2.4 Shirt | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 12.2.5 Pants | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 12.3 Non‐compliance: any error | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 12.4 Contamination with fluorescent | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected |
Analysis
Comparison 12: Doffing with double gloves versus doffing with single gloves, Outcome 2:Contamination: virus quantity
Comparison 13
CDC versus individual doffing
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 13.1 Gown: contamination with fluormarker | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.1.1 small patch | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.1.2 large patch | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.1.3 hand | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.1.4 shoe | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.1.5 underwear | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.1.6 environment | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.2 Apron: contamination with fluormarker | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.2.1 small patch | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.2.2 large patch | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.2.3 hand | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.2.4 shoe | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.2.5 underwear | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 13.2.6 environment | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected |
Comparison 14
Single‐step doffing vs CDC standard
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 14.1 Fluorescent contamination | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 14.2 Bacterial contamination | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected |
Comparison 15
Doffing with extra sanitation of gloves versus standard nosanitation
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 15.1 Bacterial contamination | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 15.1.1 Alcohol‐based hand rub | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected |
Comparison 16
Donning and doffing with instructions versus withoutinstructions
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 16.1 People with one or more errors | 1 | 120 | Risk Ratio (M‐H, Random, 95% CI) | 0.31 [0.11, 0.93] |
| 16.1.1 Basic PPE | 1 | 60 | Risk Ratio (M‐H, Random, 95% CI) | 0.15 [0.04, 0.62] |
| 16.1.2 Enhanced PPE | 1 | 60 | Risk Ratio (M‐H, Random, 95% CI) | 0.47 [0.22, 0.98] |
| 16.2 Non‐compliance: mean errors | 1 | 120 | Mean Difference (IV, Random, 95% CI) | ‐0.89 [‐1.36, ‐0.41] |
| 16.2.1 Basic PPE | 1 | 60 | Mean Difference (IV, Random, 95% CI) | ‐0.70 [‐1.15, ‐0.25] |
| 16.2.2 Enhanced PPE | 1 | 60 | Mean Difference (IV, Random, 95% CI) | ‐1.20 [‐1.87, ‐0.53] |
| 16.3 Fluorescence contamination | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected |
Analysis
Comparison 16: Donning and doffing with instructions versus without instructions,Outcome 3: Fluorescence contamination
Comparison 17
Active training in PPE use versus passive training
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 17.1 Noncompliance with PPE | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected |
Analysis
Comparison 17: Active training in PPE use versus passive training, Outcome 1:Noncompliance with PPE
Comparison 18
Doffing with hypochlorite versus doffing with alcohol‐based glovesanitiser
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 18.1 Contamination MS2 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 18.2 Contamination Ph6 | 1 | 15 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
Comparison 19
Active training in PPE doffing versus passive training
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 19.1 Noncompliance doffing protocol | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected |
Comparison 20
Computer simulation versus no simulation
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 20.1 Number of errors while donning | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 20.2 Number of errors while doffing | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected |
Comparison 21
Video‐based learning versus traditional lecture
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 21.1 Skills in PPE donning | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected |
Characteristics of studies
Characteristics of included studies [ordered by study ID]
Andonian 2019
| Study characteristics | ||
| Methods | Study design: RCT Study grouping: parallel group For simulation study, what was used for the exposure (virus, fluorescentfluid etc): 1. The optimised fluorescent slurry consisted offluorescent powder (Glitter Bug, Brevis Corporation, Salt Lake City, UT; 75mg/mL) in a viscous suspension of grape‐seed oil and water (1:6 oil‐to‐waterratio) 2. Fluorescent 2‐μm polystyrene latex bead (PLSs) (G0200, ThermoFisher Scientific, Waltham, MA) diluted in water. PLSs are commonly utilisedin aerosol research and were used to simulate pathogens Exposure simulation: 1. Fluorescent tracer mixture was applied toPPE using 1000 mL in a pesticide hand sprayer (RL Flo‐Master, Lowell, MI;2000 mL capacity) and 5 sweeping passes of sprayer from head to feet on thefront and back of the HCW. 2. A PLS suspension (25 mL) was aerosolised usinga 3‐jet Collison nebuliser (Mesa Laboratories, Inc, Butler, NJ) for 4 min ofcontinuous aerosol generation while the HCW turned 90° every 60 s | |
| Participants | Baseline characteristics 48 participants were included in the study Enhanced doffing protocol
CDC doffing protocol
Overall
Inclusion criteria: not reported, but study authors included: adults(male/female) with no prior experience doffing enhanced PPE Excluded criteria: not reported | |
| Interventions | Intervention characteristics Enhanced doffing protocol: doffing with extra instructions
CDC doffing protocol
| |
| Outcomes | How the outcome was measured: from the fluorescent tracer slurry ‐detection was by direct visualisation in a dark room using ultravioletlight. (1) The number of body sites contaminated and (2) the extent ofcontamination at each site were recorded. PLS detection was performed by (3)counting via epifluorescent microscopy and (4) quantifying the number PLSsper cm² of skin or per m3 of sampled air. (5) Teamwork dynamicswere assessed via video and coded using a task analysis of the process setsand subsets (checklist). (6) The National Aeronautics and SpaceAdministration (NASA) Task Load Index (NASA‐TLX) questionnaire assessedperceptions of workload during doffing (7) The Team Strategies and Tools toEnhance Performance and Patient Safety Teamwork Attitudes Questionnaire(T‐TAQ) assessed attitudes toward teamwork Body sites with fluorescent marker
Body sites with PLS
| |
| Notes | Outcomes Median and IQR of 22 possible contaminated sitesreported. For Fluor Marker: intervention 1 (1‐2) control 5 (2‐5) For PLS outof 12 possible contaminated sites: intervention 4 (2‐5) control 5 (5‐8).These were transformed to means and SDs for use in the data tables. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned to the control or intervention condition and thento the role of HCW or DA." Judgement comment: method of random assignment not reported |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: method of allocation concealment was not reported |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Quote: "role as either HCW or DA." Quote: "After training, all participants were given the opportunity to askquestions and were informed about their randomly assigned" Quote: "Study participants were blind to their group assignment." Judgement comment: group assignment (intervention and control) was blinded;role was blinded to participants until after training and before the doffingintervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The contamination forms were deidentified and assigned randomizednumbers for scoring purposes. Two IPs, blinded to experimental assignment,independently scored each form" Judgement comment: infection preventionists were the outcome assessors andwere blinded to intervention group |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Forty‐eight study participants (35 females, 13 males) were randomlyassigned to the control (n = 22) or intervention group (n = 26)." Quote: "Participants in each study arm were randomly assigned to the roleof control HCW (n = 11), control DA (n = 11), intervention HCW (n = 13), orintervention DA (n = 13). For the fluorescent tracer, 11 HCWs (84.6%) in theintervention group and all 13 control HCWs (100%) contaminated at least 1body area." Quote: "Coding and scoring of teamwork behaviors exhibited in thevideotaped doffing sessions were completed for 10 intervention and 11control teams. Technical difficulties resulted in missing videotapes for 3intervention teams." Judgement comment: main outcomes were listed within the methods (butscattered and hard to find). All recruited participants completed theinterventions and outcomes were collected. 1 typographical error (I assume)in reporting fluorescent tracer contamination (they reported 13 control HCWsbut there were only 11). 3 sets of teamwork behaviour outcomes recorded invideos from the intervention group were lost. However, despite the missingdata, there was a plausible difference in median (IQR) between groups thatmay not have impacted the observed effect size. |
| Selective reporting (reporting bias) | Low risk | Judgement comment: the availability of the study protocol is not reportedin the paper, but it is clear that the published report includes allexpected outcomes for this type of study. |
| Other bias | Low risk | Judgement comment: no other bias detected |
Bell 2015
| Study characteristics | ||
| Methods | Randomised, 2 parallel groups; simulation study | |
| Participants | N = 8, nurses (6), physicians 2; women 7/8 Intervention: 4, control: 4 Volunteer healthcare providers, no further details provided Location: USA | |
| Interventions | Intervention: different types of PPE compared: commercially availablePPE: neck‐to‐ankle coverall (type not reported), water impermeablesurgical gown, knee‐length impermeable leggings, Stryker hood, double gloveswith outer arm‐length surgical gloves, N95 masks; meeting CDCrecommendations; each participant was assisted in PPE donning by anexperienced trainer. Control: local, readily available attire: 2 plastic gowns worn overthe front and the back of the torso, rain‐suit pants and hood, spark‐shieldas face‐cover, ankle length shoe covers, double gloves with outer arm‐lengthsurgical gloves, N95 masks; meeting CDC recommendations; each participantwas assisted in PPE donning by an experienced trainer. | |
| Outcomes | Contamination: measured in mL of fluorescent agent with LED black lightafter doffing. Random order of 2 types of exposure: high volume or standard. High volumemeant 100 mL of fluorescent agent splashed on the torso. Standard meantworking on a manikin contaminated with fluorescent agent. Fluorescent liquidmimicked body fluids and consisted of fluorescent powder, clothes detergent,fluorescent tablets | |
| Notes | No funding or conflict of interest reported Apparently tape was used to put attire together; this resulted in moredifficult doffing but no figures reported; costs of locally availableequipment was USD 36 US, that of commercial material not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomized to one of two PPE ensembles" |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) Alloutcomes | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data |
| Selective reporting (reporting bias) | High risk | Contamination outcomes reported but no separate outcomes for high or normalexposure, however small sample and no statistical analysis by studyauthors |
| Other bias | Low risk | No indication |
Buianov 2004
| Study characteristics | ||
| Methods | Controlled simulation study, not randomised; probably cross‐over study | |
| Participants | N = 9 volunteers that carried out a 4‐h step test of average workload at atemperature of 20º C and 60% relative humidity, no further detailsprovided | |
| Interventions | Intervention: different types of PPE compared: different types ofrespirators Positive pressure suit (special biological suit, СКБ‐I) consisting of arubber hood connected to a PAPR and a 'dust‐proof' coverall in 1 piece withdifferent rates of air supply: initially 250 L/min, then 50, 100, 150, 200,250, 300 L/min. No information about the filtering piece. PPE was especiallydeveloped for highly infectious diseases such as Ebola, Marburg and Lassafever intended for use by HCW, such as doctors, nurses and orderlies Comparison: 2 different types of positive pressure hoods (ЛИЗ‐4 andПШБ‐3) together with a coverall type Biotekhnolog ‐1 Procedure: tests are carried out in a so‐called Meltserovsky room(individual room with quarantine). The pressure suit or hood and coverall isput on before entering and checked whether it functions by attaching theconnecting pipe to the air supply system. Then the worker enters the bufferzone (gateway with entrance and exit) and proceeds to the individualmeasurement room. After the step test in the individual room the HCW goes tothe buffer zone in order to treat the outside surface of the pressure suit.The worker attaches the suit to the connecting pipe of the air supply systemand treats the suit with the help of aerosol disinfectant, usually 3%‐6%hydrogen peroxide (2‐3 aerosol generators are situated at differentheights). After the aerosol rests are pumped out of the buffer zone the HCWleaves through the gateway, takes off the pressure suit and places it in thespecial container for final disinfection. | |
| Outcomes | Contamination exposure: Participants were exposed to a microbial aerosolwith a concentration of 108 CFU/m3. No further detailson the spray aerosol provided. Contamination outcome measured aerosol particles on different parts of thebody (neck, shoulder, forearm, chest, loin, thigh, shin) and the suit with'washouts' and triple agar prints. Only data from triple agar prints arepresented since the 'washouts' resulted in unreliable data (because thetextile materials used in the pressure suit were impregnated withhydrophobic materials). Triple agar prints were taken from the outsidesurface of the pressure suit, inside surface of the pressure suit, clothesand skin areas at different parts of the body (neck, shoulder and forearm,chest, loin, thigh and shin). The outcome was both expressed as CFU/m³ andas penetration rate as a percentage of the outside that has leaked insidethe PPE. It was unclear if these outcomes were expressed as an averageacross the participants and what the variation was. The study authors conclude that "despite the significant concentration ofmicrobial aerosol in the experimental room (107‐105cfu/m3) no microbial aerosol was measured on skin areas withair supply speeds of 250 L/min and higher". Additionally, the study authors assessed skin temperature, heart rate,breath rate, and moisture loss | |
| Notes | Article in Russian, data retrieved with help of a native speaker (AP) Article difficult to judge due to cultural differences in style andtranslation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | High risk | No confounders reported |
| Selection Bias NRS | Low risk | Selection of volunteers unrelated to intervention or to outcome. Startfollow‐up and intervention coincide for all participants. |
| Blinding of participants and personnel (performance bias) Alloutcomes | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear if data reported for all nine participants |
| Selective reporting (reporting bias) | Unclear risk | All data announced in methods reported in results |
| Other bias | Low risk | No other biases assessed |
Casalino 2015
| Study characteristics | ||
| Methods | Controlled before‐after study of 2 training variants | |
| Participants | N = 120, 63% nursing students, 37% medical students Age 21.2 +/‐ 3.5 years, 35% male The study authors did not present demographic data per group Location: Paris (France), Lima (Peru), and Guadalajara (Mexico), inDecember 2014 and January 2015 with no previous training in PPE use, with nospecial intention to be involved in Ebola care | |
| Interventions | Intervention: doffing with extra instructions There were 2 intervention groups that only differed in type of PPE used 1. Basic PPE + reinforced training (N = 30); basic PPE consisted of boots,goggles, surgical mask, surgical cap, impermeable apron (11 pieces ofequipment) with 6 steps for donning and 13 steps for doffing. 2. Enhanced PPE + reinforced training (N = 30); enhanced PPE consisted ofboots, full‐body impermeable suit, hood with surgical cap and mask, doublegloves, impermeable apron (9 pieces of equipment) with 6 steps for donningand 12 steps for doffing. Training for all participants consisted of 60 min of theoretical courseincluding 10 min of donning instruction and 20 min of doffing instruction.In addition, there were 3 practical training sessions per 2 students whomutually assisted each other observed by a specialist trainer who intervenedin case of non‐compliance. The sessions were held with 3‐day intervals.Compared to the control group the additional intervention was that thespecialist trainer "repeated aloud each of the steps and technical skills orprocesses necessary" to comply with the standard during the practicaltraining sessions. The sessions were also reviewed comprehensively. Control group: There were 2 control groups that differed in type of PPE used just as inthe intervention groups 1. Basic PPE + conventional training (N = 30) 2. Enhanced PPE + conventional training (N = 30) These groups received the same training as the intervention group but thespecialist‐trainer did not repeat aloud the necessary steps. | |
| Outcomes | Primary outcome: number of errors per person for donning and fordoffing and the number of people with ≥ 1 errors measured by the specialisttrainer. The study authors also measured critical errors, which were thosewhere there was contact between skin and potentially contaminated PPE, butwe did not consider this a valid measure of contamination and disregardedthis. We took measurement of the errors at the last training session as theeffect of the intervention. We disregarded the error measurements at earliertraining sessions. Secondary outcomes: errors for doffing of the gown, full‐body suitand boots; duration of donning and doffing in min at the last trainingsession | |
| Notes | Country: France, Peru Mexico; no funding reported; no conflict of interestreported The first study author, Enrique Casalino, answered some of our questionsregarding the study, but we were unable to retrieve more information on thegroup allocation and therefore classified the study as non‐randomised. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | Unclear risk | None of the confounders mentioned |
| Selection Bias NRS | Low risk | Students were randomly chosen and did not have any experience or intentionto use the knowledge and skills. |
| Blinding of participants and personnel (performance bias) Alloutcomes | High risk | Blinding not possible but students could be motivated to perform betterbecause of knowing that they were in the intervention group and not as aresult of the oral instructions. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Providers were also the assessors of compliance. We asked study authors formore information but did not get any information that increased ourconfidence in the outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported if all data were available |
| Selective reporting (reporting bias) | Low risk | All outcomes in methods section reported; no protocol available |
| Other bias | Low risk | No other biases assessed |
Casanova 2012
| Study characteristics | ||
| Methods | Controlled simulation study, non‐randomised, first intervention thencontrol condition for all participants | |
| Participants | N = 18 volunteer healthcare providers > 18 years of age; exclusioncriteria: pregnant, latex allergy, skin disorder, previous fit‐testing forN95 respirator; 17/18 right handed, 18/18 previous experience with PPE Location: USA | |
| Interventions | Intervention: doffing with double gloves 2 pairs of latex gloves; inner glove under the cuff of the gown sleeve, theouter glove, 1 size larger worn over the gown cuff; in addition, full PPEconsisted of contact isolation gown, N95 respirator and eye protection Control: 1 pair of latex gloves in addition to similar full PPE asin intervention group Doffing was performed according to CDC instructions: gloves, goggles, gown,mask or respirator in case of single gloves; in case of double gloves, outerpair of gloves first and inner pair last | |
| Outcomes | 1. Contamination of the hands, face, gloves and scrubs with bacteriophageMS2 virus; hands sampled with "glove juice method", face with a swab at theedge of the N95 respirator, shirt, pants and gloves were immersed in beefextract. All eluants were assayed by 'most probable number enrichmentinfectivity assay' (MPN). Detection level 0.15 log 10 MPN; Used paired t‐test for the analysis of continuous data to take thecross‐over into account 2. Noncompliance with doffing guidelines Contamination with bacteriophage MS2 was put on front shoulder of the gown,right side of respirator, right front of eye protection and palm of dominanthand by simulated droplet contamination; before doffing participants had toperform neck and wrist pulses on manikin | |
| Notes | No funding or conflict of interest reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | Low risk | No apparent confounders for this type of study and outcome |
| Selection Bias NRS | Low risk | No apparent selection of participants into the study |
| Blinding of participants and personnel (performance bias) Alloutcomes | Unclear risk | No blinding, but performance bias not likely because participants would nothave an interest with either intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
| Selective reporting (reporting bias) | Unclear risk | Some data only in figures and not in tables |
| Other bias | Low risk | No other biases anticipated |
Casanova 2016
| Study characteristics | ||
| Methods | Non‐randomised simulation study How was the simulation performed? Each participant was verbally guided through the donning process of EVD PPEusing the CDC protocol. After the exposure contamination was applied to thePPE worn, all participants performed a gown change on a manikin.Participants were then verbally guided through the doffing process using theCDC checklist either using a hypochlorite spray or an alcohol‐based hand rubfor all six hand or glove cleaning steps during doffing. How was the exposure simulated? Exposure to a mixture of MS2 and Φ6 suspended in phosphate‐buffered salinewas applied to 4 sites: (1) the palm of the dominant hand, (2) the shoulderof the gown opposite the dominant hand, (3) the top side of the face shieldon the same side as the dominant hand, and (4) the toe of the rubber bootopposite the dominant hand. A total of 25 µL was applied to each site in 5drops of 5 µL each to simulate droplet exposure, particularly small dropletexposure of which the HCW may not be aware. The mean virus titre applied toeach site in 25 µL was 1 × 108 for MS2 and 5 × 107 forΦ6, based on reports of viral load in body fluids during acute phases ofEVD. | |
| Participants | N= 15 (11 RNs and 4 MDs) no further details given Intervention: 5, control: 10 Study participants were all members of the Ebola care team at a largetertiary care academic medical centre. Members of the Ebola team were >18 years of age and had undergone extensive training in a simulationlaboratory in the use of EVD‐specific PPE, including donning and doffing | |
| Interventions | Intervention: doffing with extra glove sanitation Hypochlorite glove sanitiser: liquid hypochlorite at a concentration of1850 ppm was applied by spraying it on the gloves for each hand or glovesanitising step of the 16‐step doffing protocol that was used. This was theonly alternation of the usual doffing protocol. Control: alcohol‐based hand rub: 70% ethanol gel was used for eachhand or glove sanitising step of the 16‐step doffing protocol that wasused | |
| Outcomes | Contamination: 1. MS2 bacteriophage (non‐enveloped surrogate virus) 2. Φ6 bacteriophage (enveloped surrogate virus, such as Ebola) We took from the study authors' report contamination found on scrubs, or onthe bare hands or on the face of the participant | |
| Notes | Country: USA; no conflict in interests reported; funded with CDC grant | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | Low risk | Differences related to: 1. prior experience with PPE ‐ no 2.healthcare qualification or education of HCW ‐ no 3. age‐noinformation, unlikely 4. sex‐no information, unlikely 5. ambienttemperatures ‐ no, assumed similar 6. stressful activities ‐ no |
| Selection Bias NRS | Unclear risk | Allocation to group was based on belonging to the last 5 participants |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Participants were asked to close their eyes when simulated exposure wasapplied to them. However, it is unlikely that they did not notice wheresimulation exposure was applied. Participants were not blinded to the intervention, however, it is unlikelythat they behaved differently with hypochlorite or alcohol sanitiser |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data |
| Selective reporting (reporting bias) | Low risk | No protocol, but selective reporting unlikely |
| Other bias | Low risk | No other bias observed |
Chughtai 2018
| Study characteristics | ||
| Methods | Study design: RCT Study grouping: cross‐over Simulation study? If so, describe exposure simulation: after donningPPE, inert fluorescent lotion was applied on external surfaces of the PPE tosimulate contamination. Participants were given 0.5 mL of lotion and wereinstructed to rub the lotion on their hand and apply to the PPE. Fluorescentlotion was also sprayed on the front and sides, from approximately 1 m, tomimic droplet infection. For simulation study: what was used for the exposure (virus, fluorescentfluid etc): fluorescent spray: GlitterBug. Glitterbug kits. Availablefrom: glitterbug.net.au/products/. Accessed 2 January 2018 | |
| Participants | Baseline characteristics Overall
Included criteria: not reported other than "Staff and students ofthe University of New South Wales". Assuming adult, both genders Excluded criteria: excluded participants with any pre‐existingrespiratory condition, heart disease, or pregnancy | |
| Interventions | Intervention characteristics: different types of PPE compared withvarious donning and doffing protocols
| |
| Outcomes | Small patches of contamination
Large patches of contamination
Ease of use and comfort
| |
| Notes | Outcomes For the WHO attire there were 4 large patches ofcontamination, for the North Caroline PPE 2, for the CDC PPE 1 small patchand for the Health Canada PPE there was 1 small patch of contamination | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned to use 3 different PPE protocols." Judgement comment: insufficient information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) Alloutcomes | Unclear risk | Quote: "Participants did not have any training in PPE. They were providedwith the relevant protocol for donning/doffing, and procedures were examinedby a study investigator using a checklist. The study investigator read outthe donning and doffing steps, and participants followed the instructions.Videos were shown if available for each protocol that was tested." Judgement comment: no blinding possible but participants and personnel werenot aware which protocol would be better, we felt that it is unclear ifperformance bias is likely |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: procedures were examined by the study investigator whowas aware of the PPE protocol. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: data for all participants provided |
| Selective reporting (reporting bias) | Low risk | Judgement comment: there was no protocol reported in the paper for thisstudy. However, the outcomes of interest were listed in the methods andappear reasonable for the study. |
| Other bias | Low risk | Judgement comment: no other bias detected |
Curtis 2018
| Study characteristics | ||
| Methods | RCT with parallel groups How was the simulation performed? Participants had to demonstrate skills in donning PPE, working with PPE anddoffing PPE in a simulated practice setting where they were observed. AtStation 1, participants were asked to don Level C PPE. At Station 2, theparticipants were asked to demonstrate the proper technique foradministration of the Duodote auto‐injector to a simulated victim of nerveagent poisoning. Participants were then asked to use the Simple Triage andRapid Treatment triage system for 6 different disaster scenarios that weredescribed on cards attached to inflatable training manikins. At Station 3,participants were asked to decontaminate inflatable training manikinssimulating contaminated victims of a hazardous materials incident. Followingcompletion of the 3rd station, the participants doffed their Level C PPE andwere asked to complete the post‐exercise comfort survey. | |
| Participants | N = 30 volunteers. Emergency Medicine residents were randomised, results of26 are reported. The study was conducted at an urban, academic, tertiary referral centrethat provides training to Emergency Medicine residents in a 4‐yearprogramme. All Emergency Medicine residents who attended the weeklyeducational conference were recruited for this study. As there were not anymore residents available to participate at this single‐site study, thenumber needed to study for significance was not determined. Intervention: n = 13 (53% female), Control: n = 13 (46%female) | |
| Interventions | Intervention: training: video‐based learning (VBL) A training video about specific content for the training modules waswatched prior to completing a knowledge quiz and the practical exercises. AnEmergency Medicine resident in the residency programme’s disaster medicinespecialty track wrote, directed, and edited the video. The VBL modality wassetup and viewed without faculty interaction. Both educational modalitiescontained identical educational content Control: traditional lecture (TL) A PowerPoint presentation that covered the same information as the videowas presented prior to completing a knowledge quiz and the practicalexercises. | |
| Outcomes | Primary outcome: performance scores on proper donning of PPE on thepractical exercises evaluated by a blinded trained evaluator | |
| Notes | Location: USA; no funding or conflict of interest reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "department research division consultant conducted a stratifiedrandomisation of residents by post‐graduate year class level and assignedthem to either the experimental (VBL) group or the control (TL)" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Study participants identified themselves on all study tests andsurveys using employee identification numbers rather than their names" |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Study could not be blinded but unlikely that participants could haveinfluenced the outcome because they knew to which group they belonged |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All evaluators were blinded as to which study participants hadparticipated in the TL modality and which participated in the VBLmodality." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data available for 13 out of 15 participants in both groups. Missing datawere not related to the intervention. |
| Selective reporting (reporting bias) | Unclear risk | No study protocol provided. Probably all outcomes reported |
| Other bias | Unclear risk | No other bias detected |
Drews 2019
| Study characteristics | ||
| Methods | Design: a 2 (task) x 2 (gown) nested, repeated‐measurements design Group: cross‐over For simulation study: what was used for the exposure (virus, fluorescentfluid etc): no exposure was used only simulated tasks. Exposure simulation: all participants reviewed a brief presentation andwere given an opportunity to ask questions on the design, attributes, anduse of the redesigned gown. They were then introduced to the simulator andgiven patient information along with a brief description of the task theywere to perform. The simulated patients were in isolation precautions withsignage posted outside the patient room indicating the required PPE.Participants performed 2 scenarios, with a different gown (standard orre‐designed) made available prior to the start of each scenario. | |
| Participants | Male %: not reported Age (m ± SD): not reported Occupations: nurses (50%) and nurses' aides Employment duration: not reported | |
| Interventions | Intervention: modified PPE: redesigned gown: gown redesignconsiderations focused on improving the closure mechanism, providing visualcues to demarcate the contaminated outer from the clean inner surfaces,weighing down the gown material for better coverage, and making gown removaleasier by adding perforations to the tie. A closure mechanism using anasymmetrical closure approach was favoured, with the gown secured by pullinga single strap from the back to front. An adhesive strip covered by red tapewas placed at the end of the strap. Pulling the tape off the adhesive stripallowed for strap securement to the front of the gown Control: standard gown | |
| Outcomes | 1. Non‐adherence to proper use of PPE during donning, measured as: if andhow gown was closed 2. Non‐adherence of proper use of PPE during doffing, measured as: pullinggown from waist, balling up gown) 3. Non‐adherence of proper use of PPE during performance: measured as:exposure while squatting, tie or gown touches floor | |
| Notes | Sponsorship source: This work was supported by the CDC (grant number P50CA098252). The article appears as part of the supplement “PersonalProtective Equipment for Preventing Contact Transmission of Pathogens:Innovations from CDC’s Prevention Epicenters Program,” sponsored by theCDC’s Prevention Epicenters Program. Country: USA Setting Simulation learning center Authors name: Frank A. Drews Institution: Department of Psychology, and Division of Epidemiology,Department of Internal Medicine, University of Utah, Salt Lake City, US Email drews@psych.utah.edu Address: University of Utah, Department of Psychology, 380S 1530E BEH, Rm502, Salt Lake City, UT 84112, US | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | Low risk | Confounders:
|
| Selection Bias NRS | Unclear risk | No details of participants mentioned |
| Blinding of participants and personnel (performance bias) Alloutcomes | High risk | Personnel and participants could not be blinded and likely that theredesigned gown can have influenced behaviour |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors mentioned. Adherance is a rathersubjective evaluation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data reported |
| Selective reporting (reporting bias) | Unclear risk | No protocol mentioned and unclear if all outcomes reported |
| Other bias | Unclear risk | There was no washout period and it is unclear if the order of theexperiments was random. It is only reported as counter balanced |
Gleser 2018
| Study characteristics | ||
| Methods | Simulation study, quasi‐randomised study based on alternation How was the simulation performed? A volunteer HCW donned appropriate sized glove and then wetted each handwith fluorescent solution and distributed this solution equally on theglove's surfaces to simulate an external glove contamination. Immediatelythereafter, the volunteer removed their gloves, and their hands were thenexamined using a UV Box (Hand Hygeine Teaching Box "Sharing Expertise; B.Braun, Melsungen, Germany) How was the exposure simulated? 5 mL of a fluorescent solution (Schülke Optics Training fluorescent lotion;Schülke & Mayr GmbH, Vienna, Austria) on each hand | |
| Participants | N = 317 (~70% female) volunteer HCWs on 35 hospital wards in a tertiarycare university hospital Intervention: N = 146 (104 nurses, 53 physicians) Control: N = 171 (118 nurses, 53 physicians) | |
| Interventions | Intervention: modified PPE: tabs on gloves Doffy Glove, modified nitrile gloves with a textured small flap (doffingaid) above the thumb area positioned laterally on the wrist when worn thatcan be gripped during glove removal Control: standard nitrile medical examination gloves made according to thesame material formulation and manufacturing process by the same company onbehalf of IP Gloves GmbH | |
| Outcomes | Contamination: any visible fluorescence on the volunteer's skin | |
| Notes | Location: Germany; no funding or conflict of interest reported, howeverfirst author is also CEO of the start‐up that developed and market the newtypes of gloves. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "Participants were randomised for the use of either standard glovesor Doffy Gloves on an alternate daily basis" Judgement comment: quasi‐randomisation; big difference in number inintervention or control group |
| Allocation concealment (selection bias) | Unclear risk | No description provided |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Study could not be blinded but unlikely that participants could haveinfluenced the outcome, which was assessed by observers |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Assessors of contamination were aware of which glove was used andsubjective assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data reported |
| Selective reporting (reporting bias) | High risk | No study protocol provided |
| Other bias | High risk | Study authors have a big financial interest in a positive evaluation oftheir new product |
Guo 2014
| Study characteristics | ||
| Methods | Randomised, multiple arm, cross‐over, simulation study | |
| Participants | N = 50; voluntary HCW who gave informed consent; excluded were those whowere allergic to the fluorescent marker; 34/50 female, 20/50 nurses, 10/50doctors, 15/50 support staff, 5/50 allied health workers; age 32.9 ± 5.7years average; working experience 10.9 ± 5.1 years Location: Hong Kong, China | |
| Interventions | Intervention: different types of PPE compared Intervention 1: N = 50 participants. 3 types of protective clothing:1. Disposable, water‐resistant, non‐woven gown, 2. Reusable, woven cottongown, 3. Disposable, non‐woven plastic apron; and 2 different removalmethods: individually determined or CDC‐recommended. Each of the 50participants was required to test the 3 different types of PPE followed by 1of 2 different removal methods. Intervention 2: first the participant should doff according to theirown views (individual method), then a CDC instruction video was shown andparticipants were asked to perform the donning or doffing method for gownsthat was recommended by CDC in 2007: gown front and sleeves arecontaminated! Unfasten neck, then waist ties. Remove gown using a peelingmotion; pull gown from each shoulder toward the same hand. Gown will turninside out. Hold removed gown away from body, roll into a bundle and discardinto waste or linen receptacle. Control: cross‐over N = 50 participants. 3 types of protectiveclothing were compared against each other. | |
| Outcomes |
A fluorescent powder (GloGermCo,Moab,UT) especially developed fordetermining hand hygiene compliance was used in this study. The Glo Germpowder was mixed with light olive oil and water to resemble human aerosol asclosely as possible. The study authors used repeated measures analysis to take into account thecross‐over design of the study | |
| Notes | Funding Hong Kong Polytechnic University; no conflict of interestdeclared | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Interventions were offered "in random order"; study authors asked forclarification |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | No blinding possible, but no performance bias expected as participantswould not have an interest with any intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | All data reported |
| Other bias | Low risk | Not detected |
Hajar 2019
| Study characteristics | ||
| Methods | Study design: RCT Study grouping: cross‐over Exposure (virus, fluorescent fluid etc): fluorescent solution (SuperBlue Invisible Ink, Black Light World) Exposure simulation: participants donned the gowns and nitrilegloves (DenvilleScientific, Holliston, MA) in their usual manner. The glovedhands were inoculated with 0.5 mL of fluorescent solution (Super BlueInvisible Ink, Black Light World) that was rubbed over the gloved handsuntil dry (~15 s). The participants removed their PPE in their usual manner;no education was provided. | |
| Participants | Baseline characteristics Overall
Included criteria: not reported (HCW) Excluded criteria: not reported | |
| Interventions | Intervention characteristics: modified PPE Increased‐coverage gown
Standard gown
Increased coverage gown plus education
Standard gown plus education
| |
| Outcomes | Contamination outcome assessment: contamination of the hands andwrists was assessed using a black light, and the sites of contamination wererecorded. After a washout period of at least 5 min, an additional simulationwas conducted with cross‐over to the alternate gown. People with contamination
People with protocol deviation
| |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "personnel were randomized" Judgement comment: no reporting of random number generation |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: no reporting of allocation concealment |
| Blinding of participants and personnel (performance bias) Alloutcomes | High risk | Quote: "We conducted 2 non‐blinded cross‐over trials to comparecontamination of personnel during simulations of contaminated PPE removalwith the standard versus the alternative design cover gown." Judgement comment: study authors stated they were non‐blinded. 1 gown wasroutinely used in the facility and participants may have had a biasedpreference for it. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: no mentioning of blinding of outcome assessors. Probablynot blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "total, 6 participants were excluded from the analysis because theydid not complete the second assessment because they were unavailable orunable to be located after the initial assessment." Judgement comment: attrition was even in both trials, with 4 dropping out(2 each group) in trial 1 and 2 dropping out (1 each group) in trial 2. Alldata were reported for those analysed |
| Selective reporting (reporting bias) | Unclear risk | Judgement comment: no compliance data provided for second trial |
| Other bias | Unclear risk | Judgement comment: washout period very short and unclear if all contaminantwas cleared away |
Hall 2018
| Study characteristics | ||
| Methods | Simulation study, non‐randomised cross‐over study How was the simulation performed? Prior to donning PPE volunteers were screened using FluorescenceInteractive Video Exposure System (FIVES) to ensure that there was nopre‐existing contamination on their skin or scrubs from the environment,previous tests or background fluorescence. Over disposable scrubs volunteersthen donned the PPE ensembles under supervision by a buddy, and they werescreened again prior to beginning the simulation exercise. After completingthe exercise, volunteers were screened front and back using the FIVES systemto qualitatively record contamination resulting from the simulation. PPE wasthen removed according to protocol under the supervision of a buddy, andscreening was repeated to detect any post‐doffing contamination. How was the exposure simulated? 'Violet' (Visualising Infection with Optimised Light for Education andTraining) was a medical training manikin adapted to deliver simulants of 4fluorochrome‐tagged body fluids during a scenario based on a doctor andnurse undertaking clinical procedures with a suspected‐case patient. | |
| Participants | N = 11 (7 nurses, 4 doctors) Volunteer healthcare providers wererecruited via calling notices at the participating Infectious Disease (ID)units, gave informed consent and were free to withdraw at any time. 11volunteers completed the simulation exercise up to 10 times depending ontheir availability. 5 volunteers (including 1 further doctor and nurse)acted as 'buddies' to assist with doffing. All volunteers were experiencedin using the PPE ensembles adopted by their respective ID units, but if theyused an ensemble from another unit, they had to undergo training to practicedonning and doffing 10 times or until deemed competent by a staff trainer.Limiting the number of volunteers reduced user attributable variation. | |
| Interventions | Intervention: different types of PPE compared 5 'suspected case' PPE ensembles used in different infectious disease unitsaround the UK. All models met the guidance of the Advisory Committee onDangerous Pathogens endorsed by Public Health England. PPE components mettheir relevant material standards. All were donned and dry‐doffed accordingto the specific protocol relevant to the ensemble. The PPE ensembles variedbut could broadly be grouped as a 'gown model' or a 'coverall model' buteach had slight differences (e.g. use of hood vs surgical cap, boots vs bootcovers, and different glove lengths and number of pairs). Control: basic‐level PPE (surgical mask, standard length apron, 1 pairshort gloves, no standard footwear, scrubs and no buddy used fordoffing) | |
| Outcomes | Contamination: fluorescent areas seen on skin or scrubs of the volunteerpost‐doffing | |
| Notes | Location: UK; no conflict of interested reported; funding was provided byHealth and Safety Executive (HSE); Bozena Poller was funded by theHealthcare Infection Society’s Graham Ayliffe Training Fellowship | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | Low risk | Differences related to:
|
| Selection Bias NRS | Low risk | Cross‐over trial; 11 participants did the simulation up to 10 times |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Participants knew which PPE they had on but it is unlikely that they couldhave influenced the outcome, which was an objective assessment by anobserver. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The judgement of the contamination is subjective and the assessors wereaware of the type of equipment but it is unclear if this could haveinfluenced the outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "This resulted in a non‐trained volunteer participating in the roleof the nurse for 1 simulation; their data were excluded from the finalanalysis, but their participation allowed data to be captured for theirdoctor partner. In total, 19, suspected case simulations captured 37volunteers." |
| Selective reporting (reporting bias) | Unclear risk | No protocol provided |
| Other bias | Low risk | No other biases detected |
Houlihan 2017
| Study characteristics | ||
| Methods | Retrospective cohort study Invitations to participate were sent to individuals known to the studyauthors, and through organisations supporting EMT deployment involvingUK‐based staff, including non‐governmental organisations (NGOs), UKgovernment‐affiliated institutions, and the London School of Hygiene andTropical Medicine (LSHTM). The participants filled in a questionnaire withinformation about PPE use. They then underwent a blood test to assess theirantibody status. The researchers assessed the participants' risk of beingexposed to EVD based on an independent algorithm. | |
| Participants | N = 300 individuals who returned to the UK or Ireland after responding tothe West African EVD epidemic completed the survey. Of these, N = 268returned material for IgG assessment (median age 36 years range 30‐45; 57%female; 35% lab staff, 26% physicians, 20% nurses, 19% other) Inaddition, there were N = 53 non‐exposed control participants included whohad not left the UK (median age 35 years range 31‐40; 66% female) | |
| Interventions | Intervention: doffing with extra sanitation; doffing with extrainstructions There were 2 interventions that were of interest. (1) PPE removal with orwithout chlorine spray, (2) PPE removal with and without assistance.However, almost all clinical staff had used both interventions as comparedto laboratory staff who had not used them. Because there was also a bigdifference in the likelihood of exposure between these 2 occupationalgroups, the effect of protection of these measures could therefore not beanalysed. | |
| Outcomes | Level of IgG antibody against Ebola Virus as an indicator of infection | |
| Notes | Country: UK; funding by Wellcome Trust: Enhancing Research Activity inEpidemic Situations. The funders had no role in study design, datacollection and analysis, decision to publish or preparation of themanuscript; 1 study author received funding from the Wellcome Trust via theUniversity of Liverpool and also received non‐financial support from NHSBT,as part of the Convalescent Plasma Study. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | Low risk | Differences related to:
|
| Selection Bias NRS | High risk | Sample based on snowball sampling |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Participants were not aware of exposure status when they reported theirexposures. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Researchers knew who was rated as 'high risk' but objective outcomemeasure. Therefore unlikely that it was influenced |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Convenience sample; from sample 10.7% did not react |
| Selective reporting (reporting bias) | Unclear risk | No protocol provided |
| Other bias | Low risk | No other sources of bias detected |
Hung 2015
| Study characteristics | ||
| Methods | RCT, 2 parallel groups, 2 training variants | |
| Participants | Intervention group: N = 25, age 44% < 31 years, healthcare assistant56%, nurse 44%, work experience < 6 years 44%, no gender reported Control group: N = 25, age 28% < 31 years, healthcare assistant 56%,nurse 44%, work experience < 6 years 48%, no gender reported All HCW of an outpatient department of a private hospital handlinginfectious patients before admission; able to read English, basic computerskills | |
| Interventions | Intervention: training: extra computer simulation All participants were asked to don and doff N95 respirator, face shield,cap, gown, gloves for "precautions against airborne danger". Externalobservers rated the procedures for errors. All participants then attended aPPE‐training consisting of a 15‐min demonstration of donning and doffing byan "infection control link nurse". After 1 week the intervention group gotthe interactive computer simulation programme and again after 1 week wasassessed for compliance with the donning and doffing procedures. Control: the control group was assessed for compliance with donningand doffing procedures 1 week after PPE training. The group did not get thecomputer simulation training. | |
| Outcomes | Primary outcome: score on 16‐item checklist for donning and 20‐itemchecklist for doffing. Secondary outcome: IBM computer system usability questionnaire (CSUQ)consisting of 19 items with a 7‐point Likert response scale | |
| Notes | Hong Kong China; funding: Hong Komg Research Grant Council; no conflict ofinterest reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The subjects were randomly assigned to the control and experimentalgroup of the same size", page 53 |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Not possible to blind participants or providers but outcome objectivelyassessed by observers, unlikely that this was influenced |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Nurse assessing PPE compliance "was blinded about the research", page53 |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported if all participants contributed data |
| Selective reporting (reporting bias) | High risk | Results of computer usability questionnaire not fully reported |
| Other bias | Low risk | No other biases assessed |
Kpadeh Rogers 2019
| Study characteristics | ||
| Methods | Study design: non‐RCT Study grouping: n/a Simulation of the exposure (virus, fluorescent fluid etc): for eachexperiment, the top gloves on both hands were directly inoculated with 50 μLof bacterial suspension and 50 μL of GloGerm Mist liquid fluorescent marker(GloGerm, Moab, UT) to give a final concentration of 108 CFU of bacteria. Ahigh inoculum was used based on our pilot observations that organismrecovery from gloves was reduced by 1–2 logs from the original inoculum.Fluorescent marker was added to visually trace bacterial transfer throughoutall experiments. Exposure simulation: participants were asked to rub thebacteria/fluorescent marker on their hands in a standardised way. A researchteam member provided verbal instructions to ensure that doffing steps wereperformed per CDC protocols. Alcohol‐based hand rub, 63% alcohol (SterisCorp, Mentor, OH) and 2 US Environmental Protection Agency–registeredhospital disinfectants, dispatch bleach disinfecting wipes (CloroxHealthcare, Oakland, CA) and Sani‐Cloth AF3 quaternary ammonium (“quat”)disinfecting wipes (PDI Healthcare, Montvale, NJ), were used fordecontamination. Volunteers were asked to decontaminate in a manner thatensured they covered all parts of the glove surface including between allfingers. Using a single pump of the alcohol‐based hand rub, volunteersrubbed both gloved hands together, similar to routine hand hygiene in thehospital, until the gloves were completely dry. For wipe‐baseddecontamination, the volunteer used a single wipe to decontaminate bothgloves with continuous wiping for at least 1 min. We ensured a totalmanufacturer‐recommended dwell or contact time, that is, time for which theglove surface remained visibly wet, of 3 min for quat and 1 min forbleach. | |
| Participants | Baseline characteristics 10 participants were enrolled, 10 per organism Overall
Included criteria: volunteers were asked to don 2 pairs of glovesand a gown, with the under gloves representing HCW hands and the top glovesrepresenting the actual gloves worn for patient care. In total, 20 HCW (10per organism) were enrolled. Excluded criteria: not reported Pretreatment: cross‐over trial. All participants used all 3disinfectants and no disinfectant | |
| Interventions | Intervention characteristics: doffing with extra sanitation Alcohol‐based glove decontamination
Quat‐based glove decontamination
Bleach‐based glove decontamination
No glove decontamination
| |
| Outcomes | Outcome assessment for simulation study: at the end of theexperiment, gloves were sampled using a 3M sponge‐stick with 10 mLneutralising buffer (St. Paul, MN) in a standardised manner to ensuresampling of all surfaces. Sponge‐sticks were processed using previouslydescribed methods. From the eluent, successive 1/10 dilutions were made andplated on tryptic soy agar (Becton Dickinson, Sparks, MD) in triplicate forquantitative culturing. Plates were incubated overnight, and the number ofCFUs of Klebsiella pneumoniae and Methicillin‐sensitiveStaphylococcus aureus (MSSA) were calculated. The eluent was alsoenriched in gram‐negative broth (Becton Dickinson) for K. pneumoniaeand tryptic soy broth with salt (Remel, Lenexa, KS) for MSSA, incubatedovernight, and plated onto MacConkey agar and blood agar, respectively. Bacterial contamination (combined Staphylococcus and Klebsiella)
Bacterial contamination
| |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | Unclear risk | Judgement comment: differences related to:
|
| Selection Bias NRS | High risk | Judgement comment: 10 HCW performed the trial with 1 type of bacteria andanother 10 HCW performed the trial with the second type of bacteria. |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Judgement comment: participants knew which disinfectant they used, but itis unlikely that they could have influenced the outcome, which was anobjective assessment by an observer. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: outcome assessors unblinded but outcome fairlyobjective. Unlikely that they influenced the outcome measurement |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Judgement comment: apparently data from all experiments reported |
| Selective reporting (reporting bias) | Low risk | No protocol but apparently all outcomes reported |
| Other bias | Low risk | Judgement comment: no other sources of bias detected |
Mana 2018
| Study characteristics | ||
| Methods | Simulation study, randomised cross‐over study How was the simulation performed? Participants were instructed to don intervention or control gown and glovesin their usual manner. A lotion containing both exposures was rubbed ontothe gloves and then the participants rubbed gloved hands on the front areaof the gown to simulate contamination. Participants doffed the PPE again intheir usual manner. How was the exposure simulated? Exposure to contamination was simulated by a lotion containing 0.5 mL ofphosphate‐buffered saline containing 108 PFU of the enveloped virusbacteriophage Phi X174 (American Type Culture Collection (ATCC) 13706‐B1),and 0.5 mL of fluorescent lotion | |
| Participants | N = 31 11 physicians (36%), 6 nurses (19%), 14 allied health personnel(45%) 31 paired simulations | |
| Interventions | Intervention: modified PPE: gown easy doffing Assure Wear Gown with Flexneck technology (AMD Ritmed, Tonawanda, NY)designed to allow easy removal at the neck and with increased skin coverageand snugness of fit at the wrist. The gown has a double elastic neck closuresystem to aid in removal, thumb loops with smaller holes and provides morepalm coverage and elastic band around wrist to improve snugness of gown Control: Standard Safety Plus polyethylene gown (TIDI Products,Neenah, WI). Problems can occur with hand and wrist contamination due toskin exposure at the gown–glove interface despite the presence of a thumbloop intended to keep the gown in proximity to the gloves. A loose fit atthe wrist and minimal coverage of the upper palm contributes to thepotential for contamination. Contamination of the neck region often occurswhen gowns do not easily come apart at the posterior neck, resulting intearing of gown material. | |
| Outcomes | UV contamination: a black light (Ultra LightUV1 by Grizzly Gear, SCSDirect, Trumball, CT) was used to look for the fluorescent tracer on thehands, wrist, neck and chest. Bacteriophage contamination: the participants' hands and wrist were swabbedwith gauze to collect potential bacteriophage. Alcohol based hand sanitiserwas used for hand hygiene and sterile gloves were donned prior to theparticipant swabbing their neck and chest, including their clothing tocollect other potential contamination. | |
| Notes | Location: USA; financial support: this work was supported by a Merit Reviewgrant (no. 1 I01 BX002944‐01A1) from the Department of Veterans Affairs toC.J.D. AMD Ritmed provided the Assure Wear VersaGowns with Flexnecktechnology for testing, but they had no role in study design, analysis orinterpretation of the data, or writing of the manuscript. Potentialconflicts of interest: C.J.D. received research grants from Clorox, Merck,AvidBiotics, and GOJO, and has served on scientific advisory boards for 3Mand Seres Health. All other study authors reported no conflicts of interestrelevant to this article. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Healthcare personnel were randomised to perform simulations ofcontaminated glove and gown removal using either the standard or alternativedesign gown." Additional info from study authors: the random sequence was generated haveused a List Randomizer from the web‐site: www.random.org/lists/, whichprovided a random listing of which gown will be used first for eachparticipant. |
| Allocation concealment (selection bias) | Low risk | Additional info received from study authors: the allocation wasirrevocable |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Participants could not be blinded but this is unlikely to have an effect onthe outcome because this was assessed by observers |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Additional information from authors: it was not possible to blind outcomeevaluators for the fluorescence evaluation because the gowns are visiblydifferent. However, the outcome evaluators for the assessment ofbacteriophage Phi X174 contamination were blinded to the identity of thestudy groups. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Additional information from study authors: there were no missing data |
| Selective reporting (reporting bias) | Unclear risk | Additional information from study authors: we did not register the studyprotocol |
| Other bias | Low risk | No indication of other biases |
Osei‐Bonsu 2019
| Study characteristics | ||
| Methods | Simulation study, randomised How was the simulation performed? 1. Glo Germ fluorescent powder (Glo Germ Company, Moab, UT) 2. 1 mL ofStaphylococcus epidermidis in a 0.5 McFarland suspension (1.5 10 8CFU/mL). The S epidermidis was genetically engineered to stablyexpress a green fluorescent protein that is visible under a black light inbacterial cultures How was the exposure simulated? In order to simulate PPE contamination, after donning PPE, study assistants(KO, NM, and MD) used a wedge foam paint brush to liberally coatparticipants with Glo Germfluorescent powder (Glo Germ Company, Moab, UT) onboth arms, hands, and the abdomen. The brush was dipped back into the powderafter coating each arm or abdomen. These areas were thought most likely tobe contaminated in the course of patient care activities at the bedside.Participants were then also coated with S Epidermidis in the samedistribution on the body. The solution was applied by dripping droplets overthe PPE with a 1000 uL pipette by the study staff. After the opportunity toreview the assigned procedure and ask questions, participants were thenasked to doff PPE under guided observation by the study investigators. Therewas no training or practice of the doffing techniques prior to thesimulation. Prompts were given as needed to ensure the participants followedthe assigned procedure. | |
| Participants | Inclusion criteria: clinical providers and microbiology laboratorypersonnel as well as life safety administrators. Laboratory personnel andlife safety administrators do not use PPE in the context of patient care,but do use it as occupational PPE (i.e. gowns, gloves, masks, and goggles)in the laboratory or to train other staff on proper PPEusage. Exclusion criteria: individuals < 18 years of age or > 65years of age; pregnancy or breastfeeding; history of joint replacements orother prosthetic medical devices; and active inflammatory skin conditions oropen wounds. Differences between intervention groups in HCW profession type and durationof work experience Occupation: 18% MD, 67% RN, 16% non‐clinician Work experience average 5.2 years | |
| Interventions | Interventions: different doffing procedures; Doffing with extra sanitation;Doffing with double gloves; Doffing 1 step 1. CDC standard doffing procedure (Control intervention): prescribedprocedure for doffing in the following order: gloves, goggles/face shield,gown, mask/respirator, hand hygiene 2. CDC 1 step: similar to CDC procedure but gloves and gownare doffed in 1 go. 3.CDC plus extra hand hygiene: CDC plus extra disinfection of gloveswith alcohol‐based hand rub 4. CDC plus double gloves: similar to CDC procedure but 2 pairs ofgloves used and the first pair is doffed first and the second pair last | |
| Outcomes |
| |
| Notes | Location: USA Corresponce: Michelle Doll: Michelle.Doll@vcuhealth.org. Address: MichelleDoll, MD, MPH, Virginia Commonwealth University Health System, 1300 EMarshall St, North Hospital, 2nd Fl, Rm 2‐100, PO Box 980019, Richmond, VA23298 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "participants were assigned a procedure by having them pick adoffing procedure at random from a closed envelope." Judgement: likely to be random |
| Allocation concealment (selection bias) | Low risk | Quote: "Participants were assigned a procedure by having them pick adoffing procedure at random from a closed envelope." Judgement: unlikely that participants or researchers could change assignedgroup |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Judgement: personnel and participants could not be blinded, howeverunlikely that they could have an influence on the outcome which is fairlyobjective |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement: no information. However both outcomes fairly objective andunlikely that this changed the outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement: no information, apparently all data available |
| Selective reporting (reporting bias) | High risk | Not all outcomes fully reported: main outcome usability only reported asnot significant |
| Other bias | Low risk | No other biases detected |
Shigayeva 2007
| Study characteristics | ||
| Methods | Retrospective cohort study | |
| Participants | HCW who provided care or entered the room of a Toronto SARS patient whor*quired intubation, during the 24 h before and 4 h after intubation Eligible N = 879, analysed N = 795; age (median) = 41 years (range 21‐67years); employment in current occupation (median) = 12 years (range 0‐43years); 46% nurses, 14% physicians, 14% respiratory therapists, 10% imagingstaff and 16% other; 1055 exposure episodes or shifts Active training intervention: N = 511 episodes (= 385 people), Passive training intervention: N = 236 episodes (= 178 people), Comparison no active training: N = 308 episodes (= 323 people) Location: Canada | |
| Interventions | Intervention: training Intervention 1: active training: participants answered that they hadreceived any individual or group face‐to‐face training sessions Intervention 2: passive training: participants watched a video orgot written information. Comparison: no training reported Other predictors of PPE studied in a multivariate generalised estimatingequation logistic regression analysis in addition to training for bothoutcomes: phase of epidemic, occupation, work experience, hospital type,location of care, number of times patient's room entered, SARS diagnosisrecognised, Apache II score of patient. | |
| Outcomes | 1. Consistent adherences as proportion of exposure episodes. Participantswere interviewed based on a questionnaire 0.2‐10 months after the exposure.Interviewers asked about consistent use of PPE: masks, gowns, gloves and eyeprotection and possible predictors of their use, including training.Consistent adherence was defined as always wearing gloves, a gown, a mask,and eye protection. Consistent adherence was reported in 817/1055 (77%)exposure episodes. Eye protection was least with 13.5% consistent and no PPEin 23 episodes (2.2%). PPE use increased during epidemic from 34.6% at startto 97.4% in the end. 2. Doffing as proportion of exposure episodes (safe, at some risk, or atrisk). Participants were asked about their sequence of doffing PPE. Safe wasdefined as the sequence of removing gown and gloves, hand hygiene, mask,goggles, or safety glasses, hand hygiene. At some risk was considered ifhand hygiene was performed only once. At risk if no hand hygiene wasperformed or hands touched potentially contaminated face. Doffingdescription was available for 810/1055 (77%) of exposure episodes; 15.4%qualified as safe, 63% as at some risk, and 22% as at risk. | |
| Notes | Units of analysis used in studies: exposure episodes not people exposed,based on work schedules, patient assignments and health records. There were65 intubations of SARS patients of which 7 were not recognised as such atthe time of intubation. Funding Ontario Ministery of Health and Long term Care; no conflict ofInterest reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Confounding NRS | Low risk | Adjustment in multiple regression analysis for education, work experience,and presumably for age and sex |
| Selection Bias NRS | Low risk | Whole cohort assessed that was working during the epidemic. Exposure toSARS patients clearly defined |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Both the intervention and the outcome were assessed at the same time |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Both the intervention and the outcome were assessed with the samequestionnaire at the same time |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 90% HCW participated for adherence and for 77% of shifts more or lessreliable info about doffing available |
| Selective reporting (reporting bias) | Unclear risk | Not clear which predictors of adherence or safe doffing were tested andnegative |
| Other bias | Low risk | No indication of other bias |
Strauch 2016
| Study characteristics | ||
| Methods | Simulation study, cross‐over RCT How was the simulation performed? 2 different simulations of contamination of the Filtering FacepieceRespirator (FFR) were performed: 1 in which the FFR was contaminated but notthe hands and another one in which the hands were contaminated but not theFFR 1. Contamination of the FFR and clean hands: 20 participants performed 3trials of FFR with removal tabs (tab+) and tab‐ masks each in random order2. Clean FFR and contamination of hands: 20 participants performed 1 tab+trial and 1 tab‐ trial How was the exposure simulated? To contaminate the FFR, 7 mL of fluorescent tracer was brushed onto theentire outer surface of the test FFRs. As only the outer surface of the FFRwas contaminated with the fluorescent tracer, transfer from the FFR to thehands would only occur if the FFR was doffed improperly by grasping thecontaminated surface. 2. For the hand contamination test, 1 mL offluorescent tracer was applied and rubbed into the hands of the testparticipant before removal of a clean FFR with or without tabs. Thefluorescent tracer was prepared by suspending 1 g of GloGerm (GloGermCompany; Moab,UT) powder suspended in 25 mL of mineral oil. | |
| Participants | N = 20 aged 18‐60 HCW Volunteers employed as HCW, that were enrolledin a respiratory protection programme and experienced in wearing FFRs werepreferred, but a potential participant was not excluded if all of thequalities were not met. Volunteers were excluded if they had a history of skin cancer, sensitivityto UV light, or burns from a black light Country: USA | |
| Interventions | Intervention: modified PPE: masks with tabs Mask with tabs; N‐95 mask with 4 red foam tabs attached to straps to assistin mask removal Control: mask with out tabs | |
| Outcomes | Contamination of the hands resulting from exposure to a contaminatedmask Contamination of the head resulting from exposure to contaminated hands:the participant’s head, face and hair were photographed under UVA light forcontamination with fluorescent tracer. | |
| Notes | Location: USA; funding source and conflict of interest were not published;reported on Lumens as a measure of contaminate but the written results didnot match those presented in figure. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "each subject doffed one randomly assigned FFR" Unclear how randomisation was performed |
| Allocation concealment (selection bias) | Unclear risk | Unclear if allocation was irrevocable |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Not reported but unlikely to have influenced the outcome that was assessedby observers |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear if there were missing data |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk | No other biases detected |
Suen 2018
| Study characteristics | ||
| Methods | Study design: RCT Study grouping: Simulation exposure (virus, fluorescent fluid etc): fluorescentsolution (UV GERM Hygiene Spray, Glow Tec Ltd., London, England) that mimicscontaminated bodily fluids or secretions spread via contact route. Exposure simulation: fluorescent solution was sprayed onto the faceshield, 2 upper limb/gloves and anterior surfaces of the gown at a distanceof 60 cm from the participants, which represents the length of astethoscope, simulating the usual working distance between a patient and anHCW, with an average of 1.99 g fluorescent solution/per stroke. This valuewas determined using an electronic analytical balance with a precision of0.1 g (NJW‐3000, Xiangxin, Taipei, Taiwan) via obtaining the average of 20trial cases. A standard of 3 strokes was sprayed on each body part with atotal of 12 strokes made for each case. The weight of the splash in 1 strokewas 1.99 g in this study when the density of the solution was assumed as1. How was the simulation performed?: on the testing day, theparticipants watched a video about donning and doffing of the PPE ensemblesto familiarise themselves with the procedures. The experiment wassequentially conducted in 3 areas. Area A was the ‘clean zone’, where theparticipants donned the working clothes and clean PPE ensemble in front of amirror. Area B was the ‘preparation zone’, where the PPE of the participantswas contaminated with a fluorescent solution. Area C was the ‘de‐gown andtest‐zone’, wherein the participants were required to doff the PPE. | |
| Participants | Baseline characteristics Overall
Included criteria: HCWs that were willing to participate Excluded criteria: pregnant women and participants suffering fromupper respiratory tract infection and respiratory diseases requiringtreatment were excluded. Pretreatment: all participants tested the 3 PPE types | |
| Interventions | Intervention characteristics: different types of PPE compared PPE1
PPE2
PPE3
| |
| Outcomes | How was the outcome measured: 1. Areas in contamination were counted, measured, and categorised as small‐(medium‐ (1 cm² to < 3 cm²), large‐ (≥ 3 cm² to 5 cm²) or extra‐largepatch (≥ 5 cm²)The presence of fluorescent solution using UV lamp(CheckPoint, 220‐240 V / 50 Hz; Glow Tec Ltd., London, England) under a dimlight. The participants’ hair and head, face, anterior/posterior neck,left/right arms, hands or wrists, upper/lower working clothes and shoes,along with the surrounding environment (rubbish bin cover, chair, faucet(tap), and sink). 2. Deviation rate is mean of 11 issues 10 issues and 9 issues resp fordonning and same for doffing Overall small contamination sites
Overall extra‐large contamination sites
Overall deviation rate of donning PPE
Overall deviation rate of doffing PPE
Time of donning PPE
Time of doffing PPE
| |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "random order as decided by a computer‐generated randomisedtable |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Judgement comment: not possible to blind but outcome objective anddifficult to influence by providers and participants |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: data for all participants reported |
| Selective reporting (reporting bias) | Low risk | Judgement comment: no protocol provided but apparently all outcomesreported |
| Other bias | Low risk | Judgement comment: no other biases detected |
Tomas 2016
| Study characteristics | ||
| Methods | Simulation study, RCT, parallel groups How was the simulation performed? Participants removed improved gowns and gloves in their usual manner. How was the exposure simulated? Gloved hands were inoculated with 0.5 mL phosphate‐buffered saline (PBS)containing 10^10 PFUs of MS2 and 0.5 mL fluorescent lotion and the solutionswere rubbed over the gloved hands until dry. Bacteriophage MS2 was of thetype 15597‐B1 (American Type Culture Collection,VA). | |
| Participants | N = 30 HCW; no other information provided; asked study authors for moreinformation | |
| Interventions | Intervention: modified PPE: seamless gown‐glove interface A seamless PPE prototype in which adhesive material on the outer sleeve ofthe gown at the wrist attaches to the inner cuff of the gloves, providingcontinuous coverage of the wrist and hand. This design prevents exposure ofskin and requires that gloves be peeled off as the gown is removed. Theprototype seamless PPE consisted of polyethylene contact isolation gowns(SafetyPlus Polyethylene Gown, TIDI Products, Neenah, WI) and nitrile gloves(Denville Scientific, South Plainfield, NJ). Permanent contact bond adhesive(DAP Weldwood Contact Cement, DAP Products, Baltimore, MD) was appliedcircumferentially to the outer gown at the level of the wrist. Gloves werepressed to the gowns for 15 min and allowed to air dry for 24 h. Control: only described as standard PPE and assumed as gloves andgown | |
| Outcomes | 1. Outcome assessment fluorescent: hand and wrist skin contamination withthe fluorescent lotion was assessed using a black light (Ultra Light UV1 byGrizzly Gear, SCS Direct,Trumball, CT). 2. Outcome assessment bacteriophage: participants then wiped both hands andwrists with a sterile, pre‐moistened 4 x 4 gauze pad that was placed into asterile container containing 10 mL PBS and mixed in a vortex mixer for 1 minto elute the bacteriophage. Aliquots of each elutant were serially dilutedand cultured to quantify virus particles. | |
| Notes | Location: USA; funding was provided by the Department of Veteran Affairs; 1author, C.J.D. had previously received research grants from Clorox, Merck,AvidBiotics and GOJO and the same author also served on scientific advisoryboards for 3M and Seres Health. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Healthcare personnel were randomized to perform simulations ofcontaminated glove removal" We asked study authors for method of generation |
| Allocation concealment (selection bias) | Unclear risk | Unclear if irrevocable |
| Blinding of participants and personnel (performance bias) Alloutcomes | Low risk | Not blinded but objectively measured outcome |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on missing data provided |
| Selective reporting (reporting bias) | Unclear risk | No protocol published |
| Other bias | Low risk | No other biases detected |
Wong 2004
| Study characteristics | ||
| Methods | Randomised, multiple‐arm, parallel‐group, simulation study | |
| Participants | Nursing students volunteering; N = 100 nursing students who had givenwritten consent, 82% female, age 21 ± 1.2 years, 60% completed > 1 studyyear, all had been taught PPE use, none had been involved with SARSpatients | |
| Interventions | Intervention: different types of PPE compared 10 different brands and types of PPE at the time of the study in use inHong Kong hospitals; 1 type was a surgical gown and 1 the brand Barrierman,probably Tyvek by DuPont, the others were denoted as White A, White, Green,Y‐HR‐9, Yellow, Blue, Blue‐9, B‐NHK‐9, B‐HR‐9. These were categorised into 4categories: A: good water repellency and penetration resistance but poor airpermeability; B good water repellency and air permeability but poor waterpenetration resistance; C: surgical gown with poor water repellency andpenetration resistance and fair air permeability; D Barrierman, with goodwater repellency, poor air permeability and fair water penetrationresistance. Types A,B, C, and D were compared against each other | |
| Outcomes | 1. Usability rated by the users as the mean of 5‐point scales for:instructions, comfort, ease of donning and doffing, and satisfaction 2. Donning and doffing time/durations in min 3. Contamination after spraying fluorescent marker on the trunk and doffingof PPE, measured as mean number of contaminated spots that light up inUV‐light | |
| Notes | Hong Kong, China; funded by Hong Kong Infection Control Nurses’Association, Hong Kong Polytechnic University; no conflict of interest isreported in the article | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participantss were allocated a PPE using a random table page 91 |
| Allocation concealment (selection bias) | Unclear risk | Not reported and information asked from study authors did not lead to ahigher confidence in allocation concealment |
| Blinding of participants and personnel (performance bias) Alloutcomes | Unclear risk | Not blinded; page 91 and discussion page 95 indicates that they knew whatthey were wearing, obviously, as PPE Type D was a 1‐piece construct, andthey were asked to read manual for wearing. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported if any data were missing |
| Selective reporting (reporting bias) | Unclear risk | Apparently all data reported |
| Other bias | Low risk | No indication of other bias |
Zamora 2006
| Study characteristics | ||
| Methods | Randomised, 2‐arm, cross‐over, simulation study | |
| Participants | Clincians from Queen's Hospital, Kingston, ON, Canada volunteering toparticipate. N = 50; PAPR‐first N = 27, age 34.3 ± 8.7 years, height 171.8 ± 8.1, weight 76.3 ±16.7, male 16/27, anaesthetists 19/27, prior PAPR training 15/27 Enhanced respiratory and contact precautions (E‐RCP) first N = 23, age 36.8± 9.8, height 172.3 ± 7.6, male 11/23, anaesthetist 10/23, prior PAPRtraining 18/23 Location: Canada | |
| Interventions | Intervention: different types of PPE compared: PAPR versus mask PPE with PAPR, consisting of Tyvek hood (3M), Bouffant hair cover, Spartaneconomy impact goggle, 3M air‐mate breathing tube, 3M HEPA filter unit, N95mask, 3 pairs of gloves, Tyvek coverall with hood, 2 Tyvek boot covers,Astound impervious surgical gown. Doffing order: first gloves, turbo unithose, hood, gown, second gloves, belt and battery, shoe covers, thirdgloves, wash hands, new gloves, coverall, second shoe covers, gloves, newgloves, goggles, hair cover, gloves, wash hands, new mask. Comparison: E‐RCP consisting of Bouffant hair cover, Spartan economy impactgoggle, face shield (Splash shield), N95 mask, 2 pairs of gloves, Astoundimpervious gown. Doffing order: outer gloves, gown, inner gloves, washhands, new gloves, face shield, hair cover, goggles, mask, gloves, washhands. | |
| Outcomes | 1. Number of participants with presence of contamination on base layer ofclothes or skin. Contamination measured with fluorescein solution (5 mL infront of face shield and torso) plus invisible detection paste on forearmsand palms of the hands; assessment after removing of outer layer byunblinded assessor with UV lamp; blinded evaluator then inspected all skinand clothes and measured area of contamination. Secondary outcomes were:contamination of inner layers of PAPR system, area size of contamination,number of donning or doffing violations; time required for donning anddoffing. 2. Number of participants with donning or removal violation was defined asout of sequence removal, touching or tearing item of clothing, touching bodypart before hand washing. Used the Mainland‐Gart test for the analysis of cross‐over studies | |
| Notes | Funding: Physicians' Services Incorporated Foundation and ClinicalTeachers' Association of Queen's University; no Conflict of Interestdeclared | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants randomised by coin tossing |
| Allocation concealment (selection bias) | Unclear risk | Once started, order was known, but unclear if participants could still change groups and if there would be an interest todo so. |
| Blinding of participants and personnel (performance bias) Alloutcomes | Unclear risk | Participants knew attire |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Evaluators blind for attire |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Apparently all data collected and usable |
| Selective reporting (reporting bias) | Unclear risk | Apparently all outcomes reported |
| Other bias | Low risk | No indication of other bias |
CDC: Center for Disease Control and Prevention; CFU: colony‐formingunit; ECDC: European Centre for Disease Prevention and Control; EMT:emergency medical technician; EVD: Ebola virus disease; HCW:healthcare worker; IgG: immunoglobulin G; IQR: interquartile range;LED: light‐emitting diode; MD: Doctor of Medicine; MPN:most probable number; MSF: Médecins Sans Frontières; n/a: not applicable;PAPR: powered, air‐purifying respirator; PFU: plaque‐forming unit;PLS: polystyrene latex beads; PPE: personal protection equipment;RCT: randomised controlled trial; RN: Registered Nurse;SARS: severe acute respiratory syndrome; SD: standard deviation;UV: ultraviolet WHO: World Health Organization
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
|---|---|
| Abrahamson 2006 | Uncontrolled study; 1 type of training only |
| Abualenain 2018 | No comparison group |
| Alraddadi 2016 | No comparison group |
| Anderson 2017 | No highly infectious disease exposure |
| Beam 2011 | No control group with an active intervention |
| Beam 2014 | Uncontrolled study; only 1 type of training in donning and doffing studiedwith video recordings |
| Beam 2016a | Not an empirical study |
| Beam 2016b | Not an empirical study |
| Bearman 2007 | Trial of universal gloving, not as part of full‐body PPE |
| Bischoff 2019 | No highly infectious disease exposure |
| Borchert 2007 | Description of use of PPE in MHF outbreak, not a case‐control or cohortstudy |
| Bosc 2016 | Wrong comparator |
| Buianov 1991 | Study compares 2 types of PPE for highly infectious diseases but does notmeasure contamination or infection as outcome, only physiological parameters(native speaker assessment AP) |
| Butt 2016 | Wrong comparator |
| Casanova 2008 | Not a comparative study; only studied 1 method of doffing |
| Casanova 2018 | No comparison group |
| Castle 2009 | Outcome only performance with PPE and not infection rate or adherence |
| Chandramohan 2018 | No comparison group |
| Christian 2004 | Investigation of cluster of SARS infected HCW; not a case‐control or cohortstudy |
| Chughtai 2013 | Overview focusing on mask use only, not part of full‐body PPE |
| Clay 2015 | Simulation study; military HCWs; no control group |
| Coates 2000 | Outcome performance only not infection rates or adherence |
| Coca 2015 | Wrong type of participants, thermal manikin study |
| Coca 2017 | Secondary outcomes only |
| Colebunders 2004 | Description of MHF outbreak; not a case‐control or cohort study |
| Cooper 2005 | Simulation study, but of facial protection only, no full‐body PPEinvolved |
| Delaney 2016 | No comparison group |
| Doll 2017a | No comparison group |
| Doll 2017b | No comparison group |
| Doshi 2016 | No comparison group |
| Drew 2016 | No comparison group |
| DuBose 2018 | Wrong study design |
| Dunn 2015 | Case study of spread of infection in 1 hospital; used in discussionsection |
| Elcin 2016 | No comparison group |
| Fischer 2015 | Not a primary study, literature review |
| Fogel 2017 | Wrong study design |
| Foote 2017 | Wrong intervention |
| Franklin 2016 | Not an empirical study |
| Garibaldi 2019 | Secondary outcomes only |
| Gozel 2013 | Description of use of PPE among HCW exposed to CCHF; not case‐control orcohort study |
| Grélot 2015 | Measurement of thermal strain, no infection or contamination or compliancemeasured |
| Grélot 2016 | Measurement of thermal strain, no infection or contamination or compliancemeasured |
| Hendler 2000 | PPE versus no PPE; outcome performance only |
| Herlihey 2016 | No comparison group |
| Herlihey 2017 | No comparison group |
| Hersi 2015 | Not a primary study, rapid review |
| Ho 2003 | Descriptive study of SARS outbreak and HCWs use of PPE; not a case‐controlor cohort study |
| Ho 2004 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Hon 2008 | Evaluation of on‐line PPE training; uncontrolled study, no comparisontraining |
| Hormbrey 1996 | Description of introduction of new clothing; no infection or adherenceoutcome |
| Huh 2020 | No comparison group |
| Jacob 2018 | Not empirical study |
| Jaffe 2019 | No personal contamination outcome |
| Jaques 2016 | Report contains no data |
| Jeffs 2007 | Description of control of MHF outbreak; not a case‐control or cohortstudy |
| Jinadatha 2015 | Wrong type of participants, investigation of disinfection on different PPEfabrics and components |
| Jones 2020 | Not empirical study |
| Kahveci 2019 | Participants not HCWs |
| Kang 2017 | Wrong study design |
| Kang 2017a | No comparison group |
| Kappes Ramirez 2018 | Wrong outcomes |
| Keane 1977 | Description of risk of HCW only; no evaluation of PPE safety |
| Kerstiens 1999 | Desription of Ebola outbreak; not case‐control or cohort study |
| Kilinc‐Balci 2016 | Not an empirical study |
| Kilinc‐Balci 2015 | Report contains no data |
| Kim 2015 | No control group, HCWs infected with MERS CoV |
| Ko 2004 | Description of risk of EMT staff; no evaluation of PPE safety |
| Kogutt 2019 | No comparison group |
| Kratz 2017 | Report contains no data |
| Kwon 2016 | No comparison group |
| Kwon 2017 | No comparison group |
| Lai 2005 | Study of SARS IgG prevalence in HCWs who did not become sick, no PPE usemeasured |
| Lai 2011 | No personal contamination measured only environmental contamination |
| Lange 2005 | Letter to the editor; not primary study |
| Lau 2004 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Le 2004 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Lee 2017 | Report contains no data |
| Lindsley 2012 | Test respiratory protection only; not part of full‐body PPE |
| Lindsley 2014 | Tests respiratory protection only; not part of full‐body PPE |
| Liu 2009 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Loeb 2004 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Low 2005 | A review of SARS and HCW; not a primary study |
| Lowe 2014 | Description of PPE use only; no adherence or infection outcomes |
| Lu 2006 | Comparison of viral load in patients infected outside and inside hospital;comparison is with no PPE |
| Lu 2020 | No Intervention |
| Luo 2011 | Simulation study of 1 Tyvek® (duPont) suit only, no comparison suit or nocomparison doffing method |
| Ma 2004 | Retrospective case‐control study about PPE for SARS, compares consistentversus inconsistent use not 2 types |
| Makovicka 2018 | No highly infectious disease exposure |
| Malik 2006 | Participants not exposed to highly infectious diseases |
| Marklund 2002 | Description of Ebola patient transportation; not an intervention study |
| Matanock 2014 | Description of risk of infection of HCW compared to general population; noevaluation of PPE |
| McLaws 2016 | Not an empirical study |
| Mehtar 2015 | No control group, 2 infection prevention and control training courses |
| Minnich 2003 | Description of ambulance adaptation for transport of highly infectedpatients; not evaluation or intervention study |
| Mollura 2015 | Review; EVD within radiology wards and on imaging equipment |
| Moore 2005 | Review not intervention study |
| Morgan 2009 | Review of adverse effects of contact precautions |
| Mumma 2018 | No comparison group |
| Mumma 2019 | No Intervention |
| Muyembe‐Tamfum 1999 | Description of Ebola outbreak; not case‐control or cohort study |
| Nikiforuk 2017 | Wrong patient population |
| Nishiura 2005 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Northington 2007 | No comparison group; only 1 type of education with follow‐up |
| Novosad 2016 | No comparison group |
| Nyenswah 2015 | Case study of EVD cluster including HCWs, but insufficient information onPPE to draw any conclusions |
| Ofner 2003 | SARS case series only; no healthy controls; not case control or cohortstudy |
| Ofner‐Agostini 2006 | SARS case series only; no healthy controls; not case control or cohortstudy |
| Ogendo 2008 | Eye protection only; not part of full‐body PPE |
| Ong 2013 | No exposure to highly infectious diseases |
| Park 2004 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Parveen 2018 | No comparison group |
| Pei 2006 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Phan 2018 | Wrong intervention |
| Phrampus 2016 | No comparison group |
| Porteous 2018 | No personal contamination outcome |
| Quinn 2018 | Wrong outcomes |
| Ragazzoni 2015 | No control group, virtual reality simulation training study |
| Ransjo 1979 | No exposure to highly infectious diseases |
| Reynolds 2006 | Case‐control study evaluating SARS risk in HCWs in Vietnam but no inclusionof PPE use |
| Rosenberg 2016 | Report of publication of Tomas2015 |
| Russell 2015 | No control group, no outcome, before/after summary card |
| Scales 2003 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Schumacher 2010 | Comparison is no PPE; outcome is performance time only |
| Scott Taylor 2017 | Wrong outcomes |
| Seto 2003 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Shao 2015 | Not a primary study, Chinese review |
| Sorensen 2008 | No exposure to highly infectious diseases |
| Su 2017 | No comparison group |
| Suen 2017 | No highly infectious disease exposure |
| Tartari 2015 | No control group, infection control readiness checklist (from 45countries), no outcome |
| Teleman 2004 | Compares consistent versus inconsistent use of PPE, not 2 differenttypes |
| Tomas 2015 | No comparison used only description of contamination in a simulationstudy |
| Tomas 2016a | Wrong intervention |
| Torres 2015 | Not a primary study, literature review |
| Visnovsky 2019 | No personal contamination outcome |
| Weber 2018 | No comparison group |
| Weber 2019 | No Intervention |
| West 2014 | Not a primary study but a commentary |
| Williams 2019 | No comparison group |
| Xi 2016 | No comparison group |
| Yin 2004 | Case‐control study of use of PPE for SARS, not comparing 2 different typesof PPE |
| Yuan 2018 | Not empirical study |
| Zellmer 2015 | No control group, checklist for removing PPE |
| Zhou 2003 | Follow‐up of HCWs exposed to SARS and their PPE and protection measures,not comparative study |
CCHF: Crimean‐Congo haemorrhagic fever; EMT: emergency medicaltechnician; EVD: Ebola virsu disease; HCW: healthcare worker;IgG: immunoglobulin G; MERS CoV; Middle East respiratory syndromecoronavirus; MHF: Marburg haemorrhagic fever; PPE: personalprotective equipment; SARS: severe acute respiratory syndrome
Characteristics of ongoing studies [ordered by study ID]
ChiCTR2000029900
| Study name | Renmin Hospital of Wuhan University |
| Methods | Unclear |
| Participants | HCWs exposed to COVID‐19 |
| Interventions | Infection and prevention strategies |
| Outcomes | Infection |
| Starting date | Not reported |
| Contact information | Chinese trial register |
| Notes |
ChiCTR2000030317
| Study name | West China Hospital of Sichuan University |
| Methods | RCT |
| Participants | HCWs exposed to COVID‐19 |
| Interventions | Self‐made mask |
| Outcomes | Infection rate |
| Starting date | Not reported |
| Contact information | Chinese trials register |
| Notes |
ChiCTR2000030834
| Study name | Tongji Hospital Tongji Medical College Huazhong University Wuhan China‐a |
| Methods | Unclear |
| Participants | HCWs exposed to COVID‐19 |
| Interventions | Infection prevention and control |
| Outcomes | Infection |
| Starting date | Not reported |
| Contact information | Chinese trials register |
| Notes |
ChiCTR2000030895
| Study name | Tongji Hospital Tongji Medical College Huazhong University Wuhan China‐b |
| Methods | Not reported |
| Participants | HCWs |
| Interventions | Infection prevention and control |
| Outcomes | Infection |
| Starting date | Not reported |
| Contact information | Chinese trials register |
| Notes |
HCW: healthcare worker
Differences between protocol and review
We changed the title from 'Personal protective equipment for preventing highlyinfectious diseases due to contact with contaminated body fluids in health care staff'to 'Personal protective equipment for preventing highly infectious diseases due toexposure to contaminated body fluids in healthcare staff' to avoid confusion with theterm 'contact precautions'.
We replaced the statement in the methods section: "We will also include audit reportsor case reports of PPE failure in which there are no comparisons. We will not usethese for drawing conclusions but only to compare with findings produced by the abovestudy types. For audit reports, we will examine any reports of failed PPE or audits ofhealth care staff being infected or contaminated" with "We intended to also includeuncontrolled audit reports or case reports of PPE failure for descriptive purposes,but we did not find any. If we find any such reports in future updates of this review,we will not use them for drawing conclusions, but only to compare with findingsproduced by the above study types".
We added the following definition of PPE in the methods section because it waslacking: "We defined PPE as any of the above equipment designed or intended to protecthealthcare staff from contamination with body fluids".
We added an extra outcome "Time to don and doff the PPE" because we stated in ourprotocol that we would add outcomes that we had not defined in advance and that weconsidered important.
We added a more detailed description of the specific resources that we searched inaddition to the electronic databases, that is, the specific non‐governmentalorganisations (Médicins Sans Frontierès and Save the Children), and specificmanufacturers (DuPont, 3M, and Alpha Pro Tech). We could not foresee in advance whichparties we would be contacting.
When using the GRADE considerations to assess the certainty of the evidence, fornon‐randomised studies, we started at the 'low‐certainty' level, rather than the'moderate‐certainty' level outlined in the protocol, as per the recommendations of theCochrane Handbook for Systematic Reviews of Interventions (Schünemann 2017).
Contributions of authors
Conceiving the protocol: JV, SI, CT, JR, KN
Designing the protocol: JV, CT, JR, KN, ME, EM, RS
Coordinating the protocol and the review: JV, SI
Designing search strategies: KN
Data extraction: JV, BR, SI, CT, RS, BB, ET
Data analysis: JV
Writing the protocol and the review: JV, BR, FSKB, BB, ET
Providing general advice on the protocol and review: RS, FSKB
Sources of support
Internal sources
Cochrane Collaboration, UK
Bursary to Sharea Ijaz
Finnish Institute of Occupational Health, Finland
Salary for Jos Verbeek, Christina Mischke, Jani Ruotsalainen, Erja Mäkelä and KaisaNeuvonen
National Institute for Occupational Safety and Health, USA
Salary for F Selcen Kilinc Balci
External sources
No sources of support supplied
Declarations of interest
Jos Verbeek: none known
Blair Rajamaki: none known
Sharea Ijaz: none known
Christina Mischke: none known
Jani Ruotsalainen: none known
F Selcen Kilinc Balci: none known
Riitta Sauni: none known
Bronagh Blackwood: none known
Elaine Toomley: none known
References
References to studies included in this review
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