key: cord-0705949-fnyvo9nc
authors: Griswold, D. P.; Gempeler, A.; Kolias, A.; Hutchinson, P.; Rubiano, A.
title: Personal protective equipment for reducing the risk of COVID-19 infection among healthcare workers involved in emergency trauma surgery during the pandemic: an umbrella review
date: 2020-09-25
journal: nan
DOI: 10.1101/2020.09.24.20201293
sha: 43e989abf90589d1f404505c78c3d0dcf69ef506
doc_id: 705949
cord_uid: fnyvo9nc

Objective: The objective of this review was to summarise the effects of different personal protective equipment (PPE) for reducing the risk of COVID-19 infection in health personnel caring for patients undergoing trauma surgery. The purpose of the review was to inform recommendations for rational use of PPE for emergency surgery staff, particularly in low resources environments where PPE shortages and high costs are expected to hamper the safety of healthcare workers (HCWs) and affect the care of trauma patients. Introduction: Many healthcare facilities in low-and middle-income countries are inadequately resourced. COVID-19 has the potential to decimate these already strained surgical healthcare services unless health systems take stringent measures to protect healthcare workers from viral exposure. Inclusion criteria: This review included systematic reviews, experimental and observational studies evaluating the effect of different PPE on the risk of COVID-19 infection in HCWs involved in emergency trauma surgery. Indirect evidence from other healthcare settings was considered, as well as evidence from other viral outbreaks summarised and discussed for the COVID-19 pandemic. Methods: We conducted searches in the LOVE (Living OVerview of Evidence) platform for COVID-19, a system that performs automated regular searches in PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and over thirty other sources. The risk of bias assessment of the included studies was planned with the AMSTAR II tool for systematic reviews, the RoBII tool for randomised controlled trials, and the ROBINS-I tool for non-randomised studies. Data were extracted using a standardised data extraction tool and summarised narratively. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for grading the certainty of the evidence was followed. Results: We identified 17 systematic reviews that fulfilled our selection criteria and were included for synthesis. We did not identify randomised controlled trials during COVID-19 or studies additional to those included in the reviews that discussed other similar viral respiratory illnesses. Conclusions: The use of PPE drastically reduces the risk of COVID-19 compared with no mask use in HCWs in the hospital setting. N95 and N95 equivalent respirators provided more protection and were found to halve the risk of COVID-19 contagion in HCWs from moderate and high-risk environments. Eye protection also offers additional security and is associated with reduced incidence of contagion. These effects apply to emergency trauma care. Decontamination and reuse appear as feasible, cost-effective measures that would likely help overcome PPE shortages and enhance the allocation of limited resources. SUMMARY OF FINDINGS There is high certainty that the use of N95 respirators and surgical masks are associated with a reduced risk of coronaviruses respiratory illness when compared with no mask use. In moderate to high-risk environments, especially in aerosol-generating procedures, N95 respirators are associated with a more significant reduction in risk of COVID-19 infection compared with surgical masks. Eye protection also reduces the risk of contagion. Decontamination of masks and respirators with ultraviolet germicidal irradiation, vaporous hydrogen peroxide, or dry heat is effective and does not affect PPE performance or fit.

HCWs and affect the care of trauma patients. A preliminary search of PROSPERO, MEDLINE, the Cochrane 109 Database of Systematic Reviews, and the JBI Database of Systematic Reviews and Implementation Reports was 110 conducted, and no current or underway systematic reviews on the topic were identified. We considered studies that included HCWs in emergency trauma surgery settings during the COVID-19 pandemic.

Given the likelihood that reports on this specific population were scarce or even non-existent, we also included 121 studies of HCWs in any procedural and in-hospital setting, such as the operating room, the emergency room, and The primary outcome of interest was the risk of contagion to health personnel involved in the care of the described 130 population during the COVID-19 pandemic, expressed as incidence, or with association measures such as risk ratios included reports of costs associated with the use of PPE and reports on implementation strategies that could inform 137 recommendations for low resource settings. Only studies published in English or Spanish were included. We 138 included preprint studies identified in our search, but no ongoing studies were considered.

We conducted a broad evidence synthesis (umbrella review) to summarise the effects of PPE on the risk of COVID- all the available studies associated with the terms of interest. It allows for a fast (automated) search that is easy to 156 update -a crucial element given the urgent need to answer the research question rapidly and thoroughly.

Eligible studies were critically appraised by a reviewer and verified by a second reviewer using the AMSTAR tool. The 166 risk of bias was assessed for only the primary outcome: infection of healthcare workers by COVID-19 or similar. The 167 results of the critical appraisal are reported narratively and are considered for discussion of results.

All included studies, regardless of their risk of bias, underwent data extraction and synthesis.

Data extraction 170 Data were extracted from the included studies by a reviewer and verified by a second reviewer using a data 171 extraction tool from JBI SUMARI. 5 

The data extracted include specific details about the populations, study methods, interventions, and outcomes of 173 significance to the review question and specific objectives. Disagreements were solved by consensus.

Data synthesis 175 Studies were summarized narratively considering their scope, number of included studies, and risk of bias. Effect 176 sizes from systematic reviews and individual studies not included in them are expressed as odds ratios (for 177 dichotomous data) with their 95% confidence intervals.

Assessing certainty in the findings

The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for grading the 180 certainty of the evidence was followed. Grading the certainty of the evidence was not undertaken if adaptation from 181 the identified reviews using the GRADE approach was considered complete and adequate. 7, 8 The certainty of the 182 evidence was considered for interpretation and discussion of findings.

Study inclusion

The study selection process is illustrated in Figure 1 . 6 The described search identified a total of 258 records. After 187 title and abstract screening, 78 studies were considered for full-text review, of which 59 were excluded. Reasons for 188 exclusion were: wrong study design (n=29), wrong intervention (n=23), wrong outcomes (n=1), 60 wrong 189 language (n=5), [61] [62] [63] [64] [65] wrong patient population (n=2). 66, 67 This left 19 studies for appraisal, extraction, and 190 synthesis. 4, [68] [69] [70] [71] [72] [73] [74] [75] [76] [77] [78] [79] [80] [81] [82] [83] 191 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint

The copyright holder for this this version posted September 25, 2020. 198 included studies was assessed as moderate to high by JBI appraisal standards, and no disagreements occurred 199 between the reviewers. Of the 17 included systematic reviews, nine fulfilled all 11 indicators of the critical appraisal 200 tool, 69, 70, 72, [75] [76] [77] 79, 81, 82 one fulfilled ten indicators, 68 choosing not to perform risk of bias assessment given the 201 rapid publication of the review; four fulfilled nine indicators, 4, 80, 83, 84 failing to report a risk of bias assessment and 202 choosing not to combine studies for meta-analysis owing to study limitations and heterogeneity in study designs, 203 comparisons, and analyses. Two fulfilled six indicators, 71, 78 having no method of study appraisal, no method of 204 minimising errors in data extraction, failing to report a risk of bias assessment, and choosing not to combine studies 205 for meta-analysis owing to study limitations and heterogeneity in study designs, comparisons, and analyses; and one 206 fulfilled four indicators, 73 for not reporting the indicators aforementioned in the previous studies in addition to a 207 lack of future directives and recommendations for policy and clinical practice. All systematic reviews clearly stated 208 the review question, applied appropriate inclusion criteria and search strategy.

Critical Appraisal Results 

Y Y Y Y Y Y Y Y Y Y % 100.Y Y Y Y Y U Y Y N Y Y Ana L, Andrew JS, Rhonda S. 2020. Y Y Y Y Y Y Y Y Y Y Y Bartoszko JJ, Farooqi MAM, Alhazzani W, Loeb M. 2020. Y Y Y Y Y Y Y Y Y Y Y Carl-Etienne J, Toma P, Matt B, Genevieve G, Louise P. 2020. Y Y Y Y N N N N/A N/A Y Y Chou R, Dana T, Jungbauer R, Weeks C, McDonagh MS. 2020. Y Y Y Y Y Y Y N/A N/A Y Y Chu DK, Akl EA, Duda S, Solo K, Yaacoub S, Schünemann HJ, et al. 2020. Y Y Y Y Y Y Y Y Y Y Y Elaine T, Yvonne C, Christopher B, Simon S, Michael S, Xin-Hui C, et al. 2020. Y Y Y Y Y Y Y N/A N/A Y Y Fouladi Dehaghi B, Ghodrati Torbati A, Teimori G, Ghavamabadi LI, Jamshidnezhad A. 2020. Y Y Y Y N/A N/A N/A N/A N/A N N/A Iannone P, Castellini G, Coclite D, Napoletano A, Fauci AJ, Iacorossi L, et al. 2020. Y Y Y Y Y Y Y Y Y Y Y Katie O, Gertsman S, Sampson M, Webster R, Tsampalieros A, Ng R, et al. 2020. Y Y Y Y Y Y Y Y Y Y Y Liang M, Gao L, Cheng C, Zhou Q, Uy JP, Heiner K, et al. 2020. Y Y Y Y Y Y Y Y Y Y Y MacIntyre CR, Chughtai AA. 2020. Y Y Y Y N N/A N N/A N/A Y Y Offeddu V, Yung CF, Low MSF, Tam CC. 2017. Y Y Y Y Y Y Y Y Y Y Y Prashanth R, Jonathan Thomas S, Ruben D, Christopher A, Shehan H. 2020. Y Y Y Y Y Y Y N/A N/A Y Y Tom J, Mark J, Lubna AAA, Ghada B, Elaine B, Justin C, et al. 2020. Y Y Y Y Y Y Y Y Y Y Y Verbeek JH, Rajamaki B, Ijaz S, Sauni R, Toomey E, Blackwood B, et al. 2020. Y Y Y Y Y Y Y Y Y Y Y Zorko DJ, Gertsman S, O'Hearn K, Timmerman N, Ambu-Ali N, Dinh T, et al. 2020. Y Y Y Y Y Y Y N/A N/A Y

A rapid systematic review that also addressed the effect of masks to prevent COVID-19 infection considered 252 evidence from the current pandemic in addition to the SARS and MERS epidemics. 4 The review reports a reduction 253 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint

The copyright holder for this this version posted September 25, 2020. . https://doi.org/10.1101/2020.09.24.20201293 doi: medRxiv preprint of risk of transmission associated with the use of masks in general. It suggests a more significant reduction 254 associated with N95 respirators compared to surgical masks in the hospital setting (an effect seen for COVID-19 255 independently, as well as with the other coronaviruses outbreaks).

Other reviews considered evidence from viral respiratory illnesses, including influenza or H1N1, and report a 257 beneficial effect of PPE (medical masks or N95 respirators) on contagion risk reduction. 70, 75, [77] [78] [79] 81 One of these 258 reviews reports that the use of masks by HCWs and non-HCWs can reduce the risk of respiratory virus infection by 259 80% compared to no-mask (OR = 0.20, 95% CI = 0.11-0.37). 77 Furthermore, respirators were found to be more 260 protective than surgical masks; and surgical masks more protective than cloth masks. 78 There appears to be no 261 difference between respirators and medical masks when used in non-aerosol generating procedures low-risk 262 environments) 70, 81 Conversely, no significant evidence was found that supported an equivalence claim of medical 263 masks with respirators in their level of protection against COVID-19 or other similar viruses. 80 In moderate and 264 high-risk hospital settings, N95 are associated with more significant reductions in risk of contagion. 4,78

A systematic review based on experimental designs only found that N95 respirators halve the risk of any respiratory 266 illness compared to surgical masks; the certainty of the evidence was low due to baseline differences, indirectness 267 of evidence for COVID-19, and low event rates that account for imprecision. 75 The reduction in contagion risk 

Among the included studies, one reported on the use of Powered Air Purifier Respirators (PAPR). 69 Based on 272 observational studies, the authors report they did not found a difference in risk of contagion in HCWs when 273 comparing PAPR devices with other, more compliant protective elements (N95, FFP2). They found that PAPR users 274 reported higher heat tolerance but limited mobility and reduced audibility.

Regarding decontamination, we included a systematic review that assessed the effectiveness of ultra-violet 276 germicidal irradiation (UVGI) for the decontamination of PPE and its impact on PPE performance. 76 Their findings 277 support that the use of a cumulative UV-C dose of at least 40,000 J/m2 results in adequate decontamination without 278 affecting performance or fit afterwards. Another review on the subject reported that mask (N95) performance was 279 best conserved using dry heat decontamination, and that vaporous hydrogen peroxide, as well as UVGI, are effective 280 decontaminants. However, its effect on surgical masks is unknown. 83 The authors also state that bleach is not safe 281 for decontamination since it alters mask performance and might be associated with health risk for users.

. CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint

The copyright holder for this this version posted September 25, 2020. . https://doi.org/10.1101/2020.09.24.20201293 doi: medRxiv preprint A systematic review that searched for barriers and facilitators of HCWs adherence to PPE protocols included 20 283 studies of moderate to high-quality overall (10 from Asia, four from Africa, four from Central and North America, 284 and two from Australia). 74 They report that HCWs were unsure to follow recommendations when they are long and 285 ambiguous or do not reflect national or international guidelines. Some were overwhelmed because of constantly 286 changing guidelines and by the increased workload and fatigue associated with PPE use due to preparation and 287 cleaning. A serious concern was the lack of PPE or the low quality of the available items, pointing at a need to adjust 288 supplies during the pandemic. HCWs reported that it was challenging to use masks and other equipment when it 289 made patients feel isolated, frightened, or stigmatised. Of course, discomfort associated with wearing PPE was also 

The available evidence was consistent to show that the use of N95 respirators and surgical masks is associated with 299 a reduced risk of coronaviruses respiratory illness compared with no mask use, with high certainty on this beneficial 300 effect. 4, 72 In moderate to high-risk environments, especially in aerosol-generating procedures, evidence suggests 301 that N95 respirators are associated with a more significant reduction in risk of COVID-19 infection compared with 302 surgical masks; an effect seen in observational COVID-19 studies and experimental viral respiratory illness studies.

Low-quality evidence estimates from these studies suggest a relative reduction of 50% in the risk of contagion 304 associated with N95 respirators compared to surgical masks. Eye protection also significantly reduces the risk of 305 contagion compared to no-eye protection. Furthermore, the decontamination of masks and respirators with 306 ultraviolet germicidal irradiation, vaporous hydrogen peroxide, or dry heat is effective and does not affect PPE 307 performance or fit. This evidence should inform decontamination and reuse protocols to avoid shortages and 308 enhance resource allocation and use.

The costs associated with additional protective measures during the COVID-19 pandemic could be significant and 310 affect healthcare institutions in low and middle-income countries. The cost-effectiveness of interventions must also 311 be taken into consideration to generate recommendations during the current pandemic. The possibility to 312 decontaminate and reuse different types of masks can be determinant in shortages and will probably reduce costs 313 without affecting HCW's safety. A cost analysis study compared the use of disposable FFP3 standard masks vs. SR

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The copyright holder for this this version posted September 25, 2020. . https://doi.org/10.1101/2020.09.24.20201293 doi: medRxiv preprint 100 reusable respirators. 85 Disposable masks are indicated to be replaced after each surgical case, and each one 315 costs roughly $4.27 (USD). The cost per unit for a reusable respirator, supplied with an appropriate filter, is 316 approximately $44(USD), and replacement filters cost $0.37. The authors of this economic evaluation highlighted 317 that reusable PPE could be associated with considerable cost savings and estimated that the cost of acquiring a 318 respirator is recovered after it is used for the care of 10 patients. 85 

In a survey of 5,442 neurosurgical staff members in Hubei province, among 120 participants that were 320 infected, 78.3% reported wearing surgical masks, and 20.8% failed to use any protection when exposed to the 

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The copyright holder for this this version posted September 25, 2020. 

. CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint

The copyright holder for this this version posted September 25, 2020. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint

The copyright holder for this this version posted September 25, 2020. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted September 25, 2020. 

Reason for exclusion: wrong study design: narrative review describes some problems with the management of To evaluate the effectiveness of respirators (e.g., N95) versus facemasks (surgical) versus cloth masks for prevention of COVID-19 in addition to standard precautions (gowns + gloves + handwashing) in community settings, high-risk healthcare settings (e.g., intensive care unit, emergency department), and in healthcare settings with close contact but unknown risk (e.g., primary care, other settings) To also evaluate the evidence for extended use or reuse of N95 respirators for prevention of COVID-19.

N95 respirators or equivalent, surgical/medical masks, and cloth masks. To provide a quantitative assessment on the physical distance associated with reduced risk of acquiring infection when caring for an individual infected with SARS-CoV-2, SARS-CoV, or MERS-CoV.

optimum distance for avoiding person-to-person virus transmission and to assess the use of face masks and eye protection to prevent transmission of viruses.

1) risk of transmission to people in healthcare or non-healthcare settings by those infected; 2) contextual factors such as acceptability, feasibility, effect on equity, and resource considerations related to the interventions of interest.

Studies of any design and in any setting that included patients with WHO-defined confirmed or probable COVID-19, SARS, or MERS, and people in close contact with them, comparing distances between people and COVID-19 infected patients of 1 m or larger with smaller distances, with or without a face mask on the patient, or with or without a face mask, eye protection, or both on the exposed individual. An information specialist (MS) designed and conducted all searches, which were informed by a topic expert and independently peer reviewed by an Information Specialist and Assistant Managing Editor at Cochrane. In order to ensure a range of respiratory infectious disease types were captured, all nine studies that looked at coronaviruses were included (MERS = 2 and SARS = 7), as, similarly to COVID-19, they have a mixture of contact, droplet, and airborne transmission. GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding Second, the data richness of the 27 remaining studies focusing on TB, H1N1 and general respiratory virus outbreaks was assessed. From these 27 studies, the studies that scored a 3 or higher for data richness were sampled.

When new respiratory infectious diseases become widespread, such as during the COVID-19 pandemic, healthcare workers' adherence to infection prevention and control (IPC) guidelines becomes even more important. Strategies in these guidelines include the use of personal protective equipment (PPE) such as masks, face shields, gloves and gowns; the separation of patients with respiratory infections from others; and stricter cleaning routines. These strategies can be difficult and time-consuming to adhere to in practice. Authorities and healthcare facilities therefore need to consider how best to support healthcare workers to implement them. Objectives: To identify barriers and facilitators to healthcare workers' adherence to IPC guidelines for respiratory infectious diseases. . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint

The copyright holder for this this version posted September 25, 2020. . https://doi.org/10.1101/2020.09.24.20201293 doi: medRxiv preprint FIGURES Figure 1 . GRADE summary of judgements . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint

The copyright holder for this this version posted September 25, 2020. . https://doi.org/10.1101/2020.09.24.20201293 doi: medRxiv preprint

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