| Literature DB >> 32247018 |
Shahnaz Sultan1, Joseph K Lim2, Osama Altayar3, Perica Davitkov4, Joseph D Feuerstein5, Shazia M Siddique6, Yngve Falck-Ytter4, Hashem B El-Serag7.
Abstract
Entities:
Mesh:
Year: 2020 PMID: 32247018 PMCID: PMC7118600 DOI: 10.1053/j.gastro.2020.03.072
Source DB: PubMed Journal: Gastroenterology ISSN: 0016-5085 Impact factor: 22.682
Supplementary Figure 1Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram of included studies. DOH, Department of Health.
Supplementary Figure 2Search strategy.
Interpretation of the Certainty in Evidence of Effects Using the Grading of Recommendations Assessment, Development and Evaluation Framework
| Certainty level | Description |
|---|---|
| High | We are very confident that the true effect lies close to that of the estimate of the effect. |
| Moderate | We are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. |
| Low | Our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. |
| Very Low | We have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect |
Interpretation of Strong and Conditional Recommendationsa Using the Grading of Recommendations Assessment, Development and Evaluation Framework
| Implications | Strong recommendation | Conditional recommendation |
|---|---|---|
| For patients | Most individuals in this situation would want the recommended course of action and only a small proportion would not. | The majority of individuals in this situation would want the suggested course of action, but many would not. |
| For clinicians | Most individuals should receive the intervention. Formal decision aids are not likely to be needed to help individuals make decisions consistent with their values and preferences. | Different choices will be appropriate for individual patients consistent with his or her values and preferences. Use shared decision-making. Decision aids may be useful in helping patients make decisions consistent with their individual risks, values, and preferences. |
| For policy-makers | The recommendation can be adapted as policy or performance measure in most situations | Policy-making will require substantial debate and involvement of various stakeholders. Performance measures should assess whether decision-making is appropriate. |
Strong recommendations are indicated by statements that lead with “we recommend” and conditional recommendations are indicated by statements that lead with “we suggest.”
Executive Summary of Recommendations
| Variable | Recommendation statements | Strength of recommendation and certainty of evidence |
|---|---|---|
| Masks | In health care workers performing upper GI procedures | Strong recommendation, moderate certainty of evidence |
| In health care workers performing lower GI procedures regardless of COVID-19 status, | Strong recommendation, low certainty of evidence | |
| In health care workers performing upper GI procedures, in known or presumptive COVID-19 patients, the AGA recommends against the use of surgical masks only, as part of adequate PPE. | Strong recommendation, low certainty of evidence | |
| Gloves | In health care workers performing any GI procedure, regardless of COVID-19 status, the AGA recommends the use of double gloves compared with single gloves as part of appropriate PPE. | Strong recommendation, moderate certainty of evidence |
| Negative-pressure rooms | In health care workers performing any GI procedures with known or presumptive COVID-19, the AGA suggests the use of negative-pressure rooms over regular endoscopy rooms when available. | Conditional recommendation, very low certainty of evidence |
| Endoscopic disinfection | For endoscopes utilized on patients regardless of COVID status, the AGA recommends continuing standard cleaning endoscopic disinfection and reprocessing protocols. | Good practice statement |
| Triage | All procedures should be reviewed by trained medical personnel and categorized as time-sensitive or not time-sensitive as a framework for triaging procedures. | Good practice statement |
| In an open access endoscopy system where the listed indication alone may provide insufficient information to make a determination about the time-sensitive nature of the procedure, consideration should be given for the following options: a telephone consultation with the referring provider or a telehealth visit with the patient or a multidisciplinary team approach to facilitate decision-making for complicated patients. | Good practice statement |
These recommendations assume the absence of widespread reliable rapid testing for the diagnosis of COVID-19 infection or immunity.
Figure 1Surgical masks and N95 masks.
Figure 2PAPR mask.
Evidence Profile: N95 Compared to Surgical Masks for COVID-19 Prevention for Gastrointestinal Upper Endoscopic Procedures
| Infection | Certainty assessment | Patients, n ( | Effect, OR (95% CI) | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | N95 | Surgical masks | Relative | Absolute | ||
| SARS | 3 | Observational studies | Serious | Not serious | Not serious | Serious | None | 4/141 (2.8) | 24/452 (5.3) | 0.86 (0.22 to 3.33) | 7 fewer per 1000 (41 fewer to 104 more) | □◯◯◯ |
| Viral respiratory | 3 | Randomized trials | Not serious | Not serious | Serious | Serious | None | 48/1740 (2.8) | 52/1274 (4.1) | 0.78 (0.54 to 1.14) | 9 fewer per 1000 (18 fewer to 5 more) | □□◯◯ LOW |
Concern for recall bias.
Although studies are on SARS population, given the similarities in the virus we did not rate down for indirectness.
Low event rate and crosses the clinical threshold.
Although the compliance to the assigned mask type was self-reported and is not clear if there is a performance, bias study staff was doing regular checks on the study participants to control for performance bias, thus, we did not rate down for risk of bias.
Not only coronaviruses but other upper respiratory infection viruses.
Evidence Profile: N95 Compared to No Personal Protective Equipment for COVID-19 Prevention for Gastrointestinal Upper Endoscopic Procedures
| Infection | Certainty assessment | Patients, n ( | Effect, OR (95% CI) | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | N95 | no PPE | Relative | Absolute | ||
| SARS | 5 | Observational studies | Not serious | Not serious | Not serious | Not serious | Strong association | 9/163 (5.5) | 86/234 (36.8) | 0.12 (0.06 to 0.26) | 302 fewer per 1000 (334 fewer to 236 fewer) | □□□◯ MODERATE |
Although studies are on SARS population, given the similarities in the virus we did not rate down for indirectness.
Supplementary Figure 3Forest plot. Exposed vs unexposed health care workers to tracheal intubation as a risk factor for SARS transmission from systematic review by Tran et al. M-H, Mantel-Haenszel.
Evidence Profile: Powered Air-Purifying Respirators (+N95) vs N95 in Health Care Workers During Gastrointestinal Procedures
| Variable | Certainty assessment | Patients, n ( | Effect, RR (95% CI) | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | PARP | N95 | Relative | Absolute | ||
| Efficiency in particulate air | 1 | Observational studies | Not serious | Not serious | Not serious | Serious | None | High-efficiency particulate air filters filter at least 99.97% of particles 0.3 μm in diameter, compared to N95 masks that filter at least 95% of aerosol (<5 μm) | □□□◯ MODERATE | |||
| Contaminated areas on face and neck | 1 | Observational studies | Not serious | Not serious | Not serious | Very serious | None | 4/150 (2.7) | 59/150 (39.3) | 0.08 (0.03 to 0.19) | 362 fewer per 1000 (382 fewer to 319 fewer) | □□◯◯ LOW |
Only 1 study.
Very small number of events.
Supplementary Figure 4Forest plot. PAPR +N95 vs N95 in reducing contamination of health care workers. M-H, Mantel-Haenszel.
Evidence Profile: Reuse of N95 Compared to Surgical Masks for Health Care Workers During Gastrointestinal Procedures
| Variable | Certainty assessment | Impact | ||
|---|---|---|---|---|
| No. of studies | Study design | Certainty | ||
| Infection with COVID-19 | 8 | Anecdotal reports | □◯◯◯ | No direct evidence was found with regard to the safety of reuse of masks (surgical masks [SMs] and N95) during a COVID-19 pandemic. Furthermore, indirect evidence from other pandemic outbreaks did not reveal empiric data on infection rates, but rather reports of anecdotal experience or experiments under laboratory conditions or mathematical models. Anecdotal reports on using SMs over N95 as a barrier to pathogens and extend the useful life of the N95 respirator has been published. |
Risk of bias: There is no comparator with optimal PPE to understand the risk of the acceptable protection from COVID-19.
There are multiple layers of indirectness. The population is different—studies were done on influenza virus or simulation studies on healthy participants, and there are no studies on aerosol generating procedures (AGP). Outcome is indirect as well; most of these studies have tolerability of the mask or laboratory testing as outcomes.
Unable to assess for imprecision because outcome cannot be measured.
Evidence Profile: Prolonged Use of N95 Compared to Surgical Masks for Health Care Workers During Gastrointestinal Procedures as a Last Resort in Resource-Limited Settings
| Variable | Certainty assessment | Impact | ||
|---|---|---|---|---|
| No. of studies | Study design | Certainty | ||
| Infection with COVID-19 | 4 | Anecdotal reports | □◯◯◯ | No direct evidence was found with regard to the safety of extended use of masks (surgical masks [SMs] and N95) during a COVID-19 pandemic. Furthermore, indirect evidence from other pandemic outbreaks did not reveal empiric data on infection rates, but rather reports of anecdotal experience or experiments under laboratory conditions or mathematical models. Experiment on tolerability of the N95 with prolonged use on health care workers showed that health care workers were able to tolerate the N95 for 89 of 215 (41%) total shifts of 8 hours. Other 59% mask was discarded before 8 hours because it became contaminated or intolerance. |
Risk of bias: There is no comparator with optimal PPE to understand the risk of the acceptable protection from COVID-19.
There are multiple layers of indirectness. The population is different—studies were done on influenza virus or simulation studies on healthy participants, and there are no studies on AGP. Outcome is indirect as well; most of these studies have tolerability of the mask or laboratory testing as outcomes.
Unable to assess for imprecision because outcome cannot be measured.
Evidence Profile: Double Gloves Compared to Single Gloves for Health Care Workers During Gastrointestinal Procedures
| Variable | Certainty assessment | Patients n ( | Effect, RR (95% CI) | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Double gloves | Single gloves | Relative | Absolute | ||
| Contamination | 1 | Observational studies | Not serious | Not serious | Not serious | Serious | None | 5/18 (27.8) | 14/18 (77.8) | 0.36 (0.16 to 0.78) | 498 fewer per 1000 (653 fewer to 171 fewer) | □□□◯ MODERATE |
Study was done with the bacteriophage MS2, but the drops size was similar to SARS and COVID-19 to simulate droplet contamination, so we decided not to rate down. We recognize that there is some indirectness but we also took into account the large effect size.
Low event rate.
Supplementary Figure 5Forest plot. Double gloves compared to single gloves for prevention of contamination. M-H, Mantel-Haenszel.
Biocidal Agents Against SARS-CoV
| Study | Biocidal agent | Exposure time | Efficacy (reduction of viral infectivity by log10) |
|---|---|---|---|
| Rabenau, 2005 | 95% Ethanol | 30s | ≥5.5 |
| 85% Ethanol | 30s | ≥5.5 | |
| 80% Ethanol | 30s | 4.3 | |
| Rabenau, 2005 | 78% Ethanol | 30s | ≥5.0 |
| 100% 2-Propanol | 30s | ≥3.3 | |
| 70% 2-Propanol | 30s | ≥3.3 | |
| 45% and 30% 2-Propanol | 30s | ≥4.3 | |
| 1% Formaldehyde | 2 min | >3.0 | |
| 0.7% Formaldehyde | 2 min | >3.0 | |
| 0.5% Glutardialdehyde | 2 min | >4.0 | |
| Siddharta, 2017 | 75% 2-Propanol | 30s | >4.0 |
Subgroup analysis taken from Kampf, 2020.
Figure 3(A) Donning and (B) doffing of PPE.
Figure 4WHO phases of a pandemic.
Figure 5Flowchart. EGD, esophagogastroduodenoscopy; EMR, endoscopic mucosal resection; FIT, fecal immunochemical test; GIB, gastrointestinal bleeding.
Framework for Triage
| Time-sensitive | Non–time-sensitive | ||
|---|---|---|---|
| Threat to the patient’s life or permanent dysfunction of an organ, eg, diagnosis and treatment of GI bleeding or cholangitis | Risk of metastasis or progression of stage of disease, eg, work up of symptoms suggestive of cancer | Risk of rapidly worsening progression of disease or severity of symptoms, eg, management decisions, such as treatment for IBD | No short-term impact on patient-important outcomes, eg, screening or surveillance colonoscopy, follow up colonoscopy for +FIT |
+FIT, positive fecal immunochemical test; IBD, inflammatory bowel disease.
Time-sensitive procedures are defined as procedures that, if deferred, may negatively impact patient-important outcomes. The decision to defer a procedure should be made on a case-by-case basis.