PBM Module 5 Evidence-tabel

Evidence table for intervention studies (randomized controlled trials and non-randomized observational studies [cohort studies, case-control studies, case series])

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Chu, 2020

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs / cohort / case-control studies

Searched up to 26-3-2020, snowballing up to 3-5-2020.

Databases:
MEDLINE (via Ovid), PubMed, Embase, CINAHL (via Ovid), the Cochrane Library, COVID-19 Open Research Dataset Challenge, COVID-19 Research Database (WHO), Epistemonikos, EPPI Centre living systematic map of the evidence, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, relevant documents on the websites of governmental and other relevant organisations, reference lists of included papers, and relevant systematic reviews

A: Alraddadi (2016)
B: Caputo (2006)
C: Chen (2009)
D: Kim (2016)
E: Liu (2009)
F: Pei (2006)
G: Burke (2020)
H: Ki (2019)
I: Ma (2004)
J: Park (2004)
K: Peck (2004)
L: Ryu (2019)
M: Yin (2004)
N: Lau (2004) (not included in meta-analysis)

Study design: all are non-randomized comparative studies
A: retrospective cohort
B: retrospective cohort
C: retrospective cohort
D: retrospective cohort
E: case control
F: case control
G: case control

Setting and Country:
A: Saudi Arabia, Health care
B: Canada, Health care
C: China, Health care
D: South Korea, Health care
E: China, Health care
F: China, Health care
G: USA, Health care and non-health care (including household and community)
H: South Korea, Health care
I: China, Health care
J: South Korea, Health care
K: USA, Health care
L: South Korea, Health care
M: China, Health care
N: China, Non-health care (households)

Source of funding and conflicts of interest:
Funder played no role in study design, data collection or interpreting of the data. The funder was only included when defining the scope of the review. No conflicts of interest reported.

Inclusion criteria SR:
- including patients with confirmed SARS, MERS, or COVID-19

Exclusion criteria SR:
None reported

172 studies in review, of which 44 studies in meta-analysis, of which 13 for eye protection (which are included in this review)

Important patient characteristics:
N, micro-organism
A: 283, MERS
B: 33, SARS
C: 758, SARS
D: 9, MERS
E: 477, SARS
F: 443, SARS
G: 338, COVID-19
H: 446, MERS
I: 426, SARS
J: 80, MERS
K: 26, SARS
L: 34, MERS
M: 257, SARS
N: 2270, SARS

Describe intervention:

Eye protection (visors, goggles, face shields, etc.)

Describe control:

No eye protection

Endpoint of follow-up:
Not reported

For how many participants were no complete outcome data available?
Not reported

Outcome measure
Infections: according to WHO definitions.

Effect measure: RR [95% CI]:
A: 0.21 (0.03–1.51)
B: 0·35 (0·07–1·79)
C: 0·17 (0·02–1·22)
D: 0.13 (0.01-2.76)
E: 0·58 (0·33–1·01)
F: 0·53 (0·36–0·77)
G: not calculable
H: 0.50 (0.03–8.21)
I: 0·27 (0·12–0·59)
J: not calculable
K: not calculable
L: not calculable
M: 0·17 (0·09–0·32)
N: not included in meta-analysis for unknown reasons
Pooled effect (random effects model): 0·34 (0·22–0·52) favouring eye protection
Heterogeneity (I²): 43%

aOR: 0·22 (0·12–0·39) (2 studies: Yin, Ma) favouring eye protection
aRR: 0·25 (0·14–0·43) favoring eye protection

Facultative:
Level of evidence: GRADE Grading Recommendations Assessment, Development and Evaluation (Grading Recommendations Assessment, Development and Evaluation ): LOW (started at low, not downgraded).
Newcastle Ottowa Scale was used for all studies.

Sensitivity analyses:
Excluded preprints:
Unadjusted: 0.34 (0.22-0.52)
Adjusted: 0.22 (0.12-0.39)
Fixed effects:
Unadjusted: 0.36 (0.28-0.46)
Adjusted: 0.22 (0.12-0.39)
Hartung-Knapp-Sidik-Jonkman random effects model:
Unadjusted: 0.34 (0.22-0.51)
Adjusted: 0.22 (0.04-1.27)

Heterogeneity: clinical and statistical heterogeneity; explained versus unexplained (subgroup analysis)

Tian, 2021

SR and meta-analysis of RCTs / cohort / case-control studies

Searched up to 06-07-2020

Databases: MEDLINE (via Ovid), PubMed, Embase, CINAHL (via Ovid), Cochrane Central

A: Alraddadi (2016)
B: Caputo (2006)
C: Chen (2009)
D: Kim (2016)
E: Liu (2009)
F: Pei (2006)
G: Lau (2004)
H: Chatterjee (2020)
I: Kuster (2013)
J: Raboud (2010)
K: Toyokawa (2011)

A until G are similar to Chu (2020) and are therefore not specified in this row.

Study design:
H: case control
I: prospective cohort
J: retrospective cohort
K: cross-sectional

Setting and Country:
H: India
I: Canada
J: Canada
K: Japan

Source of funding and conflicts of interest: from text: “Support was provided solely from institutional and/or departmental sources. MS is supported by the Canadian Anesthesiologists Society Career Scientist Award, as well as the Merit Awards Program from the Department of Anesthesia at the University of Toronto… M.S. serves on the medical advisory board of the Hypersomnia Foundation on a voluntary basis. The remaining authors declare no competing interests.”

Inclusion criteria SR:
- articles in English
- articles on human subjects only
- the study population was comprised of HCWs in a healthcare setting with pandemic respiratory disease with a similar outbreak and transmission dynamics (droplet size) to COVID-19, including MERS, SARS, H1N1, and H5N1

Exclusion criteria SR:
- case reports, case series, editorials, narrative reviews, consensus opinions, news articles, and letters to the editor.
- studies not in health care settings

54 studies included of which 11 for face protection

Important patient characteristics:
N, micro-organism
H: 751, COVID-19
I: 563, H1N1
J: 624, SARS
K: 268, H1N1

Describe intervention:

Face protection (visors, goggles, face shields, etc.)

Describe control:

No face protection

Endpoint of follow-up:
Not reported

For how many participants were no complete outcome data available?
Not reported

Outcome measure
Infections: according to WHO definitions.

Effect measure: OR [95% CI]:
H: 0.81 (0.61 – 1.08)
I: 0.29 (0.10 – 0.89)
J: 0.33 (0.15-0.72)
K:1.14 (0.31 – 4.25)

Pooled effect (random effects model): (including A until K):
0.41 (0.27 – 0.62)
Heterogeneity (I²): 57.3%

Facultative:
Level of evidence: GRADE: MODERATE
(Downgraded 1 point because of large CI that overlaps both little to no effect, as well as appreciable benefit or appreciable harm of the intervention/exposure)

Newcastle Ottowa Scale was used for all studies.

Sensitivity analyses (excluding small studies; excluding studies with short follow-up; excluding low quality studies; relevant subgroup-analyses); mention only analyses which are of potential importance to the research question

Heterogeneity: clinical and statistical heterogeneity; explained versus unexplained (subgroup analysis)