Table 4.
Item No. | Recommendation | Criteria Met (N, %) Yes No N/A | |||
---|---|---|---|---|---|
Title and abstract | 1 | (a) Indicate the study’s design with a commonly used term in the title or the abstract | 21(100) | 0 (0) | 0 (0) |
(b) Provide in the abstract an informative and balanced summary of what was done and what was found | 21 (100) | 0 (0) | 0 (0) | ||
Introduction | |||||
Background/rationale | 2 | Explain the scientific background and rationale for the investigation being reported | 21 (100) | 0 (0) | 0 (0) |
Objectives | 3 | State-specific objectives, including any prespecified hypotheses | 21 (100) | 0 (0) | 0 (0) |
Methods | |||||
Study design | 4 | Present key elements of study design early in the paper | 21 (100) | 0 (0) | 0 (0) |
Setting | 5 | Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection | 21 (100) | 0 (0) | 0 (0) |
Participants | 6 | (a) Cohort study—Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up Case–control study—Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls Cross-sectional study—Give the eligibility criteria, and the sources and methods of selection of participants |
N/A 3 (100) 16 (76.1) |
N/A 0 (0) 2 (9.6) |
N/A 0 (0) 3 (14.3) |
(b) Cohort study—For matched studies, give matching criteria and number of exposed and unexposed Case–control study—For matched studies, give matching criteria and the number of controls per case |
3 (100) | 0 (0) | 0 (0) | ||
Variables | 7 | Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable | 19 (90.4) | 2 (9.6) | 0(0) |
Data sources/measurement | 8* | For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group | 21 (100) | 0 (0) | 0 (0) |
Bias | 9 | Describe any efforts to address potential sources of bias | 19(90.4) | 2 (9.6) | 0 (0) |
Study size | 10 | Explain how the study size was arrived at | 20 (95.2) | 1 (4.8) | 0 (0) |
Quantitative variables | 11 | Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why | 21 (100) | 0 (0) | 0 (0) |
Statistical methods | 12 | (a) Describe all statistical methods, including those used to control for confounding | 20 (95.2) | 1 (4.8) | 0 (0) |
(b) Describe any methods used to examine subgroups and interactions | 21 (100) | 0 (0) | 0 (0) | ||
(c) Explain how missing data were addressed | 3 (14.3) | 2 (9.6) | 16 (76.1) | ||
(d) Cohort study—If applicable, explain how loss to follow-up was addressed Case–control study—If applicable, explain how matching of cases and controls was addressed Cross-sectional study—If applicable, describe analytical methods taking account of sampling strategy |
20 (95.2) | 1 (4.8) | 0 (0) | ||
( e ) Describe any sensitivity analyses | 20 (95.2) | 0 (0) | 1 (4.8) | ||
Results | |||||
Participants | 13* | (a) Report numbers of individuals at each stage of study—e.g., numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analyzed | 21 (100) | 0 (0) | 0 (0) |
(b) Give reasons for non-participation at each stage | 5 (23.8) | 3 (14.3) | 13 (61.9) | ||
(c) Consider use of a flow diagram | 0 (0) | 21 (100) | 0 (0) | ||
Descriptive data | 14* | (a) Give characteristics of study participants (e.g., demographic, clinical, social) and information on exposures and potential confounders | 19 (90.4) | 1 (4.8) | 1 (4.8) |
(b) Indicate number of participants with missing data for each variable of interest | 2 (9.6) | 1 (4.8) | 18 (85.6) | ||
(c) Cohort study—Summarize follow-up time (e.g., average and total amount) | N/A | N/A | N/A | ||
Outcome data | 15* | Cohort study—Report numbers of outcome events or summary measures over time | N/A | N/A | N/A |
Case–control study—Report numbers in each exposure category, or summary measures of exposure | 3(100) | 0 (0) | 18 (0) | ||
Cross-sectional study—Report numbers of outcome events or summary measures | 19 (90.4) | 2 (9.6) | 0 (0) | ||
Main results | 16 | (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (e.g., 95% confidence interval). Make clear which confounders were adjusted for and why they were included | 19 (90.4) | 2 (9.6) | 0 (0) |
(b) Report category boundaries when continuous variables were categorized | 13 (61.9) | 1 (4.8) | 7 (33.3) | ||
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period | 13 (61.9) | 5 (23.8) | 3 (14.3) | ||
Other analyses | 17 | Report other analyses done—e.g., analyses of subgroups and interactions, and sensitivity analyses | 21 (100) | 0 (0) | 0 (0) |
Discussion | |||||
Key results | 18 | Summarize key results with reference to study objectives | 21 (100) | 0 (0) | 0 (0) |
Limitations | 19 | Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias | 11 (52.4) | 10 (47.6) | 0 (0) |
Interpretation | 20 | Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence | 15 (71.4) | 6 (28.6) | 0 (0) |
Generalisability | 21 | Discuss the generalizability (external validity) of the study results | 9 (42.9) | 12 (57.1) | 0 (0) |
Other information | |||||
Funding | 22 | Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based | 13 (61.9) | 7 (33.3) | 1 (4.8) |
Completeness of Reporting mean of the 21 studies (%) | 87.0 ± 6.4% |
"*" refer to Vandenbroucke et al., (71).