| Item No | Recommendation | Please Insert Check Where Included or N/A Where Not Applicable | |
| Title and abstract | 1 | (a) Indicate the study’s design with a commonly used term in the title or the abstract | check |
| (b) Provide, in the abstract, an informative and balanced summary of what was performed and what was found | check | ||
| Introduction | |||
| Background/rationale | 2 | Explain the scientific background and rationale for the investigation being reported | check |
| Objectives | 3 | State specific objectives, including any pre specified hypotheses | check |
| Methods | |||
| Study design | 4 | Present key elements of study design early in the paper | check |
| Setting | 5 | Describe the setting, locations and relevant dates, including periods of recruitment, treatment, follow up and data collection | check |
| Participants | 6 | (a) Cohort study—Provide the eligibility criteria and the sources and methods of selection of participants. Describe methods of follow up Case-control study—Provide the eligibility criteria and the sources and methods of case ascertainment and control selection. Provide the rationale for the choice of cases and controls Cross-sectional study—Provide the eligibility criteria and the sources and methods of selection of participants |
check |
| (b) Cohort study—For matched studies, provide matching criteria and number of treated and untreated Case-control study—For matched studies, provide matching criteria and the number of controls per case |
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| Variables | 7 | Clearly define all outcomes, exposures, predictors, potential confounders and effect modifiers. Provide diagnostic criteria, if applicable | check |
| Data sources/measurement | 8 * | For each variable of interest, provide sources of data and details of methods of assessment (measurement) Describe comparability of assessment methods if there is more than one group | check |
| Bias | 9 | Describe any efforts to address potential sources of bias | check |
| Study size | 10 | Explain how the study size was arrived at | check |
| Quantitative variables | 11 | Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why | check |
| Statistical methods | 12 | (a) Describe all statistical methods, including those used to control for confounding factors | check |
| / | (b) Describe any methods used to examine subgroups and interactions | / | |
| / | (c) Explain how missing data were addressed | check | |
| / | (d) If applicable, explain how loss to follow up was addressed | check | |
| / | (e) Describe any sensitivity analyses | / | |
| 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 | check |
| / | (b) Give reasons for nonparticipation at each stage | check | |
| Descriptive data | 14 * | (a) Give characteristics of study participants (e.g., demographic, clinical, social) and information on other treatments and potential confounders | check |
| / | (b) Indicate number of participants with missing data for each variable of interest | check | |
| / | (c) Cohort study—Summarize follow-up time (e.g., average and total amount) | check | |
| Outcome data | 15 * | Report numbers of outcome events or summary measures over time | N/A |
| Main results | 16 | (a) Provide 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 | / |
| / | (b) Report category boundaries when continuous variables were categorized | N/A | |
| / | (c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period | N/A | |
| Other analyses | 17 | Report other analyses performed—e.g., analyses of subgroups and interactions and sensitivity analyses | N/A |
| Discussion | |||
| Key results | 18 | Summarise key results with reference to study objectives | check |
| 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 | check |
| Interpretation | 20 | Provide a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies and other relevant evidence | check |
| Generalisability | 21 | Discuss the generalisability (external validity) of the study results | check |
| Other information | |||
| Funding | 22 | Provide 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 | check |
| * Provide information separately for cases and controls. Note: An Explanation and Elaboration article discusses each checklist item and provides methodological background and published examples of transparent reporting. Information on the STROBE Initiative is available at http://www.strobe-statement.org, access date 15 January 2021. | |||