Table A2.
STROBE checklist for observational studies.
| Item No | Recommendation | |
|---|---|---|
| Title and abstract | 1 | (a) Indicate the study’s design with a commonly used term in the title or the abstract |
| (b) Provide in the abstract an informative and balanced summary of what was done and what was found | ||
| Introduction | ||
| Background/rationale | 2 | Explain the scientific background and rationale for the investigation being reported |
| Objectives | 3 | State specific objectives, including any prespecified hypotheses |
| Methods | ||
| Study design | 4 | Present key elements of study design early in the paper |
| Setting | 5 | Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection |
| 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 |
| (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 | ||
| Variables | 7 | Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable |
| 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 |
| Bias | 9 | Describe any efforts to address potential sources of bias |
| Study size | 10 | Explain how the study size was arrived at |
| Quantitative variables | 11 | Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why |
| Statistical methods | 12 | (a) Describe all statistical methods, including those used to control for confounding |
| (b) Describe any methods used to examine subgroups and interactions | ||
| (c) Explain how missing data were addressed | ||
| (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 | ||
| (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 analysed |
| (b) Give reasons for non-participation at each stage | ||
| (c) Consider use of a flow diagram | ||
| Descriptive data | 14 | (a) Give characteristics of study participants (e.g., demographic, clinical, social) and information on exposures and potential confounders |
| (b) Indicate number of participants with missing data for each variable of interest | ||
| (c) Cohort study—Summarise follow-up time (e.g., average and total amount) | ||
| Outcome data | 15 | Cohort study—Report numbers of outcome events or summary measures over time |
| Case-control study—Report numbers in each exposure category, or summary measures of exposure | ||
| Cross-sectional study—Report numbers of outcome events or summary measures | ||
| 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 |
| (b) Report category boundaries when continuous variables were categorized | ||
| (c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period | ||
| Other analyses | 17 | Report other analyses done—e.g., analyses of subgroups and interactions, and sensitivity analyses |
| Discussion | ||
| Key results | 18 | Summarise key results with reference to study objectives |
| 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 |
| Interpretation | 20 | Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence |
| Generalisability | 21 | Discuss the generalisability (external validity) of the study results |
| 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 |