Title and abstract | | (a) Indicate the study’s design with a commonly used term in the title or the abstract. | 1–3 |
| | (b) Provide in the abstract an informative and balanced summary of what was done and what was found. | 3–34 |
Introduction | | | |
Background/Rationale | 2 | Explain the scientific background and rationale for the investigation being reported. | 5 |
Objectives | 3 | State specific objectives, including any prespecified hypotheses. | 5 |
Methods | | | |
Study design | 4 | Present key elements of study design early in the paper. | 5–6 |
Setting | 5 | Describe the setting, locations and relevant dates, including periods of recruitment, exposure, follow-up and data collection. | 5–6 |
Participants | | (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. | 5–6 |
| | (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. | 5–6 |
Variables | 7 | Clearly define all outcomes, exposures, predictors, potential confounders and effect modifiers. Give diagnostic criteria, if applicable. | 6–7 |
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. | 6–7 |
Bias | 9 | Describe any efforts to address potential sources of bias. | 6–7 |
Study size | 10 | Explain how the study size was arrived at. | 6–7 |
Quantitative variables | 11 | Explain how quantitative variables were handled in the analyses. if applicable. Describe which groupings were chosen and why. | 6–7 |
Statistical methods | 12 | (a) Describe all statistical methods, including those used to control for confounding. | 7 |
(b) Describe any methods used to examine subgroups and interactions. | 7 |
(c) Explain how missing data were addressed. | 7 |
(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. | 7 |
(e) Describe any sensitivity analyses. | 7 |
Results | |
Participants | 13 | (a) Report number of individuals at each stage of study—eg, numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up and analysed. | 7–8 |
(b) Give reasons for non-participation at each stage. | n/a |
(c) Consider use of a flow diagram. | n/a |
Descriptive data | 14 | (a) Give characteristics of study participants (eg, demographic, clinical, social) and information on exposures and potential confounders. | 7–8 |
(b) Indicate number of participants with missing data for each variable of interest. | 12 |
(c) Cohort study—summarise follow-up time (eg, average and total amount). | n/a |
Outcome data | 15 | Cohort study—report number of outcome events or summary measures over time. | n/a |
Case-control study—report numbers in each exposure category, or summary measures of exposure. | 7–8 |
Cross-sectional study—report number of outcome events or summary measures. | 7–8 |
Main results | 16 | (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% CI). Make clear which confounders were adjusted for and why they were included. | 7–8 |
(b) Report category boundaries when continuous variables were categorised. | 7–8 |
(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 done—eg, analyses of subgroups and interactions, and sensitivity analyses. | n/a |
Discussion | |
Key results | 18 | Summarise key results with reference to study objectives. | 8–9 |
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. | 9 |
Interpretation | 20 | Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies and other relevant evidence. | 8–9 |
Generalisability | 21 | Discuss the generalisability (external validity) of the study results. | 9–10 |
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. | 10 |