Item no. | Recommendation | Pages | |
---|---|---|---|
Title and abstract | 1 | (a) Indicate the study’s design with a commonly used term in the title or the abstract | 2 |
(b) Provide in the abstract an informative and balanced summary of what was done and what was found | 2 | ||
Introduction | |||
Background/rationale | 2 | Explain the scientific background and rationale for the investigation being reported | 3 |
Objectives | 3 | State specific objectives, including any pre-specified hypotheses | 3 |
Methods | |||
Study design | 4 | Present key elements of study design early in the paper | 4 |
Setting | 5 | Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection | 4 |
Participants | 6 | (a) Give the eligibility criteria and the sources and methods of selection of participants | 4 |
Variables | 7 | Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable | 4–5 |
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 | 5 |
Bias | 9 | Describe any efforts to address potential sources of bias | – |
Study size | 10 | Explain how the study size was arrived at | 4–5 |
Quantitative variables | 11 | Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why | 4–5 |
Statistical methods | 12 | (a) Describe all statistical methods, including those used to control for confounding | 5 |
(b) Describe any methods used to examine subgroups and interactions | 5 | ||
(c) Explain how missing data were addressed | 5 | ||
(d) If applicable, describe analytical methods taking account of sampling strategy | 5 | ||
(e) Describe any sensitivity analyses | 5 | ||
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 | 7 |
(b) Give reasons for non-participation at each stage | 4–5 | ||
(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 | 6 |
(b) Indicate number of participants with missing data for each variable of interest | – | ||
Outcome data | 15* | Report numbers of outcome events or summary measures | 6 |
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 | 6 |
(b) Report category boundaries when continuous variables were categorized | 6 | ||
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period | 6 | ||
Other analyses | 17 | Report other analyses done—e.g., analyses of subgroups and interactions, and sensitivity analyses | 6 |
Discussion | |||
Key results | 18 | Summarize key results with reference to study objectives | 7 |
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 | 7–8 |
Generalizability | 21 | Discuss the generalizability (external validity) of the study results | 7–8 |
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 | 09 |