|Title and abstract||1||Indicate the study’s design with a commonly used term in the title or the abstract; provide in the abstract an informative and balanced summary of what was done |
and what was found.
|Background/rationale||2||Explain the scientific background and rationale for the investigation being reported.|
|Objectives||3||State specific objectives, including any prespecified hypotheses.|
|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||Give the eligibility criteria, and the sources and methods of selection of participants.|
|Variables||7||Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable.|
|Data sources/ |
|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) If applicable, describe analytical methods taking account of sampling strategy.
|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 |
(b) Give reasons for non-participation at each stage.
(c) Consider use of a flow diagram.
|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.
|Outcome data||15||Report numbers of outcome events or summary measures.|
|Main results||16||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.|
|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.|
|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|