STROBE statement?checklist of items that should be included in reports of observational studies

Item NoRecommendation
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/rationale2Explain the scientific background and rationale for the investigation being reported
Objectives3State specific objectives, including any prespecified hypotheses
Methods
Study design4Present key elements of study design early in the paper
Setting5Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection
Participants6(a) Cohort study?Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-upCase-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 controlsCross 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 unexposedCase-control study?For matched studies, give matching criteria and the number of controls per case
Variables7Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable
Data sources/ measurement8* 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
Bias9Describe any efforts to address potential sources of bias
Study size10Explain how the study size was arrived at
Quantitative variables11Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why
Statistical methods12(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 addressedCase-control study?If applicable, explain how matching of cases and controls was addressedCross sectional study?If applicable, describe analytical methods taking account of sampling strategy
(e) Describe any sensitivity analyses
Results
Participants13*(a) Report numbers 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
(b) Give reasons for non-participation at each stage
(c) Consider use of a flow diagram
Descriptive data14*(a)Give characteristics of study participants (eg 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 (eg average and total amount)
Outcome data15* 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 results16(a) Report the numbers of individuals at each stage of the study?eg 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
Other analyses17Report other analyses done?eg analyses of subgroups and interactions, and sensitivity analyses
Discussion
Key results18Summarise key results with reference to study objectives
Limitations19Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias
Interpretation20Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence
Generalisability21Discuss the generalisability (external validity) of the study results
Other information
Funding22Give 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

*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and unexposed groups in cohort and cross sectional studies.

The STROBE checklist is best used in conjunction with the explanation and elaboration article.18-20 This article and separate versions of the checklist for cohort, case-control, and cross sectional studies are available at www.strobe-statement.org.