ciii 3D. STROBE Statement for Cohort Studies Item No Recommendation Page No Title and abstract 1 (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 Introduction Background /rationale 2 Explain the scientific background and rationale for the investigation being reported 4 Objectives 3 State specific objectives, including any prespecified hypotheses 4 Methods Study design 4 Present key elements of study design early in the paper 5 Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection 5 Participants 6 (a) Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up 5 (b) For matched studies, give matching criteria and number of exposed and unexposed Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable 8 Data sources/ measuremen t 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, 6 Bias 9 Describe any efforts to address potential sources of bias 6, 7 Study size 10 Explain how the study size was arrived at 8 Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why 7, 8 Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding 7, 8 (b) Describe any methods used to examine subgroups and interactions (c) Explain how missing data were addressed (d) If applicable, explain how loss to follow-up was addressed (e) Describe any sensitivity analyses Results Participants 13* (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 8, 9 (b) Give reasons for non-participation at each stage
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