strobe_checklist_v4_combined.docVIP

STROBE Statement—checklist of items that should be included in reports of observational studies Item No Recommendation Page Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract 1 (b) Provide in the abstract an informative and balanced summary of what was done and what was found 1 Introduction Background/rationale 2 Explain the scientific background and rationale for the investigation being reported 1 Objectives 3 State specific objectives, including any prespecified hypotheses 1 Methods Study design 4 Present key elements of study design early in the paper 2 Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection 2 Participants 6 (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 2 (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 Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable 2 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 N/A Bias 9 Describe any efforts to address potential sources of bias N/A Study size 10 Explain how the study size was arrived at 2 Quantitative variables 11 Explain how quantitative variables were handled in the analyse