library(Gmisc)
(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
Explain the scientific background and rationale for the investigation being reported
State specific objectives, including any prespecified hypotheses
Present key elements of study design early in the paper
Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection
(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
(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
Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable
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
Describe any efforts to address potential sources of bias
Explain how the study size was arrived at
Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why
(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 addressed
Case-control study—If applicable, explain how matching of cases and controls was addressed
Cross-sectional study—If applicable, describe analytical methods taking account of sampling strategy
(e) Describe any sensitivity analyses
(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
(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)
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
(a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included
(b) Report category boundaries when continuous variables were categorized
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period
Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses
Summarise key results with reference to study objectives
Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias
Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence
Discuss the generalisability (external validity) of the study results
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