Item No | Recommendation | Observed | |
---|---|---|---|
Title and abstract | 1 | (a) Indicate the study’s design with a commonly used term in the title or the abstract | Yes |
(b) Provide in the abstract an informative and balanced summary of what was done and what was found | Yes | ||
Introduction | |||
Background/ rationale | 2 | Explain the scientific background and rationale for the investigation being reported | Yes |
Objectives | 3 | State specific objectives, including any prespecified hypotheses | Yes |
Methods | |||
Study design | 4 | Present key elements of study design early in the paper | Yes |
Setting | 5 | Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection | Yes |
Participants | 6 | (a) Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up | Yes |
(b) For matched studies, give matching criteria and number of exposed and unexposed | Yes | ||
Variables | 7 | Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable | Yes (where applicable) |
Data sources/ measurement | 8a | 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 | Yes (where applicable) |
Bias | 9 | Describe any efforts to address potential sources of bias | Yes |
Study size | 10 | Explain how the study size was arrived at | Yes |
Quantitative variables | 11 | Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why | Yes |
Statistical methods | 12 | (a) Describe all statistical methods, including those used to control for confounding | Yes |
(b) Describe any methods used to examine subgroups and interactions | Yes | ||
(c) Explain how missing data were addressed | N/A | ||
(d) If applicable, explain how loss to follow-up was addressed | N/A | ||
(e) Describe any sensitivity analyses | N/A | ||
Results | |||
Participants | 13a | (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 | Yes |
(b) Give reasons for non-participation at each stage | Yes | ||
(c) Consider use of a flow diagram | Yes | ||
Descriptive data | 14a | (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential confounders | Yes |
(b) Indicate number of participants with missing data for each variable of interest | N/A | ||
(c) Summarise follow-up time (eg, average and total amount) | Yes | ||
Outcome data | 15a | Report numbers of outcome events or summary measures over time | Yes |
Main results | 16 | (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 | Yes |
(b) Report category boundaries when continuous variables were categorized | Yes | ||
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period | N/A | ||
Other analyses | 17 | Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses | Yes |
Discussion | |||
Key results | 18 | Summarise key results with reference to study objectives | Yes |
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 | Yes |
Interpretation | 20 | Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence | Yes |
Generalisability | 21 | Discuss the generalisability (external validity) of the study results | Yes |
Other information | |||
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 | Yes |