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 |
2–3 |
Introduction |
Background/rationale |
2 |
Explain the scientific background and rationale for the investigation being reported |
4–5 |
Objectives |
3 |
State specific objectives, including any prespecified hypotheses |
4–5 |
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 |
5–6 |
Participants |
6 |
(a) Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up |
5–6 |
(b) For matched studies, give matching criteria and number of exposed and unexposed |
N/A |
Variables |
7 |
Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable |
6 |
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 |
6–8 |
Bias |
9 |
Describe any efforts to address potential sources of bias |
N/A |
Study size |
10 |
Explain how the study size was arrived at |
9 |
Quantitative variables |
11 |
Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why |
6–8 |
Statistical methods |
12 |
(a) Describe all statistical methods, including those used to control for confounding |
8–9 |
(b) Describe any methods used to examine subgroups and interactions |
N/A |
(c) Explain how missing data were addressed |
9 |
(d) If applicable, explain how loss to follow-up was addressed |
9–10 |
(e) Describe any sensitivity analyses |
N/A |
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 |
9–10 and Figure 1
|
(b) Give reasons for non-participation at each stage |
9–10 and Figure 1
|
(c) Consider use of a flow diagram |
Figure 1 |
Descriptive data |
14* |
(a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential confounders |
Table 1 |
(b) Indicate number of participants with missing data for each variable of interest |
Table 1 |
(c) Summarise follow-up time (eg, average and total amount) |
6 |
Outcome data |
15* |
Report numbers of outcome events or summary measures over time |
10 and Figures 2 and 3
|
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 |
11 and Table 2
|
(b) Report category boundaries when continuous variables were categorized |
N/A |
(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 |
N/A |
Discussion |
Key results |
18 |
Summarise key results with reference to study objectives |
11–15 |
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 |
15–16 |
Interpretation |
20 |
Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence |
11–15 |
Generalisability |
21 |
Discuss the generalisability (external validity) of the study results |
15 |
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 |
18 |