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 |
3 |
Introduction |
|
Background/rationale |
2 |
Explain the scientific background and rationale for the investigation being reported |
5 |
Objectives |
3 |
State‐specific objectives, including any pre‐specified hypotheses |
6 |
Methods |
|
Study design |
4 |
Present key elements of study design early in the paper |
6 |
Setting |
5 |
Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow‐up and data collection |
7 |
Participants |
6 |
(a) Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow‐up |
8 |
(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/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 |
8 |
Bias |
9 |
Describe any efforts to address potential sources of bias |
17 |
Study size |
10 |
Explain how the study size was arrived at |
Figure 1
|
Quantitative variables |
11 |
Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why |
8 |
Statistical methods |
12 |
(a) Describe all statistical methods, including those used to control for confounding |
8 |
(b) Describe any methods used to examine subgroups and interactions |
8 |
(c) Explain how missing data were addressed |
8/17 |
(d) If applicable, explain how loss to follow‐up was addressed |
8 |
(e) Describe any sensitivity analyses |
‐ |
Results |
|
Participants |
13a
|
(a) Report numbers of individuals at each stage of study—for example, numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow‐up, and analysed |
10/Figure 1
|
(b) Give reasons for nonparticipation at each stage |
Figure 1
|
(c) Consider use of a flow diagram |
Figure 1
|
Descriptive data |
14a
|
(a) Give characteristics of study participants (e.g., demographic, clinical and social) and information on exposures and potential confounders |
10 |
(b) Indicate number of participants with missing data for each variable of interest |
Noted in each table |
(c) Summarise follow‐up time (e.g., average and total amount) |
13 |
Outcome data |
15a
|
Report numbers of outcome events or summary measures over time |
10–14 |
Main results |
16 |
(a) Give unadjusted estimates and, if applicable, confounder‐adjusted estimates and their precision (e.g., 95% confidence interval). Make clear which confounders were adjusted for and why they were included |
10–14 |
(b) Report category boundaries when continuous variables were categorised |
10 |
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period |
‐ |
Other analyses |
17 |
Report other analyses done—for example, analyses of subgroups and interactions, and sensitivity analyses |
10–14 |
Discussion |
|
Key results |
18 |
Summarise key results with reference to study objectives |
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 |
15–17 |
Interpretation |
20 |
Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies and other relevant evidence |
15–17 |
Generalisability |
21 |
Discuss the generalisability (external validity) of the study results |
15–19 |
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 |
2 |