| 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 |
Not applicable |
| Variables |
7 |
Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable |
Yes |
| 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 |
Yes |
| Bias |
9 |
Describe any efforts to address potential sources of bias |
|
| 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 |
Yes |
|
|
(d) If applicable, explain how loss to follow-up was addressed |
Not applicable |
|
|
(e) Describe any sensitivity analyses |
Yes |
|
Results
|
| Participants |
13 |
(a) Report numbers of individuals at each stage of study – e.g. 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 |
14 |
(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 |
Not applicable |
|
|
(c) Summarise follow-up time (e.g., average and total amount) |
|
| Outcome data |
15 |
Report numbers of outcome events or summary measures over time |
Not applicable |
| 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 |
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 |
Not applicable |
| Other analyses |
17 |
Report other analyses done – e.g. 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 |
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