Title and abstract
|
1 |
(a) Indicate the study’s design with a commonly used term in the title or the abstract |
1-2 |
(b) Provide in the abstract an informative and balanced summary of what was done and what was found |
2 |
Introduction
|
Background/rationale |
2 |
Explain the scientific background and rationale for the investigation being reported |
3-4 |
Objectives |
3 |
State specific objectives, including any prespecified hypotheses |
4 |
Methods
|
Study design |
4 |
Present key elements of study design early in the paper |
4 |
Setting |
5 |
Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection |
4-5 |
Participants |
6 |
(a) Cross-sectional study – Give the eligibility criteria and the sources and methods of selection of participants |
4-5 |
|
|
Variables |
7 |
Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable |
5-8 |
Data sources/ measurement |
8
|
For each variable of interest, give sources of data and details of assessment methods (measurement). Describe comparability of assessment methods if there is more than one group |
5-8 |
Bias |
9 |
Describe any efforts to address potential sources of bias |
6-7 |
Study size |
10 |
Explain how the study size was arrived at |
5 |
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 |
(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 |
|
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 analyzed |
5 |
(b) Give reasons for non-participation at each stage |
5 |
(c) Consider use of a flow diagram |
5 (Figure 1) |
Descriptive data |
14
|
(a) Give characteristics of study participants (e.g. demographic, clinical, social) and information on exposures and potential confounders |
8-9 |
(b) Indicate number of participants with missing data for each variable of interest |
5 |
(c) Cohort study – Summarize follow-up time (e.g., average and total amount) |
|
Outcome data |
15
|
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 |
8-9 |
Main results |
16 |
(a) Give unadjusted estimates and, if applicable, confounder-ººadjusted estimates and their precision (e.g., 95% confidence interval). Make clear which confounders were adjusted for and why they were included |
8-9 |
(b) Report category boundaries when continuous variables were categorized |
8-9 |
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period |
9 |
Other analyses |
17 |
Report other analyses done –e.g. analyses of subgroups and interactions, and sensitivity analyses |
- |
Key results |
18 |
Summarize key results with reference to study objectives |
9-10 |
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 |
13-14 |
Interpretation |
20 |
Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence |
10-13 |
Generalizability |
21 |
Discuss the generalizability (external validity) of the study results |
13 |
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 |
14 |