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