Title and abstract |
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Title |
#1a |
Indicate the study’s design with a commonly used term in the
title or the abstract |
1 |
Abstract |
#1b |
Provide in the abstract an informative and balanced summary of
what was done and what was found |
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 |
4 |
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 |
Eligibility criteria |
#6a |
Give the eligibility criteria, and the sources and methods of
selection of participants |
4 |
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#7 |
Clearly define all outcomes, exposures, predictors, potential
confounders, and effect modifiers. Give diagnostic criteria, if
applicable |
4–6 |
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. Give
information separately for exposed and unexposed groups if
applicable |
4–6 |
Bias |
#9 |
Describe any efforts to address potential sources of bias |
n/a |
Study size |
#10 |
Explain how the study size was arrived at |
4 |
Quantitative variables |
#11 |
Explain how quantitative variables were handled in the analyses.
If applicable, describe which groupings were chosen, and
why |
4-6 |
Statistical methods |
#12a |
Describe all statistical methods, including those used to
control for confounding |
4-6 |
Statistical methods |
#12b |
Describe any methods used to examine subgroups and
interactions |
4-6 |
Statistical methods |
#12c |
Explain how missing data were addressed |
6 |
Statistical methods |
#12d |
If applicable, describe analytical methods taking account of
sampling strategy |
n/a |
Statistical methods |
#12e |
Describe any sensitivity analyses |
n/a |
Results |
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Participants |
#13a |
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. Give information separately for exposed and
unexposed groups if applicable. |
Page 4 |
Participants |
#13b |
Give reasons for non-participation at each stage |
n/a |
Participants |
#13c |
Consider use of a flow diagram |
n/a |
Descriptive data |
#14a |
Give characteristics of study participants (e.g. demographic,
clinical, social) and information on exposures and potential
confounders. Give information separately for exposed and
unexposed groups if applicable. |
6 |
Descriptive data |
#14b |
Indicate number of participants with missing data for each
variable of interest |
Tables 1–4 |
Outcome data |
#15 |
Report numbers of outcome events or summary measures. Give
information separately for exposed and unexposed groups if
applicable. |
n/a |
Main results |
#16a |
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 |
6–7 |
Main results |
#16b |
Report category boundaries when continuous variables were
categorized |
n/a |
Main results |
#16c |
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 – e.g. analyses of subgroups and
interactions, and sensitivity analyses |
n/a |
Discussion |
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Key results |
#18 |
Summarize key results with reference to study objectives |
7 |
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 |
9 |
Interpretation |
#20 |
Give a cautious overall interpretation considering objectives,
limitations, multiplicity of analyses, results from similar
studies, and other relevant evidence |
9,10 |
generalizability |
#21 |
Discuss the generalizability (external validity) of the study
results |
9 |
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 |
10 |