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. 2022 Mar 22;18(3):e13352. doi: 10.1111/mcn.13352
Item no Recommendation Page #
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