| Item No | Recommendation | Page No |
Title and abstract | 1 | 1) Indicate the study’s design with a commonly used term in the title or the abstract | 1 |
2) Provide in the abstract an informative and balanced summary of what was done and what was found | 1 | ||
Introduction | |||
Background/rationale | 2 | Explain the scientific background and rationale for the investigation being reported | 2 |
Objectives | 3 | State specific objectives, including any prespecified hypotheses | 2 |
Methods | |||
Study design | 4 | Present key elements of study design early in the paper | 3 |
Setting | 5 | Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection | 3 |
Participants | 6 | 1) Give the eligibility criteria, and the sources and methods of selection of participants | NA |
Variables | 7 | Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable | NA |
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 | NA |
Bias | 9 | Describe any efforts to address potential sources of bias | NA |
Study size | 10 | Explain how the study size was arrived at | NA |
Quantitative variables | 11 | Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why | NA |
Statistical methods | 12 | 1) Describe all statistical methods, including those used to control for confounding | NA |
2) Describe any methods used to examine subgroups and interactions | NA | ||
3) Explain how missing data were addressed | NA | ||
4) If applicable, describe analytical methods taking account of sampling strategy | NA | ||
5) Describe any sensitivity analyses | NA | ||
Results | |||
Participants | 13* | 1) 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 | NA |
2) Give reasons for non-participation at each stage | NA | ||
3) Consider use of a flow diagram | NA |