Section/Topic

Item #

Recommendation

Reported on page #

Title and abstract

1

(a) Indicate the study’s design with a commonly used term in the title or the abstract

3-4

(b) Provide in the abstract an informative and balanced summary of what was done and what was found

3-4

Introduction

Background/rationale

2

Explain the scientific background and rationale for the investigation being reported

6

Objectives

3

State specific objectives, including any prespecified hypotheses

6

Methods

Study design

4

Present key elements of study design early in the paper

7

Setting

5

Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection

7,8,9,10

Participants

6

(a) Give the eligibility criteria, and the sources and methods of selection of participants

7,8

Variables

7

Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable

8,9

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

8,9

Bias

9

Describe any efforts to address potential sources of bias

Study size

10

Explain how the study size was arrived at

Quantitative variables

11

Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why

7,8

Statistical methods

12

(a) Describe all statistical methods, including those used to control for confounding

9,10

(b) Describe any methods used to examine subgroups and interactions

(c) Explain how missing data were addressed

(d) If applicable, describe analytical methods taking account of sampling strategy

(e) Describe any sensitivity analyses

Results

Participants

13*

(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

7,10

(b) Give reasons for non-participation at each stage

(c) Consider use of a flow diagram

Descriptive data

14*

(a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential confounders

10

(b) Indicate number of participants with missing data for each variable of interest

Outcome data

15*

Report numbers of outcome events or summary measures

10-14

Main results

16

(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

12,14

(b) Report category boundaries when continuous variables were categorized

(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period

Other analyses

17

Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses

Discussion

Key results

18

Summarise key results with reference to study objectives

14-17

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

18

Interpretation

20

Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence

18

Generalisability

21

Discuss the generalisability (external validity) of the study results

18

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