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