Structure

Item

Recommendation

Title and abstract

1

Indicate the study’s design with a commonly used term in the title or the abstract; provide in the abstract an informative and balanced summary of what was done
and what was found.

Introduction

Background/rationale

2

Explain the scientific background and rationale for the investigation being reported.

Objectives

3

State specific objectives, including any prespecified hypotheses.

Methods

Study design

4

Present key elements of study design early in the paper.

Setting

5

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

Participants

6

Give the eligibility criteria, and the sources and methods of selection of participants.

Variables

7

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

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.

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.

Statistical methods

12

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

Results

Participants

13

(a) 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.
(b) Give reasons for non‐participation at each stage.
Participants
(c) Consider use of a flow diagram.

Descriptive
data

14

(a) Give characteristics of study participants (e.g. demographic, clinical, social) and information on exposures and potential confounders.
(b) Indicate number of participants with missing data for each variable of interest.

Outcome data

15

Report numbers of outcome events or summary measures.

Main results

16

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

Other analyses

17

Report other analyses done—e.g. analyses of subgroups and interactions, and sensitivity analyses.

Discussion

Key results

18

Summarise key results with reference to study objectives.

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.

Interpretation

20

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

Generalisability

21

Discuss the generalisability (external validity) of the study results.

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

Item No.

Meglio 1989

Shimoji 1993

Yakovlev 2010

Yakovlev 2011

1

Y

Y

Y

Y

2

N

Y

Y

Y

3

N

Y

Y

Y

4

N

N

N

N

5

N

N

Y

Y

6

N

N

N

N

7

N

N

N

N

8

N

N

N

Y

9

N

N

N

N

10

N

N

N

N

11

Y

Y

Y

Y

12

N

N

N

N

13

N

N

N

N

14

N

N

N

N

15

Y

Y

Y

Y

16

N

N

N

N

17

N

N

N

N

18

Y

Y

Y

Y

19

N

N

N

N

20

Y

Y

Y

Y

21

Y

Y

Y

Y

22

N

N

Y

Y