Blog

Manuscript Section

Item No

Recommendation

Title and abstract

(a) Title

(b) Abstract

1

(a) Mention study design in title/abstract

(b) Abstract should be informative with a balanced summary of the methodology used and the results

Introduction

Background/

rationale

2

Provide scientific background and rationale for study being conducted

Objectives

3

Specific objectives, including any prespecified hypotheses should be stated

Methods

Study design

4

Key elements of study design should be explained early in the paper

Setting

5

Setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection should be adequately described in the methods

Participants

6

(a) Cohort study – Eligibility criteria, the sources and methods of selection of participants, and methods of follow-up should be reported

Case-control study – Eligibility criteria, the sources and methods of case ascertainment and control selection and the rationale for the choice of cases and controls should be provided

Cross-sectional study – Eligibility criteria, the sources and methods of selection of participants should be reported

(b) Matched Cohort study – Matching criteria and number of exposed and unexposed should be reported

Matched Case-control study – Matching criteria and the number of controls per case should be reported

Variables

7

All outcomes, exposures, predictors, potential confounders, and effect modifiers should be clearly mentioned. Mention diagnostic criteria, if applicable

Data sources/ measurement

8*

Sources of data and details of methods of assessment (measurement) should be given for each variable of interest.

If more than one group is included, then the comparability of the assessment methods need to be described

Bias

9

Describe any efforts taken to address potential sources of bias

Study size

10

Provide sample size calculation

Quantitative variables

11

Describe the way in which quantitative variables were analysed with explanations of groupings if any

Statistical methods

12

(a) Statistical methods need to be described in entirety , including those used to control for confounding

(b) Methods used to analyse subgroups and interactions need to be enumerated

(c) Steps taken for addressing missing data

(d) Cohort study – Loss to follow-up should be addressed, if applicable

Case-control study – Describe how matching of cases and controls was addressed, if applicable

Cross-sectional study – Sampling strategy and analytical methods to be described, if applicable

(e) Any sensitivity analyses should be explained

Results

Participants

13*

(a) Participant numbers should be reported for each stage including numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analysed

(b) Reasons for non-participation should be given for each stage

(c) Flow diagram should be considered

Descriptive data

14*

(a) Baseline demographic and clinical characteristics of study participants, and information on exposures and potential confounders should be given

(b) Number of participants with missing data should be given for each variable of interest

(c) Cohort study – Summarise follow-up time (eg, average and total amount)

Outcome data

15*

Cohort study – Numbers or summary of outcome events or measures should be presented

Case-control study – Numbers or summary measures of exposure should be given for each exposure category

Cross-sectional study – Numbers or summary of outcome events or measures should be presented

Main results

16

(a) Unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval) should be given. Adjusting of confounders to be clarified

(b) If continuous variables were categorized, the category boundaries should be presented

(c) Translate relative risk estimates into absolute risk for a meaningful time period, if relevant

Other analyses

17

Any other analyses e.g. subgroup and interactions, and sensitivity analyses should be mentioned

Discussion

Key results

18

Key results with reference to study objectives should be summarized

Limitations

19

Direction and extent of any potential bias or imprecision should be mentioned in the limitations of the study

Interpretation

20

Careful interpretation of results must be made taking into account the study objectives, analyses, limitations and results from similar studies/pertinent evidence

Generalisability

21

The application of research findings in other settings (external validity) should be mentioned

Other information

Funding

22

The source of funding and any potential conflict or the role of the funders for the current study or its primary study should be described.