STROBE Statement-Checklist
01 May 2018
STROBE Statement-Checklist
STROBE Statement-Checklist of items should be followed in reporting of all observational studies including cohort, case-control, and epidemiological studies. This article details each checklist item for different sections of the manuscripts for observational studies, and also provides recommendations for information to be included in the articles.
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. |
*Information on cases and controls for case-control studies, and exposed and unexposed groups for cohort and cross-sectional studies should be discussed separately.