Table 1.

The READUS-PV checklist

Section and topic	Item #	Checklist item
Title
	1a	If disproportionality analyses are a prominent component of the published study, the study should be identified as a “disproportionality analysis.” The type of data and name of the database(s) should be specified.
	1b	Report the name of adverse event(s) and/or drug(s) under study, when applicable.
Introduction
Background	2a	Describe the drug(s) and its utilization, the nature of the adverse event(s) under study and its frequency, and the existing knowledge on the drug–event combination.
	2b	Specify the rationale for performing the analysis, e.g., as part of routine pharmacovigilance, to investigate an overall safety profile, or to assess a pre-specified hypothesis.
	2c	Explain why individual case safety report databases and disproportionality analysis are suitable to fill the knowledge gap.
Objectives	3	State specific objectives, identifying the adverse event(s), the drug(s), and the reference group, including any pre-specified hypothesis, if applicable.
Methods
Study design	4a	Identify the study (i.e., “disproportionality analysis”) and the type of data used (e.g., “individual case safety reports”).
	4b	Provide an outline of the entire study design, including primary and sensitivity analyses performed, and other designs such as case-by-case analysis or literature review.
Data description, access, and pre-processing	5a	Specify the name of the database(s), the database(s) custodian, and the coverage. Specify the type/number of drugs included within the database and the thesaurus, taxonomies, or ontologies used for coding drugs and events.
	5b	Specify the extraction dates and describe and justify all choices used for data pre-processing, including any data transformation or exclusion, if appropriate.
Variables definition	6a	Describe the study population, including any restriction.
	6b	Describe the nature and the meaning of key variables assessed in the work.
	6c	Specify and justify any grouping of drugs or events. For drugs, specify and justify whether active ingredients/trade names/salts were considered and/or the selected role.
	6d	Describe any additional data source used, the type of data, and how they interact with individual case safety reports.
Statistical methods	7a	Present any descriptive analysis performed, specifying variables investigated, statistical tests, and significance thresholds.
	7b	Describe the measure(s) selected for the disproportionality analysis including any threshold used to identify signals of disproportionate reporting. Explain the reason for this choice if applicable.
	7c	Clearly describe any sensitivity analysis and any tool to control confounding, including any restriction, subgroup, stratification, adjustment, or interaction.
	7d	Specify the variables and methods used for the case-by-case analysis, including any algorithm or criteria used to assess causality, if performed.
	7e	Specify any statistical methods used for other data sources.
Results
Participants	8a	Specify the number of individual case safety reports included at each stage, including reasons for exclusion.
	8b	Provide key demographic and clinical characteristics of cases, if possible comparing cases with any appropriate reference group.
Disproportionality analysis	9	Present all results including confidence intervals. Present also results of sensitivity analyses, if performed.
Case-by-case analysis	10	Present the case-by-case analysis of key variables. Present the causality assessment, if applicable.
Discussion
Key results	11	Discuss key results with reference to study objectives and contextualize them within the current literature and other consulted sources. Clearly discriminate between expected reactions and emerging safety signals.
External validity	12a	Discuss the external validity of the results to the general population.
	12b	Discuss the potential relevance of results in clinical practice
	12c	Propose further study designs if applicable
Limitations	13	Present general limitations, making clear that disproportionality analysis alone cannot prove causation or measure incidence, and specific limitations, including confounding and reporting bias and efforts to mitigate them.
Declarations
	14a	Provide the source of funding/sponsorship and the role of the funders/sponsors for the present study and for any original study on which the present article is based.
	14b	Clearly identify potential commercial and intellectual conflicts of interest (e.g., link to any drug/event investigated, whether financial, legal action, or software used).
	14c	Declare any institutional approval needed or granted in the investigation.
	14d	Include a statement on data availability, code availability (including the version of the statistical software used), and protocol registration.

READUS-PV REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance