Data source heterogeneity in multi-database pharmacoepidemiologic studies: a scoping review (DIVERSE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49419
• EU PAS number:
  EUPAS39757
• Study ID:
  49419
• Official title and acronym:
  Data source heterogeneity in multi-database pharmacoepidemiologic studies: a scoping review (DIVERSE)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Netherlands

  United Kingdom (Northern Ireland)
• Study description:
  Multi-database studies (MDS) are increasingly performed in pharmacoepidemiologic research. A MDS is as a study using at least two healthcare databases, which are not linked with each other at an individual person level, either because they cover and capture information on different individuals, or because, even if populations overlap, local regulations forbid record linkage. In a MDS, analyses are carried out in parallel across each data source applying a common study protocol. Regulatory authorities often require data from multiple data sources to be used in a single study, to enhance the generalizability of results or to obtain sufficient sample size when the exposure and/or outcome is rare. MDS pose a number of challenges, including how to manage heterogeneity between the different included data sources. Despite calls for the implementation of strategies to improve replicability, increase transparency and reduce bias in MDS, and despite general recommendations to assess the comparability of data sources in MDS, to our knowledge, there is currently no guidance for how database heterogeneity should be evaluated or even identified and recorded. This scoping review is intended to inform the development of guidelines for the identification, collection and reporting of heterogeneity in MDS, and to identify areas for further research. This activity is the Objective 1 of the DIVERSE project, of the Database Special Interest Group of the International Society for Pharmacoepidemiology (ISPE).
• Study status:
  Ongoing

Research institution and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Study timelines

Date when funding contract was signed

Planned: 24/12/2020

Actual: 24/12/2020

Study start date

Planned: 01/01/2021

Actual: 01/01/2021

Date of final study report

Planned: 31/12/2023

Sources of funding

Other

More details on funding

International Society for Pharmacoepidemiology (ISPE)

Study protocol

Initial protocol

DIVERSE_protocol_v1.0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable