View Study

Status: Ongoing First registered on: 04/03/2021

Last updated on: 20/10/2022

1. Study identification

EU PAS Register NumberEUPAS39757

Official titleData source heterogeneity in multi-database pharmacoepidemiologic studies: a scoping review

Study title acronymDIVERSE

Study typeOther: Scoping review

Brief description of the studyMulti-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).

Was this study requested by a regulator?No

Is the study required by a Risk Management Plan (RMP)? Not applicable

Regulatory procedure number (RMP Category 1 and 2 studies only)

Other study registration identification numbers and URLs as applicable

2. Research centres and Investigator details

Coordinating study entity

Centre to which the investigator belongsARS

Department/Research groupOsservatorio di Epidemiologia

Organisation/affiliationAgenzia regionale di sanità della Toscana (ARS)

Website/Homepagehttp://www.ars.toscana.it/it/

Details of (Primary) lead investigator

Title Dr

Last name Gini

First name Rosa

Is this study being carried out with the collaboration of a research network?

Other centres where this study is being conducted

Multiple centres

In total how many centres are involved in this Study?2

Utrecht University Pharmacoepidemiology Center

ARS

Countries in which this study is being conducted

International study

Italy

Netherlands

United Kingdom (Northern Ireland)

3. Study timelines: initial administrative steps, progress reports and final report

PlannedActual

Date when funding contract was signed24/12/202024/12/2020

Start date of data collection01/01/202101/01/2021

Start date of data analysis

Date of interim report, if expected

Date of final study report31/12/2023

4. Sources of funding

Please provide estimates of the percentage of funding by source for this study

Names(s)Approximate % funding

Pharmaceutical companies

Charities

Government body

Research councils

EU funding scheme

OtherInternational Society for Pharmacoepidemiology (ISPE)100

5. Contact details for enquiries

Scientific Enquiries

Title Dr

Last name Gini

First name Rosa

Address line 1Via Pietro Dazzi 1

Address line 250141

Address line 3

CityFlorence

Postcode50141

CountryItaly

Phone number (incl. country code)39-0554624341

Alternative phone number

Fax number (incl. country code)

Email address rosa.gini@ars.toscana.it

Public Enquiries

Title Dr

Last name Gini

First name Rosa

Address line 1Via Pietro Dazzi 1

Address line 250141

Address line 3

CityFlorence

Postcode50141

CountryItaly

Phone number (incl. country code)39-0554624341

Alternative phone number

Fax number (incl. country code)

Email address rosa.gini@ars.toscana.it

11. Scope of the study

What is the scope of the study?

Methodology

Primary scope : Methodology

12. Main objective(s)

What is the main objective of the study?

To list and summarize existing tools and recommendations for the collection and reporting of heterogeneity in data sources used in MDS, in particular listing and classifying existing descriptors of such heterogeneity. A secondary objective is to describe how heterogeneity is leveraged to improve the quality of the evidence generated in a MDS and to assist its interpretation.

Are there primary outcomes?No

Are there secondary outcomes?No

13. Study design

What is the design of the study?

scoping review

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

Articles will be identified through searches in PubMed and Embase and by expert knowledge of relevant literature. The sensitivity of the search will be validated against a set of relevant papers identified by experts in the working group. Articles will be screened on title and abstract in duplicate using a standard screening tool and will be included if they contain recommendations or guidelines for the collection and reporting of (heterogeneity of) data sources, report tools to describe data sources or provide descriptions of multiple data sources within a network. Information will be collected from the selected articles using a data extraction tool, applied in duplicated by two independent researchers. Extracted information will be analysed in accordance with recommendations in the JBI Manual for Evidence Synthesis, and will follow the Arksey and O’Malley framework for collating and summarizing results in a narrative review. Counts of different types of articles will be provided.