Status: Ongoing First registered on: 04/03/2021
Last updated on: 04/03/2021
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 belongsUtrecht University Pharmacoepidemiology Center
Department/Research groupDivision of Pharmacoepidemiology & Clinical Pharmacology
Organisation/affiliationUtrecht Institute for Pharmaceutical Sciences
Website/Homepagewww.uu.nl/pecp
Details of (Primary) lead investigator
Title Dr
Last name Pajouheshnia
First name Romin
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

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

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 report31/12/2021
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 Pajouheshnia
First name Romin
Address line 1Universiteitsweg 99
Address line 2PO Box 80082 
Address line 3 
CityUtrecht 
Postcode3508 TB 
CountryNetherlands
Phone number (incl. country code)31639303591 
Alternative phone number 
Fax number (incl. country code) 
Email address r.pajouheshnia@uu.nl
Public Enquiries
Title Dr 
Last name Pajouheshnia 
First name Romin 
Address line 1Universiteitsweg 99 
Address line 2PO Box 80082 
Address line 3 
CityUtrecht 
Postcode3508 TB 
CountryNetherlands 
Phone number (incl. country code)31639303591 
Alternative phone number 
Fax number (incl. country code) 
Email address r.pajouheshnia@uu.nl 
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