Status: Finalised First registered on: 05/07/2016
Last updated on: 20/08/2019
1. Study identification
EU PAS Register NumberEUPAS13959
Official titleCOMPARABILITY OF POPULATION DEFINITIONS WITHIN & BETWEEN GLOBAL DATABASES – DEVELOPING TOOLS FOR OBSERVATIONAL RESEARCH
Study title acronymACO Population Definitions
Study typeObservational study
Brief description of the studyThis initial phase—the focus of this study—intends to compare prevalence and agreement rates for the different ACO definitions between different national and international databases. As such, simple ACO definitions will be used to ensure they can be operationalized across a number of databases. As each database used will be specific to a patient population and (in most cases) to one country of origin, use of multiple databases affords a unique opportunity to examine the sensitivity of findings to how populations were included in different databases. Future phases of the REG ACO Working Group’s research programme will go on to characterize the different ACO populations from a clinical perspective (cross sectionally and historically) and to explore potential differential treatment outcomes associated with the different definitions. It is expected to be considerable variation in characterization approaches in the follow-on clinical characterisation and outcome evaluation phases (owing to differences in available variables and the requirement to use a range of proxy measures in order to optimise approaches within each database). As such, this work will be treated as a separate second study phase
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 belongsOPRI Pte Ltd
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.rirl.org
Details of (Primary) lead investigator
Title Dr
Last name Krishnan
First name Jerry
Is this study being carried out with the collaboration of a research network?
Yes

Respiratory Effectiveness Group (REG)
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7
University of Groningen, Netherlands
University Hospital Vall d'Hebron, Spain
Adelphi Real World, UK
Primary Care Majorca Department, Spain
OPCRD, UK
Countries in which this study is being conducted
International study

Korea, Democratic People's Republic of
Netherlands
Poland
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/08/201631/08/2016
Start date of data collection31/10/201631/10/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report31/08/201731/08/2018
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
OtherREG100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Krishnan
First name Jerry
Address line 1University of Illinois Hospital and Health Sciences System
Address line 2 
Address line 3 
CityChicago 
Postcode 
CountryUnited States
Phone number (incl. country code)4401223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address enquiries@regresearchnetwork.org
Public Enquiries
Title Dr 
Last name Krishnan 
First name Jerry 
Address line 1University of Illinois Hospital and Health Sciences System 
Address line 2 
Address line 3 
CityChicago 
Postcode 
CountryUnited States 
Phone number (incl. country code)4401223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address enquiries@regresearchnetwork.org 
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