Clinical Practice Research Datalink

Presented by Dr Antonis Kousoulis, Head of Business Development

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Medicines DevicesCT Regulator

Biologics Standards & Controls

more dimensionsto data

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Historical Timeline

1987 - First iteration of Primary Care database

1994 - GPRD within DH

1999 - GPRD part of Medicines and Healthcare products Regulatory Agency

(MCA) 2007 - NIHR initiates Research Capability programme pilot

2011 - Plan for Growth launched

2012CPRD launched

Data and Linkage

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Data Sources

GP data

ONS

HES

Air Pollution

Mental health

HSCIC

Cancer

Registries

linkages

Lifetime

Hospital admissions

Registry entries

Hospital outpatient Hospital A&E

Birth DeathGP visits

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Primary Care Data

• ~10% of UK Population• 6.3 million active patients

• 19 million patients overall

>2 billion clinical records

612 Active Practices

• Age and gender structure of CPRDpopulation generally similar to the UK.

• Crude death rates in CPRD population verysimilar to national rates.

• Median proportion of cases with confirmed diagnosis 89%.Campbell et al, 2013; Herrett et al, 2010

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Primary Care Data – in progress

• Expanding coverage (working with RCGP, CRN)

• Data from major IT systems (Vision, EMIS, TPP)

EMISVISIONTPPOther

Research Impact

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CPRD Users

Government

Industry

Academic

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CPRD Publications

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600

800

1000

1200

1400

1600

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2000

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Publ

icati

ons

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acts

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Network of researchers citing

Global

Impact

Interventional Research

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CPRD in Drug Development

Research Early development

Late development

File & Launch

Post-MA

Epidemiology, incidence / prevalence

Drug utilization & prescribing patterns / switching

CT ‘feasibility’ & protocol optimisation

Pharmacovigilance, Pharmacoepidemiology

Current Standard of CareReal World Data

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CPRD in Interventional Research

StudyDesign

Site Recruitment & Management

Data Collection DataAnalysis

Clinical Study Report

Patient Eligibility

Recruitment at Point of Care

Mapping Healthcare

Data to vCRF

Study Variables

SAEReporting

Feasibility Protocol Optimisation

Longitudinal Primary

Care Data

Referrals for PICs

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Augmentation

StudyDesign

Site Recruitment & Management

Data Collection DataAnalysis

Clinical Study Report

Patient Eligibility

Recruitment at Point of Care

Mapping Healthcare

Data to vCRF

Study Variables

SAEReporting

Feasibility Local Approvals

Patient Engagement

Site Support and

Monitoring

Site Recruitment

Follow-up

GP Engagement

Case Study

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Background and Overview I

Sponsor – King’s College London

Study Recruitment – CPRD

‘Evaluating the effectiveness of electronically delivered decision support tools at reducing antibiotic prescribing for respiratory

tract infections’

eCRT – achieved 2% reduction in antibiotic prescribing

REDUCE (eCRT2)• Latest updated content on antibiotics prescribing• Aim to educate GP and Patient• Monthly prescribing reports

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Background and Overview II

Why is the study important?

• Antibiotic drug resistance is a growing problem

• CPRD data has demonstrated a high level of antibiotic prescribing for RTIs that can be managedwithout antibiotics

• Education and training can helpdecrease the overuse ofantibiotics

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Study Design I

• Aim: Educate GPs and patients about antibiotic prescribing• Practices randomised into control and intervention arms (60 – 60)• Intervention will last 12 months• Intervention will be delivered electronically (via DXS Point-of-Care)

Control arm• RTI Patients prescribed antibiotics at discretion of GP (no

difference from SOC)

Intervention arm• RTI Patients prescribed antibiotics at discretion of GP• GP’s decision will be informed by the study interventions

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Study Design II

Interventions

1. Motivational Webinar

- promote utilisation of the decision support tools

- current context of antibiotics prescribing nationally

2. Educational and Decision Support Tools

- summary evidence-based antibiotic prescribing recs

- patient information sheet

- risks of prescribing/not prescribing antibiotics

3. Monthly antibiotic prescribing reports

- total number of RTI consultations

- total number of antibiotic prescriptions for RTIs & others

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Study Design III

Recruitment • Starting Sept 2015• Aim to recruit 120 practices – 60 intervention, 60 control• Practices using Vision with DXS Point-of-Care• Expression of Interest forms with details of the study sent to GPs

and PMs• Consent from GPs• Practices to be informed when intervention is ‘live’• Intervention delivered electronically• RTI read code will trigger decision support tools • All practice staff to be aware of intervention at the practice• Payment - £250 per practice (control and intervention)

- £80 for 30min phone interview when trial closes

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Anticipated Impact and Outcomes

1. Development of multi-component, low-cost interventions to influence GP prescribing and practice

2. Communicate effectiveness of educational decision support tool

intervention to key audiences in order to influence routine clinical

practice in the UK

3. Reduce unnecessary antibiotics prescribing which may reduce future antimicrobial drug resistance

4. Educating GPs and Patients on the potential risks of unnecessary

antibiotics prescribing

Boggon R, Gallagher A, Williams T, van Staa T. Creating a Mother Baby Link and Pregnancy Register for a UK Population. Pharmacoepidemiol Drug Saf. 2011;20:S44. Boggon R, van Staa TP, Chapman M, Gallagher AM, Hammad TA, Richards MA. Cancer recording and mortality in the General Practice Research Database and linked

cancer registries. Pharmacoepidemiol Drug Saf. 2013;22(2):168-75.Campbell J, Dedman DJ, Eaton SC, Gallagher AM, Williams TJ. Is the CPRD GOLD Population Comparable to the U.K. Population? Pharmacoepidemiol Drug Saf.

2013;22(s1):280.Chen YC, Wu JC, Haschler I, Majeed A, Chen TJ, Wetter T. Academic impact of a public electronic health database: bibliometric analysis of studies using the general

practice research database. PLoS One. 2011;6(6):e21404.Dregan A, Moller H, Murray-Thomas T, Gulliford MC. Validity of cancer diagnosis in a primary care database compared with linked cancer registrations in England.

Population-based cohort study. Cancer Epidemiol. 2012;36(5):425-9.Dregan A, van Staa TP, McDermott L, McCann G, Ashworth M, Charlton J, Wolfe CD, Rudd A, Yardley L, Gulliford MC. Point-of-Care Cluster Randomized Trial in Stroke

Secondary Prevention Using Electronic Health Records. Stroke. 2014 Jul;45(7):2066-2071.Eaton S, Setakis E, Williams TW, van Staa TP. Linking Primary Care Data (UK GPRD) to Hospital Records (HES). Pharmacoepidemiol Drug Saf. 2010;19:S195.Gallagher AM, Puri S, van Staa TP. Linkage of the General Practice Research Database (GPRD) with Other Data Sources. Pharmacoepidemiol Drug Saf. 2011;20:S230.Gulliford MC, van Staa TP, McDermott L, McCann G, Charlton J, Dregan A; eCRT Research Team. Cluster randomized trials utilizing primary care electronic health records:

methodological issues in design, conduct, and analysis (eCRT Study). Trials. 2014 Jun 11;15(1):220.Herrett E, Thomas SL, Schoonen WM, Smeeth L, Hall AJ. Validation and validity of diagnoses in the General Practice Research Database: a systematic review. Br J Clin

Pharmacol. 2010;69(1):4-14.Herrett E, Shah AD, Boggon R, Denaxas S, Smeeth L, van Staa T, Timmis A, Hemingway H. Completeness and diagnostic validity of recording acute myocardial infarction

events in primary care, hospital care, disease registry, and national mortality records: cohort study. BMJ. 2013;346:f2350.Kousoulis AA, Rafi I, de Lusignan S. The CPRD and the RCGP: building on research success by enhancing benefits for patients and practices. Br J Gen Pract. 2015

Feb;65(631):54-5.O'Meara H, Carr DF, Evely J, Hobbs M, McCann G, van Staa T, Pirmohamed M. Electronic Health Records For Biological Sample Collection: Feasibility Study Of Statin-

Induced Myopathy Using The Clinical Practice Research Datalink. Br J Clin Pharmacol. 2013 Oct 28. [Epub ahead of print]Puri S, Williams T, Eaton S. Defining a Denominator Population for Linked Datasets. Pharmacoepidemiol Drug Saf. 2013;22(s1):229.Setakis E, Gallagher A, Williams TW, van Staa TP. Linking UK Death Certificate Data to UK Primary Care Data (GPRD) To Obtain Cause of Death. Pharmacoepidemiol

Drug Saf. 2010;19:S83.Tate RA, Beloff N, Al-Radwan B, Wickson J, Puri S, Williams T, Van Staa T, Bleach A. Exploiting the potential of large databases of electronic health records for research

using rapid search algorithms and an intuitive query interface. J Am Med Inform Assoc. 22 Nov 2013 [Epub ahead of print].Staa TP, Goldacre B, Gulliford M, Cassell J, Pirmohamed M, Taweel A, Delaney B, Smeeth L. Pragmatic randomised trials using routine electronic health records: putting

them to the test. BMJ. 2012 Feb 7;344:e55.van Staa TP et al. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two

exemplar trials. Health Technol Assess. 2014 Jul;18(43):1-146.