Clinical Practice Research Datalink Presented by Dr Antonis Kousoulis, Head of Business Development.
-
Upload
marian-burns -
Category
Documents
-
view
216 -
download
2
Transcript of Clinical Practice Research Datalink Presented by Dr Antonis Kousoulis, Head of Business Development.
Clinical Practice Research Datalink
Presented by Dr Antonis Kousoulis, Head of Business Development
2
Medicines DevicesCT Regulator
Biologics Standards & Controls
more dimensionsto data
3
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
5
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
6
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
7
Primary Care Data – in progress
• Expanding coverage (working with RCGP, CRN)
• Data from major IT systems (Vision, EMIS, TPP)
EMISVISIONTPPOther
Research Impact
9
10
CPRD Users
Government
Industry
Academic
11
CPRD Publications
0
200
400
600
800
1000
1200
1400
1600
1800
2000
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Publ
icati
ons
& A
bstr
acts
12
Network of researchers citing
Global
Impact
Interventional Research
14
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
15
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
16
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
18
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
19
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
20
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
21
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
22
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
23
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.