COMBINING ELECTRONIC HEALTH RECORDS AND PATIENT-REPORTED INFORMATION IN THE UK- PRELIMINARY RESULTS FROM WASPS (WALES SAIL + PRO STUDY)

Author(s)

Cascade E1, Ford D2, Nixon M3, Brooks C2, Heaven M21MediGuard.org, Rockville, MD, USA, 2Swansea University, Swansea, United Kingdom, 3Quintiles Global Consulting, Bracknell, Berkshire, United Kingdom

OBJECTIVES: As demand for real-world data increases, the need to adopt more time and cost-efficient research methods will grow.  Direct-to-patient studies (direct patient recruitment without physician sites) are a novel, efficient approach gaining proof in the United States.  This study’s objective was to deploy a direct-to-patient observational study in the UK including both patient-reported and electronic health data. METHODS: In October/November 2011, UK MediGuard.org members with a cholesterol marker in their profile were invited to participate via email; enrollment was supplemented with digital outreach.  Interested individuals clicked a link to access study information and screen based on self-reported diagnosis and willingness to have data linked to the SAIL warehouse.  Study subjects completed an on-line questionnaire and provided identifiers to be used only for data linkage.  The SAIL system’s NHS Trusted Third Party converted study identifiers into pseudo-identifiers allowing the linkage of patient-reported data with electronic health data. RESULTS: A total of 240 enrolled within 6 weeks: 98 from MediGuard and 142 through other digital channels.  NHS matched 226 of 240 (94%) to a pseudo-identifier (69 exactly, 157 with probability>0.9).  A total of 91 of 226 matched (41%) had at least one primary care record in SAIL and nearly all (89 of 91, 98%) had data suggesting a cholesterol problem.  Matching cholesterol test dates (±6months) were located for 66 of 89 (74%, Spearman correlation=0.786, p<0.0001) and there was a high positive correlation of total cholesterol values amongst the 1/3 of patients able to self-report data (n=28, Pearson correlation=0.785, P<0.0001).  Additional analyses exploring markers that predict patient's ability to self-report are underway. CONCLUSIONS: This study demonstrates the feasibility of linking patient reported data with electronic health information.  UK individuals are interested in participating, provide truthful information, and their patient-reported data can be linked to electronic information in the SAIL warehouse in Wales, thus offering new research possibilities.

Conference/Value in Health Info

2012-06, ISPOR 2012, Washington, D.C., USA

Value in Health, Vol. 15, No. 4 (June 2012)

Code

PCV124

Topic

Study Approaches

Disease

Cardiovascular Disorders

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