Objective testing of non-adherence to cardiovascular medications
Research type
Research Study
Full title
The diagnostic application of high performance liquid chromatography–mass spectrometry (HPLC-MS/MS)-based urine analysis in non-adherence to cardiovascular medications
IRAS ID
214704
Contact name
Pankaj Gupta
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Patients often do not take their medications (non-adherence). Non-adherence to prescribed cardiovascular medications although thought to be pandemic, is poorly addressed. This is because tools to diagnose non-adherence until recently lacked objectivity and were not clinically useful. We, in the Department of Metabolic Medicine and Chemical Pathology (DMMCP) University Hospitals of Leicester NHS Trust (UHL) in 2011, developed a unique objective test to detect non-adherence in urine using high performance liquid chromatography–tandem mass spectrometry (HPLC-MS/MS). We demonstrated a 25% non-adherence rate to antihypertensive medications in patients attending the Hypertension Clinic, UHL. Since then, the popularity of the test has grown and it is being used on a case by case basis in some clinics in UHL. DMMCP also receives samples for non-adherence testing from around 20 NHS Hospitals across the UK. It has become clear that the test needs to be properly validated into routine use. We plan a retrospective review of available data (n~1500) auditing how it has performed so far. We will analyse only existing information of samples received for non-adherence testing in the DMMCP laboratory both from clinics in UHL and from other UK centres.
We also, for the first time, aim to assess non adherence across the range of cardiovascular conditions. in this prospective study,surplus of a urine sample provided by two cohorts of patients (500 each) with cardiovascular conditions during their routine clinical attendance (acute care and outpatients) will be analysed for adherence (only after routine analysis is complete). The results will not be sent back to the patients' clinical team. Data will be code linked and researchers will not have access to any patient data.
These ground breaking studies will for the first time provide objective data on the extent of non-adherence in cardiovascular conditions, help design intervention trials and inform health economy studies.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
17/EM/0027
Date of REC Opinion
19 Jan 2017
REC opinion
Favourable Opinion