Quality and completeness of primary care recording of hypertension treatment with amlodipine, outcomes, and comorbidities: A feasibility study

Study type
Feasibility Study
Date of Approval
Study reference ID
FS000303
Lay Summary

Precision medicine refers to the tailoring of healthcare treatments to the individual. In patients with hypertension (high blood pressure) the response of an individual patient to treatment is challenging to predict in terms of blood pressure control and treatment side-effects. Precision medicine, through use of devices such as a mobile phone app to record blood pressure and side effects, can provide patients with the ability to optimise their treatment dosage and better control their hypertension.

The objective of this study is to explore the frequency and completeness of data recorded in primary care on patients with hypertension who are treated with a medicine called amlodipine, using the Clinical Practice Research Datalink (CPRD) Aurum database.

The study will investigate dosage instructions, blood pressure recording, prescription of other antihypertensive drugs, side-effects of amlodipine treatment (e.g. swollen ankles and dizziness), co-existing health problems, primary healthcare consultations and patient characteristics, such as age and sex.

The findings of the study will be used to inform further analyses on patient care after diagnosis of hypertension and clinical decision making in its treatment. Future studies may inform the design of products for improving hypertension management using precision medicine, and clinical studies that would assign patients to use these products versus the standard of care to assess how effective they are for hypertension treatment.

Technical Summary

The response of an individual patient to initiating anti-hypertensive medication is challenging to predict and can vary both in terms of blood pressure control and treatment side-effects. Dosage optimisation through precision medicine may provide patients with more flexibility to tailor treatment dosage, and to use devices to manage their own hypertension.

The objective of this study is to explore the frequency and completeness of data recorded in primary care for patients with hypertension managed using amlodipine. The study will use the Clinical Practice Research Datalink (CPRD) Aurum database to generate counts and percentages of the following measures in patients treated with amlodipine in tablet and liquid formulations:

• Dosage instructions for amlodipine
• Blood pressure recording
• Patient demographics, including age, sex, body mass index (BMI) and ethnicity
• Side-effects of treatment (including headaches, dizziness, flushing, heart palpitations, swollen ankles, fatigue)
• Comorbidities prior to amlodipine prescription (coronary heart disease, stroke, congestive heart failure, kidney function, diabetes mellitus, frailty)
• Co-prescription of other anti-hypertensive drugs
• Healthcare professional consultations in primary care

Understanding data quality in real-world primary care databases will support an evaluation of how such data sources can be used in the development and evaluation of precision medicine tools. The results from this feasibility study will inform further observational studies to design products for improving hypertension management using precision medicine, and possible interventional studies to investigate the efficacy of these products against the standard of care.

Health Outcomes to be Measured

We will tabulate counts and percentages for the following, including some cross-tabulations against the demographic variables:

Dosage instructions for amlodipine using the common dosages look-up table;
Blood pressure recording;
Patient demographics (age, sex, weight, BMI, ethnicity);
Treatment side-effects (headaches, dizziness, flushing, heart palpitations, swollen ankles, fatigue);
Comorbidities prior to amlodipine prescription (frailty, coronary heart disease, stroke, congestive heart failure, kidney function (measured by eGFR), diabetes mellitus);
Co-prescription of other anti-hypertensive drugs;
Primary healthcare professional consultations.

Collaborators

Helen Booth - Chief Investigator - CPRD
Helen Booth - Corresponding Applicant - CPRD
Bob Powell - Collaborator - University of North Carolina at Chapel Hill
Bruce Campbell - Collaborator - Closed Loop Medicine
Chisomo Mutafya - Collaborator - CPRD
Michael CAtt - Collaborator - Closed Loop Medicine
Paul Goldsmith - Collaborator - Closed Loop Medicine
Rachael Williams - Collaborator - CPRD
Suhail Shiekh - Collaborator - CPRD