Developing evidence based optimal testing strategies to monitor long term conditions in primary care

Study type
Protocol
Date of Approval
Study reference ID
21_001671
Lay Summary

The number of blood tests performed in the NHS is increasing. Over half of these blood tests take place in general practice to monitor long-term conditions (LTC). Testing blood can be unnecessary, may cause distress and lead to further tests and treatments that may not be needed. However, not testing may miss things that might be wrong.
Current guidelines on what tests people with LTC should have to monitor their condition are based on expert opinion rather than research evidence.
We want to develop evidence-based testing strategies to monitor people with high blood pressure, diabetes and chronic kidney disease in general practice. This will let patients, doctors and nurses know which are the best tests for these conditions, how often to test patients, and how to use the results. It has the potential to free up resources from general practice, reduce unnecessary testing for patients and improve overall management of LTC.
Our first aim is to find out which tests should be used to monitor LTCs. Our second aim to investigate how often these tests should be used. We will do this by reviewing existing research evidence and analysis of data from GP practices. We will build mathematical models to look at whether tests improve patient outcomes.

Technical Summary

Most patients with long term conditions (LTC) are managed in primary care; regular blood tests assess disease progression, treatment response, complications, and associated diseases. There is no robust evidence to inform recommendations on selection of tests, or test frequency for people with LTC.
The overall objective of this project is to optimise testing to monitor LTC (hypertension, T2DM and CKD) in primary care by developing evidence-based testing strategies (EBTS) and accompanying patient and clinician materials.
Aim 1: Develop evidence-based testing panels for people with LTC. Rapid reviews and clinical practice research datalink (CPRD) analysis to develop evidence-based recommendations on which tests people with LTC should have to monitor their condition. A consensus meeting of advisory panel members of will select tests for inclusion, exclusion or further analysis.
Aim 2: Develop evidence-based recommendations on frequency of monitoring. Combination of rapid review methods, CPRD analysis and cost-effectiveness modelling using a linked evidence approach to determine optimal testing panels and frequency. Value of information analysis to assess value of further research.
This project is part of a larger programme of work in which we will also (1) Explore patient, clinician and commissioner views on testing to monitor people with LTC, and (2) Produce information materials for patients and clinicians to facilitate implementation. This programme of work with feed into a efficient design cluster randomised controlled trial (CRCT) to investigate the clinical and cost-effectiveness of EBTS to monitor LTC with current practice.
This programme of work has the potential to change how LTCs are monitored in primary care, ultimately improving patient outcomes and leading to more efficient use of NHS resources.

Health Outcomes to be Measured

Outcomes to be measured

- Order rates of the most common laboratory tests (including both urine and blood tests) that are ordered in patients with type 2 diabetes, hypertension or chronic kidney disease: Renal Function tests, Liver Function tests, FBC, Lipid Profile, HbA1c, Thyroid Function tests, Glucose, ACR/Microalbumin, Bone Profile, Haematinics, C Reactive protein, and Erythrocyte sedimentation rate.

- Healthcare use: primary care consultations, tests, referrals to out-patient hospital care, and all prescriptions used by individuals diagnosed with the long term condition.

- Patient outcomes: outcomes are the diseases that each test can pick up and their complications. These outcomes will be defined by ICD10 and Read codes.
Renal Function tests and ACR/Microalbumin: CKD and complications from CKD (e.g. acute kidney injury, Hypertension and dyslipidaemia, Cardiovascular disease, end stage renal disease)
Liver Function tests: non-alcoholic fatty liver disease (NAFLD) and complications from NAFLD (e.g. Direct hepatic complications such as liver failure, metabolic complications such as type 2 diabetes)
FBC and Haematinics: Anaemia, Vit B12 deficiency, Folate deficiency, Iron deficiency.
Lipid Profile: dyslipidaemia, and cardiovascular complications, including Coronary heart disease (including angina and myocardial infarction), Stroke, Transient ischaemic attack (TIA), Peripheral arterial disease.
HbA1c and glucose: Type 2 diabetes its complications (including macro and microvascular complications, retinopathy, diabetic food disease, and metabolic complications).
Thyroid Function tests: hyper- and hypothyroidism (including Goiter, Hashimoto’s hyperthyrdodism, Graves’ disease)
Bone Profile: hyper- and hypoparathyroidism, vitamin D deficiency, bone cancer.
General outcomes: all-cause mortality, mortality related to liver disease, cardiovascular disease, and malignancy.

Collaborators

Penny Whiting - Chief Investigator - University of Bristol
Martha Elwenspoek - Corresponding Applicant - University of Bristol
Benedita Deslandes - Collaborator - University of Bristol
Chaoran Hu - Collaborator - University of Bristol
Howard Thom - Collaborator - University of Bristol
Jessica Watson - Collaborator - University of Bristol
Katie Charlwood - Collaborator - University of Bristol
Lewis Buss - Collaborator - University of Bristol
Rachel O'Donnell - Collaborator - University of Bristol
Thomas Harding - Collaborator - University of Bristol
William Hollingworth - Collaborator - University of Bristol

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Pregnancy Register