Use, risk-benefits, and costs of preventive therapies in older people with complex health needs: an analysis of NHS routinely collected data

Study type
Protocol
Date of Approval
Study reference ID
19_132
Lay Summary

BACKGROUND: As the UK population ages, the NHS is prescribing more long-term treatments to prevent fractures and heart attacks. We don't know whether these are helpful and safe in older patients with complex health needs.

PURPOSE: We will select groups of older people with complex health needs based on their number of hospital contacts, frailty, and number of drugs prescribed. We will study how often they are prescribed drugs to prevent bone fractures and heart attacks, whether they finish their prescriptions, and their risks of side effects. We will also study their risks of fractures or heart attacks if they stop the preventive treatments.

DESIGN/METHODS: We will select patients aged 65 and above with many hospital admissions; frailty; and patients prescribed many drugs. Within each group, we will calculate the risk and benefit of preventive treatments, and how much these treatments cost. We will use hospital admissions data to estimate hospital costs for fractures, cardiovascular disease, and unwanted side effects.

POTENTIAL IMPORTANCE: Our results will inform patients and clinicians on the effects of preventive treatments for patients with complex health needs.

Technical Summary

OBJECTIVES
1. To characterise older patients with complex health needs;
2. To determine their use of preventive therapies, and to study the risk-benefit and costs associated with the use of such therapies amongst them.

METHODS
- Data sources: CPRD GOLD linked to HES-ONS.
- Participants: aged 65+ on 1/1/2009, registered in CPRD for 1+ years (Objective1). Three cohorts: 1.high healthcare resource use, 2.frailty, and 3.polypharmacy (Objective2)
- Exposures: Bisphosphonates, statins, and anti-hypertensives

ANALYSIS:
- Patients' complexity characterised as number of hospital admissions (healthcare resource use), frailty (eFI), and number of different drug prescriptions (polypharmacy)
- Incidence and prevalence of preventive treatments will be estimated in each cohort. Persistence and medication possession ratios will be calculated.
- We will model the risks according to treatment use with survival analyses adjusted using inverse probability weighting.
- We will estimate rates of 'preventable events' and calculate incidence rate ratios for on- vs off-treatment periods using self-controlled case series.
- We will develop a cost model mapping the care and events pathways and populate it to estimate NHS costs associated with continuing vs stopping the preventive therapies.

Health Outcomes to be Measured

ADRs and preventable events: upper gastro-intestinal ulcers, acute kidney injury, liver failure, myopathy, falls, fractures, and cardiovascular events; NHS costs
Additional ADR will be studied depending on feasibility in the identified cohorts, e.g. osteonecrosis of the jaw, atypical femur fracture and rhabdomyolysis.

Collaborators

Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Danielle Robinson - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Gianluca Fabiano - Collaborator - University of Oxford
Ian Koblbauer - Collaborator - University of Oxford
Leena Elhussein - Collaborator - University of Oxford
Lucy Njuki - Collaborator - University of Oxford
Ruth Keogh - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Tetsuro Oda - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Victoria Y Strauss - Collaborator - University of Oxford
Ying HE - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of Oxford

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation