Burden of Disease and Treatment Patterns for Patients with Hip and Knee Osteoarthritis in the United Kingdom

Study type
Protocol
Date of Approval
Study reference ID
20_000273
Lay Summary

Osteoarthritis is a painful disease of the knees, hips and other joints in the body. About 10% of UK adults have osteoarthritis, which often gets worse over time. We don’t yet know how to stop osteoarthritis getting worse. So, we treat it by replacing the affected joint or by using medicines to reduce pain. There is not a lot of published information available to help understand the economic impacts to healthcare systems that osteoarthritis may have.
In order to develop effective approach for better prevention, diagnosis and management of osteoarthritis, it is crucial to have a stronger understanding the characteristics of those with the disease, the impact it has on patients with osteoarthritis, and the rate of the disease. To help fill aforementioned gaps, this study aims to assess (1) the characteristics of adults in the England who are more likely to be diagnosed with osteoarthritis, (2) the number of adults in the England affected by the disease, (3) how patients with osteoarthritis are treated, and (4) the impact of the disease for the English healthcare system in terms of increased resource use and costs. All the data will be coded. This means no-one can identify any of the patients in the study.

Technical Summary

Osteoarthritis (OA) is a degenerative joint disease affecting the cartilage and surrounding tissues. In the United Kingdom (UK), approximately 10% of adults have symptomatic and clinically diagnosed OA, with knee OA being the most common. There are no current treatments available to stop or slow OA progression, hence pharmacological management of OA patients focuses on symptom management (i.e. analgesics for pain), with minimal impact on the underlying disease. Published data on estimated direct and indirect costs of OA in the UK are limited, suggesting that more research into this area is imperative to understand burden of OA in the UK
This descriptive study will identify patients with hip/knee OA among adults (≥ 18 years) and estimate the annual incidence of hip/knee OA in the general population of England, from 2015 to 2019. The point prevalence (1 January 2019) will also be estimated. Prevalent patients will be defined as those with a diagnosis of hip/knee OA in their medical record anytime until 31 December 2019 (inclusive). Among prevalent patients, resource use in the primary and secondary care setting will be described using summary statistics, counts and proportions, as appropriate. In addition, associated costs will also be estimated. Treatment patterns will also be examined among prevalent patients, focusing on the drug classes patients receive. The analyses will be repeated for patients identified as having moderate-to-severe OA based on receipt of pharmacotherapy. Findings of this study could be valuable in understanding treatment patterns and outcomes among this population.

Health Outcomes to be Measured

Baseline characteristics: demographics (i.e age at index, sex, ethnicity, IMD); clinical characteristics (i.e comorbidities)
Medication Use and treatment patterns: the study will consider the following pharmacological treatments as described in the NICE British National Formulary (BNF): Treatment summary for osteoarthritis and soft tissue disorders (Reference 1): (Analgesics, NSAIDs, Cox 2 Inhibitors, Weak Opioids, Strong Opioids, Corticosteroids, Viscosupplements and Tricyclic antidepressants).
Resource utilisation: inpatient visits; outpatient visits; primary care visits (GP and nurse visit); length of hospital stays. These will be presented as all-cause and OA-related.
Direct costs: This will be an exploratory outcome. Direct costs for GP, nurse and specialists visits, hospitalisations will be explored. These will be presented as all-cause and OA-related. Only OA-related surgery will be presented.

Collaborators

Javier Cid - Chief Investigator - Evidera Ltd - UK
Alison Booth - Corresponding Applicant - Evidera, Inc
Mickael Hiligsmann - Collaborator - Maastricht University
Mireia Raluy Callado - Collaborator - Evidera, Inc
Noami Berfeld - Collaborator - Evidera, Inc
Philip Conaghan - Collaborator - University of Leeds
Ravi Iyer - Collaborator - Teva Pharmaceuticals Ltd
Robert Donaldson - Collaborator - Evidera Ltd - UK
Sangtaeck Lim - Collaborator - Teva Pharmaceuticals Ltd
Tahir Saleem - Collaborator - Teva Pharmaceuticals Ltd

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation