Occupational therapist-led versus rheumatologist-led care in people with hand osteoarthritis in Norway: an open-label, multicentre, randomised controlled, non-inferiority trial.

Background: Hand osteoarthritis is a common musculoskeletal disease with a rising prevalence due to increased life expectancy. Because the disease is diagnosed on the basis of clinical examination and the first choice of treatment is non-pharmacological, it is not a high-risk condition. We aimed to assess the non-inferiority and cost-effectiveness of occupational therapist-led care for hand osteoarthritis compared with rheumatologist-led care.

Methods: We did an open-label, multicentre, randomised controlled, non-inferiority trial at two hospitals in Norway. Participants with hand osteoarthritis aged 18 years or older were randomly assigned 1:1, stratified by centre, using a computed-generated randomisation list, to receive either standard rheumatologist-led care or occupational therapist-led care. The primary outcome was response to treatment at 6 months according to the OMERACT-OARSI criteria. Non-inferiority was tested in the intention-to-treat population using a response rate difference of 15% as a non-inferiority margin. A cost-utility analysis from the Norwegian health-care system perspective was done to assess the economic effect of occupational therapist-led care. Two patient research partners with first-hand experience of hand osteoarthritis were included in the project team from the outset and contributed to study design, development of research questions, and strategies for optimising the recruitment process. This trial was preregistered with ClinicalTrials.gov (NCT03102788) and is closed for recruitment.

Findings: Between Sept 19, 2017, and Nov 11, 2020, 374 patients were randomly assigned; 186 to rheumatologist-led care and 188 to occupational therapist-led care. Mean age was 63·6 year (SD 10·0), 302 (80·7%) of 374 participants were women and 72 (19·3%) were men. At 6 months, 48 (28·4%) of 169 participants in the rheumatologist-led group and 48 (28·6%) of 168 participants in the occupational therapist-led group were responders according to the OMERACT-OARSI criteria. Occupational therapist-led care was non-inferior to rheumatologist-led care (OR 1·01, 95% CI 0·63-1·62). Economic analysis showed that occupational therapist-led care was cost-effective up to a willingness to pay per quality-adjusted life-year of £23 255. No severe adverse events were recorded.

Interpretation: Occupational therapist-led care for hand osteoarthritis is non-inferior to rheumatologist-led care in terms of efficacy and safety. The economic evaluation indicates that occupational therapist-led care could offer a cost-saving approach with similar health outcomes, supporting the feasibility of task shifting to allied health professionals in the management of chronic conditions such as hand osteoarthritis. This approach aligns with global health-care recommendations to optimise resource use without compromising care quality.

Funding: The Norwegian Research Council, the Norwegian Rheumatism Association.