Introduction
The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Research question
What is the clinical and cost-effectiveness of surgical and non-surgical interventions for basal thumb osteoarthritis?
- Intervention: Surgical treatment (e.g Trapeziectomy, Carpometacarpal joint (CMCJ) replacement). Applicants to define and justify type(s) of surgery.
- Patient/target group: Adults with symptomatic basal thumb osteoarthritis who are candidates for surgical intervention.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. - Setting: Secondary care.
- Control: Conservative or non-surgical treatment (applicants to define and justify). Participants in the control arm may subsequently have surgical treatment if needed.
- Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
- Important outcomes: Pain (using a validated PROM for basal thumb osteoarthritis such as AusCan Score) at an appropriate timepoint post-treatment (applicants to define and justify, e.g., 6 or 12 months).
- Other outcomes: Long-term pain; functional outcomes (e.g., grip strength, key pinch and span, range of thumb movement, Kapandji score PEM score); quality of life measures (e.g.EQ-5D); patient acceptability; cost effectiveness. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant).
- Minimum duration of follow-up: Applicants to define and justify follow-up (long-term follow-up is likely to be particularly key for surgical treatments).
- Longer-term follow up: Researchers should obtain consent to allow for future follow up through efficient means (such as routine data) as part of a separately funded study e.g. to measure long-term pain.
Rationale
Basal thumb osteoarthritis (OA) is the degenerative change of the first carpometacarpal joint between the metacarpal and trapezium bones. Symptoms of basal thumb OA include pain, tenderness, and stiffness, and can negatively impact many activities of daily living and quality of life.
There are a variety of non-surgical and surgical treatments available for basal thumb OA. Non-surgical management can involve analgesic and/or anti-inflammatory medicines, splints, steroid injections and physiotherapy. If these conservative treatments fail, then surgical options such as trapeziectomy (the current gold standard treatment) and carpometacarpal joint (CMCJ) replacement (a less frequently used treatment with emerging evidence suggesting that it could improve patient outcomes and reduce recovery time) can be offered. Trapeziectomy involves the removal of the trapezium bone from the hand, while CMCJ replacement involves the replacement of the carpometacarpal joint with a prosthesis.
There is a lack of high-quality evidence comparing surgical and non-surgical treatments and therefore a need for robust clinical trials to determine the best treatments for patients and to help guide UK clinical practice. The HTA programme particularly wants to commission a study comparing the cost effectiveness of surgical versus non-surgical treatment. However, if applicants are additionally able to compare different surgical techniques with a single study, then the Programme would welcome these applications
This topic has been highlighted as a research priority by both the Royal College of Surgeons (RCS) and a James Lind Alliance priority setting partnership exercise with the British Society for Surgery of the Hand (BSSH) for common hand conditions. The HTA Programme therefore wishes to commission the trial outlined above.
Applications should be co-produced, demonstrating an equal partnership with service commissioners, providers and service users (or their advocates) in order to provide evidence and actionable findings of immediate utility to decision-makers and service users. Applicants may wish to consult the NIHR Learning for Involvement guidance on co-producing research.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.
Making an application
If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted online no later than 1pm on the 27 July 2022. Applications will be considered by the HTA Funding Committee at its meeting in September 2022.
Guidance notes and supporting information for HTA Programme applications are available.
Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in January 2023.
Applications received electronically after 13:00 hours on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.
For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk