Introduction
The aim of the 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 preoperative rehabilitation for upper limb surgery (shoulder joint replacement)?
- What is the clinical and cost-effectiveness of early versus delayed shoulder mobilisation post-surgery?
- Intervention: 1) Individualised preoperative rehabilitation (at least two months prior to surgery). 2) First rehabilitation/mobilisation within 24 hours of surgery.
- Patient group: Adults awaiting primary shoulder joint replacement. 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.
- Comparators: 1) No formal preoperative rehabilitation or usual care which does not involve an individualised programme. 2) First rehabilitation/mobilisation after 24 hours of surgery.
- Study design: A randomised controlled trial with an internal pilot phase to test key trial processes, such as recruitment and adherence. Clear stop and go criteria should be provided to inform progression from pilot to full trial. The trial design could encompass 3 stages: Stage 1 to develop the intervention package, Stage 2 to implement the intervention and assess feasibility, and Stage 3tocompleteanRCT. To answer the 2 research questions efficiently the study could employ a factorial design assessing 2 factors (preoperative rehabilitation and early mobilisation), each with 2 levels (intervention and comparator), resulting in 4 groups:
- 1) prehabilitation and early mobilisation,
- 2) prehabilitation and delayed mobilisation,
- 3) no prehabilitation and early mobilisation,
- 4) no prehabilitation and delayed mobilisation.
- Important outcomes: Shoulder function; Pain.
- Other outcomes: Quality of life (for example, EQ-5D, EQ-VAS – applicants to define and justify); PROMs; adverse events; revision of joint replacement (time to event); reoperation including dislocation; deep and superficial surgical site infection; hospital readmissions; length of stay; sleep; health economic measures (direct and indirect costs).
- Existing Core Outcomes: These 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: 12 months. Longer-term follow-up: If appropriate, researchers should consider obtaining consent to allow potential future follow-up through efficient means (such as routine data) as part of a separately funded study.
Rationale:
Shoulder joint replacement surgery is the third most common joint replacement surgery. It is used to reduce pain and movement problems in people with conditions such as osteoarthritis, rheumatoid arthritis, and fractures. NICE guidance NG157 makes a number of research recommendations for shoulder surgery, including the use of preoperative rehabilitation (or prehabilitation) and early mobilisation of the shoulder post-operatively.
There is some evidence to suggest that prehabilitation prior to surgery can have benefits for patient recovery in lower limb surgeries; findings which are thought to be applicable to upper limb surgery. Preoperative rehabilitation can include exercises to do before and after surgery that will aid recovery, advice regarding lifestyle (for example, weight management, diet, and stopping smoking) and maximising functional independence and quality of life. Interventions and advice targeting these health behaviours could enhance patient recovery through clinical outcomes (for example, pain and function), health related quality of life and by reducing the risk of post-operative complications and prolonged rehabilitation needs. Preoperative rehabilitation could also positively impact the NHS by reducing the length of hospital stays and readmission rates.
Research suggests that the sooner the shoulder can be mobilised the sooner formal shoulder rehabilitation can begin, leading to quicker functional recovery. Returning to a more normal functional existence is very important to people who have undergone surgery, and can also positively impact the NHS through reduced length of hospital stays, less need for extended postoperative rehabilitation, and reduced readmissions.
NICE guidance states the need for high quality evidence for preoperative rehabilitation interventions for people listed for shoulder replacement surgery, and early mobilisation of the shoulder post-surgery. The HTA programme therefore wishes to fund a study that will investigate the clinical and cost-effectiveness of preoperative rehabilitation and early mobilisation for shoulder replacement.
To support the ambitions of NIHR’s Best Research for Best Health: the next chapter, we strongly encourage the inclusion of nurses, midwives and allied health professionals within well-developed research teams responding to this call, to increase the building of research activity, capacity and capability across these professions.
Depending on the level of experience, this could be through the role of lead applicant, as joint co-applicant (supported by detailed mentoring plans submitted with the application), or as a co-applicant member of the research team. Through this activity, NIHR aims to support nurses, midwives and allied health professionals to become future research leaders and release the potential to lead, use, deliver and participate in research as a part of their job.
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 would like to apply for this funding opportunity, you can begin your application via the funding opportunity page.
Your application must be submitted online no later than 1pm on 28 March 2024. Applications will be considered by the HTA Funding Committee at its meeting in May 2024.
Guidance notes and supporting information for HTA Programme applications are available.
Shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2024.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).
For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.
Should you have any queries please contact htacommissioning@nihr.ac.uk