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
In people with gout, including people with gout and chronic kidney disease (CKD), what is the clinical and cost effectiveness of colchicine, NSAIDs compared with corticosteroids for managing gout flares?
- Intervention: NSAIDs or Oral corticosteroid. Choice of specific corticosteroid, duration and dose to be defined and justified by applicants, who may consider whether to consider where the appropriate use of proton pump inhibitors be offered for this patient group.
- Patient group: Adults with a gout flare, where there are relative contraindications, due to factors such as comorbidities or age, (exclusion criteria, such as renal impairment, co-occurring conditions to be defined and justified by applicants).
- Setting: Primary care.
- Comparator: Colchicine. Duration and dose to be defined and justified by applicants. Any ongoing urate-lowering therapy for chronic gout should be continued during the flare in both arms.
- Study design: Pragmatic randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. Clear stop and go criteria should be provided to inform progression from pilot to full trial.
- Important outcomes: Pain. Other outcomes: Time to resolution of pain; adverse effects; time to resolution of joint swelling and tenderness; physical function; quality of life; cost, including healthcare utilisation.
- Minimum duration of follow-up: To be defined and justified by applicants.
Rationale
Gout is the most common form of inflammatory arthritis. The burden of the disease has risen starkly in the course of the twenty-first century across Europe and particularly in the UK. It is characterised by the accumulation of urate crystals in one or more joints, most frequently in the big toe. Accordingly, chronic gout is treated with urate-lowering medication. However, until the levels of urate are sufficiently brought down, patients experience sudden flares of excruciating and debilitating pain in the affected joint(s), which become inflamed. This research brief is concerned with these acute manifestations of gout.
According to current guidance, gout flares require rapid analgesic and anti-inflammatory treatment. However, it is a widely stated belief that earlier initiation of treatment increases its effectiveness and the main justification for early initiation is to attempt to abort flares before they reach maximal pain intensity. In the UK, this is most likely to be one of the non-steroidal anti-inflammatory drugs (‘NSAIDs’, for example naproxen) which have proven effective in combatting gout-related inflammation and providing relief from pain. However, a significant proportion of the gout patient population is unable to take NSAIDs due to other medical conditions. The alternative options currently used in the NHS for the rapid treatment are colchicine tablets and oral corticosteroids, with intramuscular and intra- articular steroids generally reserved for second-line interventions. There is uncertainty as to which of medications is more effective and better tolerated.
The HTA programme intends to finance research that will enable medical practitioners and patients to make an informed choice about the acute gout treatment that is best for them.
To support the ambitions of NIHR’s Best Research for Best Health: the next chapter, NIHR strongly encourages the inclusion of nurses, midwives and allied health professionals within well-developed research teams responding to this call, to increase the building of nurse, midwife and allied health professional-related research activity, capacity and capability across the 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
Your application must be submitted online no later than 1pm on 26 July 2023. Applications will be considered by the HTA Funding Committee at its meeting in September.
HTA Programme Stage 1 guidance notes are available, alongside supporting information for applicants.
Please note that 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 January 2024.
Applications received electronically after 1pm 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, 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. 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 htacommissioning@nihr.ac.uk.