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 of adjuvant medication for the treatment of antipsychotic-induced sexual dysfunction?
- Intervention: Adjuvant medication, e.g., aripiprazole, phosphodiesterase-5 inhibitors in addition to usual care. Applicants to define and justify choice of drug and regimen.
- Patient group: Adult men and women who experience antipsychotic-induced sexual dysfunction and for whom reduction in dosage or switching is ineffective or inappropriate. Applicants to define and justify exact inclusion criteria. Consideration should be given to pre-existing or comorbid sexual disorders and to medical illness and other medications which affect sexual function.
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: Any appropriate setting. Applicants to define and justify.
- Control: Placebo plus usual care.
- 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. Well-justified innovative designs will be considered
- Important outcomes: Patient-reported sexual dysfunction; health-related quality of life.
- Other outcomes: Patient acceptability, side effects, mental health outcomes, researcher-rated sexual functioning, service utilisation, cost effectiveness, impact on relationships; medication adherence. 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: 1 year
- Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.
Rationale
Antipsychotics are a first-line treatment for people with psychotic disorders. Psychotic disorders are serious mental illnesses where people typically experience delusions, hallucinations or disordered thinking. They are usually long-term health conditions and, as such, medication is taken for long periods of time or even indefinitely.
While antipsychotics are helpful in reducing the symptoms of psychosis, it is well established that they can also cause significant side effects; one of the most frequently occurring ones is sexual dysfunction. It is estimated to be experienced by between 48-75% of people who are taking antipsychotics. Sexual dysfunction is associated with reduced quality of life, and relationship problems; it can also jeopardise adherence to medication.
It is suggested that clinicians may underestimate the presence and importance of sexual dysfunction and, indeed, it may not be considered as a priority from their perspective. However, when patients are asked directly about sexual dysfunction, they rank it as a relevant problem. The topic was identified as the fourth highest priority in the JLA Schizophrenia PSP.
The HTA Programme has previously recognised the importance of this area and funded research investigating whether switching antipsychotics is an effective approach. This study (REMEDY) closed early due to challenges with recruitment for reasons including: (a) the reluctance of clinicians and patients to switch antipsychotics if the current one(s) was working well to reduce symptoms of psychosis and (b) staff members finding it difficult to talk to their patients about sex.
The uncertainty of how to treat antipsychotic-induced sexual dysfunction remains and the HTA Programme continues to recognise the importance of the topic. A different strategy that is sometimes used in UK clinical practice is adding an additional medication. There is some evidence to suggest that the addition of an antipsychotic, such as aripiprazole, can improve sexual functioning but this evidence is not sufficiently robust to inform clinician and patient decision-making.
The HTA Programme is now interested in building on the REMEDY study and commissioning research to evaluate the effectiveness of this strategy in treating antipsychotic-induced sexual dysfunction and to resolve this treatment uncertainty. We will expect applicants to propose a feasible pathway for recruitment to this study. Applicants may wish to look at the work from the REMEDY study that might inform this. The HTA Programme would welcome a SWAT study to examine aspects of this within the internal pilot.
Co-production, which ensures that the research demonstrates an equal partnership with service commissioners, providers and service users (or their advocates), should be embedded throughout the life cycle of the project from application to completion. 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 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 by clicking the links.
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 e.g. 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