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21/28 Maintenance therapy for lichen sclerosus commissioning brief

 

Contents

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 reactive treatment compared to proactive treatment for patients with lichen sclerosus who do not have any symptoms and/or signs of disease activity?

  • Intervention: Reactive treatment of symptom flares. 
  • Patient group: People diagnosed with lichen sclerosus, (applicants should specify and justify their choice of patient group(s), which may include patients of any age and gender).
    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: Primary care, and secondary care settings if appropriate (applicants to specify and justify). 
  • Comparator: Proactive maintenance therapy (to be specified by applicants).   
  • 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: Number of flares; quality of life.
    Other outcomes: Sexual function; urinary function; progression of disease (e.g. scarring); time to recurrence; adverse effects; healthcare utilisation; cost-effectiveness; patient preferences and acceptability of regimens to patients and clinicians.
    Where established Core Outcomes exist, they should be included amongst the list of outcomes unless there is good reason to do otherwise. 
  • Minimum duration of follow-up: 12 months.
    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, e.g. to investigate malignancy rates and other long-term effects in relation to maintenance regimens.

Rationale

Lichen sclerosus (LS) is a chronic inflammatory skin condition. It may affect any part of the skin, but most often involves the genital skin and the skin around the anus. Although LS occurs mainly in women, men and children can also develop the condition. Symptoms include intense itching, pain and splitting of the skin. There is a risk of long-term complications, such as loss of normal anatomy from scarring, which can interfere with urination, bowel motions, and sexual function. In addition, people with LS are at increased risk of developing pre-cancerous conditions or genital cancer.

Current usual treatment consists of an induction course of topical steroids, usually over a three-month period, followed by proactive maintenance therapy (e.g. twice-weekly topical steroid application, using the lowest potency topical steroid that maintains remission, in order to avoid or delay malignancy.

However, there is a paucity of evidence from research to inform clinical practice. Guidelines, such as the British Association of Dermatologists guidelines for the management of lichen sclerosus (BAD 2018), are to a large extent based on expert consensus, especially with regards to long-term maintenance regimens.

The recent James Lind Alliance Priority Setting Partnership (JLA PSP) on lichen sclerosus identified a need to establish whether long-term, proactive maintenance therapy is required when there are no symptoms or signs of disease activity. Similarly, the authors of the BAD LS guideline identified a need for research in this disease area, suggesting the questions generated by the JLA PSP could guide the research agenda.

The HTA programme therefore wishes to fund the study outlined above to meet the research needs identified by patients and clinicians, and to inform future clinical guidance.

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 INVOLVE 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 on-line no later than 1pm on the 28 July 2021. Applications will be considered by the HTA Funding Committee at its meeting in September 2021.

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 2022.

Applications received electronically after 1300 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 at htacommissioning@nihr.ac.uk.