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19/87 Night-time only bracing for scoliosis

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question: Is night-time only bracing as effective as day and night bracing for prevention of curve progression in adolescent idiopathic scoliosis?

  1. Intervention: Night-time only bracing. To be defined and justified by applicants.
  2. Patient group:  Children, with adolescent idiopathic scoliosis suitable for treatment with a brace.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Any appropriate setting.  
  4. Comparator: Standard care e.g., day and night bracing. To be defined and justified by applicants.
  5. Study design: A pragmatic randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise (including the acceptability to patients and parents) as well as assess adherence and compliance to prescribed dose of bracing. Clear stop/go criteria should be provided to inform progression from pilot to full trial, which should include a demonstration of clear difference in actual duration of brace wear between the groups.  
  6. Important outcomes: Curve progression; avoidance of surgery.
    Other outcomes: Quality of life; patient reported outcome measures; psychological wellbeing; compliance; adherence; pain; quality of sleep; educational attainment.
  7. Minimum duration of follow-up: Follow-up should cover patients from diagnosis until 2 years post skeletal maturity. The HTA programme recognises a period of 5 – 9 years is likely. 
    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:

Spinal bracing is a commonly used treatment for adolescent idiopathic scoliosis. Standard care is to prescribe a brace to be worn all day and night (with a one or two-hour break) until the patient reaches skeletal maturity, in order to prevent curve progression as the child grows. Although there is sufficient evidence demonstrating bracing’s efficacy in preventing curve progression, there is a lack of good quality evidence to determine how long a brace needs to be worn per day. Some studies report that the longer a brace is worn the better the results will be, while some studies suggest that night-time only bracing is an effective treatment. However, few studies have compared night-time only bracing with all day bracing. A common finding across many studies is difficulty ensuring compliance and adherence to the prescribed dose of bracing, making it difficult to obtain and compare discreet groups. For the purpose of this brief, night-time bracing could comprise of braces only being worn during the time spent sleeping or cover the period when patients are not partaking in their daily activities, eg. school, socialising etc. 

Reducing the time spent in a brace could prove beneficial by reducing the level of physical and psychological discomfort experienced by the patients wearing the brace during their daily activities, and could lead to increased adherence.

Although recognising this is a difficult area in which to conduct randomised controlled trials, the HTA programme wishes to commission research to determine whether night-time only bracing is as effective as all day bracing for adolescent idiopathic scoliosis.

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 4th December 2019. Applications will be considered by the HTA Funding Committee at its meeting in January.

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 May.

Applications received after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email: htacommissioning@nihr.ac.uk

Telephone: Commissioning Funding Committee 02380 595510