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19/125 Cardiac rehabilitation for stable angina

 

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:

What is the clinical and cost-effectiveness of cardiac rehabilitation for patients diagnosed with stable angina?

  1. Intervention: Cardiac rehabilitation in addition to usual care (applicants should define and justify their choice of rehabilitation regimen, which should be suitable for delivery across the NHS). 
  2. Patients: Patients who have been diagnosed with stable angina (applicants should define and justify their diagnostic criteria).
    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 suitable setting accessible from the community (applicants to specify and justify). 
  4. Control: Usual care (applicants should specify usual care and explain how variation in practice will be managed).
  5. Study design: A pragmatic randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. Clear stop/go criteria should be provided to inform progression from pilot to full trial. 
  6. Important outcomes: Applicants should define outcome measures that are likely to inform/change clinical practice.  
    Other outcomes: Patient confidence in exercising; appropriate occupational and mental health outcomes; cost-effectiveness; patient experience of the intervention; facilitators and barriers of rehabilitation uptake and completion. Applicants may wish to consider the time between diagnosis and start of cardiac rehabilitation, and whether this would affect patient outcomes.
    Applicants should consider the standardised outcome measurements for patients with coronary artery disease agreed by the International Consortium Health Outcomes Measurement.
  7. 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 the longer-term clinical and cost-effectiveness of cardiac rehabilitation.

Rationale:

Angina is defined as pain (or constricting discomfort) in the chest, in the neck, shoulders, jaw, or arms, caused by an insufficient blood supply to the heart. 'Stable' angina usually occurs with physical exertion or emotional stress. It lasts for no more than 10 minutes and is relieved within minutes of rest, as well as oral medication (nitroglycerine). The condition is common and affects a significant proportion of the adult population in the UK. Angina symptoms can cause severe limitations in daily life and activities, and they are a frequent cause of premature retirement.

Patients with stable angina are advised to manage any lifestyle-associated risks and to improve their health behaviours in order to control their condition and to reduce the risk of major cardiac events, such as heart attacks.

Cardiac rehabilitation programmes aim to support people with heart disease in their understanding of their condition, in developing, regaining and maintaining physical and mental health, and in improving their quality of life. In the UK, cardiac rehabilitation is already prescribed to people who have had a heart attack or heart surgery, based on strong evidence of benefit from high quality research. However, there is insufficient evidence of the effects of cardiac rehabilitation in people with stable angina, even though experts suggest these patients might benefit from the intervention. NICE, in their latest surveillance report of clinical guideline CG126 (stable angina), confirmed an ongoing lack of evidence and is recommending further research in this area. A more recent Cochrane review (Long 2018) identified some low-quality evidence of potential benefit, but remains unable to draw reliable conclusions.

The HTA programme therefore wishes to commission a study to explore the clinical and cost-effectiveness of cardiac rehabilitation in patients with stable angina, in order to inform clinical practice and future guidance. The patient group should therefore be as inclusive as possible. Consideration may also be given to appropriate subgroup analysis to determine which groups might benefit the most from the intervention, provided this is fully justified within the application.

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 1st April 2020. Applications will be considered by the HTA Funding Committee at its meeting in May 2020.

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 September 2020.

Applications received electronically 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