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21/21 Percutaneous thermal ablation for benign thyroid nodules 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 percutaneous thermal ablation for benign thyroid nodules?

  • Intervention: Percutaneous thermal ablation. 
  • Patient group: Patients with symptomatic benign thyroid nodules (to be defined and justified by applicants).
    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: Hospital.
  • Comparator: Open surgery.
  • 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: Long-term symptom reduction, cost-effectiveness.
  • Other outcomes: Reduction of nodular volume; patient acceptability; adverse events; pain intensity; health-related quality of life; recurrence; need for additional procedures.
    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: >3 years.
  • 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

Growths on the thyroid are common in the general population. The vast majority are benign. Usually they are also asymptomatic and only discovered – if at all – during unrelated medical examinations. However, in some patients, benign thyroid nodules become large enough to cause shortness of breath, swallowing problems, hoarseness and cosmetic embarrassment. They can also cause the thyroid to become over- or under-active (hyperthyroidism and hypothyroidism respectively), with symptoms that might include restlessness, irritability, insomnia, diarrhoea, sensitivity to heat (hyperthyroidism), depression, weight gain, constipation, sensitivity to cold (hypothyroidism), tiredness, muscle fatigue, irregular menstruation and loss of libido (hyper- and hypothyroidism).

Traditionally, symptomatic benign thyroid nodules that require volume reduction of the affected gland or portion thereof have been treated with open surgery. There are signals, however, that less invasive (and possibly less costly) alternatives might be equally effective. There appears to be particular interest in the potential of percutaneous thermal ablation, such as radiofrequency or microwave ablation, in which a thin probe inserted into the affected area transmits extreme heat energy to destroy the tissue that causes symptoms. This is usually performed as an outpatient procedure, under local anaesthetic, but is currently not widely available on the NHS.

Use of such less invasive treatments is important for patients who do not want to have a scar in the neck or be exposed to potential complications of thyroid surgery such as hypoparathyroidism and recurrent laryngeal nerve damage. However, a robust comparative effectiveness evidence base between open surgery and percutaneous ablation is lacking.

In its most recent guideline on managing thyroid disease, the National Institute for Health and Care Excellence (NICE) concluded that more evidence was needed to provide a rationale for the expansion of the availability of percutaneous thermal ablation in the UK. The HTA Programme wishes to fund a study addressing this research need. Applications must demonstrate equal buy-in from surgeons, interventional radiologists and endocrinologists.

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.