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 effectiveness of amiodarone versus beta blockade for new onset atrial fibrillation in adult intensive care patients?
- Interventions: Amiodarone. Applicants to define dosage and treatment regimen.
- Patient group: Adults admitted to intensive care who experience new onset atrial fibrillation (AF; applicants to define and justify). Applicants to consider if pre-specified sub-group analyses would be appropriate.
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: Adult intensive care.
- Comparator: Beta-blockade.
- 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: Mortality (at 30 and 90 days); Length of stay (in intensive care and hospital); restoration of normal heart rate and rhythm (applicants to define and justify).
Other outcomes: Adverse events; need for and duration of organ support; requirement for further intervention; resource use.
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: Applicants to define and justify.
Rationale
New onset atrial fibrillation (NOAF) is a common arrhythmia experienced by critically ill patients. There are a number of predisposing risk factors and it is linked to both increased length of intensive care unit (ICU) and hospital stay as well as increased short- and long-term mortality.
Despite the significant impact on patient outcomes and the number of patients affected there remains significant uncertainty about appropriate treatment options which results in considerable variation in practice.
As such the HTA programme commissioned a study (CAFE: 17/71/04) to synthesise the available evidence for treatment of NOAF in critically ill patients and to identify which if any treatments showed significant promise that could be tested in a subsequent randomised trial.
Beta-blockade and amiodarone are the most frequently used agents in this setting, with some signal of effectiveness for both but with inadequate evidence to recommend one over the other. Both drugs have a range of side-effects so it is important to determine which if any is better and/or safer than the other.
A high-quality, adequately powered randomised controlled trial is therefore now warranted to compare beta-blockade with amiodarone for treatment of NOAF in critically ill patients.
If you are applying to this call you may request a confidential pre-publication version of the CAFÉ study report by contacting htafunding@nihr.ac.uk.
Making an application
Please note that this call will open late-April. The advert on the funding opportunities page will be updated with the call opening date once confirmed and the link to the application form will be available once the call opens. Potential applicants are advised to check that advert for updates on the call open date.
Your application must be submitted on-line no later than 1pm on the 15 September 2021. Applications will be considered by the HTA Funding Committee at its meeting in November 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 March 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: htacet@nihr.ac.uk