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Health Technology Assessment Programme- Management of blood pressure in elderly people with hypertension and symptomatic postural hypotension commissioning brief

National Institute for Health and Care Research

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 best strategy to manage blood pressure in elderly people with essential hypertension and symptomatic postural hypotension?

Patient group:
- Have a past or current medical history of essential hypertension (applicants to define and justify blood pressure threshold for inclusion in trial, and method of measurement).
- Presence of postural hypotension (applicants to define and justify definition and method of measurement).
- Presence of symptoms attributable to postural hypotension on standing (e.g. lightheadedness, syncope, falls).
Research should take into account the clinical heterogeneity of conditions associated with postural hypotension, and their underlying pathophysiological mechanisms when defining potential sub-groups.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
Intervention: A strategy that prioritises control of hypertension – applicants to define and justify.
Comparator: A strategy that prioritises control of postural hypotension symptoms – applicants to define and justify.
Important outcomes: Improvement or worsening of symptoms of postural hypotension; Improvement or worsening of blood pressure control (applicants to define how this is measured).
Other outcomes: Hospital admissions (injurious falls, syncope, cardiovascular events); Quality of life measures; Activities of daily living; Fidelity to strategies; Health economic measures (applicants are encouraged to explore appropriate approaches to health economic analysis for this patient group).
Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant).
Setting: Primary and/or Secondary care; Applicants to justify choice.
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. Applicants are encouraged to work collaboratively and consider study designs that allow for comparison of different interventions and strategies.
Minimum duration of follow-up: Applicants to define and justify, but should not be shorter than 12 months.
Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow-up through efficient means (such as routine data) as part of a separately funded study.

Specialties

Clinical Trials

Intensive Care Medicine

Geriatrics & Gerontology

Vascular Surgery

Eligibility Requirements

The HTA Programme will support

evidence synthesis including systematic reviews, modelling studies and meta-analyses
randomised controlled trials (blinded and unblinded)
non-randomised trials, where appropriate
network meta-analysis and expected Value of Information studies
cohort studies (retrospective or prospective)
complex and innovative trials including adaptive designs and platform studies
modelling studies and health economic models
international studies

Remit

To be within remit for the HTA researcher-led workstream:

the primary outcome of a study should be a health- or social care-related outcome. It must also have the potential to directly benefit the wider NHS, social care, or those who use these services
applications for primary research must be within the scope of the Programme and provide robust evidence for the importance and the efficacy or effectiveness of the intervention(s)
- robust evidence is evidence published in a peer reviewed journal demonstrating the efficacy or effectiveness of the intervention and reporting clinically important findings based on point estimates and associated confidence intervals
- feasibility studies showing the acceptability of the intervention or the ability to recruit participants do not alone constitute evidence of efficacy
- on rare occasions, new primary research may be required urgently. Applicants will need to convince HTA of the urgency of the research and if accepted, we may accept unpublished findings supported by datasets that allow the analysis to be replicated
if robust peer reviewed evidence of efficacy or effectiveness has not been published, HTA may accept evidence that the intervention is widely used in, or is available to, the NHS or social care and is likely to diffuse into widespread practice

We will screen all researcher-led applications to ensure they are in remit. Applications that are not in remit will not be considered by a Funding Committee.

Eligible Countries:

United Kingdom

Sponsor Details

Sponsor Institute/Organizations: National Institute for Health and Care Research

Address: NIHR, UK.

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