Introduction
The aim of the 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.
This is a brief of broader scope from which the programme is interested in potentially funding more than one proposal.
We are interested in proposals for the evaluation of interventions to improve the prevention, detection, management, monitoring or treatment of women with symptoms of, at risk of developing, or who have a diagnosis of hypertensive disorders of pregnancy. Studies should be ambitious and aim to make a step change in our knowledge and understanding within the field and not focus on incremental modifications to established interventions. The HTA programme welcomes studies that take into account health inequalities and ethnicity on the risk and management of hypertension in pregnancy.
Applicants should clearly define and justify their choice of patient group, study design and outcome measures, and explain how the research will fit into the remit of the HTA programme. Epidemiology or exploratory studies are not eligible for the HTA programme but primary research including randomised and observational studies and evidence syntheses will be considered.
Examples of topics of interest include, but are not limited to:
- Pre-pregnancy interventions to reduce the risk of hypertensive disorders in pregnancy to the mother and/or baby
- Interventions to detect hypertensive disorders in pregnancy
- Effectiveness of current diagnostic tests for the detection of hypertensive disorders in pregnancy or risks of development
- Effectiveness of screening tests for the risk of developing pre-eclampsia
- Improving the early diagnosis of pre-eclampsia
- Management of hypertensive disorders in pregnancy
- Pharmacological treatment of hypertensive disorders in pregnancy
- Effectiveness of self-management care pathways
- Interventions to prevent severe hypertension and/or pre-eclampsia
- Effectiveness of inpatient, outpatient and remote management of pre-eclampsia
- The optimal timing of delivery for the mother and the baby
- Use of monitoring to improve maternal, fetal and neonatal outcomes
- Long-term management of hypertension following pregnancy
- Interventions to reduce the risk of cardiovascular disease in women and their infants after a pregnancy affected by hypertension
- Effectiveness of screening tests for cardiovascular disease following a pregnancy affected by hypertension
Rationale
Hypertensive disorders of pregnancy affect around 10% of all pregnant women and are a major cause of maternal, fetal and neonatal morbidity and mortality e.g. increased risk of cardiovascular disease, premature birth or still birth. Hypertensive disorders of pregnancy can be pre-existing or occur before 20 weeks of pregnancy, known as chronic hypertension. Hypertension (high blood pressure) that occurs after 20 weeks of pregnancy is known as gestational hypertension, or if there is protein in the urine and/or multi-organ disease it is known as pre-eclampsia.
The prevention and earlier detection of those women at increased risk, in whom prevention of these conditions might be possible, is vital to improve outcomes for both the mother and baby, as is optimal management and treatment of hypertension and pre-eclampsia.
A James Lind Alliance Priority Setting Partnership, NICE research recommendations and recent systematic reviews show that there are a number of ongoing uncertainties about the management of hypertension in pregnancy.
Therefore, the HTA Programme wishes to commission research evaluating interventions to improve the prevention, detection, management, monitoring or treatment of hypertensive disorders of pregnancy, taking into account published and ongoing research in the field. There are several ongoing NIHR studies focussing on hypertension in pregnancy, which applicants should take into account when applying. Interventions should be defined and justified by applicants and are not limited to the examples given above. Applicants should take into account the degree of benefit, transferability and sustainability of the intervention, and the potential benefits and harm to the mother and the baby.
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 4 May 2022. Applications will be considered by the HTA Funding Committee at its meeting in July 2022.
Guidance notes and supporting information for HTA Programme applications are available.
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 November 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 by email: htagb@nihr.ac.uk