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PRP (38-01-04) Understanding disparities in the use of medical devices in the pregnancy and neonatal period

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Published: 09 January 2024

Version: 2.0 - January 2024

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Timetable and Budget

DescriptionsDeadline/Limit
Deadline for Stage 1 Applications 18 June 2024, 1pm
Notification of outcome of Stage 1 Application September 2024
Deadline for Stage 2 Application 22 October 2024, 1pm
Notification of outcome of Stage 2 Application February 2025
Earliest Potential Project Start March 2025
Project Duration Up to 24 Months
Budget £400,000 - £500,000

NB: specification deadlines amended January 2024

Introduction

The National Institute for Health and Care Research (NIHR) Policy Research Programme (PRP) invites applications for a single research project to explore Equity in Medical Devices during the Pregnancy and Neonatal Period.

This research is needed to assess whether there are disparities in the medical devices used during the pregnancy and neonatal period which are contributing to the disparities in maternal and neonatal outcomes. The research is also needed to understand how medical devices could be adapted to ensure equity in maternity and neonatal care.

Background

In 2022, the then Secretary of State, Sajid Javid, commissioned an independent review into the extent and impact of ethnic and other unfair biases in the development and use of medical devices [1]. Professor Dame Margaret Whitehead was appointed to chair and conduct the review, supported by a panel of world leading academic researchers and clinicians. The Independent review into medical devices has now concluded and the report is due to be published imminently along with the government response. The report includes a call for further work on equity in the medical devices encountered during pregnancy and the neonatal period, as part of wider investigations of health outcomes for ethnic minority and poorer women and their babies.

The Independent Review webpage hyperlinked above [in Point 3] will automatically update following publication of the report and government response. Applicants wishing to submit a proposal under this research call are advised to be aware of these plans, and check the page for any updates.

Medical devices are defined in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002): a medical device is any type of physical device or software that is used specifically for diagnosis or therapeutic purposes and is intended by the manufacturer for use on human beings.

The Government National Maternity Safety Ambition is to halve the 2010 rates of stillbirths, neonatal and maternal deaths and brain injuries in babies occurring during or soon after birth by 2025. Since 2010, we have seen a 23% reduction to the stillbirth rate and 30% reduction in the neonatal mortality rate [2]. However, there are still significant disparities in outcomes based on ethnicity and levels of deprivation.

The Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK (MBRRACE-UK) found that Black women in the UK are four times more likely to die from causes linked to pregnancy and birth compared to white women. In addition, Black and Asian babies were at 1.6 times higher risk of perinatal mortality than white babies in 2021, a small improvement from 1.8 in 2017 [3].

The National Child Mortality Database report [4] published in November 2023 stated that the estimated infant (babies under one year) death rate continued to be highest for infants of black or black British ethnicity (8.7 per 1,000 live births), approximately three times the rate of infants of white ethnicity (3.0 per 1,000 live births) between 1 April 2022 and 31 March 2023.

We understand that there are a range of factors that contribute to the disparities in maternal and neonatal outcomes. This includes living in deprivation, complex social factors, English not being a person’s first language, pre-existing health conditions, obesity and mental health conditions. It has been suggested that implicit bias in care or microaggressions may play a part in the care that black women receive. Reports from Maternity charities such as Birthrights [5] and FiveXmore [6] have made recommendations for the system to “commit to an anti-racist organisation, make ethnic minorities decision-makers in their care and improve maternity curricula and guidance for ethnic minorities”.

NHS England have published Equity and Equality guidance for Local Maternity and Neonatal Systems [7] to tackle disparities in outcomes and experience of maternity care at a local level. In 2023, NHS England also published a Three-Year Plan for Maternity and Neonatal Services [8] which sets out how NHS England will make maternity and neonatal care safer, more personalised, and more equitable for women, babies, and families.

Research Priorities

This research is needed to understand whether there are disparities in the medical devices used during pregnancy and the neonatal period, and to understand how any disparities could be addressed.

The key research priorities are as follows:

  1. To understand what medical devices are encountered during pregnancy and the neonatal period.
  2. To understand whether medical devices that have been designed with broader clinical application in mind are appropriate to be used on women during pregnancy and the neonatal period. For example, pulse oximetry devices that are used both in this period and more broadly.
  3. To understand whether the medical devices work differently for women and babies from ethnic minorities.
  4. To explore and understand whether there are racial biases in the use of medical devices encountered during pregnancy and the neonatal period and whether these are contributing to the disparities in outcomes.
  5. To understand what medical devices need to be developed to address inequalities in maternal and neonatal outcomes.
  6. To explore and understand whether existing medical devices need adapting to ensure equity in maternal and neonatal outcomes.
  7. To explore and understand whether tailored training is required for clinicians using medical devices in the care of ethnic minority women and babies.

The research will inform future policy-making decisions on whether medical devices need to be adapted and/or if training is required for clinicians when using these devices on women and babies from ethnic minorities.

Eligibility

Eligibility for the NIHR PRP is laid out in our Standard Information for Applicants and applies to all calls unless otherwise stated in the individual research specification.

Technical requirements / Expertise required

Applicants are expected to have an in-depth understanding and awareness of:

  1. the maternal and neonatal system
  2. the inequalities in outcomes and experience in the health and social care system

Applicants are also expected to have:

  1. approaches and training in the health and social care system
  2. Previous experience of qualitative research in order to gather and analyse views from a range of stakeholders.
  3. Experience of working with diverse and vulnerable populations (e.g., women from ethnic minorities and deprived areas).

Outputs

In terms of outputs, we expect the following:

  • A full research report that sets out methodology, key findings and a series of recommendations for taking work forward in this space
  • A presentation to policy customers of key findings and recommendations.

We also request regular project updates to discuss progress against agreed timelines. The appropriate frequency can be agreed with the successful applicants, but we would anticipate updates in the region of every quarter as a minimum.


Applicants are asked to consider the timing and nature of deliverables in their proposals. Policymakers will need research evidence to meet key policy decisions and timescales, so resource should be flexible to meet these needs. A meeting with DHSC officials to discuss policy requirements will be convened as a matter of priority following contracting.

Budget and duration

Applications will be assessed on value for money, we would not expect them to cost more than £500K.

The duration of the project should be as short as is consistent with delivering a high-quality study. In order to maximise the benefit from the findings, the research will need to commence as soon as possible following selection of the successful proposal and placing of contract. Capability to start promptly will be an advantage and for this commissioning round, applicants should demonstrate that studies can start by the relevant date.

Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Applicants are advised that value for money is one of the key criteria that peer reviewers and commissioning panel members will assess applications against.

Management arrangements

A research advisory group including, but not limited to, representatives of DHSC, other stakeholders [for example NHS England, Royal College of Obstetricians and Gynaecologists, Royal College of Midwives, Royal College of Anaesthetists and Royal College of Paediatrics and Child Health], and the successful applicants for the research should be established. The advisory group will provide guidance, meeting regularly over the lifetime of the research. The successful applicants should be prepared to review research objectives with the advisory group, and to share emerging findings on an ongoing basis. They will be expected to:

  • Provide regular feedback on progress
  • Produce timely reports to the advisory group
  • Produce a final report for DHSC sign off

Research contractors will be expected to work with nominated officials in DHSC, its partners and the NIHR. Key documents including, for example, research protocols, research instruments, reports and publications must be provided to DHSC in draft form allowing sufficient time for review.

Guidance on Health and Care Inequalities and associated data collection within NIHR PRP Research:

Health and care Inequalities is a high priority area within the Department of Health and Social Care and the NIHR and is often present in a majority of funded projects.We are now assessing all NIHR research proposals in relation to health inequalities. We ask that you please clearly identify in the research plan section of the application whether your application has an inequalities component or theme as well as how this research hopes to impact inequalities or not. Please also detail the core set of inequality breakdown data that will be collected, if applicable. More information on this request can be found in the Standard information for applicants.

References and key documents