Blood Pressure in Pregnancy PSP Protocol

Purpose of the PSP and background

The purpose of this protocol is to set out the aims, objectives and commitments of the Pregnancy Hypertension Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein. It is recommended that the Protocol is reviewed by the Steering Group and updated on at least a quarterly basis.

The James Lind Alliance (JLA) is a non-profit making initiative, established in 2004. It brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs). These partnerships identify and prioritise uncertainties, or ‘unanswered questions’, about the effects of treatments that they agree are the most important. The aim of this is to help ensure that those who fund health research are aware of what really matters to both patients and clinicians. The National Institute for Health and Care Research (NIHR – www.nihr.ac.uk) funds the infrastructure of the JLA to oversee the processes for priority setting partnerships, based at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton.

Hypertensive disorders complicate up to 10% of all pregnancies (National Collaborating Centre for Women’s and Children’s Health 2010) and encompass a spectrum of disorders that includes pre-eclampsia, gestational hypertension, chronic hypertension and white coat hypertension (International Society for the Study of Hypertension in Pregnancy, 2014). There is considerable overlap between the disorders; pre-eclampsia can occur either de novo or superimposed on chronic hypertension or as a progression in severity of gestational hypertension. They are all associated with an increase in adverse pregnancy outcomes with pre-eclampsia associated with the greatest risk of maternal and perinatal morbidity and mortality. Half of women with severe pre-eclampsia deliver preterm and 1 in 20 stillbirths without congenital abnormality occur in women with pre-eclampsia. In addition to this, 14-19% of infants born at term and 20- 25% of infants born preterm are below the tenth birthweight centile for gestation. Every 18 months, one woman in the UK dies from a hypertensive disorder of pregnancy (MBRRACE-UK Confidential Enquiry into Maternal Death, 2016); however, globally 40 000 women die each year from pre-eclampsia (WHO World health statistics, 2015). Furthermore, pre-eclampsia carries significant health care implications later in life; both mothers and their infants are at increased risk of subsequent cardiovascular and metabolic morbidity and mortality. Unanswered questions remain on prediction, prevention, diagnosis, management and long-term implications for maternal and child health.

Aims and objectives of the Pregnancy Hypertension PSP

The aim of the Pregnancy Hypertension PSP is to identify the unanswered questions about pregnancy hypertension from lay and clinical perspectives and then prioritise those that women, partners and clinicians agree are the most important.

The objectives of the Pregnancy Hypertension PSP are to:

• work with women, partners and clinicians to identify uncertainties about pregnancy hypertension
• to agree by consensus a prioritised list of those uncertainties, for research
• to publicise the results of the PSP and process
• to take the results to research commissioning bodies to be considered for funding.

The scope of the Pregnancy Hypertension PSP will be restricted to research questions and uncertainties relevant to the UK population and therefore uncertainties will be related to the UK only. Additional ‘bolt on’ projects may extend the scope beyond the UK; however, they may be considered by the steering group independently at a later stage and will not influence the results of this Pregnancy Hypertension PSP.

Hypertension includes other terms such as ‘high’ or ‘increased’ blood pressure. The scope will include research priorities relating to the following topics in the context of women with pregnancy hypertension women, babies, their partners and families

• hypertensive disorders including pre-eclampsia, gestational hypertension, chronic hypertension and white coat hypertension
• time period related to pregnancy (i.e. pre-conception, antenatal, post-natal and long-term health outcomes)
• management related to pregnancy hypertension (i.e. prevention, prediction, diagnosis and treatment)
• physical, social and emotional aspects
• co-morbidities such as renal disease or diabetes
• genetics
• information provision

Respondents may include:

• Women who have had babies or are pregnant and other lay persons
• Birth partners
• Secondary care healthcare professional (e.g. Obstetricians)
• Primary care healthcare professionals
• Midwives

The Steering Group

The Pregnancy Hypertension PSP will be led and managed by the following:

Representatives of women, their partners and families:

• Action On Pre-Eclampsia (APEC)
• Women with lived experience of pregnancy hypertension, and partners with relevant experience

Clinical representatives:

• Obstetrics
• Midwifery
• Neonatology
• Primary care
• Obstetric medicine
• Research science

The Partnership and the priority setting process will be supported and guided by:

The James Lind Alliance (JLA):

The Steering Group includes representation of women, partners and clinicians. Advised by the JLA, the Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process.

The wider Partners

Organisations and individuals will be invited to be involved with the PSP as partners. Partners are groups or individuals who will commit to supporting the PSP by disseminating the PSP survey and helping the PSP to gather questions and uncertainties of practical clinical importance relating to the treatment and management of the health problem in question. Partners represent the following groups:

• people who have had pregnancy hypertension
• partners of people who have had pregnancy hypertension
• medical doctors, nurses, midwives and other professionals allied to medicine with clinical experience of pregnancy hypertension
• charities and patient support groups working in this area (e.g. Stillbirth and Neonatal Death charity (SANDS), National Childbirth Trust (NCT), Tommy’s Charity, British Heart Foundation)

It is important that all organisations which can reach and advocate for these groups should be invited to become involved in the PSP. The JLA Adviser will take responsibility for ensuring the various stakeholder groups are able to contribute equally to the process.

Exclusion criteria

Some organisations may be judged by the JLA or the Steering Group to have conflicts of interest. These may be perceived to adversely affect those organisations’ views, causing unacceptable bias. As this is likely to affect the ultimate findings of the PSP, those organisations will not be invited to participate. It is possible, however, that interested parties may participate in a purely observational capacity when the Steering Group considers it may be helpful.

The methods the PSP will use

This section describes a schedule of proposed stages through which the PSP aims to fulfil its objectives. The process is iterative and dependent on the active participation and contribution of different groups. The methods adopted in any stage will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives. More details can be found in the Guidebook section of the JLA website at www.jla.nihr.ac.uk where examples of the work of other JLA PSPs can also be seen.

Step 1: Identification and invitation of potential partners

Potential partner organisations will be identified through a process of peer knowledge and consultation, through the Steering Group members’ networks. Potential partners will be contacted and informed of the establishment and aims of the Pregnancy Hypertension PSP and may be invited to attend and participate in an initial stakeholder meeting if this is being arranged.

Step 2: Initial meeting

The PSP has been formed as a collaborative effort and awareness raising with various stakeholders has enabled the recruitment of the balanced membership of the PSP Steering Group. Further awareness will be achieved through promotion of the survey, as well as by individual members of the SG contacting identified partner organisations.

Step 3: Identifying treatment uncertainties

The Steering Group will agree, working with partner organisations, best methods for soliciting from its members their questions and uncertainties of practical clinical importance relating to the prediction, treatment and management of Pregnancy Hypertension. A period of around 3 months will be given to complete this exercise.

The methods may be designed according to the nature and membership of each organisation, but must be as transparent, inclusive and representative as practicable. Methods may include membership meetings, email consultation, postal or web-based questionnaires, internet message boards or other appropriate social media processes and focus group work.

Existing sources of information about treatment uncertainties for women and clinicians will be searched. These can include question-answering services for women, partners and for clinicians; research recommendations in systematic reviews and clinical guidelines; protocols for systematic reviews being prepared and registers of ongoing research.

The starting point for identifying sources of uncertainties and research recommendations is NHS Evidence: www.evidence.nhs.uk .

Step 4: Refining questions and uncertainties

The Steering Group will agree responsibility (and amount of time likely to be required) for this stage, advised by the JLA. The JLA will participate in this process as an observer, to ensure accountability and transparency.

The consultation process will produce “raw” unanswered questions about diagnosis and the effects of treatments. These raw questions will be assembled and categorised and refined by the PSP Information Specialists into “collated indicative questions” which are clear, addressable by research and understandable to all. Similar or duplicate questions will be combined where appropriate.

Systematic reviews and guidelines will be identified and checked by the PSP Information Specialists to see to what extent these refined questions have, or have not, been answered by previous research. Sometimes, uncertainties are expressed that can in fact be resolved with reference to existing research evidence – i.e. they are "unrecognised knowns" and not uncertainties. If a question about treatment effects can be answered with existing information but this is not known, it suggests that information is not being communicated effectively to those who need it. Accordingly, the JLA recommends strongly that PSPs keep a record of these 'answerable questions' and deal with them separately from the 'true uncertainties' considered during the research priority setting process.

Uncertainties which are not adequately addressed by previous research will be collated and recorded on a template (supplied by the JLA) by the PSP Information Specialists. This will demonstrate the checking undertaken to make sure that the uncertainties have not already been answered. This is the responsibility of the Steering Group, which will need to have agreed personnel and resources to carry this accountability. The data should be submitted to the JLA for publication on its website on completion of the priority setting exercise, taking into account any changes made at the final workshop, in order to ensure that PSP results are publicly available.

Step 5: Prioritisation – interim and final stages

The aim of the final stage of the priority setting process is to prioritise through consensus the identified uncertainties relating to the treatment or management of pregnancy hypertension. This will be carried out by members of the Steering Group and the wider partnership that represents women and clinicians.

• The interim stage, to proceed from a long list of uncertainties to a shorter list to be discussed at the final priority setting workshop (e.g. up to 30), may be carried out over email or online, whereby organisations consult their membership and choose and rank their top 10 most important uncertainties. There are examples of how other PSPs have achieved this at www.jla.nihr.ac.uk in the Key Documents of the Anaesthesia and Perioperative Care PSP section and the Childhood Disability PSP section.
• The final stage, to reach, for example, 10 prioritised uncertainties, is likely to be conducted in a face-to-face meeting, using group discussions and plenary sessions.
• The methods used for this prioritisation process will be determined by consultation with the partner organisations and with the advice of the JLA Adviser. Methods which have been identified as potentially useful in this process include: adapted Delphi techniques; expert panels or nominal group techniques; consensus development conference; electronic nominal group and online voting; interactive research agenda setting and focus groups.

The JLA will facilitate this process and ensure transparency, accountability and fairness. Participants will be expected to declare their interests in advance of this meeting.

Dissemination of findings and research

Findings and research

It is anticipated that the findings of the Pregnancy Hypertension PSP will be reported to funding and research agenda setting organisations such as the NIHR and the major research funding charities. Steering Group members and partners are expected to develop the prioritised uncertainties into research questions, and to work to establish the research needs of those unanswered questions to use when approaching potential funders, or when allocating funding for research themselves, if applicable.

Publicity

As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of the Pregnancy Hypertension PSP using both internal and external communication mechanisms. The Steering Group may capture and publicise the results through descriptive reports of the process itself in Plain English. This exercise will be distinct from the production of an academic paper, which the partners are also encouraged to do. However, production of an academic paper should not take precedence over publicising of the final results.

Agreement of the Steering Group

This protocol was approved by the Steering Group:

Professor Lucy Chappell, PSP Lead

Ms Toto Gronlund, PSP Chair and JLA Adviser

Ms Gemma Singleton, PSP Co-ordinator

Dr Louise Webster, PSP Information Specialist

Dr Alison Ho, PSP Information Specialist

Ms Fiona Creighton, Lay member with lived experience

Sarah Findlay, Lay member with lived experience

Representatives from: Mr Marcus Green Action On Pre-Eclampsia (APEC)

Professor Jim Thornton, Obstetrics

Ms Rebecca Whybrow, Midwifery

Dr Chris Gale, Neonatology

Professor Richard McManus, Primary care

Dr Liza Bowen, Primary care

Professor Laura Magee, Obstetric medicine

Dr Hiten Mistry, Research science