Pregnancy and Childbirth Priority Setting Partnership Leadership team
Chief investigator - Andrew D Weeks, MD, MRCOG, Professor of International Maternal Health, University of Liverpool, UK
Technical Consultant - Dr. Teesta Dey, University of Liverpool, UK
JLA coordinator - Dr. Jonathan Gower, James Lind Alliance
Local Co-chair - Dr. Napyo Agnes, Busitema University Faculty of Health Sciences, Sanyu Africa Research Institute
Steering Group Chair - Dr. Napyo Agnes, Sanyu Africa Research Institute
Purpose of the PSP and background
Purpose
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Pregnancy and Childbirth Priority Setting Partnership (PSP) in line with James Lind Alliance (JLA) principles. This PSP will bring mothers that have experienced birth, their carers and clinicians in the field of maternity and childbirth together to identify and prioritise unanswered questions or ‘evidence uncertainties’ in the field of maternal health including pregnancy, childbirth and maternity care, using JLA methods.
Various fields including academia, research, pharmaceutical industry and medical technology play essential roles in developing and testing new treatments, but their priorities are not necessarily the same as those of patients and clinicians. Many areas of potentially important research are therefore neglected, and there can be a mismatch between the research being carried out and the research evidence needed by patients and clinicians every day. This also leads to an avoidable waste of precious research funds. The JLA – PSP method was developed to address this.
Background
Maternal mortality is unacceptably high. About 295 000 women died during and following pregnancy and childbirth in 2017. The vast majority of these deaths (94%) occurred in low-resource settings, and most could have been prevented.
Sub-Saharan Africa and Southern Asia accounted for approximately 86% (254 000) of the estimated global maternal deaths in 2017. Sub-Saharan Africa alone accounted for roughly two-thirds (196 000) of maternal deaths, while Southern Asia accounted for nearly one-fifth (58 000).
Most of the research agenda targeted towards various maternal outcomes originates or is conceived by elite scholars. However, these ideas may not be in congruence with the priorities of patients and clinicians. Ideally, health workers would provide interventions based on region-specific priorities that address adverse maternal outcomes. This is where health research that is conceived through PSPs comes into play. The health research priority setting mostly happens at the highest international levels and in developed countries with little in LIRs.
The JLA is a non-profit making initiative, established in 2004. It brings patients, carers and clinicians together in PSPs. The JLA method, is designed to raise awareness of research questions which are of direct relevance and potential benefit to patients and the clinicians who treat them. We also describe these research questions as 'evidence uncertainties'. The JLA method brings patients, carers and clinicians together in PSPs. The aim of a PSP is to help ensure that those who fund health research are aware of what really matters to patients, carers and clinicians.
In this protocol, we will conduct a Pregnancy and Childbirth Priority Setting Partnership in Uganda. We are working in association with the James Lind Alliance on involving populations whose voices are often not heard, even though they are the ‘experts by experience’ of local pregnancy and childbirth services. The primary aim is to conduct a Priority Setting Partnership using the JLA methodology and guidance to lead the identification of clinically important questions surrounding pregnancy and childbirth as well as emerging priorities for key Ugandan stakeholders, including patients (who experience pregnancy or childbirth), caregivers, health workers (knowledge users and policy makers) and researchers. Identifying Ugandan research priorities surrounding pregnancy and childbirth will help focus our research agenda and link to patient-oriented research efforts.
Aims, objectives and scope of the PSP
The aim of the pregnancy and childbirth (P&C) PSP is to identify the unanswered questions about pregnancy and childbirth from respective patient, carer and clinical perspectives and then prioritise those that they agree are the most important to address through research.
The objectives of this PSP are to:
- work with patients (experienced in pregnancy and childbirth), carers and clinicians and (or) health workers to identify uncertainties about pregnancy and childbirth to agree by consensus a prioritised list of those uncertainties, for research
- to publicise the results of the P&C – PSP and process
- to take the results to research commissioning bodies like the Ministry of Health as well as academic and other funding agencies researchers to be considered for funding
Scope
The P&C - PSP will cover aspects of care during pregnancy and childbirth, and the management of complications that arise during this period. We will include women who are trying for pregnancy, those who have experienced pregnancy-related conditions and their associated complications during pregnancy (including early pregnancy and miscarriage), childbirth and up to 6 weeks into the postpartum period. We shall include carers of these women and clinicians / health workers that offer clinical and (or) supportive care to these women.
Eligibility Criteria (exclusions and inclusions)
This PSP will be established in Eastern Uganda.
The PSP will exclude from its scope questions and comments unrelated to pregnancy or childbirth.
Patients experiencing any other condition that is not pregnancy or childbirth related will be excluded. Women that are active or exited participants of the Babygel trial will be excluded from the study for purposes of observing confidentiality in the Babygel trial.
Carers for patients experiencing any other condition other than pregnancy or childbirth related will be excluded.
Only clinicians who work with patients experiencing (or who experienced) pregnancy and childbirth related conditions will be included in the PSP.
Any organisations with commercial interest in pregnancy and childbirth conditions will be excluded from the PSP. These include some pharmaceutical companies and those that deal in trade of maternal and child health products like private maternity clinics.
Researchers will be included or have a representation on the steering group to advice on the shaping of research questions. However, they will be excluded in the prioritisation exercise. This is to ensure that the final prioritised research questions are those agreed by patients, carers and clinicians only, in line with the JLA’s mission.
All members of the PSP shall be residing and (or) practicing in Eastern Uganda. PSP members will also come from churches, mosques, schools, relevant associations and the community.
The Steering Group
The Steering Group will be responsible for discussing what implications the scope of the PSP will have for the evidence-checking stage of the process. This group includes membership of patients and carers and clinicians, as individuals or representatives from a relevant group.
The Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process, with input and advice from the JLA.
The pregnancy and childbirth PSP will be led and managed by a Steering Group. Its membership will be agreed upon once rapport has been created with the respective membership representations. We shall include women in this PSP that have had experience of childbirth. We are going to include women that are non-participants of the Babygel trial. A purposively selected VHT member will help us identify these women from the non-participating villages.
We shall choose clinicians experienced in pregnancy and childbirth from high volume health facilities including Mbale regional referral hospital, Busiu HCIV etc . These will be purposively selected. We shall look at the dataset for BabyGel project and select the health facilities from where most of the BabyGel participants deliver. These are the ones from which we shall choose the clinicians and health workers to be part of the PSP membership. Clinicians will include obstetricians / gynaecologists, and midwives. We shall only include clinicians that work in government-owned health facilities.
The PSP membership
Patient and carer representatives
- Ms.Velma Nangoye, Expectant mother, Mbale
- Ms. Olupot Sharifah, Expert mother (with a child), Busiu
- Ms. Tyamisa Hellen, Expert mother (with a child), Busiu
Clinical representatives
- Dr. Lunyolo Suzan, Medical officer, Attached to Busiu HCIV
- Sr. Makoha Sarah, Assistant nursing officer, Attached to Lwangholi HC3
- Sr. Chepkwemboi Keren, Registered midwife, Attached to Mbale regional referral hospital
Partners
- Mrs. Joyce Kidulu, Social worker Wise choices for life Uganda
- Mr. Sam Cherop, HSS coordinator, AMREF – Uganda
- Mr. Muthethu Mugisha, Joseph Community health manager, Living goods Uganda
- Sr. Kisolo Stella Abigail, Assistant district health officer in charge of, Ministry of Healith (Uganda)
Technical group
- Prof Andrew Weeks, Chief Investigator, University of Liverpool, UK
- Dr. Jonathan Gower, JLA Adviser, James Lind Alliance
- Dr. Napyo Agnes K, Local PSP Chair, Sanyu Africa Research Institute, Busitema University
Project coordinator
- Napyo Agnes Kasede, Sanyu Africa Research Institute
James Lind Alliance Adviser will be: Dr. Jonathan Gower
The Chair of the Steering Group will be: Dr. Napyo Agnes K
Partners
Organisations and individuals will be invited to be involved with the PSP as partners. Partners are organisations or groups who will commit to supporting the PSP, promoting the process and encouraging their represented groups or members to participate. Organisations which can reach and advocate for these groups will be invited to become involved in the PSP. Partners represent the following groups:
- women who have experienced pregnancy, childbirth and related complications and women who are trying for pregnancy
- carers of people who experienced pregnancy, childbirth and related complications
- health and social care professionals - with experience of managing patients that have experienced pregnancy, childbirth and related complications
Potential partners include:
- Wise choices for life, Uganda
- AMREF
- JPHIEGO
- Living goods
- Ugandan Ministry of Health including regional referral hospitals, health centre IVs, district health offices, VHTs
- Representative from the district health office (ADHO)
- Academic / research representatives like Busitema University
Exclusion criteria
Some organisations may be judged by the JLA or the Steering Group to have conflicts of interest. These may be perceived to potentially cause unacceptable bias as a member of the Steering Group. 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 steps through which the PSP aims to meet its objectives. The process is iterative and dependent on the active participation and contribution of different groups. The methods used in any step will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives.
The steering group will be formed with consultations and deliberations between the JLA adviser PSP coordinator in Uganda. After this has taken place then the following steps proceed
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 P&C - PSP. This step will take place for a period of 2 months.
Step 2: Awareness raising
The P&C-PSP will raise awareness of their proposed activity among their patient, carer and clinician communities, in order to secure support and participation. This will be done by a face-to-face meeting. This activity will also be launched via social media pathways or a suitable radio talk show. This step will be carried out as part of steps 1 and/or 3. The Steering Group will advise on when to do this. This step will take place for a period of 2 months.
The objectives for raising awareness are as follows:
- to present the proposed plan for the PSP
- to generate support for the process
- to encourage participation in the process
- to initiate discussion, answer questions and address concerns
Step 3: Identifying evidence uncertainties
The P&C-PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of 3 months will be given to complete this exercise (which may be revised by the Steering Group if required).
If the need arises, the P&C PSP will include some groups that require additional consideration. The Steering Group will consider the nature of the groups that it is targeting, their needs and how to reach potentially seldom heard or marginalised communities. We will include the names of these groups in the protocol as per when we identify them.
The Steering Group will advise and agree on the best method of consultation for reaching its groups. Some of the possible methods to use include: telephone calls, launch workshops and face-to-face meetings.
Existing sources of evidence uncertainties will include question-answering sessions for patients and carers and for clinicians; research recommendations in systematic reviews and clinical guidelines; protocols for systematic reviews being prepared and registers of ongoing research.
The data collection with the survey will be done by research assistants while conducting face to face interviews.
Step 4: Refining questions and uncertainties
The consultation process will produce ‘raw’ questions and comments indicating patients’, carers’ and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by the local co-chair together with the academic or research representatives into summary questions which are clear, addressable by research, and understandable to all. Similar or duplicate questions will be combined where appropriate. Out-of-scope and ‘answered’ submissions will be compiled separately. The Steering Group will have oversight of this process to ensure that the raw data is being interpreted appropriately and that the summary questions are being worded in a way that is understandable to all audiences. The JLA Adviser will observe to ensure accountability and transparency.
This will result in a ‘long list’ of in-scope summary questions. These are not research questions and to try and word them as such may make them too technical for a non-research audience. They will be framed as researchable questions that capture the themes and topics that people have suggested.
The summary questions will then be checked against evidence to determine whether they have already been answered by research. This will be done by the local co-chair together with the academic or research representatives. The PSP will complete the JLA Question Verification Form, which clearly describes the process used to verify the uncertainty of the questions, before starting prioritisation. The Question Verification Form includes details of the types and sources of evidence used to check uncertainty. The Question Verification Form should be published on the JLA website as soon as it has been agreed to enable researchers and other stakeholders to understand how the PSP has decided that its questions are unanswered, and any limitations of this.
Questions that are not adequately addressed by previous research will be collated and recorded on a standard JLA template by the local co-chair together with the academic or research representatives. This will show the checking undertaken to make sure that the uncertainties have not already been answered. The data will 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. This step will take a place for a period of 3 months.
The Steering Group will also consider how it will deal with submitted questions that have been answered, and questions that are out of scope.
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 about maternal health, pregnancy and childbirth. This will involve input from patients, carers and clinicians. The JLA encourages PSPs to involve as wide a range of people as possible, including those who did and did not contribute to the first consultation. There are usually two stages of prioritisation.
- Interim prioritisation is the stage where the long list of questions is reduced to a shorter list that can be taken to the final priority setting workshop. This is aimed at a wide audience, and is done using similar methods to the first consultation. With the JLA’s guidance, the Steering Group will agree the method and consider how best to reach and engage patients, carers and clinicians in the process. The most highly ranked questions (around 25) will be taken to a final priority setting workshop. Where the interim prioritisation does not produce a clear ranking or cut off point, the Steering Group will decide which questions are taken forwards to the final prioritisation.
- The final priority setting stage will be a one-day workshop facilitated by the JLA. With guidance from the JLA and input from the Steering Group, up to 30 patients, carers and clinicians will be recruited to participate in a day of discussion and ranking, to determine the top 10 questions for research. All participants will declare their interests. The Steering Group will advise on any adaptations needed to ensure that the process is inclusive and accessible. This step will take place for a period of 2 months.
At each stage of the process, all participants will be given a modest transport refund of 30,000=
Dissemination of results
The Steering Group will engage with audiences with which it will disseminate the results of the priority setting process, such as researchers, funders and the patient and clinical communities. They steering group will also determine how best to communicate the results and who will take responsibility for this. Some of the dissemination media that has been used by other PSPs’ outputs have included academic papers, lay reports, infographics, conference presentations and videos for social media. Some of these will be adapted in our PSP. The dissemination will take place for 1 month. Applicable to the Ugandan setting, we shall rely on various dissemination platforms as suggested by the SGC. These include:
- radio programs aired on community radio stations
- brochures
- Ministry of Health through the local partners
- community meetings
- community events like dialogues
The priorities will not be worded as research questions. The Steering Group will discuss how they will work with researchers and funders to establish how to address the priorities and to work out what the research questions are that will address the issues that people have prioritised. The dissemination of the results of the PSP will be led by the local co-chair (Dr. Napyo Agnes Kasede).
PSPs will report back about any activities that have come about because of the PSP, including funded research. Details of these activities will be sent to the email to the JLA.
Agreement of the Steering Group
One of the roles of the steering group is to give input during the development of the protocol. During the first SG meeting, the steering group will be brought together, protocol and PSP process presented to them and a platform for discussion opened up for their input.
The P&C-PSP Steering Group agreed the content and direction of this Protocol on 17/7/2023.
Declaration
According to the steering group committee;
- The use of the term ‘patient’ as stipulated in this PSP protocol shall mean expert women including women who have experienced pregnancy, childbirth and related complications and women who are trying for pregnancy
- The use of the term ‘carer’ as stipulated in this PSP protocol shall mean ‘attendant’ as used in the Ugandan healthcare setting
- The term ‘clinician’ as stipulated in this PSP protocol shall mean ‘health worker’ as used in the Ugandan healthcare setting