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Women’s Genital Prolapse and Incontinence (Gondar, Ethiopia)

Contents

Purpose of the PSP and James Lind Alliance

The purpose of this protocol is clearly to set out the aims, objectives and commitments of the Women’s genital prolapse and incontinence Priority Setting Partnership (PSP) in Gondar, Ethiopia, in line with James Lind Alliance (JLA) principles. The Protocol is a JLA requirement and will be published on the PSP’s page of the JLA website. The Steering Group will review the Protocol regularly and any updated version will be sent to the JLA.

The JLA is a non-profit making initiative, established in 2004. It brings patients, carers and clinicians together in PSPs. These PSPs identify and prioritise the evidence uncertainties, or ‘unanswered questions’, that they agree are the most important for research in their topic area.

The National Institute for Health and Care Research (NIHR – www.nihr.ac.uk - coordinates the infrastructure of the JLA to oversee the processes for PSPs, based at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton.

Further details about the JLA and PSPs are at http://www.jla.nihr.ac.uk/. The JLA Guide and useful templates and examples are available on the website for viewing and downloading.

The Gondar PSP is an initiative of University of Gondar, College of medicine and the Department of Health Sciences, University of Leicester. The two universities are developing a research programme to study the epidemiology and impact of pelvic organ prolapse and urinary incontinence among women living in Northern Ethiopia and to develop and evaluate conservative and surgical interventions for women which can be effectively delivered in community-based health care facilities.

Although much is known about the aetiology, impact and treatment of pelvic floor disorders in the developed world, there is less published information regarding epidemiology or prevalence in low and middle income countries (LMIC). Two recent studies in Ethiopia report differing prevalence for women experience symptoms of any pelvic floor disorders of 12% and 20%1 2. Despite a majority of women in this Eastern Ethiopian population reporting symptoms of UI and POP to be severely distressing only a third of women had sought help. This is despite growing evidence that UI and POP have significant negative impacts on women’s lives, affecting daily activities and social roles and personal and sexual relationships. UI and POP are often perceived as an inevitable part of aging or result of childbirth and women “silently wait to heal” as reported in a qualitative study from North West Ethiopia 3 4. Responses to poor knowledge and limited help seeking among women experiencing pelvic floor disorders are to increase education for women. However, the lack of effective care pathways for women in LMICs must also be addressed. Furthermore, access to surgical treatment is very limited given the number of available qualified health professionals and geographical and financial barriers for women5.

Given the lack of widespread and well-organised primary health care facilities and the low educational attainment of the majority of women in rural Ethiopia, it seems imperative to explore the perceived treatment uncertainties and concerns of women and other stakeholders before planning and implementing major research projects. This PSP has the objective of identifying these uncertainties in partnership with women, their families and communities and professional stakeholder groups.

Aims, objectives and scope of the PSP

The aim of the PSP is to identify the unanswered questions about Women’s Incontinence and Prolapse in the context of rural and urban areas in Ethiopia. The PSP will be seeking unanswered questions from patient, carer and clinical perspectives, and then prioritise those that patients, carers and clinicians agree are the most important for research to address. The PSP will help ensure that those who fund health research are aware of what really matters to patients, carers and clinicians.

The terms “genital prolapse and incontinence” were chosen by the Steering Group as the meaningful name for the PSP.

As this is the first PSP to be established in a developing African country, an important additional aim is to evaluate the feasibility of a running a PSP in this setting whilst maintaining core JLA principles, and what adaptations to the JLA process are required successfully to complete the PSP, within the constraints of low literacy, variable access to electronic media and dispersed geography.

The objectives of the PSP are to:

  • work with patients, carers and clinicians to identify uncertainties about the diagnosis, management and long term impact of Women’s genital prolapse and incontinence and its associated treatments on patients, carers, families and clinicians.
  • to agree by consensus a prioritised list of those uncertainties, for research
  • to publicise the results of the PSP and process to the research community and government agencies within Ethiopia and more widely in LMIC.
  • to use the prioritised results to promote research to commissioning organisations to be considered for funding. These will include UK funding bodies with a discrete Global Challenges Research Funding stream (MRC, NIHR, Wellcome), international bodies such as WHO, and national bodies within Ethiopia.

The scope of the PSP is defined as:

  • the, diagnosis, management and long term impact of Women’s genital prolapse and incontinence and associated treatments , including surgical and non-surgical interventions
  • patients, carers, and their families
  • patients based in Northwest Ethiopia, Dabat District
  • The primary language for the project is Amharic, though the Steering group may operate in Amharic and English.

The scope of the PSP excludes:

  • Urinary incontinence related to obstetric fistula or the consequences of fistula surgery
  • Urinary incontinence secondary to neurological disease or complications of previous continence or prolapse surgery

The Steering Group is responsible for considering what implications the scope of the PSP will have for the data analysis and evidence-checking stage of the process, mindful that time and expertise needs to be available for this work.

The objectives of the evaluation of the project

This PSP will challenge the current usual process of PSPs in western settings, where participants are generally literate and informed of their condition, where there are existing support and professionals networks for the condition, and digital technologies are in common use. The Gondar PSP will evaluate

  • how can the Gondar PSP best respect the JLA PSP principles of inclusivity, transparency, patients and professionals working together, contributing and using the evidence based
  • what adaptations to the 7 stage process are required to establish, run and complete the PSP.

Throughout the lifetime of the PSP, detailed fieldnotes and minutes will be kept and a narrative evaluation of each stage of the process will be made to record to what degree the JLA principles are adhered to, and to identify and discuss challenges to these principles. This evaluation will be included in the final report, and also developed into a monograph to be available on the PSP website for future researchers to access.

The Steering Group

The Steering Group includes membership of patients and carers and clinicians , as individuals or representatives from a relevant group.

The PSP will be led and managed by a Steering Group involving the following:

Patient and carer representatives:

  1. Abrhet Gebreegziabher (Patient representing those who have/had urinary incontinence)
  2. Elsa Weldegebrhana (Carer of patient with incontinence)
  3. Yisaem Bezae (patient representing those who have/had pelvic organ prolapse)
  4. Ambaye Dejen Tilahun (Carer of patient with pelvic organ prolapsed)

Clinical representatives:

  1. Dr Ambaye Wolde Michael, Obstetrician and Gynaecologist and representative of Women and Health Alliance International (WAHA)
  2. Tewodros Meheret Fetene, Gondar physiotherapist
  3. Workae Ejgu, Gondar nurse

NGOs working on pelvic floor disorders

  1. Wagaye Fentahun (UNFPA)
  2. Hawlt Abeyu Ejigu (Simien Mountains Mobile medical service)

Management Team:

  1. Douglas Tincello, Prof of Female Pelvic Medicine and Reconstructive Surgery, Health Sciences, University of Leicester
  2. Zelalem Mengistu, Assistant Professor obstetrics and gynecology, University of Gondar, College of Medicine and Health Sciences
  3. Dr Chris Williams, GP Principal and Clinical Lecturer, Health Sciences, University of Leicester
  4. Dr Emma Pitchforth, Senior Lecturer & Senior Research Fellow in Primary Care, University of Exeter
  5. Toto Anne Gronlund, James Lind Alliance Adviser and Chair of the Steering Group

Also, to be recruited:

Project coordinators / research assistants (Gondar based) - Two research assistants will be employed through the lifetime of the project to act as coordinators, information specialists and facilitators of the final workshop. They will have experience of qualitative research methodology and also have experience of maternity care/women’s healthcare. Two field workers will be recruited to suport the data gathering work out in the rural communities.

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.

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:

  • people who work in the University of Gondar Hospital’s catchment area
  • carers of people who have the condition
  • health and social care professionals - with experience of pelvic floor conditions

Exclusions

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 by the Steering Group, guided by the PSP’s aims and objectives.

More details of the method are in the Guidebook section of the JLA website at www.jla.nihr.ac.uk .

Step 1a: Identification and recruitment of Steering group members

Zelalem Mengistu and the Project coordinators based in Gondar have identified local networks/ regional support workers who can advocate; patients from both rural and urban areas to participate on the steering group. A further option is to have a subgroup of patients who can be involved at a distance, who have one or more representatives on the steering group, as a model of advocacy.

Clinicians have been recruited from Gondar Hospital, Addis Ababa and from rural heath visitors by invitation from ZM / DT.

The project co-ordinators/information specialist and field workers will be recruited in Gondar by regional advertisement and interview.

Step 1b: Identification and invitation of potential partners

Potential partner organisations will be identified through a process of peer knowledge and consultation, and through the Steering Group members’ networks. Potential partners will be contacted and informed of the establishment and aims of the PSP, and invited to participate. As partners, they are expected to support the PSP in communications and dissemination, and may benefit from having their logo displayed on official PSP documents and websites.

Step 1c: Awareness raising

PSPs will raise awareness of their proposed activity among their patient, carer and clinician communities, in order to secure support and participation.

Awareness raising has several objectives:

  • 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 2: Identifying evidence uncertainties

The PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of approximately 90 days will be given to complete this exercise (which may be revised by the Steering Group if required).

The Steering Group will use the following methods to reach the target groups. The aim is to be inclusive.

  • Individual household visits and interviews and group meetings in any districts within University of Gondar Hospital’s catchment area
  • Individual interviews by telephone where patient details (with mobile phone) are already held by Gondar Hospital
  • Individual interviews with patients attending clinics
  • Paper surveys for people who are literate
  • Online survey distributed through partner organizations for people who have online access
  • “Snowballing” of contact from patients, asking them to nominate friends or colleagues who they may know with the same condition

The PSP uncertainty gathering questions will be finalised by the steering group, but a single open question will be presented to address a) diagnosis, b) treatment and c) long term impact of pelvic organ prolapse, and a similar set of questions for urinary incontinence. Some examples of the typical wording for PSP uncertainties are:

“What questions about the treatments available for your genital organ prolapse would you like to see answered by research?”

“What questions about urinary incontinence would you like to see answered by research?”

At the uncertainty gathering stage, responses will be anonymised; responses will have no indentifying details attached. We will retain person identifying information in a separate database for the lifetime of the project to allow us to recontact participants for the ranking exercise and to invite them to attend the final workshops.

Some basic demographic data will be collected (age, patient/carer/health care provider, region, gender, ethnic group) to ensure the surveys capture a wide and balanced range of respondents.

Existing sources of evidence uncertainties:

  • searching clinical practice guidelines with moderate to weak quality of evidence supporting recommendations and where recommendations for future research identified.
  • Research recommendations identified in Cochrane systematic reviews and two recently completed systematic reviews, focussed explicitly on LMICs.

The time allocated to collate, analyse and categorise responses will be approximately 3 months.

Step 3&4: Refining questions and uncertainties

The consultation process will gather ‘raw’ questions and comments from patients, carers and clinicians. These raw questions will be analysed and refined by the project research fellows and steering committee members 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’ questions will be compiled separately. The Steering Group will have oversight of this process to ensure that the raw data are 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.

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 verified unanswered questions will be recorded on a standard JLA template by the PSP information specialist. This will show the verification undertaken for each question to make sure that the question has not already been answered by research.

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, along with the the Question Verification Form. This will enable researchers and other stakeholders to understand how the PSP has decided that its questions are unanswered, and any limitations of this.

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&6: Prioritisation – interim and final stages

Prioritisation of the summary questions will involve input from a wide range of patients, carers and clinicians. There will be two stages of prioritisation, although this may be modified if a small number of summary questions are derived from the submitted uncertainties. During this stage, the steering committee will determine which is the most appropriate method of prioritisation, based upon the submitted uncertainties and experience gained of the potential challenges of collecting uncertainties in this context, given that this is the first PSP to be done in such a setting. Throughout, the principles of inclusivity, transparency and multidisciplinarity will be upheld.

1. Interim prioritisation is the stage where the long list of summary questions is reduced to a shorter list that can be taken to the final priority setting workshop. 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. This will include the steering committee members and additional individuals selected to ensure balanced perspectives represented. Participants in the initial gathering exercise will be recontacted and invited to rank the short list of questions in order of importance. This will be done by a mixture of methods as above, depending on the participant’s access to electronic media, literacy and location. Electronic ranking, or ranking in a face to face or telephone interview will be employed. All returned responses will be collated to produce a final ranked list of the most highly ranked questions (around 20-25, or all of them if fewer than 20 are collected) 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.

2. The final priority setting stage will be a one-day workshop facilitated by the JLA and a local translator. This will be conducted in Gondar. 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 from the short list of 20-25. All participants will be asked to make a Declaration of Interests, to support transparency. The Steering Group will advise on any adaptations needed to ensure that the process is inclusive and accessible.

Dissemination of results

The findings will be submitted to relevant peer reviewed scientific journals in the field and to international scientific meetings.

The findings will be promoted through distributions of partnering organizations and their associated communication channels (email, newsletters, websites and social media).

Promotion targeting the general population will be through press release to national and local media outlets and through patient groups identified during the PSP process.

It should be noted that the priorities are not worded as research questions. The Steering Group 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 questions that people have prioritised. The dissemination of the results of the PSP will be led by the PSP project leads.

The JLA encourages PSPs to report back about any activities that have come about because of the PSP, including funded research. Please send any details to jla@soton.ac.uk.

Agreement of the Steering Group

The Gondar PSP Steering Group agreed the content and direction of the Amharic translation of this Protocol on 4 Dec 2019, in Gondar.

References

1. Megabiaw B, Adefris M, Rortveit G, Degu G, Muleta M, Blystad A, et al. Pelvic floor disorders among women in Dabat district, northwest Ethiopia: a pilot study. Int Urogynecol J. 2013;24(7):1135-43.
2. Dheresa M, Worku A, Oljira L, Mengistie B, Assefa N, Berhane Y. Pelvic floor disorders associated with higher-level sexual dysfunction in the Kersa district, Ethiopia. Turkish journal of obstetrics and gynecology. 2018;15(4):210-6.
3. Gjerde JL, Rortveit G, Muleta M, Blystad A. Silently waiting to heal. Experiences among women living with urinary incontinence in northwest Ethiopia. International Urogynecology Journal. 2013;24:953-8.
4. Mendes A, Hoga L, Goncalves B, Silva P, Pereira P. Adult women's experiences of urinary incontinence: a systematic review of qualitative evidence. JBI Database System Rev Implement Rep. 2017;15(5):1350-408.
5. Adefris M, Abebe SM, Terefe K, Gelagay AA, Adigo A, Amare S, et al. Reasons for delay in decision making and reaching health facility among obstetric fistula and pelvic organ prolapse patients in Gondar University hospital, Northwest Ethiopia. BMC Womens Health. 2017;17(1):64.