Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives, and commitments of the Diabetic Eye Disease (DED) in low- and middle-income countries (LMICs) Priority Setting Partnership (PSP), 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. Traditionally PSPs have focused on uncertainties about the effects of treatments, but some PSPs have chosen to broaden their scope beyond that. 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. The National Institute for Health 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.
DED is a complication of diabetes that leads to blindness if not adequately managed. DED includes diabetic retinopathy, diabetic macular oedema, and (early onset) cataract. Diabetic retinopathy is one of the most common complications of diabetes, with one in three people with diabetes affected by this condition. Virtually all blindness from diabetic retinopathy could be avoided with adequate prevention and management. Notably, approximately 80% of people with diabetes live in LMICs.1
Prevention and management of DED remain inadequate in virtually all LMICs, even though behaviour change interventions, technology, treatment options, and guidelines exist. This indicates that uncertainties remain relating to effective control of DED in resource poor settings.
For these reasons, the International Agency for the Prevention of Blindness (IAPB) in collaboration with the Fred Hollows Foundation, has decided to set up and fund a JLA PSP to identify evidence uncertainties around DED in LMICs.
The PSP began in January 2022 and aims to complete the process within 12 months.
This PSP is led by Dr Fabrizio D’Esposito, outgoing Chair of the IAPB Diabetic Retinopathy Work Group and Dr Sarity Dodson, the Director of Research at The Fred Hollows Foundation.
Aims, objectives, and scope of the PSP
The aim of the PSP is to identify the unanswered questions about DED management and prevention in LMICs from patients, carers, and healthcare providers, and then prioritise those that patients, carers, and healthcare providers agree are the most important for research to address.
In this protocol we use the term healthcare providers to refer to clinicians, but also allied healthcare personnel, and members of organisations involved in the delivery of DED care (e.g., NGOs).
The objectives of the PSP are to:
- work with patients, carers, and healthcare providers to identify uncertainties about the prevention and management of DED in LMICs;
- to agree on a prioritised list of those uncertainties for research;
- to publicise the results of the PSP and process; and
- to take the results to research commissioning bodies to be considered for funding.
The main scope of the DED in LMICs PSP is expected to be the prevention and management of DED in LMICs, focusing on four regions and one to two countries in each region. The regions are:
- Sub-Saharan Africa – Ethiopia and Kenya
- The Middle East – Pakistan
- South Asia – Nepal
- East Asia – Vietnam
- The Pacific – Fiji
The countries where the PSP will be active were decided in consultation with the Steering Group. Selection was based on burden of disease, maturity of the health care system, and World Bank income category. The scope of this PSP might be further refined in consultation with the Steering Group and key stakeholders.
Given the geographical area of the PSP, members of the Steering Group helped to inform the design of this initiative and will help with the delivery and dissemination of the survey and other activities to gather uncertainties and identify priorities in the country(ies) where they are active. This is in addition to the contribution that members of the Steering Group will make to the overall implementation of this PSP.
The Steering Group is responsible for discussing what implications the scope of the PSP will have for the evidence-checking stage of the process. Resources and expertise will be put in place to do this evidence checking.
The Steering Group
The Steering Group includes a balanced membership of patients, carers, and healthcare providers, as individuals or representatives from a relevant group.
The DED PSP will be led and managed by a Steering Group involving the following:
Patient and carer representative/s:
- Mr Reuben Magoko Carlo – Chairman of the Kenya Defeat Diabetes Association, patient representative
- Ms Shivanjani Iyer, founder of Youth Diabetes Fiji
Healthcare Providers representative/s:
- Mr Dhiraj Kumar Adhikary, Allied Ophthalmic Personnel, Nepal
- Mr Farooq Awan, Country Manager (NGO), Pakistan
- Dr Telaite Biu, Ophthalmologist, Fiji
- Ms Rashin Choudhry, DR Program Manager (NGO), Pakistan
- Dr Michael Gichangi, Ophthalmologist, Kenya
- Dr Amos Kibata Githeko, Ophthalmologist, Kenya
- Ms Lillian Kwamboka. Allied Ophthalmic Personnel, Kenya
- Dr Nyawira Mwangi, Ophthalmologist, Kenya
- Dr Eva Njenga, Diabetologist, Kenya
- Ms Komal Ram, DR Program Manager (NGO), Fiji and other Pacific Island Countries
- Dr Raba Thapa, Ophthalmologist, Nepal
- Dr Alemayehu Woldeyes, Ophthalmologist, Ethiopia
- Dr Cova Bascaran, DR-Net, UK
- Dr Fabrizio D’Esposito, IAPB DR Work Group, Australia
- Dr Sarity Dodson, The Fred Hollows Foundation, Australia
- Dr Mediya Rangi, The Fred Hollows Foundation
James Lind Alliance Adviser and Chair of the Steering Group:
- Suzannah Kinsella, 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, with input and advice from the JLA.
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:
- adult patients who have diabetes and/or diabetic retinopathy
- carers of people who have diabetes and/or diabetic retinopathy
- leading eye health NGOs (e.g., The Fred Hollows Foundation, Sightsavers, Orbis, CBM)
- professional associations (e.g., International Council of Ophthalmology)
- umbrella organisations (e.g., the International Agency for the Prevention of Blindness, the International Diabetes Federation, the NCD Alliance)
A detailed list of partners is provided in the following section.
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. More details of the method are in the Guidebook section of the JLA website at www.jla.nihr.ac.uk where examples of the work of other JLA PSPs can 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 DR PSP.
The following partners have been identified:
Global: Aravind, CBM, the Centre for Eye Research Australia, the Fred Hollows Foundation Australia, the Fred Hollows New Zealand, Hellen Keller International, the International Centre for Eye Health, the International Diabetes Federation, the NCD Alliance, Orbis International, the Seva Foundation, the Singapore National Eye Centre, Sightsavers, the World Diabetes Foundation, and any IAPB Members not already listed here.
Country level: the Clinical Officers Association of Kenya, the Diabetes Association of Pakistan, the Diabetes Endocrinology Association Nepal, the Diabetes Kenya Association, Nepal Diabetes Society, the Pacific Eye Institute, the Pacific Eye Care Society, and the Pakistan Endocrinology Society.
Step 2: Awareness raising
PSPs will need to raise awareness of their proposed activity among their patient, carer, and healthcare provider communities, in order to secure support and participation. This may be done by virtual/face-to-face meetings, or there may be other ways in which the process can be launched, e.g., via email and social media. The Steering Group should advise on when to do this. Awareness raising has several key 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 3: Identifying evidence uncertainties
The DED PSP will carry out a consultation to gather uncertainties from patients, carers, and healthcare providers. A period of four months will be given to complete this exercise (which may be revised by the Steering Group if required).
The DED PSP recognises that some groups may require additional consideration. For example, in certain contexts, local communication infrastructure and language barriers may require face to face consultations and data collection. We will work with members of the Steering Group from each country to coordinate these efforts. We will also support local members of the Steering Group to provide for participants’ accessibility requirements.
The Steering Group will use the following methods to reach the target groups:
- Online Survey
- Paper Survey
- Focus groups (face-to-face)
The online survey will be made available to people with diabetes, carers, and health care providers from all LMICs. The survey will be accessible through the IAPB website, on a dedicated webpage.
The online survey will be made available in English and in the local language of each of the focus countries in this PSP. In addition, the Steering Group may decide to make the survey available in other languages that are widely spoken in LMICs (e.g., French, Spanish, and Portuguese).
The online survey may not be readily accessible to this PSP’s target groups. To ensure that the voices of patients, carers, and health care providers from LMICs are heard and adequately represented in this PSP, the Steering Group agreed to implement additional strategies to collect uncertainties in each of the focus countries Collection of uncertainties in each of the countries is described below:
Ethiopia | TBC
Fiji | In Fiji uncertainties will be collected from:
- People with diabetes and their carers who attend awareness raising initiatives and/or eye health screenings in one rural and one urban setting;
- People with diabetes and their carers who present at diabetes and/or eye health clinics from one rural (or peri urban) and one urban setting;
- Health care providers from the diabetic retinopathy clinic in Suva (diabetic retinopathy technicians, eye nurses, and ophthalmologists);
- Nurses and physicians/surgeons from the diabetes clinic at the special outpatient departments from a semi-remote and urban setting; and
- Suva-based diabetes complication specialists (e.g., nephrologists).
Uncertainties will be collected through focus groups and face-to-face surveys. An adequately qualified and experience data collector will be recruited and trained for data collection and will be responsible for all face-to-face data collection in Fiji.
Kenya | In Kenya uncertainties will be collected from:
- People with diabetes and their carers attending diabetes support groups from rural and urban settings;
- People with diabetes and their carers presenting at diabetes clinics in one urban and one rural setting;
- people with diabetes and their carers presenting at eye health clinics in at least one urban and one rural setting;
- People with diabetes presenting at a tertiary eye care facility in one rural setting;
- Health care providers from the Diabetes Kenya Association;
- Health care providers from the Clinical Officers Association; and
- Health care providers from ISK.
Uncertainties will be collected through focus groups and face-to-face surveys. An adequately qualified and experience data collector will be recruited and trained for data collection and will be responsible for most face-to-face data collection. Some support group peer leaders may also be trained to carry out focus groups with their respective support groups. In selecting diabetes and eye clinics, the local team will also aim to include different types of providers (e.g., private, public, faith-based). In addition, the online survey will be shared with the mailing lists of the Diabetes Kenya Association and the Clinical Officers Association in English and in Swahili.
Nepal | In Nepal uncertainties will be collected from:
- People with diabetes presenting at the community eye centre in one rural and one urban setting;
- People with diabetes screened for diabetic retinopathy at the Kathmandu Hospital;
- People with diabetes presenting at the general clinics of an urban or semi-urban hospital;
- People with diabetes presenting at the tertiary eye hospital in Kathmandu;
- Female community volunteers from one urban and one rural setting;
- Allied Ophthalmic Personnel and Ophthalmologists from a secondary eye hospital and from the Tilganga Institute of Ophthalmology;
- Health care providers affiliated with the Nepal Diabetes Society; and
- Health care providers affiliated with the Diabetes and Endocrinology Association of Nepal
Uncertainties will be collected through focus groups and face-to-face surveys. The Nepali members of the Steering Group will carry out the data collection.
Pakistan | In Pakistan uncertainties will be collected from:
- People with diabetes presenting at one Basic Health Unit and one Rural Health Unit;
- People with diabetes presenting at least one Diabetes of Association of Pakistan clinic;
- People with diabetes presenting at two eye health clinics;
- Lady Health Workers practicing at two Basic Health Units;
- Healthcare providers caring for people with diabetes, ophthalmologists, and Ophthalmic Nurses from two district hospitals; and
- Diabetologists and Endocrinologists who are members of the Pakistan Endocrinology Society.
Uncertainties will be collected through focus groups and face-to-face surveys. An adequately qualified and experience data collector will be recruited and trained for data collection and will be responsible for most face-to-face data collection. In selecting eye clinics, the local team will also aim to include different types of providers (e.g., private and public). In addition, the online survey will be shared with the mailing lists of the Pakistan Endocrinology Society in English and in Urdu.
Existing sources of information on evidence uncertainties may also be searched. In particular, it is anticipated that the work of this PSP will be aligned with and complementary to a priority setting exercise being carried out by Cochrane Eyes and Vision Group. The priorities identified by the Cochrane Eyes and Vision Group may also be included in the list of uncertainties that will be prioritised by this PSP.
Step 4: Refining questions and uncertainties
The consultation process will produce ‘raw’ questions and comments indicating patients’, carers’, and healthcare providers’ areas of uncertainty. These raw questions will be categorised and refined by the Information Specialist from Cochrane Eyes and Vision Group, Iris Gordon, 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 Iris Gordon, the Information Specialist. Together with the Information Specialist, 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 Iris Gordon, the Information Specialist. This will show the checking undertaken to make sure that the uncertainties have not already been answered. 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.
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 the prevention and management of DED. This will involve input from patients, carers, and healthcare providers. 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 healthcare providers 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 is generally 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 healthcare providers 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.
Dissemination of results
The Steering Group will identify audiences with which it wants to engage when disseminating the results of the priority setting process, such as researchers, funders, and the patient and clinical communities. They will need to determine how best to communicate the results and who will take responsibility for this. Previous PSPs’ outputs have included academic papers, lay reports, infographics, conference presentations and videos for social media.
It should be noted that the priorities are not worded as research questions. The Steering Group should 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 International Agency for the Prevention of Blindness, The Fred Hollows Foundation, and Cochrane Eyes and Vision Group.
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 firstname.lastname@example.org.
Agreement of the Steering Group
The DED PSP Steering Group agreed the content and direction of this Protocol on June 1st, 2022.
1 International Diabetes Federation (2019) IDF Diabetes Atlas, 9th edn. International Diabetes Federation, Brussels.
2 Researchers will not participate in the prioritisation exercise. This is to ensure that the final prioritised research questions are those agreed by patients, carers and healthcare providers only, in line with the JLA’s mission.