Inflammatory Bowel Disease (Australia) Protocol

Contents

Purpose of the RPP and background

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Inflammatory Bowel Disease (IBD) Research Priorities Project (RPP) in line with James Lind Alliance (JLA) principles. The Protocol is a JLA requirement and will be published on the RPP’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 Priority Setting Partnerships (PSP). 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 Crohn’s & Colitis Australia (CCA) RPP is a project that will use the same approach as a PSP using a different funding model. Whereas JLA PSPs do not have direct links to commercial funding sources, the JLA has agreed to work with Crohn’s and & Colitis Australia under the aegis of its JLA Lab (a conceptual experimental space) to develop a priority setting exercise that replicates the JLA method but is funded by mixed unrestricted grants from two pharmaceutical organisations and philanthropy. The pharmaceutical organisations will not take part in the process or have access to data or materials of the priority setting work until it is publicly available information. There is no requirement to report to the funders during the process, other than to mention the source of funding in any publications. As this is clearly distinct from the JLA’s PSP principles, the work of the IBD RPP will not be described, branded or reported as a JLA PSP, but it will still follow the JLA’s rigorous and inclusive priority setting method. The JLA will assess the outcomes and any impact of the commercial funding source on the process, and report back on all findings, including how the project is perceived externally.

The aim of the RPP 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 and RPPs, based at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton, UK.

CCA lead a consortium of contributors to develop an IBD National Action Plan in 2019 published by the Australian Government. The plan notes the need for a focus on research as a priority, but does not specify research areas for attention. CCA identified JLA and the PSP process to assist it to identify the priority areas for IBD research using a proven and rigorous method.

Aims, objectives and scope of the RPP

The aim of the IBD RPP is to identify the unanswered questions about inflammatory bowel disease 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 objectives of the RPP are to:

  • work with patients, carers and clinicians to identify uncertainties about IBD prevention, treatment, symptoms, diagnosis, and living with IBD
  • to agree by consensus a prioritised list of those uncertainties, for research
  • to publicise the results of the RPP and process
  • to take the results to research commissioning bodies to be considered for funding.

The scope of the RPP is defined as:

  • prevention (limited to lifestyle factors)
  • treatment
  • symptoms
  • diagnosis
  • living with IBD
  • inclusive of Crohn’s disease, ulcerative colitis and IBD unclassified
  • Paediatric and adult

The RPP will exclude from its scope questions about:

  • Microscopic colitis and other forms of inflammatory enteritis

The Steering Group is responsible for discussing what implications the scope of the RPP 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 membership of patients and carers and clinicians , as individuals or representatives from a relevant group.

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

Patient and carer representative/s:

Blake Tierney Person Living with IBD
Marnie O’Brien Person Living with IBD
Cassandra Anslow Parent/Carer of a Person Living with IBD
A/Prof Leanne Raven CCA
Wayne Massuger CCA (Project Lead)

Clinical representative/s:

Prof Paul Pavli CCA Director, GESA (Co Chair)
Dr Rimma Goldberg Gastroenterologist GESA (Information Specialist)
A/Prof Antonina Mikocka-Walus Psychologist APS
A/Prof Susan Connor Gastroenterologist GESA
Dr Emma Halmos Dietitian  DAA, DECCAN
Dr Ed Giles Paediatric Gastroenterologist GESA
Claire Reilly IBD Nurse Practitioner GENCA

Project coordinator: Hailey Fisher CCA
James Lind Alliance Adviser and Co - chair of the Steering Group: Katherine Cowan

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 RPP as partners. Partners are organisations or groups who will commit to supporting the RPP, 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 RPP. Partners represent the following groups:

  • people who have had IBD
  • carers of people who have had IBD
  • health and social care professionals - with experience of IBD

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 RPP, 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 RPP will use

This section describes a schedule of proposed steps through which the RPP 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 RPP’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 RPP.

Step 2: Awareness raising

RPPs will need to raise awareness of their proposed activity among their patient, carer and clinician communities, in order to secure support and participation. Depending on budget, this may be done by a face-to-face meeting, or there may be other ways in which the process can be launched, e.g. via social media. It may be carried out as part of steps 1 and/or 3. The Steering Group should advise on when to do this. Awareness raising has several key objectives:

  • to present the proposed plan for the RPP
  • 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 RPP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of 6 months will be given to complete this exercise (which may be revised by the Steering Group if required).

The RPP recognises that the following groups may require additional consideration.

  • Parents of children with IBD
  • Rural and Regional
  • CALD
  • Non-members of CCA

The Steering Group will use the following methods to reach the target groups

Online and hard copy surveys via:

  • CCA membership and social media followers
  • Non CCA consumer groups IBD Support, Australian Crohn’s & Colitis Facebook Group and other Facebook/Instagram accounts
  • and rural/regional groups for IBD
  • Royal Flying Doctors Service, GESA, IBD Nurses Australia, GENCA, and other professional associations clinicians/organisations
  • in rural/remote areas.
  • Cultural groups and associations
  • Private clinics/clinicians in rural/regional areas.

Existing sources of evidence uncertainties may also be searched. [Nil identified.]

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 information specialist 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 information specialist. The RPP 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 RPP 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 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 RPP 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 IBD. This will involve input from patients, carers and clinicians. The JLA encourages RPPs 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.

1. 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.

2. 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 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.

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 RPPs’ 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 RPP will be led by the project lead and CCA CEO.

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

Agreement of the Steering Group

The IBD RPP Steering Group agreed the content and direction of this Protocol in December 2020.