Digital Technology for Adolescents and Young Persons with Inflammatory Bowel Disease PSP Protocol

Purpose of the PSP and background

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Digital Technology for Adolescents and Young Persons with Inflammatory Bowel Disease (IBD) 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 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.

Digital technologies have huge potential to capture patient data for research and support patient clinical care. The current technologies in use are mainly driven by health care providers working with commercial developers to address specific issues. Research to support their benefits and value in clinical practice is sparse. A roadmap into the potential role of digital technologies to support research is lacking. The PSP will offer a road map for health research funders working with commercial digital developers to examine the digital technologies to support 1) clinical research using digital tools and 2) research to deliver high quality clinical care that is reflective of patient needs. There are several funding calls to support digital technologies in health care. The NIHR i4i and AI health and care awards and other NHSX supported funds such as NHS test beds. For each application patients’ views are considered in a piece meal and disconnected manner. The PSP offers a unique opportunity to bring together key stakeholders to examine the whole landscape and define priorities to formulate a roadmap for years to come.

Aims, objectives and scope of the PSP

The aim of the Digital Technology for Adolescents and Young Persons with IBD PSP is to identify the unanswered questions about digital technology for adolescents and young persons with IBD [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 PSP are to:

• Work with patients, carers and healthcare professionals to identify uncertainties and unanswered questions about the role of digital technologies to improve care for adolescents and young persons with IBD;
• To agree by consensus a prioritised list of those uncertainties, for research;
• To publicise the results of the PSP and process; and
• To make results available to research commissioning bodies.

This PSP looks at digital health technology for the adolescent and young person (up to age 25 years) with IBD. Digital technologies refers to all interventions, tools and services that cover the patient journey (including but not limited to diagnostics, treatment support, monitoring, self-management, participation in research studies, use of transformative approaches such as virtual reality) using information communications technology (including but not limited to mobile phone applications, social media, chat bot, electronic portals) with the intention of improving health and accessibility to patients and/or parents/carers and/or healthcare professionals.

Adolescent and Young Person refers to the period of Adolescence during which there is biological, social, and psychological development. Previous work has clearly demonstrated that the brain undergoes significant structural and functional changes during adolescence, beginning around the onset of puberty and continuing until young people are at least 25 years of age. However, the exact timing and nature of this development is unique to each individual and is influenced by several factors, such as socioeconomic status, peer relationships, and parenting style. Such individual differences mean that two adolescents of the same age are often at different stages in their developmental trajectories; chronological age does not necessarily equate to developmental stage and highlights the need to provide developmentally appropriate healthcare. With this in mind, for the purposes of this PSP, we have chosen to not have a lower age limit to ensure that adolescents of any age (up to age 25 years) who are interested in participating are able to do so.

The PSP will exclude from its scope questions about:

• Technology that is not suitablefor an adolescent and young person with IBD.
• Electronic health records or healthcare administrative systems that are used solely by health care professionals.

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

The Digital Technology for Adolescents and Young Persons with IBD PSP will be led and managed by a Steering Group involving the following:

Patient and carer representative/s:

• Sophie Randall (Patient Information Forum)
• Ruth Wakeman (CCUK Representative)
• Rachel Ainley (CCUK Representative)
• Philip Smith (CICRA Representative)
• Jess Manson (Patient Representative)
• Anthony Kalli (Parent Representative

Clinical representative/s:

• Naila Arebi (PSP Project Co-Lead, Adult Gastroenterologist, BSG AYP Committee)
• Priya Narula (PSP Project Co-Lead, Paediatric Gastroenterologist, BSG AYP, BSPGHAN, NIHR Children and Young People MedTech Co-operative)
• Seb Shaji (Adult Gastroenterologist, BSG IBD Clinical Research Group Committee)
• Marco Gasparetto (Paediatric Gastroenterologist, BSPGHAN Research Chair)
• John McLaughlin (Adult Gastroenterologist, BSG AI Task Force and Expertise in PSP)
• Charlotte Wong (Adult Gastroenterology Trainee)
• Lisa Younge (IBD Nurse Consultant)
• Jochen Kammermeier (Paediatric Gastroenterologist, BSPGHAN IBD Chair)
• Gemma Lee (Paediatric Nurse, BSPGHAN Associate Member)
• Arati Rao (Paediatric Gastroenterology Trainee)
• Avani Devkaran (GP Clinical Lead, HVCCG)

Project coordinator:

• Philippa Howsley, NIHR Children and Young People MedTech Co-operative

James Lind Alliance Adviser and Chair of the Steering Group:

• Patricia Ellis, 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.

Partners

Organisations and individuals will be invited to be involved with the PSP as partners CCUK and CICRA. 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 have had IBD;
• carers of people who have had IBD; and
• 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 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 Digital Technology for Adolescents and Young Persons with IBD PSP.

Step 2: Awareness raising

PSPs 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 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 Digital Technology for Adolescents and Young Persons with IBD PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of [? 6-8 weeks] will be given to complete this exercise (which may be revised by the Steering Group if required).

The Digital Technology for Adolescents and Young Persons with IBD PSP recognises that the following groups may require additional consideration. [If applicable, the Steering Group should consider the nature of the groups that it is targeting, their needs and how to reach potentially seldom heard or marginalised communities - insert relevant information here].

The Steering Group will use the following methods to reach the target groups [The Steering Group should advise and agree on the best method of consultation for reaching its groups. Previous PSPs have, for example, developed online and paper surveys, or carried out face-to-face work where groups are unlikely to access the internet. The aim is to be inclusive]

• Online surveys – link on social media of IBD charities, and of national paediatric and adult societies (BSPGHAN, BSG)
• GPs could share the survey link with their IBD patients

Existing sources of evidence uncertainties may also be searched. [Please indicate which, if any, are being included, for example question-answering services 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. Newsletters of IBD charities]

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 Dr Wong and Dr Rao 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 Dr Rao and Dr Wong. 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 TBC [insert name/s]. 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 Digital Technology for Adolescents and Young Persons with IBD PSP. 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.

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 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 ? Dr Arebi and Dr Narula [insert name/s].

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 Digital Technology for Adolescents and Young Persons with IBD PSP Steering Group agreed the content and direction of this Protocol on [insert date].