Participatory codesign of patient involvement in a Learning Health System: How can data-driven care be patient-driven care?

BACKGROUND: A Learning Health System (LHS) is a model of how routinely collected health data can be used to improve care, creating 'virtuous cycles' between data and improvement. This requires the active involvement of health service stakeholders, including patients themselves. However, to date, research has explored the acceptability of being 'data donors' rather than considering patients as active contributors. The study aimed to understand how patients should be actively involved in an LHS. DESIGN: Ten participatory codesign workshops were conducted with eight experienced public contributors using visual, collective and iterative methods. This led contributors to challenge and revise not only the idea of an LHS but also revise the study aims and outputs. RESULTS: The contributors proposed three exemplar roles for patients in patient-driven LHS, which aligned with the idea of three forms of transparency: informational, participatory and accountability. 'Epistemic injustice' was considered a useful concept to express the risks of an LHS that did not provide active roles to patients (testimonial injustice) and that neglected their experience through collecting data that did not reflect the complexity of their lives (hermeneutic injustice). DISCUSSION: Patient involvement in an LHS should be 'with and by' patients, not 'about or for'. This requires systems to actively work with and respond to patient feedback, as demonstrated within the study itself by the adaptive approach to responding to contributor questions, to work in partnership with patients to create a 'virtuous alliance' to achieve change. PATIENT OR PUBLIC CONTRIBUTION: Public contributors were active partners throughout, and co-authored the paper.

Effectiveness of complex behaviour change interventions tested in randomised controlled trials for people with multiple long-term conditions (M-LTCs): systematic review with meta-analysis.

INTRODUCTION: The prevalence of multiple long-term conditions (M-LTCs) increases as adults age and impacts quality of life and health outcomes. To help people manage these conditions, complex behaviour change interventions are used, often based on research conducted in those with single LTCs. However, the needs of those with M-LTCs can differ due to complex health decision-making and engagement with multiple health and care teams. OBJECTIVES: The aim of this review is to identify whether current interventions are effective for people living with M-LTCs, and which outcomes are most appropriate to detect this change. METHODS: Five databases (MEDLINE, Embase, PsycINFO, CINAHL and Web of Science) were systematically searched, between January 1999 and January 2022, to identify randomised controlled trials evaluating effectiveness of behaviour change interventions in people with M-LTCs. Intervention characteristics, intervention effectiveness and outcome measures were meta-analysed and narratively synthesised. RESULTS: 53 eligible articles were included. Emotional well-being and psychological distress (depression and anxiety) outcomes were most amenable to change (emotional well-being: standardised mean difference (SMD) 0.31 (95% CI 0.04 to 0.58); depression psychological distress: SMD -0.45 (95% CI -0.73 to -0.16); anxiety psychological distress: SMD -0.14 (95% CI -0.28 to 0.00)), particularly for interventions with a collaborative care approach. Interventions targeting those with a physical and mental health condition and those with cognitive and/or behavioural activation approach saw larger reductions in psychological distress outcomes. Interventions that lasted for longer than 6 months significantly improved the widest variety of outcomes. CONCLUSION: Complex interventions can be successfully delivered to those with M-LTCs. These are most effective at reducing psychological distress in those with physical and mental LTCs. Further research is needed to identify the effective components of interventions for people with two or more physical LTCs and which outcome is most appropriate for detecting this change.

Distinguishing emotional distress from mental disorder in primary care: a qualitative exploration of the Four-Dimensional Symptom Questionnaire.

BACKGROUND: Primary care clinicians see people experiencing the full range of mental health problems. Determining when symptoms reflect disorder is complex. The Four-Dimensional Symptom Questionnaire (4DSQ) uniquely distinguishes general distress from depressive and anxiety disorders. It may support diagnostic conversations and targeting of treatment. AIM: To explore peoples' experiences of completing the 4DSQ and their perceptions of their resulting score profile across distress, depression, anxiety, and physical symptoms. DESIGN AND SETTING: A qualitative study was conducted in the UK with people recruited from primary care and community settings. METHOD: Participants completed the 4DSQ then took part in semi-structured telephone interviews. They were interviewed about their experience of completing the 4DSQ, their perceptions of their scores across four dimensions, and the perceived utility if used with a clinician. Interviews were transcribed verbatim and data were analysed thematically. RESULTS: Twenty-four interviews were conducted. Most participants found the 4DSQ easy to complete and reported that scores across the four dimensions aligned well with their symptom experience. Distinct scores for distress, depression, and anxiety appeared to support improved self-understanding. Some valued the opportunity to discuss their scores and provide relevant context. Many felt the use of the 4DSQ with clinicians would be helpful and likely to support treatment decisions, although some were concerned about time-limited consultations. CONCLUSION: Distinguishing general distress from depressive and anxiety disorders aligned well with people's experience of symptoms. Use of the 4DSQ as part of mental health consultations may support targeting of treatment and personalisation of care.

Reflections of patient and public involvement from a commissioned research project evaluating a nationally implemented NHS programme focused on diabetes prevention.

Patient and Public Involvement and Engagement (PPIE) in research is recognised by the National Institute for Health and Care Research as crucial for high quality research with practical benefit for patients and carers. Patient and public contributors can provide both personal knowledge and lived experiences which complement the perspectives of the academic research team. Nevertheless, effective PPIE must be tailored to the nature of the research, such as the size and scope of the research, whether it is researcher-led or independently commissioned, and whether the research aims to design an intervention or evaluate it. For example, commissioned research evaluations have potential limits on how PPIE can feed into the design of the research and the intervention. Such constraints may require re-orientation of PPIE input to other functions, such as supporting wider engagement and dissemination. In this commentary, we use the 'Guidance for Reporting Involvement of Patients and the Public' (GRIPP2) short form to share our own experiences of facilitating PPIE for a large, commissioned research project evaluating the National Health Service Diabetes Prevention Programme; a behavioural intervention for adults in England who are at high risk of developing type 2 diabetes. The programme was already widely implemented in routine practice when the research project and PPIE group were established. This commentary provides us with a unique opportunity to reflect on experiences of being part of a PPIE group in the context of a longer-term evaluation of a national programme, where the scope for involvement in the intervention design was more constrained, compared to PPIE within researcher-led intervention programmes. We reflect on PPIE in the design, analysis and dissemination of the research, including lessons learned for future PPIE work in large-scale commissioned evaluations of national programmes. Important considerations for this type of PPIE work include: ensuring the role of public contributors is clarified from the outset, the complexities of facilitating PPIE over longer project timeframes, and providing adequate support to public contributors and facilitators (including training, resources and flexible timelines) to ensure an inclusive and considerate approach. These findings can inform future PPIE plans for stakeholders involved in commissioned research.

Codesign of a digital health tool for suicide prevention: protocol for a scoping review.

INTRODUCTION: The role of digital health in providing psychological treatment and support for the prevention of suicide is well documented. Particular emphasis has been placed on digital health technologies during the COVID-19 pandemic. Providing psychological support reduces the burden of mental health conditions. The challenge is to provide support in the context of patient isolation, which highlights the role of digital technology (video conferencing, smartphone apps and social media). There is, however, a dearth of literature where experts by experience have been involved in the end-to-end process of developing digital health tools for suicide prevention. METHODS AND ANALYSIS: This study aims to codesign a digital health tool for suicide prevention focusing on the enablers and barriers. The scoping review protocol is phase I within a three-phase study. The protocol will inform the second phase of the study which is the scoping review. The results of the review will inform a funding application to National Institute for Health and Care Research to codesign a digital health tool for suicide prevention (the third phase). The search strategy will follow the Joanna Briggs Institute Reviewer's Manual for Scoping Reviews and incorporates the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist to ensure reporting standards are maintained. The methodology will be supplemented by frameworks by Arksey and O'Malley and Levac et al. The search strategy dates for screening are from November 2022 to March 2023. Five databases will be searched: Medline, Scopus, CINAHL, PsycInfo and Cochrane Database of Systematic Reviews. Grey literature searches include government and non-government health websites, Google and Google Scholar. The data will be extracted and organised into relevant categories. The results will be synthesised into themes and inform phase II of the study. ETHICS AND DISSEMINATION: Ethics granted by the University of Bradford on 15 August 2022, reference E995. The project team will design a digital health tool, results will be published in a peer-review journal and disseminated through conferences. STUDY REGISTRATION NUMBER: Safety (Mental Health) Innovation Challenge Fund 2022-2023 Protocol RM0223/42079 Ver 0.1.

Frameworks for Implementation, Uptake, and Use of Cardiometabolic Disease-Related Digital Health Interventions in Ethnic Minority Populations: Scoping Review.

BACKGROUND: Digital health interventions have become increasingly common across health care, both before and during the COVID-19 pandemic. Health inequalities, particularly with respect to ethnicity, may not be considered in frameworks that address the implementation of digital health interventions. We considered frameworks to include any models, theories, or taxonomies that describe or predict implementation, uptake, and use of digital health interventions. OBJECTIVE: We aimed to assess how health inequalities are addressed in frameworks relevant to the implementation, uptake, and use of digital health interventions; health and ethnic inequalities; and interventions for cardiometabolic disease. METHODS: SCOPUS, PubMed, EMBASE, Google Scholar, and gray literature were searched to identify papers on frameworks relevant to the implementation, uptake, and use of digital health interventions; ethnically or culturally diverse populations and health inequalities; and interventions for cardiometabolic disease. We assessed the extent to which frameworks address health inequalities, specifically ethnic inequalities; explored how they were addressed; and developed recommendations for good practice. RESULTS: Of 58 relevant papers, 22 (38%) included frameworks that referred to health inequalities. Inequalities were conceptualized as society-level, system-level, intervention-level, and individual. Only 5 frameworks considered all levels. Three frameworks considered how digital health interventions might interact with or exacerbate existing health inequalities, and 3 considered the process of health technology implementation, uptake, and use and suggested opportunities to improve equity in digital health. When ethnicity was considered, it was often within the broader concepts of social determinants of health. Only 3 frameworks explicitly addressed ethnicity: one focused on culturally tailoring digital health interventions, and 2 were applied to management of cardiometabolic disease. CONCLUSIONS: Existing frameworks evaluate implementation, uptake, and use of digital health interventions, but to consider factors related to ethnicity, it is necessary to look across frameworks. We have developed a visual guide of the key constructs across the 4 potential levels of action for digital health inequalities, which can be used to support future research and inform digital health policies.

More than a method: trusting relationships, productive tensions, and two-way learning as mechanisms of authentic co-production.

BACKGROUND: Knowledge mobilisation requires the effective elicitation and blending of different types of knowledge or ways of knowing, to produce hybrid knowledge outputs that are valuable to both knowledge producers (researchers) and knowledge users (health care stakeholders). Patients and service users are a neglected user group, and there is a need for transparent reporting and critical review of methods used to co-produce knowledge with patients. This study aimed to explore the potential of participatory codesign methods as a mechanism of supporting knowledge sharing, and to evaluate this from the perspective of both researchers and patients. METHODS: A knowledge mobilisation research project using participatory codesign workshops to explore patient involvement in using health data to improve services. To evaluate involvement in the project, multiple qualitative data sources were collected throughout, including a survey informed by the Generic Learning Outcomes framework, an evaluation focus group, and field notes. Analysis was a collective dialogic reflection on project processes and impacts, including comparing and contrasting the key issues from the researcher and contributor perspectives. RESULTS: Authentic involvement was seen as the result of "space to talk" and "space to change". "Space to talk" refers to creating space for shared dialogue, including space for tension and disagreement, and recognising contributor and researcher expertise as equally valuable to the discussion. 'Space to change' refers to space to adapt in response to contributor feedback. These were partly facilitated by the use of codesign methods which emphasise visual and iterative working, but contributors emphasised that relational openness was more crucial, and that this needed to apply to the study overall (specifically, how contributors were reimbursed as a demonstration of how their input was valued) to build trust, not just to processes within the workshops. CONCLUSIONS: Specific methods used within involvement are only one component of effective involvement practice. The relationship between researcher and contributors, and particularly researcher willingness to change their approach in response to feedback, were considered most important by contributors. Productive tension was emphasised as a key mechanism in leading to genuinely hybrid outputs that combined contributor insight and experience with academic knowledge and understanding.

We conducted a study exploring how patients could be involved in improving services using health data. This paper reports on the evaluation of that study. We collected different kinds of feedback throughout, including a survey of impacts on contributors, a focus group to reflect on what worked well and what could be done better, and also sharing thoughts throughout the study itself. We analysed this feedback together, to make sure that both contributor and researcher perspectives were considered equally.We found that the successful co-production that happened during the study was the result of having 'space to talk' and 'space to change'. Space to talk that meant we all shared our views and recognised each other as experts bringing equally important knowledge. Space to change meant that we acted on the knowledge shared, to change both the study and to change how we worked together.We found that these themes occurred at multiple levels. They were partly achieved by the specific participatory codesign methods that were used, but equally or perhaps more important was the trusting relationship between the researcher and contributors, including openness to explore tensions. The wider systems that supported involvement, in this case the financial reimbursement for contributor time, were also as important to this as the things that happened within the study itself.We recommend that future work creates 'space to talk' and 'space to change', and reports openly on how both contributors and researchers are affected by this.

Using patient and public involvement to improve the research design and funding application for a project aimed at fostering a more collaborative approach to the NHS health check: the CaVIAR project (better Care Via Improved Access to Records).

BACKGROUND: Following an initial NHS Health Check appointment, the National Institute for Health and Care Excellence (NICE) suggest patients with QRISK2 scores of ≥10% should be offered advice on lifestyle and the risks and benefits of starting a statin. NICE recommend GPs should ascertain patients' pre-existing knowledge of cardiovascular disease risk, explore health beliefs, assess readiness to change, offer support, and engage family members. Condensing this complex discussion into a short consultation may result in inadequate patient understanding of the benefits of preventive measures. An alternative approach is needed. We propose a digital adjunct giving patients the opportunity to interact with their health check results from home before returning to see their GP. Before embarking on funding applications we sought the views of patients and members of the public. METHODS: We consulted the Primary Care Research in Manchester Engagement Resource (PRIMER), an established departmental Patient and Public Involvement (PPI) group (N = 9) and then ran a workshop with 19 members of the public, co-facilitated by 4 members of PRIMER. Following a brief presentation on the background to the project, attendees were split into four groups and introduced to Ketso, a toolkit for creative engagement. Ketso was used to encourage group discussions regarding the project idea. RESULTS: This PPI work improved the study design and proposed intervention. Discussions focussed on three themes: 1) positive feedback, 2) challenges and solutions, and 3) improvements/alternatives. Positive feedback included benefits to the NHS and patients. Challenges identified related to: 1) access, 2) data security, 3) engagement, and 4) negative consequences. Workshop members generated various solutions to these challenges and made additional suggestions for improvement relating to: 1) population (e.g. also including those with QRISK2 scores ≤10%), 2) duration (e.g. ongoing access to provide continued feedback), and 3) platform content (e.g. signposting to relevant services). CONCLUSIONS: This PPI work helped identify potential challenges and solutions not previously considered by the research team. Findings have informed the subsequent intervention design and strengthened the bid for funding. We aim to ensure ongoing patient and public involvement in all future stages.