Protocol for a realist and social return on investment evaluation of the use of patient-reported outcomes in four value-based healthcare programmes.

INTRODUCTION: There is growing recognition that in order to remain sustainable, the UK's National Health Service must deliver the best patient outcomes within available resources. This focus on outcomes relative to cost is the basis of value-based healthcare (VBHC) and has led to interest in the recording of patient-reported outcome measures (PROMs) to measure patient perspectives on the impact of a health condition on their lives. Every health board in Wales is now required to collect PROMS as part of routine care. We will evaluate the VBHC programme implemented in a lead health board. The study aim is to understand what works about PROMs collection, for whom, in what contexts and why in a VBHC context. In addition, we will assess the social value of integrating PROMs collection into routine care. METHODS AND ANALYSIS: A three-stage mixed-methods study comprising a realist evaluation integrated with social return on investment (SROI) analysis across four conditions; Parkinson's disease, epilepsy, heart failure and cataract surgery. Workstream 1: Development of logic models, informed by a scoping review, documentary analysis, patient and public involvement (PPI), staff and key stakeholder engagement. Workstream 2: Realist evaluation building on multiple data sources from stages 1 to 3 to test and refine the programme theories that arise from the logic model development. Workstream 3: SROI analysis using interview data with patients, staff and carers, stakeholder and PPI engagement, anonymised routinely collected data, and questionnaires to populate a model that will explore the social value generated by the implementation of PROMs. Findings across stages will be validated with key stakeholders. ETHICS AND DISSEMINATION: The study is approved by Wales Research Ethics Committee #5 (22/WA/0044). Outcomes will be shared with key stakeholders, published in peer-reviewed journals and presented at national and international conferences.This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) licence, which permits others to distribute, remix, adapt, build on this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial.

Feminizing care pathways: Mixed-methods study of reproductive options, decision making, pregnancy, post-natal care and parenting amongst women with kidney disease.

AIMS: To identify the needs, experiences and preferences of women with kidney disease in relation to their reproductive health to inform development of shared decision-making interventions. DESIGN: UK-wide mixed-methods convergent design (Sep 20-Aug 21). METHODS: Online questionnaire (n = 431) with validated components. Purposively sampled semi-structured interviews (n = 30). Patient and public input throughout. FINDINGS: Kidney disease was associated with defeminization, negatively affecting current (sexual) relationships and perceptions of future life goals. There was little evidence that shared decision making was taking place. Unplanned pregnancies were common, sometimes influenced by poor care and support and complicated systems. Reasons for (not) wanting children varied. Complicated pregnancies and miscarriages were common. Women often felt that it was more important to be a "good mother" than to address their health needs, which were often unmet and unrecognized. Impacts of pregnancy on disease and options for alternates to pregnancy were not well understood. CONCLUSION: The needs and reproductive priorities of women are frequently overshadowed by their kidney disease. High-quality shared decision-making interventions need to be embedded as routine in a feminized care pathway that includes reproductive health. Research is needed in parallel to examine the effectiveness of interventions and address inequalities. IMPACT: We do not fully understand the expectations, needs, experiences and preferences of women with kidney disease for planning and starting a family or deciding not to have children. Women lack the knowledge, resources and opportunities to have high-quality conversations with their healthcare professionals. Decisions are highly personal and related to a number of health, social and cultural factors; individualized approaches to care are essential. Healthcare services need to be redesigned to ensure that women are able to make informed choices about pregnancy and alternative routes to becoming a parent. PATIENT OR PUBLIC CONTRIBUTION: The original proposal for this research came from listening to the experiences of women in clinic who reported unmet needs and detailed experiences of their pregnancies (positive and negative). A patient group was involved in developing the funding application and helped to refine the objectives by sharing their experiences. Two women who are mothers living with kidney disease were co-opted as core members of the research team. We hosted an interim findings event and invited patients and wider support services (adoption, fertility, surrogacy, education and maternal chronic kidney disease clinics) from across the UK to attend. We followed the UK national standards for patient and public involvement throughout.

Analysis of content and online public responses to media articles that raise awareness of the opt-out system of consent to organ donation in England.

Background: Preceded by a national media campaign, in May 2020, England switched to a soft opt-out system of organ donation which rests on the assumption that individuals meeting specific criteria have consented to organ donation unless they have expressed otherwise. We aimed to learn more about how the changes were communicated, how people responded and any discrepancies between key messages and how they were interpreted by the public. Methods: Summative content analysis of 286 stories and related reader-generated comments in leading UK online news sources (April 2019 to May 2021). Further detailed thematic analysis of 21 articles with reader-generated content, complemented by thematic content analysis coding of all 286 stories. Results: Most media coverage on both organ donation and the law change was positive, with little variation over time or between publications. The importance of organ donation, benefits of the law change, and emotive stories (often involving children) of those who had donated an organ described as "superheroes" or those who had received organs as benefiting from a "miracle" were frequently cited. In contrast, reader-generated comments were markedly more negative, for example, focusing on loss of individual freedom and lack of trust in the organ donation system. Commentators wished to be able to choose who their organs were donated to, were dismissive and blaming towards minority ethnic groups, including undermining legitimate worries about the compatibility of organ donation with religious beliefs and end of life cultural norms, understanding and acceptance of brain-stem death and systemic racism. Misinformation including use of inflammatory language was common. Conclusion: The portrayal of donors and recipients as extraordinary is unlikely to help to normalise organ donation. Undermining legitimate concerns, in particular those from ethnic minorities, can alienate and encourage harmful misinformation in underrepresented groups. The discrepancies between the tone of the articles and the readers comments suggests a lack of trust across the public, health, policy and media outlets. Easily accessible, ongoing and tailored sources are needed to mitigate misinformation and disinformation and ensure key messages are better understood and accepted in order to realise the ambitions of soft opt-out organ donation policies.

Interventions for and experiences of shared decision-making underpinning reproductive health, family planning options and pregnancy for women with or at high risk of kidney disease: a systematic review and qualitative framework synthesis.

OBJECTIVE: To determine intervention effects and synthesise qualitative research that explored women with or at high risk of kidney disease experiences of shared decision-making in relation to their reproductive health, family planning options and pregnancy. DESIGN: A systematic review of interventions and a qualitative evidence synthesis. DATA SOURCES: We searched Cochrane, CINAHL, MEDLINE, Scopus, ProQuest, Elsevier, PubMed, ScienceDirect and Web of Science. ELIGIBILITY CRITERIA: Shared decision-making interventions and qualitative studies related to reproductive health involving women with or at high risk of kidney disease published from 1980 until January 2021 in English (clinical settings, global perspective). DATA EXTRACTION AND SYNTHESIS: Titles were screened against the inclusion criteria and full-text articles were reviewed by the whole team. Framework synthesis was undertaken. RESULTS: We screened 1898 studies. No evidence-based interventions were identified. 18 qualitative studies were included, 11 kidney disease-specific studies and 7 where kidney disease was a common comorbidity. Women frequently felt unprepared and uninformed about their reproductive options. Conversations with healthcare professionals were commonly described as frustrating and unhelpful, often due to a perceived loss of autonomy and a mismatch in preferences and life goals. Examples of shared decision-making were rare. Kidney disease exacerbated societal expectations of traditional gender roles (eg, wife, mother, carer) including capability to have children and associated factors, for example, parenting, (sexual) relationships, body image and independent living (including financial barriers to starting a family). Local interventions were limited to types of counselling. A new health system model was developed to support new interventions. CONCLUSION: There is a clear need to establish new interventions, test those already in development and develop new clinical guidance for the management of women with or at high risk of kidney disease in relation to their reproductive health, including options to preserve fertility earlier. Other health conditions with established personalised reproductive care packages, for example, cancer, could be used to benchmark kidney practice alongside the new model developed here.

Assessing the efficacy of coproduction to better understand the barriers to achieving sustainability in NHS chronic kidney services and create alternate pathways.

CONTEXT: Too many people living with chronic kidney disease are opting for and starting on hospital-based dialysis compared to a home-based kidney replacement therapy. Dialysis services are becoming financially unsustainable. OBJECTIVE: This study aimed to assess the efficacy of coproductive research in chronic kidney disease service improvement to achieve greater sustainability. DESIGN: A 2-year coproductive service improvement study was conducted with multiple stakeholders with the specific intention of maximizing engagement with the national health kidney services, patients and public. SETTING AND PARTICIPANTS: A national health kidney service (3 health boards, 18 dialysis units), patients and families (n = 50), multidisciplinary teams including doctors, nurses, psychologists, social workers, and so forth (n = 68), kidney charities, independent dialysis service providers and wider social services were part of this study. FINDINGS: Coproductive research identified underutilized resources (e.g., patients on home dialysis and social services) and their potential, highlighted unmet social care needs for patients and families and informed service redesign. Education packages were reimagined to support the home dialysis agenda including opportunities for wider service input. The impacts of one size fits all approaches to dialysis on specialist workforce skills were made clearer and also professional, patient and public perceptions of key sustainability policies. DISCUSSION AND CONCLUSIONS: Patient and key stakeholders mapped out new ways to link services to create more sustainable models of kidney health and social care. Maintaining principles of knowledge coproduction could help achieve financial sustainability and move towards more prudent adult chronic kidney disease services. PATIENT OR PUBLIC CONTRIBUTION: Involved in developing research questions, study design, management and conduct, interpretation of evidence and dissemination.

Understanding the low take-up of home-based dialysis through a shared decision-making lens: a qualitative study.

OBJECTIVES: To explore how people with chronic kidney disease who are pre-dialysis, family members and healthcare professionals together navigate common shared decision-making processes and to assess how this impacts future treatment choice. DESIGN: Coproductive qualitative study, underpinned by the Making Good Decisions in Collaboration shared decision-model. Semistructured interviews with a purposive sample from February 2019 - January 2020. Interview data were analysed using framework analysis. Coproduction of logic models/roadmaps and recommendations. SETTING: Five Welsh kidney services. PARTICIPANTS: 95 participants (37 patients, 19 family members and 39 professionals); 44 people supported coproduction (18 patients, 8 family members and 18 professionals). FINDINGS: Shared decision-making was too generic and clinically focused and had little impact on people getting onto home dialysis. Preferences of where, when and how to implement shared decision-making varied widely. Apathy experienced by patients, caused by lack of symptoms, denial, social circumstances and health systems issues made future treatment discussions difficult. Families had unmet and unrecognised needs, which significantly influenced patient decisions. Protocols containing treatment hierarchies and standards were understood by professionals but not translated for patients and families. Variation in dialysis treatment was discussed to match individual lifestyles. Patients and professionals were, however, defaulting to the perceived simplest option. It was easy for patients to opt for hospital-based treatments by listing important but easily modifiable factors. CONCLUSIONS: Shared decision-making processes need to be individually tailored with more attention on patients who could choose a home therapy but select a different option. There are critical points in the decision-making process where changes could benefit patients. Patients need to be better educated and their preconceived ideas and misconceptions gently challenged. Healthcare professionals need to update their knowledge in order to provide the best advice and guidance. There needs to be more awareness of the costs and benefits of the various treatment options when making decisions.

Seeking consent for organ donation: Process evaluation of implementing a new Specialist Requester nursing role.

AIM: To explain the differences in organ donation consent outcomes of a new nursing role (Specialist Requesters) derived from the United States (US) compared with the existing nursing role (Specialist Nurses in Organ Donation). DESIGN: Thirty-month observational qualitative process evaluation: Implementation theory-informed analysis. METHODS: Qualitative content analysis of free text describing challenges, processes and practice from 996 bespoke routinely collected potential organ donor 'approach forms' from two regions: one where there was no difference, and one with an observed difference in consent outcomes. RESULTS: Region A consent rate: Specialist Requester 75.8%, Specialist Nurse in Organ Donation71.8%. Region B consent rate: Specialist Requester 71.4%, Specialist Nurse in Organ Donation 82%. Region A Specialist Requesters turned the family position from no or uncertain to support organ donation in 73% of cases, compared with 27.4% in Region B. Two Specialist Requesters in Region A were highly effective. Region B experienced problems with intervention fidelity and implementation. CONCLUSIONS: The benefits of the Specialist Requester role remain unclear. Positive differences in consent rates achieved by Specialist Requesters in the originator region reduced over time and have yet to be successfully replicated in other regions. IMPACT: The impact of Specialist Requesters on consent outcomes varied across regions and it was not known why. Specialist Requesters in Region A were better at getting family member(s) to support organ donation. In Region B, Specialist Nurse in Organ Donation consent rates were higher and problems with intervention fidelity were identified (recruitment, staffing, less experience). Policy makers need to understand it is not just a matter of waiting for the Specialist Requester intervention to work. Ongoing training and recruiting the right people with the right skills need to be addressed and consistently reviewed.

Identifying integrated health services and social care research priorities in kidney disease in Wales: research prioritisation exercise.

OBJECTIVES: To identify the shared research priorities of patients, caregivers and multidisciplinary renal health and social care professionals across Wales for integrated renal health and social care in Wales. DESIGN: Research priority setting exercise adapted from the James Lind Alliance national priority setting partnership framework in UK healthcare. SETTING: Two workshops: one in North Wales with patients, caregivers and multidisciplinary renal health and social care professionals and one in South Wales with the Welsh Renal Clinical Network (commissioners of renal services in Wales). Additional input provided from stakeholders via email correspondence and face to face communications. PARTICIPANTS: Academics n=14, patients n=16, family/carers n=6, multidisciplinary renal healthcare professionals n=40, local authority councils n=3, renal charities n=6 wider third sector organisations n=8, renal industries n=4, Welsh government social care n=3, renal service commissioners n=8. RESULTS: 38 research priority questions grouped into 10 themes were agreed. The themes included: (1) integrating health and social care, (2) education, (3) acute kidney injury, (4) chronic kidney disease and cardiovascular disease, (5) transplantation, (6) dialysis, (7) personalised medicines, (8) cross-cutting priorities, (9) specific social contexts and (10) transitional services and children. Research questions were broad and covered a range of health and social care topics. Patient and professional perspectives broadly overlapped. Research priority setting activities revealed gaps in knowledge in overall service provision and potential areas for service improvement. CONCLUSIONS: Mapping priorities in health services and social care highlighted the research needed to support renal health services delivery and commissioning in Wales.

Which factors determine treatment choices in patients with advanced kidney failure? a protocol for a co-productive, mixed methods study.

INTRODUCTION: Kidney disease is common, affecting up to 1 in 10 of the adult population, and the numbers are expected to rise over the next decade. There are three main treatments that are available to patients with kidney disease: transplantation, dialysis and supportive care without dialysis. Dialysis can occur in a dialysis unit or in a person's home, but unit-based dialysis remains the most common initial treatment for patients in Wales. This is a cause for concern as most studies suggest that it is associated with the lowest quality of life and the highest mortality, and is a more expensive treatment option.This study aims to identify the factors that lead to patients choosing unit-based haemodialysis rather than home-based dialysis with a view to informing future changes in patient education and service commissioning in Wales. A secondary aim is to determine if the co-production of research leads to more sustainable services. METHODS AND ANALYSIS: This mixed-method study taking place between October 2018 and September 2020 will use a sequential explanatory design whereby the descriptive quantitative cross-sectional analysis of linked health and administrative data sets inform qualitative data collection from patients, carers and health and care professionals. Qualitative findings will be used to interpret or explain quantitative descriptive results. Additional strands to the study include a review of materials and education provided to patients and an economic review of treatment modalities. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from Health and Care Research Wales Research Ethics Committee #5. As a co-productive study involving patients, clinicians, third sector partners and academics, findings from this study will be shared on a continual basis. Study results will be published in peer-reviewed journals and presented at national and international conferences.