Health Research Partnership Research Articles

Partnership between a consumer-led mental health research network and a large mental health research organisation: an Australian mixed methods case study

AimThis paper presents a case study review of an Australian research partnership between an independent mental health lived experience-led research network and an academic organisation established for the research and treatment of disorders of the brain and mind. The aim of the study was to explore the principles and practical requirements needed for a successful partnership that promotes inclusive research practices and power sharing and provide a framework to improve the operationalization of future similar partnerships.MethodsThis study was led and conducted by lived experience researchers. We used a mixed-method approach to data collection for data triangulation. An environmental scan of peer-reviewed and grey literature on mental health research partnerships was conducted, followed by a three-part data collection with members of both organisations. Data collection comprised an online survey, in-depth interviews, and a roundtable discussion to integrate findings and formulate recommendations.Results and ConclusionThis case study explores and describes a missed opportunity of a consumer led mental health research organisation to work successfully with an established mental health research organisation. Poor communication and unclear processes led to unmet expectations on both sides. Findings suggest the use of reflective practice by team members of both partner organisations may have been helpful in identifying further improvements to inclusive research practice, empowering consumers in inclusive mental health research.

Development and evaluation of an anti-ageism advisory group with older adults and gerontological experts: a qualitative descriptive study

BackgroundIn recent years, academics have increasingly acknowledged the importance of involving health service users and community stakeholders as active partners in health research. Yet, the involvement of older adults, the largest group of health service users, as research partners remains limited, possibly due to ageist attitudes that devalue older adults’ contributions. During the three years of our Awakening Canadians to Ageism study, we convened an advisory group consisting of older adults and gerontological experts to discuss issues related to ageism, help interpret the study findings, and develop a range of knowledge mobilization strategies to dispel ageism.MethodsTo understand the experiences of members of the advisory group and solicit recommendations for improving future groups, we conducted a qualitative descriptive study and interviewed 8 older adults and 6 gerontological experts. Data were content analyzed.ResultsFour categories that were developed to explain participants’ experiences and suggestions for future advisory groups included: organization and management, group experience, suggestions for future advisory groups and moving forward. A key finding was the value that the older adults and gerontological experts ascribed to conversations about the prevalence of ageism and their desire to continue these types of conversations in their personal groups and professional networks. Numerous helpful strategies for future advisory groups were identified, such as enhancing social diversity, both in terms of racial/ethnic/cultural representation and gender. Older adults wanted more “getting to know you time” in meetings and gerontological experts wanted more details about the research process and their role.ConclusionsThis study’s partnership approach can guide researchers seeking to involve key health service users and community stakeholders in health research and help enact positive social change.

Inclusion of librarians and information professionals in Canadian knowledge synthesis grant funding.

Librarians continually advocate for the expertise they can bring to knowledge synthesis research projects. Professional associations like the Canadian Health Libraries Association aim to promote librarians and information professionals as partners in health research. This push for representation must happen at a policy level to enact change. To that purpose, we explored the degree to which the inclusion of librarians and information professionals is represented at the funding level by healthcare research organizations in Canada. We used a list of health research funding agencies generated from Scopus searches and an independent search of Canadian health research institutions, governmental health authorities, professional associations, and research-oriented universities to identify research grants designed for knowledge synthesis research. We examined these grants to determine whether they require or specifically mention librarians in their eligibility criteria. Of the 14 knowledge synthesis grants we identified, only one required a health librarian as a member of the research team in the grant eligibility criteria. Four grants "strongly recommended" the inclusion of librarians on the research team, though this inclusion was not a contingency for funding. Most knowledge synthesis grants in Canada do not require, recommend, or mention librarians as members of the research or authorship team. Evidence suggests that librarian involvement substantially improves the quality of knowledge synthesis research projects; it would therefore benefit both librarians and knowledge synthesis work to advocate for librarian involvement as a contingency for grant funding.

Withdrawal of renin-angiotensin system inhibitors’ effect on estimated glomerular filtration rate in adults with advanced kidney disease: the STOP-ACEi RCT

Background Renin–angiotensin system inhibitors, both angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, slow progression of mild and moderate chronic kidney disease. However, some evidence suggests that discontinuation of renin–angiotensin system inhibitors in patients with advanced chronic kidney disease might increase estimated glomerular filtration rate or slow its decline. Objective To test the hypothesis that stopping angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, or a combination of both, compared with continuing these treatments, improves or stabilises kidney function in patients with progressive stages 4 or 5 chronic kidney disease based on assessment of kidney function using the modification of diet in renal disease four-variable estimated glomerular filtration rate at 3 years, follow-up. Setting Thirty-seven UK hospitals with kidney services. Design An investigator-led multicentre open-label, randomised controlled trial of 411 participants with advanced (stage 4 or 5) progressive chronic kidney disease. Participants Adult patients with advanced (estimated glomerular filtration rate < 30 ml/minute/1.73 m2) and progressive chronic kidney disease who were receiving either angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, or a combination of both. Interventions Participants were randomised in a 1 : 1 ratio using a centralised internet-based system to either discontinue renin–angiotensin system inhibitors (n = 206) or continue renin–angiotensin system inhibitors (n = 205). Main outcome measures The primary outcome was the estimated glomerular filtration rate at 3 years; measurements of estimated glomerular filtration rate made after commencing kidney replacement therapy were excluded. Secondary outcomes included development of end-stage kidney disease or starting kidney replacement therapy, a composite of either a > 50% decline in estimated glomerular filtration rate or commencement of kidney replacement therapy (including end-stage kidney disease), cystatin C, hospitalisations, blood pressure, exercise capacity and quality of life. Cardiovascular events, death and safety were recorded. Results At 3 years, the least-squares mean (± standard error) estimated glomerular filtration rate was 12.6 ± 0.7 ml/minute/1.73 m2 in the discontinuation group and 13.3 ± 0.6 ml/minute/1.73 m2 in the continuation group [difference −0.7, 95% confidence interval (−2.5 to 1.0; p = 0.42)] with a negative value favouring the continuation group. The treatment effect did not differ (heterogeneity) when data were analysed by the pre-specified subgroups. End-stage kidney disease or kidney replacement therapy occurred in 128 (62%) and 115 (56%) participants randomised to the discontinue and continue renin–angiotensin system inhibitor groups, respectively (hazard ratio 1.28, 95% confidence interval 0.99 to 1.65). The numbers of cardiovascular events and deaths observed were similar for those randomised to discontinue (108 events and 20 deaths) or continue (88 events and 22 deaths) renin–angiotensin system inhibitors. Limitations Non-white ethnic backgrounds were poorly represented, limiting the generalisability of our findings. The open-label nature of the trial may have affected clinical care and subjective end points, such as quality of life and exercise capacity. We only included patients who were receiving renin–angiotensin system inhibitors at the time of randomisation, thus excluding those who had already discontinued these agents. Conclusions Discontinuing renin–angiotensin system inhibitors in advanced and progressive chronic kidney disease does not cause a clinically relevant change in estimated glomerular filtration rate or difference in its long-term decline. Future work Future work should focus on updating clinical guidelines. Further analyses, in addition to the prespecified analyses, may be undertaken if new estimated glomerular filtration rate equations are introduced into clinical practice. Subgroup analysis by kidney disease aetiology and gender may be undertaken to look for potential differences in outcome in specific groups. Trial registration This trial is registered as STOP ACEi EudraCT Number, 2013-003798-82; ISRCTN62869767. Funding This award was funded by the Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 11/30/07), a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership. This is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 5. See the NIHR Funding and Awards website for further award information.

Safety and efficacy of autologous haematopoietic stem-cell transplantation with low-dose cyclophosphamide mobilisation and reduced intensity conditioning versus standard of care in refractory Crohn's disease (ASTIClite): an open-label, multicentre, randomised controlled trial

A previous controlled trial of autologous haematopoietic stem-cell transplantation (HSCT) in patients with refractory Crohn's disease did not meet its primary endpoint and reported high toxicity. We aimed to assess the safety and efficacy of HSCT with an immune-ablative regimen of reduced intensity versus standard of care in this patient population. This open-label, multicentre, randomised controlled trial was conducted in nine National Health Service hospital trusts across the UK. Adults (aged 18-60 years) with active Crohn's disease on endoscopy (Simplified Endoscopic Score for Crohn's Disease [SES-CD] ulcer sub-score of ≥2) refractory to two or more classes of biological therapy, with no perianal or intra-abdominal sepsis or clinically significant comorbidity, were recruited. Participants were centrally randomly assigned (2:1) to either HSCT with a reduced dose of cyclophosphamide (intervention group) or standard care (control group). Randomisation was stratified by trial site by use of random permuted blocks of size 3 and 6. Patients in the intervention group underwent stem-cell mobilisation (cyclophosphamide 1 g/m2 with granulocyte colony-stimulating factor (G-CSF) 5 μg/kg) and stem-cell harvest (minimum 2·0 × 106 CD34+ cells per kg), before conditioning (fludarabine 125 mg/m2, cyclophosphamide 120 mg/kg, and rabbit anti-thymocyte globulin [thymoglobulin] 7·5 mg/kg in total) and subsequent stem-cell reinfusion supported by G-CSF. Patients in the control group continued any available conventional, biological, or nutritional therapy. The primary outcome was absence of endoscopic ulceration (SES-CD ulcer sub-score of 0) without surgery or death at week 48, analysed in the intention-to-treat population by central reading. This trial is registered with the ISRCTN registry, 17160440. Between Oct 18, 2018, and Nov 8, 2019, 49 patients were screened for eligibility, of whom 23 (47%) were randomly assigned: 13 (57%) to the intervention group and ten (43%) to the control group. In the intervention group, ten (77%) participants underwent HSCT and nine (69%) reached 48-week follow-up; in the control group, nine (90%) reached 48-week follow-up. The trial was halted in response to nine reported suspected unexpected serious adverse reactions in six (46%) patients in the intervention group, including renal failure due to proven thrombotic microangiopathy in three participants and one death due to pulmonary veno-occlusive disease. At week 48, absence of endoscopic ulceration without surgery or death was reported in three (43%) of seven participants in the intervention group and in none of six participants in the control group with available data. Serious adverse events were more frequent in the intervention group (38 in 13 [100%] patients) than in the control group (16 in four [40%] patients). A second patient in the intervention group died after week 48 of respiratory and renal failure. Although HSCT with an immune-ablative regimen of reduced intensity decreased endoscopic disease activity, significant adverse events deem this regimen unsuitable for future clinical use in patients with refractory Crohn's disease. Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.

Characterizing research partnerships in child health research: A scoping review.

Research partnerships between researchers and knowledge users (KUs) in child health are understudied. This study examined the scope of KU engagement reported in published child health research, inclusive of health research partnership approaches and KU groups. Search strategies were developed by a health research librarian. Studies had to be in English, published since 2007, and were not excluded based on design. A two-step, multiple-person hybrid screening approach was used for study inclusion. Data on study and engagement characteristics, barriers and facilitators, and effects were extracted by one reviewer, with 10% verified by a second reviewer. Three hundred fifteen articles were included, with 243 (77.1%) published between 2019 and 2021. Community-based participatory research was the most common approach used (n = 122, 38.3%). Most studies (n = 235, 74.6%) engaged multiple KU groups (range 1-11), with children/youth, healthcare professionals, and parents/families being most frequently engaged. Reporting of barriers and facilitators and effects were variable, reported in 170 (53.8%) and 197 (62.5%) studies, respectively. Publications have increased exponentially over time. There is ongoing need to optimize evaluation and reporting consistency to facilitate growth in the field. Additional studies are needed to further our understanding of research partnerships in child health.

Addressing Ethical Challenges Related to Community and Patient Engagement in Health Research

In this post-workshop summary, we describe three ethical challenges related to engaging people with lived experience as partners in health research. We share learnings and reflective prompts from our workshop delivered as part of the Canadian Bioethics Society Workshop and Community Forum held in May 2023.

Autologous stem cell transplantation with low-dose cyclophosphamide to improve mucosal healing in adults with refractory Crohn’s disease: the ASTIClite RCT

Some text in this abstract has been reproduced from Lindsay J, Din S, Hawkey C, Hind D, Irving P, Lobo A, et al. OFR-9 An RCT of autologous stem-cell transplantation in treatment refractory Crohn’s disease (low-intensity therapy evaluation): ASTIClite. Gut 2021;70(Suppl. 4):A4. Background Treatment-refractory Crohn’s disease is characterised by chronic symptoms, poor quality of life and high costs to the NHS, and through days of work lost by patients. A previous trial of autologous haematopoietic stem cell transplant (HSCT) failed its end point of medication-free clinical remission for 3 months with no evidence of disease activity, and reported high toxicity. Subsequent studies suggest that HSCT achieves complete mucosal healing in 50% of patients, and that toxicity likely relates to the cyclophosphamide dose. Objectives The primary objective was to assess the efficacy of HSCTlite (HSCT with low-dose cyclophosphamide) compared with standard care for inducing regression of intestinal ulceration in patients with refractory Crohn’s disease at week 48. Secondary objectives included the assessment of disease activity, quality of life and regimen safety. Mechanistic objectives included immune reconstitution after HSCTlite. Design Two-arm, parallel-group randomised controlled trial with a 2 : 1 (intervention : control) allocation ratio. Setting Nine NHS trusts (eight trusts were recruitment sites; one trust was a treatment-only site). Participants Adults with treatment-refractory Crohn’s disease, for whom surgery was inappropriate or who had declined surgery. Interventions The intervention treatment was HSCTlite using cyclophosphamide, and the control was any current available treatment for Crohn’s disease, apart from stem cell transplantation. Main outcomes The primary outcome was treatment success at week 48 [mucosal healing (Simple Endoscopic Score for Crohn’s Disease ulcer subscore of 0) without surgery or death], assessed by central readers blinded to allocation and timing of assessment. Key secondary outcomes were clinical remission, Simple Endoscopic Score for Crohn’s Disease scores at week 48, change in Crohn’s Disease Activity Index scores and safety. Results The trial was halted owing to Suspected unexpected serious adverse events that took place after randomising 23 patients (HSCTlite arm, n = 13; usual-care arm, n = 10). Ten out of the 13 patients randomised to the HSCTlite arm received the intervention and nine (one death) reached the 48-week follow-up. In the usual-care arm 9 out of the 10 patients randomised reached the 48-week follow-up (one ineligible). The primary outcome was available for 7 out of 10 HSCTlite patients (including the patient who died) and six out of nine usual-care patients. Absence of endoscopic ulceration without surgery or death was reported in three out of seven (43%) HSCTlite patients, compared with zero out of six (0%) usual-care patients. Centrally read Simple Endoscopic Score for Crohn’s Disease scores [mean (standard deviation)] were 10.8 (6.3) and 10.0 (6.1) at baseline, compared with 2.8 (2.9) and 18.7 (9.1) at week 48, in the HSCT and usual-care arms, respectively. Clinical remission (Crohn’s Disease Activity Index scores of < 150) occurred in 57% and 17% of patients in the HSCTlite and usual-care arms, respectively, at week 48. Serious adverse events were more frequent in the HSCTlite arm [38 in 13 (100%) patients] than in the usual-care arm [16 in 4 (40%) patients]. Nine suspected unexpected serious adverse reactions were reported in six HSCTlite patients, including three cases of delayed renal failure due to proven thrombotic microangiopathy. Two HSCTlite patients died. Conclusions Within the limitations of reduced patient recruitment and numbers of patients assessed, HSCTlite meaningfully reduced endoscopic disease activity, with three patients experiencing resolution of ulceration. Suspected unexpected serious adverse reactions, particularly relating to thrombotic microangiopathy, make this regimen unsuitable for future clinical use. Limitations The early trial closure prevented complete recruitment, and the impact of the coronavirus pandemic prevented completion of some study investigations. Small participant numbers meant analysis could only be descriptive. Future work Owing to undetermined aetiology of thrombotic microangiopathy, further trials of HSCTlite in this population are not considered appropriate. Priorities should be to determine optimal treatment strategies for patients with refractory Crohn’s disease, including those with a stoma or multiple previous resections. Trial registration This trial is registered as ISRCTN17160440 and EudraCT 2017-002545-30. Funding This award was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership. This is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 3. See the NIHR Funding and Awards website for further award information.

Exploring power and power sharing in participatory health research partnerships: A scoping review protocol.

Participatory health research (PHR) as a research paradigm, guides the research process and strives to achieve positive change in society in the interest of people's health. In this scoping review, PHR will be used as an umbrella term considering a wide range of collaborative research approaches in the health context. PHR is conducted 'with' or 'by' those it intends to benefit, as opposed to 'on' and 'for' them. Their involvement throughout the research process seeks to shift power and decision-making from where they traditionally lay within academia toward community, patient and public end-users. Research cannot be truly participatory without concurrently addressing power dynamics within the partnership and power imbalances in decision making. Therefore, power sharing can be defined as a major factor in building effective academic-community collaborations. This scoping review aims to identify, clarify, and map existing literature on power and power sharing in PHR from both theoretical and practical perspectives. Specifically, we will explore how power is conceptualised throughout the literature, and how power and power sharing are applied and addressed in real-life PHR partnerships. This scoping review will be conducted in accordance with the guidelines outlined in the Joanna Briggs Institute (JBI) Reviewer's Manual. This scoping review will consider both empirical and non-empirical research that report on understanding power and power sharing in participatory health research partnerships. All appropriate studies will be retrieved from the following five electronic databases: PubMed, Scopus, Embase, PsycINFO, SocIndex. This review will be limited to articles published in English and from January 1998 to March 2024. As the scoping review aims to capture more than peer-reviewed and published literature, it will also include grey literature such as theses and dissertations, reports, conference proceedings, and editorials. Data from the included literature will be extracted based on the data extraction tool, defined in advance. As primary data will not be collected, ethical approval is not required to conduct the scoping review. The findings of this study will be disseminated through peer-reviewed publications.

Sharing our perspectives makes the difference - The co-creation of a PhD project with patients and relatives.

Globally, focus on user involvement in health research has increased substantially. In Denmark, it is still at an early stage with individual researchers being met with increasing demands without having much experience, guidance, or good practices to act upon. We are a group of researchers affiliated with User Perspectives and Community-based Interventions at the University of Southern Denmark (SD) and the Center for Research with Patients and Relatives (ForSa-P) at the Odense University Hospital (OUH). We work with patients and relatives in several aspects of our work – research and teaching; we share our experiences and learning in a joint session. 
 This presentation describes our experiences of co-creating a PhD project with a patient partner panel and our findings. 
 Our goal was to create knowledge on how to engage in research partnerships for PRs and researchers within the health care setting. The PhD contains a review of the literature on health research partnerships, an ethnographic study using interviews, observations and document analysis and a future Delphi study on evaluative frameworks. 5 patients and relatives (the panel) have been involved from the beginning defining the focus with the PhD student, collecting and analysing data, and disseminating findings. We do not consider user involvement a methodology, but rather a philosophy where sharing different perspectives can improve future health research and help our understanding of how to co-design and integrate care with the people needing it. 
 In the review the panel highlighted aspects they found important and have a section in the review dedicated to their impressions. Together we found that decision-making within research partnerships rests largely with researchers, hence involvement happens on researchers’ terms. When PRs where co-authors of papers, they were more often considered partners. PRs report substantial benefits of being involved such as gaining new knowledge and skills – which can support their own engagement in the management of their condition. The review dissemination (still ongoing) will include several outlets aimed at a broad audience.
 The ethnographic study (spring 22- summer 23) will further our understanding of supportive structural and personal mechanisms within research partnerships. 
 Our work in the panel shows that a PhD-collaboration between PRs and a PhD student is feasible, creates new knowledge for the parties involved, creates a joint focus, and ensures the final products incorporate different perspectives. We have encountered several structural challenges in our preliminary data and from our personal experiences of working together as partners, which are necessary to address to support inclusive way of working with people as partners in the health care system. To ensure the user perspective in broad health care we must be aware that involvement approaches require extra time, flexibility, support and focus on relationships. 
 The findings from our studies and our experiences can help our understanding of how to create partnership with PRs – which is relevant not only in the research setting, but also in a care setting where these partnerships could be key to reach sustainable integrated care.

Decolonial health literature can increase our thinking about ethics dumping.

This article draws on the underexplored or novel accounts of inclusion and the moral accounts of decolonization in African health decolonial literature to increase our understanding of how ethics dumping manifests in health research partnerships, and what more ought to be done to eliminate this phenomenon. African decolonial health literature proposes "inclusion that matters" - conceptualized as substantial, respectful and deep engagement with African agency - as a solution to end domination or mitigate the "appearance" of inclusion. Based on this supposition, the harm of ethics dumping - and I demonstrate how - is that it fails to engage the agency of Africans, and listen to or echo their voices in health and health research collaborations on the continent, or research collaborations that have significant implications for them. This account of inclusion can usefully increase our thinking about ethics dumping, which is ultimately and in several ways a failure to practice responsible science. Research is required to increase our understanding of what could reasonably constitute responsible science from a variety of perspectives.

Synthetic Knowledge Synthesis in Hospital Libraries

ABSTRACT Knowledge explosion is associated with the exponential growth of research literature production, triggering the need for new approaches to structure and synthesize knowledge. Traditional knowledge synthesis approaches have weaknesses like requiring many resources, being time and labor consuming, and being executed manually. To overcome these weaknesses, we developed a new semi-automated synthesis approach, synthetic knowledge synthesis (SKS). The new approach is a triangulation of bibliometrics, bibliometric mapping, and content analysis and can be used by hospital librarians to advance their role as partners in health research. In this paper, we present SKS and demonstrate its use.

Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries.

Use of adaptive clinical trials, particularly adaptive platform trials, has grown exponentially in response to the coronavirus disease (COVID-19) pandemic. Implementation of these trials in low- and middle-income countries (LMICs) has been fostered through the formation or modification of transnational research partnerships, typically between research groups from LMICs and high-income countries (HICs). While these partnerships are important to promote collaboration and overcome the structural and economic disadvantages faced by LMIC health researchers, it is critical to focus attention on the multiple dimensions of partnership equity. Based on informal literature reviews and a meeting with leaders of one of the multinational COVID-19 adaptive platform trials, we describe some important considerations about research partnership equity in this context. We organize these considerations into eight thematic categories: 1) epistemic structures, 2) funding, 3) ethics oversight, 4) regulatory oversight, 5) leadership, 6) post-trial access to interventions, data, and specimens, 7) knowledge translation and dissemination, and 8) research capacity strengthening and maintenance. Within each category we review normative claims that support its relevance to research partnership equity followed by discussion of how adaptive platform trials highlight new dimensions, considerations, or challenges. In aggregate, these observations provide insight into procedural and substantive equity-building measures within transnational global health research partnerships more broadly.

Understanding the evolution of trust in a participatory health research partnership: A qualitative study.

Advancements in evaluating the impact of participatory health research (PHR) have been made through comprehensive models like the community-based participatory research (CBPR) conceptual model, which provides a useful framework for exploring how context and partnership processes can influence health research design and interventions. However, challenges in operationalising aspects of the model limit our understanding and evaluation of the PHR process. Trust is frequently identified as an important component of the CBPR model, which supports the development of key partnership outcomes, such as partnership synergy. However, trust continues to be limited to a binary view (as present or absent), which is problematic given its inherently dynamic and temporal nature. The aim of this qualitative study is to understand the evolution of trust in the national public and patient involvement (PPI) network in Ireland. Participants from the PPI network (n = 15/21) completed a semistructured interview discussing the evolution of trust by reviewing four social network maps derived from a previous longitudinal study. Following Braun and Clarke, we used reflexive thematic analysis, to iteratively develop, analyse and interpret our mediated reflection of the data. Participants described the evolution of trust as a function of three contextual factors: (1) the set-up and organisation of the network, (2) how people work togetherand (3) reflection on the process and outcomes. Their descriptions across these themes seemed to vary depending on partnership type with National Partners and Site Leads having more opportunities to demonstrate trust (e.g., via leadership roles or more resources), compared to Local. Thus, visibility and the opportunity to be visible, depending on the set-up and organisation of the network and how people work together, seemingly play an important role in the evolution of trust over time. Based on these findings, we provide important questions for reflection across themes that could be considered for future PHR partnerships. Given that the opportunity and visibility to build and maintain trust over time may not be equally available to all partners, it is important to find ways to invest in and commit to equitable relationships as the key to the success (i.e., longevity) of partnerships. We reflect on/offer important implications for those engaging in PHR partnerships and those who fund such research. A Research Advisory Group comprising four research partners (representing academic, serviceand community organisations) from the PPI Ignite Network provided input and approval for the research objectives of this study as well as previously published work informing this study. Informal consultation occurred with members of this group to discuss findings from this study, assisting with the way findings are presented and described, to be accessible for diverse audiences. Two Research Advisory Group members were involved in the interpretation of the results, and one is a co-author of this manuscript (Zoe Hughes).

Co-constructing collaboration: An evidence-based approach to advance and evaluate equitable global public health research partnerships.

Equitable global health partnerships are essential to promote innovative research and strengthen research capacity to address critical public health challenges, but how to optimally evaluate such collaborations is unclear. This was a sequential, multi-method study that utilized an electronic survey informed by the literature followed by semi-structured interviews to comprehensively evaluate the experience of participating in a global research-capacity building collaboration between Nepal and U.S. clinicians and investigators. De-identified quantitative survey were analyzed to calculate descriptive and summary statistics, along with crosstabs of each variable by group. Groups were defined based on country-of-origin and Chi Square statistics calculated to assess for statistically significant differences (p<0.05) between groups. Interviews were analyzed using a descriptive qualitative approach to develop an overall thematic map. 22 survey responses (52.4% response rate) were analyzed; 13 (59.1%) from Nepal, 9 (40.9%) from the U.S. Eight participants (4 Nepal; 4 U.S.) were interviewed. Over the course of the project, all participants reported gaining experience and confidence with research. The majority of participants "strongly agreed" there was a shared understanding of goals, priorities and strategies (Nepal, 58.3%, n = 7; U.S., 88.9%, n = 8;) and that power was shared equally (Nepal, 58.3%, n = 7; U.S., 55.6%, n = 5). The over-arching theme that emerged from the interviews was the importance of 'establishing community' which participants discussed within the broader context of COVID-19. Overall, team members reported strong bi-directional benefit and a greater emphasis on perceived benefits versus challenges. Our survey tool and interview guide, designed to holistically evaluate the impact of a global partnership across various levels of the Social Ecological Model, with particular attention to power dynamics and equity, can be adapted and used by others engaged in similar research capacity collaborations.

Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial.

This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes. Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported. Supervised exercise therapy is effective and NMES may provide further benefit in mild IC.This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823.

Advancing Health Equity: An Innovative Program for Building Community Engagement in Research

Abstract: Background: The Community Research Fellows (CRF) program seeks to mobilize New Haven residents with lower incomes or from communities of color who are educated and equipped to engage as equal partners in health research at Yale University. The training program combines curriculum-based information with 'on-the-ground' experience with Yale research projects, while building relationships between CRFs and researchers. The Community Alliance for Research and Engagement launched two consecutive cohorts of the program in 2018–2020. Objectives: To assess the effect of the CRF program on participants' knowledge of the research process and confidence to engage in research and participants' satisfaction and perspectives on the program. Methods: The evaluation of the CRF program included four components: 1) Pre- and Post- Program Surveys to assess change in confidence and self-reported knowledge. 2) Curriculum Feedback Satisfaction Survey to gauge satisfaction and make program improvements after each training session. 3) Post-Program CRF Interviews to explore their CRF experiences. 4) Research Team Surveys to assess program satisfaction and areas for improvement. Results: CRFs reported increased confidence and knowledge, personal and professional growth, and interest in community-engaged research. Overall, participants were very satisfied with each training module. Conclusions: The CRF program demonstrated that community members are well-suited, well-positioned, and eager to engage in and inform public health research. CRFs bring capacity and valuable perspective to research teams. The CRF training program offers an innovative approach to address power imbalances in research and to move towards more equitable community–university partnerships for improved health outcomes.

O08 Mesenchymal stromal cells infusions in children with recessive dystrophic epidermolysis bullosa (MissionEB): a randomized controlled trial

Abstract Recessive dystrophic epidermolysis bullosa (RDEB) is one of the most severe forms of epidermolysis bullosa caused by loss-of-function mutations in the type VII collagen gene (COL7A1) leading to extensive skin and mucosal fragility and systemic complications. No active treatment is currently available. This study assesses whether repeated infusions of allogeneic umbilical cord-derived mesenchymal stromal cells are safe and can benefit children with RDEB. This is a double-blinded, randomized (1 : 1), placebo-controlled crossover trial with an internal dose de-escalation trial for safety and a further 12-month open-label study following review of the data. Around 36 participants with RDEB who are older than 6 months and younger than 16 years are being recruited at Great Ormond Street Hospital and Birmingham Children's Hospital. Participants will receive two intravenous infusions (days 0 and 14), at a dose of 2–3 × 106 cells kg–1 that could be adjusted to 1–1.5 × 106 cells kg–1 based on observed toxicities. Outcomes assessed at 3 and 6 months from day 0 in each crossover period include changes in EBDASI, iscorEB, pain, itch and quality of life scores. This is the largest cell-therapy study in children with RDEB. Previous nonrandomized trials have suggested that intravenous mesenchymal stromal cells are safe in children with RDEB and indicated early evidence of benefit. There was a need for a robust controlled study to validate these findings. The study is funded by the National Research Collaboration Programme (NIHR127963), an NHS England and NHS Improvement and National Institute for Health Research partnership, and Cure EB. ISRCTN registry (ISRCTN14409785).

Contractual Mechanisms for Securing the Public Interest in Data Sharing in Public-Private Health Research Partnerships

Public private partnerships (PPPs) are increasingly common in health research, with large European investment over the last 20 years and renewed focus in the wake of the global health crisis COVID-19. PPPs have been used for health research that seeks to collect, analyse and share personal data from research participants, often on the basis of informed or broad consent. PPPs are underpinned by contracts, both to govern the use of data and samples necessary for health research, and to govern the agreement between the public and private contracting parties of a project. This raises the question of how far contracts adequately protect public interests, for example in privacy and data protection when patient data are exposed to a broader range of potential uses from the private sector. A core principle of contract law is that you cannot contract for unlawful activity. As such, contracts could be void if their design or performance entails a breach of statute or common law, for example data protection and privacy laws or the common law duty of confidentiality. This paper analyses the implications of this general principle of illegality for contracts underpinning PPPs in health research, particularly to understand the extent to which it could operate to protect the public interest as conceived by privacy and data protection law. The paper will show how this heavily policy-driven doctrine has scope to ensure that contracts and contract terms that are contrary to public policy are void or unenforceable which, in the context of PPPs using personal information for health innovation and research, is a welcome, though limited, accountability mechanism in private law that could operate to serve the public interest.

Subacromial spacers for adults with symptomatic, irreparable rotator cuff tears: the START:REACTS novel group sequential adaptive RCT

Background A balloon spacer is a relatively simple addition to an arthroscopic debridement procedure for irreparable rotator cuff tears. Objective To evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears. Design A multicentre participant-and assessor-blinded randomised controlled trial comparing arthroscopic debridement with the InSpace® (Stryker, Kalamazoo, MI, USA) balloon to arthroscopic debridement alone, using a novel adaptive design. Pretrial simulations informed stopping boundaries for two interim analyses, using outcome data from early and late time points. Setting A total of 24 NHS centres. Participants Adults with a symptomatic, irreparable rotator cuff tear for whom conservative management had been unsuccessful. Interventions Arthroscopic debridement of the subacromial space plus insertion of the InSpace balloon compared with arthroscopic debridement alone. Main outcome measures Oxford Shoulder Score at 12 months. Results A predefined stopping boundary was met at the first interim analysis. Recruitment stopped with 117 participants randomised. We obtained primary outcome data on 114 participants (97%). The mean Oxford Shoulder Score at 12 months was 34.3 in the debridement-only group (59 participants of 61 randomised) and 30.3 in the debridement with balloon group (55 participants of 56 randomised; mean difference: −4.2; 95% confidence interval −8.2 to −0.26; p = 0.037). There was no difference in safety events. In the cost-effectiveness analysis, debridement-only dominated with a probability of &lt;1% that the device is cost-effective. Magnetic resonance imaging substudy To evaluate the function of the balloon, we developed a dynamic magnetic resonance imaging protocol to induce humeral movement by activating the deltoid. The pandemic restricted recruitment, so the sample size was small (n = 17). Statistical methodology study We applied the novel adaptive design approach to data from seven previous randomised controlled trials. The method would have been applicable to five of these trials and would have made substantial savings in time to recruitment, without compromising the main findings of the included trials. Interim analysis interpretation study We asked potential data monitoring committee members to review interim analysis reports presented using Bayesian and frequentist frameworks. They did not always follow the stopping rules and would benefit from additional information to support decision-making. Limitations The InSpace balloon could be beneficial in a different population although we are not aware of it being widely used for other purposes. As a result of the pandemic, we were not able to complete data collection for objective measures. Conclusions In this efficient adaptive trial, clinical and cost-effectiveness favoured the control treatment without the InSpace balloon. Therefore, we do not recommend this device for the treatment of irreparable rotator cuff tears. Future work There is an urgent need for high-quality research into interventions for people with irreparable rotator cuff tears as there is a lack of good evidence for all available treatment options at present. Trial registration This trial is registered as ISRCTN17825590. Funding This project (project reference 16/61/18) was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council and National Institute for Health and Care Research (NIHR) partnership. The trial is co-sponsored by the University of Warwick and University Hospitals Coventry and Warwickshire NHS Trust. This study will be published in full in Efficacy and Mechanism Evaluation; Vol. 10, No 3. See the NIHR Journals Library website for further project information.