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Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations.

ABSTRACT: Introduction Transparent collaborations between patient organisations (POs) and clinical research sponsors (CRS) can identify and address the unmet needs of patients and caregivers. These insights can improve clinical trial participant experience and delivery of medical innovations necessary to advance health outcomes and standards of care. We share our experiences from such a collaboration undertaken surrounding the SENSCIS^® clinical trial (NCT02597933), and discuss its impact during, and legacy beyond, the trial.Summary We describe the establishment of a community advisory board (CAB): a transparent, multiyear collaboration between the scleroderma patient community and a CRS. We present shared learnings from the collaboration, which is split into three main areas: (1) the implementation and conduct of the clinical trial; (2) analysis and dissemination of the results; and (3) aspects of the collaboration not related to the trial.1. The scleroderma CAB reviewed and provided advice on trial conduct and reporting. This led to the improvement and optimisation of trial procedures; meaningful, patient-focused adaptations were made to address challenges relevant to scleroderma-associated interstitial lung disease patients.2. To ensure that results of the trial were accessible to lay audiences and patients, written lay summaries were developed by the trial sponsor with valuable input from the CAB to ensure that language and figures were understandable.3. The CAB and the CRS also collaborated to co-develop opening tools for medication blister packs and bottles. In addition, to raise disease awareness among physicians, patients and caregivers, educational materials to improve diagnosis and management of scleroderma were co-created and delivered by the CAB and CRS.Conclusions This collaboration between POs and a CRS, in a rare disease condition, led to meaningful improvements in patient safety, comfort and self-management and addressed information needs. This collaboration may serve as a template of best practice for future collaborations between POs, research sponsors and other healthcare stakeholders.

SUBMITTER: Roennow A

PROVIDER: S-EPMC7745690 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations.

Roennow Annelise A Sauvé Maureen M Welling Joep J Riggs Robert J RJ Kennedy Ann Tyrrell AT Galetti Ilaria I Brown Edith E Leite Catarina C Gonzalez Alex A Portales Guiraud Alexandra Paula AP Houÿez François F Camp Rob R Gilbert Annie A Gahlemann Martina M Moros Lizette L Luna Flores Jose Luis JL Schmidt Friedrich F Sauter Wiebke W Finnern Henrik H

BMJ open 20201216 12

<b>Introduction</b> Transparent collaborations between patient organisations (POs) and clinical research sponsors (CRS) can identify and address the unmet needs of patients and caregivers. These insights can improve clinical trial participant experience and delivery of medical innovations necessary to advance health outcomes and standards of care. We share our experiences from such a collaboration undertaken surrounding the SENSCIS<sup>®</sup> clinical trial (NCT02597933), and discuss its impact ...[more]

PMID: 33328257

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Project description:AimsThe aim of this paper is to present a novel case for the formation, operation and evaluation of a community advisory aboard comprised of Muslims residing in the San Francisco Bay Area, California that utilised a community based participatory approach to address local Muslim mental health needs. The CAB was recruited in partnership with the Muslim Community Association (MCA), one of the largest Islamic centres in the San Franscisco Bay Area. In addition to describing the development of the CAB, the authors present the findings of the evaluation and synthesis of best processes based on CAB members' feedback.MethodsTo evaluate the perceived community advisory board members' perceptions of their roles and elicit feedback on how to enhance the relationship between the university team and the CAB, an evaluation was conducted by an independent team who was not part of the research process. Data was collected using anonymous individual surveys and small group open discussions that were conducted over three evaluation meetings. The evaluation utilised mixed method data collection strategies using questions from Schulz et al. (, Evaluation and Program Planning 26, 249-262), an instrument for evaluating dimensions of group dynamics within CBPR partnerships.ResultsResults of the evaluation within the sphere of CAB operation indicated that CAB members found the greatest satisfaction from their contributions through direct participation in the research activities that were conducted by the university-CAB team. The collective responses indicated that most CAB members were satisfied with trust built between the university-CAB team and the diversity represented in the members of the board. However, given that the Bay Area is home to a very diverse Muslim community, challenges in recruiting representatives that account for all possible self-identifying groups was reported by the CAB with recommendations to recruit religious leaders. Recommendations also included eliciting funds for potential financial compensation for CAB members.ConclusionsThe Stanford-San Francisco Bay Area CAB demonstrated that empowering community members through direct participation, creating channels and safe spaces for feedback help create community rooted research that carry the true voices of marginalised communities and reflects their evolving needs.

Project description:BackgroundTo improve the implementation of clinical trial interventions, there is a need to facilitate communication between key stakeholders and research teams. Community Advisory Boards (CAB) bring together a range of stakeholders not historically included in the research process to inform and work collaboratively with research teams.ObjectiveTo describe our procedures and processes for (1) integration of a CAB into a pragmatic clinical trial of a telehealth-delivered group mindfulness program for persons with chronic low back pain (cLBP) within primary care, and (2) for the rapid uptake and implementation of CAB recommendations.MethodsThe CAB we convened includes persons with cLBP who have undergone the mindfulness intervention, health care system leadership, advocacy groups, and mindfulness experts. The CAB members underwent a two hour initial training that introduced the research process and the CAB's role as research partners. The CAB met monthly for 1 hour. We used the Lighting Report method to summarize meetings and share feedback with the research team.ResultsThe recommendations of the CAB during the first year they met were divided into recruitment, informed consent, and survey recommendations. The study website also was overhauled based on recommendations, including a more engaging first page with rotating images of nature and testimonials. The language on the website was edited to be more concise and participant-friendly. The CAB recommended talking points to discuss with participants during screening or informed consent about the benefits of participating in research.ConclusionWe established a CAB that represented diverse perspectives, organizations, and experience with cLBP and mindfulness. The differing perspectives of the CAB resulted in recommendations that the research team itself would not have decided on their own. The Lightning Reports were also an effective way to efficiently communicate the CAB recommendations to the research team.

Project description:BackgroundHospital boards have statutory responsibility for upholding the quality of care in their organisations. International research on quality in hospitals resulted in a research-based guide to help senior hospital leaders develop and implement quality improvement (QI) strategies, the QUASER Guide. Previous research has established a link between board practices and quality of care; however, to our knowledge, no board-level intervention has been evaluated in relation to its costs and consequences. The aim of this research was to evaluate these impacts when the QUASER Guide was implemented in an organisational development intervention (iQUASER).MethodsWe conducted a 'before and after' cost-consequences analysis (CCA), as part of a mixed methods evaluation. The analysis combined qualitative data collected from 66 interviews, 60 hours of board meeting observations and documents from 15 healthcare organisations, of which 6 took part on iQUASER, and included direct and opportunity costs associated with the intervention. The consequences focused on the development of an organisation-wide QI strategy, progress on addressing 8 dimensions of QI (the QUASER challenges), how organisations compared to benchmarks, engagement with the intervention and progress in the implementation of a QI project.ResultsWe found that participating organisations made greater progress in developing an organisation-wide QI strategy and became more similar to the high-performing benchmark than the comparators. However, progress in addressing all 8 QUASER challenges was only observed in one organisation. Stronger engagement with the intervention was associated with the implementation of a QI project. On average, iQUASER costed £23 496 per participating organisation, of which approximately 44% were staff time costs. Organisations that engaged less with the intervention had lower than average costs (£21 267 per organisation), but also failed to implement an organisation-wide QI project.ConclusionWe found a positive association between level of engagement with the intervention, development of an organisation-wide QI strategy and the implementation of an organisation-wide QI project. Support from the board, particularly the chair and chief executive, for participation in the intervention, is important for organisations to accrue most benefit. A board-level intervention for QI, such as iQUASER, is relatively inexpensive as a proportion of an organisation's budget.

Project description:BackgroundA critical policy issue in Australia and worldwide is the escalating rates of work-related mental injury that have been linked to the lack of help-seeking behaviours of at-risk workers. Strategic alliances between community organisations, statutory bodies, and mental health service providers could expand the efficacy and reach of mental health literacy and peer support initiatives that can encourage help-seeking, however, there is limited evidence to support the development of such approaches. This study used a qualitative design based on collaboration theory to explore the factors influencing community organisation leaders' decisions to provide such initiatives through collaboration with relevant third parties.MethodsRepositories of submissions into mental health reviews and publicly available registers in Australia were used to identify twenty-two participant organisations (n = 22), which were categorised according to the International Classification of Non-Profit Organisations (Culture & Recreation, Social Services, and Development & Housing). Eleven of these organisations demonstrated an interest in collaborating with third parties and extending efforts to deliver work-related mental health initiatives through contributions to mental health reviews. Leaders were interviewed to understand differences in perspectives on potential collaborations.ResultsOrganisations that did not make submissions were reluctant to engage in such efforts due to limitations in expertise/capacity, and perceived mission misalignment. Third-party support from statutory bodies and mental health service providers addressing these perceived limitations may improve their confidence, and willingness to engage. Regardless of their category, all considered the benefit of such collaboration included improving the acceptability, approachability, availability, and efficacy of work-related mental health initiatives. Equity was seen as supporting decision-making/leadership, while power imbalance was a barrier. Third-party contributions that could facilitate collaboration included expert support/credibility, administration, formal structures, supportive policy, and joining networks, however, red tape was a challenge. Shared values, vision, practice, and networking were identified as supporting positive communication and interpersonal relations.ConclusionThe study establishes that, adequately supported and resourced, community organisations are willing to align strategically with statutory bodies and mental health service providers to use their unique position in the community to deliver work-related mental health literacy and peer support programmes for at-risk workers to improve help-seeking behaviours.

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Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations.

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Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations.

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