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Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.

ABSTRACT: Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research.A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders' perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al.The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research.Collaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research.

SUBMITTER: Nurmi SM

PROVIDER: S-EPMC5657119 | biostudies-other | 2017 Oct

REPOSITORIES: biostudies-other

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Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.

Nurmi Sanna-Maria SM Halkoaho Arja A Kangasniemi Mari M Pietilä Anna-Maija AM

BMC medical ethics 20171025 1

<h4>Background</h4>Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is cond ...[more]

PMID: 29070032

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Project description:BackgroundGetting research into policy and practice in healthcare is a recognised, world-wide concern. As an attempt to bridge the gap between research and practice, research funders are requesting more interdisciplinary and collaborative research, while actual experiences of such processes have been less studied. Accordingly, the purpose of this study was to gain more knowledge on the interdisciplinary, collaborative and partnership research process by investigating researchers' experiences of and approaches to the process, based on their participation in an inventive national research programme. The programme aimed to boost collaborative and partnership research and build learning structures, while improving ways to lead, manage and develop practices in Swedish health and social services.MethodsInterviews conducted with project leaders and/or lead researchers and documentation from 20 projects were analysed using directed and conventional content analysis.ResultsCollaborative approaches were achieved by design, e.g. action research, or by involving practitioners from several levels of the healthcare system in various parts of the research process. The use of dual roles as researcher/clinician or practitioner/PhD student or the use of education designed especially for practitioners or 'student researchers' were other approaches. The collaborative process constituted the area for the main lessons learned as well as the main problems. Difficulties concerned handling complexity and conflicts between different expectations and demands in the practitioner's and researcher's contexts, and dealing with human resource issues and group interactions when forming collaborative and interdisciplinary research teams. The handling of such challenges required time, resources, knowledge, interactive learning and skilled project management.ConclusionsCollaborative approaches are important in the study of complex phenomena. Results from this study show that allocated time, arenas for interactions and skills in project management and communication are needed during research collaboration to ensure support and build trust and understanding with involved practitioners at several levels in the healthcare system. For researchers, dealing with this complexity takes time and energy from the scientific process. For practitioners, this puts demands on understanding a research process and how it fits with on-going organisational agendas and activities and allocating time. Some of the identified factors may be overlooked by funders and involved stakeholders when designing, performing and evaluating interdisciplinary, collaborative and partnership research.

Project description:Background: The Rare Disease Research Partnership (RAinDRoP) was established in 2018 to bring together a wide variety of diverse voices in the rare disease community in Ireland and form a research partnership. This approach enabled clinicians, patients, carers and researchers to work together to identify top research priorities for rare diseases, which focused on a life-course perspective rather than a disease-specific need. Methods: A participatory multiple phase approach was used to identify research priorities for rare diseases. The research process involved three main phases: Phase I, Public Consultation Survey on Research in Rare Diseases in Ireland (PCSRRDI); Phase II, Research Prioritisation Workshop (RPW); Phase III, Follow-up Public Consultation and Prioritisation Survey (FWPCPS). Results: In total, 240 individuals completed the phase I PCSRRDI, which comprised of a cross-section of health care professionals, researchers and people living with rare diseases. One thousand and fifteen statements were collected, reflecting issues and shared challenges in rare diseases. A shortlisting step by step was used to identify any statements that had received a total score of above 50% into 10-12 researchable questions or statements per the theme for the phase II workshop. Phase II was focused on three main themes: (1) Route to Diagnosis, (2) Living with Rare Disease, (3) Integrated and Palliative Care. In total, 62 individuals attended the overall workshop; 42 participated in the prioritisation sessions. A cross-section of health care professionals, researchers and people living with rare diseases were engaged at each workshop. Seventy-five individuals completed the final phase III public ranking by priority responses, and they ranked the top 15 research priorities defined by the multi-stakeholders at the phase II consensus meeting. Conclusions: This study identified priorities for rare diseases research aimed at improving the health and wellbeing of people living with rare diseases.

Project description:BackgroundThe conceptualization of the home as a care environment and maintaining a high standard of care requires different professionals to collaborate. This study will explore collaborative practice in home care, needs and expectations of the stakeholders involved, and identify their roles and tasks. Secondly, it will investigate possible strategies to improve home care management and, more particularly, optimize collaborative practice in home care.MethodsThe study will be conducted during three distinct consecutive phases, within a multiphase mixed-methods design. Phase 1 will use a quantitative approach in which a social network analysis will be conducted to have an overview of collaborative practice in home care in French-speaking Switzerland. Phases 2 and 3 will be qualitative and focus on three different situations involving different locations (rural and urban) and different home care functioning (home care provided by agencies and home care providing by independent caregivers). In each situation, semi-structured interviews will be conducted with home care recipients and their home caregivers. In phase 2, results of phase 1's network analysis will be discussed, such as roles, needs, and expectations of all stakeholders involved in home care. In phase 3, phase 2's findings will be discussed and strategies to improve home care and to optimize collaborative practice will be explored.DiscussionOver the past years, home care has grown considerably. Therefore, more and more different caregivers are involved in the recipients' homes. Since optimal coordination between these different caregivers is a prerequisite for quality and safe care, it is essential to investigate the existing collaborative practice and how it is functioning. This study will provide knowledge on roles, needs and expectations of different caregivers involved in home care. It will also allow for strategies to optimize collaborative practice and thus ensure comprehensive care for recipients. Finally, it will serve as a basis for future studies that can be conducted to address identified needs.

Project description:IntroductionValue and waste in preclinical and clinical research projects are intensively debated in biomedicine at present. Such different aspects as the need for setting objectives and priorities, improving study design, quality of reporting, and problematic incentives of the academic reward system are addressed. While this debate is also fueled by ethical considerations and thus informed by bioethical research, up to now, the field of bioethics lacks a similar extensive debate. Nonetheless, bioethical research should not go unquestioned regarding its scientific or social value. What exactly constitutes the value of bioethical research, however, remains widely unclear so far.MethodsThis explorative study investigated possible value dimensions for bioethical research by conducting a qualitative literature analysis of researchers' statements about the value of their studies. 40 bioethics articles published 2015 in four relevant journals (The American Journal of Bioethics, Bioethics, BMC Medical Ethics and Journal of Medical Ethics) were analyzed. The value dimensions of "advancing knowledge" (e.g. research results that are relevant for science itself and for further research) and "application" (e.g. increasing applicability of research results in practice) were used as main deductive categories for the analysis. Further subcategories were inductively generated.ResultsThe analysis resulted in 62 subcategories representing a wide range of value dimensions for bioethical research. Of these, 45 were subcategories of "advancing knowledge" and 17 of "application". In 21 articles, no value dimensions related to "application" was found; the remaining 19 articles mentioned "advancing knowledge" as well as "application". The value dimensions related to "advancing knowledge" were, in general, more fine-grained.ConclusionsEven though limitations arise regarding the sample, the study revealed a plethora of value dimensions that can inform further debates about what makes bioethical research valuable for science and society. Besides theoretical reflections on the value of bioethics more meta-research in bioethics is needed.

Project description:PurposeToday's clinical trial partnerships frequently join multi-disciplinary investigators and stakeholders, from different countries and cultures, to conduct research with a broad array of goals. This diversity, while a strength, can also foster divergent views about priorities and what constitutes success, thereby posing challenges for management, operations, and evaluation. As a sponsor and partner in such collaborations, we seek to assist and support their development and implementation of sound research strategies, to optimize their efficiency, sustainability, and public health impact. This report describes our efforts using an adaptation of the well-established Kaplan-Norton strategy management paradigm, in our clinical trials setting. We share findings from our first test of the utility and acceptance of this approach for evaluating and managing research strategies in a collaborative clinical research partnership.ResultsFindings from pilot studies and our first implementation in an ongoing clinical research partnership in Liberia, provide initial support for our hypothesis that an adapted version of the Kaplan-Norton strategy management model can have use in this setting. With leadership from within the partnership, analysis artifacts were gathered, and assessments made using standardized tools. Practical feasibility, resonance of the findings with partners, and convergence with other empirical assessments lend initial support for the view that this approach holds promise for obtaining meaningful, useable results for assessing and improving clinical research management.Conclusions and implicationsEngaged leadership, thoughtful timing to align with partnership planning cycles, support for the process, and an eye towards the collaboration's long-term goals appear important for developing model understanding and practice. Skepticism about evaluations, and unease at exposing weaknesses, may hinder the effort. Acceptance of findings and associated opportunities for improvement by group leadership, support a growing sense of validity. Next steps aim to test the approach in other partnerships, streamline the methodology for greater ease of use, and seek possible correlations of strategy management assessments with performance evaluation. There is hardly a better example than the COVID-19 pandemic, to spotlight the need for efficient and effective clinical research partnerships to address global health challenges. While heartened by the collaborative spirit driving the effort so far, we cannot let our enthusiasm lull us into thinking that nobility of purpose or an abundance of good will is sufficient. Careful monitoring and adjustment of clinical research strategy in response to changes (e.g., demographics, pathogen evolution, research acceptance, political and cultural environments) are vital to making the needed adjustments that can guide these programs toward successful outcomes. We hope that our work can raise awareness about the importance, relevance, and feasibility of sound strategy management in clinical research partnerships, especially during this time when there is so much at stake.

Project description:IntroductionAdvancements 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.Study aimThe aim of this qualitative study is to understand the evolution of trust in the national public and patient involvement (PPI) network in Ireland.Setting and participantsParticipants 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.AnalysisFollowing Braun and Clarke, we used reflexive thematic analysis, to iteratively develop, analyse and interpret our mediated reflection of the data.ResultsParticipants 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 together and (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.DiscussionGiven 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.Patient or public contributionA Research Advisory Group comprising four research partners (representing academic, service and 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).

Project description:BackgroundEffective social and behavioral sciences teaching in medical education requires integration with clinical experience, as well as collaboration between social and behavioral sciences experts and clinical faculty. However, teaching models for achieving this integration have not been adequately established, nor has the collaboration process been described. This study aims to propose a collaborative clinical case conference model to integrate social and behavioral sciences and clinical experience. Additionally, we describe how social and behavioral science experts and clinical faculty collaborate during the development of the teaching method.MethodsA team of medical teachers and medical anthropologists planned for the development of a case conference based on action research methodology. The initial model was planned for a 3-h session, similar to a Clinicopathological Conference (CPC) structure. We evaluated each session based on field notes taken by medical anthropologists and post-session questionnaires that surveyed participants' reactions and points of improvement. Based on the evaluation, a reflective meeting was held to discuss revisions for the next trial. We incorporated the development process into undergraduate medical curricula in clinical years and in a postgraduate and continuous professional development session for residents and certified family physicians in Japan. We repeated the plan-act-observe-reflection process more than 15 times between 2015 and 2018.ResultsThe development of the collaborative clinical case conference model is summarized in three phases: Quasi-CPC, Interactive, and Co-constructive with unique structures and underlying paradigms. The model successfully contributed to promoting the participants' recognition of the clinical significance of social and behavioral sciences. The case preparation entailed unique and significant learning of how social and behavioral sciences inform clinical practice. The model development process promoted the mutual understanding between clinical faculty and anthropologists, which might function as faculty development for teachers involved in social and behavioral sciences teaching in medical education.ConclusionsThe application of appropriate conference models and awareness of their underlying paradigms according to educational situations promotes the integration of social and behavioral sciences with clinical medicine education. Faculty development regarding social and behavioral sciences in medical education should focus on collaboration with scholars with different paradigmatic orientations.

Project description:ImportanceLong-term evidence for the effectiveness and cost-effectiveness of collaborative dementia care management (CDCM) is lacking.ObjectiveTo evaluate whether 6 months of CDCM is associated with improved patient clinical outcomes and caregiver burden and is cost-effective compared with usual care over 36 months.Design, setting, and participantsThis was a prespecified secondary analysis of a general practitioner (GP)-based, cluster randomized, 2-arm clinical trial conducted in Germany from January 1, 2012, to December 31, 2014, with follow-up until March 31, 2018. Participants were aged 70 years or older, lived at home, and screened positive for dementia. Data were analyzed from March 2011 to March 2018.InterventionThe intervention group received CDCM, comprising a comprehensive needs assessment and individualized interventions by nurses specifically qualified for dementia care collaborating with GPs and health care stakeholders over 6 months. The control group received usual care.Main outcomes and measuresMain outcomes were neuropsychiatric symptoms (Neuropsychiatric Inventory [NPI]), caregiver burden (Berlin Inventory of Caregivers' Burden in Dementia [BIZA-D]), health-related quality of life (HRQOL, measured by the Quality of Life in Alzheimer Disease scale and 12-Item Short-Form Health Survey [SF-12]), antidementia drug treatment, potentially inappropriate medication, and cost-effectiveness (incremental cost per quality-adjusted life year [QALY]) over 36 months. Outcomes between groups were compared using multivariate regression models adjusted for baseline scores.ResultsA total of 308 patients, of whom 221 (71.8%) received CDCM (mean [SD] age, 80.1 [5.3] years; 142 [64.3%] women) and 87 (28.2%) received usual care (mean [SD] age, 79.2 [4.5] years; 50 [57.5%] women), were included in the clinical effectiveness analyses, and 428 (303 [70.8%] CDCM, 125 [29.2%] usual care) were included in the cost-effectiveness analysis (which included 120 patients who had died). Participants receiving CDCM showed significantly fewer behavioral and psychological symptoms (adjusted mean difference [AMD] in NPI score, -10.26 [95% CI, -16.95 to -3.58]; P = .003; Cohen d, -0.78 [95% CI, -1.09 to -0.46]), better mental health (AMD in SF-12 Mental Component Summary score, 2.26 [95% CI, 0.31-4.21]; P = .02; Cohen d, 0.26 [95% CI, -0.11 to 0.51]), and lower caregiver burden (AMD in BIZA-D score, -0.59 [95% CI, -0.81 to -0.37]; P < .001; Cohen d, -0.71 [95% CI, -1.03 to -0.40]). There was no difference between the CDCM group and usual care group in use of antidementia drugs (adjusted odds ratio, 1.91 [95% CI, 0.96-3.77]; P = .07; Cramér V, 0.12) after 36 months. There was no association with overall HRQOL, physical health, or use of potentially inappropriate medication. The CDCM group gained QALYs (0.137 [95% CI, 0.000 to 0.274]; P = .049; Cohen d, 0.20 [95% CI, -0.09 to 0.40]) but had no significant increase in costs (437€ [-5438€ to 6313€] [US $476 (95% CI, -$5927 to $6881)]; P = .87; Cohen d, 0.07 [95% CI, -0.14 to 0.28]), resulting in a cost-effectiveness ratio of 3186€ (US $3472) per QALY. Cost-effectiveness was significantly better for patients living alone (CDCM dominated, with lower costs and more QALYs gained) than for those living with a caregiver (47 538€ [US $51 816] per QALY).Conclusions and relevanceIn this secondary analysis of a cluster randomized clinical trial, CDCM was associated with improved patient, caregiver, and health system-relevant outcomes over 36 months beyond the intervention period. Therefore, it should become a health policy priority to initiate translation of CDCM into routine care.Trial registrationClinicalTrials.gov Identifier: NCT01401582.

Project description:Current research ethics frameworks were developed on the footprint of biomedical, experimental research and present several pitfalls when applied to non-experimental social sciences. This work explores how the normative principles underpinning policy and regulatory frameworks of research ethics and the related operational processes work in practice in the context of collaborative health and social care research. The work was organised in three phases. First, UK research ethics policy documents were analysed thematically, with themes further organised under the categories of 'Principles' and 'Processes'. Next, we conducted a scoping review of articles about research ethics in the context of collaborative health and social care research, published in English between 2010 and 2022. We then held an exploratory focus group with ten academic researchers with relevant experience to gather their views on how the research ethics system works in practice in England (UK). The thematic framework developed in the first phase supported the analysis of the articles included in the scoping review and of focus group data. The analysis of policy documents identified twelve themes. All were associated to both a principle and a related operational process. The scoping review identified 31 articles. Across these, some themes were barely acknowledged (e.g., Compliance with legislation). Other themes were extensively covered (e.g., The working of Research Ethics Committees), often to discuss issues and limitations in how, in practice, the research ethics system and its processes deal with collaborative research and to suggest options for improvement. Focus group data were largely consistent with the findings of the scoping review. This work provides evidence of the poor alignment between how the research ethics system is normatively expected to work and how it works in practice and offers options that could make research ethics more fit for purpose when addressing collaborative research in health and social care.

Dataset Information

Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.

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Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.

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