Dataset Information

A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement.

ABSTRACT: Objectives:To promote medical device EU regulatory understanding in the biomedical research community and encourage greater levels of clinical engagement to further medical device research innovation, translation and effective clinical trials. Methods:An interdisciplinary, iterative, needs-based design approach was used to develop medical device regulatory training, information and clinical expertise resources. Results:A multimedia based self-paced e-Learning course focusing on the 'Fundamentals of Medical Device Design and Regulation' was produced in tandem with an interactive online web portal: Medtech Translate. Conclusions:Health research translation relies on both clinical input and regulation to drive progress and to ensure quality and safety standards from concept development to clinical investigation. A lack of regulatory awareness and access to clinical expertise has the potential to significantly impact on health research translation and ambition for market. Our interdisciplinary academic-regulator-clinical-industry led approach meets the need for a coordinated stakeholder response to support innovation and promote growth in the medical technology sector.

SUBMITTER: Miller AM

PROVIDER: S-EPMC7560120 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement.

Miller Anne-Marie AM Behan Robert R Smith Ian I Griffin Matthew M Keane Fionnuala F Langan James J O'Rourke Colm C McAleenan Niall N Pandit Abhay A Watson Mark M

Health policy and technology 20201015

<h4>Objectives</h4>To promote medical device EU regulatory understanding in the biomedical research community and encourage greater levels of clinical engagement to further medical device research innovation, translation and effective clinical trials.<h4>Methods</h4>An interdisciplinary, iterative, needs-based design approach was used to develop medical device regulatory training, information and clinical expertise resources.<h4>Results</h4>A multimedia based self-paced e-Learning course focusin ...[more]

PMID: 33083213

Similar Datasets

Project description:BackgroundHealth research funding agencies are increasingly promoting evidence use in health practice and policy. Building on work suggesting how agencies can support such knowledge translation (KT), this paper discusses an online survey to assess KT training needs of researchers and research users as part of a Canadian provincial capacity-building effort.MethodsThe survey comprised 24 multiple choice and open-ended questions including demographics, interest in learning KT skills, likelihood of participating in training, and barriers and facilitators to doing KT at work. More than 1,200 people completed the survey. The high number of responses is attributed to an engagement strategy involving partner organizations (health authorities, research institutes, universities) in survey development and distribution. SPSS was used to analyze quantitative results according to respondents' primary role, geographic region, and work setting. Qualitative results were analyzed in NVivo.ResultsOver 85 percent of respondents are interested in learning more about the top KT skills identified. Research producers have higher interest in disseminating research results; research users are more interested in the application of research results. About one-half of respondents require beginner-level training in KT skills; one-quarter need advanced training. Time and cost constraints are the biggest barriers to participating in KT training. More than one-half of respondents have no financial support for travel and almost one-half lack support for registration fees. Time is the biggest challenge to integrating KT into work.ConclusionsOnline surveys are useful for determining knowledge translation training needs of researchers, research users and ultimately organizations. In this case, findings suggest the importance of considering all aspects of KT in training opportunities, while taking into account different stakeholder interests. Funders can play a role in developing new training opportunities as part of a broad effort, with partners, to build capacity for the use of health research evidence. Survey results would ideally be complemented with an objective needs assessment based on core competencies, and should be acted on in a way that acknowledges the complexity of knowledge translation in healthcare, existing training activities, and the expertise stakeholders already have but may not refer to as knowledge translation.

Project description:Introduction/objectivesThe engagement of patients and other stakeholders is a critical element in the design of patient-centered outcomes research studies. However, methodology for scalable engagement in research management particularly activities such as operationalization of principles and setting of priorities is not well-developed. The objective of this study is to describe a novel approach for scalable stakeholder engagement in research aligned with the Patient-Centered Outcomes Research Institute (PCORI) engagement principles, which was evaluated in a national clinical data research network.Materials and methodsPatient, patient advocate, clinician, and researcher stakeholders were recruited from clinical sites, as well as social media sites related to the 3 conditions of focus, heart failure, obesity, and Kawasaki disease. The engagement strategy was designed, implemented, and mapped to the PCORI engagement principles. Evaluation included internal assessment and quantitative measures of online engagement.ResultsWe operationalized the PCORI principles with 12 stakeholder engagement strategies and convened stakeholder advisory boards and online research prioritization panels to determine research priorities in a rigorous, deliberative process. A total of 46 advisors (20 patients) and 339 panelists (159 patients) actively participated. There were not significant differences between patients and clinicians in level of online engagement. Nonetheless, while patients reported a slightly greater challenge with following online discussion, they overall had a more favorable opinion about use of the online format.Discussion/conclusionAn efficient way to engage large numbers of representative stakeholders in research is a necessary first step to assure the public of trustworthy use of data networks for health research. This paper describes a comprehensive approach to engagement in patient-centered outcomes research management that informs ongoing development of rigorous methodologies in this area.

Project description:PurposeMore and more people survive cancer, but the disease and its treatment often lead to impairment. Multidisciplinary ambulatory oncological rehabilitation (OR) programs have thus been developed. SW!SS REHA, the organization of major Swiss rehabilitation clinics, has defined ambulatory OR quality criteria for its members (about 50% of the Swiss rehabilitation capacity). However, SW!SS REHA criteria are not fully implemented and/or interpreted differently by different specialties or in different linguistic regions in Switzerland. The aim of our study was to carry out an online survey of existing outpatient programs to define quality criteria for an ideal OR program in Switzerland.MethodsA mixed methods approach was used for the survey-qualitative and quantitative. The qualitative part consisted of a guided discussion with OR experts and the quantitative part of an online survey. The quantitative part comprised the development and evaluation of an online questionnaire. It served to record the opinions of OR centers in Switzerland on the desired situation of outpatient rehabilitation.ResultsEighteen OR centers and 71 (49.7% response rate) OR actors participated in the online survey. The survey results indicate that some of the SW!SS REHA quality and performance criteria only partially match with the desired OR criteria for Switzerland. Key disparities occur particularly in the program design and structure and specifically around how many interventions are required to constitute an OR program, the extent of standardization versus individualization of the program, i.e., how many and which modules in a program should be obligatory, and finally the duration and intensity of the program. The online survey did not generate any statistical evidence that OR requirements vary significantly between different linguistic regions and among different specialties.ConclusionsCancer patients are heterogeneous with respect to cancer type, prognosis, and disability level, such that a standard program cannot be uniformly applied. Therefore, a flexible program is required with few mandatory modules and additional individual modules to achieve the threshold number of modules that would constitute a multidisciplinary OR program. Intensity and frequency of OR needs to consider the health state of the participants. The results indicate a need to modify some of the existing SW!SS REHA criteria to ensure that more patients can gain access and benefit form evidence-based OR interventions. Furthermore, the survey provides important findings so that the existing OR offer can be improved with the goal that OR centers will be able to be quality certified in the future.

Project description:ObjectiveThe objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research.DesignWe observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis.SettingThe study was conducted online.ParticipantsPatient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study.Main outcome measuresTranscripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE.ResultsBoth projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups.ConclusionsOur findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

Dataset Information

A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement.

Publications

A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets