Participatory methods used in the evaluation of medical devices: a comparison of focus groups, interviews, and a survey.

BACKGROUND: Stakeholder engagement in evaluation of medical devices is crucial for aligning devices with stakeholders' views, needs, and values. Methods for these engagements have however not been compared to analyse their relative merits for medical device evaluation. Therefore, we systematically compared these three methods in terms of themes, interaction, and time-investment. METHODS: We compared focus groups, interviews, and an online survey in a case-study on minimally invasive endoscopy-guided surgery for patients with intracerebral haemorrhage. The focus groups and interviews featured two rounds, one explorative focussing on individual perspectives, and one interactive focussing on the exchange of perspectives between participants. The comparison between methods was made in terms of number and content of themes, how participants interact, and hours invested by all researchers. RESULTS: The focus groups generated 34 themes, the interviews 58, and the survey 42. Various improvements for the assessment of the surgical procedure were only discussed in the interviews. In focus groups, participants were inclined to emphasise agreement and support, whereas the interviews consisted of questions and answers. The total time investment for researchers of focus groups was 95 h, of interviews 315 h, and survey 81 h. CONCLUSIONS: Within the context of medical device evaluation, interviews appeared to be the most appropriate method for understanding stakeholder views since they provide a scope and depth of information that is not generated by other methods. Focus groups were useful to rapidly bring views together. Surveys enabled a quick exploration. Researchers should account for these methodological differences and select the method that is suitable for their research aim.

How to coach student professional development during times of challenges and uncertainties.

BACKGROUND: What we teach our (bio)medical students today may differ from the future context under which they will operate as health professionals. This shifting and highly demanding profession requires that we equip these students with adaptive competencies for their future careers. We aimed to develop a framework to promote and facilitate professional development from day one, guided by self-awareness and self-directed learning. APPROACH: Based on self-directed, transformative and experiential learning, patient involvement and teamwork, we developed a 3-year longitudinal personal-professional development (LPPD) program in the (bio)medical sciences undergraduate curriculum to stimulate self-driven professional development in a variable context. Through group meetings and individual coach consultations, students address topics such as self-awareness, self-directed and lifelong learning, collaboration, well-being and resilience. To drive learning students receive extensive narrative feedback on an essay assignment. EVALUATION: Experiences and outcomes were evaluated with questionnaires and in-depth interviews. Students and coaches value personal and professional development in a safe learning environment that encourages self-exploration, diversity and connection. Over time, students show more self-awareness and self-directedness and increasingly apply trained skills, resulting in professional identity formation. Students need more clarification to understand the concept of assessment as learning. IMPLICATIONS: With the generic content of a longitudinal program embedded in a meaningful environment, the personal and professional development of students can be facilitated and stimulated to face future challenges. When translating to other curricula, we suggest considering the complexity of professional development and the time expenditure needed for students to explore, experiment and practice. An early start and thorough integration are recommended.

Value Assessment Frameworks for HTA Agencies: The Organization of Evidence-Informed Deliberative Processes.

Priority setting in health care has been long recognized as an intrinsically complex and value-laden process. Yet, health technology assessment agencies (HTAs) presently employ value assessment frameworks that are ill fitted to capture the range and diversity of stakeholder values and thereby risk compromising the legitimacy of their recommendations. We propose "evidence-informed deliberative processes" as an alternative framework with the aim to enhance this legitimacy. This framework integrates two increasingly popular and complementary frameworks for priority setting: multicriteria decision analysis and accountability for reasonableness. Evidence-informed deliberative processes are, on one hand, based on early, continued stakeholder deliberation to learn about the importance of relevant social values. On the other hand, they are based on rational decision-making through evidence-informed evaluation of the identified values. The framework has important implications for how HTA agencies should ideally organize their processes. First, HTA agencies should take the responsibility of organizing stakeholder involvement. Second, agencies are advised to integrate their assessment and appraisal phases, allowing for the timely collection of evidence on values that are considered relevant. Third, HTA agencies should subject their decision-making criteria to public scrutiny. Fourth, agencies are advised to use a checklist of potentially relevant criteria and to provide argumentation for how each criterion affected the recommendation. Fifth, HTA agencies must publish their argumentation and install options for appeal. The framework should not be considered a blueprint for HTA agencies but rather an aspirational goal-agencies can take incremental steps toward achieving this goal.

Participatory workshops are not enough to prevent policy implementation failures: an example of a policy development process concerning the drug interferon-beta for multiple sclerosis.

A possible explanation for policy implementation failure is that the views of the policy's target groups are insufficiently taken into account during policy development. It has been argued that involving these groups in an interactive process of policy development could improve this. We analysed a project in which several target populations participated in workshops aimed to optimise the utilisation of an expensive novel drug (interferon beta) for patients with Multiple Sclerosis. All participants seemed to agree on the appropriateness of establishing a central registry of Multiple Sclerosis patients and developing guidelines. Nevertheless, these policy measures were not implemented. Possible explanations include (1) the subject no longer had high priority when the costs appeared lower than expected, (2) the organisers had paid insufficient attention to the perceived problems of parties involved, and (3) changes within the socio-political context. The workshops in which representatives of the policy's target populations participated did not provide enough interactivity to prevent policy implementation failure.