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.

There is more than 'I' in self-directed learning: An exploration of self-directed learning in teams of undergraduate students.

Preparing future professionals for highly dynamic settings require self-directed learning in authentic learning situations. Authentic learning situations imply teamwork. Therefore, designing education for future professionals requires an understanding of how self-directed learning develops in teams. We followed (bio-)medical sciences students (n = 15) during an 8-month period in which they worked on an innovation project in teams of 4-6 students. Template analysis of 39 transcripts of audio-recorded group meetings revealed three mechanisms along which group dynamics influenced self-directed learning behaviour. First, if expressions of emotions were met with an inquisitive response, this resulted in self-monitoring or feelings of responsibility. Second, openness in the group towards creativity or idea exploration stimulated critical thinking. Third, disputational talk frustrated learning, because it adversely affected group cohesion. We conclude that emotions, openness, and relatedness are important drivers of self-directed learning in teams and hence should be given explicit attention in designing collaborative learning for future professionals.

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.

An Overview of Stakeholders, Methods, Topics, and Challenges in Participatory Approaches Used in the Development of Medical Devices: A Scoping Review.

BACKGROUND: There is a wide variety of participatory approaches to involve stakeholders in the development of medical devices, but there is no comprehensive overview of these approaches. We therefore studied what participatory approaches are used in the development of medical devices as well as the most important characteristics and challenges of these approaches. METHODS: We conducted a scoping review and searched PubMed, Embase and Web of Science for articles published between July 2014 and July 2019. Papers were included if they presented original research featuring any form of stakeholder participation in the development of medical devices. We used The Spectrum of Public Participation to categorise the approach of each paper. Subsequently, we described the characteristics of each approach: the stakeholders involved, data collection methods, and topics addressed. We also identified challenges of the approaches as reported by researchers. RESULTS: 277 papers were included, which could be categorised into three levels of participation: collaboration, involvement, and consultation. Patients and healthcare professionals are frequently engaged in all approaches. The most often used methods are workshops in the collaboration approach papers, and interviews in the involvement and consultation approach papers. Topics addressed in all approaches are: the problem, device requirements, design choices, testing, and procedural aspects of involvement. Reported challenges entail issues related to sampling, analysis, social dynamics, feasibility, and the limited number of topics that can be addressed. CONCLUSION: Participatory approaches reported in literature can be categorised in three overarching approaches that have comparable methodological characteristics. This suggests that if researchers want to apply a participatory approach it is not necessary to adopt a pre-determined approach, such as 'participatory action research' (PAR). Instead, they can independently determine the degree of participation, stakeholders, methods, topics, and strategies to account for challenges, making sure the participatory approach fits their research question and context.

Seeing the Other: How Residents Expand Their Perspective by Learning With the Arts.

Background: Engaging with the arts can enrich medical education by fostering transformative learning, reflection, and a holistic view of the patient. Objective: To explore the development of professional competence of residents in prolonged arts-based medical education. Methods: We followed residents (n=99) of various specialties as they engaged in arts-based learning through creative and reflective assignments such as painting, sculpting, and formal analysis. Participants were interviewed about their learning process and experiences, one-on-one and in small groups, by independent researchers using short, semistructured interviews. We used grounded theory to inform an iterative process for data collection and analysis over the course of 3 years (2016-2018). Results: Seven themes were constructed, which showed that (1) slowing down education provides room for reflection; (2) absence of judgment and rules sparks experimentation; (3) engaging with emotions fostered reflection and motivation; (4) the artists' methods provided a perspective change; (5) a holistic view on the patient emerged; (6) residents understood the need to take control over their professional development; and (7) there were barriers to overcome in terms of hierarchy and expectations. Our investigation shows that interns and residents undergo a perspective transformation. Key to the development of the physicians in training is the open and affective nature of the arts in education. Conclusions: Arts-based learning results in a new perspective for physicians in training in line with patient-centered health care and self-directed learning.

Co-learning and co-teaching in a newly introduced research learning community.

BACKGROUND: Research clerkships are usually designed as individual learning projects focusing on research skills training, such as research design, data analysis and reporting. When the COVID-19 pandemic triggered an urgent need for digital education, we redesigned a research clerkship with the challenging aim to maintain original quality for more students than usual with limited teaching staff. APPROACH: We introduced the concept of a research learning community (RLC) with co-teaching and co-learning to a group of 14 students and seven teaching faculty using digital platforms. Small groups of students participated in the RLC, which was supervised weekly by the teachers. Research experts were continuously involved and led workshops. EVALUATION: Using a qualitative design, we analysed experiences from the perspectives of students and faculty. We performed an inductive thematic content analysis of three focus group interviews and used 14 student reports for triangulation. The results indicate that apart from developing research skills, students valued peer assistance, attention to uncertainty and learning beyond individual research projects. The teachers/research experts reported that co-teaching and co-learning had contributed to their professional development. In terms of organisation, students and faculty recognised that the RLC model allowed for interdisciplinary learning, facilitated by a digital platform. IMPLICATIONS: To develop students' research skills, embedding a clerkship in an RLC is an attractive alternative to individual research clerkships. The obligatory learning goals are met. Co-learning and co-teaching foster faculty's and students' professional development. When translating to other curricula, we recommend stating common goals in addition to individual objectives.

Innovators' views on involving users and patients in surgical device development: a qualitative interview study.

OBJECTIVES: Involving end-users and patients in the development of surgical devices, even when patients are not end-users, is deemed important in policy and in academia since it could improve strategic choices in research and development (R&D). Nonetheless, research into innovators' views on end-user and patient involvement is rare. This study explores what end-users and patients are being involved by innovators during development, what methods for involvement are being used and what topics are being discussed with these end-users and patients. DESIGN: A qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts. PARTICIPANTS: 15 interviews were conducted with 19 innovators of 14 surgical devices. SETTING: Innovation practices of surgical devices in the Netherlands and Belgium. RESULTS: End-users were engaged in R&D with formal methods and in unsystematic ways. These users all work in the clinical domain, for example, as surgeons or nurses. The innovators engaged users to analyse problems for which a device could be a solution, define functionalities, make design choices, analyse usability, ensure safety and improve aesthetics. Patients were rarely involved. Innovators stated that patients are not considered to be end-users, that physicians can represent patient interests and that involving patients is unethical as false expectations could be raised. CONCLUSION: Innovators involve end-users with methods and unsystematic ways in the development of surgical devices. Despite governmental calls for patient involvement in the development of medical devices and surgical devices, innovators do not generally involve patients.

Practice-based learning: an appropriate means to acquire the attitude and skills for evidence-based medicine.

OBJECTIVES:   To evaluate a practice-based, self-directed EBM-course in an undergraduate medical curriculum in terms of EBM attitude and motivation beliefs. METHODS: This study was conducted in a 4-week course of the first-year undergraduate medical curriculum, which takes place twice in an academic year. One group of students (n=210) received a normal EBM-module in November. A practice-based EBM-module was implemented in January for another group of students (n=130). We approached all students following the courses for participation in our research project. In a quasi-experimental design, a validated survey was used to assess students' EBM task value and self-efficacy on a 7-point Likert-scale. In the experimental group, complementary qualitative data were gathered on attitude and motivation by open evaluative questions. RESULTS: Overall response rate was 93,5%, resulting in 191 students in the control group and 127 students in the experimental group. We did not find differences between the groups in terms of EBM task value and self-efficacy. However, the experimental group showed a higher increased perception of the importance of EBM in decision making in clinical practice (60.0% vs 77.2%; χ2(1, N=318) = 8.432, p=0.004). These students obtained a better understanding of the complexities and time-consuming nature of EBM in medical practice. CONCLUSIONS: The practice-based EBM-course helps students to reflect on practice and knowledge critically. Our findings indicate that integrating clinical practice in the undergraduate learning environment fosters attitude and motivation, suggesting that practice-based learning in EBM education may advance student development as a critically reflective practitioner.

Dealing with delicate issues in continuous deep sedation. Varying practices among Dutch medical specialists, general practitioners, and nursing home physicians.

BACKGROUND: This article examines delicate issues in continuous deep sedation (CDS) from the perspectives of different types of physicians. The following sensitive issues involved in CDS were investigated: artificial hydration, sedation for nonphysical discomfort, the relationship between CDS and euthanasia, and patient involvement in decision making for CDS. METHODS: A structured retrospective questionnaire concerning the most recent case of CDS during the past 12 months was sent to a sample of medical specialists (n = 727), general practitioners (n = 626), and nursing home physicians (n = 111). RESULTS: Response rates were 26.4% for medical specialists, 37.4% for general practitioners, and 59.5% for nursing home physicians. Indications for CDS differed among the types of physicians. General practitioners (25.0%) were most often confronted with a patient request for euthanasia before starting CDS compared with medical specialists (8.9%) and nursing home physicians (6.5%). A decision to forgo artificial hydration in CDS was more often made by nursing home physicians (91.3%) compared with medical specialists (53.7%) and general practitioners (51.2%). Shorter survival was found for patients sedated for nonphysical discomfort (vs other patients) by general practitioners. Among all patients, 74.5% were involved in decision making before the start of CDS. CONCLUSIONS: The present study demonstrates notable differences in CDS practice among various types of physicians. To what extent this is related to different patient populations or to different expertise requires further investigation. The use of CDS for nonphysical discomfort calls for critical examination to avoid ambiguous practice.

Improving prescription in palliative sedation: compliance with dutch guidelines.

BACKGROUND: Two guidelines addressing palliative sedation have been published in the Netherlands in 2002 and 2003. The objective of the present study is to determine adherence to the guidelines for palliative sedation with regard to prescription. The study is restricted to the practice of continuous deep palliative sedation. METHODS: A structured retrospective questionnaire was administered to 1464 physicians concerning their last case of deep sedation during the past 12 months. Physicians included Dutch hospital specialists, general practitioners, and nursing home physicians. RESULTS: The response rate was 36%. A total of 43% (95% confidence interval [CI], 37%-49%) of the responding physicians did not adhere to the guidelines. Sources of deviation were the use of basic medication other than a benzodiazepine (30%), which mostly involved morphine, and omissions in adjuvant medication (13%). Nonsignificant positive association was found for consultation of a palliative care expert (odds ratio [OR], 3.86; 95% CI, 0.92-8.87). Significant positive association was found for the physician being a palliative care expert himself or herself (OR, 4.42; 95% CI, 1.42-13.75) and the use of guidelines (OR, 1.74; 95% CI, 1.02-2.98). Treatment of pain symptoms (OR, 2.21; 95% CI, 1.28-3.82), anxiety (OR, 2.32; 95% CI, 1.33-4.06), vomiting (OR, 6.52; 95% CI, 1.08-39.50), and loss of dignity (OR, 3.93; 95% CI, 1.80-8.58) also correlated positively. Treatment of delirium correlated negatively with adherence to the guidelines (OR, 0.22; 95% CI,0.11-0.44). CONCLUSIONS: The rate of 43% noncompliance to the guidelines was mostly owing to the omission of continued antipsychotic treatment for delirium and the use of morphine as the single therapy for the purpose of deep sedation. Future efforts, like better use and knowledge of the guidelines and a larger involvement of consultation teams, should increase adherence to the guidelines.

Factors associated with HPV vaccine uptake in teenage girls: a systematic review.

BACKGROUND: Since 2006 Human papillomavirus (HPV) vaccination has become available to adolescent girls and women in an increasing number of countries, to protect against the virus causing cervical cancer. The vaccine series is offered in three doses over 6 months, and this study aimed to identify factors associated with initiation and/or completion of the 3 dose series in (pre-) adolescent girls. Previous studies have considered intention to vaccinate rather than actual vaccination uptake. METHODS: A systematic search of Medline, Medline in process, Embase and CINAHL, from 2006 to March 2011 for articles related to HPV-vaccine uptake among adolescent girls and factors potentially associated with uptake yielded 25 studies. RESULTS: The majority of studies were surveys or retrospective reviews of data, only 5 studies reported data on program completion. Most were conducted in the United States (20/25). Higher vaccine uptake was associated with having health insurance, of older age, receipt of childhood vaccines, a higher vaccine related knowledge, more healthcare utilization, having a healthcare provider as a source of information and positive vaccine attitudes. In US settings, African American girls were less likely to have either initiated or completed the three dose vaccination series. CONCLUSIONS: HPV vaccination programs should focus on narrowing disparities in vaccine receipt in ethnic and racial groups and on providing correct information by a reliable source, e.g. healthcare providers. School-based vaccination programs have a high vaccine uptake. More studies are required to determine actual vaccine course completion and factors related to high uptake and completion, and information from a broader range of developed and developing settings is needed.

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.