Participatory Methods Used In The Evaluation Of Medical Devices: A Comparison Of Focus groups, Interviews, And A Survey

Author:

Woudstra Kas1,Tummers Marcia2,Klijn Catharina JM3,Sondag Lotte3,Schreuder Floris3,Reuzel Rob2,Rovers Maroeska1

Affiliation:

1. Department of Operating Rooms, Radboudumc

2. Department of Health Evidence, Radboudumc

3. Department of Neurology, Donders Institute for Brain, Cognition, and Behavior, Radboudumc

Abstract

Abstract 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 hours, of interviews 315 hours, and survey 81 hours. Conclusions Interviewing is the most appropriate method for understanding stakeholder views, since interviews provide a scope and depth of information that is not generated by other methods. Focus groups are useful to rapidly bring views together. Surveys enable a quick exploration. Researchers should account for these methodological differences and select the method that is suitable for their research aim.

Publisher

Research Square Platform LLC

Reference34 articles.

1. Royal College of Surgeons. Future of surgery [Internet]. 2022 [cited 2022 Jul 14]. Available from: https://futureofsurgery.rcseng.ac.uk/#start

2. IDEAL-D Framework for Device Innovation;Marcus HJ;Ann Surg,2022

3. FDA (Food and Drug Administration). Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. FDA draft guidance database; 2019.

4. The European Parliament and the Council of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council.Official Journal of the European Communities. 2017;(L).

5. Bitkina OV, Kim HK, Park J. Usability and user experience of medical devices: An overview of the current state, analysis methodologies, and future challenges. Int J Ind Ergon [Internet]. 2020;76(November 2019):102932. Available from: https://doi.org/10.1016/j.ergon.2020.102932

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3