Developing a Patient-Centered Benefit-Risk Survey: A Community-Engaged Process
| Autor: | Holly L. Peay, Ilene L. Hollin, John F.P. Bridges, Caroline Young, Caroline Hanson |
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| Rok vydání: | 2015 |
| Předmět: |
Guiding Principles
Process (engineering) Biomedical Technology Phase (combat) Risk Assessment Interviews as Topic 03 medical and health sciences 0302 clinical medicine Surveys and Questionnaires Medicine Humans 030212 general & internal medicine Set (psychology) Qualitative Research Medical education Community engagement business.industry United States Food and Drug Administration 030503 health policy & services Health Policy Public Health Environmental and Occupational Health Stakeholder Review Committees Patient Preference Public relations United States Clinical trial Government Regulation Patient Participation 0305 other medical science business |
| Zdroj: | Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 19(6) |
| ISSN: | 1524-4733 |
| Popis: | Objectives To provide a community-engaged process to inform the design of a stated-preferences experiment. The process involved integrating patients and caregivers of people with Duchenne/Becker muscular dystrophy, advocates, clinicians, and the sponsor in conceptualizing and developing a benefit-risk survey on the basis of phase III trial results. Methods Our community-engagement process for the development of a stated-preference survey included a set of five guiding principles with a foundation in the principles of community-engaged research. Engagement efforts were carried out through an informal network of three committees. Members of the leadership, stakeholder, and review committees comprised patients, caregivers, clinicians, advocacy leadership, and industry representatives. Results Committee members participated in 15 hours of formal engagement including interviews and conference calls that ranged from 45 to 90 minutes, plus additional less-formal ad hoc communication. Committees comprised 20 individuals across three committees including adults with DMD (n = 6), parents of children with DMD (n = 6), clinicians (n = 3), members of research and advocacy organizations (n = 4), and an industry representative (n = 1). Community engagement informed attribute selection, survey length, word choice, and eligibility criteria. Challenges in the process included managing diverse stakeholder perspectives, time requirements, and the inherent tension between outcomes used in clinical trials versus attributes that correspond to patient- and family-relevant outcomes. Conclusions We demonstrated how community engagement can successfully influence study design to support the design of a relevant survey instrument that is ethical, acceptable, meaningful to the community, and enhances patient-centered benefit-risk assessment for regulatory decision making. |
| Databáze: | OpenAIRE |
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