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19-04-2017 | Special Section: Measuring What Matters (by invitation only) | Uitgave 1/2018

Quality of Life Research 1/2018

Beyond study participants: a framework for engaging patients in the selection or development of clinical outcome assessments for evaluating the benefits of treatment in medical product development

Tijdschrift:
Quality of Life Research > Uitgave 1/2018
Auteurs:
Hilary Wilson, Ebony Dashiell-Aje, Milena Anatchkova, Karin Coyne, Asha Hareendran, Nancy Kline Leidy, Colleen A. McHorney, Kathy Wyrwich
Belangrijke opmerkingen

Electronic supplementary material

The online version of this article (doi:10.​1007/​s11136-017-1577-6) contains supplementary material, which is available to authorized users.

Abstract

Background

Patients are participating more actively in health care decision-making with regard to their health, as well as in the broader realm of assessing the value of medical products and influencing decisions about their registration and reimbursement. There is an increasing trend to include patients’ perspectives throughout the stages of medical product development by broadening the traditional study-participant role to that of an active partner throughout the process. Including patients in the selection and development of clinical outcome assessments (COAs) to evaluate the benefit of treatment is particularly important. Still, despite widespread enthusiasm, there is substantial uncertainty regarding how and when to engage patients in this process.

Purpose

This manuscript proposes a methodological framework for engaging patients at varying levels in the selection and development of COAs for medical product development.

Framework

The framework builds on the Food and Drug Administration’s roadmap for patient-focused COA. Methods for engaging patients across each stage in this roadmap are summarized by levels of engagement. Opportunities and examples of patient engagement (PE) in the selection and/or development of COAs are summarized, together with best practices and practical considerations.

Conclusion

This paper offers a framework for understanding, planning, and implementing methods to advance PE in the selection and/or development of COAs for evaluating the benefit of medical products. The intent is to further this important discussion and enhance the process and outcome of PE in this context.

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Extra materiaal
Supplementary material 1 (DOCX 18 kb)
11136_2017_1577_MOESM1_ESM.docx
Literatuur
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