定义以患者为中心:临床护理与研究的机遇、挑战及影响

Defining Patient-Centricity: Opportunities, Challenges, and Implications for Clinical Care and Research.

作者信息

Robbins Dennis A, Curro Frederick A, Fox Chester H

机构信息

1 Integrated Decisions, Ethics, Alternatives and Solutions, Imperial Beach, CA, USA.

2 PEARL Practice Based Research Network, New York University, NY, USA.

出版信息

Ther Innov Regul Sci. 2013 May;47(3):349-355. doi: 10.1177/2168479013484159.

Abstract

The Patient-Centered Outcomes Research Institute (PCORI), created and funded by the Affordable Care Act, is charged with bringing the patient perspective to clinical research design and the outcomes that are studied. However, there is no consensus definition of "patient-centeredness" or "patient-centricity." This paper distinguishes between the terms and describes an infrastructure for supporting the concept of patient-centricity. The patient's role needs to be described in a way that makes it feasible to implement health care delivery and support parameters to conduct clinical research over a sustained period of time. The authors propose the use of a structured Practice-Based Clinical Research Network to perform patient-centered outcomes research consistent with the requirements of the pharmaceutical sector in a safe, ethical, and effective manner and congruent with the principles of Good Clinical Practice (GCP).

摘要

患者为中心的结果研究协会(PCORI)由《平价医疗法案》设立并提供资金,其职责是将患者的观点纳入临床研究设计以及所研究的结果之中。然而,对于“以患者为中心”或“患者中心性”并没有一致的定义。本文区分了这两个术语,并描述了一个支持患者中心性概念的基础设施。需要以一种能够在持续一段时间内实施医疗保健服务和支持参数以开展临床研究的方式来描述患者的角色。作者提议使用一个结构化的基于实践的临床研究网络,以安全、符合伦理且有效的方式开展符合制药行业要求并与《药物临床试验质量管理规范》(GCP)原则相一致的以患者为中心的结果研究。

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