Patient involvement in clinical research: why, when, and how.
Patient involvement in clinical research: why, when, and how.
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DOI：
10.2147/ppa.s104259
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发表时间：
2016
影响因子：
2.2
通讯作者：
Flores A
中科院分区：
文献类型：
--
作者：
Sacristán JA;Aguarón A;Avendaño-Solá C;Garrido P;Carrión J;Gutiérrez A;Kroes R;Flores A
以患者为中心的医学方法的发展逐渐允许更多的患者参与自己的医疗决策。然而，这种变化在临床研究中并没有以同样的速度发生，在临床研究中，研究通常继续在患者身上进行，但不是与患者一起进行。这项工作描述了为什么，什么时候，以及如何更积极的患者参与研究过程。提出了具体措施，以改善患者参与1）确定优先事项，2）研究领导和设计，3）改善临床试验的可及性，4）准备和监督提供给参与者的信息，5）患者经验的研究后评价，以及6）结果的传播和应用。为了实现这些目标，需要改变对研究所依据的伦理原则的相对强调。必须抛弃目前基于仁慈原则的模式，而应该接受一种坚持自主和不伤害的道德原则的模式。有必要提高患者和整个社会对研究目标和过程的信息水平;目标是促进专家患者的逐步出现。
The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient.