Haroutounian Simon, Holzer Katherine J, Kerns Robert D, Veasley Christin, Dworkin Robert H, Turk Dennis C, Carman Kristin L, Chambers Christine T, Cowan Penney, Edwards Robert R, Eisenach James C, Farrar John T, Ferguson McKenzie, Forsythe Laura P, Freeman Roy, Gewandter Jennifer S, Gilron Ian, Goertz Christine, Grol-Prokopczyk Hanna, Iyengar Smriti, Jordan Isabel, Kamp Cornelia, Kleykamp Bethea A, Knowles Rachel L, Langford Dale J, Mackey Sean, Malamut Richard, Markman John, Martin Kathryn R, McNicol Ewan, Patel Kushang V, Rice Andrew S C, Rowbotham Michael, Sandbrink Friedhelm, Simon Lee S, Steiner Deborah J, Vollert Jan
Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, United States.
Departments of Psychiatry, Neurology, and Psychology, Yale University, New Haven, CT, United States.
Pain. 2024 May 1;165(5):1013-1028. doi: 10.1097/j.pain.0000000000003121. Epub 2023 Dec 19.
In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.
在传统的临床研究模式中,患者通常仅作为参与者被纳入。然而,近年来情况有所转变,强调了患者作为研究团队成员在整个临床研究生命周期中所带来的价值和贡献。越来越明显的是,要开展对目标疾病患者既有意义又可行的研究,让患者从研究的最早阶段就参与到研究的规划、实施和传播过程中会带来重要益处。事实上,研究资助者和监管机构现在明确鼓励,有时甚至要求患者作为研究伙伴参与其中。尽管这种方法在某些临床研究领域已变得很常见,但在临床疼痛研究中仍然是个例外。因此,临床试验中的方法、测量与疼痛评估倡议组织召集了一次会议,参会人员包括患者伙伴以及来自学术界、患者权益倡导团体、政府监管机构、研究资助组织、学术期刊和生物制药行业的国际代表,目的是就如何以有效且有针对性的方式推动患者参与临床疼痛研究的各个阶段制定共识性建议。本文总结了此次会议的成果,并为患者伙伴有意义且真实地参与临床疼痛研究提供了思考,包括关于代表性、时机、持续参与、测量、报告以及研究传播等方面的建议。