Hanson Laura C, Bull Janet, Wessell Kathryn, Massie Lisa, Bennett Rachael E, Kutner Jean S, Aziz Noreen M, Abernethy Amy
Division of Geriatric Medicine and Palliative Care Program, University of North Carolina, Chapel Hill, North Carolina, USA; Cecil B. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina, USA.
Four Seasons Hospice and Palliative Care, Flat Rock, North Carolina, USA.
J Pain Symptom Manage. 2014 Dec;48(6):1021-30. doi: 10.1016/j.jpainsymman.2014.04.008. Epub 2014 May 23.
The Palliative Care Research Cooperative Group (PCRC) is the first clinical trials cooperative for palliative care in the U.S.
To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial.
The parent study was a multisite randomized controlled trial enrolling adults with life expectancy anticipated to be one to six months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semistructured interviews with 18 site principal investigators (PIs) and clinical research coordinators (CRCs) and reviewed recruitment rates. Interviews covered three topics: 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC.
All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of 381 patients. Site enrollment ranged from 1 to 109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients' needs, support from clinical champions, and the additional resources of a trials cooperative group.
The recruitment experience from the multisite PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field.
姑息治疗研究合作组（PCRC）是美国首个姑息治疗临床试验合作组。
描述PCRC首次临床试验期间的招募障碍及策略。
母研究是一项多中心随机对照试验，纳入预期寿命为1至6个月的成年人，随机分为停用他汀类药物（干预组）与继续使用他汀类药物（对照组）。为研究最佳招募实践，我们对18位研究点主要研究者（PI）和临床研究协调员（CRC）进行了半结构化访谈，并审查了招募率。访谈涵盖三个主题：1）成功的招募策略，2）招募障碍，3）PI和CRC的最佳角色。
所有符合条件的研究点PI和CRC均完成访谈，并提供了他汀类药物方案招募的数据。母研究完成了381例患者的招募。各研究点的入组人数从1至109名参与者不等，平均每个研究点入组25人。五个主要障碍包括难以找到符合条件的患者、疾病严重程度、家属和医疗服务提供者的保护意识、在多个场所寻找患者以及招募活动缺乏资源。五个有效的招募策略包括系统筛选患者名单、传达有针对性的信息以使研究具有相关性、制定灵活的方案以满足患者需求、获得临床支持者的支持以及试验合作组提供的额外资源。
多中心PCRC的招募经验为姑息治疗临床试验的有效招募方法提供了新见解。这些结果将为PCRC的培训材料提供参考，并可能有助于该领域的其他研究者。
