Boland Jason, Currow David C, Wilcock Andrew, Tieman Jennifer, Hussain Jamilla Akhter, Pitsillides Constantine, Abernethy Amy P, Johnson Miriam J
Hull York Medical School, University of Hull, Hull, United Kingdom.
Discipline, Palliative and Supportive Services, Flinders University, Daw Park, South Australia, Australia.
J Pain Symptom Manage. 2015 Apr;49(4):762-772.e5. doi: 10.1016/j.jpainsymman.2014.09.018. Epub 2014 Dec 27.
The challenges of palliative care clinical trial recruitment are well documented.
The aim of the study was to review tested strategies to improve recruitment to trials of people with a range of conditions who may access palliative care services but are not explicitly stated to be "palliative."
This was a systematic review with narrative description. The Cochrane, Embase, PubMed, PsycINFO, and CINAHL electronic databases were searched (English; January 2002 to February 2014) for quasi-experimental and randomized controlled trials (RCTs) testing the effect of recruitment strategies on accrual to clinical trials of people with organ failure and cancer. Titles, abstracts, and retrieved articles were screened by two researchers and categorized by recruitment challenge: 1) patients with reduced cognition, 2) those requiring emergency treatment, and 3) willingness of patients and clinical staff to contribute to trials.
Of 549 articles identified, 15 were included. Thirteen reported RCTs and two papers reported three quasi-experimental studies. Five were cluster RCTs of recruiting sites/institutions. One was a randomized cluster, crossover, feasibility study. Seven studies recruited patients with cancer. Others included patients with dementia, stroke, cardiovascular disease, diabetes, frail elderly, and bereaved carers. Some interventions improved recruitment: memory aid, contact before arrival, cluster consent, "opt out" consent. Others either reduced recruitment (formal mental capacity assessment) or made no difference (advance research directive; a variety of educational, supportive, and advertising interventions).
Successful strategies from other disciplines could be considered by palliative care researchers. Tailored, efficient, evidence-based strategies must be developed, acknowledging that strategies with face validity are not necessarily the most effective.
姑息治疗临床试验招募面临的挑战已有充分记录。
本研究旨在回顾经测试的策略，以改善对可能接受姑息治疗服务但未明确界定为“姑息治疗”的各类疾病患者进行临床试验的招募情况。
这是一项带有叙述性描述的系统评价。检索了Cochrane、Embase、PubMed、PsycINFO和CINAHL电子数据库（英文；2002年1月至2014年2月），以查找测试招募策略对器官衰竭和癌症患者临床试验入组影响的半实验性和随机对照试验（RCT）。两名研究人员对标题、摘要和检索到的文章进行筛选，并按招募挑战进行分类：1）认知能力下降的患者；2）需要紧急治疗的患者；3）患者和临床工作人员参与试验的意愿。
在识别出的549篇文章中，纳入了15篇。13篇报告了RCT，2篇论文报告了3项半实验性研究。5项是招募地点/机构的整群RCT。1项是随机整群交叉可行性研究。7项研究招募了癌症患者。其他研究纳入了痴呆、中风、心血管疾病、糖尿病、体弱老年人和丧亲照顾者等患者。一些干预措施改善了招募情况：记忆辅助工具、提前联系、整群同意、“退出”同意。其他措施要么减少了招募（正式的心智能力评估），要么没有效果（预先研究指示；各种教育、支持和广告干预措施）。
姑息治疗研究人员可考虑借鉴其他学科的成功策略。必须制定量身定制、高效且基于证据的策略，同时要认识到表面上有效的策略不一定是最有效的。
