Overcoming Recruitment Challenges in Palliative Care Clinical Trials
Overcoming Recruitment Challenges in Palliative Care Clinical Trials
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DOI：
10.1200/jop.2013.000996
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发表时间：
2013-11-01
影响因子：
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通讯作者：
Abernethy, Amy P.
中科院分区：
文献类型：
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作者：
LeBlanc, Thomas W.;Lodato, Jordan E.;Abernethy, Amy P.
目的：姑息治疗越来越被视为癌症护理的必要组成部分，特别是对晚期疾病患者。因此，需要严格的临床试验来建立姑息治疗的证据基础，但临床研究，特别是参与者的招募是困难的。主要障碍包括（1）患者因素，（2）“把关”，（3）伦理问题。在这里，我们讨论了一种方法来克服这些障碍，使用姑息治疗试验（PCT）作为一个案例study.Patients和方法：PCT是一个2 × 2 × 2因子随机对照试验（RCT）的不同服务提供模式，以改善疼痛控制的姑息设置。它采用了一种将循证战略与“社会营销”原则相结合的招募协议，这种方法涉及营销技术的系统应用。主要组成部分包括（1）一个包容性的分诊算法，（2）针对特定利益相关者的信息手册，（3）一个专门的招聘护士，和（4）标准化的措辞在所有研究communications.Results：从一个合格的池607例患者，PCT入组461例患者超过26个月。20%的被转诊到姑息治疗服务的患者入组（筛选后符合条件的患者中有76%）。几个常见的障碍最小化;在那些谁拒绝参与，家庭不感兴趣是不常见的（5%），因为是施加负担的看法（4%）。结论：临床试验招聘姑息治疗的挑战是显着的，但并非不可逾越的。一个精心设计的招聘和保留协议可以是有效的。我们设计和部署基于社会营销的协议的经验表明了这种方法的好处。
Purpose: Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research-especially participant recruitment-is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study.Patients and Methods: The PCT was a 2 x 2 x 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications.Results: From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%).Conclusion: Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach.