Howerton Mollie W, Gibbons M Chris, Baffi Charles R, Gary Tiffany L, Lai Gabriel Y, Bolen Shari, Tilburt Jon, Tanpitukpongse Teerath Peter, Wilson Renee F, Powe Neil R, Bass Eric B, Ford Jean G
Department of Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland 21205, USA.
Cancer. 2007 Feb 1;109(3):465-76. doi: 10.1002/cncr.22436.
Providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials because they often introduce the opportunity of clinical trials. The purpose of the current systematic review was to describe provider-related factors influencing recruitment of underrepresented populations to cancer clinical trials.
To find original studies on the recruitment of underrepresented populations to cancer clinical trials, electronic databases from January 1966 to December 2005 were searched; hand-searched titles in 34 journals from January 2003 to January 2006; and reference lists were examined of eligible articles. Title and abstract reviews were conducted to identify relevant studies. Potential articles were then abstracted using a structured instrument and a serial review process by 2 investigators.
Eighteen studies were eligible for review: 13 targeted healthcare providers, 3 targeted patients/participants, and 2 targeted both providers and patients. The study designs included randomized controlled trial, concurrent controlled trial, case-control, descriptive, and qualitative. A lack of available protocols and/or a lack of provider awareness about clinical trials prevented providers from discussing the opportunity of clinical trials in 2 studies. In 14 studies, patient accrual was affected by provider attitudinal barriers relating to patient adherence to the study protocol, patient mistrust of research, patient costs, data collection costs, and/or patient eligibility. Providers' communication methods were barriers in 5 studies and promoters in 1 study.
A heterogeneous body of evidence suggests that several provider-related factors influence recruitment of underrepresented groups to clinical trials. Future recruitment efforts should address these factors.
医疗服务提供者在成功招募代表性不足的患者参与癌症临床试验中发挥着至关重要的作用,因为他们常常为患者提供参与临床试验的机会。本系统评价的目的是描述影响代表性不足人群参与癌症临床试验招募工作的与医疗服务提供者相关的因素。
为查找关于招募代表性不足人群参与癌症临床试验的原始研究,检索了1966年1月至2005年12月的电子数据库;手工检索了2003年1月至2006年1月34种期刊的标题;并查阅了符合条件文章的参考文献列表。通过标题和摘要审查来识别相关研究。然后由2名研究人员使用结构化工具和系列审查流程对潜在文章进行摘要提取。
18项研究符合审查条件:13项针对医疗服务提供者,3项针对患者/参与者,2项同时针对医疗服务提供者和患者。研究设计包括随机对照试验、同期对照试验、病例对照研究、描述性研究和定性研究。在2项研究中,由于缺乏可用方案和/或医疗服务提供者对临床试验缺乏了解,导致他们无法与患者讨论参与临床试验的机会。在14项研究中,患者入组受到与患者遵守研究方案、患者对研究的不信任、患者费用、数据收集费用和/或患者资格相关的医疗服务提供者态度障碍的影响。在5项研究中,医疗服务提供者的沟通方式是障碍,而在1项研究中是促进因素。
大量不同类型的证据表明,若干与医疗服务提供者相关的因素会影响代表性不足群体参与临床试验的招募工作。未来的招募工作应解决这些因素。