Edinboro P C, Lawrence W, Nixon D W, Zfass A, Duckworth P F, King R
American Cancer Society, Mid-Atlantic Division (Virginia Council), Glen Allen, USA.
Cancer. 1998 Dec 1;83(11):2384-90.
In April 1991, the Virginia Division of the American Cancer Society (ACS) initiated the feasibility phase of the Colon Polyp Prevention Study (CPPS) to determine whether a high fiber supplement would decrease new adenomatous colorectal polyp occurrence. The feasibility phase had two specific objectives: 1) to evaluate accrual and compliance to the designed protocol and 2) to evaluate and demonstrate the effectiveness of volunteers as research assistants. The CPPS is an innovative project in which trained volunteers play a significant role in the research process.
In the CPPS, volunteer adjunct researchers (VARs) were trained to perform individual dietary data collection and intervention and other general study monitoring functions. VARs were trained, certified, and monitored in the performance of their assigned tasks by ACS staff and expert consultants.
A total of 119 volunteers were trained as VARs, 74 of whom were certified and matched to a study participant. Between 1991-1995, only six VARs left the study. After active accrual of participants to the study ceased in 1995, 38 VARs (50% of the certified VARs) continued to monitor the active study participants. All VARs were consistently able to conduct the functions for which they were trained.
In spite of expected volunteer attrition rates, a core of 38 dedicated VARs were matched to 72 participants and demonstrated the ability to perform selected data collecting activities on a consistent and efficient basis. The use of trained volunteers has allowed the CPPS to function in its feasibility phase at personnel cost considerably less than that of other similar cancer prevention trials.
1991年4月,美国癌症协会弗吉尼亚分部启动了结肠息肉预防研究(CPPS)的可行性阶段,以确定高纤维补充剂是否会降低新发腺瘤性结直肠息肉的发生率。可行性阶段有两个具体目标:1)评估对设计方案的入组率和依从性;2)评估并证明志愿者作为研究助手的有效性。CPPS是一个创新项目,训练有素的志愿者在研究过程中发挥着重要作用。
在CPPS中,志愿者辅助研究人员(VARs)接受培训,以进行个人饮食数据收集、干预及其他一般研究监测功能。ACS工作人员和专家顾问对VARs进行培训、认证,并监测他们执行指定任务的情况。
共有119名志愿者接受了VARs培训,其中74人获得认证并与一名研究参与者配对。1991年至1995年期间,只有6名VARs退出了研究。1995年停止积极招募研究参与者后,38名VARs(占获得认证的VARs的50%)继续监测仍在参与研究的参与者。所有VARs都始终能够履行他们所接受培训的职能。
尽管预计会有志愿者流失率,但38名敬业的VARs核心成员与72名参与者配对,并证明有能力持续、高效地开展选定的数据收集活动。使用训练有素的志愿者使CPPS在可行性阶段得以运作,其人员成本远低于其他类似的癌症预防试验。