Lien Karen, Zeng Liang, Bradley Nicole, Culleton Shaelyn, Popovic Marko, Di Giovanni Julia, Jamani Rehana, Cramarossa Gemma, Nguyen Janet, Koo Kaitlin, Jon Florencia, Chow Edward
Rapid Response Radiotherapy Program, Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Canada.
World J Oncol. 2011 Oct;2(5):217-224. doi: 10.4021/wjon357w. Epub 2011 Oct 28.
In June 2003, the Rapid Response Radiotherapy Program (RRRP) implemented changes to recruitment strategies in attempts to increase patient accrual to research studies. Such modifications included the use of a dedicated research assistant to screen for and identify eligible study patients, the introduction of more appropriate inclusion criteria, and the switch towards telephone interviews to minimize patient burden. The purpose of this study is to provide an update on patient accrual in the RRRP.
All patients seen in the RRRP from January 2002 to December 2009 were recorded in a prospective database. Reasons for referral, eligibility for clinical trials, reasons for non-accrual, and various demographics information were recorded. Descriptive statistics summarized findings.
A total of 4726 patient visits were recorded from January 1st, 2002 to December 31st, 2009. Prior to changes, the overall rate of accrual into research studies was 14.9% versus 48.1% after changes were implemented. Patients were not accrued onto studies mainly to due ineligibility according to study protocol. Other reasons such as language barrier (12.1%), physician objection (3.5%), patient declining participation (11.3%) and lack of a research assistant (9.3%) were cited.
Changes in clinical structure and study design can significantly impact accrual patterns in palliative radiotherapy studies. Despite these changes however, the majority of patients are still not enrolled in studies. Therefore additional efforts need to be made to maximize patient accrual and minimize attrition.
2003年6月,快速反应放射治疗计划(RRRP)对招募策略进行了调整,试图增加参与研究的患者数量。这些调整包括使用专门的研究助理筛选和确定符合条件的研究患者,引入更合适的纳入标准,以及转向电话访谈以尽量减轻患者负担。本研究的目的是提供RRRP中患者招募情况的最新信息。
将2002年1月至2009年12月在RRRP就诊的所有患者记录在前瞻性数据库中。记录转诊原因、临床试验资格、未被纳入的原因以及各种人口统计学信息。描述性统计总结研究结果。
2002年1月1日至2009年12月31日共记录了4726次患者就诊。在调整之前,参与研究的总体比例为14.9%,调整后为48.1%。患者未被纳入研究主要是因为不符合研究方案的资格。还提到了其他原因,如语言障碍(12.1%)、医生反对(3.5%)、患者拒绝参与(11.3%)和缺乏研究助理(9.3%)。
临床结构和研究设计的改变可显著影响姑息性放射治疗研究中的招募模式。然而,尽管有这些改变,大多数患者仍未参与研究。因此,需要做出更多努力以最大限度地增加患者招募并尽量减少损耗。