Movsas Benjamin, Hunt Daniel, Watkins-Bruner Deborah, Lee W Robert, Tharpe Heather, Goldstein Desiree, Moore Joan, Dayes Ian S, Parise Sara, Sandler Howard
Henry Ford Health System, Detroit, Michigan.
RTOG Statistical Center, Philadelphia, Pennsylvania.
Pract Radiat Oncol. 2014 May-Jun;4(3):187-191. doi: 10.1016/j.prro.2013.07.014. Epub 2013 Sep 16.
Missing data are a significant problem in clinical trials, particularly for quality of life (QOL), which cannot be obtained retrospectively. The purpose of this study was to evaluate the feasibility of an electronic web-based strategy for QOL data collection in a cooperative group radiation oncology trial setting.
Radiation Therapy Oncology Group (RTOG) 0828 was a prospective National Cancer Institute cooperative group companion study of RTOG-0415, a randomized study of conventional versus hypofractionated radiation. Forty-nine English-speaking patients with favorable risk prostate cancer who enrolled on RTOG-0415 consented to using web-based technology for completing QOL. In RTOG-0415, using paper forms, the 6-month QOL compliance rate was 52%. The purpose of RTOG-0828 was to test the feasibility of a web-based strategy with the goal of increasing the 6-month QOL completion rate by 25% (from 52% to 77%) for a relative improvement of ~50%. The web-based tool used in this study was VisionTree Optimal Care (VTOC; VisionTree Software, Inc, San Diego, CA), a Health-Insurance-Portability-Accountability-Act secure, online technology that allows real-time tracking and e-mail reminders. The primary endpoint was the 6-month compliance rate for the validated QOL instrument, Expanded Prostate Index Composite.
The QOL completion rate at baseline was 98%. Compared with the prior 52% QOL completion rate at 6 months using paper forms, the QOL web-based completion rate at 6 months was 90% (2-sided P value < .001). At 12 months, the EPIC completion rate was 82% (compared with 36% using paper forms).
This RTOG study suggests that a web-based strategy to collect QOL appears to be feasible in the cooperative group radiation oncology trial setting and is associated with an increase in the 6-month QOL compliance rate compared with the prior method of using paper forms. The RTOG plans to further test this strategy in a head-and-neck cancer trial across all participating RTOG sites.
缺失数据是临床试验中的一个重大问题，尤其是对于无法通过回顾性获取的生活质量（QOL）数据而言。本研究的目的是评估在协作组放射肿瘤学试验环境中，基于网络的电子策略收集QOL数据的可行性。
放射治疗肿瘤学组（RTOG）0828是美国国立癌症研究所协作组对RTOG - 0415进行的一项前瞻性伴随研究，RTOG - 0415是一项关于传统放疗与大分割放疗的随机研究。49名入选RTOG - 0415的、风险较低且说英语的前列腺癌患者同意使用基于网络的技术来完成生活质量评估。在RTOG - 0415中，使用纸质表格时，6个月生活质量评估的完成率为52%。RTOG - 0828的目的是测试基于网络的策略的可行性，目标是将6个月生活质量评估的完成率提高25%（从52%提高到77%），相对提高约50%。本研究中使用的基于网络的工具是VisionTree Optimal Care（VTOC；VisionTree软件公司，加利福尼亚州圣地亚哥），这是一种符合《健康保险流通与责任法案》安全标准的在线技术，可实现实时跟踪和电子邮件提醒。主要终点是经过验证的生活质量评估工具——扩展前列腺指数综合量表（Expanded Prostate Index Composite）的6个月完成率。
基线时生活质量评估的完成率为98%。与之前使用纸质表格在6个月时52%的生活质量评估完成率相比，基于网络的生活质量评估在6个月时的完成率为90%（双侧P值<0.001）。在12个月时，扩展前列腺指数综合量表的完成率为82%（相比之下，使用纸质表格时为36%）。
这项RTOG研究表明，在协作组放射肿瘤学试验环境中，基于网络的生活质量数据收集策略似乎是可行的，并且与之前使用纸质表格的方法相比，6个月生活质量评估的完成率有所提高。RTOG计划在所有参与的RTOG站点进行的头颈癌试验中进一步测试该策略。
