膀胱内治疗和手术作为膀胱癌治疗选择的比较 (CISTO) 研究:在一项大型、务实、以患者为中心的试验中获得的有关管理和患者入组的经验教训。
The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study: Lessons learned about management and patient enrollment in a large, pragmatic, patient-centered trial.
发表日期:2024 Oct 14
作者:
Krupa K Nathan, Kristin M Follmer, Michael G Nash, Erika M Wolff, Jenney R Lee, Solange Mecham, Marielle Yano, Sung Min Kim, Bryan A Comstock, John L Gore, Angela B Smith
来源:
CANCER
摘要:
患者和公众参与临床研究的增长凸显了确保大型、以患者为中心的结果试验成功的操作实践文献的缺乏。作者的目的是确定膀胱内治疗和手术作为膀胱癌治疗选择的比较 (CISTO) 研究小组推出的工具,以确定它们在这项观察性、实用性试验中最大限度地提高患者入组率的有效性。这项研究的主要结果是36 个 CISTO 研究中心的患者筛查和入组。运营策略包括 CISTOquestion 电子邮件通信和所有站点会议,特别是会议中的民意调查绩效数据,以及有关 CISTO 研究管理实践的非匿名反馈调查。使用患者队列数据的相关性分析来衡量有效性,包括筛查、入组、事后排除和事后排除率。2021 年 4 月实施 CISTOquestion 后,平均筛查和入组有所上升,平均筛查次数有所上升从每月 7.42 名患者增加到 26.8 名患者,入组人数从每月 3.76 名患者增加到 16 名患者。 CISTOquestion 的使用与所有研究中心的患者筛查和入组增加密切相关。 83% 的事后排除率高于平均水平 (≥0.092) 的网站发送的 CISTO 问题查询数量低于平均水平。民意调查表现和调查数据显示,所有使用 CISTOquestion 的调查受访者都发现它是一种宝贵且易于访问的资源。在 CISTO 研究中实施的旨在提高患者登记率的多种操作工具中,CISTOquestion 是一种用于解决资格问题的集中电子邮件,对总体患者增长最有利。© 2024 美国癌症协会。
The growth of patient and public involvement in clinical research highlights the paucity of literature on operational practices that ensure the success of large, patient-centered outcomes trials. The authors' objective was to identify tools launched by the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study team to determine their effectiveness in maximizing patient enrollment in this observational, pragmatic trial.The primary outcomes for this study were patient screening and enrollment across 36 CISTO study sites. The operational strategies included CISTOquestion email correspondence and All Sites Meetings, specifically poll performance data from meetings, and a nonanonymized feedback survey about the CISTO study's management practices. Effectiveness was measured using correlation analysis with patient cohort data, including screenings, enrollments, post-hoc exclusions, and the post-hoc exclusion rate.Average screenings and enrollment rose after the implementation of CISTOquestion in April 2021, with the average number of screenings rising from 7.42 to 26.8 patients per month and enrollment rising from 3.76 to 16 patients per month. Use of CISTOquestion was correlated strongly with increased patient screenings and enrollment across all study sites. Eighty-three percent of sites with above-average post-hoc exclusion rates (≥0.092) sent below the average number of CISTOquestion inquiries. Poll performance and survey data revealed that all survey respondents who used CISTOquestion found that it was a valuable and accessible resource.Of the several operational tools implemented within the CISTO study that aimed to improve patient enrollment, CISTOquestion, a centralized email for addressing eligibility questions, was most beneficial to overall patient accrual.© 2024 American Cancer Society.