膀胱癌膀胱内治疗与手术治疗方案比较(CISTO)研究:在一项以患者为中心的大型务实试验中,从管理和患者入组方面汲取的经验教训。

IF 6.1 2区 医学 Q1 ONCOLOGY Cancer Pub Date : 2024-10-14 DOI:10.1002/cncr.35600
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
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引用次数: 0

摘要

背景:随着患者和公众参与临床研究的增多,有关确保以患者为中心的大型结果试验取得成功的操作方法的文献越来越少。作者的目的是确定膀胱癌膀胱内治疗与手术治疗方案比较(CISTO)研究小组推出的工具,以确定这些工具在最大限度地提高这项观察性、务实性试验的患者入组人数方面的有效性:本研究的主要结果是 36 个 CISTO 研究机构的患者筛选和入组情况。操作策略包括 CISTO 问题电子邮件通信和所有研究点会议,特别是会议中的投票绩效数据,以及关于 CISTO 研究管理实践的非匿名反馈调查。通过与患者队列数据(包括筛查人数、注册人数、事后排除人数和事后排除率)的相关性分析来衡量效果:2021 年 4 月实施 CISTOquestion 后,平均筛查人数和注册人数均有所增加,平均筛查人数从每月 7.42 人增至 26.8 人,注册人数从每月 3.76 人增至 16 人。在所有研究机构中,CISTOquestion 的使用与患者筛查和注册人数的增加密切相关。在事后排除率高于平均水平(≥0.092)的研究机构中,有 83% 的机构发送的 CISTOquestion 问卷数量低于平均水平。民意测验结果和调查数据显示,所有使用 CISTOquestion 的调查对象都认为它是一个有价值的、可利用的资源:结论:在 CISTO 研究中实施的几种旨在改善患者注册情况的操作工具中,CISTOquestion(用于解决资格问题的集中式电子邮件)对患者的总体注册情况最为有利。
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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.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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来源期刊
Cancer
Cancer 医学-肿瘤学
CiteScore
13.10
自引率
3.20%
发文量
480
审稿时长
2-3 weeks
期刊介绍: The CANCER site is a full-text, electronic implementation of CANCER, an Interdisciplinary International Journal of the American Cancer Society, and CANCER CYTOPATHOLOGY, a Journal of the American Cancer Society. CANCER publishes interdisciplinary oncologic information according to, but not limited to, the following disease sites and disciplines: blood/bone marrow; breast disease; endocrine disorders; epidemiology; gastrointestinal tract; genitourinary disease; gynecologic oncology; head and neck disease; hepatobiliary tract; integrated medicine; lung disease; medical oncology; neuro-oncology; pathology radiation oncology; translational research
期刊最新文献
A systematic review and meta-analysis of patient-relevant outcomes in comprehensive cancer centers versus noncomprehensive cancer centers. American Society of Clinical Oncology guideline update on palliative care for patients with cancer: Addressing the reality gap. Embrace with caution: The limitations of generative artificial intelligence in responding to patient health care queries. Expression of Concern. Global disparities in cancer care: Bridging the gap in affordability and access to medications between high and low-income countries.
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