Association of Perceived Benefit or Burden of Research Participation With Participants' Withdrawal From Cancer Clinical Trials.
Association of Perceived Benefit or Burden of Research Participation With Participants' Withdrawal From Cancer Clinical Trials.
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DOI：
10.1001/jamanetworkopen.2022.44412
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发表时间：
2022-11-01
影响因子：
13.8
通讯作者：
Mao, Jun J.
中科院分区：
文献类型：
--
作者：
Ulrich, Connie M.;Ratcliffe, Sarah J.;Zhou, Qiuping;Huang, Liming;Hochheimer, Camille;Gordon, Thomas;Knafl, Kathleen;Miller, Victoria;Naylor, Mary D.;Schapira, Marilyn M.;Richmond, Therese S.;Grady, Christine;Mao, Jun J.
这项调查研究分析了患者参与研究的感知收益和负担与保留癌症临床试验的关系。参与者退出癌症临床试验 (CCT) 与感知到的益处或感知到的负担相关吗？在这项针对 334 名成年癌症患者的调查研究中，退出试验的患者中有 13.4% 认为获益等于或大于负担，而认为获益小于负担的患者中有 33.3%，这是一个显着差异。这项研究的结果表明，为了增加 CCT 参与者的保留率，利益相关者之间需要进行更广泛的对话，以在整个 CCT 过程中以道德和以患者为中心关注利益。癌症临床试验 (CCT) 中的人员流失可能会导致系统偏差、分析力度不足以及改善治疗的科学知识的丧失。在参与者经历了试验之后，很少有人关注保留率，尤其是感知到的好处和负担的作用。检查患者感知的参与研究的益处和负担与 CCT 保留之间的关联。这项调查研究是在美国东北部地区国家癌症研究所指定的综合癌症中心进行的。该样本包括参与癌症治疗试验的被诊断患有癌症的成年患者。数据收集时间为 2015 年 9 月至 2019 年 6 月。自 2019 年 11 月至 2022 年 10 月，研究数据分析一直在进行。自我报告的验证调查工具，列出了 22 项研究参与的益处和 23 项负担，患者可以使用 5 点李克特量表（范围从 1（强烈不同意）到 5（强烈同意））进行评分。主要结局是实际退出 CCT，复合结局是复合退出，包括实际退出和退出想法。使用双变量和多变量逻辑回归。在样本中的 334 名参与者中，平均 (SD) 年龄为 61.9 (11.5) 岁，其中包括 174 名女性 (52.1%)。提到最多的好处包括抱负和行动导向的目标，包括帮助他人（94.2%）、为社会做出贡献（90.3%）、受到尊重（86.2%）和希望治愈（86.0%）。担心接受安慰剂（61.3%）、重新安排生活（41.9%）和经历令人烦恼的不良反应（41.6%）是显着的负担。负担评分增加与实际退出（调整后比值比[OR]，1.86；95% CI，1.1-3.17；P = .02）或复合退出（调整后OR，3.44；95% CI，2.09-5.67；P < .001）概率较高相关。获益评分的增加与综合戒断率的降低相关（调整后 OR，0.40；95% CI，0.24-0.66；P < .001）。对于认为收益等于或大于负担的参与者，有 13.4% 退出。对于那些认为收益小于负担的人，33.3% 退出（调整后 OR，3.38；95% CI，1.13-10.14；P = .03）。综合结果的退出风险甚至更高（调整后 OR，7.70；95% CI，2.76-21.48；P < .001）。这项调查研究发现，患者从参与 CCT 中感受到了重要的好处，并且这种看法与保留试验有关，即使是那些也感到负担很大的患者也是如此。利益相关者之间进行更广泛的对话可以在整个 CCT 过程中以道德和以患者为中心关注利益，从而提高保留率。
This survey study analyzes the association of patients' perceived benefits and burdens of research participation with retention in cancer clinical trials. Is participant withdrawal from cancer clinical trials (CCTs) associated with perceived benefits or perceived burdens? In this survey study of 334 adult patients with cancer, 13.4% of those who withdrew from trial participation perceived the benefits as being equal to or greater than the burdens compared with 33.3% of patients who perceived the benefits as being less than the burdens, which was a significant difference. Findings of this study suggest that, to increase the retention of participants in CCTs, a broader dialogue among stakeholders is needed to inform an ethical and patient-centric focus on benefits throughout the course of a CCT. Attrition in cancer clinical trials (CCTs) can lead to systematic bias, underpowered analyses, and a loss of scientific knowledge to improve treatments. Little attention has focused on retention, especially the role of perceived benefits and burdens, after participants have experienced the trial. To examine the association between patients’ perceived benefits and burdens of research participation and CCT retention. This survey study was conducted at a National Cancer Institute–designated comprehensive cancer center in the Northeast region of the US. The sample included adult patients with a cancer diagnosis participating in cancer therapeutic trials. Data were collected from September 2015 to June 2019. Analysis of study data was ongoing since November 2019 through October 2022. Self-reported validated survey instrument with a list of 22 benefits and 23 burdens of research participation that can be rated by patients with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). A primary outcome was actual withdrawal from the CCT, and a composite outcome was composite withdrawal that included both actual withdrawal and thoughts of withdrawing. Bivariate and multivariable logistic regressions were used. Among the 334 participants in the sample, the mean (SD) age was 61.9 (11.5) years and 174 women (52.1%) were included. Top-cited benefits included both aspirational and action-oriented goals, including helping others (94.2%), contributing to society (90.3%), being treated respectfully (86.2%), and hoping for a cure (86.0%). Worry over receiving a placebo (61.3%), rearranging one’s life (41.9%), and experiencing bothersome adverse effects (41.6%) were notable burdens. An increased burden score was associated with a higher probability of actual withdrawal (adjusted odds ratio [OR], 1.86; 95% CI, 1.1-3.17; P = .02) or composite withdrawal (adjusted OR, 3.44; 95% CI, 2.09-5.67; P < .001). An increased benefit score was associated with lower composite withdrawal (adjusted OR, 0.40; 95% CI, 0.24-0.66; P < .001). For participants who reported the benefits as being equal to or greater than the burdens, 13.4% withdrew. For those who perceived the benefits as being less than the burdens, 33.3% withdrew (adjusted OR, 3.38; 95% CI, 1.13-10.14; P = .03). The risk of withdrawal was even higher for the composite outcome (adjusted OR, 7.70; 95% CI, 2.76-21.48; P < .001). This survey study found that patients perceived important benefits from CCT participation, and this perception was associated with trial retention, even among those who also perceived substantial burdens. A broader dialogue among stakeholders can inform an ethical and patient-centric focus on benefits throughout the course of a CCT to increase retention.
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DOI：
10.1016/0749-5978(91)90020-t
发表时间：
1991-12-01
影响因子：
4.6
作者：
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通讯作者：
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DOI：
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影响因子：
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DOI：
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发表时间：
2007-03-07
影响因子：
4.7
作者：
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影响因子：
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作者：
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