Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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DOI：
10.1007/s13142-011-0025-3
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发表时间：
2011-03-01
影响因子：
3.6
通讯作者：
Basch, Ethan M.
中科院分区：
文献类型：
--
作者：
Bruner, Deborah Watkins;Hanisch, Laura J.;Basch, Ethan M.
美国国家癌症研究所 (NCI) 正在开发患者报告的不良事件通用术语标准，称为“PRO-CTCAE”。 PRO-CTCAE 包含一个患者报告项目库，可以在临床试验中进行管理，以直接捕获患者在癌症治疗期间的不良事件经历，以及一个通过计算机或电话管理这些项目的软件平台。为了更好地了解参与癌症临床研究的利益相关者对 PRO-CTCAE 方法在临床研究中捕获不良事件信息的潜在价值的印象，以及他们对在 NCI 资助的癌症试验中实施 PRO-CTCAE 的障碍和策略的看法，进行了一项调查。开展了一项包括结构化和开放式问题的调查，以引发人们对使用患者报告结果 (PRO) 进行不良事件报告的看法，并探讨在癌症试验中实施 PRO-CTCAE 的后勤考虑因素。该调查以电子方式和纸质形式分发给 NCI 合作小组网络中的领导层和委员会成员，包括主要研究人员、临床研究人员、研究护士、数据管理员、患者权益倡导者以及 NCI 和食品药品管理局的代表。 2008 年 10 月至 2009 年 2 月期间，共收集了 727 份调查。大多数受访者 (93%) 同意，患者报告不良症状将有助于增进对癌症试验中患者治疗体验的了解，并且分别有 88%、80% 和 76% 的受访者赞同在临床试验中使用 PRO-CTCAE 项目将提高症状数据收集的完整性、准确性和效率。超过四分之三的人认为患者报告有助于告知治疗剂量调整以及 FDA 对药物的监管评估。 88% 的人认为临床试验中的患者愿意在就诊时通过计算机自我报告不良症状，68% 的人认为患者每周会通过互联网或自动电话系统在家中自我报告。缺乏计算机以及有限的空间和人员被认为是诊所自我报告的潜在障碍，但这些被认为只要有足够的资金就可以克服。大多数调查受访者将 PRO-CTCAE 项目和软件视为提高不良事件数据质量和全面性、增强临床决策以及促进患者与临床医生沟通的一种手段。正在进行研究以评估在癌症临床试验中实施该测量的测量特性和可行性。
The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.