School of Nursing, Abramson Cancer Center, University of Pennsylvania, Claire M. Fagin Hall, Room 330, 418 Curie Boulevard, Philadelphia, PA 19104-4217 USA.
Transl Behav Med. 2011 Mar;1(1):110-22. doi: 10.1007/s13142-011-0025-3.
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.
美国国家癌症研究所(NCI)正在开发一种患者报告版的通用不良事件术语标准,称为“PRO-CTCAE”。PRO-CTCAE 由一系列患者报告项目组成,可以在临床试验中使用,直接捕捉癌症治疗期间患者对不良事件的体验,以及一个用于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使用 PRO-CTCAE 方法在临床研究中捕捉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。调查采用了包括结构化和开放式问题的调查,以了解对使用患者报告结局(PROs)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。该调查通过电子方式和纸质方式分发给 NCI 合作组网络的领导和委员会成员的便利样本,包括主要研究者、临床研究者、研究护士、数据管理员、患者代言人以及 NCI 和食品药品监督管理局的代表。在 2008 年 10 月至 2009 年 2 月期间,共收集了 727 份调查问卷。大多数受访者(93%)认为,患者对不良症状的报告将有助于提高对癌症试验中患者治疗体验的理解,分别有 88%、80%和 76%的受访者认为,在临床试验中管理 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,患者报告将有助于为治疗剂量调整和药物的 FDA 监管评估提供信息。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行报告不良症状,68%的人认为患者可以通过互联网或自动电话系统每周从家中自行报告。缺乏计算机以及有限的空间和人员被视为门诊自我报告的潜在障碍,但有足够的资金,这些障碍是可以克服的。大多数调查受访者认为,PRO-CTCAE 项目和软件是提高不良事件数据质量和全面性、增强临床决策制定和促进医患沟通的一种手段。正在进行研究以评估该措施在癌症临床试验中的测量性能和可行性。
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