使用美国国家癌症研究所的患者报告结局版常见不良事件术语标准（PRO-CTCAE），对癌症临床研究中的症状性不良事件进行患者自由文本报告。
Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
机构信息
Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Program on Health and Clinical Informatics, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
出版信息
J Am Med Inform Assoc. 2019 Apr 1;26(4):276-285. doi: 10.1093/jamia/ocy169.
OBJECTIVE
The study sought to describe patient-entered supplemental information on symptomatic adverse events (AEs) in cancer clinical research reported via a National Cancer Institute software system and examine the feasibility of mapping these entries to established terminologies.
MATERIALS AND METHODS
Patients in 3 multicenter trials electronically completed surveys during cancer treatment. Each survey included a prespecified subset of items from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Upon completion of the survey items, patients could add supplemental symptomatic AE information in a free text box. As patients typed into the box, structured dropdown terms could be selected from the PRO-CTCAE item library or Medical Dictionary for Regulatory Activities (MedDRA), or patients could type unstructured free text for submission.
RESULTS
Data were pooled from 1760 participants (48% women; 78% White) who completed 8892 surveys, of which 2387 (26.8%) included supplemental symptomatic AE information. Overall, 1024 (58%) patients entered supplemental information at least once, with an average of 2.3 per patient per study. This encompassed 1474 of 8892 (16.6%) dropdowns and 913 of 8892 (10.3%) unstructured free text entries. One-third of the unstructured free text entries (32%) could be mapped post hoc to a PRO-CTCAE term and 68% to a MedDRA term.
DISCUSSION
Participants frequently added supplemental information beyond study-specific survey items. Almost half selected a structured dropdown term, although many opted to submit unstructured free text entries. Most free text entries could be mapped post hoc to PRO-CTCAE or MedDRA terms, suggesting opportunities to enhance the system to perform real-time mapping for AE reporting.
CONCLUSIONS
Patient reporting of symptomatic AEs using a text box functionality with mapping to existing terminologies is both feasible and informative.
目的
本研究旨在描述通过美国国家癌症研究所软件系统报告的癌症临床研究中患者输入的症状性不良事件（AE）补充信息，并探讨将这些条目映射到既定术语的可行性。
材料和方法
3 项多中心试验中的患者在癌症治疗期间通过电子方式完成了调查。每个调查都包括美国国家癌症研究所患者报告结局版通用不良事件术语标准（PRO-CTCAE）的预定子集项目。完成调查项目后，患者可以在自由文本框中添加补充症状性 AE 信息。当患者在框中输入内容时，可以从 PRO-CTCAE 项目库或监管活动医学词典（MedDRA）中选择结构化下拉术语，或者患者可以输入非结构化自由文本进行提交。
结果
从完成 8892 份调查的 1760 名参与者（48%为女性；78%为白人）中汇总了数据，其中 2387 份（26.8%）包含补充症状性 AE 信息。总体而言，1024 名（58%）患者至少输入了一次补充信息，每位患者平均每个研究输入 2.3 次。这包括 8892 个下拉列表中的 1474 个（16.6%）和 8892 个非结构化自由文本条目中的 913 个（10.3%）。三分之一的非结构化自由文本条目（32%）可以事后映射到 PRO-CTCAE 术语，68%可以映射到 MedDRA 术语。
讨论
参与者经常在特定于研究的调查项目之外添加补充信息。尽管许多人选择提交非结构化自由文本条目，但近一半的人选择了结构化下拉列表术语。大多数自由文本条目可以事后映射到 PRO-CTCAE 或 MedDRA 术语，这表明有机会增强系统以实现 AE 报告的实时映射。
结论
使用具有现有术语映射功能的文本框功能报告症状性 AE 是可行且有信息意义的。
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