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)
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)
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DOI：
10.1093/jamia/ocy169
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发表时间：
2019-04-01
影响因子：
6.4
通讯作者：
Basch, Ethan M.
中科院分区：
文献类型：
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作者：
Chung, Arlene E.;Shoenbill, Kimberly;Basch, Ethan M.
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的症状性不良事件（AE）的患者输入的补充信息，并检查这些条目映射到已建立的Terminology.Materials和方法的可行性在3个多中心试验的患者在癌症治疗过程中以电子方式完成调查。每项调查均包括美国国家癌症研究所患者报告结局版本不良事件通用术语标准（PRO-CTCAE）中预先指定的项目子集。完成调查项目后，患者可在自由文本框中添加补充症状性AE信息。当患者输入框中时，可以从PRO-CTCAE条目库或国际医学用语词典（MedDRA）中选择结构化的MedDRA术语，或者患者可以输入非结构化的自由文本以提交。（48%为女性; 78%为白色），完成了8892项调查，其中2387项（26.8%）包括补充症状性AE信息。总体而言，1024例（58%）患者至少输入一次补充信息，每项研究每例患者平均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%映射到MedDRA术语。讨论参与者经常添加研究特定调查项目以外的补充信息。几乎一半的人选择了结构化的词条，尽管许多人选择提交非结构化的自由文本条目。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进行实时映射AE reporting.Conclusions患者报告的症状性AE使用文本框功能与映射到现有的术语是可行的和翔实的。
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.