在癌症临床试验单位使用电子平台从患者收集不良事件数据的一项试点研究。

A Pilot Study on the Collection of Adverse Event Data from the Patient Using an Electronic Platform in a Cancer Clinical Trial Unit.

作者信息

Grahvendy Minna, Brown Bena, Wishart Laurelie R

机构信息

Cancer Trials Unit, Princess Alexandra Hospital, Queensland Health, 199 Ipswich Rd, Woolloongabba, QLD, 4102, Australia.

School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.

出版信息

Drugs Real World Outcomes. 2024 Dec;11(4):725-734. doi: 10.1007/s40801-024-00461-y. Epub 2024 Nov 2.

DOI:10.1007/s40801-024-00461-y

PMID:39487922

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11589020/

Abstract

BACKGROUND AND OBJECTIVE

Accurate and robust adverse event (AE) data collection is crucial in cancer clinical trials to ensure participant safety. Frameworks have been developed to facilitate the collection of AE data and now the traditional workflows are facing renewal to include patient-reported data, improving completeness of AE data. We explored one of these workflows in a cancer clinical trial unit.

METHODS

The study was a single-site study conducted at a tertiary hospital located in Australia. Patients consenting to a clinical trial were eligible for inclusion in this study. Participants used an electronic platform-My Health My Way (MHMW)-to report their symptomatic data weekly for 24 weeks. A symptom list was included within the platform, along with a free text field. Data reported via the platform was compared with data recorded in the patient's medical chart. Time taken to compile data from each source was recorded, along with missing data points. Agreement between patient-reported data and data recorded in the medical notes was assessed using Kappa and Gwet's AC; time taken to compile data and missing data points were assessed using a Wilcoxon signed rank test.

RESULTS

Low agreement was found between patient- and clinician-reported data (- 0.482 and - 0.159 by Kappa and Gwet's AC respectively). Only 127 (30%) of the total 428 AEs were reported by both MHMW and medical notes. Patients reported higher rates of symptoms from the symptom list, while clinicians reported higher rates of symptoms outside of the symptom list. Time taken to compile the data from MHMW was significantly less than that taken to review medical notes (2.19 min versus 5.73 min respectively; P < 0.001). There were significantly less missing data points from the MHMW data compared with the medical notes (1.4 versus 7.8; P < 0.001).

CONCLUSIONS

This study confirms previous reports that patient- and clinician-reported adverse event data show low agreement. This study also shows that clinical trial sites could significantly reduce the work performed by research staff in the collection of adverse event data by implementing an electronic, patient-reported platform.

摘要

背景与目的

准确且可靠的不良事件（AE）数据收集对于癌症临床试验至关重要，以确保参与者的安全。已开发出相关框架来促进AE数据的收集，如今传统工作流程正面临更新，以纳入患者报告的数据，提高AE数据的完整性。我们在一个癌症临床试验单位探索了其中一种工作流程。

方法

该研究是在澳大利亚一家三级医院进行的单中心研究。同意参加临床试验的患者符合本研究的纳入标准。参与者使用电子平台——“我的健康我的方式”（MHMW），每周报告其症状数据，为期24周。平台中包含一份症状清单以及一个自由文本字段。将通过平台报告的数据与患者病历中记录的数据进行比较。记录从每个来源汇编数据所需的时间以及缺失的数据点。使用Kappa和Gwet's AC评估患者报告的数据与病历中记录的数据之间的一致性；使用Wilcoxon符号秩检验评估汇编数据所需的时间和缺失的数据点。

结果

患者报告的数据与临床医生报告的数据之间一致性较低（Kappa和Gwet's AC分别为-0.482和-0.159）。在总共428例不良事件中，只有127例（30%）由MHMW和病历均报告。患者报告的症状清单中的症状发生率较高，而临床医生报告的症状清单外的症状发生率较高。从MHMW汇编数据所需的时间明显少于查阅病历所需的时间（分别为2.19分钟和5.73分钟；P<0.001）。与病历相比，MHMW数据中的缺失数据点明显更少（1.4对7.8；P<0.001）。