Adverse Event Assessment and Reporting in Exercise Oncology: A Review

Riley M. Dunn, Sandra C. Hayes, Carolina X. Sandler, Rosalind R. Spence
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Abstract

ABSTRACT Exercise oncology trials report few adverse events, but the extent to which these adverse events are assessed and reported has yet to be quantified. The aim of this review was to evaluate adverse events assessment and reporting in exercise oncology trials that informed the American College of Sports Medicine’s 2019 Exercise Guidelines for Cancer Survivors, the leading guidelines document in exercise oncology. All trials that inform the Exercise Guidelines for Cancer Survivors were sourced for evaluation. In total, 231 clinical trials were identified. Approximately one-in-two trials included no detail of adverse event assessment methods and did not report intervention-related harms. Trials that described an adverse event assessment protocol reported higher numbers of adverse events compared with trials that did not. Many trials reported that adverse events were related to exercise; however, the majority of the trials did not define how this relationship was determined. Although the benefit of exercise postcancer is well established, findings from this review highlight the inadequacies of adverse events reporting within the exercise oncology field. The development and evaluation of a standardized adverse events assessment and reporting protocol for use in exercise oncology trials is needed.
运动肿瘤学不良事件评估与报告综述
运动肿瘤学试验很少报告不良事件,但这些不良事件的评估和报告程度尚未量化。本综述的目的是评估运动肿瘤学试验中的不良事件评估和报告,这些试验为美国运动医学学院2019年癌症幸存者运动指南提供了信息,该指南是运动肿瘤学的主要指导文件。所有为《癌症幸存者运动指南》提供信息的试验均用于评估。总共确定了231项临床试验。大约1 / 2的试验没有包括不良事件评估方法的细节,也没有报告干预相关的危害。与没有描述不良事件评估方案的试验相比,描述不良事件评估方案的试验报告的不良事件数量更多。许多试验报告不良事件与运动有关;然而,大多数试验并没有定义这种关系是如何确定的。尽管癌症后运动的益处已得到充分证实,但本综述的发现强调了运动肿瘤学领域不良事件报告的不足。需要制定和评估用于运动肿瘤学试验的标准化不良事件评估和报告协议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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