Institute of Pharmacy, Department of Clinical Pharmacy, University of Bonn, An der Immenburg 4, 53121, Bonn, Germany.
National Center for Tumor Diseases (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany.
BMC Cancer. 2023 Jul 5;23(1):629. doi: 10.1186/s12885-023-11115-7.
To include the patient perspective in the assessment of adverse events in oncology, a patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (CTCAE) was developed by the US National Cancer Institute, the so called PRO-CTCAE. The objective of this study was the development of disease-specific PRO-CTCAE item sets for patients with breast cancer (BC), multiple myeloma (MM), and prostate cancer (PC).
The cross-sectional survey was conducted at three German outpatient cancer centers. Prevalence and importance of the 78 PRO-CTCAE symptoms were assessed using a patient questionnaire. To select the most relevant PRO-CTCAE items for each tumor entity, symptoms were ranked based on patient answers.
101 patients with BC, 107 with MM, and 66 with PC participated. The final item sets contained 21 symptoms (BC) or 19 symptoms (MM and PC), respectively. Eight symptoms (fatigue, muscle pain, insomnia, joint pain, general pain, dizziness, shortness of breath, and swelling) were represented in all three item sets. Fatigue was the symptom with the highest ranking across item sets followed by insomnia. Symptoms with the highest rankings represented in only one item set were symptoms affecting the urogenital system in the PC item set, blurred vision in the BC item set, and decreased appetite in the MM item set.
Individual PRO-CTCAE item sets for a German patient population were developed for the three tumor entities on the basis of patients' differences in symptom profiles and perceptions. The quality and psychometric criteria of the newly compiled item sets should be evaluated in validation studies.
为了将患者视角纳入肿瘤不良反应评估中，美国国家癌症研究所开发了一种患者报告结局（PRO）版通用不良事件术语标准（CTCAE），即所谓的 PRO-CTCAE。本研究的目的是为乳腺癌（BC）、多发性骨髓瘤（MM）和前列腺癌（PC）患者开发特定疾病的 PRO-CTCAE 项目集。
该横断面调查在德国的三个门诊癌症中心进行。使用患者问卷评估 78 项 PRO-CTCAE 症状的流行程度和重要性。为了选择每个肿瘤实体中最相关的 PRO-CTCAE 项目，根据患者的回答对症状进行排名。
共有 101 名 BC 患者、107 名 MM 患者和 66 名 PC 患者参与了研究。最终的项目集分别包含 21 个症状（BC）或 19 个症状（MM 和 PC）。有 8 个症状（疲劳、肌肉疼痛、失眠、关节疼痛、全身疼痛、头晕、呼吸急促和肿胀）在三个项目集中均有体现。疲劳是所有项目集中排名最高的症状，其次是失眠。在仅一个项目集中出现的症状中，与 PC 项目集相关的是泌尿系统症状，与 BC 项目集相关的是视力模糊，与 MM 项目集相关的是食欲减退。
基于患者在症状谱和感知方面的差异，为德国患者群体开发了针对这三种肿瘤实体的个体化 PRO-CTCAE 项目集。新编译的项目集的质量和心理计量学标准应在验证研究中进行评估。
