评估健康相关生活质量问卷在非小细胞肺癌常见症状性不良事件中的捕获能力
Evaluating health-related quality of life questionnaires in capturing common symptomatic adverse events in non-small cell lung cancer.
作者
作者单位
- European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium. Electronic address: lotte.vanderweijst@eortc.org.
- Institute for Clinical & Applied Health Research, University of Hull, United Kingdom; Section of Patient Centred Outcomes Research, University of Leeds, United Kingdom.
- European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
- Leeds Institute of Medical Research, University of Leeds, United Kingdom.
- Department of Clinical Medicine and Surgery, University of Naples Federico II, Italy.
- Paris-Saclay University, Department of Cancer Medicine, Gustave Roussy, Villejuif, France.
- Università Vita-Salute San Raffaele, Milan, Italy; IRCCS Ospedale San Raffaele, Department of Medical Oncology, Milan, Italy.
摘要
中文
尽管不良事件（AE）报告已取得进展，但临床医师评估与患者报告的症状性不良事件之间常存在差异，这在非小细胞肺癌（NSCLC）临床试验中亦不例外。本研究探讨了患者报告问卷，尤其是EORTC核心问卷（QLQ-C30）和肺癌专用模块（QLQ-LC29），在NSCLC系统治疗中捕获患者报告症状性不良事件的程度。研究对系统性NSCLC治疗公开可获取的产品特性摘要（SmPC）中报告的症状性不良事件与EORTC QLQ-C30和QLQ-LC29捕获的患者报告结局进行了系统比较。纳入非常常见（≥10%）和常见（1%–10%）的AE，并进行了结构化映射分析以识别SmPC和EORTC问卷之间症状性AE的重叠与缺口。我们分析了38种系统治疗药物，发现EORTC QLQ-C30和QLQ-LC29能有效捕获腹泻、恶心呕吐、疼痛及皮肤问题等（非常）常见症状性AE，这些症状在超过75%的SmPC中均有报告。研究共识别出62项未被EORTC工具捕获的症状性AE，其中多数（58.1%）仅被报告一次，仅有两项症状性AE在超过50%的SmPC中被报告：水肿（65.8%）和发热（57.9%）。这些AE在EORTC条目库中已有充分覆盖。本研究强调临床试验中AE报告需采用结合临床医师评估与患者报告结局的双重策略，并展示了EORTC QLQ-C30和QLQ-LC29问卷捕获患者报告常见症状性AE的能力，同时补充使用EORTC条目库中的条目以捕获遗漏的症状性AE。未来研究应集中优化这些工具的整合，以确保更广泛的症状性AE被捕获，从而最终支持对治疗对患者健康及生活质量影响的理解。
English
Despite advancements in adverse events (AEs) reporting, discrepancies often arise between clinician-assessed and patient-reported symptomatic AEs, including in non-small cell lung cancer (NSCLC) trials. This study investigates the extent to which patient-reported questionnaires, particularly the EORTC Questionnaire - Core (QLQ-C30) and the lung cancer-specific module (QLQ-LC29) capture patient-reported symptomatic AEs in systemic treatments for NSCLC. A systematic comparison was conducted between symptomatic AEs reported in publicly available Summary of Product Characteristics (SmPC) of systemic NSCLC treatments and patient-reported outcomes captured by the EORTC QLQ-C30 and QLQ-LC29. AEs classified as very common (≥10%) or common (1%-10%) were included. A structured mapping exercise was undertaken to identify overlaps and gaps between symptomatic AEs captured by SmPC and EORTC questionnaires. We analysed 38 systemic treatments and found that the EORTC QLQ-C30 and QLQ-LC29 effectively capture (very) common symptomatic AEs such as diarrhea, nausea and vomiting, pain and skin problems, which are reported in over 75% of SmPCs. A total of 62 symptomatic AEs identified were not captured by the EORTC measures. The majority (58.1%) of these were only reported once and only two symptomatic AEs were reported in >50% of SmPCs: oedema(65.8%) andpyrexia(57.9%). These AEs are well-covered in the EORTC item library. This study highlights the need for a dual approach to AE reporting in clinical trials that combines clinician assessments with patient-reported outcomes. It also demonstrates the ability of the EORTC QLQ-C30 and QLQ-LC29 questionnaires to capture patient-reported common symptomatic AEs, with the addition of an item list from the EORTC Item Library to capture missing symptomatic AEs. Future research should concentrate on optimizing the integration of these tools to ensure that a broad spectrum of symptomatic AEs is captured, ultimately supporting the understanding of treatment impact on patient health and quality of life.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q1
- 影响因子
- 5.3
- 新锐分区
- 2区