a Department of Oncology , Rigshospitalet, University of Copenhagen , Copenhagen , Denmark.
b Department of Oncology , Odense University Hospitalet , Odense , Denmark.
Acta Oncol. 2019 May;58(5):603-609. doi: 10.1080/0284186X.2018.1563713. Epub 2019 Jan 30.
The systematic use of a Patient-Reported Outcome (PRO) as symptom monitoring during cancer treatment and follow-up has the potential to increase symptom awareness, secure timely management of side effects, improve health-related quality of life and improve data quality. This study was conducted to identify the patients' experience during chemoradiotherapy for squamous cell carcinoma of the head and neck (HNSCC) and to investigate how these symptoms correspond with different PRO questionnaires. Semi-structured interviews on acute side effects were performed until saturation with HNSCC patients treated with high-dose radiotherapy (RT) ± concomitant chemotherapy. The symptoms were thematically grouped in organ classes in accordance with Medical Dictionary for Regulatory Activities (MedDRA). PRO questionnaires validated for patients with HNSCC during RT were identified in the literature and were compared to the patients' symptoms. Thirteen patients were interviewed. The most frequently mentioned symptoms were oral pain, decreased appetite, dysphagia, dry mouth, fatigue and hoarseness, in order of frequency. A comparison between the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H&N35), the Functional Assessment of Cancer Therapy General and Head and Neck (FACT-H&N), the M.D. Anderson Symptom Inventory Head and Neck questionnaire (MDASI-HN), selected items from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the symptoms described by the patients showed that the PROs do not cover the same symptoms, and no specific questionnaire covers all patient's experiences. We find, that questionnaires applied in the field of PRO among patients with HNSCC undergoing RT may not fully comprise the experiences of patients and we recommend, that experiences of patients must be included in the design of trials involving PRO, in order to decrease the likelihood of missing out reports of acute side effects.
系统地使用患者报告的结局（PRO）作为癌症治疗和随访期间的症状监测，有可能提高症状意识，及时管理副作用，改善健康相关生活质量，并提高数据质量。本研究旨在确定接受头颈部鳞状细胞癌（HNSCC）放化疗患者的治疗体验，并探讨这些症状如何与不同的 PRO 问卷相对应。通过对半结构访谈，对接受高剂量放疗（RT）±同期化疗的 HNSCC 患者的急性副作用进行了调查，直至达到饱和。根据监管活动医学词典（MedDRA），将症状按器官类别进行主题分组。在文献中确定了针对 RT 期间接受 HNSCC 治疗的患者验证的 PRO 问卷，并将其与患者的症状进行比较。对 13 名患者进行了访谈。最常提到的症状按频率依次为口腔疼痛、食欲下降、吞咽困难、口干、疲劳和声音嘶哑。EORTC QLQ-H&N35（欧洲癌症研究与治疗组织生活质量问卷-头颈部）、FACT-H&N（癌症治疗功能评估-一般和头颈部）、MDASI-HN（安德森症状清单-头颈部问卷）和 PRO-CTCAE（不良事件常用术语标准的患者报告结局版本）的部分项目与患者描述的症状之间的比较表明，PRO 没有涵盖相同的症状，也没有特定的问卷涵盖所有患者的体验。我们发现，应用于接受 RT 的 HNSCC 患者 PRO 领域的问卷可能无法全面涵盖患者的体验，我们建议，在涉及 PRO 的临床试验设计中必须纳入患者的体验，以减少遗漏急性副作用报告的可能性。
