行头颈鳞状细胞癌（HNSCC）放射治疗（RT）的患者经历一系列严重的不良反应（AEs）。用于量化这些AE的患者报告结果（PRO）措施是医疗保健的必要和重要组成部分；然而，目前可用的PRO选项通常仅衡量与疾病相关的症状或非RT治疗的AE。本研究旨在开发一种简洁的PRO措施，以量化与HNSCC的RT相关的最常见AE。本研究遵循美国食品和药物管理局的指导方针进行了定性研究，以开发患者报告的RT相关AE（功能评估癌症治疗法-头颈放疗[FACT-HN-RAD]评价措施）。该研究包括（1）临床试验的文献回顾；（2）回顾性概念启发采访（CEIs）的二次分析；（3）对实践放射肿瘤学家的电子调查；（4）对现有项目进行映射，以制定措施的草稿版本；（5）通过患者认知采访进行内容和面部效度的验证。对CEI数据和实践放射肿瘤学家的访谈进行了分析。数据分析从2022年7月1日至2023年4月21日期间进行。调查和定性访谈。 HNSCC患者报告的与RT相关的最常见AE。在19名CEI参与者中，14名（平均年龄[范围]为67 [49-86]岁；12[86％]男性和2[14％]女性）描述了与RT相关的AE，并纳入了二次分析。11名（79％）患者报告出现吞咽困难；8名（57％）患者有口腔疼痛；7名（50％）患者出现口干；7名（50％）患者体重减轻；6名（43％）患者皮肤灼烧；5名（36％）患者丧失味觉；5名（36％）患者声音变化（36％）；以及5名（36％）患者疲劳。9名放射肿瘤学家（平均实践时间[范围]为8 [1-42]年；5名[56％]男性和4名[44％]女性）报告了最常见的AE：9名（100％）放射肿瘤学家报道出现味觉障碍；7名（78％）报道出现干口；7名（78％）报道出现口腔炎或口腔疼痛；8名（89％）报道出现吞咽困难或咽痛；6名（67％）报道皮肤炎症；3名（33％）报道疲劳。这些数据共同支撑了一个包含疼痛、吞咽困难、干口、味觉障碍、声音变化、皮炎、疲劳和体重减轻的8项AE评定措施的制定。对10名患者进行的认知采访（平均年龄[范围]为61 [29-84]岁；8名[80％]男性和2名[20％]女性）展示了强有力的面部效度，所有患者（100％）都表示该措施反映了他们接受RT的经历，并表示问卷的长度“刚刚好”。 这项8项FACT-HN-RAD措施捕捉到了与HNSCC的RT相关的患者报告的最常见AE和医生报告的AE。该措施提供了一种在临床和研究环境中连续监测患者报告的治疗相关AE和康复情况的手段。未来的工作将评估该措施的心理测量学效度。

Patients undergoing radiation therapy (RT) for head and neck squamous cell carcinoma (HNSCC) experience a range of debilitating adverse effects (AEs). Patient-reported outcome (PRO) measures to quantify these AEs are a necessary and important component of health care; however, currently available PRO options often measure only disease-related symptoms or AEs of non-RT treatments.To develop a brief PRO measure of the most common AEs associated with RT for HNSCC.This was a qualitative study that followed the US Food and Drug Administration guidelines to develop a brief measure of patient-reported RT-related AEs (the Functional Assessment of Cancer Therapy-Head and Neck Radiotherapy [FACT-HN-RAD] measure). The study included (1) a literature review of clinical trials; (2) secondary analysis of retrospective concept elicitation interviews (CEIs); (3) electronic surveys of practicing radiation oncologists; (4) mapping of existing items to inform the development of the draft version of the measure; and (5) validation of content and face validity via patient cognitive interviews. Analysis was performed of CEI data and interviews with practicing radiation oncologists. Data analysis was conducted from July 1, 2022, to April 21, 2023.Surveys and qualitative interviews.The most common patient-reported RT-related AEs among patients with HNSCC.Of 19 CEI participants, 14 (mean [range] age, 67 [49-86] years; 12 [86%] men and 2 [14%] women) described RT-related AEs and were included in the secondary analysis. Eleven (79%) patients reported difficulty swallowing; 8 (57%), oral pain; 7 (50%), dry mouth; 7 (50%), weight loss; 6 (43%), skin burning; 5 (36%), loss of taste; 5 (36%), voice changes (36%); and 5 (36%), fatigue. Nine radiation oncologists (mean [range] time in practice, 8 [1-42] years; 5 [56%] men and 4 [44%] women) reported the most common AEs: 9 (100%) reported dysgeusia; 7 (78%), xerostomia; 7 (78%), mucositis or oral pain; 8 (89%), dysphagia or odynophagia; 6 (67%), dermatitis; and 3 (33%), fatigue. Together these data informed the development of an 8-item AE-focused measure of pain, dysphagia, xerostomia, dysgeusia, voice changes, dermatitis, fatigue, and weight loss. Cognitive interviews with 10 patients (mean [range] age, 61 [29-84] years; 8 [80%] men and 2 [20%] women) demonstrated strong face validity; all (100%) reported that the measure reflected their experience with RT and stated that the length of the questionnaire was "just right."The 8-item FACT-HN-RAD measure captures the most common patient- and physician-reported AEs related to RT for HNSCC. This measure offers a means to serially monitor patient-reported treatment-related AEs and recovery over time in both clinical and research settings. Future work will evaluate the psychometric validity of the measure.