BACKGROUND Patients with cancer who are treated with immune checkpoint modulators (ICMs) have their health-related quality of life (HRQOL) measured using general patient-reported outcome (PRO) tools. To the authors' knowledge, no instrument has been developed to date specifically for patients treated with ICMs. The objective of the current study was to develop a toxicity subscale PRO instrument for patients treated with ICMs to assess HRQOL. METHODS Input was collected from a systematic review as well as patients and physicians experienced with ICM treatment. Descriptive thematic analysis was used to evaluate the qualitative data obtained from patient focus groups and interviews, which informed an initial list of items that described ICM side effects and their impact on HRQOL. These inputs informed item generation and/or reduction to develop a toxicity subscale. RESULTS Focus groups and individual interviews with 37 ICM-treated patients generated an initial list of 176 items. After a first round of item reduction that produced a shortened list of 76 items, 16 physicians who care for patients who are treated with ICMs were surveyed with a list of 49 patient-reported side effects and 11 physicians participated in follow-up interviews. A second round of item reduction was informed by the physician responses to produce a list of 25 items. CONCLUSIONS To the authors' knowledge, this 25-item list is the first HRQOL-focused toxicity subscale for patients treated with ICMs and was developed in accordance with US Food and Drug Administration guidelines, which prioritize patient input in developing PRO tools. The subscale will be combined with the Functional Assessment of Cancer Therapy-General (FACT-G) to form the FACT-ICM. Prior to recommending the formal use of this PRO instrument, the authors will evaluate its validity and reliability in longitudinal studies involving substantially more patients.

中文翻译：

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癌症治疗-免疫检查点调节剂（FACT-ICM）功能评估的发展：一种毒性子量表，用于测量接受ICM治疗的癌症患者的生活质量。

背景技术使用免疫检查点调节剂（ICM）治疗的癌症患者，其健康相关生活质量（HRQOL）使用一般患者报告的结局（PRO）工具进行测量。据作者所知，迄今为止尚未开发出专门针对接受ICM治疗的患者的仪器。本研究的目的是为ICM治疗的患者开发一种毒性低于量表的PRO仪器，以评估HRQOL。方法：从系统评价以及具有ICM治疗经验的患者和医生那里收集信息。描述性主题分析用于评估从患者焦点小组和访谈中获得的定性数据，这些数据为描述ICM副作用及其对HRQOL影响的项目的初始清单提供了信息。这些输入通知了物品的产生和/或减少，从而形成了毒性子量表。结果焦点小组和对37位接受ICM治疗的患者的个人访谈产生了176个项目的初始列表。在第一轮减少项目后，缩短了76个项目的清单，然后对16位照顾ICM治疗患者的医生进行了调查，列出了49位患者报告的副作用，并且有11位医生参加了后续访谈。由医师回复告知第二轮项目减少，以产生25个项目的清单。结论据作者所知，该25个项目清单是针对使用ICM治疗的患者的第一个针对HRQOL的毒性亚量表，并且是根据美国食品药品监督管理局的指南制定的，该指南在开发PRO工具时优先考虑患者的意见。该分量表将与癌症治疗一般功能评估（FACT-G）相结合，形成FACT-ICM。在建议正式使用该PRO仪器之前，作者将在涉及更多患者的纵向研究中评估其有效性和可靠性。