Objective: To develop a symptom-focused index to evaluate representative symptoms, treatment side effects, and emotional and functional well-being of patients with carcinoid syndrome (CS). Methods: The Development of the Functional Assessment of Cancer Therapy Carcinoid Syndrome Symptom Index (FACT-CSI) followed U.S. Food and Drug Administration guidelines for the development of patient-reported outcome (PRO) measures and involved: (a) literature review; (b) interviews with 14 CS patients; (c) interviews with 9 clinicians; and (d) instrument development involving input from a range of PRO measure development and CS experts. The resulting draft instrument underwent cognitive interviews with 7 CS patients. Results: Forty-six CS sources were reviewed. Analysis of patient interviews produced 23 patient-reported symptoms. The most frequently-endorsed physical symptoms were flushing, diarrhea, abdominal pain, fatigue, and food sensitivity/triggers. Seven priority CS emotional and functional themes were also identified by patients. Expert interviews revealed 12 unique priority symptoms—the most common being diarrhea, flushing, wheezing, edema, abdominal pain/cramping, fatigue, and 8 emotional and functional concerns. Through an iterative process of team and clinical collaborator meetings, data review, item reduction and measure revision, 24 items were selected for the draft symptom index representing symptoms, emotional concerns, global assessment of treatment side effects, and functional well-being. Cognitive interview results demonstrated strong content validity, including positive endorsement of item clarity (> 86% across items), symptom relevance (> 70% for most items), and overall measure content (86%). Conclusions: The FACT-CSI is a content-relevant, symptom-focused index reflecting the highest priority and clinically relevant symptoms and concerns of people with CS.


中文翻译：

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癌症治疗功能评估 - 类癌综合征症状指数 (FACT-CSI) 的发展。

目的：开发一个以症状为中心的指数来评估类癌综合征（CS）患者的代表性症状、治疗副作用以及情绪和功能健康。方法：癌症治疗类癌综合征症状指数 (FACT-CSI) 的功能评估的开发遵循美国食品和药物管理局制定患者报告结果 (PRO) 措施的指南，并涉及：(a) 文献回顾；(b) 采访 14 名 CS 患者；(c) 与 9 名临床医生面谈；(d) 仪器开发涉及一系列 PRO 测量开发和 CS 专家的投入。由此产生的文书草案对 7 名 CS 患者进行了认知访谈。结果：审查了 46 个 CS 来源。对患者访谈的分析产生了 23 种患者报告的症状。最常被认可的身体症状是潮红、腹泻、腹痛、疲劳和食物敏感性/诱因。患者还确定了七个优先的 CS 情绪和功能主题。专家访谈揭示了 12 种独特的优先症状——最常见的是腹泻、潮红、喘息、水肿、腹痛/痉挛、疲劳，以及 8 种情绪和功能问题。通过团队和临床合作者会议、数据审查、项目缩减和测量修订的迭代过程，选择了 24 个项目作为症状指数草案，代表症状、情绪问题、治疗副作用的整体评估和功能健康。认知访谈结果显示出很强的内容效度，包括对项目清晰度的积极认可（> 86% 的项目）、症状相关性（> 大多数项目为 70%）和整体测量内容（86%）。结论：FACT-CSI 是一个内容相关、以症状为中心的指数，反映了 CS 患者的最高优先级和临床相关症状和担忧。