BACKGROUND This study evaluated pre-defined aspects of content validity of the 18-item NCCN FACT-Ovarian Symptom Index (NFOSI-18) and its Disease-Related Symptoms-Physical (DRS-P) subscale, as clinical trial outcome tools for patients with advanced ovarian cancer. METHODS Twenty-one women (mean age 59.5 years) diagnosed with advanced ovarian cancer completed the NFOSI-18 and participated in a cognitive interview to explore: (1) whether 'pain' and 'cramps' are considered redundant; (2) whether 'fatigue' and 'lack of energy' are overlapping concepts; (3) whether patients consider severity when responding to the item "I am bothered by constipation;" and (4) factors considered when responding to the item "I am sleeping well." Interviews were audio-recorded, transcribed, and analyzed qualitatively. RESULTS Pain was associated with discomfort, hurt, and life interference; 'cramps' was associated with pain, muscle tightening, and menstrual or digestive issues. Most (81%) considered the items "I have pain" and "I have cramps in my stomach area" to be more different than similar. Participants associated 'fatigue' with intense tiredness and 'lack of energy' with motivation and capability to complete daily activities. Item comparisons revealed a majority (65%) considered the items to be more different than similar. When responding to "I am bothered by constipation," patients indicated constipation severity was related to bother. Finally, patients considered disease, treatment, and other factors when responding to "I am sleeping well." CONCLUSIONS Findings support content validity of the NFOSI-18 and its DRS-P as originally constructed. We propose an alternative scoring option that excludes the item "I am sleeping well" from the DRS-P when used as a symptom-focused index for clinical research in a regulatory context.

中文翻译：

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18项NCCN / FACT卵巢症状指数及其与疾病相关的症状-物理（DRS-P）分量表的进一步内容验证，可用于晚期卵巢癌临床试验。

背景这项研究评估了18个项目的NCCN FACT-卵巢症状指数（NFOSI-18）及其疾病相关症状-物理量表（DRS-P）量表的内容效度的预定义方面，作为针对患有以下疾病的患者的临床试验结果工具晚期卵巢癌。方法：21名平均年龄为59.5岁的晚期卵巢癌女性完成了NFOSI-18并参加了一次认知访谈，以探讨：（1）是否认为“疼痛”和“痉挛”是多余的；（2）“疲劳”和“精力不足”是否是重叠的概念；（3）患者对“我便秘困扰”的回答时是否考虑严重程度；（4）在回答“我睡得好”项目时考虑的因素。对访谈进行录音，转录和定性分析。结果疼痛与不适，受伤和生活干扰有关。“抽筋”与疼痛，肌肉紧绷以及月经或消化问题有关。大多数（81％）认为“我有疼痛”和“我的胃部有抽筋”项目比相似的项目有更多不同。参与者将“疲劳”与强烈的疲劳感联系在一起，将“精力不足”与完成日常活动的动力和能力联系在一起。项目比较显示，大多数（65％）认为项目比相似项目差异更大。当回答“我被便秘困扰”时，患者表示便秘严重程度与困扰有关。最后，患者在回答“我睡得很好”时考虑了疾病，治疗和其他因素。结论结果支持最初构建的NFOSI-18及其DRS-P的内容有效性。我们提出了一种替代评分方案，该方案将DRS-P中的“我睡得好”一词用作法规环境下针对临床研究的症状重点指标时。