Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.
Value Health. 2012 Jan;15(1):183-90. doi: 10.1016/j.jval.2011.08.1739. Epub 2011 Oct 26.
By using methods consistent with recent regulatory guidance on patient-reported outcomes as endpoints in clinical trials, we created a new version of the Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (FBSI), with emphasis on patient input during the development process.
We obtained input on the most important symptoms to monitor during treatment for stage III or IV breast cancer from 52 patients recruited from National Comprehensive Cancer Network institutions as well as support service organizations. Participating patients shared their top-priority symptoms/concerns through open-ended interviews and symptom checklists. To ensure adequate content coverage, we evaluated results alongside the original version of the FBSI, which was created on the basis of a survey of oncology clinicians at National Comprehensive Cancer Network institutions and items in the Functional Assessment of Chronic Illness Therapy measurement system. We also obtained input from 10 National Comprehensive Cancer Network oncologists regarding whether symptoms were primarily related to disease or treatment.
We selected breast cancer-related symptoms and concerns endorsed as high priority by both oncology patients and clinicians for inclusion in the new National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index-16 (NFBSI-16), which includes all eight items from the original FBSI and eight additional items from Functional Assessment of Chronic Illness Therapy measures. The NFBSI-16 is formatted by subscale: Disease-Related Symptom, Treatment Side-Effect, and General Function and Well-Being. Results provide preliminary support for NFBSI-16's internal consistency reliability (α = 0.87) and validity as evidenced by moderate-to-strong relationships with expected criteria.
Reflecting the priority symptoms of breast cancer patients and clinicians, the NFBSI-16 can be used to help evaluate the effectiveness of treatments for advanced breast cancer in clinical practice and research.
通过使用与最近临床试验中患者报告结局终点的监管指导原则一致的方法，我们创建了一个新的功能性评估癌症疗法-乳腺癌症状指数（FBSI）版本，重点是在开发过程中患者的投入。
我们从美国国家综合癌症网络机构以及支持服务组织招募的 52 名患者那里获得了关于在治疗 III 或 IV 期乳腺癌期间监测最重要症状的意见。参与患者通过开放式访谈和症状清单分享了他们的首要症状/关注点。为了确保内容充分涵盖，我们评估了结果与 FBSI 的原始版本一起，该版本是基于对美国国家综合癌症网络机构肿瘤学临床医生的调查以及功能性评估慢性疾病治疗测量系统中的项目创建的。我们还从 10 名美国国家综合癌症网络肿瘤学家那里获得了有关症状是否主要与疾病或治疗有关的意见。
我们选择了癌症患者和临床医生都认为是高优先级的乳腺癌相关症状和关注点，纳入新的美国国家综合癌症网络-功能性评估癌症疗法-乳腺癌症状指数-16（NFBSI-16），该指数包括原始 FBSI 的所有八项条目和来自功能性评估慢性疾病治疗措施的八项附加条目。NFBSI-16 按子量表格式排列：疾病相关症状、治疗副作用和一般功能和健康状况。结果初步支持 NFBSI-16 的内部一致性可靠性（α=0.87）和有效性，证据是与预期标准的中度至强关系。
反映了乳腺癌患者和临床医生的优先症状，NFBSI-16 可用于帮助评估临床实践和研究中治疗晚期乳腺癌的有效性。
