Ma Jinfei, Zou Zihao, Pazo Emmanuel Eric, Moutari Salissou, Liu Ye, Jin Feng
Department of Breast Surgery, The First Affiliated Hospital of China Medical University, Shenyang, China.
Department of Ophthalmology, He Eye Hospital, Shenyang, China.
JMIR Med Inform. 2021 Mar 2;9(3):e18269. doi: 10.2196/18269.
Breast cancer remains the most common neoplasm diagnosed among women in China and globally. Health-related questionnaire assessments in research and clinical oncology settings have gained prominence. The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) is a rapid and powerful tool to help evaluate disease- or treatment-related symptoms, both physical and emotional, in patients with breast cancer for clinical and research purposes. Prevalence of individual smartphones provides a potential web-based approach to administrating the questionnaire; however, the reliability of the NFBSI-16 in electronic format has not been assessed.
This study aimed to assess the reliability of a web-based NFBSI-16 questionnaire in breast cancer patients undergoing systematic treatment with a prospective open-label randomized crossover study design.
We recruited random patients with breast cancer under systematic treatment from the central hospital registry to complete both paper- and web-based versions of the questionnaires. Both versions of the questionnaires were self-assessed. Patients were randomly assigned to group A (paper-based first and web-based second) or group B (web-based first and paper-based second). A total of 354 patients were included in the analysis (group A: n=177, group B: n=177). Descriptive sociodemographic characteristics, reliability and agreement rates for single items, subscales, and total score were analyzed using the Wilcoxon test. The Lin concordance correlation coefficient (CCC) and Spearman and Kendall τ rank correlations were used to assess test-retest reliability.
Test-retest reliability measured with CCCs was 0.94 for the total NFBSI-16 score. Significant correlations (Spearman ρ) were documented for all 4 subscales-Disease-Related Symptoms Subscale-Physical (ρ=0.93), Disease-Related Symptoms Subscale-Emotional (ρ=0.85), Treatment Side Effects Subscale (ρ=0.95), and Function and Well-Being Subscale (ρ=0.91)-and total NFBSI-16 score (ρ=0.94). Mean differences of the test and retest were all close to zero (≤0.06). The parallel test-retest reliability of subscales with the Wilcoxon test comparing individual items found GP3 (item 5) to be significantly different (P=.02). A majority of the participants in this study (255/354, 72.0%) preferred the web-based over the paper-based version.
The web-based version of the NFBSI-16 questionnaire is an excellent tool for monitoring individual breast cancer patients under treatment, with the majority of participants preferring it over the paper-based version.
乳腺癌仍是中国及全球女性中诊断出的最常见肿瘤。在肿瘤学研究和临床环境中，与健康相关的问卷调查评估日益重要。美国国立综合癌症网络-癌症治疗功能评估-乳腺癌症状指数（NFBSI-16）是一种快速且有效的工具，可用于评估乳腺癌患者与疾病或治疗相关的身体和情感症状，以用于临床和研究目的。个人智能手机的普及为问卷调查提供了一种潜在的基于网络的管理方式；然而，电子格式的NFBSI-16的可靠性尚未得到评估。
本研究旨在通过前瞻性开放标签随机交叉研究设计，评估基于网络的NFBSI-16问卷在接受系统治疗的乳腺癌患者中的可靠性。
我们从中心医院登记处招募正在接受系统治疗的随机乳腺癌患者，以完成纸质版和网络版问卷。两个版本的问卷均为自我评估。患者被随机分配到A组（先纸质版后网络版）或B组（先网络版后纸质版）。共有354名患者纳入分析（A组：n = 177，B组：n = 177）。使用Wilcoxon检验分析描述性社会人口学特征、单个项目、子量表和总分的可靠性及一致率。使用Lin一致性相关系数（CCC）以及Spearman和Kendall τ等级相关性来评估重测信度。
NFBSI-16总分的CCC重测信度为0.94。所有4个子量表——疾病相关症状子量表-身体（ρ = 0.93）、疾病相关症状子量表-情感（ρ = 0.85）、治疗副作用子量表（ρ = 0.95）和功能与幸福感子量表（ρ = 0.91）——与NFBSI-16总分（ρ = 0.94）均有显著相关性（Spearman ρ）。测试和重测的平均差异均接近零（≤0.06）。通过Wilcoxon检验比较单个项目的子量表平行重测信度发现，GP3（项目5）有显著差异（P = 0.02）。本研究中的大多数参与者（255/354，72.0%）更喜欢网络版而非纸质版。
基于网络的NFBSI-16问卷是监测接受治疗的个体乳腺癌患者的优秀工具，大多数参与者更喜欢它而非纸质版。
