Xu Chao, Huang Feng, Wang Shunxing, Tan Zhijun, Zhang Haiyue, Yang Zhe, Liang Ying, Lu Zhou, Shang Lei
Department of Health Statistics, Faculty of Preventive Medicine, Fourth Military Medical University, Xi'an, China.
Department of Knee Joint Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, China.
Ann Med. 2025 Dec;57(1):2524088. doi: 10.1080/07853890.2025.2524088. Epub 2025 Jun 28.
The objective of this study was to develop a culturally relevant and clinically robust Patient-Reported Outcome (PRO) scale for patients with lumbar disc herniation (LDH), supporting standardized disease monitoring and quality of life assessment.
An initial 54-item pool was generated through literature review, patient interviews, and expert consultation. In the first round, 163 LDH patients were surveyed, and items were screened using exploratory factor analysis, critical ratio analysis, Cronbach's α, Pearson correlation, and discrete trend analysis. This yielded a 29-item trial scale. In the second round, 350 patients completed the scale for further refinement. In the third round, 539 patients were assessed for test-retest reliability and internal consistency. Validity was examined through content and criterion-related validity analyses.
The final PRO scale comprised 29 items across five dimensions: Physical Symptoms (5), Physical Dysfunction (11), Psychological emotion (5), Social Adaptation (4), and Therapeutic Effect (4), explaining 69.07% of total variance. The overall Cronbach's α coefficient was 0.95, with subscale values between 0.81 and 0.94. Test-retest reliability was 0.85. Content validity was strong, with content validity ratios from 0.60 to 1.00 and content validity indices from 0.90 to 1.00. Criterion-related validity was supported by correlations of 0.74 with the Oswestry Disability Index and 0.62 with the Self-Rating Anxiety Scale.
The developed PRO scale is comprehensive, reliable, and valid for assessing the physical, psychological, and social impacts of LDH. It is well-suited for clinical use and quality of life evaluation in LDH patients.
本研究的目的是为腰椎间盘突出症（LDH）患者开发一种具有文化相关性且临床稳健的患者报告结局（PRO）量表，以支持标准化的疾病监测和生活质量评估。
通过文献综述、患者访谈和专家咨询生成了一个初始的54个条目的题库。在第一轮中，对163例LDH患者进行了调查，并使用探索性因子分析、临界比分析、克朗巴哈α系数、皮尔逊相关性和离散趋势分析对条目进行筛选。由此产生了一个29个条目的试验量表。在第二轮中，350例患者完成了该量表以进行进一步完善。在第三轮中，对539例患者进行了重测信度和内部一致性评估。通过内容效度和效标关联效度分析来检验效度。
最终的PRO量表由29个条目组成，分为五个维度：身体症状（5个）、身体功能障碍（11个）、心理情绪（5个）、社会适应（4个）和治疗效果（4个），解释了总方差的69.07%。总体克朗巴哈α系数为0.95，各子量表值在0.81至0.94之间。重测信度为0.85。内容效度较强，内容效度比在0.60至1.00之间，内容效度指数在0.90至1.00之间。效标关联效度得到支持，与奥斯威斯利功能障碍指数的相关性为0.74，与自评焦虑量表的相关性为0.62。
所开发的PRO量表全面、可靠且有效，可用于评估LDH对身体、心理和社会的影响。它非常适合用于LDH患者的临床应用和生活质量评估。
