Development and validation of the reported outcome scale for patients with lumbar disc herniation

Objective 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.Methods An initial 54-item pool was generate...

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Main Authors: Chao Xu, Feng Huang, Shunxing Wang, Zhijun Tan, Haiyue Zhang, Zhe Yang, Ying Liang, Zhou Lu, Lei Shang
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Annals of Medicine
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Online Access:https://www.tandfonline.com/doi/10.1080/07853890.2025.2524088
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author Chao Xu
Feng Huang
Shunxing Wang
Zhijun Tan
Haiyue Zhang
Zhe Yang
Ying Liang
Zhou Lu
Lei Shang
author_facet Chao Xu
Feng Huang
Shunxing Wang
Zhijun Tan
Haiyue Zhang
Zhe Yang
Ying Liang
Zhou Lu
Lei Shang
author_sort Chao Xu
collection DOAJ
description Objective 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.Methods 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.Results 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.Conclusion 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.
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spelling doaj-art-f4e176572af64c4d822fd3acb60dde5d2025-08-20T03:24:26ZengTaylor & Francis GroupAnnals of Medicine0785-38901365-20602025-12-0157110.1080/07853890.2025.2524088Development and validation of the reported outcome scale for patients with lumbar disc herniationChao Xu0Feng Huang1Shunxing Wang2Zhijun Tan3Haiyue Zhang4Zhe Yang5Ying Liang6Zhou Lu7Lei Shang8Department of Health Statistics, Faculty of Preventive Medicine, Fourth Military Medical University, Xi'an, ChinaAirforce Medical Center, Fourth Military Medical University, Haidian district, Beijing, ChinaDepartment of Knee Joint Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, ChinaDepartment of Health Statistics, Faculty of Preventive Medicine, Fourth Military Medical University, Xi'an, ChinaDepartment of Health Statistics, Faculty of Preventive Medicine, Fourth Military Medical University, Xi'an, ChinaDepartment of Health Statistics, Faculty of Preventive Medicine, Fourth Military Medical University, Xi'an, ChinaDepartment of Health Statistics, Faculty of Preventive Medicine, Fourth Military Medical University, Xi'an, ChinaAirforce Health Service Training Base, Fourth Military Medical University, Xi'an, ChinaDepartment of Health Statistics, Faculty of Preventive Medicine, Fourth Military Medical University, Xi'an, ChinaObjective 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.Methods 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.Results 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.Conclusion 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.https://www.tandfonline.com/doi/10.1080/07853890.2025.2524088Lumbar disc herniationpatient reported outcomescale preparationreliabilityvalidity
spellingShingle Chao Xu
Feng Huang
Shunxing Wang
Zhijun Tan
Haiyue Zhang
Zhe Yang
Ying Liang
Zhou Lu
Lei Shang
Development and validation of the reported outcome scale for patients with lumbar disc herniation
Annals of Medicine
Lumbar disc herniation
patient reported outcome
scale preparation
reliability
validity
title Development and validation of the reported outcome scale for patients with lumbar disc herniation
title_full Development and validation of the reported outcome scale for patients with lumbar disc herniation
title_fullStr Development and validation of the reported outcome scale for patients with lumbar disc herniation
title_full_unstemmed Development and validation of the reported outcome scale for patients with lumbar disc herniation
title_short Development and validation of the reported outcome scale for patients with lumbar disc herniation
title_sort development and validation of the reported outcome scale for patients with lumbar disc herniation
topic Lumbar disc herniation
patient reported outcome
scale preparation
reliability
validity
url https://www.tandfonline.com/doi/10.1080/07853890.2025.2524088
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