Reliability and validity analysis of the instrument for evaluating clinical applicability of guidelines (version 2.0)_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Miao ^1,2,3,4,5 , DIAO Sha ^2,3,4,5 , ZENG Linan ^2,3,4,5 , YI Qiusha ^2,3,4,5 , LI Hailong ^2,3,4,5 , CHEN Zhe ^1,2,3,4,5 , HUANG Chao ⁶ ,  WANG Qiang ⁶ ,  ZHANG Lingli ^2,3,4,5,7

1. West China School of Pharmacy, Sichuan University, Chengdu 610041, P. R. China;
2. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
3. Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
4. NMPA Key Laboratory for Technical Research on Drug Products in Vitro and in Vivo Correlation, Chengdu 610041, P. R. China;
5. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu 610041, P. R. China;
6. Medical Management Service Guidance Center, National Health Commission of the People’s Republic of China, Beijing 100044, P. R. China;
7. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

WANG Qiang, Email: jason2019@sina.cn; ZHANG Lingli, Email: zhanglingli@scu.edu.cn

Keywords：

The instrument of clinical applicability of guidelines (version 2.0); Reliability; Validity

DOI：

10.7507/1672-2531.202209044

Video：

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Objective To evaluate the reliability and validity of the instrument of clinical applicability of guidelines (version 2.0). Methods The experts of domestic medical institutions were investigated by questionnaire, and the instrument of clinical applicability of guidelines (version 2.0) were evaluated the guidelines for the diagnosis and treatment of tinea mantis and tinea pedis (revised edition 2017) and the guidelines for the diagnosis and treatment of cerebral hemorrhage in China (2019). Using Cronbach's α coefficient and Spearman-Brown coefficient to evaluate the inherent reliability and split-half reliability. The content validity was evaluated by calculating the content validity index of the item level and the adjusted Kappa value. The correlation coefficient between each item and the dimension and the hypothesis test were used to evaluate the convergent and discriminant validity. The structural validity was evaluated by using structural equation model to evaluate the structural validity of the tool. Results The Cronbach's α coefficient and Spearman-Brown coefficient of the instrument of clinical applicability of guidelines (version 2.0) were both greater than 0.7, the content validity index (S-CVI/Ave) were more than 0.8, the success rates of convergent were 100%, and the success rates of discriminant validity calibration were 100% and 96%. In the second-order confirmatory factor analysis model, the χ²/ df were less than 3, the fitting index (CFI), the goodness of fit index (GFI) and the adjustment goodness of fit index (AGFI) were all greater than 0.9. The root mean square residual (RMR) were all less than 0.05, and approximate error root mean square (RMSEA) were less than 0.09. The P value of RESEA hypothesis test were more than 0.05. Conclusion The instrument of clinical applicability of guidelines (version 2.0) has good reliability and validity, which can be further verified in practical application in the future.

Citation： ZHANG Miao, DIAO Sha, ZENG Linan, YI Qiusha, LI Hailong, CHEN Zhe, HUANG Chao, WANG Qiang, ZHANG Lingli. Reliability and validity analysis of the instrument for evaluating clinical applicability of guidelines (version 2.0). Chinese Journal of Evidence-Based Medicine, 2023, 23(1): 80-84. doi: 10.7507/1672-2531.202209044 Copy

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2.	曾力楠, 李幼平, 张伶俐, 等. 国内外制订临床指南的指南的循证评价. 中国循证医学杂志, 2016, 16(11): 1322-1330.
3.	林茂, 曾力楠, 李佳莲, 等. 全球指南临床适用性评价工具现状的系统评价. 中国循证医学杂志, 2020, 20(4): 437-443.
4.	曾力楠, 易秋莎, 张川, 等. 制订指南临床适用性评价工具. 中国循证医学杂志, 2020, 20(4): 466-475.
5.	李海龙, 张川, 黄超, 等. 指南临床适用性评价工具信效度分析. 中国循证医学杂志, 2020, 20(4): 378-382.
6.	李思雨, 刁莎, 石雨晴, 等. 指南临床适用性评价工具(2.0版). 中国循证医学杂志, 2023, DOI:10.7507/1672-2531.202207136.
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9.	中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国脑出血诊治指南(2019). 中华神经科杂志, 2019, 52(12): 994-1005.
10.	Tabachnick BG, Fidell LS. Using multivariate statistics (5th Edition). New York: Allyn and Bacon, 2007.
11.	邓晨卉, 刘洋, 张宇, 等. SF-12量表在西部农村青少年中信度及效度评价. 中国公共卫生, 2016, 32(11): 1513-1516.
12.	王山, 樊文洁, 俞婉琦, 等. SF-36量表应用于城市化居民生命质量评价的信度和效度分析. 中华流行病学杂志, 2016, 37(3): 344-347.
13.	邱建青, 周密, 邱培媛, 等. 匹兹堡睡眠质量指数用于农村老年人群的信效度分析. 现代预防医学, 2016, 43(10): 1835-1838.
14.	史静琤, 莫显昆, 孙振球. 量表编制中内容效度指数的应用. 中南大学学报(医学版), 2012, 37(2): 152-155.
15.	温忠麟, 侯杰泰, 马什赫伯特. 结构方程模型检验: 拟合指数与卡方准则. 心理学报, 2004, 36(2): 186-194.
16.	李鲁, 王红妹, 沈毅. SF-36健康调查量表中文版的研制及其性能测试. 中华预防医学杂志, 2002, 36(2): 109-113.
17.	付华鹏, 刘扬, 刘红波, 等. SF-36健康调查量表应用于城市贫困人群的信度和效度. 中国卫生统计, 2004, 21(2): 109-110.
18.	江梅. 总体相关系数比较的假设检验. 中国卫生统计, 2010, 27(1): 83,87.
19.	罗纪聪, 赵景宏, 成琼, 等. 健康生命量表应用于自动化腹膜透析和持续非卧床腹膜透析患者生命质量评价的信效度研究. 中国血液净化, 2020, 19(7): 445-448.
20.	Brouwers MC, Kho ME, Browman GP, et al. Development of the AGREE Ⅱ, part 2: assessment of validity of items and tools to support application. CMAJ, 2010, 182(10): E472-E478.
21.	Li H, Xie R, Wang Y, et al. A new scale for the evaluation of clinical practice guidelines applicability: development and appraisal. Implement Sci, 2018, 13(1): 61.

1. The ADAPTE collaboration. The ADAPTE process: resource toolkit for guideline adaptation, version 2.0. Available at: https://g-i-n.net/working-groups/adaptation.
2. 曾力楠, 李幼平, 张伶俐, 等. 国内外制订临床指南的指南的循证评价. 中国循证医学杂志, 2016, 16(11): 1322-1330.
3. 林茂, 曾力楠, 李佳莲, 等. 全球指南临床适用性评价工具现状的系统评价. 中国循证医学杂志, 2020, 20(4): 437-443.
4. 曾力楠, 易秋莎, 张川, 等. 制订指南临床适用性评价工具. 中国循证医学杂志, 2020, 20(4): 466-475.
5. 李海龙, 张川, 黄超, 等. 指南临床适用性评价工具信效度分析. 中国循证医学杂志, 2020, 20(4): 378-382.
6. 李思雨, 刁莎, 石雨晴, 等. 指南临床适用性评价工具(2.0版). 中国循证医学杂志, 2023, DOI:10.7507/1672-2531.202207136.
7. 孙振球, 徐勇勇. 医学统计学. 北京: 人民卫生出版社, 2020.
8. 中国医师协会皮肤科分会, 中华医学会皮肤病学分会. 手癣和足癣诊疗指南(2017修订版). 中国真菌学杂志, 2017, 12(6): 321-324.
9. 中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国脑出血诊治指南(2019). 中华神经科杂志, 2019, 52(12): 994-1005.
10. Tabachnick BG, Fidell LS. Using multivariate statistics (5th Edition). New York: Allyn and Bacon, 2007.
11. 邓晨卉, 刘洋, 张宇, 等. SF-12量表在西部农村青少年中信度及效度评价. 中国公共卫生, 2016, 32(11): 1513-1516.
12. 王山, 樊文洁, 俞婉琦, 等. SF-36量表应用于城市化居民生命质量评价的信度和效度分析. 中华流行病学杂志, 2016, 37(3): 344-347.
13. 邱建青, 周密, 邱培媛, 等. 匹兹堡睡眠质量指数用于农村老年人群的信效度分析. 现代预防医学, 2016, 43(10): 1835-1838.
14. 史静琤, 莫显昆, 孙振球. 量表编制中内容效度指数的应用. 中南大学学报(医学版), 2012, 37(2): 152-155.
15. 温忠麟, 侯杰泰, 马什赫伯特. 结构方程模型检验: 拟合指数与卡方准则. 心理学报, 2004, 36(2): 186-194.
16. 李鲁, 王红妹, 沈毅. SF-36健康调查量表中文版的研制及其性能测试. 中华预防医学杂志, 2002, 36(2): 109-113.
17. 付华鹏, 刘扬, 刘红波, 等. SF-36健康调查量表应用于城市贫困人群的信度和效度. 中国卫生统计, 2004, 21(2): 109-110.
18. 江梅. 总体相关系数比较的假设检验. 中国卫生统计, 2010, 27(1): 83,87.
19. 罗纪聪, 赵景宏, 成琼, 等. 健康生命量表应用于自动化腹膜透析和持续非卧床腹膜透析患者生命质量评价的信效度研究. 中国血液净化, 2020, 19(7): 445-448.
20. Brouwers MC, Kho ME, Browman GP, et al. Development of the AGREE Ⅱ, part 2: assessment of validity of items and tools to support application. CMAJ, 2010, 182(10): E472-E478.
21. Li H, Xie R, Wang Y, et al. A new scale for the evaluation of clinical practice guidelines applicability: development and appraisal. Implement Sci, 2018, 13(1): 61.

Chinese Journal of Evidence-Based Medicine

Reliability and validity analysis of the instrument for evaluating clinical applicability of guidelines (version 2.0)

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