[1] CHEN Rui - lin, SHEN Qing - yan, NIU Ke - min, et al. Study on Performance Evaluation of Chinese Medicine Patient Reporting Outcome Scale for Nonalcoholic Fatty Liver Disease [J]. Modern Traditional Chinese Medicine, 2021, (01): 10-14. [doi: 10.13424/j.cnki.mtcm.2021.01.003]
Study on Performance Evaluation of Chinese Medicine Patient Reporting Outcome Scale for Nonalcoholic Fatty Liver Disease
- Article number:
- 1672-0571(2021)01-0010-05
- Keywords:
- Nonalcoholic fatty liver disease; International patient reporting outcome scale; Reliability; Validity; Evaluation
- ZTFLH:
- R256.49
- Code:
- A
- Abstract:
- Objective: To evaluate the scientific performance of Chinese medicine PRO scale for nonalcoholic fatty liver disease ( NAFLD) in terms of reliability and validity according to the development standard of the international patient reported outcomes ( PRO) scale. Methods: 200 cases of NAFLD patients were included in the study. NAFLD TCM Pro scale was issued, and the data results were summarized. Cronbach’ s alpha method and split half reliability method were used to evaluate the internal consistency reliability and split half reliability of the scale, so as to evaluate the reliability of the scale; correlation coefficient method and factor analysis method were used to evaluate the content validity and structural validity of the scale, so as to evaluate the validity of the scale. Results: 198 copies of the scale were recycled and the recycle rate was 99%. Whole Cronbach’ sαcoefficient of NAFLD TCM Pro scale was 0. 903, and the scores of physiology, psychology and treatment were 0. 862, 0. 682 and 0. 617 respectively, all of which were greater than 0. 6, which indicated the qualified internal consistency reliability; the whole Spearman Brown coefficient of the scale was 0.864, greater than 0. 6, and the three domains of physiology, psychology and treatment were 0. 862, 0. 659 and 0. 497 respectively. Except the treatment field, all had qualified split half reliability; Spearman coefficients of all items and domains were greater than 0. 2, and P < 0. 01, indicating that the scale had good content validity; factor analysis showed that 61. 858% of the variables could be explained by common factors, which indicated that the scale had good structural validity. Conclusion: NAFLD TCM PRO scale has good reliability and validity, and has certain reliability and effectiveness, which can be used in the clinical efficacy evaluation of traditional Chinese medicine treatment of NAFLD.
References:
[1] LazoM , Clark JM. The epidemiology of nonalcoholic fatty liver disease : a global perspective. Sem in Liver Dis ,2008 ,28 :339 — 350 .
[2]周滔,张声生,郁强.调肝理脾法治疗非酒精性脂肪肝的临床队列研究[J].北京中医药,2013,32(6):403-405.
[3]李靖,于成福,吕志平,等.清肝方治疗26例脂肪肝的CT疗效评价[J].安徽中医学院学报,2013,32(2):26-29.
[4]何慧明.非酒精性脂肪肝患者血脂?肝功能特征及临床意义[J].医学理论与实践,2020,33(20):3458-3460.
[5] US Department of Health and Human Serrvices FDA CDER, CBER, CDRH. Guidance for Industry : Patient -Reported Outcome Measures: Use in medical product development to support labeling claims draft guidance [ J] .Health and Quality of Life Outcomes,2006,4:79.
[6] Scientific Advisory Committee of the Medical Out – comes Trust. Assessing health status and quality of life instruments: attributes and review[ J] . Qual Life Res, 2002, 11( 3) :193 -205.
[7]殷秀雯,陈瑞琳,申青艳,等.非酒精性脂肪性肝病中医PRO量表的研制与条目筛选[J].中西医结合肝病杂志,2020,30(5):450-452.
[8]申青艳.非酒精性脂肪肝中医PRO量表的制定[D].北京:北京中医药大学,2017.
[9]唐旭东,王萍,刘保延,等.基于慢性胃肠疾病患者报告临床结局测量量表的编制及信度?效度分析[J].中医杂志,2009,50(1):27-29.
[10]中华医学会肝脏病学会脂肪肝和酒精性肝病学组.非酒精性脂肪性肝病诊疗指南.胃肠病学和病学杂志,2010,19(6)∶483-487.
[11]罗仕娟,佘世锋,朗建英,等.中医肝病临床疗效评价量表的信度与效度分析[J].中国中医基础医学杂志,2016,22(10):1350-1353.
[12]马文军,潘波.问卷的信度和效度以及如何用SAS软件分析.中国卫生统计,2000,17(6):364-365.
[13]吴明隆.问卷统计分析实务-SPSS操作与应用[M].重庆:重庆大学出版社,2010:244.
[14]李灿,辛玲.调查问卷的信度与效度的评价方法研究[J].中国卫生统计,2008,(5):541-544.
[15]夏洪涛,李卫青,马全庆.PRO量表的翻译及在中医药疗效评价中的应用探析[J].山西中医,2014,30(6):1-3.
[16]任君,周芬,杨国彦,等.患者报告结局指标的优越性与局限性[J].现代中医临床,2014,21(4):20-23.
[17]张晟,陈月.中医患者报告结局量表的研究现状[J].中华中医药杂志,2018,33(3):1026-1029.
[18]杨亚男,倪青,张美珍.患者报告结局纳入中医疗效评价体系的可行性及国内现状探析[J].环球中医药,2019,12(3):361-365.
[19]周盐,蒋雨薇,郑培永.中医药治疗非酒精性脂肪肝病临床研究进展[J].辽宁中医杂志,2019,46(6):1327-1330.
[20]王静.非酒精性脂肪肝中医治疗进展[J].医学理论与实践,2017,30(12):1747-1749.
Memo
基金项目:第四批全国中医(临床?基础)优秀人才研修项目(国中医药人教发[2017]24号);北京市卫生系统高层次卫生技术人才培养计划(2015-3-114);北京市属医院科研培育计划项目(PZ2016021)
通讯作者:周滔,主任医师,副教授?E-mail:zhoutao0903@126.com