Developing the criteria for evaluating quality of individualization in homeopathic clinical trial reporting:a preliminary study

作     者：Subhranil Saha Munmun Koley Subhasish Ganguly Prasanta Rath Pulak Roy Chowdhury Seikh Intaj Hossain 

作者机构：Clinical Research Unit(Homeopathy)Central Council for Research in Homeopathy Department of Organon of Medicine and Homeopathic PhilosophyD N De Homeopathic Medical College and Hospital Department of Community MedicineNational Institute of Homeopathy Upasana Diagnostic CenterSalt Lake City Paikpari Block Primary Health Center 

出 版 物：《Journal of Integrative Medicine》 (结合医学学报（英文版）)

年 卷 期：2014年第12卷第1期

页      面：13-19页

学科分类：1002[医学-临床医学] 1010[医学-医学技术（可授医学、理学学位）] 100215[医学-康复医学与理疗学] 10[医学] 

主　　题：clinical trials consensus Delphi homeopathy individualization reliability validity 

摘      要：OBJECTIVE： This study describes the development of a preliminary version of an instrument that attempts to assess the quality of reports of individualized homeopathic prescriptions in clinical trials and observational studies. METHODS： A multidisciplinary panel of 15 judges produced an initial version of the instrument through iterative Delphi rounds and pilot-tested the instrument on five clinical trials. Later they assessed, under blind conditions, the individualization quality of 40 randomly-selected research reports. The final version of the instrument included six criteria. These items were scored consistently by all the raters regardless of background. RESULTS： The instrument appeared to have adequate face and content validity, acceptable internal consistency or reliability （Cronbach＇s a 0.606 - 0.725）, significant discriminant validity （F = 398.7; P 〈 0.000 1）, moderate interrater reliability （Fleiss K 0.533）, agreeable test-retest reliability （Cohen＇s K 0.765 - 0.934）, moderate sensitivity （0.4; 95% confidence interval 0.253- 0.566）, and high specificity （1.0; 95% confidence interval 0.891-1.000）. CONCLUSION： The initial data suggest that this instrument may be a promising systematic tool amendable for further development.