Developing the criteria for evaluating quality of individualization in homeopathic clinical trial reporting: a preliminary study.
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 α 0.606 - 0.725), significant discriminant validity (F = 398.7; P < 0.000 1), moderate interrater reliability (Fleiss κ 0.533), agreeable test-retest reliability (Cohen's κ 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).


CONCLUSIONS
The initial data suggest that this instrument may be a promising systematic tool amendable for further development.
Clinical Research Unit (Homeopathy), Central Council for Research in Homeopathy, Siliguri 734006, West Bengal, India; E-mail: drsubhranilsaha@hotmail.com.
Subhranil
S
Saha
Clinical Research Unit (Homeopathy), Central Council for Research in Homeopathy, Siliguri 734006, West Bengal, India.
Munmun
M
Koley
Department of Organon of Medicine and Homeopathic Philosophy, D N De Homeopathic Medical College and Hospital, Kolkata 700046, West Bengal, India.
Subhasish
S
Ganguly
Department of Community Medicine, National Institute of Homeopathy, Kolkata 700114, West Bengal, India.
Prasanta
P
Rath
Upasana Diagnostic Center, Salt Lake City, Kolkata 700064, West Bengal, India.
Pulak
P
Roy Chowdhury
Paikpari Block Primary Health Center, District Purba Medinipur 721134, West Bengal, India.
Seikh Intaj
SI
Hossain
D000328:Adult; D005069:Evaluation Studies as Topic; D005260:Female; D006705:Homeopathy / Q000592:standards*; D006801:Humans; D008297:Male; D057285:Precision Medicine / Q000592:standards*; D011786:Quality Control; D011795:Surveys and Questionnaires