Clinical Research Unit (Homeopathy), Central Council for Research in Homeopathy, Siliguri 734006, West Bengal, India; E-mail:
Clinical Research Unit (Homeopathy), Central Council for Research in Homeopathy, Siliguri 734006, West Bengal, India.
J Integr Med. 2014 Jan;12(1):13-9. doi: 10.1016/S2095-4964(14)60009-1.
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.
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.
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).
The initial data suggest that this instrument may be a promising systematic tool amendable for further development.
本研究描述了一种初步工具的开发，该工具旨在评估临床试验和观察性研究中个体化顺势疗法处方报告的质量。
一个由 15 名评判员组成的多学科小组通过迭代德尔菲法产生了该工具的初始版本，并在五项临床试验中对该工具进行了试点测试。随后，他们在盲条件下评估了 40 份随机选择的研究报告的个体化质量。该工具的最终版本包括 6 个标准。所有评分者（无论背景如何）均一致对这些项目进行评分。
该工具似乎具有足够的表面效度和内容效度、可接受的内部一致性或可靠性（Cronbach's α 0.606-0.725）、显著的判别效度（F = 398.7；P < 0.0001）、适度的评分者间可靠性（Fleiss κ 0.533）、可接受的测试-重测可靠性（Cohen's κ 0.765-0.934）、适度的敏感性（0.4；95%置信区间 0.253-0.566）和高度的特异性（1.0；95%置信区间 0.891-1.000）。
初步数据表明，该工具可能是一种有前途的系统工具，可进一步开发。
