Developing the criteria for evaluating quality of individualization in homeopathic clinical trialreporting: A preliminary study

doi:10.1016/S2095-4964(14)60009-1

Abstract

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).

Conclusion

The initial data suggest that this instrument may be a promising systematic tool amendable for further development.

Key words: Clinical trials, Consensus, Delphi, Homeopathy, Individualization, Reliability, Validity

Subhranil Saha, Munmun Koley, Subhasish Ganguly, Prasanta Rath, Pulak Roy Chowdhury, Seikh Intaj Hossain. Developing the criteria for evaluating quality of individualization in homeopathic clinical trialreporting: A preliminary study. Journal of Integrative Medicine, 2014, 12(1): 13-19.

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http://www.jcimjournal.com/EN/Y2014/V12/I1/13

[1]	Blackstone V . Single or multiple medicine prescribing-a debate[J]. Br Hom J, 1993,82:37-52 doi: 10.1016/S0007-0785(05)80952-4
[2]	Linde K, Melchart D . Randomized controlled trials of individualized homeopathy: a state-of-the-art review[J]. J Altern Complement Med, 1998,4(4):371-388 doi: 10.1089/act.1998.4.371 pmid: 9884175
[3]	Klejnen J , Knipschild P, ter Riet G.Clinical trials of homeopathy[J]. BMJ, 1991,302(6772):316-323 doi: 10.1136/bmj.302.6772.316
[4]	Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB . Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials[J]. Lancet, 1997,350(9081):834-843 doi: 10.1016/S0140-6736(97)02293-9
[5]	Mathie RT, Hacke D, Clausen J, Nicolai T, Riley DS, Fisher P . Randomized controlled trials of homeopathy in humans: characterising the research journal literature for systematic review[J]. Homeopathy, 2013,102(1):3-24 doi: 10.1016/j.homp.2012.10.002
[6]	Saha S, Koley M . Homeopathic treatment of headaches and migraine: a meta-analysis of the randomized controlled trials[J]. Asian J Pharm Clin Res, 2013,6(Suppl. 3):194-199
[7]	Koley M, Saha S, Arya JS, Choubey G, Ghosh S, Purkait R, Mondal R, Kundu B, Mukherjee R . A study on drug utilization and prescription habits of physicians in a government homeopathic hospital in West Bengal, India[J]. J Integr Med, 2013,11(5):305-313 doi: 10.3736/jintegrmed2013048
[8]	Brien SB, Harrison H, Daniels J, Lewith G . Monitoring improvement in health during homeopathic intervention. Development of an assessment tool based on Hering’s Law of Cure: the Hering’s Law Assessment Tool(HELAT)[J]. Homeopathy, 2012,101(1):28-37 doi: 10.1016/j.homp.2011.10.002
[9]	Harrison H. . The development and use of Hering’s Law Assessment Tool (HELAT) in clinical trials. Homoeopathy Research Institute (HRI) Research Article. 2012; (18). [2012-12-27]. 2012-12-27]. .
[10]	Yousuf MI. Using experts’ opinion through Delphi technique. Practical Assessment, Research and Evaluation. 2007; 12(4). [2012-12-12]. THER].Yousuf MI. Using experts’ opinion through Delphi technique. Practical Assessment, Research and Evaluation. 2007; 12(4).2012-12-12]. .
[11]	Kalaian SA, Kasim RM. Terminating sequential Delphi survey data collection. Practical Assessment, Research and Evaluation. 2012; 17(5). 2012-12-12]. .
[12]	Hsu CC, Sandford BA. The Delphi technique: making sense of consensus. Practical Assessment, Research and Evaluation. 2007; 12(10).[ 2012-12-12]. .
[13]	Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer’s Disease International . Global prevalence of dementia: a Delphi consensus study[J]. Lancet, 2005,366(9503):2112-2117 doi: 10.1007/BF03075138 pmid: 16360788
[14]	Landis JR, Koch GG . The measurement of observer agreement for categorical data[J]. Biometrics, 1977,33(1):159-174 doi: 10.2307/2529310
[15]	Linstone HA . The Delphi technique. Fowles RB.Handbook of future research[M]. Westport: Greenwood, 1978: 273-300
[16]	Chalmers TC, Smith H, Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A . A method for assessing the quality of a randomized control trial[J]. ControlIed Clin Trials, 1981,2(1):31-49 doi: 10.1016/0197-2456(81)90056-8 pmid: 7261638
[17]	Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clin Trials. 1996; 17(1):1-12. doi: 10.1016/0197-2456(95)00134-4 pmid: 872179710001000
[18]	Polit DF, Beck CT. Nursing research: generating and assessing evidence for nursing practice. 8th ed. Philadelphia: Lippincott Williams &THER].Polit DF, Beck CT. Nursing research: generating and assessing evidence for nursing practice. 8th ed. Philadelphia: Lippincott Williams &Wilkins. 2008. doi: 10.1016/j.nepr.2013.04.001
[19]	. Rose-Grippa MK, Haber J, LoBiondo-Wood G, Gorney-Moreno MJ. Nursing research: methods, critical appraisal and utilization. 4th ed. St. Louis:Mosby. 1998.
[20]	Linstone HA, Turoff M. The Delphi method: Techniques and applications. Reading, MA:Addison-Wesley. 1975.
[21]	Dalkey NC, Helmer O. An experimental application of the Delphi method to the use of experts (Report No. RM-727-PR)( Abridged). . Santa Monica, CA: the RAND Corporation. 1962.
[22]	Hasson F, Keeney S , McKenna H.Research guidelines for the Delphi survey technique[J]. J Adv Nurs, 2000,32(4):1008-1015 doi: 10.1046/j.1365-2648.2000.t01-1-01567.x pmid: 11095242
[23]	Keeney S, Hasson F , McKenna H.Consulting the oracle: ten lessons from using the Delphi technique in nursing research[J]. J Adv Nurs, 2006,53(2):205-212 doi: 10.1111/jan.2006.53.issue-2

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