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.

/ / Recommend

Add to citation manager EndNote| Reference Manager|ProCite|BibTeX|RefWorks

URL: http://www.jcimjournal.com/EN/10.1016/S2095-4964(14)60009-1

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

Related Articles 15

[1]	Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Ana Elisa Madureira Padula, Livia Mitchiguian Hotta, Amarilysde Toledo Cesar, José Nelson Martins Diniz, Helen de Freitas Santos, Edson Zangiacomi Martinez. Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study). Journal of Integrative Medicine, 2022, 20(3): 221-229.
[2]	Rui-jin Qiu, Min Li, Jia-yuan Hu, Jing Chen, Hong-cai Shang. Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine. Journal of Integrative Medicine, 2021, 19(5): 389-394.
[3]	Angelika Homberg, Katja Krug, Nadja Klafke, Katharina Glassen, Cornelia Mahler, Svetla Loukanova. Consensus views on competencies and teaching methods for an interprofessional curriculum on complementary and integrative medicine: A Delphi study. Journal of Integrative Medicine, 2021, 19(3): 282-290.
[4]	Mikhail Teppone. Medicine has always been “Modern” and “Scientific” from ancient times to the present day. Journal of Integrative Medicine, 2019, 17(4): 229-237.
[5]	Arthur Yin Fan, Hui Ouyang, Xinru Qian, Hui Wei, David Dehui Wang, Deguang He, Haihe Tian, Changzhen Gong, Amy Matecki, Sarah Faggert Alemi. Discussions on real-world acupuncture treatments for chronic low-back pain in older adults. Journal of Integrative Medicine, 2019, 17(2): 71-76.
[6]	Ubiratan Cardinalli Adler, Ana Carolina Acorinte, Fernando Oliveira Calzavara, Adriano Andréda Silva, Amarilys de Toledo Cesar, Maristela Schiabel Adler, Edson Zangiacomi Martinez, José Carlos Fernandes Galduróz. Double-blind evaluation of homeopathy on cocaine craving: A randomized controlled pilot study. Journal of Integrative Medicine, 2018, 16(3): 178-184.
[7]	Shubha Singhal, Vandana Roy. Awareness, practice and views about integrating AYUSH in allopathic curriculum of allopathic doctors and interns in a tertiary care teaching hospital in New Delhi, India. Journal of Integrative Medicine, 2018, 16(2): 113-119.
[8]	Shahnaz Karkon Varnosfaderani, Fataneh Hashem-Dabaghian, Gholamreza Amin, Mahbubeh Bozorgi, Ghazaleh Heydarirad, Esmaeil Nazem, Mohsen Nasiri Toosi, Seyed Hamdollah Mosavat. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial. Journal of Integrative Medicine, 2018, 16(2): 126-131.
[9]	Salvatore Chirumbolo, Geir Bjørklund. Homeopathic potencies of Arnica montana L. change gene expression in a Tamm-Horsfall protein-1 cell line in vitro model: The role of ethanol as a possible confounder and statistical bias. Journal of Integrative Medicine, 2017, 15(4): 255-264.
[10]	Saeed Ahmad, Tayyeba Rehman, Waheed Mumtaz Abbasi. Effects of homoeopathic ultrahigh dilutions of Aconitum napellus on Baker's yeast-induced fever in rabbits. Journal of Integrative Medicine, 2017, 15(3): 209-213.
[11]	Jin Yu, Chao-qin Yu, Qi Cao, Li Wang, Wen-jun Wang, Li-rong Zhou, Jing Li, Qiao-hong Qian. Consensus on the integrated traditional Chinese and Western medicine criteria of diagnostic classification in polycystic ovary syndrome (draft). Journal of Integrative Medicine, 2017, 15(2): 102-109.
[12]	Jesmin Mondal, Asmita Samadder, Anisur Rahman Khuda-Bukhsh. Psorinum 6× triggers apoptosis signals in human lung cancer cells. Journal of Integrative Medicine, 2016, 14(2): 143-153.
[13]	Santu Kumar Saha, Sourav Roy, Anisur Rahman Khuda-Bukhsh. Ultra-highly diluted plant extracts of Hydrastis canadensis and Marsdenia condurango induce epigenetic modifications and alter gene expression profiles in HeLa cells in vitro. Journal of Integrative Medicine, 2015, 13(6): 400-411.
[14]	Subhranil Saha, Munmun Koley, Jogendra Singh Arya, Gurudev Choubey, Shubhamoy Ghosh, Subhasish Ganguly, Aloke Ghosh, Sangita Saha, Malay Mundle. Medicine prescription practices of homeopathic undergraduate students in West Bengal, India. Journal of Integrative Medicine, 2014, 12(1): 7-12.
[15]	Munmun Koley, Subhranil Saha, Jogendra Singh Arya, Gurudev Choubey, Shubhamoy Ghosh, Rajib Purkait, Ramkumar Mondal, Bapi Kundu, Rajarshi Mukherjee. A study on drug utilization and prescription habits of physicians in a government homeopathic hospital in West Bengal, India. Journal of Chinese Integrative Medicine, 2013, 11(5): 305-313.

Metrics

Viewed

Full text

Abstract

Cited

Shared

Discussed

Comments

Recommended 10

[1]	Dong Yang, Yong-ping Du, Qing Shen, Wei Chen, Yan Yu, Guang-lei Chen. Expression of alpha-smooth muscle actin in renal tubulointerstitium in patients with kidney collateral stasis. Journal of Chinese Integrative Medicine, 2008, 6(1): 41-44
[2]	Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[3]	Xi Lin, Jian-ping Liu. Herbal medicines for viral myocarditis. Journal of Chinese Integrative Medicine, 2008, 6(1): 76
[4]	Xi Lin, Jian-ping Liu. Tai chi for treating rheumatoid arthritis. Journal of Chinese Integrative Medicine, 2008, 6(1): 82
[5]	Liang-ping Hu, Hui Gao. Discrimination of errors in statistical analysis of medical papers published in the first issue of 2006 in Journal of Chinese Integrative Medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 98-106
[6]	Yan-bo Zhu , Qi Wang, Cheng-yu Wu, Guo-ming Pang, Jian-xiong Zhao, Shi-lin Shen, Zhong-yuan Xia , Xue Yan . Logistic regression analysis on relationships between traditional Chinese medicine constitutional types and overweight or obesity. Journal of Chinese Integrative Medicine, 2010, 8(11): 1023-1035
[7]	Wei Xu, Meng Shi, Jian-gang Liu, Cheng-long Wang . Collagen protein expressions in ischemic myocardium of rats with acute myocardial infarction and effects of qi-tonifying, yin-tonifying and blood-activating herbs and detoxifying and blood-activating herbs. Journal of Chinese Integrative Medicine, 2010, 8(11): 1041-1047
[8]	Tao Wang , Feng Qin. Effects of Chinese herbal medicine Xiaoyao Powder on monoamine neurotransmitters in hippocampus of rats with postpartum depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1075-1079
[9]	Ying Xu , Chang-chun Zeng , Xiu-yu Cai , Rong-ping Guo , Guang Nie , Ying Jin. Chromaticity and optical spectrum colorimetry of the tongue color in different syndromes of primary hepatic carcinoma. Journal of Chinese Integrative Medicine, 2012, 10(11): 1263-1271
[10]	Xiang-ying Mao , Qin Bian , Zi-yin Shen. Analysis of the osteogenetic effects exerted on mesenchymal stem cell strain C3H10T1/2 by icariin via MAPK signaling pathway in vitro. Journal of Chinese Integrative Medicine, 2012, 10(11): 1272-1278