Evaluation of the Modified Naranjo Criteria for Assessing Causal Attribution of Clinical Outcome to Homeopathic Intervention as Presented in Case Reports

Abstract

Objectives The objective of this study was to establish the reliability and content validity of the “Modified Naranjo Criteria for Homeopathy—Causal Attribution Inventory” as a tool for attributing a causal relationship between the homeopathic intervention and outcome in clinical case reports.

Methods Purposive sampling was adopted for the selection of information-rich case reports using pre-defined criteria. Eligible case reports had to fulfil a minimum of nine items of the CARE Clinical Case Reporting Guideline checklist and a minimum of three of the homeopathic HOM-CASE CARE extension items. The Modified Naranjo Criteria for Homeopathy Inventory consists of 10 domains. Inter-rater agreement in the scoring of these domains was determined by calculating the percentage agreement and kappa (κ) values. A κ greater than 0.4, indicating fair agreement between raters, in conjunction with the absence of concerns regarding the face validity, was taken to indicate the validity of a given domain. Each domain was assessed by four raters for the selected case reports.

Results Sixty case reports met the inclusion criteria. Inter-rater agreement/concordance per domain was “perfect” for domains 1 (100%, κ = 1.00) and 2 (100%, κ = 1.00); “almost perfect” for domain 8 (97.5%, κ = 0.86); “substantial” for domains 3 (96.7%, κ = 0.80) and 5 (91.1%, κ = 0.70); “moderate” for domains 4 (83.3%, κ = 0.60), 7 (67.8%, κ = 0.46) and 9 (99.2%, κ = 0.50); and “fair” for domain 10 (56.1%, κ = 0.38). For domains 6A (46.7%, κ = 0.03) and 6B (50.3%, κ = 0.18), there was “slight agreement” only. Thus, the validity of the Modified Naranjo Criteria for Homeopathy tool was established for each of its domains, except for the two that pertain to direction of cure (domains 6A and 6B).

Conclusion The Modified Naranjo Criteria for Homeopathy—Causal Attribution Inventory was identified as a valid tool for assessing the likelihood of a causal relationship between a homeopathic intervention and clinical outcome. Improved wordings for several criteria have been proposed for the assessment tool, under the new acronym “MONARCH”. Further assessment of two MONARCH domains is required.

Keywords

validation - Modified Naranjo Criteria - causal relationship - homeopathic intervention - clinical outcome - case reports

Authors' Contributions

CDL, VKG, RvH, and LR conceptualized the study; CDL collected the data; CDL, VKG, NM and AMM evaluated the cases; RvH and LR compiled and blinded the data; CDL and RS analyzed and interpreted the data and drafted the manuscript. All authors reviewed and provided final approval of the version to be published.

Note

This study was PhD work of the corresponding author, performed under the experienced supervision of Padma Shri Dr. V K. Gupta, MD (Hom.). The experts (raters) were also MD (Hom.) with 10 years teaching/research experience.

Dr. Robbert van Haselen, Director, World Integrated Medicine Forum, R&D Consultancy, International Institute for Integrated Medicine (INTMEDI), United Kingdom and Dr. Lex Rutten, independent researcher, Netherlands, were the advisers in this study. Both coordinated the blinding of raters and helped in reaching agreement/consensus among them.

Publikationsverlauf

Eingereicht: 31. Mai 2019

Angenommen: 14. November 2019

Artikel online veröffentlicht:
25. März 2020

• References

• 1 Gopikrishna V. A report on case reports. J Conserv Dent 2010; 13: 265-271
• 2 Nissen T, Wynn R. The history of the case report: a selective review. JRSM Open 2014; 5: 2054270414523410
• 3 Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach. BMC Med Res Methodol 2011; 11: 100
• 4 Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D. CARE Group. The CARE guidelines: consensus-based clinical case reporting guideline development. BMJ Case Rep 2013; 2013: 38-43
• 5 van Haselen RA. Towards improving the reporting quality of clinical case reports in complementary medicine: assessing and illustrating the need for guideline development. Complement Ther Med 2015; 23: 141-148
• 6 Arimone Y, Miremont-Salamé G, Haramburu F. et al. Inter-expert agreement of seven criteria in causality assessment of adverse drug reactions. Br J Clin Pharmacol 2007; 64: 482-488
• 7 Srinivasan R, Ramya G. Adverse drug reaction — causality assessment. Int J Res Pharm Chem 2011; 1: 606-612
• 8 Rutten LA. The importance of case histories for accepting and improving homeopathy. Complement Ther Med 2013; 21: 565-570
• 9 Rutten L. Data collection: treat every variable as a treasure. Homeopathy 2015; 104: 190-196
• 10 van Haselen RA. Homeopathic clinical case reports: development of a supplement (HOM-CASE) to the CARE clinical case reporting guideline. Complement Ther Med 2016; 25: 78-85
• 11 Dean ME, Coulter MK, Fisher P, Jobst KA, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. J Altern Complement Med 2007; 13: 19-23
• 12 Robinson RS. Purposive sampling. In: Michalos AC. , ed. Encyclopedia of Quality of Life and Well-Being Research. Dordrecht: Springer; 2014
• 13 McHugh ML. Interrater reliability: the kappa statistic. Biochem Med (Zagreb) 2012; 22: 276-282
• 14 Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med 2005; 37: 360-363