Evaluation of the Modified Naranjo Criteria for Assessing Causal Attribution of Clinical Outcome to Homeopathic Intervention as Presented in Case ReportsFunding None.
31 May 2019
14 November 2019
25 March 2020 (online)
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.
Keywordsvalidation - Modified Naranjo Criteria - causal relationship - homeopathic intervention - clinical outcome - case reports
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.
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.
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