Reliability of ayurvedic diagnosis for knee osteoarthritis patients – A nested diagnostic study within a randomized controlled trial

Dr. med. Christian Kessler

Background
Ayurveda is a traditional Indian system of medicine. The customized Ayurvedic approach consists of a combination of several diagnostic procedures and subsequent individualized therapeutic interventions. Evaluation of inter-rater reliability of Ayurvedic diagnoses has rarely been performed. Aim of this study was to evaluate inter-rater reliability of Ayurvedic diagnosis for patients with knee osteoarthritis.
Methods: A diagnostic reliability study of 30 patients and 4 Ayurvedic experts was nested in a RCT. Patients were diagnosed in a sequential order by all experts utilizing a semi-structured patient history form. A Delphi consensus procedure was performed in order to reach agreement on the items to be diagnosed. An inter-rater reliability analysis using Fleiss’s kappa and Cohen’s kappa statistics was performed to determine a chance-corrected measure of agreement among raters.

Results
120 different ratings and 30 consensus ratings were performed and analyzed. While high percentages of agreement for main diagnostic entities and the final Ayurveda diagnosis (95% consensus agreement on main diagnosis) could be observed, this was not reflected by the corresponding kappa values, which largely yielded fair to poor inter-rater agreement kappas for central diagnostic aspects such as prakriti and agni (κ values between 0 and 0.4). Notably, agreement on disease related entities was better than those of constitutional entities.

Conclusions
This is the first diagnostic study embedded in a clinical trial on patients with knee osteoarthritis utilizing a multimodality whole systems approach. Results showed a contrast between the high agreement of the consented final diagnosis and disagreement on certain diagnostic details. Future diagnostic studies should have larger samples sizes and a methodology more tailored to the specificities of traditional whole systems of medicine. Equal emphasis will need to be placed on all core diagnostic components of Ayurveda, both constitutional and disease specific, using detailed structured history taking forms.

Keywords: Ayurveda, Ayurvedic, Diagnostic, Reliability, Osteoarthritis, Whole Systems of Medicine, Complementary Medicine
Registration: The study as part of an RCT was registered at clinicaltrials.gov under NCT01225133 (initial release 10/06/2010).
Primary Funding Source: Ministry of AYUSH, Government of India.

Christian S Kessler1,2, Antonio Morandi3, Abhimanyu Kumar4, Kartar S. Dhiman5, Shivenarain Gupta6,7, Katja Icke1, Carina Bühner1, Elmar Stapelfeldt2, Manfred Wischnewsky8, Ludwig Kronpaß9, Vijayendra Murthy10 Andreas Michalsen1,2 and Claudia M. Witt1,11,12
1 Institute for Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, Luisenstr. 57, 10117 Berlin, Germany
2 Immanuel Hospital Berlin, Department for Complementary Medicine, Königstr. 63, 14109 Berlin, Germany
3 Ayurvedic Point, School of Ayurvedic Medicine, Corso Sempione 63, 20149 Milan, Italy
4Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhavan
No.61-65, Institutional Area, Janakpuri, New Delhi 110058, India
5 All India Institute of Ayurveda, Mathura Road, Gautampuri, Sarita Vihar, New Delhi 110076, India
6 European Academy of Ayurveda, Forsthausstr. 6, 63633 Birstein, Germany
7 Department of Kaya Cikitsa, J.S. Ayurveda College & P.D. Patel Ayurveda Hospital, College Road, Nadiad 387001, India
8 University of Bremen, Department of Mathematics and Computer Science, Bibliothekstr., 28259 Bremen, Germany
9 AyurSan-Zentrum Sankt Salvator, Klosterberg 15, 94086 Bad Griesbach, Germany
10 Primary Care & Population Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom
11 Institute of Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Sonneggstrasse 6, 8091 Zurich, Switzerland
12 University of Maryland School of Medicine, Center for Integrative Medicine, 520 W. Lombard Street
East Hall, Baltimore, MD 21201, USA

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