The Comparison Of Causality Assessment Methods For Adverse Drug Reactions

ObjectiveDifferent causality assessment methods were used to assess the causal relationship between Shuxuetong Injection and the occurrence of adverse events (AEs), and the results were assessed for consistency further. There will be references available to use adverse drug reactions (ADRs) causality assessment methods in ADR monitoring study and randomized controlled trials on Traditional Chinese Medicine (TCM) field.MethodsThis is a prospective, systematically intensive hospital monitoring with registration. We collected basic information of inpatients who have been prescribed a Chinese medicine Shuxuetong Injection over a period of time from the hospital information system, and then observed and followed up the patients to recorded the condition of AEs in the period of Shuxuetong Injection administration.The patients who were hospitalized in the neurology department wards of Guangdong Province Hospital of Chinese Medicine and used Shuxuetong Injection will be monitored during May 2013 to February 2014 by TCM pratitioners. The basic information and AEs information were collected. The causality assessment between Shuxuetong Injection and AEs were evaluated by practtioners using Karch&Lasagna approach, Naranjo approach, WHO-UMC approach, China’s Ministry of Health approach and Bayesian approach, respectively.ResultsA total of 962 patients were monitored within this period. There were 539 males (56.03%) and 423 females (43.97%), their average age is 65.86 years old. Adverse events were found in 27 cases, including 7 cases with causality assessment of Shuxuetong injection for "possible",20 (74.07%) cases for "impossible". The incidence of adverse reaction was 0.73%. In the evaluation of causality assessment method for ADRs, five kinds of method were consistent with 22.2% (6 events in 27 cases), were evaluated as "impossible/suspicious/ doubt",1 cases of adverse events were consistent with the evaluation for "centain", "probable" and "possible". Among them, the WHO-UMC method and the China Ministry of Health assessment method were compared, and the consistent rate and Kappa were 92.6% and 0.85; Comparing Karch and Lasagna method and the Chinese Ministry of health assessment method, the consistent rate and Kappa value were 85.20% and 0.74; Comparing Karch and Lasagna method and the other four kinds of evaluation methods, the consistent rates and Kappa values were from 48.10% to 85.20% and from-0.02 to 0.74; Observing the Naranjo method and the other four kinds of evaluation methods, the consistent rates and Kappa values were from 37.00 to 62.90% and from 0.11 to 0.34; Observing the WHO-UMC method and the other four kinds of evaluation methods, the consistent rates and Kappa values were from 59.30 to 92.60% and from 0.11 to 0.85; Observing the China Ministry of Health method and the remaining four methods, the consistent rates and Kappa values were from 51.80 to 92.60% and from 0.01 to 0.85; Observing the Bayesian method and the other four kinds of evaluation methods, the consistent rates and Kappa values were from 37.00 to 59.30% and from-0.02 to 0.11.ConclusionThe results of this study showed that there was an excellent consistency between the WHO-UMC method and China Ministry of Health assessment method; and consistency of Karch & Lasagna method and China Ministry of Health assessment method was good. Comparing the Naranjo’s method and the Bayesian method and the rest four methods respectively, consistency to the four kinds of methods were low, especially in the Bayesian method. This study has some limitations, such as the sample size is relatively small, did not perform analysis for impact factors of consistency. Need to be supplemented and improved in the future research.