Your browser doesn't support javascript.
loading
Comparison of different methods for causality assessment of adverse drug reactions.
Behera, Sapan Kumar; Das, Saibal; Xavier, Alphienes Stanley; Velupula, Srinivas; Sandhiya, Selvarajan.
Afiliación
  • Behera SK; Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
  • Das S; Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
  • Xavier AS; Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
  • Velupula S; Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
  • Sandhiya S; Department of Pharmacology, Kakatiya Medical College/MGM Hospital, Warangal, Telangana, India.
Int J Clin Pharm ; 40(4): 903-910, 2018 Aug.
Article en En | MEDLINE | ID: mdl-30051231
Background The causality assessment of adverse drug reactions (ADRs) remains a challenge, and none of the different available method of causality assessment used for assessing adverse reactions has been universally accepted as the gold standard. Objective To examine the agreement and correlation among three broad approaches for causality assessment of ADRs viz. World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, Naranjo algorithm, and updated Logistic method. Setting ADR monitoring centre (AMC) of a tertiary care teaching hospital in India. Method A total of 230 cases of ADR from April 2017 to August 2017 were retrospectively analyzed by each of these three methods. The agreement among the different methods was calculated by Cohen's kappa (κ), and Spearman's correlation was used to find the correlation among these methods. Main outcome measures Cohen's kappa value and Spearman's correlation coefficient for comparison among the different methods. Results The Cohen's κ used for analyzing the agreement between WHO-UMC system and Naranjo algorithm was 0.45, between WHO-UMC system and updated Logistic method was 0.405, and between Naranjo algorithm and updated Logistic method was 0.606. The Spearman's correlation coefficient was 0.793 for Naranjo algorithm vs. updated Logistic method, 0.735 for WHO-UMC system vs. Naranjo algorithm, and 0.696 for WHO-UMC system vs. updated Logistic method. Conclusion Causality assessment based on objective measurements (scores and probabilities) like updated Logistic method and Naranjo algorithm are less prone to subjective variations compared to the WHO-UMC system which is based on expert judgement.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sistemas de Registro de Reacción Adversa a Medicamentos / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Farmacovigilancia Tipo de estudio: Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male País/Región como asunto: Asia Idioma: En Revista: Int J Clin Pharm Año: 2018 Tipo del documento: Article País de afiliación: India Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sistemas de Registro de Reacción Adversa a Medicamentos / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Farmacovigilancia Tipo de estudio: Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male País/Región como asunto: Asia Idioma: En Revista: Int J Clin Pharm Año: 2018 Tipo del documento: Article País de afiliación: India Pais de publicación: Países Bajos