Can Decisional Algorithms Replace Global Introspection in the Individual Causality Assessment of Spontaneously Reported ADRs?

Macedo, Ana; Marques, Francisco Batel; Ribeiro, Carlos Fontes

doi:10.2165/00002018-200629080-00006

Cited by 49 publications

(36 citation statements)

References 37 publications

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“…These finding were similar to those of Macedo et al (2006). Others have stated that experts, working independently without a framework, frequently disagree on causality assessments because they have the same limitation (subjectivity), which leads to poor reproducibility and to different conclusions.…”

Section: Comparison Of Methodssupporting

confidence: 82%

How We Assess Causality

Jones

Kingery

2014

Mann's Pharmacovigilance

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Section: Comparison Of Methodssupporting

confidence: 82%

How We Assess Causality

Jones

Kingery

2014

Mann's Pharmacovigilance

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“…Hence, doctors assessing ADRs face the need to make causality assessment judgements on drug-related events. Several methods for assessing causality of ADRs have been proposed that can be classified into three broad categories: 1) expert judgement, also called global introspection; 2) algorithms; 3) and probabilistic methods such as Bayesian approaches [25][26][27][28][29][30]. However, as a result of problems of validity and reproducibility, none of the diagnostic methods are completely satisfactory.…”

Section: Discussionmentioning

confidence: 99%

Hospital DoctorsÂ’ Views and Concerns about Pharmacovigilance

PF¹

2015

J Pharmacovigil

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IntroductionAdverse drug reactions (ADRs) are a relevant problem in health care, and particularly in the hospital setting [1][2][3]. Unfortunately, ADRs are underreported in general [4], and particularly in hospitals [5]. Knowledge and attitudes of health professionals appear to be strongly associated with underreporting in a high proportion of studies [6]. Therefore, it is important to know the opinions, perceptions and attitudes of hospital doctors with respect to ADRs because their knowledge can help to improve the spontaneous reporting of ADRs. Several studies have assessed the knowledge, behaviour and attitudes of physicians regarding ADRs and their reporting to the pharmacovigilance systems [7][8][9][10][11][12][13][14]. Nevertheless, those studies have not evaluated specifically the doubts, uncertainties, misunderstandings and misconceptions that medical doctors may have about ADRs and pharmacovigilance systems, which are barriers to the development of pharmacovigilance activities. Thus, the objective of our study was to analyze the opinions and doubts that hospital doctors have about ADRs and pharmacovigilance activities. MethodsA survey was carried out in a tertiary university hospital. The design of the study was qualitative because this type of methodological research allows us to understand the perceptions of doctors adequately. The qualitative technique used in the study was the focus group discussion methodology [15]. Participants were selected using a theoretical sampling model. Focus group discussions were carried out among physicians (house staff and residents in training) from different medical specialties. The groups were naturally occurring using pre-existing groups of people who worked together in the same medical department of the hospital. Thirteen focus group nonstructured discussions were conducted and 296 physicians (each focus group had approximately 22 participants) from the following medical specialities participated: Anaesthesiology, Cardiology, Dermatology, Endocrinology, Gastroenterology, Infectious diseases, Internal medicine, Intensive care medicine, Nephrology, Pneumology, Neurology, Psychiatry, and Rheumatology.Focus groups were held from January 2008 to December 2013, and the running of the groups took place in the annual pharmacovigilance sessions in each of the departments of the medical specialities described above. These sessions lasted from 45 to 60 minutes in which the pharmacovigilance program of the hospital was introduced. In the first part of the sessions, the global results of the program and the specific results relating to each medical department were presented by a clinical pharmacologist specialised in pharmacovigilance. News and other topics to do with pharmacovigilance were also introduced. In the second part of the sessions, the participants were encouraged to share their points of view and doubts about the different aspects of ADRs and pharmacovigilance activities, and an open discussion was held. The participants were told that the purpose of the sessions ...

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“…As relying on the opinion of a single expert would be too subjective, all crucial data available are considered by three experts to reach a consensus. This concept is used as a standardized method by the DILI network study group [88], and outscored other numerical scores in some studies [89]. However, a clear limitation of this strategy is the absence of expert panels who can be contacted in daily routine.…”

Section: Assessment Of Dili In Patients With Cirrhosismentioning

confidence: 99%