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Various causality assessments were used, and results on causal assessments of ICU admissions related to ADE were mentioned in only four articles [ 10, 13, 16, 17].> -wrap-foot> ItalianItalian Group on Intensive Care Evaluation NDD, not documented; WHO, World Health Organization.
In order to improve the accuracy of our assessments, individual causality assessments were undertaken using the Naranjo causality assessment tool [15].
Causality assessments are difficult, and inter-rater agreements vary enormously [27], but we feel that our methods were as robust as is possible in relation to assessment of individual cases.
Investigators provided causality assessments for unsolicited events.
Investigators provided causality assessments for unsolicited AEs.
Formal causality assessments are important and influence policy decisions.
Similar(41)
Nine of the 11 cases with detailed interviews underwent causality assessment; 2 were not assessed due to AEs occurring beyond the 1-month screening timeframe (figure 2).
Inter-rater agreement (ADE vs control group, 3 causality assessment methods and preventability assessment) was assessed with the kappa test [31].
Two clinicians reviewed structured case reports and assessed causality by consensus and by using a causality assessment instrument.
The guidance also does not recommend a causality assessment scale reflecting varying degrees of certainty in causal link.
The comparison of ADE-drug associations with the information in the SPC was additionally assessed by taking into account a patient-reported causality assessment.
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