2008
DOI: 10.3233/jrs-2008-0435
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The development of a tool to assess the quality of case reports of adverse events

Abstract: About one-third of the published literature on adverse drug reactions (ADRs) and adverse events (AEs) consists of case reports. Unfortunately, the majority of case reports fall short of providing sufficient details for critical evaluation. Potentially valuable information is therefore frequently lost. The study was aimed at developing a quality assessment tool for case reports of AEs. A preliminary scale of 35 items for conventional drugs (and an additional 6 items for herbal preparations) was initially develo… Show more

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Cited by 8 publications
(5 citation statements)
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References 27 publications
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“…An important advantage compared with the earlier implementation of documentation grading in VigiBase is that the vigiGrade completeness score considers each dimension in parallel, instead of in sequence: even when information on time-to-onset is lacking, the other dimensions are evaluated and accounted for in the total completeness score. vigiGrade considers many of the same fields as does the structured assessment proposed by Agbabiaka et al [ 13 ], but is less comprehensive. Specifically, it does not evaluate dimensions for which absence of information cannot be distinguished from information on absence in VigiBase.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…An important advantage compared with the earlier implementation of documentation grading in VigiBase is that the vigiGrade completeness score considers each dimension in parallel, instead of in sequence: even when information on time-to-onset is lacking, the other dimensions are evaluated and accounted for in the total completeness score. vigiGrade considers many of the same fields as does the structured assessment proposed by Agbabiaka et al [ 13 ], but is less comprehensive. Specifically, it does not evaluate dimensions for which absence of information cannot be distinguished from information on absence in VigiBase.…”
Section: Discussionmentioning
confidence: 99%
“…More recently, Agbabiaka et al [ 13 ] proposed a structured assessment of the quality of individual case reports in scientific publications. Their questionnaire is very comprehensive and is intended as a support for manual review but not for automated assessment.…”
Section: Introductionmentioning
confidence: 99%
“…After the completion of the exhaustive preliminary checklist, which included all possible pertinent items that would need to be reported, a voting round, followed by a validation round, was then performed twice. The rationale for doing so was to allow an external verification at each step of the process to rapidly identify any problem concerning the phraseology or the clarity of each retained item (Fig. ).…”
Section: Methodsmentioning
confidence: 99%
“…Such reporting guidelines already exist for randomized controlled trials , observational studies , systematic reviews and meta‐analyses , diagnoses , and health economic evaluations . Reporting guidelines for case reports for adverse events were first published in 2007 .…”
mentioning
confidence: 99%
“…Applying Hung, Hillier and Ernst's ( 22 ) modified version of the Agbabiaka tool ( 54 ), the distribution of the quality assessment scores across the 26 papers, covering 35 case reports, was as follows: low quality (0), lower-medium quality (9), upper-medium quality (10) and high quality (7). Only one single case report used a validated instrument to assess causality, the Naranjo scale.…”
Section: Quality Assessment Of Case Reportsmentioning
confidence: 99%