Guidelines for Submitting Adverse Event Reports for Publication

Kelly, William N.; Arellano, Félix; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph; Fernandez, Alina M.; Freedman, Stephen B.; Goldsmith, David; Huang, Kui; Jones, Judith K.; McLeay, Rachel; Moore, Nicholas; Stather, Rosie; Trenque, Thierry; Troutman, William G.; Puijenbroek, Eugène van; Williams, Frank G.; Wise, Robert P.

doi:10.2515/therapie/2009041

Cited by 57 publications

(43 citation statements)

References 16 publications

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“…Empirical evidence suggests that a journal's adoption of the CONSORT statement as a guide to authors is associated with an increase in the completeness of published randomised trials 13. Guidelines have been developed for adverse-event case reports14; however, general reporting guidelines for case reports do not exist. Our primary objective was to develop reporting guidelines for case reports through a consensus-based process.…”

Section: Introductionmentioning

confidence: 99%

The CARE guidelines: consensus-based clinical case reporting guideline development

et al. 2013

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A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.

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Section: Introductionmentioning

confidence: 99%

The CARE guidelines: consensus-based clinical case reporting guideline development

et al. 2013

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“…The network hosts an up-to-date library of reporting guidelines for health research on their website (www.equator-network.org). Currently, at least two sets of guidelines have been identified which if used, may improve the quality of case report literature [68], [69]. In addition examples of standardized reporting tools used to evaluate the cause of adverse events exist such as the Consolidated Standard of Reporting Trials (CONSORT) Statement for reporting adverse events in clinical trials, [70] and the Naranjo Causality Scale for reporting adverse reactions to pharmaceuticals.…”

Section: Discussionmentioning

confidence: 99%

The Quality of Reports on Cervical Arterial Dissection following Cervical Spinal Manipulation

et al. 2013

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BackgroundCervical artery dissection (CAD) and stroke are serious harms that are sometimes associated with cervical spinal manipulation therapy (cSMT). Because of the relative rarity of these adverse events, studying them prospectively is challenging. As a result, systematic review of reports describing these events offers an important opportunity to better understand the relation between adverse events and cSMT. Of note, the quality of the case report literature in this area has not yet been assessed.Purpose1) To systematically collect and synthesize available reports of CAD that have been associated with cSMT in the literature and 2) assess the quality of these reports.MethodsA systematic review of the literature was conducted using several databases. All clinical study designs involving CADs associated with cSMT were eligible for inclusion. Included studies were screened by two independent reviewers for the presence/absence of 11 factors considered to be important in understanding the relation between CAD and cSMT.ResultsOverall, 43 articles reported 901 cases of CAD and 707 incidents of stroke reported to be associated with cSMT. The most common type of stroke reported was ischemic stroke (92%). Time-to-onset of symptoms was reported most frequently (95%). No single case included all 11 factors.ConclusionsThis study has demonstrated that the literature infrequently reports useful data toward understanding the association between cSMT, CADs and stroke. Improving the quality, completeness, and consistency of reporting adverse events may improve our understanding of this important relation.

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“…We received no replies from 23 experts (48%) even after two email reminders were sent, 10 experts responded but could not participate due to lack of time. Fifteen (15) items fell below the endorsement frequency level of 60% (12 items from the general table and 3 items from the additional table on herbal preparations) and these were excluded from the round two list. The majority of the participating experts were of the opinion that the list was comprehensive; that the questions were clear enough and there was no need to simplify them.…”

Section: Resultsmentioning

confidence: 99%

“…As we were preparing this manuscript, a guideline for submitting adverse event reports for publication was published [15]. This guideline summarises details of suspected AEs that should be reported.…”

Section: Total Scorementioning

confidence: 99%

“…The frequently low quality of published case reports and the lack of guidelines for reporting them has been a cause for concern for many years [14,26]. The first attempt at such a guideline has only recently been published [15]. A high quality AE report should contain a clear and explicit title, a structured and detailed clinical description of the event, and adequate information for direct comparisons with similar cases [8].…”

Section: Introductionmentioning

confidence: 99%

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The development of a tool to assess the quality of case reports of adverse events

Agbabiaka

Savović²,

Harris

et al. 2008

International Journal of Risk and Safety in Medicine

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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 developed. Forty-eight (48) experts were invited to assess this list and modify it for face and content validity in three rounds of a Delphi process. The resulting scale of 21 items, 18 of which relates to general AEs and three items specific to herbal preparations. These items evaluate the quality of case reports in three domains: (i) drug information and therapeutic regimen (5 items); (ii) patient history, diagnosis and medications (8 items); and (iii) details of adverse events (5 items). It was tested for reliability by 16 experts using 5 randomly selected case reports. Our quality score is comprehensive and reliable. It could be an advance over existing instruments and form a basis for further developments in this area of pharmacovigilance.

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Guidelines for Submitting Adverse Event Reports for Publication

Cited by 57 publications

References 16 publications

The CARE guidelines: consensus-based clinical case reporting guideline development

The CARE guidelines: consensus-based clinical case reporting guideline development

The Quality of Reports on Cervical Arterial Dissection following Cervical Spinal Manipulation

The development of a tool to assess the quality of case reports of adverse events

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