Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trialsReportar como inadecuado

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, 17:207

First Online: 22 April 2016Received: 19 August 2015Accepted: 17 March 2016DOI: 10.1186-s13063-016-1327-z

Cite this article as: Hodkinson, A., Gamble, C. & Smith, C.T. Trials 2016 17: 207. doi:10.1186-s13063-016-1327-z


BackgroundThe quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials.

MethodsPublications related to clinical trials of orlistat were identified through comprehensive literature searches. A request was made to Roche Genentech; South San Francisco, CA, USA for clinical study reports related to the orlistat trials identified in our search. We compared adverse events, serious adverse events, and the reporting of 15 harms criteria in both document types and compared meta-analytic results using data from the clinical study reports against the journal publications.

ResultsFive journal publications with matching clinical study reports were available for five independent clinical trials. Journal publications did not always report the complete list of identified adverse events and serious adverse events. We found some differences in the magnitude of the pooled risk difference between both document types with a statistically significant risk difference for three adverse events and two serious adverse events using data reported in the clinical study reports; these events were of mild intensity and unrelated to the orlistat. The CONSORT harms reporting criteria were often satisfied in the methods section of the clinical study reports 70–90 % of the methods section criteria satisfied in the clinical study reports compared to 10–50 % in the journal publications, but both document types satisfied 80–100 % of the results section criteria, albeit with greater detail being provided in the clinical study reports.

ConclusionsIn this case study, journal publications provided insufficient information on harms outcomes of clinical trials and did not specify that a subset of harms data were being presented. Clinical study reports often present data on harms, including serious adverse events, which are not reported or mentioned in the journal publications. Therefore, clinical study reports could support a more complete, accurate, and reliable investigation, and researchers undertaking evidence synthesis of harm outcomes should not rely only on incomplete published data that are presented in the journal publications.

KeywordsHarms Orlistat Clinical study report Adverse event Adverse effect Randomised controlled trial Systematic review Evidence-based healthcare Obesity AbbreviationsAEsadverse events

BMJBritish Medical Journal

CONSORTConsolidated Standards of Reporting Trials

CPRDClinical Practice Research Data-link

CSRsclinical study reports

EMAEuropean Medicines Agency

EUEuropean Union

JAMAJournal of the American Medical Association


MedDRAMedical Dictionary for Regulatory Activities

RAPreporting analysis plan

RDrisk difference

RRrelative risk

SAEsserious adverse events

Sdstandard deviation

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1327-z contains supplementary material, which is available to authorized users.

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Autor: Alex Hodkinson - Carrol Gamble - Catrin Tudur Smith


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