Abstract
BackgroundTo describe how frequently harm is reported in the abstract of high impact factor medical journals.MethodsDesign and population: We carried out a blinded structured review of a random sample of 363 Randomised Controlled Trials (RCTs) carried out on human beings, and published in high impact factor medical journals in 2003. Main endpoint: 1) Proportion of articles reporting harm in the abstract; and 2) Proportion of articles that reported harm in the abstract when harm was reported in the main body of the article. Analysis: Corrected Prevalence Ratio (cPR) and its exact confidence interval were calculated. Non-conditional logistic regression was used.Results363 articles and 407 possible comparisons were studied. Overall, harm was reported in 135 abstracts [37.2% (CI95%:32.2 to 42.4)]. Harm was reported in the main text of 243 articles [66.9% (CI95%: 61.8 to 71.8)] and was statistically significant in 54 articles [14.9% (CI95%: 11.4 to 19.0)]. Among the 243 articles that mentioned harm in the text, 130 articles [53.5% (CI95% 47.0 to 59.9)] reported harm in the abstract; a figure that rose to 75.9% (CI95%: 62.4 to 86.5) when the harm reported in the text was statistically significant. Harm in the abstract was more likely to be reported when statistically significant harm was reported in the main body of the article [cPR = 1.70 (CI95% 1.47 to 1.92)] and when drug companies (not public institutions) funded the RCTs [cPR = 1.29 (CI95% 1.03 to 1.67)].Conclusions published in high impact factor medical journals underreport harm, even when harm is reported in the main body of the article.
Highlights
To describe how frequently harm is reported in the abstract of high impact factor medical journals
Abstracts published in high impact factor medical journals underreport harm, even when harm is reported in the main body of the article
About the way abstracts report harm in phase III and IV randomized controlled trials published in high impact journals, those considered gold standard for clinical evidence and those with the highest capacity to influence medical decision making
Summary
To describe how frequently harm is reported in the abstract of high impact factor medical journals. Adherence to the best clinical evidence has become an important guiding principle in both the medical and health policy decision-making processes. Because of its relevance in medical decision making [1117], quality of reporting abstracts, and the way harm is reported, has been considered an important issue [18,19,20]. About the way abstracts report harm in phase III and IV randomized controlled trials published in high impact journals, those considered gold standard for clinical evidence and those with the highest capacity to influence medical decision making. Our objective was to describe how frequently harm is reported in the abstracts of high impact factor medical journals
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