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Reporting Bias in Diagnostic and Prognostic Studies: Time for Action

¹ Departments of Laboratory Medicine and Pathology , Children’s Hospital and Harvard Medical School, Boston, MA
² Centre for Statistics in Medicine, Oxford, UK
³ Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

^aAddress correspondence to this author at:, Department of Laboratory Medicine, Children’s Hospital Boston, 300 Longwood Ave., Boston, MA 02115, E-mail nader.rifai@childrens.harvard.edu

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Truth is not only violated by falsehood; it may be equally outraged by silence. —Henri-Frédéric Amiel (1812–1881)

Publication bias and selective reporting are recognized problems in the biomedical literature (1)(2)(3). Positive or favorable findings are more likely to be reported than negative or inconclusive ones. Authors are often disappointed by negative findings and use multiple comparisons and subgroup analyses to generate positive results, while giving scant attention to analyses of negative results (4). Contrary to common beliefs, studies with positive results and those with negative results have been shown to be equivalent with respect to the quality of study design and execution (5), and authors and sponsors, rather than journal editors, appear to be primarily responsible for the reporting bias (5)(6)(7). Publication of only selected results distorts the research evidence base that underpins the practice of evidence-based medicine. This practice diminishes the value of systematic reviews and metaanalyses, leads to unnecessary duplication of efforts, and prevents the derivation of unbiased estimates for the risk–benefit ratio of a drug therapy or a diagnostic evaluation. Furthermore, such dubious publication practices are inconsistent with researchers’ moral responsibilities (8).

Concerns over selective reporting of clinical trial results have been growing over the past several years (9)(10)(11). Comprehensive registration of clinical trials and public disclosure of study results have been suggested as the optimal solutions for this problem. Efforts to address this issue were intensified after the New York State Attorney General filed a lawsuit against GlaxoSmithKline on June 2, 2004, alleging the withholding of information regarding the efficacy and safety of paroxetine, a selective serotonin reuptake inhibitor, in children with depression (12). Shortly thereafter, the House of Delegates . . . [Full Text of this Article]