Under-reporting of Adverse Events in the Biomedical Literature

Purpose: To address the under-reporting of research results, with emphasis on the underreporting/distorted reporting of adverse events in the biomedical research literature.Design/methodology/approach: A four-step approach is used:(1) To identify the characteristics of literature that make it adequate to support policy;(2) to show how each of these characteristics becomes degraded to make inadequate literature;(3) to identify incentives to prevent inadequate literature; and(4) to show policy implications of inadequate literature.Findings: This review has provided reasons for, and examples of, adverse health effects of myriad substances(1) being under-reported in the premiere biomedical literature, or(2) entering this literature in distorted form. Since there is no way to gauge the extent of this under/distorted-reporting, the quality and credibility of the ‘premiere’ biomedical literature is unknown. Therefore, any types of meta-analyses or scientometric analyses of this literaturewill have unknown quality and credibility. The most sophisticated scientometric analysis cannot compensate for a highly flawed database.Research limitations: The main limitation is in identifying examples of under-reporting. There are many incentives for under-reporting and few dis-incentives.Practical implications: Almost all research publications, addressing causes of disease, treatments for disease, diagnoses for disease, scientometrics of disease and health issues, and other aspects of healthcare, build upon previous healthcare-related research published. Many researchers will not have laboratories or other capabilities to replicate or validate the published research, and depend almost completely on the integrity of this literature. If the literature is distorted, then future research can be misguided, and health policy recommendations can be ineffective or worse.Originality/value: This review has examined a much wider range of technical and nontechnical causes for under-reporting of adverse events in the biomedical literature than previous studies.

Statistically Non-significant Papers in Environmental Health Studies included more Outcome Variables

Objective The number of analyzed outcome variables is important in the statistical analysis and interpretation of research findings. This study investigated published papers in the field of environmental health studies. We aimed to examine whether differences in the number of reported outcome variables exist between papers with non-significant findings compared to those with significant findings. Articles on the maternal exposure to mercury and child development were used as examples. Methods Articles published between 1995 and 2013 focusing on the relationships between maternal exposure to mercury and child development were collected from Medline and Scopus. Results Of 87 extracted papers, 73 used statistical significance testing and 38（43.7%） of these reported ＇non-significant＇（P〉0.05） findings. The median number of child development outcome variables in papers reporting ＇significant＇（n=35） and ＇non-significant＇（n=38） results was 4 versus 7, respectively（Mann-Whitney test P-value=0.014）. An elevated number of outcome variables was especially found in papers reporting non-significant associations between maternal mercury and outcomes when mercury was the only analyzed exposure variable. Conclusion Authors often report analyzed health outcome variables based on their P-values rather than on stated primary research questions. Such a practice probably skews the research evidence.