Abstract
BACKGROUND: Physicians reading the medical literature attempt to determine whether research studies are valid. However, articles with negative results may not provide sufficient information to allow physicians to properly assess validity. METHODS: We analyzed all original research articles with negative results published in 1997 in the weekly journals BMJ, JAMA, Lancet, and New England Journal of Medicine as well as those published in the 1997 and 1998 issues of the bimonthly Annals of Internal Medicine (N = 234). Our primary objective was to quantify the proportion of studies with negative results that comment on power and present confidence intervals. Secondary outcomes were to quantify the proportion of these studies with a specified effect size and a defined primary outcome. Stratified analyses by study design were also performed. RESULTS: Only 30% of the articles with negative results comment on power. The reporting of power (range: 15%-52%) and confidence intervals (range: 55-81%) varied significantly among journals. Observational studies of etiology/risk factors addressed power less frequently (15%, 95% CI, 8-21%) than did clinical trials (56%, 95% CI, 46-67%, p < 0.001). While 87% of articles with power calculations specified an effect size the authors sought to detect, a minority gave a rationale for the effect size. Only half of the studies with negative results clearly defined a primary outcome. CONCLUSION: Prominent medical journals often provide insufficient information to assess the validity of studies with negative results.