Publication bias: what is it? How do we measure it? How do we avoid it?

Abstract

Publication bias occurs when results of published studies are systematically different from results of unpublished studies. The term "dissemination bias" has also been recommended to describe all forms of biases in the research-dissemination process, including outcome-reporting bias, time-lag bias, gray-literature bias, full-publication bias, language bias, citation bias, and media-attention bias. We can measure publication bias by comparing the results of published and unpublished studies addressing the same question. Following up cohorts of studies from inception and comparing publication levels in studies with statistically significant or "positive" results suggested greater odds of formal publication in those with such results, compared to those without. Within reviews, funnel plots and related statistical methods can be used to indicate presence or absence of publication bias, although these can be unreliable in many circumstances. Methods of avoiding publication bias, by identifying and including unpublished outcomes and unpublished studies, are discussed and evaluated. These include searching without limiting by outcome, searching prospective trials registers, searching informal sources, including meeting abstracts and PhD theses, searching regulatory body websites, contacting authors of included studies, and contacting pharmaceutical or medical device companies for further studies. Adding unpublished studies often alters effect sizes, but may not always eliminate publication bias. The compulsory registration of all clinical trials at inception is an important move forward, but it can be difficult for reviewers to access data from unpublished studies located this way. Publication bias may be reduced by journals by publishing high-quality studies regardless of novelty or unexciting results, and by publishing protocols or full-study data sets. No single step can be relied upon to fully overcome the complex actions involved in publication bias, and a multipronged approach is required by researchers, patients, journal editors, peer reviewers, research sponsors, research ethics committees, and regulatory and legislation authorities.