A Call for Examining Replication and Bias in Special Education Research

Background The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention. Methodology/Principal Findings We review and summarise the evidence from a series of cohort studies that have assessed study publication bias and outcome reporting bias in randomised controlled trials. Sixteen studies were eligible of which only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Eleven of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40–62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. Conclusions Recent work provides direct empirical evidence for the existence of study publication bias and outcome reporting bias. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.

The veracity of substantive research claims hinges on the way experimental data are collected and analyzed. In this article, we discuss an uncomfortable fact that threatens the core of psychology's academic enterprise: almost without exception, psychologists do not commit themselves to a method of data analysis before they see the actual data. It then becomes tempting to fine tune the analysis to the data in order to obtain a desired result-a procedure that invalidates the interpretation of the common statistical tests. The extent of the fine tuning varies widely across experiments and experimenters but is almost impossible for reviewers and readers to gauge. To remedy the situation, we propose that researchers preregister their studies and indicate in advance the analyses they intend to conduct. Only these analyses deserve the label "confirmatory," and only for these analyses are the common statistical tests valid. Other analyses can be carried out but these should be labeled "exploratory." We illustrate our proposal with a confirmatory replication attempt of a study on extrasensory perception.