Abstract
BackgroundRandomized controlled trials (RCTs) often have more than one primary outcome and frequently have secondary and harm outcomes. Comparison of outcomes between study arms is the primary focus of RCTs, but there are times when the relation between outcomes is important, such as determining whether an intermediate outcome and a clinical outcome have a strong association. We sought to determine how often reports of RCTs depict the relations among outcomes at the individual patient level and, for those studies that use composite outcomes, how often the relations between component elements are depicted.MethodsWe selected 20 general, specialty and subspecialty medical journals with high impact factors that publish original clinical research. We identified every RCT in the 2011 and 2012 issues and randomly selected 10 articles per journal. For each article we recorded the number of outcomes, the number of composite outcomes and how often the relations between outcomes or elements of composite outcomes were portrayed.ResultsAll but 16 of the 200 RCTs had more than one outcome. Thus, outcomes could have been related in 92% of studies, but such relations were only reported in 2 (1%). A total of 33 (17%) investigations measured a composite outcome, 32 of which showed data for each component. None, however, showed cross-tabulation of the components.ConclusionsReaders are rarely shown the relation between outcomes. Mandatory posting of datasets or requirements for detailed appendices would allow readers to see these cross-tabulations, helping future investigators know which outcomes are redundant, which provide unique information and which are most responsive to changes in the independent variables. While not every relationship between outcomes requires depiction, at present such information is seldom portrayed.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0584-6) contains supplementary material, which is available to authorized users.
Highlights
Randomized controlled trials (RCTs) often have more than one primary outcome and frequently have secondary and harm outcomes
The conclusions of a pediatric asthma study that showed that one inhaler reduced days missed from school more than another would be different if there was a strong negative correlation between days missed from school and improvement in forced expiratory volume (FEV-1) than if there was a strong positive correlation
Data abstraction We reviewed the entire RCT report including all print and online supplements and appendices using a data collection instrument we developed for this study
Summary
Randomized controlled trials (RCTs) often have more than one primary outcome and frequently have secondary and harm outcomes. Future researchers may wish to know how well an or inexpensively obtained secondary outcome relates to a more clinically important, patient-centered outcome that is more difficult or costly to obtain Such knowledge could help in the selection of outcomes in future trials. The conclusions of a pediatric asthma study that showed that one inhaler reduced days missed from school (the primary clinical outcome) more than another would be different if there was a strong negative correlation between days missed from school and improvement in forced expiratory volume (FEV-1) than if there was a strong positive correlation The latter would suggest that improvement in airflow was not on the causal pathway from inhaler use to better school attendance, requiring investigators to check their data for bias or to revise their theoretical model
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