title: Is the relationship among outcome variables shown in randomized trials?
abstract: BACKGROUND
  Randomized 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.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  All 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.
  
  
  CONCLUSIONS
  Readers 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.
authors.affiliation: Department of Emergency Medicine, University of California, 924 Westwood Blvd, Suite 300, Los Angeles, CA, 90024, USA. schriger@ucla.edu.
authors.forename: David L
authors.initials: DL
authors.lastname: Schriger
authors.affiliation: Department of Emergency Medicine, University of California, 924 Westwood Blvd, Suite 300, Los Angeles, CA, 90024, USA. richelle@ucla.edu.
authors.forename: Richelle J
authors.initials: RJ
authors.lastname: Cooper
authors.affiliation: Department of Emergency Medicine, University of California, 924 Westwood Blvd, Suite 300, Los Angeles, CA, 90024, USA. lopez.ana@gmail.com.
authors.forename: Ana
authors.initials: A
authors.lastname: Lopez-O'Sullivan
authors.affiliation: Department of Emergency Medicine, University of California, 924 Westwood Blvd, Suite 300, Los Angeles, CA, 90024, USA. CWystrach@mednet.ucla.edu.
authors.forename: Carter
authors.initials: C
authors.lastname: Wystrach
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK. doug.altman@csm.ox.ac.uk.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
mesh_terms: D003430:Cross-Sectional Studies; D006801:Humans; D010506:Periodicals as Topic; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome