title: Participant demographics reported in "Table 1" of randomised controlled trials: a case of "inverse evidence"?
abstract: BACKGROUND
  Data supporting external validity of trial results allows clinicians to assess the applicability of a study's findings to their practice population. Socio-economic status (SES) of trial participants may be critical to external validity given the relationship between social and economic circumstances and health. We explored how this is documented in reports of RCTs in four major general medical journals.
  
  
  METHODS
  The contents lists of four leading general medical journals were hand searched to identify 25 consecutive papers reporting RCT results in each journal (n = 100). Data on demographic characteristics were extracted from each paper's Table 1 only (or equivalent).
  
  
  RESULTS
  Authors infrequently reported key demographic characteristics relating to SES of RCT participants. Age and gender of participants were commonly reported. Less than 10% reported occupational group, employment status, income or area based measures of disadvantage.
  
  
  CONCLUSIONS
  Without adequate reporting of key indicators of SES in trial participants it is unclear if lower SES groups are under-represented. If such groups are systematically under-recruited into trials, this may limit the external validity and applicability of study findings to these groups. This is in spite of the higher health-care need in more disadvantaged populations. Under-representation of low SES groups could underestimate the reported effect of an intervention for those with a higher baseline risk. The marginal benefit identified in a trial with poor or no representation of lower SES participants could significantly underestimate the potential benefit to a low SES community. More transparency in this reporting and greater attention to the impact of SES on intervention outcomes in clinical trials is needed. This could be considered in the next revision of the CONSORT statement.
authors.affiliation: Department of General Practice, University of Melbourne, 200 Berkeley St, Carlton, VIC 3053, Australia. j.furler@unimelb.edu.au
authors.forename: John
authors.initials: J
authors.lastname: Furler
authors.forename: Parker
authors.initials: P
authors.lastname: Magin
authors.forename: Marie
authors.initials: M
authors.lastname: Pirotta
authors.forename: Mieke
authors.initials: M
authors.lastname: van Driel
mesh_terms: D000367:Age Factors; D054624:Health Status Disparities; D054625:Healthcare Disparities / Q000706:statistics & numerical data*; D006801:Humans; D018579:Patient Selection; D010506:Periodicals as Topic / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012737:Sex Factors; D012923:Social Class; D012959:Socioeconomic Factors