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Table 4 Overall consistency and discrepancy between protocols and corresponding published reports by published report-derived type of study, N = 143 published reports

From: From protocol to published report: a study of consistency in the reporting of academic drug trials

  Exploratory published reports N = 96 Confirmatory published reports N = 47 Crude OR Adjusted OR#
  n % (95 % CI) n % (95 % CI) OR (95 % CI) OR (95 % CI)
Overall consistency 53 55 % (45 to 65 %) 17 36 % (22 to 50 %) 0.46 (0.22 to 0.94) 0.37 (0.17 to 0.83)
Individual discrepancies
Type of study 17 18 % (10 to 25 %) 6 13 % (3 to 22 %) 0.68 (0.25 to 1.87) 0.64 (0.21 to 1.48)
Primary objective 21 22 % (14 to 30 %) 5 11 % (2 to 19 %) 0.43 (0.15 to 1.21) 0.56 (0.11 to 2.80)
Primary endpoint 34 35 % (26 to 45 %) 13 28 % (15 to 40 %) 0.70 (0.32 to 1.50) 0.68 (0.31 to 1.48)
  1. *Prevalence in each subgroup; for example, 53 of 96 exploratory published reports (55 %) showed overall consistency
  2. #Adjusted for the association between published reports of the same trial (median: one published report per trial, range: one to eight)