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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)