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Table 1 Results for different outcome definitions of further bleeding in TRIGGER

From: Outcome pre-specification requires sufficient detail to guard against outcome switching in clinical trials: a case study

Time-point Method of assessment Definition Liberal policy (n (%)) (n = 403) Restrictive policy (n (%)) (n = 533) Odds ratioc(95% CI) P value
In hospitala Clinical judgement or visual inspection Recurrent and persistent bleeding 31 (5.8) 18 (4.5) 0.94 (0.37–2.40) 0.89
In hospitala Clinical judgement or visual inspection Recurrent bleeding only 21 (4.0) 8 (2.0) 0.46 (0.22–0.98) 0.04
In hospitala Visual inspection only Recurrent and persistent bleeding 24 (4.5) 9 (2.2) 0.54 (0.22–1.33) 0.18
In hospitala Visual inspection only Recurrent bleeding only 14 (2.6) 3 (0.7) 0.23 (0.11–0.50) < 0.001
Day 28b Clinical judgement or visual inspection Recurrent and persistent bleeding 42 (8.2) 27 (6.9) 0.83 (0.50–1.37) 0.47
Day 28b Clinical judgement or visual inspection Recurrent bleeding only 32 (6.3) 17 (4.3) 0.58 (0.39–0.86) 0.007
Day 28b Visual inspection only Recurrent and persistent bleeding 31 (6.1) 13 (3.3) 0.50 (0.32–0.78) 0.002
Day 28b Visual inspection only Recurrent bleeding only 21 (4.1) 7 (1.8) 0.39 (0.20–0.76) 0.006
  1. aIn hospital: 1 patient was excluded from the analysis because of missing data on further bleeding (this left 532 patients in the liberal policy group and 403 in the restrictive policy group)
  2. bDay 28: 31 patients were excluded from the analysis because of missing data on further bleeding (this left 512 patients in the liberal policy group and 393 in the restrictive policy group)
  3. cAnalysis was conducted using generalised estimating equations, with an exchangeable correlation structure within clusters and robust standard errors. The model adjusted for the following covariates: presence of shock; age; the number of co-morbidities; and the presence of coagulation