Parameter | Pediatric Journals (n = 18) | General Journals (n = 14) |
---|---|---|
Motive(s) for termination* | Â | Â |
   Adequately reported | 18 (100) | 12 (86) |
   Terminated for efficacy | 3 (17) | 3 (21) |
   Terminated for harm | 2 (11) | 4 (29) |
   Terminated for futility | 3 (17) | 4 (29) |
   Other reasons reported (stand-alone or additional) | 13 (72) | 2 (14) |
Rationale for termination (i.e. stopping guidelines/rules) | Â | Â |
   Reported | 15 (73) | 13 (93) |
   Unclear or Not Reported | 3 (17) | 1 (7) |
DMC role in early termination | Â | Â |
   Reported | 3 (17) | 12 (86) |
   Unclear or Not Reported | 15 (83) | 2 (14) |
Timing of early termination # | Â | Â |
   Reported | 8 (44) | 8 (57) |
   Unclear or Not Reported | 10 (56) | 6 (43) |
Adjustment of results for interim analysis (p value, CI or estimate) | Â | Â |
   Reported | 2 (11) | 8 (57) |
   Unclear or Not Reported | 16 (89) | 6 (43) |
Section of paper where reference to early termination was reported | Â | Â |
   Title/Abstract | 4 (22) | 5 (36) |
   Methods | 14 (78) | 14 (100) |
   Results | 13 (72) | 6 (43) |
   Discussion | 10 (56) | 3 (21) |