Underpowered trials in critical care medicine: How to deal with them?

Critical Care

Volumn 14, Issue 3, 2010, Pages

  Roozenbeek, Bob ^a,b   Lingsma, Hester F ^b   Steyerberg, Ewout W ^b   Maas, Andrew I R ^a  

^a ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^b ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); CRITICALLY ILL PATIENT; EFFECT SIZE; HUMAN; INTENSIVE CARE; LETTER; PREDICTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TRAUMATIC BRAIN INJURY; EPIDEMIOLOGY; METHODOLOGY; NOTE; STANDARD;

BIAS (EPIDEMIOLOGY); CLINICAL TRIALS AS TOPIC; INTENSIVE CARE; RESEARCH DESIGN;

EID: 77953126361     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/cc9021     Document Type: Letter

References (6)

1. Aberegg SK, Richards DR, O'Brien JM. Delta inflation: a bias in the design of randomized controlled trials in critical care medicine. Crit Care 2010, 14:R77. 10.1186/cc8990, 20429873.
2. Maas AI, Roozenbeek B, Manley GT. Clinical trials in traumatic brain injury: past experience and current developments. Neurotherapeutics 2010, 7:115-126. 10.1016/j.nurt.2009.10.022, 20129503.
3. Maas AI, Steyerberg EW, Marmarou A, McHugh GS, Lingsma HF, Butcher I, Lu J, Weir J, Roozenbeek B, Murray GD. IMPACT recommendations for improving the design and analysis of clinical trials in moderate to severe traumatic brain injury. Neurotherapeutics 2010, 7:127-134. 10.1016/j.nurt.2009.10.020, 20129504.
4. Roozenbeek B, Maas AI, Lingsma HF, Butcher I, Lu J, Marmarou A, McHugh GS, Weir J, Murray GD, Steyerberg EW. Baseline characteristics and statistical power in randomized controlled trials: selection, prognostic targeting, or covariate adjustment?. Crit Care Med 2009, 37:2683-2690. 10.1097/CCM.0b013e3181ab85ec, 19885979.
5. Hernández AV, Steyerberg EW, Butcher I, Mushkudiani N, Taylor GS, Murray GD, Marmarou A, Choi SC, Lu J, Habbema JD, Maas AI. Adjustment for strong predictors of outcome in traumatic brain injury trials: 25% reduction in sample size requirements in the IMPACT study. J Neurotrauma 2006, 23:1295-1303. 10.1089/neu.2006.23.1295, 16958582.
6. McHugh GS, Butcher I, Steyerberg EW, Marmarou A, Lu J, Lingsma HF, Weir J, Maas AI, Murray GD. A simulation study evaluating approaches to the analysis of ordinal outcome data in randomized controlled trials in traumatic brain injury: results from the IMPACT Project. Clin Trials 2010, 7:44-57. 10.1177/1740774509356580, 20156956.