Are unadjusted analyses of clinical trials inappropriately biased toward the null?

Stroke

Volumn 40, Issue 3, 2009, Pages 672-673

  Kent, David M ^a   Trikalinos, Thomas A ^a   Hill, Michael D ^b  

^a TUFTS MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALGARY   (Canada)

Author keywords

Clinical trials; Statistical analysis

Indexed keywords

FIBRINOLYTIC AGENT;

CLINICAL RESEARCH; CLINICAL TRIAL; DATA ANALYSIS; DATA BASE; DISEASE SEVERITY; EDITORIAL; FIBRINOLYTIC THERAPY; HUMAN; OUTCOMES RESEARCH; PRIORITY JOURNAL; RATING SCALE; RISK ASSESSMENT; STATISTICAL ANALYSIS; STROKE; FACTUAL DATABASE; METHODOLOGY; NONLINEAR SYSTEM; NOTE; RANDOMIZED CONTROLLED TRIAL; RISK; STATISTICS;

CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; HUMANS; NONLINEAR DYNAMICS; ODDS RATIO; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RISK ADJUSTMENT; STROKE;

EID: 62449228058     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/STROKEAHA.108.532051     Document Type: Editorial

References (14)

1. Kent DM, Hay ward RA. Limitations of applying summary results of clinical trials to individual patients: the need for risk stratification. JAMA. 2007;298:1209-1212.
2. Kent DM, Hayward RA. When averages hide individual differences in clinical trials. Am Scientist. 2007;95:60-68.
3. Gray LJ, Bath P, Collier T. Should stroke trials adjust for functional outcome for baseline prognostic factors? Stroke. 2009;40:888-894.
4. Choi SC. Sample size in clinical trials with dichotomous endpoints: use of covariables. Journal of Biopharmaceutical Statistics. 1998;8:367-375.
5. Johnston KC, Connors AF, Wagner DP, Haley EC. Risk adjustment effect on stroke clinical trials. Stroke. 2004;35:e43-e45.
6. Hemandez AV, Steyerberg EW, Butcher I, Mushkudiani N, Taylor GS, Murray GD, Marmarou A, Choi SC, Lu J, Habbema JDF, Maas AIR. 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.
7. Hernandez AV, Eijkemans MJC, Steyerberg EW. Randomized controlled trials with time-to-event outcomes: how much does prespecified covariate adjustment increase power? Ann Epidemiol. 2006;16:41-48.
8. Hernandez AV, Steyerberg EW, Habbema JDF. Clinical trials with dichotomous end-points: covariate adjustment increases power and potentially reduces sample size. J Clin Epidemiol. 2004;57:454-460.
9. Steyerberg EW, Bossuyt PMM, Lee KL. Clinical trials in acute myocardial infarction: should we adjust for baseline characteristics? Am Heart J. 2000;139:745-751.
10. Greenland S. Interpretation and choice of effect measures in epidemiologic analysis. Am J Epidemiol. 1987;125:761-768.
11. Gail MH, Wieand S, Piantadosi S. Biased estimates of treatment effect in randomized experiments with nonlinear regressions and omitted covariates. Biometrika. 1984;71:431-444.
12. Doi M, Nakamura T, Yomamoto E. Conservative tendency of the crude odds ratio. J Japan Statist Soc. 2001;31:53-65.
13. Kent DM, Selker HP, Ruthazer R, Bluhmki E, Hacke W. The stroke-thrombolytic predictive instrument: a predictive instrument for intravenous thrombolysis in acute ischemic stroke. Stroke. 2006;37: 2957-2962.
14. Savitz SI, Fisher M. Future of neuroprotection for acute stroke: in the aftermath of the SAINT trials. Ann Neurol. 2007;61:396-402.