Vance Berger

Selection Bias and Covariate Imbalances in Randomized Clinical Trials

• Gebundenes Buch

Produktbeschreibung

Selection bias can, and does, occur, even in randomized clinical trials. Steps need to be taken in order to ensure that this does not compromise the integrity of clinical trials; hence "Selection Bias and Covariate Imbalances in Randomized Clinical Trials" offers a comprehensive treatment of the subject and the methodology involved. This book:
_ Provides an overview of the hierarchy of study designs, and justifies the position of randomised trials at the top of this hierarchy.
_ Discusses the strengths and defects of randomisation, and provides real evidence to justify concern regarding its defects.
_ Outlays the damaging consequences that selection bias causes when it does occur.
_ Considers courses of action that can be taken to manage/ contain the problem.
_ Presents methods that can be used to detect selection bias in randomised trials, and methods to correct for selection bias.
_ Concludes by providing a comprehensive plan for managing baseline imbalances and selection bias in randomised trials, and proposing open problems for future research.

Illustrated with case studies, this book introduces groundbreaking ideas and research that will be invaluable to researchers and practitioners who design and analyse clinical trials. It will also be of interest to graduate students within the field of biostatistics.

Produktdetails

• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 224
• Erscheinungstermin: 1. Juni 2005
• Englisch
• Abmessung: 235mm x 157mm x 17mm
• Gewicht: 450g
• ISBN-13: 9780470863626
• ISBN-10: 0470863625
• Artikelnr.: 14737350

Autorenporträt

Vance Berger is the author of Selection Bias and Covariate Imbalances in Randomized Clinical Trials, published by Wiley.

Inhaltsangabe

Preface. Part I: Is There a Problem with Reliability in Medical Studies? 1
An Evolution of Comparative Methodology. 1.1 Single-subject studies. 1.2
Case series and cohort studies. 1.3 Historical controls. 1.4 Parallel
control groups. 1.5 Matched studies. 1.6 Randomization. 1.7 Advance
randomization. 1.8 Allocation concealment. 1.9 Residual selection bias. 2
Susceptibility of Randomized Trials to Subversion and Selection Bias. 2.1
Can randomized trials be subverted? 2.2 If randomized trials are subverted,
do they cease to be randomized trials? 2.3 What is masking? 2.4 What is
allocation concealment? 2.5 A double standard. 2.6 What if allocation
concealment could be ensured? 3 Evidence of Selection Bias in Randomized
Trials. 3.1 The burden of proof regarding the existence of selection bias
in randomized trials. 3.2 Indirect population-level evidence that selection
bias exists in randomized trials. 3.3 Direct trial-level evidence that
selection bias exists in randomized trials. 3.4 In search of better
evidence. 4 Impact of Selection Bias in Randomized Trials. 4.1 Quantifying
the prediction of future allocations: balanced blocks. 4.2 Quantifying
prediction of future allocations: unbalanced blocks. 4.3 Quantifying
covariate imbalance resulting from selection bias. 4.4 Quantifying the bias
resulting from covariate imbalance. Part II: Actions to be Taken to Improve
the Reliability of Medical Studies. 5 Preventing Selection Bias in
Randomized Trials. 5.1 Minimizing the Impact of Selection Bias. 5.2 Biased
Selection of Investigators. 5.3 Minimizing the prediction of future
allocations. 6 Detecting Selection Bias in Randomized Trials. 6.1 Baseline
Imbalances in Observed Covariates. 6.2 Testing for selection bias without
baseline analyses. 6.3 The selection covariate. 6.4 The role of the reverse
propensity score in third-order residual selection bias. 6.5 Using the
reverse propensity score To Test for selection bias: the Berger-Exner test
and graph. 6.6 Using the screening log to test for selection bias. 6.7 The
Ivanova-Barrier-Berger (IBB) Detection Method. 6.8 Interpreting negative
tests of selection bias. 6.9 When should one test for selection bias? 6.10
Who should test for selection bias? 7 Adjusting for Selection Bias in
Randomized Trials. 7.1 Methods proposed for addressing non-random baseline
imbalances. 7.2 Selection bias arising from a complete lack of allocation
concealment. 7.3 Selection bias arising from imperfect allocation
concealment. 8 Managing Selection Bias in Randomized Trials. 8.1 Action
points during the design phase of the trial. 8.2 Action points during the
conduct of the trial. 8.3 Action points during the analysis of trial data.
8.4 Action points by party. References. Author Index. Subject Index.

Rezensionen

"...recommended to all practitioners and researchers in thefield of clinical trials..." ( Biometrics , December 2005)
" ... informative and interesting to read" (Phamaceutical Statistics Volume 5:2)