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Tutorials in Biostatistics, Volume 1, Statistical Methods in Clinical Studies

Tutorials in Biostatistics, Volume 1, Statistical Methods in Clinical Studies

Ralph B. D'Agostino (Editor)

ISBN: 978-0-470-02366-2

Sep 2005

466 pages



The Tutorials in Biostatistics have become a very popular feature of the prestigious Wiley journal, Statistics in Medicine (SIM). The introductory style and practical focus make them accessible to a wide audience including medical practitioners with limited statistical knowledge.   This book represents the first of two volumes presenting the best tutorials published in SIM, focusing on statistical methods in clinical studies. Topics include the design and analysis of clinical trials, epidemiology, survival analysis, and data monitoring. Each tutorial is focused on a medical problem, has been fully peer-reviewed and edited, and is authored by leading researchers in biostatistics.   Many articles include an appendix on the latest developments since publication in the journal and additional references.

This will appeal to statisticians working in medical research, as well as statistically-minded clinicians, biologists, epidemiologists and geneticists. It will also appeal to graduate students of biostatistics.


Preface to Volume 1.


1.1 Epidemiology.

Computing Estimates of Incidence, including Lifetime Risk: Alzheimer’s Disease in the Framingham Study. The Practical Incidence Estimators (PIE) Macro. (Alexa Beiser et al).

The Applications of Capture-Recapture Models to Epidemiological Data. (Anne Chao et al).

1.2 Adjustment Methods.

Propensity Score Methods for Bias Reduction in the Comparison of a Treatment to a Non-Randomized Control Group (Ralph B. D’Agostino Jr.).

1.3 Agreement Statistics.

Kappa Coefficients in Medical Research (Helen Chmura Kraemer et al).

1.4 Survival Models.

Survival Analysis in Observational Studies (Kate Bull and David J. Spiegelhalter).

Methods for Interval-Censored Data (Jane C. Lindsey and Louise M. Ryan).

Analysis of Binary Outcomes in Longitudinal Studies Using Weighted Estimating Equations and Discrete-Time Survival Methods: Prevalence and Incidence of Smoking in an Adolescent Cohort (John B. Carlin et al).


2.1 Prognostic Variables.

Categorizing a Prognostic Variable: Review of Methods, Code for Easy Implementation and Applications to Decision-Making about Cancer Treatments (Madhu Mazumdar and Jill R. Glassman).

2.2 Prognostic/Clinical Prediction Models.

Development of Health Risk Appraisal Functions in the Presence of Multiple Indicators: The Framingham Study Nursing Home Institutionalization Model (R. B. D’Agostino et al).

Multivariable Prognostic Models: Issues in Developing Models, Evaluating Assumptions and Adequacy, and Measuring and Reducing Errors (Frank E. Harrell Jr et al).

Development of a Clinical Prediction Model for an Ordinal Outcome: The World Health Organization Multicentre Study of Clinical Signs and Etiological Agents of Pneumonia, Sepsis and Meningitis in Young Infants (Frank E. Harrell Jr. et al).

Using Observational Data to Estimate Prognosis: An Example Using a Coronary Artery Disease Registry (Elizabeth R. DeLong et al).


3.1 Design.

Designing Studies for Dose Response (Weng Kee Wong and Peter A. Lachenbruch.).

3.2 Monitoring.

Bayesian Data Monitoring in Clinical Trials (Peter M. Fayers et al).

3.3 Analysis.

Longitudinal Data Analysis (Repeated Measures) in Clinical Trials (Paul S. Albert).

Repeated Measures in Clinical Trials: Simple Strategies for Analysis Using Summary Measures (Stephen Senn et al).

Strategies for Comparing Treatments on a Binary Response with Multi-Centre Data (Alan Agresti, and Jonathan Hartzel).

A Review of Tests for Detecting a Monotone Dose–Response Relationship with Ordinal Response Data (Christy Chuang-Stein and Alan Agresti).

"The articles within the volume are self-contained, well written, and accessible to readers of widely ranging backgrounds. These volumes should be extremely valuable to practitioners…" (Journal of the American Statistical Association, December 2005)

"The biostatistical practitioners who use a broad range of statistical methods would definitely find beneficial and useful to have 'Tutorials in Biostatistics'…" (E-STREAMS, September 2005)

“ …this book gives a well-written and concise overview of selected biostatistical subjects.”  (Journal of the Royal Statistical Society, Series A, June 2005)