Statistical Methods in Healthcare

Foreword xix

Preface xxi

Editors xxiii

Contributors xxv

Part One STATISTICS IN THE DEVELOPMENT OF PHARMACEUTICAL PRODUCTS

1 Statistical Aspects in ICH, FDA and EMA Guidelines 3
Allan Sampson and Ron S. Kenett

2 Statistical Methods in Clinical Trials 22
Telba Irony, Caiyan Li and Phyllis Silverman

3 Pharmacometrics in Drug Development 56
Serge Guzy and Robert Bauer

4 Interactive Clinical Trial Design 78
Zvia Agur

5 Stage-wise Clinical Trial Experiments in Phases I, II and III 103
Shelemyahu Zacks

6 Risk Management in Drug Manufacturing and Healthcare 122
Ron S. Kenett

7 The Twenty-first Century Challenges in Drug Development 155
Yafit Stark

Part Two STATISTICS IN OUTCOMES ANALYSIS

8 The Issue of Bias in Combined Modelling and Monitoring of Health Outcomes 169
Olivia A. J. Grigg

9 Disease Mapping 185
Annibale Biggeri and Dolores Catelan

10 Process Indicators and Outcome Measures in the Treatment of Acute Myocardial Infarction Patients 219
Alessandra Guglielmi, Francesca Ieva, Anna Maria Paganoni and Fabrizio Ruggeri

11 Meta-analysis 230
Eva Negri

Part Three STATISTICAL PROCESS CONTROL IN HEALTHCARE

12 The Use of Control Charts in Healthcare 253
William H. Woodall, Benjamin M. Adams and James C. Benneyan

13 Common Challenges and Pitfalls Using SPC in Healthcare 268
Victoria Jordan and James C. Benneyan

14 Six Sigma in Healthcare 286
Shirley Y. Coleman

15 Statistical Process Control in Clinical Medicine 309
Per Winkel and Nien Fan Zhang

Part Four APPLICATIONS TO HEALTHCARE POLICY AND IMPLEMENTATION

16 Modeling Kidney Allocation: A Data-driven Optimization Approach 335
Inbal Yahav

17 Statistical Issues in Vaccine Safety Evaluation 353
Patrick Musonda

18 Statistical Methods for Healthcare Economic Evaluation 365
Caterina Conigliani, Andrea Manca and Andrea Tancredi

19 Costing and Performance in Healthcare Management 386
Rosanna Tarricone and Aleksandra Torbica

Part Five APPLICATIONS TO HEALTHCARE MANAGEMENT

20 Statistical Issues in Healthcare Facilities Management 407
Daniel P. O'Neill and Anja Drescher

21 Simulation for Improving Healthcare Service Management 426
Anne Shade

22 Statistical Issues in Insurance/payor Processes 445
Melissa Popkoski

23 Quality of Electronic Medical Records 456
Dario Gregori and Paola Berchialla

References 475

Index 481