Statistical Methods in Healthcare

1. Auflage 2012
ISBN: 978-0-470-67015-6
Verlag: Wiley

Buch, Englisch, 520 Seiten, Format (B × H): 175 mm x 249 mm, Gewicht: 907 g

In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed.

With a focus on finding solutions to these challenges, this book:

* Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development.
* Offers a broad coverage of standards and established methods through leading edge techniques.
* Uses an integrated, case-study based approach, with focus on applications.
* Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance.
* Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes.
* Addresses the use of modern Statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision.

Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.

Autoren/Hrsg.

Faltin, Frederick W

Faltin, Frederick

Kenett, Ron S

Kenett, Ron

Ruggeri, Fabrizio

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik
• Mathematik | Informatik Mathematik Stochastik Mathematische Statistik

Inhaltsverzeichnis

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

Synopsis 3

References 19

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

Synopsis 22

References 54

Further Reading 54

3 Pharmacometrics in Drug Development 56
Serge Guzy and Robert Bauer

Synopsis 56

4 Interactive Clinical Trial Design 78
Zvia Agur

Synopsis 78

Adaptive Clinical Trial Design Methods 99

Acknowledgements 100

References 100

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

Synopsis 103

References 120

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

Synopsis 122

References 152

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

Synopsis 155

References 166

Part Two STATISTICS IN OUTCOMES ANALYSIS

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

Synopsis 169

References 182

9 Disease Mapping 185
Annibale Biggeri and Dolores Catelan

Synopsis 185

References 210

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

Synopsis 219

References 228

11 Meta-analysis 230
Eva Negri

Synopsis 230

References 247

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

Synopsis 253

Acknowledgements 265

References 265

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

Synopsis 268

References 285

14 Six Sigma in Healthcare 286
Shirley Y. Coleman

Synopsis 286

References 307

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

Synopsis 309

Appendix A 328

15.A.1 The EWMA Chart 328

15.A.2 Logistic Regression 329

15.A.3 Autocovariance and Autocorrelation 330

Acknowledgements 330

References 330

Part Four APPLICATIONS TO HEALTHCARE POLICY AND IMPLEMENTATION

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

Synopsis 335

Acknowledgement 352

References 352

17 Statistical Issues in Vaccine Safety Evaluation 353
Patrick Musonda

Synopsis 353

References 362

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

Synopsis 365

References 383

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

Synopsis 386

References 403

Part Five APPLICATIONS TO HEALTHCARE MANAGEMENT

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

Synopsis 407

References 425

21 Simulation for Improving Healthcare Service Management 426
Anne Shade

Synopsis 426

References 444

22 Statistical Issues in Insurance/payor Processes 445
Melissa Popkoski

Synopsis 445

Reference 455

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

Synopsis 456

References 475

Index 481