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Dynamic Treatment Regimes: Statistical Methods for Precision Medicine provides a comprehensive introduction to statistical methodology for the evaluation and discovery of dynamic treatment regimes from data. Researchers and graduate students in statistics, data science, and related quantitative disciplines with a background in probability and statistical inference and popular statistical modeling techniques will be prepared for further study of this rapidly evolving field. A dynamic treatment regime is a set of sequential decision rules, each corresponding to a key decision point in a disease or disorder process, where each rule takes as input patient information and returns the treatment option he or she should receive. Thus, a treatment regime formalizes how a clinician synthesizes patient information and selects treatments in practice. Treatment regimes are of obvious relevance to precision medicine, which involves tailoring treatment selection to patient characteristics in an evidence-based way. Of critical importance to precision medicine is estimation of an optimal treatment regime, one that, if used to select treatments for the patient population, would lead to the most beneficial outcome on average. Key methods for estimation of an optimal treatment regime from data are motivated and described in detail. A dedicated companion website presents full accounts of application of the methods using a comprehensive R package developed by the authors. The authors’ website www.dtr-book.com includes updates, corrections, new papers, and links to useful websites.
Statistical Methods for Dynamic Treatment Regimes shares state of the art of statistical methods developed to address questions of estimation and inference for dynamic treatment regimes, a branch of personalized medicine. This volume demonstrates these methods with their conceptual underpinnings and illustration through analysis of real and simulated data. These methods are immediately applicable to the practice of personalized medicine, which is a medical paradigm that emphasizes the systematic use of individual patient information to optimize patient health care. This is the first single source to provide an overview of methodology and results gathered from journals, proceedings, and technical reports with the goal of orienting researchers to the field. The first chapter establishes context for the statistical reader in the landscape of personalized medicine. Readers need only have familiarity with elementary calculus, linear algebra, and basic large-sample theory to use this text. Throughout the text, authors direct readers to available code or packages in different statistical languages to facilitate implementation. In cases where code does not already exist, the authors provide analytic approaches in sufficient detail that any researcher with knowledge of statistical programming could implement the methods from scratch. This will be an important volume for a wide range of researchers, including statisticians, epidemiologists, medical researchers, and machine learning researchers interested in medical applications. Advanced graduate students in statistics and biostatistics will also find material in Statistical Methods for Dynamic Treatment Regimes to be a critical part of their studies.
The Bipolar Book covers not only clinical and pathophysiological matters, but also technical aspects of the evidence accumulation for treatment of bipolar disorder. This approach brings in stimulating discussions on available data originating from current randomized controlled trials with specified considerations of bipolar mania, depression, and prophylaxis by providing accompanying recommendations for an improved evidence formation and synthesis. The Bipolar Book provides a clinician-friendly view of debatable issues on the existing randomized trials based evidence and the ways of improving them by respecting distinctive fluctuating pattern of bipolar disorder.
There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others
Personalized medicine is a medical paradigm that emphasizes systematic use of individual patient information to optimize that patient's health care, particularly in managing chronic conditions and treating cancer. In the statistical literature, sequential decision making is known as an adaptive treatment strategy (ATS) or a dynamic treatment regime (DTR). The field of DTRs emerges at the interface of statistics, machine learning, and biomedical science to provide a data-driven framework for precision medicine. The authors provide a learning-by-seeing approach to the development of ATSs, aimed at a broad audience of health researchers. All estimation procedures used are described in sufficient heuristic and technical detail so that less quantitative readers can understand the broad principles underlying the approaches. At the same time, more quantitative readers can implement these practices. This book provides the most up-to-date summary of the current state of the statistical research in personalized medicine; contains chapters by leaders in the area from both the statistics and computer sciences fields; and also contains a range of practical advice, introductory and expository materials, and case studies.
This book examines recent developments in Operations Management, and focuses on four major application areas: dynamic pricing, assortment optimization, supply chain and inventory management, and healthcare operations. Data-driven optimization in which real-time input of data is being used to simultaneously learn the (true) underlying model of a system and optimize its performance, is becoming increasingly important in the last few years, especially with the rise of Big Data.
This issue of Clinics in Plastic Surgery, guest edited by Drs. Charles Scott Hultman and Michael W. Neumeister, is devoted to Burn Care: Reconstruction, Rehabilitation, and Recovery. Articles in this issue include: Role of Physiatry in the Management of Chronic Pain; New Concepts in OT, PT, RT: Focus on Functional Cutaneous Units; Rehabilitation in the Acute vs Outpatient Setting; Role of Anesthesia in the Management of Chronic Pain; Pathophysiology and Treatment of Hypertophic Burn Scars; Laser Modulation of Hypertrophic Scars; Fat Grafting for Burn, Traumatic, and Surgical Scars; Peripheral Neuropathy and Nerve Compression Syndromes; New Frontiers in Skin Grafting: The Painless, Scarless Donor Site; Tissue Rearrangements: The Power of the Z-pasty; Prefabricated Flaps for Burn Reconstruction; Microsurgery: Timing and Indications in Burn Patients; Hand Reconstruction: Functional Results; Head and Neck Reconstruction; Vascularized Composite Allotransplantation: Hand and Face; Ethics in the Setting of the Burned Patient; Psychosocial-spiritual Needs of Burn Patients; Aftercare, Survivorship, and Peer Support; Global Health Initiatives, Public Policy, and International Missions;Outcomes: Scar Scales, Physiologic Metrics, Measuring QOL; and Big Data: EBM and Best Practices.
This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.