This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Contemporary Clinical Practice: The Holding Environment Under Assault is devoted to the examination of contemporary social problems and their impact on the clinical process. State-of-the-art psychodynamic theories will be applied to the understanding of how war, terrorism, politics, government regulations, and other environmental problems influence interactions between clinicians and their patients.

It is a turbulent time for STM publishing. With moves towards open access to scientific literature, the future of medical journals is uncertain and unpredictable. This is the only book of its kind to address this problematic issue. Richard Smith, a previous editor of the British Medical Journal for twenty five years and one of the most influential people within medical journals and medicine depicts a compelling picture of medical publishing. Drawn from the author's own extensive and unrivalled experience in medical publishing, Smith provides a refreshingly honest analysis of current and future trends in journal publishing including peer review, ethics in medical publishing, the influence of the pharmaceutical industry as well as that of the mass media, and the risk that money can cloud objectivity in publishing. Full of personal anecdotes and amusing tales, this is a book for everyone, from researcher to patient, author to publisher and editor to reader. The controversial and highly topical nature of this book, will make uncomfortable reading for publishers, researchers, funding bodies and pharmaceutical companies alike making this useful resource for anyone with an interest in medicine or medical journals. Topic covered include: Libel and medical journals; Patients and medical journals; Medical journals and the mass media; Medical journals and pharmaceutical companies: uneasy bedfellows; Editorial independence; misconduct; and accountability; Ethical support and accountability for journals; Peer review: a flawed process and Conflicts of interest: how money clouds objectivity. This is a unique offering by the former BMJ editor- challenging, comprehensive and controversial. This must be the most controversial medical book of the 21st Century John Illman, MJA News Lively, full of anecdote and he [Smith] is brutally honest British Journal of Hospital Medicine ************************************************************************************************* Please note that the reference to Arup Banerjee on page 100 of this book should be to Anjan Banerjee. We apologise to Professor Arup Banerjee for this oversight. *************************************************************************************************

In the past two decades a number of studies have shown that abnormalities in the function and structure of coronary microcirculation can be detected in several cardiovascular diseases. On the basis of the clinical setting in which it occurs, coronary microvascular dysfunction (CMD) can be classified into four types: CMD in the absence of any other cardiac disease; CMD in myocardial diseases; CMD in obstructive epicardial coronary artery disease; and iatrogenic CMD. In some instances CMD represents an epiphenomenon, whereas in others it represents an important marker of risk or may contribute to the pathogenesis of myocardial ischemia, thus becoming a possible therapeutic target. This book provides an update on coronary physiology and a systematic assessment of microvascular abnormalities in cardiovascular diseases, in the hope that it will assist clinicians in prevention, detection and management of CMD in their everyday activity.

Nutrition and Epigenetics presents new information on the action of diet and nutritional determinants in regulating the epigenetic control of gene expression in health and disease. Each chapter gives a unique perspective on a different nutritional or dietary component or group of components, and reveals novel mechanisms by which dietary factors mod

The second edition of this volume provides insight and practical illustrations on how modern statistical concepts and regression methods can be applied in medical prediction problems, including diagnostic and prognostic outcomes. Many advances have been made in statistical approaches towards outcome prediction, but a sensible strategy is needed for model development, validation, and updating, such that prediction models can better support medical practice. There is an increasing need for personalized evidence-based medicine that uses an individualized approach to medical decision-making. In this Big Data era, there is expanded access to large volumes of routinely collected data and an increased number of applications for prediction models, such as targeted early detection of disease and individualized approaches to diagnostic testing and treatment. Clinical Prediction Models presents a practical checklist that needs to be considered for development of a valid prediction model. Steps include preliminary considerations such as dealing with missing values; coding of predictors; selection of main effects and interactions for a multivariable model; estimation of model parameters with shrinkage methods and incorporation of external data; evaluation of performance and usefulness; internal validation; and presentation formatting. The text also addresses common issues that make prediction models suboptimal, such as small sample sizes, exaggerated claims, and poor generalizability. The text is primarily intended for clinical epidemiologists and biostatisticians. Including many case studies and publicly available R code and data sets, the book is also appropriate as a textbook for a graduate course on predictive modeling in diagnosis and prognosis. While practical in nature, the book also provides a philosophical perspective on data analysis in medicine that goes beyond predictive modeling. Updates to this new and expanded edition include: • A discussion of Big Data and its implications for the design of prediction models • Machine learning issues • More simulations with missing ‘y’ values • Extended discussion on between-cohort heterogeneity • Description of ShinyApp • Updated LASSO illustration • New case studies

The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.