In 1998, health expenditures in the United States accounted for 12.9% of national income-the highest share of income devoted to health in the developed world. The United States also spends more on medical research than any other country-in 2000, the federal government dedicated $18.4 billion to it, compared with only $3.7 billion for the entire European Union. In this book, leading health economists ask whether we are getting our money's worth. From an economic perspective, they find, the answer is a resounding "yes": in fact, considering the extraordinary value of improvements to health, we may even be spending too little on medical research. The evidence these papers present and the conclusions they reach are both surprising and convincing: that growth in longevity since 1950 has been as valuable as growth in all other forms of consumption combined; that medical advances producing 10% reductions in mortality from cancer and heart disease alone would add roughly $10 trillion-a year's GDP-to the national wealth; or that the average new drug approved by the FDA yields benefits worth many times its cost of development. The papers in this book are packed with these and many other surprising revelations, their sophisticated analysis persuasively demonstrating the massive economic benefits we can gain from investments in medical research. For anyone concerned about the cost and the value of such research-from policy makers to health care professionals and economists-this will be a landmark book.

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.

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.

It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics. It can aid companies seeking to make claims about the cost-effectiveness of their product, as well as allowing early consideration of the economic value of therapies which may be important to improving initial adoption decisions. It is also vital for addressing the requirements of regulatory bodies. Economic Evaluation in Clinical Trials provides practical advice on how to conduct cost-effectiveness analyses in controlled trials of medical therapies. This new edition has been extensively rewritten and revised; topics discussed range from design issues such as the types of services that should be measured and price weights, to assessment of quality-adjusted life years. Illustrative materials, case histories and worked examples are included to encourage the reader to apply the methods discussed. These exercises are supported with datasets, programmes and solutions made available online.

This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

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.

In Spirituality and Health Research: Methods, Measurement, Statistics, and Resources, Dr. Harold G. Koenig leads a comprehensive overview of this complex subject. Dr. Koenig is one of the world’s leading authorities on the relationship between spirituality and health, and a leading researcher on the topic. As such, he is distinctively qualified to author such a book. This unique source of information on how to conduct research on religion, spirituality, and health includes practical information that goes well beyond what is typically taught in most undergraduate, graduate, or even post-doctoral level courses. This volume reviews what research has been done, discusses the strengths and limitations of that research, provides a research agenda for the future that describes the most important studies that need to be done to advance the field, and describes how to actually conduct that research (design, statistical analysis, and publication of results). It also covers practical matters such as how to write fundable grants to support the research, where to find sources of funding support for research in this area, and what can be done even if the researcher has little or no funding support. The information gathered together here, which has been reviewed for accuracy and comprehensiveness by research design and statistical experts, has been acquired during a span of over twenty-five years that Dr. Koenig spent conducting research, reviewing others’ research, reviewing research grants, and interacting with mainstream biomedical researchers both within and outside the field of spirituality and health. The material is presented in an easy to read and readily accessible form that will benefit researchers at almost any level of training and experience.

It has become trite to observe that increases in health care costs have become unsustainable. How best for policy to address these increases, however, depends in part on the degree to which they represent increases in the real quantity of medical services as opposed to increased unit prices of existing services. And an even more fundamental question is the degree to which the increased spending actually has purchased improved health. Accounting for Health and Health Care addresses both these issues. The government agencies responsible for measuring unit prices for medical services have taken steps in recent years that have greatly improved the accuracy of those measures. Nonetheless, this book has several recommendations aimed at further improving the price indices.

Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.