For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.
Representing the first book on the topic, this work offers the reader an introduction to the Japanese systems for health technology assessment (HTA) officially introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2016. Policy and guidelines are discussed, with the relevant methods and conditions of cost-effectiveness analysis explained alongside. Numerous instructive examples and exercises, ranging from basic to advanced, impart valuable knowledge and insight on the quantitative methods for economic evaluation, which will appeal to both beginners and experts. This guidebook is authored by Japan’s foremost expert in HTA and pharmacoeconomics, with a view to strengthening the reader’s expertise in value-based healthcare and decision-making. The methods presented are essential to informing regulatory, local and patient decisions; as such, the book is equally recommended to industry and government, as well as academia, and anyone with an interest in Japanese HTA.
A timely work describing how localized hospital-based health technology assessment (HB-HTA) complements general, ‘arms-length’ HTA agency efforts, and what has been the collective global impact of HB-HTA across the globe. While HB-HTA has gained significant momentum over the past few years, expertise in the field, and information on the operation and organization of HB-HTA, has been scattered. This book serves to bring this information together to inform those who are currently working in the field of HTA at the hospital, regional, national or global level. In addition, this book is intended for decision-makers and policy-makers with a stake in determining the uptake and decommissioning of new and established technologies in the hospital setting. HTA has traditionally been performed at the National/Regional level by HTA Agencies, typically linked to governments. Yet hospitals are the main entry door for most health technologies (HTs). Hospital decision-makers must undertake multiple high stakes investment and disinvestment decisions annually for innovative HTs, usually without adequate information. Despite the existence of arms-length HTA Agencies, inadequate information is available to hospital decision-makers either because relevant HTA reports are not yet released at the time of entry of new technologies to the field, or because even when the report exists, the information contained is insufficient to clarify the contextualized informational needs of hospital decision makers. Therefore, there has recently been a rising trend toward hospital-based HTA units and programs. These units/programs complement the work of National/Regional HTA Agencies by providing the key and relevant evidence needed by hospital decision makers in their specific hospital context, and within required decision-making timelines. The emergence of HB-HTA is creating a comprehensive HTA ecosystem across health care levels, which creates better bridges for knowledge translation through relevance and timeliness.
This book provides an introduction to decision analytic cost-effectiveness modelling, giving the theoretical and practical knowledge required to design and implement analyses that meet the methodological standards of health technology assessment organisations. The book guides you through building a decision tree and Markov model and, importantly, shows how the results of cost-effectiveness analyses are interpreted. Given the complex nature of cost-effectiveness modelling and the often unfamiliar language that runs alongside it, we wanted to make this book as accessible as possible whilst still providing a comprehensive, in-depth, practical guide that reflects the state of the art – that includes the most recent developments in cost-effectiveness modelling. Although the nature of cost effectiveness modelling means that some parts are inevitably quite technical, across the 13 chapters we have broken down explanations of theory and methods into bite-sized pieces that you can work through at your own pace; we have provided explanations of terms and methods as we use them. Importantly, the exercises and online workbooks allow you to test your skills and understanding as you go along.
This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
New technologies with the potential to improve the health of populations are continuously being introduced. But not every technological development results in clear health gains. Health technology assessment provides evidence-based information on the coverage and usage of health technologies, enabling them to be evaluated properly and applied to health care efficaciously, promoting the most effective ones while also taking into account organizational, societal and ethical issues. This book reviews the relationship between health technology assessment and policy-making, and examines how to increase the contribution such research makes to policy- and decision-making processes. By communicating the value and potential of health technology assessment to a wider audience, both within and beyond decision-making and health care management, it aims ultimately to contribute to improve the health status of the population through the delivery of optimum health services.
Pathophysiology of Cardiovascular Disease has been divided into four sections that focus on heart dysfunction and its associated characteristics (hypertrophy, cardiomyopathy and failure); vascular dysfunction and disease; ischemic heart disease; and novel therapeutic interventions. This volume is a compendium of different approaches to understanding cardiovascular disease and identifying the proteins, pathways and processes that impact it.
This report addresses the concepts and controversy surrounding health technology assessment in Europe, with a particular focus on selected Member States including Sweden, the Netherlands, Finland, France, Germany and the United Kingdom. It is intended to identify and address current considerations regarding HTA methodological and process issues related to the prioritization and financing of modern health care. In particular, it describes the processes and challenges for identifying and prioritizing assessments; assesses and compares current assessment methods and procedures; and highlights the barriers to effective implementation. The report also ascertains the roles and terms of engagement of key stakeholders, and captures the opportunities and challenges for the use of HTA guidance in general priority-setting, decision-making and health-care provision.
This is the first book to offer a comprehensive guide to involving patients in health technology assessment (HTA). Defining patient involvement as patient participation in the HTA process and research into patient aspects, this book includes detailed explanations of approaches to participation and research, as well as case studies. Patient Involvement in HTA enables researchers, postgraduate students, HTA professionals and experts in the HTA community to study these complementary ways of taking account of patients’ knowledge, experiences, needs and preferences. Part I includes chapters discussing the ethical rationale, terminology, patient-based evidence, participation and patient input. Part II sets out methodology including: Qualitative Evidence Synthesis, Discrete Choice Experiments, Analytical Hierarchy Processes, Ethnographic Fieldwork, Deliberative Methods, Social Media Analysis, Patient-Reported Outcome Measures, patients as collaborative research partners and evaluation. Part III contains 15 case studies setting out current activities by HTA bodies on five continents, health technology developers and patient organisations. Each part includes discussion chapters from leading experts in patient involvement. A final chapter reflects on the need to clearly define the goals for patient involvement within the context of the HTA to identify the optimal approach. With cohesive contributions from more than 80 authors from a variety of disciplines around the globe, it is hoped this book will serve as a catalyst for collaboration to further develop patient involvement to improve HTA. "If you’re not involving patients, you're not doing HTA!" - Dr. Brian O’Rourke, President and CEO of CADTH, Chair of INAHTA
