A modern definition of health goes beyond the biological dimension to encompass human functionality and well-being. Quality of life is one of the most popular health-related concepts and simultaneously reflects several dimensions of individual health. Health-related quality of life (HRQoL) is taken to include physical, psychological, and social aspects of positive well-being as well as negative effects of illness, treatment, and infirmity. Quality of life outcomes are now considered an important indicator of the success of both diagnostic and therapeutic procedures. In this book, recognized experts discuss the findings of various studies, including their own, regarding HRQoL in patients with cardiovascular diseases. The impact of the newest forms of medical treatment on well-being is considered in patients with arterial hypertension, coronary artery disease, heart failure, arrhythmias, and stroke as well as in patients who have undergone interventional procedures or have implantable cardiac devices. By summarizing established facts and presenting new data, this book will be an invaluable source of information for all practitioners in the field.

After 13 years there are new areas to discuss and more recent trials to be included. Good clinical practice; evaluation of quality of life; measurement of the benefit: risk comparison; determination of cost- effectiveness and cost utility; stopping rules for trials; meta-analysis and subgroup analysis are all new sections. The references are expanded from 305 to 512 and include the recent advances in trial design, such as the n-of-1 trials and megatrials, and up-to-date examples to illustrate the points made in the 20 chapters.

Bradford Hill has defined a clinical trial as "A carefully and ethically designed experiment with the aim of answering some precisely framed question" 1]. This definition specifies a careful design and requires the provision of adequate controls. Random allocation of treatments to subjects is important to ensure is entitled that the treated and control groups are similar. Therefore this book Randomised Controlled Clinical Trials. We can define a randomised controlled trial by rewriting Bradford Hill's definition as follows, "A carefully and ethi cally designed experiment which includes the provision of adequate and ap propriate controls by a process of randomisation, so that precisely framed questions can be answered. " I am a firm advocate ofRandomised Controlled Clinical Trials but intend to give a balanced view of the advantages and disadvantages of these ethical experiments. This book is directed primarily at the medical research worker, although certain chapters may find a wider application. When discussing a randomised controlled trial, it is neither practicable nor desirable to divorce theory from practice, however the first ten chapters con centrate mainly on theory, and the remainder focus on practice. The segment on trial design is followed by sections on writing the protocol, designing the forms, conducting the trial, and analysing the results. This book is meant to serve both as a reference manual and a practical guide to the design and performance of a trial."

After 13 years there are new areas to discuss and more recent trials to be included. Good clinical practice; evaluation of quality of life; measurement of the benefit:risk comparison; determination of cost- effectiveness and cost utility; stopping rules for trials; meta-analysis and subgroup analysis are all new sections. The references are expanded from 305 to 512 and include the recent advances in trial design, such as the n-of-1 trials and megatrials, and up-to-date examples to illustrate the points made in the 20 chapters.