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"This book presents a system of critical appraisal applicable to clinical, epidemiological and public health studies and to many other fields. It assumes no prior knowledge. The methods are relevant to students, practitioners and policymakers. The book shows how to assess if the results of one study or of many studies show a causal effect. The book discusses study designs: randomised and non-randomised trials, cohort studies, case-control studies, and surveys, showing the presentation of results including person-time and survival analysis, and issues in the selection of subjects. The system shows how to describe a study, how to detect and assess selection biases, observation bias, confounding, and chance variation, and how to assess internal validity and external validity (generalisability). Statistical methods are presented assuming no previous knowledge, and showing applications to each study design. Positive features of causation including strength, dose-response, and consistency are discussed. The book shows how to do systematic reviews and meta-analyses, and discusses publication bias. Systems of assessing all evidence are shown, leading to a general method of critical appraisal based on 20 key questions in five groups, which can be applied to any type of study or any topic. Six chapters show the application of this method to randomised trials, prospective and retrospective cohort studies, and case-control studies. An appendix summarises key statistical methods, each with a worked example. Each main chapter has self-test questions, with answers provided."

"Summary:Critical appraisal is now accepted as central to the development of rational health care and evidence-based medicine, by applying it to questions of aetiology, clinical therapy, and health care management. The reader will learn how to assess the strengths and weaknesses of new studies, and how to conduct their own studies"

"This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives."

"The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically–relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, Cardiovascular clinical trials : putting the evidence into practice, provides a succinct overview of recent major clinical trials, the gold standard for all medical treatment, across all the major cardiovascular subspecialties, to ensure you’re up–to–date on the most critical findings Guides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology."

"This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials."