Pragmatic Randomized Clinical Trials Using Primary Data Collection And Electronic Health Records

Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed. This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) Encompasses analytic aspects of such trials Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records

This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Prevention Practice in Primary Care systematically explores state-of-the-art practical approaches to effective prevention in primary care. Guided by theory and evidence, the book reviews approaches to risk factor identification and modification for the major causes of mortality in adulthood, including cancer, stroke, and cardiovascular disease.

Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

Our world is facing unprecedented technological development, which affects all the sectors of society. The 4th industrial revolution has brought numerous advances that are currently integrated in our daily life, including artificial intelligence (A.I.), internet of things (IoT), genetic engineering, 3D-printing and robotics. The health care sector is one of the most impacted by these technologies of the so-called digital era. From the simple advent of medical records to robotic surgery, health care has significantly changed from the XX to XXI century and is constantly changing, incorporating novel technologies. Nephrology is itself an innovative branch of medicine, created as a discipline in the 1960s, with breakthrough inventions, such as the dialysis machine, which made it possible to prolong life of those who suffer from chronic kidney disease; kidney transplant, with point-of-care immunosuppression that favours maintenance of kidney allografts for long years; kidney biopsy, which made it possible to discover the mysteries of glomerulonephritis and nephropathology. Novel technologies, such as A.I., IoT, robotics, stem cells, 3D-printing, mHealth, eHealth and several others are starting to be applied in nephrology, with promising results. It is possible that a great part of these technologies will become routinely available in clinical practice, and the burden of kidney diseases will significantly decrease once prevention, prediction, detection, monitoring and treatment of kidney diseases are more precise, with patients taking part in the process and becoming more and more connected. This book gathers essential information on the technologies that have been applied in nephrology and that can be applied in the future, with real possibilities of improving the care of kidney diseases. At first glance, this work is directed to the entire nephrology community and all the healthcare professionals that deal with kidney diseases. Researchers from different fields, not directly linked to nephrology, may also be interested in the book since many of the topics presented are related to other areas and serve as examples of their uses in medicine, such as artificial intelligence, robotics, and big data. Finally, the content provides an important resource to medical students, discussing technologies that will certainly be integrated in their professional practice.

In an age when electronic health records (EHRs) are an increasingly important source of data, this essential textbook provides both practical and theoretical guidance to researchers conducting epidemiological or clinical analysis through EHRs. Split into three parts, the book covers the research journey from start to finish. Part 1 focuses on the challenges inherent when working with EHRs, from access to data management, and raising issues such as completeness and accuracy which impact the validity of any research project. Part 2 examines the core research process itself, with chapters on research design, sampling, and analysis, as well as emerging methodological techniques. Part 3 demonstrates how EHR research can be made meaningful, from presentation to publication, and includes how findings can be applied to real-world issues of public health. Supported by case studies throughout, and applicable across a range of research software programs (including R, SPSS, and SAS), this is the ideal text for students and researchers engaging with EHRs across epidemiological and clinical research.

Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs