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

Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. Unlike pharmacological treatments, these have no specific requirements for approval. Consequently, they can be widely proposed in clinical pra

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.

Physicians who choose to serve in public-sector mental healthcare settings and physicians-in-training assigned to public-sector mental health clinics may not be fully prepared for the many roles of the public and community psychiatrist. Public and Community Psychiatry is a concise guide for the resident and early-career psychiatrist called upon to serve in the roles of public-sector clinician, team member, advocate, administrator, and academician. Each chapter includes a concise description of these various roles and responsibilities and offers engaging examples of the public psychiatrist at work, as well as case-based problems typical of those faced by the public psychiatrist. Each chapter also features works of art and literature, usually from the public domain, in order to incorporate the core strengths of medical humanities into the dialogue of public-sector mental healthcare. This book aims to provide a level of support to psychiatrists that fosters their desire, individually and collectively, to serve the poor and the marginalized with grit and determination, and to broadly consider their potential to improve not only their patients' well-being, but also these patients' incorporation into their respective communities.

This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications. Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.

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.

Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.

Behavioral Intervention Research in Hospice and Palliative Care: Building an Evidence Base sets forth research considerations and guidelines to build evidence-based interventions to improve end-of-life care. It is an in-depth introduction to implementation research and showcases how a clinical need is identified to inform an intervention. The book extensively examines the various phases of intervention research, including design, implementation, evaluation, dissemination and translation. The book focuses on methodological, ethical and practical issues. The science behind the quality of hospice and palliative care lags behind that of traditional medical practice, despite the continuous growth of palliative care interdisciplinary teams. Researching, developing and testing strategies is essential to advancing the effectiveness and value of this care. - Informs readers how to conduct intervention research toward identifying best care - Advises readers on design, implementation and evaluation of research - Provides step-by-step templates to develop an intervention study - Includes mock protocols from successful intervention trials - Synthesizes lessons learned by established intervention researchers in hospice and palliative care

This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.