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Randomized Clinical Trials Of Nonpharmacological Treatments

Author: Isabelle Boutron
Publisher: CRC Press
ISBN: 1420088025
Size: 33.89 MB
Format: PDF
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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 practice but may not have been adequately evaluated. This situation is an important barrier for the evaluation of the beneficial effects of these treatments and the conduct of clinical trials. Randomized Clinical Trials of Nonpharmacologic Treatments focuses on the methods for assessing nonpharmacological treatments, highlighting specific issues and trial design. Features: Chapters written by international experts in the field Highlights specific issues in assessing nonpharmacological treatments in trials including: how to overcome the difficulties of blinding patients, care providers, and outcome assessors the complexity of the intervention, the learning curve, and the clustering effect placebos that can be used issues of assessing harm and assessing the applicability of trials Presents a variety of trial designs for nonpharmacological treatments—including cluster randomized controlled trials, expertise-based trials, pragmatic trials, and nonrandomized trials. Provides several examples of the planning, conduct, analyses, and reporting of trials in different fields, including surgery, technical interventions, medical devices, rehabilitation, psychotherapy, and behavioral interventions. Providing practical examples that underline these issues and solutions, this book is one of the first to exclusively explore this topic, discussing various categories of treatments, from surgical procedures to psychotherapy.

Field Trials Of Health Interventions

Author: Richard H. Morrow
Publisher: Oxford University Press, USA
ISBN: 0198732864
Size: 53.32 MB
Format: PDF
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Before new interventions can be used in disease control programmes, it is essential that they are carefully evaluated in "field trials", which may be complex and expensive undertakings. Descriptions of the detailed procedures and methods used in trials that have been conducted in the past have generally not been published. As a consequence, those planning such trials have few guidelines available and little access to previously accumulated knowledge. In this book the practical issues of trial design and conduct are discussed fully and in sufficient detail for the text to be used as a "toolbox" by field investigators. The toolbox has now been extensively tested through use of the first two editions and this third edition is a comprehensive revision, incorporating the many developments that have taken place with respect to trials since 1996 and involving more than 30 contributors. Most of the chapters have been extensively revised and 7 new chapters have been added.

Textbook Of Clinical Trials

Author: David Machin
Publisher: John Wiley & Sons
ISBN: 0470010150
Size: 29.59 MB
Format: PDF
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Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

Pain Management And The Opioid Epidemic

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459540
Size: 12.74 MB
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Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Clinical Trials Design In Operative And Non Operative Invasive Procedures

Author: Kamal M.F. Itani
Publisher: Springer
ISBN: 3319538772
Size: 18.52 MB
Format: PDF, Docs
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The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists

Medical Uses Of Statistics

Author: John C. Bailar
Publisher: John Wiley & Sons
ISBN: 1118211189
Size: 46.76 MB
Format: PDF
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A new edition of the classic guide to the use of statistics in medicine, featuring examples from articles in the New England Journal of Medicine Medical Uses of Statistics has served as one of the most influential works on the subject for physicians, physicians-in-training, and a myriad of healthcare experts who need a clear idea of the proper application of statistical techniques in clinical studies as well as the implications of their interpretation for clinical practice. This Third Edition maintains the focus on the critical ideas, rather than the mechanics, to give practitioners and students the resources they need to understand the statistical methods they encounter in modern medical literature. Bringing together contributions from more than two dozen distinguished statisticians and medical doctors, this volume stresses the underlying concepts in areas such as randomized trials, survival analysis, genetics, linear regression, meta-analysis, and risk analysis. The Third Edition includes: Numerous examples based on studies taken directly from the pages of the New England Journal of Medicine Two added chapters on statistics in genetics Two new chapters on the application of statistical methods to studies in epidemiology New chapters on analyses of randomized trials, linear regression, categorical data analysis, meta-analysis, subgroup analyses, and risk analysis Updated chapters on statistical thinking, crossover designs, p-values, survival analysis, and reporting research results A focus on helping readers to critically interpret published results of clinical research Medical Uses of Statistics, Third Edition is a valuable resource for researchers and physicians working in any health-related field. It is also an excellent supplemental book for courses on medicine, biostatistics, and clinical research at the upper-undergraduate and graduate levels. You can also visit the New England Journal of Medicine website for related information.

Introduction To Public Health For Chiropractors

Author: Michael T. Haneline
Publisher: Jones & Bartlett Learning
ISBN: 0763758221
Size: 20.59 MB
Format: PDF, Docs
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Public health is of concern to practicing chiropractors, as well as chiropractic students. The vast majority of chiropractors utilize public health concepts every day as an integral part of patient care. For instance, they give advice on risk factors that should be avoided and protective factors to be added by their patients to enhance healing and prevent illness. Pubic health is also part of the curriculum at all chiropractic colleges and is tested by the National Board. No public health textbooks are available that are specifically designed for the chiropractor. Consequently, college instructors are forced to make-do with class notes and generic texts that do not address the specific issues relevant to chiropractic. This book will not only be of interest to chiropractic students, but also practicing chiropractors because it will provide information they can utilize to provide better care by positively intervening with their patients and their communities regarding public health matters.

Strategies To Reduce Sodium Intake In The United States

Author: Committee on Strategies to Reduce Sodium Intake
Publisher: National Academies Press
ISBN: 0309148057
Size: 43.48 MB
Format: PDF, Kindle
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Reducing the intake of sodium is an important public health goal for Americans. Since the 1970s, an array of public health interventions and national dietary guidelines has sought to reduce sodium intake. However, the U.S. population still consumes more sodium than is recommended, placing individuals at risk for diseases related to elevated blood pressure. Strategies to Reduce Sodium Intake in the United States evaluates and makes recommendations about strategies that could be implemented to reduce dietary sodium intake to levels recommended by the Dietary Guidelines for Americans. The book reviews past and ongoing efforts to reduce the sodium content of the food supply and to motivate consumers to change behavior. Based on past lessons learned, the book makes recommendations for future initiatives. It is an excellent resource for federal and state public health officials, the processed food and food service industries, health care professionals, consumer advocacy groups, and academic researchers.

Pharmaceutical Statistics Using Sas

Author: Alex Dmitrienko
Publisher: SAS Institute
ISBN: 1599943573
Size: 66.99 MB
Format: PDF, Docs
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Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.