The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials

Author: National Research Council

Publisher: National Academies Press

Published: 2010-12-21

Total Pages: 163

ISBN-13: 030918651X

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Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.


Reducing Risks for Mental Disorders

Reducing Risks for Mental Disorders

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1994-01-01

Total Pages: 636

ISBN-13: 0309049393

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The understanding of how to reduce risk factors for mental disorders has expanded remarkably as a result of recent scientific advances. This study, mandated by Congress, reviews those advances in the context of current research and provides a targeted definition of prevention and a conceptual framework that emphasizes risk reduction. Highlighting opportunities for and barriers to interventions, the book draws on successful models for the prevention of cardiovascular disease, injuries, and smoking. In addition, it reviews the risk factors associated with Alzheimer's disease, schizophrenia, alcohol abuse and dependence, depressive disorders, and conduct disorders and evaluates current illustrative prevention programs. The models and examination provide a framework for the design, application, and evaluation of interventions intended to prevent mental disorders and the transfer of knowledge about prevention from research to clinical practice. The book presents a focused research agenda, with recommendations on how to develop effective intervention programs, create a cadre of prevention researchers, and improve coordination among federal agencies.


Relieving Pain in America

Relieving Pain in America

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-10-26

Total Pages: 383

ISBN-13: 030921484X

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Chronic pain costs the nation up to $635 billion each year in medical treatment and lost productivity. The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In this report, the IOM offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. The IOM recommends that HHS develop a comprehensive plan with specific goals, actions, and timeframes. Better data are needed to help shape efforts, especially on the groups of people currently underdiagnosed and undertreated, and the IOM encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. Because pain varies from patient to patient, healthcare providers should increasingly aim at tailoring pain care to each person's experience, and self-management of pain should be promoted. In addition, because there are major gaps in knowledge about pain across health care and society alike, the IOM recommends that federal agencies and other stakeholders redesign education programs to bridge these gaps. Pain is a major driver for visits to physicians, a major reason for taking medications, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain in human lives, dollars, and social consequences, relieving pain should be a national priority.


Field Trials of Health Interventions

Field Trials of Health Interventions

Author: Peter G. Smith

Publisher:

Published: 2015

Total Pages: 479

ISBN-13: 0198732864

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This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.


Nutrition in the Prevention and Treatment of Disease

Nutrition in the Prevention and Treatment of Disease

Author: Ann M. Coulston

Publisher: Academic Press

Published: 2017-04-28

Total Pages: 1075

ISBN-13: 0128029471

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Nutrition in the Prevention and Treatment of Disease, Fourth Edition, is a compilation of current knowledge in clinical nutrition and an overview of the rationale and science base of its application to practice in the prevention and treatment of disease. In its fourth edition, this text continues the tradition of incorporating new discoveries and methods related to this important area of research Generating and analyzing data that summarize dietary intake and its association with disease are valuable tasks in treating disease and developing disease prevention strategies. Well-founded medical nutrition therapies can minimize disease development and related complications. Providing scientifically sound, creative, and effective nutrition interventions is both challenging and rewarding. - Two new chapters on metabolomics and translational research, which have come to be used in nutrition research in recent years. The new areas of study are discussed with the perspective that the application of the scientific method is by definition an evolutionary process. - A new chapter on Genetics and Diabetes which reviews the latest research on causal genetic variants and biological mechanisms responsible for the disease, and explores potential interactions with environmental factors such as diet and lifestyle. - Includes all major "omics" – the exposome, metabolomics, genomics, and the gut microbiome. - Expands the microbiota portions to reflect complexity of diet on gut microbial ecology, metabolism and health


The CAPRISA Clinical Trials: HIV Treatment and Prevention

The CAPRISA Clinical Trials: HIV Treatment and Prevention

Author: Quarraisha Abdool Karim

Publisher: Springer

Published: 2018-04-29

Total Pages: 243

ISBN-13: 9783319837567

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Since its inception 14 years ago, CAPRISA has conducted numerous clinical studies that have influenced international TB-HIV treatment guidelines as well as HIV prevention through innovations in the microbicide and vaccine fields. This book provides a historical account of how each of CAPRISA’s high impact studies was created, developed, implemented, analysed and communicated. In doing so, the reader is taken on a journey that provides glimpses into the genesis of research ideas and how this ultimately leads to a range of HIV prevention and treatment studies that have impacted the global response to the HIV and TB epidemics. Comprised of 5 sections, the book details the following: HIV epidemic in South Africa and the establishment of a research centre to undertake clinical, epidemiological and laboratory research on HIV. CAPRISA’s clinical trials on HIV and HSV-2 prevention. These studies investigated the impact of tenofovir gel as topical antiretroviral pre-exposure prophylaxis (PrEP), implementation of topical PrEP through family planning clinics, conditional cash incentives for HIV prevention, HIV vaccines, and passive immunisation with broadly neutralising antibodies. CAPRISA’s research on the treatment of HIV and TB co-infection. A review of the major scientific findings from the CAPRISA studies on acute infection and genital mucosal immunology. Essential support activities for the conduct of clinical trials, including research laboratories and pharmacies, as well as establishing effective communication and sustainable structures for community engagement to maintain effective and respectful partnerships with participating communities. The book concludes with a chapter about the challenges facing future HIV prevention and treatment trials. The CAPRISA Clinical Trials: HIV Treatment and Prevention is a resource for undergraduate and postgraduate students, health care providers, doctors, decision-makers and researchers who are seeking guidance and insights on clinical trials – their creation, conduct and impact.


Polyphenols: Prevention and Treatment of Human Disease

Polyphenols: Prevention and Treatment of Human Disease

Author: Ronald Ross Watson

Publisher: Academic Press

Published: 2018-08-06

Total Pages: 486

ISBN-13: 0128130091

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Polyphenols in Prevention and Treatment of Human Disease, Second Edition authoritatively covers evidence of the powerful health benefits of polyphenols, touching on cardiovascular disease, cancer, obesity, diabetes and osteoporosis. This collection represents the contributions of an international group of experts in polyphenol research who share their expertise in endocrinology, public health, cardiology, pharmacology, agriculture and veterinary science. Researchers from diverse backgrounds will gain insight into how clinical observations and practices can feed back into the research cycle, thus allowing them to develop more targeted insights into the mechanisms of disease. This reference fills a void in research where nutritionists and alternative therapies may be applicable. - Describes polyphenol modulation of blood flow and oxygenation as a potential mechanism of protection against vascular atherosclerosis - Describes how polyphenols and antioxidants frequently change immune defenses and actions - Focuses on the most important areas of research and provides insights into their relationships and translational opportunities


Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 334

ISBN-13: 0309124999

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In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.


Prevention Vs. Treatment

Prevention Vs. Treatment

Author: Halley S. Faust

Publisher: OUP USA

Published: 2012

Total Pages: 414

ISBN-13: 0199837376

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Is prevention better than cure, or treatment more important because people need rescue? In this volume the prevention-treatment relationship is examined factually by economists and scholars of health policy and evidence-based medicine.