Meta-Analysis of Controlled Clinical Trials
Meta-Analysis of Controlled Clinical Trials

Author: Anne Whitehead

Publisher: John Wiley & Sons

Published: 2003-01-17

Total Pages: 352

ISBN-13: 0470854197

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Over the last twenty years there has been a dramatic upsurge in the application of meta-analysis to medical research. This has mainly been due to greater emphasis on evidence-based medicine and the need for reliable summaries of the vast and expanding volume of clinical research. At the same time there have been great strides in the development and refinement of the associated statistical methodology. This book describes the planning, conduct and reporting of a meta-analysis as applied to a series of randomized controlled clinical trials. * The various approaches are presented within a general unified framework. * Meta-analysis techniques are described in detail, from their theoretical development through to practical implementation. * Each topic discussed is supported by detailed worked examples. * A comparison of fixed and random effects approaches is included, as well as a discussion of Bayesian methods and cumulative meta-analysis. * Fully documented programs using standard statistical procedures in SAS are available on the Web. Ideally suited for practising statisticians and statistically-minded medical professionals, the book will also be of use to graduate students of medical statistics. The book is a self-contained and comprehensive account of the subject and an essential purchase for anyone involved in clinical trials.

Small Clinical Trials
Small Clinical Trials

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-01-01

Total Pages: 221

ISBN-13: 0309171148

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Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Finding What Works in Health Care
Finding What Works in Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-07-20

Total Pages: 267

ISBN-13: 0309164257

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Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Cognitive Behavioral Therapy for Tinnitus
Cognitive Behavioral Therapy for Tinnitus

Author: Eldré W. Beukes

Publisher: Plural Publishing

Published: 2020-10-28

Total Pages: 271

ISBN-13: 1635503035

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For many individuals afflicted with tinnitus, the condition causes substantial distress. While there is no known cure for tinnitus, cognitive behavioral therapy (CBT) can offer an effective strategy for managing the symptoms and side effects of chronic tinnitus. Cognitive Behaviorial Therapy for Tinnitus is the first book to provide comprehensive CBT counseling materials specifically developed for the management of tinnitus. This valuable professional book has two primary purposes: to provide clinical guidelines for audiologists who are offering CBT-based counseling for tinnitus and to provide self-help materials for individuals with tinnitus. In addition, these materials may be of interest to researchers developing evidence-based therapies for tinnitus. The book is structured into three sections. Section A provides background information about the theoretical aspects of CBT and some practical tips on how to use this book. Section B provides the CBT counseling, or self-help materials, which can be used by both audiologists and those with tinnitus. Finally, Section C provides some supplementary materials for clinicians that can aid monitoring and engagement of individuals experiencing tinnitus during the course of intervention. Key Features: * The CBT materials contained in this text have been tested in numerous clinical trials across the globe (Australia, Germany, Sweden, United Kingdom, and the United States) both as self-help book chapters and self-help materials delivered via the Internet. * The counseling materials are presented at minimum reading grade level (U.S. 6th grade level) to maximize reader engagement. * The authors of this book have extensive experience in the management of tinnitus, offering useful insights for clinicians and those with tinnitus. * Includes expert advice videos for each chapter to facilitate its adoption to clinical practice.

Introduction to Randomized Controlled Clinical Trials
Introduction to Randomized Controlled Clinical Trials

Author: John N.S. Matthews

Publisher: CRC Press

Published: 2006-06-26

Total Pages: 304

ISBN-13: 1420011308

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Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials prov

Cochrane Handbook for Systematic Reviews of Interventions
Cochrane Handbook for Systematic Reviews of Interventions

Author: Julian P. T. Higgins

Publisher: Wiley

Published: 2008-11-24

Total Pages: 672

ISBN-13: 9780470699515

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Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.

Knowing What Works in Health Care
Knowing What Works in Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2008-05-29

Total Pages: 279

ISBN-13: 0309113563

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There is currently heightened interest in optimizing health care through the generation of new knowledge on the effectiveness of health care services. The United States must substantially strengthen its capacity for assessing evidence on what is known and not known about "what works" in health care. Even the most sophisticated clinicians and consumers struggle to learn which care is appropriate and under what circumstances. Knowing What Works in Health Care looks at the three fundamental health care issues in the United States-setting priorities for evidence assessment, assessing evidence (systematic review), and developing evidence-based clinical practice guidelines-and how each of these contributes to the end goal of effective, practical health care systems. This book provides an overall vision and roadmap for improving how the nation uses scientific evidence to identify the most effective clinical services. Knowing What Works in Health Care gives private and public sector firms, consumers, health care professionals, benefit administrators, and others the authoritative, independent information required for making essential informed health care decisions.

Sharing Clinical Trial Data
Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Modern Methods of Clinical Investigation
Modern Methods of Clinical Investigation

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1990-02-01

Total Pages: 241

ISBN-13: 0309042860

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The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Principles and Practice of Clinical Research
Principles and Practice of Clinical Research

Author: John I. Gallin

Publisher: Elsevier

Published: 2011-04-28

Total Pages: 447

ISBN-13: 0080489567

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The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government