Download or read book Bias in Clinical Intervention Research written by Lise Lotte Gluud and published by . This book was released on 2005 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Cochrane Handbook for Systematic Reviews of Interventions written by Julian P. T. Higgins and published by Wiley. This book was released on 2008-11-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Selection Bias and Covariate Imbalances in Randomized Clinical Trials written by Vance Berger and published by John Wiley & Sons. This book was released on 2007-10-22 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Selection bias can, and does, occur, even in randomized clinical trials. Steps need to be taken in order to ensure that this does not compromise the integrity of clinical trials; hence “Selection Bias and Covariate Imbalances in Randomized Clinical Trials” offers a comprehensive treatment of the subject and the methodology involved. This book: Provides an overview of the hierarchy of study designs, and justifies the position of randomised trials at the top of this hierarchy. Discusses the strengths and defects of randomisation, and provides real evidence to justify concern regarding its defects. Outlays the damaging consequences that selection bias causes when it does occur. Considers courses of action that can be taken to manage/ contain the problem. Presents methods that can be used to detect selection bias in randomised trials, and methods to correct for selection bias. Concludes by providing a comprehensive plan for managing baseline imbalances and selection bias in randomised trials, and proposing open problems for future research. Illustrated with case studies, this book introduces groundbreaking ideas and research that will be invaluable to researchers and practitioners who design and analyse clinical trials. It will also be of interest to graduate students within the field of biostatistics.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Systematic Reviews in Health Care written by Matthias Egger and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this best-selling book has been thoroughly revised and expanded to reflect the significant changes and advances made in systematic reviewing. New features include discussion on the rationale, meta-analyses of prognostic and diagnostic studies and software, and the use of systematic reviews in practice.
Download or read book Planning Clinical Research written by Robert A. Parker and published by Cambridge University Press. This book was released on 2016-10-12 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: Planning clinical research requires many decisions. The authors of this book explain key decisions with examples showing what works and what does not.
Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.
Download or read book Randomized Controlled Trials written by Alehandro R. Jadad and published by John Wiley & Sons. This book was released on 2007-07-23 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials are one of the most powerful and revolutionary tools of research. This book is a convenient and accessible description of the underlying principles and practice of randomized controlled trials and their role in clinical decision-making. Structured in a jargon-free question-and-answer format, each chapter provides concise and understandable information on a different aspect of randomized controlled trials, from the basics of trial design and terminology to the interpretation of results and their use in driving evidence-based medicine. The authors end each chapter with their musings, going beyond the evidence or citations, and sometimes even beyond orthodox correctness to share their thoughts and concerns about different aspects of randomized controlled trials, and their role within the health system. Updated to include insights from the last decade, this second edition challenges over-reliance on randomized controlled trials by debating their strengths and limitations and discussing their optimal use in modern healthcare. It also includes a new and increasingly relevant chapter on the ethics of randomized trials. World renowned writers and thinkers Drs Jadad and Enkin bring you this invaluable book for busy health professionals who wish to understand the theory of randomized controlled trials and their influence on clinical, research or policy decisions.
Download or read book Users Guides to the Medical Literature written by Gordon Guyatt and published by McGraw Hill Professional. This book was released on 2008-03-01 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: The “essential” companion to the landmark Users' Guides to the Medical Literature - completely revised and updated! 5 STAR DOODY'S REVIEW! "This second edition is even better than the original. Information is easier to find and the additional resources that will be available at www.JAMAevidence.com will provide readers with a one-stop source for evidence-based medicine."--Doody's Review Service Evidence-based medicine involves the careful interpretation of medical studies and its clinical application. And no resource helps you do it better-and faster-than Users' Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice. This streamlined reference distills the most clinically-relevant coverage from the parent Users' Guide Manual into one highly-focused, portable resource. Praised for its clear explanations of detailed statistical and mathematical principles, The Essentials concisely covers all the basic concepts of evidence-based medicine--everything you need to deliver optimal patient care. It's a perfect at-a-glance source for busy clinicians and students, helping you distinguish between solid medical evidence and poor medical evidence, tailor evidence-based medicine for each patient, and much more. Now in its second edition, this carry-along quick reference is more clinically relevant--and more essential--than ever! FEATURES Completely revised and updated with all new coverage of the basic issues in evidence-based medicine in patient care Abundant real-world examples drawn from the medical literature are woven throughout, and include important related principles and pitfalls in using clinical research in patient care decisions Edited by over 60 internationally recognized editors and contributors from around the globe Also look for JAMAevidence.com, a new interactive database for the best practice of evidence based medicine.
Download or read book The Philosophy of Evidence based Medicine written by Jeremy H. Howick and published by John Wiley & Sons. This book was released on 2011-02-23 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evidence-based medicine (EBM) has become a required element of clinical practice, but it is critical for the healthcare community to understand the ongoing controversy surrounding EBM. Seeking to address questions raised by critics, The Philosophy of Evidence-based Medicine challenges the over dependency of EBM on randomized controlled trials. This book also explores EBM methodology and its relationship with other approaches used in medicine.
Download or read book Evaluating What Works written by Dorothy V. M. Bishop and published by CRC Press. This book was released on 2023-12-07 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Those who work in allied health professions and education aim to make people’s lives better. Often, however, it is hard to know how effective this work has been: would change have occurred if there was no intervention? Is it possible we are doing more harm than good? To answer these questions and develop a body of knowledge about what works, we need to evaluate interventions. Objective intervention research is vital to improve outcomes, but this is a complex area, where it is all too easy to misinterpret evidence. This book uses practical examples to increase awareness of the numerous sources of bias that can lead to mistaken conclusions when evaluating interventions. The focus is on quantitative research methods, and exploration of the reasons why those both receiving and implementing intervention behave in the ways they do. Evaluating What Works: Intuitive Guide to Intervention Research for Practitioners illustrates how different research designs can overcome these issues, and points the reader to sources with more in-depth information. This book is intended for those with little or no background in statistics, to give them the confidence to approach statistics in published literature with a more critical eye, recognise when more specialist advice is needed, and give them the ability to communicate more effectively with statisticians. Key Features: Strong focus on quantitative research methods Complements more technical introductions to statistics Provides a good explanation of how quantitative studies are designed, and what biases and pitfalls they can involve.
Download or read book Randomised Controlled Trials written by Alejandro R. Jadad and published by Wiley-Blackwell. This book was released on 1998 with total page 123 pages. Available in PDF, EPUB and Kindle. Book excerpt: The contributors to this study present a balanced view of the strengths and weaknesses of randomised controlled trials in the medical setting. They cover all the essential issues without using statistics.
Download or read book Clinical Epidemiology written by Patrick S. Parfrey and published by Humana. This book was released on 2016-10-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on improving the diagnosis, prognosis, and management of human disease, this book takes on the issues of research design, measurement, and evaluation which are critical to clinical epidemiology. This second edition of Clinical Epidemiology: Practice and Methods opens with how best to frame a clinical research question, the ethics associated with doing a research project in humans, and the definition of various biases that occur in clinical research. From there, it continues by examining issues of design, measurement, and analysis associated with various research designs, including determination of risk in longitudinal studies, assessment of therapy in randomized controlled clinical trials, and evaluation of diagnostic tests, and then delves into the more specialized area of clinical genetic research, before concluding with basic methods used in evidence-based decision making including critical appraisal, aggregation of multiple studies using meta-analysis, health technology assessment, clinical practice guidelines, development of health policy, translational research, how to utilize administrative databases, and knowledge translation. Written for the highly successful Methods in Molecular Biology series, chapters include the kind of detail and practical advice to ensure real world success. Comprehensive and authoritative, Clinical Epidemiology: Practice and Methods, Second Edition is intended to educate researchers on how to undertake clinical research and should be helpful not only to medical practitioners but also to basic scientists who want to extend their work to humans, to allied health professionals interested in scientific evaluation, and to trainees in clinical epidemiology.
Download or read book Peer Review in Health Sciences written by Tom Jefferson and published by BMJ Books. This book was released on 2003-09-26 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book has established itself as the authoritative text on health sciences peer review. Contributions from the world's leading figures discuss the state of peer review, question its role in the currently changing world of electronic journal publishing, and debate where it should go from here. The second edition has been thoroughly revised and new chapters added on qualitative peer review, training, consumers and innovation.
