Randomized Controlled Trials

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Randomized Controlled Trials

Author : Alehandro R. Jadad
ISBN : 9780470766163
Genre : Medical
File Size : 62.35 MB
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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.
Category: Medical

Introduction To Randomized Controlled Clinical Trials Second Edition

Author : John N.S. Matthews
ISBN : 1584886242
Genre : Mathematics
File Size : 22.37 MB
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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 provides a concise presentation of the principles applied in this area. It details the concepts behind randomization and methods for designing and analyzing trials and also includes information on meta-analysis and specialized designs, such as cross-over trials, cluster-randomized designs, and equivalence studies. This latest edition features new and revised references, examples, exercises, and a new chapter dedicated to binary outcomes and survival analysis. It also presents numerous examples taken from the medical literature, contains exercises at the end of each chapter, and offers solutions in an appendix. The author uses Minitab and R software throughout the text for implementing the methods that are presented. Comprehensive and accessible, Introduction to Randomized Controlled Clinical Trials is well-suited for those familiar with elementary statistical ideas and methods who want to further their knowledge of the subject.
Category: Mathematics

Randomized Control Trials In The Field Of Development

Author : Florent Bédécarrats
ISBN : 9780198865360
Genre : Business & Economics
File Size : 76.38 MB
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Randomized Control Trials in the Field of Development provides a critical perspective on the use of randomized control trials in development and poverty alleviation policies, warning against their excessive use and proposing improvements and alternatives.
Category: Business & Economics

A Practical Guide To Using Qualitative Research With Randomized Controlled Trials

Author : Alicia O'Cathain
ISBN : 9780198802082
Genre : Clinical trials
File Size : 40.2 MB
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When global policy makers and service providers introduce new interventions, we expect the products to be evaluated by academic researchers. The gold standard for measuring the effectiveness of an intervention is the randomised controlled trial (RCT). The participants in a RCT are randomlyallocated to receive either the new intervention or a placebo. Historically, RCTs have been conducted to estimate the effectiveness of drugs. Today the trials have become an invaluable research method used across multiple disciplines. Currently, academics are introducing qualitative research with RCTs. The methodology of qualitative research is in many ways the opposite of a RCT, as it emphasises subjectivity rather than objectivity, and flexibility over standardisation. A Practical Guide to using Qualitative Research withRandomized Controlled Trials is a "how-to" manual on combining these contrasting methodologies to get the best result. Guiding the reader through the use of qualitative research in RCTs, this text illustrates how to prepare for, undertake, and implement the results of a RCT in new ways. Divided into three parts, this book covers the process of using qualitative research with RCTs from start to finish. Section one outlines how to introduce qualitative research in the context of RCTs, section two provides practical guidance for using qualitative research with RCTs, and the finalsection guides the reader on how to engage with relevant stakeholders. Each chapter focuses on the key steps of undertaking qualitative research in RCTs, giving examples of how to write a proposal, select research questions, integrate qualitative and quantitative components, and much more. A Practical Guide to using Qualitative Research with Randomized Controlled Trials is ideal for researchers who are leading, undertaking, or planning to undertake qualitative research with RCTs. With its detailed explanations and inspiring examples, this book is also a one of a kind tool forpostgraduate students wishing to conduct their own RCT using qualitative research.
Category: Clinical trials

Analysis Of Data From Randomized Controlled Trials

Author : Jos W.R. Twisk
ISBN : 3030818640
Genre : Mathematics
File Size : 65.78 MB
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This book provides a practical guide to the analysis of data from randomized controlled trials (RCT). It gives an answer to the question of how to estimate the intervention effect in an appropriate way. This problem is examined for different RCT designs, such as RCTs with one follow-up measurement, RCTs with more than one follow-up measurement, cluster RCTs, cross-over trials, stepped wedge trials, and N-of-1 trials. The statistical methods are explained in a non-mathematical way and are illustrated by extensive examples. All datasets used in the book are available for download, so readers can reanalyse the examples to gain a better understanding of the methods used. Although most examples are taken from epidemiological and clinical studies, this book is also highly recommended for researchers working in other fields.
Category: Mathematics

Can Randomised Controlled Trials End Poverty

Author : Taibat Hussain
ISBN : 9783346229359
Genre : Business & Economics
File Size : 69.69 MB
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Essay from the year 2020 in the subject Economics - Macro-economics, general, grade: 67.0, School of Oriental and African Studies, University of London, language: English, abstract: This essay provides an overview of randomized controlled trials (RCTs) and their meteoric rise. Then the author discusses key limitations to the use of RCTs, from a theoretical and methodological lens and provides a country-study example. In recent times, randomized controlled trials (RCTs) as a method of impact evaluation of the effectiveness of development interventions have sparked enthusiasm and optimism among a wide range of stakeholders. Evidence from randomized evaluations is increasingly being used to understand and address poverty-related problems. To that extent, advocates of RCTs labeled the "randomistas" as proffer RCTs the "gold standard" for developing effective poverty reduction policies. Gold standard, in this sense, being the best and most accurate method (without restriction) to designing development interventions and assessing what works and what does not.
Category: Business & Economics

Taming Randomized Controlled Trials In Education

Author : Keith Morrison
ISBN : 9781000089929
Genre : Education
File Size : 25.51 MB
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There is a recent surge in the use of randomized controlled trials (RCTs) within education globally, with disproportionate claims being made about what they show, ‘what works’, and what constitutes the best ‘evidence’. Drawing on up-to-date scholarship from across the world, Taming Randomized Controlled Trials in Education critically addresses the increased use of RCTs in education, exploring their benefits, limits and cautions, and ultimately questioning the prominence given to them. While acknowledging that randomized controlled trials do have some place in education, the book nevertheless argues that this place should be limited. Drawing together all arguments for and against RCTs in a comprehensive and easily accessible single volume, the book also adds new perspectives and insights to the conversation; crucially, the book considers the limits of their usefulness and applicability in education, raising a range of largely unexplored concerns about their use. Chapters include discussions on: The impact of complexity theory and chaos theory. Design issues and sampling in randomized controlled trials. Learning from clinical trials. Data analysis in randomized controlled trials. Reporting, evaluating and generalizing from randomized controlled trials. Considering key issues in understanding and interrogating research evidence, this book is ideal reading for all students on Research Methods modules, as well as those interested in undertaking and reviewing research in the field of education.
Category: Education

Handbook Of Statistical Methods For Randomized Controlled Trials

Author : KyungMann Kim
ISBN : 9781498714648
Genre : Mathematics
File Size : 81.5 MB
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Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.
Category: Mathematics

Introduction To Randomized Controlled Clinical Trials

Author : John N.S. Matthews
ISBN : 9781420011302
Genre : Mathematics
File Size : 57.22 MB
Format : PDF
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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
Category: Mathematics

1 Regulations And Ethics Surrounding Cluster Randomized Controlled Trials And Other Clinical Trials In Emergency Medicine

Author :
ISBN : OCLC:1163805207
Genre :
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Introduction: A cluster randomized controlled trial is performed as an intervention in a group of subjects (collectively labeled as a u2018clusteru2019), rather than for an individual. Despite ethical issues inherent in obtaining informed consent for patient participation in cluster randomized controlled trials, many countries and regions have aggressively pursued these trials to increase the quality of medical evidence. However, Japan has yet to create an established guideline for obtaining informed consent for cluster randomized controlled trials. Recently, we have made the study protocol for a cluster randomized controlled trial on resuscitation science in Japan. The aim of this study was to share this experience and develop a method for obtaining informed consent in cluster randomized controlled trials of resuscitation science in Japan and other regions.Methods: We reviewed previous literature on research ethics and international regulations to identify the core features of informed consent in cluster randomized controlled trials of resuscitation science.Results: Waivers or modifications of informed consent may be necessary in some clinical research on resuscitation science and cluster randomized controlled trials in which it is essentially impossible to obtain individual informed consent. In addition, if needed, a gatekeeper should be chosen to represent a wider group of community representatives or advisers before taking the decision to permit the study. Conclusions: To support studies of cluster randomized controlled trials including resuscitation science, we shared our experience through the large cluster randomized controlled trial focusing resuscitation science in Japan and presented suggestions on ethical issues.

Pragmatic Randomized Clinical Trials

Author : Cynthia J. Girman
ISBN : 9780128176641
Genre : Science
File Size : 51.4 MB
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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
Category: Science

Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials

Author : Toshiro Tango
ISBN : 9781351648141
Genre : Mathematics
File Size : 37.44 MB
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Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website: Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html
Category: Mathematics

Randomised Clinical Trials

Author : David Machin
ISBN : 9781119524649
Genre : Medical
File Size : 26.96 MB
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Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process. This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book: Provides comprehensive coverage of randomised clinical trials, ranging from basic to advanced Features several new chapters, updated case studies and examples, and references to changes in regulations Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure Covers paired trial designs and trials with more than two interventions Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.
Category: Medical

Congress And Program Evaluation

Author : Clinton T. Brass
ISBN : IND:30000122494622
Genre : Political Science
File Size : 41.55 MB
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Program evaluations can play an important role in public policy debates and in oversight of government programs, potentially affecting decisions about program design, operation, and funding. One technique that has received significant recent attention is the randomised controlled trial (RCT). There are also many other types of evaluation, including the observational and qualitative designs.
Category: Political Science

Field Experiments In Political Science And Public Policy

Author : Peter John
ISBN : 9781317680178
Genre : Political Science
File Size : 31.64 MB
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Field experiments -- randomized controlled trials -- have become ever more popular in political science, as well as in other disciplines, such as economics, social policy and development. Policy-makers have also increasingly used randomization to evaluate public policies, designing trials of tax reminders, welfare policies and international aid programs to name just a few of the interventions tested in this way. Field experiments have become successful because they assess causal claims in ways that other methods of evaluation find hard to emulate. Social scientists and evaluators have rediscovered how to design and analyze field experiments, but they have paid much less attention to the challenges of organizing and managing them. Field experiments pose unique challenges and opportunities for the researcher and evaluator which come from working in the field. The research experience can be challenging and at times hard to predict. This book aims to help researchers and evaluators plan and manage their field experiments so they can avoid common pitfalls. It is also intended to open up discussion about the context and backdrop to trials so that these practical aspects of field experiments are better understood. The book sets out ten steps researchers can use to plan their field experiments, then nine threats to watch out for when they implement them. There are cases studies of voting and political participation, elites, welfare and employment, nudging citizens, and developing countries.
Category: Political Science

Randomized Clinical Trials

Author : David Machin
ISBN : 0470319224
Genre : Medical
File Size : 35.32 MB
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Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Randomized clinical trials are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organisations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Randomized Clinical Trials provides comprehensive coverage of such trials, ranging from elementary to advanced level. Written by authors with considerable experience of clinical trials, Randomized Clinical Trials is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context.
Category: Medical

Designing Randomised Trials In Health Education And The Social Sciences

Author : D. Torgerson
ISBN : 0230537367
Genre : Social Science
File Size : 34.49 MB
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The book focuses on the design of rigorous trials rather than their statistical underpinnings, with chapters on: pragmatic designs; placebo designs; preference approaches; unequal allocation; economics; analytical approaches; randomization methods. It also includes a detailed description of randomization procedures and different trial designs.
Category: Social Science

Randomized Controlled Trials To Evaluate Impact

Author : Rahel C. Kahlert
ISBN : OCLC:827931998
Genre :
File Size : 33.91 MB
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Policy makers in education and international development have lately gravitated toward the randomized controlled trial (RCT)--an evaluation design that randomly assigns a sample of people or households into an intervention group and a control group in order to measure the differential effect of the intervention--as a means to determine program impact. As part of federal regulations, the U.S. Department of Education and the U.S. Agency for International development explicitly declared a preference for the RCT.