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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
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.
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.
Randomized controlled trials (RCTs) are considered by many researchers and providers to be the gold standard of health and social service effectiveness research. However, there exist scant resources that deal with the complex nature of designing and implementing RCTs in community-based settings. This clearly written pocket guide provides researchers and social service practitioners insight into each step of an RCT. The goal of this text is to enable readers to understand, design, and implement a community-based RCT. From the initial stage of planning the RCT and developing its conceptual foundations through implementation, the authors provide a wealth of detail and case studies from social work practice research that assist readers to comprehend the detailed information provided. Accessible, concrete advice is woven throughout the text and tackles the many design and implementation challenges that arise in community practice settings. The importance of utilizing a mix of qualitative and quantitative methods is encouraged due to the intricate nature of RCT research in community-based environments. Through utilizing practical case examples, this pocket guide reviews the essentials of RCTs in a manner that will appeal to researchers, practitioners and students alike who are seeking the necessary tools to build the empirical knowledge base for community-based psychosocial interventions for social work.
The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting
Author : Christopher J. Bulpitt Publisher : Springer Science & Business Media Page : 270 pages File Size : 26,69 MB Release : 2013-04-17 Category : Medical ISBN : 1475763581
Bradford Hill has defined a clinical trial as "A carefully and ethically designed experiment with the aim of answering some precisely framed question" [1]. This definition specifies a careful design and requires the provision of adequate controls. Random allocation of treatments to subjects is important to ensure is entitled that the treated and control groups are similar. Therefore this book Randomised Controlled Clinical Trials. We can define a randomised controlled trial by rewriting Bradford Hill's definition as follows, "A carefully and ethi cally designed experiment which includes the provision of adequate and ap propriate controls by a process of randomisation, so that precisely framed questions can be answered. " I am a firm advocate ofRandomised Controlled Clinical Trials but intend to give a balanced view of the advantages and disadvantages of these ethical experiments. This book is directed primarily at the medical research worker, although certain chapters may find a wider application. When discussing a randomised controlled trial, it is neither practicable nor desirable to divorce theory from practice, however the first ten chapters con centrate mainly on theory, and the remainder focus on practice. The segment on trial design is followed by sections on writing the protocol, designing the forms, conducting the trial, and analysing the results. This book is meant to serve both as a reference manual and a practical guide to the design and performance of a trial.
Author : U. S. Department of Health and Human Services Publisher : CreateSpace Page : 108 pages File Size : 40,2 MB Release : 2013-04-09 Category : Medical ISBN : 9781484077146
The internal validity of a study reflects the extent to which the design and conduct of the study have prevented bias(es). One of the key steps in a systematic review is assessment of a study's internal validity, or potential for bias. This assessment serves to: (1) identify the strengths and limitations of the included studies; (2) investigate, and potentially explain heterogeneity in findings across different studies included in a systematic review; and (3) grade the strength of evidence for a given question. The risk of bias assessment directly informs one of four key domains considered when assessing the strength of evidence. With the increase in the number of published systematic reviews and development of systematic review methodology over the past 15 years, close attention has been paid to the methods for assessing internal validity. Until recently this has been referred to as “quality assessment” or “assessment of methodological quality.” In this context “quality” refers to “the confidence that the trial design, conduct, and analysis has minimized or avoided biases in its treatment comparisons.” To facilitate the assessment of methodological quality, a plethora of tools has emerged. Some of these tools were developed for specific study designs (e.g., randomized controlled trials (RCTs), cohort studies, case-control studies), while others were intended to be applied to a range of designs. The tools often incorporate characteristics that may be associated with bias; however, many tools also contain elements related to reporting (e.g., was the study population described) and design (e.g., was a sample size calculation performed) that are not related to bias. The Cochrane Collaboration recently developed a tool to assess the potential risk of bias in RCTs. The Risk of Bias (ROB) tool was developed to address some of the shortcomings of existing quality assessment instruments, including over-reliance on reporting rather than methods. Several systematic reviews have catalogued and critiqued the numerous tools available to assess methodological quality, or risk of bias of primary studies. In summary, few existing tools have undergone extensive inter-rater reliability or validity testing. Moreover, the focus of much of the tool development or testing that has been done has been on criterion or face validity. Therefore it is unknown whether, or to what extent, the summary assessments based on these tools differentiate between studies with biased and unbiased results (i.e., studies that may over- or underestimate treatment effects). There is a clear need for inter-rater reliability testing of different tools in order to enhance consistency in their application and interpretation across different systematic reviews. Further, validity testing is essential to ensure that the tools being used can identify studies with biased results. Finally, there is a need to determine inter-rater reliability and validity in order to support the uptake and use of individual tools that are recommended by the systematic review community, and specifically the ROB tool within the Evidence-based Practice Center (EPC) Program. In this project we focused on two tools that are commonly used in systematic reviews. The Cochrane ROB tool was designed for RCTs and is the instrument recommended by The Cochrane Collaboration for use in systematic reviews of RCTs. The Newcastle-Ottawa Scale is commonly used for nonrandomized studies, specifically cohort and case-control studies.
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.
The use of randomised controlled trials (RCTs), most commonly a medical sciences research tool, is a hotly debated topic in Education. This book examines the controversial aspects of RCTs in Education and sets out the potential and pitfalls of the method. Drawing on their own extensive experience of running RCTs, and their work at the Centre for Evidence and Social Innovation (CESI) at Queen’s University, Belfast, the authors provide a thorough practical introduction to the use of randomised controlled trials in education. Using real data sets, chapters equip the reader with all of the key knowledge and skills required to design, run, analyse and report an RCT. Coverage includes: · Step-by-step guidance on analysing data · How to assess the reliability and validity of results · Advice on balancing the demands of various stakeholders Essential reading for postgraduate and more experienced researchers, as well as teachers and educationalists seeking to increase their knowledge and understanding of the use of such methods in education.
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.