How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research

Cluster randomised trials are trials in which groups (or clusters) of individuals are randomly allocated to different forms of treatment. In health care, these trials often compare different ways of managing a disease or promoting healthy living, in contrast to conventional randomised trials which randomise individuals to different treatments, classically comparing new drugs with a placebo. They are increasingly common in health services research. This book addresses the statistical, practical, and ethical issues arising from allocating groups of individuals, or clusters, to different interventions. Key features: Guides readers through the stages of conducting a trial, from recruitment to reporting. Presents a wide range of examples with particular emphasis on trials in health services research and primary care, with both principles and techniques explained. Topics are specifically presented in the order in which investigators think about issues when they are designing a trial. Combines information on the latest developments in the field together with a practical guide to the design and implementation of cluster randomised trials. Explains principles and techniques through numerous examples including many from the authors own experience. Includes a wide range of references for those who wish to read further. This book is intended as a practical guide, written for researchers from the health professions including doctors, psychologists, and allied health professionals, as well as statisticians involved in the design, execution, analysis and reporting of cluster randomised trials. Those with a more general interest will find the plentiful examples illuminating.

Designing and Conducting Research in Health and Human Performance shows students how to become effective producers and consumers of health and human performance research. The book provides comprehensive coverage of both quantitative and qualitative research methods and includes step-by-step guidance for writing effective research proposals and theses. In addition, the authors show how to read, assess, interpret, and apply published research and how to conduct basic studies in health, physical education, exercise science, athletic training, and recreation. Designing and Conducting Research in Health and Human Performance is filled with illustrative examples that emphasize the real-world applications of research methods. Throughout, the authors draw on a variety of examples that were selected because they provide a context to further the understanding of health and human performance research. Research to Practice examples and Tips are included by the authors to help students better appreciate the book's content. These study aids provide suggestions and additional resources to assist students in understanding the research process. Key Terms, defined and highlighted, enrich each chapter. Chapter Review Questions, designed to help students comprehend and follow best practices in research methods, close each chapter. Online resources and guides developed by the authors to support and enhance students' learning of important research concepts are available.

Randomi sed 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  Randomi sed 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.

The Delphi Technique in Nursing and Health Research is a practical guide to using the Delphi methodology for students and researchers in nursing and health. It adopts a logical step-by-step approach, introducing the researcher to the Delphi, outlining its development, analysing key characteristics and parameters for its successful use and exploring its applications in nursing and health. The book addresses issues of methodology, design, framing the research question, sampling, instrumentation, methodological rigour, reliability and validity, and methods of data analysis. The Delphi Technique in Nursing and Health Research enables the reader to be aware of the limitations of the technique and possible solutions, to design a Delphi questionnaire for each of the different rounds of a study, to consider different approaches to the technique in relation to a study, to analyse the data from each round of a Delphi study, and to understand the importance of feedback between rounds. Key Features A practical guide to facilitate use of the Delphi technique Provides the reader with the necessary information to participate in and conduct Delphi studies Examines different types of Delphi, including the e-Delphi, and modifications made to the technique Includes examples of real empirical investigations, brief case scenarios and key learning points for each chapter Explores the role of the Delphi researcher Explores ethical issues and issues of anonymity, use of experts and controlled feedback

READ ALL ABOUT IT! David Spiegelhalter has recently joined the ranks of Isaac Newton, Charles Darwin and Stephen Hawking by becoming a fellow of the Royal Society. Originating from the Medical Research Council’s biostatistics unit, David has played a leading role in the Bristol heart surgery and Harold Shipman inquiries. Order a copy of this author’s comprehensive text TODAY! The Bayesian approach involves synthesising data and judgement in order to reach conclusions about unknown quantities and make predictions. Bayesian methods have become increasingly popular in recent years, notably in medical research, and although there are a number of books on Bayesian analysis, few cover clinical trials and biostatistical applications in any detail. Bayesian Approaches to Clinical Trials and Health-Care Evaluation provides a valuable overview of this rapidly evolving field, including basic Bayesian ideas, prior distributions, clinical trials, observational studies, evidence synthesis and cost-effectiveness analysis. Covers a broad array of essential topics, building from the basics to more advanced techniques. Illustrated throughout by detailed case studies and worked examples Includes exercises in all chapters Accessible to anyone with a basic knowledge of statistics Authors are at the forefront of research into Bayesian methods in medical research Accompanied by a Web site featuring data sets and worked examples using Excel and WinBUGS – the most widely used Bayesian modelling package Bayesian Approaches to Clinical Trials and Health-Care Evaluation is suitable for students and researchers in medical statistics, statisticians in the pharmaceutical industry, and anyone involved in conducting clinical trials and assessment of health-care technology.

Here is a 'must-read' for all health promotion researchers and practitioners eager to stay one step ahead of the pack. A panoply of insightful and promising new approaches is presented for consideration and exploration in our contemporary behavioral science arsenal. – M. Elaine Auld, MPH, CHES, Chief Executive Officer, Society for Public Health Education «This book is an essential addition to the health practice and research literature, concentrating on theories that have not been extensively covered elsewhere and that have great currency. It provides an up-to-date rendition on the interplay among contemporary public health concerns, sound public health practice, and the theoretical bases for practice.»– Robert M. Goodman, PhD, MPH, Dean and Professor, School of Health, Physical Education, and Recreation, Indiana University «The authors of Emerging Theories provide vivid descriptions of the state of the science in health promotion and presents an exciting map for future research. Understanding and using theories is the hallmark of an excellent practitioner. Creating and elaborating theories is the mark of an excellent researcher. This text will be very valuable for both.» – Noreen M. Clark, PhD, Myron E. Wegman Distinguished University Professor; Director, Center for Managing Chronic Disease, University of Michigan «Emerging Theories captures the dynamic growth in theories of health promotion and illustrates how divergent theoretical perspectives are being integrated into richer explanatory and practice models.» – Matthew W. Kreuter, PhD, MPH, Professor of Social Work and Medicine; Director, Health Communication Research Laboratory, Washington University in St. Louis

This book provides thorough and specific guidance on how to prepare defense-related scientific and technical reports, including classified scientific and technical reports. It includes an appendix describing the workings of the Defense Technical Information Center, the central repository for defense-related scientific and technical reports, and an appendix addressing tone and style, including pertinent information from the United States Government Printing Office Style Manual 2000, the official style guide of the U.S. Government and, therefore, the Department of Defense. Every facet of preparing defense-related scientific and technical reports is addressed, thereby making it unnecessary for the user to have to refer to the standards and numerous regulations pertaining to this subject. In effect, the book provides «one-stop shopping» for the user. Also, some of the official guidance on preparing defense-related scientific and technical reports requires interpretation, and in those cases the book provides a prudent analysis of that information and prescribes a «best practices» course for the user.

Having so many theories put together thoughtfully, proximally, in a single book will help the field come to grips with what the role is of theories as we go forward and address the individual actions, and societal and community influencers of individual action, that promote healthy behaviors. –Jim Marks, director, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention New and longstanding threats to public health, such as violence, drug misuse, HIV/AIDS, and homelessness are creating an ever greater demand for innovative theories that are responsive to the changes in the larger social environment. This important work is designed to fill the demand by assembling a careful selection of new and emerging health promotion theories into a single volume, written with an emphasis on practical application of theory to health promotion and health education programs.

An essential, up-to-date guide to the design of studies and selection of the correct QoL instruments for observational studies and clinical trials. Quality of Life (QoL) outcomes or Person/Patient Reported Outcome Measures (PROMs) are now frequently being used in randomised controlled trials (RCTs) and observational studies. This book provides a practical guide to the design, analysis and interpretation of studies that use such outcomes. QoL outcomes tend to generate data with discrete, bounded and skewed distributions. Many investigators are concerned about the appropriateness of using standard statistical methods to analyse QoL data and want guidance on what methods to use. QoL outcomes are frequently used in cross-sectional surveys and non-randomised health-care evaluations. Provides a user-friendly guide to the design and analysis of clinical trials and observational studies in relation to QoL outcomes. Discusses the problems caused by QoL outcomes and presents intervention options to help tackle them. Guides the reader step-by-step through the selection of appropriate QoLs. Features exercises and solutions and a supporting website providing downloadable data files. Illustrated throughout with examples and case studies drawn from the author’s experience, this book offers statisticians and clinicians guidance on choosing between the numerous available QoL instruments.

The bestselling guide to qualitative research, updated and expanded Qualitative Research is the essential guide to understanding, designing, conducting, and presenting a qualitative research study. This fourth edition features new material covering mixed methods, action research, arts-based research, online data sources, and the latest in data analysis, including data analysis software packages as well as narrative and poetic analysis strategies. A new section offers multiple ways of presenting qualitative research findings. The reader-friendly, jargon-free style makes this book accessible to both novice and experienced researchers, emphasizing the role of a theoretical framework in designing a study while providing practical guidance. Qualitative research reaches beyond the what, where, and when of quantitative analysis to investigate the why and how behind human behavior and the reasons that govern such behavior, but this presents a number of significant challenges. This guide is an invaluable reference for students and practitioners alike, providing the deep understanding that this sometimes difficult area of research requires to produce accurate results. The book contains a step-by-step guide to analyzing qualitative data and an addendum for graduate students with a template for a thesis, dissertation, or grant application. Build a strong foundation in qualitative research theory and application Design and implement effective qualitative research studies Communicate findings more successfully with clear presentation Explore data sources, data analysis tools, and the different types of research