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The Essential Guide to N-of-1 Trials in Health

Author: Jane Nikles

Publisher: Springer

Published: 2015-10-05

Total Pages: 245

ISBN-13: 9401772002

N-of-1 trials, a type of individualized randomized controlled trial, are relevant to almost every discipline in medicine and psychology. They can tell the clinician with precision whether a treatment works in that individual, which distinguishes from the information available from most other trial designs. They have the potential to revolutionize the way clinical medicine is practiced. Whether you are a busy clinician, a researcher or a student, this book provides everything you need to know about N-of-1 trials. Written and edited by some of the world’s leading experts on N-of-1 trials, the book presents state of the art knowledge about N-of-1 trials, with chapters on ethics, statistics, health economics, design, analysis and reporting, and more. Full of examples and well illustrated, it is a comprehensive compendium of issues surrounding the design, conduct, interpretation and implementation of N-of-1 trials in a health system.

N of 1

Author: Glenn Sabin

Publisher: Fon Press

Published: 2016-12-27

Total Pages: 214

ISBN-13: 9780997548228

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Twenty-five years ago my doctors had no cure for my cancer. So I went on a quest to find my own treatment. This is my story... Glenn Sabin was diagnosed with "incurable" leukemia (CLL). He embarked on a journey researching lifestyle changes, and conducted a personal experiment, chronicled through Harvard, now part of the medical literature.

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.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Author: Agency for Health Care Research and Quality (U.S.)

Publisher: Government Printing Office

Published: 2013-02-21

Total Pages: 204

ISBN-13: 1587634236

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This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

The Shangri-La Diet

Author: Seth Roberts

Publisher: Penguin

Published: 2007-04-24

Total Pages: 225

ISBN-13: 1101042869

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As seen in the New York Times and on Good Morning America-now updated by the author. Imagine a diet that's as easy as "a spoonful of sugar" (or extra-light olive oil) twice a day. A diet that actually reduces appetite and cravings. A diet that's based on a wealth of scientific findings but is simple enough for anyone to stick to. A diet with results that amaze almost everyone who tries it. Psychology professor Seth Roberts asks a simple question most weight-loss experts haven't thought to tackle: What makes people hungry? Based on a new understanding of how the human body regulates hunger, The Shangri-La Diet presents a strikingly simple and surprisingly effective way to lose weight-without giving up favorite foods. Simple and counterintuitive, this extraordinary new diet is changing the way the world thinks about weight loss-one success story at a time.

Analysis of Data from Randomized Controlled Trials

Author: Jos W.R. Twisk

Publisher: Springer Nature

Published: 2021-10-15

Total Pages: 167

ISBN-13: 3030818659

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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.

n=1: How the Uniqueness of Each Individual Is Transforming Healthcare

Author: John Koster

Publisher: Easton Studio Press, LLC

Published: 2015-01-27

Total Pages: 167

ISBN-13: 1632260190

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This book, n=1 is a collaboration of physician health system CEO, venture capital entrepreneur and leading global business advisor and best-selling business author. These differing perspectives provide insights into the forces transforming the global society, business and professions with a focus on US healthcare and its transformation. Healthcare leaders must develop the incisive questions that challenge the orthodoxies hindering organizational transformation. Our experience indicates leaders of successful non-healthcare organizations develop cultures of inquiry that guide their organizations through dramatic market change. Unique individuals are the driving force in the transformation of healthcare. Digitization has democratized information, which feeds the desire of people to act, behave and be treated as unique individuals. Scientific innovation is revealing the importance of our biologic individuality. The financial risk of healthcare is increasingly passed to individuals and providers, fueling changes in financial incentives. An individual with information knows their options, and wants to choose the option most suited to his or her unique healthcare needs and financial means. This profound and fundamental change in the individual’s expectations and behavior is accelerating healthcare transformation. The title of this book, n = 1, is a symbol of the uniqueness of individuals. The n=1 will transform healthcare.

Smart Health Choices

Author: Les Irwig

Publisher: Judy Irwig

Published: 2008

Total Pages: 255

ISBN-13: 1905140177

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Every day we make decisions about our health - some big and some small. What we eat, how we live and even where we live can affect our health. But how can we be sure that the advice we are given about these important matters is right for us? This book will provide you with the right tools for assessing health advice.

Single-Case Experimental Designs for Clinical Research and Neurorehabilitation Settings

Author: Robyn Tate

Publisher: Routledge

Published: 2019-01-15

Total Pages: 260

ISBN-13: 0429948158

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This book is a practical resource designed for clinicians, researchers, and advanced students who wish to learn about single-case research designs. It covers the theoretical and methodological underpinnings of single-case designs, as well as their practical application in the clinical and research neurorehabilitation setting. The book briefly traces the history of single-case experimental designs (SCEDs); outlines important considerations in understanding and planning a scientifically rigorous single-case study, including internal and external validity; describes prototypical single-case designs (withdrawal-reversal designs and the medical N-of-1 trial, multiple-baseline designs, alternating-treatments designs, and changing-criterion designs) and required features to meet evidence standards, threats to internal validity, and strategies to address them; addresses data evaluation, covering visual analysis of graphed data, statistical techniques, and clinical significance; and provides a practical ten-step procedure for implementing single-case methods. Each chapter includes detailed illustrative examples from the neurorehabilitation literature. Novel features include: A focus on the neurorehabilitation setting, which is particularly suitable for single-case designs because of the complex and often unique presentation of many patients/clients. A practical approach to the planning, implementation, data analysis, and reporting of single-case designs. An appendix providing a detailed summary of many recently published SCEDs in representative domains in the neurorehabilitation field, covering basic and instrumental activities of daily living, challenging behaviours, disorders of communication and cognition, mood and emotional functions, and motor-sensory disabilities. It is valuable reading for clinicians and researchers in several disciplines working in rehabilitation, including clinical and neuropsychology, education, language and speech pathology, occupational therapy, and physical therapy. It is also an essential resource for advanced students in these fields who need a textbook for specialised courses on research methodology and use of single-case design in applied clinical and research settings.

Crossing the Quality Chasm

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-08-19

Total Pages: 360

ISBN-13: 0309072808

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Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.