Advances in Mixed Methods Research
Advances in Mixed Methods Research

Author: Manfred Max Bergman

Publisher: SAGE

Published: 2008-05-06

Total Pages: 202

ISBN-13: 1446241211

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Advances in Mixed Methods Research provides an essential introduction to the fast-growing field of mixed methods research. Bergman′s book examines the current state of mixed-methods research, exploring exciting new ways of conceptualizing and conducting empirical research in the social and health sciences. Contributions from the world′s leading experts in qualitative, quantitative, and mixed methods approaches are brought together, clearing the way for a more constructive approach to social research. These contributions cover the main practical and methodological issues and include a number of different visions of what mixed methods research is. The discussion also covers the use of mixed methods in a diverse range of fields, including sociology, education, politics, psychology, computational science and methodology. This book represents an important contribution to the ongoing debate surrounding the use of mixed methods in the social sciences and health research, and presents a convincing argument that the conventional, paradigmatic view of qualitative and quantitative research is outdated and in need of replacement. It will be essential reading for anyone actively engaged in qualitative, quantitative and mixed methods research and for students of social research methods. Manfred Max Bergman is Chair of Methodology and Political Sociology at the University of Basel.

Small Clinical Trials
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.

Educating Children with Autism
Educating Children with Autism

Author: National Research Council

Publisher: National Academies Press

Published: 2001-11-11

Total Pages: 324

ISBN-13: 0309210011

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Autism is a word most of us are familiar with. But do we really know what it means? Children with autism are challenged by the most essential human behaviors. They have difficulty interacting with other people-often failing to see people as people rather than simply objects in their environment. They cannot easily communicate ideas and feelings, have great trouble imagining what others think or feel, and in some cases spend their lives speechless. They frequently find it hard to make friends or even bond with family members. Their behavior can seem bizarre. Education is the primary form of treatment for this mysterious condition. This means that we place important responsibilities on schools, teachers and children's parents, as well as the other professionals who work with children with autism. With the passage of the Individuals with Disabilities Education Act of 1975, we accepted responsibility for educating children who face special challenges like autism. While we have since amassed a substantial body of research, researchers have not adequately communicated with one another, and their findings have not been integrated into a proven curriculum. Educating Children with Autism outlines an interdisciplinary approach to education for children with autism. The committee explores what makes education effective for the child with autism and identifies specific characteristics of programs that work. Recommendations are offered for choosing educational content and strategies, introducing interaction with other children, and other key areas. This book examines some fundamental issues, including: How children's specific diagnoses should affect educational assessment and planning How we can support the families of children with autism Features of effective instructional and comprehensive programs and strategies How we can better prepare teachers, school staffs, professionals, and parents to educate children with autism What policies at the federal, state, and local levels will best ensure appropriate education, examining strategies and resources needed to address the rights of children with autism to appropriate education. Children with autism present educators with one of their most difficult challenges. Through a comprehensive examination of the scientific knowledge underlying educational practices, programs, and strategies, Educating Children with Autism presents valuable information for parents, administrators, advocates, researchers, and policy makers.

Sharing Clinical Trial Data
Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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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.

Conducting GCP-Compliant Clinical Research
Conducting GCP-Compliant Clinical Research

Author: Wendy Bohaychuk

Publisher: John Wiley & Sons

Published: 1999-06-02

Total Pages: 234

ISBN-13: 9780471988243

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Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including: Standard operating procedures for investigators Standard operating procedures for sponsors and CROs GCP - an indexed reference Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

Methodological Issues and Strategies in Clinical Research
Methodological Issues and Strategies in Clinical Research

Author: Alan E. Kazdin

Publisher: Amer Psychological Assn

Published: 2002-11-15

Total Pages: 913

ISBN-13: 9781557989598

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The third edition of this resource is intended to assist students and professionals in increasing their mastery of the range of methodological approaches available with which to examine clinical issues and phenomena. Contributors explore experimental design; the principles, procedures and practices that govern research; assessment of study constructs and their interrelationships; potential sources of artifact and bias; methods of data analysis and interpretation; ethical issues; and publication and communication of research findings. With 19 new articles and significantly revised and expanded introductory material, this edition features many scholarly contributions that explicate core concepts, survey contemporary issues, and elaborate on ethical responsibilities. Additions include articles on mediators and moderators of effects, on methods for studying the efficacy and effectiveness of psychotherapy, and on ways of incorporating systematic observation and evaluation into clinical practice to improve patient care.

Stevens' Handbook of Experimental Psychology, Methodology in Experimental Psychology
Stevens' Handbook of Experimental Psychology, Methodology in Experimental Psychology

Author: John T. Wixted

Publisher: John Wiley & Sons

Published: 2004-01-16

Total Pages: 915

ISBN-13: 0471178861

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Now available in paperback. This revised and updated edition of the definitive resource for experimental psychology offers comprehensive coverage of the latest findings in the field, as well as the explosion of research in neuroscience. Volume Four: Methodology in Experimental Psychology, organized by topic, focuses on the comparative research methods used to measure psychological, social, behavioral, and cognitive processes in human development.

Methodological Issues & Strategies in Clinical Research
Methodological Issues & Strategies in Clinical Research

Author: Alan E. Kazdin

Publisher:

Published: 2009

Total Pages: 765

ISBN-13:

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This book provides readings designed to improve understanding of methodology and to enhance research practices in clinical psychology. The intended audience is persons who are in training or are actively involved in research. The primary focus of the readings is clinical psychology, but the issues and methods are relevant to other areas as well, such as counseling, educational and school psychology, psychiatry, and social work. /// Several readings have been included to address a broad range of practices, procedures, and strategies for developing a sound knowledge base. The goal was to select, from a large literature on methodology and design, a special set of engaging articles of use to students and professionals alike. The articles address a wide range of topics within clinical research. /// The content of this book addresses experimental design, principles, procedures, and practices that govern research, assessment, sources of artifact and bias, data analyses and interpretation, ethical issues, and publication and communication of the results of research. (PsycINFO Database Record (c) 2004 APA, all rights reserved).