Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation

by Stephen J. Walters

Author	: Stephen J. Walters
Publisher	: John Wiley & Sons
Total Pages	: 389
Release	: 2009-10-26
Genre	: Medical
ISBN	: 047075382X

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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.

Recent Advances in Clinical Trial Design and Analysis

by Peter F. Thall

Author	: Peter F. Thall
Publisher	: Springer Science & Business Media
Total Pages	: 263
Release	: 2012-12-06
Genre	: Medical
ISBN	: 1461520096

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Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.

Registries for Evaluating Patient Outcomes

by Agency for Healthcare Research and Quality/AHRQ

Author	: Agency for Healthcare Research and Quality/AHRQ
Publisher	: Government Printing Office
Total Pages	: 385
Release	: 2014-04-01
Genre	: Medical
ISBN	: 1587634333

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. 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.

The Prevention and Treatment of Missing Data in Clinical Trials

by National Research Council

Author	: National Research Council
Publisher	: National Academies Press
Total Pages	: 163
Release	: 2010-12-21
Genre	: Medical
ISBN	: 030918651X

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Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Patient-Reported Outcomes in Performance Measurement

by David Cella

Author	: David Cella
Publisher	: RTI Press
Total Pages	: 97
Release	: 2015-09-17
Genre	: Medical
ISBN	: 193483114X

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Patient-reported outcomes (PROs) are measures of how patients feel or what they are able to do in the context of their health status; PROs are reports, usually on questionnaires, about a patient's health conditions, health behaviors, or experiences with health care that individuals report directly, without modification of responses by clinicians or others; thus, they directly reflect the voice of the patient. PROs cover domains such as physical health, mental and emotional health, functioning, symptoms and symptom burden, and health behaviors. They are relevant for many activities: helping patients and their clinicians make informed decisions about health care, monitoring the progress of care, setting policies for coverage and reimbursement of health services, improving the quality of health care services, and tracking or reporting on the performance of health care delivery organizations. We address the major methodological issues related to choosing, administering, and using PROs for these purposes, particularly in clinical practice settings. We include a framework for best practices in selecting PROs, focusing on choosing appropriate methods and modes for administering PRO measures to accommodate patients with diverse linguistic, cultural, educational, and functional skills, understanding measures developed through both classic and modern test theory, and addressing complex issues relating to scoring and analyzing PRO data.

Quality of Life Assessment: Key Issues in the 1990s

by Stuart R. Walker

Author	: Stuart R. Walker
Publisher	: Springer Science & Business Media
Total Pages	: 514
Release	: 1993
Genre	: Health & Fitness
ISBN	: 9780792389910

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This book reviews current methodology for assessing the health status of patients -- their 'quality of life' -- and shows how this methodology can be applied to specific diseases such as cancer, rheumatoid arthritis, angina and Parkinson's disease.

Quality of Life

by Peter M. Fayers

Author	: Peter M. Fayers
Publisher	: John Wiley & Sons
Total Pages	: 460
Release	: 2013-05-23
Genre	: Medical
ISBN	: 1118699459

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Quality of life studies form an essential part of the evaluation of any treatment. Written by two authors who are well respected within this field, Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes, Second Edition lays down guidelines on assessing, analysing and interpreting quality of life data. The new edition of this standard book has been completely revised, updated and expanded to reflect many methodological developments emerged since the publication of the first edition. Covers the design of instruments, the practical aspects of implementing assessment, the analyses of the data, and the interpretation of the results Presents all essential information on Quality of Life Research in one comprehensive volume Explains the use of qualitative and quantitative methods, including the application of basic statistical methods Includes copious practical examples Fills a need in a rapidly growing area of interest New edition accommodates significant methodological developments, and includes chapters on computer adaptive testing and item banking, choosing an instrument, systematic reviews and meta analysis This book is of interest for everyone involved in quality of life research, and it is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and practitioners in the fields of cancer and other chronic diseases. Reviews of the First Edition – Winner of the first prize in the Basis of Medicine Category of the BMA Medical Book Competition 2001: “This book is highly recommended to clinicians who are actively involved in the planning, analysis and publication of QoL research.” CLINICAL ONCOLOGY “This book is highly recommended reading.” QUALITY OF LIFE RESEARCH

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies

by OECD

Author	: OECD
Publisher	: OECD Publishing
Total Pages	: 447
Release	: 2019-10-17
Genre	:
ISBN	: 9264805907

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This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Field Trials of Health Interventions

by Peter G. Smith

Author	: Peter G. Smith
Publisher	:
Total Pages	: 479
Release	: 2015
Genre	: Health & Fitness
ISBN	: 0198732864

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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.