A mixed model approach for intent-to-treat analysis in longitudinal clinical trials with missing values PDF Download
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Author: Hrishikesh Chakraborty
Publisher: RTI Press
ISBN:
Category : Computers
Languages : en
Pages : 12
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Book Description
Missing values and dropouts are common issues in longitudinal studies in all areas of medicine and public health. Intent-to-treat (ITT) analysis has become a widely accepted method for the analysis of controlled clinical trials. In most controlled clinical trials, some patients do not complete their intended followup according to the protocol for a variety of reasons; this problem generates missing values. Missing values lead to concern and confusion in identifying the ITT population, which makes the data analysis more complex and challenging. No adequate strategy exists for ITT analyses of longitudinal controlled clinical trial data with missing values. Several ad hoc strategies for dealing with missing values for an ITT analysis are common in the practice of controlled clinical trials. We performed a detailed investigation based on simulation studies to develop recommendations for this situation. We compared sizes (type I errors) and power between some popular ad hoc approaches and the linear mixed model approach under different missing value scenarios. Our results suggest that, for studies with a high percentage of missing values, the mixed model approach without any ad hoc imputation is more powerful than other options.
Author: Hrishikesh Chakraborty
Publisher: RTI Press
ISBN:
Category : Computers
Languages : en
Pages : 12
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Book Description
Missing values and dropouts are common issues in longitudinal studies in all areas of medicine and public health. Intent-to-treat (ITT) analysis has become a widely accepted method for the analysis of controlled clinical trials. In most controlled clinical trials, some patients do not complete their intended followup according to the protocol for a variety of reasons; this problem generates missing values. Missing values lead to concern and confusion in identifying the ITT population, which makes the data analysis more complex and challenging. No adequate strategy exists for ITT analyses of longitudinal controlled clinical trial data with missing values. Several ad hoc strategies for dealing with missing values for an ITT analysis are common in the practice of controlled clinical trials. We performed a detailed investigation based on simulation studies to develop recommendations for this situation. We compared sizes (type I errors) and power between some popular ad hoc approaches and the linear mixed model approach under different missing value scenarios. Our results suggest that, for studies with a high percentage of missing values, the mixed model approach without any ad hoc imputation is more powerful than other options.
Author: Hrishikesh Chakraborty
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 9
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Book Description
Author: Craig Mallinckrodt
Publisher: CRC Press
ISBN: 1351737686
Category : Mathematics
Languages : en
Pages : 291
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Book Description
Analyzing Longitudinal Clinical Trial Data: A Practical Guide provide practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice.?This book, with its example-oriented approach that includes numerous SAS and R code fragments, is an essential resource for statisticians and graduate students specializing in medical research. The authors provide clear descriptions of the relevant statistical theory and illustrate practical considerations for modeling longitudinal data. Topics covered include choice of endpoint and statistical test; modeling means and the correlations between repeated measurements; accounting for covariates; modeling categorical data; model verification; methods for incomplete (missing) data that includes the latest developments in sensitivity analyses, along with approaches for and issues in choosing estimands; and means for preventing missing data. Each chapter stands alone in its coverage of a topic. The concluding chapters provide detailed advice on how to integrate these independent topics into an over-arching study development process and statistical analysis plan.
Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163
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Book Description
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.
Author: Souraya Sidani
Publisher: John Wiley & Sons
ISBN: 1119610133
Category : Medical
Languages : en
Pages : 448
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Book Description
Nursing and Health Interventions covers the conceptual, empirical, and practical knowledge required for engaging in intervention research. This revised edition provides step-by-step guidance on the complex process of intervention development and methods for developing, delivering, evaluating and implementing intervention, supported by a wealth of examples. The text describes each essential aspect of intervention research, from generating an intervention theory, to procedures for adopting evidence-based interventions in practice. This second edition provides up-to-date coverage of intervention research and its impact on improving standards of care. Throughout the text, readers are provided with the foundational knowledge required for generating evidence that informs treatment decisions in practice, and choosing the best approaches for designing, delivering, evaluating and implementing interventions. A valuable ‘one-stop’ resource for students, researchers, and health professionals alike, this book: Covers the importance and issues of evidence-based healthcare practice, the role of theory in research in the intervention design and evaluation, and evaluation of effectiveness and implementation of interventions in a single volume Reviews the decision-making steps and the knowledge needed to inform decisions in research and practice Discusses the limitations of evidence derived from randomized controlled trials (RCTs) Written by leading experts in the field, Nursing and Health Interventions remains an invaluable resource for nursing and healthcare students, researchers, and health practitioners wanting to understand and apply intervention to improve the quality of care.
Author: Roderick J. A. Little
Publisher: John Wiley & Sons
ISBN: 1118595696
Category : Mathematics
Languages : en
Pages : 463
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Book Description
An up-to-date, comprehensive treatment of a classic text on missing data in statistics The topic of missing data has gained considerable attention in recent decades. This new edition by two acknowledged experts on the subject offers an up-to-date account of practical methodology for handling missing data problems. Blending theory and application, authors Roderick Little and Donald Rubin review historical approaches to the subject and describe simple methods for multivariate analysis with missing values. They then provide a coherent theory for analysis of problems based on likelihoods derived from statistical models for the data and the missing data mechanism, and then they apply the theory to a wide range of important missing data problems. Statistical Analysis with Missing Data, Third Edition starts by introducing readers to the subject and approaches toward solving it. It looks at the patterns and mechanisms that create the missing data, as well as a taxonomy of missing data. It then goes on to examine missing data in experiments, before discussing complete-case and available-case analysis, including weighting methods. The new edition expands its coverage to include recent work on topics such as nonresponse in sample surveys, causal inference, diagnostic methods, and sensitivity analysis, among a host of other topics. An updated “classic” written by renowned authorities on the subject Features over 150 exercises (including many new ones) Covers recent work on important methods like multiple imputation, robust alternatives to weighting, and Bayesian methods Revises previous topics based on past student feedback and class experience Contains an updated and expanded bibliography The authors were awarded The Karl Pearson Prize in 2017 by the International Statistical Institute, for a research contribution that has had profound influence on statistical theory, methodology or applications. Their work "has been no less than defining and transforming." (ISI) Statistical Analysis with Missing Data, Third Edition is an ideal textbook for upper undergraduate and/or beginning graduate level students of the subject. It is also an excellent source of information for applied statisticians and practitioners in government and industry.
Author: Ronit Elk
Publisher: Springer Publishing Company
ISBN: 0826108822
Category : Health & Fitness
Languages : en
Pages : 582
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Book Description
There has been remarkable progress in understanding, preventing, detecting, diagnosing, and treating cancer, resulting in a reduction of cancer incidence and mortality in the United States. Despite this, the cancer burden varies considerably by race/ethnicity and socioeconomic status. Cancer incidence rates vary markedly between racial/ethnic groups, but even more startling are the differences in outcome across groups. Cancer Disparities: Causes and Evidence-Based Solutions helps readers understand the scope and causes of this inequity by providing a detailed analysis of the many factors that result in cancer disparities across the cancer continuum, including the role of race/ethnicity, socioeconomic status, access to and use of services, insurance status, geographic variables, and differences in treatment provided to patients. Further, it is the first book to describe evidence-based, concrete solutions that can be used to reduce or even eliminate cancer health disparities. Fifteen previously unpublished studies of interventions designed specifically to achieve health equality are described. These studies focus on contextually and culturally appropriate strategies to enhance cancer prevention, screening and early detection, treatment, symptom management, and quality of life in underserved populations.
Author: Geert Molenberghs
Publisher: John Wiley & Sons
ISBN: 9780470510438
Category : Medical
Languages : en
Pages : 526
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Book Description
Missing Data in Clinical Studies provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches. The authors focus on practical and modeling concepts, providing an extensive set of case studies to illustrate the problems described. Provides a practical guide to the analysis of clinical trials and related studies with missing data. Examines the problems caused by missing data, enabling a complete understanding of how to overcome them. Presents conventional, simple methods to tackle these problems, before addressing more advanced approaches, including sensitivity analysis, and the MAR missingness mechanism. Illustrated throughout with real-life case studies and worked examples from clinical trials. Details the use and implementation of the necessary statistical software, primarily SAS. Missing Data in Clinical Studies has been developed through a series of courses and lectures. Its practical approach will appeal to applied statisticians and biomedical researchers, in particular those in the biopharmaceutical industry, medical and public health organisations. Graduate students of biostatistics will also find much of benefit.
Author: Donald B. Rubin
Publisher: John Wiley & Sons
ISBN: 0470317361
Category : Mathematics
Languages : en
Pages : 258
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Book Description
Demonstrates how nonresponse in sample surveys and censuses can be handled by replacing each missing value with two or more multiple imputations. Clearly illustrates the advantages of modern computing to such handle surveys, and demonstrates the benefit of this statistical technique for researchers who must analyze them. Also presents the background for Bayesian and frequentist theory. After establishing that only standard complete-data methods are needed to analyze a multiply-imputed set, the text evaluates procedures in general circumstances, outlining specific procedures for creating imputations in both the ignorable and nonignorable cases. Examples and exercises reinforce ideas, and the interplay of Bayesian and frequentist ideas presents a unified picture of modern statistics.
Author: Steven Piantadosi
Publisher: Springer Nature
ISBN: 3319526367
Category : Medical
Languages : en
Pages : 2573
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Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
