Pragmatic Randomized Clinical Trials
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Pragmatic Randomized Clinical Trials
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Author : Cynthia J. Girman
language : en
Publisher: Academic Press
Release Date : 2021-04-08
Pragmatic Randomized Clinical Trials written by Cynthia J. Girman and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-08 with Science categories.
Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed. This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) Encompasses analytic aspects of such trials Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records
Pragmatic Randomized Clinical Trials
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Author : Cynthia J. Girman
language : en
Publisher: Elsevier
Release Date : 2021-04-14
Pragmatic Randomized Clinical Trials written by Cynthia J. Girman and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-14 with Science categories.
Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation and dissemination of pragmatic randomized trials. The book contains chapters encompassing common designs, along with the advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize such trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed. This comprehensive resource is valuable not only for biostatitians, but also for several members of biomedical field who are interested in applying pragmatic randomized clinical trials in their research. Brings typical designs and challenges of pragmatic randomized clinical trials (pRCTs) Encompasses analytic aspects for sample size determination of such trials Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records
Design And Analysis Of Pragmatic Trials
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Author : Song Zhang
language : en
Publisher: CRC Press
Release Date : 2023-05-16
Design And Analysis Of Pragmatic Trials written by Song Zhang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-16 with Medical categories.
This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design. Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.
Clinical Trials
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Author : Timothy M. Pawlik
language : en
Publisher: Springer Nature
Release Date : 2020-03-10
Clinical Trials written by Timothy M. Pawlik and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-10 with Medical categories.
This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.
Challenges In Conducting A Pragmatic Randomized Controlled Trial Of Two Technology Supported Approaches To Support Medication Treatment Decisions
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Author : Kelly R. Williams
language : en
Publisher:
Release Date : 2020
Challenges In Conducting A Pragmatic Randomized Controlled Trial Of Two Technology Supported Approaches To Support Medication Treatment Decisions written by Kelly R. Williams and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Clinical trials categories.
This case study describes a cluster-randomized control trial comparing the effectiveness of two technology-based approaches to collaborative decision-making during mental health medication treatment visits. The case study reviews the impetus for the research trial, components of each approach, study design, and recruitment processes and discusses how diverse stakeholders were engaged in all aspects of the research. Throughout the case study, details regarding methodological processes and challenges specific to randomization, data collection, and primary outcome measures are explained. Through the presentation of these challenges and subsequent impacts on data interpretation, this case study offers insights into workable solutions and the importance of methodological transparency in the conduct of patient-centered comparative effective research in real-world settings.
Pragmatic Randomized Trials Without Standard Informed Consent
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Author : Rahul Nayak
language : en
Publisher:
Release Date : 2015
Pragmatic Randomized Trials Without Standard Informed Consent written by Rahul Nayak and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with categories.
Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. Web-based survey conducted in December 2014. 2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). Respondent's recommendation to an ethics review board and personal preference as a potential participant for how to obtain consent or notification in the 2 research scenarios. A majority of respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in line with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Framing effects could have impacted respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. A majority of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.
Clinical Trials In Psychiatry
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Author : Brian S. Everitt
language : en
Publisher: John Wiley & Sons
Release Date : 2008-04-15
Clinical Trials In Psychiatry written by Brian S. Everitt and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-15 with Medical categories.
At last – a new edition of the highly acclaimed book Clinical Trials in Psychiatry This book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials. Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding: Recent important psychiatric trials More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration) An extended chapter on meta-analysis Further discussion of sub-group analysis Special features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section. From the reviews of the First Edition: “Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors’ enthusiasm and grasp of clinical trial research make for a gripping and insightful read...it is one of the very best books that has been written on clinical trials.” THE BRITISH JOURNAL OF PSYCHIATRY "The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications... an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research.” PSYCHOLOGICAL MEDICINE
Randomized Clinical Trials Of Nonpharmacological Treatments
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Author : Isabelle Boutron
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Randomized Clinical Trials Of Nonpharmacological Treatments written by Isabelle Boutron and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Mathematics categories.
Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. Unlike pharmacological treatments, these have no specific requirements for approval. Consequently, they can be widely proposed in clinical pra
The Prevention And Treatment Of Missing Data In Clinical Trials
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2010-12-21
The Prevention And Treatment Of Missing Data In Clinical Trials written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-21 with Medical categories.
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
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Author : David Cella
language : en
Publisher: RTI Press
Release Date : 2015-09-17
Patient Reported Outcomes In Performance Measurement written by David Cella and has been published by RTI Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-17 with Medical categories.
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.
