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Hospitals that participate in clinical trials may provide better patient care
March 25, 2008
CHICAGO - Hospitals that participate in clinical trials appear to provide better care for patients with heart attacks or other acute heart events and have lower death rates than hospitals that do not participate in clinical trials, according to a report in the March 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Quality of care for common conditions such as acute coronary syndromes has slowly improved after the implementation of clinical guidelines, performance measurement and quality improvement efforts. Recent studies suggest that physician leadership, presence of shared goals, administrative support and credible feedback are associated with better hospital performance. Three of these characteristics are also believed to be important in successfully conducting hospital-based clinical trials. "We hypothesized that these same elements required for hospitals to participate in trials could induce beneficial changes in the hospital environment, thereby leading to better processes and outcomes of care for patients treated outside the trial setting," the authors write.
Sumit R. Majumdar, M.D., M.P.H., of the University of Alberta, Canada, and colleagues analyzed data from 174,062 patients with two specific types of heart conditions, high-risk non-ST-segment elevation acute coronary syndrome with unstable angina and non-ST-segment elevation myocardial infarction. The patients were admitted to 494 hospitals participating in Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE)-an ongoing, voluntary, observational data collection and quality improvement initiative-from Jan. 1, 2001 to June 30, 2006. Process-of-care and in-hospital outcome data were collected. Patients were split into three groups: those treated at hospitals with no trial participation (29,984 patients), low trial participation (93,705 patients) and high trial participation (50,373 patients).
In total, 4,590 patients (2.6 percent) were enrolled in clinical trials, with 145 hospitals having no enrollment, 226 hospitals having a midpoint of 1 percent enrollment and 123 hospitals having a midpoint of 4.9 percent enrollment.
The overall (composite) median (midpoint) guideline adherence scores increased with increasing levels of trial participation, from 76.9 percent among hospitals with no trial enrollment, 78.3 percent for hospitals with low trial enrollment and 81.1 percent among hospitals with high trial enrollment. "In-hospital mortality decreased with increasing trial participation: 5.9 percent vs. 4.4 percent vs. 3.5 percent," the authors write. "Patients treated at hospitals that participated in trials had significantly lower mortality than patients treated at non-participating hospitals."
"In conclusion, patients treated at hospitals that participate in clinical trials seem to receive better quality of care and seem to have significantly better outcomes than patients treated at hospitals that do not participate in trials-at least in the setting of acute coronary syndrome," the authors conclude. "For policy makers and physicians, our findings should assuage some of the concerns related to the possible opportunity costs and potential downsides of participating in the clinical research enterprise."
JAMA and Archives Journals
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Clinical Trials - A Practical Guide to Design, Analysis, and Reporting
by Duolao Wang (Author), Ameet Bakhai (Author)
Clinical trials form the backbone of evidence-based medicine, and appreciating clinical trial methods allows readers to critique, design and report clinical trials. This book is a friendly 'jargon buster' which aims to demystify the subject. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language, the book explains - with illustrations of numerous trial examples - the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often...
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Fundamentals of Clinical Trials
by Lawrence M. Friedman (Author), Curt D. Furberg (Author), David L. DeMets (Author)
This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The text uses numerous examples of published clinical trials from a variety of medical disciplines to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered, but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this...
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Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics)
by Steven Piantadosi (Author)
Learn rigorous statistical methods to ensure valid clinical trials This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions. The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and...
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A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)
by Phillip I. Good (Author)
This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting. Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the...
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A Concise Guide to Clinical Trials
by Allan Hackshaw (Author)
Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews,...
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Introduction to Statistical Methods for Clinical Trials (Texts in Statistical Science)
by Thomas D. Cook (Author), David L DeMets (Author)
Clinical trials have taken a prominent role in the research and approval of new drugs. To conduct rigorous clinical studies, present and future biostatisticians need a good background in the design and analysis of data gleaned from those studies. This text provides a summary of statistical design, including cross-over designs, sample size estimation, sequential methods for interim analyses, survival analysis, and repeated measures. The authors also discuss a number of topics not addressed in other books on the subject, including the use of surrogate variables, meta-analysis, and longitudinal designs. Each chapter includes examples and exercises, and data sets are available for download from the Internet.
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Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators
by Judy Stone (Author)
In Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators, you will discover how to Attract drug companies to your site Land a study on good terms Recruit patient volunteers --- and keep them happy! Implement easy strategies for coordinating studies Organize your clinical trial activities Demystify regulatory requirements
Conducting Clinical Research is a practical, user-friendly how-to manual for medical professionals, physicians, nurses, study coordinators and investigators who are interested in learning what it takes to carry out clinical trials. Everything is covered from how drugs are developed to how to attract drug companies to a site, land a study, recruit volunteers, coordinate studies, organize...
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Principles and Practice of Clinical Trial Medicine
by Richard Chin (Author), Bruce Y Lee (Author)
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.
*Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data.
*Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to...
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A Step-By-Step Guide to Clinical Trials
by Marilyn Mulay (Author)
Provides a practical approach to understanding the components of a clinical research trial as well as the tools to conduct a well- organized study. Designed for those interested in developing or enhancing skills to coordinate all aspects of clinical trials such as regulatory requirements, budgeting, contracts, patient recruitments and participation, and gathering and recording clear, invaluable data.
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Clinical Trials: A Practical Approach
by Stuart J. Pocock (Author)
This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.
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