7 results
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2. Exploring the ethical and regulatory issues in pragmatic clinical trials.
- Author
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Califf RM and Sugarman J
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- Biomedical Research standards, Clinical Trials as Topic standards, Humans, National Institutes of Health (U.S.), Surveys and Questionnaires, United States, Biomedical Research ethics, Biomedical Research legislation & jurisprudence, Clinical Trials as Topic ethics, Clinical Trials as Topic legislation & jurisprudence, Decision Making ethics, Research Design standards
- Abstract
The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges. In this article, the authors briefly survey the current state of evidence that is available to inform clinical care and other health-related decisions and discuss the potential for pragmatic clinical trials to improve this state of affairs. They then propose a new working definition for pragmatic research that centers upon fitness for informing decisions about health and health care. Finally, they introduce a project, jointly undertaken by the National Institutes of Health Health Care Systems Research Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), which addresses 11 key aspects of current systems for regulatory and ethical oversight of clinical research that pose challenges to conducting pragmatic clinical trials. In the series of articles commissioned on this topic published in this issue of Clinical Trials, each of these aspects is addressed in a dedicated article, with a special focus on the interplay between ethical and regulatory considerations and pragmatic clinical research aimed at informing "real-world" choices about health and health care., (© The Author(s) 2015.) more...
- Published
- 2015
- Full Text
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3. Getting Farther Ahead by Staying Behind: A Second-Year Evaluation of Florida's Policy to End Social Promotion
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University of Arkansas, Education Working Paper Archive, Greene, Jay P., and Winters, Marcus A.
- Abstract
Social promotion has long been the normal practice in American schools. Critics of this practice, whereby students are promoted to the next grade regardless of academic preparation, have suggested that students would benefit academically if they were made to repeat a grade. Supporters of social promotion claim that retaining students (i.e, holding them back) disrupts them socially, producing greater academic harm than promotion would. A number of states and school districts, including Florida, Texas, Chicago, and New York City, have attempted to curtail social promotion, by requiring students to demonstrate academic preparation on a standardized test before they can be promoted to the next grade. This study analyzes the effects of Florida's test-based promotion policy on student achievement two years after initial retention. It builds upon our previous evaluation of the policy in two ways. First, we examine whether the initial benefits of retention observed in the previous study continue, expand, or contract in the second year after students are retained. Second, we determine whether discrepancies between our evaluation and the evaluation of a test-based promotion policy in Chicago are caused by differences in how researchers examined the issue, or by differences in the nature of the programs. Our analysis shows that, after two years of the policy, retained Florida students made significant reading gains relative to the control group of socially promoted students. These academic benefits grew substantially from the first to the second year after retention. That is, students lacking in basic skills who are socially promoted appear to fall further and further behind over time, whereas retained students appear to be able to catch up on the skills they are lacking. Further, we find these positive results in Florida, both when we use the same research design that we used in our previous study, and when we use a design similar to that employed by the evaluation of the program in Chicago. The differences between the Chicago and Florida evaluations appear to be caused by differences in the details of the programs, and not by differences in how the programs were evaluated. (Contains 5 tables and 10 footnotes.) more...
- Published
- 2006
4. Organizational status of quality assurance and end-user perceptions of information technology for information management
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P C, Pendharkar, J A, Rodger, D J, Paper, and L B, Burky
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Computer Communication Networks ,Quality Assurance, Health Care ,Attitude of Health Personnel ,Information Management ,New England ,Research Design ,Data Interpretation, Statistical ,Health Care Sector ,Regression Analysis ,Documentation ,Health Facilities ,Health Facility Administration - Abstract
This article investigates the relationship between quality assurance (QA) and perceptions of the importance of information technology (IT) for information management in the health care industry. This issue is important because effective information management is recognized as a necessary condition for quality management. The unit of analysis of the article is the health care functional department. Data from 34 health care departments were collected and used for the analysis. Four specific hypotheses were proposed and tested. Our results suggest that end-user perceptions of the importance of IT for information management depends on formalization of QA, perceived importance of QA, time since QA was embraced, and number of people in the QA function. more...
- Published
- 2000
5. Incorporating individual historical controls and aggregate treatment effect estimates into a Bayesian survival trial: a simulation study
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Lisa V. Hampson, Marie-Cécile Le Deley, Caroline Brard, Nathalie Gaspar, Gwénaël Le Teuff, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Statistical Methodology [Bâle, Suisse], Novartis Pharma AG, Département de cancérologie de l'enfant et de l'adolescent [Gustave Roussy], Institut Gustave Roussy (IGR), Unité de Méthodologie et de Biostatistique [Lille] (UMB), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER, We acknowledge for the design, analysis, interpretation of the simulation study, and for the writing of the manuscript, funding from – PhD grant from doctoral school of public health, Paris-Sud, Paris-Saclay – Lisa Hampson’s contribution to the paper was partly funded by the UK Medical Research Council (grant MR/M013510/1) and was completed while she was an employee of Lancaster University – Ligue contre le cancer, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER, and Bodescot, Myriam more...
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Simulation study ,Epidemiology ,Computer science ,Bayesian probability ,Health Informatics ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Power prior ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Adjuvants, Immunologic ,[SDV.CAN] Life Sciences [q-bio]/Cancer ,Randomized controlled trial ,law ,Statistics ,Prior probability ,Humans ,Computer Simulation ,030212 general & internal medicine ,Set (psychology) ,Baseline (configuration management) ,Bayesian randomised survival trial ,Randomized Controlled Trials as Topic ,Weibull distribution ,Osteosarcoma ,lcsh:R5-920 ,Phosphatidylethanolamines ,030503 health policy & services ,Aggregate (data warehouse) ,Bayes Theorem ,Variance (accounting) ,Models, Theoretical ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,Control Groups ,Mixture prior ,3. Good health ,[SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences ,Research Design ,Sample Size ,Individual control data ,0305 other medical science ,lcsh:Medicine (General) ,Aggregate treatment effect ,Acetylmuramyl-Alanyl-Isoglutamine ,Rare disease ,Algorithms ,Research Article - Abstract
Background Performing well-powered randomised controlled trials (RCTs) of new treatments for rare diseases is often infeasible. However, with the increasing availability of historical data, incorporating existing information into trials with small sample sizes is appealing in order to increase the power. Bayesian approaches enable one to incorporate historical data into a trial’s analysis through a prior distribution. Methods Motivated by a RCT intended to evaluate the impact on event-free survival of mifamurtide in patients with osteosarcoma, we performed a simulation study to evaluate the impact on trial operating characteristics of incorporating historical individual control data and aggregate treatment effect estimates. We used power priors derived from historical individual control data for baseline parameters of Weibull and piecewise exponential models, while we used a mixture prior to summarise aggregate information obtained on the relative treatment effect. The impact of prior-data conflicts, both with respect to the parameters and survival models, was evaluated for a set of pre-specified weights assigned to the historical information in the prior distributions. Results The operating characteristics varied according to the weights assigned to each source of historical information, the variance of the informative and vague component of the mixture prior and the level of commensurability between the historical and new data. When historical and new controls follow different survival distributions, we did not observe any advantage of choosing a piecewise exponential model compared to a Weibull model for the new trial analysis. However, we think that it remains appealing given the uncertainty that will often surround the shape of the survival distribution of the new data. Conclusion In the setting of Sarcome-13 trial, and other similar studies in rare diseases, the gains in power and accuracy made possible by incorporating different types of historical information commensurate with the new trial data have to be balanced against the risk of biased estimates and a possible loss in power if data are not commensurate. The weights allocated to the historical data have to be carefully chosen based on this trade-off. Further simulation studies investigating methods for incorporating historical data are required to generalise the findings. Electronic supplementary material The online version of this article (10.1186/s12874-019-0714-z) contains supplementary material, which is available to authorized users. more...
- Published
- 2019
- Full Text
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6. Improving study design for antidepressant effectiveness assessment
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Naudet, Florian, Millet, Bruno, Reymann, Jean-Michel, Falissard, Bruno, Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Service de Psychiatrie, Centre Hospitalier Guillaume Régnier, Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], This paper was supported by the Institut National de la Santé et de la Recherche Médicale (INSERM)., Le Corre, Morgane, Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 ), Centre d'Investigation Clinique [Rennes] ( CIC ), Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Comportement et noyaux gris centraux [Rennes], Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Service de Pharmacologie, and Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR) more...
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Depressive Disorder, Major ,clinical trials ,[SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication ,Psychometrics ,[ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health ,[ SDV.SP.MED ] Life Sciences [q-bio]/Pharmaceutical sciences/Medication ,[SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health ,Reproducibility of Results ,effectiveness ,methodology ,Original Articles ,Personality Assessment ,Antidepressive Agents ,Observational Studies as Topic ,Double-Blind Method ,[SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication ,Research Design ,Surveys and Questionnaires ,antidepressants ,[SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health ,Outcome Assessment, Health Care ,depression ,Humans ,Randomized Controlled Trials as Topic - Abstract
Antidepressants effectiveness in major depressive disorder (MDD) is still questioned because the extrapolation of randomized controlled trial (RCT) results to “real life” settings is problematic. The application of the RCT paradigm in a disorder of this type, where global care plays a central role, raises questions regarding the internal and external validity of this type of study. Outcome measurement, attrition rates, the ability of the double‐blind design to control for expectations, placebo response, the representativeness of trial participants and publication bias are major methodological pitfalls. This review discusses these issues. It is illustrated using original data and proposes some alternatives for assessing antidepressant effectiveness via different approaches. Some are easy to implement, such as ecological measures, qualitative approaches, improvement of analytical strategy and improvement of blinding procedures. Some are sophisticated, involving temporary deception to deal with the confounding effect of expectations, and they raise ethical issues. Others resort to external validity, this being the case in observational studies. But all are necessary to explore antidepressant effectiveness. Copyright © 2013 John Wiley & Sons, Ltd. more...
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- 2013
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7. A New Methodology for the History of Economic Thought
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Igersheim, Herrade, Le Chapelain, Charlotte, Centre d'EPistémologie et d'ERgologie Comparatives (CEPERC), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Bureau d'Économie Théorique et Appliquée (BETA), Université de Lorraine (UL)-Université de Strasbourg (UNISTRA)-Institut National de la Recherche Agronomique (INRA)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Recherche Agronomique (INRA)-Université de Strasbourg (UNISTRA)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Centre d'EPistémologie et d'ERgologie Comparatives - UMR 7304 (CEPERC), Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU), Universitat Autònoma de Barcelona (UAB), and Herrade Igersheim's contribution to this paper is partially supported by the Spanish Ministry of Education and Science through grant SEJ2005-01481/ECON and FEDER. more...
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Wirtschaftswissenschaft ,Volkswirtschaftstheorie ,Economics ,historical analysis ,Interdisziplinarität ,theoretical economics ,Forschungsarten der Sozialforschung ,interdisciplinarity ,Basic Research, General Concepts and History of Economics ,Wissenschaftsgeschichte ,basic research ,ddc:330 ,thinking ,Social sciences, sociology, anthropology ,ComputingMilieux_MISCELLANEOUS ,Sozialwissenschaften, Soziologie ,cliometrics ,economic theory ,Wirtschaft ,methodology ,Methodologie ,history of economic thought ,[SHS.ECO]Humanities and Social Sciences/Economics and Finance ,development of methods ,Denken ,ökonomische Theorie ,history of science ,Allgemeines, spezielle Theorien und Schulen, Methoden, Entwicklung und Geschichte der Wirtschaftswissenschaften ,Research Design ,Methodenentwicklung ,ddc:300 ,historische Analyse ,Grundlagenforschung - Abstract
Der Artikel unternimmt zu beweisen wie eine historische Vorgehensweise dazu beitragen kann verschiedene Probleme der modernen Wirtschaftstheorie besser zu verstehen. Erstens erläutern die Verfasser ihre 'Forschungsmethodologie', um die Relevanz der historischen Analyse in den Wirtschaftswissenschaften widerzuspiegeln. Die Verfasser betonen deren interdisziplinäre Vorgehensweise, da sie die Moral- und politische Philosophie, die Dogmengeschichte, die Wirtschaftstheorie sowie die modernen analytischen Instrumente einschließt. Zweitens präsentieren die Verfasser zwei Beispiele von vollendeten oder laufenden Arbeiten, die auf ihrer Methodologie beruhen. The article aims to stress that historical approach can contribute to address issues faced by modern economic theory. So as to show the relevance of historical analysis in economics, the author's first state the 'methodology' they use in their researches. The author's emphasize their interdisciplinary feature since it involves moral and political philosophy, history of economic thought, economic theory and modern analytical tools. Second, they suggest two examples of works, finished or current, which are based on their methodology. more...
- Published
- 2006
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