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Principles and procedures for data and safety monitoring in pragmatic clinical trials

Gregory E. Simon, Susan M. Shortreed, Rebecca C. Rossom, Robert B. Penfold, Jo Ann M. Sperl-Hillen, Patrick O'Connor
2019 Trials  
risks; monitoring quality and timeliness of study data; and considering interim analyses for early detection of benefit, harm, or futility.  ...  Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and traditional explanatory clinical trials.  ...  In many pragmatic trials, outcome data are extracted from records generated by routine health care operations [1, 5, 15] .  ... 
doi:10.1186/s13063-019-3869-3 pmid:31815644 pmcid:PMC6902512 fatcat:5kfzvrtklfgndlytf3dqufrdia

Interaction Mining: The New Frontier of Customer Interaction Analytics [chapter]

Vincenzo Pallotta, Rodolfo Delmonte
2013 Studies in Computational Intelligence  
In this paper, we present our solution for pragmatic analysis of call center conversations in order to provide useful insights for enhancing Call Center Analytics to a level that will enable new metrics  ...  Interaction Mining approach in order to address the current business challenges in call centers quality monitoring and assessment.  ...  It is important to note that while the purpose is similar, namely turning unstructured data into structured data for performing quantitative analysis, Text Mining focuses on pattern extraction from documents  ... 
doi:10.1007/978-3-642-31546-6_6 fatcat:yqdiy52bfzd2flaqvyrpocht6e

Introduction to the Issue on Automatic Assessment of Health Disorders Based on Voice, Speech, and Language Processing

Juan I. Godino-Llorente, Douglas O'Shaughnessy, Tan Lee, Najim Dehak, Claudia Manfredi
2020 IEEE Journal on Selected Topics in Signal Processing  
The authors introduce a new active data representation method for feature extraction in AD dementia recognition.  ...  In "Multimodal and multi-output deep learning architectures for the automatic assessment of voice quality using the GRB scale," Arias-Londoño et al. propose a technique based on deep learning to objectively  ...  His recent research interests include automatic assessment of voice disorder, speech disorder and language impairment, analysis of child and elderly speech, and speech under pressure.  ... 
doi:10.1109/jstsp.2020.2978566 fatcat:32x76k4fnfhpbcpixz365muapm

Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Non-Individualised Homeopathic Treatment

Yvonne Fok, Petter Viksveen, Aaron To, Jonathan Davidson, Robert Mathie
2019 Homeopathy  
Ten trials had data that were extractable for analysis. Significant heterogeneity undermined the planned meta-analyses or their meaningful interpretation.  ...  For each study, to assess its risk of bias and to determine whether its study attitude was predominantly 'pragmatic' or 'explanatory'. Methods Systematic review.  ...  Acknowledgments We thank Daniela Hacke, Karl und Veronica Carstens-Stiftung, Essen, Germany, for assistance with the literature search and retrieval of relevant full-text articles.  ... 
doi:10.1055/s-0038-1677481 pmid:30699444 fatcat:hslgy3hhire73anu7cue466h6a

Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Individualised Homeopathic Treatment

Susanne Ulbrich-Zürni, Petter Viksveen, E. Roberts, Elizabeth Baitson, Lynn Legg, Jonathan Davidson, Robert Mathie
2018 Homeopathy  
Eight trials had data that were extractable for analysis: for four heterogeneous trials with design Ia, the pooled OR was statistically non-significant; collectively for three clinically heterogeneous  ...  For each study, to assess the risk of bias and to determine whether its study attitude was predominantly 'pragmatic' or 'explanatory'. Methods Systematic review.  ...  Acknowledgments We thank Daniela Hacke, Karl und Veronica Carstens-Stiftung, Essen, Germany, for assistance with the literature search and retrieval of relevant full-text articles.  ... 
doi:10.1055/s-0038-1667129 pmid:30121049 fatcat:nof7itpcrrgv3i4amx53vpvu34

A USER-DRIVEN SELECTION OF VGI BASED ON MINIMUM ACCEPTABLE QUALITY LEVELS

G. Bordogna, P. Carrara, L. Criscuolo, M. Pepe, A. Rampini
2015 ISPRS Annals of the Photogrammetry, Remote Sensing and Spatial Information Sciences  
The paper first briefly presents a view on VGI components and suitable quality indices, then it describes a logic architecture for managing them and for enabling a querying mechanism to the datasets.  ...  In order to overcome this weakness, the authors propose to perform an user-driven assessment on VGI items in order to filter only those that satisfy minimally acceptable quality levels defined according  ...  and automatically extracted from VGI analysis itself.  ... 
doi:10.5194/isprsannals-ii-3-w5-277-2015 fatcat:eqc5ijo7gzgbxidpjydblawjtm

Subject index

2006 JAMIA Journal of the American Medical Informatics Association  
See Data Extraction and Longitudinal Time Anal- ysis.  ...  , for synthesis of data from disparate data- bases, 289 -301 Data set minimum, for care of HIV patients in developing coun- tries, pragmatic approach to construction of, 253-260 Decision support system  ...  accuracy of identification using automatic text categorization of x-ray reports, 696 -698 X XML-based data management system for synthesis of data from disparate databases, 289 -301 X-ray reports accuracy  ... 
doi:10.1197/s1067-5027(06)00177-0 fatcat:4szekiclqzfvrcndhtrmvjp62u

Handling quality in crowdsourced geographic information [chapter]

Laura Criscuolo, Paola Carrara, Gloria Bordogna, Monica Pepe, Francesco Zucca, Roberto Seppi, Alessandro Oggioni, Anna Rampini
2016 European Handbook of Crowdsourced Geographic Information  
While spatial information quality is an established discipline in traditional scientific geographical information (GI), standards and protocols for representing and assessing the quality of geographic  ...  In this framework, and based on the research carried out in Criscuolo et al. (2014) , we also introduce a methodology for quality assessment, based on the given representation, which goes beyond the limitations  ...  The present work is based on the research carried out in the framework of a PhD programme of the University of Pavia, Dept. of Earth and Environmental Sciences, and has been supported by the Institute for  ... 
doi:10.5334/bax.e fatcat:iahhl7fuxbgadefogadeikoyqu

Design and Evaluation of an Augmented Reality-Based Exergame System to Reduce Fall Risk in the Elderly

Meiling Chen, Qingfeng Tang, Shoujiang Xu, Pengfei Leng, Zhigeng Pan
2020 International Journal of Environmental Research and Public Health  
After comparing the average score in a dataset product of UEQ-S Data Analysis Tool, it was found that the pragmatic quality aspect was categorized as good, while the hedonic quality aspect was categorized  ...  It was shown that the average scores for each aspect were: pragmatic quality score (1.652 ± 0.868); hedonic quality score (1.880 ± 0.962); and overall score was 1.776 ± 0.819.  ...  The average score for each aspect were: pragmatic quality (1.652 ± 0.868), hedonic quality (1.880 ± 0.962), and the overall score was 1.776 ± 0.819.  ... 
doi:10.3390/ijerph17197208 pmid:33019759 fatcat:4r2ekl25fraa7j2j73rpdqq6wu

Big Data for Clinical Trials: Automated Collection of SpO2 for a Trial of Oxygen Targets during Mechanical Ventilation

Kevin G. Buell, Jonathan D. Casey, Li Wang, Jonathan P. Wanderer, Wesley H. Self, Todd W. Rice, Matthew W. Semler
2020 Journal of medical systems  
As pragmatic trials recruit a larger number of patients, automated extraction of SpO 2 could allow collection of more granular data on oxygenation for conduct, monitoring, and analysis.  ...  We developed a technique for automated extraction of large-volume data on SpO 2 values for use in a randomized clinical trial.  ... 
doi:10.1007/s10916-020-01632-4 pmid:32737684 pmcid:PMC7394476 fatcat:2dlzejsb5bap3hbxnuntt7o5e4

Automatic Intonation Recognition for the Prosodic Assessment of Language-Impaired Children

Fabien Ringeval, Julie Demouy, György Szaszak, Mohamed Chetouani, Laurence Robel, Jean Xavier, David Cohen, Monique Plaza
2011 IEEE Transactions on Audio, Speech, and Language Processing  
The automatic approach used in this study to assess LIC's prosodic skills confirms the clinical descriptions of the subjects' communication impairments.  ...  An automatic system was then used to assess LIC's prosodic skills by comparing the intonation recognition scores with those obtained by the control group.  ...  ., grammatical, pragmatic and affective, cf. Section I-A) are assessed using the PEPS-C with a constrained speech framework.  ... 
doi:10.1109/tasl.2010.2090147 fatcat:m2fugwvbrvah3aijtz2xxuzw5e

Developing a Measurement Instrument for Subjective Aspects of Information Quality

Rosanne Price, Dina Neiger, Graeme Shanks
2008 Communications of the Association for Information Systems  
The InfoQual framework provides a sound theoretical basis for defining information quality at three levels: syntactic (form), semantic (content), and pragmatic (usage).  ...  Having quality information is crucial for effective operations and decision making within organisations.  ...  The instrument is intended to allow assessment of subjective IQ for a given data set using the pragmatic criteria. III.  ... 
doi:10.17705/1cais.02203 fatcat:t7jiejxjvzbyda6thnnpnuxroa

From Nonclinical Research to Clinical Trials and Patient-registries: Challenges and Opportunities in Biomedical Research

José M. de la Torre Hernández, Elazer R. Edelman
2017 Revista española de cardiología (English ed.)  
The only way to provide better solutions for health care is innovation, true innovation. The only source of true innovation is research, good research indeed.  ...  There is increasing demand for evidence to guide clinical practice but, paradoxically, biomedical research has become increasingly complex, expensive, and difficult to integrate into clinical care with  ...  Automatic data extraction is feasible for some data, such as laboratory results and demographics but extraction from EHR of more detailed elements in clinical registries will require the personnel administering  ... 
doi:10.1016/j.rec.2017.07.008 pmid:28838647 pmcid:PMC5975372 fatcat:lqc3ycc4ivcenn6m6yw2yauyma

CONQUEST: A Quality Improvement Program for Defining and Optimizing Standards of Care for Modifiable High-Risk COPD Patients

Luis Alves, Rachel Pullen, John R Hurst, Marc Miravitlles, Victoria Carter, Rongchang Chen, Amy Couper, Mark Dransfield, Alexander Evans, Antony Hardjojo, David Jones, Rupert Jones (+14 others)
2022 Patient Related Outcome Measures  
The COllaboration on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST) aims to improve the quality of COPD care in primary care.  ...  Regular, automated collection and analysis of data, combined with a cyclical review of the implementation process, will be conducted for long-term, continuous improvement and health impact evaluation.  ...  Writing, editorial support, and/or formatting assistance in the development of this manuscript was provided by Shilpa Suresh, MSc, of the Observational and Pragmatic Research Institute, Singapore.  ... 
doi:10.2147/prom.s296506 fatcat:a4rhzvh42vf6rdf7l4z4jskqj4

Prescribing Data in General Practice Demonstration (PDGPD) project - a cluster randomised controlled trial of a quality improvement intervention to achieve better prescribing for chronic heart failure and hypertension

Margaret Williamson, Magnolia Cardona-Morrell, Jeffrey D Elliott, James F Reeve, Nigel P Stocks, Jon Emery, Judith M Mackson, Jane M Gunn
2012 BMC Health Services Research  
De-identified data on practice, doctor and patient characteristics and their treatment for CHF and HT are extracted at six-monthly intervals before and after the intervention.  ...  Methods: A pragmatic multi site cluster RCT began recruiting practices in October 2009 to evaluate the effects of a multi-faceted quality improvement (QI) intervention on prescribing practice among Australian  ...  Continue the quality improve activity Assess current data, reflect on progress and plan next quality improvement cycle. Step 1.  ... 
doi:10.1186/1472-6963-12-273 pmid:22913571 pmcid:PMC3515472 fatcat:ygsyxdqnxrdppnwevr3hhqupha
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