Results 71 to 80 of about 6,158,274 (301)

Series: Pragmatic trials and real world evidence: Paper 8 Data collection and management Data collection in Pragmatic Trials [PDF]

, 2017
Pragmatic trials can improve our understanding of how treatments will perform in routine practice. In a series of eight papers, the GetReal Consortium has evaluated the challenges in designing and conducting pragmatic trials and their specific ...
Matthias Egger, Egger, Matthias, Anna-Katharina Meinecke, Gaelle Nachbaur, Zuidgeest, Mira, Sven Trelle, Kafatos, George, Paco Welsing, Work Package 3 of the GetReal consortium, Burke, Des, George Kafatos, Des Burke, Trelle, Sven, Meinecke, Anna-Katharina, Maria Kubin, Nachbaur, Gaelle, Mira Zuidgeest, Welsing, Paco, Kubin, Maria, Meinecke, Anna Katharina   +19 more
core   +3 more sources

Electroencephalographic Normalization as a Biomarker of Clinical Recovery in Down Syndrome Regression Disorder

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective Down syndrome regression disorder is a syndrome characterized by subacute loss of cognitive, behavioral, and functional abilities in individuals with Down syndrome. Electroencephalography abnormalities are frequently observed during evaluation, but it remains unclear whether these findings represent a dynamic marker of disease ...
Jonathan D. Santoro, Mackenzie Silverman, Maeve C. Lucas, Mariam M. Yousuf, Samuel T. Otey, Stella V. Gray, Brittany Jordan, Madeline D. Kahan, Latanya D. Agurs, Michelle Van Hirtum Das, Deborah Holder, Devin King, Eileen A. Quinn, Ryan Kammeyer, Michael S. Rafii   +14 more
wiley   +1 more source

A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study

Contemporary Clinical Trials Communications, 2016
Objective: Methods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic
A.H. Warriner, P.J. Foster, A. Mudano, N.C. Wright, M.E. Melton, S.E. Sattui, W. Calmbach, J.R. Curtis, M. Kilgore, C.E. Lewis, W. Pace, K.G. Saag   +11 more
doaj   +1 more source

Upper Cervical Cord Area as a Biomarker of Conversion to Secondary Progressive Multiple Sclerosis

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective This study assessed whether upper cervical cord area (UCCA) measured on routine brain MRI can serve as a biomarker of conversion to SPMS. Methods This is a single‐center retrospective cohort study of RRMS patients with cross‐sectional and longitudinal analyses of clinical and MRI data. Future SPMS converters were matched by age, sex,
Nabil K. El Ayoubi, Sola Al Ghazal, Salem Hannoun, Medhat A. Siddik, Nour M. Najjar, Jim Dagher, Joseph Abboud, Myriam G. Semaan, Samia J. Khoury   +8 more
wiley   +1 more source

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

Trials, 2019
Background All clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and ...
Gregory E. Simon, Susan M. Shortreed, Rebecca C. Rossom, Robert B. Penfold, Jo Ann M. Sperl-Hillen, Patrick O’Connor   +5 more
doaj   +1 more source

Pragmatic clinical trials in the context of regulation of medicines [PDF]

Upsala Journal of Medical Sciences, 2018
The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data. From a regulatory perspective, when evaluating a new medicine before approving marketing authorization, there will never be enough patients studied in all subgroups that may potentially be at higher ...
Gedeborg, Rolf, Cline, Charles, Zethelius, Björn, Salmonson, Tomas   +3 more
openaire   +4 more sources

Deep Learning Pose Estimation for Phenotyping of Co‐Occurring Hyperkinetic Movement Disorders

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective To explore whether routine outpatient video combined with deep learning‐based pose estimation and clinically interpretable kinematic features can support multi‐label phenotyping of co‐occurring hyperkinetic movement disorders (HMDs).
Laura Cif, Diane Demailly, Gabriella A. Horvàth, Juan Dario Ortigoza Escobar, Nathalie Dorison, Mayté Castro Jiménez, Cécile A. Hubsch, Thomas Wirth, Gun‐Marie Hariz, Sophie Huby, Morgan Dornadic, Zohra Souei, Muhammad Mushhood Ur Rehman, Simone Hemm, Mehdi Boulaymen, Eduardo M. Moraud, Jocelyne Bloch, Xavier Vasques   +17 more
wiley   +1 more source

Against pragmatism: on efficacy, effectiveness and the real world

Trials, 2009
Explanatory and pragmatic trials represent ends of a continuum of attitudes about clinical trial design. Recent literature argues that pragmatic trials are more informative about clinical care in the real world. Although there is place for more pragmatic
Kitsios Georgios, Kent David M
doaj   +1 more source

Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

BMC Health Services Research, 2020
Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS.
Meg Wiggins, Mary Sawtell, Octavia Wiseman, Christine McCourt, Sandra Eldridge, Rachael Hunter, Ekaterina Bordea, Connor Mustard, Ainul Hanafiah, Bethan Hatherall, Vivian Holmes, Anita Mehay, Helliner Robinson, Cathryn Salisbury, Lorna Sweeney, Kade Mondeh, Angela Harden   +16 more
doaj   +1 more source

Global Equity in Clinical Trials: A Pragmatic Approach

JCO Global Oncology
Hussain I. Rangoonwala, Jennifer S. Morgan, Elias Melly, Abraham Siika, Patrick J. Loehrer, Naftali Busakhala   +5 more
doaj   +3 more sources