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Качественная клиническая практика, 2020 Pragmatic clinical trials (PCTs) allow combining the advantages of observational trials in real-world evidence with the scientific rigor of randomized clinical trials (RCTs), and thereby provide more effective answers to questions of real-world evidence ...
O. R. Shevchenko, A. S. Kolbin
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Implementing pragmatic clinical trials in hepatology. [PDF]
Hepatology, 2023 Patients with chronic liver disease would benefit from pragmatic trial designs. A pragmatic trial seeks to inform clinical decision-making by providing evidence for the adoption of an intervention into real-world clinical practice. A trial’s pragmatism is based on the efficiency by which it identifies, recruits, and follows patients, the degree to ...
Tapper EB, Serper M, Goldberg DS.
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International Journal of Population Data ScienceThe randomized clinical trial framework has proven to be a robust way of evaluating and comparing medications and procedures for many years. The promise of measured and unmeasured balance and equipoise through randomization remains very appealing ...
Jeff Bakal +2 more
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Randomized in error in pragmatic clinical trials. [PDF]
Contemp Clin TrialsPragmatic trials that combine electronic health record data and patient-reported data may be subject to selection bias due to the differential post-randomization exclusion of participants who are randomized in error. Such situations are often caused by inevitable reasons, such as incomplete patient medical records at the pre-randomization stage.
Tong G, Coronado GD, Li C, Li F.
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Empirical research related to the ethics of pragmatic clinical trials: A scoping review [PDF]
Learning Health SystemsBackground Pragmatic clinical trials (PCTs) offer insights into real‐world intervention effectiveness, but they may involve challenging ethical issues. Empirical ethics research may inform deliberations about them.
Kayla R. Mehl +2 more
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Untapped Potential? Representativeness in Pragmatic Clinical Trials. [PDF]
JAMAThis JAMA Viewpoint explores the potential of pragmatic clinical trials to improve demographic representativeness and health equity in clinical research.
Propes C, Mehl K, Morain SR.
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Pragmatic Clinical Trials: The Ethics of Conducting Research in the Real World. [PDF]
Mayo Clin ProcVaszar LT +3 more
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Independence estimators for re-randomisation trials in multi-episode settings: a simulation study
BMC Medical Research Methodology, 2021 Background Re-randomisation trials involve re-enrolling and re-randomising patients for each new treatment episode they experience. They are often used when interest lies in the average effect of an intervention across all the episodes for which it would
Brennan C. Kahan +3 more
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What Is a Pragmatic Clinical Trial? [PDF]
Journal of Investigative Dermatology, 2015 Pragmatic trials Pragmatic clinical trials seek to determine the effectiveness of an intervention in a real-world setting to inform clinical decision making (Roland and Torgerson, 1998). Researchers designing pragmatic trials take particular care to ensure that the study population is as similar as possible to the population on which the intervention ...
Williams, Hywel C. +2 more
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Gatekeepers for pragmatic clinical trials [PDF]
Clinical Trials, 2015 To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the ...
Danielle M, Whicher +3 more
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