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Pragmatic clinical trials

open access: yesКачественная 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
doaj   +5 more sources

Implementing pragmatic clinical trials in hepatology. [PDF]

open access: yesHepatology, 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.
europepmc   +4 more sources

Pragmatic Clinical Trials, Linkages and Agreements: Interjurisdictional Collaboration on Pragmatic Clinical Trials

open access: yesInternational Journal of Population Data Science
The 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
doaj   +2 more sources

Empirical research related to the ethics of pragmatic clinical trials: A scoping review [PDF]

open access: yesLearning Health Systems
Background 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
doaj   +2 more sources

Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies [PDF]

open access: yesTrials, 2023
Background With recent growth in the conduct of pragmatic clinical trials, the reliance on frontline staff to contribute to trial-related activities has grown as well.
Lisa A. Juckett   +2 more
doaj   +2 more sources

Randomized in error in pragmatic clinical trials. [PDF]

open access: yesContemp Clin Trials
Pragmatic 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.
europepmc   +3 more sources

Protecting seriously ill populations during pragmatic clinical trials. [PDF]

open access: yesJ Am Geriatr Soc, 2023
Abstract Pragmatic clinical trials (PCTs) emphasize real‐world effectiveness methodology to address the limitations of results from explanatory randomized clinical trials (RCTs), which often fail to translate to real‐world medical practice. An inherent tension in the conduct of PCTs is that the research must impose a minimal burden on
Teno JM, Hanson LC, Lima JC, Saliba D.
europepmc   +3 more sources

Independence estimators for re-randomisation trials in multi-episode settings: a simulation study

open access: yesBMC 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
doaj   +1 more source

Effectiveness of group arts therapies (art therapy, dance movement therapy and music therapy) compared to group counselling for diagnostically heterogeneous psychiatric community patients: study protocol for a randomised controlled trial in mental health services (the ERA study)

open access: yesTrials, 2023
Background Arts therapies are widely but inconsistently provided in community mental health. Whilst they are appealing to patients, evidence for their effectiveness is mixed. Trials to date have been limited to one art-form or diagnosis.
Catherine E. Carr   +5 more
doaj   +1 more source

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