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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]
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
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]
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]
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]
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]
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
Pragmatic Clinical Trials: The Ethics of Conducting Research in the Real World. [PDF]
Vaszar LT +3 more
europepmc +2 more sources
Independence estimators for re-randomisation trials in multi-episode settings: a simulation study
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
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

