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Embedding Pragmatic Trials into Emergency and Critical Care (Matthew W. Semler, MD, MSc; Jonathan D. Casey, MD, MSc)

Embedding Pragmatic Trials into Emergency and Critical Care (Matthew W. Semler, MD, MSc; Jonathan D. Casey, MD, MSc)10/29/20210 CommentsSlidesSpeakers
​Matthew W. Semler, MD, MSc
Assistant Professor
Vanderbilt University Medical Center
Jonathan D. Casey, MD, MSc
Assistant Professor
Vanderbilt University Medical Center
TopicEmbedding Pragmatic Trials into Emergency and Critical CareKeywordsPragmatic clinical trials; Study design; Comparative effectiveness trials; Treatment effect; SMART trial; PreVent trial; Exception from Informed Consent (EFIC)
Key PointsEmergency medical clinicians are faced with common decisions in everyday practice with little to no data from randomized clinical trials to help inform their decisions.Four barriers to comparative effectiveness trials in a critical care setting are a brief therapeutic window, patients with multiple co-morbidities, the inability of the patient to consent to research, and analyzing average treatment effect rather than individual treatment effect.The PreVent Trial studied the use of bag-mask ventilation to prevent hypoxemia for patients who had been administered anesthesia in preparation for intubation.Efficient, pragmatic trial procedures that don’t delay treatment enable comparative effectiveness randomized clinical trials to be conducted effectively.After 50 years of debate about bag-mask ventilation during this interval period, the PreVent Trial found that bag-mask ventilation cut the rate of hypoxemia by 50% without affecting aspiration.The SMART Trial was a cluster-randomized, multiple-crossover trial of fluid management that studied patient outcomes when Balanced Crystalloids were used versus Saline solution.The large sample size of over 15,000 patients provided the SMART trial with the power to detect that a balanced crystalloid fluid prevented Major Adverse Kidney Events in 1% of patients compared to Saline solution. /li>Exception from Informed Consent (EFIC), implemented in 1996 allows trials in emergency situations of the condition is life-threatening, existing treatments are unproven or unsatisfactory, and research involves no more than minimal risk.Analyzing Individual Treatment Effects will allow clinical providers to tailor their decisions to their individual patient.Discussion ThemesClinical equipoise poses a challenge for comparative effectiveness trials.
Key to getting buy-in from clinician stakeholders is explaining the importance of the research to the pat

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