Abstract
To determine the association between intensive care unit (ICU) characteristics and clinicians' decision to decline eligible patients for randomization into a multicentered pragmatic comparative-effectiveness controlled trial. Screening logs from the Adjunctive Glucocorticoid Therapy in Septic Shock Trial (ADRENAL) and site-level data from the College of Intensive Care Medicine and Australia New Zealand Intensive Care Society were examined. The effects of ICU characteristics such as tertiary academic status, research coordinator availability, number of admissions, and ICU affiliations on clinicians declining to randomize eligible patients were calculated using mixed effects logistic regression modelling. There were 21,818 patients screened for inclusion in the ADRENAL trial at 69 sites across five countries, out of which 5,501 were eligible, 3,800 were randomized and 659 eligible patients were declined for randomization by the treating clinician. The proportion of eligible patients declined by clinicians at individual ICUs ranged from 0 to41%. In the multivariable model, none of the ICU characteristics were significantly associated with higher clinician decline rate. Neither tertiary academic status, nor other site-level variables were significantly associated with increased rate of clinicians declining eligible patients.
Highlights
Prompt enrollment of eligible patients into randomized controlled trials (RCTs) is recognized as a research priority [1]
There were 21,818 patients screened for inclusion in the ADRENAL trial at 69 sites across five countries, out of which 5,501 were eligible, 3,800 were randomized and 659 eligible patients were declined for randomization by the treating clinician
The proportion of eligible patients declined by clinicians at individual intensive care unit (ICU) ranged from 0 to41%
Summary
Prompt enrollment of eligible patients into randomized controlled trials (RCTs) is recognized as a research priority [1]. Enrolment of patients into RCTs in critical care poses challenges including difficulties in obtaining consent because of their altered conscious state due to either underlying conditions or acute therapeutic interventions [2, 3]. Within this environment, attending clinicians may decline to enroll potentially eligible patients, which has been reported to occur for 3–15% of eligible patients [3, 4]. A detailed evaluation of the influence of site-level factors on the clinician decline rate, that is the proportion of eligible patients that are declined for randomization by the treating clinician, in critical care RCTs has not been performed. We hypothesized that factors such as the academic and tertiary status of the intensive care unit (ICU) and availability of dedicated research staff may be associated with reduced clinician decline rate
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