Robert H Schmicker1, Graham Nichol2, Clifton W Callaway3, Sheldon Cheskes4, George Sopko5, Henry E Wang6. 1. Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA. 2. Departments of Medicine and Emergency Medicine, University of Washington, Seattle, WA. 3. Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA. 4. Division of Family and Community Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Ontario, Canada. 5. National Heart, Lung, and Blood Institute, Bethesda, MD. 6. Department of Emergency Medicine, The University of Texas Health Science Center at Houston, Houston, TX.
Abstract
OBJECTIVE: Clinical trial investigators often assemble internal study monitoring committees (SMCs) to measure individual or group adherence with trial performance benchmarks. We examined the processes and results of study monitoring in an international trial of out-of-hospital cardiac arrest. METHODS: We studied SMC operations for the Resuscitation Outcomes Consortium (ROC) Continuous Chest Compressions (CCC) trial, which compared continuous with interrupted chest compressions upon survival after out-of-hospital cardiac arrest. The SMC defined trial performance benchmarks, which included compliance with the intervention, cardiopulmonary resuscitation (CPR) process data availability and timely data completion. Trial investigators received monthly performance reports. We determined rates of trial noncompliance and suspension from the trial. RESULTS: ROC-CCC enrolled a total of 23,711 subjects in the primary analysis population. Across 113 enrolling agencies, the SMC monitored performance for a total 2,367 agency-months. Emergency medical services agencies were on probation for a total of 178 (7.5%) agency-months. Fifty-five agencies were placed on probation at least once, of which 78% improved their performance and were approved for continued participation in the trial. A total of 12 agencies were suspended from trial participation. Data monitoring resulted in high-quality CPR (mean chest compression fraction = 0.80), 87% CPR process availability and timely data completion (75th and 95th percentiles prehospital data = 22 and 57 days; hospital data = 58 and 118 days). CONCLUSIONS: Study monitoring procedures may play an important role in ensuring the performance quality in acute care clinical trials.
OBJECTIVE: Clinical trial investigators often assemble internal study monitoring committees (SMCs) to measure individual or group adherence with trial performance benchmarks. We examined the processes and results of study monitoring in an international trial of out-of-hospital cardiac arrest. METHODS: We studied SMC operations for the Resuscitation Outcomes Consortium (ROC) Continuous Chest Compressions (CCC) trial, which compared continuous with interrupted chest compressions upon survival after out-of-hospital cardiac arrest. The SMC defined trial performance benchmarks, which included compliance with the intervention, cardiopulmonary resuscitation (CPR) process data availability and timely data completion. Trial investigators received monthly performance reports. We determined rates of trial noncompliance and suspension from the trial. RESULTS: ROC-CCC enrolled a total of 23,711 subjects in the primary analysis population. Across 113 enrolling agencies, the SMC monitored performance for a total 2,367 agency-months. Emergency medical services agencies were on probation for a total of 178 (7.5%) agency-months. Fifty-five agencies were placed on probation at least once, of which 78% improved their performance and were approved for continued participation in the trial. A total of 12 agencies were suspended from trial participation. Data monitoring resulted in high-quality CPR (mean chest compression fraction = 0.80), 87% CPR process availability and timely data completion (75th and 95th percentiles prehospital data = 22 and 57 days; hospital data = 58 and 118 days). CONCLUSIONS: Study monitoring procedures may play an important role in ensuring the performance quality in acute care clinical trials.
Authors: Robert H Schmicker; Graham Nichol; Peter Kudenchuk; Jim Christenson; Christian Vaillancourt; Henry E Wang; Tom P Aufderheide; Ahamed H Idris; Mohamud R Daya Journal: Resuscitation Date: 2021-06-05 Impact factor: 6.251