Retesting the Hypothesis of a Clinical Randomized Controlled Trial in a Simulation Environment to Validate Anesthesia Simulation in Error Research (the VASER Study)

BACKGROUND:Simulation has been used to investigate clinical questions in anesthesia, surgery, and related disciplines, but there are few data demonstrating that results apply to clinical settings. We asked “would results of a simulation-based study justify the same principal conclusions as those of...

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Veröffentlicht in:Anesthesiology (Philadelphia) 2017-03, Vol.126 (3), p.472-481
Hauptverfasser: Merry, Alan F, Hannam, Jacqueline A, Webster, Craig S, Edwards, Kylie-Ellen, Torrie, Jane, Frampton, Chris, Wheeler, Daniel W, Gupta, Arun K, Mahajan, Ravi P, Evley, Rachel, Weller, Jennifer M
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container_end_page 481
container_issue 3
container_start_page 472
container_title Anesthesiology (Philadelphia)
container_volume 126
creator Merry, Alan F
Hannam, Jacqueline A
Webster, Craig S
Edwards, Kylie-Ellen
Torrie, Jane
Frampton, Chris
Wheeler, Daniel W
Gupta, Arun K
Mahajan, Ravi P
Evley, Rachel
Weller, Jennifer M
description BACKGROUND:Simulation has been used to investigate clinical questions in anesthesia, surgery, and related disciplines, but there are few data demonstrating that results apply to clinical settings. We asked “would results of a simulation-based study justify the same principal conclusions as those of a larger clinical study?” METHODS:We compared results from a randomized controlled trial in a simulated environment involving 80 cases at three centers with those from a randomized controlled trial in a clinical environment involving 1,075 cases. In both studies, we compared conventional methods of anesthetic management with the use of a multimodal system (SAFERsleep; Safer Sleep LLC, Nashville, Tennessee) designed to reduce drug administration errors. Forty anesthesiologists each managed two simulated scenarios randomized to conventional methods or the new system. We compared the rate of error in drug administration or recording for the new system versus conventional methods in this simulated randomized controlled trial with that in the clinical randomized controlled trial (primary endpoint). Six experts were asked to indicate a clinically relevant effect size. RESULTS:In this simulated randomized controlled trial, mean (95% CI) rates of error per 100 administrations for the new system versus conventional groups were 6.0 (3.8 to 8.3) versus 11.6 (9.3 to 13.8; P = 0.001) compared with 9.1 (6.9 to 11.4) versus 11.6 (9.3 to 13.9) in the clinical randomized controlled trial (P = 0.045). A 10 to 30% change was considered clinically relevant. The mean (95% CI) difference in effect size was 27.0% (−7.6 to 61.6%). CONCLUSIONS:The results of our simulated randomized controlled trial justified the same primary conclusion as those of our larger clinical randomized controlled trial, but not a finding of equivalence in effect size.
doi_str_mv 10.1097/ALN.0000000000001514
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RESULTS:In this simulated randomized controlled trial, mean (95% CI) rates of error per 100 administrations for the new system versus conventional groups were 6.0 (3.8 to 8.3) versus 11.6 (9.3 to 13.8; P = 0.001) compared with 9.1 (6.9 to 11.4) versus 11.6 (9.3 to 13.9) in the clinical randomized controlled trial (P = 0.045). A 10 to 30% change was considered clinically relevant. The mean (95% CI) difference in effect size was 27.0% (−7.6 to 61.6%). CONCLUSIONS:The results of our simulated randomized controlled trial justified the same primary conclusion as those of our larger clinical randomized controlled trial, but not a finding of equivalence in effect size.</description><identifier>ISSN: 0003-3022</identifier><identifier>EISSN: 1528-1175</identifier><identifier>DOI: 10.1097/ALN.0000000000001514</identifier><identifier>PMID: 28079566</identifier><language>eng</language><publisher>United States: Copyright by , the American Society of Anesthesiologists, Inc. 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RESULTS:In this simulated randomized controlled trial, mean (95% CI) rates of error per 100 administrations for the new system versus conventional groups were 6.0 (3.8 to 8.3) versus 11.6 (9.3 to 13.8; P = 0.001) compared with 9.1 (6.9 to 11.4) versus 11.6 (9.3 to 13.9) in the clinical randomized controlled trial (P = 0.045). A 10 to 30% change was considered clinically relevant. The mean (95% CI) difference in effect size was 27.0% (−7.6 to 61.6%). CONCLUSIONS:The results of our simulated randomized controlled trial justified the same primary conclusion as those of our larger clinical randomized controlled trial, but not a finding of equivalence in effect size.</description><subject>Anesthesia - standards</subject><subject>Australia</subject><subject>Humans</subject><subject>Medication Errors - prevention &amp; control</subject><subject>New Zealand</subject><subject>Prospective Studies</subject><subject>Reproducibility of Results</subject><subject>Simulation Training - methods</subject><issn>0003-3022</issn><issn>1528-1175</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcFuGyEQhlGUKnbTvkFVcUwOm8KyGPZoWU5SyWol2_J1xe7O1rQsOMAmcp4nD1osJ1GbQ7gMA9__z0g_Ql8ouaKkFN-mix9X5J9DOS1O0JjyXGaUCn6KxumVZYzk-Qh9DOF3agVn8gyNcklEySeTMXpaQoQQtf2F4xbw7X7nUg06YNdhhWdGW90og5fKtq7Xj9DimbPRO2PSde11-tM2kSvdD0ZF7Sye23vtne3BRhwd3iijWxUBT22adDD_j07quffO4yUEUL7Z4ovDJpvpar7Eqzi0-8tP6EOnTIDPz_Ucra_n69lttvh58302XWQN45MiyzuqpKo7RkhZKskmquGsERKoKHJBZMGhEy3viq7mpOSyJo2sqQDCWklAsHN0cbTdeXc3pF2rXocGjFEW3BAqKrmkhMm8SGhxRBvvQvDQVTuve-X3FSXVIZ4qxVO9jSfJvj5PGOoe2lfRSx4JkEfgwZkIPvwxwwP4agvKxO373n8BEGGdSw</recordid><startdate>201703</startdate><enddate>201703</enddate><creator>Merry, Alan F</creator><creator>Hannam, Jacqueline A</creator><creator>Webster, Craig S</creator><creator>Edwards, Kylie-Ellen</creator><creator>Torrie, Jane</creator><creator>Frampton, Chris</creator><creator>Wheeler, Daniel W</creator><creator>Gupta, Arun K</creator><creator>Mahajan, Ravi P</creator><creator>Evley, Rachel</creator><creator>Weller, Jennifer M</creator><general>Copyright by , the American Society of Anesthesiologists, Inc. 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source MEDLINE; Journals@Ovid Complete; EZB-FREE-00999 freely available EZB journals
subjects Anesthesia - standards
Australia
Humans
Medication Errors - prevention & control
New Zealand
Prospective Studies
Reproducibility of Results
Simulation Training - methods
title Retesting the Hypothesis of a Clinical Randomized Controlled Trial in a Simulation Environment to Validate Anesthesia Simulation in Error Research (the VASER Study)
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