An evaluation of factors that may influence clinicians' decisions not to enroll eligible patients into randomized trials in critical care
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 S...
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| Veröffentlicht in: | PloS one 2021-07, Vol.16 (7), p.e0255361-e0255361 |
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| creator | Ramanan, Mahesh Billot, Laurent Rajbhandari, Dorrilyn Myburgh, John Venkatesh, Balasubramanian |
| description | 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. |
| doi_str_mv | 10.1371/journal.pone.0255361 |
| format | Article |
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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.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0255361</identifier><identifier>PMID: 34314449</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Clinical Decision-Making ; Clinical trials ; Consent ; Critical Care ; Critical care medicine ; Decision-making ; Enrollments ; Evaluation ; Glucocorticoids ; Humans ; Intensive care ; Intensive Care Units ; Intervention ; Logistic Models ; Medicine ; Medicine and Health Sciences ; Multicenter Studies as Topic ; Patients ; People and places ; Physicians - psychology ; Randomization ; Randomized Controlled Trials as Topic ; Research and Analysis Methods ; Sepsis ; Septic shock ; Tertiary Care Centers ; Variables</subject><ispartof>PloS one, 2021-07, Vol.16 (7), p.e0255361-e0255361</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Ramanan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Ramanan et al 2021 Ramanan et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-80fc6a53cf13860c33a28e1ee3becb4e417cc1993e666960d1c936bba7ba93b63</citedby><cites>FETCH-LOGICAL-c692t-80fc6a53cf13860c33a28e1ee3becb4e417cc1993e666960d1c936bba7ba93b63</cites><orcidid>0000-0003-4509-4015</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8315530/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8315530/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34314449$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Maerz, Linda L.</contributor><creatorcontrib>Ramanan, Mahesh</creatorcontrib><creatorcontrib>Billot, Laurent</creatorcontrib><creatorcontrib>Rajbhandari, Dorrilyn</creatorcontrib><creatorcontrib>Myburgh, John</creatorcontrib><creatorcontrib>Venkatesh, Balasubramanian</creatorcontrib><title>An evaluation of factors that may influence clinicians' decisions not to enroll eligible patients into randomized trials in critical care</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>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.</description><subject>Clinical Decision-Making</subject><subject>Clinical trials</subject><subject>Consent</subject><subject>Critical Care</subject><subject>Critical care medicine</subject><subject>Decision-making</subject><subject>Enrollments</subject><subject>Evaluation</subject><subject>Glucocorticoids</subject><subject>Humans</subject><subject>Intensive care</subject><subject>Intensive Care Units</subject><subject>Intervention</subject><subject>Logistic Models</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Multicenter Studies as Topic</subject><subject>Patients</subject><subject>People and places</subject><subject>Physicians - psychology</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Research and Analysis 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One</addtitle><date>2021-07-27</date><risdate>2021</risdate><volume>16</volume><issue>7</issue><spage>e0255361</spage><epage>e0255361</epage><pages>e0255361-e0255361</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><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.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>34314449</pmid><doi>10.1371/journal.pone.0255361</doi><tpages>e0255361</tpages><orcidid>https://orcid.org/0000-0003-4509-4015</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Clinical Decision-Making Clinical trials Consent Critical Care Critical care medicine Decision-making Enrollments Evaluation Glucocorticoids Humans Intensive care Intensive Care Units Intervention Logistic Models Medicine Medicine and Health Sciences Multicenter Studies as Topic Patients People and places Physicians - psychology Randomization Randomized Controlled Trials as Topic Research and Analysis Methods Sepsis Septic shock Tertiary Care Centers Variables |
| title | An evaluation of factors that may influence clinicians' decisions not to enroll eligible patients into randomized trials in critical care |
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