Effect sizes in ongoing randomized controlled critical care trials

Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such asse...
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Autor*in:	Elliott E. Ridgeon [verfasserIn] Rinaldo Bellomo [verfasserIn] Scott K. Aberegg [verfasserIn] Rob Mac Sweeney [verfasserIn] Rachel S. Varughese [verfasserIn] Giovanni Landoni [verfasserIn] Paul J. Young [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2017

Schlagwörter:	Intensive care unit Critical care Intensive care Randomized clinical trial Clinical trial design

Übergeordnetes Werk:	In: Critical Care - BMC, 2015, 21(2017), 1, Seite 9
Übergeordnetes Werk:	volume:21 ; year:2017 ; number:1 ; pages:9

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/s13054-017-1726-x

Katalog-ID:	DOAJ05696238X

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520			\|a Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred.
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allfields	10.1186/s13054-017-1726-x doi (DE-627)DOAJ05696238X (DE-599)DOAJd98110e10a044a8ead666b615418199d DE-627 ger DE-627 rakwb eng RC86-88.9 Elliott E. Ridgeon verfasserin aut Effect sizes in ongoing randomized controlled critical care trials 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred. Intensive care unit Critical care Intensive care Randomized clinical trial Clinical trial design Medical emergencies. Critical care. Intensive care. First aid Rinaldo Bellomo verfasserin aut Scott K. Aberegg verfasserin aut Rob Mac Sweeney verfasserin aut Rachel S. Varughese verfasserin aut Giovanni Landoni verfasserin aut Paul J. Young verfasserin aut In Critical Care BMC, 2015 21(2017), 1, Seite 9 (DE-627)331258269 (DE-600)2051256-9 1466609X nnns volume:21 year:2017 number:1 pages:9 https://doi.org/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/article/d98110e10a044a8ead666b615418199d kostenfrei http://link.springer.com/article/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/toc/1364-8535 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2017 1 9
spelling	10.1186/s13054-017-1726-x doi (DE-627)DOAJ05696238X (DE-599)DOAJd98110e10a044a8ead666b615418199d DE-627 ger DE-627 rakwb eng RC86-88.9 Elliott E. Ridgeon verfasserin aut Effect sizes in ongoing randomized controlled critical care trials 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred. Intensive care unit Critical care Intensive care Randomized clinical trial Clinical trial design Medical emergencies. Critical care. Intensive care. First aid Rinaldo Bellomo verfasserin aut Scott K. Aberegg verfasserin aut Rob Mac Sweeney verfasserin aut Rachel S. Varughese verfasserin aut Giovanni Landoni verfasserin aut Paul J. Young verfasserin aut In Critical Care BMC, 2015 21(2017), 1, Seite 9 (DE-627)331258269 (DE-600)2051256-9 1466609X nnns volume:21 year:2017 number:1 pages:9 https://doi.org/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/article/d98110e10a044a8ead666b615418199d kostenfrei http://link.springer.com/article/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/toc/1364-8535 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2017 1 9
allfields_unstemmed	10.1186/s13054-017-1726-x doi (DE-627)DOAJ05696238X (DE-599)DOAJd98110e10a044a8ead666b615418199d DE-627 ger DE-627 rakwb eng RC86-88.9 Elliott E. Ridgeon verfasserin aut Effect sizes in ongoing randomized controlled critical care trials 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred. Intensive care unit Critical care Intensive care Randomized clinical trial Clinical trial design Medical emergencies. Critical care. Intensive care. First aid Rinaldo Bellomo verfasserin aut Scott K. Aberegg verfasserin aut Rob Mac Sweeney verfasserin aut Rachel S. Varughese verfasserin aut Giovanni Landoni verfasserin aut Paul J. Young verfasserin aut In Critical Care BMC, 2015 21(2017), 1, Seite 9 (DE-627)331258269 (DE-600)2051256-9 1466609X nnns volume:21 year:2017 number:1 pages:9 https://doi.org/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/article/d98110e10a044a8ead666b615418199d kostenfrei http://link.springer.com/article/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/toc/1364-8535 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2017 1 9
allfieldsGer	10.1186/s13054-017-1726-x doi (DE-627)DOAJ05696238X (DE-599)DOAJd98110e10a044a8ead666b615418199d DE-627 ger DE-627 rakwb eng RC86-88.9 Elliott E. Ridgeon verfasserin aut Effect sizes in ongoing randomized controlled critical care trials 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred. Intensive care unit Critical care Intensive care Randomized clinical trial Clinical trial design Medical emergencies. Critical care. Intensive care. First aid Rinaldo Bellomo verfasserin aut Scott K. Aberegg verfasserin aut Rob Mac Sweeney verfasserin aut Rachel S. Varughese verfasserin aut Giovanni Landoni verfasserin aut Paul J. Young verfasserin aut In Critical Care BMC, 2015 21(2017), 1, Seite 9 (DE-627)331258269 (DE-600)2051256-9 1466609X nnns volume:21 year:2017 number:1 pages:9 https://doi.org/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/article/d98110e10a044a8ead666b615418199d kostenfrei http://link.springer.com/article/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/toc/1364-8535 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2017 1 9
allfieldsSound	10.1186/s13054-017-1726-x doi (DE-627)DOAJ05696238X (DE-599)DOAJd98110e10a044a8ead666b615418199d DE-627 ger DE-627 rakwb eng RC86-88.9 Elliott E. Ridgeon verfasserin aut Effect sizes in ongoing randomized controlled critical care trials 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred. Intensive care unit Critical care Intensive care Randomized clinical trial Clinical trial design Medical emergencies. Critical care. Intensive care. First aid Rinaldo Bellomo verfasserin aut Scott K. Aberegg verfasserin aut Rob Mac Sweeney verfasserin aut Rachel S. Varughese verfasserin aut Giovanni Landoni verfasserin aut Paul J. Young verfasserin aut In Critical Care BMC, 2015 21(2017), 1, Seite 9 (DE-627)331258269 (DE-600)2051256-9 1466609X nnns volume:21 year:2017 number:1 pages:9 https://doi.org/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/article/d98110e10a044a8ead666b615418199d kostenfrei http://link.springer.com/article/10.1186/s13054-017-1726-x kostenfrei https://doaj.org/toc/1364-8535 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2017 1 9
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Ridgeon</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Effect sizes in ongoing randomized controlled critical care trials</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2017</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. 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The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. 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callnumber-first	R - Medicine
author	Elliott E. Ridgeon
spellingShingle	Elliott E. Ridgeon misc RC86-88.9 misc Intensive care unit misc Critical care misc Intensive care misc Randomized clinical trial misc Clinical trial design misc Medical emergencies. Critical care. Intensive care. First aid Effect sizes in ongoing randomized controlled critical care trials
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topic_title	RC86-88.9 Effect sizes in ongoing randomized controlled critical care trials Intensive care unit Critical care Intensive care Randomized clinical trial Clinical trial design
topic	misc RC86-88.9 misc Intensive care unit misc Critical care misc Intensive care misc Randomized clinical trial misc Clinical trial design misc Medical emergencies. Critical care. Intensive care. First aid
topic_unstemmed	misc RC86-88.9 misc Intensive care unit misc Critical care misc Intensive care misc Randomized clinical trial misc Clinical trial design misc Medical emergencies. Critical care. Intensive care. First aid
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title	Effect sizes in ongoing randomized controlled critical care trials
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title_full	Effect sizes in ongoing randomized controlled critical care trials
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author_browse	Elliott E. Ridgeon Rinaldo Bellomo Scott K. Aberegg Rob Mac Sweeney Rachel S. Varughese Giovanni Landoni Paul J. Young
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title_sort	effect sizes in ongoing randomized controlled critical care trials
callnumber	RC86-88.9
title_auth	Effect sizes in ongoing randomized controlled critical care trials
abstract	Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred.
abstractGer	Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred.
abstract_unstemmed	Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. Interpretation of trial results could be improved by systematic assessment of the plausibility of trial hypotheses; however, such assessment has not been attempted in the field of critical care medicine. The purpose of this study was to determine clinicians’ views about prior probabilities and plausible effect sizes for ongoing critical care trials where the primary endpoint is landmark mortality. Methods We conducted a systematic review of clinical trial registries in September 2015 to identify ongoing critical care medicine trials where landmark mortality was the primary outcome, followed by a clinician survey to obtain opinions about ten large trials. Clinicians were asked to estimate the probability that each trial would demonstrate a mortality effect equal to or larger than that used in its sample size calculations. Results Estimates provided by individual clinicians varied from 0% to 100% for most trials, with a median estimate of 15% (IQR 10–20%). The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. Further work is needed to determine whether pooled estimates obtained by surveying clinicians are replicable and accurate or whether other methods of estimating prior probability are preferred.
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title_short	Effect sizes in ongoing randomized controlled critical care trials
url	https://doi.org/10.1186/s13054-017-1726-x https://doaj.org/article/d98110e10a044a8ead666b615418199d http://link.springer.com/article/10.1186/s13054-017-1726-x https://doaj.org/toc/1364-8535
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author2	Rinaldo Bellomo Scott K. Aberegg Rob Mac Sweeney Rachel S. Varughese Giovanni Landoni Paul J. Young
author2Str	Rinaldo Bellomo Scott K. Aberegg Rob Mac Sweeney Rachel S. Varughese Giovanni Landoni Paul J. Young
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up_date	2024-07-03T23:43:33.668Z
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Ridgeon</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Effect sizes in ongoing randomized controlled critical care trials</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2017</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract Background An important limitation of many critical care trial designs is that they hypothesize large, and potentially implausible, reductions in mortality. 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The median largest absolute mortality reduction considered plausible was 4.5% (IQR 3.5–5%), compared with a median absolute mortality reduction used in sample size calculations of 5% (IQR 3.6–10%) (P = 0.27). Conclusions For some of the largest ongoing critical care trials, many clinicians regard prior probabilities as low and consider that plausible effects on absolute mortality are less than 5%. 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Effect sizes in ongoing randomized controlled critical care trials

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