Assessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial

Objectives:. Non-mortality septic shock outcomes (e.g., Sequential Organ Failure Assessment score) are important clinical endpoints in pivotal sepsis trials. However, comparisons of observed longitudinal non-mortality outcomes between study groups can be biased if death is unequal between study grou...

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Autores principales:	Michael O. Harhay, PhD, Alessandro Gasparini, PhD, Allan J. Walkey, MD, MS, Gary E. Weissman, MD, MSHP, Michael J. Crowther, PhD, Sarah J. Ratcliffe, PhD, James A. Russell, MD, on behalf of the Vasopressin and Septic Shock Trial (VASST) Investigators, J. A. Russell, K. R. Walley, C. L. Holmes Boulton, J. T. Granton, P. C. Hebert, D. J. Cooper, S. Mehta, J. Singer, A. C. Gordon, M. M. Storms, S. Jones, G. R. Bernard, A. S. Slutsky, G. A. Wells, A. Gasparini, B. Savage, D. Ayers, R. Woods, K. Wu, M. Maralit, L. Smith, K. Foley, A. Suri, M. Steinberg, B. Howe, P. Galt, A. Higgins, M. E. LeBlanc, A. M. Sutherland, A. Sham, A. McLeod, D. R. Dorscheid, M. Hameed, L. Lazosky, S. Helderweirt, C. Honeyman, T. Terins, D. Chittock, J. Ronco, S. Logie, G. Wood, F. Auld, V. Stedham, M. Mantle, L. Fox, G. D. McCauley, J. D. Rolf, C. Erbacher, G. Martinka, S. Goulding, S. Silverwood, L. Leung, S. Keenan, J. Murray, M. Van Osch, B. Light, M. Dominique, P. Gray, R. Stimpson, S. Rosser, D. Bell, W. Janz, T. McArdle, I. Watpool, A. Matte-Martyn, D. J Cook, E. McDonald, F. Clarke, A. Tkaczyk, N. Zytaruk, T. Stewart, C. Martinez-Motta, R. MacDonald, V. Sivanantham, R. Hodder, J. Foxall, M. Lewis, M. Ward, C. Dos Santos, J. Friedrich, D. Scales, O. Smith, I. DeCampos, A. Richards, H. Michalopoulos, U. Bakshi, W. Sibbald, T. Smith, K. Code, B. Bojilov, C. Dale, M. Keogh, M. Meade, L. Hand, C. Martin, J. Kehoe, V. Binns, M. McGuire, G. Poirier, L. Provost, J. Muscedere, C. Diemer, V. Pellegrino, A. Hilton, S. Morrison, C. Weatherburn, K. Moulden, C. Harry, J. J. Presneill, M. S Robertson, J. F. Cade, B. D. Howe, D. K. Barge, C. A. Boyce, F. Healy, C. Wright, D. Weyandt, J. Barrett, C. Walker, S. Burton, G. Dobb, S. Perryman, J. Chamberlain, L. Thomas, A. Bersten, L. Daly, T. Hunt, D. Wood, B. Patel, J. Larson, M. Rady, G. LeBrun, E. Boyd, R. Rush
Formato:	article
Lenguaje:	EN
Publicado:	Wolters Kluwer 2020
Materias:	Medical emergencies. Critical care. Intensive care. First aid RC86-88.9
Acceso en línea:	https://doaj.org/article/2056019742ec46f58eab1b0a39ae1800
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id	oai:doaj.org-article:2056019742ec46f58eab1b0a39ae1800
record_format	dspace
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical emergencies. Critical care. Intensive care. First aid RC86-88.9
spellingShingle	Medical emergencies. Critical care. Intensive care. First aid RC86-88.9 Michael O. Harhay, PhD Alessandro Gasparini, PhD Allan J. Walkey, MD, MS Gary E. Weissman, MD, MSHP Michael J. Crowther, PhD Sarah J. Ratcliffe, PhD James A. Russell, MD on behalf of the Vasopressin and Septic Shock Trial (VASST) Investigators J. A. Russell K. R. Walley C. L. Holmes Boulton J. T. Granton P. C. Hebert D. J. Cooper S. Mehta J. Singer A. C. Gordon M. M. Storms S. Jones J. A. Russell M. M. Storms K. R. Walley G. R. Bernard A. S. Slutsky G. A. Wells A. Gasparini B. Savage D. Ayers R. Woods K. Wu M. Maralit L. Smith K. Foley A. Suri M. Steinberg B. Howe P. Galt A. Higgins M. M. Storms M. E. LeBlanc A. M. Sutherland A. Sham A. McLeod D. R. Dorscheid M. Hameed L. Lazosky S. Helderweirt C. Honeyman T. Terins D. Chittock J. Ronco L. Smith S. Logie G. Wood F. Auld V. Stedham M. Mantle L. Fox G. D. McCauley J. D. Rolf C. Erbacher G. Martinka S. Goulding S. Silverwood L. Leung S. Keenan J. Murray M. Van Osch B. Light M. Dominique P. Gray R. Stimpson S. Rosser D. Bell W. Janz P. C. Hebert T. McArdle I. Watpool J. T. Granton M. Steinberg A. Matte-Martyn D. J Cook E. McDonald F. Clarke A. Tkaczyk N. Zytaruk T. Stewart A. Suri C. Martinez-Motta R. MacDonald V. Sivanantham R. Hodder J. Foxall M. Lewis M. Ward C. Dos Santos J. Friedrich D. Scales O. Smith I. DeCampos A. Richards H. Michalopoulos U. Bakshi W. Sibbald T. Smith K. Code B. Bojilov C. Dale M. Keogh M. Meade L. Hand C. Martin J. Kehoe V. Binns M. McGuire G. Poirier L. Provost J. Muscedere C. Diemer D. J. Cooper V. Pellegrino A. Hilton S. Morrison C. Weatherburn K. Moulden C. Harry J. J. Presneill M. S Robertson J. F. Cade B. D. Howe D. K. Barge C. A. Boyce F. Healy C. Wright D. Weyandt J. Barrett C. Walker P. Galt S. Burton G. Dobb S. Perryman J. Chamberlain L. Thomas A. Bersten L. Daly T. Hunt D. Wood B. Patel J. Larson M. Rady G. LeBrun E. Boyd R. Rush Assessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial
description	Objectives:. Non-mortality septic shock outcomes (e.g., Sequential Organ Failure Assessment score) are important clinical endpoints in pivotal sepsis trials. However, comparisons of observed longitudinal non-mortality outcomes between study groups can be biased if death is unequal between study groups or is associated with an intervention (i.e., informative censoring). We compared the effects of vasopressin versus norepinephrine on the Sequential Organ Failure Assessment score in the Vasopressin and Septic Shock Trial to illustrate the use of joint modeling to help minimize potential bias from informative censoring. Design:. Secondary analysis of the Vasopressin and Septic Shock Trial data. Setting:. Twenty-seven ICUs in Canada, Australia, and United States. Subjects:. Seven hundred sixty-three participants with septic shock who received blinded vasopressin (n = 389) or norepinephrine infusions (n = 374). Measurements and Main Results:. Sequential Organ Failure Assessment scores were calculated daily until discharge, death, or day 28 after randomization. Mortality was numerically higher in the norepinephrine arm (28 d mortality of 39% vs 35%; p = 0.25), and there was a positive association between higher Sequential Organ Failure Assessment scores and patient mortality, characteristics that suggest a potential for bias from informative censoring of Sequential Organ Failure Assessment scores by death. The best-fitting joint longitudinal (i.e., linear mixed-effects model) and survival (i.e., Cox proportional hazards model for the time-to-death) model showed that norepinephrine was associated with a more rapid improvement in the total Sequential Organ Failure Assessment score through day 4, and then the daily Sequential Organ Failure Assessment scores converged and overlapped for the remainder of the study period. Conclusions:. Short-term reversal of organ dysfunction occurred more rapidly with norepinephrine compared with vasopressin, although differences between study arms did not persist after day 4. Joint models are an accessible methodology that could be used in critical care trials to assess the effects of interventions on the longitudinal progression of key outcomes (e.g., organ dysfunction, biomarkers, or quality of life) that may be informatively truncated by death or other censoring events.
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author	Michael O. Harhay, PhD Alessandro Gasparini, PhD Allan J. Walkey, MD, MS Gary E. Weissman, MD, MSHP Michael J. Crowther, PhD Sarah J. Ratcliffe, PhD James A. Russell, MD on behalf of the Vasopressin and Septic Shock Trial (VASST) Investigators J. A. Russell K. R. Walley C. L. Holmes Boulton J. T. Granton P. C. Hebert D. J. Cooper S. Mehta J. Singer A. C. Gordon M. M. Storms S. Jones J. A. Russell M. M. Storms K. R. Walley G. R. Bernard A. S. Slutsky G. A. Wells A. Gasparini B. Savage D. Ayers R. Woods K. Wu M. Maralit L. Smith K. Foley A. Suri M. Steinberg B. Howe P. Galt A. Higgins M. M. Storms M. E. LeBlanc A. M. Sutherland A. Sham A. McLeod D. R. Dorscheid M. Hameed L. Lazosky S. Helderweirt C. Honeyman T. Terins D. Chittock J. Ronco L. Smith S. Logie G. Wood F. Auld V. Stedham M. Mantle L. Fox G. D. McCauley J. D. Rolf C. Erbacher G. Martinka S. Goulding S. Silverwood L. Leung S. Keenan J. Murray M. Van Osch B. Light M. Dominique P. Gray R. Stimpson S. Rosser D. Bell W. Janz P. C. Hebert T. McArdle I. Watpool J. T. Granton M. Steinberg A. Matte-Martyn D. J Cook E. McDonald F. Clarke A. Tkaczyk N. Zytaruk T. Stewart A. Suri C. Martinez-Motta R. MacDonald V. Sivanantham R. Hodder J. Foxall M. Lewis M. Ward C. Dos Santos J. Friedrich D. Scales O. Smith I. DeCampos A. Richards H. Michalopoulos U. Bakshi W. Sibbald T. Smith K. Code B. Bojilov C. Dale M. Keogh M. Meade L. Hand C. Martin J. Kehoe V. Binns M. McGuire G. Poirier L. Provost J. Muscedere C. Diemer D. J. Cooper V. Pellegrino A. Hilton S. Morrison C. Weatherburn K. Moulden C. Harry J. J. Presneill M. S Robertson J. F. Cade B. D. Howe D. K. Barge C. A. Boyce F. Healy C. Wright D. Weyandt J. Barrett C. Walker P. Galt S. Burton G. Dobb S. Perryman J. Chamberlain L. Thomas A. Bersten L. Daly T. Hunt D. Wood B. Patel J. Larson M. Rady G. LeBrun E. Boyd R. Rush
author_facet	Michael O. Harhay, PhD Alessandro Gasparini, PhD Allan J. Walkey, MD, MS Gary E. Weissman, MD, MSHP Michael J. Crowther, PhD Sarah J. Ratcliffe, PhD James A. Russell, MD on behalf of the Vasopressin and Septic Shock Trial (VASST) Investigators J. A. Russell K. R. Walley C. L. Holmes Boulton J. T. Granton P. C. Hebert D. J. Cooper S. Mehta J. Singer A. C. Gordon M. M. Storms S. Jones J. A. Russell M. M. Storms K. R. Walley G. R. Bernard A. S. Slutsky G. A. Wells A. Gasparini B. Savage D. Ayers R. Woods K. Wu M. Maralit L. Smith K. Foley A. Suri M. Steinberg B. Howe P. Galt A. Higgins M. M. Storms M. E. LeBlanc A. M. Sutherland A. Sham A. McLeod D. R. Dorscheid M. Hameed L. Lazosky S. Helderweirt C. Honeyman T. Terins D. Chittock J. Ronco L. Smith S. Logie G. Wood F. Auld V. Stedham M. Mantle L. Fox G. D. McCauley J. D. Rolf C. Erbacher G. Martinka S. Goulding S. Silverwood L. Leung S. Keenan J. Murray M. Van Osch B. Light M. Dominique P. Gray R. Stimpson S. Rosser D. Bell W. Janz P. C. Hebert T. McArdle I. Watpool J. T. Granton M. Steinberg A. Matte-Martyn D. J Cook E. McDonald F. Clarke A. Tkaczyk N. Zytaruk T. Stewart A. Suri C. Martinez-Motta R. MacDonald V. Sivanantham R. Hodder J. Foxall M. Lewis M. Ward C. Dos Santos J. Friedrich D. Scales O. Smith I. DeCampos A. Richards H. Michalopoulos U. Bakshi W. Sibbald T. Smith K. Code B. Bojilov C. Dale M. Keogh M. Meade L. Hand C. Martin J. Kehoe V. Binns M. McGuire G. Poirier L. Provost J. Muscedere C. Diemer D. J. Cooper V. Pellegrino A. Hilton S. Morrison C. Weatherburn K. Moulden C. Harry J. J. Presneill M. S Robertson J. F. Cade B. D. Howe D. K. Barge C. A. Boyce F. Healy C. Wright D. Weyandt J. Barrett C. Walker P. Galt S. Burton G. Dobb S. Perryman J. Chamberlain L. Thomas A. Bersten L. Daly T. Hunt D. Wood B. Patel J. Larson M. Rady G. LeBrun E. Boyd R. Rush
author_sort	Michael O. Harhay, PhD
title	Assessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial
title_short	Assessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial
title_full	Assessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial
title_fullStr	Assessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial
title_full_unstemmed	Assessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial
title_sort	assessing the course of organ dysfunction using joint longitudinal and time-to-event modeling in the vasopressin and septic shock trial
publisher	Wolters Kluwer
publishDate	2020
url	https://doaj.org/article/2056019742ec46f58eab1b0a39ae1800
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spelling	oai:doaj.org-article:2056019742ec46f58eab1b0a39ae18002021-11-25T07:51:12ZAssessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial2639-802810.1097/CCE.0000000000000104https://doaj.org/article/2056019742ec46f58eab1b0a39ae18002020-04-01T00:00:00Zhttp://journals.lww.com/10.1097/CCE.0000000000000104https://doaj.org/toc/2639-8028Objectives:. Non-mortality septic shock outcomes (e.g., Sequential Organ Failure Assessment score) are important clinical endpoints in pivotal sepsis trials. However, comparisons of observed longitudinal non-mortality outcomes between study groups can be biased if death is unequal between study groups or is associated with an intervention (i.e., informative censoring). We compared the effects of vasopressin versus norepinephrine on the Sequential Organ Failure Assessment score in the Vasopressin and Septic Shock Trial to illustrate the use of joint modeling to help minimize potential bias from informative censoring. Design:. Secondary analysis of the Vasopressin and Septic Shock Trial data. Setting:. Twenty-seven ICUs in Canada, Australia, and United States. Subjects:. Seven hundred sixty-three participants with septic shock who received blinded vasopressin (n = 389) or norepinephrine infusions (n = 374). Measurements and Main Results:. Sequential Organ Failure Assessment scores were calculated daily until discharge, death, or day 28 after randomization. Mortality was numerically higher in the norepinephrine arm (28 d mortality of 39% vs 35%; p = 0.25), and there was a positive association between higher Sequential Organ Failure Assessment scores and patient mortality, characteristics that suggest a potential for bias from informative censoring of Sequential Organ Failure Assessment scores by death. The best-fitting joint longitudinal (i.e., linear mixed-effects model) and survival (i.e., Cox proportional hazards model for the time-to-death) model showed that norepinephrine was associated with a more rapid improvement in the total Sequential Organ Failure Assessment score through day 4, and then the daily Sequential Organ Failure Assessment scores converged and overlapped for the remainder of the study period. Conclusions:. Short-term reversal of organ dysfunction occurred more rapidly with norepinephrine compared with vasopressin, although differences between study arms did not persist after day 4. Joint models are an accessible methodology that could be used in critical care trials to assess the effects of interventions on the longitudinal progression of key outcomes (e.g., organ dysfunction, biomarkers, or quality of life) that may be informatively truncated by death or other censoring events.Michael O. Harhay, PhDAlessandro Gasparini, PhDAllan J. Walkey, MD, MSGary E. Weissman, MD, MSHPMichael J. Crowther, PhDSarah J. Ratcliffe, PhDJames A. Russell, MDon behalf of the Vasopressin and Septic Shock Trial (VASST) InvestigatorsJ. A. RussellK. R. WalleyC. L. Holmes BoultonJ. T. GrantonP. C. HebertD. J. CooperS. MehtaJ. SingerA. C. GordonM. M. StormsS. JonesJ. A. RussellM. M. StormsK. R. WalleyG. R. BernardA. S. SlutskyG. A. WellsA. GaspariniB. SavageD. AyersR. WoodsK. WuM. MaralitL. SmithK. FoleyA. SuriM. SteinbergB. HoweP. GaltA. HigginsM. M. StormsM. E. LeBlancA. M. SutherlandA. ShamA. McLeodD. R. DorscheidM. HameedL. LazoskyS. HelderweirtC. HoneymanT. TerinsD. ChittockJ. RoncoL. SmithS. LogieG. WoodF. AuldV. StedhamM. MantleL. FoxG. D. McCauleyJ. D. RolfC. ErbacherG. MartinkaS. GouldingS. SilverwoodL. LeungS. KeenanJ. MurrayM. Van OschB. LightM. DominiqueP. GrayR. StimpsonS. RosserD. BellW. JanzP. C. HebertT. McArdleI. WatpoolJ. T. GrantonM. SteinbergA. Matte-MartynD. J CookE. McDonaldF. ClarkeA. TkaczykN. ZytarukT. StewartA. SuriC. Martinez-MottaR. MacDonaldV. SivananthamR. HodderJ. FoxallM. LewisM. WardC. Dos SantosJ. FriedrichD. ScalesO. SmithI. DeCamposA. RichardsH. MichalopoulosU. BakshiW. SibbaldT. SmithK. CodeB. BojilovC. DaleM. KeoghM. MeadeL. HandC. MartinJ. KehoeV. BinnsM. McGuireG. PoirierL. ProvostJ. MuscedereC. DiemerD. J. CooperV. PellegrinoA. HiltonS. MorrisonC. WeatherburnK. MouldenC. HarryJ. J. PresneillM. S RobertsonJ. F. CadeB. D. HoweD. K. BargeC. A. BoyceF. HealyC. WrightD. WeyandtJ. BarrettC. WalkerP. GaltS. BurtonG. DobbS. PerrymanJ. ChamberlainL. ThomasA. BerstenL. DalyT. HuntD. WoodB. PatelJ. LarsonM. RadyG. LeBrunE. BoydR. RushWolters KluwerarticleMedical emergencies. Critical care. Intensive care. First aidRC86-88.9ENCritical Care Explorations, Vol 2, Iss 4, p e0104 (2020)

Assessing the Course of Organ Dysfunction Using Joint Longitudinal and Time-to-Event Modeling in the Vasopressin and Septic Shock Trial

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