Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial

Joanne E. Natale, Ruth Lebet, Jill G. Joseph, Christine Ulysse, Judith Ascenzi, David Wypij, Martha A.Q. Curley, Martha A.Q. Curley, David Wypij, Geoffrey L. Allen, Derek C. Angus, Lisa A. Asaro, Judy A. Ascenzi, Scot T. Bateman, Santiago Borasino, Cindy Darnell Bowens, G. Kris Bysani, Ira M. Cheifetz, Allison S. Cowl, Brenda L. Dodson & 27 others E. Vincent S. Faustino, Lori D. Fineman, Heidi R. Flori, Linda S. Franck, Rainer G. Gedeit, Mary Jo C. Grant, Andrea L. Harabin, Catherine Haskins-Kiefer, James H. Hertzog, Larissa Hutchins, Aileen L. Kirby, Ruth M. Lebet, Michael A. Matthay, Gwenn E. McLaughlin, Joanne E. Natale, Phineas P. Oren, Nagendra Polavarapu, James B. Schneider, Adam J. Schwarz, Thomas P. Shanley, Shari Simone, Lewis P. Singer, Lauren R. Sorce, Edward J. Truemper, Michele A. Vander Heyden, R. Scott Watson, Claire R. Wells

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objective To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. Study design We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Result Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P<.0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P<.001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P=.01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P<.001). Conclusions Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. Trial registration ClinicalTrials.gov: NCT00814099.

Original languageEnglish (US)
Pages (from-to)204-208.e1
JournalJournal of Pediatrics
Volume184
DOIs
StatePublished - May 1 2017
Externally publishedYes

Fingerprint

Parental Consent
Critical Care
Clinical Trials
Pediatrics
Parents
Hispanic Americans
Respiratory Insufficiency
Artificial Respiration
Critical Illness

Keywords

  • cluster randomized trial
  • disparity
  • RESTORE

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial. / Natale, Joanne E.; Lebet, Ruth; Joseph, Jill G.; Ulysse, Christine; Ascenzi, Judith; Wypij, David; Curley, Martha A.Q.; Curley, Martha A.Q.; Wypij, David; Allen, Geoffrey L.; Angus, Derek C.; Asaro, Lisa A.; Ascenzi, Judy A.; Bateman, Scot T.; Borasino, Santiago; Bowens, Cindy Darnell; Bysani, G. Kris; Cheifetz, Ira M.; Cowl, Allison S.; Dodson, Brenda L.; Faustino, E. Vincent S.; Fineman, Lori D.; Flori, Heidi R.; Franck, Linda S.; Gedeit, Rainer G.; Grant, Mary Jo C.; Harabin, Andrea L.; Haskins-Kiefer, Catherine; Hertzog, James H.; Hutchins, Larissa; Kirby, Aileen L.; Lebet, Ruth M.; Matthay, Michael A.; McLaughlin, Gwenn E.; Natale, Joanne E.; Oren, Phineas P.; Polavarapu, Nagendra; Schneider, James B.; Schwarz, Adam J.; Shanley, Thomas P.; Simone, Shari; Singer, Lewis P.; Sorce, Lauren R.; Truemper, Edward J.; Vander Heyden, Michele A.; Watson, R. Scott; Wells, Claire R.

In: Journal of Pediatrics, Vol. 184, 01.05.2017, p. 204-208.e1.

Research output: Contribution to journalArticle

Natale, JE, Lebet, R, Joseph, JG, Ulysse, C, Ascenzi, J, Wypij, D, Curley, MAQ, Curley, MAQ, Wypij, D, Allen, GL, Angus, DC, Asaro, LA, Ascenzi, JA, Bateman, ST, Borasino, S, Bowens, CD, Bysani, GK, Cheifetz, IM, Cowl, AS, Dodson, BL, Faustino, EVS, Fineman, LD, Flori, HR, Franck, LS, Gedeit, RG, Grant, MJC, Harabin, AL, Haskins-Kiefer, C, Hertzog, JH, Hutchins, L, Kirby, AL, Lebet, RM, Matthay, MA, McLaughlin, GE, Natale, JE, Oren, PP, Polavarapu, N, Schneider, JB, Schwarz, AJ, Shanley, TP, Simone, S, Singer, LP, Sorce, LR, Truemper, EJ, Vander Heyden, MA, Watson, RS & Wells, CR 2017, 'Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial', Journal of Pediatrics, vol. 184, pp. 204-208.e1. https://doi.org/10.1016/j.jpeds.2017.02.006
Natale, Joanne E. ; Lebet, Ruth ; Joseph, Jill G. ; Ulysse, Christine ; Ascenzi, Judith ; Wypij, David ; Curley, Martha A.Q. ; Curley, Martha A.Q. ; Wypij, David ; Allen, Geoffrey L. ; Angus, Derek C. ; Asaro, Lisa A. ; Ascenzi, Judy A. ; Bateman, Scot T. ; Borasino, Santiago ; Bowens, Cindy Darnell ; Bysani, G. Kris ; Cheifetz, Ira M. ; Cowl, Allison S. ; Dodson, Brenda L. ; Faustino, E. Vincent S. ; Fineman, Lori D. ; Flori, Heidi R. ; Franck, Linda S. ; Gedeit, Rainer G. ; Grant, Mary Jo C. ; Harabin, Andrea L. ; Haskins-Kiefer, Catherine ; Hertzog, James H. ; Hutchins, Larissa ; Kirby, Aileen L. ; Lebet, Ruth M. ; Matthay, Michael A. ; McLaughlin, Gwenn E. ; Natale, Joanne E. ; Oren, Phineas P. ; Polavarapu, Nagendra ; Schneider, James B. ; Schwarz, Adam J. ; Shanley, Thomas P. ; Simone, Shari ; Singer, Lewis P. ; Sorce, Lauren R. ; Truemper, Edward J. ; Vander Heyden, Michele A. ; Watson, R. Scott ; Wells, Claire R. / Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial. In: Journal of Pediatrics. 2017 ; Vol. 184. pp. 204-208.e1.
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abstract = "Objective To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. Study design We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Result Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5{\%}) compared with White (11.7{\%}) or Hispanic children (13.2{\%}). Among those offered consent, parents of Black (29.5{\%}) and Hispanic children (25.9{\%}) more frequently refused consent than parents of White children (18.2{\%}, P<.0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95{\%} CI 1.56-2.95, P<.001) and Hispanic (OR 1.44, 95{\%} CI 1.10-1.88, P=.01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95{\%} CI 1.37-3.36, P<.001). Conclusions Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. Trial registration ClinicalTrials.gov: NCT00814099.",
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author = "Natale, {Joanne E.} and Ruth Lebet and Joseph, {Jill G.} and Christine Ulysse and Judith Ascenzi and David Wypij and Curley, {Martha A.Q.} and Curley, {Martha A.Q.} and David Wypij and Allen, {Geoffrey L.} and Angus, {Derek C.} and Asaro, {Lisa A.} and Ascenzi, {Judy A.} and Bateman, {Scot T.} and Santiago Borasino and Bowens, {Cindy Darnell} and Bysani, {G. Kris} and Cheifetz, {Ira M.} and Cowl, {Allison S.} and Dodson, {Brenda L.} and Faustino, {E. Vincent S.} and Fineman, {Lori D.} and Flori, {Heidi R.} and Franck, {Linda S.} and Gedeit, {Rainer G.} and Grant, {Mary Jo C.} and Harabin, {Andrea L.} and Catherine Haskins-Kiefer and Hertzog, {James H.} and Larissa Hutchins and Kirby, {Aileen L.} and Lebet, {Ruth M.} and Matthay, {Michael A.} and McLaughlin, {Gwenn E.} and Natale, {Joanne E.} and Oren, {Phineas P.} and Nagendra Polavarapu and Schneider, {James B.} and Schwarz, {Adam J.} and Shanley, {Thomas P.} and Shari Simone and Singer, {Lewis P.} and Sorce, {Lauren R.} and Truemper, {Edward J.} and {Vander Heyden}, {Michele A.} and Watson, {R. Scott} and Wells, {Claire R.}",
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TY - JOUR

T1 - Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial

AU - Natale, Joanne E.

AU - Lebet, Ruth

AU - Joseph, Jill G.

AU - Ulysse, Christine

AU - Ascenzi, Judith

AU - Wypij, David

AU - Curley, Martha A.Q.

AU - Curley, Martha A.Q.

AU - Wypij, David

AU - Allen, Geoffrey L.

AU - Angus, Derek C.

AU - Asaro, Lisa A.

AU - Ascenzi, Judy A.

AU - Bateman, Scot T.

AU - Borasino, Santiago

AU - Bowens, Cindy Darnell

AU - Bysani, G. Kris

AU - Cheifetz, Ira M.

AU - Cowl, Allison S.

AU - Dodson, Brenda L.

AU - Faustino, E. Vincent S.

AU - Fineman, Lori D.

AU - Flori, Heidi R.

AU - Franck, Linda S.

AU - Gedeit, Rainer G.

AU - Grant, Mary Jo C.

AU - Harabin, Andrea L.

AU - Haskins-Kiefer, Catherine

AU - Hertzog, James H.

AU - Hutchins, Larissa

AU - Kirby, Aileen L.

AU - Lebet, Ruth M.

AU - Matthay, Michael A.

AU - McLaughlin, Gwenn E.

AU - Natale, Joanne E.

AU - Oren, Phineas P.

AU - Polavarapu, Nagendra

AU - Schneider, James B.

AU - Schwarz, Adam J.

AU - Shanley, Thomas P.

AU - Simone, Shari

AU - Singer, Lewis P.

AU - Sorce, Lauren R.

AU - Truemper, Edward J.

AU - Vander Heyden, Michele A.

AU - Watson, R. Scott

AU - Wells, Claire R.

PY - 2017/5/1

Y1 - 2017/5/1

N2 - Objective To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. Study design We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Result Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P<.0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P<.001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P=.01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P<.001). Conclusions Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. Trial registration ClinicalTrials.gov: NCT00814099.

AB - Objective To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. Study design We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Result Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P<.0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P<.001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P=.01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P<.001). Conclusions Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. Trial registration ClinicalTrials.gov: NCT00814099.

KW - cluster randomized trial

KW - disparity

KW - RESTORE

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DO - 10.1016/j.jpeds.2017.02.006

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JO - Journal of Pediatrics

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