Randomized Controlled Trial

. 2017 May:184:204-208.e1.

doi: 10.1016/j.jpeds.2017.02.006. Epub 2017 Mar 2.

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

Joanne E Natale¹, Ruth Lebet², Jill G Joseph³, Christine Ulysse⁴, Judith Ascenzi⁵, David Wypij⁴, Martha A Q Curley⁶; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators

Collaborators, Affiliations

Collaborators

Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators:
Martha A Q Curley⁷, David Wypij⁸, Geoffrey L Allen⁹, Derek C Angus¹⁰, Lisa A Asaro¹¹, Judy A Ascenzi¹², Scot T Bateman¹³, Santiago Borasino¹⁴, Cindy Darnell Bowens¹⁵, G Kris Bysani¹⁶, Ira M Cheifetz¹⁷, Allison S Cowl¹⁸, Brenda L Dodson¹⁹, E Vincent S Faustino²⁰, Lori D Fineman²¹, Heidi R Flori²², Linda S Franck²³, Rainer G Gedeit²⁴, Mary Jo C Grant²⁵, Andrea L Harabin²⁶, Catherine Haskins-Kiefer²⁷, James H Hertzog²⁸, Larissa Hutchins²⁹, Aileen L Kirby³⁰, Ruth M Lebet³¹, Michael A Matthay³², Gwenn E McLaughlin³³, Joanne E Natale³⁴, Phineas P Oren³⁵, Nagendra Polavarapu³⁶, James B Schneider³⁷, Adam J Schwarz³⁸, Thomas P Shanley³⁹, Shari Simone⁴⁰, Lewis P Singer⁴¹, Lauren R Sorce⁴², Edward J Truemper⁴³, Michele A Vander Heyden⁴⁴, R Scott Watson⁴⁵, Claire R Wells⁴⁶

Affiliations

¹ Department of Pediatrics, University of California, Davis, CA. Electronic address: jenatale@ucdavis.edu.
² Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA.
³ Betty Irene Moore School of Nursing, University of California, Davis, CA.
⁴ Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA; Department of Cardiology, Boston Children's Hospital, Boston, MA.
⁵ Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Children's Hospital, Baltimore, MD.
⁶ Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA; Department of Anesthesia and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Department of Critical Care and Cardiovascular Nursing, Boston Children's Hospital, Boston, MA.
⁷ Principal Investigator; School of Nursing and the Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Critical Care and Cardiovascular Program, Boston Children's Hospital, Boston, MA.
⁸ Principal InvestigatorData Coordinating Center; Department of Biostatistics, Harvard School of Public Health, Boston, MA; Department of Pediatrics, Harvard Medical School, Boston, MA; Department of Cardiology, Boston Children's Hospital, Boston, MA.
⁹ Children's Mercy Hospital, Kansas City, MO.
¹⁰ Clinical Research, Investigation and Systems Modeling of Acute Illness Center, Pittsburgh, PA.
¹¹ Department of Cardiology, Boston Children's Hospital, Boston, MA.
¹² The Johns Hopkins Hospital, Baltimore, MD.
¹³ University of Massachusetts Memorial Children's Medical Center, Worcester, MA.
¹⁴ Children's Hospital of Alabama, Birmingham, AL.
¹⁵ Children's Medical Center of Dallas, Dallas, TX.
¹⁶ Medical City Children's Hospital, Dallas, TX.
¹⁷ Duke Children's Hospital, Durham, NC.
¹⁸ Connecticut Children's Medical Center, Hartford, CT.
¹⁹ Department of Pharmacy, Boston Children's Hospital, Boston, MA.
²⁰ Yale-New Haven Children's Hospital, New Haven, CT.
²¹ University of California San Francisco Benioff Children's Hospital at San Francisco, San Francisco, CA.
²² University of California at San Francisco Benioff Children's Hospital at Oakland, Oakland, CA.
²³ University of California at San Francisco School of Nursing, San Francisco, CA.
²⁴ Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.
²⁵ Primary Children's Hospital, Salt Lake City, UT.
²⁶ National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.
²⁷ Florida Hospital for Children, Orlando, FL.
²⁸ Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE.
²⁹ The Children's Hospital of Philadelphia, Philadelphia, PA.
³⁰ Oregon Health & Science University Doernbecher Children's Hospital, Portland, OR.
³¹ School of Nursing, University of Pennsylvania, Philadelphia, PA.
³² University of California at San Francisco School of Medicine, San Francisco, CA.
³³ Holtz Children's Hospital, Jackson Health System, Miami, FL.
³⁴ University of California Davis Children's Hospital, Sacramento, CA.
³⁵ St. Louis Children's Hospital, St. Louis, MO.
³⁶ Advocate Children's Hospital-Oak Lawn, Oak Lawn, IL.
³⁷ Cohen Children's Medical Center of New York, Hyde Park, NY.
³⁸ Children's Hospital of Orange County, Orange, CA.
³⁹ C. S. Mott Children's Hospital at the University of Michigan, Ann Arbor, MI.
⁴⁰ University of Maryland Medical Center, Baltimore, MD.
⁴¹ The Children's Hospital at Montefiore, Bronx, NY.
⁴² Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.
⁴³ Children's Hospital and Medical Center, Omaha, NE.
⁴⁴ Children's Hospital at Dartmouth, Dartmouth, NH.
⁴⁵ Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA.
⁴⁶ University of Arizona Medical Center, Tucson, AZ.

PMID: 28410087
DOI: 10.1016/j.jpeds.2017.02.006

Free article

Randomized Controlled Trial

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

Joanne E Natale et al. J Pediatr. 2017 May.

Free article

. 2017 May:184:204-208.e1.

doi: 10.1016/j.jpeds.2017.02.006. Epub 2017 Mar 2.

Authors

Collaborators

Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators:
Martha A Q Curley⁷, David Wypij⁸, Geoffrey L Allen⁹, Derek C Angus¹⁰, Lisa A Asaro¹¹, Judy A Ascenzi¹², Scot T Bateman¹³, Santiago Borasino¹⁴, Cindy Darnell Bowens¹⁵, G Kris Bysani¹⁶, Ira M Cheifetz¹⁷, Allison S Cowl¹⁸, Brenda L Dodson¹⁹, E Vincent S Faustino²⁰, Lori D Fineman²¹, Heidi R Flori²², Linda S Franck²³, Rainer G Gedeit²⁴, Mary Jo C Grant²⁵, Andrea L Harabin²⁶, Catherine Haskins-Kiefer²⁷, James H Hertzog²⁸, Larissa Hutchins²⁹, Aileen L Kirby³⁰, Ruth M Lebet³¹, Michael A Matthay³², Gwenn E McLaughlin³³, Joanne E Natale³⁴, Phineas P Oren³⁵, Nagendra Polavarapu³⁶, James B Schneider³⁷, Adam J Schwarz³⁸, Thomas P Shanley³⁹, Shari Simone⁴⁰, Lewis P Singer⁴¹, Lauren R Sorce⁴², Edward J Truemper⁴³, Michele A Vander Heyden⁴⁴, R Scott Watson⁴⁵, Claire R Wells⁴⁶

Affiliations

¹ Department of Pediatrics, University of California, Davis, CA. Electronic address: jenatale@ucdavis.edu.
² Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA.
³ Betty Irene Moore School of Nursing, University of California, Davis, CA.
⁴ Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA; Department of Cardiology, Boston Children's Hospital, Boston, MA.
⁵ Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Children's Hospital, Baltimore, MD.
⁶ Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA; Department of Anesthesia and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Department of Critical Care and Cardiovascular Nursing, Boston Children's Hospital, Boston, MA.
⁷ Principal Investigator; School of Nursing and the Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Critical Care and Cardiovascular Program, Boston Children's Hospital, Boston, MA.
⁸ Principal InvestigatorData Coordinating Center; Department of Biostatistics, Harvard School of Public Health, Boston, MA; Department of Pediatrics, Harvard Medical School, Boston, MA; Department of Cardiology, Boston Children's Hospital, Boston, MA.
⁹ Children's Mercy Hospital, Kansas City, MO.
¹⁰ Clinical Research, Investigation and Systems Modeling of Acute Illness Center, Pittsburgh, PA.
¹¹ Department of Cardiology, Boston Children's Hospital, Boston, MA.
¹² The Johns Hopkins Hospital, Baltimore, MD.
¹³ University of Massachusetts Memorial Children's Medical Center, Worcester, MA.
¹⁴ Children's Hospital of Alabama, Birmingham, AL.
¹⁵ Children's Medical Center of Dallas, Dallas, TX.
¹⁶ Medical City Children's Hospital, Dallas, TX.
¹⁷ Duke Children's Hospital, Durham, NC.
¹⁸ Connecticut Children's Medical Center, Hartford, CT.
¹⁹ Department of Pharmacy, Boston Children's Hospital, Boston, MA.
²⁰ Yale-New Haven Children's Hospital, New Haven, CT.
²¹ University of California San Francisco Benioff Children's Hospital at San Francisco, San Francisco, CA.
²² University of California at San Francisco Benioff Children's Hospital at Oakland, Oakland, CA.
²³ University of California at San Francisco School of Nursing, San Francisco, CA.
²⁴ Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.
²⁵ Primary Children's Hospital, Salt Lake City, UT.
²⁶ National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.
²⁷ Florida Hospital for Children, Orlando, FL.
²⁸ Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE.
²⁹ The Children's Hospital of Philadelphia, Philadelphia, PA.
³⁰ Oregon Health & Science University Doernbecher Children's Hospital, Portland, OR.
³¹ School of Nursing, University of Pennsylvania, Philadelphia, PA.
³² University of California at San Francisco School of Medicine, San Francisco, CA.
³³ Holtz Children's Hospital, Jackson Health System, Miami, FL.
³⁴ University of California Davis Children's Hospital, Sacramento, CA.
³⁵ St. Louis Children's Hospital, St. Louis, MO.
³⁶ Advocate Children's Hospital-Oak Lawn, Oak Lawn, IL.
³⁷ Cohen Children's Medical Center of New York, Hyde Park, NY.
³⁸ Children's Hospital of Orange County, Orange, CA.
³⁹ C. S. Mott Children's Hospital at the University of Michigan, Ann Arbor, MI.
⁴⁰ University of Maryland Medical Center, Baltimore, MD.
⁴¹ The Children's Hospital at Montefiore, Bronx, NY.
⁴² Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.
⁴³ Children's Hospital and Medical Center, Omaha, NE.
⁴⁴ Children's Hospital at Dartmouth, Dartmouth, NH.
⁴⁵ Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA.
⁴⁶ University of Arizona Medical Center, Tucson, AZ.

PMID: 28410087
DOI: 10.1016/j.jpeds.2017.02.006

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.

Keywords: RESTORE; cluster randomized trial; disparity.

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

Collaborators

Affiliations

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

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