Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial
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 Titr...
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| Veröffentlicht in: | The Journal of pediatrics 2017-05, Vol.184, p.204-208.e1 |
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| container_title | The Journal of pediatrics |
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| creator | Natale, Joanne E., MD, PhD Lebet, Ruth, RN, MSN, CCNS-P Joseph, Jill G., MD, PhD Ulysse, Christine, BS Ascenzi, Judith, RN, DNP Wypij, David, PhD Curley, Martha A.Q., RN, PhD |
| description | 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 Failur e (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 |
| doi_str_mv | 10.1016/j.jpeds.2017.02.006 |
| format | Article |
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Study design We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failur e (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.</description><identifier>ISSN: 0022-3476</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/j.jpeds.2017.02.006</identifier><identifier>PMID: 28410087</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>African Americans ; Child ; Child, Preschool ; cluster randomized trial ; Critical Care ; disparity ; European Continental Ancestry Group ; Female ; Hispanic Americans ; Humans ; Infant ; Male ; Parents ; Pediatrics ; Refusal to Participate ; RESTORE</subject><ispartof>The Journal of pediatrics, 2017-05, Vol.184, p.204-208.e1</ispartof><rights>Elsevier Inc.</rights><rights>2017 Elsevier Inc.</rights><rights>Copyright © 2017 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c529t-40362ddb79e0b84c3ed678099657dd2e2669cb7726fb7dee47647f825b5917143</citedby><cites>FETCH-LOGICAL-c529t-40362ddb79e0b84c3ed678099657dd2e2669cb7726fb7dee47647f825b5917143</cites><orcidid>0000-0001-5228-6694 ; 0000-0002-0146-0549</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0022347617301919$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28410087$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Natale, Joanne E., MD, PhD</creatorcontrib><creatorcontrib>Lebet, Ruth, RN, MSN, CCNS-P</creatorcontrib><creatorcontrib>Joseph, Jill G., MD, PhD</creatorcontrib><creatorcontrib>Ulysse, Christine, BS</creatorcontrib><creatorcontrib>Ascenzi, Judith, RN, DNP</creatorcontrib><creatorcontrib>Wypij, David, PhD</creatorcontrib><creatorcontrib>Curley, Martha A.Q., RN, PhD</creatorcontrib><creatorcontrib>Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators</creatorcontrib><title>Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial</title><title>The Journal of pediatrics</title><addtitle>J Pediatr</addtitle><description>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 Failur e (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.</description><subject>African Americans</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>cluster randomized trial</subject><subject>Critical Care</subject><subject>disparity</subject><subject>European Continental Ancestry Group</subject><subject>Female</subject><subject>Hispanic Americans</subject><subject>Humans</subject><subject>Infant</subject><subject>Male</subject><subject>Parents</subject><subject>Pediatrics</subject><subject>Refusal to Participate</subject><subject>RESTORE</subject><issn>0022-3476</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcuO1DAQRS0EYpqBL0BCXrIgoeyk_ViAhMLwkBoxGoa15dgVcEgnjZ0g9d_jTDcs2LAq2XXvLdUpQp4yKBkw8bIv-wP6VHJgsgReAoh7ZMNAy0KoqrpPNgCcF1UtxQV5lFIPALoGeEguuKoZgJIbcryxLtiB2tHTq_n7GBx9G9LBxjAHTDSM9NpGHOcsucFuSblOHW2mMeXPtW3pzsZv-IJ-WoY5pDAjvUYf7BxzVLPGuOxpcghthjDevW5jHvmYPOjskPDJuV6Sr--ubpsPxe7z-4_Nm13htlzPRQ2V4N63UiO0qnYVeiEVaC220nuOXAjtWim56FrpEfO2tewU37ZbzSSrq0vy_JR7iNPPBdNs9iE5HAY74rQkw5RSQnEmeZZWJ6mLU0oRO3OIYW_j0TAwK3PTmzvmZmVugJvMPLuenQcs7R79X88fyFnw6iTAvOavgNEkF3B0GVNENxs_hf8MeP2P351J_sAjpn5a4pgJGmZSNpgv69nXqzNZAdNMV78B8wmnoQ</recordid><startdate>20170501</startdate><enddate>20170501</enddate><creator>Natale, Joanne E., MD, PhD</creator><creator>Lebet, Ruth, RN, MSN, CCNS-P</creator><creator>Joseph, Jill G., MD, PhD</creator><creator>Ulysse, Christine, BS</creator><creator>Ascenzi, Judith, RN, DNP</creator><creator>Wypij, David, PhD</creator><creator>Curley, Martha A.Q., RN, PhD</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-5228-6694</orcidid><orcidid>https://orcid.org/0000-0002-0146-0549</orcidid></search><sort><creationdate>20170501</creationdate><title>Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial</title><author>Natale, Joanne E., MD, PhD ; Lebet, Ruth, RN, MSN, CCNS-P ; Joseph, Jill G., MD, PhD ; Ulysse, Christine, BS ; Ascenzi, Judith, RN, DNP ; Wypij, David, PhD ; Curley, Martha A.Q., RN, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c529t-40362ddb79e0b84c3ed678099657dd2e2669cb7726fb7dee47647f825b5917143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>African Americans</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>cluster randomized trial</topic><topic>Critical Care</topic><topic>disparity</topic><topic>European Continental Ancestry Group</topic><topic>Female</topic><topic>Hispanic Americans</topic><topic>Humans</topic><topic>Infant</topic><topic>Male</topic><topic>Parents</topic><topic>Pediatrics</topic><topic>Refusal to Participate</topic><topic>RESTORE</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Natale, Joanne E., MD, PhD</creatorcontrib><creatorcontrib>Lebet, Ruth, RN, MSN, CCNS-P</creatorcontrib><creatorcontrib>Joseph, Jill G., MD, PhD</creatorcontrib><creatorcontrib>Ulysse, Christine, BS</creatorcontrib><creatorcontrib>Ascenzi, Judith, RN, DNP</creatorcontrib><creatorcontrib>Wypij, David, PhD</creatorcontrib><creatorcontrib>Curley, Martha A.Q., RN, PhD</creatorcontrib><creatorcontrib>Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Natale, Joanne E., MD, PhD</au><au>Lebet, Ruth, RN, MSN, CCNS-P</au><au>Joseph, Jill G., MD, PhD</au><au>Ulysse, Christine, BS</au><au>Ascenzi, Judith, RN, DNP</au><au>Wypij, David, PhD</au><au>Curley, Martha A.Q., RN, PhD</au><aucorp>Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial</atitle><jtitle>The Journal of pediatrics</jtitle><addtitle>J Pediatr</addtitle><date>2017-05-01</date><risdate>2017</risdate><volume>184</volume><spage>204</spage><epage>208.e1</epage><pages>204-208.e1</pages><issn>0022-3476</issn><eissn>1097-6833</eissn><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 Failur e (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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28410087</pmid><doi>10.1016/j.jpeds.2017.02.006</doi><orcidid>https://orcid.org/0000-0001-5228-6694</orcidid><orcidid>https://orcid.org/0000-0002-0146-0549</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | African Americans Child Child, Preschool cluster randomized trial Critical Care disparity European Continental Ancestry Group Female Hispanic Americans Humans Infant Male Parents Pediatrics Refusal to Participate RESTORE |
| title | Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial |
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