{"id":"https://openalex.org/W2255677352","doi":"https://doi.org/10.1542/peds.2015-0512","title":"Deferred Consent for Randomized Controlled Trials in Emergency Care Settings","display_name":"Deferred Consent for Randomized Controlled Trials in Emergency Care Settings","publication_year":2015,"publication_date":"2015-10-06","ids":{"openalex":"https://openalex.org/W2255677352","doi":"https://doi.org/10.1542/peds.2015-0512","mag":"2255677352","pmid":"https://pubmed.ncbi.nlm.nih.gov/26438711"},"language":"en","primary_location":{"id":"doi:10.1542/peds.2015-0512","doi":"https://doi.org/10.1542/peds.2015-0512","is_oa":false,"landing_page_url":"https://doi.org/10.1542/peds.2015-0512","pdf_url":null,"source":{"id":"https://openalex.org/S77494981","display_name":"PEDIATRICS","issn_l":"0031-4005","issn":["0031-4005","1098-4275"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","erih-plus","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315734","host_organization_name":"American Academy of Pediatrics","host_organization_lineage":["https://openalex.org/P4310315734"],"host_organization_lineage_names":["American Academy of Pediatrics"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatrics","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5004861350","display_name":"Katie L. Harron","orcid":"https://orcid.org/0000-0002-3418-2856","observed_orcids":["https://orcid.org/0000-0002-3418-2856"]},"institutions":[{"id":"https://openalex.org/I45129253","display_name":"University College London","ror":"https://ror.org/02jx3x895","country_code":"GB","type":"education","lineage":["https://openalex.org/I124357947","https://openalex.org/I45129253"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Katie Harron","raw_affiliation_strings":["Institute of Child Health, University College London, London, England;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Child Health, University College London, London, England;","institution_ids":["https://openalex.org/I45129253"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5069937739","display_name":"Kerry Woolfall","orcid":"https://orcid.org/0000-0002-5726-5304","observed_orcids":["https://orcid.org/0000-0002-5726-5304"]},"institutions":[{"id":"https://openalex.org/I146655781","display_name":"University of Liverpool","ror":"https://ror.org/04xs57h96","country_code":"GB","type":"education","lineage":["https://openalex.org/I146655781"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Kerry Woolfall","raw_affiliation_strings":["University of Liverpool, Liverpool, England; and"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Liverpool, Liverpool, England; and","institution_ids":["https://openalex.org/I146655781"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032242852","display_name":"Kerry M. Dwan","orcid":"https://orcid.org/0000-0001-6918-1215","observed_orcids":["https://orcid.org/0000-0001-6918-1215"]},"institutions":[{"id":"https://openalex.org/I146655781","display_name":"University of Liverpool","ror":"https://ror.org/04xs57h96","country_code":"GB","type":"education","lineage":["https://openalex.org/I146655781"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Kerry Dwan","raw_affiliation_strings":["University of Liverpool, Liverpool, England; and"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Liverpool, Liverpool, England; and","institution_ids":["https://openalex.org/I146655781"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5000981717","display_name":"Carrol L. Gamble","orcid":"https://orcid.org/0000-0002-3021-1955","observed_orcids":["https://orcid.org/0000-0002-3021-1955"]},"institutions":[{"id":"https://openalex.org/I146655781","display_name":"University of Liverpool","ror":"https://ror.org/04xs57h96","country_code":"GB","type":"education","lineage":["https://openalex.org/I146655781"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Carrol Gamble","raw_affiliation_strings":["University of Liverpool, Liverpool, England; and"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Liverpool, Liverpool, England; and","institution_ids":["https://openalex.org/I146655781"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5034867789","display_name":"Quen Mok","orcid":"https://orcid.org/0000-0003-4807-9275","observed_orcids":["https://orcid.org/0000-0003-4807-9275"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Quen Mok","raw_affiliation_strings":["Pediatric Intensive Care Unit, and"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pediatric Intensive Care Unit, and","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015882350","display_name":"Padmanabhan Ramnarayan","orcid":"https://orcid.org/0000-0003-0784-8154","observed_orcids":["https://orcid.org/0000-0003-0784-8154"]},"institutions":[{"id":"https://openalex.org/I2800129641","display_name":"Great Ormond Street Hospital","ror":"https://ror.org/00zn2c847","country_code":"GB","type":"healthcare","lineage":["https://openalex.org/I2800129641","https://openalex.org/I2800349819"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Padmanabhan Ramnarayan","raw_affiliation_strings":["Children\u2019s Acute Transport Service, Great Ormond Street Hospital, London, England"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Children\u2019s Acute Transport Service, Great Ormond Street Hospital, London, England","institution_ids":["https://openalex.org/I2800129641"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5005303580","display_name":"Ruth E. Gilbert","orcid":"https://orcid.org/0000-0001-9347-2709","observed_orcids":["https://orcid.org/0000-0001-9347-2709"]},"institutions":[{"id":"https://openalex.org/I45129253","display_name":"University College London","ror":"https://ror.org/02jx3x895","country_code":"GB","type":"education","lineage":["https://openalex.org/I124357947","https://openalex.org/I45129253"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Ruth Gilbert","raw_affiliation_strings":["Institute of Child Health, University College London, London, England;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Child Health, University College London, London, England;","institution_ids":["https://openalex.org/I45129253"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":4.2453,"has_fulltext":false,"cited_by_count":58,"citation_normalized_percentile":{"value":0.94272086,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":88,"max":99},"biblio":{"volume":"136","issue":"5","first_page":"e1316","last_page":"e1322"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.9848999977111816,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.9848999977111816,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T14437","display_name":"Ethics and Legal Issues in Pediatric Healthcare","score":0.011099999770522118,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13147","display_name":"Ethics and bioethics in healthcare","score":0.001500000013038516,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/deferred-consent","display_name":"deferred consent","score":0.9959999918937683},{"id":"https://openalex.org/keywords/pediatric-intensive-care","display_name":"pediatric intensive care","score":0.984000027179718},{"id":"https://openalex.org/keywords/central-venous-catheters","display_name":"central venous catheters","score":0.8019999861717224},{"id":"https://openalex.org/keywords/informed-consent","display_name":"informed consent","score":0.5619999766349792},{"id":"https://openalex.org/keywords/family-consent","display_name":"family consent","score":0.4009999930858612},{"id":"https://openalex.org/keywords/catch-trials","display_name":"catch trials","score":0.5339999794960022},{"id":"https://openalex.org/keywords/research-ethics","display_name":"research ethics","score":0.5519999861717224}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9289069175720215},{"id":"https://openalex.org/C68122502","wikidata":"https://www.wikidata.org/wiki/Q764527","display_name":"Informed consent","level":3,"score":0.7535456418991089},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.6609194874763489},{"id":"https://openalex.org/C2779171700","wikidata":"https://www.wikidata.org/wiki/Q7136783","display_name":"Parental consent","level":4,"score":0.47975954413414},{"id":"https://openalex.org/C2780724011","wikidata":"https://www.wikidata.org/wiki/Q1295316","display_name":"Emergency department","level":2,"score":0.46035951375961304},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.4486970901489258},{"id":"https://openalex.org/C194828623","wikidata":"https://www.wikidata.org/wiki/Q2861470","display_name":"Emergency medicine","level":1,"score":0.43335726857185364},{"id":"https://openalex.org/C187212893","wikidata":"https://www.wikidata.org/wiki/Q123028","display_name":"Pediatrics","level":1,"score":0.4205700755119324},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.3343595564365387},{"id":"https://openalex.org/C118552586","wikidata":"https://www.wikidata.org/wiki/Q7867","display_name":"Psychiatry","level":1,"score":0.160916268825531},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.1449931561946869},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.10979634523391724},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.0920223593711853},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D002405","descriptor_name":"Catheterization, Central Venous","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002648","descriptor_name":"Child","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004632","descriptor_name":"Emergency Medical Services","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D018579","descriptor_name":"Patient Selection","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D057828","descriptor_name":"Informed Consent By Minors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":4,"locations":[{"id":"doi:10.1542/peds.2015-0512","doi":"https://doi.org/10.1542/peds.2015-0512","is_oa":false,"landing_page_url":"https://doi.org/10.1542/peds.2015-0512","pdf_url":null,"source":{"id":"https://openalex.org/S77494981","display_name":"PEDIATRICS","issn_l":"0031-4005","issn":["0031-4005","1098-4275"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","erih-plus","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315734","host_organization_name":"American Academy of Pediatrics","host_organization_lineage":["https://openalex.org/P4310315734"],"host_organization_lineage_names":["American Academy of Pediatrics"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatrics","raw_type":"journal-article"},{"id":"pmid:26438711","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/26438711","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatrics","raw_type":"Journal Article"},{"id":"pmh:oai:eprints.ucl.ac.uk.OAI2:10114932","doi":null,"is_oa":false,"landing_page_url":"https://discovery.ucl.ac.uk/id/eprint/10114932/","pdf_url":null,"source":{"id":"https://openalex.org/S4306400024","display_name":"UCL Discovery (University College London)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I45129253","host_organization_name":"University College London","host_organization_lineage":["https://openalex.org/I45129253"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Pediatrics , 136 (5) E1316-E1322. (2015)","raw_type":"Article"},{"id":"pmh:oai:eprints.ucl.ac.uk.OAI2:1483831","doi":null,"is_oa":false,"landing_page_url":"http://discovery.ucl.ac.uk/1483831/","pdf_url":null,"source":{"id":"https://openalex.org/S4306400024","display_name":"UCL Discovery (University College London)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I45129253","host_organization_name":"University College London","host_organization_lineage":["https://openalex.org/I45129253"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"PEDIATRICS , 136 (5) E1316-E1322. (2015)","raw_type":"Article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9763000011444092,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[{"id":"https://openalex.org/G1610190260","display_name":"MRC North West Hub for Trials Methodology Research","funder_award_id":"MR/K025635/1","funder_id":"https://openalex.org/F4320334626","funder_display_name":"Medical Research Council"},{"id":"https://openalex.org/G205952512","display_name":"Centre for Health service and Academic Partnership in Translational eHealth Research (CHAPTER)","funder_award_id":"MR/K006584/1","funder_id":"https://openalex.org/F4320334626","funder_display_name":"Medical Research Council"}],"funders":[{"id":"https://openalex.org/F4320334626","display_name":"Medical Research Council","ror":"https://ror.org/03x94j517"}],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":33,"referenced_works":["https://openalex.org/W289424700","https://openalex.org/W1843487858","https://openalex.org/W1926884931","https://openalex.org/W1965574306","https://openalex.org/W1968203029","https://openalex.org/W1978815599","https://openalex.org/W1980922918","https://openalex.org/W1983611842","https://openalex.org/W1992756852","https://openalex.org/W2007540060","https://openalex.org/W2007664096","https://openalex.org/W2008500636","https://openalex.org/W2012441881","https://openalex.org/W2017779293","https://openalex.org/W2034329675","https://openalex.org/W2066788882","https://openalex.org/W2088727060","https://openalex.org/W2090335296","https://openalex.org/W2093138075","https://openalex.org/W2099004651","https://openalex.org/W2099038982","https://openalex.org/W2100648787","https://openalex.org/W2101388726","https://openalex.org/W2109437070","https://openalex.org/W2133820329","https://openalex.org/W2140404760","https://openalex.org/W2144462910","https://openalex.org/W2155677320","https://openalex.org/W2168580006","https://openalex.org/W2170623128","https://openalex.org/W2171012064","https://openalex.org/W2171723063","https://openalex.org/W4243034825"],"related_works":["https://openalex.org/W2226322964","https://openalex.org/W1941211433","https://openalex.org/W3190944801","https://openalex.org/W2973186089","https://openalex.org/W2312869813","https://openalex.org/W2770749894","https://openalex.org/W2322659413","https://openalex.org/W2168580006","https://openalex.org/W2102389695","https://openalex.org/W2090335296"],"abstract_inverted_index":{"BACKGROUND:":[0],"There":[1],"is":[2],"limited":[3],"experience":[4],"in":[5,16,20,36,42,56,73,140,235],"using":[6],"deferred":[7,93,193,269],"consent":[8,30,95,124,142,194,215,234,270],"for":[9,34,111,136,143,213],"studies":[10,27],"involving":[11],"children,":[12],"which":[13],"was":[14,109,151],"legalized":[15],"the":[17,48,229,258],"United":[18],"Kingdom":[19],"2008.":[21],"We":[22],"aimed":[23],"to":[24,63,85,96,122,154,163,267],"inform":[25],"future":[26],"by":[28,244],"evaluating":[29],"rates":[31,160],"and":[32,58,91,101,138],"reasons":[33],"nonconsent":[35],"a":[37,86,128],"large":[38],"randomized":[39,224],"controlled":[40,225],"trial":[41,87],"pediatric":[43],"intensive":[44],"care.":[45],"METHODS:":[46],"In":[47],"CATCH":[49],"trial,":[50],"eligible":[51],"children":[52,75,115,144,180,204,247],"from":[53,127],"14":[54],"PICUs":[55],"England":[57],"Wales":[59],"were":[60,81,188,211],"randomly":[61,83],"assigned":[62,84],"3":[64],"types":[65],"of":[66,114,130,168,176,203,222,242,260],"central":[67,88],"venous":[68,89],"catheters.":[69],"To":[70],"avoid":[71],"delay":[72],"treatment,":[74],"admitted":[76,116,181,205],"on":[77,117,182,206],"an":[78,118,152,183,207],"emergency":[79,119,184,223],"basis":[80,185,209],"first":[82],"catheter,":[90],"we":[92],"seeking":[94,141,233],"use":[97,259],"already":[98,261],"collected":[99,262],"data":[100,263],"blood":[102],"samples":[103],"until":[104],"after":[105],"stabilization.":[106],"RESULTS:":[107],"Consent":[108],"obtained":[110],"984/1358":[112],"(72%)":[113],"basis.":[120],"Failure":[121],"obtain":[123,268],"resulted":[125],"mainly":[126],"lack":[129],"opportunity":[131,153],"(early":[132],"discharge":[133],"or":[134,250],"transfer)":[135],"survivors":[137],"difficulties":[139],"who":[145,210,248],"died.":[146],"For":[147,179],"admissions":[148],"where":[149],"there":[150],"approach":[155],"(n":[156,195,216],"=":[157,196,217],"1298),":[158],"inclusion":[159],"differed":[161],"according":[162],"survival":[164],"status:":[165],"93/984":[166],"(9%)":[167],"consented":[169],"patients":[170],"died,":[171],"compared":[172,199],"with":[173,200],"58/314":[174],"(18%)":[175],"nonconsented":[177],"patients.":[178],"whose":[186],"families":[187],"approached,":[189],"984/1178":[190],"(84%)":[191],"provided":[192],"15":[197],"sites),":[198],"441/641":[201],"(69%)":[202],"elective":[208],"approached":[212],"prospective":[214],"9":[218],"sites).":[219],"CONCLUSIONS:":[220],"Design":[221],"trials":[226],"should":[227],"balance":[228],"potential":[230],"burden":[231],"that":[232],"difficult":[236],"situations":[237],"may":[238],"cause":[239],"against":[240],"risk":[241],"bias":[243],"disproportionately":[245],"excluding":[246],"die":[249],"are":[251,271],"transferred.":[252],"Ethics":[253],"committees":[254],"could":[255],"consider":[256],"approving":[257],"when":[264],"best":[265],"efforts":[266],"unsuccessful.":[272]},"counts_by_year":[{"year":2026,"cited_by_count":5},{"year":2025,"cited_by_count":6},{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":1},{"year":2022,"cited_by_count":6},{"year":2021,"cited_by_count":7},{"year":2020,"cited_by_count":8},{"year":2019,"cited_by_count":10},{"year":2018,"cited_by_count":5},{"year":2017,"cited_by_count":3},{"year":2016,"cited_by_count":4},{"year":2015,"cited_by_count":1}],"updated_date":"2026-11-03T10:50:19.383937","created_date":"2016-06-24T00:00:00"}