Katie Harron1, Kerry Woolfall2, Kerry Dwan2, Carrol Gamble2, Quen Mok3, Padmanabhan Ramnarayan4, Ruth Gilbert5. 1. Institute of Child Health, University College London, London, England; 2. University of Liverpool, Liverpool, England; and. 3. Pediatric Intensive Care Unit, and. 4. Children's Acute Transport Service, Great Ormond Street Hospital, London, England. 5. Institute of Child Health, University College London, London, England; r.gilbert@ucl.ac.uk.
Abstract
BACKGROUND: There is limited experience in using deferred consent for studies involving children, which was legalized in the United Kingdom in 2008. We aimed to inform future studies by evaluating consent rates and reasons for nonconsent in a large randomized controlled trial in pediatric intensive care. METHODS: In the CATCH trial, eligible children from 14 PICUs in England and Wales were randomly assigned to 3 types of central venous catheters. To avoid delay in treatment, children admitted on an emergency basis were first randomly assigned to a trial central venous catheter, and we deferred seeking consent to use already collected data and blood samples until after stabilization. RESULTS: Consent was obtained for 984/1358 (72%) of children admitted on an emergency basis. Failure to obtain consent resulted mainly from a lack of opportunity (early discharge or transfer) for survivors and difficulties in seeking consent for children who died. For admissions where there was an opportunity to approach (n = 1298), inclusion rates differed according to survival status: 93/984 (9%) of consented patients died, compared with 58/314 (18%) of nonconsented patients. For children admitted on an emergency basis whose families were approached, 984/1178 (84%) provided deferred consent (n = 15 sites), compared with 441/641 (69%) of children admitted on an elective basis who were approached for prospective consent (n = 9 sites). CONCLUSIONS: Design of emergency randomized controlled trials should balance the potential burden that seeking consent in difficult situations may cause against risk of bias by disproportionately excluding children who die or are transferred. Ethics committees could consider approving the use of already collected data when best efforts to obtain deferred consent are unsuccessful.
BACKGROUND: There is limited experience in using deferred consent for studies involving children, which was legalized in the United Kingdom in 2008. We aimed to inform future studies by evaluating consent rates and reasons for nonconsent in a large randomized controlled trial in pediatric intensive care. METHODS: In the CATCH trial, eligible children from 14 PICUs in England and Wales were randomly assigned to 3 types of central venous catheters. To avoid delay in treatment, children admitted on an emergency basis were first randomly assigned to a trial central venous catheter, and we deferred seeking consent to use already collected data and blood samples until after stabilization. RESULTS: Consent was obtained for 984/1358 (72%) of children admitted on an emergency basis. Failure to obtain consent resulted mainly from a lack of opportunity (early discharge or transfer) for survivors and difficulties in seeking consent for children who died. For admissions where there was an opportunity to approach (n = 1298), inclusion rates differed according to survival status: 93/984 (9%) of consented patients died, compared with 58/314 (18%) of nonconsented patients. For children admitted on an emergency basis whose families were approached, 984/1178 (84%) provided deferred consent (n = 15 sites), compared with 441/641 (69%) of children admitted on an elective basis who were approached for prospective consent (n = 9 sites). CONCLUSIONS: Design of emergency randomized controlled trials should balance the potential burden that seeking consent in difficult situations may cause against risk of bias by disproportionately excluding children who die or are transferred. Ethics committees could consider approving the use of already collected data when best efforts to obtain deferred consent are unsuccessful.
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Authors: Padmanabhan Ramnarayan; Alvin Richards-Belle; Laura Drikite; Michelle Saull; Izabella Orzechowska; Robert Darnell; Zia Sadique; Julie Lester; Kevin P Morris; Lyvonne N Tume; Peter J Davis; Mark J Peters; Richard G Feltbower; Richard Grieve; Karen Thomas; Paul R Mouncey; David A Harrison; Kathryn M Rowan Journal: JAMA Date: 2022-04-26 Impact factor: 157.335
Authors: Jeremy Furyk; Kristin McBain-Rigg; Kerrianne Watt; Theophilus I Emeto; Richard C Franklin; Donna Franklin; Andreas Schibler; Stuart R Dalziel; Franz E Babl; Catherine Wilson; Natalie Phillips; Robin Ray Journal: BMJ Open Date: 2017-11-15 Impact factor: 2.692
Authors: Vicky Chalos; Rob A van de Graaf; Bob Roozenbeek; Adriaan C G M van Es; Heleen M den Hertog; Julie Staals; Lukas van Dijk; Sjoerd F M Jenniskens; Robert J van Oostenbrugge; Wim H van Zwam; Yvo B W E M Roos; Charles B L M Majoie; Hester F Lingsma; Aad van der Lugt; Diederik W J Dippel Journal: Trials Date: 2020-07-14 Impact factor: 2.279
Authors: Jeremy Furyk; Kris McBain-Rigg; Bronia Renison; Kerrianne Watt; Richard Franklin; Theophilus I Emeto; Robin A Ray; Franz E Babl; Stuart Dalziel Journal: BMC Med Ethics Date: 2018-11-20 Impact factor: 2.652