Document Detail


Factors affecting consent in pediatric critical care research.
MedLine Citation:
PMID:  22120768     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSE: Consent for research is a difficult and unpredictable process in pediatric critical care populations. The objectives of this study were to describe consent rates in pediatric critical care research and their association with patient, legal guardian, consent process, and study design-related factors. METHODS: A prospective, cohort study was conducted from 2009 to 2010 in six tertiary care pediatric intensive care units (PICU) in Canada with legal guardians of patients who were approached for consent for any ongoing PICU research study. Data were recorded on details of the consent process for all consent encounters. RESULTS: We recorded 271 consent encounters. The overall consent rate was 80.1% (217/271). We observed higher consent rates when the research assistant was introduced by a member of the clinical team prior to approaching the family (89.7 vs. 77.7%; P = 0.04). Legal guardians of cardiac surgery patients were less likely to provide consent than those of all other patients (75.3 vs. 86.0%; P = 0.03). There was no difference in consent rates between therapeutic (117/145, 80.7%) versus non-therapeutic studies (100/126, 79.4%; P = 0.88). CONCLUSION: This study provides future researchers with consent data for determination of recruitment rates, sample sizes, budget estimations, and study timelines. Future pediatric critical care studies should consider incorporating the lower consent rates in cardiac surgery patients and routine introduction of the research assistant to the family by a member of the patient's care team into their study designs. The potential influence of parental factors on consent rates in pediatric critical care studies requires further research.
Authors:
Kusum Menon; Roxanne E Ward; Isabelle Gaboury; Margot Thomas; Ari Joffe; Karen Burns; Deborah Cook
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-11-26
Journal Detail:
Title:  Intensive care medicine     Volume:  -     ISSN:  1432-1238     ISO Abbreviation:  -     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7704851     Medline TA:  Intensive Care Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Pediatrics, University of Ottawa, Ottawa, Canada, menon@cheo.on.ca.
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