Avanti Garde1, Katie O'Hearn2, Stuart Nicholls2, Kusum Menon3. 1. University of Ottawa, 75 Laurier Ave E, Ottawa, Ontario K1N 6N5, Canada. 2. Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Research Building 2, 2nd Floor, Room 2119, Ottawa, Ontario K1H 8L1, Canada. 3. Department of Pediatrics, University of Ottawa, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada. Electronic address: menon@cheo.on.ca.
Abstract
OBJECTIVES: Reporting of consent rates in published articles is important to determine potential sources of bias and validity and generalizability of results. Our objective was to determine the percentage of critical care studies for which the consent rate was reported. STUDY DESIGN AND SETTING: We reviewed all articles published in eight medical journals in 2013. Studies meeting the following inclusion criteria were selected: (1) randomized controlled trial (RCT) or observational clinical study, (2) study population involving critically ill patients, and (3) part of the study occurring in an intensive care unit. RESULTS: A total of 1,871 articles were screened of which 156 were included. The consent rate was discernable in 30.8% of articles (48/156, 95% confidence interval: 24.1, 38.4) with a median consent rate of 86.9% (interquartile range, 71.6, 94.1). A statement on Research Ethics Board approval was included in 96.8% of studies. There was a significant difference in reporting of consent rates between RCTs and non-RCTs (58.70% vs. 19.09%, P < 0.0001). CONCLUSION: Consent rates are reported in less than one-third of critical care studies. We encourage journals to require reporting of consent rates to improve interpretation, validity, and generalizability of critical care study results.
OBJECTIVES: Reporting of consent rates in published articles is important to determine potential sources of bias and validity and generalizability of results. Our objective was to determine the percentage of critical care studies for which the consent rate was reported. STUDY DESIGN AND SETTING: We reviewed all articles published in eight medical journals in 2013. Studies meeting the following inclusion criteria were selected: (1) randomized controlled trial (RCT) or observational clinical study, (2) study population involving critically ill patients, and (3) part of the study occurring in an intensive care unit. RESULTS: A total of 1,871 articles were screened of which 156 were included. The consent rate was discernable in 30.8% of articles (48/156, 95% confidence interval: 24.1, 38.4) with a median consent rate of 86.9% (interquartile range, 71.6, 94.1). A statement on Research Ethics Board approval was included in 96.8% of studies. There was a significant difference in reporting of consent rates between RCTs and non-RCTs (58.70% vs. 19.09%, P < 0.0001). CONCLUSION: Consent rates are reported in less than one-third of critical care studies. We encourage journals to require reporting of consent rates to improve interpretation, validity, and generalizability of critical care study results.
Authors: Ewoud Ter Avest; Barbara C van Munster; Raymond J van Wijk; Sanne Tent; Sanne Ter Horst; Ting Ting Hu; Lisanne E van Heijst; Felien S van der Veer; Fleur E van Beuningen; Jan Cornelis Ter Maaten; Hjalmar R Bouma Journal: BMJ Open Date: 2021-07-15 Impact factor: 2.692