Co-Enrolment to Intensive Care Studies – A UK Perspective

Weideman HP Wheeler AP Bernard GR . Comparison of two fluid-management strategies in acute lung injury. N Engl J Med 2006;354: 2564–75.

Angus D Mira JP Vincent JL . Improving clinical trials in the critically ill. Crit Care Med 2010;38: 527–32.

ANZICS Clinical Trials Group: Co-enrollment Policy (CTG19a (2011) Version 021011) http://www.anzics.com.au/ctg/ctgdocuments Accessed 15 March 2013.

Canadian Critical Care Trials Group. Enrolment of 1 ICU Patient into 2 Randomized Trials: Guidelines of the CCCTG, 2007. http://www.ccctg.ca/ccctg/media/Banners/PDF%20Documents/CCCTG-Coenrolment-Guidelines-Mar2011.pdf Accessed 15 March 2013.

Cook DJ Blythe D Rischbieth A . for the Canadian Critical Care Trials Group. (2008) Enrolment of ICU patients into clinical studies: a tri-national survey. Crit Care Med 2008;37: 51–56.

Coenrolment to critical care studies and trials in the United Kingdom – A guidance document December 2012. http://www.ics.ac.uk/latest_news/JICS_co_enrolement Accessed April 2013.

Byar DP Schoenfeld DA Green SB . Design considerations for AIDS trials. N Engl J Med 1990;323: 1343–48.

Larntz K Neaton JD Wentworth DN . Data analysis issues for protocols with overlapping enrollment. Stat Med 1996;15: 2445–53.

Nichol G Powell JL Emerson S . On coenrollment in clinical resuscitation studies: review and experience from randomized trials. Resuscitation 2010;81: 792–95.

Schoenfeld D Hayden D Oldmixon C . Statistical design and analysis issues for the ARDS Clinical Trials Network: the Coordinating Center perspective. Clin Invest 2012;2: 275–89.

Fergusson D . The impact of co-enrollment in clinical trials. Critical Care Canada Forum 2009. http://www.criticalcarecanada.com/presentations/2009/co-enrollment.pdf Accessed 15 March 2013.

Randolph AG . The unique challenges of enrolling patients into multiple clinical trials. Crit Care Med 2009;37: S107–S111.

Harron K Lee T Ball T . for the CATCH team. Making co-enrolment feasible for randomised controlled trials in paediatric intensive care. PLoS One 2012;7: e41791.

Burgess E Singhal N Amin H . Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study. Arch Dis Child Fetal Neonatal Ed 2003;88: F280.

Burnet K Benson J Earl H . A survey of breast cancer patients' views on entry into several clinical studies. Eur J Cancer Care (Engl) 2004;13: 32–35.

Morley CJ Lau R Davis PG Morse C . What do parents think about enrolling their premature babies in several research studies? Arch Dis Child Fetal Neonatal Ed 2005;90: 225–28.

Barrett KA Fergusson ND Athaide V . Surrogate decision makers' attitudes towards research decision making for critically ill patients. Intensive Care Med 2012;38: 1616–23.

Newman JT Smart A Reese TR . Surrogate and patient discrepancy regarding consent for critical care research. Crit Care Med 2012;40: 2590–94.

Lim D Chan MF Childs C . Surrogate consent for critical care research: exploratory study on public perception and influences on recruitment. Crit Care 2013;17: R5.

Cook D McDonald E Smith O . Coenrolment of critically ill patients into multiple studies: patterns, predictors and consequences. Crit Care 2013;17: R1.