Enrollment of intensive care unit patients into clinical studies: A trinational survey of researchers ctices

Critical Care Medicine

Volumn 36, Issue 7, 2008, Pages 2100-2105

  Cook, Deborah J ^a,b   Blythe, David ^c   Rischbieth, Amanda ^d   Hebert, Paul C ^e,f   Zytaruk, Nicole ^b   Menon, Kusum ^e   Erikson, Simon ^g   Fowler, Robert ^h   Heels Ansdell, Diane ^b   Meade, Maureen O ^a,b  

^a Australian and New Zealand Intensive Care Society   (Australia)

^b MCMASTER UNIVERSITY   (Canada)

^c FREMANTLE HOSPITAL   (Australia)

^d UNIVERSITY OF ADELAIDE   (Australia)

^e UNIVERSITY OF OTTAWA   (Canada)

^f OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^g PRINCESS MARGARET HOSPITAL FOR CHILDREN   (Australia)

^h UNIVERSITY OF TORONTO   (Canada)

Author keywords

Critical care; Intensive care; Randomized trials; Research; Studies

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CLINICAL RESEARCH; CRITICALLY ILL PATIENT; DEMOGRAPHY; HEALTH CARE QUALITY; INTENSIVE CARE; INTENSIVE CARE UNIT; MEDICAL DECISION MAKING; METHODOLOGY; PATIENT CARE; PERSONNEL; PHYSICIAN; PHYSICIAN ATTITUDE; PRIORITY JOURNAL; RELIABILITY; RESEARCH ETHICS; RESEARCH SUBJECT; ADULT; AUSTRALIA; CANADA; CHILD; ETHICS; HEALTH PERSONNEL ATTITUDE; HUMAN; MEDICINE; NEW ZEALAND; PATIENT SELECTION; PERSONNEL MANAGEMENT; RANDOMIZED CONTROLLED TRIAL;

ADULT; ATTITUDE OF HEALTH PERSONNEL; AUSTRALIA; CANADA; CHILD; CRITICAL CARE; HUMANS; INTENSIVE CARE UNITS; NEW ZEALAND; PATIENT SELECTION; PERSONNEL SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SPECIALTIES, MEDICAL;

EID: 47249125817     PISSN: 00903493     EISSN: 15300293     Source Type: Journal    
DOI: 10.1097/CCM.0b013e31817c00b0     Document Type: Article

References (27)

1. Wasserfallen JB, Bossuat C, Perrin E, et al: Costs borne by families of children hospitalized in a pediatric intensive care unit: a pilot study. Swiss Med Wkly 2006; 136:800-804
2. Truog RD, Robinson W, Randolph A, et al: Is informed consent always necessary for randomized controlled trials? N Engl J Med 1999; 11:804-807
3. Morgenweck CJ: Innovation to research: some transitional obstacles in critical care units. Crit Care Med 2003; 31(3 Suppl):S172-7
4. Luce J, Cook DJ, Martin TR, et al, for the Writing Committee of the American Thoracic Society Conference on the Ethical Conduct of Clinical Research Involving the Critically Ill: Luce J, Cook DJ, Martin T (cochairs): The ethical conduct of clinical research involving critically ill patients in the United States and Canada: Principles and recommendations. Am J Resp Crit Care Med 2004; 170:1375-1384
5. Franck LS: Research with newborn participants: doing the right research the right way. J Perinat Neonatal Nurs 2005; 19:177-186
6. Yarborough M: What good are we doing? The role of clinical research in enhancing critical care medicine. J Crit Care 1993; 8:228-236
7. Bigatello LM, George E, Hurford WE: Ethical considerations for research in critically ill patients. Crit Care Med 2003; 31(3 Suppl): S178-S181
8. Paparrigopoulos T, Melissaki A, Efthymiou A, et al: Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG). Ethical intensive care research: development of an ethics handbook. Crit Care Resusc 2005; 7:310-321
9. Griffith LE, Cook DJ, Guyatt GH, et al: Comparison of open versus closed questionnaire formats in obtaining demographic information from Canadian general internists. J Clin Epidemiol 1999; 52:997-1005
10. Survey Monkey Website. Available at: http:// www.surveymonkey.com. Accessed December 9, 2007
11. Annane E, Outin H, Fisch C, et al: The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 2004; 30:321-324
12. Corticosteroid Randomization After Significant Head Injury (CRASH) Trial Collaborators: Effect of intravenous corticosteroid on the death within 14 days in 10,008 adults with clinically significant head injury (MRC CRASH): Randomized placebo controlled trial. Lancet 2004; 364:1321-1328
13. Harvey SE, Elbourne D, Ashcroft J, et al: In- formed consent in clinical trials in critical care. Intensive Care Med 2006; 32:2020-2025
14. The Hypothermia in Traumatic Brain Injury in Children (HiTBIC): Available at: http:// clinicaltrials.gov/ct/show/NCT00282269. Accessed December 9, 2007
15. The Saline versus Albumin Evaluation (SAFE) Study Investigators: A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 2004; 350:2247-2256
16. The Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE SUGAR) Study. Available at: http://clinicaltrials.gov/ct/show/NCT00220987. Accessed December 9, 2007
17. National Health and Medical Research Council (NHMRC). National Statement on Ethical Conduct in Research involving Humans 2007. Available at: http://www.nhmrc.gov. au/publications/synopses/e72syn.htm. Accessed December 9, 2007
18. Morley CJ, Lau R, Davis PG, et al: What do parents think about enrolling their premature babies in several research studies? Arch Dis Child Fetal Neonate Ed 2005; 90: 225-228
19. Scales DC, Smith OM, Barrett K, et al. for the CCCTG: Patient evaluations rating methods for inclusion in trials (PERMIT) Pilot Study. Am J Resp Crit Care Med 2007; 175:508b.
20. Edwards P, Roberts I, Clarke M, et al: Increasing response rate to postal questionnaires: Systematic review. BMJ 2002; 324:1-9
21. McColl E, Jacoby A, Thomas L, et al: Design and use of questionnaires: A review of best practice applicable to surveys of health service staff and patients. Executive Summary. Health Technol Assess 2001; 5(31).
22. Kim HL, Hollowell CM, Patel RV, et al: Use of new technology in endourology and laparoscopy by American urologists: Internet and postal survey. Urology 2000; 56:760-765
23. Raziano DB, Jayadevappa R, Valenzuela D, et al: E-mail versus conventional postal mail survey of geriatric chiefs. Gerontologist 2001; 41:799-804
24. Leece P, Bhandari M, Sprague S, et al: Internet versus mailed questionnaires: A randomized comparison. J Med Internet Res 2004; 6:e30
25. Brathwaite D, Emery J, de Lusignan S, et al: Using the internet to conduct surveys of health professionals: A valid alternative? Family Practice 2003; 20:545-551
26. Passmore C, Dobbie AE, Parchman M, et al: Guidelines for constructing a survey. Fam Med 2002; 34:281-286
27. Cook DJ, Brower R, Cooper J, et al: Multicenter clinical research in critical care. Crit Care Med 2002; 30:1636-1643