Research recruitment practices and critically ill patients: A multicenter, cross-sectional study (the consent study)

American Journal of Respiratory and Critical Care Medicine

Volumn 187, Issue 11, 2013, Pages 1212-1218

  Burns, Karen E A ^a,b   Zubrinich, Celia ^c   Tan, Wylie ^d   Raptis, Stavroula ^b   Xiong, Wei ^a   Smith, Orla ^a,b,e   McDonald, Ellen ^f,g   Marshall, John C ^a,b   Saginur, Raphael ^h   Heslegrave, Ron ⁱ   Rubenfeld, Gordon ^b,j   Cook, Deborah J ^f,g  

^a ST MICHAEL'S HOSPITAL   (Canada)

^b ST MICHAEL'S HOSPITAL   (Canada)

^c ALFRED HOSPITAL   (Australia)

^d UNIVERSITY OF TORONTO   (Canada)

^e UNIVERSITY OF TORONTO   (Canada)

^f ST JOSEPH S HOSPITAL   (Canada)

^g MCMASTER UNIVERSITY   (Canada)

^h UNIVERSITY OF OTTAWA   (Canada)

ⁱ UNIVERSITY HEALTH NETWORK   (Canada)

^j SUNNYBROOK RESEARCH INSTITUTE   (Canada)

more..

Author keywords

Coenrollment; Consent; Critical care; Research participation; Research recruitment

Indexed keywords

ADULT; AGED; ARTICLE; CLINICAL DECISION MAKING; CLINICAL PRACTICE; CRITICALLY ILL PATIENT; FEMALE; HUMAN; INTENSIVE CARE UNIT; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; OBSERVATIONAL STUDY; PATIENT PARTICIPATION; PRACTICE GUIDELINE; PREDICTOR VARIABLE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RESEARCH SUBJECT; WORKLOAD;

AGED; CRITICAL CARE; CRITICAL ILLNESS; CROSS-SECTIONAL STUDIES; DECISION MAKING; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFORMED CONSENT; INTENSIVE CARE UNITS; MALE; MIDDLE AGED; ONTARIO; PATIENT SELECTION; PROSPECTIVE STUDIES; RESEARCH DESIGN;

EID: 84878998764     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201208-1537OC     Document Type: Article

References (46)

1. Cook D, Brower R, Cooper J, Brochard L, Vincent JL. Multicenter clinical research in adult critical care. Crit Care Med 2002;30:1636-1643. (Pubitemid 34756253)
2. National Institutes of Health, Office of Human Subjects Research. Regulations and ethical guidelines. Directives for human experimentation: the Nuremberg code [accessed 2012 Mar 26]. Available from: http://ohsr.od.nih.gov/ guidelines/nuremberg.html
3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont Report: ethical principles and guidelines for the protection of human subjects of research 3. 44 Federal Register 23192 (1979).
4. Luce JM. Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 2003;31(3, Suppl):S153-S160. (Pubitemid 36379560)
5. Upadya A, Muralidharan V, Thorevska N, Amoateng-Adjepong Y, Manthous CA. Patient, physician, and family member understanding of living wills. Am J Respir Crit Care Med 2002;166:1430-1435. (Pubitemid 35387291)
6. Coppolino M, Ackerson L. Do surrogate decision makers provide accurate consent for intensive care research? Chest 2001;119:603-612. (Pubitemid 32163776)
7. Bolmsjö I, Hermeré n G. Interviews with patients, family, and caregivers in amyotrophic lateral sclerosis: comparing needs. J Palliat Care 2001;17:236-240. (Pubitemid 33712553)
8. Shalowitz DI, Garrett-Mayer E, Wendler D. The accuracy of surrogate decision makers: a systematic review. Arch InternMed 2006;166:493-497.
9. Burns KE, Zubrinich C, Marshall J, Cook D. The "Consent to Research" paradigm in critical care: challenges and potential solutions. Intensive Care Med 2009;35:1655-1658.
10. Holt R, Siddiqi N, Young J. The ethics of consent in delirium studies. J Psychosom Res 2008;65:283-287.
11. Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troché G, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 2002;288:862-871.
12. Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourne D, Brampton W, Williams D, Young D, Rowan K; PAC-Man Study Collaboration. Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PACMan): a randomised controlled trial. Lancet 2005;366:472-477. (Pubitemid 41111695)
13. Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, et al.; CRASH Trial Collaborators. Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH Trial): randomised placebo-controlled trial. Lancet 2004;364:1321-1328.
14. Perner A, Ibsen M, Bonde J. Attitudes to drug trials among relatives of unconscious intensive care patients. BMC. Anesthesiology 2010;10:6.
15. Burns KEA, Magyarody NM, Duffett M, Nisenbaum R, Cook DJ. Attitudes of the general public toward alternative consent models. Am J Crit Care 2011;20:75-83.
16. Duffett M, Burns K, Kho ME, Lauzier F, Meade MO, et al. Consent in critical care trials: a survey of Canadian research ethics boards and critical care researchers. J Crit Care 2011;26:533.e11-533.e22.
17. Mitka M. Aiding emergency research aim of report on exceptions to informed consent. JAMA 2007;298:2608-2609. (Pubitemid 350254969)
18. Burns KEA, Raptis S, Rizvi L, Cook DJ. Coenrollment in a national cross-sectional study of research recruitment practices: the Consent Study [abstract]. Am J Respir Crit Care Med 2012;185:A2544.
19. Burns KEA, Zubrinich C, Tan W, Smith O, McDonald E, Skrobik Y, Saginur R, Jeffs L, Marshall J, Heslegrave R, et al. Understanding barriers to recruitment and the rationale for providing consent for participation in critical care research: the Consent Study (a CCCTG project) [abstract]. Am J Respir Crit Care Med 181;2010:A6047.
20. Wilkins R. PCCF + version 5F user's guide: automated geographic coding based on the Statistics Canada postal code conversion files. Catalogue no. 82F0086-XDB. Ottawa, Ontario, Canada: Health Analysis Division, Statistics Canada; 2010.
21. Kleinbaum DG. Applied regression analysis and other multivariable methods. Boston: Duxbury Press; 1998, pp. xviii, 798.
22. Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol 2007;165:710-718. (Pubitemid 46348374)
23. Grap MJ, Munro CL. Subject recruitment in critical care nursing research: a complex task in a complex environment. Heart Lung 2003;32:162-168. (Pubitemid 36735183)
24. Glassberg AE, Luce JM, Matthay MA; National Heart, Lung, and Blood Institute Clinical Trials Network. Reasons for nonenrollment in a clinical trial of acute lung injury. Chest 2008;134:719-723.
25. Marshall J, Cook DJ. Barriers to investigator-initiated research: a survey of the Canadian Critical Care Trials Group [abstract]. Am J Respir Crit Care Med 2005;33:A82.
26. Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Goldsmith D, Myburgh J, Norton R, Scheinkestel C; RENAL Replacement Therapy Trial Investigators. Screening and study enrolment in the Randomized Evaluation of Normal vs. Augmented Level (RENAL) Replacement Therapy Trial. Blood Purif 2009;27:199-205.
27. Crowley ST, Chertow GM, Vitale J, O'Connor T, Zhang J, Schein RM, Choudhury D, Finkel K, Vijayan A, Paganini E, et al.; VA/NIH Acute Renal Failure Trial Network Study Group. Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study. Clin J Am Soc Nephrol 2008;3:955-961.
28. Mancebo J, Fernández R, Blanch L, Rialp G, Gordo F, Ferrer M, Rodríguez F, Garro P, Ricart P, Vallverdú I, et al. A multicenter trial of prolonged prone ventilation in severe acute respiratory distress syndrome. Am J Respir Crit Care Med 2006;173:1233-1239. (Pubitemid 43848394)
29. Robertson CS, McCullough LB, Brody B. Finding family for prospective consent in emergency research. Clin Trials 2007;4:631-637. (Pubitemid 351567519)
30. Saver JL, Kidwell C, Eckstein M, Ovbiagele B, Starkman S; FAST-MAG Pilot Trial Investigators. Physician-investigator phone elicitation of consent in the field: a novel method to obtain explicit informed consent for prehospital clinical research. Prehosp Emerg Care 2006;10:182-185.
31. Cook DJ, Blythe D, Rischbieth A, Hebert PC, Zytaruk N, Menon K, Erikson S, Fowler R, Heels-Ansdell D, Meade MO. Enrollment of intensive care unit patients into clinical studies: a trinational survey of researchers' experiences, beliefs, and practices. Crit Care Med 2008;36:2100-2105.
32. Cook D, McDonald E, Smith O, Zytaruk N, Heels-Ansdell D, Watpool I, McArdle T, Matte A, Clarke F, Vallance S, et al.; PROTECT Research Coordinators; PROTECT Investigators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group. Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences. Crit Care 2013;17:R1.
33. Soltner C, Lassalle V, Galienne-Bouygues S, Pottecher J, Floccard B, Delapierre L, Jungfer F, Sargentini C, Alberti C, Beydon L; Lifrea Group. Written information that relatives of adult intensive care unit patients would like to receive - a comparison to published recommendations and opinion of staff members. Crit Care Med 2009;37:2197-2202.
34. Fan E, Shahid S, Kondreddi VP, Bienvenu OJ, Mendez-Tellez PA, Pronovost PJ, Needham DM. Informed consent in the critically ill: a two-step approach incorporating delirium screening. Crit Care Med 2008;36:94-99.
35. Egerod I, Christensen BV, Johansen L. Trends in sedation practices in Danish intensive care units in 2003: a national survey. Intensive Care Med 2006;32:60-66. (Pubitemid 43039377)
36. Mehta S, Burry L, Fischer S, Martinez-Motta JC, Hallett D, Bowman D, Wong C, Meade MO, Stewart TE, Cook DJ; Canadian Critical Care Trials Group. Canadian survey of the use of sedatives, analgesics, and neuromuscular blocking agents in critically ill patients. Crit Care Med 2006;34:374-380. (Pubitemid 43145615)
37. Chertow GM, Pascual MT, Soroko S, Savage BR, Himmelfarb J, Ikizler TA, Paganini EP, Mehta RL; PICARD. Reasons for non-enrollment in a cohort study of ARF: the Program to Improve Care in Acute Renal Disease (PICARD) experience and implications for a clinical trials network. Am J Kidney Dis 2003;42:507-512. (Pubitemid 37048126)
38. Scales DC, Smith OM, Pinto R, Barrett KA, Friedrich JO, Lazar NM, Cook DJ, Ferguson ND. Patients' preferences for enrolment into critical-care trials. Intensive Care Med 2009;35:1703-1712.
39. Barrett K, Ferguson ND, Athaide N, Cook DJ, Friedrich JO, McDonald E, Pinto R, Smith OM, Scales DC. Substitute decision makers' attitudes towards research decision-making for critically ill patients. Int Care Med 2012;38:1616-1623.
40. Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research: consensus statement from the coalition conference of acute resuscitation and critical care researchers. JAMA 1995;273:1283-1287.
41. Pinder M, Tshukutsoane S, Scribante J, Piccolo R, Lipman J. Critical care research and pre-emptive informed consent: a practical approach used in Chris Hani Baragwanath ICU. Intensive Care Med 1998;24:353-357. (Pubitemid 28203885)
42. Aramendi JI, Mestres C-A, Martinez-León J, Campos V, Muñoz G, Navas C. Triflusal versus oral anticoagulation for primary prevention of thromboembolism after bioprosthetic valve replacement (TRAC): prospective, randomized, co-operative trial. Eur J Cardiothorac Surg 2005;27:854-860. [Published erratum appears in Eur J Cardiothorac Surg 28:188] (Pubitemid 40585681)
43. Ciroldi M, Cariou A, Adrie C, Annane D, Castelain V, Cohen Y, Delahaye A, Joly LM, Galliot R, Garrouste-Orgeas M, et al.; Famirea Study Group. Ability of family members to predict patient's consent to critical care research. Intensive Care Med 2007;33:807-813. (Pubitemid 46675320)
44. Mehta S, Quittnat Pelletier F, Brown M, Ethier C, Wells D, Burry L, MacDonald R. Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study. Intensive Care Med 2012;38:47-54.
45. Luce JM, Cook DJ, Martin TR, Angus DC, Boushey HA, Curtis JR, Heffner JE, Lanken PN, Levy MM, Polite PY, et al.; American Thoracic Society. The ethical conduct of clinical research involving critically ill patients in the United States and Canada: principles and recommendations. Am J Respir Crit Care Med 2004;170:1375-1384.
46. Barrett KA, Scales DC. Considering the vulnerabilities of surrogate decision-makers when obtaining consent for critical care research. Intensive Care Med 2012;38:4-6.