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Volumn 28, Issue 1, 2013, Pages 28-39

Rates and determinants of informed consent: A case study of an international thromboprophylaxis trial

(21)  Smith, Orla M a   McDonald, Ellen b   Zytaruk, Nicole b   Foster, Denise c   Matte, Andrea a   Clarke, France b   Meade, Laurie d   O'Callaghan, Nicole e   Vallance, Shirley f   Galt, Pauline g   Rajbhandari, Dorrilyn h   Rocha, Marcelo i   Mehta, Sangeeta a   Ferguson, Niall D a   Hall, Richard j   Fowler, Robert a   Burns, Karen a   Qushmaq, Ismael k   Ostermann, Marlies l   Heels Ansdell, Diane b   more..


Author keywords

Clinical research; Critical care; Informed consent; Intensive care; Randomized trials; Studies

Indexed keywords

DALTEPARIN; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN;

EID: 84870807491     PISSN: 08839441     EISSN: 15578615     Source Type: Journal    
DOI: 10.1016/j.jcrc.2012.08.005     Document Type: Article
Times cited : (20)

References (39)
  • 1
    • 0037348877 scopus 로고    scopus 로고
    • Innovation to research: some transitional obstacles in critical care units
    • Morgenweck C.J. Innovation to research: some transitional obstacles in critical care units. Crit Care Med 2003, 31:S172-S177.
    • (2003) Crit Care Med , vol.31
    • Morgenweck, C.J.1
  • 2
    • 0037351813 scopus 로고    scopus 로고
    • Ethical considerations for research in critically ill patients
    • Bigatello L.M., George E., Hurford W.E. Ethical considerations for research in critically ill patients. Crit Care Med 2003, 31:S178-S181.
    • (2003) Crit Care Med , vol.31
    • Bigatello, L.M.1    George, E.2    Hurford, W.E.3
  • 3
    • 10644279911 scopus 로고    scopus 로고
    • The ethical conduct of clinical research involving critically ill patients in the United States and Canada: principles and recommendations
    • Luce J.M., Cook D.J., Martin T.R., et al. 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.
    • (2004) Am J Resp Crit Care Med , vol.170 , pp. 1375-1384
    • Luce, J.M.1    Cook, D.J.2    Martin, T.R.3
  • 4
    • 37549050140 scopus 로고    scopus 로고
    • Informed consent in the critically ill: a two-step approach incorporating delirium screening
    • Fan E., Shahid S., Kondreddi V.P., et al. Informed consent in the critically ill: a two-step approach incorporating delirium screening. Crit Care Med 2008, 36:94-99.
    • (2008) Crit Care Med , vol.36 , pp. 94-99
    • Fan, E.1    Shahid, S.2    Kondreddi, V.P.3
  • 5
    • 0037906263 scopus 로고    scopus 로고
    • Moral justifications for surrogate decision making in the intensive care unit: implications and limitations
    • Arnold R.M., Kellum J. Moral justifications for surrogate decision making in the intensive care unit: implications and limitations. Crit Care Med 2003, 31:S347-S353.
    • (2003) Crit Care Med , vol.31
    • Arnold, R.M.1    Kellum, J.2
  • 6
    • 0344686265 scopus 로고    scopus 로고
    • Research ethics and consent in the intensive care unit
    • Luce J.M. Research ethics and consent in the intensive care unit. Curr Opin Crit Care 2003, 9:540-544.
    • (2003) Curr Opin Crit Care , vol.9 , pp. 540-544
    • Luce, J.M.1
  • 7
    • 0034121325 scopus 로고    scopus 로고
    • Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit. Canadian Critical Care Trials group
    • Foster D., Cook D., Granton J., et al. Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit. Canadian Critical Care Trials group. Crit Care Med 2000, 28:867-871.
    • (2000) Crit Care Med , vol.28 , pp. 867-871
    • Foster, D.1    Cook, D.2    Granton, J.3
  • 8
    • 84870799946 scopus 로고    scopus 로고
    • Quantifying threats to the feasibility of clinical trials in critically ill patients
    • Rose L., Burns K., Smith O., et al. Quantifying threats to the feasibility of clinical trials in critically ill patients. Am J Resp Crit Care Med 2009, 179:A1580.
    • (2009) Am J Resp Crit Care Med , vol.179
    • Rose, L.1    Burns, K.2    Smith, O.3
  • 9
    • 5044223264 scopus 로고    scopus 로고
    • Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial
    • Roberts I., Yates D., Sandercock P., et al. 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.
    • (2004) Lancet , vol.364 , pp. 1321-1328
    • Roberts, I.1    Yates, D.2    Sandercock, P.3
  • 10
    • 1342289565 scopus 로고    scopus 로고
    • The effect of waiving consent on enrollment in a sepsis trial
    • Annane D., Outin H., Fisch C., et al. The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 2004, 30:321-324.
    • (2004) Intensive Care Med , vol.30 , pp. 321-324
    • Annane, D.1    Outin, H.2    Fisch, C.3
  • 11
    • 33750223042 scopus 로고    scopus 로고
    • Informed consent in clinical trials in critical care: experience from the PAC-man study
    • Harvey S.E., Elbourne D., Ashcroft J., et al. Informed consent in clinical trials in critical care: experience from the PAC-man study. Intensive Care Med 2006, 32:2020-2025.
    • (2006) Intensive Care Med , vol.32 , pp. 2020-2025
    • Harvey, S.E.1    Elbourne, D.2    Ashcroft, J.3
  • 12
    • 63249128249 scopus 로고    scopus 로고
    • Intensive versus conventional glucose control in critically ill patients
    • NICE-SUGAR Study Investigators
    • Finfer S., Chittock D.R., et al. Intensive versus conventional glucose control in critically ill patients. N Engl J Med 2009, 360:1283-1297. NICE-SUGAR Study Investigators.
    • (2009) N Engl J Med , vol.360 , pp. 1283-1297
    • Finfer, S.1    Chittock, D.R.2
  • 13
    • 79953797206 scopus 로고    scopus 로고
    • Dalteparin versus unfractionated heparin in critically ill patients
    • The PROTECT Investigators for the Canadian Critical Care Trials Group, the Australian and New Zealand Intensive Care Society Clinical Trials Groupthe Australian and New Zealand Intensive Care Society Clinical Trials Group
    • Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med 2011, 364:1305-1314. The PROTECT Investigators for the Canadian Critical Care Trials Group, the Australian and New Zealand Intensive Care Society Clinical Trials Groupthe Australian and New Zealand Intensive Care Society Clinical Trials Group.
    • (2011) N Engl J Med , vol.364 , pp. 1305-1314
  • 14
    • 79953780315 scopus 로고    scopus 로고
    • PROphylaxis for ThromboEmbolism in critical care trial protocol and analysis plan
    • for the PROTECT Investigators, the Canadian Critical Care Trials Groupthe Canadian Critical Care Trials Group, Australian and New Zealand Intensive Care Society Trials GroupAustralian and New Zealand Intensive Care Society Trials Group
    • Cook D., Meade M., Guyatt G., et al. PROphylaxis for ThromboEmbolism in critical care trial protocol and analysis plan. J Crit Care 2011, 26:223.e1-223.e9. for the PROTECT Investigators, the Canadian Critical Care Trials Groupthe Canadian Critical Care Trials Group, Australian and New Zealand Intensive Care Society Trials GroupAustralian and New Zealand Intensive Care Society Trials Group.
    • (2011) J Crit Care , vol.26
    • Cook, D.1    Meade, M.2    Guyatt, G.3
  • 15
    • 28444475946 scopus 로고    scopus 로고
    • Prophylaxis of thromboembolism in critical care (PROTECT) trial: a pilot study
    • for the PROTECT Investigators, the Canadian Critical Care Trials Groupthe Canadian Critical Care Trials Group, Australian and New Zealand Intensive Care Society Trials GroupAustralian and New Zealand Intensive Care Society Trials Group
    • Cook D.J., Rocker G., Meade M., et al. Prophylaxis of thromboembolism in critical care (PROTECT) trial: a pilot study. J Crit Care 2005, 20:364-372. for the PROTECT Investigators, the Canadian Critical Care Trials Groupthe Canadian Critical Care Trials Group, Australian and New Zealand Intensive Care Society Trials GroupAustralian and New Zealand Intensive Care Society Trials Group.
    • (2005) J Crit Care , vol.20 , pp. 364-372
    • Cook, D.J.1    Rocker, G.2    Meade, M.3
  • 16
    • 84868303637 scopus 로고    scopus 로고
    • Understanding barriers to recruitment and why patients and surrogates consent for critical care research: the consent study (A CCCTG project)
    • Burns K.E.A., Zubrinich C., Tan W., et al. Understanding barriers to recruitment and why patients and surrogates consent for critical care research: the consent study (A CCCTG project). Am J Resp Crit Care Med 2010, 181:A6047.
    • (2010) Am J Resp Crit Care Med , vol.181
    • Burns, K.E.A.1    Zubrinich, C.2    Tan, W.3
  • 17
    • 72449193119 scopus 로고    scopus 로고
    • Patients' preferences for enrolment into critical-care trials
    • Scales D.C., Smith O.M., Pinto R., et al. Patients' preferences for enrolment into critical-care trials. Intensive Care Med 2009, 35:1703-1712.
    • (2009) Intensive Care Med , vol.35 , pp. 1703-1712
    • Scales, D.C.1    Smith, O.M.2    Pinto, R.3
  • 18
    • 84868304336 scopus 로고    scopus 로고
    • Proxy evaluations rating methods for inclusion into trials (PERMIT 2)
    • Barrett K., Athaide V., Smith O.M., et al. Proxy evaluations rating methods for inclusion into trials (PERMIT 2). Am J Resp Crit Care Med 2009, 179:A1573.
    • (2009) Am J Resp Crit Care Med , vol.179
    • Barrett, K.1    Athaide, V.2    Smith, O.M.3
  • 19
    • 77952592332 scopus 로고    scopus 로고
    • Attitudes to drug trials among relatives of unconscious intensive care patients
    • Perner A., Ibsen M., Bonde J. Attitudes to drug trials among relatives of unconscious intensive care patients. BMC Anesthesiol 2010, 10:6.
    • (2010) BMC Anesthesiol , vol.10 , pp. 6
    • Perner, A.1    Ibsen, M.2    Bonde, J.3
  • 20
    • 33645826554 scopus 로고    scopus 로고
    • Genetic research and testing in critical care: surrogates' perspective
    • Freeman B.D., Kennedy C.R., Coopersmith C.M., et al. Genetic research and testing in critical care: surrogates' perspective. Crit Care Med 2006, 34:986-994.
    • (2006) Crit Care Med , vol.34 , pp. 986-994
    • Freeman, B.D.1    Kennedy, C.R.2    Coopersmith, C.M.3
  • 21
    • 72449173379 scopus 로고    scopus 로고
    • Who should consent for research in adult intensive care? Preferences of patients and their relatives: a pilot study
    • Chenaud C., Merlani P., Verdon M., et al. Who should consent for research in adult intensive care? Preferences of patients and their relatives: a pilot study. J Med Ethics 2009, 35:709-712.
    • (2009) J Med Ethics , vol.35 , pp. 709-712
    • Chenaud, C.1    Merlani, P.2    Verdon, M.3
  • 22
    • 34247570585 scopus 로고    scopus 로고
    • Ability of family members to predict patient's consent to critical care research
    • Ciroldi M., Cariou A., Adrie C., et al. Ability of family members to predict patient's consent to critical care research. Intensive Care Med 2007, 33:807-813.
    • (2007) Intensive Care Med , vol.33 , pp. 807-813
    • Ciroldi, M.1    Cariou, A.2    Adrie, C.3
  • 23
    • 49149089179 scopus 로고    scopus 로고
    • Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study
    • Crowley S.T., Chertow G.M., Vitale J., et al. 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.
    • (2008) Clin J Am Soc Nephrol , vol.3 , pp. 955-961
    • Crowley, S.T.1    Chertow, G.M.2    Vitale, J.3
  • 24
    • 0041358521 scopus 로고    scopus 로고
    • 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
    • Chertow G.M., Pascual M.T., Soroko S., et al. 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.
    • (2003) Am J Kidney Dis , vol.42 , pp. 507-512
    • Chertow, G.M.1    Pascual, M.T.2    Soroko, S.3
  • 25
    • 72449129037 scopus 로고    scopus 로고
    • The "consent to research" paradigm in critical care: challenges and potential solutions
    • Burns K.E., Zubrinich C., Marshall J., et al. The "consent to research" paradigm in critical care: challenges and potential solutions. Intensive Care Med 2009, 35:1655-1658.
    • (2009) Intensive Care Med , vol.35 , pp. 1655-1658
    • Burns, K.E.1    Zubrinich, C.2    Marshall, J.3
  • 26
    • 54249107603 scopus 로고    scopus 로고
    • Reasons for nonenrollment in a clinical trial of acute lung injury
    • Glassberg A.E., Luce J.M., Matthay M.A., et al. Reasons for nonenrollment in a clinical trial of acute lung injury. Chest 2008, 134:719-723.
    • (2008) Chest , vol.134 , pp. 719-723
    • Glassberg, A.E.1    Luce, J.M.2    Matthay, M.A.3
  • 27
    • 0032717613 scopus 로고    scopus 로고
    • Barriers to participation in randomised controlled trials: a systematic review
    • Ross S., Grant A., Counsell C., et al. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 1999, 52:1143-1156.
    • (1999) J Clin Epidemiol , vol.52 , pp. 1143-1156
    • Ross, S.1    Grant, A.2    Counsell, C.3
  • 28
    • 16544372147 scopus 로고    scopus 로고
    • Why cancer patients enter randomized clinical trials: exploring the factors that influence their decision
    • Wright J.R., Whelan T.J., Schiff S., et al. Why cancer patients enter randomized clinical trials: exploring the factors that influence their decision. J Clin Oncol 2004, 22:4312-4318.
    • (2004) J Clin Oncol , vol.22 , pp. 4312-4318
    • Wright, J.R.1    Whelan, T.J.2    Schiff, S.3
  • 29
    • 77955186389 scopus 로고    scopus 로고
    • Comprehension and informed consent: assessing the effect of a short consent form
    • Stunkel L., Benson M., McLellan L., et al. Comprehension and informed consent: assessing the effect of a short consent form. IRB 2010, 32:1-9.
    • (2010) IRB , vol.32 , pp. 1-9
    • Stunkel, L.1    Benson, M.2    McLellan, L.3
  • 30
    • 34047223877 scopus 로고    scopus 로고
    • Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening?
    • Beardsley E., Jefford M., Mileshkin L. Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening?. J Clin Oncol 2007, 25:e13-e14.
    • (2007) J Clin Oncol , vol.25
    • Beardsley, E.1    Jefford, M.2    Mileshkin, L.3
  • 31
    • 17044370896 scopus 로고    scopus 로고
    • Recommendations for informed consent forms for critical care clinical trials
    • Silverman H.J., Luce J.M., Lanken P.N., et al. Recommendations for informed consent forms for critical care clinical trials. Crit Care Med 2005, 33:867-882.
    • (2005) Crit Care Med , vol.33 , pp. 867-882
    • Silverman, H.J.1    Luce, J.M.2    Lanken, P.N.3
  • 32
    • 0037350241 scopus 로고    scopus 로고
    • Is the concept of informed consent applicable to clinical research involving critically ill patients?
    • Luce J.M. Is the concept of informed consent applicable to clinical research involving critically ill patients?. Crit Care Med 2003, 31:S153-S160.
    • (2003) Crit Care Med , vol.31
    • Luce, J.M.1
  • 33
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel E.J., Wendler D., Grady C. What makes clinical research ethical?. JAMA 2000, 283:2701-2711.
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 34
    • 77956206807 scopus 로고    scopus 로고
    • Strategies for overcoming site and recruitment challenges in research studies based in intensive care units
    • Chlan L., Guttormson J., Tracy M.F., et al. Strategies for overcoming site and recruitment challenges in research studies based in intensive care units. Am J Crit Care 2009, 18:410-417.
    • (2009) Am J Crit Care , vol.18 , pp. 410-417
    • Chlan, L.1    Guttormson, J.2    Tracy, M.F.3
  • 35
    • 20944447796 scopus 로고    scopus 로고
    • Risk of post-traumatic stress symptoms in family members of intensive care unit patients
    • Azoulay E., Pochard F., Kentish-Barnes N., et al. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med 2005, 171:987-994.
    • (2005) Am J Respir Crit Care Med , vol.171 , pp. 987-994
    • Azoulay, E.1    Pochard, F.2    Kentish-Barnes, N.3
  • 36
    • 33644976726 scopus 로고    scopus 로고
    • The accuracy of surrogate decision makers: a systematic review
    • Shalowitz D.I., Garrett-Mayer E., Wendler D. The accuracy of surrogate decision makers: a systematic review. Arch Intern Med 2006, 166:493-497.
    • (2006) Arch Intern Med , vol.166 , pp. 493-497
    • Shalowitz, D.I.1    Garrett-Mayer, E.2    Wendler, D.3
  • 37
    • 1842327388 scopus 로고    scopus 로고
    • Proxies' decisions about clinical research participation for their charges
    • Muncie H.L., Magaziner J., Hebel J.R., et al. Proxies' decisions about clinical research participation for their charges. J Am Geriatr Soc 1997, 45:929-933.
    • (1997) J Am Geriatr Soc , vol.45 , pp. 929-933
    • Muncie, H.L.1    Magaziner, J.2    Hebel, J.R.3
  • 38
    • 84859909923 scopus 로고    scopus 로고
    • Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study
    • Mehta S., Pelletier F.Q., Brown M., et al. Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study. Intensive Care Med 2012, 38:37-54.
    • (2012) Intensive Care Med , vol.38 , pp. 37-54
    • Mehta, S.1    Pelletier, F.Q.2    Brown, M.3
  • 39
    • 0035116532 scopus 로고    scopus 로고
    • Do surrogate decision makers provide accurate consent for intensive care research?
    • Coppolino M., Ackerson L. Do surrogate decision makers provide accurate consent for intensive care research?. Chest 2001, 119:603-612.
    • (2001) Chest , vol.119 , pp. 603-612
    • Coppolino, M.1    Ackerson, L.2


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