Co-enrollment of critically ill patients into multiple studies: Patterns, predictors and consequences

Critical Care

Volumn 17, Issue 1, 2013, Pages

  Cook, Deborah ^a   McDonald, Ellen ^a   Smith, Orla ^b   Zytaruk, Nicole ^a   Heels Ansdell, Diane ^a   Watpool, Irene ^c   McArdle, Tracy ^c   Matte, Andrea ^b   Clarke, France ^a   Vallance, Shirley ^d   Finfer, Simon ^e   Galt, Pauline ^f   Crozier, Tim ^f   Fowler, Rob ^b   Arabi, Yaseen ^g   Woolfe, Clive ^h   Orford, Neil ⁱ   Hall, Richard ^j   Adhikari, Neill K J ^b   Ferland, Marie Clauide ^k   Marshall, John ^b   Meade, Maureen ^a   more..

^a MCMASTER UNIVERSITY MEDICAL CENTRE   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c UNIVERSITY OF OTTAWA   (Canada)

^d Peri operative Medicine   (Australia)

^e UNIVERSITY OF SYDNEY   (Australia)

^f MONASH MEDICAL CENTRE   (Australia)

^g KING SAUD BIN ABDULAZIZ UNIVERSITY FOR HEALTH SCIENCES   (Saudi Arabia)

^h ROYAL PRINCE ALFRED HOSPITAL   (Australia)

ⁱ Intensive Care Unit   (Australia)

^j DALHOUSIE UNIVERSITY   (Canada)

^k LAVAL UNIVERSITY   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DALTEPARIN; HEPARIN;

ADULT; ADVERSE OUTCOME; APACHE; ARTICLE; CRITICALLY ILL PATIENT; DECISION MAKING; DEEP VEIN THROMBOSIS; DISEASE SEVERITY; FEMALE; HUMAN; INTENSIVE CARE UNIT; LEG THROMBOSIS; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; PRIORITY JOURNAL; THROMBOCYTOPENIA; THROMBOSIS PREVENTION;

EID: 84871998024     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/cc11917     Document Type: Article

References (22)

1. Randolph AG. The unique challenges of enrolling patients into multiple clinical trials. Crit Care Med 2009, 37:S107-S111. 10.1097/CCM.0b013e3181921c9d, 19104209.
2. Abdool Karim Q, Kharsany AB, Naidoo K, Yende N, Gengiah T, Omar Z, Arulappan N, Mlisana KP, Luthuli LR, Abdool Karim SS. Co-enrollment in multiple HIV prevention trials - experiences from the CAPRISA 004 Tenofovir gel trial. Contemp Clin Trials 2011, 32:333-338. 10.1016/j.cct.2011.01.005, 21278001.
3. Larntz K, Neaton JD, Wentworth DN, Yurik T. Data analysis issues for protocols with overlapping enrolment. Stat Med 1996, 15:2445-2453. 10.1002/(SICI)1097-0258(19961130)15:22<2445::AID-SIM462>3.0.CO;2-8, 8931212.
4. Nicole G, Powell JL, Emerson DS. On coenrollment in clinical resuscitation studies: review and experience from randomized trials. Resuscitation 2010, 81:792-795. 10.1016/j.resuscitation.2010.03.014, 20418007.
5. Cook DJ, Blythe D, Rischbieth A, Hebert PC, Zytaruk N, Menon K, Erikson S, Fowler R, Heels-Ansdell D, Meade MO, The Canadian Critical Care Trials Group Enrolment of ICU patients into clinical studies: a tri-national survey. Crit Care Med 2008, 37:51-56. The Canadian Critical Care Trials Group.
6. 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 Neonate Ed 2005, 90:225-228.
7. Angus DC, Mira JP, Vincent JL. Improving trials in the critically ill. Crit Care Med 2010, 38:527-532. 10.1097/CCM.0b013e3181c0259d, 19851096.
8. Cook DJ, Meade M, Guyatt G, Walter SD, Heels-Ansdell D, Geerts W, Warkentin T, Cooper DJ, Zytaruk N, Vallance S, Berwanger O, Rocha M, Qushmaq I, Crowther MA, The PROTECT Investigators, the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group PROphylaxis for ThromboEmbolism in Critical Care Trial protocol and analysis plan. J Crit Care 2011, 26:223. e1-9, The PROTECT Investigators, the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group.
9. Cook DJ, Meade M, Guyatt G, Walter SD, Heels-Ansdell D, Warkentin Zytaruk NT, Crowther MA, Geerts W, Cooper DJ, Vallance S, Qushmaq I, Rocha M, Berwanger O, Vlahakis N. PROTECT Investigators for the Canadian Critical Care Trials Group and the 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. PROTECT Investigators for the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group.
10. Canadian Critical Care Trials Group Canadian Critical Care Trials Group., http://www.ccctg.ca
11. Lacroix J, Hebert P, Fergusson D, Tinmouth A, Blajchman MA, Callum J, Cook DJ, Marshall J, McIntyre L, Turgeon A, ABLE Study Group The Age of Blood Evaluation (ABLE) randomization controlled trial: study design. Transfus Med Rev 2011, 25:197-205. 10.1016/j.tmrv.2011.03.001, 21550205, ABLE Study Group.
12. Spinella PC, Carroll CL, Staff I, Gross R, McQuay J, Keibel L, Wade CE, Holcomb JB. Duration of red blood cell storage is associated with increased incidence of deep vein thrombosis and in hospital mortality in patients with traumatic injuries. Crit Care 2009, 13:R151. 10.1186/cc8050, 2784373, 19772604.
13. Cook DJ, Crowther M, Meade M, Rabbat C, Griffith L, Schiff D, Geerts W, Guyatt GH. Deep venous thrombosis in medical-surgical critically ill patients: prevalence, incidence and risk factors. Crit Care Med 2005, 33:1565-1571. 10.1097/01.CCM.0000171207.95319.B2, 16003063.
14. Geerts WH, Code K, Jay R, Chen E, Szalai JP. A prospective study of venous thromboembolism after major trauma. N Engl J Med 1994, 331:1601-1606. 10.1056/NEJM199412153312401, 7969340.
15. Katsios C, Griffith L, Spinella P, Lacroix J, Crowther M, Hebert P, Meade M, Geerts W, Rabbat C, Cook D. Red blood cell transfusion and increased length of storage are not associated with deep vein thrombosis in medical-surgical critically ill patients: a prospective observational cohort study. Crit Care 2011, 15:R263. 10.1186/cc10526, 3388665, 22044745.
16. McCann SK, Campbell MK, Entwistle VA. Reasons for participating in randomized controlled trials: conditional altruism and considerations for self. Trials 2010, 11:31-41. 10.1186/1745-6215-11-31, 2848220, 20307273.
17. Van Spall HGC, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high impact general medical journals. JAMA 2007, 297:1233-1240. 10.1001/jama.297.11.1233, 17374817.
18. Finfer S, Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Gårdlund B, Marshall JC, Rhodes A. Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock. Intensive Care Med 2008, 34:1935-1947. 10.1007/s00134-008-1266-6, 2995439, 18839141.
19. Luce J, Cook DJ, Martin TR, Angus DC, Boushey HA, Curtis JR, Heffner JE, Lanken PH, Levy MM, Polite PY, Rocker GM, Truog R, American Thoracic Society 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. American Thoracic Society.
20. Curley MA. Respiratory research in the critically ill pediatric patient: why is it so difficult?. Respir Care 2011, 56:1247-1254. discussion 1254-1257, 10.4187/respcare.01255, 21944679.
21. Cook DJ, Burns K, Finfer S, Kissoon N, Bhagwanjee S, Annane D, Sprung C, Fowler R, Latronico N, Marshall J. Clinical research ethics for critically ill patients: a pandemic proposal. Crit Care Med 2010, 38:e138-142.
22. McDonald E, Lutz K, Tkaczyk A, Tessmer C, Clarke F, Maclennan M, Cook DJ. Enrolment, co-enrolment and non-enrolment in ICU research. Crit Care Med 2007, 35:184A.