Skip to main content
Top
Published in: Trials 1/2011

Open Access 01-12-2011 | Research

A trial on unruptured intracranial aneurysms (the TEAM trial): results, lessons from a failure and the necessity for clinical care trials

Authors: Jean Raymond, Tim E Darsaut, Andrew J Molyneux

Published in: Trials | Issue 1/2011

Login to get access

Abstract

The trial on endovascular management of unruptured intracranial aneurysms (TEAM), a prospective randomized trial comparing coiling and conservative management, initiated in September 2006, was stopped in June 2009 because of poor recruitment (80 patients). Aspects of the trial design that may have contributed to this failure are reviewed in the hope of identifying better ways to successfully complete this special type of pragmatic trial which seeks to test two strategies that are in routine clinical use. Cultural, conceptual and bureaucratic hurdles and difficulties obstruct all trials. These obstacles are however particularly misplaced when the trial aims to identify what a good medical practice should be. A clean separation between research and practice, with diverging ethical and scientific requirements, has been enforced for decades, but it cannot work when care needs to be provided in the presence of pervasive uncertainty. Hence valid and robust scientific methods need to be legitimately re-integrated into clinical practice when reliable knowledge is in want.
A special status should be reserved for what we would call 'clinical care trials', if we are to practice in a transparent and prospective fashion a medicine that leads to demonstrably better patient outcomes.
Appendix
Available only for authorised users
Literature
1.
go back to reference Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R: International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: A randomised trial. Lancet. 2002, 360: 1267-1274. 10.1016/S0140-6736(02)11314-6.CrossRefPubMed Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R: International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: A randomised trial. Lancet. 2002, 360: 1267-1274. 10.1016/S0140-6736(02)11314-6.CrossRefPubMed
2.
go back to reference Molyneux AJ, Kerr RS, Birks J, Ramzi N, Yarnold J, Sneade M, Rischmiller J, Collaborators ISAT: Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long-term follow-up. Lancet Neurol. 2009, 8 (5): 427-433. 10.1016/S1474-4422(09)70080-8.CrossRefPubMedPubMedCentral Molyneux AJ, Kerr RS, Birks J, Ramzi N, Yarnold J, Sneade M, Rischmiller J, Collaborators ISAT: Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long-term follow-up. Lancet Neurol. 2009, 8 (5): 427-433. 10.1016/S1474-4422(09)70080-8.CrossRefPubMedPubMedCentral
3.
go back to reference Raymond J: Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009, 22 (1): 96-102. 10.1097/WCO.0b013e32831fee91. ReviewCrossRefPubMed Raymond J: Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009, 22 (1): 96-102. 10.1097/WCO.0b013e32831fee91. ReviewCrossRefPubMed
4.
go back to reference Cowan JA, Ziewacz J, Dimick JB, Upchurch GR, Thompson BG: Use of endovascular coil embolization and surgical clip occlusion for cerebral artery aneurysms. J Neurosurg. 2007, 107 (3): 530-535. 10.3171/JNS-07/09/0530.CrossRefPubMed Cowan JA, Ziewacz J, Dimick JB, Upchurch GR, Thompson BG: Use of endovascular coil embolization and surgical clip occlusion for cerebral artery aneurysms. J Neurosurg. 2007, 107 (3): 530-535. 10.3171/JNS-07/09/0530.CrossRefPubMed
5.
go back to reference Wiebers DO, Whisnant JP, Huston J, Meissner I, Brown RD, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC: International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: Natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003, 362: 103-110. 10.1016/S0140-6736(03)13860-3.CrossRefPubMed Wiebers DO, Whisnant JP, Huston J, Meissner I, Brown RD, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC: International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: Natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003, 362: 103-110. 10.1016/S0140-6736(03)13860-3.CrossRefPubMed
6.
go back to reference Raymond J, Guillemin F, Proust F, Molyneux AJ, Fox AJ, Claiborne JS, Meder JF, Rouleau I: The Trial on Endovascular Aneurysm Management (TEAM) Collaborative Group: Unruptured Intracranial Aneurysms. A Critical Review of the International Study of Unruptured Intracranial Aneurysms (ISUIA) and of Appropriate Methods to Address the Clinical Problem. Interv Neuroradiol. 2008, 14 (1): 85-96.PubMedPubMedCentral Raymond J, Guillemin F, Proust F, Molyneux AJ, Fox AJ, Claiborne JS, Meder JF, Rouleau I: The Trial on Endovascular Aneurysm Management (TEAM) Collaborative Group: Unruptured Intracranial Aneurysms. A Critical Review of the International Study of Unruptured Intracranial Aneurysms (ISUIA) and of Appropriate Methods to Address the Clinical Problem. Interv Neuroradiol. 2008, 14 (1): 85-96.PubMedPubMedCentral
7.
go back to reference Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D: Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003, 34 (6): 1398-1403. 10.1161/01.STR.0000073841.88563.E9.CrossRefPubMed Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D: Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003, 34 (6): 1398-1403. 10.1161/01.STR.0000073841.88563.E9.CrossRefPubMed
8.
go back to reference Naggara O, White PM, Guilbert F, Roy D, Weill A, Raymond J: Endovascular treatment of unruptured intracranial aneurysms: A systematic review of the literature on safety and efficacy. Radiology. 2010, 256 (3): 887-897. 10.1148/radiol.10091982.CrossRefPubMed Naggara O, White PM, Guilbert F, Roy D, Weill A, Raymond J: Endovascular treatment of unruptured intracranial aneurysms: A systematic review of the literature on safety and efficacy. Radiology. 2010, 256 (3): 887-897. 10.1148/radiol.10091982.CrossRefPubMed
9.
go back to reference Raymond J: Managing unruptured aneurysms: the ethical solution to the dilemma. Can J Neurol Sci. 2009, 36 (2): 138-142.CrossRefPubMed Raymond J: Managing unruptured aneurysms: the ethical solution to the dilemma. Can J Neurol Sci. 2009, 36 (2): 138-142.CrossRefPubMed
10.
go back to reference Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I, TEAM Collaborative Group: The TEAM trial: safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: a randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years. Trials. 2008, 9: 43-CrossRefPubMedPubMedCentral Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I, TEAM Collaborative Group: The TEAM trial: safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: a randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years. Trials. 2008, 9: 43-CrossRefPubMedPubMedCentral
11.
go back to reference Raymond J, Chagnon M, Collet JP, Guilbert F, Weill A, Roy D: A randomized trial on the safety and efficacy of endovascular treatment of unruptured intracranial aneurysms is feasible. Interv Neuroradiol. 2004, 10 (2): 103-112.PubMedPubMedCentral Raymond J, Chagnon M, Collet JP, Guilbert F, Weill A, Roy D: A randomized trial on the safety and efficacy of endovascular treatment of unruptured intracranial aneurysms is feasible. Interv Neuroradiol. 2004, 10 (2): 103-112.PubMedPubMedCentral
12.
go back to reference NIHR Health Technology Assessment Programme (HTA): Trial of endovascular aneurysm management; a randomised comparison and cost effectiveness analysis of endovascular coiling compared with indefinite deferral of treatment in 2000 patients over 10 years. (last updated Ocotber 12, 2010; accessed October 20, 2010), [http://www.hta.ac.uk/1740] NIHR Health Technology Assessment Programme (HTA): Trial of endovascular aneurysm management; a randomised comparison and cost effectiveness analysis of endovascular coiling compared with indefinite deferral of treatment in 2000 patients over 10 years. (last updated Ocotber 12, 2010; accessed October 20, 2010), [http://​www.​hta.​ac.​uk/​1740]
14.
go back to reference Dilts DM, Sandler AB: Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. J Clin Oncol. 2006, 24 (28): 4545-52. 10.1200/JCO.2005.05.0104.CrossRefPubMed Dilts DM, Sandler AB: Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. J Clin Oncol. 2006, 24 (28): 4545-52. 10.1200/JCO.2005.05.0104.CrossRefPubMed
15.
go back to reference Raymond J on behalf of the TEAM collaborative group: Reflections on the TEAM trial: Why clinical care and research should be reconciled. Can J Neurol Sci. 2011, 38 (2): 198-202.CrossRef Raymond J on behalf of the TEAM collaborative group: Reflections on the TEAM trial: Why clinical care and research should be reconciled. Can J Neurol Sci. 2011, 38 (2): 198-202.CrossRef
16.
go back to reference Lederle FA, Wilson SE, Johnson GR, Reinke DB, Littooy FN, Acher CW, Ballard DJ, Messina LM, Gordon IL, Chute EP, Krupski WC, Busuttil SJ, Barone GW, Sparks S, Graham LM, Rapp JH, Makaroun MS, Moneta GL, Cambria RA, Makhoul RG, Eton D, Ansel HJ, Freischlag JA, Bandyk D, Aneurysm Detection and Management Veterans Affairs Cooperative Study Group: Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002, 346 (19): 1437-44. 10.1056/NEJMoa012573.CrossRefPubMed Lederle FA, Wilson SE, Johnson GR, Reinke DB, Littooy FN, Acher CW, Ballard DJ, Messina LM, Gordon IL, Chute EP, Krupski WC, Busuttil SJ, Barone GW, Sparks S, Graham LM, Rapp JH, Makaroun MS, Moneta GL, Cambria RA, Makhoul RG, Eton D, Ansel HJ, Freischlag JA, Bandyk D, Aneurysm Detection and Management Veterans Affairs Cooperative Study Group: Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002, 346 (19): 1437-44. 10.1056/NEJMoa012573.CrossRefPubMed
17.
go back to reference Djulbegovic M, Beyth RJ, Neuberger MM, Stoffs TL, Vieweg J, Djulbegovic B, Dahm P: Screening for prostate cancer: systematic review and meta-analysis of randomised controlled trials. BMJ. 2010, 341: c4543-10.1136/bmj.c4543.CrossRefPubMedPubMedCentral Djulbegovic M, Beyth RJ, Neuberger MM, Stoffs TL, Vieweg J, Djulbegovic B, Dahm P: Screening for prostate cancer: systematic review and meta-analysis of randomised controlled trials. BMJ. 2010, 341: c4543-10.1136/bmj.c4543.CrossRefPubMedPubMedCentral
18.
go back to reference Houdart E: Debate. What have we done? What is next? Satellite symposium on innovation and progress in neuro-endovascular therapies. 10th congress of World federation of Interventional and Therapeutic Neuroradiology (WFITN). 2009, Montreal, Quebec, CANADA Houdart E: Debate. What have we done? What is next? Satellite symposium on innovation and progress in neuro-endovascular therapies. 10th congress of World federation of Interventional and Therapeutic Neuroradiology (WFITN). 2009, Montreal, Quebec, CANADA
19.
go back to reference Derdeyn CP, Chimowitz MI: Angioplasty and stenting for atherosclerotic intracranial stenosis: rationale for a randomized clinical trial. Neuroimaging Clin N Am. 2007, 17 (3): 355-63. 10.1016/j.nic.2007.05.001. viii-ix. ReviewCrossRefPubMedPubMedCentral Derdeyn CP, Chimowitz MI: Angioplasty and stenting for atherosclerotic intracranial stenosis: rationale for a randomized clinical trial. Neuroimaging Clin N Am. 2007, 17 (3): 355-63. 10.1016/j.nic.2007.05.001. viii-ix. ReviewCrossRefPubMedPubMedCentral
20.
go back to reference Khatri P, Hill MD, Palesch YY, Spilker J, Jauch EC, Carrozzella JA, Demchuk AM, Martin R, Mauldin P, Dillon C, Ryckborst KJ, Janis S, Tomsick TA, Broderick JP: Interventional Management of Stroke III Investigators: Methodology of the Interventional Management of Stroke III Trial. Int J Stroke. 2008, 3 (2): 130-137. 10.1111/j.1747-4949.2008.00151.x.CrossRefPubMedPubMedCentral Khatri P, Hill MD, Palesch YY, Spilker J, Jauch EC, Carrozzella JA, Demchuk AM, Martin R, Mauldin P, Dillon C, Ryckborst KJ, Janis S, Tomsick TA, Broderick JP: Interventional Management of Stroke III Investigators: Methodology of the Interventional Management of Stroke III Trial. Int J Stroke. 2008, 3 (2): 130-137. 10.1111/j.1747-4949.2008.00151.x.CrossRefPubMedPubMedCentral
21.
22.
go back to reference Taylor KM, Margolese RG, Soskolne CL: Physicians' Reasons for Not Entering Eligible Patients in a Randomized Clinical Trial of Surgery for Breast Cancer. N Engl J Med. 1984, 310: 1363-1367. 10.1056/NEJM198405243102106.CrossRefPubMed Taylor KM, Margolese RG, Soskolne CL: Physicians' Reasons for Not Entering Eligible Patients in a Randomized Clinical Trial of Surgery for Breast Cancer. N Engl J Med. 1984, 310: 1363-1367. 10.1056/NEJM198405243102106.CrossRefPubMed
23.
go back to reference Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, Redmond C, Fisher E, Wolmark N, Deutsch M, Montague E, Saffer E, Wickerham L, Lerner H, Glass A, Shibata H, Deckers P, Ketcham A, Oishi R, Russell I: Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med. 1985, 312 (11): 665-673. 10.1056/NEJM198503143121101.CrossRefPubMed Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, Redmond C, Fisher E, Wolmark N, Deutsch M, Montague E, Saffer E, Wickerham L, Lerner H, Glass A, Shibata H, Deckers P, Ketcham A, Oishi R, Russell I: Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med. 1985, 312 (11): 665-673. 10.1056/NEJM198503143121101.CrossRefPubMed
24.
go back to reference Angell M: Patients' preferences in randomized clinical trials. N Engl J Med. 1984, 310 (21): 1385-1387. 10.1056/NEJM198405243102111.CrossRefPubMed Angell M: Patients' preferences in randomized clinical trials. N Engl J Med. 1984, 310 (21): 1385-1387. 10.1056/NEJM198405243102111.CrossRefPubMed
25.
go back to reference Ellenberg SS: Randomization designs in comparative clinical trials. N Engl J Med. 1984, 310 (21): 1404-1408. 10.1056/NEJM198405243102141.CrossRefPubMed Ellenberg SS: Randomization designs in comparative clinical trials. N Engl J Med. 1984, 310 (21): 1404-1408. 10.1056/NEJM198405243102141.CrossRefPubMed
26.
go back to reference Marquis D: An argument that all prerandomized clinical trials are unethical. J Med Philos. 1986, 11 (4): 367-383.CrossRefPubMed Marquis D: An argument that all prerandomized clinical trials are unethical. J Med Philos. 1986, 11 (4): 367-383.CrossRefPubMed
27.
go back to reference Naggara O, Raymond J, Guilbert F, Roy D, Weill A, Altman DG: Critical Methodology in Neurovascular Disease Clinical Research: I. Analysis by categorizing or dichotomizing continuous variables is inadvisable: an example from the natural history of unruptured aneurysms. Am J Neuroradiol. 2011, Naggara O, Raymond J, Guilbert F, Roy D, Weill A, Altman DG: Critical Methodology in Neurovascular Disease Clinical Research: I. Analysis by categorizing or dichotomizing continuous variables is inadvisable: an example from the natural history of unruptured aneurysms. Am J Neuroradiol. 2011,
28.
go back to reference Darsaut T, Findlay JM, Raymond J, the CURES collaborative group: The CURES Trial: A randomized comparison of surgical and endovascular management of unruptured intracranial aneurysms. Can J Neurol Sci. 2011, 38 (2): 236-41.CrossRefPubMedPubMedCentral Darsaut T, Findlay JM, Raymond J, the CURES collaborative group: The CURES Trial: A randomized comparison of surgical and endovascular management of unruptured intracranial aneurysms. Can J Neurol Sci. 2011, 38 (2): 236-41.CrossRefPubMedPubMedCentral
29.
go back to reference Dilts DM, Sandler A, Cheng S, Crites J, Ferranti L, Wu A, Gray R, MacDonald J, Marinucci D, Comis R: Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group. Clin Cancer Res. 2008, 14 (11): 3427-33. 10.1158/1078-0432.CCR-07-5060.CrossRefPubMedPubMedCentral Dilts DM, Sandler A, Cheng S, Crites J, Ferranti L, Wu A, Gray R, MacDonald J, Marinucci D, Comis R: Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group. Clin Cancer Res. 2008, 14 (11): 3427-33. 10.1158/1078-0432.CCR-07-5060.CrossRefPubMedPubMedCentral
30.
go back to reference McMahon AD, Conway DI, MacDonald TM, McInnes GT: The unintended consequences of clinical trials regulations. PLOS Med. 2009, 3 (11): e1000131-10.1371/journal.pmed.1000131.CrossRefPubMed McMahon AD, Conway DI, MacDonald TM, McInnes GT: The unintended consequences of clinical trials regulations. PLOS Med. 2009, 3 (11): e1000131-10.1371/journal.pmed.1000131.CrossRefPubMed
31.
go back to reference Keim B: Tied up in Red Tape. European trials shut down. Nat Med. 2007, 13 (2): 110-PubMed Keim B: Tied up in Red Tape. European trials shut down. Nat Med. 2007, 13 (2): 110-PubMed
32.
go back to reference Sox HC, Greenfield S: Comparative effectiveness research: a report from the Institute of Medicine. Ann Intern Med. 2009, 151 (3): 203-5.CrossRefPubMed Sox HC, Greenfield S: Comparative effectiveness research: a report from the Institute of Medicine. Ann Intern Med. 2009, 151 (3): 203-5.CrossRefPubMed
34.
go back to reference Sandercock P, Lindley R, Wardlaw J, Dennis M, Lewis S, Venables G, Kobayashi A, Czlonkowska A, Berge E, Slot KB, Murray V, Peeters A, Hankey G, Matz K, Brainin M, Ricci S, Celani MG, Righetti E, Cantisani T, Gubitz G, Phillips S, Arauz A, Prasad K, Correia M, Lyrer P: IST-3 Collaborative Group. Third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke. Trials. 2008, 9: 37-CrossRefPubMedPubMedCentral Sandercock P, Lindley R, Wardlaw J, Dennis M, Lewis S, Venables G, Kobayashi A, Czlonkowska A, Berge E, Slot KB, Murray V, Peeters A, Hankey G, Matz K, Brainin M, Ricci S, Celani MG, Righetti E, Cantisani T, Gubitz G, Phillips S, Arauz A, Prasad K, Correia M, Lyrer P: IST-3 Collaborative Group. Third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke. Trials. 2008, 9: 37-CrossRefPubMedPubMedCentral
35.
go back to reference The SoS Investigators: Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent Or Surgery trial): a randomised controlled trial. Lancet. 2002, 360 (9338): 965-70. 10.1016/S0140-6736(02)11078-6.CrossRef The SoS Investigators: Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent Or Surgery trial): a randomised controlled trial. Lancet. 2002, 360 (9338): 965-70. 10.1016/S0140-6736(02)11078-6.CrossRef
36.
go back to reference Dennis M, Sandercock PA, Reid J, Graham C, Murray G, Venables G, CLOTS Trials Collaboration: Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial. Lancet. 2009, 373: 1958-65. 10.1016/S0140-6736(09)60941-7.CrossRefPubMed Dennis M, Sandercock PA, Reid J, Graham C, Murray G, Venables G, CLOTS Trials Collaboration: Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial. Lancet. 2009, 373: 1958-65. 10.1016/S0140-6736(09)60941-7.CrossRefPubMed
37.
go back to reference The CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration: Thigh-Length Versus Below-Knee Stockings for Deep Venous Thrombosis Prophylaxis After Stroke. A Randomized Trial. Ann Intern Med. 2010, 153: 553-562.CrossRef The CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration: Thigh-Length Versus Below-Knee Stockings for Deep Venous Thrombosis Prophylaxis After Stroke. A Randomized Trial. Ann Intern Med. 2010, 153: 553-562.CrossRef
38.
go back to reference Houdart E: The need for new regulations on randomized clinical trials in surgical treatments. Neuroradiol. 2010, 52 (11): 1061-1062. 10.1007/s00234-010-0759-5.CrossRef Houdart E: The need for new regulations on randomized clinical trials in surgical treatments. Neuroradiol. 2010, 52 (11): 1061-1062. 10.1007/s00234-010-0759-5.CrossRef
39.
go back to reference Department of Health, Education, and Welfare: The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. 1979, Washington, DC: OPRR Reports Department of Health, Education, and Welfare: The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. 1979, Washington, DC: OPRR Reports
40.
go back to reference Beecher HK: Ethics and clinical research. N Engl J Med. 1966, 274 (24): 1354-1360. 10.1056/NEJM196606162742405.CrossRefPubMed Beecher HK: Ethics and clinical research. N Engl J Med. 1966, 274 (24): 1354-1360. 10.1056/NEJM196606162742405.CrossRefPubMed
42.
go back to reference Marquis D: Leaving therapy to chance. The Hasting Center Report. 1983, 13 (4): 40-47. 10.2307/3561721.CrossRef Marquis D: Leaving therapy to chance. The Hasting Center Report. 1983, 13 (4): 40-47. 10.2307/3561721.CrossRef
43.
go back to reference Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, Schwartz JS: Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med. 2009, 151 (3): 206-9.CrossRefPubMed Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, Schwartz JS: Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med. 2009, 151 (3): 206-9.CrossRefPubMed
44.
go back to reference Vickers AJ, Scardino PT: The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost. Trials. 2009, 10: 14-10.1186/1745-6215-10-14.CrossRefPubMedPubMedCentral Vickers AJ, Scardino PT: The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost. Trials. 2009, 10: 14-10.1186/1745-6215-10-14.CrossRefPubMedPubMedCentral
45.
go back to reference Schwartz D, Lellouch J: Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967, 20: 637-48. 10.1016/0021-9681(67)90041-0. [Reprinted in J Clin Epidemiol 2009;62:499-505.]CrossRefPubMed Schwartz D, Lellouch J: Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967, 20: 637-48. 10.1016/0021-9681(67)90041-0. [Reprinted in J Clin Epidemiol 2009;62:499-505.]CrossRefPubMed
46.
go back to reference Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K: A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009, 62 (5): 464-75. 10.1016/j.jclinepi.2008.12.011.CrossRefPubMed Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K: A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009, 62 (5): 464-75. 10.1016/j.jclinepi.2008.12.011.CrossRefPubMed
48.
go back to reference Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, CONSORT group; Pragmatic Trials in Healthcare (Practihc) group: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, CONSORT group; Pragmatic Trials in Healthcare (Practihc) group: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral
49.
go back to reference Maclure M: Explaining pragmatic trials to pragmatic policy-makers. CMAJ. 2009, 180 (10): 1001-3. Also published in J Clin Epidemiol. 2009 May;62(5):476-8CrossRefPubMedPubMedCentral Maclure M: Explaining pragmatic trials to pragmatic policy-makers. CMAJ. 2009, 180 (10): 1001-3. Also published in J Clin Epidemiol. 2009 May;62(5):476-8CrossRefPubMedPubMedCentral
50.
go back to reference Cargill V, Cohen D, Kroenke K, Neuhauser D: Ongoing patient randomization: an innovation in medical care research. Health Serv Res. 1986, 21 (5): 663-78.PubMedPubMedCentral Cargill V, Cohen D, Kroenke K, Neuhauser D: Ongoing patient randomization: an innovation in medical care research. Health Serv Res. 1986, 21 (5): 663-78.PubMedPubMedCentral
51.
go back to reference Appelbaum PS, Roth LH, Lidz C: The therapeutic misconception: Informed consent in psychiatric research. Int J Law Psychiatry. 1982, 5 (3-4): 319-29. 10.1016/0160-2527(82)90026-7.CrossRefPubMed Appelbaum PS, Roth LH, Lidz C: The therapeutic misconception: Informed consent in psychiatric research. Int J Law Psychiatry. 1982, 5 (3-4): 319-29. 10.1016/0160-2527(82)90026-7.CrossRefPubMed
Metadata
Title
A trial on unruptured intracranial aneurysms (the TEAM trial): results, lessons from a failure and the necessity for clinical care trials
Authors
Jean Raymond
Tim E Darsaut
Andrew J Molyneux
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-64

Other articles of this Issue 1/2011

Trials 1/2011 Go to the issue