메뉴 건너뛰기




Volumn 57, Issue 6, 2005, Pages 1244-1253

Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: A systematic review

Author keywords

Acute traumatic brain injury; CONSORT; Covariate adjustment; Randomized clinical trials; Reporting; Subgroup analysis; Systematic review

Indexed keywords

4 PHOSPHONOMETHYLPIPECOLIC ACID; DEXAMETHASONE; MANNITOL; METHYLPREDNISOLONE; NIMODIPINE; TROMETAMOL;

EID: 29244476263     PISSN: 0148396X     EISSN: None     Source Type: Journal    
DOI: 10.1227/01.NEU.0000186039.57548.96     Document Type: Review
Times cited : (44)

References (51)
  • 1
    • 0035901579 scopus 로고    scopus 로고
    • The revised CONSORT statement for reporting randomized trials: Explanation and elaboration
    • Altman DG, Schultz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T: CONSORT GROUP (Consolidated Standards of Reporting Trials): The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Intern Med 134:663-694, 2001.
    • (2001) Ann Intern Med , vol.134 , pp. 663-694
    • Altman, D.G.1    Schultz, K.F.2    Moher, D.3    Egger, M.4    Davidoff, F.5    Elbourne, D.6    Gotzsche, P.C.7    Lang, T.8
  • 2
    • 0034712491 scopus 로고    scopus 로고
    • Subgroup analysis and other (mis)uses of baseline data in clinical trials
    • Assmann SF, Pocock SJ, Enos LE, Kasten LE: Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 355:1064-1069, 2000.
    • (2000) Lancet , vol.355 , pp. 1064-1069
    • Assmann, S.F.1    Pocock, S.J.2    Enos, L.E.3    Kasten, L.E.4
  • 4
    • 0037247573 scopus 로고    scopus 로고
    • Promising strategies to minimize secondary brain injury after head trauma
    • Bayir H, Clark RS, Kochanek PM: Promising strategies to minimize secondary brain injury after head trauma. Crit Care Med 31[Suppl]:S112-S117, 2003.
    • (2003) Crit Care Med , vol.31 , Issue.SUPPL.
    • Bayir, H.1    Clark, R.S.2    Kochanek, P.M.3
  • 5
    • 0020673332 scopus 로고
    • Megadose steroids in severe head injury: Results of a prospective double blind clinical trial
    • Braakman R, Scheuten HJ, Blaauw-van Dishoeck M, Minderhoud JM: Megadose steroids in severe head injury: Results of a prospective double blind clinical trial. J Neurosurg 58:326-330, 1983.
    • (1983) J Neurosurg , vol.58 , pp. 326-330
    • Braakman, R.1    Scheuten, H.J.2    Blaauw-van Dishoeck, M.3    Minderhoud, J.M.4
  • 6
    • 1842453957 scopus 로고    scopus 로고
    • Subgroup analyses in randomized trials: Risks of subgroup-specific analyses: Power and sample size for the interaction test
    • Brookes ST, Whitley E, Egger M, Davey Smith G, Mulheran PA, Peters TJ: Subgroup analyses in randomized trials: Risks of subgroup-specific analyses: Power and sample size for the interaction test. J Clin Epidemiol 57:229-236, 2004.
    • (2004) J Clin Epidemiol , vol.57 , pp. 229-236
    • Brookes, S.T.1    Whitley, E.2    Egger, M.3    Davey Smith, G.4    Mulheran, P.A.5    Peters, T.J.6
  • 8
    • 2442692780 scopus 로고    scopus 로고
    • Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published results
    • Chan A, Hróbjartsson A, Haahr MT, Gótzsche PC, Altman DG: Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published results. JAMA 291:2457-2465, 2004.
    • (2004) JAMA , vol.291 , pp. 2457-2465
    • Chan, A.1    Hróbjartsson, A.2    Haahr, M.T.3    Gótzsche, P.C.4    Altman, D.G.5
  • 9
    • 0031693315 scopus 로고    scopus 로고
    • Sample size in clinical trials with dichotomous endpoints: Use of covariables
    • Choi SC: Sample size in clinical trials with dichotomous endpoints: Use of covariables. J Biopharm Stat 8:367-375, 1998.
    • (1998) J Biopharm Stat , vol.8 , pp. 367-375
    • Choi, S.C.1
  • 10
    • 0035074348 scopus 로고    scopus 로고
    • Design and statistical issues in multicenter trials of severe head injury
    • Choi SC, Bullock R: Design and statistical issues in multicenter trials of severe head injury. Neurol Res 23:190-192, 2001.
    • (2001) Neurol Res , vol.23 , pp. 190-192
    • Choi, S.C.1    Bullock, R.2
  • 11
    • 0036158909 scopus 로고    scopus 로고
    • Misclassification and treatment effect on primary outcome measures in clinical trials of severe neurotrauma
    • Choi SC, Clifton GL, Marmarou A, Miller ER: Misclassification and treatment effect on primary outcome measures in clinical trials of severe neurotrauma. J Neurotrauma 19:17-22, 2002.
    • (2002) J Neurotrauma , vol.19 , pp. 17-22
    • Choi, S.C.1    Clifton, G.L.2    Marmarou, A.3    Miller, E.R.4
  • 13
    • 1642318602 scopus 로고    scopus 로고
    • Subgroup analysis in clinical trials
    • Cook DI, Gebski VJ, Keech AC: Subgroup analysis in clinical trials. Med J Aust 180:289-291, 2004.
    • (2004) Med J Aust , vol.180 , pp. 289-291
    • Cook, D.I.1    Gebski, V.J.2    Keech, A.C.3
  • 14
    • 1542610658 scopus 로고    scopus 로고
    • Prehospital hypertonic saline resuscitation of patients with hypotension and severe traumatic brain injury: A randomized controlled trial
    • For the HTS Study Investigators
    • Cooper DJ, Myles PS, McDermott FT, Murray LJ, Laidlaw J, Cooper G, Tremayne AB, Bernard SS, Ponsford J: For the HTS Study Investigators: Prehospital hypertonic saline resuscitation of patients with hypotension and severe traumatic brain injury: A randomized controlled trial. JAMA 291: 1350-1357, 2004.
    • (2004) JAMA , vol.291 , pp. 1350-1357
    • Cooper, D.J.1    Myles, P.S.2    McDermott, F.T.3    Murray, L.J.4    Laidlaw, J.5    Cooper, G.6    Tremayne, A.B.7    Bernard, S.S.8    Ponsford, J.9
  • 15
    • 0034816635 scopus 로고    scopus 로고
    • Improving clinical outcomes from acute subdural hematomas with the emergency preoperative administration of high doses of mannitol: A randomized trial
    • Cruz J, Minoja G, Okuchi K: Improving clinical outcomes from acute subdural hematomas with the emergency preoperative administration of high doses of mannitol: A randomized trial. Neurosurgery 49:864-871, 2001.
    • (2001) Neurosurgery , vol.49 , pp. 864-871
    • Cruz, J.1    Minoja, G.2    Okuchi, K.3
  • 16
    • 0036765828 scopus 로고    scopus 로고
    • Major clinical and physiological benefits of early high doses of mannitol for intraparenchymal temporal lobe hemorrhages with abnormal pupilary widening: A randomized trial
    • Cruz J, Minoja G, Okuchi K: Major clinical and physiological benefits of early high doses of mannitol for intraparenchymal temporal lobe hemorrhages with abnormal pupilary widening: A randomized trial. Neurosurgery 51:628-638, 2002.
    • (2002) Neurosurgery , vol.51 , pp. 628-638
    • Cruz, J.1    Minoja, G.2    Okuchi, K.3
  • 17
    • 0034643618 scopus 로고    scopus 로고
    • Size and quality of randomised controlled trials in head injury: Review of published studies
    • Dickinson K, Bunn F, Wentz R, Edwards P, Roberts I: Size and quality of randomised controlled trials in head injury: Review of published studies. Br Med J 320:1308-1311, 2000.
    • (2000) Br Med J , vol.320 , pp. 1308-1311
    • Dickinson, K.1    Bunn, F.2    Wentz, R.3    Edwards, P.4    Roberts, I.5
  • 18
    • 0347593988 scopus 로고    scopus 로고
    • Clinical trials in traumatic brain injury: Lessons for the future
    • Doppenberg EM, Choi SC, Bullock R: Clinical trials in traumatic brain injury: Lessons for the future. J Neurosurg Anesthesiol 16:87-94, 2004.
    • (2004) J Neurosurg Anesthesiol , vol.16 , pp. 87-94
    • Doppenberg, E.M.1    Choi, S.C.2    Bullock, R.3
  • 22
    • 15844413520 scopus 로고    scopus 로고
    • Traumatic subarachnoid hemorrhage and its treatment with nimodipine
    • German tSAH Study Group
    • Harders A, Kakarieka A, Braakman R: Traumatic subarachnoid hemorrhage and its treatment with nimodipine. German tSAH Study Group. J Neurosurg 85:82-89, 1996.
    • (1996) J Neurosurg , vol.85 , pp. 82-89
    • Harders, A.1    Kakarieka, A.2    Braakman, R.3
  • 24
    • 0031777876 scopus 로고    scopus 로고
    • Should we adjust for covariates in non-linear regression analyses of randomized trials?
    • Hauck WW, Anderson S, Marcus SM: Should we adjust for covariates in non-linear regression analyses of randomized trials? Control Clin Trials 19:248-256, 1998.
    • (1998) Control Clin Trials , vol.19 , pp. 248-256
    • Hauck, W.W.1    Anderson, S.2    Marcus, S.M.3
  • 25
    • 2942592425 scopus 로고    scopus 로고
    • Clinical trials with dichotornous end-points: Covariate adjustment increased power and potentially reduces sample size
    • Hernández AV, Steyerberg EW, Habbema JDF: Clinical trials with dichotornous end-points: Covariate adjustment increased power and potentially reduces sample size. J Clin Epidemiol 57:454-460, 2004.
    • (2004) J Clin Epidemiol , vol.57 , pp. 454-460
    • Hernández, A.V.1    Steyerberg, E.W.2    Habbema, J.D.F.3
  • 27
    • 0036713796 scopus 로고    scopus 로고
    • Regional differences in patient characteristics, case management, and outcomes in traumatic brain injury: Experience from tirilazad trials
    • Hukkelhoven CW, Steyerberg EW, Farace E, Habbema JD, Marshall LF, Maas AI: Regional differences in patient characteristics, case management, and outcomes in traumatic brain injury: Experience from tirilazad trials. J Neurosurg 97:549-557, 2002.
    • (2002) J Neurosurg , vol.97 , pp. 549-557
    • Hukkelhoven, C.W.1    Steyerberg, E.W.2    Farace, E.3    Habbema, J.D.4    Marshall, L.F.5    Maas, A.I.6
  • 28
    • 0034675235 scopus 로고    scopus 로고
    • Quality of randomised controlled trials in head injury
    • Hukkelhoven CW, Steyerberg EW, Maas AI: Quality of randomised controlled trials in head injury. Br Med J 321:704, 2000.
    • (2000) Br Med J , vol.321 , pp. 704
    • Hukkelhoven, C.W.1    Steyerberg, E.W.2    Maas, A.I.3
  • 32
    • 0033015939 scopus 로고    scopus 로고
    • Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations
    • Maas AI, Steyerberg EW, Murray GD, Bullock R, Baethmann A, Marshall LF, Teasdale GM: Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations. Neurosurgery 44:1286-1298, 1999.
    • (1999) Neurosurgery , vol.44 , pp. 1286-1298
    • Maas, A.I.1    Steyerberg, E.W.2    Murray, G.D.3    Bullock, R.4    Baethmann, A.5    Marshall, L.F.6    Teasdale, G.M.7
  • 33
    • 0033388868 scopus 로고    scopus 로고
    • Evaluation of designs for clinical trials of neuroprotective agents in head injury
    • Machado SG, Murray GD, Teasdale GM: Evaluation of designs for clinical trials of neuroprotective agents in head injury. J Neurotrauma 16:1131-1138, 1999.
    • (1999) J Neurotrauma , vol.16 , pp. 1131-1138
    • Machado, S.G.1    Murray, G.D.2    Teasdale, G.M.3
  • 35
    • 0034017340 scopus 로고    scopus 로고
    • Epidemiology of severe cranial injuries
    • Masson F: Epidemiology of severe cranial injuries [in French]. Ann Fr Anesth Reanim 19:261-269, 2000.
    • (2000) Ann Fr Anesth Reanim , vol.19 , pp. 261-269
    • Masson, F.1
  • 36
    • 0033388098 scopus 로고    scopus 로고
    • Failure of the competitive N-methyl-D-aspartate antagonist Selfotel (CGS 19755) in the treatment of severe head injury: Results of two phase III clinical trials
    • The Selfotel Investigators
    • Morris GF, Bullock R, Marshall SB, Marmarou A, Maas A, Marshall LF: Failure of the competitive N-methyl-D-aspartate antagonist Selfotel (CGS 19755) in the treatment of severe head injury: Results of two phase III clinical trials. The Selfotel Investigators. J Neurosurg 91:737-743, 1999.
    • (1999) J Neurosurg , vol.91 , pp. 737-743
    • Morris, G.F.1    Bullock, R.2    Marshall, S.B.3    Marmarou, A.4    Maas, A.5    Marshall, L.F.6
  • 38
    • 0035218013 scopus 로고    scopus 로고
    • Trials within trials: Confirmatory subgroup analyses in controlled clinical experiments
    • Moyé LA, Deswal A: Trials within trials: Confirmatory subgroup analyses in controlled clinical experiments. Control Clin Trials 22:605-619, 2001.
    • (2001) Control Clin Trials , vol.22 , pp. 605-619
    • Moyé, L.A.1    Deswal, A.2
  • 39
    • 0036260647 scopus 로고    scopus 로고
    • The Clinical Trials in Head Injury Study Group: Clinical trials in head injury
    • Narayan RK, Michel ME: The Clinical Trials in Head Injury Study Group: Clinical trials in head injury. J Neurotrauma 19:503-557, 2002.
    • (2002) J Neurotrauma , vol.19 , pp. 503-557
    • Narayan, R.K.1    Michel, M.E.2
  • 40
    • 0033035420 scopus 로고    scopus 로고
    • Clinical trials in head injury
    • Reinert MM, Bullock R: Clinical trials in head injury. Neurol Res 21:330-338, 1999.
    • (1999) Neurol Res , vol.21 , pp. 330-338
    • Reinert, M.M.1    Bullock, R.2
  • 41
    • 0026632552 scopus 로고
    • Results of a prospective randomized trial for treatment of severely brain-injured patients with hyperbaric oxygen
    • Rockswold GL, Ford SE, Anderson DC, Bergman TA, Sherman RE: Results of a prospective randomized trial for treatment of severely brain-injured patients with hyperbaric oxygen. J Neurosurg 76:929-934, 1992.
    • (1992) J Neurosurg , vol.76 , pp. 929-934
    • Rockswold, G.L.1    Ford, S.E.2    Anderson, D.C.3    Bergman, T.A.4    Sherman, R.E.5
  • 42
    • 0019524246 scopus 로고
    • Steroids in severe head injury: A prospective randomized clinical trial
    • Saul TG, Ducker TB, Salcman M, Carro E: Steroids in severe head injury: A prospective randomized clinical trial. J Neurosurg 54:596-600, 1981.
    • (1981) J Neurosurg , vol.54 , pp. 596-600
    • Saul, T.G.1    Ducker, T.B.2    Salcman, M.3    Carro, E.4
  • 43
    • 2442612039 scopus 로고    scopus 로고
    • Subgroup analysis: Application to individual patient decisions
    • Simes RJ, Gebski VJ, Keech AC: Subgroup analysis: Application to individual patient decisions. Med J Aust 180:467-469, 2004.
    • (2004) Med J Aust , vol.180 , pp. 467-469
    • Simes, R.J.1    Gebski, V.J.2    Keech, A.C.3
  • 44
    • 1442271816 scopus 로고    scopus 로고
    • Document CPMP/EWP/2863/99, EMEA, London, May 22
    • The European Agency for the Evaluation of Medicinal Products Committee for Proprietary Medicinal Products (CPMP): Points to consider on adjustment for baseline characteristics. Document CPMP/EWP/2863/99, EMEA, London, May 22, 2003.
    • (2003) Points to Consider on Adjustment for Baseline Characteristics
  • 45
    • 0028356736 scopus 로고
    • A multicenter trial of the efficacy of nimodipine on outcome after severe head injury
    • The European Study Group on Nimodipine in Severe Head Injury: A multicenter trial of the efficacy of nimodipine on outcome after severe head injury. J Neurosurg 80:797-804, 1994.
    • (1994) J Neurosurg , vol.80 , pp. 797-804
  • 46
    • 3042820618 scopus 로고    scopus 로고
    • Randomized trials of neurosurgical interventions: A systematic appraisal
    • Vranos G, Tatsioni A, Polyzoidis K, Ioannidis JP: Randomized trials of neurosurgical interventions: A systematic appraisal. Neurosurgery 55:18-26, 2004.
    • (2004) Neurosurgery , vol.55 , pp. 18-26
    • Vranos, G.1    Tatsioni, A.2    Polyzoidis, K.3    Ioannidis, J.P.4
  • 47
    • 0034804020 scopus 로고    scopus 로고
    • Assessing outcome in head injury trials
    • Wilson JT: Assessing outcome in head injury trials. Curr Pharm Des 7:1537-1552, 2001.
    • (2001) Curr Pharm des , vol.7 , pp. 1537-1552
    • Wilson, J.T.1
  • 49
    • 0029761661 scopus 로고    scopus 로고
    • Effects of pegorgotein on neurologic outcome of patients with severe head injury: A multicenter, randomized controlled trial
    • Young B, Runge JW, Waxman KS, Harrington T, Wilberger J, Muizelaar JP, Boddy A, Kupiec JW: Effects of pegorgotein on neurologic outcome of patients with severe head injury: A multicenter, randomized controlled trial. JAMA 276:538-543, 1996.
    • (1996) JAMA , vol.276 , pp. 538-543
    • Young, B.1    Runge, J.W.2    Waxman, K.S.3    Harrington, T.4    Wilberger, J.5    Muizelaar, J.P.6    Boddy, A.7    Kupiec, J.W.8
  • 50
    • 0025737883 scopus 로고
    • Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials
    • Yusuf S, Wittes J, Probstfield J, Tyroler HA: Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 266:93-98, 1991.
    • (1991) JAMA , vol.266 , pp. 93-98
    • Yusuf, S.1    Wittes, J.2    Probstfield, J.3    Tyroler, H.A.4
  • 51
    • 0037908856 scopus 로고    scopus 로고
    • Study on therapeutic mechanism and clinical effect of mild hypothermia in patients with severe head injury
    • Zhi D, Zhang S, Lin X: Study on therapeutic mechanism and clinical effect of mild hypothermia in patients with severe head injury. Surg Neurol 59:381-385, 2003.
    • (2003) Surg Neurol , vol.59 , pp. 381-385
    • Zhi, D.1    Zhang, S.2    Lin, X.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.