메뉴 건너뛰기




Volumn 43, Issue 3, 2014, Pages 937-948

Observer bias in randomized clinical trials with time-to-event outcomes: Systematic review of trials with both blinded and non-blinded outcome assessors

Author keywords

Bias; Blinding; Observer bias; Randomized clinical trials; Time to event

Indexed keywords

DRUG; PLACEBO;

EID: 84902649358     PISSN: 03005771     EISSN: 14643685     Source Type: Journal    
DOI: 10.1093/ije/dyt270     Document Type: Article
Times cited : (96)

References (42)
  • 1
    • 33750444213 scopus 로고    scopus 로고
    • Who is blind in randomized clinical trials? An analysis of 200 trials and a survey of authors
    • Haahr M, Hróbjartsson A. Who is blind in randomized clinical trials? An analysis of 200 trials and a survey of authors. Clin Trials 2006;3:360-65.
    • (2006) Clin Trials , vol.3 , pp. 360-365
    • Haahr, M.1    Hróbjartsson, A.2
  • 2
    • 79951950456 scopus 로고    scopus 로고
    • Do unblinded assessors bias muscle strength outcomes in randomized controlled trials of progressive resistance strength training in older adults?
    • Liu CJ, LaValley M, Latham NK. Do unblinded assessors bias muscle strength outcomes in randomized controlled trials of progressive resistance strength training in older adults? Am J Phys Med Rehabil 2011;90:190-96.
    • (2011) Am J Phys Med Rehabil , vol.90 , pp. 190-196
    • Liu, C.J.1    LaValley, M.2    Latham, N.K.3
  • 3
    • 80051550048 scopus 로고    scopus 로고
    • Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis
    • Amit O, Mannino F, Stone AM et al. Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis. Eur J Cancer 2011;47:1772-78.
    • (2011) Eur J Cancer , vol.47 , pp. 1772-1778
    • Amit, O.1    Mannino, F.2    Stone, A.M.3
  • 4
    • 0028091401 scopus 로고
    • The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial
    • Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology 1994;44:16-20.
    • (1994) Neurology , vol.44 , pp. 16-20
    • Noseworthy, J.H.1    Ebers, G.C.2    Vandervoort, M.K.3    Farquhar, R.E.4    Yetisir, E.5    Roberts, R.6
  • 6
    • 77953662309 scopus 로고    scopus 로고
    • Topic of histopathology blinding in nonclinical safety biomarker qualification studies
    • Burkhardt JE, Ennulat D, Pandher K et al. Topic of histopathology blinding in nonclinical safety biomarker qualification studies. Toxicol Pathol 2010;38:666-67.
    • (2010) Toxicol Pathol , vol.38 , pp. 666-667
    • Burkhardt, J.E.1    Ennulat, D.2    Pandher, K.3
  • 7
    • 0004948828 scopus 로고
    • Blind slide reading or the uninformed versus the informed pathologist
    • Dodd DC. Blind slide reading or the uninformed versus the informed pathologist. Comments Toxicol 1988;2:88-91.
    • (1988) Comments Toxicol , vol.2 , pp. 88-91
    • Dodd, D.C.1
  • 8
    • 80051550977 scopus 로고    scopus 로고
    • PhRMA working group. Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group
    • Stone AM, Bushnell W, Denne J et al. PhRMA working group. Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group. Eur J Cancer 2011;47:1763-71.
    • (2011) Eur J Cancer , vol.47 , pp. 1763-1771
    • Stone, A.M.1    Bushnell, W.2    Denne, J.3
  • 10
    • 84868308325 scopus 로고    scopus 로고
    • Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials
    • Savović J, Jones HE, Altman DG et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med 2012;157: 429-38.
    • (2012) Ann Intern Med , vol.157 , pp. 429-438
    • Savović, J.1    Jones, H.E.2    Altman, D.G.3
  • 11
    • 0035906296 scopus 로고    scopus 로고
    • Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials
    • Devereaux PJ, Manns BJ, Ghali WA et al. Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials. JAMA 2001;285:2000-03.
    • (2001) JAMA , vol.285 , pp. 2000-2003
    • Devereaux, P.J.1    Manns, B.J.2    Ghali, W.A.3
  • 12
    • 84858387206 scopus 로고    scopus 로고
    • Observer bias in randomized clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors
    • Hróbjartsson A, Thomsen AS, Emanuelsson F et al. Observer bias in randomized clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. BMJ 2012;344:e1119.
    • (2012) BMJ , vol.344
    • Hróbjartsson, A.1    Thomsen, A.S.2    Emanuelsson, F.3
  • 13
    • 84875161703 scopus 로고    scopus 로고
    • Observer bias in randomized clinical trials with measurement scale outcomes: systematic review of trials with both blinded and nonblinded outcome assessors
    • Hróbjartsson A, Thomsen AS, Emanuelsson F et al. Observer bias in randomized clinical trials with measurement scale outcomes: systematic review of trials with both blinded and nonblinded outcome assessors. CMAJ 2013;185:E201-11.
    • (2013) CMAJ , vol.185
    • Hróbjartsson, A.1    Thomsen, A.S.2    Emanuelsson, F.3
  • 14
    • 34547450763 scopus 로고    scopus 로고
    • Practical methods for incorporating summary time-to-event data into meta-analysis
    • Tierney JF, Stewart LA, Ghersi D, Burdett S, Sydes MR. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials 2007;8:16.
    • (2007) Trials , vol.8 , pp. 16
    • Tierney, J.F.1    Stewart, L.A.2    Ghersi, D.3    Burdett, S.4    Sydes, M.R.5
  • 16
    • 0025737427 scopus 로고
    • Cyclophosphamide and plasma exchange in multiple sclerosis
    • Noseworthy JH, Vandervoort MK, Penman M et al. Cyclophosphamide and plasma exchange in multiple sclerosis. Lancet 1991;337:1540-41.
    • (1991) Lancet , vol.337 , pp. 1540-1541
    • Noseworthy, J.H.1    Vandervoort, M.K.2    Penman, M.3
  • 17
    • 79959579500 scopus 로고    scopus 로고
    • Recombinant human bone morphogeneticprotein-2: a randomized trial in open tibial fractures treated with reamed nail fixation
    • Aro HT, Govender S, Patel AD et al. Recombinant human bone morphogeneticprotein-2: a randomized trial in open tibial fractures treated with reamed nail fixation. J Bone Joint Surg Am 2011;93:801-08.
    • (2011) J Bone Joint Surg Am , vol.93 , pp. 801-808
    • Aro, H.T.1    Govender, S.2    Patel, A.D.3
  • 18
    • 0036899744 scopus 로고    scopus 로고
    • Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients
    • Govender S, Csimma C, Genant HK et al. Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients. J Bone Joint Surg Am 2002;84-A: 2123-34.
    • (2002) J Bone Joint Surg Am , vol.84 A , pp. 2123-2134
    • Govender, S.1    Csimma, C.2    Genant, H.K.3
  • 19
    • 84881312927 scopus 로고    scopus 로고
    • Stem cell-based therapy for prevention of delayed fracture union: a randomized and prospective preliminary study
    • Liebergall M, Schroeder J, Mosheiff R et al. Stem cell-based therapy for prevention of delayed fracture union: a randomized and prospective preliminary study. Mol Ther 2013;21:1631-38.
    • (2013) Mol Ther , vol.21 , pp. 1631-1638
    • Liebergall, M.1    Schroeder, J.2    Mosheiff, R.3
  • 20
    • 1842294582 scopus 로고    scopus 로고
    • Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial
    • Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group
    • Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med 1997;126:264-74.
    • (1997) Ann Intern Med , vol.126 , pp. 264-274
  • 21
    • 9044238842 scopus 로고    scopus 로고
    • Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS
    • The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group
    • Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS. The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Arch Ophthalmol 1996;114:23-33.
    • (1996) Arch Ophthalmol , vol.114 , pp. 23-33
  • 22
    • 0036202668 scopus 로고    scopus 로고
    • A randomized controlled clinical trial of intravitreous fomivirsen for treatment of newly diagnosed peripheral cytomegalovirus retinitis in patients with AIDS
    • Vitravene Study Group.
    • Vitravene Study Group. A randomized controlled clinical trial of intravitreous fomivirsen for treatment of newly diagnosed peripheral cytomegalovirus retinitis in patients with AIDS. Am J Ophthalmol 2002;133:467-74.
    • (2002) Am J Ophthalmol , vol.133 , pp. 467-474
  • 23
    • 0029143294 scopus 로고
    • Oral ganciclovir as maintenance treatment for cytomegalovirus retinitis in patients with AIDS
    • Syntex Cooperative Oral Ganciclovir Study Group
    • Drew WL, Ives D, Lalezari JP et al. Oral ganciclovir as maintenance treatment for cytomegalovirus retinitis in patients with AIDS. Syntex Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1995;333:615-20.
    • (1995) N Engl J Med. , vol.333 , pp. 615-620
    • Drew, W.L.1    Ives, D.2    Lalezari, J.P.3
  • 24
    • 0028959729 scopus 로고
    • Intravenous vs. oral ganciclovir: European/ Australian comparative study of efficacy and safety in the prevention of cytomegalovirus retinitis recurrence in patients with AIDS
    • The Oral Ganciclovir European and Australian Cooperative Study Group.
    • The Oral Ganciclovir European and Australian Cooperative Study Group. Intravenous vs. oral ganciclovir: European/ Australian comparative study of efficacy and safety in the prevention of cytomegalovirus retinitis recurrence in patients with AIDS. AIDS 1995;9:471-77.
    • (1995) AIDS , vol.9 , pp. 471-477
  • 25
    • 0030454921 scopus 로고    scopus 로고
    • Oral ganciclovir for cytomegalovirus retinitis in patients with AIDS: results of two randomized studies
    • Squires KE. Oral ganciclovir for cytomegalovirus retinitis in patients with AIDS: results of two randomized studies. AIDS 1996;10(Suppl 4):S13-18.
    • (1996) AIDS , vol.10 , Issue.SUPPL. 4
    • Squires, K.E.1
  • 26
    • 0037061903 scopus 로고    scopus 로고
    • A controlled trial of valganciclovir as induction therapy for cytomegalovirus retinitis
    • Martin DF, Sierra-Madero J, Walmsley S et al. A controlled trial of valganciclovir as induction therapy for cytomegalovirus retinitis. N Engl J Med 2002;346:1119-26.
    • (2002) N Engl J Med , vol.346 , pp. 1119-1126
    • Martin, D.F.1    Sierra-Madero, J.2    Walmsley, S.3
  • 27
    • 0036137373 scopus 로고    scopus 로고
    • Roche Cooperative Oral Ganciclovir Study Group. High dose oral ganciclovir treatment for cytomegalovirus retinitis
    • Lalezari JP, Friedberg DN, Bissett J et al. Roche Cooperative Oral Ganciclovir Study Group. High dose oral ganciclovir treatment for cytomegalovirus retinitis. J Clin Virol 2002;24:67-77.
    • (2002) J Clin Virol , vol.24 , pp. 67-77
    • Lalezari, J.P.1    Friedberg, D.N.2    Bissett, J.3
  • 28
    • 0242467965 scopus 로고    scopus 로고
    • The use of a collagen sponge/living cell composite material to treat donor sites in burn patients
    • Still J, Glat P, Silverstein P, Griswold J, Mozingo D. The use of a collagen sponge/living cell composite material to treat donor sites in burn patients. Burns 2003;29:837-41.
    • (2003) Burns , vol.29 , pp. 837-841
    • Still, J.1    Glat, P.2    Silverstein, P.3    Griswold, J.4    Mozingo, D.5
  • 29
    • 33744815209 scopus 로고    scopus 로고
    • Recombinant human bone morphogenetic protein-2 in open tibial fractures. A subgroup analysis of data combined from two prospective randomized studies
    • Swiontkowski MF, Aro HT, Donell S et al. Recombinant human bone morphogenetic protein-2 in open tibial fractures. A subgroup analysis of data combined from two prospective randomized studies. J Bone Joint Surg Am 2006;88:1258-65.
    • (2006) J Bone Joint Surg Am , vol.88 , pp. 1258-1265
    • Swiontkowski, M.F.1    Aro, H.T.2    Donell, S.3
  • 30
    • 84902684061 scopus 로고    scopus 로고
    • (19 June 2012, date last accessed).
    • http://www.fda.gov/downloads/AdvisoryCommittees/Committe esMeetingMaterials/MedicalDevices/MedicalDevicesAdvisory Committee/NeurologicalDevicesPanel/UCM247246.doc (19 June 2012, date last accessed).
  • 31
    • 67649097288 scopus 로고    scopus 로고
    • Larval therapy for leg ulcers (VenUS II): randomized controlled trial
    • Dumville JC, Worthy G, Bland JM et al. Larval therapy for leg ulcers (VenUS II): randomized controlled trial. BMJ 2009; 338:b773.
    • (2009) BMJ , vol.338
    • Dumville, J.C.1    Worthy, G.2    Bland, J.M.3
  • 32
    • 0031563023 scopus 로고    scopus 로고
    • Treatment of cytomegalovirus retinitis with a sustained-release ganciclovir implant
    • The Ganciclovir Implant Study Group
    • Musch DC, Martin DF, Gordon JF, Davis MD, Kuppermann BD. Treatment of cytomegalovirus retinitis with a sustained-release ganciclovir implant. The Ganciclovir Implant Study Group. N Engl J Med 1997;337:83-90.
    • (1997) N Engl J Med , vol.337 , pp. 83-90
    • Musch, D.C.1    Martin, D.F.2    Gordon, J.F.3    Davis, M.D.4    Kuppermann, B.D.5
  • 33
    • 0031663471 scopus 로고    scopus 로고
    • Influence of a mindfulness meditation-based stress reduction intervention on rates of skin clearing in patients with moderate to severe psoriasis undergoing phototherapy (UVB) and photochemotherapy (PUVA)
    • Kabat-Zinn J, Wheeler E, Light T et al. Influence of a mindfulness meditation-based stress reduction intervention on rates of skin clearing in patients with moderate to severe psoriasis undergoing phototherapy (UVB) and photochemotherapy (PUVA). Psychosom Med 1998;60:625-32.
    • (1998) Psychosom Med , vol.60 , pp. 625-632
    • Kabat-Zinn, J.1    Wheeler, E.2    Light, T.3
  • 34
    • 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 1991;266:93-98.
    • (1991) JAMA , vol.266 , pp. 93-98
    • Yusuf, S.1    Wittes, J.2    Probstfield, J.3    Tyroler, H.A.4
  • 35
    • 0028434656 scopus 로고
    • The politics of AIDS. Introduction
    • Singer M. The politics of AIDS. Introduction. Soc Sci Med 1994;38:1321-24.
    • (1994) Soc Sci Med , vol.38 , pp. 1321-1324
    • Singer, M.1
  • 36
    • 0030923529 scopus 로고    scopus 로고
    • Publication bias: evidence of delayed publication in a cohort study of clinical research projects
    • Stern JM, Simes RJ. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997;315:640-45.
    • (1997) BMJ , vol.315 , pp. 640-645
    • Stern, J.M.1    Simes, R.J.2
  • 37
    • 84902684052 scopus 로고    scopus 로고
    • (28 June 2012, date last accessed).
    • www.fda.gov/downloads/Drugs/GuidanceComplianceRegula toryInformation/Guidances/UCM071590.pdf (28 June 2012, date last accessed).
  • 38
    • 49249111441 scopus 로고    scopus 로고
    • Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?
    • Dodd LE, Korn EL, Freidlin B et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 2008;26:3791-96.
    • (2008) J Clin Oncol , vol.26 , pp. 3791-3796
    • Dodd, L.E.1    Korn, E.L.2    Freidlin, B.3
  • 39
    • 33847658810 scopus 로고    scopus 로고
    • Reporting methods of blinding in randomized controlled trials assessing non-pharmacological treatments. A systematic review
    • Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P. Reporting methods of blinding in randomized controlled trials assessing non-pharmacological treatments. A systematic review. PLoS Med 2007;4:e61.
    • (2007) PLoS Med , vol.4
    • Boutron, I.1    Guittet, L.2    Estellat, C.3    Moher, D.4    Hróbjartsson, A.5    Ravaud, P.6
  • 40
    • 58149092613 scopus 로고    scopus 로고
    • Radiographs of hip fractures were digitally altered to mask surgeons to the type of implant without compromising the reliability of quality ratings or making the rating process more difficult
    • Collaboration for Outcomes Assessment in Surgical Trials (COAST) Musculoskeletal Group
    • Karanicolas PJ, Bhandari M, Walter SD, Heels-Ansdell D, Guyatt GH. Collaboration for Outcomes Assessment in Surgical Trials (COAST) Musculoskeletal Group. Radiographs of hip fractures were digitally altered to mask surgeons to the type of implant without compromising the reliability of quality ratings or making the rating process more difficult. J Clin Epidemiol 2009;62:214-23.e1.
    • (2009) J Clin Epidemiol , vol.62
    • Karanicolas, P.J.1    Bhandari, M.2    Walter, S.D.3    Heels-Ansdell, D.4    Guyatt, G.H.5
  • 41
    • 0036742105 scopus 로고    scopus 로고
    • Improved interobserver variation after training of doctors in the Neer system. A randomized trial
    • Brorson S, Bagger J, Sylvest A, Hrobjartsson A. Improved interobserver variation after training of doctors in the Neer system. A randomized trial. J Bone Joint Surg Br 2002;84:950-54.
    • (2002) J Bone Joint Surg Br , vol.84 , pp. 950-954
    • Brorson, S.1    Bagger, J.2    Sylvest, A.3    Hrobjartsson, A.4
  • 42
    • 66849130887 scopus 로고    scopus 로고
    • Development and application of a real-time on-line blinded independent central review of interim PET scans to determine treatment allocation in lymphoma trials
    • Meignan M, Itti E, Bardet S et al. Development and application of a real-time on-line blinded independent central review of interim PET scans to determine treatment allocation in lymphoma trials. J Clin Oncol 2009;27:2739-41.
    • (2009) J Clin Oncol , vol.27 , pp. 2739-2741
    • Meignan, M.1    Itti, E.2    Bardet, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.