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Volumn 267, Issue 2, 2013, Pages 328-338

How to demonstrate similarity by using noninferiority and equivalence statistical testing in radiology research

Author keywords

[No Author keywords available]

Indexed keywords

COMPARATIVE STUDY; COMPUTED TOMOGRAPHIC ANGIOGRAPHY; CONFIDENCE INTERVAL; DIAGNOSTIC ACCURACY; EQUIVALENCE; HUMAN; MEDICAL RESEARCH; NONINFERIORITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RADIATION DOSE; RADIOLOGY; RECEIVER OPERATING CHARACTERISTIC; REVIEW; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL PARAMETERS; STUDY DESIGN; SYSTEMATIC ERROR;

EID: 84876892984     PISSN: 00338419     EISSN: 15271315     Source Type: Journal    
DOI: 10.1148/radiol.12120725     Document Type: Review
Times cited : (134)

References (39)
  • 1
    • 4644254894 scopus 로고    scopus 로고
    • Negative results in cancer clinical trials: Equivalence or poor accruaľ
    • Costa LJ, Xavier AC, del Giglio A. Negative results in cancer clinical trials: equivalence or poor accruaľ Control Clin Trials 2004;25(5):525-533.
    • (2004) Control Clin Trials , vol.25 , Issue.5 , pp. 525-533
    • Costa, L.J.1    Xavier, A.C.2    Del Giglio, A.3
  • 2
    • 0034939731 scopus 로고    scopus 로고
    • Negative results of randomized clinical trials published in the surgical literature: Equivalency or error
    • Dimick JB, Diener-West M, Lipsett PA. Negative results of randomized clinical trials published in the surgical literature: equivalency or erroř Arch Surg 2001;136(7):796-800.
    • (2001) Arch Surg , vol.136 , Issue.7 , pp. 796-800
    • Dimick, J.B.1    Diener-West, M.2    Lipsett, P.A.3
  • 3
    • 0036678663 scopus 로고    scopus 로고
    • Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children
    • Krysan DJ, Kemper AR. Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children. Pediatr Infect Dis J 2002;21(8):753-758.
    • (2002) Pediatr Infect Dis J , vol.21 , Issue.8 , pp. 753-758
    • Krysan, D.J.1    Kemper, A.R.2
  • 4
    • 33644792767 scopus 로고    scopus 로고
    • Reporting of noninferiority and equivalence randomized trials: An extension of the consort statement
    • Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006;295(10):1152-1160.
    • (2006) JAMA , vol.295 , Issue.10 , pp. 1152-1160
    • Piaggio, G.1    Elbourne, D.R.2    Altman, D.G.3    Pocock, S.J.4    Evans, S.J.5    Consort, G.6
  • 5
    • 0034595229 scopus 로고    scopus 로고
    • Claims of equivalence in medical research: Are they supported by the evidence?
    • Greene WL, Concato J, Feinstein AR. Claims of equivalence in medical research: are they supported by the evidence? Ann Intern Med 2000;132(9):715-722.
    • (2000) Ann Intern Med , vol.132 , Issue.9 , pp. 715-722
    • Greene, W.L.1    Concato, J.2    Feinstein, A.R.3
  • 6
    • 2342571078 scopus 로고    scopus 로고
    • Superiority trials, noninferiority trials, and prisoners of the 2-sided null hypothesis
    • Sackett DL. Superiority trials, noninferiority trials, and prisoners of the 2-sided null hypothesis. ACP J Club 2004;140(2):A11.
    • (2004) ACP J Club , vol.140 , Issue.2
    • Sackett, D.L.1
  • 7
    • 15244355307 scopus 로고    scopus 로고
    • Choice of delta: Requirements and reality results of a systematic review
    • discussion 99-107
    • Lange S, Freitag G. Choice of delta: requirements and reality -results of a systematic review. Biom J 2005;47(1):12-27; discussion 99-107.
    • (2005) Biom J , vol.47 , Issue.1 , pp. 12-27
    • Lange, S.1    Freitag, G.2
  • 10
    • 84876924584 scopus 로고    scopus 로고
    • Chmp guideline on the choice of the non-inferiority margin
    • EMEA Accessed March 14, 2012
    • EMEA. CHMP Guideline on the choice of the non-inferiority margin. European Medicines Agency Web site. http://www.ema.europa. eu/docs/en-GB/ document-library/Scientific-guideline/2009/09/WC500003636.pdf. Accessed March 14, 2012.
    • European Medicines Agency Web site
  • 11
    • 84876929736 scopus 로고    scopus 로고
    • Guidance for industry: Non-inferiority clinical trials
    • FDA Accessed March 14, 2012
    • FDA. Guidance for industry: non-inferiority clinical trials. FDA Web site. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf. Accessed March 14, 2012.
    • FDA Web site
  • 13
    • 84860140620 scopus 로고    scopus 로고
    • Low-dose abdominal ct for evaluating suspected appendicitis
    • Kim K, Kim YH, Kim SY, et al. Low-dose abdominal CT for evaluating suspected appendicitis. N Engl J Med 2012;366(17):1596-1605.
    • (2012) N Engl J Med , vol.366 , Issue.17 , pp. 1596-1605
    • Kim, K.1    Kim, Y.H.2    Kim, S.Y.3
  • 14
    • 33748440113 scopus 로고    scopus 로고
    • Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: Randomised controlled trial
    • OCTOPUS Study Investigators
    • af Geijerstam JL, Oredsson S, Britton M; OCTOPUS Study Investigators. Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial. BMJ 2006;333(7566):465.
    • (2006) BMJ , vol.333 , Issue.7566 , pp. 465
    • Af Geijerstam, J.L.1    Oredsson, S.2    Britton, M.3
  • 15
    • 79960509008 scopus 로고    scopus 로고
    • A prospective comparison of standard-dose ct enterography and 50% reduced-dose ct enterography with and without noise reduction for evaluating crohn disease
    • Lee SJ, Park SH, Kim AY, et al. A prospective comparison of standard-dose CT enterography and 50% reduced-dose CT enterography with and without noise reduction for evaluating Crohn disease. AJR Am J Roentgenol 2011;197(1):50-57.
    • (2011) AJR Am J Roentgenol , vol.197 , Issue.1 , pp. 50-57
    • Lee, S.J.1    Park, S.H.2    Kim, A.Y.3
  • 16
    • 78249261294 scopus 로고    scopus 로고
    • Image quality and radiation exposure with a low tube voltage protocol for coronary ct angiography results of the protection ii trial
    • Hausleiter J, Martinoff S, Hadamitzky M, et al. Image quality and radiation exposure with a low tube voltage protocol for coronary CT angiography results of the PROTECTION II Trial. JACC Cardiovasc Imaging 2010;3(11):1113- 1123.
    • (2010) JACC Cardiovasc Imaging , vol.3 , Issue.11 , pp. 1113-1123
    • Hausleiter, J.1    Martinoff, S.2    Hadamitzky, M.3
  • 17
    • 34147194443 scopus 로고    scopus 로고
    • Extramural depth of tumor invasion at thin-section mr in patients with rectal cancer: Results of the mercury study
    • MERCURY Study Group
    • MERCURY Study Group. Extramural depth of tumor invasion at thin-section MR in patients with rectal cancer: results of the MERCURY study. Radiology 2007;243(1):132-139.
    • (2007) Radiology , vol.243 , Issue.1 , pp. 132-139
  • 18
    • 60549102685 scopus 로고    scopus 로고
    • Degree of error of thin-section mr in measuring extramural depth of tumor invasion in patients with rectal cancer
    • author rely 647-648
    • Park SH. Degree of error of thin-section MR in measuring extramural depth of tumor invasion in patients with rectal cancer. Radiology 2008;246(2):647; author reply 647-648.
    • (2008) Radiology , vol.246 , Issue.2 , pp. 647
    • Park, S.H.1
  • 19
    • 84908219488 scopus 로고
    • Statistical methods for assessing agreement between two methods of clinical measurement
    • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1(8476):307-310.
    • (1986) Lancet , vol.1 , Issue.8476 , pp. 307-310
    • Bland, J.M.1    Altman, D.G.2
  • 20
    • 33644789375 scopus 로고    scopus 로고
    • Quality of reporting of noninferiority and equivalence randomized trials
    • Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA 2006;295(10):1147-1151.
    • (2006) JAMA , vol.295 , Issue.10 , pp. 1147-1151
    • Le Henanff, A.1    Giraudeau, B.2    Baron, G.3    Ravaud, P.4
  • 21
    • 78149435107 scopus 로고    scopus 로고
    • Room for improvement in conducting and reporting noninferiority randomized controlled trials on drugs: A systematic review
    • Wangge G, Klungel OH, Roes KC, de Boer A, Hoes AW, Knol MJ. Room for improvement in conducting and reporting noninferiority randomized controlled trials on drugs: a systematic review. PLoS ONE 2010;5(10):e13550.
    • (2010) PLoS ONE , vol.5 , Issue.10
    • Wangge, G.1    Klungel, O.H.2    Roes, K.C.3    De Boer, A.4    Hoes, A.W.5    Knol, M.J.6
  • 22
    • 80052618816 scopus 로고    scopus 로고
    • The usefulness of a preoperative compact im-ager, a hand-held gamma-camera for breast cancer sentinel node biopsy: Final results of a prospective double-blind, clinical study
    • Kerrou K, Pitre S, Coutant C, et al. The usefulness of a preoperative compact im-ager, a hand-held gamma-camera for breast cancer sentinel node biopsy: final results of a prospective double-blind, clinical study. J Nucl Med 2011;52(9):1346-1353.
    • (2011) J Nucl Med , vol.52 , Issue.9 , pp. 1346-1353
    • Kerrou, K.1    Pitre, S.2    Coutant, C.3
  • 23
    • 33344464920 scopus 로고    scopus 로고
    • Abdominal and iliac arterial stenoses: Comparative double-blinded randomized study of diagnostic accuracy of 3d mr angiography with gadodiamide or gadopentetate dimeglumine
    • Schaefer PJ, Boudghene FP, Brambs HJ, et al. Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine. Radiology 2006;238(3):827-840.
    • (2006) Radiology , vol.238 , Issue.3 , pp. 827-840
    • Schaefer, P.J.1    Boudghene, F.P.2    Brambs, H.J.3
  • 24
    • 33845633243 scopus 로고    scopus 로고
    • Mr imaging: Effectiveness and costs at triage of patients with nonacute knee symptoms
    • Vincken PWJ, ter Braak APM, van Erkel AR, et al. MR imaging: effectiveness and costs at triage of patients with nonacute knee symptoms. Radiology 2007;242(1):85-93.
    • (2007) Radiology , vol.242 , Issue.1 , pp. 85-93
    • Vincken, P.W.J.1    Ter Braak, A.P.M.2    Van Erkel, A.R.3
  • 25
    • 37349096405 scopus 로고    scopus 로고
    • Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: A randomized controlled trial
    • Anderson DR, Kahn SR, Rodger MA, et al. Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial. JAMA 2007;298(23):2743-2753.
    • (2007) JAMA , vol.298 , Issue.23 , pp. 2743-2753
    • Anderson, D.R.1    Kahn, S.R.2    Rodger, M.A.3
  • 26
    • 42049095662 scopus 로고    scopus 로고
    • Diagnosis of pulmonary embolism by multidetector ct alone or combined with venous ultrasonography of the leg: A randomised non-inferiority trial
    • Righini M, Le Gal G, Aujesky D, et al. Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomised non-inferiority trial. Lancet 2008;371(9621):1343-1352.
    • (2008) Lancet , vol.371 , Issue.9621 , pp. 1343-1352
    • Righini, M.1    Le Gal, G.2    Aujesky, D.3
  • 27
    • 0037407912 scopus 로고    scopus 로고
    • Sample size estimation: How many individuals should be studied?
    • Eng J. Sample size estimation: how many individuals should be studied? Radiology 2003;227(2):309-313.
    • (2003) Radiology , vol.227 , Issue.2 , pp. 309-313
    • Eng, J.1
  • 29
    • 0029098036 scopus 로고
    • On the sample size for one-sided equivalence of sensitivities based upon mcnemar's test
    • Lu Y, Bean JA. On the sample size for one-sided equivalence of sensitivities based upon McNemar's test. Stat Med 1995;14(16):1831-1839.
    • (1995) Stat Med , vol.14 , Issue.16 , pp. 1831-1839
    • Lu, Y.1    Bean, J.A.2
  • 30
    • 0031467706 scopus 로고    scopus 로고
    • Establishing equivalence of two treatments and sample size requirements in matched-pairs design
    • Nam JM. Establishing equivalence of two treatments and sample size requirements in matched-pairs design. Biometrics 1997;53(4):1422-1430.
    • (1997) Biometrics , vol.53 , Issue.4 , pp. 1422-1430
    • Nam, J.M.1
  • 31
    • 0032580373 scopus 로고    scopus 로고
    • Equivalence test and confidence interval for the difference in proportions for the paired-sample design
    • Tango T. Equivalence test and confidence interval for the difference in proportions for the paired-sample design. Stat Med 1998;17(8):891-908.
    • (1998) Stat Med , vol.17 , Issue.8 , pp. 891-908
    • Tango, T.1
  • 32
    • 0037196214 scopus 로고    scopus 로고
    • Tests for equivalence or non-inferiority for paired binary data
    • Liu JP, Hsueh HM, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med 2002;21(2):231-245.
    • (2002) Stat Med , vol.21 , Issue.2 , pp. 231-245
    • Liu, J.P.1    Hsueh, H.M.2    Hsieh, E.3    Chen, J.J.4
  • 33
    • 0036774023 scopus 로고    scopus 로고
    • The virtual colonoscopy study: A large multicenter clinical trial designed to compare two diagnostic screening procedures
    • Durkalski VL, Palesch YY, Pineau BC, Vining DJ, Cotton PB. The virtual colonoscopy study: a large multicenter clinical trial designed to compare two diagnostic screening procedures. Control Clin Trials 2002;23(5):570-583.
    • (2002) Control Clin Trials , vol.23 , Issue.5 , pp. 570-583
    • Durkalski, V.L.1    Palesch, Y.Y.2    Pineau, B.C.3    Vining, D.J.4    Cotton, P.B.5
  • 34
    • 33646150005 scopus 로고    scopus 로고
    • Breast disease: Clinical application of us elastography for diagnosis
    • Itoh A, Ueno E, Tohno E, et al. Breast disease: clinical application of US elastography for diagnosis. Radiology 2006; 239(2):341-350.
    • (2006) Radiology , vol.239 , Issue.2 , pp. 341-350
    • Itoh, A.1    Ueno, E.2    Tohno, E.3
  • 35
    • 0141518516 scopus 로고    scopus 로고
    • Receiver operating characteristic curves and their use in radiology
    • Obuchowski NA. Receiver operating characteristic curves and their use in radiology. Radiology 2003;229(1):3-8.
    • (2003) Radiology , vol.229 , Issue.1 , pp. 3-8
    • Obuchowski, N.A.1
  • 36
    • 2342446592 scopus 로고    scopus 로고
    • Receiver operating characteristic (roc) curve: Practical review for radiologists
    • Park SH, Goo JM, Jo CH. Receiver operating characteristic (ROC) curve: practical review for radiologists. Korean J Radiol 2004;5(1):11-18.
    • (2004) Korean J Radiol , vol.5 , Issue.1 , pp. 11-18
    • Park, S.H.1    Goo, J.M.2    Jo, C.H.3
  • 37
    • 67349239678 scopus 로고    scopus 로고
    • A non-inferiority test of areas under two parametric roc curves
    • Jin H, Lu Y. A non-inferiority test of areas under two parametric ROC curves. Contemp Clin Trials 2009;30(4):375-379.
    • (2009) Contemp Clin Trials , vol.30 , Issue.4 , pp. 375-379
    • Jin, H.1    Lu, Y.2
  • 38
    • 33645469682 scopus 로고    scopus 로고
    • Tests of equivalence and non-inferiority for diagnostic accuracy based on the paired areas under roc curves
    • Liu JP, Ma MC, Wu CY, Tai JY. Tests of equivalence and non-inferiority for diagnostic accuracy based on the paired areas under ROC curves. Stat Med 2006;25(7):1219-1238.
    • (2006) Stat Med , vol.25 , Issue.7 , pp. 1219-1238
    • Liu, J.P.1    Ma, M.C.2    Wu, C.Y.3    Tai, J.Y.4


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