메뉴 건너뛰기




Volumn 13, Issue 1, 2015, Pages

Comparison of registered and published outcomes in randomized controlled trials: A systematic review

Author keywords

Clinicaltrials.gov; Primary outcome; Publication bias; Reporting bias; Selection bias; Trial registration

Indexed keywords

ARTICLE; CONTROLLED STUDY; DISEASE REGISTRY; HUMAN; INTERMETHOD COMPARISON; MEDICAL LITERATURE; PREVALENCE; PROSPECTIVE STUDY; PUBLICATION; PUBLISHING; RANDOMIZED CONTROLLED TRIAL; SELECTION BIAS; SYSTEMATIC REVIEW; VALIDITY; PEER REVIEW; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; STANDARDS; STATISTICAL BIAS; TREATMENT OUTCOME;

EID: 84960384323     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/s12916-015-0520-3     Document Type: Article
Times cited : (182)

References (42)
  • 1
    • 77950273246 scopus 로고    scopus 로고
    • CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials
    • Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.
    • (2010) BMJ , vol.340 , pp. c869
    • Moher, D.1    Hopewell, S.2    Schulz, K.F.3    Montori, V.4    Gotzsche, P.C.5    Devereaux, P.J.6
  • 2
    • 79955720342 scopus 로고    scopus 로고
    • Treatment of acute otitis media in children
    • Newman DH, Shreves AE. Treatment of acute otitis media in children. N Engl J Med. 2011;364(18):1775. doi: 10.1056/NEJMc1102207#SA1. author reply 7-8.
    • (2011) N Engl J Med , vol.364 , Issue.18 , pp. 1775
    • Newman, D.H.1    Shreves, A.E.2
  • 3
    • 4544223937 scopus 로고    scopus 로고
    • Clinical trial registration: a statement from the International Committee of Medical Journal Editors
    • DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292(11):1363-4. doi: 10.1001/jama.292.11.1363.
    • (2004) JAMA , vol.292 , Issue.11 , pp. 1363-1364
    • DeAngelis, C.D.1    Drazen, J.M.2    Frizelle, F.A.3    Haug, C.4    Hoey, J.5    Horton, R.6
  • 4
    • 84977875692 scopus 로고    scopus 로고
    • Food and Drug Administration Act of 2007, Stat. 2007: 110-85.
    • (2007) Stat. , pp. 110-185
  • 6
    • 84860444921 scopus 로고    scopus 로고
    • Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010
    • Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA. 2012;307(17):1838-47. doi: 10.1001/jama.2012.3424.
    • (2012) JAMA , vol.307 , Issue.17 , pp. 1838-1847
    • Califf, R.M.1    Zarin, D.A.2    Kramer, J.M.3    Sherman, R.E.4    Aberle, L.H.5    Tasneem, A.6
  • 7
    • 69849092717 scopus 로고    scopus 로고
    • Comparison of registered and published primary outcomes in randomized controlled trials
    • Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA. 2009;302(9):977-84. doi: 10.1001/jama.2009.1242.
    • (2009) JAMA , vol.302 , Issue.9 , pp. 977-984
    • Mathieu, S.1    Boutron, I.2    Moher, D.3    Altman, D.G.4    Ravaud, P.5
  • 8
    • 70349636711 scopus 로고    scopus 로고
    • Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis
    • Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med. 2009;6(9):e1000144. doi: 10.1371/journal.pmed.1000144.
    • (2009) PLoS Med , vol.6 , Issue.9 , pp. e1000144
    • Ross, J.S.1    Mulvey, G.K.2    Hines, E.M.3    Nissen, S.E.4    Krumholz, H.M.5
  • 9
    • 84889101512 scopus 로고    scopus 로고
    • Discrepancies between registered and published primary outcome specifications in analgesic trials: ACTTION systematic review and recommendations
    • Smith SM, Wang AT, Pereira A, Chang RD, McKeown A, Greene K, et al. Discrepancies between registered and published primary outcome specifications in analgesic trials: ACTTION systematic review and recommendations. Pain. 2013;154(12):2769-74. doi: 10.1016/j.pain.2013.08.011.
    • (2013) Pain , vol.154 , Issue.12 , pp. 2769-2774
    • Smith, S.M.1    Wang, A.T.2    Pereira, A.3    Chang, R.D.4    McKeown, A.5    Greene, K.6
  • 10
    • 2442692780 scopus 로고    scopus 로고
    • Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles
    • Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291(20):2457-65. doi: 10.1001/jama.291.20.2457.
    • (2004) JAMA , vol.291 , Issue.20 , pp. 2457-2465
    • Chan, A.W.1    Hrobjartsson, A.2    Haahr, M.T.3    Gotzsche, P.C.4    Altman, D.G.5
  • 11
    • 69449100622 scopus 로고    scopus 로고
    • Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement
    • Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535. doi: 10.1136/bmj.b2535.
    • (2009) BMJ , vol.339 , pp. b2535
    • Moher, D.1    Liberati, A.2    Tetzlaff, J.3    Altman, D.G.4
  • 14
    • 0032580320 scopus 로고    scopus 로고
    • Two-sided confidence intervals for the single proportion: comparison of seven methods
    • Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17(8):857-72.
    • (1998) Stat Med , vol.17 , Issue.8 , pp. 857-872
    • Newcombe, R.G.1
  • 15
    • 71649108002 scopus 로고    scopus 로고
    • Undisclosed changes in outcomes in randomized controlled trials: an observational study
    • Ewart R, Lausen H, Millian N. Undisclosed changes in outcomes in randomized controlled trials: an observational study. Ann Fam Med. 2009;7(6):542-6. doi: 10.1370/afm.1017.
    • (2009) Ann Fam Med , vol.7 , Issue.6 , pp. 542-546
    • Ewart, R.1    Lausen, H.2    Millian, N.3
  • 16
    • 84903315554 scopus 로고    scopus 로고
    • Registration and design alterations of clinical trials in critical care: a cross-sectional observational study
    • Anand V, Scales DC, Parshuram CS, Kavanagh BP. Registration and design alterations of clinical trials in critical care: a cross-sectional observational study. Intensive Care Med. 2014;40(5):700-22. doi: 10.1007/s00134-014-3250-7.
    • (2014) Intensive Care Med , vol.40 , Issue.5 , pp. 700-722
    • Anand, V.1    Scales, D.C.2    Parshuram, C.S.3    Kavanagh, B.P.4
  • 17
    • 77955506490 scopus 로고    scopus 로고
    • Outcome reporting among drug trials registered in ClinicalTrials.gov
    • Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med. 2010;153(3):158-66. doi: 10.7326/0003-4819-153-3-201008030-00006.
    • (2010) Ann Intern Med , vol.153 , Issue.3 , pp. 158-166
    • Bourgeois, F.T.1    Murthy, S.2    Mandl, K.D.3
  • 18
    • 84866028434 scopus 로고    scopus 로고
    • Publication of sports medicine-related randomized controlled trials registered in ClinicalTrials.gov
    • Chahal J, Tomescu SS, Ravi B, Bach Jr BR, Ogilvie-Harris D, Mohamed NN, et al. Publication of sports medicine-related randomized controlled trials registered in ClinicalTrials.gov. Am J Sports Med. 2012;40(9):1970-7. doi: 10.1177/0363546512448363.
    • (2012) Am J Sports Med , vol.40 , Issue.9 , pp. 1970-1977
    • Chahal, J.1    Tomescu, S.S.2    Ravi, B.3    Bach, B.R.4    Ogilvie-Harris, D.5    Mohamed, N.N.6
  • 19
    • 82755190482 scopus 로고    scopus 로고
    • Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov
    • Gandhi R, Jan M, Smith HN, Mahomed NN, Bhandari M. Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov. BMC Musculoskelet Disord. 2011;12:278. doi: 10.1186/1471-2474-12-278.
    • (2011) BMC Musculoskelet Disord , vol.12 , pp. 278
    • Gandhi, R.1    Jan, M.2    Smith, H.N.3    Mahomed, N.N.4    Bhandari, M.5
  • 20
    • 84876291451 scopus 로고    scopus 로고
    • Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions
    • Hannink G, Gooszen HG, Rovers MM. Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions. Ann Surg. 2013;257(5):818-23. doi: 10.1097/SLA.0b013e3182864fa3.
    • (2013) Ann Surg , vol.257 , Issue.5 , pp. 818-823
    • Hannink, G.1    Gooszen, H.G.2    Rovers, M.M.3
  • 21
    • 84897417340 scopus 로고    scopus 로고
    • Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications
    • Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014;160(7):477-83. doi: 10.7326/M13-0480.
    • (2014) Ann Intern Med , vol.160 , Issue.7 , pp. 477-483
    • Hartung, D.M.1    Zarin, D.A.2    Guise, J.M.3    McDonagh, M.4    Paynter, R.5    Helfand, M.6
  • 22
    • 80052994097 scopus 로고    scopus 로고
    • Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy
    • Huic M, Marusic M, Marusic A. Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy. PLoS One. 2011;6(9):e25258. doi: 10.1371/journal.pone.0025258.
    • (2011) PLoS One , vol.6 , Issue.9 , pp. e25258
    • Huic, M.1    Marusic, M.2    Marusic, A.3
  • 24
    • 84866743055 scopus 로고    scopus 로고
    • Quality of registration for clinical trials published in emergency medicine journals
    • Jones CW, Platts-Mills TF. Quality of registration for clinical trials published in emergency medicine journals. Ann Emerg Med. 2012;60(4):458-64. doi: 10.1016/j.annemergmed.2012.02.005.
    • (2012) Ann Emerg Med , vol.60 , Issue.4 , pp. 458-464
    • Jones, C.W.1    Platts-Mills, T.F.2
  • 25
    • 84861798773 scopus 로고    scopus 로고
    • Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis
    • Khan NA, Lombeida JI, Singh M, Spencer HJ, Torralba KD. Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis. Arthritis Rheum. 2012;64(7):2059-67. doi: 10.1002/art.34393.
    • (2012) Arthritis Rheum , vol.64 , Issue.7 , pp. 2059-2067
    • Khan, N.A.1    Lombeida, J.I.2    Singh, M.3    Spencer, H.J.4    Torralba, K.D.5
  • 26
    • 84891625435 scopus 로고    scopus 로고
    • Registration rates, adequacy of registration, and a comparison of registered and published primary outcomes in randomized controlled trials published in surgery journals
    • Killeen S, Sourallous P, Hunter IA, Hartley JE, Grady HL. Registration rates, adequacy of registration, and a comparison of registered and published primary outcomes in randomized controlled trials published in surgery journals. Ann Surg. 2014;259(1):193-6. doi: 10.1097/SLA.0b013e318299d00b.
    • (2014) Ann Surg , vol.259 , Issue.1 , pp. 193-196
    • Killeen, S.1    Sourallous, P.2    Hunter, I.A.3    Hartley, J.E.4    Grady, H.L.5
  • 27
    • 84892188215 scopus 로고    scopus 로고
    • Comparison of registered and published primary outcomes in randomized controlled trials of gastroenterology and hepatology
    • Li XQ, Yang GL, Tao KM, Zhang HQ, Zhou QH, Ling CQ. Comparison of registered and published primary outcomes in randomized controlled trials of gastroenterology and hepatology. Scand J Gastroenterol. 2013;48(12):1474-83. doi: 10.3109/00365521.2013.845909.
    • (2013) Scand J Gastroenterol , vol.48 , Issue.12 , pp. 1474-1483
    • Li, X.Q.1    Yang, G.L.2    Tao, K.M.3    Zhang, H.Q.4    Zhou, Q.H.5    Ling, C.Q.6
  • 28
    • 84880646383 scopus 로고    scopus 로고
    • Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine: an empirical methodological study.
    • pii: e002968.
    • Liu JP, Han M, Li XX, Mu YJ, Lewith G, Wang YY, et al. Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine: an empirical methodological study. BMJ Open. 2013;3(7):pii: e002968. doi: 10.1136/bmjopen-2013-002968.
    • (2013) BMJ Open. , vol.3 , Issue.7
    • Liu, J.P.1    Han, M.2    Li, X.X.3    Mu, Y.J.4    Lewith, G.5    Wang, Y.Y.6
  • 29
    • 84860596518 scopus 로고    scopus 로고
    • Misleading abstract conclusions in randomized controlled trials in rheumatology: comparison of the abstract conclusions and the results section
    • Mathieu S, Giraudeau B, Soubrier M, Ravaud P. Misleading abstract conclusions in randomized controlled trials in rheumatology: comparison of the abstract conclusions and the results section. Joint Bone Spine. 2012;79(3):262-7. doi: 10.1016/j.jbspin.2011.05.008.
    • (2012) Joint Bone Spine , vol.79 , Issue.3 , pp. 262-267
    • Mathieu, S.1    Giraudeau, B.2    Soubrier, M.3    Ravaud, P.4
  • 30
    • 79951720484 scopus 로고    scopus 로고
    • Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: a systematic review
    • Milette K, Roseman M, Thombs BD. Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: a systematic review. J Psychosom Res. 2011;70(3):205-17. doi: 10.1016/j.jpsychores.2010.09.015.
    • (2011) J Psychosom Res , vol.70 , Issue.3 , pp. 205-217
    • Milette, K.1    Roseman, M.2    Thombs, B.D.3
  • 31
    • 84870564237 scopus 로고    scopus 로고
    • Prospective registration and outcome-reporting bias in randomized controlled trials of eczema treatments: a systematic review
    • Nankervis H, Baibergenova A, Williams HC, Thomas KS. Prospective registration and outcome-reporting bias in randomized controlled trials of eczema treatments: a systematic review. J Invest Dermatol. 2012;132(12):2727-34. doi: 10.1038/jid.2012.231.
    • (2012) J Invest Dermatol , vol.132 , Issue.12 , pp. 2727-2734
    • Nankervis, H.1    Baibergenova, A.2    Williams, H.C.3    Thomas, K.S.4
  • 32
    • 84873138810 scopus 로고    scopus 로고
    • Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials
    • Pinto RZ, Elkins MR, Moseley AM, Sherrington C, Herbert RD, Maher CG, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther. 2013;93(3):299-309. doi: 10.2522/ptj.20120206.
    • (2013) Phys Ther , vol.93 , Issue.3 , pp. 299-309
    • Pinto, R.Z.1    Elkins, M.R.2    Moseley, A.M.3    Sherrington, C.4    Herbert, R.D.5    Maher, C.G.6
  • 33
    • 84879105177 scopus 로고    scopus 로고
    • Comparison of randomized controlled trial registry entries and content of reports in surgery journals
    • Rosenthal R, Dwan K. Comparison of randomized controlled trial registry entries and content of reports in surgery journals. Ann Surg. 2013;257(6):1007-15. doi: 10.1097/SLA.0b013e318283cf7f.
    • (2013) Ann Surg , vol.257 , Issue.6 , pp. 1007-1015
    • Rosenthal, R.1    Dwan, K.2
  • 34
    • 84864012781 scopus 로고    scopus 로고
    • Comparison of arthroplasty trial publications after registration in ClinicalTrials.gov
    • Smith HN, Bhandari M, Mahomed NN, Jan M, Gandhi R. Comparison of arthroplasty trial publications after registration in ClinicalTrials.gov. J Arthroplasty. 2012;27(7):1283-8. doi: 10.1016/j.arth.2011.11.005.
    • (2012) J Arthroplasty , vol.27 , Issue.7 , pp. 1283-1288
    • Smith, H.N.1    Bhandari, M.2    Mahomed, N.N.3    Jan, M.4    Gandhi, R.5
  • 35
    • 84875139810 scopus 로고    scopus 로고
    • Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer
    • Vera-Badillo FE, Shapiro R, Ocana A, Amir E, Tannock IF. Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer. Ann Oncol. 2013;24(5):1238-44. doi: 10.1093/annonc/mds636.
    • (2013) Ann Oncol , vol.24 , Issue.5 , pp. 1238-1244
    • Vera-Badillo, F.E.1    Shapiro, R.2    Ocana, A.3    Amir, E.4    Tannock, I.F.5
  • 36
    • 84930623843 scopus 로고    scopus 로고
    • Discrepancies between registration and publication of randomised controlled trials: an observational study
    • 2042533313517688.
    • Walker KF, Stevenson G, Thornton JG. Discrepancies between registration and publication of randomised controlled trials: an observational study. JRSM Open. 2014;5(5):2042533313517688.
    • (2014) JRSM Open , vol.5 , Issue.5
    • Walker, K.F.1    Stevenson, G.2    Thornton, J.G.3
  • 37
    • 81255129522 scopus 로고    scopus 로고
    • Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis
    • Wildt S, Krag A, Gluud L. Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis. BMJ Open. 2011;1(2):e000309. doi: 10.1136/bmjopen-2011-000309.
    • (2011) BMJ Open , vol.1 , Issue.2 , pp. e000309
    • Wildt, S.1    Krag, A.2    Gluud, L.3
  • 38
    • 84855595256 scopus 로고    scopus 로고
    • Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review
    • You B, Gan HK, Pond G, Chen EX. Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. J Clin Oncol. 2012;30(2):210-6. doi: 10.1200/JCO.2011.37.0890.
    • (2012) J Clin Oncol , vol.30 , Issue.2 , pp. 210-216
    • You, B.1    Gan, H.K.2    Pond, G.3    Chen, E.X.4
  • 39
    • 84876047415 scopus 로고    scopus 로고
    • Use of trial register information during the peer review process
    • Mathieu S, Chan AW, Ravaud P. Use of trial register information during the peer review process. PLoS One. 2013;8(4):e59910. doi: 10.1371/journal.pone.0059910.
    • (2013) PLoS One , vol.8 , Issue.4 , pp. e59910
    • Mathieu, S.1    Chan, A.W.2    Ravaud, P.3
  • 40
    • 84936880467 scopus 로고    scopus 로고
    • The most important tasks for peer reviewers evaluating a randomized controlled trial are not congruent with the tasks most often requested by journal editors
    • Chauvin A, Ravaud P, Baron G, Barnes C, Boutron I. The most important tasks for peer reviewers evaluating a randomized controlled trial are not congruent with the tasks most often requested by journal editors. BMC Med. 2015;13:158. doi: 10.1186/s12916-015-0395-3.
    • (2015) BMC Med , vol.13 , pp. 158
    • Chauvin, A.1    Ravaud, P.2    Baron, G.3    Barnes, C.4    Boutron, I.5
  • 41
    • 79952267051 scopus 로고    scopus 로고
    • The ClinicalTrials.gov results database--update and key issues
    • Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database--update and key issues. N Engl J Med. 2011;364(9):852-60. doi: 10.1056/NEJMsa1012065.
    • (2011) N Engl J Med , vol.364 , Issue.9 , pp. 852-860
    • Zarin, D.A.1    Tse, T.2    Williams, R.J.3    Califf, R.M.4    Ide, N.C.5
  • 42
    • 79952266571 scopus 로고    scopus 로고
    • Comparison of protocols and registry entries to published reports for randomised controlled trials
    • Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev. 2011;1:MR000031. doi: 10.1002/14651858.MR000031.pub2.
    • (2011) Cochrane Database Syst Rev , vol.1 , pp. MR000031
    • Dwan, K.1    Altman, D.G.2    Cresswell, L.3    Blundell, M.4    Gamble, C.L.5    Williamson, P.R.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.