메뉴 건너뛰기




Volumn 19, Issue 1, 2018, Pages

Outcome pre-specification requires sufficient detail to guard against outcome switching in clinical trials: A case study

Author keywords

Clinical trial; Outcome reporting bias; Selective outcome reporting

Indexed keywords

ACUTE DISEASE; ARTICLE; CASE STUDY; CLINICAL OUTCOME; CLUSTER ANALYSIS; CONTROLLED STUDY; ERYTHROCYTE TRANSFUSION; FEASIBILITY STUDY; HUMAN; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; THERAPY EFFECT; TREATMENT RESPONSE; UPPER GASTROINTESTINAL BLEEDING; BIOASSAY; CLASSIFICATION; GASTROINTESTINAL HEMORRHAGE; METHODOLOGY; NOMENCLATURE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; RISK FACTOR; STATISTICAL BIAS; TIME FACTOR; TREATMENT OUTCOME;

EID: 85046300778     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-018-2654-z     Document Type: Article
Times cited : (10)

References (22)
  • 1
    • 17144387322 scopus 로고    scopus 로고
    • Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors
    • Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005;330(7494):753.
    • (2005) BMJ , vol.330 , Issue.7494 , pp. 753
    • Chan, A.W.1    Altman, D.G.2
  • 2
    • 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.
    • (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
  • 3
    • 84872080748 scopus 로고    scopus 로고
    • SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
    • Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
    • (2013) BMJ , vol.346
    • Chan, A.W.1    Tetzlaff, J.M.2    Gotzsche, P.C.3    Altman, D.G.4    Mann, H.5    Berlin, J.A.6
  • 4
    • 33749011140 scopus 로고    scopus 로고
    • An empirical evaluation of multifarious outcomes in pharmacogenetics: beta-2 adrenoceptor gene polymorphisms in asthma treatment
    • Contopoulos-Ioannidis DG, Alexiou GA, Gouvias TC, Ioannidis JP. An empirical evaluation of multifarious outcomes in pharmacogenetics: beta-2 adrenoceptor gene polymorphisms in asthma treatment. Pharmacogenet Genomics. 2006;16(10):705-11.
    • (2006) Pharmacogenet Genomics , vol.16 , Issue.10 , pp. 705-711
    • Contopoulos-Ioannidis, D.G.1    Alexiou, G.A.2    Gouvias, T.C.3    Ioannidis, J.P.4
  • 5
    • 52649129348 scopus 로고    scopus 로고
    • Systematic review of the empirical evidence of study publication bias and outcome reporting bias
    • Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3(8):e3081.
    • (2008) PLoS One , vol.3 , Issue.8
    • Dwan, K.1    Altman, D.G.2    Arnaiz, J.A.3    Bloom, J.4    Chan, A.W.5    Cronin, E.6
  • 6
    • 79952266571 scopus 로고    scopus 로고
    • Comparison of protocols and registry entries to published reports for randomised controlled trials
    • MR000031
    • 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. https://doi.org/10.1002/14651858.MR000031.pub2
    • (2011) Cochrane Database Syst Rev. , Issue.1
    • Dwan, K.1    Altman, D.G.2    Cresswell, L.3    Blundell, M.4    Gamble, C.L.5    Williamson, P.R.6
  • 7
    • 0036667853 scopus 로고    scopus 로고
    • Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee
    • Hahn S, Williamson PR, Hutton JL. Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee. J Eval Clin Pract. 2002;8(3):353-9.
    • (2002) J Eval Clin Pract , vol.8 , Issue.3 , pp. 353-359
    • Hahn, S.1    Williamson, P.R.2    Hutton, J.L.3
  • 8
    • 56749166123 scopus 로고    scopus 로고
    • Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation
    • Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008;5(11):e217. discussion e217
    • (2008) PLoS Med , vol.5 , Issue.11
    • Rising, K.1    Bacchetti, P.2    Bero, L.3
  • 9
    • 70449633381 scopus 로고    scopus 로고
    • Outcome reporting in industry-sponsored trials of gabapentin for off-label use
    • Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361(20):1963-71.
    • (2009) N Engl J Med , vol.361 , Issue.20 , pp. 1963-1971
    • Vedula, S.S.1    Bero, L.2    Scherer, R.W.3    Dickersin, K.4
  • 11
    • 84969945193 scopus 로고    scopus 로고
    • Investigation of bias in meta-analyses due to selective inclusion of trial effect estimates: empirical study
    • Page MJ, Forbes A, Chau M, Green SE, McKenzie JE. Investigation of bias in meta-analyses due to selective inclusion of trial effect estimates: empirical study. BMJ Open. 2016;6(4):e011863.
    • (2016) BMJ Open , vol.6 , Issue.4
    • Page, M.J.1    Forbes, A.2    Chau, M.3    Green, S.E.4    McKenzie, J.E.5
  • 12
    • 85029830783 scopus 로고    scopus 로고
    • Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy
    • Mayo-Wilson E, Li T, Fusco N, Bertizzolo L, Canner JK, Cowley T, et al. Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy. J Clin Epidemiol. 2017;91:95-110.
    • (2017) J Clin Epidemiol , vol.91 , pp. 95-110
    • Mayo-Wilson, E.1    Li, T.2    Fusco, N.3    Bertizzolo, L.4    Canner, J.K.5    Cowley, T.6
  • 13
    • 84915746347 scopus 로고    scopus 로고
    • Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study
    • Ramagopalan S, Skingsley AP, Handunnetthi L, Klingel M, Magnus D, Pakpoor J, et al. Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study. F1000Res. 2014;3:77.
    • (2014) F1000Res , vol.3 , pp. 77
    • Ramagopalan, S.1    Skingsley, A.P.2    Handunnetthi, L.3    Klingel, M.4    Magnus, D.5    Pakpoor, J.6
  • 14
    • 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.
    • (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
  • 15
    • 85020419684 scopus 로고    scopus 로고
    • Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis
    • Mayo-Wilson E, Fusco N, Li T, Hong H, Canner JK, Dickersin K, investigators M. Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. J Clin Epidemiol. 2017;86:39-50.
    • (2017) J Clin Epidemiol , vol.86 , pp. 39-50
    • Mayo-Wilson, E.1    Fusco, N.2    Li, T.3    Hong, H.4    Canner, J.K.5    Dickersin, K.6
  • 16
    • 84880737883 scopus 로고    scopus 로고
    • Restrictive vs liberal blood transfusion for acute upper gastrointestinal bleeding: rationale and protocol for a cluster randomized feasibility trial
    • Jairath V, Kahan BC, Gray A, Dore CJ, Mora A, Dyer C, et al. Restrictive vs liberal blood transfusion for acute upper gastrointestinal bleeding: rationale and protocol for a cluster randomized feasibility trial. Transfus Med Rev. 2013;27(3):146-53.
    • (2013) Transfus Med Rev , vol.27 , Issue.3 , pp. 146-153
    • Jairath, V.1    Kahan, B.C.2    Gray, A.3    Dore, C.J.4    Mora, A.5    Dyer, C.6
  • 17
    • 84938508860 scopus 로고    scopus 로고
    • Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial
    • Jairath V, Kahan BC, Gray A, Dore CJ, Mora A, James MW, et al. Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial. Lancet. 2015;386(9989):137-44.
    • (2015) Lancet , vol.386 , Issue.9989 , pp. 137-144
    • Jairath, V.1    Kahan, B.C.2    Gray, A.3    Dore, C.J.4    Mora, A.5    James, M.W.6
  • 18
    • 84880000889 scopus 로고    scopus 로고
    • Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial
    • Kahan BC, Jairath V, Murphy MF, Dore CJ. Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial. Trials. 2013;14:206.
    • (2013) Trials , vol.14 , pp. 206
    • Kahan, B.C.1    Jairath, V.2    Murphy, M.F.3    Dore, C.J.4
  • 19
    • 77949273859 scopus 로고    scopus 로고
    • Methodology for randomized trials of patients with nonvariceal upper gastrointestinal bleeding: recommendations from an international consensus conference
    • Laine L, Spiegel B, Rostom A, Moayyedi P, Kuipers EJ, Bardou M, et al. Methodology for randomized trials of patients with nonvariceal upper gastrointestinal bleeding: recommendations from an international consensus conference. Am J Gastroenterol. 2010;105(3):540-50.
    • (2010) Am J Gastroenterol , vol.105 , Issue.3 , pp. 540-550
    • Laine, L.1    Spiegel, B.2    Rostom, A.3    Moayyedi, P.4    Kuipers, E.J.5    Bardou, M.6
  • 20
    • 77649173768 scopus 로고
    • Longitudinal data analysis using generalized linear models
    • Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13-22.
    • (1986) Biometrika , vol.73 , Issue.1 , pp. 13-22
    • Liang, K.Y.1    Zeger, S.L.2
  • 21
    • 84899908854 scopus 로고    scopus 로고
    • The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies
    • Kahan BC, Jairath V, Dore CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014;15:139.
    • (2014) Trials , vol.15 , pp. 139
    • Kahan, B.C.1    Jairath, V.2    Dore, C.J.3    Morris, T.P.4
  • 22
    • 84880319391 scopus 로고    scopus 로고
    • Propensity scores used for analysis of cluster randomized trials with selection bias: a simulation study
    • Leyrat C, Caille A, Donner A, Giraudeau B. Propensity scores used for analysis of cluster randomized trials with selection bias: a simulation study. Stat Med. 2013;32(19):3357-72.
    • (2013) Stat Med , vol.32 , Issue.19 , pp. 3357-3372
    • Leyrat, C.1    Caille, A.2    Donner, A.3    Giraudeau, B.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.