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Volumn 62, Issue 7, 2009, Pages 695-702

Inadequate planning and reporting of adjudication committees in clinical trials: Recommendation proposal

Author keywords

Adjudication committee; Classification bias; Clinical event committee; Endpoint committee; Randomized controlled trials; Recommendations

Indexed keywords

CLASSIFICATION; MEDICAL LITERATURE; METHODOLOGY; PLANNING; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK FACTOR;

EID: 67349170300     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2008.09.011     Document Type: Review
Times cited : (47)

References (32)
  • 1
    • 0036480190 scopus 로고    scopus 로고
    • Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second platelet IIb/IIIa antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial
    • Mahaffey K.W., Roe M.T., Dyke C.K., Newby L.K., Kleiman N.S., Connolly P., et al. Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second platelet IIb/IIIa antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial. Am Heart J 143 (2002) 242-248
    • (2002) Am Heart J , vol.143 , pp. 242-248
    • Mahaffey, K.W.1    Roe, M.T.2    Dyke, C.K.3    Newby, L.K.4    Kleiman, N.S.5    Connolly, P.6
  • 4
    • 0029093425 scopus 로고
    • Surveillance and ascertainment of cardiovascular events. The Cardiovascular Health Study
    • Ives D.G., Fitzpatrick A.L., Bild D.E., Psaty B.M., Kuller L.H., Crowley P.M., et al. Surveillance and ascertainment of cardiovascular events. The Cardiovascular Health Study. Ann Epidemiol 5 (1995 Jul) 278-285
    • (1995) Ann Epidemiol , vol.5 , pp. 278-285
    • Ives, D.G.1    Fitzpatrick, A.L.2    Bild, D.E.3    Psaty, B.M.4    Kuller, L.H.5    Crowley, P.M.6
  • 5
    • 3042782723 scopus 로고    scopus 로고
    • Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial
    • Ferguson J.J., Califf R.M., Antman E.M., Cohen M., Grines C.L., Goodman S., et al. Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA 292 (2004) 45-54
    • (2004) JAMA , vol.292 , pp. 45-54
    • Ferguson, J.J.1    Califf, R.M.2    Antman, E.M.3    Cohen, M.4    Grines, C.L.5    Goodman, S.6
  • 6
    • 0033135701 scopus 로고    scopus 로고
    • The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial: results with and without the end-point committee's final decision on end-points
    • Naslund U., Grip L., Fischer-Hansen J., Gundersen T., Lehto S., and Wallentin L. The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial: results with and without the end-point committee's final decision on end-points. Eur Heart J 20 (1999 May) 771-777
    • (1999) Eur Heart J , vol.20 , pp. 771-777
    • Naslund, U.1    Grip, L.2    Fischer-Hansen, J.3    Gundersen, T.4    Lehto, S.5    Wallentin, L.6
  • 7
    • 17944380212 scopus 로고    scopus 로고
    • Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study
    • Mahaffey K.W., Harrington R.A., Akkerhuis M., Kleiman N.S., Berdan L.G., Crenshaw B.S., et al. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study. Curr Control Trials Cardiovasc Med 2 (2001) 187-194
    • (2001) Curr Control Trials Cardiovasc Med , vol.2 , pp. 187-194
    • Mahaffey, K.W.1    Harrington, R.A.2    Akkerhuis, M.3    Kleiman, N.S.4    Berdan, L.G.5    Crenshaw, B.S.6
  • 9
    • 0037024301 scopus 로고    scopus 로고
    • Association of journal quality indicators with methodological quality of clinical research articles
    • Lee K.P., Schotland M., Bacchetti P., and Bero L.A. Association of journal quality indicators with methodological quality of clinical research articles. JAMA 287 (2002) 2805-2808
    • (2002) JAMA , vol.287 , pp. 2805-2808
    • Lee, K.P.1    Schotland, M.2    Bacchetti, P.3    Bero, L.A.4
  • 10
    • 23044436673 scopus 로고    scopus 로고
    • The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement
    • Mills E.J., Wu P., Gagnier J., and Devereaux P.J. The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp Clin Trials 26 (2005 Aug) 480-487
    • (2005) Contemp Clin Trials , vol.26 , pp. 480-487
    • Mills, E.J.1    Wu, P.2    Gagnier, J.3    Devereaux, P.J.4
  • 11
    • 20444394060 scopus 로고    scopus 로고
    • An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently
    • Mills E., Wu P., Gagnier J., Heels-Ansdell D., and Montori V.M. An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently. J Clin Epidemiol 58 (2005) 662-667
    • (2005) J Clin Epidemiol , vol.58 , pp. 662-667
    • Mills, E.1    Wu, P.2    Gagnier, J.3    Heels-Ansdell, D.4    Montori, V.M.5
  • 12
    • 33750877515 scopus 로고    scopus 로고
    • Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review reporting methods of blinding in randomized trials assessing nonpharmacological treatments
    • Boutron I., Estellat C., Guittet L., Dechartres A., Sackett D.L., Hrobjartsson A., et al. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 3 (2006) e425
    • (2006) PLoS Med , vol.3
    • Boutron, I.1    Estellat, C.2    Guittet, L.3    Dechartres, A.4    Sackett, D.L.5    Hrobjartsson, A.6
  • 13
    • 33847658810 scopus 로고    scopus 로고
    • Reporting methods of blinding in randomized trials assessing nonpharmacological treatments
    • Boutron I., Guittet L., Estellat C., Moher D., Hrobjartsson A., and Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 4 (2007) e61
    • (2007) PLoS Med , vol.4
    • Boutron, I.1    Guittet, L.2    Estellat, C.3    Moher, D.4    Hrobjartsson, A.5    Ravaud, P.6
  • 14
    • 3042793005 scopus 로고    scopus 로고
    • Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials
    • Boutron I., Tubach F., Giraudeau B., and Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol 57 (2004) 543-550
    • (2004) J Clin Epidemiol , vol.57 , pp. 543-550
    • Boutron, I.1    Tubach, F.2    Giraudeau, B.3    Ravaud, P.4
  • 16
    • 0035906296 scopus 로고    scopus 로고
    • Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials
    • Devereaux P.J., Manns B.J., Ghali W.A., Quan H., Lacchetti C., Montori V.M., et al. Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials. JAMA 285 (2001) 2000-2003
    • (2001) JAMA , vol.285 , pp. 2000-2003
    • Devereaux, P.J.1    Manns, B.J.2    Ghali, W.A.3    Quan, H.4    Lacchetti, C.5    Montori, V.M.6
  • 18
    • 0031079743 scopus 로고    scopus 로고
    • Outcome assessment for clinical trials: how many adjudicators do we need? Canadian Lung Oncology Group
    • Walter S.D., Cook D.J., Guyatt G.H., King D., and Troyan S. Outcome assessment for clinical trials: how many adjudicators do we need? Canadian Lung Oncology Group. Control Clin Trials 18 (1997) 27-42
    • (1997) Control Clin Trials , vol.18 , pp. 27-42
    • Walter, S.D.1    Cook, D.J.2    Guyatt, G.H.3    King, D.4    Troyan, S.5
  • 19
    • 4344661128 scopus 로고    scopus 로고
    • Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial
    • Schnitzer T.J., Burmester G.R., Mysler E., Hochberg M.C., Doherty M., Ehrsam E., et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet 364 (2004) 665-674
    • (2004) Lancet , vol.364 , pp. 665-674
    • Schnitzer, T.J.1    Burmester, G.R.2    Mysler, E.3    Hochberg, M.C.4    Doherty, M.5    Ehrsam, E.6
  • 20
    • 0037439493 scopus 로고    scopus 로고
    • A prospective cohort study determining the prevalence of thrombotic events in children with acute lymphoblastic leukemia and a central venous line who are treated with L-asparaginase: results of the prophylactic antithrombin replacement in kids with acute lymphoblastic leukemia treated with asparaginase (PARKAA) study
    • Mitchell L.G., Andrew M., Hanna K., Abshire T., Halton J., Anderson R., et al. A prospective cohort study determining the prevalence of thrombotic events in children with acute lymphoblastic leukemia and a central venous line who are treated with L-asparaginase: results of the prophylactic antithrombin replacement in kids with acute lymphoblastic leukemia treated with asparaginase (PARKAA) study. Cancer 97 (2003) 508-516
    • (2003) Cancer , vol.97 , pp. 508-516
    • Mitchell, L.G.1    Andrew, M.2    Hanna, K.3    Abshire, T.4    Halton, J.5    Anderson, R.6
  • 21
    • 26244453309 scopus 로고    scopus 로고
    • Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial
    • Dormandy J.A., Charbonnel B., Eckland D.J., Erdmann E., Massi-Benedetti M., Moules I.K., et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 366 (2005) 1279-1289
    • (2005) Lancet , vol.366 , pp. 1279-1289
    • Dormandy, J.A.1    Charbonnel, B.2    Eckland, D.J.3    Erdmann, E.4    Massi-Benedetti, M.5    Moules, I.K.6
  • 22
    • 0037964755 scopus 로고    scopus 로고
    • Multicenter evaluation of the reproducibility of the proposed antifungal susceptibility testing method for fermentative yeasts of the antifungal susceptibility testing subcommittee of the European committee on antimicrobial susceptibility testing (AFST-EUCAST)
    • Cuenca-Estrella M., Moore C.B., Barchiesi F., Bille J., Chryssanthou E., Denning D.W., et al. Multicenter evaluation of the reproducibility of the proposed antifungal susceptibility testing method for fermentative yeasts of the antifungal susceptibility testing subcommittee of the European committee on antimicrobial susceptibility testing (AFST-EUCAST). Clin Microbiol Infect 9 (2003) 467-474
    • (2003) Clin Microbiol Infect , vol.9 , pp. 467-474
    • Cuenca-Estrella, M.1    Moore, C.B.2    Barchiesi, F.3    Bille, J.4    Chryssanthou, E.5    Denning, D.W.6
  • 23
    • 33646180879 scopus 로고    scopus 로고
    • Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee
    • Petersen J.L., Haque G., Hellkamp A.S., Flaker G.C., Mark Estes III N.A., Marchlinski F.E., et al. Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee. Contemp Clin Trials 27 (2006) 260-268
    • (2006) Contemp Clin Trials , vol.27 , pp. 260-268
    • Petersen, J.L.1    Haque, G.2    Hellkamp, A.S.3    Flaker, G.C.4    Mark Estes III, N.A.5    Marchlinski, F.E.6
  • 28
    • 1842867053 scopus 로고    scopus 로고
    • Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial
    • Anderson G.L., Limacher M., Assaf A.R., Bassford T., Beresford S.A., Black H., et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 291 (2004) 1701-1712
    • (2004) JAMA , vol.291 , pp. 1701-1712
    • Anderson, G.L.1    Limacher, M.2    Assaf, A.R.3    Bassford, T.4    Beresford, S.A.5    Black, H.6
  • 29
    • 13444309949 scopus 로고    scopus 로고
    • Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial
    • Albers G.W., Diener H.C., Frison L., Grind M., Nevinson M., Partridge S., et al. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA 293 (2005) 690-698
    • (2005) JAMA , vol.293 , pp. 690-698
    • Albers, G.W.1    Diener, H.C.2    Frison, L.3    Grind, M.4    Nevinson, M.5    Partridge, S.6
  • 30
    • 0041694480 scopus 로고    scopus 로고
    • Ximelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: Rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V)
    • Halperin J.L. Ximelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: Rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V). Am Heart J 146 (2003) 431-438
    • (2003) Am Heart J , vol.146 , pp. 431-438
    • Halperin, J.L.1
  • 31
    • 0346688601 scopus 로고    scopus 로고
    • Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group
    • Soares H.P., Daniels S., Kumar A., Clarke M., Scott C., Swann S., et al. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ 328 (2004) 22-24
    • (2004) BMJ , vol.328 , pp. 22-24
    • Soares, H.P.1    Daniels, S.2    Kumar, A.3    Clarke, M.4    Scott, C.5    Swann, S.6
  • 32
    • 23044457478 scopus 로고    scopus 로고
    • A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases
    • Eliakim R., Sharma V.K., Yassin K., Adler S.N., Jacob H., Cave D.R., et al. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol 39 (2005) 572-578
    • (2005) J Clin Gastroenterol , vol.39 , pp. 572-578
    • Eliakim, R.1    Sharma, V.K.2    Yassin, K.3    Adler, S.N.4    Jacob, H.5    Cave, D.R.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.