A systematic review of the quality of publications reporting coronary artery bypass grafting trials

Canadian Journal of Surgery

Volumn 50, Issue 4, 2007, Pages 266-277

  Farrokhyar, Forough ^a   Chu, Rong ^b   Whitlock, Richard ^a   Thabane, Lehana ^a,c  

^a MCMASTER UNIVERSITY   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

^c CENTRE FOR EVALUATION OF MEDICINES   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 34548309352     PISSN: 0008428X     EISSN: 14882310     Source Type: Journal    
DOI: None     Document Type: Review

References (77)

1. Parolari A, Alamanni F, Cannata A, et al. Off-pump versus on-pump coronary artery bypass: meta-analysis of currently available randomized trials. Ann Thorac Surg 2003; 76:37-40.
2. van der Heijden GJ, Nathoe HM, Jansen EW, et al. Meta-analysis on the effect of off-pump coronary bypass surgery. Eur J Cardiothorac Surg 2004;26:81-4.
3. Cheng DC, Bainbridge D, Martin JE, et al, Does off-pump coronary artery bypass reduce mortality, morbidity, and resource utilization when compared with conventional coronary artery bypass? A metaanalysis of randomized trials. Anesthesiology 2005;102:188-203.
4. Bath FJ, Owen VE, Bath PM. Quality of full and final publications reporting acute stroke trials: a systematic review. Stroke 1998;29:2203-10.
5. Chan KB, Man-Son-Hing M, Molnar FJ, et al. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. CMAJ 2001;165:1197-202.
6. Ko CY, Sack J, Chang JT, et al. Reporting randomized, controlled trials: where quality of reporting may be improved. Dis Colon Rectum 2002;45:443-7.
7. Thakur A, Wang EC, Chiu TT, et al. Methodology standards associated with quality reporting in clinical studies in pediatric surgery journals. J Pediatr Surg 2001;36:1160-4.
8. Soares HP, Daniels S, Kumar A, 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 2004;328:22-4.
9. Hebert RS, Wright SM, Dittus RS, et al. Prominent medical journals often provide insufficient information to assess the validity of studies with negative results. J Negat Results Biomed 2002;1.1.
10. Altman DG, Moher D, Schulz KF. Peer review of statistics in medical research. Reporting power calculations is important. BMJ 2002;325:491.
11. Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA 1994;272:122-4.
12. Latronico N, Botteri M, Minelli C, et al. Quality of reporting of randomised controlled trials in the intensive care literature. A systematic analysis of papers published in Intensive Care Medicine over 26 years. Intensive Care Med 2002;28:1316-23.
13. Mills E, Loke YK, Wu P, et al. Determining the reporting quality of RCTs in clinical pharmacology. Br J Clin Pharmacol 2004;58:61-5.
14. Alderson P, Green S, Higgins J. Cochrane Reviewers' Handbook 4.2.2. In: Alderson P, Green S, Higgins J, editors. The Cochrane Library, Issue 1. Chichester (UK): John Wiley & Sons Ltd; 2004.
15. Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134: 663-94.
16. Landis JR, Koch GG. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics 1977;33:363-74.
17. Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous out-comes. Biometrics 1986;42:121-30.
18. Horton NJ, Bebchuk JD, Jones CL, et al. Goodness-of-fit for GEE: an example with mental health service utilization. Stat Med 1999;18:213-22.
19. Wan IY, Arifi AA, Wan S, et al. Beating heart revascularization with or without cardiopulmonary bypass: evaluation of inflammatory response in a prospective randomized study. J Thorac Cardiovasc Surg 2004;127:1624-31.
20. Legare JF, Buth KJ, King S, et al. Coronary bypass surgery performed off pump does not result in lower in-hospital morbidity than coronary artery bypass grafting performed on pump. Circulation 2004; 109:887-92.
21. Ahonen J, Sahlman A, Yli-Hankala A, et al. No effect of cardiopulmonary bypass on hypnosis in patients anaesthetized with propofol and alfentanil. Br J Anaesth 2004;92:137-9.
22. Gerola LR, Buffolo E, Jasbik W, et al. Off-pump versus on-pump myocardial revascularization in low-risk patients with one or two vessel disease: perioperative results in a multicenter randomized controlled trial. Ann Thorac Surg 2004;77:569-73.
23. Straka Z, Widimsky P, Jirasek K, et al. Offpump versus on-pump coronary surgery: final results from a prospective randomized study PRAGUE-4. Ann Thorac Surg 2004;77:789-93.
24. Khan NE, De Souza A, Mister R, et al. A randomized comparison of off-pump and on-pump multivessel coronary-artery bypass surgery. N Engl J Med 2004;350:21-8.
25. Dorman BH, Kratz JM, Multani MM, et al. A prospective, randomized study of endothelin and postoperative recovery in offpump versus conventional coronary artery bypass surgery. J Cardiothorac Vasc Anesth 2004;18:25-9.
26. Alwan K, Falcoz PE, Alwan J, et al. Beating versus arrested heart coronary revascularization: evaluation by cardiac troponin I release. Ann Thorac Surg 2004;77:2051-5.
27. Puskas JD, Williams WH, Mahoney EM, et al. Off-pump vs conventional coronary artery bypass grafting: early and 1-year graft patency, cost, and quality-of-life out-comes: a randomized trial. JAMA 2004; 291:1841-9.
28. Gulielmos V, Menschikowski M, Dill H, et al. Interleukin-1, interleukin-6 and myocardial enzyme response after coronary artery bypass grafting-a prospective randomized comparison of the conventional and three minimally invasive surgical techniques. Eur J Cardiothorac Surg 2000; 18:594-601.
29. Baker RA, Andrew MJ, Ross IK, et al. The Octopus II stabilizing system: biochemical and neuropsychological outcomes in coronary artery bypass surgery. Heart Surg Forum 2001;4(Suppl 1):S19-S23.
30. Muneretto C, Bisleri G, Negri A, et al. Off-pump coronary artery bypass surgery technique for total arterial myocardial revascularization: a prospective randomized study. Ann Thorac Surg 2003;76:778-82.
31. Lund C, Hol PK, Lundblad R, et al. Comparison of cerebral embolization during off-pump and on-pump coronary artery bypass surgery. Ann Thorac Surg 2003;76:765-70.
32. Parolari A, Alamanni F, Juliano G, et al. Oxygen metabolism during and after cardiac surgery: role of CPB, Ann Thorac Surg 2003;76:737-43.
33. Lee JD, Lee SJ, Tsushima WT, et al. Benefits of off-pump bypass on neurologic and clinical morbidity: a prospective randomized trial. Ann Thorac Surg 2003; 76:18-25.
34. Penttila HJ, Lepojarvi MV, Kiviluoma KT, et al. Myocardial preservation during coronary surgery with and without cardiopulmonary bypass. Ann Thorac Surg 2001; 71:565-71.
35. Guler M, Kirali K, Toker ME, et al. Different CABG methods in patients with chronic obstructive pulmonary disease. Ann Thorac Surg 2001;71:152-7.
36. Wandschneider W, Thalmann M, Trampitsch E, et al. Off-pump coronary bypass operations significantly reduce S100 release: an indicator for less cerebral damage? Ann Thorac Surg 2000;70:1577-9.
37. Lingaas PS. Clinical and angiographic out-come of coronary surgery with and without cardiopulmonary bypass: a prospective randomized trial. Heart Surg Forum 2004;7:37-41.
38. Ascione R, Lloyd CT, Underwood MJ, et al. Inflammatory response after coronary revascularization with or without cardiopulmonary bypass. Ann Thorac Surg 2000;69:1198-204.
39. Sahlman A, Ahonen J, Nemlander A, et al. Myocardial metabolism on off-pump surgery; a randomized study of 50 cases. Scand Cardiovasc J 2003,57:211-5.
40. Matata BM, Sosnowski AW, Galinanes M. Off-pump bypass graft operation significantly reduces oxidative stress and inflammation. Ann Thorac Surg 2000;69:785-91.
41. Wehlin L, Vedin J, Vaage J, et al. Activation of complement and leukocyte receptors during on- and off pump coronary artery bypass surgery. Eur J Cardiothorac Surg 2004;25:35-42.
42. Wildhirt SM, Schulze C, Schulz C, et al. Reduction of systemic and cardiac adhesion molecule expression after off-pump versus conventional coronary artery bypass grafting. Shock 2001;16(Suppl 1):55-9.
43. Motallebzadeh R, Kanagasabay R, Bland M, et al. S100 protein and its relation to cerebral microemboli in on-pump and off-pump coronary artery bypass surgery. Eur J Cardiothorac Surg 2004;25:409-14.
44. Selvanayagam JB, Petersen SE, Francis JM, et al. Effects of off-pump versus on-pump coronary surgery on reversible and irreversible myocardial injury: a randomized trial using cardiovascular magnetic resonance imaging and biochemical markers. Circulation 2004;109:345-50.
45. Puskas JD, Williams WH, Duke PG, et al. Off-pump coronary artery bypass grafting provides complete revascularization with reduced myocardial injury, transfusion requirements, and length of stay: a prospective randomized comparison of two hundred unselected patients undergoing off-pump versus conventional coronary artery bypass grafting. J Thorac Cardiovasc Surg 2003;125:797-808.
46. Nathoe HM, van Dijk D, Jansen EW, et al. A comparison of on-pump and off-pump coronary bypass surgery in low-risk patients. N Engl J Med 2003;348:394-402.
47. Zamvar V, Williams D, Hall J, et al. Assessment of neurocognitive impairment after off-pump and on-pump techniques for coronary artery bypass graft surgery: prospective randomised controlled trial. BMJ 2002;325:1268.
48. Al Ruzzeh S, Hoare G, Marczin N, et al. Off-pump coronary artery bypass surgery is associated with reduced neutrophil activation as measured by the expression of CD11b: a prospective randomized study. Heart Surg Forum 2003;6:89-93.
49. Tang AT, Knott J, Nanson J, et al. A prospective randomized study to evaluate the renoprotective action of beating heart coronary surgery in low risk patients. Eur J Cardiothorac Surg 2002;22:118-23.
50. Carrier M, Perrault LP, Jeanmart H, et al. Randomized trial comparing off-pump to on-pump coronary artery bypass grafting in high-risk patients. Heart Surg Forum 2003;6:E89-92.
51. van Dijk D, Jansen EW, Hijman R, et al. Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a randomized trial. JAMA 2002;287:1405-12.
52. Lloyd CT, Ascione R, Underwood MJ, et al. Serum S-100 protein release and neuropsychologic outcome during coronary revascularization on the beating heart: a prospective randomized study. J Thorac Cardiovasc Surg 2000;119:148-54.
53. van Dijk D, Nierich AP, Jansen EW, et al. Early outcome after off-pump versus on-pump coronary bypass surgery: results from a randomized study. Circulation 2001;104:1761-6.
54. Czerny M, Baumer H, Kilo J, et al. Complete revascularization in coronary artery bypass grafting with and without cardiopulmonary bypass. Ann Thorac Surg 2001;71:165-9.
55. Ascione R, Caputo M, Calori G, et al. Predictors of atrial fibrillation after conventional and beating heart coronary surgery: A prospective, randomized study. Circulation 2000;102:1530-5.
56. Diegeler A, Hirsch R, Schneider F, et al. Neuromonitoring and neurocognitive outcome in off-pump versus conventional coronary bypass operation. Ann Thorac Surg 2000;69:1162-6.
57. Velissaris T, Tang AT, Murray M, et al. A prospective randomized study to evaluate stress response during beating-heart and conventional coronary revascularization. Ann Thorac Surg 2004;78:506-12.
58. Ascione R, Williams S, Lloyd CT, et al. Reduced postoperative blood loss and transfusion requirement after beating-heart coronary operations: a prospective randomized study. J Thorac Cardiovasc Surg 2001;121:689-96.
59. Caputo M, Yeatman M, Narayan P, et al. Effect of off-pump coronary surgery with right ventricular assist device on organ function and inflammatory response: a randomized controlled trial. Ann Thorac Surg 2002;74:2088-95.
60. Rankin KP, Kochamba GS, Boone KB, et al. Presurgical cognitive deficits in patients receiving coronary artery bypass graft surgery. J Int Neuropsychol Soc 2003;9: 913-24.
61. Celik JB, Gormus N, Topai A, et al. Effect of off-pump and on-pump coronary artery bypass grafting on renal function. Ren Fail 2005;27:183-8.
62. Lund C, Sundet K, Tennoe B, et al. Cerebral ischemic injury and cognitive impairment after off-pump and on-pump coronary artery bypass grafting surgery. Ann Thorac Surg 2005;80:2126-31.
63. Wehlin L, Vedin J, Vaage J, et al. Peripheral blood monocyte activation during coronary artery bypass grafting with or without cardiopulmonary bypass. Scand Cardiovasc J 2005;39:78-86.
64. Parolari A, Mussoni L, Frigerio M, et al. Increased prothrombotic state lasting as long as one month after on-pump and off-pump coronary surgery. J Thorac Cardiovasc Surg 2005;130:303-8.
65. Blacher C, Neumann J, Jung LA, et al. Off-pump coronary artery bypass grafting does not reduce lymphocyte activation. Int J Cardiol 2005;101:473-9.
66. Rastan AJ, Bittner HB, Gummert JF, et al. On-pump beating heart versus off-pump coronary artery bypass surgery-evidence of pump-induced myocardial injury. Eur J Cardiothorac Surg 2005;27:1057-64.
67. Angelini GD, Taylor FC, Reeves BC, et al. Early and midterm outcome after off-pump and on-pump surgery in Beating Heart Against Cardioplegic Arrest Studies (BHACAS 1 and 2): a pooled analysis of two randomised controlled trials. Lancet 2002;359:1194-9.
68. Kobayashi J, Tashiro T, Ochi M, et al. Early outcome of a randomized comparison of off-pump and on-pump multiple arterial coronary revascularization. Circulation 2005;112(9 Suppl):I338-I343.
69. Carey TS. Randomized controlled trials in surgery: an essential component of scientific progress. Spine 1999;24:2553-5.
70. McCulloch P, Taylor I, Sasako M, et al. Randomised trials in surgery: problems and possible solutions. BMJ 2002;324: 1448-51.
71. McLeod RS, Wright JG, Solomon MJ, et al. Randomized controlled trials in surgery: issues and problems. Surgery 1996;119:483-6.
72. Solomon MJ, McLeod RS. Surgery and the randomised controlled trial: past, present and future. Med J Aust 1998;169: 380-3.
73. Devereaux PJ, Bhandari M, Clarke M, et al. Need for expertise based randomised controlled trials. BMJ 2005;330:88.
74. Thoma A, Farrokhyar F, Bhandari M, et al. Users' guide to the surgical literature. How to assess a randomized controlled trial in surgery. Can J Surg 2004;47: 200-8.
75. Nicolucci A, Grilli R, Alexanian AA, et al. Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A lost opportunity for meta-analysis. JAMA 1989; 262:2101-7.
76. Liberati A, Himel HN, Chalmers TC. A quality assessment of randomized control trials of primary treatment of breast cancer. J Clin Oncol 1986;4:942-51.
77. Gotzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clin Trials 1989;10:31-56.