Side effects are incompletely reported among systematic reviews in gastroenterology

Journal of Clinical Epidemiology

Volumn 68, Issue 2, 2015, Pages 144-153

  Mahady, Suzanne E ^a,b   Schlub, Timothy ^a   Bero, Lisa ^c   Moher, David ^d   Tovey, David ^e   George, Jacob ^b   Craig, Jonathan C ^a,f  

^a UNIVERSITY OF SYDNEY   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^e Cochrane Editorial Unit ^*  (United Kingdom)

^f CHILDREN S HOSPITAL AT WESTMEAD   (Australia)

Author keywords

Adverse events; Gastroenterology; Harms; Meta Analyses; Outcomes reporting bias; Systematic reviews

Indexed keywords

ADVERSE OUTCOME; ARTICLE; DRUG INDUSTRY; GASTROENTEROLOGY; HUMAN; INFLAMMATORY BOWEL DISEASE; IRRITABLE COLON; JOURNAL IMPACT FACTOR; MEDICAL LITERATURE; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK REDUCTION; SYSTEMATIC REVIEW; SYSTEMATIC REVIEW (TOPIC); TREATMENT OUTCOME; ADVERSE DRUG REACTION; INTERVENTION STUDY; LITERATURE; METHODOLOGY; PUBLICATION; PUBLISHING; STANDARDS;

DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GASTROENTEROLOGY; HUMANS; INTERVENTION STUDIES; PERIODICALS AS TOPIC; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; REVIEW LITERATURE AS TOPIC;

EID: 84920658109     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2014.06.016     Document Type: Article

References (53)

1. P.N. Papanikolaou, and J.P. Ioannidis Availability of large-scale evidence on specific harms from systematic reviews of randomized trials Am J Med 117 2004 582 589
2. I. Pitrou, I. Boutron, N. Ahmad, and P. Ravaud Reporting of safety results in published reports of randomized controlled trials Arch Intern Med 169 2009 1756 1761
3. S. Hopewell, L. Wolfenden, and M. Clarke Reporting of adverse events in systematic reviews can be improved: survey results J Clin Epidemiol 61 2008 597 602
4. J.P. Ioannidis Adverse events in randomized trials: neglected, restricted, distorted, and silenced Arch Intern Med 169 2009 1737 1739
5. J.P. Ioannidis, and J. Lau Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas JAMA 285 2001 437 443
6. A.B. Haidich, C. Birtsou, T. Dardavessis, I. Tirodimos, and M. Arvanitidou The quality of safety reporting in trials is still suboptimal: survey of major general medical journals J Clin Epidemiol 64 2011 124 135
7. N.A. Patsopoulos, A.A. Analatos, and J.P. Ioannidis Relative citation impact of various study designs in the health sciences JAMA 293 2005 2362 2366
8. V.M. Montori, N.L. Wilczynski, D. Morgan, R.B. Haynes Hedges Team Systematic reviews: a cross-sectional study of location and citation counts BMC Med 1 2003 2
9. J.J. Kirkham, K.M. Dwan, D.G. Altman, C. Gamble, S. Dodd, and R. Smyth The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews BMJ 340 2010 c365
10. A.W. Chan, A. Hrobjartsson, M.T. Haahr, P.C. Gotzsche, and D.G. Altman Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles JAMA 291 2004 2457 2465
11. A.W. Chan, K. Krleza-Jeric, I. Schmid, and D.G. Altman Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research CMAJ 171 2004 735 740
12. D. Madigan, D.W. Sigelman, J.W. Mayer, C.D. Furberg, and J. Avorn Under-reporting of cardiovascular events in the rofecoxib Alzheimer disease studies Am Heart J 164 2012 186 193
13. I. Chalmers From optimism to disillusion about commitment to transparency in the medico-industrial complex J R Soc Med 99 2006 337 341
14. S.E. Nissen, and K. Wolski Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes [Erratum in: N Engl J Med 2007;357:100] N Engl J Med 356 2007 2457 2471
15. D.J. Graham, D. Campen, R. Hui, M. Spence, C. Cheetham, and G. Levy Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study Lancet 365 2005 475 481
16. J.A. Baron, R.S. Sandler, R.S. Bresalier, A. Lanas, D.G. Morton, and R. Riddell Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial [Erratum in: Lancet 2008;372:1732] Lancet 372 2008 1756 1764
17. J.P. Ioannidis, S.J. Evans, P.C. Gotzsche, R.T. O'Neill, D.G. Altman, and K. Schulz Better reporting of harms in randomized trials: an extension of the CONSORT statement Ann Intern Med 141 2004 781 788
18. A.R. Jadad, D.J. Cook, A. Jones, T.P. Klassen, P. Tugwell, and M. Moher Methodology and reports of systematic reviews and meta-Analyses: a comparison of Cochrane reviews with articles published in paper-based journals JAMA 280 1998 278 280
19. A.W. Jorgensen, J. Hilden, and P.C. Gotzsche Cochrane reviews compared with industry supported meta-Analyses and other meta-Analyses of the same drugs: systematic review BMJ 333 2006 782
20. Y.K. Loke, D. Price, A. Herxheimer Cochrane Adverse Effects Methods Group Systematic reviews of adverse effects: framework for a structured approach BMC Med Res Methodol 7 2007 32
21. R. Chou, R. Fu, S. Carson, S. Saha, and M. Helfand Methodological shortcomings predicted lower harm estimates in one of two sets of studies of clinical interventions J Clin Epidemiol 60 2007 18 28
22. R. Chou, N. Aronson, D. Atkins, A.S. Ismaila, P. Santaguida, and D.H. Smith AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the effective health-care program J Clin Epidemiol 63 2010 502 512
23. A. Liberati, D.G. Altman, J. Tetzlaff, C. Mulrow, P.C. Gøtzsche, and J.P. Ioannidis The PRISMA statement for reporting systematic reviews and meta-Analyses of studies that evaluate health care interventions: explanation and elaboration PLoS Med 6 2009 e1000100
24. D. Moher, D.J. Cook, S. Eastwood, I. Olkin, D. Rennie, and D.F. Stroup Improving the quality of reports of meta-Analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-Analyses Lancet 354 1999 1896 1900
25. Available at http://grants.nih.gov/clinicaltrials-fdaaa/definitions.htm. Accessed November 2013.
26. S. Bent, A. Padula, and A.L. Avins Brief communication: better ways to question patients about adverse medical events: a randomized, controlled trial [Erratum in: Ann Intern Med 2006;145:156] Ann Intern Med 144 2006 257 261
27. I. Ferreira-Gonzalez, G. Permanyer-Miralda, J.W. Busse, P.J. Devereaux, G.H. Guyatt, and P. Alonso-Coello Composite outcomes can distort the nature and magnitude of treatment benefits in clinical trials Ann Intern Med 150 2009 566 567
28. I. Boutron, S. Dutton, P. Ravaud, and D.G. Altman Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes JAMA 303 2010 2058 2064
29. V.M. Montori, R. Jaeschke, H.J. Schunemann, M. Bhandari, J.L. Brozek, and P.J. Devereaux Users' guide to detecting misleading claims in clinical research reports BMJ 329 2004 1093 1096
30. S. Golder, and Y.K. Loke Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies? Br J Clin Pharmacol 66 2008 767 773
31. A. Lundh, S. Sismondo, J. Lexchin, O.A. Busuioc, and L. Bero Industry sponsorship and research outcome Cochrane Database Syst Rev 2012 MR000033
32. J. Lexchin, L.A. Bero, B. Djulbegovic, and O. Clark Pharmaceutical industry sponsorship and research outcome and quality: systematic review BMJ 326 2003 1167 1170
33. A.S. Tunis, M.D. McInnes, R. Hanna, and K. Esmail Association of study quality with completeness of reporting: have completeness of reporting and quality of systematic reviews and meta-Analyses in major radiology journals changed since publication of the PRISMA statement? Radiology 269 2013 413 426
34. K.P. Lee, M. Schotland, P. Bacchetti, and L.A. Bero Association of journal quality indicators with methodological quality of clinical research articles JAMA 287 2002 2805 2808
35. T. Berghmans, A.P. Meert, C. Mascaux, M. Paesmans, J.J. Lafitte, and J.P. Sculier Citation indexes do not reflect methodological quality in lung cancer randomised trials Ann Oncol 14 2003 715 721
36. A.C. Ford, N.J. Talley, P.S. Schoenfeld, E.M. Quigley, and P. Moayyedi Efficacy of antidepressants and psychological therapies in irritable bowel syndrome: systematic review and meta-Analysis Gut 58 2009 367 378
37. S.B. Menees, M. Maneerattannaporn, H.M. Kim, and W.D. Chey The efficacy and safety of rifaximin for the irritable bowel syndrome: a systematic review and meta-Analysis Am J Gastroenterol 107 2012 28 35
38. V. Andresen, V.M. Montori, J. Keller, C.P. West, P. Layer, and M. Camilleri Effects of 5-hydroxytryptamine (serotonin) type 3 antagonists on symptom relief and constipation in nonconstipated irritable bowel syndrome: a systematic review and meta-Analysis of randomized controlled trials Clin Gastroenterol Hepatol 6 2008 545 555
39. B.C. Johnston, S.S. Ma, J.Z. Goldenberg, K. Thorlund, P.O. Vandvik, and M. Loeb Probiotics for the prevention of Clostridium difficile-Associated diarrhea: a systematic review and meta-Analysis Ann Intern Med 157 2012 878 888
40. A.C. Ford, W.J. Sandborn, K.J. Khan, T.A. Ullman, N.J. Talley, and P. Moayyedi Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-Analysis Am J Gastroenterol 106 2011 644 659
41. K.J. Khan, M.C. Dubinsky, A.C. Ford, T.A. Ullman, N.J. Talley, and P. Moayyedi Efficacy of immunosuppressive therapy for inflammatory bowel disease: a systematic review and meta-Analysis Am J Gastroenterol 106 2011 630 642
42. A. Orlando, G. Leandro, M. Olivo, A. Andriulli, and M. Cottone Radiofrequency thermal ablation vs. percutaneous ethanol injection for small hepatocellular carcinoma in cirrhosis: meta-Analysis of randomized controlled trials Am J Gastroenterol 104 2009 514 524
43. R. Tsang, L. Colley, and L.D. Lynd Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials J Clin Epidemiol 62 2009 609 616
44. T. Awad, K. Thorlund, G. Hauser, D. Stimac, M. Mabrouk, and C. Gluud Peginterferon alpha-2a is associated with higher sustained virological response than peginterferon alfa-2b in chronic hepatitis C: systematic review of randomized trials Hepatology 51 2010 1176 1184
45. R.S. Taylor, B.C. Reeves, P.E. Ewings, and R.J. Taylor Critical appraisal skills training for health care professionals: a randomized controlled trial [ISRCTN46272378] BMC Med Educ 4 2004 30
46. N.M. Lai, C.L. Teng, and M.L. Lee Interpreting systematic reviews: are we ready to make our own conclusions? A cross-sectional study BMC Med 9 2011 30
47. L. Zorzela, S. Golder, Y. Liu, K. Pilkington, L. Hartling, and A. Joffe Quality of reporting in systematic reviews of adverse events: systematic review BMJ 348 2014 f7668
48. M. Docherty, and R. Smith The case for structuring the discussion of scientific papers BMJ 318 1999 1224 1225
49. A.C. Tricco, J. Tetzlaff, B. Pham, J. Brehaut, and D. Moher Non-Cochrane vs. Cochrane reviews were twice as likely to have positive conclusion statements: cross-sectional study J Clin Epidemiol 62 2009 380 386.e1
50. A.M. Moseley, M.R. Elkins, R.D. Herbert, C.G. Maher, and C. Sherrington Cochrane reviews used more rigorous methods than non-Cochrane reviews: survey of systematic reviews in physiotherapy J Clin Epidemiol 62 2009 1021 1030
51. A. Delaney, S.M. Bagshaw, A. Ferland, K. Laupland, B. Manns, and C. Doig The quality of reports of critical care meta-Analyses in the Cochrane Database of Systematic Reviews: an independent appraisal Crit Care Med 35 2007 589 594
52. V. Prasad, A. Vandross, C. Toomey, M. Cheung, J. Rho, and S. Quinn A decade of reversal: an analysis of 146 contradicted medical practices Mayo Clin Proc 88 2013 790 798
53. B. Hart, A. Lundh, and L. Bero Effect of reporting bias on meta-Analyses of drug trials: reanalysis of meta-Analyses BMJ 344 2012 d7202