DEPERROR: Risks of systematic errors in drug and non-drug randomized clinical trials assessing intervention effects in patients with unipolar depression

Journal of Affective Disorders

Volumn 179, Issue , 2015, Pages 121-127

  Krogh, Jesper ^a   Hjorthøj, Carsten Rygaard ^a   Jakobsen, Janus Christian ^b   Lindschou, Jane ^b   Kessing, Lars Vedel ^a   Nordentoft, Merete ^a   Gluud, Christian ^b  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b Rigshospitalet   (Denmark)

Author keywords

Bias; Blinding; Depression; Effect estimates; Randomized clinical trials; Trial characteristics

Indexed keywords

ANTIDEPRESSANT AGENT;

COMORBIDITY; DRUG SCREENING; FOLLOW UP; FUNDING; GEOGRAPHIC DISTRIBUTION; HEALTH CARE PERSONNEL; HUMAN; INTENTION TO TREAT ANALYSIS; MAJOR DEPRESSION; METHODOLOGY; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROFESSIONAL STANDARD; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK; SYSTEMATIC ERROR; THERAPY EFFECT; DEPRESSION; PROCEDURES; STANDARDS; STATISTICAL BIAS;

BIAS (EPIDEMIOLOGY); DEPRESSION; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RISK;

EID: 84926431618     PISSN: 01650327     EISSN: 15732517     Source Type: Journal    
DOI: 10.1016/j.jad.2015.03.042     Document Type: Review

References (31)

1. American Pscyhiatric Association 2010. Treatment of patients with major depressive disorder. 〈https://psychiatryonline.org/guidelines〉.
2. G. Andrews, G. Henderson, and W. Hall Prevalence, comorbidity, disability and service utilisation: overview of the Australian National Mental Health Survey Br. J. Psychiatry 178 2001 145 153
3. M. Bauer, A. Pfennig, E. Severus, P.C. Whybrow, J. Angst, and H.J. Moller World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of unipolar depressive disorders, Part 1: Update 2013 on the acute and continuation treatment of unipolar depressive disorders World J. Biol. Psychiatry 14 2013 334 385
4. L. Bero Industry sponsorship and research outcome: a Cochrane review JAMA Intern. Med. 173 2013 580 581
5. L. Bero Why the Cochrane risk of bias tool should include funding source as a standard item (editorial) Cochrane Database Syst. Rev. 12 2013 ED000075
6. D.G. Blazer, R.C. Kessler, K.A. McGonagle, and M.S. Swartz The prevalence and distribution of major depression in a national community sample: The National Comorbidity Survey Am. J. Psychiatry 7 1994 979 986
7. A. Cipriani, L. Malvini, T.A. Furukawa, and C. Barbui Relationship between quality of reports of antidepressant randomized controlled trials and treatment estimates: systematic review, meta-analysis, and meta-regression analysis J. Clin. Psychopharmacol. 27 2007 352 356
8. G.M. Cooney, K. Dwan, C.A. Greig, D.A. Lawlor, J. Rimer, F.R. Waugh, M. McMurdo, and G.E. Mead Exercise for depression Cochrane Database Syst. Rev. 9 2013 CD004366
9. P. Gøtzsche Comments on the Jonathan Sterne Editorial on bias and funding source Cochrane Database Syst. Rev. 2013 10.1002/14651858.ED000076
10. P.E. Greenberg, R.C. Kessler, H.G. Birnbaum, S.A. Leong, S.W. Lowe, P.A. Berglund, and P.K. Corey-Lisle The economic burden of depression in the United States: how did it change between 1990 and 2000 J. Clin. Psychiatry 64 2003 1465 1475
11. R.P. Greenberg, R.F. Bornstein, M.D. Greenberg, and S. Fisher A meta-analysis of antidepressant outcome under "blinder" conditions J. Consult. Clin. Psychol. 60 1992 664 669
12. M. Haahr, and A. Hrobjartsson Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors Clin. Trials 3 2006 360 365
13. Higgins, J.P.T., Green S. (editors). 2011. Cochrane Handbook for Systematic Reviews of Interventions. 〈http://community.cochrane.org/handbook〉.
14. T. Hoffmann, T. English, and P. Glasziou Reporting of interventions in randomised trials: an audit of journal instructions to authors Trials 15 2014 20 10.1186/1745-6215-15-20
15. J. Howick, C. Friedemann, M. Tsakok, R. Watson, T. Tsakok, J. Thomas, R. Perera, S. Fleming, and C. Heneghan Are treatments more effective than placebos? A systematic review and meta-analysis PLoS One 8 5 2013 e62599
16. J. Jakobsen, and C. Gluud The necessity of randomized clinical trials Br. J. Med. Med. Res. 3 2013 1453 1468
17. L.L. Kjaergard, and C. Gluud Funding, disease area, and internal validity of hepatobiliary randomized clinical trials Am. J. Gastroenterol. 97 2002 2708 2713
18. H. Knuppel, C. Metz, J.J. Meerpohl, and D. Strech How psychiatry journals support the unbiased translation of clinical research. A cross-sectional study of editorial policies PLoS One 8 2013 e75995
19. A. Lundh, S. Sismondo, J. Lexchin, O.A. Busuioc, and L. Bero Industry sponsorship and research outcome Cochrane Database Syst. Rev. 12 2012 MR000033
20. H.J. Moller, I. Bitter, J. Bobes, K. Fountoulakis, C. Hoschl, and S. Kasper Position statement of the European Psychiatric Association (EPA) on the value of antidepressants in the treatment of unipolar depression Eur. Psychiatry 27 2012 114 128
21. J. Moncrieff, S. Wessely, and R. Hardy Active placebos versus antidepressants for depression Cochrane Database. Syst. Rev. 2004 CD003012
22. National Institute of Clinical Excellence 2009. Depression in adults. The Treatment and Management of Depression in Adults. 〈https://www.nice.org.uk/nicemedia/live/12329/45888/45888.pdf〉.
23. E. Nuesch, S. Trelle, S. Reichenbach, A.W. Rutjes, E. Burgi, M. Scherer, D.G. Altman, and P. Juni The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study BMJ 339 2009 b3244
24. J. Pildal, A. Hrobjartsson, K.J. Jorgensen, J. Hilden, D.G. Altman, and P.C. Gotzsche Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials Int. J. Epidemiol. 36 2007 847 857
25. J. Savovic, H. Jones, D. Altman, R. Harris, P. Juni, J. Pildal, B. Als-Nielsen, E. Balk, C. Gluud, L. Gluud, J. Ioannidis, K. Schulz, R. Beynon, N. Welton, L. Wood, D. Moher, J. Deeks, and J. Sterne Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials: combined analysis of meta-epidemiological studies Health Technol. Assess. 16 2012 1 82
26. J. Savovic, H.E. Jones, D.G. Altman, R.J. Harris, P. Juni, J. Pildal, B. Als-Nielsen, E.M. Balk, C. Gluud, L.L. Gluud, J.P. Ioannidis, K.F. Schulz, R. Beynon, N.J. Welton, L. Wood, D. Moher, J.J. Deeks, and J.A. Sterne Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials Ann. Intern. Med. 157 2012 429 438
27. V. Siersma, B. Als-Nielsen, w. Chen, J. Hilden, L. Gluud, and C. Gluud Multivariable modelling for meta-epidemiological assessment of the association between trial quality and treatment effects estimated in randomized clinical trials Stat. Med. 26 2006 2745 2758
28. D. Spaner, R.C. Bland, and S.C. Newman Major depressive disorder Acta Pscyhiatr. Scand. Suppl. 376 1994 7 15
29. J. Sterne Why the Cochrane risk of bias tool should not include funding source as a standard item (editorial) Cochrane Database Syst. Rev 20 2013
30. E.H. Turner, A.M. Matthews, E. Linardatos, R.A. Tell, and R. Rosenthal Selective publication of antidepressant trials and its influence on apparent efficacy N. Engl. J. Med. 358 2008 252 260
31. L. Wood, M. Egger, L. Gluud, K. Schulz, P. Jüni, D. Altman, C. Gluud, R. Martin, A. Wood, and J. Sterne Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study BMJ 336 2008 601 605