The use and abuse of multiple outcomes in randomized controlled depression trials

Contemporary Clinical Trials

Volumn 32, Issue 2, 2011, Pages 299-304

  Tyler, Kristin M ^a   Normand, Sharon Lise T ^a   Horton, Nicholas J ^a  

^a SMITH COLLEGE   (United States)

Author keywords

Clinical trial; Depression studies; Global tests; Joint models; Multiple outcomes; Multiplicity; Trial registries

Indexed keywords

ARTICLE; CLINICAL TRIAL; DATA ANALYSIS; DEPRESSION; HUMAN; METHODOLOGY; OUTCOME ASSESSMENT;

BIAS (EPIDEMIOLOGY); DEPRESSIVE DISORDER; HUMANS; PSYCHIATRIC STATUS RATING SCALES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; TREATMENT OUTCOME;

EID: 79551561780     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2010.12.007     Document Type: Article

References (42)

1. Pocock S.J., Geller N.L., Tsiatis A.A. The analysis of multiple endpoints in clinical trials. Biometrics 1987, 43:487-498.
2. Sankoh A.J., D'Agostino R.B., Huque M.F. Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoints issues. Stat Med 2003, 22(20):3133-3150.
3. Neuhäuser M. How to deal with multiple endpoints in clinical trials. Fundam Clin Pharmacol 2006, 20(6):515-523.
4. Yoon F, Fitzmaurice GM, Lipsitz SR, Horton NJ, Normand SL. Alternative methods for testing treatment effects on the basis of multiple outcomes: simulation and case study. In revision.
5. Bretz F., Branson M., D'Agostino Multiple Endpoints. The Wiley Encyclopedia of Clinical Trials (Volume 3) 2008, 181-186. Wiley Interscience, Hoboken, NJ. L. Sullivan, J. Massaro (Eds.).
6. Freemantle N., Calvert M., Wood J., Eastaugh J., Griffin C. Composite outcomes in randomized trials: Greater precision but with greater uncertainty?. JAMA 2003, 289(19):2554-2559.
7. Teixeira-Pinto A., Siddique J., Gibbons R., Normand S.L. Statistical approaches to modeling multiple outcomes in psychiatric studies. Psychiatr Ann 2009, 39(7):729-735.
8. Al-Marzouki S., Roberts I., Evans S., Marshall T. Selective reporting in clinical trials: analysis of trial protocols accepted by the Lancet. Lancet 2008, 372(9634):201.
9. Chan A.W., Hrobjartsson A., Haahr M.T., Gotzsche P.C., Altman D.G. Empirical evidence for selective reporting of outcomes in randomized trials. JAMA 2004, 291(20):2457-2465.
10. Turner E.H., Matthews A.M., Linardatos E., Tell R.A., Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008, 358:252-260.
11. Viereck C., Boudes P. An analysis of current pharmaceutical industry practices for making clinical trial results publicly accessible. Contemp Clin Trials 2009, 30(4):293-299.
12. Food and Drug Administration Food and Drug Administration Amendment Act 2007 (FDAAA-2007) 2007, Government Printing Office, Washington, DC.
13. Dartmouth-Hitchcock Medical Center [Online]. c2010 [cited 2010 Nov 29]. Clinical Trials Registration. Available from: http://www.dhmc.org/webpage.cfm?site_id=2&org_id=102&morg_id=0&sec_id=44393&gsec_id=36824&item_id=55844.
14. International Committee of Medical Journal Editors [Online]. c2009 [cited 2010 Nov 29]. Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Available from: http://www.icmje.org/.
15. Simon G.E., VonKorff M., Barlow W. Health care costs of primary care patients with recognized depression. Arch Gen Psychiatry 1995, 52(10):850-856.
16. Radloff L.S. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1977, 1(3):385-401.
17. Beck A.T., Ward C.H., Mendelson M., Mock J.E., Erbaugh J.K. An inventory for measuring depression. Arch Gen Psychiatry 1961, 4:561-571.
18. Beck A.T., Steer R.A., Ball R., Ranieri W. Comparison of Beck Depression Inventories IA and II in psychiatric outpatients. J Pers Assess 1996, 67(3):588-597.
19. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 2009, 23:56-62.
20. Montgomery S.A., Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979, 134:382-389.
21. Lautrette A., Darmon M., Megarbane B., Joly L.M., Chevret S., Adrie C., et al. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med 2007, 356(5):469-478.
22. Harris A.H.S., Reeder R., Hyun J.K. Common statistical and research design problems in manuscripts submitted to high-impact psychiatry journals: what editors and reviewers want authors to know. J Psychiatr Res 2009, 43(15):1231-1234.
23. Bolton P., Bass J., Betancourt T., Speelman L., Onyango G., Clougherty K., et al. Interventions for depression symptoms among adolescent survivors of war and displacement in northern Uganda: a randomized controlled trial. JAMA 2007, 298(5):519-527.
24. Bryant R.A., Mastrodomenico J., Felmingham K., Hopwood S., Kenny L., Kandris E., et al. Treatment of acute stress disorder: a randomized controlled trial. Arch Gen Psychiatry 2008, 65(5):659-667.
25. Eranti S., Mogg A., Pluck G., Landau S., Purvis R., Brown R., et al. A randomized, controlled trial with 6-month follow-up of repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression. Am J Psychiatry 2007, 164(1):73-81.
26. Nurnberg H., Hensley P., Heiman J., Croft H., Debattista C., Paine S. Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial. JAMA 2008, 300(4):395-404.
27. Sultzer D.L., Davis S.M., Tariot P., Dagerman K., Lebowitz B., Lyketsos C., et al. Clinical symptom responses to atypical anti-psychotic medications in Alzheimer's disease: phase 1 outcomes from the CATIE-AD effectiveness trial. Am J Psychiatry 2008, 165(7):844-854.
28. Strong V., Waters R., Hibberd C., Murray G., Wall L., Walker J., et al. Management of depression for people with cancer (SMaRT oncology 1): a randomized trial. Lancet 2008, 372:40-48.
29. Welton A.J., Vickers M.R., Kim J., Ford D., Lawton B.A., MacLennan A.H., et al. Health related quality of life after combined hormone replacement therapy: a randomized controlled trial. BMJ 2008, 337:a1190.
30. Lespérance F., Frasure-Smith N., Koszycki D., Laliberté M., van Zyl L., Baker B., et al. Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial. JAMA 2007, 297(4):367-379.
31. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988, 75(4):800-802.
32. Raskin J., Wiltse C.G., Siegal A., Sheikh J., Xu J., Dinkel J.J., et al. Efficacy of duloxetine on cognitive, depression, and pain in elderly patients with major depressive disorder: an 8-week, double-blind, placebo-controlled trial. Am J Psychiatry 2007, 164(6):900-909.
33. Goldberg J.F., Perlis R.H., Ghaemi S.N., Calabrese J.R., Bowden C.L., Wisniewski S., et al. Adjunctive antidepressant use and symptomatic recovery among bipolar depressed patients with concomitant manic symptoms: findings from the STEP-BD. Am J Psychiatry 2007, 164:1348-1355.
34. Altman D.G., Schulz K.F., Moher D., Egger M., Davidoff F., Elbourne D., et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001, 134(8):663-694.
35. Moher D., Schulz K.F., Altman D.G. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001, 285(15):1987-1991.
36. Schulz K.F., Altman D.G., Moder D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. J Clin Epidemiol 2010, 63(3):834-840.
37. Robinson R.G., Jorge R.E., Moser D.J., Acion L., Solodkin A., Small S.L., et al. Escitalopram and problem-solving therapy for prevention of post stroke depression: a randomized controlled trial. JAMA 2008, 299(20):2391-2400.
38. Schulz K.F., Grimes D.A. Multiplicity in randomized trials 1: endpoints and treatments. Lancet 2005, 365:1348-1353.
39. Millis S.R. Statistical practices: the seven deadly sins. Child Neuropsychol 2003, 9(3):221-233.
40. Rothman K.J., Greenland S. Modern Epidemiology 1998, Lippincott Williams & Wilkins, Philadelphia. 2nd ed.
41. Enhancing the Vitality of the National Institutes of Health. Organizational Change to Meet New Challenges. National Research Council (US) and Institute of Medicine (US) Committee on the Organizational Structure of the National Institutes of Health 2003, National Academies Press (US, Washington (DC.
42. Mathieu S., Boutron I., Moher D., Altman D.G., Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009, 302(9):977-984.