Social Psychiatry and Psychiatric Epidemiology

, Volume 48, Issue 6, pp 975–984

Influence of sociodemographic and socioeconomic features on treatment outcome in RCTs versus daily psychiatric practice

  • R. van der Lem
  • P. M. Stamsnieder
  • N. J. A. van der Wee
  • T. van Veen
  • F. G. Zitman
Original Paper

Abstract

Purpose

Sociodemographic and socioeconomic characteristics of participants in antidepressant and psychotherapy efficacy trials (AETs and PETs) for major depressive disorder (MDD) may limit the generalizability of the results. We compared trial participants with daily practice patients. We subsequently assessed the influence of socio-demographic and socioeconomic status on treatment outcome in daily practice.

Methods

Data on daily practice patients were derived through routine outcome monitoring (ROM). We included 626 patients with MDD according to the MINIplus. Distributions of age, gender, race, marital status and employment status were compared with participants in 63 selected AETs and PETs. Influence of these features on treatment outcome was explored through multivariate regression analysis.

Results

Trial participants were older, more often male (diff. 4 %, p = 0.05), white (diff. 4 %, p < 0.001) and not married (diff. 7 %, p = 0.003). Although significant, most differences were relatively small. However, the difference in employment status was striking: 34 % of the ROM patients were currently working versus 68 % of the trial participants (diff. 34 %, p < 0.001). Being employed contributed to a positive treatment outcome: OR 1.8 for response [50 % reduction of Montgomery Asberg Rating Scale for Depression (MADRS)], OR 1.9 for remission (MADRS ≤10).

Conclusions

Employment status should be taken into account while interpreting results from randomized controlled trials and as predictor of treatment success in daily practice.

Keywords

Major depressive disorder Randomized controlled trial Sociodemographic status Socioeconomic status Patient selection 

Supplementary material

127_2012_624_MOESM1_ESM.doc (37 kb)
Supplementary material 1 (DOC 37 kb)

References

  1. 1.
    Rothwell PM (2005) External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet 365:82–93PubMedCrossRefGoogle Scholar
  2. 2.
    Wells KB (1999) Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research. Am J Psychiatry 156:5–10PubMedGoogle Scholar
  3. 3.
    Tunis SR, Stryer DB, Clancy CM (2003) Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 290:1624–1632PubMedCrossRefGoogle Scholar
  4. 4.
    Mulder RT, Frampton C, Joyce PR, Porter R (2003) Randomized controlled trials in psychiatry. Part II: their relationship to clinical practice. Aust N Z J Psychiatry 37:265–269PubMedCrossRefGoogle Scholar
  5. 5.
    Licht RW, Gouliaev G, Vestergaard P, Frydenberg M (1997) Generalisability of results from randomised drug trials. A trial on antimanic treatment. Br J Psychiatry 170:264–267PubMedCrossRefGoogle Scholar
  6. 6.
    Stewart JW, McGrath PJ, Quitkin FM (1992) Can mildly depressed outpatients with atypical depression benefit from antidepressants? Am J Psychiatry 149:615–619PubMedGoogle Scholar
  7. 7.
    Moller HJ (2011) How close is evidence to truth in evidence-based treatment of mental disorders? Eur Arch Psychiatry Clin NeurosciGoogle Scholar
  8. 8.
    Zimmerman M, Mattia JI, Posternak MA (2002) Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? Am J Psychiatry 159:469–473PubMedCrossRefGoogle Scholar
  9. 9.
    Wisniewski SR, Rush AJ, Nierenberg AA, Gaynes BN, Warden D, Luther JF et al (2009) Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report. Am J Psychiatry 166:599–607PubMedCrossRefGoogle Scholar
  10. 10.
    Zetin M, Hoepner CT (2007) Relevance of exclusion criteria in antidepressant clinical trials: a replication study. J Clin Psychopharmacol 27:295–301PubMedCrossRefGoogle Scholar
  11. 11.
    van der Lem R, van der Wee NJ, van Veen T, Zitman FG (2011) The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice. Psychol Med 41:1353–1363PubMedCrossRefGoogle Scholar
  12. 12.
    Button KS, Wiles NJ, Lewis G, Peters TJ, Kessler D (2012) Factors associated with differential response to online cognitive behaviavoural therapy. Soc Psychiatry Psychiatr Epidemiol 47:827–833PubMedCrossRefGoogle Scholar
  13. 13.
    Aberg-Wistedt A, Agren H, Ekselius L, Bengtsson F, Akerblad AC (2000) Sertraline versus paroxetine in major depression: clinical outcome after six months of continuous therapy. J Clin Psychopharmacol 20:645–652PubMedCrossRefGoogle Scholar
  14. 14.
    Kornstein SG, Schatzberg AF, Thase ME, Yonkers KA, McCullough JP, Keitner GI et al (2000) Gender differences in treatment response to sertraline versus imipramine in chronic depression. Am J Psychiatry 157:1445–1452PubMedCrossRefGoogle Scholar
  15. 15.
    Joyce PR, Mulder RT, Luty SE, Sullivan PF, McKenzie JM, Abbott RM et al (2002) Patterns and predictors of remission, response and recovery in major depression treated with fluoxetine or nortriptyline. Aust N Z J Psychiatry 36:384–391PubMedCrossRefGoogle Scholar
  16. 16.
    Papakostas GI, Petersen T, Mischoulon D, Hughes ME, Spector AR, Alpert JE et al (2003) Functioning and interpersonal relationships as predictors of response in treatment-resistant depression. Compr Psychiatry 44:44–50PubMedCrossRefGoogle Scholar
  17. 17.
    Baca E, Garcia-Garcia M, Porras-Chavarino A (2004) Gender differences in treatment response to sertraline versus imipramine in patients with nonmelancholic depressive disorders. Prog Neuropsychopharmacol Biol Psychiatry 28:57–65PubMedCrossRefGoogle Scholar
  18. 18.
    Lowe B, Schenkel I, Bair MJ, Gobel C (2005) Efficacy, predictors of therapy response, and safety of sertraline in routine clinical practice: prospective, open-label, non-interventional postmarketing surveillance study in 1878 patients. J Affect Disord 87:271–279PubMedCrossRefGoogle Scholar
  19. 19.
    Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L et al (2006) Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry 163:28–40PubMedCrossRefGoogle Scholar
  20. 20.
    Jarrett RB, Eaves GG, Grannemann BD, Rush AJ (1991) Clinical, cognitive, and demographic predictors of response to cognitive therapy for depression: a preliminary report. Psychiatry Res 37:245–260PubMedCrossRefGoogle Scholar
  21. 21.
    Sotsky SM, Glass DR, Shea MT, Pilkonis PA, Collins JF, Elkin I et al (1991) Patient predictors of response to psychotherapy and pharmacotherapy: findings in the NIMH Treatment of Depression Collaborative Research Program. Am J Psychiatry 148:997–1008PubMedGoogle Scholar
  22. 22.
    Thase ME, Reynolds CF III, Frank E, Simons AD, McGeary J, Fasiczka AL et al (1994) Do depressed men and women respond similarly to cognitive behavior therapy? Am J Psychiatry 151:500–505PubMedGoogle Scholar
  23. 23.
    Hatcher S (2008) The STAR*D trial: the 300 lb gorilla is in the room, but does it block all the light? Evid Based Ment Health 11:97–99PubMedCrossRefGoogle Scholar
  24. 24.
    Percevic R, Lambert MJ, Kordy H (2004) Computer-supported monitoring of patient treatment response. J Clin Psychol 60:285–299PubMedCrossRefGoogle Scholar
  25. 25.
    Lem RVD, Stamsnieder P, Wee NVD, Veen TV, Zitman FG (eds) Socio-demographic features in randomized controlled trials for major depression: generalizability and individualization. Int J Person Cent Med 1:268–278Google Scholar
  26. 26.
    Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E et al (1998) The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 59(Suppl 20):22–33PubMedGoogle Scholar
  27. 27.
    de Beurs E, den Hollander-Gijsman ME, van Rood YR, van der Wee NJ, Giltay EJ, van Noorden MS et al (2011) Routine outcome monitoring in the Netherlands: practical experiences with a web-based strategy for the assessment of treatment outcome in clinical practice. Clin Psychol Psychother 18:1–12PubMedCrossRefGoogle Scholar
  28. 28.
    Asberg M, Montgomery SA, Perris C, Schalling D, Sedvall G (1978) A comprehensive psychopathological rating scale. Acta Psychiatr Scand Suppl 5–27Google Scholar
  29. 29.
    Altman DG (1991) Practical statistics for medical Research. Chapman and Hall/CRC, London, pp 229–276Google Scholar
  30. 30.
    Donders AR, van der Heijden GJ, Stijnen T, Moons KG (2006) Review: a gentle introduction to imputation of missing values. J Clin Epidemiol 59:1087–1091PubMedCrossRefGoogle Scholar
  31. 31.
    Royston P (2005) Multiple imputation of missing values: update. Stata J 5:188–201Google Scholar
  32. 32.
    Hollon SD, Derubeis RJ, Evans MD, Wiemer MJ, Garvey MJ, Grove WM et al (1992) Cognitive therapy and pharmacotherapy for depression. Singly and in combination. Arch Gen Psychiatry 49:774–781PubMedCrossRefGoogle Scholar
  33. 33.
    Falconnier L (2009) Socioeconomic status in the treatment of depression. Am J Orthopsychiatry 79:148–158PubMedCrossRefGoogle Scholar
  34. 34.
    Goekoop JG, Hoeksema T, Knoppert-Van der Klein EA, Klinkhamer RA, Van Gaalen HA, Van Londen L et al (1992) Multidimensional ordering of psychopathology. A factor-analytic study using the Comprehensive Psychopathological Rating Scale. Acta Psychiatr Scand 86:306–312PubMedCrossRefGoogle Scholar
  35. 35.
    Van HL, Schoevers RA, Dekker J (2008) Predicting the outcome of antidepressants and psychotherapy for depression: a qualitative, systematic review. Harv Rev Psychiatry 16:225–234PubMedCrossRefGoogle Scholar
  36. 36.
    Butterworth P, Leach LS, Pirkis J, Kelaher M (2012) Poor mental health influences risk and duration of unemployment: a prospective study. Soc Psychiatry Psychiatr Epidemiol 47:1013–1021PubMedCrossRefGoogle Scholar
  37. 37.
    Posternak MA, Zimmerman M, Keitner GI, Miller IW (2002) A reevaluation of the exclusion criteria used in antidepressant efficacy trials. Am J Psychiatry 159:191–200PubMedCrossRefGoogle Scholar
  38. 38.
    van der Lem R, de Wever WW, van der Wee NJ, van VT, Cuijpers P, Zitman FG (2012) The generalizability of psychotherapy efficacy trials in major depressive disorder: an analysis of the influence of patient selection in efficacy trials on symptom outcome in daily practice. BMC Psychiatry 12:192Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • R. van der Lem
    • 1
    • 3
  • P. M. Stamsnieder
    • 2
  • N. J. A. van der Wee
    • 1
    • 4
  • T. van Veen
    • 1
  • F. G. Zitman
    • 1
  1. 1.Department of PsychiatryLeiden University Medical Center/RivierduinenLeidenThe Netherlands
  2. 2.Kern HuisartsenpraktijkenDuivenThe Netherlands
  3. 3.Het DokRotterdamThe Netherlands
  4. 4.Leiden Institute for Brain and CognitionLeidenThe Netherlands

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