What is the threshold for a clinically relevant effect? the case of major depressive disorders

Pim Cuijpers, Erick Turner, Sander L. Koole, Annemiek Van Dijke, Filip Smit

Research output: Contribution to journalReview article

48 Citations (Scopus)

Abstract

Background Randomized trials can show whether a treatment effect is statistically significant and can describe the size of the effect. There are, however, no validated methods available for establishing the clinical relevance of these outcomes. Recently, it was proposed that a standardized mean difference (SMD) of 0.50 be used as cutoff for clinical relevance in the treatment of depression. Methods We explore what the effect size means and why the size of an effect has little bearing on its clinical relevance. We will also examine how the "minimally important difference," as seen from the patient perspective, may be helpful in deciding where the cutoff for clinical relevance should be placed for a given condition. Results Effect sizes in itself cannot give an indication of the clinical relevance of an intervention because the outcome itself determines the clinical relevance and not only the size of the effects. The "minimal important difference" (MID) could be used as a starting point for pinpointing the cutoff for clinical relevance. A first, rough attempt to implement this approach for depression resulted in a tentative clinical relevance cutoff of SMD = 0.24. Using this cutoff, psychotherapy, pharmacotherapy, and combined treatment have effect sizes above this cutoff. Discussion Statistical outcomes cannot be equated with clinical relevance. The "MID" may be used for pinpointing the cutoff for clinical relevance, but more work in this area is needed.

Original languageEnglish (US)
Pages (from-to)374-378
Number of pages5
JournalDepression and Anxiety
Volume31
Issue number5
DOIs
StatePublished - 2014

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Major Depressive Disorder
Depression
Psychotherapy
Therapeutics
Drug Therapy

Keywords

  • clinical relevance
  • depression
  • effect size
  • minimal important difference

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology
  • Medicine(all)

Cite this

What is the threshold for a clinically relevant effect? the case of major depressive disorders. / Cuijpers, Pim; Turner, Erick; Koole, Sander L.; Van Dijke, Annemiek; Smit, Filip.

In: Depression and Anxiety, Vol. 31, No. 5, 2014, p. 374-378.

Research output: Contribution to journalReview article

Cuijpers, Pim ; Turner, Erick ; Koole, Sander L. ; Van Dijke, Annemiek ; Smit, Filip. / What is the threshold for a clinically relevant effect? the case of major depressive disorders. In: Depression and Anxiety. 2014 ; Vol. 31, No. 5. pp. 374-378.
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