TY - JOUR

T1 - What is the threshold for a clinically relvent effect?

T2 - The case of major depressive disorders

AU - Cuijpers, Pim

AU - Turner, Erick H.

AU - Koole, Sander L.

AU - van Dijke, Annemiek

AU - Smit, Filip

PY - 2014/5

Y1 - 2014/5

N2 - BackgroundRandomized 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.MethodsWe 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.ResultsEffect 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.DiscussionStatistical 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.

AB - BackgroundRandomized 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.MethodsWe 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.ResultsEffect 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.DiscussionStatistical 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.

KW - Health sciences

KW - depression

KW - effect size

KW - clinical relevance

KW - minimal important difference

UR - http://www.scopus.com/inward/record.url?scp=84899478856&partnerID=8YFLogxK

U2 - 10.1002/da.22249

DO - 10.1002/da.22249

M3 - Scientific review articles

C2 - 24677535

VL - 31

SP - 374

EP - 378

JO - Depression and Anxiety

JF - Depression and Anxiety

SN - 1091-4269

IS - 5

ER -