What Is the Threshold for a Clinically Relevant Effect? The Case of Major Depressive Disorders

Cuijpers, Pim; Turner, Erick H.; Koole, Sander L.; Dijke, Annemiek van; Smit, Filip

doi:10.1002/da.22249

Cited by 170 publications

(148 citation statements)

References 21 publications

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“…In a meta-analysis of psychodynamic therapy (PDT) including different mental disorders, Steinert et al (2017) chose a margin of g = 0.25, which is among the smallest margins ever used in psychotherapy and medical research (Gladstone andVach, 2014, Figure 2, Steinert et al, 2017, p. 944). This margin is very close to both (a) the threshold for a minimally important difference specifically suggested for depression (0.24, Cuijpers et al, 2014), and (b) the margin recommended by Gladstone and Vach (2014) to protect against degradation of treatment effects in non-inferiority trials (d = −0.23).…”

Section: Equivalence and Non-inferiority Marginssupporting

confidence: 75%

Equivalence and non-inferiority testing in psychotherapy research

et al. 2018

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Section: Equivalence and Non-inferiority Marginssupporting

confidence: 75%

Equivalence and non-inferiority testing in psychotherapy research

et al. 2018

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“…Still, it should be noted that when comparing antidepressive medications with placebo alone, effect sizes cannot provide sufficient information on the clinical relevance of treatment effects in individual clinical contexts, so this issue is likely to remain controversial. 9,38 The results of our analyses indicate that antidepressants have higher short-term effects when compared with placebo also in primary care.…”

Section: Discussionmentioning

confidence: 84%

Efficacy and Acceptability of Pharmacological Treatments for Depressive Disorders in Primary Care: Systematic Review and Network Meta-Analysis

Linde

Kriston

Rücker

et al. 2015

The Annals of Family Medicine

138

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PURPOSE The purpose of this study was to investigate whether antidepressants are more effective than placebo in the primary care setting, and whether there are differences between substance classes regarding efficacy and acceptability. METHODSWe conducted literature searches in MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and PsycINFO up to December 2013. Randomized trials in depressed adults treated by primary care physicians were included in the review. We performed both conventional pairwise meta-analysis and network meta-analysis combining direct and indirect evidence. Main outcome measures were response and study discontinuation due to adverse effects. RESULTSA total of 66 studies with 15,161 patients met the inclusion criteria. In network meta-analysis, tricyclic and tetracyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), a serotonin-noradrenaline reuptake inhibitor (SNRI; venlafaxine), a low-dose serotonin antagonist and reuptake inhibitor (SARI; trazodone) and hypericum extracts were found to be significantly superior to placebo, with estimated odds ratios between 1.69 and 2.03. There were no statistically significant differences between these drug classes. Reversible inhibitors of monoaminoxidase A (rMAO-As) and hypericum extracts were associated with significantly fewer dropouts because of adverse effects compared with TCAs, SSRIs, the SNRI, a noradrenaline reuptake inhibitor (NRI), and noradrenergic and specific serotonergic antidepressant agents (NaSSAs).CONCLUSIONS Compared with other drugs, TCAs and SSRIs have the most solid evidence base for being effective in the primary care setting, but the effect size compared with placebo is relatively small. Further agents (hypericum, rMAO-As, SNRI, NRI, NaSSAs, SARI) showed some positive results, but limitations of the currently available evidence makes a clear recommendation on their place in clinical practice difficult.

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“…It is not clear what the threshold for a clinically significant effect size is for treatments in depression, but in an earlier paper, we showed that an effect size of d=0.24 could be considered as a ‘minimally important difference’ as seen from the patient perspective 6. We will use this as the threshold for a clinical significant difference between treatments.…”

Section: The First Step: Statistical Power Of Individual Trialsmentioning

confidence: 97%

Are all psychotherapies equally effective in the treatment of adult depression? The lack of statistical power of comparative outcome studies

Cuijpers

2016

Evid Based Mental Health

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More than 100 comparative outcome trials, directly comparing 2 or more psychotherapies for adult depression, have been published. We first examined whether these comparative trials had sufficient statistical power to detect clinically relevant differences between therapies of d=0.24. In order to detect such an effect size, power calculations showed that a trial would need to include 548 patients. We selected 3 recent meta-analyses of psychotherapies for adult depression (cognitive behaviour therapy (CBT), interpersonal psychotherapy and non-directive counselling) and examined the number of patients included in the trials directly comparing other psychotherapies. The largest trial comparing CBT with another therapy included 178 patients, and had enough power to detect a differential effect size of only d=0.42. None of the trials in the 3 meta-analyses had enough power to detect effect sizes smaller than d=0.34, but some came close to the threshold for detecting a clinically relevant effect size of d=0.24. Metaanalyses may be able to solve the problem of the low power of individual trials. However, many of these studies have considerable risk of bias, and if we only focused on trials with low risk of bias, there would no longer be enough studies to detect clinically relevant effects. We conclude that individual trials are heavily underpowered and do not even come close to having sufficient power for detecting clinically relevant effect sizes. Despite this large number of trials, it is still not clear whether there are clinically relevant differences between these therapies.

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What Is the Threshold for a Clinically Relevant Effect? The Case of Major Depressive Disorders

Abstract: 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.

Cited by 170 publications

References 21 publications

Equivalence and non-inferiority testing in psychotherapy research

Equivalence and non-inferiority testing in psychotherapy research

Efficacy and Acceptability of Pharmacological Treatments for Depressive Disorders in Primary Care: Systematic Review and Network Meta-Analysis

Are all psychotherapies equally effective in the treatment of adult depression? The lack of statistical power of comparative outcome studies

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