Articlehybrid2021

Effective dose 50 method as the minimal clinically important difference: Evidence from depression trials

Clarissa Bauer‐Staeb · Daphne Kounali · Nicky J. Welton · Emma Griffith · Nicola Wiles · Glyn Lewis +2 more

99 citations0/0 files storedJournal of Clinical Epidemiology

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Health Systems, Economic Evaluations, Quality of Life Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes Statistical Methods in Clinical Trials

Abstract

OBJECTIVE: Previous research on the minimal clinically important difference (MCID) for depression and anxiety is based on population averages. The present study aimed to identify the MCID across the spectrum of baseline severity. STUDY DESIGN AND SETTINGS: The present analysis used secondary data from 2 randomized controlled trials for depression (n = 1,122) to calibrate the Global Rating of Change with the PHQ-9 and GAD-7. The MCID was defined as a change in scores corresponding to a 50% probability of patients "feeling better", given their baseline severity, referred to as Effective Dose 50 (ED50). RESULTS: MCID estimates depended on baseline severity and ranged from no change for very mild up to 14 points (52%) on the PHQ-9 and up to 10 points (48%) on the GAD-7 for very high severity. The average MCID estimates were 3.7 points (23%) and 3.3 (28%) for the PHQ-9 and GAD-7 respectively. CONCLUSION: The ED50 method generates MCID estimates across the spectrum of baseline severity, offering greater precision but at the cost of greater complexity relative to population average estimates. This has important implications for evaluations of treatments and clinical practice where users can use these results to tailor the MCID to specific populations according to baseline severities.

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References

2001The PHQ-9 2006A Brief Measure for Assessing Generalized Anxiety Disorder 1991Clinical significance: A statistical approach to defining meaningful change in psychotherapy research.1991Clinical significance: A statistical approach to defining meaningful change in psychotherapy research.1989Measurement of health status 2007Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes 2014Minimal Clinically Important Difference 2014The effects of psychotherapies for major depression in adults on remission, recovery and improvement: A meta-analysis

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