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Effective Dose 50 method as the Minimal Clinically Important Difference: Evidence from depression trials

Bauer-Staeb, C; Kounali, D-Z; Welton, NJ; Griffith, E; Wiles, NJ; Lewis, G; Faraway, JJ; (2021) Effective Dose 50 method as the Minimal Clinically Important Difference: Evidence from depression trials. Journal of Clinical Epidemiology 10.1016/j.jclinepi.2021.04.002. (In press). Green open access

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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 two randomised 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 employ these results to tailor the MCID to specific populations according to baseline severities.

Type: Article
Title: Effective Dose 50 method as the Minimal Clinically Important Difference: Evidence from depression trials
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jclinepi.2021.04.002
Publisher version: https://doi.org/10.1016/j.jclinepi.2021.04.002
Language: English
Additional information: This is an Open Access article published under a Creative Commons Attribution 4.0 International (CC BY 4.0) Licence (https://creativecommons.org/licenses/by/4.0/).
Keywords: Clinically Meaningful Change, GAD-7, MCID, Minimal Clinically Important Difference, PHQ-9, Primary Care
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry
URI: https://discovery.ucl.ac.uk/id/eprint/10127238
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