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Cited by 99Health Systems, Economic Evaluations, Quality of LifeStatistical Methods in Clinical TrialsAnxiety, Depression, Psychometrics, Treatment, Cognitive Processes

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

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Bauer-Staeb, Clarissa, Kounali, Daphne-Zacharenia, Welton, Nicky J., Griffith, Emma, Wiles, Nicola J., Lewis, Glyn, Faraway, Julian J., Button, Katherine S.·2021·Journal of Clinical Epidemiology
DOI 10.1016/j.jclinepi.2021.04.002PMC PMC8485844
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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 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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  • Clinical response was defined as either a ≥50% reduction from Baseline or an absolute decrease from Baseline of at least the instrument's minimum clinically important difference (MCID; 5 points for PHQ-9; 10 points for PCL-5 total; 4 points for GAD-7), whichever criterion was met.

    “clinical response was defined as either a ≥ 50% reduction from Baseline or an absolute decrease from Baseline of at least the instrument's minimum clinically important difference (MciD; 5 points for PhQ-9; 10 points for Pcl-5 total; 4 points for GaD-7), whichever criterion was met (Bauer-staeb et al. 2021;Kounali et al. 2022;löwe et al. 2004)”

    From Feasibility, tolerability, and preliminary effectiveness of an accelerated bilateral intermittent theta-burst stimulation protocol in adults with posttraumatic stress disorder and comorbid depressive disorder following mild traumatic brain injury (2026) · cites this paper as Bauer-Staeb et al. 2021

    The Discussion reports that English primary-care services use a 4-point GAD-7 change to capture improvement, but describes it as a reliable-change threshold, not a fixed MCID. The paper's MCID estimates vary with baseline severity; its Discussion reports average estimates of 3.7 points for PHQ-9 and 3.3 for GAD-7. It does not establish the cited 5-point PHQ-9 or 10-point PCL-5 thresholds, or define response as either a 50% reduction from baseline or an MCID decrease. (LLM, conf=0.88)

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Research works printed but not linked: 15

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Authors
Bauer-Staeb, C., Kounali, D.-Z., Welton, N. J., Griffith, E., Wiles, N. J., Lewis, G., Faraway, J. J., & Button, K. S.
Affiliations
  • University of Bristol (GB)
  • Avon and Wiltshire Mental Health Partnership NHS Trust (GB)
  • University College London (GB)
  • University of Bath (GB)
Corresponding author
Button, Katherine S.
ORCID
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2021-09
Volume
137
Pages
200-208
ISSN
0895-4356 (ISSN-L)
DOI
10.1016/j.jclinepi.2021.04.002
PMC
PMC8485844
OpenAlex
W3153924331
Cited by
99
References
9
Citations by year
2026: 31 · 2025: 23 · 2024: 17 · 2023: 18 · 2022: 9 · 2021: 1
FWCI
8.59
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Clinical Epidemiology (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, other-oa)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Explore Bristol Research (acceptedVersion, cc-by)
  • UCL Discovery (University College London) (submittedVersion)
  • Bristol Research (University of Bristol) (submittedVersion, cc-by)
Funders
  • NIHR
  • NIHR PGfAR
Topics
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Keywords
minimal clinically important difference, depression, anxiety, baseline severity, PHQ-9, GAD-7, global rating of change, treatment response, patient-reported outcomes
MeSH terms
Minimal Clinically Important Difference, Adult, Anxiety, Depression, Female, Humans, Male, Middle Aged, Severity of Illness Index

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