Symptoms of Major Depressive Disorder Scale

Performance of a Novel Patient-Reported Symptom Measure

PRO Consortium's Depression Working Group

Research output: Contribution to journalArticle

Abstract

Background: The Symptoms of Major Depressive Disorder Scale (SMDDS) was expressly developed on the basis of qualitative data to directly incorporate patients' voices into evaluation of treatment benefit in major depressive disorder (MDD) clinical trials. Objectives: To collect quantitative data necessary to refine/optimize the SMDDS and document its psychometric properties. Methods: In this multicenter, observational study, participants with clinically diagnosed MDD completed questionnaires in 2 waves. Wave 1 was designed to refine the SMDDS using Rasch measurement evaluations and item reduction analyses. On a subset of wave 1 subjects, 7 to 12 months later, wave 2 further examined item performance and measurement properties. Exploratory factor analyses and assessments of construct validity and reliability (internal consistency and reproducibility) were completed. Results: Using wave 1 data (N = 315; females = 71%, white = 81%, mean age = 44 years), the SMDDS was revised from 36 to 16 items. The Rasch item threshold map indicated that all but 1 item (suicidal ideation) were appropriately ordered. The 207 wave 2 participants were 74% females, 82% white, with a mean age of 45 years. The exploratory factor analyses resulted in a single component (all standardized factor loadings >0.46). Cronbach α was 0.93 and the 7-day test-retest intraclass correlation coefficient (n = 93) was 0.84 (95% confidence interval 0.77-0.89). SMDDS scores discriminated between MDD severity levels. Conclusions: The 16-item SMDDS generated highly reliable scores with substantial evidence of construct validity. On the basis of the evidence of appropriate content validity and sound psychometric performance, the Food and Drug Administration qualified the SMDDS as an outcome measure to support exploratory efficacy endpoints in MDD clinical trials.

Original languageEnglish (US)
Pages (from-to)906-915
Number of pages10
JournalValue in Health
Volume22
Issue number8
DOIs
StatePublished - Aug 1 2019

Fingerprint

Major Depressive Disorder
Psychometrics
Statistical Factor Analysis
Outcome Assessment (Health Care)
Clinical Trials
Suicidal Ideation
United States Food and Drug Administration
Reproducibility of Results
Multicenter Studies
Observational Studies
Economics
Confidence Intervals

Keywords

  • content validity
  • depression
  • major depressive disorder
  • patient-reported symptom measure

ASJC Scopus subject areas

  • Health Policy
  • Public Health, Environmental and Occupational Health

Cite this

Symptoms of Major Depressive Disorder Scale : Performance of a Novel Patient-Reported Symptom Measure. / PRO Consortium's Depression Working Group.

In: Value in Health, Vol. 22, No. 8, 01.08.2019, p. 906-915.

Research output: Contribution to journalArticle

PRO Consortium's Depression Working Group. / Symptoms of Major Depressive Disorder Scale : Performance of a Novel Patient-Reported Symptom Measure. In: Value in Health. 2019 ; Vol. 22, No. 8. pp. 906-915.
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abstract = "Background: The Symptoms of Major Depressive Disorder Scale (SMDDS) was expressly developed on the basis of qualitative data to directly incorporate patients' voices into evaluation of treatment benefit in major depressive disorder (MDD) clinical trials. Objectives: To collect quantitative data necessary to refine/optimize the SMDDS and document its psychometric properties. Methods: In this multicenter, observational study, participants with clinically diagnosed MDD completed questionnaires in 2 waves. Wave 1 was designed to refine the SMDDS using Rasch measurement evaluations and item reduction analyses. On a subset of wave 1 subjects, 7 to 12 months later, wave 2 further examined item performance and measurement properties. Exploratory factor analyses and assessments of construct validity and reliability (internal consistency and reproducibility) were completed. Results: Using wave 1 data (N = 315; females = 71{\%}, white = 81{\%}, mean age = 44 years), the SMDDS was revised from 36 to 16 items. The Rasch item threshold map indicated that all but 1 item (suicidal ideation) were appropriately ordered. The 207 wave 2 participants were 74{\%} females, 82{\%} white, with a mean age of 45 years. The exploratory factor analyses resulted in a single component (all standardized factor loadings >0.46). Cronbach α was 0.93 and the 7-day test-retest intraclass correlation coefficient (n = 93) was 0.84 (95{\%} confidence interval 0.77-0.89). SMDDS scores discriminated between MDD severity levels. Conclusions: The 16-item SMDDS generated highly reliable scores with substantial evidence of construct validity. On the basis of the evidence of appropriate content validity and sound psychometric performance, the Food and Drug Administration qualified the SMDDS as an outcome measure to support exploratory efficacy endpoints in MDD clinical trials.",
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