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Abstract
Objective A new patient-reported outcome (PRO) measure developed to assess the impact of major depressive disorder (MDD) on partner and family interactions and quality of relationships, the Depression and Family Functioning Scale (DFFS), was analyzed to establish its reliability, validity, and responsiveness.
Methods Data from a multi-center, prospective, 2-year observational study were analyzed to assess the psychometric properties of the DFFS in patients with MDD (nBaseline = 478; nMonth2 = 433). Measures administered to assess validity included the Sheehan Disability Scale (SDS), Arizona Sexual Experiences Scale (ASEX) and Short Form Health Survey–12 (SF-12). Reliability (Cronbach’s alphas and intra-class correlations), construct validity (factor analysis and correlations), discriminating ability (analyses of variance), and responsiveness (standardized effect size estimates) were evaluated.
Results Principal components analyses indicated a single underlying dimension, confirmed by highly satisfactory Cronbach’s alphas (αBaseline = 0.85, αMonth2 = 0.89). The DFFS demonstrated satisfactory test–re-test reliability in patients with the same SDS family life/home responsibilities ratings at baseline and month 2 (intraclass correlation = 0.75). Correlations with other measures showed convergent and divergent validity; e.g., the DFFS correlated better with SF-12 mental component scores (rBaseline = −0.35, rMonth2 = −0.49) than with SF-12 physical component scores (rBaseline = −0.05, rMonth2 = −0.31). Hypothesis tests were generally as predicted; many were statistically significant, substantiating DFFS discriminating ability. Standardized effect size estimates of responsiveness ranged from 0.44–0.84, demonstrating that the items were capable of detecting change.
Conclusions The psychometric analyses support the reliability, validity, and responsiveness of the DFFS and its usefulness for assessing the impact of depression on family functioning. The DFFS can potentially provide important information not captured in clinical practice and facilitate more comprehensive evaluation of MDD treatments.
Transparency
Declaration of funding
This study was funded by Lundbeck SAS. Lundbeck provided funding to RTI-HS to conduct the study and develop the manuscript, and collaborated with RTI Health Solutions in study design, interpretation of data, the decision to submit the manuscript for publication, and approval of the final manuscript.
Declaration of financial/other relationships
All authors contributed equally to the work. CF and ND are employees of Lundbeck, sponsor of this study. VW, LN, DBD, NW, and SY are employees of RTI Health Solutions, the organization conducting the work. CL is an employee of Hospital Ste Marguerite. The authors have no additional financial relationships or otherwise to declare. CMRO Peer Reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
The authors thank the patients and investigators for their participation in the study, and particularly acknowledge the scientific and operational PERFORM Teams at Lundbeck and MAPI-Registrat.
Previous presentations
Portions of this research were presented at the Meeting on Patient Reported Outcomes and Person Centered Care in Mental Health – Diagnosis, Prevention, and Treatment in Mental Health: Effectiveness and Comparative Effectiveness, International Center of Mental Health Policy and Economics, Washington, DC, September 26–28, 2014, and at the Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Philadelphia, Pennsylvania, May 16–20, 2015.