Validation of Neuro-QoL and PROMIS Mental Health Patient Reported Outcome Measures in Persons with Huntington Disease

J Huntingtons Dis. 2019;8(4):467-482. doi: 10.3233/JHD-190364.

Abstract

Background: Patient-reported outcomes (PROs) for mental health are important for persons with Huntington disease (HD) who commonly experience symptoms of depression, anxiety, irritability, anger, aggression, and apathy. Given this, there is a need for reliable and valid patient-reported outcomes measures of mental health for use as patient-centered outcomes in clinical trials.

Objective: Thus, the purpose of this study was to establish the psychometric properties (i.e., reliability and validity) of six Neuro-QoL and PROMIS mental health measures to support their clinical utility in persons with HD.

Methods: 294 individuals with premanifest (n = 102) or manifest HD (n = 131 early HD; n = 61 late HD) completed Neuro-QoL/PROMIS measures of Emotional and Behavioral Dyscontrol, Positive Affect and Well-Being, Stigma, Anger, Anxiety, and Depression, legacy measures of self-reported mental health, and clinician-rated assessments of functioning.

Results: Convergent validity and discriminant validity for the Neuro-QoL and PROMIS measures of Emotional and Behavioral Dyscontrol, Positive Affect and Well-Being, Stigma, Anger, Anxiety, and Depression, were supported in persons with HD. Neuro-QoL measures of Anxiety and Depression also demonstrated moderate sensitivity and specificity (i.e., they were able to distinguish between individuals with and without clinically significant anxiety and depression).

Conclusions: Findings provide psychometric support for the clinical utility of the Neuro-QoL/PROMIS measures of mental health measures in persons with HD. As such, these measures should be considered for the standardized assessment of health-related quality of life in persons with HD.

Keywords: Huntington disease; Neuro-QoL; PROMIS; emotion; mental health; reliability; validity.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adult
  • Behavioral Symptoms / diagnosis*
  • Behavioral Symptoms / etiology
  • Female
  • Humans
  • Huntington Disease / complications
  • Huntington Disease / psychology*
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures*
  • Psychometrics / instrumentation
  • Psychometrics / standards*
  • Quality of Life / psychology*
  • Reproducibility of Results
  • Sensitivity and Specificity