Relationship between the Short-Form 12 (SF-12) and Schizophrenia Symptom Rating Scales in a Randomized Controlled Clinical Trial of Paliperidone Palmitate 3 Monthly Formulation
Author(s)
Nandy M1, Murray R2, Sanga P2, Keenan A2, Jamieson C3, Lim P2, Gopal S2
1The College of New Jersey, Ewing Township, NJ, USA, 2Janssen Research and Development, LLC, Titusville, NJ, USA, 3Janssen Research & Development, LLC, Milpitas, CA, USA
OBJECTIVES: There is increasing emphasis on understanding impact of core symptoms and functioning on well-being and quality-of-life (QOL) to achieve holistic outcomes in schizophrenia. The short-form-12 (SF-12) is a widely used generic measure of self-reported health-related QOL (HRQOL). Relationship of SF-12 as an outcome measure of HRQOL in patients with schizophrenia with clinically relevant symptom rating scales for schizophrenia was evaluated. METHODS: Post-hoc analyses were conducted from a randomized, placebo-controlled, relapse prevention phase 3 study (NCT01529515) of paliperidone palmitate 3-monthly (PP3M) in patients with schizophrenia. SF-12 (version 2.0) was administered before open-label transition phase and end of double-blind phase. SF-12 subscales (bodily pain, general health, mental health, physical health, vitality, role physical, role mental, social functioning) and summary scores (mental component summary [MCS], physical component summary [PCS]) were normalized with a range of 0-100 and population mean (SD) of 50(10). Linear regression for change in SF-12 and common schizophrenia symptom rating scales (Positive and Negative Syndrome Scale [PANSS], Personal and Social Performance [PSP], Clinical Global Impression – Severity [CGI-S] and Involvement Evaluation Questionnaire [IEQ]) on change in MCS/PCS, with baseline MCS/PCS added as a covariate, were conducted. RESULTS: Improvements in PANSS positive (p<0.0001; R2=0.330), negative (p=0.002; R2=0.305) and in PSP (p<0.0001; R2=0.326) and CGI-S (p=0.0034; R2=0.302) were significantly associated with improvements in MCS but were not associated with improvements in PCS (PANSS [negative: p=0.786; R2=0.163; positive: p=0.501; R2=0.165], PSP (p=0.345; R2=0.167) and CGI-S (p=0.9268; R2=0.163). Improvements in IEQ urging were significantly associated with improvements in mental health subscale score (p=0.0143; R2=0.2564). CONCLUSIONS: A clear and significant relationship was observed between the SF-12 MCS score and validated psychiatric rating scales (PANSS, PSP and CGI-S) of schizophrenia. Other components and subscales of SF-12 did not show clear relationship. Change in symptoms measured by SF-12 MCS may reflect a change in patient’s QOL.
Conference/Value in Health Info
2021-05, ISPOR 2021, Montreal, Canada
Value in Health, Volume 24, Issue 5, S1 (May 2021)
Code
PND5
Topic
Clinical Outcomes, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes, Patient-reported Outcomes & Quality of Life Outcomes, Performance-based Outcomes
Disease
Neurological Disorders