Clinical Validation of PROMIS Global Short Form in Pregnancy
Health-related quality of life (HRQoL) is an important patient-reported outcome, yet research regarding HRQoL during pregnancy is limited. We examined HRQoL during pregnancy using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Short Form (GSF) and validated the GSF compared to legacy HRQoL measures. We evaluated HRQoL among 161 women seeking pregnancy care in urban clinic settings. Participants completed measures of HRQoL, social support, antenatal depression, and utility. Descriptive statistics and correlation coefficients were calculated. Participants averaged 27(±6.6) years and were culturally diverse: 42% self-identified as Hispanic, 37% Black, non-Hispanic, 14% White, non-Hispanic and 7% multiracial or other. Mean estimated gestational age was 9 (±4.6) weeks. PROMIS GSF Physical T-scores were significantly correlated with SF-12 Physical Component Score (PCS) and Mental Component Score (MCS) HRQoL measures (correlation coefficient=0.40 and 0.49, p-value<0.0001, respectively), the Modified Kendler Social Support Index (MKSSI) (correlation coefficient=0.42, p-value<0.0001), and the Visual Analog Scale (VAS) measure of utility (correlation coefficient=0.19, p-value =0.04). GSF Mental T-scores were associated with SF-12 MCS and PCS (correlation coefficient=0.66, p-value<0.0001, and 0.26, p-value<0.01, respectively), MKSSI (correlation coefficient=0.50, p-value<0.0001), and VAS (correlation coefficient=0.29, p-value<0.01). GSF Physical and Mental scores were inversely associated with the Edinburgh Postpartum Depression Scale (EPDS), correlation coefficient= −0.62 and − 0.71, respectively (p-value<0.0001). GSF-derived utility measures demonstrate significant correlation with SF-12 PCS and MCS, MKSSI, EPDS, and VAS. Overall, PROMIS GSF domains demonstrate correlation with legacy HRQoL measures as well as validated measures of social support, depression, and utility among a diverse cohort of pregnant women.
KeywordsHealth related quality of life (HRQoL) Utility Pregnancy PROMIS
Compliance with Ethical Standards
Conflict of Interest
Dr. Gariepy received a Clinical Translational Science Award (CTSA Grant Number UL1 TR000142) from the National Center for Advancing Translational Science (NCATS). Dr. Lundsberg was supported by CTSA Grant Number UL1 TR000142. Dr. Yonkers has no conflicts of interest related to the current publication; outside the submitted work; she has worked as a consultant for Pontifax regarding premenstrual dysphoric disorders, received NIH funding, and royalties from Up-to-Date. Dr. Schwarz and Dr. Vilardo declare no conflict of interest.
All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
This study was funded by CTSA Grant Number UL1 TR000142 from the National Center for Advancing Translational Science (NCATS), a component of the National Institutes of Health (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NIH.
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