The longitudinal relationship between patient-reported outcomes and clinical characteristics among patients with focal segmental glomerulosclerosis in the Nephrotic Syndrome Study Network.
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Troost Jonathan P, Waldo Anne, Carlozzi Noelle E, Murphy Shannon, Modersitzki Frank, Trachtman Howard, Nachman Patrick H, Reidy Kimberly J, Selewski David T, Herreshoff Emily G, Srivastava Tarak, Gibson Keisha L, Derebail Vimal K, Lin Jen Jar, Hingorani Sangeeta, Fornoni Alessia, Fervenza Fernando C, Sambandam Kamalanathan, Athavale Ambarish M, Kopp Jeffrey B, Reich Heather N, Adler Sharon G, Greenbaum Larry A, Dell Katherine M, Appel Gerald, Wang Chia-Shi, Sedor John, Kaskel Frederick J, Lafayette Richard A, Atkinson Meredith A, Lieske John C, Sethna Christine B, Kretzler Matthias, Hladunewich Michelle A, Lemley Kevin V, Brown Elizabeth, Meyers Kevin E, Gadegbeku Crystal A, Holzman Lawrence B, Jefferson Jonathan Ashley, Tuttle Katherine R, Singer Pamela, Hogan Marie C, Cattran Daniel C, Barisoni Laura, Gipson Debbie S, Nephrotic Syndrome Study Network
Аннотация
METHODS: FSGS patients ≥8 years of age enrolled in the Nephrotic Syndrome Study Network completed Patient-Reported Outcomes Measurement Information System PRO measures of health-related quality of life (HRQoL) (children: global health, mobility, fatigue, pain interference, depression, anxiety, stress and peer relationships; adults: physical functioning, fatigue, pain interference, sleep impairment, mental health, depression, anxiety and social satisfaction) at baseline and during longitudinal follow-up for a maximum of 5 years. Linear mixed-effects models were used to determine which demographic, clinical and laboratory features were associated with PROs for each of the eight children and eight adults studied.
RESULTS: There were 45 children and 114 adult FSGS patients enrolled that had at least one PRO assessment and 519 patient visits. Multivariable analyses among children found that edema was associated with global health (-7.6 points, P = 0.02) and mobility (-4.2, P = 0.02), the number of reported symptoms was associated with worse depression (-2.7 per symptom, P = 0.009) and anxiety (-2.3, P = 0.02) and the number of emergency room (ER) visits in the prior 6 months was associated with worse mobility (-2.8 per visit, P < 0.001) and fatigue (-2.4, P = 0.03). Multivariable analyses among adults found the number of reported symptoms was associated with worse function in all eight PROMIS measures and the number of ER visits was associated with worse fatigue, pain interference, sleep impairment, depression, anxiety and social satisfaction. Laboratory markers of disease severity (i.e. proteinuria, estimated glomerular filtration rate and serum albumin) did not predict PRO in multivariable analyses, with the single exception of complete remission and better pain interference scores among children (+9.3, P = 0.03).
CONCLUSIONS: PROs provide important information about HRQoL for persons with FSGS that is not captured solely by the examination of laboratory-based markers of disease. However, it is critical that instruments capture the patient experience and FSGS clinical trials may benefit from a disease-specific instrument more sensitive to within-patient changes.