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1.
Spinal Cord ; 56(4): 332-340, 2018 04.
Article in English | MEDLINE | ID: mdl-29269778

ABSTRACT

STUDY DESIGN: Multi-center, repeated measures OBJECTIVES: Evaluate psychometric properties of the SCIM-III in children. SETTING: Seven facilities in North America METHODS: One-hundred and twenty-seven youths, mean age of 10.8 years and chronic spinal cord injury/dysfunction completed two administrations of the Spinal Cord Independence Measure-III (SCIM-III). Mean, standard deviation, range values were calculated for SCIM-III total and subscales for the entire sample, four age groups and injury characteristics. Test-retest reliability, concurrent validity, and floor and ceiling effects were examined. RESULTS: Total SCIM-III and self-care (SC) subscale scores for the youngest age group were lower than those for the three older age groups. There were statistically significant differences in SC subscale scores between neurological level (NL) C5-T1 and T2 -T12; C5-T1 and L1-S4/5; and T2-T12 and L1-S4/5 and in in-room, and indoor/outdoor mobility subscale scores between C1-C4 and T2-T12; C1-C4 and L1-S4/5; C5-T1 and T2-T12; C5-T1 and L1-S4/5; and T2-T12 and L1-S4/5. All scores between motor complete and motor incomplete differed. Test-retest reliability was good (ICC values = > 0.84) and there was moderate to strong correlation between SCIM-III and the FIM® Instrument (r = 0.77-0.92). Ceiling effects were present in the SC subscale for the oldest age group (24%) and for NL L1-S4/5 (35.5%) and in in-room mobility subscale for 6-12 (45.7%), 13-15 (30.43%) and 16-17 (60%) ages, paraplegia (42.4%), tetraplegia (37.1%), incomplete injuries (50%), and T2-T12 (38%) and L1-S4/5 (100%) NL. CONCLUSION: Despite limitations in content range, the SCIM-III is reproducible, and a valid indicator of physical functioning in youth with SCI/D 6 years of age and older. SPONSORSHIP: The study was funded by the Craig H. Neilsen Foundation, Spinal Cord Injury Research on the Translation Spectrum, Senior Research Award Grant #282592 (Mulcahey, PI).


Subject(s)
Exercise/physiology , Movement Disorders/etiology , Psychometrics/methods , Spinal Cord Injuries/physiopathology , Spinal Cord Injuries/psychology , Activities of Daily Living , Adolescent , Age Factors , Analysis of Variance , Child , Child, Preschool , Female , Humans , Male , Movement Disorders/diagnosis , Neurologic Examination/instrumentation , Neurologic Examination/methods , North America/epidemiology , Paraplegia/diagnosis , Paraplegia/etiology , Quadriplegia/diagnosis , Quadriplegia/etiology , Reproducibility of Results , Retrospective Studies , Spinal Cord Injuries/epidemiology
3.
Sleep Med ; 36: 172-177, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28668666

ABSTRACT

OBJECTIVE: To determine GHB levels in breast milk of women taking sodium oxybate (Xyrem) for treatment of narcolepsy and cataplexy. METHODS: Two women with narcolepsy and cataplexy treated with sodium oxybate before pregnancy collected breast milk for analysis of GHB concentration after resuming sodium oxybate postpartum. One woman collected samples across two consecutive nights (doses: 3.0 gm and 4.5 gm twice per night) five months after delivering her first child; the other collected samples on three separate days (doses: 2.25 gm and 3.0 gm twice per night) nine months after the births of her first two children. GHB concentration was determined by gas chromatography/mass spectrometry. RESULTS: Milk GHB levels before sodium oxybate ranged from 5.81 to 7.60 µM. Levels were 2-4 times higher four hours after the first sodium oxybate dose (10.44-23.58 µM) and 3-5 times higher four hours after the second dose (ie, eight hours after first dose; 14.60-34.01 µM). GHB levels returned to endogenous levels 6-10 h following the second dose, however variability was observed between patients and pregnancies. Higher breast milk GHB levels were observed with higher doses for both patients. CONCLUSIONS: Sodium oxybate is transmitted to breast milk. Despite its short half-life, GHB concentrations remained two-to-five times higher than endogenous levels four hours after both nighttime doses. To avoid excess GHB exposure, breastfeeding mothers who take sodium oxybate should consider expressing and discarding their morning milk. Future work should examine milk GHB levels after chronic sodium oxybate and determine whether levels change as milk composition changes across the postpartum period.


Subject(s)
Milk, Human/drug effects , Narcolepsy/drug therapy , Narcolepsy/metabolism , Sodium Oxybate/pharmacokinetics , Wakefulness-Promoting Agents/pharmacokinetics , Adult , Female , Gas Chromatography-Mass Spectrometry , Humans , Milk, Human/chemistry , Sodium Oxybate/therapeutic use , Time Factors , Wakefulness-Promoting Agents/therapeutic use
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