Validation of a Phosphorus Food Frequency Questionnaire in Patients with Kidney Failure Undertaking Dialysis.

Nutritional guidelines recommended limiting dietary phosphorus as part of phosphorus management in patients with kidney failure. Currently, there is no validated phosphorus food frequency questionnaire (P-FFQ) to easily capture this nutrient intake. An FFQ of this type would facilitate efficient screening of dietary sources of phosphorus and assist in developing a patient-centered treatment plan. The objectives of this study were to develop and validate a P-FFQ by comparing it with the 24 hr multi-pass recall. Fifty participants (66% male, age 70 ± 13.3 years) with kidney failure undertaking dialysis were recruited from hospital nephrology outpatient departments. All participants completed the P-FFQ and 24 hr multi-pass recalls with assistance from a renal dietitian and then analysed using nutrient analysis software. Bland-Altman analyses were used to determine the agreement between P-FFQ and mean phosphorus intake from three 24 hr multi-pass recalls. Mean phosphorous intake was 1262 ± 400 mg as determined by the 24 hr multi pass recalls and 1220 ± 348 mg as determined by the P-FFQ. There was a moderate correlation between the P-FFQ and 24 hr multi pass recall (r = 0.62, p = 0.37) with a mean difference of 42 mg (95% limits of agreement: 685 mg; -601 mg, p = 0.373) between the two methods. The precision of the P-FFQ was 3.33%, indicating suitability as an alternative to the 24 hr multi pass recall technique. These findings indicate that the P-FFQ is a valid, accurate, and precise tool for assessing sources of dietary phosphorus in people with kidney failure undertaking dialysis and could be used as a tool to help identify potentially problematic areas of dietary intake in those who may have a high serum phosphate.

Teriflunomide slows BVL in relapsing MS: A reanalysis of the TEMSO MRI data set using SIENA.

OBJECTIVE: To assess, using structural image evaluation using normalization of atrophy (SIENA), the effect of teriflunomide, a once-daily oral immunomodulator, on brain volume loss (BVL) in patients with relapsing forms of MS enrolled in the phase 3 TEMSO study. METHODS: TEMSO MR scans were analyzed (study personnel masked to treatment allocation) using SIENA to assess brain volume changes between baseline and years 1 and 2 in patients treated with placebo or teriflunomide. Treatment group comparisons were made via rank analysis of covariance. RESULTS: Data from 969 patient MRI visits were included in this analysis: 808 patients had baseline and year 1 MRI; 709 patients had baseline and year 2 MRI. Median percentage BVL from baseline to year 1 and year 2 for placebo was 0.61% and 1.29%, respectively, and for teriflunomide 14 mg, 0.39% and 0.90%, respectively. BVL was lower for teriflunomide 14 mg vs placebo at year 1 (36.9% relative reduction, p = 0.0001) and year 2 (30.6% relative reduction, p = 0.0001). Teriflunomide 7 mg was also associated with significant reduction in BVL vs placebo over the 2-year study. The significant effects of teriflunomide 14 mg on BVL were observed in both patients with and without on-study disability worsening. CONCLUSIONS: The significant reduction of BVL vs placebo over 2 years achieved with teriflunomide is consistent with its effects on delaying disability worsening and suggests a neuroprotective potential. CLASSIFICATION OF EVIDENCE: Class II evidence shows that teriflunomide treatment significantly reduces BVL over 2 years vs placebo. CLINICALTRIALSGOV IDENTIFIER: NCT00134563.