Glycemic relapse in a collaborative primary care-based type 2 diabetes management program.

OBJECTIVES: The purpose of this study is to evaluate the incidence of glycemic relapse in patients who attained their glycosylated hemoglobin (A1C) goal through a health system-wide collaborative primary care-based pharmacist- and Certified Diabetes Care and Education Specialist (CDCES)-led type 2 diabetes (T2D) management program and to identify relapse risk factors. METHODS: This retrospective cohort study examined patients with T2D in the diabetes management program with a baseline A1C of at least 9% who attained their A1C goal. The primary outcome was incidence of glycemic relapse. Time to relapse was estimated using Kaplan-Meier curve, and a cox proportional hazards model was fitted to identify the risk factors for glycemic relapse. RESULTS: Three hundred sixty-two patients were followed-up for a median of 10.5 (interquartile range 12.1) months after program completion; 38 patients (10.5%) experienced a glycemic relapse. Kaplan-Meier analysis estimated a 12-month relapse rate of 8.3%. The presence of a medication adherence barrier, presence of a higher number of chronic medications at baseline, presence of a baseline body mass index (BMI) of 30-39.9, and use of insulin at program completion increased risk for glycemic relapse in a univariate model. In multivariate regression, baseline BMI of 30-39.9 remained statistically significant. Older age at baseline was associated with a statistically significantly decreased relapse risk in both models. CONCLUSION: This study highlights a low incidence of glycemic relapse for patients with T2D who reach their A1C goal through a collaborative primary care-based pharmacist- and CDCES-led T2D management program. The presence of risk factors for glycemic relapse may indicate a need for ongoing intensive care despite achieving A1C goal.

Generation and annotation of the DNA sequences of human chromosomes 2 and 4.

Human chromosome 2 is unique to the human lineage in being the product of a head-to-head fusion of two intermediate-sized ancestral chromosomes. Chromosome 4 has received attention primarily related to the search for the Huntington's disease gene, but also for genes associated with Wolf-Hirschhorn syndrome, polycystic kidney disease and a form of muscular dystrophy. Here we present approximately 237 million base pairs of sequence for chromosome 2, and 186 million base pairs for chromosome 4, representing more than 99.6% of their euchromatic sequences. Our initial analyses have identified 1,346 protein-coding genes and 1,239 pseudogenes on chromosome 2, and 796 protein-coding genes and 778 pseudogenes on chromosome 4. Extensive analyses confirm the underlying construction of the sequence, and expand our understanding of the structure and evolution of mammalian chromosomes, including gene deserts, segmental duplications and highly variant regions.

Reliability of a cognitive endpoint for use in a multiple sclerosis pharmaceutical trial.

OBJECTIVE: Determine reliability and basic psychometric properties of a composite cognitive endpoint, MS-COG, for monitoring change in cognitive function in MS drug trials. BACKGROUND: 50% of MS patients have cognitive impairment that impacts ability to work and quality of life. We selected neuropsychological tests based on sensitivity to MS cognitive impairment, availability of alternate forms, cross-cultural utility, and feasibility for multicenter trials, and assessed the reliability and validity of a composite endpoint, MS-COG. DESIGN/METHODS: Administered SRT, BVMT-R, PASAT, and SDMT to 60 MS patients at 4 US centers twice over 45days, along with symptom inventories by patients and informants. RESULTS: The MS-COG had test-retest reliability of 0.91. Processing Speed and Memory indices had reliabilities of 0.89 and 0.86, with modest practice effects. Reliability was high for the RR MS and SP MS subgroups as well, with correlations of .90 and .93, respectively for MS-COG. Overall, 42% of subjects obtained MS-COG scores in the impaired range, with SP MS subjects performing 0.8 SD below RR MS subjects. Impairment correlated well (r=0.37 to 0.40) with informant reports but was inconsistent with patient report, with the least reliable assessments by those with greater symptom severity. CONCLUSIONS: The MS-COG is a reliable, repeatable measure of MS cognitive functioning that is sensitive to cognitive impairment in SP MS and RR MS patients and feasible for multicenter clinical trials. Further development is warranted.

Minimal neuropsychological assessment of MS patients: a consensus approach.

Cognitive impairment is common in multiple sclerosis (MS), yet patients seen in MS clinics and neurologic practices are not routinely assessed neuropsychologically. In part, poor utilization of NP services may be attributed to a lack of consensus among neuropsychologists regarding the optimal approach for evaluating MS patients. An expert panel composed of neuropsychologists and psychologists from the United States, Canada, United Kingdom, and Australia was convened by the Consortium of MS Centers (CMSC) in April, 2001. Our objectives were to: (a) propose a minimal neuropsychological (NP) examination for clinical monitoring of MS patients and research, and (b) identify strategies for improving NP assessment of MS patients in the future. The panel reviewed pertinent literature on MS-related cognitive dysfunction, considered psychometric factors relevant to NP assessment, defined the purpose and optimal characteristics of a minimal NP examination in MS, and rated the psychometric and practical properties of 36 candidate NP measures based on available literature. A 90-minute NP battery, the Minimal Assessment of Cognitive Function in MS (MACFIMS), emerged from this discussion. The MACFIMS is composed of seven neuropsychological tests, covering five cognitive domains commonly impaired in MS (processing speed/working memory, learning and memory, executive function, visual-spatial processing, and word retrieval). It is supplemented by a measure of estimated premorbid cognitive ability. Recommendations for assessing other factors that may potentially confound interpretation of NP data (e.g., visual/sensory/motor impairment, fatigue, and depression) are offered, as well as strategies for improving NP assessment of MS patients in the future.