The economic burden of progressive chronic kidney disease among patients with type 2 diabetes.

AIMS: To estimate the rate of progression of chronic kidney disease (CKD) among patients with type 2 diabetes (T2D) and calculate medical costs associated with progression. METHODS: We conducted a retrospective cohort study of 25,576 members at Kaiser Permanente who had T2D and at least one serum creatinine measurement in 2005. Using estimated glomerular filtration rate (eGFR), we assigned patients to baseline stages of kidney function (stage 0-2, >60ml/min/1.73m(2), n=21,008; stage 3, 30-59, n=3,885; stage 4, 15-29, n=683). We examined all subsequent eGFRs through 2010 to assess progression of kidney disease. Medical costs at baseline and incremental costs during follow-up were assessed. RESULTS: Mean age of patients was 60.6years, 51% were men, and mean diabetes duration was 5.3years. At baseline, 17.9% of patients with T2D also had stage 3 or 4 CKD. Incremental adjusted costs that occurred over follow-up (from baseline) was on average $4569, $12,617, and $33,162 per patient per year higher among patients who progressed from baseline stage 0-2, stage 3, and stage 4 CKD, respectively, compared to those who did not progress. Across all stages of CKD, those who progressed to a higher stage of CKD from baseline had follow-up costs that ranged from 2 to 4 times higher than those who did not progress. CONCLUSIONS: Progression of CKD in T2D drives substantial medical care costs. Interventions designed to minimize decline in progressive kidney function, particularly among patients with stage 3 or 4 CKD, may reduce the economic burden of CKD in T2D.

Restless legs syndrome (RLS) augmentation associated with dopamine agonist and levodopa usage in a community sample.

OBJECTIVE: Assess the rate of augmentation as it occurs during standard long-term dopaminergic treatment of RLS, potential risk factors or predictors of augmentation, the relationship between treatment duration and augmentation, and the clinical impact of augmentation on subjects' health outcomes. METHODS: Two hundred sixty-six patients with dopamine-treated RLS completed a one-time online survey. All subjects were recruited by their PCP/neurologist and were 18 or older. Augmentation was assessed using NIH guidelines and an augmentation classification system was developed through this research. RESULTS: Overall, 20% of the patients were classified as having definitive or highly suggestive clinical indications of augmentation. Five factors were considered likely to reflect increased risk of developing augmentation, including more frequent RLS symptoms pre-treatment, greater discomfort with RLS symptoms before treatment, and longer treatment duration. RLS augmentation occurred at a rate of about 8% each year for at least the first 8 years of dopamine treatment. Subjects reporting definite or highly suggestive clinical indicators of augmentation had an average IRLS score of 23.6, indicating generally inadequate treatment with generally poor clinical outcomes. Only 25% of the patients reported no indications of augmentation and they were the only group to show on average a low (<15) IRLS score and good clinical outcomes. CONCLUSIONS: As currently used, long term dopaminergic treatment for an average ± SD of 2.7 ± 2.4 years produced significant augmentation problems in at least 20% of the patients and only 25% of the patients were totally free of this problem. It is important for physicians to carefully screen patients for changes in RLS symptoms for as long as they are on dopamine agents, with particular attention paid to those patients who present with the most severe RLS symptoms prior to treatment initiation. Given the marked increase in suffering with augmentation, a method for early detection and intervention would be an important contribution to the effective management and treatment of RLS.

Effect of ropinirole on sleep outcomes in patients with restless legs syndrome: meta-analysis of pooled individual patient data from randomized controlled trials.

STUDY OBJECTIVE: To compare the effects of ropinirole with those of placebo on sleep, as evaluated by specific domains of the Medical Outcomes Study (MOS) sleep scale, as well as the Clinical Global Impression-Improvement (CGI-I) scale, in patients with restless legs syndrome (RLS). DESIGN: Meta-analysis of six randomized, double-blind, placebo-controlled, parallel-group trials conducted in the United States and Europe. PATIENTS: A total of 1679 patients aged 18-79 years with primary moderate-to-severe RLS who received ropinirole (835 patients) or placebo (844 patients). MEASUREMENTS AND MAIN RESULTS: A systematic review of MEDLINE (January 1980-January 2007) and clinical trial registers was performed to identify placebo-controlled trials of ropinirole that used the 12-item MOS sleep scale to assess sleep in patients with RLS. Individual patient data from both published and nonpublished trials were pooled for meta-analysis. In the eligible studies, immediate-release ropinirole 0.25-6 mg or placebo had been given for at least 12 weeks. In addition, sleep scale summary scores for the domains of sleep quantity, adequacy, disturbance, and daytime somnolence had to have been assessed at baseline and at 12 weeks. Our meta-analysis found that at baseline study patients slept an average of 5.8 hours/night. At the end of 12 weeks, ropinirole-treated patients slept a mean of 2.5 hours/week more and had a 21% greater improvement from baseline in sleep adequacy scores compared with patients receiving placebo. Ropinirole-treated patients also had 14% less sleep disturbance and 8% less daytime somnolence than patients receiving placebo. Clinicians rated 63% of ropinirole-treated patients and 47% of patients receiving placebo as responders based on the CGI-I scale. Mixed effects analysis of covariance was used to estimate treatment effect adjusting for study center as a random effect, as well as the following fixed effects known to affect sleep: baseline sleep characteristics, age, sex, and chronic medical conditions. All differences were statistically significant (p<0.05), even after adjusting for multiple comparisons. CONCLUSION: Pooled data from six similarly designed clinical trials provide evidence that ropinirole improves sleep quantity and adequacy, and lessens sleep disturbance and daytime somnolence in patients with primary RLS.

Psychometric evaluation and tests of validity of the Medical Outcomes Study 12-item Sleep Scale (MOS sleep).

OBJECTIVE: To validate the psychometric properties of the Medical Outcomes Study (MOS) Sleep Scale in subjects with restless legs syndrome (RLS). METHODS: Data from a clinical trial program involving two Phase III, double-blind, placebo-controlled trials of ropinirole in subjects with moderate-to-severe primary RLS were analyzed. Subjects were assessed on the MOS Sleep Scale at baseline, Weeks 8 and 12. RESULTS: The baseline validation population included 551 subjects on which full longitudinal data are available. Psychometric assessment of four MOS sleep domains revealed satisfactory item convergent validity (r > 0.40) for most items. All domain items in both trials surpassed the standard for item discriminant validity, with no significant floor or ceiling effects. The MOS sleep domain scores showed good internal consistency reliability. Concurrent validity (r = 0.40) was exceeded in correlations between the RLS overall quality-of-life score and sleep problems index II. The clinical validity of the MOS Sleep Scale was demonstrated against self-reported RLS symptoms and clinician-determined severity; changes in MOS Sleep Scale were responsive to improvements in RLS severity, as measured by the Clinical Global Impression-Improvement and Severity-of-Illness scales. CONCLUSION: The MOS Sleep Scale is a reliable, valid tool for assessing changes in the sleep of subjects with moderate-to-severe primary RLS. The somnolence domain failed to relate to clinical severity of RLS, indicating a possible sleep-wake relationship unique to RLS. Use of this scale to evaluate other conditions causing sleep disturbance is supported.

Integration of service systems for homeless persons with serious mental illness through the ACCESS program. Access to Community Care and Effective Services and Supports.

OBJECTIVE: The aim of this study was to evaluate the first of the two core questions around which the ACCESS (Access to Community Care and Effective Services and Supports) evaluation was designed: Does implementation of system-change strategies lead to better integration of service systems? METHODS: The study was part of the five-year federal ACCESS service demonstration program, which sought to enhance integration of service delivery systems for homeless persons with serious mental illness. Data were gathered from nine randomly selected experimental sites and nine comparison sites in 15 of the nation's largest cities on the degree to which each site implemented a set of systems integration strategies and the degree of systems integration that ensued among community agencies across five service sectors: mental health, substance abuse, primary care, housing, and social welfare and entitlement services. Integration was measured across all interorganizational relationships in the local service networks (overall systems integration) and across relationships involving only the primary ACCESS grantee organization (project-centered integration). RESULTS: Contrary to expectations, the nine experimental sites did not demonstrate significantly greater overall systems integration than the nine comparison sites. However, the experimental sites demonstrated better project-centered integration than the comparison sites. Moreover, more extensive implementation of strategies for system change was associated with higher levels of overall systems integration as well as project-centered integration at both the experimental sites and the comparison sites. CONCLUSIONS: The ACCESS demonstration was successful in terms of project-centered integration but not overall system integration.

Service systems integration and outcomes for mentally ill homeless persons in the ACCESS program. Access to Community Care and Effective Services and Supports.

OBJECTIVE: The authors evaluated the second of the two core questions around which the ACCESS (Access to Community Care and Effective Services and Supports) evaluation was designed: Does better integration of service systems improve the treatment outcomes of homeless persons with severe mental illness? METHODS: The ACCESS program provided technical support and about $250,000 a year for four years to nine sites to implement strategies to promote systems integration. These sites, along with nine comparison sites, also received funds to support outreach and assertive community treatment programs to assist 100 clients a year at each site. Outcome data were obtained at baseline and three and 12 months later from 7,055 clients across four annual cohorts at all sites. RESULTS: Clients at all sites demonstrated improvement in outcome measures. However, the clients at the experimental sites showed no greater improvement on measures of mental health or housing outcomes across the four cohorts than those at the comparison sites. More extensive implementation of systems integration strategies was unrelated to these outcomes. However, clients of sites that became more integrated, regardless of the degree of implementation or whether the sites were experimental sites or comparison sites, had progressively better housing outcomes. CONCLUSIONS: Interventions designed to increase the level of systems integration in the ACCESS demonstration did not result in better client outcomes.