Random plasma glucose in serendipitous screening for glucose intolerance: screening for impaired glucose tolerance study 2.

BACKGROUND: With positive results from diabetes prevention studies, there is interest in convenient ways to incorporate screening for glucose intolerance into routine care and to limit the need for fasting diagnostic tests. OBJECTIVE: The aim of this study is to determine whether random plasma glucose (RPG) could be used to screen for glucose intolerance. DESIGN: This is a cross-sectional study. PARTICIPANTS: The participants of this study include a voluntary sample of 990 adults not known to have diabetes. MEASUREMENTS: RPG was measured, and each subject had a 75-g oral glucose tolerance test several weeks later. Glucose intolerance targets included diabetes, impaired glucose tolerance (IGT), and impaired fasting glucose(110) (IFG(110); fasting glucose, 110-125 mg/dl, and 2 h glucose < 140 mg/dl). Screening performance was measured by area under receiver operating characteristic curves (AROC). RESULTS: Mean age was 48 years, and body mass index (BMI) was 30.4 kg/m(2); 66% were women, and 52% were black; 5.1% had previously unrecognized diabetes, and 24.0% had any "high-risk" glucose intolerance (diabetes or IGT or IFG(110)). The AROC was 0.80 (95% CI 0.74-0.86) for RPG to identify diabetes and 0.72 (0.68-0.75) to identify any glucose intolerance, both highly significant (p < 0.001). Screening performance was generally consistent at different times of the day, regardless of meal status, and across a range of risk factors such as age, BMI, high density lipoprotein cholesterol, triglycerides, and blood pressure. CONCLUSIONS: RPG values should be considered by health care providers to be an opportunistic initial screening test and used to prompt further evaluation of patients at risk of glucose intolerance. Such "serendipitous screening" could help to identify unrecognized diabetes and prediabetes.

Naildex: pilot evaluation of an onychodystrophy severity instrument.

A valid and reliable measure that captures onychodystrophy disease severity is important for both clinical and research applications. Three hundred and twenty-two patients at two Veterans Affairs Medical Centers with clinical evidence of onychodystrophy suggesting onychomycosis (at least 25% in a distal subungual pattern) were examined using Naildex parameters. Naildex scores were calculated by a combination of: per cent of each nail infected, area of each nail and number of infected nails. Patients also completed a nail-specific quality of life questionnaire (NailQoL) and nail samples were collected and examined mycologically. Data was analysed for all enrolled patients (n = 322) and patients with mycologically-confirmed onychomycosis (n = 243). Inter-rater reliability was calculated from two examiners who each evaluated 17 patients with mycologically-confirmed onychomycosis. Significant correlations (P < 0.01) between Naildex and NailQoL as well as proxy measures (duration of infection) indicated construct validity of the instrument for all patients as well as mycologically-confirmed cases. Strong correlation (r = 0.754, P < 0.01, n = 17) indicated high inter-rate reliability. This pilot evaluation suggests that Naildex is a valid and reliable measure of onychomycosis severity.

Language disparities between patients and dermatologists in describing acne lesions.

BACKGROUND: There are no studies evaluating the comprehension of terms used by dermatologists to describe acne lesions. OBJECTIVE: The goal is to evaluate the comprehension of terms and pictures representing various acne lesions. METHODS: Patients were asked to describe terms and pictures of various acne lesions. Responses were graded as nonspecific, consistent, or inconsistent with physicians' description of the same lesion. RESULTS: For 5 of 9 terms and for 2 of 6 pictures, the majority of responses were inconsistent or nonspecific. LIMITATIONS: Our sample size was limited and did not represent all ethnic groups, educational levels, and geographic regions. We did not record which patients had acne versus which patients did not. Finally, the wording of the question "What words would you use to describe what you see in the picture?" may be misleading. CONCLUSIONS: Patients have limited understanding of terminology commonly used by dermatologists to describe acne lesions.

NailQoL: a quality-of-life instrument for onychomycosis.

BACKGROUND: The disease burden onychomycosis is not trivial. The aim is to develop a quality of life instrument to measure the onychomycosis burden. METHODS: 402 patients with mycologically-confirmed onychomycosis completed a baseline questionnaire of 39 quality of life items (modified Skindex-29 questions and 10 additional nail-specific questions). Internal consistency, reproducibility and responsiveness of the final instrument, NailQoL were measured. RESULTS: 15 items consisting of symptom (3), emotion (10), and functional (2) domains were retained in NailQoL. Symptom and emotion subscales = 0.80-0.92. Administration alpha demonstrated good internal consistency (Cronbach's of the instrument to 46 patients at one month after baseline revealed good reproducibility (ICC 0.88-0.91). Responsiveness was measured in 292 patients at 18 months; statistically significant better NailQoL scores were found in individuals with complete cure (mycological and clinical) (P < 0.01). CONCLUSION: NailQoL represents a new concise, valid, reliable, and responsive instrument for measuring burden of skin disease for patients with onychomycosis.

Reduced 6-month resource use and costs associated with cilostazol in patients after successful coronary stent implantation: results from the Cilostazol for RESTenosis (CREST) trial.

BACKGROUND: The CREST trial demonstrated that after successful coronary stent implantation, the 6-month rate of target vessel revascularization (TVR) was similar (15.4% vs 16%, P = .90) for the 2 treatment groups, but restenosis rate was lower (22.0% vs 34.5%, P = .002) in cilostazol-treated patients. We sought to evaluate resource use, cost, and cost-effectiveness of cilostazol in CREST. METHODS: A total of 705 patients were randomized to cilostazol 100 mg twice daily (n = 354) versus placebo (n = 351) for 6 months. Resources included rehospitalizations, medications, and outpatient services. Costs were determined from the Medicare fee schedule. Cilostazol was priced at 1.64 dollars a day. Base-case cost and cost-effectiveness analysis was performed for the entire population using TVR as a measure of effectiveness. Sensitivity analysis was conducted among 526 patients because restenosis data were available only for this patient population. A bootstrap resample approach (5000 samples) was used to obtain confidence intervals for cost differences. RESULTS: For the entire population, costs of rehospitalizations, concomitant medications, outpatient tests, and physician or emergency department visits were lower during follow-up for cilostazol-treated patients. Overall, total 6-month follow-up costs remained 447 dollars lower for cilostazol (4178 dollars vs 4625 dollars), although this difference did not reach significance (95% CI -1458 dollars to 515 dollars). Cilostazol is likely a cost-saving strategy (similar rate of TVR and lower costs). Sensitivity analysis showed that cilostazol is likely a dominant strategy (lower restenosis rate and costs, 85% dominant, 88.9% <1000 dollars per restenosis averted). CONCLUSIONS: Treatment with cilostazol is likely a cost-saving or dominant strategy in patients with successful coronary bare metal stent implantation. Cilostazol may offer a low-cost alternative to restenosis prevention in patients who do not receive drug-eluting stents.

Baseline quality of life and anxiety in solid organ transplant recipients: a pilot study.

BACKGROUND: Solid organ transplant recipients on high doses of immunosuppression are at increased risk for the development of nonmelanoma skin cancer (NMSC). OBJECTIVE: The objective was to assess the possible factors impacting quality of life (QOL) in solid organ transplant recipients. METHODS: Patients were seen in a dermatology clinic integrated within the transplant center at a university-based hospital. One anxiety questionnaire and three QOL questionnaires were administered to each patient. A regression model was used to determine possible predictors of anxiety and lower QOL. RESULTS: The baseline scores on the QOL instruments and anxiety questionnaire indicate poor organ-specific and general QOL as well as high levels of anxiety. Time since transplant was predictive of lower QOL as measured by Skindex-16 (p<.01). While not significant, number of NMSCs correlated with higher anxiety as measured by the STAI (p=.055). CONCLUSIONS: While transplant patients enjoy longer survival, the quality of the extended life has room for improvement. Future studies will determine how QOL changes over time as these patients develop more numerous and aggressive skin cancers. Intervention with regular screening may not only lessen morbidity associated with skin cancer but may improve overall QOL in the posttransplant period.

Coronary stent restenosis in patients treated with cilostazol.

BACKGROUND: Restenosis after implantation of coronary artery stents remains a significant clinical problem. We undertook a randomized, double-blind, placebo-controlled trial to determine whether cilostazol, a drug that suppresses intimal proliferation, would reduce renarrowing in patients after stent implantation in native coronary arteries. METHODS AND RESULTS: We assigned 705 patients who had successful coronary stent implantation to receive, in addition to aspirin, cilostazol 100 mg BID or placebo for 6 months; clopidogrel 75 mg daily was administered to all patients for 30 days. Restenosis was determined by quantitative coronary angiography at 6 months. The minimal luminal diameter at 6 months for cilostazol-treated patients was 1.77 mm for the analysis segment (stent plus 5-mm borders) compared with 1.62 mm in the placebo group (P=0.01). Restenosis, defined as > or =50% narrowing, occurred in 22.0% of patients in the cilostazol group and in 34.5% of the placebo group (P=0.002), a 36% relative risk reduction. Restenosis was significantly lower in cilostazol-treated diabetics (17.7% versus 37.7%, P=0.01) and in those with small vessels (23.6% versus 35.2%, P=0.02), long lesions (29.9% versus 46.6%, P=0.04), and left anterior descending coronary artery site (19.3% versus 39.8%, P=0.001). There was no difference in bleeding, rehospitalization, target-vessel revascularization, myocardial infarction, or death. CONCLUSIONS: Treatment with the drug cilostazol resulted in a significantly larger minimal luminal diameter and a significantly lower binary restenosis rate compared with placebo-treated patients. These favorable effects were apparent in patients at high risk for restenosis.

Methods for the economic and quality of life supplement to the cilostazol for RESTenosis (CREST) trial.

OBJECTIVE: To determine economic and quality of life outcomes for the Cilostazol for RESTenosis (CREST) trial, which is investigating the efficacy of cilostazol vs. placebo in preventing post-stent restenosis. DESIGN: CREST is a prospective, multicenter, randomized, placebo-controlled, double-blind trial. SETTING: 20 clinical sites; the Emory Center for Outcomes Research (ECOR) will serve as the economic and data coordinating center. PATIENTS: 705 patients (>18 years) who have undergone successful, uncomplicated placement of an intracoronary stent in a native coronary artery. INTERVENTION: Cilostazol (100 mg twice daily) or placebo for 6 months. COSTS: Primary endpoint, total direct medical costs at 6 months; secondary endpoints, initial hospital costs and follow-up costs. QOL: Health-related quality of life (QOL) will be assessed using the EQ-5D and the Seattle Angina Questionnaire at baseline and at 1, 3, and 6 months. Cost-effectiveness analysis: Preliminary data show that cilostazol is clinically superior to placebo and if the mean cost for the cilostazol arm is higher than that for placebo, cost-effectiveness analysis will be determined for the cost per episode of restenosis prevented, the cost per episode of major clinical and angiographic endpoints averted, and the cost per quality-adjusted life-years gained.