Postoperative outcomes associated with topical skin adhesives among women having hysterectomies.

BACKGROUND: Multiple options are available for closure of hysterectomy incisions. This study compared postoperative clinical and economic outcomes using topical skin adhesive (2-octyl cyanoacrylate; OCA) vs. conventional skin closure in women undergoing total abdominal hysterectomy. METHODS: A multi-hospital administrative database was used to identify women discharged in 2005 who had undergone total abdominal hysterectomy. Patients, classified by skin closure as suture (n = 21,201), staples (n = 23,441), OCA (n = 880), or staples + OCA (n = 489), were compared on length of inpatient stay (LOS), total inpatient cost, and non-prophylactic antibiotic treatment after day four. RESULTS: The unadjusted mean LOS was 3.9, 4.5, 3.7, and 5.2 days for suture, staples, OCA, and staples + OCA, respectively; and the percentages of patients having antibiotic treatment were 12.93, 17.51, 11.14, and 23.72. There were overall differences in adjusted mean LOS, mean total cost, and antibiotic treatment (p < 0.0001). Pairwise comparisons indicated no difference between sutures and OCA, whereas the outcomes for each of the non-staple groups were more favorable than those for the staple group (p < 0.01). Results were similar in adjusted comparisons, with pairwise comparisons between OCA and staples at or near the threshold for significance. CONCLUSIONS: 2-octyl cyanoacrylate appears to be a safe and cost-effective alternative to topical sutures for patients having total abdominal hysterectomy. There were less favorable outcomes in groups receiving staples.

Risk of amputation in patients with diabetic foot ulcers: a claims-based study.

The objective of this study was to undertake a retrospective analysis of claims data of diabetic foot ulcer (DFU) patients to determine the rates of amputation and identify the risk and protective factors. Rates of amputation were calculated in patients diagnosed with DFU in the MEDSTAT Marketscan database between January 2000 and December 2002, who had prediagnosis coverage of 90 days. A nested case-control study was conducted using a 1 : 10 ratio of amputee cases to randomly selected nonamputee controls matched on follow-up days. The association of co-morbid conditions, demographic factors, and severity (5+ outpatient claims for DFU) on amputation was estimated by adjusted odds ratios (AOR) with 95% confidence intervals (CIs). The 5911 eligible patients yielded an incidence density rate of 2.30 amputations per 100 person years (95% CI = 1.91, 2.77). The 116 cases and 1153 controls averaged 307.3 and 308.5 observation days, respectively. Amputation was significantly increased by male gender (AOR 1.98), Charlson co-morbidity scores of 4-5 and 6+ (AOR = 2.89 and 5.36, respectively), renal disease (AOR = 2.11), peripheral vascular disease (AOR = 2.67), and 5+ outpatient DFU services (AOR = 2.17). Practitioners may consider more aggressive care and earlier referral to specialists for DFU patients who fit risk profiles for amputation, which include peripheral vascular disease, multiple co-morbid conditions, and repeated outpatient DFU services.

Examination of nighttime sleep-related problems during double-blind, placebo-controlled trials of galantamine in patients with Alzheimer's disease.

BACKGROUND: Acetylcholinesterase inhibitors (AChEI) are now widely used as treatment for Alzheimer's disease (AD). Their cholinomimetic action has the potential to influence sleep quality and donepezil has been associated with sleeprelated adverse events. This study examined whether galantamine, an AChEI with nicotinic modulation, is associated with nighttime sleeprelated problems. METHODS: Using data combined from three randomized, double-blind trials, galantamine (GAL) and placebo-treated patients were compared on sleep-related adverse events and concomitant medications. Verbatim descriptions by patients, as recorded by physicians, were used to classify adverse events into insomnia/sleep problems and nightmares/dreams. New concomitant medications findings from double-blind, placebo-controlled were counted when prescribed for sleep-related indications. Treatment arms were 705 subjects on GAL 24 mg (12 mg BID), 279 on GAL 16 mg (8 mg BID), and 714 on placebo. RESULTS: Comparing GAL 24, GAL 16, and placebo arms, the respective rates for insomnia/sleep problems were 2.6, 1.1, and 2.2% and for nightmares were 1.1, 0.4, and 0.1%. Comparisons between GAL arms and placebo were not significant, with the exception of GAL 24 for nightmares (p = 0.02). However, due to the low frequency of nightmares in each group the clinical relevance of this difference is unknown. Rates of use for all concomitant medications indicated for sleep were 5.4, 2.9, and 4.6%, respectively, with no significant differences between GAL arms and placebo. CONCLUSION: These results support previous studies that have shown maintenance of good sleep hygiene during treatment with galantamine.

Health-related quality of life for caregivers of patients with Alzheimer disease.

We investigated the relationship of caregivers' health-related quality of life (HRQOL) to the burden of caring for patients with Alzheimer disease (AD) and resource utilization. Caregiver HRQOL was assessed using the SF-12 Mental and Physical Summary scores. Compared with a normative, age-adjusted sample, the 2477 caregivers had lower mental and physical scores (for the latter, only those <54 years of age). Increased caregiver mental functioning was associated with caregiver support and perceived quality of patient medical care, fewer hours of caregiving, and fewer patient behavioral symptoms. The burden of caregiving has substantial effects on HRQOL. Interventions that improve AD status and reduce caregiving hours have the potential to improve caregivers' HRQOL.

Sleep-related outcomes in persons with mild to moderate Alzheimer disease in a placebo-controlled trial of galantamine.

STUDY OBJECTIVES: To recognize the potential effect of acetylcholinesterase-inhibiting medications on sleep quality when used for the treatment of mild to moderate Alzheimer disease and describe sleep outcomes for patients treated with galantamine. DESIGN: This study examined sleep quality among individuals with mild to moderate Alzheimer disease using data from a 3-month, double-blind, flexible-dose trial of galantamine. The hypothesis was no difference in sleep quality between galantamine- and placebo-treated subjects. PATIENTS: 136 patients treated with galantamine 24 mg per day and 125 patients treated with placebo. MEASUREMENTS: Based on caregiver reports, the sleep-related outcome measures were the Pittsburgh Sleep Quality Index and the sleep disorders item from the Neuropsychiatric Inventory. Using a P-value of 0.05 (2-tailed), analysis of covariance was used to compare treatments on mean change from baseline to month 3 (Pittsburgh Sleep Quality Index) or mean score at month 3 (Neuropsychiatric Inventory), adjusted for baseline score and investigator. RESULTS: Both patient groups had an average age of 75 years and a mean Mini-Mental Status Examination score of 20. There were no significant differences between groups on the Pittsburgh Sleep Quality Index total (P=0.59) or subscales. For galantamine and placebo, the mean adjusted changes from baseline on the total Pittsburgh Sleep Quality Index were 0.01 and -0.17, respectively. There also was no difference on the Neuropsychiatric Inventory sleep score at month 3 (P=0.51). CONCLUSIONS: Medications to treat Alzheimer disease should maintain sleep quality and have a neutral effect on sleep. These results further confirm the lack of sleep problems associated with galantamine treatment.

Co-use of donepezil and hypnotics among Alzheimer's disease patients living in the community.

BACKGROUND: In clinical trials, sleep problems have been identified as side effects of donepezil, an acetylcholinesterase (AChE)-inhibiting medication for the treatment of Alzheimer's disease (AD). Poor sleep quality can exacerbate behavior problems among patients and add to the burden experienced by their caregivers. We examined the relationship between co-use of donepezil and hypnotics in a large sample of persons with AD living in the community. METHOD: This secondary data analysis used cross-sectional subjects from a multiwave, consumer-based survey of AD caregivers conducted in 1997 and 1998. Rates of hypnotic use among users and non-users of donepezil were compared using chi-square analysis for independent samples, and multivariate logistic regression was used to identify significant independent correlates of hypnotic use. RESULTS: A total of 2638 caregivers completed at least 1 study wave. Use of hypnotics was higher in the donepezil subgroup (9.78%) compared with subjects not taking this medication (3.93%). Multivariate analysis demonstrated that donepezil use was independently linked to increased hypnotic use after controlling for the potential confounding effects of disruptive behavior and depressive symptoms (adjusted odds ratio = 3.34, p <.001). CONCLUSION: In this large community sample, donepezil use was statistically linked to increased hypnotic use. Because sleep quality may be a critical issue for persons with AD and their caregivers, more rigorous evaluation of sleep problems linked to AChE-inhibitor treatment is indicated.