Efficacy and safety of a novel once-daily extended-release ciprofloxacin tablet formulation for treatment of uncomplicated urinary tract infection in women

The efficacy and safety of a novel once-daily extended-release ciprofloxacin (ciprofloxacin ER) 500-mg dose were compared with those of an immediate-release ciprofloxacin (ciprofloxacin IR) 250-mg twice-daily dose, each administered orally for 3 days in the treatment of acute uncomplicated urinary tract infection (uUTI) in women. Adult female outpatients (mean age, 39 years) with clinical signs and symptoms of acute uUTI and a positive pretreatment urine culture (> or =10(5) CFU/ml) were enrolled in a multicenter, randomized, double-blind, noninferiority trial. Patients were assessed at a test-of-cure visit (4 to 11 days posttreatment) and a late-posttreatment visit (4 to 6 weeks posttreatment) for microbiological and clinical outcomes and safety. The primary efficacy endpoint and microbiological eradication rate at the test-of-cure visit in the ciprofloxacin ER group (254/272; 93.4%) were noninferior to those in the ciprofloxacin IR group (225/251; 89.6%) (95% confidence interval [CI] of difference, -0.99%, 8.59%). Clinical-cure rates at the test-of-cure visit were 85.7% (233/272) for ciprofloxacin ER and 86.1% (216/251) for ciprofloxacin IR (95% CI of difference, -6.37%, 5.57%). At the late-posttreatment visit, microbiological and clinical outcomes were similar for the two treatments and consistent with test-of-cure results. Both treatments were well tolerated, but the frequencies of nausea and diarrhea were lower in the ciprofloxacin ER group than in the ciprofloxacin IR group (nausea, ER, 0.6%; IR, 2.2%; P = 0.033; diarrhea, ER, 0.2%; IR, 1.4%; P = 0.037). Once-daily ciprofloxacin ER was safe, effective, and noninferior to twice-daily ciprofloxacin IR in the treatment of acute uUTI. Additionally, ciprofloxacin ER was associated with significantly reduced frequencies of nausea and diarrhea.     

Double-loop approach: recruitment and retention of minority nursing faculty

A culturally diverse work force is vital to meeting the health care needs of an increasingly diverse population. The lack of minority faculty has been documented as a barrier to recruitment and retention of culturally diverse nursing students. Literature that addresses the nursing faculty shortage and the shortage of minority nurse educators is investigated. A double-loop approach to recruitment and retention of minority nursing faculty is proposed and includes the strategies of focused faculty searches, emphasizing internal resources of the academic institution, traditional and distance mentoring, nursing department initiatives, welcoming activities, and campus programs.     

Insulin Resistance, ��-Cell Dysfunction, and Conversion to Type 2 Diabetes in a Multiethnic Population: The Insulin Resistance Atherosclerosis Study

OBJECTIVE

Insulin resistance and β-cell function are major predictors of type 2 diabetes, but studies using direct methods of insulin resistance and secretion are few and relatively small. Furthermore, the strength of these associations has not been tested in different ethnic groups and various states of glucose tolerance, family history of diabetes, and obesity.

RESEARCH DESIGN AND METHODS

Predictors of incident diabetes were evaluated in Hispanic, non-Hispanic white, and African American participants in the Insulin Resistance Atherosclerosis Study (aged 40–69 years). In 557 participants with normal glucose tolerance and 269 with impaired glucose tolerance (IGT), insulin sensitivity (insulin sensitivity index [S^I]) and first-phase insulin secretion (acute insulin response [AIR]) were directly measured using the frequently sampled intravenous glucose tolerance test.

RESULTS

At the 5-year follow-up examination, 128 (15.5%) individuals had developed diabetes. Both S^I (odds ratio × 1 SD 0.50 [95% CI 0.37–0.68]) and AIR (0.51 [0.40–0.65]) were independent predictors of incident diabetes even after adjustment for age, sex, ethnicity, center, IGT, family history of diabetes, and BMI. The strength of the relation of S^I and AIR to incident diabetes was not significantly affected by potential interactions of age, sex, ethnicity, glucose tolerance, BMI, or family history of diabetes (P ≥ 0.15).

CONCLUSIONS

Both insulin sensitivity and β-cell function predict conversion to diabetes in different ethnic groups and various states of glucose tolerance, family history of diabetes, and obesity. The prevention of type 2 diabetes should focus on interventions that improve both insulin resistance and insulin secretion.Insulin resistance and insulin secretion are major predictors of type 2 diabetes, but much of the evidence is the result of studies that use surrogate measures of insulin resistance and β-cell function (1–4). There are few studies that have measured insulin resistance and secretion by direct methods. These studies have enrolled relatively few participants and have targeted individuals from a single ethnic group. In the study by Martin et al. (5), there were 25 incident cases of diabetes among 151 offspring of white parents who both had type 2 diabetes. In a subsequent report by Goldfine et al. (6), this cohort of individuals was compared with a cohort of 181 subjects with normal glucose tolerance (NGT) with only 6 incident cases of diabetes during a mean follow-up of 25 years (6). In the Pima Indian report, 200 subjects were studied and 38 developed type 2 diabetes (7). In a more recent study from the Netherlands, 101 white individuals with impaired glucose tolerance (IGT) were enrolled and 35 developed diabetes (8). Risk of progression to IGT and diabetes associated with direct measures of insulin sensitivity and secretion was also examined in 399 Pima Indians (9) and in 81 first-degree relatives of African Americans with type 2 diabetes (10). None of these studies adjusted their results for glucose tolerance status and adiposity. Furthermore, there are few data on how insulin resistance and secretion perform in different ethnic groups and various states of glucose tolerance, family history of diabetes, and obesity.Because the significance of insulin resistance and secretion could differ by ethnic group, parental history of diabetes, and obesity, we examined the heterogeneity of the relation of insulin resistance and β-cell function to future development of type 2 diabetes. The Insulin Resistance Atherosclerosis Study (IRAS) is a large epidemiological study on insulin resistance and cardiovascular risk factors among individuals of three ethnic groups (African Americans, Hispanics, and non-Hispanic whites) (11). Insulin sensitivity and first-phase insulin secretion were directly measured using the frequently sampled intravenous glucose tolerance test with MINMOD analysis.     

Cost-effectiveness of screening with B-type natriuretic peptide to identify patients with reduced left ventricular ejection fraction

OBJECTIVES: This study was designed to evaluate the cost-effectiveness of screening patients with a B-type natriuretic peptide (BNP) blood test to identify those with depressed left ventricular systolic function. BACKGROUND: Asymptomatic patients with depressed ejection fraction (EF) may have less progression to heart failure if they can be identified and treated. METHODS: We used a decision model to estimate economic and health outcomes for different screening strategies using BNP and echocardiography to detect left ventricular EF <40% for men and women age 60 years. We used published data from community cohorts (gender-specific BNP test characteristics, prevalence of depressed EF) and randomized trials (benefit from treatment). RESULTS: Screening 1,000 asymptomatic patients with BNP followed by echocardiography in those with an abnormal test increased the lifetime cost of care (176,000 US dollars for men, 101,000 US dollars for women) and improved outcome (7.9 quality-adjusted life years [QALYs] for men, 1.3 QALYs for women), resulting in a cost per QALY of 22,300 US dollars for men and 77,700 US dollars for women. For populations with a prevalence of depressed EF of at least 1%, screening with BNP followed by echocardiography increased outcome at a cost < 50,000 US dollars per QALY gained. Screening would not be attractive if a diagnosis of left ventricular dysfunction led to significant decreases in quality of life or income. CONCLUSIONS: Screening populations with a 1% prevalence of reduced EF (men at age 60 years) with BNP followed by echocardiography should provide a health benefit at a cost that is comparable to or less than other accepted health interventions.     

The prognostic importance of different definitions of worsening renal function in congestive heart failure

BACKGROUND: Worsening renal function in patients hospitalized for heart failure portends a poor prognosis. However, criteria used to define worsening renal function are arbitrary, and the implications of different definitions remain unclear. We therefore compared the prognostic importance of various definitions of worsening renal function in 1,002 patients hospitalized for congestive heart failure (CHF). METHODS AND RESULTS: The patient population was 49% female, aged 67 +/- 15 years. Twenty-three percent had a prior history of renal failure, 73% had known depressed ejection fraction, and 63% had known CHF. On admission to the hospital, 47% were receiving ACE inhibitors, 22% beta-blockers, 70% diuretics and 6% NAID's. 72% developed increased serum creatinine during the hospitalization, with 20% developing an increase of > or = 0.5 mg/dL. Worsening renal function predicted both in-hospital mortality and length of stay > 10 days. Even an increased creatinine of 0.1 mg/dL was associated with worse outcome. Sensitivity for death decreased from 92% to 65% as the threshold for increased creatinine was raised from 0.1 to 0.5 mg/dL, with specificity increasing from 28% to 81%. At a threshold of a 0.3 mg/dL increase, sensitivity was 81% and specificity was 62% for death and 64% and 65% for length of stay >10 days. Adding a requirement of final creatinine of > or = 1.5 mg/dL improved specificity. CONCLUSIONS: This analysis demonstrates that any detectable decrease in renal function is associated with increased mortality and prolonged hospital stay. This suggests that therapeutic interventions which improve renal function might be beneficial.     

Prognostic judgments and triage decisions for patients with acute congestive heart failure

STUDY OBJECTIVES: To determine how well triage physicians judge the probability of death or severe complications that require treatment only available in an ICU to maintain life for patients with acute congestive heart failure (CHF). DESIGN: Prospective cohort study. SETTING: An urban university hospital, a Veteran's Administration hospital, and a community hospital. Patients or participants: Patients were those visiting the emergency department (ED) with acute CHF, excluding those who already required a treatment only available in an ICU to maintain life, and those with possible or definite myocardial infarction. Physician participants were those caring for the patients in the ED. MEASUREMENTS AND RESULTS: We performed chart reviews to ascertain whether each patient died or had severe complications develop by 4 days. We collected judgments of the probability of this outcome from the physicians taking care of the study patients in the ED. The prevalence of death or severe complications was 43 per 1,032 patients (4.2%). The mean +/- SD of physicians' judgments of the probability of this outcome was 32.1 +/- 28.4%. A calibration curve that stratified these judgments by decile demonstrated that physicians consistently overestimated this probability (p < 0.01). Physicians' judgments were only moderately good at discriminating which patients would have the outcome (receiver operating characteristic curve area, 0.715). Patients admitted to an ICU received the highest average predicted probability (56.4%), followed by those admitted to a telemetry unit (34.1%), to a regular hospital ward (29.8%), and those sent home (17.9%.) CONCLUSIONS: Physicians drastically overestimated the probability of a severe complication that would require critical care for patients with acute CHF who were candidates for ICU admission. Their judgments of this probability were associated with their triage decisions, as they should be according to several guidelines for ICU triage. Overestimation of the probability of severe complications may have lead to overutilization of scarce critical care resources. Current critical care triage guidelines should be revised to take this difficulty into account, and better predictive models for patients potentially requiring critical care should be developed.     

Impact of socio-economic status on hospital length of stay following injury: a multicenter cohort study

Background

Injury is second only to cardiovascular disease in terms of acute care costs in North America. One key to improving injury care efficiency is to generate knowledge on the determinants of resource use. Socio-economic status (SES) is a documented risk factor for injury severity and mortality but its impact on length of stay (LOS) for injury admissions is unknown. This study aimed to examine the relationship between SES and LOS following injury.This multicenter retrospective cohort study was based on adults discharged alive from any trauma center (2007–2012; 57 hospitals; 65,486 patients) in a Canadian integrated provincial trauma system. SES was determined using ecological indices of material and social deprivation. Mean differences in LOS adjusted for age, gender, comorbidities, and injury severity were generated using multivariate linear regression.

Results

Mean LOS was 13.5 days. Patients in the highest quintile of material/social deprivation had a mean LOS 0.5 days (95 % CI 0.1-0.9)/1.4 days (1.1-1.8) longer than those in the lowest quintile. Patients in the highest quintiles of both social and material deprivation had a mean LOS 2.6 days (1.8-3.5) longer than those in the lowest quintiles.

Conclusions

Results suggest that patients admitted for traumatic injury who suffer from high social and/or material deprivation have longer acute care LOS in a universal-access health care system. The reasons behind observed differences need to be further explored but may indicate that discharge planning should take patient SES into consideration.