The effectiveness of sublingual and topical compounded bioidentical hormone replacement therapy in postmenopausal women: an observational cohort study.

Prior studies demonstrated improved menopausal symptom relief following treatment with compounded bioidentical hormone replacement therapy; however, clinical effectiveness studies evaluating different routes of bioidentical hormone replacement therapy administration are lacking. The objective of this study was to determine the effectiveness of sublingual and topical compounded bioidentical hormone replacement therapy for the treatment of vasomotor, mood, and other quality-of-life symptoms in post-menopausal women. This was a prospective, observational cohort study of women > or = 18 years of age who received a compounded sublingual or topical bioidentical hormone replacement therapy preparation between January 1, 2003 and October 1, 2010 in a community pharmacy. Data collection included patient demographics, comorbidities, hormone regimens, and therapeutic outcomes. Patients rated their vasomotor, mood, and quality-of-life symptoms as absent, mild, moderate, or severe at baseline, at one to three months follow-up, and three to six months follow-up. Baseline characteristics were compared using the chi-square test for categorical variables and the Wilcoxon rank sum test for continuous variables. Symptom intensity between baseline and follow-up periods were compared using the Wilcoxon signed-rank test. A total of 200 patients met study criteria; 160 received topical bioidentical hormone replacement therapy, and 40 received sublingual bioidentical hormone replacement therapy. Most sublingually-treated patients (70%) received an estrogen combination and 100% received progesterone. Nearly half (43%) of the topically treated patients received an estrogen combination (43%) and 99% received progesterone. The percentage of sublingually treated patients reporting "moderate" or "severe" symptoms was significantly reduced at one to three months follow-up for the following target symptoms: hot flashes (31%, P = 0.04), night sweats (38%, P < 0.01), irritability (36%, P = 0.01), anxiety (42%, P < 0.01), emotional lability (38%, P < 0.01), sleep disturbances (35%, P < 0.01), memory loss (35%, P = 0.04), fatigue (33%, P = 0.04), and libido (26%, P = 0.03). Similar reductions were seen at three to six months follow-up compared to baseline. Patients who received topical therapy did not experience significant symptom reductions at one to three months follow-up; however, significant symptom reduction was seen at three to six months for the following: emotional lability (31%, P < 0.01), irritability (29%, P = 0.02), and night sweats (20%, P = 0.04). Compounded sublingual bioidentical hormone replacement therapy is effective in reducing vasomotor, mood, and quality-of-life symptoms experienced in post-menopausal women. Topical therapy does not appear to improve symptoms as extensively or rapidly as sublingual therapy.

The effect of statin therapy on the incidence of infections: a retrospective cohort analysis.

BACKGROUND: Statins have been postulated to prevent infection through immunomodulatory effects. OBJECTIVES: To compare the incidence of infections in statin users to that in nonusers within the same health care system. METHODS: This was a retrospective cohort study of patients enrolled as Tricare Prime or Plus in the San Antonio military multimarket. Statin users were patients who received a statin for at least 3 months between October 1, 2004 and September 30, 2005. Nonusers were patients who did not receive a statin within the study period (October 1, 2003-September 30, 2009). Inpatient and outpatient International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes were used to determine the incidence of infections during the follow-up period (October 1, 2005-September 30, 2009) via multivariable regression analysis and time to infection via Cox regression analysis. RESULTS: Of 45,247 patients who met the study criteria, 12,981 (29%) were statin users and 32,266 were nonusers. After adjustments for age, gender, Charlson Comorbidity Score, tobacco use, alcohol abuse/dependence, health care utilization and use of specific medication classes, statin use was associated with an increased incidence of common infections (odds ratio [OR]: 1.13; 95% confidence interval [CI]: 1.06-1.19) but not influenza or fungal infections (OR: 1.06, 95% CI: 0.80-1.39; OR: 0.97; 95% CI: 0.91-1.04, respectively). Time-to-first infection was similar in statin users and nonusers in all infection categories examined. CONCLUSIONS: Statin use was associated with an increased incidence of common infections but not influenza or fungal infections. This study does not support a protective role of statins in infection prevention; however, the influence of potential confounders cannot be excluded.

Trends in catheter-associated urinary tract infections among a national cohort of hospitalized adults, 2001-2010.

BACKGROUND: Catheter-associated urinary tract infections (CAUTIs) have become a major public health concern in the United States. This study provides national estimates of CAUTI incidence, mortality, and associated hospital length of stay (LOS) over a 10-year period. METHODS: This was a retrospective analysis of the National Hospital Discharge Surveys from 2001 to 2010. Adults age ≥18 years with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure code for urinary catheter placement or other major procedure were included. Urinary tract infections were identified by ICD-9-CM code. Data weights were applied to derive national estimates. Predictors of CAUTI were identified using a logistic regression model. RESULTS: These data represent 70.4 million catheterized patients, 3.8 million of whom developed a CAUTI. The incidence of CAUTIs decreased from 9.4 cases/100 catheterizations in 2001 to 5.3 cases/100 catheterizations in 2010. Mortality in patients with a CAUTI declined from 5.4% in 2001 to 3.7% in 2010. Median (interquartile range [IQR]) hospital LOS also declined, from 9 days (IQR, 5-16 days) in 2001 to 7 days (IQR, 4-12 days) in 2010. Independent predictors of CAUTI included female sex, emergency hospital admission, transfer from another facility, and Medicaid payment (P < .0001 for all variables). CONCLUSIONS: The incidence of CAUTIs in US hospitals declined over the study period. Furthermore, patients with these infections experienced lower hospital mortality and shorter hospital LOS.

Impact of a new method of warfarin management on patient satisfaction, time, and cost.

STUDY OBJECTIVE: International normalized ratio self-testing with online remote monitoring and management (STORM2) is an alternative to anticoagulation clinic management, but the patient's perspective of this method has not been evaluated in the United States; thus we sought to evaluate the impact of STORM2 on patient satisfaction, time, and cost. DESIGN: Prospective pre- and postintervention study. SETTING: Freestanding clinical research center. PATIENTS: Forty-three patients treated with long-term warfarin therapy and monitored initially in the anticoagulation clinic setting and then with STORM2, referred from 11 medical practices. INTERVENTION: Patients were asked to complete a survey and the Duke Anticoagulation Satisfaction Scale (DASS) before (at baseline) and after at least 3 months of STORM2 (at follow-up). MEASUREMENTS AND MAIN RESULTS: Patient satisfaction and time were assessed by survey and the DASS. Costs were measured from the patient's perspective. Overall 90% of responders preferred STORM2 to traditional clinic management. The DASS questions indicated that patients were more satisfied with their anticoagulation treatment and more likely to recommend oral anticoagulation to a friend after experiencing STORM2. In addition, patients found STORM2 to be less complicated and more convenient than traditional clinic management. For each traditional monthly visit, patients drove 20 miles and expended a total of 1.8 hours; using 55¢/mile for mileage reimbursement and $15/hour for lost wages, the cost for each visit was $38. The total cost for four STORM2 visits per month was $10, for a net savings of $28 per patient per month. A total of 76% of patients were willing to pay additional money to eliminate a monthly clinic visit. CONCLUSION: STORM2 is more convenient, less complicated, preferred by patients, and saves patients time and money compared with clinic management.

The United States' progress toward eliminating catheter-related bloodstream infections: incidence, mortality, and hospital length of stay from 1996 to 2008.

BACKGROUND: Approximately 250,000 catheter-related bloodstream infections (CRBSIs) occurred in the United States in 2002. These preventable infections unnecessarily increase mortality and prolong hospitalization. This study provides national estimates of CRBSIs over 13 years (1996-2008) and identifies trends in mortality and hospital length of stay. METHODS: We analyzed data from the National Hospital Discharge Surveys from 1996 to 2008. Adults ≥20 years of age with an ICD-9-CM code for CRBSI (996.62 or 993.3x) were included. Population estimates were obtained from the US Census Bureau, and incidence rates were reported per 10,000 persons. RESULTS: These data represent 1.5 million discharges. CRBSIs increased from 4.3 cases/10,000 persons in 1996 to 7.0 cases/10,000 persons in 2003. Thereafter, rates declined until 2008 (5.1 cases/10,000 persons). Mortality declined from 7.6% in 1996 to 5.9% in 2008. Median hospital length of stay (8 days) remained constant throughout the study period. CONCLUSION: CRBSIs in US adults increased from 1996 to 2003 then declined until 2008. Patient mortality also declined throughout the study period, whereas hospital length of stay remained constant.

The environmental and social influences of HIV/AIDS in sub-Saharan Africa: a focus on rural communities.

The Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) pandemic has caused far-reaching effects in sub-Saharan Africa. The pandemic has effectively diminished the workforce, increased poverty rates, reduced agricultural productivity, and transformed the structure of many rural households. HIV/AIDS further strains the already fragile relationship between livelihood and the natural and social environments of these regions. Therefore, the objective of this review is to characterize the impact of HIV/AIDS on the environment and the social infrastructure of rural sub-Saharan Africa. There are many aspects of rural life that contribute to disease transmission of HIV/AIDS and that pose unique challenges to the population dynamics in sub-Saharan Africa. Widespread AIDS-related mortality has caused a decrease in population growth for many African countries. In turn, these alterations in population dynamics have resulted in a decrease in the percentage of prime-age working adults, as well as a gender disparity, whereby, females carry a growing burden of household responsibilities. There is a rising proportion of older adults, often females, who assume the role of provider and caretaker for other dependent family members. These changing dynamics have caused many to exploit their natural surroundings, adopting less sustainable land use practices and utilizing protected resources as a primary means of generating revenue.

A clinical pathway for community-acquired pneumonia: an observational cohort study.

BACKGROUND: Six hospitals instituted a voluntary, system-wide, pathway for community acquired pneumonia (CAP). We proposed this study to determine the impact of pathway antibiotics on patient survival, hospital length of stay (LOS), and total hospital cost. METHODS: Data were collected for adults from six U.S. hospitals with a principal CAP discharge diagnosis code, a chest infiltrate, and medical notes indicative of CAP from 2005-2007. Pathway and non-pathway cohorts were assigned according to antibiotics received within 48 hours of admission. Pathway antibiotics included levofloxacin 750 mg monotherapy or ceftriaxone 1000 mg plus azithromycin 500 mg daily. Multivariable regression models assessed 90-day mortality, hospital LOS, total hospital cost, and total pharmacy cost. RESULTS: Overall, 792 patients met study criteria. Of these, 505 (64%) received pathway antibiotics and 287 (36%) received non-pathway antibiotics. Adjusted means and p-values were derived from Least Squares regression models that included Pneumonia Severity Index risk class, patient age, heart failure, chronic obstructive pulmonary disease, and admitting hospital as covariates. After adjustment, patients who received pathway antibiotics experienced lower adjusted 90-day mortality (p = 0.02), shorter mean hospital LOS (3.9 vs. 5.0 days, p < 0.01), lower mean hospital costs ($2,485 vs. $3,281, p = 0.02), and similar mean pharmacy costs ($356 vs. $442, p = 0.11). CONCLUSIONS: Pathway antibiotics were associated with improved patient survival, hospital LOS, and total hospital cost for patients admitted to the hospital with CAP.

Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study.

BACKGROUND: Bioidentical Hormone Replacement Therapy (BHRT) is believed it to be a safer and equally effective alternative to Conventional Hormone Therapy for the relief of menopausal symptoms; however, data are needed to support these claims. The objective of this study is to evaluate the effectiveness of compounded BHRT provided in six community pharmacies. METHODS: This was an observational cohort study of women between the ages of 18-89 who received a compounded BHRT product from January 1, 2003 to April 30, 2010 in six community pharmacies. Data included patient demographics, comorbidities, therapeutic outcomes, and hormone therapies. Women self-rated menopausal symptoms as absent, mild, moderate, or severe. Descriptive statistics were used to characterize the patient population, BHRT use, and adverse events. Patient symptom severity was compared at baseline and 3 to 6 months follow-up using the Wilcoxon signed-rank test. RESULTS: Women (n = 296) receiving BHRT at Oakdell Pharmacy had a mean (standard deviation) age of 52 (9) years. The most common BHRT dosage forms utilized were topical (71%) and oral (43%). Compounded BHRT regimens were generally initiated at low doses regardless of route. Women experienced a 25% decrease in emotional lability (p < 0.01), a 25% decrease in irritability (p < 0.01), and a 22% reduction in anxiety (p = 0.01) within 3 to 6 months. These women also experienced a 14% reduction in night sweats (p = 0.09) and a 6% reduction in hot flashes (p = 0.50). CONCLUSIONS: This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.

Emergence of community-acquired methicillin-resistant Staphylococcus aureus skin and soft tissue infections as a common cause of hospitalization in United States children.

BACKGROUND: Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) was first observed in pediatric patients in the late 1990s. Since then, possible risk factors for contracting CA-MRSA have been hypothesized, but supporting studies are limited. METHODS: We analyzed hospital discharge records for patients with a principal International Classification of Diseases, Ninth Revision code for skin and soft tissue infections, collected from 1996 to 2006 by the United States National Center for Health Statistics. Noninstitutional, short-stay hospitals in the United States participated. The sample was limited to patients aged ≤19 years. Staphylococcus aureus and CA-MRSA were defined by International Classification of Diseases, Ninth Revision codes. Data weights were used to derive regional and national estimates. Population estimates were obtained from the US Bureau of the Census, and incidence rates were reported per 100,000 persons. Risk factors for CA-MRSA were first identified using χ(2) and χ(2) goodness-of-fit tests, then by multivariable logistic regression. RESULTS: These data represent 616,375 pediatric discharges for skin and soft tissue infections from U.S. hospitals between 1996 and 2006. This represents approximately 69.9 hospitalizations for skin and soft tissue infections per 100,000 U.S. children per year. Staphylococcus aureus and CA-MRSA accounted for 19.6% and 9.6% of these cases, respectively. The rate of hospitalization for CA-MRSA skin and soft tissue infections increased dramatically over the study period; from less than one case per 100,000 in 1996 to 25.5 cases per 100,000 in 2006. Rates of CA-MRSA varied by region, with the South region having the highest rate (11.5 per 100,000 US children), followed by the West (5.2), Northeast (3.4), and Midwest (3.2). Peak CA-MRSA incidence occurred from May to December; however, the incidence in the South region was consistently higher than other regions for most months and the period of peak incidence was longer than other regions. Independent risk factors for CA-MRSA included survey year, race, geographic region, hospital size, and health insurance status (P < .0001 for all risk factors). CONCLUSIONS: Pediatric hospitalizations for methicillin-susceptible S. aureus and CA-MRSA skin and soft tissue infections are on the rise. Possible risk factors for CA-MRSA infection include White race, residence in the South region of the United States, and lack of health insurance.

Influenza vaccination rates among pharmacists.

OBJECTIVES: To quantify influenza vaccination rates and determine perceived barriers to influenza vaccination among U.S. pharmacists from various practice settings. DESIGN: Prospective study. SETTING: United States in 2008. PARTICIPANTS: 1,028 respondents, including 895 pharmacists. INTERVENTION: A survey request was distributed manually at the 2008 National Community Pharmacists Association annual meeting, and an initial e-mail was sent with two follow-up e-mails to all pharmacists who receive e-mails via Pharmacist e-link. MAIN OUTCOME MEASURES: Vaccination rates and barriers to vaccination among pharmacists. RESULTS: Pharmacists reported an influenza vaccination rate of 78%, with coverage varying across practice settings: hospital (88%), academia (86%), clinic (83%), and community (75%). Employers infrequently required the influenza vaccine as a condition of employment (7%), and slightly more than one-half (58%) compensated pharmacists for being vaccinated; both of these were significantly associated with higher influenza vaccination rates (P < 0.001 for both). One-quarter of pharmacists (26%) expressed at least one issue regarding the influenza vaccine. Pharmacists were significantly less likely to be vaccinated if they expressed a concern (91% vs. 43%, P < 0.0001). Community pharmacists were significantly less likely to be compensated for receiving the influenza vaccination and significantly more likely to express one or more concerns than pharmacists from any other practice setting. CONCLUSION: Pharmacists reported high influenza vaccination rates overall, with slight variability among practice settings. Although employers infrequently required influenza vaccination, approximately one-half of employers compensated their pharmacists for being vaccinated. Employer incentives and pharmacist attitudes were highly correlated with influenza vaccination.