Understanding caregiver burden from multiple perspectives: dyadic agreement between caregiver and care recipient.

PURPOSE: Caregiver burden (CB) is typically self-assessed by caregivers. However, an emerging concept is assessment of CB by the recipients of care, i.e., the patient. The specific objectives are (1) to assess the level of agreement between care recipients' and caregivers' view on CB, across financial, physical, emotional, and social domains; (2) to explore two care recipient perspectives: their self-perceived burden (CR-SPB), and their interpretation of the caregiver's view (Proxy-CB). METHODS: Data were collected from 504 caregiver-care recipient dyads in the U.S. using an online Qualtrics panel. The survey assessed caregiver burden using CarerQol and newly developed items. The level of agreement between responses was quantified using weighted kappa (κ) coefficients for individual items and intraclass correlation coefficients (ICC) for index/summary scores. RESULTS: The average age of caregivers was 49.2 years, and 62.7 years for care recipients. Dyads most commonly consisted of spouses/partners (34.5%); 68.3% lived together. Proxy-CB aligned more closely with caregiver's view, with moderate to substantial agreement across CB domains (from κ = 0.48 for emotional to κ = 0.66 for financial). In the same perspective, the CarerQol-7D Index showed moderate agreement (ICC = 0.58) and the summary score of CB items substantial agreement (ICC = 0.76). Care recipients generally overestimated  CB in the Proxy-CB perspective, while they underestimated it in the CR-SPB perspective. CONCLUSION: Results demonstrate there is a difference between perspectives. Strong agreement in Proxy-CB perspective suggests that care recipients can potentially substitute for caregivers depending on the domain. CR-SPB agrees less with caregivers and may provide complementary information.

Comparison of the EQ-HWB and EQ-HWB-S With Other Preference-Based Measures Among United States Informal Caregivers.

OBJECTIVES: Several measures have been used or developed to capture the health and well-being of caregivers, including the EQ Health and Well-being (EQ-HWB) and its short form, EQ-HWB-S. This study aimed to evaluate the psychometric properties and construct validity of the EQ-HWB/EQ-HWB-S in a US caregiver population. METHODS: A cross-sectional survey was conducted involving 504 caregivers. Eligible participants were 18+ years old, provided unpaid care to a relative/friend aged 18+ in the past 6 months, and spent on average of at least 1 hour per week caregiving. Survey included the following measures: EQ-HWB, Adult Social Care Outcomes Toolkit for Carers-Carer, CarerQol, and EQ-5D-5L. Psychometric properties were assessed using response distributions, floor/ceiling effects, Spearman's correlation for convergent validity, and effect sizes (ES) for known-group validity based on caregiving situations and intensity. RESULTS: The average age of caregivers was 49.2 (SD = 15.4), with 57.5% being female. More than half (54.4%) reported high caregiving intensity, and 68.3% lived with the care recipient. The EQ-HWB-S index showed a strong positive correlation with the EQ-5D-5L (rs = 0.72), Adult Social Care Outcomes Toolkit for Carers (rs = 0.54), and CarerQol (rs = 0.54) indices. Notably, the EQ-HWB-S index showed the largest ES among measures in differentiating caregiving scenarios with a large ES for caregiver's general health (d = 1.00) and small ES for caregiving intensity (d = 0.39). CONCLUSIONS: Results support construct validity of EQ-HWB and EQ-HWB-S as measures for assessing health and well-being of adult informal caregivers in comparison with other validated instruments. Differing levels of known-group validity across anchors emphasize the importance of selecting appropriate measures for caregivers, depending on research question and/or intervention aims.

Budget impact of introducing subcutaneous vedolizumab as a maintenance therapy in biologic-naïve and biologic-experienced patients with ulcerative colitis in France.

BACKGROUND: Inflammatory bowel disease poses significant social and economic burdens. We assessed the budget impact of including the recently approved subcutaneous (SC) formulation of vedolizumab as maintenance therapy (MT) in patients with ulcerative colitis (UC) in France. METHODS: A decision-analytic model was developed from a French payer's perspective over 5 years to assess budget impact of including vedolizumab SC as MT for UC following induction therapy with vedolizumab intravenous (IV), by subtracting outcomes of a 'world without vedolizumab SC' from a 'world with vedolizumab SC.' Comparators included approved therapies: infliximab (branded/biosimilar), adalimumab (branded/biosimilar), golimumab, ustekinumab, and vedolizumab IV. The model predicts drug, medical, and total costs, including indirect costs in a scenario analysis. A one-way sensitivity analysis explored the impact of varying individual parameters. RESULTS: Including vedolizumab SC as MT following vedolizumab IV induction yielded total cost savings of €59,176,842 (biologic-naïve) and €22,004,135 (biologic-experienced) versus a world without vedolizumab SC. Including indirect costs yielded cost savings in biologic-naïve (€62,600,716) and biologic-experienced (€24,314,915) populations in a world with vedolizumab SC. CONCLUSIONS: Introducing vedolizumab SC as MT after IV induction is expected to have substantial cost savings to a health plan from a French payer's perspective versus a world without vedolizumab SC.

Major Cardiovascular Events in Patients with Gout and Associated Cardiovascular Disease or Heart Failure and Chronic Kidney Disease Initiating a Xanthine Oxidase Inhibitor.

BACKGROUND: Several observational studies and meta-analyses have suggested that treating hyperuricemia in patients with gout and moderate or severe chronic kidney disease (CKD) may improve renal and cardiovascular (CV) outcomes. OBJECTIVE: To evaluate the impact of initiating allopurinol or febuxostat treatment on major CV events in patients with gout, preexisting CV disease (CVD) or heart failure (HF), and stage 3 or 4 CKD in a real-world setting. METHODS: Patients with gout (aged >18 years) who initiated allopurinol or febuxostat treatment between 2009 and 2013 after a diagnosis of stage 3 or 4 CKD and CVD-including coronary artery disease (CAD), cerebrovascular disease, and peripheral vascular disease (PVD)-or HF were selected from the MarketScan databases. The major CV events included CAD-specific, cerebrovascular disease-specific, and PVD-specific events. Cox proportional hazards modeling identified the predictors of major CV events in aggregate, and of CAD, cerebrovascular disease, and PVD events, individually. RESULTS: During follow-up, 2426 patients (370 receiving febuxostat and 2056 receiving allopurinol; 63% male; mean age, 73 years) had 162 major CV events (3.8% in those receiving febuxostat vs 7.2% in those receiving allopurinol; P = .015). The rates of major CV events per 1000 person-years were 51.8 (95% confidence interval [CI], 28-87) in patients initiating febuxostat and 99.3 (95% CI, 84-117) among those initiating allopurinol. Overall, 49.4% of patients had a CAD event, 32.5% had a PVD event, and 23.5% had a cerebrovascular disease-specific event. Febuxostat initiation was associated with a significantly lower risk for a major CV event versus patients who initiated allopurinol (hazard ratio, 0.52; P = .02), driven in large part by lower PVD-specific events (P = .026). CONCLUSION: Patients with moderate-to-severe CKD and CVD or HF who initiated febuxostat treatment had a significantly lower rate of major CV events than patients who initiated allopurinol.

Cost Comparison of Urate-Lowering Therapies in Patients with Gout and Moderate-to-Severe Chronic Kidney Disease.

BACKGROUND: Patients with chronic kidney disease (CKD) are at increased risk for developing gout and having refractory disease. Gout flare prevention relies heavily on urate-lowering therapies such as allopurinol and febuxostat, but clinical decision making in patients with moderate-to-severe CKD is complicated by significant comorbidity and the scarcity of real-world cost-effectiveness studies. OBJECTIVE: To compare total and disease-specific health care expenditures by line of therapy in allopurinol and febuxostat initiators after diagnosis with gout and moderate-to-severe CKD. METHODS: A retrospective observational cohort study was conducted to compare mean monthly health care cost (in 2012 U.S. dollars) among gout patients with CKD (stage 3 or 4) who initiated allopurinol or febuxostat. The primary outcome was total mean monthly health care expenditures, and the secondary outcome was disease-specific (gout, diabetes, renal, and cardiovascular disease [CVD]) expenditures. Gout patients (ICD-9-CM 274.xx) aged ≥ 18 years with concurrent CKD (stage 3 or 4) were selected from the MarketScan databases (January 2009-June 2012) upon allopurinol or febuxostat initiation. Patients were followed until disenrollment, discontinuation of the qualifying study agent, or use of the alternate study agent. Patients initiating allopurinol were subsequently propensity score-matched (1:1) to patients initiating febuxostat. Five generalized linear models (GLMs) were developed, each controlling for propensity score, to identify the incremental costs (vs. allopurinol) associated with febuxostat initiation in first-line (without prior allopurinol exposure) and second-line (with prior allopurinol exposure) settings. RESULTS: Propensity score matching yielded 2 cohorts, each with 1,486 patients (64.6% male, mean [SD] age 67.4 [12.8] years). Post-match, 74.6% of patients had stage 3 CKD; 82.9% had CVD; and 42.1% had diabetes. The post-match sample was well balanced on numerous comorbidities and medication exposures with the following exception: 50.0% of febuxostat initiators were treated in the second-line setting; that is, they had baseline exposure to allopurinol, whereas only 4.2% of allopurinol initiators had baseline exposure to febuxostat. Unadjusted mean monthly cost was $1,490 allopurinol and $1,525 febuxostat (P = 0.809). GLM results suggest that first-line febuxostat users incurred significantly (P = 0.009) lower cost than allopurinol users ($1,299 vs. $1,487), whereas second-line febuxostat initiators incurred significantly (P = 0.001) higher cost ($1,751 vs. $1,487). Febuxostat initiators in both settings had significantly (P < 0.001) higher gout-specific cost, due to higher febuxostat acquisition cost. Increased gout-specific cost in the first-line febuxostat cohort was offset by significantly (P < 0.001) lower CVD ($288 vs. $459) and renal-related cost ($86 vs. $216). There were no significant differences in either renal or CVD costs (adjusted) between allopurinol initiators treated almost exclusively in the first-line setting and second-line febuxostat patients. CONCLUSIONS: Gout patients with concurrent CKD, initiating treatment with febuxostat in a first-line setting, incurred significantly less total cost than patients initiating allopurinol during the first exposure to each agent. Conversely, patients treated with second-line febuxostat following allopurinol incurred significantly higher total cost than patients initiating allopurinol. There was no significant difference in total cost between the agents across line of therapy. Although study findings suggest the potential for CVD and renal-related savings to offset febuxostat's higher acquisition cost in gout patients with moderate-to-severe CKD, this is the first such retrospective evaluation. Future research is warranted to both demonstrate the durability of study findings and to better elucidate the mechanism by which associated cost offsets occur. DISCLOSURES: No outside funding supported this study. Turpin is an employee of Takeda Pharmaceuticals U.S.A. Mitri and Wittbrodt were employees of Takeda Pharmaceuticals U.S.A. at the time of this study. Tidwell and Schulman are employees of Outcomes Research Solutions, consultants to Takeda Pharmaceuticals U.S.A. All authors contributed to the design of the study and to the writing and review of the manuscript. All authors read and approved the final manuscript. Tidwell and Schulman collected the data, and all authors participated in data interpretation.

A retrospective, observational study of patient outcomes for critically ill patients receiving parenteral nutrition.

OBJECTIVE: To evaluate health care-related utilization for critically ill patients receiving parenteral nutrition (PN) administered via a premixed multichamber bag (MCB) or compounded solutions (COM). DESIGN: A retrospective database analysis of critically ill patients (intensive care unit stay ≥ 3 days) receiving PN and discharged between January 1, 2010, and June 30, 2011, using the Premier Hospital Database. Patients were identified as receiving MCB or COM on the basis of product description codes. Primary outcomes were length of stay (LOS) and total costs. Comorbidities and clinical outcomes were identified using International Classificaion of Diseases, Ninth Revision diagnosis codes. All costs reported were for inpatient services only. Patients receiving MCB and COM were matched on key patient and hospital characteristics using a propensity score methodology. Multivariate regression models for cost and LOS used generalized linear models with a log link and gamma distribution. RESULTS: A total of 42,631 patients met the inclusion criteria (MCB = 5,679; COM = 36,952), and the final matched population included 3,559 patients from each cohort. Baseline patient and hospital characteristics were well matched between groups. Adjusted multivariate models demonstrated a small difference between groups for LOS (MCB = 9.40 days vs. COM = 9.65 days; P = 0.014). In addition, patients receiving MCB incurred approximately 9.1% less in total costs (MCB = $37,790 vs. COM = $41,569; P < 0.001). CONCLUSIONS: Overall, patients receiving MCB and COM experienced similar LOS, though patients receiving MCB had significantly lower overall costs. Interpretation of the study findings is subject to several limitations, and additional studies that include explicit identification of the method for compounding are needed.

Parenteral nutrition prescribing pattern: a medical chart review of 191 preterm infants.

BACKGROUND: In 2005, the European Society for Clinical Nutrition and Metabolism released guidelines for the use of pediatric parenteral nutrition (PN). The purpose of this study was to compare PN prescribing patterns in preterm infants with current guideline recommendations. MATERIALS AND METHODS: Six neonatologists in Germany conducted observational, retrospective medical chart reviews on preterm infants <28 days postnatal, hospitalized from October 2009 to April 2011. Infants with a complete medical record who received PN for a minimum of 4 days were enrolled. Patient weight and the change in daily amino acids and intravenous fat emulsion (IVFE) doses administered for the first 7 days of life were abstracted. Median data were used to determine quartiles to compare study results with the current guidelines. RESULTS: Only 30% of patients met current guidelines that recommend all preterm infants receive amino acids on the first day of life. When amino acids were given, the dose was lower than recommended in the current guidelines. The start of IVFE by day 3 of life was given only to 34% of patients despite the guideline recommendation of 100%. CONCLUSION: This study identified several gaps between the current guidelines and patient care that should be explored further.

Bloodstream infections associated with parenteral nutrition preparation methods in the United States: a retrospective, large database analysis.

BACKGROUND: The incidence of bloodstream infection (BSI) among patients receiving parenteral nutrition (PN) is reported to vary widely from 1.3%-39%. BSI rates in a large inpatient population were compared in this study to determine if PN prepared by different methods was associated with BSI. METHODS: Data from Premier Perspective, the largest inpatient cost-based clinical and financial claims database in the United States, were analyzed. Included were all hospitalized patients age ≥18 years who received any PN from January 1, 2005, to December 31, 2007. BSI rates, the primary dependent variable, were defined as the occurrence ICD-9 codes of 038.x (septicemia), 995.91 (sepsis), 995.92 (severe sepsis), and 790.7 (bacteremia). The exposure cohort received PN in a commercial multichamber bag (MCB) (n = 4669), whereas the comparator group received PN prepared by a pharmacy (either hospital compounded or outsourced; n = 64,315). Observed data were adjusted using multivariate logistic regression for baseline differences, risk factors, and potential confounders, with propensity score matching as a sensitivity analysis. RESULTS: The observed and adjusted BSI rates indicate that MCB is associated with fewer infections than pharmacy-prepared PN (observed 17.5% vs 26.6%; adjusted 19.6% vs 25.9%, both P < .001). Propensity-matched scores found similar results with observed BSI rates of 18.9% in patients receiving MCB and 24.6% in patients receiving a compounded PN. CONCLUSION: Both the observed rate of BSI and adjusted probability of developing a BSI remained significantly lower for the MCB than the compounded PN group.

Bloodstream infections in patients receiving manufactured parenteral nutrition with vs without lipids: is the use of lipids really deleterious?

BACKGROUND: This study compared overall bacterial and bloodstream infection rates in patients receiving premixed parenteral nutrition (PN) with vs without lipid emulsion. METHODS: Data from hospitalized patients who were ≥18 years of age and receiving premixed PN between 2005 and 2007 were extracted from the Premier Perspective database. Data were categorized into 2 groups: patients who received premixed PN only and those receiving premixed PN with lipids. Multiple logistic regression was used to adjust for risk factors and potential confounders, reporting the probability of risk for an infection. RESULTS: The group without lipids was observed to have lower rates of both overall bacterial infection (43.5% vs 53.5%) and bloodstream infection (14.5% vs 18.9%). However, after adjusting for baseline characteristics, there were no significant differences in overall risk of bacterial infections (51.4% vs 53.5%; odds ratio [OR] = 1.11; 95% confidence interval [CI], 0.96-1.27) or bloodstream infections (19.6% vs 19.2%; 0.97; 0.81-1.16). In a subset of patients in the intensive care unit for ≥3 days, lower overall bacterial infection rates (58.3% vs 67.3%) and bloodstream infection rates (31.0% vs 37.0%) were observed in the group without lipids. After adjustment, there were no significant differences in risk of overall bacterial infection (OR = 0.95; 95% CI, 0.75-1.22) or bloodstream infection (0.92; 0.71-1.19) between the 2 groups. CONCLUSIONS: When administered with premixed PN, lipid emulsion was not significantly associated with an increase in the risk of infectious morbidity when compared to omitting lipids from therapy.

Methods to identify and compare parenteral nutrition administered from hospital-compounded and premixed multichamber bags in a retrospective hospital claims database.

PURPOSE: Use of parenteral nutrition (PN) is indicated for patients who are unable to meet their needs enterally. PN may be administered via custom-compounded mix or commercially available ready-to-use multichamber bags (MCB), but little is known about potential differences in clinical outcomes between these delivery systems. This study was undertaken to assess the feasibility of comparing custom-compounded and MCB PN in a large hospital claims database. METHODS: Hospital claims data from the Premier Perspective Comparative Hospital Database (PCD) reported from 2005 through 2007 were analyzed. The authors searched the data for patients who received any PN products, including compounded PN and MCB PN. Coding algorithms for identifying patient characteristics, risk factors, and outcomes of interest were explored. RESULTS: Using hospital billing claims, the authors identified patients in the database treated with premixed PN from multichamber bags ("MCB only," n = 4699) and patients treated with custom-compounded PN solution ("compounded PN," n = 64,315). Methods of identifying PN administration groups, patient characteristics and risk factors, outcomes of interest, and data limitations are described. CONCLUSIONS: Exploratory analysis suggests that comparisons of PN administered via compounding and MCB are possible using the Premier data. The ability to control for many identifiable risk factors allows data to be presented for the use of PN and related outcomes in both a clinically sensible and relevant manner, albeit with some limitations.

Nutrition therapy cost analysis in the US: pre-mixed multi-chamber bag vs compounded parenteral nutrition.

BACKGROUND: Bloodstream infections (BSI) occur in up to 350 000 inpatient admissions each year in the US, with BSI rates among patients receiving parenteral nutrition (PN) varying from 1.3% to 39%. BSI-attributable costs were estimated to approximate $US12 000 per episode in 2000. While previous studies have compared the cost of different PN preparation methods, this analysis evaluates both the direct costs of PN and the treatment costs for BSI associated with different PN delivery methods to determine whether compounded or manufactured pre-mixed PN has lower overall costs. OBJECTIVE: The purpose of this study was to compare costs in the US associated with compounded PN versus pre-mixed multi-chamber bag (MCB) PN based on underlying infection risk. METHODS: Using claims information from the Premier Perspective™ database, multivariate logistic regression was used to estimate the risk of infection. A total of 44 358 hospitalized patients aged ≥18 years who received PN between 1 January 2005 and 31 December 2007 were included in the analyses. A total of 3256 patients received MCB PN and 41 102 received compounded PN. The PN-associated costs and length of stay were analysed using multivariate ordinary least squares regression models constructed to measure the impact of infectious events on total hospital costs after controlling for baseline and clinical patient characteristics. RESULTS: There were 7.3 additional hospital days attributable to BSI. After adjustment for baseline variables, the probability of developing a BSI was 30% higher in patients receiving compounded PN than in those receiving MCB PN (16.1% vs 11.3%; odds ratio = 1.56; 95% CI 1.37, 1.79; p < 0.0001), demonstrating 2172 potentially avoidable infections. The observed daily mean PN acquisition cost for patients receiving MCB PN was $US164 (including all additives and fees) compared with $US239 for patients receiving compounded PN (all differences p < 0.001). With a mean cost attributable to BSI of $US16 141, the total per-patient savings (including avoided BSI and PN costs) was $US1545. CONCLUSION: In this analysis of real-world PN use, MCB PN is associated with lower costs than compounded PN with regards to both PN acquisition and potential avoidance of BSI. Our base case indicates that $US1545 per PN patient may be saved; even if as few as 50% of PN patients are candidates for standardized pre-mix formulations, a potential savings of $US773 per patient may be realized.

Variation in antibiotic treatment for diabetic patients with serious foot infections: a retrospective observational study.

BACKGROUND: Diabetic foot infections are common, serious, and diverse. There is uncertainty about optimal antibiotic treatment, and probably substantial variation in practice. Our aim was to document whether this is the case: A finding that would raise questions about the comparative cost-effectiveness of different regimens and also open the possibility of examining costs and outcomes to determine which should be preferred. METHODS: We used the Veterans Health Administration (VA) Diabetes Epidemiology Cohorts (DEpiC) database to conduct a retrospective observational study of hospitalized patients with diabetic foot infections. DEpiC contains computerized VA and Medicare patient-level data for VA patients with diabetes since 1998, including demographics, ICD-9-CM diagnostic codes, antibiotics prescribed, and VA facility. We identified all patients with ICD-9-CM codes for cellulitis/abscess of the foot and then sub-grouped them according to whether they had cellulitis/abscess plus codes for gangrene, osteomyelitis, skin ulcer, or none of these. For each facility, we determined: 1) The proportion of patients treated with an antibiotic and the initial route of administration; 2) The first antibiotic regimen prescribed for each patient, defined as treatment with the same antibiotic, or combination of antibiotics, for at least 5 continuous days; and 3) The antibacterial spectrum of the first regimen. RESULTS: We identified 3,792 patients with cellulitis/abscess of the foot either alone (16.4%), or with ulcer (32.6%), osteomyelitis (19.0%) or gangrene (32.0%). Antibiotics were prescribed for 98.9%. At least 5 continuous days of treatment with an unchanged regimen of one or more antibiotics was prescribed for 59.3%. The means and (ranges) across facilities of the three most common regimens were: 16.4%, (22.8%); 15.7%, (36.1%); and 10.8%, (50.5%). The range of variation across facilities proved substantially greater than that across the different categories of foot infection. We found similar variation in the spectrum of the antibiotic regimen. CONCLUSIONS: The large variations in regimen appear to reflect differences in facility practice styles rather than case mix. It is unlikely that all regimens are equally cost-effective. Our methods make possible evaluation of many regimens across many facilities, and can be applied in further studies to determine which antibiotic regimens should be preferred.

Impact of surgical site infections on length of stay and costs in selected colorectal procedures.

BACKGROUND: Length of stay (LOS) and inpatient costs for open-abdomen colorectal procedures have not been examined recently. The aim of this study was to determine LOS and costs for several colorectal procedures in the context of factors potentially associated with surgical site infection (SSI). METHODS: We used a large U.S. hospital database to identify the variables associated with longer LOS and higher costs for colorectal procedures from January 1, 2005, through June 30, 2006. The study population consisted of all patients >18 years, identified via International Classification of Disease, Ninth Revision, procedural codes for elective colorectal surgery. Patient demographics, surgical procedure, and a modified Study of the Efficacy of Nosocomial Infection Control (SENIC) infection risk score were examined using logistic regression as predictors of LOS >or=1 week and cost >or=$15,000. Patients given cefotetan as surgical prophylaxis were compared with patients given cefazolin/metronidazole. Superficial and deep SSIs were considered; intra-abdominal infection was not. RESULTS: The 25,825 patients were of average age 63 years, with 53% being female and 75% being Caucasian. The overall infection rate was 3.7%. The mean LOS was 7.25 days, and the mean +/- standard deviation total cost per patient $13,746 +/- $13,330. Rates of infection, LOS, and mean hospital costs were all greater for patients with a high SENIC score and increasing disease acuity. Values for these outcome variables were highest for procedures involving stoma formation, followed by operations on the small bowel and large bowel. Variables independently predictive of longer LOS were SSI (odds ratio [OR] 11.74; 95% confidence interval [CI] 9.67, 14.26), age >or=65 years (OR 1.90; 95% CI 1.81, 2.01), and high SENIC score (OR 1.79; 95% CI 1.67, 1.92), whereas Caucasian race (OR 0.86; 95% CI 0.81, 0.91) was predictive of a shorter LOS. Cefazolin/metronidazole was not predictive of a shorter LOS compared with cefotetan (OR 1.06; 95% CI 0.96, 1.17) but was associated with significantly more hospitalizations with costs >or=$15,000 (OR 1.39; 95% CI 1.23, 1.56). CONCLUSIONS: Length of stay and cost rise proportionally with SENIC score, disease acuity, and patient characteristics such as age. Surgical site infections are significantly and independently associated with LOS and cost and contribute to inpatient morbidity and expense. Cefotetan has limited availability, and substitutions are utilized increasingly. Although equally efficacious in elective colon procedures, cefotetan used as surgical prophylaxis was associated with lower hospitalization costs than cefazolin plus metronidazole.

Burden of illness associated with lower urinary tract symptoms including overactive bladder/urinary incontinence.

OBJECTIVES: To determine the effect of lower urinary tract symptoms, including overactive bladder/urinary incontinence, on health outcomes. METHODS: Data were obtained from the 2006 U.S. National Health and Wellness Survey. Cases (those who reported experiencing a sudden overwhelming urge to urinate, a frequent urge to urinate, or urinating >8 times/d) were matched 1:1 with controls (those not experiencing any symptoms) by age, race, sex, educational attainment, and comorbidity status. The outcome measures assessed included health resource use, work productivity loss/activity impairment, and health-related quality of life. RESULTS: Of the 62,833 respondents to the 2006 U.S. National Health and Wellness Survey, 13,957 case-control pairs were matched. The presence of lower urinary tract symptoms, including OAB/UI symptoms, was significantly associated with increased resource use (emergency room visits, odds ratio -1.57, 95% confidence interval -1.47-1.68; hospitalizations, odds ratio -1.56, 95% confidence interval 1.43-1.69; medical provider visits, odds ratio -1.52, 95% confidence interval 1.41-1.63), 8.03% greater overall work productivity loss (P < .001), 12.88% greater activity impairment (P < .001), and decreased health- related quality of life (mental scores, 4.07 points lower [P < .001]; physical scores, 4.14 points lower [P < .001]). CONCLUSIONS: The burden of illness associated with lower urinary tract conditions, including OAB/UI, extend beyond the diagnosed population. The appropriate diagnosis and treatment of symptoms could lead to better clinical, economic, and humanistic outcomes.

Comparative costs of ertapenem and cefotetan as prophylaxis for elective colorectal surgery.

BACKGROUND AND PURPOSE: The costs of treating surgical site infections can be considerable. There is a cost associated with the prophylactic use of antibiotics; however, the use of prophylactic agents may reduce infection rates and lengths of stay, thus offsetting the overall treatment cost and potentially generating cost savings to hospitals. This project was intended to determine the potential cost impact of using ertapenem 1 g vs. cefotetan 2 g as prophylaxis for elective colorectal surgery. METHODS: Cost analysis using efficacy data from the PREVENT clinical trial and drug acquisition and total hospital costs in 2005 dollars from Premier's Perspective Comparative Database in patients > or = 18 year of age, evaluable at four weeks after elective surgery of the colon or rectum and prophylactic treatment with ertapenem (n = 338) or cefotetan (n = 334). The primary outcome measures were the rate of prophylactic drug failure and the difference between the ertapenem and cefotetan groups in costs related to and total hospital stay. Prophylactic failure was defined as a surgical site infection, unexplained antibiotic use, or anastomotic leak. RESULTS: Prophylactic failure occurred in 28.1% of the patients receiving ertapenem and 42.8% of those receiving cefotetan (p < 0.05). The most common prophylactic failure was surgical site infection: 18.3% for ertapenem, 31.1% for cefotetan, difference (95% confidence interval) -13.0% (-19.5, -6.5%) (p < 0.05). The mean +/- standard deviation length of stay for all patients, including prophylactic successes and failures, was 7.6 +/- 6.6 days for ertapenem and 8.7 +/- 9.5 days for cefotetan. The mean per-patient cost of prophylactic drugs and hospital room and board was $15,245 with ertapenem and $17,428 cefotetan, a net difference of -$2,181. CONCLUSIONS: Ertapenem used in prophylaxis for elective colorectal operations results in a lower rate of surgical site infection and a shorter average length of stay than cefotetan. The calculated net difference in prophylactic antibiotic drug and hospital costs represents a saving of $2,181 per patient with ertapenem relative to cefotetan.

Defining success in diabetes disease management: digging deeper in the data.

We evaluated the effectiveness of a diabetes life coach program designed to address the concerns of limited coordination and collaboration of care for chronically ill patients in the physician office. The program emphasized lipid, blood pressure, and glycemic control, using personal coaching, group classes, reminders, and customized feedback. The target population was all health plan members over age 18 with type 1 or 2 diabetes mellitus in 6 primary care practice sites in the Hampton Roads area of Virginia. Primary outcomes were 1 Health Plan Employer Data and Information Set measure (A1c poor control of >9% or no test), 3 American Diabetes Association (ADA) measures (A1c <7%, blood pressure of <130/80 mmHg, low-density lipoprotein cholesterol [LDL-C] of <100 mg/dL), 1 pharmacy measure (percentage of patients filling at least 1 insulin prescription), and 2 self-reported behavioral measures (percentage adherent to a meal plan and percentage adherent to an activity plan). We assessed overall program outcomes and differences between individual physician practices and evaluated outcomes separately for engaged compared with non-engaged program participants. Outcomes for 1117 participants were evaluated. Statistically significant improvement at P < 0.05 was noted in all 7 targeted measures compared with baseline. Participants who were engaged in the life coach program were 40% less likely to experience poor control of their A1c, 50% more likely to meet the ADA A1c goal of < 7%, 11% more likely to meet their blood pressure goal of <130/80 mmHg, and 7% more likely to meet their LDL-C goal of <100 mg/dL compared with those not engaged. Patients who became engaged in the program performed significantly better in the key diabetes indicators that ultimately lead to reductions in the complications of the disease over time. Our study contributes to the evidence that clinical multidisciplinary, collaborative models of care can influence and improve the management of diabetes.

Cost analysis of five antimicrobial regimens for the treatment of intra-abdominal infection.

BACKGROUND: Cost of treatment is an important consideration in antimicrobial agent selection for intra-abdominal infection. We analyzed the relation between the total cost of inpatient stay and the initial selection of antimicrobial agent. METHODS: Actual costs of inpatient care were calculated for 1,234 patients treated at 22 hospitals with one of five antimicrobial regimens: Ampicillin/sulbactam (n = 428), ertapenem (n = 143), ceftriaxone (n = 101), levofloxacin (n = 245), or piperacillin/tazobactam (n = 317) for intra-abdominal infections. Length of stay (LOS), demographic data, diagnosis, disease severity index, intensive care unit (ICU) stay, and total and specific costs were obtained from a large hospital-based, service level, comparative database for five types of infection (appendicitis, cholecystitis, diverticulitis, pancreatitis, and postoperative infection). RESULTS: The LOS was shorter for appendicitis (3.8 days) and cholecystitis (4.6 days) than for diverticulitis (11.4 days), pancreatitis (8.1 days), or postoperative infection (8.4 days). Length of stay and total cost were most closely related to severity index (p < 0.01) and ICU days (p < 0.01). When patient and hospital characteristics and correlations within hospitals were accounted for in the model, piperacillin/tazobactam was associated with significantly higher cost than ertapenem, ampicillin/sulbactam, and levofloxacin. CONCLUSIONS: In assessing pharmacoeconomic outcomes in the treatment of intra-abdominal infection, cost of treatment, although lower with certain antimicrobial agents, is dependent on severity-of-illness indicators.

Comparative costs of ertapenem and piperacillin-tazobactam in the treatment of diabetic foot infections.

PURPOSE: To evaluate potential cost savings, trial data were used to determine the clinical outcomes for i.v. ertapenem given once daily and i.v. piperacillin-tazobactam given every six hours daily in treating diabetic foot infections. METHODS: A cost-minimization analysis (CMA) was conducted on the drug-dosing data of the subset of patients enrolled in a recent double-blind randomized trial who were treated solely as inpatients and were clinically evaluable at fi nal assessment (n = 99). Cost per dose was calculated from (a) average hospital acquisition price per dose for ertapenem ($40.52) or piperacillin-tazobactam ($13.58), (b) average U.S. wages and benefits for labor, based on nine published time-and-motion studies of i.v. antibiotic preparation and administration ($3.10), and (c) consumable supplies, using a 40% discount off the manufacturer list price ($2.90). For each patient, the actual number of antibiotic doses given was multiplied by total cost per dose. RESULTS: There were no significant differences between antibiotic groups with respect to patient demographics, percentage with a severe wound, and mean days of i.v. therapy. Compared with piperacillin-tazobactam, patients treated with ertapenem received significantly fewer mean doses (25.5 versus 7.5; p < 0.0001) and lower antibiotic-related costs ($502.76 versus $355.55, respectively; p < 0.001). The $147.21 difference between groups accounts for approximately 3% of total hospital Medicare reimbursements for these infections. CONCLUSION: A CMA of treatment of diabetic foot infections showed that, compared with piperacillin-tazobactam given four times daily i.v., ertapenem given once daily i.v. was associated with lower drug acquisition and supply costs and less time and labor devoted to preparation and administration of i.v. therapy.

High- versus low-dose fluconazole therapy for empiric treatment of suspected invasive candidiasis among high-risk patients in the intensive care unit: a cost-effectiveness analysis.

BACKGROUND: High-dose fluconazole is an alternative for patients with candidemia caused by Candida glabrata or other Candida species with decreased fluconazole susceptibility. However, empiric high-dose fluconazole is not currently recommended and may result in higher drug costs and toxicity. OBJECTIVE: To determine the cost-effectiveness of using empiric high-dose fluconazole in intensive care unit (ICU) with suspected invasive candidiasis. DESIGN: Decision analytic model. TARGET POPULATION: ICU patients with suspected invasive candidiasis. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: Low-dose fluconazole (loading dose of 800 mg followed by 400 mg daily) vs. high-dose fluconazole (loading dose of 1600 mg followed by 800 mg daily). Generic fluconazole costs were used for the analysis. OUTCOME MEASURES: Incremental life expectancy and incremental cost per discounted life year (DLY) saved. RESULT OF BASE-CASE ANALYSIS: Based on current national levels of fluconazole resistance and ability to correctly identify patients with candidemia, high-dose fluconazole was the more effective but more expensive treatment strategy. Empiric high-dose fluconazole therapy decreased the mortality rate by 0.15% compared to low-dose strategy with a cost-effectiveness rate of $55,526 per DLY saved. RESULTS OF SENSITIVITY ANALYSIS: Empirical high-dose fluconazole was an acceptable treatment strategy (using $100,000 per DLY saved as threshold) unless the physical age of an ICU survivor was 66 years or older. Empirical high-dose fluconazole was an acceptable treatment strategy using $50,000 per DLY saved with minor changes in parameters estimates. LIMITATIONS: The estimates of our model may not be applicable to all ICU patients. Other hospitals with differences in fluconazole resistance, prevalence of invasive candidiasis, or duration of fluconazole therapy may produce different results. CONCLUSION: These results suggest that empiric high-dose fluconazole therapy should reduce the mortality associated with invasive candidiasis at an acceptable cost.

Economic analysis of inadequate fluconazole therapy in non-neutropenic patients with candidaemia: a multi-institutional study.

Mortality significantly increases in patients with candidaemia who receive inappropriate fluconazole therapy. The goals of this study were to compare hospital length of stay and costs for non-neutropenic patients with candidaemia treated with fluconazole based on the empirical dose and time until initiation of therapy. A retrospective cohort study was conducted of patients with candidaemia who were prescribed fluconazole at the onset of candidaemia or later. Hospital-related costs were compared based on time to initiation of fluconazole therapy and empirical fluconazole dose. A total of 192 non-neutropenic patients (55% male; mean age+/-standard deviation, 56+/-17 years) were identified. Isolated Candida species included C. albicans (59%), C. glabrata (15%), C. parapsilosis (11%), C. tropicalis (6%), C. krusei (3%) or other Candida spp. (6%). Time to initiation of fluconazole was Day 0 (35.4%), Day 1 (14.1%), Day 2 (26.6%) or Day >or=3 (23.9%). Thirty-two patients (17%) received a dose of fluconazole >or=6 mg/kg on Day 0. Total costs were lowest for patients started on fluconazole on the culture day with adequate doses ($35,459+/-25,988) compared with all other patients ($52,158+/-53,492) (P=0.0088). After controlling for covariates, each 1-day delay in fluconazole therapy was associated with increased total hospital costs of $6392+/-3000 (P=0.0344), and an adequate fluconazole dose was associated with decreased total hospital costs of $18,744+/-7173 (P=0.0097). A delay or an inadequate dose or fluconazole in patients with candidaemia was associated with increased hospital costs. Improved methods to diagnose patients with candidaemia quickly are needed.