Direct Costs Incurred Among Women Undergoing Surgical Procedures to Treat Uterine Fibroids.

BACKGROUND: Uterine fibroids (UF) affect up to 70%-80% of women by 50 years of age and represent a substantial economic burden on patients and society. Despite the high costs associated with UF, recent studies on the costs of UF-related surgical treatments remain limited. OBJECTIVE: To describe the health care resource utilization (HCRU) and all-cause costs among women diagnosed with UF who underwent UF-related surgery. METHODS: Data from the IBM MarketScan Commercial Claims and Encounters database and Medicaid Multi-State database were independently, retrospectively analyzed from January 1, 2009, to December 31, 2015. Women aged 18-64 years with ≥ 1 UF claim from January 1, 2010, to December 31, 2014, a claim for a UF-related surgery (hysterectomy, myomectomy, uterine artery embolization [UAE], or ablation) from January 1, 2010, to November 30, 2015, and continuous enrollment for ≥ 1 year presurgery and ≥ 30 days postsurgery qualified for study inclusion. A 1-year period before the date of the first UF-related surgical claim after the first UF diagnosis was used to report baseline demographic and clinical characteristics. Surgery characteristics were reported. All-cause HCRU and costs (adjusted to 2017 U.S. dollars) were described by the 14 days pre-, peri-, and 30 days postoperative periods, and independently by the inpatient or outpatient setting. RESULTS: Overall, 113,091 patients were included in this study: commercial database, n = 103,814; Medicaid database, n = 9,277. Median time from the initial UF diagnosis to first UF-related surgical procedure was 33 days for the commercial population and 47 days for the Medicaid population. Hysterectomy was the most common UF-related surgery received after UF diagnosis (commercial, 68% [n = 70,235]; Medicaid, 75% [n = 6,928]). In both populations, 97% of patients had ≥ 1 outpatient visit from 14 days presurgery to 30 days postsurgery (commercial, n = 100,402; Medicaid, n = 9,023), and the majority of all UF-related surgeries occurred in the outpatient setting (commercial, 64% [n = 66,228]; Medicaid, 66% [n = 6,090]). Mean total all-cause costs for patients with UF who underwent any UF-related surgery were $15,813 (SD $13,804) in the commercial population (n = 95,433) and $11,493 (SD $26,724) in the Medicaid population (n = 4,785). Mean total all-cause costs for UF-related surgeries for the commercial/Medicaid populations were $17,450 (SD $13,483)/$12,273 (SD $19,637) for hysterectomy, $14,216 (SD $16,382)/$11,764 (SD $15,478) for myomectomy, $17,163 (SD $13,527)/$12,543 (SD $23,777) for UAE, $8,757 (SD $9,369)/$7,622 (SD $50,750) for ablation, and $12,281 (SD $10,080)/$5,989 (SD $5,617) for myomectomy and ablation. Mean total all-cause costs for any UF-related surgery performed in the outpatient setting in the commercial and Medicaid populations were $14,396 (SD $11,466) and $6,720 (SD $10,374), respectively, whereas costs in the inpatient setting were $18,345 (SD $16,910) and $21,805 (SD $43,244), respectively. CONCLUSIONS: This retrospective analysis indicated that surgical treatment options for UF continue to represent a substantial financial burden. This underscores the need for alternative, cost-effective treatments for the management of UF. DISCLOSURES: This study was sponsored by Allergan, Dublin, Ireland. Allergan played a role in the conduct, analysis, interpretation, writing of the report, and decision to publish this study. Harrington and Ye are employees of Allergan. Stafkey-Mailey, Fuldeore, and Yue are employees of Xcenda. Ta was a contractor at Allergan at the time the study was conducted and is currently supported by a training grant from Allergan. Bonine, Shih, and Gillard are employees of Allergan and have stock, stock options, and/or restricted stock units as employees of Allergan. Banks has no disclosures to report. This study was presented as a poster at Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX.

Development of a bedside tool to predict the probability of drug-resistant pathogens among hospitalized adult patients with gram-negative infections.

BACKGROUND: We developed a clinical bedside tool to simultaneously estimate the probabilities of third-generation cephalosporin-resistant Enterobacteriaceae (3GC-R), carbapenem-resistant Enterobacteriaceae (CRE), and multidrug-resistant Pseudomonas aeruginosa (MDRP) among hospitalized adult patients with Gram-negative infections. METHODS: Data were obtained from a retrospective observational study of the Premier Hospital that included hospitalized adult patients with a complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI), hospital-acquired/ventilator-associated pneumonia (HAP/VAP), or bloodstream infection (BSI) due to Gram-negative bacteria between 2011 and 2015. Risk factors for 3GC-R, CRE, and MDRP were ascertained by multivariate logistic regression, and separate models were developed for patients with community-acquired versus hospital-acquired infections for each resistance phenotype (N = 6). Models were converted to a singular user-friendly interface to estimate the probabilities of a patient having an infection due to 3GC-R, CRE, or MDRP when ≥ 1 risk factor was present. RESULTS: Overall, 124,068 patients contributed to the dataset. Percentages of patients admitted for cUTI, cIAI, HAP/VAP, and BSI were 61.6, 4.6, 16.5, and 26.4%, respectively (some patients contributed > 1 infection type). Resistant infection rates were 1.90% for CRE, 12.09% for 3GC-R, and 3.91% for MDRP. A greater percentage of the resistant infections were community-acquired relative to hospital-acquired (CRE, 1.30% vs 0.62% of 1.90%; 3GC-R, 9.27% vs 3.42% of 12.09%; MDRP, 2.39% vs 1.59% of 3.91%). The most important predictors of having an 3GC-R, CRE or MDRP infection were prior number of antibiotics; infection site; infection during the previous 3 months; and hospital prevalence of 3GC-R, CRE, or MDRP. To enable application of the six predictive multivariate logistic regression models to real-world clinical practice, we developed a user-friendly interface that estimates the risk of 3GC-R, CRE, and MDRP simultaneously in a given patient with a Gram-negative infection based on their risk (Additional file 1). CONCLUSIONS: We developed a clinical prediction tool to estimate the probabilities of 3GC-R, CRE, and MDRP among hospitalized adult patients with confirmed community- and hospital-acquired Gram-negative infections. Our predictive model has been implemented as a user-friendly bedside tool for use by clinicians/healthcare professionals to predict the probability of resistant infections in individual patients, to guide early appropriate therapy.

Healthcare resource utilization and costs among women diagnosed with uterine fibroids compared to women without uterine fibroids.

Objective: To perform a retrospective, matched-cohort, longitudinal evaluation of annual pre- and post-diagnosis costs incurred among women with uterine fibroids (UF) (cases) compared to controls without UF. Methods: Data were derived from the IBM Watson Health MarketScan Commercial Claims and Encounters and Medicaid Multi-State databases. Women aged 18-64 years with ≥1 inpatient or outpatient medical claim with an initial UF diagnosis (index date) from 1 January 2010 to 31 December 2014 were included. Healthcare resource utilization (HCRU) data including pharmacy, outpatient and inpatient hospital claims were collected for 1 year pre-index and ≤5 years post-index. All-cause costs (adjusted to 2017 $US) were compared between cases and controls using multivariable regression models. Results: Analysis included 205,098 (Commercial) and 24,755 (Medicaid) case-control pairs. HCRU and total all-cause healthcare costs were higher for cases versus controls during the pre-index year and all years post-index. Total unadjusted mean all-cause costs were $1197 higher (p < .0001; Commercial) and $2813 higher (standardized difference 0.08; Medicaid) for cases during the pre-index year. Total adjusted mean all-cause costs in the first year post-index were $14,917 for cases versus $5717 for controls in the Commercial population, and $20,244 versus $10,544, respectively, in the Medicaid population. In Years 2-5 post-index, incremental mean adjusted total costs decreased, but remained significantly higher for cases versus controls at all time points in both populations (all p < .05). Conclusions: Costs were higher for women with UF compared to women without UF during the pre-index year and over 5 years post-index; differences were greatest in the first year post-index.

Patient reported outcomes in routine care: advancing data capture for HIV cohort research.

INTRODUCTION: Computerized collection of standardized measures of patient reported outcomes (PROs) provides a novel paradigm for data capture at the point of clinical care. Comparisons between data from PROs and Electronic Health Records (EHR) are lacking. We compare EHR and PRO for capture of depression and substance abuse and their relationship to adherence to antiretroviral therapy (ART). METHODS: This retrospective study includes HIV-positive patients at an HIV clinic who completed an initial PRO assessment April 2008-July 2009. The questionnaire includes measures of depression (PHQ-9) and substance abuse (ASSIST). Self-reported ART adherence was modeled using separate logistic regression analyses (EHR vs PRO). RESULTS: The study included 782 participants. EHR vs PRO diagnosis of current substance abuse was 13% (n = 99) vs 6% (n = 45) (P < .0001), and current depression was 41% (n = 317) vs 12% (n = 97) (P < .0001). In the EHR model, neither substance abuse (OR = 1.25; 95% CI = 0.70-2.21) nor depression (OR = 0.93; 95% CI = 0.62-1.40) was significantly associated with poor ART adherence. Conversely, in the PRO model, current substance abuse (OR = 2.78; 95% CI = 1.33-5.81) and current depression (OR = 1.93; 95% CI = 1.12-3.33) were associated with poor ART adherence. DISCUSSIONS: The explanatory characteristics of the PRO model correlated best with factors known to be associated with poor ART adherence (substance abuse; depression). The computerized capture of PROs as a part of routine clinical care may prove to be a complementary and potentially transformative health informatics technology for research and patient care.

Short-term effect of fenofibrate on C-reactive protein: A meta-analysis of randomized controlled trials.

BACKGROUND: C-reactive protein (CRP) is positively associated with risk for cardiovascular disease and all-cause mortality. Some but not all randomized and non-randomized clinical trials found significant associations between fenofibrate therapy and CRP but the direction and magnitude of the association varied across studies. The duration of treatment, patient populations and sample sizes varied greatly, and most short-term studies (i.e., ≤ 12 weeks) had fewer than 50 patients. In this study we meta-analyzed randomized clinical trials to determine the short-term effect of fenofibrate on CRP. METHODS: Two reviewers independently searched PubMed and other online databases for short-term randomized clinical trials that reported CRP concentrations before and after fenofibrate treatment. Of the 81 studies examined, 14 studies with 540 patients were found eligible. Data for the change in CRP and corresponding measures of dispersion were extracted for use in the meta-analysis. RESULTS: The weighted mean CRP concentrations before and after fenofibrate therapy were 2.15 mg/L and 1.53 mg/L (-28.8% change), respectively. Inverse-variance weighted random effects meta-analysis revealed that short-term fenofibrate treatment significantly lowers CRP by 0.58 mg/L (95% CI: 0.36-0.80). There was significant heterogeneity between studies (Q statistic = 64.5, P< 0.0001, I2 = 79.8%). There was no evidence of publication bias and sensitivity analysis revealed that omitting any of the 14 studies did not lead to a different conclusion from the overall meta-analysis result. CONCLUSION: Short-term treatment with fenofibrate significantly lowers CRP concentration. Randomized trials that will recruit patients based with high baseline CRP concentrations and with change in CRP as a primary outcome are needed.

The role of toxicity-related regimen changes in the development of antiretroviral resistance.

In an effort to evaluate factors associated with the development of antiretroviral (ARV) resistance, we assessed the prevalence of toxicity-related regimen changes and modeled its association to the subsequent development of ARV resistance in a cohort of treatment-naive individuals initiating ARV therapy (ART). A retrospective analysis of patients initiating ART was conducted at the UAB 1917 Clinic from 1 January 2000 to 30 September 2007. Cox proportional hazards models were fit to identify factors associated with the development of resistance to ≥1 ARV drug class. Among 462 eligible participants, 14% (n=64) developed ARV resistance. Individuals with ≥1 toxicity-related regimen change (HR=3.94, 95% CI=1.09-14.21), initiating ART containing ddI or d4T (4.12, 1.19-14.26), and from a minority race (2.91, 1.16-7.28) had increased risk of developing resistance. Achieving virologic suppression within 12 months of ART initiation (0.10, 0.05-0.20) and higher pretreatment CD4 count (0.85 per 50 cells/mm(3), 0.75-0.96) were associated with decreased hazards of resistance. Changes in ART due to drug intolerance were associated with the subsequent development of ARV resistance. Understanding the role of ARV drug selection and other factors associated with the emergence of ARV resistance will help inform interventions to improve patient care and ensure long-term treatment success.

Darunavir outcomes study: comparative effectiveness of virologic suppression, regimen durability, and discontinuation reasons for three-class experienced patients at 48 weeks.

Several new antiretroviral (ARV) agents for treatment experienced HIV-infected patients have been approved since June 2006, including darunavir (DRV) and raltegravir (RAL). While efficacious in clinical trials, the effectiveness, durability, and tolerability of these new ARVs remains understudied in the context of routine clinical care. The Darunavir Outcomes Study is a prospective cohort study of three-class ARV-experienced patients changing regimens at the 1917 Clinic after 1/7/2006. All treatment decisions were at the discretion of primary providers. Multivariate (MV) logistic regression for 48 week VL < 400c/ml and Cox models for regimen durability were completed. Propensity score methods controlled for sociodemographics. Among 108 patients, mean age of 46, 48% were white, 80% male, with prior exposure to a mean 10.5 ARVs. Overall, 64% of patients achieved 48-week VL < 400 c/ml. In MV modeling DRV/rll (OR = 5.77;95%CI = 1.62-20.58) and RAL (OR = 3.84;95%CI = 1.23-11.95) use increased odds of 48-week suppression. Use of these agents exhibited a trend towards prolonged regimen durability in Cox models. Among those highly ARV-experienced, regimens containing DRV/r and/or RAL were more likely to achieve 48-week VL < 400 c/ml and exhibited a trend towards prolonged durability. New agents have transformed the treatment landscape for ARV-experienced patients, with effectiveness in routine clinical care mirroring efficacy in clinical trials.

Routine, self-administered, touch-screen, computer-based suicidal ideation assessment linked to automated response team notification in an HIV primary care setting.

BACKGROUND: Human immunodeficiency virus (HIV) and AIDS continue to be associated with an underrecognized risk for suicidal ideation, attempted suicide, and completed suicide. Suicidal ideation represents an important predictor for subsequent attempted and completed suicide. We sought to implement routine screening of suicidal ideation and associated conditions using computerized patient-reported outcome (PRO) assessments. METHODS: Two geographically distinct academic HIV primary care clinics enrolled patients who attended scheduled visits from December 2005 through February 2009. Touch-screen, computer-based PRO assessments were implemented into routine clinical care. Substance abuse, alcohol consumption, depression, and anxiety were assessed. The 9-item Patient Health Questionnaire assesses the frequency of suicidal ideation in the preceding 2 weeks. A response of "nearly every day" triggered an automated page to predetermined clinic personnel, who completed more detailed self-harm assessments. RESULTS: Overall, 1216 patients (740 from the University of Alabama at Birmingham and 476 from the University of Washington) completed the initial PRO assessment during the study period. Patients were predominantly white (646 [53%]) and male (959 [79%]), with a mean age (+/- standard deviation) of 44 +/- 10 years. Among surveyed patients, 170 (14%) endorsed some level of suicidal ideation, whereas 33 (3%) admitted suicidal ideation nearly every day. In multivariable analysis, suicidal ideation risk was lower with advancing age (odds ratio [OR], 0.74 per 10 years; 95% confidence interval [CI], 0.58-0.96) and was increased with current substance abuse (OR, 1.88; 95% CI, 1.03-3.44) and more-severe depression (OR, 3.91 for moderate depression [95% CI, 2.12-7.22] and 25.55 for severe depression [95% CI, 12.73-51.30]). DISCUSSION: Suicidal ideation was associated with current substance abuse and depression. The use of novel technologies to incorporate routine self-reported screening for suicidal ideation and other health domains allows for timely detection and intervention for this life-threatening condition.

Fasting Triglyceride Concentrations are Associated with Early Mortality Following Antiretroviral Therapy in Zambia.

BACKGROUND: In developing countries, 8 to 71% of patients initiating highly active antiretroviral therapy (HAART) die within the first year of treatment. Apart from baseline CD4 count, viral load, hemoglobin, BMI and stage of the disease, there may be other variables that contribute to AIDS-related mortality. We investigated the potential role of nutrition, lipids and insulin resistance-related phenotypes in predicting early mortality. METHODS: We recruited 210 HAART-naïve HIV/AIDS patients in Lusaka, Zambia. Dietary intake, anthropometric measurements, fasting serum insulin, glucose, and lipid profiles were assessed at baseline. Mortality was assessed after 90 days of follow-up. We used logistic regression models to identify variables associated with mortality. RESULTS: The mean±SD for age, BMI and CD4 count at baseline were 34±7.4 y, 20±3 kg/m(2) and 138±52 cells/µL, respectively. Sixteen patients (7.6%) died during follow-up. Triglyceride concentrations were associated with increased mortality [odds ratio (OR) for 1 mmol/L increase in triglyceride concentration=2.51; 95% CI: 1.34-4.71]. This association remained significant (OR=3.24; 95% CI: 1.51-6.95) after adjusting for age, gender, smoking, alcohol use, total cholesterol, BMI, CD4 count and n3 fatty acid intake. Apart from higher n3 fat intake which was inversely associated with mortality (survivors: 1.81±0.99% total energy/day vs. non-survivors 1.28±0.66% energy/day, P=0.04), there were no other macronutrients associated with mortality. CONCLUSION: Triglyceride concentrations at the time of initiating HAART are independently associated with increased risk for early mortality. If this association is confirmed in larger studies, assessment of triglycerides could become part of routine care of HIV patients initiating HAART in developing countries.

Methods for nutrigenomics and longevity studies in Drosophila: effects of diets high in sucrose, palmitic acid, soy, or beef.

Nutrigenomics is the study of gene-nutrient interactions and how they affect the health and metabolism of an organism. Combining nutrigenomics with longevity studies is a natural extension and promises to help identify mechanisms whereby nutrients affect the aging process, life span, and, with the incorporation of age-dependent functional measures, health span. The topics we discuss in this chapter are genetic techniques, dietary manipulations, metabolic studies, and microarray analysis methods to investigate how nutrition affects gene expression, life span, triglyceride levels, total protein levels, and live weight in Drosophila. To better illustrate nutrigenomic techniques, we analyzed Drosophila larvae or adults fed control diets (high sucrose) and compared these with larvae or adults fed diets high in the saturated fat palmitic acid, soy, or 95% lean ground beef. The main results of these studies are, surprisingly, that triglyceride and total protein levels are significantly decreased by the beef diet in all adults, and total protein levels are significantly increased in male flies fed the soy diet. Furthermore, and less surprisingly, we found that all three experimental diets significantly decreased longevity and increased the length of time to develop from egg to adult. We also describe preliminary microarray results with adult flies fed the different diets, which suggest that only about 2-3% of the approx 18,000 genes have significantly altered mRNA expression levels compared with flies fed a control sucrose diet. The significance of these results and other types of nutrigenomics and longevity analyses is discussed.