Validity and performance of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) among advanced urothelial cancer patients.

PURPOSE: The recent increase in emerging novel therapies in the bladder cancer therapeutic area has increased the need for fit-for-purpose patient-reported outcome (PRO) measures for these patients. This study evaluates the psychometric properties of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) in 182 patients with advanced urothelial cancer (UC) and fills an important gap by demonstrating its validity for use in clinical trials. METHODS: Data were collected as part of a multicentre, open-label study of durvalumab in patients with inoperable or metastatic solid tumours. Psychometric properties evaluated include item and subscale characteristics (including correlation analysis), reliability (estimated using Cronbach's α), validity (by independent sample t test), responsiveness (using mixed models with repeated measures), and clinically meaningful changes using both anchor-based and distribution-based methods. RESULTS: One hundred and seventy-two patients completed the FACT-Bl questionnaire at baseline. Many individual items had floor or ceiling effects indicative of minimal symptoms and high functioning. The psychometric properties of the existing established scales were assessed and found to range from acceptable to very good. Internal consistency (most Cronbach's α coefficients range 0.66-0.85) and stability (test-retest reliability) generally exceeded standards for good reliability (most estimated intraclass correlations [ICCs] exceeded 0.70, although ICCs for some items [e.g. emotional well-being, ICC 0.58; social well-being, ICC 0.66] were lower than 0.70). Evidence for known-group validity of relevant FACT-Bl subscales and total score was demonstrated by significant differences between groups defined by baseline tumour burden and quality of life scores (difference of FACT-Bl total between low/high tumour burden groups 11.72 (p = 0.001); difference between low/high QoL scores groups 30.51 (p < 0.0001)). The FACT-Bl subscale and total scores were responsive to changes in bladder cancer symptom severity. Clinically meaningful changes in FACT-Bl scores were estimated. CONCLUSIONS: Results support the use of the FACT-Bl within this patient population in future clinical research.

Evaluation of a Diabetes Self-Management Program: Claims Analysis on Comorbid Illnesses, Health Care Utilization, and Cost.

BACKGROUND: An estimated 30.3 million Americans have diabetes mellitus. The US Department of Health and Human Services created national objectives via its Healthy People 2020 initiative to improve the quality of life for people who either have or are at risk for diabetes mellitus, and hence, lower the personal and national economic burden of this debilitating chronic disease. Diabetes self-management education interventions are a primary focus of this initiative. OBJECTIVE: The aim of this study was to evaluate the impact of the Better Choices Better Health Diabetes (BCBH-D) self-management program on comorbid illness related to diabetes mellitus, health care utilization, and cost. METHODS: A propensity score matched two-group, pre-post design was used for this study. Retrospective administrative medical and pharmacy claims data from the HealthCore Integrated Research Environment were used for outcome variables. The intervention cohort included diabetes mellitus patients who were recruited to a diabetes self-management program. Control cohort subjects were identified from the HealthCore Integrated Research Environment by at least two diabetes-associated claims (International Classification of Diseases-Ninth Revision, ICD-9 250.xx) within 2 years before the program launch date (October 1, 2011-September 30, 2013) but did not participate in BCBH-D. Controls were matched to cases in a 3:1 propensity score match. Outcome measures included pre- and postintervention all-cause and diabetes-related utilization and costs. Cost outcomes are reported as least squares means. Repeated measures analyses (generalized estimating equation approach) were conducted for utilization, comorbid conditions, and costs. RESULTS: The program participants who were identified in HealthCore Integrated Research Environment claims (N=558) were matched to a control cohort of 1669 patients. Following the intervention, the self-management cohort experienced significant reductions for diabetes mellitus-associated comorbid conditions, with the postintervention disease burden being significantly lower (mean 1.6 [SD 1.6]) compared with the control cohort (mean 2.1 [SD 1.7]; P=.001). Postintervention all-cause utilization was decreased in the intervention cohort compared with controls with -40/1000 emergency department visits vs +70/1000; P=.004 and -5780 outpatient visits per 1000 vs -290/1000; P=.001. Unadjusted total all-cause medical cost was decreased by US $2207 in the intervention cohort compared with a US $338 decrease in the controls; P=.001. After adjustment for other variables through structural equation analysis, the direct effect of the BCBH-D was -US $815 (P=.049). CONCLUSIONS: Patients in the BCBH-D program experienced reduced all-cause health care utilization and costs. Direct cost savings were US $815. Although encouraging, given the complexity of the patient population, further study is needed to cross-validate the results.

Benefits of Diabetes Self-Management for Health Plan Members: A 6-Month Translation Study.

BACKGROUND: Diabetes self-management education has been shown to be effective in controlled trials. However, few programs that meet American Association of Diabetes Educators standards have been translated into widespread practice. OBJECTIVE: This study examined the translation of the evidence-based Better Choices, Better Health-Diabetes program in both Internet and face-to-face versions. METHODS: We administered the Internet program nationally in the United States (n=1010). We conducted face-to-face workshops in Atlanta, Georgia; Indianapolis, Indiana; and St. Louis, Missouri (n=232). Self-report questionnaires collected health indicator, health behavior, and health care utilization measures. Questionnaires were administered on the Web or by mail. We determined hemoglobin A1c (HbA1c) from blood samples collected via mailed kits. Paired t tests determined whether changes between baseline and 6 months differed significantly from no change. Subgroup analyses determined whether participants with specific conditions benefited (high HbA1c, depression, hypoglycemia, nonadherence to medication taking, and no aerobic exercise). We calculated the percentage of participants with improvements of at least 0.4 effect size in at least one of the 5 above measures. RESULTS: Of the 1242 participants, 884 provided 6-month follow-up questionnaires. There were statistically significant improvements in 6 of 7 health indicators (including HbA1c) and in 7 of 7 behaviors. For each of the 5 conditions, there were significant improvements among those with the condition (effect sizes 0.59-1.1). A total of 662 (75.0%) of study participants improved at least 0.4 effect size in at least one criterion, and 327 (37.1%) improved in 2 or more. CONCLUSIONS: The Diabetes Self-Management Program, offered in two modes, was successfully disseminated to a heterogeneous national population of members of either insured or administered health plans. Participants had small but significant benefits in multiple measures. The program appears effective in improving diabetes management.

A Diabetes Self-Management Program: 12-Month Outcome Sustainability From a Nonreinforced Pragmatic Trial.

BACKGROUND: Diabetes self-management education has been shown to be effective in controlled trials. The 6-week Better Choices, Better Health-Diabetes (BCBH-D) self-management program was also associated with an improvement in health outcomes in a 6-month translation study. OBJECTIVE: The objective of this study was to determine whether a national translation of the BCBH-D self-management program, offered both Web-based and face-to-face, was associated with improvements in health outcomes (including HbA1c) and health behaviors (including recommended medical tests) 1 year after intervention. METHODS: Web-based programs were administered nationally, whereas face-to-face workshops took place in Atlanta, Indianapolis, and St Louis. Self-report questionnaires were either Web-based or administered by mail, at baseline and 1 year, and collected health and health-behavior measures. HbA1c blood samples were collected via mailed kits. A previous 6-month study found statistically significant improvements in 13 of 14 outcome measures, including HbA1c. For this study, paired t test compared baseline with 1-year outcomes. Subgroup analyses determined whether participants with specific conditions improved (high HbA1c, depression, hypoglycemia, nonadherence to medication, no aerobic exercise). The percentage of participants with improvements in effect size of at least 0.4 in at least 1 of the 5 measures was calculated. RESULTS: A total of 857 participants with 1-year data (69.7% of baseline participants) demonstrated statistically significant 1-year improvements in 13 of 15 outcome measures; 79.9% (685/857) of participants showed improvements in effect size of 0.4 or greater in at least 1 of the 5 criterial measures. CONCLUSIONS: Participants had small but significant benefits in multiple measures. Improvements previously noted at 6 months were maintained or amplified at 1 year.

A patient preference and satisfaction study of ciclesonide nasal aerosol and mometasone furoate aqueous nasal spray in patients with perennial allergic rhinitis.

Patients' preference and satisfaction with their nasal allergy medications may be influenced by their sensory attributes. This study evaluates patient preference and satisfaction with ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) compared with mometasone furoate aqueous nasal spray (MFNS). Symptomatic subjects with perennial allergic rhinitis (PAR) were randomized to CIC-HFA at 74 micrograms or MFNS at 200 micrograms q.d. in an open-label, two-period, crossover study. Subject preference was recorded as total preference score (TPS; average of 17 individual preference items) at the end of treatment period 2, and satisfaction was assessed with a 76-item, self-administered instrument at baseline and at the end of each 2-week treatment period. The primary assessments were TPS and regimen attributes composite satisfaction score composed of two of nine satisfaction subscales: sensory impact (including medication running out of the nose, medication running down the throat, and impact on smell and taste) and regimen management (comprised of issues relating to dosing and ability to remember to take medication). Two hundred ninety-four subjects completed the study. A total of 68.1% of subjects preferred CIC-HFA (p < 0.0001 versus MFNS), with a mean TPS of 68.3 versus 31.7 for the MFNS group. The regimen attributes composite satisfaction score significantly (p < 0.0001 for each treatment period) favored CIC-HFA versus MFNS at the end of treatment period 1 (85.5 vs 77.6) and treatment period 2 (83.0 versus 73.5), respectively. In this study, subjects reported higher preference for and satisfaction with CIC-HFA compared with MFNS, suggesting significant differences in patient perception of attributes in favor of CIC-HFA. Clinical trial registration URL and registration number: www.clinicaltrials.gov/ct2/show/NCT01401465.

Validation of the allergic rhinitis treatment satisfaction and preference scale.

Allergic rhinitis (AR) affects 7.8% of U.S. adults and 10-30% of the population worldwide. AR symptoms (rhinorrhea, congestion, sneezing, nasal/ocular pruritus, and postnasal drainage) significantly impact sleep and reduce cognitive and emotional functioning affecting work and school productivity. Although effective, intranasal corticoid (INS) steroid delivery systems are often associated with adverse sensory attributes, affecting patient adherence and reducing efficacy. Patient satisfaction with treatment characteristics predicts adherence levels that can better inform treatment decisions. This study was designed to evaluate psychometric evidence for the self-administered Allergic Rhinitis Treatment Satisfaction and Preference (ARTSP) scale as a patient-reported outcomes measure for use in clinical research. Analytic methods included qualitative analysis of patient focus groups and psychometric analysis of scale data collected from 185 AR subjects enrolled in a randomized, 2-week, crossover, comparative U.S. clinical trial. Qualitative analysis conceptually supported nine treatment satisfaction subscales. Reliability by Cronbach alpha met accepted standards. Evidence was found for construct validity using structural equation modeling, criterion validity from correlation patterns between treatment satisfaction and health-related quality of life scales, and discriminant validity analysis based on AR symptom-defined groups. Responsiveness was shown by significant change in treatment satisfaction subscales among AR symptom change groups. Scores on treatment preference items discriminated between the aqueous and aerosol INS formulations. The ARTSP scale is a conceptually sound, reliable, valid, and responsive measure of patient evaluations of alternative therapies, providing detailed information about treatment characteristics that are likely to influence adherence levels and subsequent AR clinical control.

Diagnosing Laryngopharyngeal Reflux: A Comparison between 24-hour pH-Impedance Testing and Pharyngeal Probe (Restech) Testing, with Introduction of the Sataloff Score.

OBJECTIVE: The purpose of this study was to compare the diagnostic utility of pH monitoring using 24-hour esophageal pH-Impedance (HEMII-pH) testing versus pharyngeal pH (Restech) testing (Respiratory Technology Corporation, Houston, Texas) for diagnosing laryngopharyngeal reflux (LPR). METHODS: Retrospectively, patients were reviewed who had completed a Reflux Symptom Index (RSI) survey and stroboscopy within 60 days before or after undergoing simultaneous esophageal pH-Impedance monitoring and Restech testing. Reflux Finding Score (RFS) was determined by 4 blinded observers. 80.45% of patients were on anti-reflux medications at the time of study and had incomplete response to treatment for reflux. Improvement on reflux treatment was determined by evaluating presenting pre-pH monitoring RFS, post treatment RFS, and improvement of symptoms. Pearson correlation coefficients were calculated to assess relationships among RSI, RFS, and test results from HEMII-pH and Restech tests. RESULTS: Eighty-seven patients were included in the analysis. The inter-rater reliability of the RFS determination was 74.57%, and the intra-rater reliability was 67.00%. Subjects who had a positive RYAN Score had a significant correlation with RFS (r of 0.222 and p-value of 0.0492). There was no correlation between RFS and number or percent time of reflux events, longest event, total number of events, or percent of time at alkaline pH for either HEMII-PH or Restech test. RSI correlated better with HEMII-pH test than with Restech for percent time spent in both upright (r of 0.226 and p-value of 0.029) and supine position (r of 0.261 and a p-value of 0.032). Restech correlated better with total patient symptom Scores including cough, heartburn, burping, and throat clearing, with a r of 0.242 and a p-value of 0.048. Restech detected more percent time in reflux for total reflux, supine reflux, and upright reflux (p-value less than 0.0001). Restech also detected longer event times than Impedance (p-value of less than 0.0001). When diagnosis of LPR is based on the definition of CRC, the Sataloff Score test had 70.45% sensitivity and 80.95% specificity. The RYAN Score had a sensitivity of 72%, and a specificity of 56.45%, and the Wu Score had a sensitivity of 62.16%, and specificity of 54.05%. When the Sataloff and Wu Score were used together, the sensitivity was 71.45%, specificity 100%, positive predictive value of 100%, and a negative predictive value of 59.46%. CONCLUSION: The amount of time of reflux events correlates with symptoms better than the number of events. The HEMII-pH test was able to detect more events of pH<4 than Restech, possibly because there might have been more acid events below than above the upper esophageal sphincter, while Restech detected more total events. Restech recorded longer event times than HEMII-pH test. Since length of time correlates with RFS (probably reflecting laryngeal inflammation), and since laryngeal clearance of acid is more similar to pharyngeal than esophageal clearance, this finding might prove valuable clinically. The Sataloff Score has a sensitivity of 70.45%, and a specificity of 80.95% and appears useful clinically to detect mild to moderate that is missed by the RYAN Score. A combination of Sataloff Score and Wu Score may be clinically valuable to identify LPR with an increased sensitivity of 71.45% and increased specificity of 100%. The Wu Score is not yet available for the general clinical use, but the Sataloff Score is.

Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin.

BACKGROUND: Tesamorelin, a growth hormone-releasing hormone analogue, decreases visceral adipose tissue (VAT) by 15%-20% over 6-12 months in individuals with human immunodeficiency virus (HIV)-associated abdominal adiposity, but it is unknown whether VAT reduction is directly associated with endocrine and metabolic changes. METHODS: In 2 phase III, randomized, double-blind studies, men and women with HIV-associated abdominal fat accumulation were randomly assigned (ratio, 2:1) to receive tesamorelin or placebo for 26 weeks. At week 26, patients initially receiving tesamorelin were randomly assigned to continue receiving tesamorelin or to receive placebo for an additional 26 weeks. In per-protocol analysis of 402 subjects initially randomly assigned to receive tesamorelin, those with ≥8% reduction in VAT were defined a priori as responders per the statistical analysis plan. Post hoc analyses were performed to assess differences between responders and nonresponders. RESULTS: Compared with tesamorelin nonresponders, responders experienced greater mean (±SD) reduction in triglyceride levels (26 weeks: -0.6 ± 1.7 mmol/L vs -0.1 ± 1.2 mmol/L [P = .005]; 52 weeks: -0.8 ± 1.8 mmol/L vs 0.0 ± 1.1 mmol/L [P = .003]) and attenuated changes in fasting glucose levels (26 weeks: 1 ± 16 mg/dL vs 5 ± 14 mg/dL [P = .01]; 52 weeks: -1 ± 14 mg/dL vs 8 ± 17 mg/dL [P < .001]), hemoglobin A1c levels (26 weeks: 0.1 ± 0.3% vs 0.3 ± 0.4% [P < .001]; 52 weeks: 0.0 ± 0.3% vs 0.2 ± 0.5% [P = .003]), and other parameters of glucose homeostasis. Similar patterns were seen for adiponectin levels, with significant improvement in responders vs nonresponders. Changes in lipid levels and glucose homeostasis were significantly associated with percentage change in VAT. CONCLUSIONS: In contrast to nonresponders, HIV-infected patients receiving tesamorelin with ≥8% reduction in VAT have significantly improved triglyceride levels, adiponectin levels, and preservation of glucose homeostasis over 52 weeks of treatment. CLINICALTRIALS.GOV REGISTRATION: NCT00123253, NCT00435136, NCT00608023.

Contribution of coexisting sulfate and iron reducing bacteria to methylmercury production in freshwater river sediments.

We investigated microbial methylmercury (CH(3)Hg) production in sediments from the South River (SR), VA, an ecosystem contaminated with industrial mercury (Hg). Potential Hg methylation rates in samples collected at nine sites were low in late spring and significantly higher in late summer. Demethylation of (14)CH(3)Hg was dominated by (14)CH(4) production in spring, but switched to producing mostly (14)CO(2) in the summer. Fine-grained sediments originating from the erosion of river banks had the highest CH(3)Hg concentrations and were potential hot spots for both methylation and demethylation activities. Sequencing of 16S rRNA genes of cDNA recovered from sediment RNA extracts indicated that at least three groups of sulfate-reducing bacteria (SRB) and one group of iron-reducing bacteria (IRB), potential Hg methylators, were active in SR sediments. SRB were confirmed as a methylating guild by amendment experiments showing significant sulfate stimulation and molybdate inhibition of methylation in SR sediments. The addition of low levels of amorphous iron(III) oxyhydroxide significantly stimulated methylation rates, suggesting a role for IRB in CH(3)Hg synthesis. Overall, our studies suggest that coexisting SRB and IRB populations in river sediments contribute to Hg methylation, possibly by temporally and spatially separated processes.

Comparing the use of intravenous antibiotics under the medical benefit with the use of oral antibiotics under the pharmacy benefit in treating skin and soft tissue infections.

PURPOSE: To assess differences in the simultaneous management of pharmacy and medical benefits by analyzing the health care utilization and costs associated with managed care patients who received oral linezolid as a pharmacy benefit or intravenous (IV) daptomycin or IV vancomycin as medical benefits for skin and soft tissue infections (SSTIs). METHODOLOGY: The first medical or pharmacy claim from 03/01/2007 to 03/01/2010 was defined as the index date. Patients 18-64 years of age, with an inpatient SSTI diagnosis and > or = 1 target antibiotic claim(s), were included. Follow-up was 45 days; hospitalizations, emergency room (ER) visits, outpatient medical services, prescription fills, and total health care costs were compared for the treatments using univariate generalized linear modeling (GLM) analyses. Total health care costs were compared with GLM multivariate analyses adjusting for baseline covariate values. RESULTS: Of the 8,905 patients included, 2,123 received linezolid, 5,503 vancomycin, and 1,279 daptomycin therapy; 14.4% of linezolid, 37.7% of vancomycin, and 22.8% of daptomycin patients were re-hospitalized (p < 0.001). A smaller proportion of linezolid patients (8.6%) required emergency services, versus 11.6% of vancomycin and 10.8% of daptomycin patients (p < 0.001). Multivariate analyses showed vancomycin costs to be significantly lower than daptomycin costs, -$5,425 (95% CI, -$1,535 to -$9,315), and a significantly higher mean cost difference for vancomycin, $11,182 (95% CI, $6,255 to $16,108), and daptomycin, $16,607 (95% CI, $9,426 to $23,788), versus linezolid. CONCLUSION: Patients treated with oral linezolid had fewer re-hospitalizations and emergency room visits and lower total costs compared with patients who received vancomycin or daptomycin therapy, suggesting that oral linezolid, which is covered under members' pharmacy benefits, may be more cost-effective than the two intravenous treatments for SSTIs.

Metabolic effects of a growth hormone-releasing factor in patients with HIV.

BACKGROUND: Visceral adipose tissue accumulates during antiretroviral therapy in many patients who are infected with the human immunodeficiency virus (HIV); this process is associated with an increased cardiovascular risk. We assessed the use of a growth hormone-releasing factor analogue, tesamorelin, to decrease visceral adiposity. METHODS: We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks. The primary end point was the percent change from baseline in visceral adipose tissue as shown on computed tomography. Secondary end points included triglyceride levels, the ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol, the level of insulin-like growth factor I (IGF-I), and self-assessed body image. Glycemic measures included glucose and insulin levels. RESULTS: The measure of visceral adipose tissue decreased by 15.2% in the tesamorelin group and increased by 5.0% in the placebo group; the levels of triglycerides decreased by 50 mg per deciliter and increased by 9 mg per deciliter, respectively, and the ratio of total cholesterol to HDL cholesterol decreased by 0.31 and increased by 0.21, respectively (P<0.001 for all comparisons). Levels of total cholesterol and HDL cholesterol also improved significantly in the tesamorelin group. Levels of IGF-I increased by 81.0% in the tesamorelin group and decreased by 5.0% in the placebo group (P<0.001). Adverse events did not differ significantly between the two study groups, but more patients in the tesamorelin group withdrew from the study because of an adverse event. No significant differences were observed in glycemic measures. CONCLUSIONS: Daily tesamorelin for 26 weeks decreased visceral fat and improved lipid profiles, effects that might be useful in HIV-infected patients who have treatment-associated central fat accumulation. (ClinicalTrials.gov number, NCT00123253 [ClinicalTrials.gov] .).

Complications and Economic Burden Associated With Obtaining Tissue for Diagnosis and Molecular Analysis in Patients With Non-Small-Cell Lung Cancer in the United States.

PURPOSE: With an increase in biomarker-directed therapies, tissue biopsy to identify targetable genomic and immunologic alterations has become the mainstay of managing patients with non-small-cell lung cancer (NSCLC); however, little is known about the associated economic impact and complication rate. This study assesses the frequency, complications, and costs of diagnostic and postprogression biopsy. METHODS: This retrospective, observational study was conducted using administrative claims data from more than 30 million commercially insured individuals in the United States (2006 to 2014). Data were analyzed for the overall population and by time of biopsy (diagnostic or postprogression biopsy). RESULTS: Of 20,013 eligible patients, 13,411 (67%) received a diagnostic biopsy, whereas only 2,056 (10%) received a postprogression biopsy (mean cost, $9,977 and $16,806, respectively). Complication rates were similar at diagnosis and after progression, on the day of biopsy (10% v 7%, respectively) and within 30 days (63% v 61%, respectively). Mean costs were higher among patients with a complication compared with those without a complication on the day of biopsy (diagnostic biopsy, $12,030 v $6,508, respectively; postprogression biopsy, $22,593 v $7,812, respectively), within 7 days of biopsy (diagnostic biopsy, $13,657 v $7,765, respectively; postprogression biopsy, $23,969 v $8,932, respectively), and within 30 days of biopsy (diagnostic biopsy, $24,968 v $15,988, respectively; postprogression biopsy, $30,293 v $12,494, respectively; P < .001 for all comparisons). CONCLUSION: From 2006 to 2014, postprogression biopsies were not common practice in NSCLC. Complication rates were similar at diagnosis and after progression, with mean costs higher among patients with a complication than those without a complication. With increasing demands for effective novel targeted therapies and safe testing methods, these data may be valuable in determining the budget impact and comparing complication rates with newer, less invasive molecular testing methods, including plasma circulating tumor DNA testing.

Prostate cancer screening and shared decision-making preferences among African-American members of the Prince Hall Masons.

OBJECTIVES: Shared decision making (SDM) is recommended as one method to assist men in making an informed decision about prostate cancer screening (PCS). SDM preferences for PCS have not been evaluated among African-American (AA) men. Given AA men's increased risk and the uncertainty surrounding screening, it is critical to determine how to assist AA men in making an informed decision. We assessed the extent to which a sample of AA men wished to engage in SDM regarding PCS and the demographic and psychological characteristics associated with SDM preferences. METHODS: Participants completed a telephone interview that covered demographic and medical information, SDM preferences, PCS knowledge, decisional conflict, and satisfaction with previous screening decisions. Subjects included 286 AA men aged 40-70, who were members of a Masonic organization. RESULTS: Fifty-seven percent preferred SDM, 36% preferred to make their own decision, and 7% wanted their doctor to decide. A higher level of education and older age were associated with preferring SDM (p<0.05), while men with greater PCS knowledge were more likely to prefer to make the decision independently (p<0.05). CONCLUSIONS: Results suggest that physicians need to be prepared to discuss PCS with their patients. Further, more attention may be needed to engage younger, less educated, and less knowledgeable men as they may be less likely to discuss PCS. This understanding of AA men's preferences for PCS decisions helps to clarify the issues that health professionals need to consider when attempting to assist AA men in making a PCS decision.

Impact of chronic Immune Thrombocytopenic Purpura (ITP) on health-related quality of life: a conceptual model starting with the patient perspective.

BACKGROUND: Immune thrombocytopenic purpura (ITP), a condition characterized by autoimmune-mediated platelet destruction and suboptimal platelet production, is associated with symptoms such as bruising, epistaxis, menorrhagia, mucosal bleeding from the gastrointestinal and urinary tracts and, rarely central nervous system bleeding. The aim of this research is to develop a conceptual model to describe the impact of ITP and its treatment on patients' health-related quality of life (HRQoL). METHODS: A literature search and focus groups with adult ITP patients were conducted to identify areas of HRQoL affected by ITP. Published literature was reviewed to identify key HRQoL issues and existing questionnaires used to assess HRQoL. Focus group transcripts were reviewed, and common themes were extracted by grouping conceptual categories that described the impact on HRQoL. RESULTS: The literature synthesis and themes from the focus group data suggest that decreased platelet counts, disease symptoms, and treatment side effects influence multiple domains of HRQoL for ITP patients. Key areas affected by ITP and its treatments include emotional and functional health, work life, social and leisure activities, and reproductive health. CONCLUSION: ITP affects various areas of HRQoL. This conceptual model will help inform the evaluation of therapeutic strategies for ITP.

Overlap of Asthma and Chronic Obstructive Pulmonary Disease in Patients in the United States: Analysis of Prevalence, Features, and Subtypes.

BACKGROUND: Although asthma and chronic obstructive pulmonary disease (COPD) are clinically distinct diseases, they represent biologically diverse and overlapping clinical entities and it has been observed that they often co-occur. Some research and theorizing suggest there is a common comorbid condition termed asthma-chronic obstructive pulmonary disease overlap (ACO). However, the existence of ACO is controversial. OBJECTIVE: The objective of this study is to describe patient characteristics and estimate prevalence, health care utilization, and costs of ACO using claims-based diagnoses confirmed with medical record information. METHODS: Eligible patients were commercial US health plan enrollees; ≥40 years; had asthma, COPD, or ACO; ≥3 prescription fills for asthma/COPD medications; and ≥2 spirometry tests. Records for a random sample of 5000 patients with ACO were reviewed to validate claims-based diagnoses. RESULTS: The estimated ACO prevalence was 6% (estimated 10,250/183,521) among 183,521 full study patients. In the claims-based cohorts, the comorbidity burden for ACO was greater versus asthma but similar to COPD cohorts. Medication utilization was higher in ACO versus asthma and COPD. Mean total health care costs were significantly higher for ACO versus asthma but similar to COPD. In confirmed diagnoses cohorts, mean total health care costs (medical plus pharmacy) were lower for ACO versus COPD but similar to asthma (US $20,035; P=.56). Among confirmed cases, where there was medical record evidence, smoking history was higher in ACO (300/343, 87.5%) versus asthma cohorts (100/181, 55.2%) but similar to COPD (68/84, 81%). CONCLUSIONS: ACO had more comorbidities, medication utilization, and costs than patients with asthma or COPD but differences were not seen after confirmation with medical records.

Real-world effectiveness, adherence and persistence among patients with type 2 diabetes mellitus initiating dulaglutide treatment.

OBJECTIVES: To assess glycemic effectiveness, adherence and persistence within 6 months of treatment initiation with dulaglutide, a once weekly GLP-1 receptor agonist, in a US real-world setting. METHODS: This retrospective claims analysis included adults (≥18 years) with T2DM from the HealthCore Integrated Research Database, who had HbA1c laboratory results around initiation and within 6 months after initiation. Glycemic control was assessed by change in HbA1c from pre-initiation to post-initiation. Patients were considered adherent if their proportion of days covered (PDC) was ≥0.80; persistence was measured as days of continuous therapy from initiation to 6 months after initiation with no gaps >45 days between fills. RESULTS: Of the 308 analyzed patients, the majority (n = 188; 61%) were adherent to dulaglutide (mean PDC 0.76; SD 0.26), with 115 patients (37%) discontinuing treatment. Mean persistence was 152 days/5 months. Mean HbA1c decreased from 8.49% (SD 1.70, median 8.20%) at baseline to 7.59% (SD 1.51, median 7.30%) at follow-up, corresponding to a mean HbA1c change of -0.90% (95% confidence interval [CI] -1.08 to -0.73; p < .01; median -0.70%). Patients who were adherent to or persistent with dulaglutide experienced larger reductions (-1.14% and -1.12% respectively), as did those without prior GLP-1 RA use (-1.03%). The proportion of patients with HbA1c <7% increased from 18% to 40%. CONCLUSIONS: Dulaglutide was associated with a significant decrease in HbA1c levels 6 months after treatment initiation. Patients who adhered to or persisted with dulaglutide therapy, or were naïve to GLP-1 RA use, experienced greater decreases in HbA1c levels.