BACKGROUND: Diabetes is a prevalent chronic condition in the United States that results in considerable morbidity and mortality, frequent use of the health care system, and high health care expenditures. Adherence to antidiabetic medications can help improve health outcomes and lower health care utilization and expenditures. The Pharmacy Quality Alliance (PQA) Proportion of Days Covered (PDC): Diabetes All Class medication adherence measure was developed and endorsed to improve adherence to noninsulin antidiabetic medications; however, it has not been assessed in a commercial population of diabetes patients over a 1-year time frame. OBJECTIVE: To determine the association between adherence, as defined in the PQA medication adherence measures, and health care utilization and expenditure among commercially insured individuals using antidiabetic medications. METHODS: This 1-year retrospective study evaluated a cohort of individuals from IBM MarketScan Research Databases (2009-2015) with noninsulin antidiabetic medications. Eligible study subjects included adults (aged ≥ 18 years at index date) with continuous enrollment in their health plans for 6 months before (i.e., baseline period) and 12 months after (i.e., study period) the index date and ≥ 2 prescriptions dispensed for any medication included in the PQA PDC Diabetes All Class medication adherence measure, with at least 150 days between the first and last fill during the study period. The index date was defined as the first fill for a medication included in the PQA PDC Diabetes All Class adherence measure after a 180-day baseline period. Generalized linear models with log link and gamma distribution (expenditure) or negative binomial distribution (utilization) assessed relationships between adherence (≥ 80% PDC) and health care utilization and expenditure while adjusting for potential confounders. Cost ratios (CR) and rate ratios (RR) were computed using beta coefficients. Cohort characteristics were compared using t-tests, Wilcoxon rank sum tests, or chi-square tests with an alpha level of 0.001 set a priori. RESULTS: A total of 1,576,112 individuals were eligible; of these, 1,028,176 (65.2%) were adherent. Significant differences in demographic characteristics were observed between adherent and nonadherent groups (P < 0.001). Multivariable analyses demonstrated that adherence was associated with the following: (a) 16.6% fewer inpatient (RR = 0.834, 95% CI = 0.819-0.850) and 3.6% more outpatient service visits (RR = 1.036, 95% CI = 1.032-1.039) and (b) 16.8% lower inpatient expenditures (CR = 0.833, 95% CI = 0.829-0.836); 2.6% lower outpatient expenditures (CR = 0.974, 95% CI = 0.970-0.978); 16.4% higher prescription drug expenditures (CR = 1.164, 95% CI = 1.159-1.169); and 4.2% lower total (CR = 0.958, 95% CI = 0.954-0.962) expenditures. Adherent subjects were associated with lower incremental per member per month expenditures for inpatient (-$31.74), outpatient (-$10.09), and total (-$30.82) expenditures, yet higher prescription drug expenditures ($25.60) compared with nonadherent subjects. CONCLUSIONS: Adherence to noninsulin antidiabetic medications was associated with more outpatient and fewer inpatient visits, as well as lower total expenditures compared with nonadherence. DISCLOSURES: Funding was provided by grants from Pharmacy Quality Alliance, Merck & Co. (Kenilworth, NJ), and SinfoniaRx. In addition, Chinthammit reports personal fees from Eli Lilly and Company, outside the submitted work. Axon reports grants from the American Association of Colleges of Pharmacy and the Arizona Department of Health Services, outside the submitted work. Taylor reports grants from the Arizona Department of Health Services, outside the submitted work. Warholak reports grants from Novartis and the Arizona Department of Health Services, outside the submitted work. Chinthammit and Campbell disclose that this work was completed during their employment at the University of Arizona. This research was presented as a poster at the AMCP Annual Meeting 2019; March 25-28, 2019; San Diego, CA.

Background: According to the American College of Cardiology/the American Heart Association (ACC/AHA) recommendations, health-related risk behaviors for secondary prevention of myocardial infarction (MI) are critical to determine. Objective: This study aimed to compare health-related risk behaviors between MI survivors and propensity-score matched non-MI controls using nationally representative data. Methods: This cross-sectional, matched case-control study used publicly available Behavioral Risk Factor Surveillance System (BRFSS) 2017 data. Older adults with MI were propensity-score-matched to their non-MI controls. The 10 dependent variables included body mass index (BMI), smoking status, heavy alcohol consumption, influenza vaccine, length of time since last routine and cholesterol checkup, alcohol consumption, fruit and vegetable consumption, and physical activity. Chi-square tests and binomial logistic regression were used to examine the health-related risk behaviors differences between MI survivors and propensity-score-matched non-MI controls. Results: The final study sample consisted of 18,021 MI survivors and 54,063 non-MI controls after propensity score matching. Multivariable logistic regression analysis showed significant differences between MI survivors and matched non-MI controls in terms of cholesterol checkup, smoking status, and alcohol consumption. For example, multivariate analysis of health-related risk behaviors showed MI survivors were more likely to be smokers (AOR = 1.46, 95% CI: 1.28-1.68). Conclusion: Based on this national survey of adults, MI survivors were more likely to be smokers but less likely to consume alcohol compared to their propensity-score-matched controls. Moreover, MI survivors were more likely to have their cholesterol checkup within the past 2 years compared to matched non-MI controls. Although lower alcohol consumption and greater chances of cholesterol checkups are reassuring health-related behaviors, interventions are needed to minimize the chances of smoking in this population.

PIK3CA mutation frequency varies among breast cancer (BC) subtypes. Recent evidence suggests combination therapy with the PI3K inhibitor (PI3Ki) alpelisib and endocrine therapy (ET) improves response rates and progression-free survival (PFS) in PIK3CA -mutant, hormone receptor positive (HR+) BC versus ET alone; thus, better understanding the clinical and epidemiologic elements of these mutations is warranted. This systematic review characterizes the PIK3CA mutation epidemiology, type of testing approaches (e.g., liquid or tissue tumor biopsy), and stability/concordance (e.g., consistency in results by liquid versus solid tumor sample, by the same method over time) in patients with HR+/HER2– advanced (locally unresectable) or metastatic disease (HR+/HER2– mBC) and explores performance (e.g., pairwise concordance, sensitivity, specificity, or predictive value) of respective mutation findings. A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and select conference abstracts (i.e., AACR, ASCO, SABCS, ECCO, and ESMO conferences between 2014 and 2017) identified 39 studies of patients with HR+, HER2– mBC. The median prevalence of PIK3CA mutation was 36% (range: 13.3% to 61.5%); identified testing approaches more commonly used tissue over liquid biopsies and primarily utilized next-generation sequencing (NGS), polymerase chain reaction (PCR), or Sanger sequencing. There was concordance and stability between tissues (range: 70.4% to 94%) based on limited data. Given the clinical benefit of the PI3Ki alpelisib in patients with PIK3CA mutant HR+/HER2– mBC, determination of tumor PIK3CA mutation status is of importance in managing patients with HR+/HER2– mBC. Prevalence of this mutation and utility of test methodologies likely warrants PIK3CA mutation testing in all patients with this breast cancer subtype via definitive assessment of PIK3CA mutational status.

PIK3CA mutations may have prognostic value for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, representing an important potential target for systemic therapy. Prognostic and predictive values associated with PIK3CA mutations are not well understood. A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and conference abstracts was performed for English-language articles published January 1993 through April 2019. Articles were categorized by treatment arms based on experimental and treatment drug classes. Information on progression-free survival (PFS), hazard ratios, overall survival, response rate, and clinical benefit rate was obtained. A total of 17 studies were included. Among those evaluating non-PI3Ki based therapies, 91% showed numerically shorter median PFS, ranging from 1.5 to 19.2 months and 1.8 to 29.6 months for the mutant versus non-mutant subgroups, respectively. Where reported (n = 13 studies), PFS was shorter between those arms offering endocrine monotherapy (range, 1.6-14.7 months) compared with a corresponding targeted therapy + endocrine monotherapy (range, 3.9-29.6 months). Of 5 PI3Ki-based arms comparing PFS, higher median PFS in PIK3CA mutant versus non-mutant cases was demonstrated. PFS was shorter for patients with PIK3CA mutant (range, 1.6-19.2 months) compared with PIK3CA wild-type (range, 1.8-29.6 months) in 10 (71%) of 14 treatment arms reporting PFS. Studies (n = 4) not reporting PFS reported response rate, but there were no clear directional trends. The presence of PIK3CA mutations may be associated with worse clinical outcomes in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. Clinical outcomes such as PFS may be improved using a combination of PI3Ki-based therapies and endocrine therapies among this population. However, more research is warranted to fully elucidate this association. (C) 2019 Elsevier Inc. All rights reserved.

Abstract Background Older surgical patients are at high risk of developing postoperative delirium. Non-pharmacological strategies are recommended for delirium prevention, but no pharmacological agents have compelling evidence to decrease the incidence of delirium. The purpose of this study was to assess whether perioperative melatonin decreases the incidence of delirium in older adults undergoing surgical procedures. Methods A systematic search using PubMed/Medline, Embase, PsycINFO, CINAHL, and references of identified articles published in English between January 1990 and October 2017 was performed. Two independent reviewers screened titles and abstracts, and then extracted data following a full-text review of included articles with consensus generation and bias assessment. Studies reporting outcomes for melatonin or ramelteon use to prevent delirium in postoperative hospitalized patients (mean age ≥ 50 years) were eligible for inclusion. Data were pooled using a fixed-effects model to generate a forest plot and obtain a summary odds ratio for the outcome of interest (delirium incidence). Cochran’s Q and I2 values were used to investigate heterogeneity. Results Of 335 records screened, 6 studies were selected for the qualitative analysis and 6 were included in the meta-analysis (n = 1155). The mean age of patients in included studies ranged from 59 to 84 years. Patients in intervention groups typically received melatonin or ramelteon at daily doses of two to eight milligrams around cardiothoracic, orthopedic, or hepatic surgeries for one to nine days, starting on the evening before or the day of surgery. The incidence of delirium ranged from 0 to 30% in the intervention groups versus 4–33% in the comparator groups, and was significantly reduced in the melatonin group, with a summary effect of the meta-analysis yielding an odds ratio of 0.63 (95% CI 0.46 to 0.87; 0.006; I2 = 72.1%). A one study removed analysis reduced overall odds ratio to 0.310 (95% CI 0.19 to 0.50), while reducing heterogeneity (Cochran’s Q = 0.798, I2 = 0.000). Conclusion Perioperative melatonin reduced the incidence of delirium in older adults in the included studies. While optimal dosing remains an unanswered question, the potential benefit of melatonin and melatonin receptor agonists may make them a reasonable option to use for delirium prevention in older adults undergoing surgical procedures.

e13037 Background: The predictive and prognostic value of PIK3CA mutation in HR+/HER2–metastatic breast cancer (mBC) is not known. This study aimed to assess clinical prognosis for patients with HR+/HER2–mBC with or without PIK3CA mutation. Methods: A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and select conference abstracts was performed by two independent researchers. English-language articles published 01/1993 to 12/2017 with patients with HR+/HER2– mBC treated with monotherapy or combination therapy and reporting efficacy and safety were included. Studies were summarized by PIK3CA mutation status, clinical outcomes, and mechanism of action (PI3Ki-based therapies vs. non-PI3Ki targeted therapies vs. endocrine monotherapies). Results: Of 558 full-text articles reviewed, 12 met inclusion criteria, encompassing 20 distinct study arms. Eight arms combined PI3Ki with antiestrogens (fulvestrant, n = 5; letrozole, n = 2; tamoxifen, n = 1); six arms investigated an endocrine monotherapy (fulvestrant, n = 4, letrozole, n = 1, exemestane, n = 1); four arms investigated a non-PI3Ki targeted therapy (mTOR inhibitors, n = 2, ribociclib, n = 1, palbociclib, n = 1). Across ten non-PI3Ki- based study arms that reported median PFS, nine arms showed a numerically lower median PFS in the PIK3CA mutant subgroup relative to the non-mutant subgroup (non-PI3Ki targeted therapies, 4/4; endocrine monotherapies 5/6). All four PI3Ki-based arms that reported median PFS demonstrated a numerical benefit of median PFS in PIK3CA mutant vs. non-mutant patients. Findings from other available outcomes were generally consistent. Conclusions: PIK3CA mutation may exhibit both prognostic and predictive value in HR+/HER2- mBC. PIK3CA mutant cohorts may be associated with worse clinical prognosis vs. wild-type when treated with non-PI3Ki- based therapies. However, PI3Ki-based therapy may yield oncologic benefit for such patients. As this study is qualitative in nature, future investigation using a quantitative approach is warranted.

Abstract Introduction: Clinical research on the predictive value of PIK3CA mutations in hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2–) metastatic breast cancer (mBC) has advanced in recent years. However, knowledge of epidemiological prevalence has not been systematically evaluated. This study aimed to report prevalence of PIK3CA mutation using different biopsy techniques as well as specific hotspot mutations across the available literature. Methods: A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and select conference abstracts was performed by two independent researchers that included, but was not limited to, keywords: “breast neoplasm”, “PIK3CA protein”, “hormone receptor positive”, and “metastases”. English-language studies in HR+, HER2– mBC detailing the prevalence of PIK3CA mutations and published between January 1993 through August 2017 were included. Content analysis was employed to quantify collected data elements. Results: Of 558 studies included for full-text review, 36 met inclusion criteria. Most included studies (n = 18) were observational in nature. A total of 4,247 samples were tested for genetic mutations. Most studies used tissue biopsy samples (n = 33; 89%). Tumor samples accounted for 84.6% of all samples (n = 3597). Liquid biopsies were performed in 4 studies (11%) and accounted for 15.3% of all samples (n = 650). One study reported both liquid and tumor biopsy data. Overall, reported prevalence of the PIK3CA mutation ranged from 13.3% to 61.5%. Median prevalence was 36.4% (25th percentile = 28.6%; 75th percentile = 48.4%). Among studies using tissue biopsies, the majority reported prevalence from 16.7% to 61.5%. Among studies using liquid biopsies, the majority (n = 3) reported prevalence from 43.3% to 46.8%; one other study reported 13.3%. The most commonly tested hotspot mutations were H1047R and E545K. Among studies reporting specific hotspot mutation prevalence (n = 9), the H1047R hotspot mutation prevalence in these studies ranged between 25% and 75% while the E545K prevalence ranged between 11.1% and 50%. Conclusions: Although discrepancies exist with respect to mutation prevalence estimated across various tissue vs. liquid biopsy techniques, PIK3CA mutations and mutation hotspots (specifically H1047R and E545K) frequently occur in HR+/HER2– mBC. Citation Format: Lea Mollon, Alejandra Aguilar, Elizabeth Anderson, Joni Dean, Lisa Davis, Terri Warholak, Ayal A. Aizer, Emma Platt, Aditya Bardiya, Derek Tang. A systematic literature review of the prevalence of PIK3CA mutations and mutation hotspots in HR+/HER2- metastatic breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 1207.

Introduction: This study aimed to identify biopsy and analytical testing methods for PIK3CA mutation in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) via a systematic literature review. Understanding the available biopsy and analytical methods for PIK3CA mutation and its publication trends over time may support understanding of emerging technology trends. Methods: A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and select conference abstracts was performed by two independent researchers that included, but was not limited to, keywords: “breast neoplasm,” “PIK3CA protein,” “hormone receptor positive,” and “metastases.” English-language studies in HR+, HER2- mBC reporting either biopsy or analytical testing methods for PIK3CA mutation and published between January 1993 through August 2017 were included. Content analysis was employed to quantify collected data elements. Results: Of 558 studies included for full-text review, 36 met inclusion criteria. Total number of samples tested among this subgroup were 4,247 (tumor = 3,597; liquid = 650). Sample size ranged from 9 to 618 (median = 47). The most common methods used for identifying PIK3CA mutations were tumor biopsies (n = 33) while liquid biopsies only occurred in four studies. One study reported both liquid and tumor biopsy data. Formalin-fixed, paraffin-embedded (FFPE) tissue samples were used in most studies examining tumor samples (n = 28). Among liquid biopsies, circulating tumor cells (CTC) (n = 2), cell-free DNA (cfDNA) (n = 1), and circulating tumor DNA (ctDNA) (n = 1) were used. Techniques for DNA analyses included PCR (n = 14), NGS (n = 14), Sanger (n = 7), mass spectrometry (n = 5) and liquid chip technology (n = 1). Some studies used multiple methods (n = 5). Most studies using NGS were cross-sectional (n = 9); other studies using NGS (n=4) were clinical trials. Among clinical trials (n = 9), four used PCR only (sample size range 30 to 550), two used NGS only (sample size range 16 to 28), one used Sanger sequencing only (sample size = 21) and two used both NGS and PCR methods (sample size range 26 to 55). Of fourteen studies using NGS, thirteen were published from 2015 to 2017, which may be indicative of a transition to newer methodology. While PCR remained a commonly used analytical method regardless of sample size, NGS has become more common than PCR in recent publication years. Conclusions: The majority of studies utilized PCR for PIK3CA analytical testing despite newer technologies available. NGS methodology was used more frequently in more recent publications. However, the relative accuracy between PCR and NGS testing is yet to be fully understood. Citation Format: Elizabeth Anderson, Lea Mollon, Alejandra Aguilar, Joni Dean, Lisa Davis, Terri Warholak, Ayal Aizer, Emma Platt, Aditya Bardiya, Derek Tang. Biopsy and analytical testing methods used to identify PIK3CA mutations in hormone receptor-positive, human epidermal growth factor receptor-negative metastatic breast cancer: A systematic literature review [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 2193.

Introduction: This systematic literature review sought to determine the concordance of PIK3CA mutations in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) patients. Methods: A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and select conference abstracts was performed by two independent researchers that included, but was not limited to, keywords: “breast neoplasm,” “PIK3CA protein,” “hormone receptor positive,” and “metastases.” Databases were searched for English-language publications in HR+, HER2- mBC published between January 1993 through August 2017. Studies were included if results reported were specific to patients with HR+, HER2- mBC and reported data comparing PIK3CA mutations from liquid biopsies versus tumor biopsies or primary tumor samples versus metastatic lesion samples. Concordance was assessed between tissue samples (mutations found in primary tumors versus those from metastatic lesions) and between biopsy methods (i.e., tumor biopsy versus liquid biopsy) when the assessment was done at a variety of time points including time of initial diagnosis and time of diagnosis at disease progression. Content analysis was employed to quantify collected data elements. Results: Of 558 studies included for full-text review, four met inclusion criteria (number of patient samples [n]=358). One study (n = 9) found the concordance between the mutation status of primary breast tumors to the mutation status of metastatic lesions to be 100%. Three studies (n = 47; n = 55; n = 247) determined the concordance of PIK3CA mutations between tumor biopsies and liquid biopsies with concordance ranging from 70.4% to 94%. One study found that the concordance of circulating tumor DNA (ctDNA) against tumor biopsy was higher among metastatic lesions only (81.6%) relative to using all tumor samples (either primary or metastatic lesions) (70.4%). Conclusions: Available evidence suggested high level of concordance across sampling methods as well as across time. However, additional evidence is needed to increase study generalizability as well as to assess other possible confounding factors, such as differential timing between tumor and liquid biopsies. Citation Format: Alejandra Aguilar, Joni Dean, Elizabeth Anderson, Lea Mollon, Lisa Davis, Terri Warholak, Ayal Aizer, Emma Platt, Aditya Bardiya, Derek Tang. Concordance of PIK3CA mutations in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer: A systematic literature review [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 2217.

Little is known about how individuals manage pain and what characteristics lead to the utilization of specific pain management strategies. This cross-sectional study used questionnaire data from a sample of pharmacists with a registered, active e-mail address on file with the State Board of Pharmacy. The questionnaire collected data on demographics, pain management strategies, pain characteristics, and pain management outcomes. Participants who reported chronic pain were included in the analysis. A hierarchical logistic regression (HLR) was performed to identify variables differentiating opioid users from non-opioid users with significance set at p ≤ 0.1. Linear regression was conducted to describe pain level differences between opioid users and non-opioid users with significance set at 0.05. Fifty-seven opioid users (mean age 53±14, 52% males) and 100 non-opioid users (mean age 52±14, 47% males) completed the questionnaire. HLR analysis revealed that the statistically significant variables distinguishing opioid users and non-opioid users were: arthritis (OR=3.2, p= 0.03), NSAID use (OR=3.7, p= 0.04), and OTC NSAID use (OR=0.32, p=0.039). Differences in level of pain between opioid users and non-opioid users was significant (p = 0.0018) when adjusted for age, sex, accident/injury, arthritis, ER visit, and pain interfering with daily activities. The study showed opioid users had a higher level of pain and were more likely to use NSAIDs or have arthritis compared to non-opioid users. Individuals with progressive, pain causing conditions not adequately managed by other modalities may lead to higher levels of pain and the subsequent use of more potent analgesics. Further research is warranted to better distinguish which modalities may be more effective in certain groups.

Background: Little is known regarding the health-related quality of life among myocardial infarction (MI) survivors in the United States. The purpose of this population-based study was to identify differences in health-related quality of life domains between MI survivors and propensity score matched controls. Methods: This retrospective, cross-sectional matched case-control study examined differences in health-related quality of life (HRQoL) among MI survivors of myocardial infarction compared to propensity score matched controls using data from the 2015 Behavioral Risk Factor Surveillance System (BRFSS) survey. Propensity scores were generated via logistic regression for MI survivors and controls based on gender, race/ethnicity, age, body mass index (BMI), smoking status, and comorbidities. Chi-square tests were used to compare differences between MI survivors to controls for demographic variables. A multivariate analysis of HRQoL domains estimated odds ratios. Life satisfaction, sleep quality, and activity limitations were estimated using binary logistic regression. Social support, perceived general health, perceived physical health, and perceived mental health were estimated using multinomial logistic regression. Significance was set at p < 0.05. Results: The final sample consisted of 16,729 MI survivors matched to 50,187 controls (n = 66,916). Survivors were approximately 2.7 times more likely to report fair/poor general health compared to control (AOR = 2.72, 95% CI: 2. 43-3.05) and 1.5 times more likely to report limitations to daily activities (AOR = 1.46, 95% CI: 1.34-1.59). Survivors were more likely to report poor physical health > 15 days in the month (AOR = 1.63, 95% CI: 1.46-1.83) and poor mental health > 15 days in the month (AOR = 1.25, 95% CI: 1.07-1.46) compared to matched controls. There was no difference in survivors compared to controls in level of emotional support (rarely/never: AOR = 0.75, 95% CI: 0.48-1. 18; sometimes: AOR = 0.73, 95% CI: 0.41-1.28), hours of recommended sleep (AOR = 1.14, 95% CI: 0.94-1.38), or life satisfaction (AOR = 1.62, 95% CI: 0.99-2.63). Conclusion: MI survivors experienced lower HRQoL on domains of general health, physical health, daily activity, and mental health compared to the general population.

Objective: To determine if an exam using multiple cases to test research design concepts measured only one cognitive skill, concept classification, and to determine if item difficulty varied according to the research design used for the case.Methods: The exam consisted of 50 multiple choice items associated with five example abstracts: a randomized controlled trial, pretest-posttest, crossover, retrospective cohort, and descriptive designs. A Rasch analysis was conducted to determine dimensionality (i.e., measured a single skill). Items were stratified by design to explore the relationship between item difficulty and study design. Overall difficulty was assessed using an item person map.Results: The exam was administered to 101 students; the mean was 88.4% (mean score = 44.2; SD = 3.5). The Rasch analysis indicated the exam primarily measured one cognitive skill, presumably concept classification. The stratified analysis indicated that overall no single research design was more difficult than other designs; however, the type of research design and item topic interacted so that an easy item for one design could be difficult when associated with a different study design.Conclusions: The exam appeared to function more like a mastery exam documenting that most students performed well rather than as an exam for ranking students by ability. That item topic interacted with study design to affect item difficulty, indicates that items on the same topic are needed to test basic design concepts across study designs. (C) 2015 Elsevier Inc. All rights reserved.

An optional VAN loading dose (LD) of 25–30 mg/kg (total body weight), followed by maintenance dose (MD) of 15–20 mg/kg intravenously (IV) Q8–12H is recommended for patients with normal renal function. Studies suggest MO patients may require lower mg/kg doses to achieve therapeutic trough concentrations (TTCs). Our institutional VAN dosing protocol for MO patients (BMI ≥ 40 kg/m2) was revised in 2015 to recommend: LD 25–30 mg/kg (max 3000 mg), MD 12.5–15 mg/kg (max 2000 mg) IV Q8–12H. We evaluated initial TTC attainment, clinical and safety endpoints post protocol revision. MO adult patients who received IV VAN between June 1, 2012–May 31, 2013 (pre-protocol revision) and August 1, 2015–July 31, 2016 (post-protocol revision) were included. Perioperative VAN, one-time doses, pregnancy, cystic fibrosis, hemodialysis and patients receiving VAN prior to admission were excluded. A total of 615 patients were screened, with 200 included for analysis (100 per group). Baseline demographics and VAN dosing are shown in Table 1. Initial TCs were drawn for 86 patients in the pre-revision group, and for 69 patients in the post-revision group. Initial VAN TCs are displayed in Table 2. Duration of VAN therapy was significantly shorter post-revision (5 days vs. 2 days, p ≤ 0.01). Mortality (14% vs. 10%, P = 0.38) and hospital length of stay (8.5 days vs. 7 days, p=0.09) were comparable between groups. There was no difference in the incidence of VAN-associated nephrotoxicity (16% vs. 10%, P = 0.20). Baseline Demographics Baseline Demographics Initial VAN TCs Initial VAN TCs The revised VAN dosing protocol for MO patients improved initial TTC attainment and decreased incidence of subtherapeutic TCs compared with current standard of care recommendations with no difference in clinical or safety outcomes. All authors: No reported disclosures.

Summary Objectives: To evaluate user satisfaction among practices receiving services provided by the Arizona Regional Extension Center (REC). Methods: This program evaluation utilized a mixed-methods approach including: 1) a mail-based survey targeting all 489 REC member practices; and 2) a series of telephone-based focus groups using a convenience sample of rural and urban REC member practices. Targeted respondents were key contacts who handle interactions with the REC at each practice. Program evaluators at the University of Arizona and experts at Arizona Health-e Connection (AzHeC) created the questionnaires, focus group script, participant invitation and follow up documents via a collaborative process. Regression and Rasch analyses were used to identify key factors associated with satisfaction with REC and to assess questionnaire validity, respectively. Results: Responses from both the focus groups and survey revealed that most of the respondents were satisfied with the current services, despite the presence of satisfaction gaps between practices of various characteristics: respondents that were clinicians, practices using web-based electronic health record systems (EHRs), and practices that had achieved Stage 1 Meaningful Use had a higher level of satisfaction compared with their respective counterparts. Focus group participants provided suggestions for improving REC services. Conclusions: Most respondents reported being satisfied with REC services. Specialized representatives may be needed for practices at different stages of Meaningful Use to further improve REC satisfaction in order to facilitate more efficient adoption of EHRs. Citation: Tang D, Rutala M, Ihde C, Bills A, Mollon L, Warholak T. An exploratory, population-based, mixedmethods program evaluation of user satisfaction of services provided by a regional extension center (REC). Appl Clin Inf 2014; 5: 1–24 http://dx.doi.org/10.4338/ACI-2013-06-RA-0037

risk than younger individuals of peri-implant complications such as lead dislodgement and pneumothorax, although data regarding late complications of pacemaker implantation in this population are scarce. As a late complication occurring years after pacemaker implantation, pacemaker erosion is uncommon and is reported in 0.9% of individuals treated with pacemakers or AICDs. It is demonstrated to be due to a small or superficial subcutaneous pacemaker pocket or local infection. Although the exact rate of pacemaker extrusion in this population is not known, elderly adults with predisposing factors such as a thin subcutaneous fat layer, fragile skin tissue, depressed immunity, and cognitive impairment are particularly vulnerable to this complication. Pacemaker erosion may be treated locally by surgical revision of the pocket without removal of the device. If left untreated, total extrusion of the generator may occur. In the case of total extrusion of the generator, the system is usually considered to be contaminated, and the device and the leads are extracted, with replacement of a new system at a different site. Although individuals commonly recognize thinning of the skin and discomfort due to impending extrusion, it may not cause any symptoms, as in this individual. The revision operation of the generator in this individual had been done through the same incision, which contributed to the process. This case highlights the need for frequent follow-up visits in elderly adults with pacemakers—even those without complaints. Early recognition and proper management of individuals experiencing device extrusion is essential to avoid potentially serious consequences.

Ulcerative colitis (UC) produces bloody diarrhoea, severe abdominal pain, and need for clinic visits, hospitalizations, and surgeries. UC results in reduced health-related quality of life for patients and large direct medical and indirect costs for health systems and employers. Patients with the most severe disease require the most medical services, and these patients have larger costs than patients with mild or moderate disease. Despite biological therapies being quite expensive, they are indicated for patients unresponsive to initial standard therapies. Future hospitalizations may be reduced by starting a biological treatment. Cost-effectiveness results vary between countries, health systems, and model designs. Since restorative proctocolectomy can be curative, this surgery dominates biological therapy by being both less costly and more effective when measuring health system costs and patient quality-adjusted life years for 20 years. However the dose, duration, and effectiveness of biological treatments significantly impact estimates of their cost-effectiveness.

The Forgotten Minorities: Health Disparities of the Lesbian, Gay, Bisexual, and Transgendered Communities Lea Mollon (bio) I woke up early that morning for an appointment with my primary care provider; I did not want to be late because I was a new patient and had waited a month for the appointment. Since I had moved across town to attend college, it was no longer feasible to go to my long-time primary care provider (PCP). Although seeing a new PCP made me slightly apprehensive, I had no idea that I would leave the physician's office feeling ashamed. The office seemed like any other office—pamphlets about women's health were displayed in a holder attached to the wall, there were comfortable chairs for waiting, and magazines were lying on a table ready for perusal. The receptionist at the front desk was friendly and welcoming. At check-in, I began to describe my medical history on a patient intake form that listed the typical medical questions that one would expect. Then I reached the section of the intake form that requested demographic information. One question asked for "Current relationship status" and the response options were: Single; Married; and Widowed. I didn't fit any of those descriptions. I also noticed the omissions of questions concerning sexual orientation and gender identity. Thus, I checked the box for single despite my two-year long relationship with my partner. When the nurse led me to the exam room to assess my vital signs, she made small talk and we laughed a little, which made me slightly more comfortable. When the PCP came into the room, she introduced herself and shook my hand. We reviewed the information in my intake form together and everything seemed straightforward until she asked me if I was sexually active. I told her that I was, to which she replied, "Would you like birth control?" When I told her that I didn't need it, she proceeded to tell me about unwanted pregnancy and the benefits of birth control, even though I did not request this information. She asked, "So, are you using protection to prevent pregnancy?" I simply said, "I don't have sex with men." That statement was met with a long pause as she just stared at me. The moment seemed to linger forever and I did not know which of us was more uncomfortable. "So, you're a lesbian?" she asked, to which I quickly replied, "I'm gay." I suddenly felt embarrassed. She sighed deeply as if to indicate that what I had just [End Page 1] disclosed was deeply disturbing. She did not say anything else and stepped out of the room. I was left in the examining room wondering what would happen when she returned. At one point, I considered leaving. She returned with the nurse, who stood in the corner watching as the PCP conducted what seemed like an extremely superficial and rushed physical examination. At the end of my exam, I was given directions to a laboratory for some blood tests and a business card for the provider's office so that I could make a follow-up appointment. I never did get the blood tests and I never returned to that provider. At the time, I did not suspect that many of my future experiences with health care providers would involve repetitive and awkward explanations about my relationship status, my sexual identity, and why I didn't need birth control. Unfortunately, experiences like this are not rare for lesbian, gay, bisexual, and transgendered (LGBT) people seeking access to medical services; it seems that many LGBT people have negative experiences with their health care providers and the health care system. In addition to the lack of adequate, informed, and culturally sensitive provider and patient education, the LGBT communities face undue health disparities and inequities that should be addressed. (See below.) Health care professionals should be made aware of these disparities in order to improve quality and cultural sensitivity in care for this underserved population. On April 15th, 2011, President Obama signed a presidential memorandum regarding hospital visitation and health decision making for same-sex partners. It states that hospitals accepting...