Evaluating the relationship between quality measure adherence definitions and economic outcomes in commercial health plans: a retrospective diabetes cohort study.

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.

Health-related risk behaviors among myocardial infarction survivors in the United States: A propensity score matched study.

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.

A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2- Metastatic Breast Cancer.

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.

A Systematic Literature Review of the Prognostic and Predictive Value of PIK3CA Mutations in HR+/HER2- Metastatic Breast Cancer.

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.

Melatonin for the prevention of postoperative delirium in older adults: a systematic review and meta-analysis.

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.

A comparison of the pharmacologic and nonpharmacologic strategies used to manage chronic pain: Opioid users versus nonusers.

BACKGROUND: Multimodal and multidomain strategies are currently recommended for the management of chronic pain. However, there is little information available on how individuals (opioid users versus nonusers) with chronic pain use multimodal strategies in pain management. METHODS: This cross-sectional study used questionnaire data from a sample of pharmacists with chronic pain. The questionnaire collected data on demographics, pain characteristics, pain management strategies, and pain management outcomes. The association between the number of strategies used and opioid use were evaluated by linear regression. Differences between the groups in nonsteroidal anti-inflammatory drugs (NSAIDs) use and types of strategies used in managing the pain were analyzed using logistic regressions. A hierarchical logistic regression was performed to identify potential predictors differentiating opioid users from nonusers. RESULTS: Fifty-seven opioid users and 100 nonusers with chronic pain completed the questionnaire. Opioid users reported higher levels of pain at baseline (7.6 ± 1.7 vs. 6.7 ± 2.2; P = 0.011); however, pain levels after treatment were comparable (2.9 ± 1.9 vs. 3.2 ± 2.4; P = 0.33). Although there was no significant difference in the total number of strategies, the number of pharmacologic strategies was significantly higher in opioid users (P = 0.007). The type of pain management strategies and the use of NSAIDs were similar in both groups after adjusting for potential confounders. The significant predictors of opioid use from hierarchical logistic regression analysis were: lower use of over-the-counter NSAIDs (odds ratio [OR] 0.4; 95% CI 0.2-0.9), using more interventions (OR 1.2; 95% CI 1.1-1.3), reliance on pharmacologic strategies (OR 10.8; 95% CI 2.1-55.7), using combination of pharmacologic and nonpharmacologic strategies (OR 3.7; 95% CI 0.9-15.8), and less interference with daily activities after treatment (OR 0.2; 95% CI 0.1-0.9). CONCLUSION: Opioid use was primarily related to the use of prescription pharmacologic strategies, but not to age or gender. Posttreatment pain levels were similar between opioid users and nonusers; however, opioid users used more nonopioid medications than nonusers did.

Health related quality of life among myocardial infarction survivors in the United States: a propensity score matched analysis.

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.

Cost-effectiveness of biological agents used in ulcerative colitis.

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.