The roles of type 2 diabetes and obesity in disease activity and progression of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.

OBJECTIVE: We examined the roles of type 2 diabetes (T2D) and obesity in disease activity and fibrosis progression/regression in patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH). METHODS: This multi-center, retrospective study included patients with suspected or histologically proven NAFLD/NASH from the NASH Clinical Research Network. Outcomes included disease activity and rate of fibrosis, assessed using liver-biopsy driven measures (NAFLD activity score [NAS] and fibrosis score [FS]). Logistic regression and doubly robu estimation of causal effects tested relationships among T2D, obesity, and NAFLD/NASH. RESULTS: The analytical sample included 870 adult patients with baseline biopsy data and 157 patients with multiple biopsy data. Patients with NAFLD/NASH and T2D had significantly higher baseline average NAS (4.52 vs. 4.13; p = 0.009) and FS (2.17 vs. 1.56; p < 0.0001); those with T2D had a significantly greater reduction in average NAS over time (-0.77/year vs. -0.17/year; p = 0.0008). Change in FS over time did not differ significantly by T2D status (-0.23/year vs. -0.04/year; p = 0.34). Baseline NAS, baseline FS, and change in average NAS over time did not differ significantly by obesity status (4.17 vs. 4.47; p = 0.16; 1.73 vs.1.92; p = 0.31; -0.40/year vs. -0.59/year; p = 0.62, respectively). Patients with obesity had a slight increase in FS but those without obesity had a reduction in average FS over time (0.07/year vs. -0.27/year; p = 0.008). CONCLUSIONS: Patients with NAFLD/NASH and T2D had greater baseline disease activity versus those without T2D, but there was greater regression of disease activity over time among those with T2D. Patients with NAFLD/NASH and obesity had worsening of fibrosis versus those without obesity. NCT00063622.

Physician-approved protocols increase naloxone dispensing rates.

OBJECTIVE: To measure the impact of the implementation of a law that allows pharmacists to provide naloxone under a physician-approved protocol on naloxone dispensing rates in an all-payer population across the United States. METHODS: Prescription claims from a national grocery chain for 31 states and Area Heath Resource File were used for this retrospective study. The study sample included all patients who filled at least one naloxone prescription during the study period from July 16, 2014 to January 16, 2017. A stepwise autoregression was performed for 30 consecutive months to evaluate the change in naloxone prescription dispensing rate. The primary independent variable was "implementation of the physician-approved protocol." The primary outcome measure was the rate of naloxone prescriptions dispensed per month per state. Secondary outcome measures were naloxone dispensing rates by each payer. RESULTS: Number of patients who received naloxone prescriptions in the states with physician-approved protocol was 423% higher compared to states without the protocol. The overall model showed that the naloxone dispensing rate was 6 times higher in the states with a physician-approved protocol. In the payer-based models, comparing states with and without protocol, the dispensing rate was highest for Medicare (9.0 times) followed by Private (4.6 times), Medicaid (3.2 times), and Cash (3.1 times). The number of prescriptions dispensed in the low-employment states with the protocol was 17.59 times higher compared to states without the protocol. CONCLUSIONS: Implementation of physician-approved protocol was strongly associated with an increase in naloxone dispensing rates, especially in the low-employment states.

The impact of community pharmacy utilization of immunization information systems on vaccination rates: Results of a clustered randomized controlled trial.

BACKGROUND: Adult immunization rates in the United States remain low. More convenient access to immunization information systems (IIS) may improve vaccination rates. OBJECTIVE: The objective of this multilevel, clustered, randomized controlled study was to measure the impact of providing pharmacists with software and training to query IIS for patient vaccine history/recommendations on adult influenza, pneumococcal, herpes zoster, and Td/Tdap vaccination rates. METHODS: California Rite Aid pharmacy districts were randomized into intervention/control groups using stratified randomization based on baseline influenza vaccination rates. Store demographic characteristics were collected at baseline (January 1-December 31, 2018). During follow-up (April 1, 2019-March 31, 2020), intervention group stores received access to ImmsLink, software that allows health care providers to review immunization records from IIS and identify a patient's recommended vaccinations. The difference-in-difference between intervention and control groups compared the changes in vaccination rates from baseline to follow-up by calculating adjusted ratios of risk ratios (RRRs). Analysis was performed at the store level. RESULTS: Thirty-six districts comprising 501 Rite Aid stores (intervention: n = 244 stores; control: n = 257) were included. We found no significant differences in vaccination rates between groups: influenza, 19-64 years (adjusted RRR 0.99 [95% CI 0.83-1.17]); influenza, ≥65 years (1.02 [0.86-1.22]); herpes zoster (1.07 [0.90-1.28]); pneumococcal (0.95, 0.80-1.14); and Td/Tdap (0.88, 0.73-1.05). Reasons that recommended vaccines were not given in the intervention group included patient being deferred to future visit, patient declining, patient having already received the vaccination, patient declining because of cost, or vaccine being unavailable. Overall, pharmacist engagement with ImmsLink was low. CONCLUSION: Providing pharmacists with software and training to query IIS did not improve vaccination rates compared with control pharmacies in this study. Factors such as an inconvenient interface or inadequate training or motivation may have caused low engagement with the software and should be considered in future interventions.

Differential Cost-Sharing Undermines Treatment Adherence to Combination Therapy: Evidence from Diabetes Treatment.

INTRODUCTION: The objective of this study was to measure the influence of differences in out-of-pocket (OOP) costs for type 2 diabetes (T2D) medications on within-patient adherence behavior towards combination drug therapy regimens. METHODS: This was an observational, retrospective, paired sample study in patients with T2D using longitudinal pharmacy data from the 2009-2014 Medical Expenditure Panel Survey (MEPS) augmented with socio-demographic factors. We took a within-patient approach to minimize confounding effects by including patients who maintained the same number of diabetes drug classes over 2 years of MEPS. For each patient, we selected the most and least costly drug classes in the second year and examined their corresponding adherence behavior measured by medication possession ratio. The primary hypothesis tested the significance of the correlation between magnitude of the OOP cost difference and behavioral response in adherence. RESULTS: Analysis included 1189 patients representing over 4.2 million US residents with T2D. A significant negative correlation (p < 0.001) was observed between the differences of OOP costs and adherence to the most and least costly medications compared within patients. Reduction in adherence to the most costly medication was generally observed when the difference in OOP costs was greater than $33/month. A greater variability in adherence was observed when the cost difference exceeded $2.39/month as compared to other cost difference ranges (p < 0.001), indicative of choices being made. CONCLUSIONS: As OOP costs increased, adherence variability increased initially until a cost threshold, beyond which the adherence to the more costly medication decreased. In addition to OOP cost, adherence was also influenced by type of medication and self-perception of health. Given the complex correlation between OOP costs and adherence to medication, we suggest a careful approach to cost-sharing in the current insurance drug design and relevant insurance policies.

Autism, music and Alexithymia: A musical intervention to enhance emotion recognition in adolescents with ASD.

BACKGROUND: Difficulties identifying and describing emotions in Autism Spectrum Disorder (ASD) have been linked with an increased prevalence of Type 2 Alexithymia. Alexithymia is associated with difficulties in interpreting and verbally labelling physiological arousal. Children and adults with ASD show typical patterns of physiological arousal to music and can attribute verbal labels to musical emotions. AIM: This pilot study aimed to develop a music-based intervention to improve facial and vocal emotion recognition (ER) and Alexithymia in adolescents with ASD. METHODS AND PROCEDURES: Adolescents with ASD completed 5 music sessions and pre and post-tests of Alexithymia, ER and language. Each intervention began with a researcher-led group analysis of the emotions expressed in a series of musical excerpts, followed by a group-led discussion of the participants' experiences of these emotions and the ways they may be communicated. Finally, the likely causes and outward expression of these emotions were discussed. OUTCOME AND RESULTS: Results showed that at pre-test, chronological age (CA) and receptive vocabulary were significantly associated with recognition of facial and verbal emotions and Not hiding emotions. At post-test, older children showed a greater increase in recognition of voices and in emotional bodily awareness. Correlations suggested a trend towards increased ER in voices and faces in children with lower language scores. CONCLUSIONS AND IMPLICATIONS: Music-based interventions may enhance ER in adolescents with ASD and Alexithymia. Limitations and recommendations for future investigations are discussed.

Challenges and Facilitators of Implementing a Physician-approved Naloxone Protocol: A Mixed-methods Study.

OBJECTIVES: In 2015, the State of Ohio passed legislation to allow pharmacists to dispense naloxone under a physician-approved protocol. The legislation allows all individuals authorized under a physician-approved protocol to personally furnish naloxone without requiring clients to be seen by a licensed prescriber, thus expanding the capacity of Ohio's community distribution programs. We aimed to evaluate the implementation of legislation allowing for a physician-approved protocol in pharmacies and other naloxone distribution sites in Ohio, and to compare barriers and facilitators of implementing the law changes among sites that implemented a physician-approved protocol versus sites that did not. METHODS: The study used a convergent parallel mixed-method design. Random samples from all pharmacies registered with the State of Ohio Board of Pharmacy and community naloxone distribution sites were selected. Quantitative data were collected via survey (n = 168) and qualitative data were collected via semi-structured interviews (n = 17). RESULTS: Most survey respondents agreed that the policy has expanded access to naloxone at their site for individuals who want or need the medication. Both pharmacies and other naloxone distribution sites identified that leadership and organizational support facilitated protocol implementation and cost, stigma, and lack of naloxone demand challenged protocol implementation. CONCLUSIONS: The study identified barriers and facilitators to the implementation of a physician-approved protocol within Ohio. The majority of respondents stated they could implement a protocol. However, barriers of cost, lack of public awareness of naloxone availability, and stigma remain for pharmacies and other naloxone distribution sites.

Hearing the feeling: Auditory emotion perception in Williams syndrome.

BACKGROUND: Studies investigating recognition of facial expressions of emotions in Williams syndrome (WS) have reported difficulties in recognising negative expressions of emotion and a reliance on atypically developing underlying processes during task performance. AIM: The aim of the study was to extend these findings to the recognition of emotions in auditory domains. METHOD AND PROCEDURES: Children and adolescents with WS, together with chronological (CA) and verbal mental age matched (VMA) typically developing (TD) comparison groups, were asked to judge expressions of happiness, sadness, anger, and fear in vocal and musical conditions. OUTCOMES AND RESULTS: Total emotion recognition scores did not differ between WS and VMA matched groups but profiles of discrimination across emotion categories were markedly different. For all groups, the accessibility of emotion category cues differed across music and speech domains. The results suggested that emotion discrimination is more strongly linked with cognitive ability in WS than in TD. CONCLUSIONS AND IMPLICATIONS: Although WS and TD groups showed a significantly different profile of discrimination across emotion categories, similarities in the pattern of discrimination across domains and in the correlates of auditory emotion processing were observed. The results are discussed in the context of typical and atypical developmental trajectories and compensatory mechanisms in WS.