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BackgroundAccumulating evidence indicates that children with newly diagnosed epilepsy have comorbidities including cognitive challenges. Research investigating comorbidities has focused on clinical epilepsy characteristics and neurobiological/genetic correlates. The role that sociodemographic disadvantage (SD) may play has received less attention. We investigated the role of SD in cognitive status in youth with newly diagnosed epilepsy over a follow-up of 36 months to determine the degree, extent, and duration of the role of disadvantage.MethodsA total of 289 children (six to 16 years) within six weeks of their first seizure along with 167 siblings underwent comprehensive neuropsychological assessments (intelligence, language, memory, executive function, processing speed, and academic achievement) at baseline, 18 months later, and at 36 months from baseline. Baseline demographic information (race, caregivers education, household income, and parental marital status), clinical epilepsy characteristics (e.g., age of onset), and magnetic resonance imaging (MRI) and electroencephalographic (EEG) information was collected.ResultsAn SD index was computed for each family and categorized into four groups by level of disadvantage. In children and siblings, the least disadvantaged group exhibited the highest Full-Scale IQ, neuropsychological factor scores, and academic performances, whereas the most disadvantaged showed the polar opposite with the worst performances across all tests. Findings remained stable and significant over 36 months. Linear regression analyses indicated that disadvantage was a more constant and stable predictor of cognitive and academic performance over time compared with clinical epilepsy characteristics and MRI/EEG abnormalities.ConclusionsThis study indicates the strong association between SD and cognitive/academic performance in children with newly diagnosed epilepsy and their siblings is significant and predictive of three-year cognitive outcomes.

ABSTRACTLeprosy is an infectious neglected tropical disease, which can cause irreversible disabilities if not diagnosed in time. Colombia continues to show high rates of leprosy-related disability, mainly due to a delay in diagnosis. Limited knowledge is available that explains this delay, therefore our study aimed to explore the perceptions and experiences of leprosy health professionals with the delay in leprosy diagnosis in the Cesar and Valle del Cauca departments, Colombia. Nine semi-structured expert interviews with leprosy health professionals were conducted in May-June 2023 in Colombia. Thematic analysis was performed to analyse the interview results. Our analysis highlighted that the main reasons for delay at the health system-level included accessibility issues to obtain a diagnosis, lack of expertise by health staff, and barriers related to the organisation of the care pathway. Individual – and community-level factors included a lack of leprosy awareness among the general population and leprosy-related stigma. Diagnostic delay consists of a fluid interplay of various factors. Structural changes within the health system, such as organising integral leprosy care centres and highlighting leprosy in the medical curriculum, as well as awareness-related interventions among the general population, might help reducing diagnostic delays.

Abstract Background Understanding patients’ perspectives regarding drug tolerability, in addition to effectiveness, provides a complete picture of the patient experience and supports more informed therapeutic decision-making. The item library of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to measure patient-reported frequency, severity, and interference of adverse events (AEs) associated with cancer therapies. This qualitative interview study assessed the suitability of items selected from the PRO-CTCAE library for assessing tolerability of selexipag, a medication targeting the prostacyclin pathway for patients with pulmonary arterial hypertension (PAH). Methods Two rounds of 10 qualitative, web-assisted telephone interviews following a semi-structured guide were conducted in individuals with recent experience taking oral selexipag for PAH. Each interview included concept elicitation to gather participants’ perspectives on symptomatic AEs (type, frequency, severity, and interference) and cognitive debriefing of PRO-CTCAE items addressing the most frequently reported AEs of oral selexipag. Results Interviews were conducted with 20 participants with PAH (mean [range] age 50 [24–68] years; 75% female; 85% in World Health Organization Functional Class II–III), comprising different races/ethnicities, levels of education, and employment status. Fifteen participants were currently treated with selexipag; five had taken selexipag for ≥ 6 months before discontinuing. The most frequently reported AEs included headache, jaw pain, and nausea (n = 15, 12, and 10 participants, respectively). Diarrhea and headache were identified as the most bothersome AEs by 5 and 4 participants, respectively. Some AEs were transitory (e.g., jaw pain); others were long-lasting (e.g., muscle pain). Based on findings from Round 1 interviews, a flushing item was added and the PRO-CTCAE general pain item was modified to be specific to jaw pain for testing in Round 2. Interview findings identified the following AEs as relevant to assess in a PAH clinical trial: nausea, vomiting, diarrhea, flushing, jaw pain, headache, aching muscles, and aching joints. Conclusions The PRO-CTCAE items selected in this study and the additional symptomatic AEs identified as patient-relevant have the potential to be included in assessments capturing the patient perspective on tolerability in future studies of selexipag and possibly other PAH therapies.

(1) Background: The global burden of leprosy is not shared equally; with the majority of cases being diagnosed in Brazil, India, and Indonesia. Understanding the methods of active case detection (ACD) used in high and low endemic regions is vital for the development of future screening programs. (2) Methods: A systematic search of three databases, PubMed, Embase and Web of Science, was conducted for English language papers, published since the year 2000, which discussed the use of active case detection methods for leprosy screening. The paper utilised the Integrated Screening Action Model (I-SAM) as a tool for the analysis of these methods. (3) Results: 23 papers were identified from 11 different countries. The papers identified 6 different methods of active case detection: Household contact/social contact identification; door-to-door case detection; screening questionnaire distribution; rapid village surveys; school-based screening; and prison-based screening. 15 were located in high endemic regions and 8 of these were located in low endemic regions. (4) Conclusions: For selecting the appropriate methods of active case finding, the leprosy endemicity must be taken into consideration. The findings contribute to policy decision making allowing for more successful future leprosy case detection programs to be designed, ultimately reducing the global burden of the disease, and achieving the WHO’s aim of zero leprosy.

Stigmatisation is a major issue faced by those affected by leprosy globally. Reducing stigmatisation encourages care seeking behaviour to occur earlier and can help reduce harm and spread of leprosy. This systematic literature review aimed to summarise what effective stigma reducing interventions exist for leprosy, and as a secondary question explore what evidence exists regarding their cost. A systematic literature review was conducted. Three databases-PubMed, Embase and Web of science-were searched using the search terms "leprosy", "interven*", "reduc*", and "stigma*".Seventeen publications were eligible for inclusion in the review. The current manuscript identified interventions under 6 main categories (i) Information, education, and communication (IEC) (ii) community led projects, (iii) Socioeconomic rehabilitation, (iv) mixed interventions, (v) integration of leprosy within the health system and (vi) Cosmetic or surgical care. Specific evidence regarding cost was only provided by one out of the seventeen papers. Multiple interventions were shown to successfully reduce leprosy related stigma, however, information on their cost is not readily available. The evidence uncovered by this review is restricted to three Asian countries; Nepal, India and Indonesia. To ensure the success of stigma reduction in leprosy interventions worldwide these interventions need to be tried in other leprosy endemic areas to test their effectiveness across contextual and cultural scenarios.

PURPOSE: To evaluate the effects of daratumumab, lenalidomide, and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) on patient-reported outcomes (PROs) in the phase III MAIA study. PATIENTS AND METHODS: PROs were assessed on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item and the EuroQol 5-dimensional descriptive system at baseline and every 3 months during treatment. By mixed-effects model, changes from baseline are presented as least squares means with 95% CIs. RESULTS: A total of 737 transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma were randomly assigned to D-Rd (n = 368) or Rd (n = 369). Compliance with PRO assessments was high at baseline (> 90%) through month 12 (> 78%) for both groups. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item global health status scores improved from baseline in both groups and were consistently greater with D-Rd at all time points. A global health status benefit was achieved with D-Rd, regardless of age (< 75 and ≥ 75 years), baseline Eastern Cooperative Oncology Group (ECOG) performance status score, or depth of response. D-Rd treatment resulted in significantly greater reduction in pain scores as early as cycle 3 (P = .0007 v Rd); the magnitude of change was sustained through cycle 12. Reductions in pain with D-Rd were clinically meaningful in patients regardless of age, ECOG status, or depth of response. Similarly, PRO improvements were observed with D-Rd and Rd on the EuroQol 5-dimensional descriptive system visual analog scale score. CONCLUSION: D-Rd compared with Rd was associated with faster and sustained clinically meaningful improvements in PROs, including pain, in transplant-ineligible patients with newly diagnosed multiple myeloma regardless of age, baseline ECOG status, or depth of treatment response.

Background: To achieve zero leprosy cases in Santa Cruz, Bolivia, we designed a community-based active detection and provision of single-dose rifampicin post-exposure prophylaxis (SDR-PEP) to household contacts with new leprosy patients. Methods: From July to August 2021, we assessed the current knowledge, attitude, and practices through structured interviews and focus group discussions with community representatives and health staff. This was followed by sensitization sessions, the training of health staff, and the reinforcement of referral mechanisms. Teams, including health staff and community volunteers, visited all new leprosy patients detected in 2021–2023 and household contacts. Results: Among 115 community representatives, knowledge about leprosy etiology was attributed to non-biological factors (74%); fear accounted for 77%, and access to care was perceived as weak (74%), but the outlook was improved by SDR-PEP (80%). Among the 217 health staff interviewed, the programmatic barriers identified were a lack of referral feedback (67%), limited supplies for diagnosis and prevention, and ineffective training (64%). We visited 70 new patients and 258 household contacts. The median age in household contacts was 25 years old; 49% were women, 98% were eligible for SDR-PEP, and all who were eligible accepted it. Those who were non-eligible included one tuberculosis patient and six newly detected leprosy patients (23‰). Conclusions: A community-based intervention was successful in Santa Cruz, Bolivia. Misbeliefs and a lack of knowledge were identified as barriers. Programmatic components should be reinforced for SDR-PEP extension.

Abstract Background Relapsed refractory multiple myeloma (RRMM) is a disease that is nonresponsive or progressive on therapy, and although patients can achieve remission, relapse is common. As more treatment options become available for multiple myeloma (MM), it is important to understand patients' experiences of current and emerging therapies. Aims This study aimed to better understand patient experiences with treatment and therapies for MM using qualitative interviews and patient‐reported information (PRI) shared on social media. Methods Semistructured qualitative interviews were conducted with adults with RRMM who resided in the United States. In addition to the interviews, PRI was collected from YouTube and a patient advocacy website. Key themes from the interviews and PRI were summarized, and illustrative quotes were extracted. Results Twenty participants were interviewed; 11 were female, and mean (standard deviation) age was 60 (7.0) years. The PRI included 14 posts and 19 unique contributors (10 were female). Similar treatment‐related symptoms were reported in the interviews and PRI. Fatigue and pain were the most frequently reported symptoms while receiving treatment in both the interviews and PRI. These symptoms had a meaningful impact on health‐related quality of life (HRQOL); being off treatment and returning to normal living was described as an ideal treatment outcome. Nearly all interview participants (n = 18) preferred a treatment that would allow for a treatment‐free interval, if it had the same efficacy and safety profile as a continuous treatment. Conclusion The symptom experience reported in this study is consistent with known RRMM symptoms and HRQOL impacts. Additionally, this study highlighted that patients' treatment expectations are changing relative to their past treatment experience. Individuals living with RRMM strongly desire therapies with a treatment‐free interval and minimal impact on their HRQOL.

Abstract Background In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) from ALCYONE. Methods The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire were administered at baseline, every 3 months (year 1) and every 6 months (until progression). Treatment effects were assessed using a repeated-measures, mixed-effects model. Results Compliance with PRO assessments was comparable at baseline (> 90%) and throughout study (> 76%) for both treatment groups. Improvements from baseline were observed in both groups for EORTC QLQ-C30 Global Health Status (GHS), most functional scales, symptom scales and EQ-5D-5L visual analog scale (VAS). Between-group differences were significant for GHS (p = 0.0240) and VAS (p = 0.0160) at month 3. Improvements in pain were clinically meaningful in both groups at all assessment time points. Cognitive function declined in both groups, but the magnitude of the decline was not clinically meaningful. Conclusions Patients with transplant-ineligible NDMM demonstrated early and continuous improvements in health-related quality of life, including improvements in functioning and symptoms, following treatment with D-VMP or VMP. Trial registration ClinicalTrials.gov identifier NCT02195479 , registered September 21, 2014

Abstract Background Smoldering multiple myeloma (SMM) is an early form of multiple myeloma (MM). SMM is typically considered asymptomatic, and research on how it affects health-related quality of life (HRQoL) is limited. This study assessed the symptoms and HRQoL of patients with SMM and those who progressed from SMM to MM and evaluated the content validity of two patient-reported outcome instruments (EORTC QLQ-C30 and nine items from the EORTC QLQ-MY20) for use in SMM clinical trials. To address these objectives, concept elicitation and cognitive interviews were conducted with SMM patients and recently diagnosed MM patients. Results Fifteen adult SMM and six adult MM participants with a prior SMM diagnosis were interviewed. On average, SMM study participants were 61 years old (46.0–78.0), 11 (73%) were female, and diagnosed 2.6 (±2.0) years ago. Each participant had experienced at least one symptom, most commonly tiredness/fatigue, weakness, and pain. The most common HRQoL impacts were emotional and physical. SMM study participants demonstrated good understanding of both the EORTC QLQ-C30 and EORTC QLQ-MY20 subscales and found them relevant to their SMM health state. The average age of MM participants was 53 years old (39.0–62.0); 5 (83%) were female and diagnosed 1.9 years ago (±2.1). MM participants most commonly reported tiredness, weakness, constipation, shortness of breath, and dry mouth as occurring when they progressed from SMM to MM. Conclusions Although previously described as asymptomatic, these SMM participants reported experiencing symptoms that affected their lives. Additionally, the EORTC subscales measured symptoms SMM patients experienced. The participants with MM reported that the symptom burden and HRQoL impacts increased when diagnosed with MM. These findings suggest the need for increased surveillance of symptoms within the SMM population and further suggest that the EORTC subscales can be used to assess symptoms and impacts in both the SMM and MM populations.

Abstract Background Social media platforms give patients a voice by allowing them to discuss their health and connect with others. These unfiltered and genuine reports offer direct access to what matters most to patients. Exploring the patient-reported outcomes discussed in these platforms reveal clinical insights and behavioral patterns of the real-world patient journey. This research study reviewed health-related quality of life (HRQoL) concepts reported by patients with multiple myeloma (MM). Methods Data were obtained using the Belong.life patient-powered research network (PPRN) using social media listening methods. The analysis cohort consisted of adults diagnosed with MM who signed into the Belong.life platform by June 2018. Natural language processing and medical neural networks were utilized to extract text data to mine and scan for concepts using programmed algorithms. The textual review of the data was conducted on two levels: the over-arching concept of interest (broad symptom and impact classification) and the more specific symptom and impacts report. Concepts were analyzed descriptively and summarized by age, gender, context of report, and stage of disease/treatment journey. Results Two hundred thirty patients with MM from the United States (52%), Israel (42%), Canada (3%), and 3% from Egypt, France, Greece, India, United Kingdom, and Australia were identified. A total of 57% were female and at account registration the median age was 57 years. A total of 126 patients had evaluable text data to search concepts being discussed. The PPRN platform identified 93% of the concepts from the conceptual model developed based on prior literature review. The most commonly reported symptoms were neuropathy, tiredness, nausea, back pain, fatigue, and bone pain. Back pain appeared as the most prominent symptom early in the disease and sometimes occurred prior to MM diagnosis. Tiredness, nausea, fatigue, and bone pain were frequently reported after MM diagnosis, with the start of treatment. Conclusion Patient-oriented social media platforms, such as Belong.life, can capture and contribute to a holistic vision of concepts surrounding patients’ HRQoL. The ability to understand when a certain debilitating symptom appeared and to which sub-population of patients may allow for a personalized approach to treatment, improving adherence and quality of care as well as increasing patient well-being.

Heather Rozjabek,1 John Fastenau,1 Anne LaPrade,2 Nikoletta Sternbach2 1Janssen Global Services, Raritan, NJ, USA; 2Kantar, New York, NY, USACorrespondence: John FastenauJanssen Global Services, LLC, 700 US-202, Raritan, NJ 08869, USATel +1 908 429 1872Email JFastena@its.jnj.comIntroduction: While it is generally believed that people living with more severe obesity experience greater negative impacts on health-related quality of life (HRQoL), their experience may be impacted by other factors such as age, gender, and type 2 diabetes mellitus (T2DM).Methods: The 36-Item Short Form Health Survey physical component score and mental component score, Work Productivity and Activity Impairment, and Patient Activation Measure® data from the 2018 National Health and Wellness Survey were analyzed in adults by body mass index (BMI) categories (normal weight: ≥ 18.5–< 25kg/m2, overweight: ≥ 25–< 30kg/m2, class 1 obesity: ≥ 30–< 35kg/m2, class 2 obesity: ≥ 35–< 40kg/m2, class 3 obesity: ≥ 40kg/m2, combined class 2/3 obesity: ≥ 35kg/m2). Findings were further stratified across age groups (young: 18– 35y, middle-aged: 36– 64y, older: ≥ 65y), by gender, and by T2DM status.Results: Overall, as BMI increased people had greater negative effects on HRQoL, felt less involved with and in control of their healthcare, and had greater work productivity and activity impairments. The largest declines were generally observed between class 2 and 3 obesity categories. Young adults with obesity were more likely to feel less engaged with their health care than middle-aged/older adults with obesity. The effects of obesity on HRQoL and patient activation were generally consistent by gender. People with T2DM and obesity tended to have greater declines in physical functioning and more work and activity impairments than people with obesity without T2DM. The proportion of people trying to lose weight increased with increasing BMI category, and people with T2DM were less likely to exercise and more likely to diet than those without T2DM.Conclusion: Increasing levels of obesity tended to have a greater negative impact on HRQoL, patient activation, work productivity, and weight loss behaviors, but some differences in effects by age, gender, and T2DM status were observed.Keywords: obesity, health-related quality of life, HRQoL, activation, productivity, behaviors

InP/InGaAs/InP double heterojunction bipolar transistors (DHBT) have been designed for increased bandwidth digital and analog circuits, and fabricated using a conventional mesa structure. These devices exhibit a maximum 450 GHz f,tau and 490 GHz f,max, which is highest simultaneous f,tau and f,max for any HBT. The devices have been scaled vertically for reduced electron collector transit time and aggressively scaled laterally to minimize the base-collector capacitance associated with thinner collectors. The DC current gain beta is ~ 40 and BVCEO = 3.9 V. The devices operate up to 25 mW/um^2 dissipation (failing at Je = 10 mA/um^2, Vce = 2.5 V, delta T,failure = 301 K) and the there is no evidence of current blocking up to Je = 12 mA/um^2 at V,ce = 2.0 V from the base-collector grade. The devices reported here employ a 30 nm highly doped InGaAs base, and a 120 nm collector containing an InGaAs/InAlAs superlattice grade at the base-collector junction.

InP-In0.53Ga0.47As-InP double heterojunction bipolar transistors (DHBT) have been designed for use in high bandwidth digital and analog circuits, and fabricated using a conventional mesa structure. These devices exhibit a maximum 391-GHz f(t), and 505-GHz f(max), which is the highest f(t) reported for an InP DHBT--as well as the highest simultaneous f(t) and f(max) for any mesa HBT. The devices have been aggressively scaled laterally for reduced base-collector capacitance Ccb. In addition, the base sheet resistance rho(s) along with the base and emitter contact resistivities rho(c) have been lowered. The DC current gain beta is approximate to 36 and BV,CEO = 5.1 V. The devices reported here employ a 30-nm highly doped InGaAs base, and a 150-nm collector containing an InGaAs-InAlAs superlattice grade at the base-collector junction. From this device design we also report a 142-GHz static frequency divider (a digital figure of merit for a device technology) fabricated on the same wafer. The divider operation is fully static, operating from f(clk) = 3 to 142.0 GHz while dissipating approximate to 800 mW of power in the circuit core. The circuit employs single-buffered emitter coupled logic (ECL) and inductive peaking. A microstrip wiring environment is employed for high interconnect density, and to minimize loss and impedance mismatch at frequencies > 100 GHz.

We report an InP-InGaAs-InP double heterojunction bipolar transistor (DHBT), fabricated using a conventional triple mesa structure, exhibiting a 370-GHz f(t) and 459-GHz f(max), which is to our knowledge the highest f(tau)reported for a mesa InP DHBT--as well as the highest simultaneous f(t) and f(max) for any mesa HBT. The collector semiconductor was undercut to reduce the base-collector capacitance, producing a Ccb/Ic ratio of 0.28 ps/V at Vcb = 0.5 V. The BV,CEO is 5.6 V and the devices fail thermally only at > 18 mW/um^2, allowing dc bias from J(e) = 4.8 mA/um^2 at Vce = 3.9 V to J(e) = 12.5 mA/um^2 at Vce = 1.5 V. The device employs a 30 nm carbon-doped InGaAs base with graded base doping, and an InGaAs-InAlAs superlattice grade in the base-collector junction that contributes to a total depleted collector thickness of 150 nm.

Objectives: The advent of large databases, wearable technology, and novel communications methods has the potential to expand the pool of candidate research participants and offer them the flexibility and convenience of participating in remote research. However, reports of their effectiveness are sparse. We assessed the use of various forms of outreach within a nationwide randomized clinical trial being conducted entirely by remote means. Methods: Candidate participants at possibly higher risk for atrial fibrillation were identified by means of a large insurance claims database and invited to participate in the study by their insurance provider. Enrolled participants were randomly assigned to one of two groups testing a wearable sensor device for detection of the arrhythmia. Results: Over 10 months, the various outreach methods used resulted in enrollment of 2659 participants meeting eligibility criteria. Starting with a baseline enrollment rate of 0.8% in response to an email invitation, the recruitment campaign was iteratively optimized to ultimately include website changes and the use of a five-step outreach process (three short, personalized emails and two direct mailers) that highlighted the appeal of new technology used in the study, resulting in an enrollment rate of 9.4%. Messaging that highlighted access to new technology outperformed both appeals to altruism and appeals that highlighted accessing personal health information. Conclusions: Targeted outreach, enrollment, and management of large remote clinical trials is feasible and can be improved with an iterative approach, although more work is needed to learn how to best recruit and retain potential research participants. Trial registration: Clinicaltrials.gov NCT02506244. Registered 23 July 2015. Keywords: Clinical trials, Clinical research, Digital technology, Remote enrollment, Remote monitoring, Outreach

We report an InP/InGaAs/InP double heterojunction bipolar transistor fabricated in a triple-mesa structure, exhibiting simultaneous 404 GHz fτ and 901 GHz fmax. The emitter and base contacts were defined by electron beam lithography with better than 10 nm resolution and smaller than 20 nm alignment error. The base-collector junction has been passivated by depositing a SiNx layer prior to benzocyclobutene planarization, improving the open-base breakdown voltage BVCEO from 3.7 to 4.3 V.

This study assessed rates of learning disabilities (LD) by several psychometric definitions in children with epilepsy and identified risk factors. Participants (N = 173, ages 8-15 years) completed IQ screening, academic achievement testing, and structured interviews. Children with significant head injury, chronic physical conditions, or mental retardation were excluded. Using an IQ-achievement discrepancy definition, 48% exceeded the cutoff for LD in at least one academic area; using low-achievement definitions, 41% to 62% exceeded cutoffs in at least one academic area. Younger children with generalized nonabsence seizures were at increased risk for math LD using the IQ-achievement discrepancy definition; age of seizure onset and attention-deficit/hyperactivity disorder (ADHD) were risk factors for reading and math LD using low-achievement definitions. Writing was the most common domain affected, but neither ADHD nor seizure variables reliably identified children at risk for writing LD. Although children with earlier seizure onset, generalized nonabsence seizures, and comorbid ADHD appear to be at increased risk for some types of LD by some definitions, these findings largely suggest that all children with epilepsy should be considered vulnerable to LD. A diagnosis of epilepsy (even with controlled seizures and less severe seizure types) should provide sufficient cause to screen school-age children for LD and comorbid ADHD. (Contains 5 tables, 1 figure and 2 notes.)

**Background:** Few studies have attempted to assess the effectiveness of formulary management in reducing the antipsychotic costs and utilization across U.S. state Medicaid programs, despite concerns about the potential impact of such formulary management on Medicaid patient health outcomes. **Objectives:** Compare antipsychotic utilization and total costs across Medicaid states with preferred drug list (PDL) programs vs. states without PDLs in place. **Methods:** The following data from 48 Medicaid fee-for-service (FFS) programs were collected for calendar year 2010: antipsychotic prescription use (IMS Health); formulary management (MediMedia, Medicaid FFS programs’ websites), and patient enrollment (MediMedia). For each program, the total antipsychotic cost per capita was estimated by multiplying antipsychotic utilization by list price (First DataBank), then dividing by program enrollment. To control for differences in the prevalence of antipsychotic use among Medicaid patients across states, cost estimates were adjusted using state-level mental-health illness prevalence data (Kaiser Family Foundation, Substance Abuse and Mental Health Services Administration [SAMHSA], and Thomson Healthcare). Volume-based market share of branded antipsychotics was also calculated to compare branded vs. generic antipsychotic use across states. Significance of difference between the means of PDL and non-PDL states was tested using a two-sided, two sample t-test, assuming unequal variances between samples. **Results:** Among the 48 states studied, 33 (68.8%) used PDLs as a means to limit access to branded antipsychotic medications, including those states with the largest populations with a mental-health illness (e.g. New York, California, Texas). In our analyses, the average difference in antipsychotic costs per capita between PDL and non-PDL states was less than $0.6M or 1.5% (p=0.95). The average difference in antipsychotic utilization per capita was less than 2.8% (p=0.91) and in branded antipsychotic market share was 0.7% (p=0.59). **Conclusions:** Although a majority of Medicaid states use PDLs to manage antipsychotic utilization, this analysis found no evidence of significant advantages for these Medicaid programs in terms of lowering percapita antipsychotic costs or increasing generic utilization.

Background: Research shows evidence of increased sialylation in post‐mortem Alzheimer's Disease (AD) cases. Sialylation is a form of glycosylation with the attachment of N‐acetyl‐neuraminic acid or sialic acid (SA) to glycoproteins and lipids. There are two major forms of sialylation, N‐ and O‐linked SA, modifications that regulate microglia cellular interactions and immune response. Yet it is unclear how these forms of sialylation contribute to AD pathology and modify disease progression. We hypothesize specific microglia sialylation patterns early in disease progression contribute to pathological burden and dampen immune response. Methods: We utilized brain tissue from 10 post‐mortem human AD cases, focused on frontal, hippocampal, and cerebellar regions, and 5XFAD mouse model of amyloid pathology. To Identify N‐linked SA bonds, we focused on α‐2,6 SA which was recognized by a plant‐derived lectin. Aβ plaques, neurofibrillary tangles, microglia, and α‐2,6 SA were labelled with immunofluorescent markers in cortical brain tissue. Samples were imaged with confocal microscopy. To identify O‐linked SA bonds, Alcian Blue and Periodic Acid Schiff stains were used in novel ways to differentiate subsets of neutral and charged O‐linked SA bonds. Samples were imaged on a Aperio microscope slide scanner. Results: 12‐month‐old 5XFAD mice have significantly higher percent of α‐2,6 SA coverage in the plaque microenvironment compared to WT littermates (p<0.001). Pearson correlation analysis determined significantly greater α‐2,6 microglia sialylation (r = 0.522; p<0.0001) compared to plaque sialylation (r = 0.262) in the 5XFAD mouse model. Post‐mortem human AD cases displayed similar microglia sialylation patterns. Yet there was no significant correlation of between tau and α‐2,6 SA (r = ‐0.143; p<0.0001) in human AD compared to microglia sialylation (r = 0.279). Qualitatively, 5XFAD mice and human AD display similar recognition of Aβ plaque with O‐linked glycosylation patterns. Conclusions: We observed significant α‐2,6 sialylation of microglia in 5XFAD mice and post‐mortem human AD which was independent of tau pathology. Additionally, intriguing patterns of O‐linked SA are present surrounding Aβ plaques using novel histological techniques. Next, we will closely investigate subsets of sialylated microglia to determine what forms of O‐linked SA may reduce clearance of debris by microglia while actively comparing Aβ plaque sialylation in human AD cases. [ABSTRACT FROM AUTHOR]