High-frequency Ultrasound in the Assessment before and after Applying HArmonyCa™.

AIM: To describe a clinical case of ultrasound (US) used to evaluate, before, post-immediately, and after 4 months, the facial application of a volumizing and biostimulating substance. BACKGROUND: Detecting the behavior of injected filler materials with high-frequency US-guided application is the future of natural facial rejuvenation with more predictable and satisfactory results. TECHNIQUE: A patient indicated for orofacial harmonization (OFH) procedures through volumizing and biostimulating material application was invited to participate. The technique was performed by applying HArmonyCa™ (Allergan Aesthetics, Irvine, CA, USA) in the gonial, preauricular, and bilateral lateral zygomatic angle regions. The first evaluations used the US images before and after product application with a Logiq e® high-frequency US device (GE Healthcare, Chicago, IL, USA) with a probe/linear transducer of 18 MHz. About 4 months after the procedure, a new assessment with the same initial acquisition pattern was performed. The first evaluation showed normal-looking anatomical structures without the esthetic material. Immediately after the procedure and 4 months later, the assessments presented semi-permanent esthetic fillers as dispersed lobulated hyperechogenic areas with a cloud aspect. CONCLUSION: High-frequency US was efficient in the static evaluation of HArmonyCa™ behavior on the facial skin. CLINICAL SIGNIFICANCE: The US-guided application of injectable products in specific areas has minimal side effects and contributes to more predictable and satisfactory results. How to cite this article: Gouveia RSA, Tostes LLL, Bezerra FV, et al. High-frequency Ultrasound in the Assessment before and after Applying HArmonyCa™. J Contemp Dent Pract 2024;25(1):10-14.

Advanced prescription of injectable anticancer drugs: Safety assessment in a European Comprehensive Cancer Centre using the risk matrix approach.

AIMS: The purpose of this work was to assess failures in the advanced prescription of parenteral anticancer agents in an adult day oncology care unit with more than 100 patients per day. METHODS: An a priori descriptive analysis was carried out by using the risk matrix approach. After defining the scope in a multidisciplinary meeting, we determined at each step the failure modes (FMs), their effects (E) and their associated causes (C). A severity score (S) was assigned to all effects and a probability of occurrence (O) to all causes. These S and O indicators, were used to obtain a criticality index (CI) matrix. We assessed the risk control (RC) of each failure in order to define a residual criticality index (rCI) matrix. RESULTS: During risk analysis, 14 FMs were detected, and 61 scenarios were identified considering all possible effects and causes. Nine situations (15%) were highlighted with the maximum CI, 18 (30%) with a medium CI, and 34 (55%) with a negligible CI. Nevertheless, among all these critical situations, only three (5%) had an rCI to process (i.e., missed dose adjustment, multiple prescriptions and abnormal biology data); the others required monitoring only. Clinicians' and pharmacists' knowledge of these critical situations enables them to manage the associated risks. CONCLUSIONS: Advanced prescription of injectable anticancer drugs appears to be a safe practice for patients when combined with risk management. The major risks identified concerned missed dose adjustment, prescription duplication and lack of consideration for abnormal biology data.

Trends in utilization, demographics, and costs of platelet-rich plasma injections: a ten-year nationwide investigation.

INTRODUCTION: Platelet-Rich Plasma (PRP) has become one of the most popular biologic treatments in orthopedic surgery. Despite this, its utilization over the last decade has not been investigated. METHODS: We conducted a search using Current Procedural Terminology codes to identify patients who received PRP injections between 2010 and 2019 using the PearlDiver database. The purpose was to 1) determine annual trends of PRP injections of the ankle, hip, knee, shoulder, and elbow for cartilaginous, tendinous, ligamentous, meniscal/labral, and miscellaneous pathologies; 2) compare baseline demographics of patients receiving these injections; and 3) analyze costs. RESULTS: A total of 23,716 patients who received PRP injections were identified; 54.4% were female. The incidence of PRP injections was between 1.6 and 4.3 per 100,000 orthopedic patients. The most common anatomic locations targeted for PRP therapy was the knee (36.7%), followed by the shoulder/elbow (30.5%), then the ankle (19.6%) and hip (13.6%). Subgroup analysis revealed that most common use of PRP was for knee cartilaginous pathologies, followed by shoulder/elbow tendinous pathologies. The number of injections used in the knee significantly increased between 2010 and 2019 (p< 0.001), and trended toward significantly increasing in the shoulder/elbow (p = 0.055). Average annual costs for PRP injections ranged from $711.65 for ankles and $1,711.63 for hips; costs significantly changed for 3 of the 4 anatomic locations. By 2019, average PRP injection costs for each area clustered around $1000. CONCLUSION: Between 2010 and 2019, there was an increase in usage of PRP injections in the knee (cartilaginous pathologies) and the shoulder/elbow (tendinous pathologies). PRP costs demonstrated early variability but clustered around $1000 by 2019. Further studies into drivers of prices and cost-effectiveness of PRP are needed to provide clarity into the true costs to patients and healthcare providers.

Training for Awake, Office-Based Laryngeal Procedures-The Laryngology Fellow's Perspective.

OBJECTIVE: The aim was to explore recent laryngology graduates' perspectives on their experience, competency, and challenges learning office-based procedures during fellowship training in the United States and Canada. METHODS: Anonymous 22-item questionnaire survey was distributed electronically to fellowship-trained laryngologists having completed fellowship within past 5 years. RESULTS: Ninety fellowship-trained laryngologists between 2018 and 2022 were surveyed. Response rate was 48.9% (n = 44), 1 declined participation, with 20 different fellowship programs represented. Fellows were frequently provided the opportunity to act as primary surgeon for most procedures, except for laryngeal botulinum toxin injection, diagnostic laryngeal electromyography, trans-nasal esophagoscopy, secondary tracheoesophageal puncture, and high-resolution pharyngeal manometry. A majority reported high (n = 27, 62.8%) or moderate (n = 12, 27.9%) confidence with vocal fold injection augmentation. Various techniques were taught: transoral (74.4%), cricothyroid (74.4%), thyrohyoid (69.8%), transcartilagenous (14.0%), and catheter-needle (25.6%). Numerous statistically significant associations with independent procedure involvement and competence were identified. Laryngeal botulinum toxin injection was a procedure performed with high frequency but low volume of independent fellow involvement, and the procedure with which fellows reported wanting more practice learning. Most common training barriers included patient being awake, patient consenting to trainee performing the procedure, and the technical challenge/complexity of the procedure. Teaching methods/tools largely focused on informal debriefing (97.3%) and case by case troubleshooting (81.1%). CONCLUSIONS: Laryngology fellows are well trained with favorable perceived levels of competence for numerous office-based procedures, particularly vocal fold injection augmentation. Procedures for which fellows reported a low level of independent participation trended towards lower perceived competency. LEVEL OF EVIDENCE: 5 Laryngoscope, 134:873-881, 2024.

Racial disparities in utilization of first-generation versus second-generation long-acting injectable antipsychotics in Medicaid beneficiaries with schizophrenia.

BACKGROUND: Multiple studies report racial disparities in antipsychotic prescription patterns. This study assessed demographic and clinical factors associated with the utilization of first-generation (FG) versus second-generation (SG) long-acting injectable (LAI) antipsychotics. METHODS: This retrospective, observational cohort analysis used claims data from the IBM MarketScan® Multi-State Medicaid database. The study included adults with an LAI claim between 01-January-2009 and 31-December-2018, an ICD-9-CM or ICD-10-CM diagnosis of schizophrenia, race recorded as Black or White, and ≥12 months of continuous enrollment before the index LAI. Descriptive analysis detailed the relationship between race and FG or SG LAI initiation. Multivariate logistic regression was used to assess potential associations with FG vs. SG LAI initiation, including clinical and demographic factors, comorbidities, and index year. RESULTS: A total of 10,773 patients were included: 6659 (62 %) Black and 4114 (38 %) White. Black patients had a higher utilization of FG LAIs than White patients (46.8 % vs. 38.9 %) over the 10 years analyzed. Black patients were more likely to utilize FG LAIs than White patients (odds ratio: 1.47; 95 % CI: 1.34, 1.62) after controlling for index year and covariates (race, age, gender, insurance plan type, Quan-Charlson Comorbidity index score, comorbidities, prior medications). Significant predictors of FG LAI utilization were older age, type of baseline oral antipsychotic (FG vs SG), type of coverage (managed care vs fee for service), and greater comorbidity burden. CONCLUSION: The utilization of FG LAIs was greater in Black compared to White Medicaid beneficiaries with schizophrenia over a 10-year period. These findings suggest that racial disparities exist in LAI initiation, with implications for differential quality of schizophrenia treatment.

[Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle].

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.

Assessment of adherence to, and persistence with, an electromechanical autoinjector for subcutaneous interferon beta-1a injections for multiple sclerosis treatment over 3 years.

BACKGROUND: Self-administration of subcutaneous interferon beta-1a (sc IFN ß-1a) can be achieved with the RebiSmart® electromechanical autoinjector. This study investigated adherence to, and duration of persistence with, the newest version of the device (v1.6) among 2644 people receiving sc IFN ß-1a for multiple sclerosis (MS). RESEARCH DESIGN AND METHODS: This retrospective, observational study utilized data from RebiSmart® devices, recorded on the MSdialog database, between January 2014 and November 2019. Adherence and persistence were evaluated over a 3-year period and assessed in relation to age, sex, injection type, and injection depth. RESULTS: The population of RebiSmart® users (N = 2644) comprised of 1826 (69.1%) females and mean age was 39 (range 16-83) years. Adherence to RebiSmart® use and data transfer to the MSdialog database was consistently high (mean 91.7%; range 86.8-92.6%), including across all variables (81.6-100%). Mean (±SD) persistence during the study period was 1.35 ± 1.06 years, with a maximum recorded persistence of 5.1 years. In multivariate analysis, the longest durations of persistence were observed among older individuals and males (p < 0.0001 and p = 0.0078, respectively). CONCLUSIONS: People living with MS were highly adherent to use of the RebiSmart® device, with higher persistence generally observed for older and/or male individuals.

It is important for people living with multiple sclerosis (MS) to take their medication regularly ­ and to keep doing so ­ in order to control their symptoms. Some people with MS receive a medication called interferon beta-1a (Rebif®) as a subcutaneous injection (given just under the skin), and the RebiSmart® electromechanical autoinjector was designed to help them to self-inject such medication. This study aimed to find out whether people were using the RebiSmart® device as often as they should be, and how long they continued to use it for. Information was taken from the MSdialog database, which recorded peoples' use of the RebiSmart® device between January 2014 and November 2019. Records for 2644 people using the device were analyzed. Results showed that the RebiSmart® device was used most of the time (around 91.7%). On average, people kept using the device for around a year and 4 months before stopping. This duration was generally longer for men compared with women, and longer for older people than younger people. These results increase our understanding of how people are using the RebiSmart® device to treat their MS symptoms.

Qualitative Histologic Assessment vs. Geomorphometric Analysis of Nerve Fiber Shape after the Intraneural Application of Liposomal Bupivacaine / Evaluación Histológica Cualitativa Versus Análisis Geomorfométrico de la Forma de la Fibra Nerviosa Después de la Aplicación Intraneural de Bupivacaína Liposomal

SUMMARY: The preserved form of all components of the nerve fiber is a prerequisite for the proper conduction of the nerve impulse. various factors can change the shape of nerve fibers. In everyday practice, qualitative histological analysis is the gold standard for detecting changes in shape. Geometric morphometry is an innovative method that objectively enables the assessment of changes in nerve fibers' shape after local anesthetics action. A total of sixty sciatic nerves were used as material, which was intraneural injected with saline solution in the control group (n=30), and a solution of 1.33 % liposomal bupivacaine (n=30) in the test group. After the animals were sacrificed, nerve samples were taken and histological preparations were made. The preparations were first described and examined using a qualitative histological method, after which digital images were made. The images were entered into the MorphoJ program and processed using the method of geometric morphometry. Qualitative histological examination revealed no differences in nerve fibers after intraneurally applied physiological solution and liposomal bupivacaine. Using the method of geometric morphometry, a statistically significant change in the shape of axons was found after intraneurally applied saline solution and liposomal bupivacaine (p=0.0059). No significant differences in histological changes were found after the qualitative histological analysis of nerve fiber cross-section preparations. A statistically significant change in the shape of nerve fiber axons was observed after geometric morphometric analysis of digital images after intraneural application of saline and liposomal bupivacaine.

La forma conservada de todos los componentes de la fibra nerviosa es un requisito previo para la conducción correcta del impulso nervioso. Varios factores pueden cambiar la forma de las fibras nerviosas. En la práctica diaria, el análisis histológico cualitativo es el estándar de oro para detectar cambios de forma. La morfometría geométrica es un método innovador que permite evaluar objetivamente los cambios en la forma de las fibras nerviosas después de la acción de los anestésicos locales. Se utilizó como material un total de sesenta nervios ciáticos, que se inyectaron intraneuralmente con solución salina en el grupo control (n=30), y una solución de bupivacaína liposomal al 1,33 % (n=30) en el grupo de prueba. Después de sacrificados los animales, se tomaron muestras de nervios y se realizaron preparaciones histológicas. Primero se describieron y examinaron las preparaciones utilizando un método histológico cualitativo, después de lo cual se tomaron imágenes digitales. Las imágenes fueron ingresadas al programa MorphoJ y procesadas mediante el método de morfometría geométrica. El examen histológico cualitativo no reveló diferencias en las fibras nerviosas después de la aplicación intraneural de solución fisiológica y bupivacaína liposomal. Usando el método de morfometría geométrica, se encontró un cambio estadísticamente significativo en la forma de los axones después de la aplicación intraneural de solución salina y bupivacaína liposomal (p = 0,0059). No se encontraron diferencias significativas en los cambios histológicos después del análisis histológico cualitativo de las preparaciones de secciones transversales de fibras nerviosas. Se observó un cambio estadísticamente significativo en la forma de los axones de las fibras nerviosas después del análisis de morfometría geométrica de imágenes digitales después de la aplicación intraneural de solución salina y bupivacaína liposomal.

Prefilled Syringe Injection Force Impact Assessment from Back Pressure: An Approach for Testing Syringe Injectability In Situ vs. In Vitro.

Prefilled syringes are commonly used combination products for parenteral drug and vaccine administration. The characterization of these devices is through functionality testing, such as injection and extrusion force performance. This testing is typically completed by measuring these forces in a nonrepresentative environment (i.e., dispensed in-air) or route of administration conditions. Although injection tissue may not always be feasible or accessible for use, questions from the health authorities make it increasingly important to understand the impact of tissue back pressure on device functionality. Particularly for injectables containing larger volumes and higher viscosities, which can widely impact injection and user experience. This work evaluates a comprehensive, safe, and cost-effective in situ testing model to characterize extrusion force while accounting for the variable range of opposing forces (i.e., back pressure) experienced by the user during injection into live tissue with a novel test configuration. Due to the variability of back pressure presented by human tissue for both subcutaneous and intramuscular injections, tissue back pressure was simulated (0 psi-13.1 psi) using a controlled, pressurized injection system. Testing was conducted across different syringe sizes (2.25 mL, 1.5 mL, and 1.0 mL) and types (Luer lock and stake needle) with two simulated drug product viscosities product (1 cP and 20 cP). Extrusion force was measured using a Texture Analyzer mechanical testing instrument with crosshead speeds of 100 mm/min and 200 mm/min. The results demonstrated that there is a contribution of increasing back pressure on extrusion force across all syringe types, viscosities, and injection speeds that can be predicted using the proposed empirical model. Moreover, this work demonstrated that the factors that largely influence the average and maximum extrusion force during injection are syringe and needle geometries, viscosity, and back pressure. This understanding of the device usability may aid in the development of more robust prefilled syringe designs to minimize use-related risks.

Treatment Journey From Diagnosis to the Successful Implementation of a Long-Acting Injectable Antipsychotic Agent in Young Adults With Schizophrenia.

Objective: Long-acting injectable antipsychotic agents (LAIs) are effective in schizophrenia relapse prevention but are often underutilized. This study aims to understand treatment patterns leading to a successful LAI implementation following schizophrenia diagnosis in a large dataset that included commercially insured patients in the United States.Methods: Patients aged 18-40 years with a first schizophrenia diagnosis (per ICD-9 or ICD-10 criteria), successful second-generation LAI implementation (defined a priori as ≥ 90 consecutive days of use), and ≥ 1 second-generation oral antipsychotic agent (OA) were identified from IBM MarketScan Commercial and Medicare Supplemental databases from January 1, 2012, to December 31, 2019. Outcomes were measured descriptively.Results: Of 41,391 patients with newly diagnosed schizophrenia, 1,836 (4%) received ≥ 1 LAI; 202 (< 1%) met eligibility criteria of successful LAI implementation following ≥ 1 second-generation OA. Median (range) time between diagnosis and first LAI was 289.5 (0-2,171) days, time between LAI initiation and successful implementation was 90.0 (90-1,061) days, and time to LAI discontinuation after successful implementation was 166.5 (91-799) days. Before LAI initiation, 58% received ≥ 2 OAs. For 86% with successful LAI implementation, the implementation was accomplished with the first LAI.Conclusions: In this dataset of mainly commercially insured patients, LAI use in early-phase schizophrenia was very low (4%). For the majority for whom a LAI was successfully implemented per a priori definition, the implementation was accomplished with the first LAI and in a short period of time (90 days). However, even when LAIs were used in early-phase schizophrenia, they were generally not the first therapy, as most patients had several prior OA treatments.

[Introduction of a joint academic project between the Japan Academy of Nursing Science and the Japanese Pharmacological Society: a scoping review on assessment and preventive care of insulin balls].

Japanese Academy of Nursing Science (JANS) and the Japanese Pharmacological Society (JPS) have been conducting human interaction at each other's scientific meeting symposia in a home-and-away fashion since 2018. JANS and JPS have been working on a joint scientific project, "Scoping Review: Insulin Balls" since 2021. At the 95th Annual Meeting of the JPS held in 2022, we reported from a nursing perspective on the theme of "Assessment and preventive care of insulin balls from a scoping review". Subcutaneous injection into insulin balls has been reported to cause poor blood glucose control. Therefore, it is important to prevent insulin balls. In this study, we had the research questions, "What methods are available for assessment of the insulin injection site?" and "What is the care to prevent induration and how effective is it?" and conducted a scoping review. Regarding methods of injection site assessment, most of the literature identified the injection site by palpation, visual examination, and ultrasonography. About the preventive care, there were some reports of insulin balls occurring because patients have been injecting insulin at the same site, even though healthcare professionals instructed them to avoid the same site. Some of the literature had specific teaching methods such as hand site rotation and calendar injection method, and they were reported effective. In the future, we plan to proceed with the review including care after the development of insulin balls.

Complications of fillers in the lips and perioral area: Prevention, assessment, and management focusing on ultrasound guidance.

An ever-increasing interest in perioral rejuvenation with dermal fillers reflects the esthetic importance of this region. However, filler injections in the lips and perioral area have been associated with various complications. Such complications are classified according to severity (mild, moderate, severe) or by the time of onset: immediate (within 24 h after injection), early (24 h to 4 weeks post-procedure), and late or delayed (>4 weeks after injection). While most complications are mild and manageable, vascular compromise, infections, and the development of delayed-onset nodules may significantly undermine the ultimate esthetic outcome and cause substantial morbidity. These more serious complications often require more invasive treatment modalities. This article details the prevention and management of such adverse events and discusses safe filler injection principles, including safety recommendations for the lips. Lastly, we highlight the use of ultrasound guidance in complication prevention (vascular mapping, filler identification, location, and extent), assessment (identification of intravascular embolus or external vascular compression by the filler implant), and management (real-time imaging of hyaluronidase or other drug injection in the affected area). Esthetic practitioners should be versed in injection anatomy, and the prevention, recognition, and management of filler complications in the perioral area.

Predictors for Initiation of Atypical Long-Acting Injectable Antipsychotic Agents in a Commercial Claims Cohort of Individuals With Early-Phase Schizophrenia.

Objective: Long-acting injectable antipsychotic agents (LAIs) have improved clinical effectiveness and adherence versus oral antipsychotic agents (OAs); however, a minority of individuals with schizophrenia are treated with LAIs compared with OAs. This cohort study aimed to evaluate predictors of initiation of atypical LAIs among patients with newly diagnosed schizophrenia in the United States.Methods: Using claims data from IBM MarketScan Commercial and Medicare Supplemental databases between January 1, 2013, and March 31, 2020, adults with first diagnosis of schizophrenia, ≥ 1 OA claim following diagnosis, and continuous benefits were identified. To evaluate predictors of LAI initiation, a Cox proportional hazard regression model per independent predictors and main outcome (ie, LAI initiation) was performed.Results: Of 3,639 patients with early-phase schizophrenia, 369 (10%) had ≥ 1 LAI claim(s) after ≥ 1 OA claim(s). Several factors present prior to LAI initiation were significantly (P < .0001) predictive of LAI initiation: greater monthly OA switches (hazard ratio [95% CI]: 11.39 [7.01-18.51]), unsuccessful OA implementation (3.09 [2.39-3.98]), greater monthly schizophrenia-related hospitalizations (20.83 [14.22-30.51]), and greater monthly schizophrenia-related emergency department visits (4.13 [2.07-8.22]).Conclusions: In this analysis of pharmacy claims records for patients with early-phase schizophrenia, results suggest that LAIs are used less frequently in the early phase than reported in later stages. Their initiation is often reactive to relapse or disease exacerbation, rather than proactive as a relapse-prevention tool for early-phase schizophrenia. These data highlight the underuse of LAIs, particularly in the early phase when they could make the most difference.

Early versus late administration of long-acting injectable antipsychotic agents among patients with newly diagnosed schizophrenia: an analysis of a commercial claims database.

This study was designed to assess healthcare resource utilization (HCRU) and costs in patients with newly diagnosed schizophrenia based on timing and context of long-acting injectable antipsychotic agent (LAI) initiation. Using claims data, patients (aged 18-40 years) with first schizophrenia diagnosis January 2013-September 2019 (index date), no LAI or oral antipsychotic agent claims during 12-month preindex period, and continuous benefit enrollment from 12 months before index date to 12 months after first LAI administration were identified. Patients were grouped based on timing [early (≤1 year after index date) vs. late] and circumstances [reactive (after schizophrenia-related event) vs. proactive] of LAI initiation. Of 1290 patients with at least one LAI claim, 306 met criteria for early ( n = 204; reactive, n = 107; proactive, n = 97) and late ( n = 102; n = 75; n = 27) initiation. HCRU and costs were numerically lower in early versus late groups, and significantly lower for proactive initiation in both groups. Comparing worst-case (late-reactive) and best-case (early-proactive) scenarios, the average annual cost difference was $7195.13 ( P = 0.0233), with major drivers being emergency department ($171.28; P < 0.05) and other outpatient ($2845.73; P < 0.00001) visits. In addition to the clinical advantages previously described in the literature, the proactive use of LAIs in early-phase schizophrenia is associated with lower healthcare costs.

Stratified assessment and warning regimen for prevention of acute adverse reactions to iodinated contrast media: results of 150,343 cases in a tertiary hospital.

For contrast-enhanced CT examinations, there is a lack of comprehensive optimal management strategies of risk factors to reduce the risk of iodinated contrast media (ICM)-induced acute adverse reactions (AAR). Here, we determine the relationship between the rate of ICM-AAR and a stratified assessment and warning (SAW) regimen, which integrated risk identification, stratification, early warning, and prevention. A total of 120,822 cases in the conventional assessment period (58 years ± 15, 55.25% men) and 150,343 cases (58 years ± 14, 55.83% men) in the SAW period were enrolled. The results showed that the total AAR incidence in the SAW period (414/150,343, 0.28%) was lower than that in the conventional assessment period (506/120,822, 0.42%, P < 0.001), in which the proportion of AAR patients decreased by one-third. It mainly presented as decreases in mild and moderate reactions (P < 0.001), and a decrease in the proportion of moderate AAR patients (P = 0.001). Subgroup analysis showed lower mild and moderate AAR incidence in patients with different risk levels and with different ICM injection parameters following SAW regimen. We concluded that SAW regimen was associated with lower incidence of mild and moderate AAR, and decreased proportion of moderate AAR patients, which held potential for improved ICM safety.

Understanding patient cost-sharing thresholds for diabetes treatment attributes via a discrete choice experiment.

BACKGROUND: The process used to prefer certain products across drug classes for diabetes is generally focused on comparative effectiveness and cost. However, payers rarely tie patient preference for treatment attributes to formulary management resulting in a misalignment of value defined by providers, payers, and patients. OBJECTIVES: To explore patients' willingness to pay (WTP) for the predetermined high-value and low-value type 2 diabetes mellitus (T2DM) treatments within a health plan. METHODS: A cross-sectional discrete choice experiment (DCE) survey was used to determine patient preference for the benefit, risk, and cost attributes of T2DM treatments. A comprehensive literature review of patient preference studies in diabetes and a review of guidelines and medical literature identified study attributes. Patients and diabetes experts were interviewed and instructed to identify, prioritize, and comment on which attributes of diabetes treatments were most important to T2DM patients. The patients enrolled in a health plan were asked to respond to the survey. A multinomial logit model was developed to determine the relative importance and the patient's WTP of each attribute. The patients' relative values based on WTPs for T2DM treatments were calculated and compared with the treatments by a health plan. RESULTS: A total of 7 attributes were selected to develop a web-based DCE questionnaire survey. The responses from a total of 58 patients were analyzed. Almost half (48.3%) of the respondents took oral medications and injections for T2DM. The most prevalent side effects due to diabetes medications were gastrointestinal (43.1%), followed by weight gain (39.7%) and nausea (32.8%). Patients were willing to pay more for treatments with proven cardiovascular benefit and for the risk reduction of hospitalization from heart failure. On the other hand, they would pay less for treatments with higher gastrointestinal side effects. Patients were willing to pay the most for sodium-glucose cotransporter 2 inhibitor and glucagon-like peptide 1 receptor agonist agents and the least for dipeptidyl peptidase-4 inhibitors and thiazolidinediones. CONCLUSIONS: This study provides information to better align patient, provider, and payer preferences in both benefit design and value-based formulary strategy for diabetes treatments. A preferred placement of treatments with cardiovascular benefits and lower adverse gastrointestinal side effects may lead to increased adherence to medications and improved clinical outcomes at a lower overall cost to both patients and their health plan. DISCLOSURES: This study was supported by a grant from the PhRMA Foundation.

The Epidemiology of Platelet-Rich Plasma Injections From 2010 to 2020 in a Large US Commercial Insurance Claims Database: A Recent Update.

INTRODUCTION: The popularity of platelet-rich plasma (PRP) injections for the treatment of orthopaedic conditions has grown markedly. We sought to better define the trends in the usage of orthopaedic PRP injections across an insured US population over the past decade. METHODS: The PearlDiver M91Ortho commercial administrative claims database was queried for all patients receiving PRP injections for orthopaedic conditions from 2010 through the first quarter of 2020 (Q1.2020). Trends in PRP use, reimbursement charges, demographics, joints injected, and administering physicians were assessed over time and reported as year-over-year (YOY) changes. RESULTS: Over the study period, 14,096 unique patients had 17,759 orthopaedic PRP injections. The number of PRP injections administered had a YOY increase of 7.1% (144 injections/year, 95% confidence interval [CI] = 89 to 199, Ptrend = 0.0009). A YOY increase of 895% was observed in total nonsurgical charges ($683,974/yr, 95% CI 441,504 to 926,444, Ptrend = 0.0009). The median age of PRP recipients increased (YOY change = +0.6 years, 95% CI 0.4 to 0.8, Ptrend = 0.0005). Injections to the elbow (YOY change = -0.8%, 95% CI -0.10% to [-0.06%], Ptrend = 0.005) and foot/ankle (YOY change = -1.0%, 95% CI -1.4% to [-0.06%], Ptrend = 0.002) decreased, whereas hip (YOY change = +0.4%, 95% CI 0.2% to 0.6%, Ptrend = 0.019), knee (YOY change = +0.9%, 95% CI 0.3% to 1.2%, Ptrend = 0.016), and spine (YOY change = +0.2%, 95% CI 0.0% to 0.4%, Ptrend = 0.033) injections increased. PRP injections given by sports medicine orthopaedic surgeons (YOY change = +0.8%, 95% CI 0.6% to 1.2%, Ptrend <0.0001) increased over time, whereas those by general orthopaedic surgeons decreased (YOY change = -0.9, 95% CI -1.2 to [-0.6%], Ptrend = 0.001). CONCLUSION: PRP injections quadrupled in prevalence from 2010 to Q1.2020, with a projected increase in annual usage in this data set of 66% by 2030. As greater evidence-based indications for PRP use are identified, more specialists and insurance providers may consider expanding their involvement in this growing field. LEVEL OF EVIDENCE: III, retrospective cohort study.

Assessment of innate immune response modulating impurities in glucagon for injection.

Glucagon for Injection is a polypeptide hormone medication used to treat patients with severe hypoglycemia or low blood sugar. Only recently, was a generic version of glucagon for injection approved by the FDA. While the generic version was deemed equivalent to its brand-name counterpart, the two glucagon products were produced using different manufacturing processes. The brand-name glucagon is produced via recombinant DNA while the generic glucagon is produced by peptide synthesis. Different manufacturing processes can result in different levels of innate immune response modulating impurities (IIRMIs). This study utilized a cell-based assay method, which allows for detection of a broad spectrum of impurities, to investigate the IIRMI risks of the generic glucagon to make sure it has similar or less immunogenicity risks than the brand-name glucagon product. Three commercial cell lines (RAW-Blue™, HEK-Blue™-hNOD1 and HEK-Blue™-hNOD2) carrying a secreted embryonic alkaline phosphatase reporter construct were used to quantify the level of innate immune responses after being treated with the glucagon drugs. The study results showed that despite differences in manufacturing process, the innate immunogenicity risk in the synthetic (generic) glucagon was at negligible level and comparable to the recombinant (brand-name) glucagon product.

Readmissions, costs, and duration to subsequent outpatient visit after hospital discharge among Medicaid beneficiaries utilizing oral versus long-acting injectable antipsychotics in bipolar disorder or schizophrenia.

BACKGROUND: Long-acting injectable antipsychotics (LAIs) may reduce hospitalizations versus oral formulations (OAP) in bipolar disorder (BP) and schizophrenia/schizoaffective disorder (SCZ), but the impact on time to outpatient follow-up is less understood. OBJECTIVES: To assess hospital readmissions and medical costs among Medicaid beneficiaries with BP or SCZ utilizing OAP or LAI SGAs. METHODS: Cross-sectional and longitudinal analyses utilized comprehensive administrative claims of Oklahoma Medicaid beneficiaries (≥18 years) with BP or SCZ between 1 January 2013 and 31 December 2017. Readmissions, total direct medical costs, and psychiatry-related outpatient visits were assessed via generalized linear models and generalized estimating equations, controlling for demographic and clinical covariates. RESULTS: Among 2523 included members, LAI utilization was associated with 1.50 and 1.73 times higher odds of any hospitalization and any readmission, respectively (p < .05). Cases involving both BP and SCZ were associated with a 2.40 times higher odds of any readmission, 2.26 times higher number of readmissions, and 24.5% higher costs (p < .001). Of the 468 members with a subsequent psychiatry-related outpatient visit, LAIs were associated with a 23.9% shorter duration to outpatient visit and 16.4% lower costs (p < .05). CONCLUSION: In contrast to prior studies, this real-world investigation noted higher hospitalizations and readmissions among LAIs relative to OAP medications, but among members with a hospitalization or ED visit, LAIs were associated with shorter durations to outpatient visits and lower costs. Those with diagnoses of both BP with SCZ had higher odds of any readmission, number of readmissions, and costs relative to those with bipolar disorder alone and may be a key target for interventions.

This study compared long-acting antipsychotics that were administered by injection (LAIs) to antipsychotic agents taken orally (OAPs) among Medicaid members with bipolar disorder and/or schizophrenia. Readmission to the emergency department (ED) or hospital (within 30 days of a previous visit) and costs were observed to be similar with LAIs relative to OAPs. Among members who went to the hospital, a shorter time to psychiatric follow-up outpatient visit and lower costs were observed among those taking LAIs relative to OAPs.

Expert recommendations on the assessment and management of complications due to hyaluronic acid soft tissue filler injections in Asians.

BACKGROUND: The use of hyaluronic acid (HA) fillers for medical aesthetic purposes is increasing worldwide. Nonetheless, adverse events do occur because of patient-specific issues, injection technique, or product factors. It would be mandatory to consider cultural and anatomical features of Asians in preventing and managing the complications of HA injections. METHODS: Literature search of studies looking at current evidence and guidelines on the management of complications following HA filler injections in Asian patients was conducted. This was followed by an expert group discussion that was convened to reach consensus recommendations on the best clinical practices. RESULTS: The expert panel provided specific recommendations focusing on the safe use of soft tissue fillers in Asian patients, including early identification of adverse events and how to prevent and comprehensively manage these outcomes. CONCLUSIONS: Here, we provide consensus statements of Asian experts in dermatology, plastic surgery, ophthalmology, and aesthetic medicine mainly focusing on AEs with higher risk for Asians and can be used to guide physicians in treating Asian population.