Randomized Evaluation of a Remote Management Program to Improve Guideline-Directed Medical Therapy: The DRIVE Trial.

BACKGROUND: Several SGLT2i (sodium-glucose transport protein 2 inhibitors) and GLP1-RA (glucagon-like peptide-1 receptor agonists) reduce cardiovascular events and improve kidney outcomes in patients with type 2 diabetes; however, utilization remains low despite guideline recommendations. METHODS: A randomized, remote implementation trial in the Mass General Brigham network enrolled patients with type 2 diabetes with increased cardiovascular or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP1-RA were randomly assigned to simultaneous virtual patient education with concurrent prescription of SGLT2i or GLP1-RA (ie, Simultaneous) or 2 months of virtual education followed by medication prescription (ie, Education-First) delivered by a multidisciplinary team driven by nonlicensed navigators and clinical pharmacists who prescribed SGLT2i or GLP1-RA using a standardized treatment algorithm. The primary outcome was the proportion of patients with prescriptions for either SGLT2i or GLP1-RA by 6 months. RESULTS: Between March 2021 and December 2022, 200 patients were randomized. The mean age was 66.5 years; 36.5% were female, and 22.0% were non-White. Overall, 30.0% had cardiovascular disease, 5.0% had cerebrovascular disease, and 1.5% had both. Mean estimated glomerular filtration rate was 77.9 mL/(min‧1.73 m2), and mean urine/albumin creatinine ratio was 88.6 mg/g. After 2 months, 69 of 200 (34.5%) patients received a new prescription for either SGLT2i or GLP1-RA: 53.4% of patients in the Simultaneous arm and 8.3% of patients in the Education-First arm (P<0.001). After 6 months, 128 of 200 (64.0%) received a new prescription: 69.8% of patients in the Simultaneous arm and 56.0% of patients in Education-First (P<0.001). Patient self-report of taking SGLT2i or GLP1-RA within 6 months of trial entry was similarly greater in the Simultaneous versus Education-First arm (69 of 116 [59.5%] versus 37 of 84 [44.0%]; P<0.001) Median time to first prescription was 24 (interquartile range [IQR], 13-50) versus 85 days (IQR, 65-106), respectively (P<0.001). CONCLUSIONS: In this randomized trial, a remote, team-based program identifies patients with type 2 diabetes and high cardiovascular or kidney risk, provides virtual education, prescribes SGLT2i or GLP1-RA, and improves guideline-directed medical therapy. These findings support greater utilization of virtual team-based approaches to optimize chronic disease management. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06046560.

Primary immunodeficiency diseases treated with immunoglobulin and associated comorbidities.

Background: Primary immunodeficiency diseases (PIDD) consist of a heterogeneous group of disorders characterized by various aspects of immune dysregulation. Although the most universally recognized manifestation of PIDD is an increased susceptibility to infections, there is a growing body of evidence that patients with PIDD often have a higher incidence of lung disease, autoimmunity, autoinflammatory disorders, and malignancy. Objective: The purpose of this study was to better understand the noninfectious complications of PIDD by determining the comorbid disease prevalence across various age groups, genders, and immunoglobulin replacement types compared with the general population. Methods: A large U.S. insurance claims database was retrospectively analyzed for patients who had a diagnosis of PIDD and who had received intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG). The prevalences of 31 different comorbid conditions in the Elixhauser comorbidity index were compared among the 3125 patients in the PIDD population to > 37 million controls separated by gender and by 10-year age cohorts. Results: In the PIDD population, statistically significantly higher comorbid diagnoses included chronic obstructive pulmonary disease-asthma in 51.5%, rheumatoid disease in 14%, deficiency anemia in 11.8%, hypothyroidism in 21.2%, lymphoma in 16.7%, neurologic disorders in 9.7%, arrhythmias in 19.9%, electrolyte disorders in 23.6%, coagulopathies in 16.9%, and weight loss in 8.4%. Conclusion: PIDD that require immunoglobulin replacement are associated with an increased risk of numerous comorbid conditions that affect morbidity and mortality. Recognition and increased awareness of these noninfectious complications can allow for better monitoring, care coordination, targeted treatments, and improved prognosis.

Mental Health and Substance Misuse-Related Emergency Department Discharges in Urban Counties of North Carolina.

BACKGROUND: National evidence suggests that there is considerable variation between regions in emergency department utilization for routine health care needs. Many emergency departments are poorly equipped to manage the needs of patients with mental health or substance misuse diagnoses, who could often be more effectively managed in other settings. We sought to quantify differences in the frequency of mental health and substance misuse-related emergency department encounters across urban counties in North Carolina. METHODS: Data from the 2010 North Carolina State Emergency Department and Inpatient Databases were analyzed with descriptive, bivariate, and multivariate statistics. Primary discharge diagnoses were classified using the International Classification of Disease, Ninth Revision, Clinical Modification codes included with the databases. RESULTS: The overall rate of mental health and substance misuse encounters in urban counties was 19.1 encounters per 1,000 people (4.5% of all emergency department encounters). This rate ranged from 6.4 encounters per 1,000 people (2.4% of encounters) in Wake County to 30.1 encounters per 1,000 people (6.4%) in Orange County. LIMITATIONS: There is a possibility of nondifferential classification error in the state databases, as coding practices and coding errors may vary between facilities. We were unable to confirm diagnoses through additional clinical information or Diagnostic and Statistical Manual criteria. CONCLUSION: Mental health and substance misuse-related encounters constitute a small percentage of emergency department encounters in North Carolina's urban counties, with significant variation between counties. Diverting some of these encounters to community-based mental health and substance misuse health care providers could reduce emergency department utilization while improving the quality of care delivered to this vulnerable patient population.

Influence of acute and chronic streptozotocin-induced diabetes on the rat tendon extracellular matrix and mechanical properties.

Diabetes is a major risk factor for tendinopathy, and tendon abnormalities are common in diabetic patients. The purpose of the present study was to evaluate the effect of streptozotocin (60 mg/kg)-induced diabetes and insulin therapy on tendon mechanical and cellular properties. Sprague-Dawley rats (n = 40) were divided into the following four groups: nondiabetic (control), 1 wk of diabetes (acute), 10 wk of diabetes (chronic), and 10 wk of diabetes with insulin treatment (insulin). After 10 wk, Achilles tendon and tail fascicle mechanical properties were similar between groups (P > 0.05). Cell density in the Achilles tendon was greater in the chronic group compared with the control and acute groups (control group: 7.8 ± 0.5 cells/100 µm(2), acute group: 8.3 ± 0.4 cells/100 µm(2), chronic group: 10.9 ± 0.9 cells/100 µm(2), and insulin group: 9.2 ± 0.8 cells/100 µm(2), P < 0.05). The density of proliferating cells in the Achilles tendon was greater in the chronic group compared with all other groups (control group: 0.025 ± 0.009 cells/100 µm(2), acute group: 0.019 ± 0.005 cells/100 µm(2), chronic group: 0.067 ± 0.015, and insulin group: 0.004 ± 0.004 cells/100 µm(2), P < 0.05). Patellar tendon collagen content was ∼32% greater in the chronic and acute groups compared with the control or insulin groups (control group: 681 ± 63 µg collagen/mg dry wt, acute group: 938 ± 21 µg collagen/mg dry wt, chronic: 951 ± 52 µg collagen/mg dry wt, and insulin group: 596 ± 84 µg collagen/mg dry wt, P < 0.05). In contrast, patellar tendon hydroxylysyl pyridinoline cross linking and collagen fibril organization were unchanged by diabetes or insulin (P > 0.05). Our findings suggest that 10 wk of streptozotocin-induced diabetes does not alter rat tendon mechanical properties even with an increase in collagen content. Future studies could attempt to further address the mechanisms contributing to the increase in tendon problems noted in diabetic patients, especially since our data suggest that hyperglycemia per se does not alter tendon mechanical properties.

Methods, rationale, and design for a remote pharmacist and navigator-driven disease management program to improve guideline-directed medical therapy in patients with type 2 diabetes at elevated cardiovascular and/or kidney risk.

AIM: Describe the rationale for and design of Diabetes Remote Intervention to improVe use of Evidence-based medications (DRIVE), a remote medication management program designed to initiate and titrate guideline-directed medical therapy (GDMT) in patients with type 2 diabetes (T2D) at elevated cardiovascular (CV) and/or kidney risk by leveraging non-physician providers. METHODS: An electronic health record based algorithm is used to identify patients with T2D and either established atherosclerotic CV disease (ASCVD), high risk for ASCVD, chronic kidney disease, and/or heart failure within our health system. Patients are invited to participate and randomly assigned to either simultaneous education and medication management, or a period of education prior to medication management. Patient navigators (trained, non-licensed staff) are the primary points of contact while a pharmacist or nurse practitioner reviews and authorizes each medication initiation and titration under an institution-approved collaborative drug therapy management protocol with supervision from a cardiologist and/or endocrinologist. Patient engagement is managed through software to support communication, automation, workflow, and standardization. CONCLUSION: We are testing a remote, navigator-driven, pharmacist-led, and physician-overseen management strategy to optimize GDMT for T2D as a population-level strategy to close the gap between guidelines and clinical practice for patients with T2D at elevated CV and/or kidney risk.

Differences in Patient Demographics and Healthcare Costs of Patients with PIDD Receiving Intravenous or Subcutaneous Immunoglobulin Therapies in the United States.

BACKGROUND: Primary immune-deficiency disease (PIDD) is a rare, debilitating disease of the immune system that predisposes the affected individual to infection, autoimmune conditions, and neoplasm. A major component of the cost of treating PIDD is the high price of immunoglobulin drugs, which can be administered via an intravenous (IV) or subcutaneous (SC) route. OBJECTIVE: To compare real-world costs for patients with PIDD who are receiving IV immunoglobulin (IVIG) or SC immunoglobulin (SCIG) treatment, from a US payer perspective, using a large claims database. METHODS: Based on 2011 to 2013 data from the PharMetrics Plus database, a large national healthcare claims database, patients who were newly diagnosed with PIDD were included in the study if they had ≥2 claims for PIDD that were ≥90 days apart, and if they were treatment-naïve for a minimum of 1 year before the study period. Patients who switched the route of immunoglobulin administration were excluded, with the exception of patients who received SCIG who could initially receive ≤2 IV-loading infusions, as directed by treatment guidelines. We used propensity score analysis to match the patients in the SCIG cohort to patients in the IVIG cohort based on age, sex, and all Elixhauser comorbidities. We compared the patient characteristics and direct medical costs (all-cause, PIDD-related, and pharmacy-related) before and after matching, using t-tests for continuous variables, chi-square test for categorical variables, and Wilcoxon rank-sum test for differences in medians. RESULTS: A total of 1639 patients with PIDD (986 who received IVIG and 653 who received SCIG) met all the study inclusion criteria. Compared with the patients who received IVIG, the patients who received SCIG were predominantly female (58% vs 63%, respectively) and significantly younger (mean age, 49.1 vs 40.3 years, respectively). Significantly fewer patients who received SCIG than those receiving IVIG had claims with International Classification of Diseases, Ninth Revision codes for Elixhauser comorbidities, including cardiovascular and pulmonary conditions, diabetes, renal failure, liver disease, cancers, weight loss, fluid and electrolyte disorders, and psychoses (P <.05 for all), and their Charlson Comorbidity Index scores were lower than those receiving IVIG (1.74 vs 3.01, respectively; P ≤.05 for all). After matching the 2 cohorts (N = 553 in each), the 1-year postindex median total PIDD-related costs were significantly lower in the IVIG group than in the SCIG group ($38,064 vs $43,266, respectively; P = .002). CONCLUSIONS: In matched analyses, PIDD-related treatment costs were higher for patients who received SCIG than for those who received IVIG. Furthermore, patients who received SCIG were significantly younger and had significantly less comorbidities than their counterparts who received IVIG, suggesting that patient characteristics that reflect a desire and greater capacity for autonomy may affect physicians' choice of the route of administration for immunoglobulin.

Two comparative assessments of intravenous immunoglobulin therapy switching patterns in the treatment of chronic inflammatory demyelinating polyneuropathy in the US.

Purpose: For chronic inflammatory demyelinating polyneuropathy (CIDP) patients, each branded intravenous immunoglobulin (IVIG) treatment differs in production processes, virus elimination, formulation, and composition. Given the limited availability of real-world data comparing IVIGs for CIDP, this study evaluated switching patterns between IVIG products in 2 separate retrospective databases. Patients and methods: Two independent analytic teams retrospectively evaluated IVIG treatment-naïve patients with an ICD diagnosis code for CIDP. Study 1 used integrated healthcare claims from IMS LifeLink PharMetrics Plus™ and Study 2 used the Truven MarketScan® Database. All analyses were descriptive, with outcomes assessed during the 2-year post-index period. Results: One-quarter of IVIG patients switched therapies within the 2-year study period. In both studies, switching rates were lowest for IVIG-G (Gamunex®-C) (Study 1: 9.8%, Study 2: 8.9%), followed by IVIG-F (Flebogamma®) (Study 1: 25.0%, Study 2: 18.2%), and highest for IVIG-other (Octagam®/Gammaplex®) (Study 1: 50.0%, Study 2: 33.3%). When patients were switched, most switched to IVIG-G (Study 1: 51.6%, Study 2: 54.3%). Conclusion: The small proportion of CIDP switchers in 2 independent studies suggests that IVIG therapy is generally well tolerated. However, differences existed in switch rates for different IVIG products. The reason for low switching rates could not be assessed in this study; therefore, further studies are required to detect possible relevant differences in effectiveness and tolerability.

The value of self-medication: summary of existing evidence.

AIM: The aim of this review was to identify the international evidence that is currently available on the economic value of self-care through responsible self-medication, in terms of the measures related to access to treatment, time, and productivity. METHODS: A targeted literature search was conducted for 1990-2016, including data gathered from members of the World Self-Medication Industry and searches on PubMed, EBSCOHost, and Google Scholar. Specific searches of individual drug classes known to be switched to non-prescription status in this period were also conducted. RESULTS: A total of 71 articles were identified, of which 17 (11 modeling studies, six retrospective analyses) were included in the review. Evidence from modeling studies and retrospective analyses of grouped data across a range of common conditions for which non-prescription medications are available in different countries/regions showed that the use of non-prescription products for the treatment of common conditions or for symptom management (e.g. allergies, chronic pain, migraine, vaginitis, gastrointestinal symptoms, or common cold symptoms) had considerable value to patients, payers, and employers alike in terms of cost savings and improved productivity. Potential benefits of self-medication were also identified in preventative healthcare strategies, such as those for cardiovascular health and osteoporosis. LIMITATIONS: This review was limited by a targeted, but non-systematic approach to literature retrieval, as well as the inclusion of unpublished reports/white papers and patient self-reported data. CONCLUSIONS: The evidence identified in this literature review shows that responsible, appropriate self-medication with non-prescription products can provide significant economic benefits for patients, employers, and healthcare systems worldwide.

Healthcare Cost and Utilization before and after Diagnosis of Pseudomonas aeruginosa among Patients with Non-Cystic Fibrosis Bronchiectasis in the U.S.

Non-cystic fibrosis bronchiectasis (NCFBE) is a rare, chronic lung disease characterized by bronchial inflammation and permanent airway dilation. Chronic infections with P. aeruginosa have been linked to higher morbidity and mortality. To understand the impact of P. aeruginosa in NCFBE on health care costs and burden, we assessed healthcare costs and utilization before and after P. aeruginosa diagnosis. Using data from 2007 to 2013 PharMetrics Plus administrative claims, we included patients with ≥2 claims for bronchiectasis and >1 claim for P. aeruginosa; then excluded those with a claim for cystic fibrosis. Patients were indexed at first claim for P. aeruginosa and were required to have >12 months before and after the index P. aeruginosa. The mean differences in utilization and costs were assessed using paired Student's t-tests for statistical significance. Mean total healthcare costs per patient were $36,213 pre-P. aeruginosa diagnosis versus $67,764 post-P. aeruginosa, an increase of 87% (p < 0.0001). Inpatient costs represented the largest proportion of total healthcare costs post-P. aeruginosa (54%) with an increase of four hospitalizations per patient (p < 0.0001). NCFBE patients with evidence of P. aeruginosa incur substantially greater healthcare costs and utilization after P. aeruginosa diagnosis. Future research should explore methods of earlier identification of NCFBE patients with P. aeruginosa, as this may lead to fewer severe exacerbations, thereby resulting in a reduction in hospitalizations and healthcare costs.

One-year Prevalence, Comorbidities, and Cost of Hospitalizations for Alpha-1 Antitrypsin Deficiency among Patients with Chronic Obstructive Pulmonary Disease in the United States.

Objectives: Little is known about severe chronic obstructive pulmonary disease (COPD) exacerbations among patients with Alpha-1 Antitrypsin Deficiency (AATD). We assessed inpatients with AATD and COPD among a sample of COPD inpatients to ascertain demographic, clinical and economic differences in the course of disease and treatment. Methods: Using data from the 2009 Nationwide Inpatient Sample (NIS), we identified COPD (ICD-9-CM: 491.xx, 492.xx, or 496.xx) patients with AATD (273.4). We compared patient demographics and healthcare outcomes (eg, length of stay, inpatient death, type and number of procedures, and cost of care) between COPD patients with and without alpha-1 antitrypsin deficiency. Frequencies and percentages for patient demographics were compared using bivariate statistics (eg, chi-square test). Recognizing the non-parametric nature of length of stay and cost, we calculated median values and interquartile ranges for these variables for each group of patients. Finally, the risk of inpatient death was estimated using logistic regression. Results: Of 840 242 patients with COPD (10.8% of the NIS sample population), 0.08% (684) had a primary or secondary diagnosis code for AATD. COPD+AATD were younger (56 vs 70, p<0.0001) and as a result, less likely to be covered by Medicare (44% vs 62%, p<0.0001). AATD patients were also more likely to have comorbid non-alcoholic liver disease (7% vs 2%, p<0.0001), depression (17% vs 13%, p=0.0328), and pulmonary circulation disorders (7% vs 4%, p=0.0299). Patients with AATD had a 14% longer length of stay (IRR = 1.14, 95% CI 1.07, 1.21) and a mean cost of $1487 (p=0.0251) more than COPD inpatients without AATD. Conclusions: AATD is associated with increased mean length of stay and cost, as well as higher frequency of comorbid non-alcoholic liver disease, depression, and pulmonary circulation disorders. Future research should assess other differences between AATD and the general COPD population such as natural history of disease, treatment responsiveness and disease progression.

The dilemma of diabetes in chronic inflammatory demyelinating polyneuropathy.

PURPOSE: We reviewed the literature on chronic inflammatory demyelinating polyneuropathy (CIDP) in diabetes mellitus (DM) and explored real-world data on the prevalence and treatment of CIDP within DM. METHODS: A literature search of Scopus was performed for the terms chronic inflammatory demyelinating polyradiculoneuropathy, chronic inflammatory demyelinating polyneuropathy, CIDP, and prevalence, incidence, epidemiology, or diabetes; peripheral neuropathy and prevalence or diabetes. We also searched through the reference lists of the resulting publications for additional findings that may have been missed. Additional publications on guidelines for the diagnosis of CIDP and diabetic neuropathy were also included. A descriptive analysis of the 2009-2013 PharMetrics Plus™ Database was performed to estimate the prevalence and treatment of CIDP within the DM population. RESULTS: There is an increasing body of literature suggesting that the prevalence of CIDP tends to be higher in diabetic patients, especially in those of older age. Our real-world data seem to support published findings from the literature. For the total cohort (N=101,321,694), the percent prevalence of CIDP (n=8,173) was 0.008%; DM (n=4,026,740) was 4%. The percent prevalence of CIDP without DM (n=5,986) was 0.006%; CIDP with DM (n=2,187) was 9-fold higher at 0.054%. For patients >50years old, there was a significantly higher percentage of CIDP with DM than CIDP without DM. Approximately 50% of CIDP patients were treated with IVIg, 23%-24% with steroids, 1%-2% with PE, and 20%-23% received no treatment. CONCLUSIONS: In addition to the growing evidence of higher prevalence of CIDP in DM, our findings reinforce the need for heightened awareness of the association of CIDP and DM.

Incidence and Cost of Ankle Sprains in United States Emergency Departments.

BACKGROUND: Ankle sprains represent a common injury in emergency departments, but little is known about common complications, procedures, and charges associated with ankle sprains in emergency departments. HYPOTHESIS: There will be a higher incidence of ankle sprains among younger populations (≤25 years old) and in female patients. Complications and procedures will differ between ankle sprain types. Lateral ankle sprains will have lower health care charges relative to medial and high ankle sprains. STUDY DESIGN: Descriptive epidemiological study. LEVEL OF EVIDENCE: Level 3. METHODS: A cross-sectional study of the 2010 Nationwide Emergency Department Sample was conducted. Outcomes such as charges, complications, and procedures were compared using propensity score matching between lateral and medial as well as lateral and high ankle sprains. RESULTS: The sample contained 225,114 ankle sprains. Female patients sustained more lateral ankle sprains (57%). After propensity score adjustment, lateral sprains incurred greater charges than medial ankle sprains (median [interquartile range], $1008 [$702-$1408] vs $914 [$741-$1108]; P < 0.01). Among complications, pain in the limb (1.92% vs 0.52%, P = 0.03), sprain of the foot (2.96% vs 0.70%, P < 0.01), and abrasion of the hip/leg (1.57% vs 0.35%, P = 0.03) were more common in lateral than medial ankle sprain events. Among procedures, medial ankle sprains were more likely to include diagnostic radiology (97.91% vs 83.62%, P < 0.01) and less likely to include medications than lateral ankle sprains (0.87% vs 2.79%, P < 0.01). Hospitalizations were more common following high ankle sprains than lateral ankle sprains (24 [6.06%] vs 1 [0.25%], P < 0.01). CONCLUSION: Ankle sprain emergency department visits account for significant health care charges in the United States. Age- and sex-related differences persist among the types of ankle sprains. CLINICAL RELEVANCE: The health care charges associated with ankle sprains indicate the need for additional preventive measures. There are age- and sex-related differences in the prevalence of ankle sprains that suggest these demographics may be risk factors for ankle sprains.

Cachexia among US cancer patients.

BACKGROUND: Cancer cachexia is a debilitating condition and results in poor prognosis. The purpose of this study was to assess hospitalization incidence, patient characteristics, and medical cost and burden of cancer cachexia in the US. METHODS: This study used a cross-sectional analysis of the Nationwide Inpatient Sample (NIS) for 2009. Five cancers reported to have the highest cachexia incidence were assessed. The hospitalization incidence related to cachexia was estimated by cancer type, cost and length of stay were compared, and descriptive statistics were reported for each cancer type, as well as differences being compared between patients with and without cachexia. RESULTS: Risk of inpatient death was higher for patients with cachexia in lung cancer (OR = 1.32; CI = 1.20-1.46) and in all cancers combined (OR = 1.76; CI = 1.67-1.85). The presence of cachexia increased length of stay in lung (IRR = 1.05; CI = 1.03-1.08), Kaposi's sarcoma (IRR = 1.47; CI = 1.14-1.89) and all cancers combined (IRR = 1.09; CI = 1.08-1.10). Additionally, cachectic patients in the composite category had a longer hospitalization stay compared to non-cachectic patients (3-9 days for those with cachexia and 2-7 days for those without cachexia). The cost of inpatient stay was significantly higher in cachexic than non-cachexic lung cancer patients ($13,560 vs $13 190; p < 0.0001), as well as cachexic vs non-cachexic cancer patients in general (14 751 vs 13 928; p < 0.0001). CONCLUSIONS: Cachexia increases hospitalization costs and length of stay in several cancer types. Identifying the medical burden associated with cancer cachexia will assist in developing an international consensus for recognition and coding by the medical community and ultimately an effective treatment plans for cancer cachexia.

Cachexia & debility diagnoses in hospitalized children and adolescents with complex chronic conditions: evidence from the Kids' Inpatient Database.

OBJECTIVE: To characterize the frequency, cost, and hospital-reported outcomes of cachexia and debility in children and adolescents with complex chronic conditions (CCCs). METHODS: We identified children and adolescents (aged ≤20 years) with CCCs, cachexia, and debility in the Kids' Inpatient Database [Healthcare Cost and Utilization Project, Agency for Healthcare Research & Quality]. We then compared the characteristics of patients and hospitalizations, including cost and duration of stay, for CCCs with and without cachexia and/or debility. We examined factors that predict risk of inpatient mortality in children and adolescents with CCCs using a logistic regression model. We examined factors that impact duration of stay and cost in children and adolescents with CCCs using negative binomial regression models. All costs are reported in US dollars in 2014 using Consumer Price Index inflation adjustment. RESULTS: We estimated the incidence of hospitalization of cachexia in children and adolescents with CCCs at 1,395 discharges during the sample period, which ranged from 277 discharges in 2003 to 473 discharges in 2012. We estimated the incidence of hospitalization due to debility in children and adolescents with CCCs at 421 discharges during the sample period, which ranged from 39 discharges in 2003 to 217 discharges in 2012. Cachexia was associated with a 60% increase in the risk of inpatient mortality, whereas debility was associated with a 40% decrease in the risk of mortality. Cachexia and debility increased duration of stay in hospital (17% and 39% longer stays, respectively). Median cost of hospitalization was $15,441.59 and $23,796.16 for children and adolescents with cachexia and debility, respectively. CONCLUSIONS: Incidence of hospitalization for cachexia in children and adolescents with CCCs is less than that for adults but the frequency of cachexia diagnoses increased over time. Estimates of the incidence of hospitalization with debility in children and adolescents with CCCs have not been reported, but our study demonstrates that the frequency of these discharges is also increasing.

Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function.

BACKGROUND: Risk evaluation and mitigation strategies (REMS), as mandated by the US Food and Drug Administration (FDA) for medications with the potential for harm, are increasingly incorporating rigid protocols for patient evaluation, but little is known about compliance with these programs. Despite the inherent limitations, data on administrative claims may provide an opportunity to investigate adherence to these programs. METHODS: We assessed adherence to liver function test (LFT) requirements included in the REMS program for bosentan through use of administrative claims. Patients observed in the Optum Research Database who were initiators of bosentan from November 20, 2001 to March 31, 2013 were included. Adherence to LFTs was calculated using pharmacy claims for bosentan dispensation and medical claims for laboratory services, and was assessed at the time of drug initiation and within specified time intervals throughout follow-up. RESULTS: Of 742 patients, 523 (70.5%) had ≥1 qualifying LFT. Among patients with ≥12 dispensations, claims for LFTs at individual dispensations were 53.2-64.0%. Median proportion of dispensations with ≥1 LFT was 0.8 among patients with ≥6 (interquartile range, 0.7-1.0) or ≥12 (0.7-0.9) dispensations. Adherence was 90-100% for 33.3% of all initiators, whereas 29.3% of initiators were non-adherent (defined as <50% of on-therapy LFTs). CONCLUSIONS: Analyses of administrative claims suggest that the REMS program for bosentan may not have adequately guaranteed adherence to the program's monthly monitoring of LFTs. Such investigations of existing REMS programs may provide insight on how to accomplish more successful evaluation of REMS.

One-year prevalence, comorbidities and cost of cachexia-related inpatient admissions in the USA.

BACKGROUND: Cachexia is a condition characterized as a loss in body mass or metabolic dysfunction and is associated with several prevalent chronic health conditions including many cancers, COPD, HIV, and kidney disease, with between 10 and 50% of patients with these conditions having cachexia. Currently there is little research into cachexia and our objective is to characterize cachexia patients, their healthcare utilization, and associated hospitalization costs. Given the increasing prevalence of chronic diseases, it is important to better understand cachexia so that the condition can be better diagnosed and managed. METHODS: We utilized one year (2009) of the Nationwide Inpatient Sample (NIS). The NIS represents all inpatient stays at a random 20% sample of all hospitals within the United States. We grouped cachexia individuals by primary or secondary discharge diagnosis and then compared those with cachexia to all others in terms of length of stay (LOS) and total cost. Finally we looked into factors predicting increased LOS using a negative binomial model. RESULTS: We estimated US prevalence for cachexia-related inpatient admissions at 161,898 cases. Cachexia patients were older, with an average age of 67.95 versus 48.10 years in their non-cachexia peers. Hospitalizations associated with cachexia had an increased LOS compared to non-cachexia patients (6 versus 3 days), with average costs per stay $4641.30 greater. Differences were seen in loss of function (LOF) with cachexia patients, mostly in the major LOF category (52.60%), whereas non-cachexia patients were spread between minor, moderate, and major LOF (36.28%, 36.11%, and 21.26%, respectively). Significant positive predictors of increased LOS among cachexia patients included urban hospital (IRR=1.21, non-teaching urban; IRR=1.23, teaching urban), having either major (IRR=1.41) or extreme (IRR=2.64) LOF, and having a primary diagnosis of pneumonia (IRR=1.15). CONCLUSION: We have characterized cachexia and seen it associated with increased length of stay, increased cost, and more severe loss of function in patients compared to those without cachexia.