Background Extracorporeal membrane oxygenation (ECMO) provides life support to patients undergoing cardiopulmonary surgeries when other interventions are ineffective. Unfractionated heparin (UFH) is routinely used during ECMO due to increased risk of thrombosis. However, in some cases, like antithrombin deficiency, UFH is not efficacious, and heparin resistance (HR) can develop. There is considerable confusion about HR and what additional management strategies should be taken. Objectives This study compared clinical and economic outcomes associated with antithrombin concentrate (ATc) + UFH versus bivalirudin in adult patients undergoing ECMO. Methods This retrospective cohort study used data from the 2014-2023 TriNetX database and the 2018-2021 Premier Healthcare Database. Adult patients treated with ATc + UFH or bivalirudin within 3 days of ECMO initiation who did not undergo cardiopulmonary bypass (CPB) or coronary artery bypass grafting (CABG) during their ECMO hospital stay were identified. Propensity score matching was performed to balance the groups. Thromboembolic events, bleeding events, heparin-induced thrombocytopenia, hospital mortality, length of stay, and total hospital cost were compared. Results A total of 1601 patients (276 ATc + UFH, and 1352 bivalirudin) were identified from TriNetX, and 1592 (264 ATc + UFH, and 1528 bivalirudin) from Premier. ATc + UFH was associated with lower odds of thrombotic and bleeding events compared to bivalirudin only. Length of stay and total hospital costs trended lower for patients prescribed antithrombin and UFH. Conclusions Antithrombin + UFH may be a preferable option for managing ECMO patients, particularly those with heparin resistance.

Pregnant individuals with antithrombin (AT) deficiency have an increased risk for thromboembolic complications during pregnancy, delivery, and postpartum. Overall, the risk of venous thromboembolism (VTE) is approximately five times higher in pregnant women than in non-pregnant women. VTE, including pulmonary embolism, is a leading cause of pregnancy-related mortality in the US and is associated with significant long-term morbidity. However, optimal management strategies, including the role of antithrombin concentrate (ATc) in this high-risk population, remain unclear, with current recommendations based primarily on expert consensus and case reports. We conducted a retrospective cohort analysis to describe real-world ATc use and assess thromboembolic outcomes in pregnant individuals with AT deficiency, including those with persistently low AT levels at delivery. We utilized electronic health record data from the TriNetX Dataworks US network to identify a study population comprising pregnant individuals meeting the following inclusion criteria: (1) presence of an inpatient delivery encounter between Jan 1, 2015—Dec 31, 2024; (2) history of an AT level ≤80% within the 9 months leading up to the delivery encounter; and (3) history of diagnosed primary thrombophilia, as determined by International Classification of Diseases codes. We evaluated demographic and clinical characteristics, including maternal age and obstetric comorbidity burden, using the Obstetric Comorbidity Index (OBCMI), a validated scoring system that estimates the risk of maternal morbidity based on pre-existing and pregnancy-related conditions. We also examined the association between peripartum ATc administration and venous thromboembolism (VTE), with descriptive statistics used to compare clinical and outcome variables between ATc and non-ATc encounters. We identified a total of 154 delivery encounters from 114 patients impacted by AT deficiency, corresponding to approximately 1.5 deliveries per year, among which 13.6% (n=21) involved ATc administration. The median maternal age at delivery was 31 years [25th, 75th percentiles: 27, 35]. OBCMI scores were similar between groups, with an overall median of 26 [17, 40]. Deliveries involving ATc use had higher rates of VTE history (57.1% vs. 39.1%). To draw clinically relevant comparisons, we focused on a subgroup of delivery encounters with AT levels measured during the hospitalization. Among encounters with peripartum AT levels ≤80% (n=14), 71.4% (n=10) involved ATc use. In this subgroup, peripartum VTE occurred in 0% of ATc-treated encounters (n=0/10) compared to 25.0% (n=1/4) in those without ATc. Restricting encounters with peripartum AT levels ≤60% (n=9), an even higher proportion received ATc (77.8%, n=7). In this subgroup, peripartum VTE occurred in 0% (n=0/7) of ATc-treated encounters compared to 50.0% (n=1/2) in those without ATc. Of note, among encounters with AT levels ≤60% at delivery, LMWH was also used at some point during the hospitalization in 100% (n=7) of ATc-administered cases and 50.0% (n=1) of non-ATc cases. In a sample of delivery encounters for obstetric patients with AT deficiency, ourfindings demonstrate that in concert with peripartum LMWH, ATc use may be associated with lower rates of VTE and related complications, particularly in those with persistently low peripartum AT levels. ATc-treated encounters more often included a history of VTE and lower baseline AT levels. While these findings are not definitive due to the small sample size and non-randomized nature of the comparison, these real-world data support the safety and efficacy of ATc in obstetric patients with AT deficiency, consistent with current expert guidelines for selected cases.

BACKGROUND:Antithrombin (AT) deficiency is a severe thrombophilia associated with increased rates of maternal morbidity, mortality, and greater healthcare resource utilization during pregnancy and postpartum. METHODS:Two large U.S. healthcare databases were queried for women aged 15-44 with delivery-related encounters: Cerner Real-World Data (CRWD, 01/01/2000-12/31/2021) and Premier Healthcare Database (PHD, 01/01/2016-01/01/2019). Individuals receiving cardiopulmonary bypass were excluded. Three cohorts were created: 1) Individuals who had AT levels tested any time between 9-months pre- through 3-months post-delivery (CRWD Test Cohort); 2) individuals prescribed AT concentrate (ATc) within 1-year pre- or 1-year post-delivery in CRWD (CRWD Medication Cohort); and 3) the same criteria as 2) applied to PHD (PHD Medication Cohort). RESULTS:There were 5411 individuals in the CRWD Test Cohort, 13 in the CRWD Medication Cohort and 38 in the PHD Medication Cohort. Demographic and baseline clinical characteristics were similar across cohorts. AT level testing occurred pre-delivery in 47.9 % of the CRWD Test Cohort and 23.1 % of the CRWD Medication Cohort. ATc was administered during the delivery hospitalization to 0.1 %, 23.1 % and 50.0 % of the CRWD Test, CRWD Medication, and PHD Medication Cohorts, respectively. Across cohorts, 5.4-7.9 % of individuals experienced thrombosis during the delivery-related encounter. Mean (SD) total costs for delivery through 1-year post-delivery were $190,894 ($276,893) with $123,763 ($177,122) of total costs related to abnormal coagulation. CONCLUSION:Opportunities exist to enhance the care of pregnant individuals with low AT levels throughout pregnancy, aiming for optimal maternal outcomes.

Objective: To evaluate in-hospital clinical outcomes after open and laparoscopic bowel resection (BR) with or without alvimopan treatment.Background: Delayed return of gastrointestinal function after BR may be associated with greater postoperative morbidity and increased hospital length of stay (LOS). In clinical trials, alvimopan-a peripherally acting mu-opioid receptor antagonist-accelerated gastrointestinal recovery after open BR.Methods: A retrospective matched-cohort study (NCT01150760) was conducted using a national inpatient database. Each alvimopan patient was exact matched (surgical procedure, surgeon specialty) and propensity score matched (baseline characteristics) to a nonalvimopan BR patient. Outcomes included gastrointestinal and other morbidity (cardiovascular, pulmonary, infection, cerebrovascular, thromboembolic); mortality; readmission rate; and intensive care unit (ICU) stay (intent-to-treat [ITT] population). Postoperative LOS and estimated cost were also compared (modified ITT population).Results: Each cohort included 3525 ITT patients with similar baseline characteristics. Gastrointestinal (29.8% vs 35.7%) and other morbidity (cardiovascular [19.4% vs 24.0%], pulmonary [7.3% vs 10.5%], infectious [9.6% vs 11.8%], thromboembolic [1.2% vs 2.1%]), mortality (0.4% vs 1.0%), and mean ICU stay (0.3 vs 0.6 days) were lower in the alvimopan group (P <= 0.003 for each). Postoperative LOS and estimated direct cost were lower for all alvimopan patients and after laparoscopic and open BR (LOS: -1.1, -0.8, and -1.8 days respectively; cost: -$2345, -$1382, and -$3218, respectively; P <= 0.0008 for each).Conclusions: On average, alvimopan-treated patients had a lower incidence of mortality and most incidents of morbidities. Length of stay, ICU use, and estimated cost were also lower with comparable readmissions. These results in patients outside the clinical trial setting include laparoscopic colectomy and demonstrate a potential association between acceleration of gastrointestinal recovery and improved early postoperative outcomes.

PURPOSE:This study assessed the direct economic burden of restless legs syndrome (RLS) among patients treated with dopamine agonists (DAs) using a large United States managed care database.DESIGN:Retrospective database analysis.METHODOLOGY:Patients were required to have > or =1 prescriptions for a DA (i.e., pergolide, pramipexole, ropinirole) between 1/1/2005 and 12/31/2007 (date of first DA, or "index"); continuous enrollment for > or =6 months before and > or =12 months after index; > or =1 diagnosis of RLS, before and after index; and no diagnosis of Parkinson's disease. Study measures included annual all-cause and RLS-related costs by care setting (hospitalizations, emergency room, office, pharmacy, other, total) and treatment-pattern events (discontinuations, switches, adjunctive treatments, titrations).PRINCIPAL FINDINGS:A total of 7,796 patients met the inclusion criteria. About 70% of patients received ropinirole, and 30% received pramipexole at index. Approximately 91% had >1 RLS-related office visits, and patients filled an average of 6.5 RLS-related prescriptions (DAs, gabapentin, carbidopa/levodopa) during the 1-year follow-up period. Mean (SD) all-cause health care costs were $11,485 ($21,362) per patient, mostly due to multiple medical conditions occurring with RLS. RLS-related costs were 6.7% of total all-cause costs (mean [SD] $774 [$1,504]), consisting of office visits (16%), pharmacy (63%), and other costs (20%). Approximately 58% had a treatment-pattern event suggesting a dopamine-related side effect. Opioids were the most commonly used adjunctive therapy (13% of patients).CONCLUSION:We found relatively low costs associated with RLS treatment. These findings should encourage expanding the coverage of treatment to reduce the suffering and costs associated with RLS.

Objective: To describe the development and psychometric properties of a daily subjective (patient-reported) sleep diary, the Subjective Post Sleep Diary (SPSD), that assesses sleep in relation to Restless Legs Syndrome (RLS).Methods: In 2008, the SPSD was developed de novo guided by input from 56 individuals in the US with RLS obtained via focus groups and one-on-one cognitive debriefing sessions. The psychometric properties of the SPSD were evaluated among an additional 470 RLS subjects in the US using three different administration routes; the internet only (N = 130), an Interactive Voice Response System (IVRS; N = 146) only and a hybrid version (internet and/or IVRS; N = 194).Results: A 12-item sleep diary assessing the key sleep parameters associated with RLS was developed and shown to have face validity following several rounds of focus groups and cognitive debriefing sessions. The SPSD items had high correlations with other sleep instruments and low correlations with constructs unrelated to sleep, and high known-groups predictive ability.Conclusions: The Subjective Post Sleep Diary (SPSD) is a short, valid and responsive instrument for measuring RLS-related sleep via the internet, IVRS or a combination of the two modes for US English speakers. (C) 2011 Elsevier B.V. All rights reserved.

To assess prevalence, disease burden, and costs of primary Restless Legs Syndrome (RLS) in the US. In 2007, 61,792 (20%) of 313,000 subjects from a representative US panel completed an online “global opinions” survey identifying respondents reporting all four diagnostic features of RLS. 4,484 met all criteria. 1,400 were randomly selected to complete a questionnaire to exclude those with diagnoses indicating possible secondary RLS. Those that did not have diagnoses associated with secondary RLS were asked to complete the Cambridge‐Hopkins RLS questionnaire to exclude RLS mimics. Prevalence was estimated for the following groups: (1) RLS symptomatic, (2) primary RLS, and (3) primary RLS sufferers (symptoms ≥2/wk with moderate‐to‐severe distress). The primary RLS completed a larger online survey including the IRLS, EuroQol, Work Productivity and Activity Impairment questionnaire, and questions about healthcare resource use. The validated diagnostic tools and exclusion of medical conditions likely to cause RLS provide a very conservative estimate of US census‐weighted prevalence of 2.4% for primary RLS and 1.5% for primary RLS sufferers. About 33% of respondents had a physician diagnosis of RLS. Primary RLS sufferers had a mean productivity loss of 1 day/wk. All RLS‐related costs increased with RLS symptom severity, with increasingly significant decrements in health status, sleep disturbance, and work productivity. Even this very conservative approach finds RLS in this cohort to be common, under‐diagnosed, and carried a significant personal and social burden. © 2010 Movement Disorder Society

Background Because of the subjective nature of Restless Legs Syndrome (RLS) symptoms and the impact of these symptoms on sleep, patient-reported outcomes (PROs) play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of this study was to validate a new measure, the Post Sleep Questionnaire (PSQ), to assess sleep dysfunction in subjects with moderate-to-severe RLS symptoms. Methods Pooled data were analyzed from two 12-week, randomized, placebo-controlled trials of gabapentin enacarbil (N = 540). At baseline and Week 12, subjects completed the PSQ and other validated health surveys: IRLS Rating Scale, Clinical Global Impression of Improvement (CGI-I), Profile of Mood States (POMS), Medical Outcomes Study Scale-Sleep (MOS-Sleep), and RLS-Quality of Life (RLSQoL). Pooled data were used post hoc to examine the convergent, divergent, known-group validity and the responsiveness of the PSQ. Results Convergent validity was demonstrated by significant correlations between baseline PSQ items and total scores of IRLS, POMS, RLSQoL, and the MOS-Sleep Scale (p ≤ 0.007 each). Divergent validity was demonstrated through the lack of significant correlations between PSQ items and demographic characteristics. Correlations (p < 0.0001) between RLS severity groups and PSQ items demonstrated known-group validity. Mean changes in investigator- and subject-rated CGI-I scores for each PSQ item (p < 0.0001) demonstrated the PSQ's responsiveness to patient change as reported by their care provider. Conclusions Although these analyses were potentially limited by the use of clinical trial data and not prospective data from a study conducted solely for validation purposes, the PSQ demonstrated robust psychometric properties and is a valid instrument for assessing sleep and sleep improvements in subjects with moderate-to-severe RLS symptoms. Trial Registration This study analyzed data from two registered trials, NCT00298623 and NCT00365352 .

OBJECTIVETo examine relationships between weekly fluctuations in self-rated joint pain and other health outcomes among adults with osteoarthritis (OA).METHODSIn this observational study, 287 adults (aged > or = 50 yrs) with hip or knee OA were recruited from 16 medical practices across the United States. Patients were telephoned weekly for 12 weeks to assess pain/stiffness, daily activities/function, productivity, emotional well-being, quality of life, and healthcare utilization. Associations between changes in joint pain levels and other health outcomes were evaluated using a generalized estimating equation model.RESULTSThe mean (SD) pain score at Week 1 was 4.2 (2.1) on the Western Ontario and McMaster Universities OA index (WOMAC) pain subscale (0 = no pain, 10 = extreme pain); during the study, 49% of patients reported a between-week fluctuation of > or = 2 points. A 2-point decrease in WOMAC pain subscale score was associated with a 22% decrease in number of days of limited activity/week (beta = -0.107; 95% confidence interval -0.163, -0.051); a 48% decrease in number of days of missed work/week (beta = -0.217; 95% CI -0.395, -0.039); a 14% decrease in number of nights with pain-related sleep interference/week (beta = -0.068; 95% CI -0.109, -0.027). Patients were 1.6 times more likely to contact a healthcare provider when their pain changed from "acceptable" to "unacceptable."CONCLUSIONWeekly fluctuations in pain levels and other health outcomes were identified among adults with OA. Decreases in patient-reported pain were associated with improvements in daily activities/functioning and decreases in work absenteeism, sleep interference, and healthcare resource use.

OBJECTIVES:This study evaluated the influence of features of community social environment and service system integration on service use, housing, and clinical outcomes among homeless people with serious mental illness.STUDY SETTING:A one-year observational outcome study was conducted of homeless people with serious mental illness at 18 sites.DATA SOURCES:Measures of community social environment (e.g., social capital) were based on local surveys and voting records. Housing affordability was assessed with housing survey data. Service system integration was assessed through interviews with key informants at each site to document interorganizational transactions. Standardized clinical measures were used to assess clinical and housing outcomes in face-to-face interviews.RESEARCH DESIGN:Structural equation modeling was used to determine the relationship between (1) characteristics of the social environment (social capital, housing affordability); (2) the level of integration of the service system for persons who are homeless in each community; (3) access to and use of services by individual clients; and (4) successful exit from homelessness or clinical improvement.PRINCIPAL FINDINGS:Social capital was associated with greater service systems integration, which was associated in turn with greater access to assistance from a public housing agency and to a greater probability of exiting from homelessness at 12 months. Housing affordability also predicted exit from homelessness. Neither environmental factors nor systems integration predicted outcomes for psychiatric problems, substance abuse, employment, physical health, or income support.CONCLUSION:Community social capital and service system integration are related through a series of direct and indirect pathways with better housing outcomes but not with superior clinical outcomes for homeless people with mental illness. Implications for designing improved service systems are discussed.

This paper explores two mental health systems in rural North Carolina that provide services to people with severe mental disorders. Recent findings show rural people with mental disorders receive less mental health care than their urban counterparts. This study asks whether rural service systems differ from urban systems in the way that their services are coordinated and structured. A popular conception is that public mental health systems in the United States are uncoordinated with many services provided outside the mental health sector. Rural service providers are seen as even more dependent on nonspecialized mental health providers than their urban counterparts. While many rural service barriers are attributed to the rural environment, little is known about rural service systems and how their organization might contribute to or negate barriers to care. Social network methods were used in this study to compare two rural with four urban systems of care. Findings confirm that mental health systems fit the de facto hypothesis, but that rural systems differ in ways not anticipated by the hypothesis. Rather than being more dependent on nonmental health agencies, rural mental health agencies are more interdependent.