Greater Healthcare Resource Utilization Research Articles

Patient-Reported and Economic Racial and Ethnic Disparities in Patients with Psoriatic Arthritis: Results from the National Health and Wellness Survey.

Psoriatic arthritis (PsA) is a chronic, autoimmune form of arthritis that is associated with a substantial humanistic and economic burden. Potential differences in patient-reported outcomes (PROs) and economic outcomes among groups of varying PsA severity and different races/ethnicities have not been well studied. This cross-sectional study assessed sociodemographic data, PROs, and economic outcomes for participants with PsA from the National Health and Wellness Survey (2018-2020). Multivariable analyses were used to assess the association of self-reported PsA severity and race/ethnicity with health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), healthcare resource utilization (HCRU), and medical costs. This study included 1544 participants with PsA (1073 non-Hispanic white, 114 non-Hispanic Black, 223 Hispanic, and 134 Other). Self-reported moderate/severe PsA was associated with significantly worse HRQoL and WPAI, greater HCRU, and higher costs than self-reported mild PsA. Black participants reported more absenteeism (31.11% vs. 16.69%; P = 0.007) and activity impairment (54.27% vs. 47.96%; P = 0.047) than white participants, and fewer healthcare provider (5.93 vs. 7.42; P = 0.039) and rheumatologist visits (0.29 vs. 0.53; P = 0.028) over the past 6months. No differences in outcomes were observed between Hispanic and white participants. Race/ethnicity moderated the association of perceived PsA severity and PROs and HCRU, such that white participants with self-reported moderate/severe PsA had a higher likelihood of depression (P < 0.001), lower HRQoL (P < 0.001), and more emergency room visits (P = 0.001) than those with self-reported mild PsA. Race/ethnicity did not moderate the relationship of PROs, HCRU, and economic outcomes among Black or Hispanic participants. Participants with self-reported moderate/severe PsA reported a greater burden than those with self-reported mild PsA. Black participants had a greater humanistic burden than white participants but reported lower HCRU. Moderation results were driven by white participants, suggesting important differences in PROs, HCRU, and perception of PsA severity across race/ethnicity groups. Small sample sizes in Hispanic and non-Hispanic racial/ethnic groups limited ability to discern differences related to disease severity in these groups. Further research is needed to better understand the differential burden of PsA among individuals with varying perceptions of PsA severity across different racial/ethnic groups.

Patient-Reported Racial and Ethnic Disparities in Patients With Ulcerative Colitis: Results From the National Health and Wellness Survey.

Ulcerative colitis (UC) is an inflammatory condition characterized by chronic, disabling gastrointestinal symptoms that can have detrimental effects on psychological, social, and professional quality of life. Few studies have examined patient-reported outcomes (PROs) and economic outcomes among individuals with varying UC severity and across different racial/ethnic groups. This cross-sectional study assessed sociodemographic data, PROs, and economic outcomes for participants from the National Health and Wellness Survey (2018, 2019, and 2020) with UC. Multivariable analyses were used to assess the association of self-reported UC severity and race/ethnicity with health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), healthcare resource utilization (HCRU), and medical costs. This study included 1500 participants with UC (1150 non-Hispanic White, 99 non-Hispanic Black, and 251 Hispanic). Moderate/severe disease was associated with significantly worse HRQoL and WPAI, greater HCRU, and higher direct medical costs than mild UC. Compared with non-Hispanic White participants, non-Hispanic Black participants reported better HRQoL, whereas Hispanic participants reported more HCRU and higher medical costs. Race/ethnicity significantly interacted with UC severity level in predicting labor force participation. Participants with moderate/severe disease had worse outcomes than those with mild UC. Additionally, racial/ethnic differences were found in HRQoL, employment, WPAI, HCRU, and direct medical costs. Notably, Hispanic participants showed distinct patterns, particularly in how disease severity influenced employment outcomes. Further research is needed to better understand the differential burden among patients across racial/ethnic groups.

Antithrombin testing and treatment in pregnancy: Their real-world relationship to clinical outcomes

BackgroundAntithrombin (AT) deficiency is a severe thrombophilia associated with increased rates of maternal morbidity, mortality, and greater healthcare resource utilization during pregnancy and postpartum. MethodsTwo 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). ResultsThere 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. ConclusionOpportunities exist to enhance the care of pregnant individuals with low AT levels throughout pregnancy, aiming for optimal maternal outcomes.

Evaluating prevalence and consequence of residual disease in individuals with psoriasis receiving apremilast treatment: results from a US patient survey

Purpose: This noninterventional, cross-sectional survey estimated the prevalence and consequences of residual disease in apremilast-treated US adults with moderate to severe psoriasis. Materials and Methods: Residual disease was defined as experiencing moderate, severe, or very severe psoriasis over the past week or having ≥3% body surface area affected, despite treatment. Factors associated with residual disease and its effects on flare-ups, humanistic burden, and health care resource utilization (HCRU) were evaluated. Results: Of the 344 apremilast users (mean age, 44.9 years; female, 65.4%), 174 (50.6%) had residual disease. It was more prevalent in Black versus White participants (OR, 4.5; 95% CI, 1.6–12.2), those receiving apremilast for ≥1 versus <1 year (OR, 16.5; 95% CI, 7.9–34.4), those reporting ≥2 versus 0 to 1 flare-ups during the past 3 months (OR, 10.0; 95% CI, 5.0–20.1), and those with ≥4 versus 1 to 3 body regions affected at time of survey (OR, 8.6; 95% CI, 3.8–19.8). Participants with versus without residual disease self-reported more psoriasis flare-ups over the past 3 months (mean, 4.7 vs 0.9; p < .001) and more anxiety (89.7% vs 50.0%; p < .001) and depression (69.0% vs 23.6%; p < .001) over the past 30 days. Conclusion: Generally, participants with versus without residual disease also had significantly more comorbidities and greater HCRU.

Loneliness and its cross-sectional associations with health, health behaviours, and perceptions in Finnish patients with overweight or obesity taking part in the Healthy Weight Coaching

ObjectiveTo investigate cross-sectional associations between loneliness and health, health behaviours, and perceptions in Finnish individuals with overweight or obesity (BMI ≥25 kg/m2). MethodsWe used baseline data from patients participating, in 2016–2022, in a real-life digital 12-month weight management program known as Healthy Weight Coaching. Patients completed several questionnaires such as those related to loneliness, healthcare resource utilization, physical activity, and life satisfaction. BMI was computed based on self-reported weight and height. In addition to investigating individual health variables, we studied the association between loneliness and factor-analysis-derived health and wellbeing clusters. ResultsData were available from 2000 individuals (16.7% men, median age 48 years, median BMI 39.2 kg/m2). Altogether, 11.6%, 42.4%, and 46.0% reported feeling lonely, somewhat lonely, and not lonely, respectively. Feeling lonely was associated with higher BMI, greater healthcare resource utilization, lower life satisfaction, burdensomeness of life, more negative perceptions related to obesity and to the upcoming coaching, lower daytime energy, and reduced 20-min brisk walk results, a measure of functional capacity. Of the five factor-analysis-derived clusters, loneliness was adversely associated with “Life satisfaction” [lonely, 0.337 (0.270–0.421), p < 0.001; somewhat lonely, 0.545 (0.475–0.625), p < 0.001]. Moreover, loneliness associated with “Negative perceptions of obesity/daytime fatigue” [lonely, 4.627 (3.391–6.314), p < 0.001; somewhat lonely 2.021 (1.694–2.412), p < 0.001], and “Obesity/low physical activity” [lonely, 1.474 (1.105–1.966), p = 0.008; somewhat lonely, 1.220 (1.019–1.460), p = 0.030]. ConclusionsLoneliness had several untoward associations with health, health behaviours, and perceptions. Further research should explore the intricate relationship between obesity, loneliness, and physical and psychosocial health. Trial registrationThe trial is registered at clinicaltrials.cov (Clinical Trials Identifier NCT04019249).

0491 Exploring COMISA, Sleep-related Symptoms, and Healthcare Utilization in Military Personnel

Abstract Introduction Insomnia and obstructive sleep apnea (OSA) are the two most common sleep disorders seen in clinical practice. Comorbid insomnia and OSA (COMISA) is a very common clinical presentation. The purpose of this study was to estimate the effect of COMISA on sleep, daytime symptoms, and healthcare resource utilization compared to OSA or insomnia alone among military personnel. Methods Military personnel with sleep problems were recruited from two military treatment facilities. Insomnia and OSA were defined using validated cutoffs on the Insomnia Severity Index and Berlin Questionnaire, respectively, and COMISA was defined as comorbid insomnia and OSA. Subjective and objective sleep were measured via standardized sleep diaries and a commercial wearable (Fitbit Inspire 2) over ten days. Daytime symptoms (e.g., sleepiness, depression, anxiety, pain) were assessed using standardized self-report questionnaires. Subjective cognition was assessed via three Likert items. Healthcare resource utilization (HCRU) was assessed using an established questionnaire tailored for this study. To compare differences between COMISA, OSA, and insomnia groups, one-way ANOVA was performed. Results The final sample included 201 participants (n=113, 43.8[%] men, mean age=44.5 [SD=12.7]) who self-reported being of White (111, 55.2%), Black (50, 24.9%), Hispanic (21, 10.5%) or Other (19, 9.5%) race. Of these, 22 (10.9%) were categorized as insomnia alone, 98 (48.8%) as OSA alone, and 81(40.3%) as COMISA. Relative to individuals with OSA, individuals with COMISA demonstrated worse subjective (but not objective) sleep; worse subjective daytime symptoms; worse subjective memory, attention, and executive function; and increased healthcare utilization including total HCRU and outpatient visits to internal medicine, neurology, emergency department, and urgent care. Some but few significant differences were observed between participants with insomnia relative to those with COMISA. Conclusion Among military personnel with sleep problems and relative to OSA alone, COMISA was associated with worse subjective sleep, worse daytime symptoms, worse subjective cognition, and greater HCRU. Future research should seek to seek to improve health and economic outcomes among individuals with COMISA. Support (if any) DoD (W81XWH1990006 via the Medical Technology Enterprise Consortium)

Racial and Ethnic Disparities in Health-Related Outcomes in Crohn's Disease: Results From the National Health and Wellness Survey.

Crohn's disease (CD) is a chronic inflammatory condition affecting the entire gastrointestinal tract that is associated with significant humanistic, clinical, and economic burdens. Few studies have assessed the association between CD severity and patient-reported outcomes (PROs), healthcare resource utilization (HCRU), and medical costs; even fewer have examined differences in disease outcomes among patients of various racial/ethnic groups. In this cross-sectional study, sociodemographic data, PROs, and economic outcomes for participants with self-reported CD were collected from the National Health and Wellness Survey (2018-2020). Multivariable analyses were used to assess the association of CD severity and race/ethnicity with health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), HCRU, and medical costs. Analyses included 1077 participants with CD (818 non-Hispanic White, 109 non-Hispanic Black, and 150 Hispanic). Participants with self-reported moderate/severe CD reported significantly worse HRQoL and WPAI, greater HCRU, and higher medical costs than those with self-reported mild CD. Non-Hispanic Black participants reported better HRQoL and fewer healthcare provider visits than non-Hispanic White participants. There were no significant differences in PROs between non-Hispanic White and Hispanic groups. Interactions between race/ethnicity and CD severity emerged for some, but not all groups: Specifically, non-Hispanic Black participants with moderate/severe CD reported greater absenteeism and more gastroenterologist visits than non-Hispanic Black participants with mild CD. Participants with moderate/severe CD reported worse PROs, greater HCRU, and higher medical costs than those with mild CD. Additionally, racial/ethnic differences were found across several HCRU and economic outcomes. Further research is needed to better understand factors contributing to burden among patients with varying CD severity across racial/ethnic groups.

Prevalence and burden of chronic cough in France.

Chronic cough is a common condition that is associated with lower health-related quality of life and greater healthcare resource use. There are limited data on the prevalence, population characteristics and burden of chronic cough in France. This was a cross-sectional study based on responses from French adult residents to the 2020 National Health and Wellness Survey. Respondents with chronic cough were compared to 1:3 propensity score-matched controls without chronic cough. The weighted lifetime and 12-month prevalence of chronic cough were estimated as 7.5% and 4.8%, respectively. Respondents with chronic cough reported significantly worse perceived health than matched controls, with lower mean±sd scores of 46.68±9.28 versus 50.42±8.26 on the physical health component and 40.32±9.87 versus 44.32± 9.69 on the mental health component of the Medical Outcomes Study 12-item Short Form Survey Version 2 survey (p<0.001 for both comparisons). Respondents with chronic cough also had higher rates of moderate-to-severe forms of anxiety (24.4% versus 12.4%) and depression (36.4% versus 20.2%); higher rates of multiple forms of sleep disturbance; greater impairment of work productivity (38.2% versus 25.5%) and other activities (41.8% versus 28.2%; p<0.001 for all comparisons). Respondents with chronic cough also had higher rates of all-cause healthcare resource use including emergency room visits, hospitalisation, and overall and specialist healthcare provider visits compared to controls (p<0.001 for all comparisons). Chronic cough is a common condition in France that is associated with lower health-related quality of life and greater healthcare resource utilisation.

Healthcare Utilization and Cost of Care Analysis of Patients with Sickle Cell Disease with High Vs. Low Biomarkers: A Retrospective Chart Review

Sickle cell disease (SCD) is a red blood cell (RBC) disorder that is associated with frequent and unpredictable vaso-occlusive episodes (VOEs) including pulmonary hypertension, acute chest syndrome, chronic anemia, priapism, splenic and renal dysfunction, and stoke. The total cost to manage a SCD patient with a life expectancy of 64 years is between $1.3-$2.1M. Within the United States alone, up to 67% of adults have ≥3 VOEs per yearthat accounts for most of the healthcare utilization, including 78% of emergency room (ER) visits and 95% of hospitalizations. Despite the same single gene mutation of beta-globin, the frequency of VOEs amongst patients is highly variable. The pathophysiology of VOEs involves a complex interplay between circulating blood cells and elevated plasma factors that promote abnormal interactions to the vascular endothelium. Nearly a half century ago studies demonstrated RBC adhesion strongly correlates with disease severity however only recently standardized testing has become available to assess adhesion clinically. More specifically, we developed a suite of RBC health biomarkers and deployed our flow adhesion bioassays in our landmark, observational study (ELIPSIS). We established that flow adhesion of whole blood to vascular cell adhesion molecule-1 (FA -WB-VCAM) at baseline stratified SCD patients with severe disease phenotypes and validated the clinical predictive value of FA-WB-VCAM two years post-ELIPSIS. The objective of this study was to determine whether baseline FA-WB-VCAM biomarker levels could predict patients more likely to receive direct healthcare contact (ER visits/hospital admissions) to manage SCD complications. This study was a retrospective assessment of clinical FA-WB-VCAM in individuals with SCD during steady state between January 2020 through March 2023. Flow adhesion assays were performed using pulsatile, shear flow (1.67Hz, 1.0 dyne/cm 2). SCD patients that received at least 3 steady state FA-WB-VCAM biomarker evaluations within 1-year were included in this analysis. Clinical site received an IRB waiver to obtain patient-reported ER visits and hospitalizations during relevant time periods. We calculated a composite adhesion index by averaging baseline FA-WB-VCAM biomarker evaluations and established SCD disease severity by quantifying the number of ER visits and hospital admissions one year after the most recent FA-WB-VCAM biomarker evaluation. The non-parametric Wilcoxon matched pairs signed rank test was used to test the statistical differences between groups. Data are presented as mean ± standard error of mean. A p-value &amp;lt; 0.05 was considered statistically significant. Out of a total of 3939 clinical tests performed, 366 samples were obtained for “baseline” indications. Of these, only 28 samples were analyzed from 9 unique patients who met the study criteria described above. The average flow adhesion of whole blood to VCAM-1 (FA-WB-VCAM) in SCD patients with high adhesion phenotypes (&amp;gt;400 cells/mm 2) was significantly higher than the low/moderate SCD cohort (mean high=603±78 cells/mm 2, mean low/moderate=343±28 cells/mm 2, p=0.02). More important, the high adhesion cohort had more ER visits (11 vs. 5) and hospitalizations (24 vs 9) and significantly higher healthcare costs ($35,871 vs. $13,563). This is the first healthcare cost analysis assessing the relationship between SCD patients stratified by their adhesive phenotype using the standardized, clinical adhesion biomarker FA-WB-VCAM, and healthcare utilization. The previous ELIPSIS study established that baseline FA-WB-VCAM stratifies patients based on their risk of developing self-reported VOCs during a 6-month longitudinal observation period and their risk of higher clinical disease severity in a 2-year follow-up study. Consistent with this data, the current study demonstrated that a cohort of SCD patients with elevated baseline adhesion phenotypes based on FA-WB-VCAM had a greater utilization of healthcare resources (ER visits and hospitalizations) and had a higher cost of care during the retrospective observation period. These data suggest that RBC health as indicated by “baseline” FA-WB-VCAM levels may predict lower health care utilization and costs, and that this biomarker may be a plausible surrogate endpoint to assess the pharmaco-economic impact of SCD-modifying therapies.

Red Blood Cell Transfusion Dependence Is Associated with Greater Healthcare Resource Utilization, Higher Medical Cost, and Poorer Prognosis in Patients with Lower-Risk Myelodysplastic Syndromes: A 28-Year Retrospective Observation Study Result

Myelodysplastic syndromes (MDS) encompass a heterogeneous group of myeloid neoplasms characterized by cytopenia due to inefficient hematopoiesis, with a considerable risk of progression to acute myeloid leukemia (AML) or early mortality. In lower-risk MDS (LR-MDS) patients, anemia and its associated complications have been the focus of clinical attention. A significant portion of these patients eventually develop red blood cell transfusion dependence (RBC TD), which has been linked to a poorer prognosis. Given the limited efficacy of available treatments in reducing RBC TD, most patients face increased risks of chronic anemia and various complications. Moreover, RBC TD is known to be associated with reduced overall survival (OS) and leukemia-free survival (LFS). This study aimed to assess the impact of RBC TD on the socioeconomic burden and clinical prognosis of LR-MDS patients, utilizing an electronic medical records (EMR) database spanning nearly 30 years of MDS patient data. This retrospective observational study examined adult MDS patients (≥ 18 years of age) treated at Samsung Medical Center in the Republic of Korea. Eligible patients were diagnosed with MDS between Sep 1, 1994, to Apr 1, 2022 (index period), with the observation period spanning from Sep 1, 1994, to Sep 1, 2022. Baseline assessments included estimation of revised international prognostic scoring system (IPSS-R) scores, categorizing patients with very low, low or intermediate risks as lower-risk MDS (LR-MDS). TD was defined as the occurrence of any 16-week period with RBC transfusion of ≥ 2 units per 8 weeks, without consecutive 56-day period without transfusion. Healthcare resource utilization (HCRU), medical costs, and prognosis indicators including overall survival (OS) and AML-free survival (AFS) were analyzed and compared between patients who experiencing TD and those not (non-TD). Out of 831 MDS patients, 349 (42.0%) were classified as lower-risk at baseline. Among LR-MDS patients, 29.5% (103/349) experienced TD while 23.3% (194/831) experienced TD in the entire study population. The median age at diagnosis of MDS was 63 (ranging from 18 to 89), and 65.3% (543/831) were male. In LR-MDS patients, there were no significant differences in either baseline age (61 vs 63, P=0.16) or gender (71.8% vs 61.0% males, P=0.053) between TD and non-TD groups. However, TD group exhibited significantly higher median erythropoietin (EPO) level than non-TD group (290.5U/L vs. 112U/L, P&amp;lt;0.001) among LR-MDS patients with available baseline serum EPO levels (76 TD and 178 non-TD). Among the 76 TD LR-MDS patients with baseline serum EPO levels, 51 (67.1%) exhibited &amp;gt; 200U/L, which is considered a clinical threshold for erythropoiesis-stimulating agent (ESA) treatment. As shown in Table 1, RBC TD was consistently associated with greater HCRU and higher medical costs, especially in LR-MDS patients. TD LR-MDS patients had higher rates of outpatient department and emergency room visits (15676 vs. 8303 visits and 587 vs. 328 visits per 1000 person-years [PY], respectively), and increased hospitalizations (709 vs. 456 per 1000 PY), with longer hospital stays (13343 vs. 8272 days per 1000 PY). Furthermore, TD LR-MDS patients required over four-times of packed RBC units than non-TD patients (31107 vs. 7073 units per 1000 PY). Consequently, TD LR-MDS patients incurred higher total medical cost than their non-TD counterpart (13.5 million vs. 6.1 million USD per 1000 PY). Median OS (58.4 months vs. 103.1 months) and AFS (52.7 months vs. 102.7 months) were both significantly shorter in the TD group compared to the non-TD group among LR-MDS patients, while the differences in OS and AFS did not reach the level of significance in the entire study population (Table 1 and Figure 1). Notably, median OS after the first documented RBC TD event was 33.8 months (95% confidence interval: 24.7-58.5 months) in LR-MDS patients. The findings of this study indicate that RBC TD can be a strong predictor of increased HCRU and medical costs, as well as decreased OS and AFS over a 20-year period following the initial diagnosis of LR-MDS. Given that a majority of LR-MDS patients experiencing TD may not be eligible for ESA treatment due to elevated EPO levels exceeding 200U/L, and the use of cytotoxic agents is not usually recommended for these patients, these results highlight a substantial unmet need for alternative treatment options to address RBC TD in LR-MDS patients.

Healthcare resource utilisation andeconomic burden ofpatients with adequate andinadequate responses to biological andtargeted synthetic disease-modifying antirheumatic drugs forrheumatoid arthritis inJapan.

To compare healthcare resource utilisation (HCRU) and direct costs between responders versus non-responders to advanced therapies for rheumatoid arthritis (RA). Patients initiating ≥1 advanced therapy (October 2018 - September 2019) with ≥1 RA claim (6-month pre-index period), ≥2 RA claims (any period), and ≥12 months follow-up were identified from the Medical Data Vision claims database. HCRU and all-cause and RA-related costs [direct medical, emergency department (ED), laboratory, and pharmacy] were compared between responders and non-responders. Adjusted incidence rate ratios (IRRs) for HCRU or cost were calculated via multivariable analyses. Among 2446 patients [non-responders (n = 1817); responders (n = 629)], non-responders had significantly longer hospitalisation days [IRR: 1.8 (95% CI: 1.2 - 2.6)], and significantly more ED visits [2.5 (1.5 - 4.2)] and prescriptions [1.1 (1.1 - 1.2)]. Mean all-cause hospital/outpatient medical costs were significantly higher for non-responders [1.4 (1.3 - 1.6), ¥530,895 versus ¥357,009 ($3992 versus $2684) for responders; ¥173,886 ($1307) difference]; RA-related medical costs showed a similar trend [¥351,306 vs ¥253,030 ($2641 vs $1902); ¥98,276 ($739) difference]. No differences between responders and non-responders were observed in mean all-cause and RA-related pharmacy costs. Non-responders to advanced therapies had greater HCRU and all-cause/RA-related direct costs as compared with responders, suggesting a need for more effective RA therapies to reduce the economic burden associated with non-response.

Burden of chronic cough on social participation, healthcare resource utilisation and activities of daily living in the Canadian Longitudinal Study on Aging (CLSA)

BackgroundChronic cough is a common troublesome condition, but it is unclear whether dry or productive chronic cough and sex, impacts the burden of cough differently. MethodsThe Canadian Longitudinal Study on Aging is a nationally generalizable, stratified random sample of adults aged 45–85 years. Chronic cough was identified based on a self-reported daily cough in the last 12 months assessed at baseline (2011–2015) and follow-up (2015–2018). Odds ratios (95 % CI) for cough status and change in social participation activities (SPA), healthcare resource utilisation (HCRU), basic activities of daily living (ADLs) and instrumental activities of daily living (IADLs) were estimated using a weighted generalised estimating equation (WGEE). Results were stratified by sex, and adjusted for age, sex, smoking, body mass index, education, respiratory diseases and retirement status. ResultsOverall, chronic cough was associated with less SPA, greater HCRU and impaired ADL/IADLs. Productive chronic cough in males was associated with SPA limited by health, ED visits and hospitalisation. Females with productive chronic cough was associated with reduced frequency of SPA and ED visit. Dry chronic cough in females was associated with SPA limited by health and ED visits. Both types of cough was associated with at least 1 impaired basic ADL, but only in females with productive chronic cough was there an association with any impairment in IADLs. ConclusionChronic cough is associated with a greater burden on social participation, healthcare use and personal care.

Burden of chronic cough in the UK: results from the 2018 National Health and Wellness Survey.

Chronic cough, defined as daily cough for at least 8 weeks, negatively affects quality of life and work productivity and increases healthcare resource utilisation. We aimed to determine the prevalence and burden of chronic cough in the UK. Study participants were general population respondents to the 2018 UK National Health and Wellness Survey (NHWS). Respondents completed survey questions relating to health, quality of life, work productivity and activity impairment, and use of healthcare resources. Prevalence estimates were projected to the UK population using post-stratification sampling weights to adjust for sampling bias. The population with chronic cough was matched 1:3 with a group without chronic cough, using propensity score matchingon age, sex and the modified Charlson Comorbidity Index. Of 15 000 NHWS respondents, 715 reported chronic cough in the previous 12 months and 918 during their lifetime. Weighted to the UK adult population, the 12-month prevalence of chronic cough was 4.9% and lifetime prevalence was 6.2%. Prevalence of chronic cough was higher among older respondents and those with smoking histories. Chronic cough respondents experienced higher rates of severe anxiety and depression in the past 2 weeks than matched controls. Poor sleep quality and loss of work productivity were also observed. More chronic cough respondents visited a healthcare provider in the past 6 months than respondents without chronic cough with a mean of 5.8 and 3.7 visits per respondent, respectively. Adults with chronic cough report lower quality of life, reduced work productivity and greater healthcare resource utilisation than matched controls without chronic cough.

#4018 CHARACTERISATION OF THE CLINICAL, HUMANISTIC AND ECONOMIC BURDEN OF ANAEMIA IN CHRONIC KIDNEY DISEASE: A SYSTEMATIC LITERATURE REVIEW

Abstract Background and Aims Chronic kidney disease (CKD) is defined as structural kidney damage and/or decreased kidney function (glomerular filtration rate &amp;lt;60mL/min/1.73 m2) persisting for ≥3 months [1]. Anaemia is a frequent CKD comorbidity associated with increased cardiovascular (CV) morbidity, mortality, reduced health-related quality of life (HRQoL) and greater healthcare resource utilisation (HRU) [2]. Our systematic literature review provided an overview of the clinical, humanistic and economic burden of anaemia of CKD. Method A search was performed in MEDLINE, EMBASE, MEDLINE IN-PROCESS, Cochrane Controlled Trials Register and the Cochrane Database of Systematic Reviews from database inception to 10 April 2022, using predefined criteria to identify cohort, cross-sectional, observational and cost studies, economic evaluations, conceptual model studies, systematic and literature reviews (complemented by grey literature and congress abstract searches and back-referencing relevant review papers [2016–2021]). Full-text selected citations were examined by two independent reviewers. Clinical burden parameters included CKD progression, differences in progression between patients with/without CKD anaemia, time to blood transfusion and association of CKD stage/progression with CV outcomes or mortality. Humanistic burden included HRQoL and caregiver burden. Economic burden was determined by HRU and direct/indirect costs. Results Data were extracted from 115 studies (12,109 database records, 79 supplementary items; Figure 1), including patients: pre- or non-dialysis (n = 61), on dialysis (n = 21), mixed non-/on dialysis (n = 19) and unknown dialysis status (n = 14). Incidence of advanced CKD was significantly higher in adult non-dialysis dependent (NDD) patients with anaemia of CKD vs those without (incidence per 1000 person-years: 15 to ∼85 vs 3 to ∼25). Patients with CKD anaemia had a higher risk of disease progression than those without anaemia (n = 21), e.g. non-dialysis stage 1–5 adults with CKD anaemia had ∼double the risk of developing end-stage CKD (hazard ratio [95% confidence interval [CI]] = 2.08 [1.50–2.89]). Median time to dialysis initiation was significantly lower in adult NDD stage 1–5 patients with anaemia of CKD vs those without anaemia (45.1 vs 68.3 months p&amp;lt;0.01). A higher proportion of stage 3 adult NDD patients with anaemia of CKD progressed to stage 4 or 5 over follow-up periods of 1, 2 and 3 years vs those without anaemia (40% vs 20%; 60% vs 25%; 75% vs 30%, respectively). Available data from the 43 studies reporting humanistic burden suggested significantly worse HRQoL in patients with vs without CKD anaemia; e.g. non-dialysis adults with CKD anaemia had worse 36-item kidney disease and QoL scores for symptoms/problems, effect- and burden-of CKD. Comparative caregiver burden data in patients with/without CKD anaemia were limited. Limited available evidence from an economic perspective suggested higher HRU in patients with anaemia of CKD vs those without. Patients with anaemia of CKD has ∼2 times greater risk of hospitalisation due to heart failure vs those without (crude incidence rate ratio [95% CI] = 1.9 [1.6–2.1]). Similarly, patients with anaemia of CKD has significantly higher risk of hospitalisations (adjusted relative risk [ARR] [95% CI] = 1.33 [1.31–1.34]) and emergency department visits (ARR [95% CI] = 1.14 [1.12–1.15]) in a multivariate logistic regressions model. No data were available on change in economic parameters over time or on inter-relationships between humanistic/economic burden parameters. There were no published disease models in CKD anaemia; Figure 2 illustrates identified relationships between clinical, humanistic and economic burden parameters. Conclusion Based on limited moderate-to-good quality data, we found that patients with CKD anaemia face greater clinical, humanistic and economic burdens than those without anaemia, with significantly worse HRQoL and greater HRU. CKD anaemia was also associated with a higher risk of CKD progression.

Health care resource utilization, quality metrics, and costs of bladder cancer within the Oncology Care Model.

New and emerging therapies have significantly changed the bladder cancer (BC) treatment landscape and can potentially affect spending and patient care in CMS' Oncology Care Model (OCM), a service delivery and payment model for voluntarily participating practices. The objectives of this analysis were to estimate health care resource utilization (HCRU) and benchmark spending per OCM episode of BC, and to model spending drivers and quality metrics. Retrospective cohort study. A retrospective cohort study was conducted of OCM episodes triggered by receipt of anticancer therapy among Medicare beneficiaries from 2016 to 2018. Based on this, an average performance estimation was conducted to assess the impact of hypothetical changes in novel therapy use by OCM practices. BC accounted for approximately 3% (n = 60,099) of identified OCM episodes. Relative to low-risk episodes, high-risk episodes were associated with greater HCRU and worse OCM quality metrics. Mean spending per high-risk episode was $37,857 (low-risk episode: $9204), with $11,051 spent on systemic therapies and $7158 on inpatient services. In the estimation, high- and low-risk BC exceeded the spending target by 1.7% and 9.4%, respectively. This did not affect payments to practices and no retrospective payments were necessary. As 3% of OCM episodes were attributed to BC, with only one-third classified as high-risk, controlling expenditure on novel therapies for advanced BC is unlikely to affect overall practice performance. The average performance estimation further emphasized the minimal impact that novel therapy spending in high-risk BC has on OCM payments to practices.

Von Willebrand Disease Epidemiology, Burden of Illness and Management: A Systematic Review.

Although hereditary von Willebrand disease (VWD) is the most common bleeding disorder, its epidemiology is not well understood. A systematic review (PROSPERO CRD42020197674/CRD42021244374) on the epidemiology/burden of illness of VWD was conducted to better understand patients' unmet needs. Observational studies (published January 1, 2010 to April 14, 2021) were identified in MEDLINE and Embase databases, using free-text keywords and thesaurus terms for VWD and outcomes of interest. Pragmatic web-based searches of the gray literature, including conference abstracts, were performed, and reference lists of retained publications were manually searched for additional sources. Case reports and clinical trials (phase 1-3) were excluded. Outcomes of interest were incidence, prevalence, mortality, patient characteristics, burden of illness, and therapeutic management/treatments currently used for VWD. Of the 3095 identified sources, 168 were included in this systematic review. Reported VWD prevalence (22 sources) ranged from 108.9 to 2200 per 100,000 in population-based studies and from 0.3 to 16.5 per 100,000 in referral-based studies. Reported times between first symptom onset and diagnosis (two sources; mean 669 days; median 3 years) highlighted gaps in timely VWD diagnosis. Bleeding events reported in 72-94% of the patients with VWD (all types; 27 sources) were mostly mucocutaneous including epistaxis, menorrhagia, and oral/gum bleeding. Poorer health-related quality of life (three sources) and greater health care resource utilization (three sources) were reported for patients with VWD than in general populations. Available data suggest that patients with VWD experience high disease burden in terms of bleeding, poor quality of life, and health care resource utilization.

Characteristics and clinical manifestations of monkeypox among people with and without HIV in the United States: a retrospective cohort.

To compare characteristics and clinical manifestations of monkeypox (MPX) between people with and without HIV in the United States. Retrospective cohort study using TriNetX, a federated research network. Patients 18 years and older with MPX were identified based on the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code B04 and divided into two groups: people with HIV (PWH) and people without HIV. Differences in baseline characteristics, clinical manifestations, and all-cause healthcare utilization were examined between groups. Outcomes were reported before and after propensity score matching. Of 322 cases of MPX included, 29% ( n = 93) were PWH. Baseline characteristics were similar, but PWH were more likely to identify as Black or African American persons (24% vs. 11%, P = 0.0303) or as Hispanic or Latino persons (24% vs. 11%, P = 0.0345) and more likely to report lifestyle factors affecting health status. Rash and rectal pain were more common in PWH (25% vs. 11%, P < 0.01, and 25% vs. 10%, P < 0.001, respectively). In addition, PWH had higher rates of anal or rectal abscesses (11% vs. 0%, P < 0.0001), phimosis (11% vs. 0%, P < 0.0001), and pneumonia (11% vs. 0%, P < 0.0001). More PWH required urgent care visits (53% vs. 29%, P < 0.0001) and hospitalizations (11% vs. 4%, P = 0.0314), but not emergency department visits (42% vs. 58%, P = 0.0085). PWH had higher rates of clinical manifestations and required greater utilization of healthcare resources for any reason compared with those without HIV.

Canadian Cancer Trials Group (CCTG) LY.17: A Randomized Phase II Study Evaluating Novel Salvage Therapy Pre-Autologous Stem Cell Transplant (ASCT) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR-DLBCL) - Outcome of Rituximab-Dose-Intensive Cyclophosphamide, Etoposide, Cisplatin (R-DICEP) Versus R-GDP

Introduction: The CCTG LY.12 trial established rituximab combined with gemcitabine, dexamethasone and cisplatin (R-GDP) as a standard salvage chemotherapy option prior to ASCT for patients (pts) with relapsed/refractory (RR) DLBCL (Crump JCO 2014). CCTG LY.17 is an ongoing multi-arm randomized phase II "pick a winner" trial evaluating novel salvage therapy compared with R-GDP in ASCT-eligible RR-DLBCL pts. Methods: The primary endpoint of the study is overall response rate (ORR) using CT imaging. According to the protocol futility rule, any treatment arm with an ORR lower than the R-GDP control arm at the first interim analysis (n = 16), or less than 10% higher at the second interim analysis (n=32) would not continue to full target accrual of 64 pts per treatment arm. Encouraging results could then be pursued in a larger phase III trial designed to detect differences in progression-free survival (PFS). This report involves the component of the trial that randomly allocated pts to either 1 cycle of inpatient R-DICEP (Rituximab 375mg/m2 IV or 1400mg sc days 1 and 5 plus dose-intensive Cyclophosphamide 5.25g/m2, Etoposide 1050mg/m2, Cisplatin 105mg/m2 divided over days 2-4, with daily filgrastim starting day 15 until apheresis of blood stem cells approximately between days 20-22) or to 3 cycles of outpatient R-GDP. This report is the result of the protocol-specified second interim analysis. Results: A total of 67 pts were randomized to R-DICEP (n=32) or to R-GDP (n=35) between April 2016 and April 2021. Table 1 lists baseline pt characteristics. Four pts (R-DICEP=2, R-GDP=2) were not evaluable for response. The ORR was 65.6% for R-DICEP (70.0% for evaluable pts), which was 17% greater than the ORR of 48.6% for R-GDP (51.5% for evaluable pts). Additionally, only 1 (3.1%) R-DICEP pts versus (vs) 11 (31.4%) R-GDP pts experienced progressive disease as best response to salvage therapy. Of interest, the ORR to salvage was 40% (14/35) for pts primary refractory to RCHOP (no response to RCHOP or progressive disease during or <3mo post RCHOP) vs 75% (24/32) for those who relapsed >3mo post RCHOP (p=0.006), with ORR to R-DICEP of 50% vs 81.3% and ORR to R-GDP of 31.6% vs 68.8% for primary refractory vs relapse >3mo, respectively. The ORR based on PET-CT scan was 50.0% vs 31.4% for the R-DICEP (n=26) vs R-GDP (n=25) arms, respectively. Overall, 23 (71.9%) R-DICEP pts and 19 (54.3%) R-GDP pts underwent ASCT. In total, 26 out of 27 (96.3%) R-DICEP, and 18 out of 20 (90%) R-GDP pts underwent successful autologous blood stem cell collection (requiring >1 attempt in 0 R-DICEP and 2 R-GDP pts). The median time to neutrophil engraftment post-ASCT was 13 (1-32) and 12 (1-22) days, and to platelet engraftment was 12 (1-50) and 16 (7-22) days for R-DICEP and R-GDP pts, respectively. Regarding adverse events (AEs) of salvage therapy and subsequent ASCT, R-DICEP pts had higher rates of culture positive infection (84% vs 40%), platelet (96.6% vs 60.0%) and red cell (75.0% vs 42.9%) transfusions, diarrhea (44% vs 14%), serious adverse events (50% vs 34.3%), and treatment-related mortality (3.1% vs 0%) but similar rates of other AEs including arrhythmia (6% vs 9%), bleeding (0 vs 0), fungal infections (0 vs 0) and pneumonitis (0 vs 0). At a median duration of follow-up of 26.9 months (R-DICEP 26.4 months and R-GDP 27.4 months), the 1-year PFS rate was 42% for R-DICEP and 32% for R-GDP (HR 0.59, 95%CI: 0.32-1.09, logrank p=0.09), and 1-year OS rate was 65% for R-DICEP and 55% for R-GDP (HR 0.675, 95%CI: 0.333-1.369, logrank p=0.27). Conclusions: Although the 17% improvement in ORR for R-DICEP vs R-GDP in the second interim analysis exceeded the pre-specified 10% threshold required proceed to full accrual of 64 pts in the R-DICEP arm, we decided to stop accrual to the R-DICEP arm of the LY.17 trial due to slow accrual, higher AE rates, and greater utilization of healthcare resources including hospitalization needed to administer treatment, which limits feasibility of R-DICEP at several Canadian centres. The LY.17 trial continues testing other salvage regimens. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Abstract 10345: Comparison of Clinical Characteristics, Positive Airway Pressure Usage, and Healthcare Resource Utilization in Obstructive Sleep Apnea Patients With Heart Failure With Preserved vs Reduced Ejection Fraction

Introduction: The prevalence of obstructive sleep apnea (OSA) in heart failure (HF) patients varies from 30 to 50%. The differences in clinical characteristics, healthcare resource utilization (HCRU), and positive airway pressure (PAP) usage between HF with preserved ejection fraction (HFpEF) vs. HF with reduced ejection fraction (HFrEF) in OSA patients are not well known. Objective: To compare clinical characteristics, PAP usage, and HCRU in OSA patients with HFpEF vs HFrEF. Methods: Retrospective cohort study using US administrative claims data linked to objective PAP usage data over one year. HFpEF and HFrEF were identified by ICD-9/10 codes associated with healthcare encounters 1 year before starting PAP therapy. Pearson’s Chi-squared and Wilcoxon rank-sum tests were used as applicable to compare baseline characteristics and PAP usage, and the pre to post-PAP initiation difference in the number of health care encounters. Results: In total, 7,419 patients with HF and OSA were identified, of which 57% had HFpEF. HFpEF patients were majority female (54%) and older than those with HFrEF (64.1 ± 11.52 vs 59.7 ± 11.24 years, p&lt;0.001). HFpEF had a higher overall comorbidity burden, although coronary artery disease, atrial fibrillation, and other arrhythmias were more prevalent in HFrEF. Both prior to and after PAP therapy, HCRU was higher in HFpEF patients compared to HFrEF (Table 2a). There were no differences in PAP usage between HFpEF and HFrEF (3.6 ± 2.9 vs 3.7 ± 3.0 hrs/night, p=0.070) over the first year of PAP therapy. There was a significant reduction in ER visits and all cause hospitalizations after 1 year of PAP therapy initiation, which was similar between groups (Table 2b). Conclusions: Although there were differences in clinical characteristics between HFpEF and HFrEF patients with OSA, and HFpEF is associated with greater HCRU, PAP therapy usage was similar, and both groups experienced a similar reduction in HCRU after the first year of PAP initiation.

Health care utilization and costs associated with functional status in patients with psoriatic arthritis.

BACKGROUND: The Health Assessment Questionnaire Disability Index (HAQ-DI) has been validated and widely used in psoriatic arthritis (PsA) clinical trials for the assessment of patient functional status. Significant improvements in the HAQ-DI have been reported in response to therapeutic interventions; however, few US studies have evaluated the economic impact of functional disability in patients with PsA. OBJECTIVE: To evaluate the association of functional status with health care resource utilization (HCRU) and total health care costs in US patients diagnosed with PsA. METHODS: This retrospective study included adult patients with PsA enrolled in FORWARD between July 2009 and June 2019 who completed 1 or more HAQ-DI questionnaires between January 2010 and December 2019. Patient demographics, clinical characteristics, and patient-reported outcomes were collected from the most recent questionnaire. HCRU and total health care costs (2019 US dollars) for all hospitalizations, emergency department (ED) visits, outpatient visits, diagnostic tests, and procedures were assessed for the 6 months prior to survey completion. Negative binomial regression models (HCRU outcomes) and generalized linear models with γ distribution and log-link function (cost outcomes) were used to assess the relationship between HAQ-DI and HCRU and cost outcomes, respectively. RESULTS: A total of 828 patients with PsA who completed HAQ-DI questionnaires were included. The mean (SD) age was 58.5 (13.5) years, 72.3% were female, and 92.3% were White. The mean (SD) disease duration was 17.5 (12.4) years, and the mean (SD) HAQ-DI score at the time of the patients' most recent questionnaire was 0.9 (0.7). More severe functional disability, measured by higher HAQ-DI score, was significantly associated with increased risk (incident rate ratio [95% CI]) of hospitalizations (1.68 [1.11-2.55]), ED visits (2.09 [1.47-2.96]), outpatient visits (1.14 [1.05-1.24]), and diagnostic tests (1.42 [1.16-1.74]). There was also a significant positive association between greater HAQ-DI score and increased total annualized health care costs (incremental amount [95% CI], 1.13 [1.03-1.23]) and medical costs (1.38 [1.13-1.69]), but there was no significant association found with pharmacy costs. Total adjusted average patient medical costs increased with increasing HAQ-DI score. CONCLUSIONS: Among patients with PsA enrolled in FORWARD, more functional disability-as measured by higher HAQ-DI scores-was associated with greater HCRU and increased total health care costs. These results suggest that improving functional status in patients with PsA may reduce economic burden for health care payers and systems. DISCLOSURES: Dr Ogdie has received consulting fees from Amgen, AbbVie, Bristol Myers Squibb, Celgene, CorEvitas (formerly Corrona), Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB and has received grant support from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases, Rheumatology Research Foundation, National Psoriasis Foundation, Pfizer (University of Pennsylvania), Amgen (FORWARD), and Novartis (FORWARD). Dr Hwang has received consulting fees from Novartis and UCB and has received grant support (5KL2TR003168-03) from the University of Texas Health Science Center at Houston Center of Clinical and Translational Sciences KL2 program. Drs Veeranki and Shafrin were employees of PRECISIONheor at the time of this analysis. Ms Portelli and Mr Sison are employees of PRECISIONheor. Ms Pedro has nothing to disclose. Dr Hass is an employee of H. E. Outcomes, providing consulting services to Novartis. Dr Hur was an employee of Novartis at the time of this analysis. Dr Kim was a postdoctoral fellow at the University of Texas at Austin and Baylor Scott and White Health, providing services to Novartis at the time of this analysis. Dr Yi is an employee of Novartis. Dr Michaud received grant funding from the Rheumatology Research Foundation at the time of this analysis. This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ.