Large National Sample Research Articles

Assessing Pharmacokinetic Correlates of Escitalopram-Related Adverse Drug Reactions.

To assess the pharmacokinetic correlates of reported adverse drug reactions (ADRs) under antidepressant treatment with escitalopram (ESC) using a large therapeutic drug monitoring database. A large naturalistic sample of inpatients and outpatients prescribed ESC was analyzed. ADRs were classified using the Udvalg for Kliniske Undersogelser side effect rating scale. We compared ESC-treated patients with (n = 35) and without ADRs (n = 273) using ESC plasma concentrations as the primary outcome. We also compared ADR rates in the 2 groups based on 2 cut-off ESC levels reflecting the recommended upper thresholds of the therapeutic reference range of 80 ng/mL, suggested by the consensus therapeutic drug monitoring guidelines, and 40 ng/mL, based on recent meta-analysis data. The effects of age, sex, smoking, daily ESC dose, plasma concentrations, and concentrations corrected for daily dose were included in a binary logistic regression model to predict ADRs. No differences in clinical, demographic, or pharmacokinetic parameters were observed between patients with and without ADRs ( P > 0.05). Patients with ESC-related ADRs were more frequently diagnosed with psychotic disorders than those without (25% vs. 7.1%, P = 0.004). None of the variables was associated with ADR risk. Overall, ADR rates were not significantly different in patients above versus below thresholds of ESC concentrations (ESC concentrations >40 [n = 59] vs. ≤40 ng/mL [n = 249] and >80 [n = 8] vs. ≤80 ng/mL [n = 300]; P = 0.56 and P = 1.0, respectively). No distinct pharmacokinetic patterns underlying ESC-associated ADRs were observed. Further studies with more specific assessments of ADRs in larger cohorts are required to better identify potential underlying patterns.

Prader-Willi syndrome in a large sample from Spain: general features, obesity and regular use of psychotropic medication.

Prader-Willi syndrome (PWS), a genetically determined disorder, the most frequent cause of early onset obesity, is associated with physical and cognitive dysfunctions and behavioural disturbances; these disturbances are frequently treated with psychotropic medication. The aim of this cross-sectional study was to describe the characteristics of the first large national sample of persons with PWS in Spain and analyse the relationships of those characteristics with key demographic and clinical factors, particularly with obesity and the regular use of psychotropic medication. Participants were recruited among all members of the Spanish Prader-Willi Association who agreed to take part in the study and fulfilled its inclusion criteria. Family and patient demographic features, family size and birth order, intelligence quotient (IQ), anthropometric measures, lifestyle habits, behavioural disturbances (with the Aberrant Behavior Checklist) and clinical data, as well as use of psychotropic drugs and their side effects (with the UKU scale), were collected in genetically confirmed cases of PWS. Bivariate and logistic regression analyses were used for determining the associations of demographic and clinical factors with both obesity and the regular use of psychotropic medication. The cohort included 177 participants (aged 6-48years), that is, 90 (50.8%) males and 87 (49.2%) females. Behavioural disturbances were present in a range of 75% to 93% of participants; psychotropic medication was prescribed to 81 (45.8%) of them. Number of siblings showed a direct correlation with IQ, especially among males, and inappropriate speech was more intense in only-child females. Obesity was, in parallel, strongly associated with ascending age and with not being currently under growth hormone (GH) treatment. Participants taking any psychotropic medication were characterised by more frequent age ≥30years, high level of hyperactivity and a psychiatric diagnosis. Characterisation of persons with PWS in Spain confirms their physical and behavioural phenotype and supports the long-term application of GH therapy and the rational use of psychotropic medication.

What Strategic Planning Methods are Most Related to Higher Capacity Organizations: An Empirical Investigation

Considering the controversy around strategic planning effectiveness for nonprofits, we first ask, “Does strategic planning matter?”. A survey was administered to 1,256 nonprofit organizations to determine a. their capacity to plan and b. what strategic planning processes they used. Using regression analysis, it was found that the presence of a strategic plan acted as a statistically significant indicator of higher organizational capacity. Next, strategic methods were evaluated to determine which ones were associated with higher capacity scores. This research makes two main contributions. First, it enhances, using a large national sample the academic debate as to the usefulness of strategic planning. Second, for practitioners, this research demonstrates which strategic methods were found to be associated with the highest performing organizations, using our capacity indicator. Based on these findings we believe that nonprofit managers can optimize their resources and focus on those methods that provide them with the highest return on their strategic efforts. Additionally, nonprofit faculty now have data to suggest what strategic planning methods should be taught in our classrooms.

On improbable carrots

Membership in the EU is sometimes presented as a reward for Serbia’s eventual acknowledgement of Kosovo’s independence. Although membership in the EU has been a strategic goal of Serbian foreign policy, the EU is often perceived as working against Serbian national interests regarding Kosovo’s status. Relying on the cognitive dissonance theory, we hypothesize that in addition to a direct negative association between the support for Serbia’s territorial integrity and the EU membership, there is also an interactive effect: the association should be moderated by one’s opinion on when and whether Serbia will become a member of the EU. These hypotheses are examined using public opinion data based on a large national sample of adult Serbian citizens. The results support the interaction hypothesis: the attitude that Kosovo should remain part of Serbia is a stronger predictor of the (negative) evaluation of the EU among those respondents who do not believe that Serbia will become an EU member in the future.

PREDICTORS OF HOSPICE AND END-OF-LIFE CARE: GEOGRAPHIC LOCATION, PATIENT PORTALS, NURSING HOME CARE, AND HOME HEALTH

Abstract Hospice is considered an indicator of high-quality care at end-of-life (EOL) often allowing patients to receive care aligned with their values, in their homes, surrounded by support and loved-ones. However, there is a need to address access barriers to hospice and enroll patients earlier in their disease trajectory. Understanding predictors of hospice use will help identify strategies for addressing hospice inequities, promoting longer hospice stays, and improving overall EOL outcomes. Focusing on research methodologies with large cohorts and national samples, this symposium examines the associations of health care services and inequalities on key EOL outcomes and hospice use. First, Autumn Decker will describe profiles of hospice use and EOL experience by geographic location and race from the National Health and Aging Trends Study. Next, Dr. Jennifer Portz will summarize the association between types of patient portal use and EOL outcomes including hospitalization, advance directives, and hospice use. Dr. Ellis Dillon will follow with a description of hospice use and short hospice length of enrollment for Conneticut’s Medicaid decedents, comparing decedents with nursing home stays to those without. Lastly, Dr. Olga Jarrin will present findings from her study of home health care use during the last 3 years of life as a predictor of death with hospice in a Medicare cohort. Our discussant, Dr. Karla Washington, will lead us in a conversation outlining the role of health care services, such as home health, nursing home care, and patient portals, for promoting access to hospice earlier and for all patients.

Sexual Minority Youth Reporting SOGIE-Based Harassment to Adults at School: The Roles of Experienced Harassment, Outness, Safety, and Adult Support at School.

Despite a proliferation of bullying prevention programs in recent time, limited work has investigated support-seeking behaviors in response to elevated bullying levels among sexual minority youth (SMY). To address this gap, the current study examined how harassment targeting SOGIE (sexual orientation, gender identity, and gender expression), sexual identity outness, school safety, and perceptions of teacher/staff support were associated with SMY talking to an adult at school about harassment. A large contemporary national sample of SMY (N = 5538) between the ages 13-18 (Mage = 15.53, SD = 1.33) who experienced at least one form of SOGIE-based harassment in the past year was leveraged for analyses. Hierarchical multivariable logistic regressions revealed more frequent SOGIE-based harassment was associated with greater odds of reporting harassment to school personnel, particularly among SMY who felt safe at school. Findings highlight the need for school-based interventions to foster school safety among SMY who experience peer harassment to promote their reporting of this behavior.

Testing the structure of the BERRI using exploratory and confirmatory factor analysis

BackgroundThe wellbeing of Children Looked After (CLA) is a multifaceted construct given their adverse experiences and greater risk of mental health complications. There is a clear need for a comprehensive mental health and psycho-adjustment measure for diagnostic and monitoring purposes within this population. ObjectiveThe aim of this study is to test, explore and validate the optimal factor structure of a new mental health and psycho-adjustment measure looking at Behavior, Emotions, Relationship, Risk, and Indicators (BERRI). Participants and SettingThe data were extracted from an existing large naturalistic sample of CLA for whom the BERRI was used as part of their placement providers’ service provision (N = 1543, 45% female). The surveys were completed by their primary carer reporting the child’s experiences during the previous month. MethodsBoth an exploratory factor analysis (EFA) and a confirmatory factor analysis (CFA) were conducted to assess the 87-item measure’s initial factor structure. For cross-validation purposes, the database was split 60–40 between a ‘train’ and a ‘test’ sub-sample. ResultsAn eight-factor structure (Dysregulation, Vulnerability, Neurodiverse needs, Negative self and emotions, Emotional disconnect, Barriers to connection, Risk to self, and Disrupted routines) emerged. This was subsequently validated by the CFA suggesting a good fit (CFI = 0.951, SRMR = 0.08, and RMSEA = 0.038) and good internal consistency. ConclusionsOur study supported the structure validity and internal consistency of a mental health and psycho-adjustment measure specifically developed for CLA. Recommendations for further research relating to the tool’s applicability in other populations are proposed.

Opioid and Non-Opioid Pharmacotherapy Use for Pain Management Among Privately Insured Pediatric Patients With Cancer in the United States.

This study examined the trends and patterns of opioid and non-opioid pharmacotherapy use among a large national sample of privately insured pediatric patients with cancer in the United States. We identified pediatric (aged < 21) patients diagnosed with central nervous system (CNS), lymphoma, gonadal, leukemia, or bone cancer from MarketScan data 2005-2019. We examined the proportion of patients who filled a prescription for the following 5 types of pharmacotherapy: opioid, anticonvulsant, non-steroidal anti-inflammatory drug (NSAID), antidepressant, and muscle relaxant during active cancer treatment. We assessed the trends and patterns in pharmacotherapy using multivariable logistic regressions. Among 4174 patients included, 2979 (71%) had an opioid prescription; 746 (18%), 384 (9%), 202 (5%), and 169 (4%) had anticonvulsant, NSAID, antidepressant and muscle relaxant prescriptions, respectively. Multivariable logistic regression showed a nonlinear trend in the use of opioids among pediatric patients with cancer over time such that use slightly increased until 2012 (OR of 1.40 [95% CI, 1.12-1.73] for 2012 vs. 2006) but then decreased thereafter (OR of 0.51 [0.37-0.68] for 2018 vs. 2012). The use of anticonvulsants, NSAIDs, and muscle relaxants increased significantly linearly over time (all P < .005). There has been a downward trend in the use of opioids in recent years among pediatric patients with cancer and an upward trend in the use of non-opioid pharmacotherapy for pain management potentially as an alternative to opioids.

Development and initial validation of the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M): An item bank for evaluating mobility of people who use lower-limb orthoses.

Lower limb orthoses (LLOs) are externally-applied leg braces that are designed to improve or maintain mobility in people with a variety of health conditions that affect lower limb function. Clinicians and researchers are therefore often motivated to measure LLO users' mobility to select or assess the effectiveness of these devices. Patient-reported outcome measures (PROMs) can provide insights into important aspects of a LLO user's mobility for these purposes. However, few PROMs are available to measure mobility of LLO users. Those few that exist have issues that may limit their clinical or scientific utility. The objective of this study was to create a population-specific item bank for measuring mobility of LLO users. Previously-developed candidate items were administered in a cross-sectional study to a large national sample of LLO users. Responses from study participants (n = 1036) were calibrated to a graded response statistical model using Item Response Theory methods. A set of 39 items was found to be unidimensional, locally independent, and function without bias due to characteristics unrelated to mobility. The set of final calibrated items, termed the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M) item bank, was evaluated for initial evidence of convergent, divergent, and known groups construct validity. OPRO-M was strongly correlated with existing PROMs designed to measure aspects of physical function. Conversely, OPRO-M was weakly correlated with PROMs that measured unrelated constructs, like sleep disturbance and depression. OPRO-M also showed an ability to differentiate groups with expected mobility differences. Two fixed-length short forms were created from the OPRO-M item bank. Items on the short forms were selected based on statistical and clinical criteria. Collectively, results from this study indicate that OPRO-M can effectively measure mobility of LLO users, and OPRO-M short forms can now be recommended for use in routine clinical practice and research studies.

Rostral Anterior Cingulate Cortex Oscillatory Power Indexes Treatment-Resistance to Multiple Therapies in Major Depressive Disorder

Introduction: High rostral anterior cingulate cortex (rACC) activity is proposed as a nonspecific prognostic marker for treatment response in major depressive disorder, independent of treatment modality. However, other studies report a negative association between baseline high rACC activation and treatment response. Interestingly, these contradictory findings were also found when focusing on oscillatory markers, specifically rACC-theta power. An explanation could be that rACC-theta activity dynamically changes according to number of previous treatment attempts and thus is mediated by level of treatment-resistance. Methods: Primarily, we analyzed differences in rACC- and frontal-theta activity in large national cross-sectional samples representing various levels of treatment-resistance and resistance to multimodal treatments in depressed patients (psychotherapy [n = 175], antidepressant medication [AD; n = 106], repetitive transcranial magnetic stimulation [rTMS; n = 196], and electroconvulsive therapy [ECT; n = 41]), and the respective difference between remitters and non-remitters. For exploratory purposes, we also investigated other frequency bands (delta, alpha, beta, gamma). Results: rACC-theta activity was higher (p < 0.001) in the more resistant rTMS and ECT patients relative to the less resistant psychotherapy and AD patients (psychotherapy-rTMS: d = 0.315; AD-rTMS: d = 0.320; psychotherapy-ECT: d = 1.031; AD-ECT: d = 1.034), with no difference between psychotherapy and AD patients. This association was even more pronounced after controlling for frontal-theta. Post hoc analyses also yielded effects for delta, beta, and gamma bands. Conclusion: Our findings suggest that by factoring in degree of treatment-resistance during interpretation of the rACC-theta biomarker, its usefulness in treatment selection and prognosis could potentially be improved substantially in future real-world practice. Future research should however also investigate specificity of the theta band.

Why Economic Growth Stimulates More Growth in Some Countries Rather than Others

Leontief multipliers are an important component of economic growth. However, input–output analysis is generally treated as a methodological tool for studying other questions in development. The size of multipliers themselves is of interest, as they determine how much nations benefit economically from the growth of base industries. Of the three types of multipliers—industrial supply purchases by firms, consumer goods purchases by workers, and growth derived from all sources—only the first has attracted attention in the global value chain literature; the other two have been neglected. We use OECD data on a large sample of nations in 2005, 2010, and 2015 to show that significant cross-national and inter-industrial differences exist in the size of multipliers. Contrary to expectations, higher-income countries can sometimes have lower multipliers than lower-income countries. The largest multipliers tend to be in the global South. We then provide a model explaining the differences in multipliers in terms of the domesticity of purchases, the wage intensity of production, the geographical size of the country, and the changing roles of GDP per capita and education as societies develop. The significance of these findings for development policy is discussed.

Outcomes of Concurrent Ventral Hernia Repair and Cholecystectomy Compared to Ventral Hernia Repair Alone.

Introduction It has been suggested that hernia repair with concomitant cholecystectomy increases the risk of postoperative complications due to potential mesh contamination. This study compares postoperative outcomes and complications between patients who underwent ventral hernia repair (VHR) with and without concomitant cholecystectomy (CCY). Methods Using the American College of SurgeonsNational Surgical Quality Improvement Program (ACS NSQIP) database,from 2005 to 2019, we queried patients who underwent ventral hernia repairsusing the current procedural terminology (CPT) codes 49652-49657 (laparoscopic) and 49560-49566 (open), with or without cholecystectomy. The ACS NSQIP is a prospective, systematic study of patients who underwent major general surgical procedures aggregating data from over 200 hospitals. Cases involving additional concomitant procedures were excluded. Primary outcomes of interest were 30-day mortality, length of stay, readmission, return to operating room (OR), and postoperative complications. The odds ratio for primary outcomes was calculated using multivariable binomial logistic regression to control for patient risk factors. Results In total, 167586 cases were identified, 165,758 ventral hernia repairs alone, and 1,828 ventral hernia repairs with concomitant cholecystectomy. There was no difference in 30-day mortality, length of stay, readmission, return to the operating room, or postoperative complications between groups. Patients who underwent simultaneous VHR/CCY when compared to those who had VHR alone, had no differences in the rate of surgical site infections (1.86% vs. 1.97%, P = 0.57) orsepsis (0.82% vs. 0.41%, P = 0.10). Conclusion In a large national sample, there is no significant difference in postoperative outcomes, specifically infection-related complications, when comparing VHR along with concurrent VHR/CCY.Our findings suggest no increased risks for patients undergoing concurrent ventral hernia repair and cholecystectomy. Hence, surgeons might consider this combined approach to offer the best value-based care, especially when it could eliminate the need for a second operation and the risk of infection is low. Prospective studies with more procedural-specific information for hernia repairs and indications for cholecystectomy are neededhowever it is likely safe to perform both procedures during the same setting in cholecystectomy cases lacking signs of acute infection.

The effect of survey administration mode on youth mental health measures: Social desirability bias and sensitive questions

AimResearch on trends in youth mental health is used to inform government policy and service funding decisions. It often uses interviewer-administered surveys, which may be affected by mode effects related to social desirability bias. This study sought to determine the impact of survey administration mode on mental health measures, comparing mode effects for sensitive mental health measures (psychological distress and wellbeing) and non-sensitive (physical activity) measures. MethodsData were from two large national community samples of young Australians aged 12–25 years conducted in 2020 (N = 6238) and 2022 (N = 4122), which used both interviewer-administered and self-report modes of data collection. ResultsResults showed participants reported lower psychological distress and higher wellbeing in the interviewer-assisted compared with the self-report mode. No mode effects were found for the non-sensitive physical activity measures. No interaction between mode and gender was found, but an age group by mode interaction revealed that those in the 18–21 and 22–25-year age groups were more strongly affected than younger adolescents. ConclusionsThese findings suggest underestimates of mental health issues from interview survey formats, particularly for young adults. The results show how even a weak mode effect can have a large impact on mental health prevalence indicators. Researchers and policy makers need to be aware of the impact social desirability bias can have on mental health measures and consider taking steps to mitigate this effect.

What factors are associated with public support for climate change adaptation policy in the U.S.?

As climate change impacts increase in frequency and magnitude, policies, and actions to promote climate change adaptation are critical to reduce negative consequences to infrastructure and society. Despite the urgency of adaptation, there have been few systematic efforts to understand the dynamics of public support for adaptation efforts at the local level in the U.S., partly because of the context- and location-specific nature of many adaptation actions. In this paper we use novel survey data to identify the role of demographics, extreme weather experience, awareness of climate change adaptation, risk perceptions, and perceived efficacy in predicting general support for local climate adaptation policy. We utilize a large national sample of U.S. adults (N = 37,088) collected over 12 waves between 2019 and 2022. We find that risk perceptions, beliefs about global warming, awareness of climate change adaptation, and perceived efficacy of local governments are key drivers of support for local adaptation policy. We provide policymakers, educators, and communicators with key guidelines for enhancing public support for adaptation policies. These insights are critical to expanding climate adaptation efforts and policy implementation at the local and national levels in the U.S.

A comparison of men and women undergoing septoplasty-the Swedish national septoplasty register.

Men represent more than two-thirds of septoplasty patients in many studies, but differences between men and women in terms of patient selection or outcome are seldom reported. This study aims to investigate whether women undergoing septoplasty differ from men in critical variables before and after surgery, in a large national sample of septoplasties. Cross-sectional register study. The study includes 2,532 patients from the National Swedish Septoplasty Register undergoing septoplasty with or without additional turbinoplasty on the indication of nasal obstruction in 2014-2019. Patients in the register have not been preselected. Preoperative variables and postoperative outcome were compared between men and women. Men accounted for 1,829 (72%) of the patients. There was no significant difference between men and women in severity of self-reported nasal obstruction or type of surgery performed (septoplasty with or without turbinoplasty). Mean postoperative nasal obstruction 12 months after surgery and overall satisfaction with the result were similar. Women, however, reported more complications 12 months postoperatively, while men reported more problems with snoring and obstructive sleep apnea preoperatively. In this large national patient cohort undergoing septoplasty, we found no differences in preoperative nasal obstruction or postoperative patient-rated outcome in men and women undergoing septoplasty, despite the fact that 72% of the patients were men. It thus remains unclear why women are under-represented in septoplasty surgery in this and many other cohorts.

Association of Serum Vitamin D With Periodontal Disease

ObjectiveThere are conflicting reports on the relationship between vitamin D and periodontal disease. Our research is intended to further analyse the association between serum 25(OH)D3, a vitamin D precursor and periodontal disease based on a large national survey sample in Japan. MethodsWe downloaded the 2009–2018 National Health and Nutrition Examination Survey (NHANES) cycle, which included a total of 23,324 samples. Logistic regression of factors influencing perioral disease including periodntal disease, and subgroup logistic regression were performed to analyse the relationship between serum vitamin D and perioral disease, using WTMEC2YR as weights for regression analysis. Then machine learning model–based prediction of perioral disease onset was performed, and the machine learning algorithms used included boost tree, artificial neural network, AdaBoost, and random forest. ResultsWe evaluated the vitamin D, age, sex, race, education, marriage, body mass index, ratio of family income to poverty (PIR), smoking, alcohol consumption, diabetes, and hypertension as variables in the included samples. Vitamin D was negatively associated with perioral disease; compared with Q1, the odds ratios and 95% CI were 0.8 (0.67–0.96) for Q2, 0.84 (0.71–1.00) for Q3, and 0.74 (0.6–0.92) for Q4 (P for trend <.05), respectively. The results of the subgroup analysis showed that the effect of 25(OH)D3 on periodontal disease was more pronounced in women younger than 60 years. Based on the accuracy and receiver operating characteristic curve, we concluded that a boost tree was a relatively good model to predict periodontal disease. ConclusionsVitamin D might be a protective factor for periodontal disease, and boost tree analysis we emplyed was a relatively good model to predict perioral disease.

Association between uric acid and depressive symptoms in older adults: The Korea National Health and Nutrition Examination Survey.

Uric acid is known for its antioxidant capacity; however, whether uric acid is independently associated with depression in the older population remains controversial. The current study aimed to investigate the association between uric acid and depressive symptoms in older adults according to sex, using a large national sample population. Data from the 2016, 2018, and 2020 Korean National Health and Nutrition Examination Surveys were analyzed, and 5609 participants older than 60years were included in this study. We defined a Patient Health Questionnaire-9 score ≥5 as indicating the presence of depressive symptoms. The prevalence of depressive symptoms was higher in women with lower uric acid levels than in those with higher uric acid levels. In women, the lower levels of uric acid were significantly associated with depressive symptoms in the multivariable logistic regression analysis (odds ratio, 1.36; 95% confidence interval, 1.10-1.68; p=0.005). However, no significant association between uric acid levels and depressive symptoms was observed in men. The findings of this study suggest that uric acid is associated with depressive symptoms in older women, but not in men. Relatively lower serum uric acid levels in women compared to men and sex differences in oxidative stress may explain the significant association of uric acid levels and depressive symptoms in older women. Further research is needed on sex differences in the relationship between serum uric acid levels and depressive symptoms.

Dementias Among Older Males and Females in the U.S. Medicare System With and Without HIV.

Despite the growing concern that people with HIV (PWH) will experience a disproportionate burden of dementia as they age, very few studies have examined the sex-specific prevalence of dementia, including Alzheimer disease and related dementias (AD/ADRD) among older PWH versus people without HIV (PWOH) using large national samples. We constructed successive cross-sectional cohorts including all PWH aged 65+ years from U.S. Medicare enrollees and PWOH in a 5% national sample of Medicare data from 2007 to 2019. All AD/ADRD cases were identified by ICD-9-CM/ICD-10-CM diagnosis codes. Prevalence of AD/ADRD was calculated for each calendar year by sex-age strata. Generalized estimating equations were used to assess factors associated with dementia and calculate the adjusted prevalence. PWH had a higher prevalence of AD/ADRD, which increased over time compared with PWOH, especially among female beneficiaries and with increasing age. For example, among those aged 80+ years, the prevalence increased from 2007 to 2019 (females with HIV: 31.4%-44.1%; females without HIV: 27.4%-29.9%; males with HIV: 26.2%-33.3%; males without HIV: 21.0%-23.5%). After adjustment for demographics and comorbidities, the differences in dementia burden by HIV status remained, especially among older age groups. Older Medicare enrollees with HIV had an increased dementia burden over time compared with those without HIV, especially women and older subjects. This underscores the need to develop tailored clinical practice guidelines that facilitate the integration of dementia and comorbidity screening, evaluation, and management into the routine primary care of aging PWH.

National survey of financial burdens and experience among patients with cancer receiving charitable co-pay assistance.

6647 Background: High healthcare costs can pose a barrier to access and contribute to financial hardship among patients with cancer. Charitable co-pay assistance (CPA) foundations provide financial support to patients facing high out-of-pocket costs, but little is known about the sociodemographic characteristics, financial burdens, views and experience of those receiving assistance. Methods: We conducted a national, cross-sectional survey of CPA grant recipients receiving financial assistance from the HealthWell Foundation (charitable CPA foundation) to cover cancer drug costs. The primary outcome of interest was self-reported financial distress (FACIT-COST). Secondary outcomes included measures of out-of-pocket spending, patient perspectives on CPA support, healthcare access and costs, and the impact of financial burden on healthcare utilization. Results: Among 1,108 CPA grant recipients, over 20 cancer types were represented, including 30% with solid tumors and 70% hematologic malignancy. Average age of CPA recipients was 72 (range: 41-92), 60% were male, 88% white, 55% college educated, and 67% had annual income &lt; $60,000. 96% had Medicare (53% Traditional, 43% Advantage, 58% with supplemental insurance), and 66% believed insurance would prevent them from paying high drug costs. However, 54% reported spending &gt; $500 per month on healthcare, with 39% spending &gt; 10% of household income. Among 17% reporting delays in starting therapy due to cost, 28% reported delay &gt; 4 weeks. Overall, 18% reported skipping medical services due to cost, and 24% believed they would not have received their treatment without CPA. On the COST scale, 56% reported mild financial toxicity (COST 14-25) and 27% moderate/severe (COST &lt; 14) despite CPA. In bivariate analysis, younger age, solid tumor, lower income, female gender, higher anxiety and depression (PHQ4), greater comorbidity, and traditional Medicare were all significantly associated with greater financial distress (lower COST scores, P &lt; 0.05 for all). Most (76%) CPA recipients believed that doctors should be aware of costs when making decisions, and 91% supported Medicare negotiating drug prices with manufacturers. With regard to why they required CPA, only 6% attributed it to failure to discuss costs with their doctor, 14% to the healthcare system, 51% to poor insurance coverage, 61% to their financial status, and 82% to high drug costs. Notably, 73% reported a decrease in financial concerns as a result of CPA. Conclusions: In this large national sample of CPA grant recipients with cancer, most had Medicare and believed insurance would shield them from high drug costs, yet many reported delays in starting therapy prior to CPA and ongoing financial distress. CPA may play an important role in securing access to therapy but these findings highlight an ongoing need to address financial toxicity and understand potential disparities in access to CPA.

Comparison of Out-of-Pocket Spending on Ultra-Expensive Drugs in Medicare Part D vs Commercial Insurance

Little is known about how out-of-pocket burden differs between Medicare and commercial insurance for ultra-expensive drugs. To investigate out-of-pocket spending for ultra-expensive drugs in the Medicare Part D program vs commercial insurance. This was a retrospective, population-based cohort study of individuals using ultra-expensive drugs included in a 20% nationally random sample of prescription drug claims from Medicare Part D and individuals aged 45 to 64 years using ultra-expensive drugs included in a large national convenience sample of outpatient pharmaceutical claims from commercial insurance plans. Claims data from 2013 through 2019 were used, and data were analyzed in February 2023. Claims-weighted mean out-of-pocket spending per beneficiary per drug by insurance type, plan, and age. In 2019, 37 324 and 24 159 individuals using ultra-expensive drugs were identified in the 20% Part D and commercial samples, respectively (mean [SD] age, 66.2 [11.7] years; 54.9% female). A statistically significant higher share of commercial enrollees vs Part D beneficiaries were female (61.0% vs 51.0%; P < .001), and a statistically significantly lower share were using 3 or more branded medications (28.7% vs 42.6%; P < .001). Mean out-of-pocket spending per beneficiary per drug in 2019 was $4478 in Part D (median [IQR], $4169 [$3369-$5947]) compared with $1821 for commercial (median [IQR], $1272 [$703-$1924]); these differences were statistically significant every year. Differences in out-of-pocket spending comparing commercial enrollees aged 60 to 64 years and Part D beneficiaries aged 65 to 69 years exhibited similar magnitudes and trends. By plan, mean out-of-pocket spending per beneficiary per drug in 2019 was $4301 (median [IQR], $4131 [$3000-$6048]) in Medicare Advantage prescription drug (MAPD) plans, $4575 (median [IQR], $4190 [$3305-$5799]) in stand-alone prescription drug plans (PDPs), $1208 (median [IQR], $752 [$317-$1240]) in health maintenance organization plans, $1569 (median [IQR], $838 [$481-$1472]) in preferred provider organization plans, and $4077 (median [IQR], $2882 [$1075-$4226]) in high-deductible health plans. There were no statistically significant differences between MAPD plans and stand-alone PDPs in any study year. Mean out-of-pocket spending was statistically significantly higher in MAPD plans compared with health maintenance organization plans and in stand-alone PDPs compared with preferred provider organization plans in each study year. This cohort study demonstrated that the $2000 out-of-pocket cap included in the Inflation Reduction Act may substantially moderate the potential increase in spending faced by individuals who use ultra-expensive drugs when moving from commercial insurance to Part D coverage.