Perspectives on Lower Extremity Peripheral Artery Disease: A Qualitative Study of Early Diagnosis and Treatment and the Impact of Health Disparities.

Lower-extremity peripheral artery disease (PAD), the accumulation of atherosclerotic plaque in the arteries of the legs, causes substantial morbidity and mortality. Frequent under- and delayed diagnosis result in poor outcomes, disproportionately affecting individuals from racial and ethnic minority groups. To understand barriers to early detection and treatment and factors contributing to disparities, American Medical Group Association (AMGA) conducted roundtable discussions and semistructured interviews in 2021. Eighteen participants discussed PAD evaluation, diagnosis, early medical management, and disparities in care. A qualitative case study approach and data reduction methods were used to generate themes, draw conclusions, and make actionable recommendations. Identified themes included lack of (1) prioritization of PAD for population health; (2) engagement of primary care providers in early evaluation and referral; (3) "ownership" of lower-extremity PAD within health systems; and (4) focus on disparities in care. Participant solutions included (1) financial impact of early PAD management, in the context of value-based payment; (2) embedding an advanced practice provider into a vascular surgery practice to facilitate evaluation and provide medical therapy; and (3) leveraging care coordination, multidisciplinary clinics, and telehealth technology to provide comprehensive care for patients with PAD and address disparities. A deliberate focused effort is necessary to close gaps and the accompanying disparities in early evaluation, diagnosis, and treatment for people with lower-extremity PAD. The authors describe 3 models that can be emulated to improve care for this high-risk population. With improved reimbursement and better medical therapies, now is the time to focus on early diagnosis and management of PAD.

Assessment of racial and ethnic inequities in copay card utilization and enrollment in copay adjustment programs.

BACKGROUND: Increases in consumer cost sharing lead to decreases in the use of both high- and low-value care. Copay assistance was designed to reduce out-of-pocket (OOP) cost burden. Commercial insurers have recently instituted copay adjustment programs (CAPs), which exclude copay assistance from deductibles and OOP cost maximums, thereby effectively increasing the financial burden on patients. The utilization of these programs by specific demographic populations is unknown. OBJECTIVE: To assess utilization of copay assistance and CAP exposure in a commercially insured patient population and examine potential differences in the use of each of these programs by non-White and by White patients. METHODS: A retrospective, cross-sectional study using IQVIA Longitudinal Access and Adjudication Data, linked to Experian Marketing Solutions, LLC consumer data, identified unique patients who were younger than 65 years, covered by commercial insurance, had at least 1 pharmacy claim for treatment within prespecified therapeutic areas, and had full financial data visibility on paid claims (ie, nonmissing data on costs associated with the pharmacy claim and the secondary payer) between January 1, 2019, and September 30, 2021. Analyses of copay card use or CAP exposure (defined as the likelihood to be included in the accumulator or maximizer program) between non-White and White patient populations were adjusted for age, gender, household income, patient state of residence, pharmacy benefit manager, state-level CAP policy, and overall drug cost. RESULTS: In total, 4,073,599 unique patients (5.6% of the total database population) were included in the copay card analysis. In adjusted analyses, there were no significant differences in copay card utilization between non-White patients and White patients (odds ratio [OR] = 0.995, 95% CI = 0.99-1.00; P = 0.0964). However, among copay card users, non-White patients were significantly more likely to be exposed to CAPs, as either maximizers (OR = 1.27, 95% CI = 1.22-1.33; P < 0.0001) or accumulators (OR = 1.31, 95% CI = 1.26-1.36; P < 0.0001), compared with White patients. CONCLUSIONS: In an adjusted analysis of this selected sample of a commercially insured population, there was no difference in the use of copay cards between non-White and White patients. CAP exposure, however, was significantly higher among non-White patients. This increased exposure suggests a disproportionate effect due to this reduction in copay assistance benefits, which has the potential to exacerbate racial and ethnic disparities in access to medications. DISCLOSURES: This study was sponsored by Janssen Scientific Affairs, LLC. Mr Ingham, Dr Sadik, and Dr Song are employees of Janssen Scientific Affairs, LLC. Dr Zhao is an employee of IQVIA. Dr Fendrick is a consultant for AbbVie, Amgen, Bayer, CareFirst BlueCross BlueShield, Centivo, Community Oncology Association, Covered California, EmblemHealth, Exact Sciences, Freedman Health, GRAIL, Harvard University, Health & Wellness Innovations, Health at Scale Technologies, HealthCorum, Hygeia, MedsIncontext, MedZed, Merck, Mercer, Montana Health Cooperative, Pair Team, Penguin Pay, Phathom Pharmaceuticals, Proton Intelligence, Risalto Health, Risk International, Sempre Health, Silver Fern Health, State of Minnesota, Teladoc Health, US Department of Defense, Virginia Center for Health Innovation, Wellth, Wildflower Health, Yale New Haven Health System, and Zansors; received research funds from Agency for Healthcare Research and Quality (AHRQ), Boehringer-Ingelheim, Gary and Mary West Health Policy Center, Arnold Ventures, National Pharmaceutical Council, Patient-Centered Outcomes Research Institute (PCORI), Pharmaceutical Research and Manufacturers of America (PhRMA), Robert Wood Johnson (RWJ) Foundation, State of Michigan/The Centers for Medicare & Medicaid Services (CMS); and has an outside position at the American Journal of Managed Care (AJMC; co-editor), Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) member, VBID Health (partner).

Real-World Racial Variation in Treatment and Outcomes Among Patients with Peripheral Artery Disease.

INTRODUCTION: Prior studies have found considerable disparities in prevalence and outcomes for patients with peripheral arterial disease (PAD). This study compared rates of diagnostic testing, treatment patterns, and outcomes after diagnosis of PAD among commercially insured Black and White patients in the United States. METHODS: Optum's de-identified Clinformatics® Data Mart Database (1/2016-6/2021) were used to identify Black and White patients with PAD; first PAD diagnosis was deemed study index date. Baseline demographics, markers of disease severity, and healthcare costs were compared between cohorts. Patterns of medical management and rates of major adverse limb events (MALE; including acute or chronic limb ischemia, lower-limb amputation) and cardiovascular (CV) events (stroke, myocardial infarction) during the available follow-up period were described. Outcomes were compared between cohorts using multinomial logistic regression models, Kaplan-Meier survival analysis, and Cox proportional hazards models. RESULTS: A total of 669,939 patients were identified, with 454,382 White patients and 96,162 Black patients. Black patients were younger on average (71.8 years vs. 74.2 years), but had higher comorbid burden, concomitant risk factors, and CV medication use at baseline. Prevalence of diagnostic testing, revascularization procedures, and medication use was numerically higher among Black patients. Black patients were also more likely than the White patients to receive medical therapy without a revascularization procedure [adjusted odds ratio with 95% confidence interval (CI) = 1.47 (1.44-1.49)]. However, Black patients with PAD had higher incidence of MALE and CV events than White patients [adjusted hazard ratio for composite event (95% CI) = 1.13, (1.11-1.15)]. Except myocardial infarction, the hazards of individual components of MALE and CV events were also significantly higher among Black patients with PAD. CONCLUSIONS: Results of this real-world study suggest that Black patients with PAD have higher disease severity at the time of diagnosis and are at increased risk of experiencing adverse outcomes following diagnosis.

Healthcare resource utilization and costs associated with inflammatory bowel disease among patients with chronic inflammatory diseases: a retrospective cohort study.

BACKGROUND: Chronic inflammatory diseases (CIDs; ankylosing spondylitis [AS], psoriatic arthritis [PsA], psoriasis [PsO], or rheumatoid arthritis [RA]) and inflammatory bowel disease (IBD; Crohn's disease and ulcerative colitis) are associated with substantial economic burden. The relative increased costs among patients with CIDs and concomitant IBD compared to those without IBD is an important consideration when deciding on the clinical management of patient symptoms. Given the increasing use of novel agents for the treatment of CIDs, including those that may increase the risk of IBD in patients with CIDs, the objective of the study was to describe the incidence of IBD and to quantify healthcare resource utilization (HRU) and costs associated with IBD among patients with CIDs. METHODS: The IBM MarketScan® Research Databases (1/2010-7/2017) were used to identify adult patients with ≥2 claims with a diagnosis of either AS/PsA/PsO/RA (index date was a random claim for AS/PsA/PsO/RA). The one-year incidence rate of IBD was calculated following the index date. HRU and healthcare costs were compared between patients developing and not developing IBD in the year following the index date, adjusting for baseline characteristics. RESULTS: A total of 537,450 patients with CIDs (mean age = 54.0 years; 63.1% female) were included in the study. The 1-year incidence rate of IBD was 0.52% (range = 0.39% in patients with PsO but without PsA to 1.73% in patients with AS). Patients who developed IBD (N = 2778) had significantly higher rates of inpatient, outpatient, and emergency room visits (incidence rate ratios [IRR] = 2.91, 1.35, 1.81; all P < 0.0001), compared to patients without IBD (N = 534,672). Patients who developed IBD had $18,500 (P < 0.0001) higher total costs per year, including $15,121 (P < 0.0001) higher medical costs and $3380 higher pharmacy costs (P < 0.0001). CONCLUSION: Higher HRU and costs were observed in patients with concomitant CID and IBD compared to patients with CID alone. Consideration should be given to treatment decisions that adequately manage CID and IBD to ensure optimal clinical and economic outcomes.

A US hospital budget impact analysis of a skin closure system compared with standard of care in hip and knee arthroplasty.

BACKGROUND: Medicare's mandatory bundle for hip and knee arthroplasty necessitates provider accountability for quality and cost of care to 90 days, and wound closure may be a key area of consideration. The DERMABOND® PRINEO® Skin Closure System (22 cm) combines a topical skin adhesive with a self-adhering mesh without the need for dressing changes or suture or staple removal. This study estimated the budget impact of the Skin Closure System compared to other wound closure methods for hip and knee arthroplasty. METHODS: A 90-day economic model was developed assuming 500 annual hip/knee arthroplasties for a typical US hospital setting. In current practice, wound closure methods for the final skin layer were set to 50% sutures and 50% staples. In future practice, this distribution shifted to 20% sutures, 20% staples, and 60% Skin Closure System. Health care resources included materials (eg, staplers, steri-strips, and traditional/barbed sutures), standard or premium dressings, outpatient visits, and home care visits. An Expert Panel, comprised of three orthopedic physician assistants, two orthopedic surgeons, and a home health representative, was used to inform several model parameters. Other inputs were informed by national data or literature. Unit costs were based on list prices in 2016 US dollars. Uncertainty in the model was explored through one-way sensitivity and alternative scenario analyses. RESULTS: The analysis predicted that use of Skin Closure System in the future practice could achieve cost savings of $56.70 to $79.62 per patient, when standard or premium wound dressings are used, respectively. This translated to an annual hospital budgetary savings ranging from $28,349 to $39,809 when assuming 500 arthroplasties. Dressing materials and postoperative health care visits were key model drivers. CONCLUSIONS: Use of the Skin Closure System may provide cost savings within hip and knee arthroplasties due to decreases in resource utilization in the postacute care setting.

Circadian cholinergic rhythms: implications for cholinesterase inhibitor therapy.

Therapies for Alzheimer's disease (AD) at present augment the deteriorating cholinergic system, are reasonably well tolerated, and are convenient, given once or twice a day. They may, however, support or oppose endogenous circadian cholinergic rhythms. Drugs with a duration of action longer than a day are at odds with the physiology of the cholinergic system, which is active during the day and quiescent at night. Sleep and the consolidation of daytime experience into memory may be disturbed. Tolerance commonly develops, substantial counterregulatory increases in acetylcholinesterase (AChE) have been measured, and brain AChE inhibition is lower than predicted. Therefore, the duration of action and timing of administration, as they relate to natural cholinergic rhythms, are factors to be considered in optimizing cholinergic AD therapeutics.

Effects of galantamine versus donepezil on sleep in patients with mild to moderate Alzheimer disease and their caregivers: a double-blind, head-to-head, randomized pilot study.

OBJECTIVE: To examine the effects of galantamine and donepezil on patient and caregiver sleep. METHODS: In this randomized, 8-week, double-blind, parallel-group, multicenter, pilot comparison of galantamine and donepezil, safety and efficacy data were collected. Objective and subjective changes in sleep of patients (N = 63) and their caregivers were measured. Clinicians assessed changes in patient global function. As this was a pilot study, only descriptive statistics are presented. RESULTS: In general, neither galantamine nor donepezil, at stable doses, were associated with decrements in actigraphy sleep measurements. However, mean scores in all measures of sleep showed a tendency for minimal improvements in galantamine-treated patients and minimal decrements in the donepezil-treated patients. The same tendencies were present in caregiver sleep measures. Global function either improved or remained stable in a higher percentage of patients treated with galantamine than with donepezil. Galantamine and donepezil were both well tolerated and safe. CONCLUSIONS: This pilot study was the first to compare the effects of these drugs on sleep in patients or caregivers. Both drugs were safe and well tolerated. Neither galantamine nor donepezil negatively affected sleep; however, on every measure, there were suggestions of slightly more benefit associated with galantamine treatment. Although these results are suggestive of a differential effect of the drugs on sleep, further research is needed to confirm the clinical significance.

Reduction of caregiver burden in Alzheimer's disease by treatment with galantamine.

Alzheimer's disease is a progressive condition characterized by a loss of cognition, altered behavior, and a loss of functional ability, such as bathing, dressing, toileting, and organizing finances. Family and friends provide nearly three quarters of all care for patients with Alzheimer's disease. This informal care results in significant burden to caregivers. Caregiver burden is the set of physical, psychological or emotional, social, and financial problems that family members may experience when caring for impaired older adults. Caregivers of Alzheimer's disease patients report higher rates of physical symptoms, mortality, depression, and fatigue, as well as adverse effects on employment compared with those who are not caregivers for Alzheimer's disease patients. In many cases, the same family members are responsible for both out-of-pocket expenditures and caregiving duties. For this article, a MEDLINE search using the key words "caregiver and Alzheimer's disease" and "cost and Alzheimer's disease" was performed. The purpose of this article is to review the literature on caregiver burden, the components of caregiver burden, effects of caregiving on the health of caregivers, the cost of Alzheimer's disease on the caregiver and society, and the benefits attainable with treatment.

Examination of nighttime sleep-related problems during double-blind, placebo-controlled trials of galantamine in patients with Alzheimer's disease.

BACKGROUND: Acetylcholinesterase inhibitors (AChEI) are now widely used as treatment for Alzheimer's disease (AD). Their cholinomimetic action has the potential to influence sleep quality and donepezil has been associated with sleeprelated adverse events. This study examined whether galantamine, an AChEI with nicotinic modulation, is associated with nighttime sleeprelated problems. METHODS: Using data combined from three randomized, double-blind trials, galantamine (GAL) and placebo-treated patients were compared on sleep-related adverse events and concomitant medications. Verbatim descriptions by patients, as recorded by physicians, were used to classify adverse events into insomnia/sleep problems and nightmares/dreams. New concomitant medications findings from double-blind, placebo-controlled were counted when prescribed for sleep-related indications. Treatment arms were 705 subjects on GAL 24 mg (12 mg BID), 279 on GAL 16 mg (8 mg BID), and 714 on placebo. RESULTS: Comparing GAL 24, GAL 16, and placebo arms, the respective rates for insomnia/sleep problems were 2.6, 1.1, and 2.2% and for nightmares were 1.1, 0.4, and 0.1%. Comparisons between GAL arms and placebo were not significant, with the exception of GAL 24 for nightmares (p = 0.02). However, due to the low frequency of nightmares in each group the clinical relevance of this difference is unknown. Rates of use for all concomitant medications indicated for sleep were 5.4, 2.9, and 4.6%, respectively, with no significant differences between GAL arms and placebo. CONCLUSION: These results support previous studies that have shown maintenance of good sleep hygiene during treatment with galantamine.

Health-related quality of life for caregivers of patients with Alzheimer disease.

We investigated the relationship of caregivers' health-related quality of life (HRQOL) to the burden of caring for patients with Alzheimer disease (AD) and resource utilization. Caregiver HRQOL was assessed using the SF-12 Mental and Physical Summary scores. Compared with a normative, age-adjusted sample, the 2477 caregivers had lower mental and physical scores (for the latter, only those <54 years of age). Increased caregiver mental functioning was associated with caregiver support and perceived quality of patient medical care, fewer hours of caregiving, and fewer patient behavioral symptoms. The burden of caregiving has substantial effects on HRQOL. Interventions that improve AD status and reduce caregiving hours have the potential to improve caregivers' HRQOL.

The increasing burden of Alzheimer disease.

Alzheimer disease is a progressive degenerative disease that affects cognition, the ability to perform activities of daily living, and behavior. Cognitive, behavioral, and functional decline associated with progressive Alzheimer disease places a considerable burden on caregivers and the health care system. Earlier detection, better diagnosis, earlier intervention, and increased treatment may help reduce this burden.

Identifying patients with gastroesophageal reflux disease: validation of a practical screening tool.

A reliable, accurate noninvasive method for identifying patients with gastroesophageal reflux disease (GERD) in the primary care setting is needed. A population-based case-finding instrument may assist managed care organizations in identifying candidates for disease management or quality improvement programs. Our aim was to develop and validate a GERD case-finding instrument. A 12-item "GERD Screener" was developed based on literature review and expert opinion with questions about heartburn and regurgitation frequency and severity and medication use, as well demographics and exclusion criteria. Categorical and continuous scoring methods with and without medication use were developed a priori. Using a telephone interview in a medical group, we identified and enrolled 100 subjects with a history of GERD-like symptoms and 103 controls. Each subject completed the GERD Screener, a validated gastrointestinal symptom questionnaire, the Digestive Health Symptom Index (DHSI), and was evaluated independently by two gastroenterologists using a structured format. Agreement by the two physicians that symptoms were consistent with GERD and required an intervention was considered the gold standard. In all, 70 subjects were classified as having GERD and 106 as controls using the gold standard (K = 0.73; 95% CI, 0.63-0.82). The scoring method for the screening instrument using a continuous measure of GERD symptoms (frequency and severity) and weighted medication use resulted in an area under ROC of 0.89 (95% CI, 0.84-0.94). Using a cutoff of >9 points, this measure was 83% sensitive and 83% specific. Compared to the gold standard, the DHSI GERD subscale has an area under ROC of 0.89 (95% CI, 0.84-0.94). The GERD Screener was highly correlated with the DHSI GERD subscale, r = 0.78 (95% CI 0.72-0.83; P < 0.0001). In conclusion, the GERD Screener has demonstrated construct, convergent, and predictive validity. It is shorter than existing validated instruments, practical, and easily administered, which may reduce the response and administrative burden. This may serve as a valuable case-finding instrument in primary-care and managed-care organizations wishing to implement programs to improve the quality and efficiency of care.