Diversity in randomized clinical trials for peripheral artery disease: a systematic review.

BACKGROUND: Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD. METHODS: Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics. RESULTS: A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%). CONCLUSIONS: The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations. REGISTRATION: The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).

Cost Burden and Cost Influencers of Inferior Vena Cava Filter Placement and Retrieval among Medicare Beneficiaries with Acute Venous Thromboembolism.

PURPOSE: To examine the frequency, costs, and cost influencers of inferior vena cava filters (IVCFs) placements and retrievals among a national sample of patients using Medicare data. MATERIALS AND METHODS: This retrospective cohort study used the U.S. Medicare 100% database, a nationally representative sample of all U.S. patients aged ≥65 years, from 2014 through 2020. Procedures and clinical characteristics were identified from the diagnosis and procedure codes on Medicare claims. Beneficiaries aged ≥65 years with newly diagnosed venous thromboembolism (VTE) were identified and followed to obtain data on IVCF placements and retrievals. Data on the costs of the index IVCF procedures and any subsequent IVCF placements and retrievals were obtained. Multivariate models were used to estimate the impact of patient and clinical characteristics on costs. RESULTS: Among 501,216 patients with newly diagnosed VTE, 4,995 (1%) received an IVCF placement; of these, 1,215 (24.3%) had a retrieval procedure. Beneficiaries with IVCF placements and retrievals differed from a demographic and clinical perspective than from those without. Costs varied by the site of service, VTE acuity, and VTE type. Cost influencers included age, race, census region, service location, and VTE type. CONCLUSIONS: IVCF placement costs were driven by baseline patient characteristics (age, race, geographic residence, acute VTE diagnosis, and inpatient site of service), whereas retrieval costs were driven by age and deep vein thrombosis diagnosis. Strategies to mitigate the retrieval costs or the need to retrieve IVCFs may reduce the overall cost burden of IVCFs.

Downstream Revenue Realized by Facilities Placing Inflatable Penile Prosthesis in Medicare Beneficiaries to Treat Erectile Dysfunction.

OBJECTIVE: To quantify the incremental downstream revenue generated from subsequent treatment of men who received an inflatable penile prosthesis (IPP) to treat erectile dysfunction (ED), compared to men without ED. METHODS: The 100% Medicare Standard Analytic Files were used to conduct a retrospective claims analysis of the 5-year revenue generated by patients receiving IPP to treat their ED, compared to a propensity-matched cohort of men without ED. Men aged 65 years or older with ED who underwent IPP implantation (Current Procedural Terminology 54405) in a hospital outpatient setting between January 1, 2016 and December 31, 2021, and who had continuous Medicare Parts A and B enrollment for 12 months pre-index IPP and 5 years post-index IPP discharge date were included in the study. Men without ED but with comparable characteristics were identified and used as a comparator group. Revenue received by hospitals from Medicare was defined as the sum of payments for patient services, other payor-paid amounts, patient deductibles, copayments, and coinsurance. Revenue was inflated to 2022 US dollars. The mean values and their corresponding standard deviations (SD) are reported. RESULTS: After matching, there were 2905 men with ED who received an IPP and 7462 men without ED. The IPP cohort showed a significantly higher 5-year cumulative revenue (mean=$34,571 [SD=$50,234]) compared to the men without ED (mean=$3189 [SD=$11,527]). When stratified by diagnosis type, the differences in revenue were $10,258 for circulatory disease, $2646 for diabetes, $2013 for urology, and $1043 for prostate cancer. Significantly more IPP patients had at least 1 health encounter for these conditions over the 5-year follow-up period than their matched controls (55.0% vs 7.8% for circulatory, 46.7% vs 16.8% for urology, 19.3% vs 3.6% for diabetes, and 19.0% vs 3.0% for prostate cancer). CONCLUSION: Men with ED who received IPP generated substantially higher revenue for the healthcare system over a 5-year period, nearly 10 times as much, compared to men without ED, excluding the initial cost of the IPP procedure. The presence of ED, coupled with IPP usage, is associated with significantly increased healthcare revenue across a range of medical conditions compared to men without ED. These findings emphasize the financial implications for advanced ED programs to improve access to necessary care for these patients. Healthcare facilities may leverage these insights to effectively allocate resources to deliver critical healthcare to men with ED.

Quantifying the number of US men with erectile dysfunction who are potential candidates for penile prosthesis implantation.

Introduction: Penile prosthesis implantation (PPI) is a treatment option recommended in clinical guidelines for erectile dysfunction (ED). However, a limited number of urologists perform PPI procedures in the United States. Aim: To quantify the number of insured men with ED in the United States and project the number of potential candidates for PPI in 2022. Methods: An Excel-based disease impact model was constructed using a top-down estimation approach. The starting US male population consisted of adult men from 2022 US Census data after exclusion of age-specific mortality rates from the National Vital Statistics Reports. Men with health insurance were included in the model based on insurance status data from the US Census database. ED prevalence and ED treatment rates were obtained from administrative claims data analyses-the Merative MarketScan Commercial Database (18-64 years) and the 5% Medicare Standard Analytical Files (≥65 years)-and literature-based estimates of patient-reported ED prevalence. Outcomes: The number of men with ED in the United States and the number of potential candidates for PPI were estimated. Results: By utilizing ED prevalence based on administrative claims, an estimated 8.3% of insured men (10,302,540 estimated men [8,882,548 aged 18-64 years and 1,419,992 aged ≥65 years]) had a diagnosis of ED and sought ED care, out of 124,318,519 eligible US men aged ≥18 years in 2022. An estimated 17.1% of men with an ED diagnosis claim could benefit from PPI in 2022 (1,759,248 men aged ≥18 years). Patient self-reported ED prevalence across all ages ranged from 5.1% to 70.2%. Scenario analyses applying the patient self-reported ED prevalence range revealed the number of men in the United States who could benefit from PPI could have been higher than 1.7 million if their ED symptoms were diagnosed by health care providers. Clinical Implications: Most men with ED in the United States are undertreated, and many could benefit from PPI. Strengths and Limitations: This analysis is a US population-level estimation. However, given this study utilized a variety of assumptions, the results may vary if different model assumptions are applied. Conclusions: This disease impact model estimated that approximately 10.3 million men were diagnosed with ED by their health care providers and sought ED care in the United States in 2022. Of those, 1.7 million men could be PPI candidates and benefit from the treatment option.

A systematic review of discounting in national health economic evaluation guidelines: healthcare value implications.

Aim: This review summarizes the discounting approaches recommended in current economic evaluation (EE) guidelines for healthcare programs and interventions. Materials & methods: A systematic review of EE guidelines for healthcare, published up to July 2022, was conducted. Results: A total of 52 EE guidelines were reviewed. The majority of these guidelines recommend equal discounting (80.8%) rather than differential discounting (9.6%). The rationale for equal discounting includes recommendations by the government, consistency with other countries, and economic development. However, the rationale for differential discounting is based on the interest in short-term government bonds and anticipated budget changes. Discussion: This review demonstrates variation in both discounting approaches and rates across EE guidelines and underscores the need for a global consensus on discounting approaches.

Transarterial therapies in patients with hepatocellular carcinoma eligible for transarterial embolization: a US cost-effectiveness analysis.

OBJECTIVES: To assess the cost-effectiveness of transarterial radioembolization (TARE) versus conventional transarterial chemoembolization (cTACE) and drug-eluting beads chemoembolization (DEE-TACE) for patients with unresectable early- to intermediate-stage hepatocellular carcinoma (HCC). DESIGN: A cohort-based Markov model with a five-year time horizon was developed to evaluate the cost-effectiveness of the three embolization treatments. Upon entering the model, patients with HCC received either TARE or one of the two other embolization treatments. Patients remained in a "watch and wait" state for tumor downstaging that allowed them to move to health states such as liver transplant, resection, systemic therapies, or cure. Clinical input parameters were retrieved from the published literature, and where values could not be sourced, assumptions were made and validated by clinical experts. Health benefits were quantified using quality-adjusted life years (QALYs). Cost input parameters were obtained from various sources, including the Medicare Cost Report, IBM® Micromedex RED BOOK, and published literature. RESULTS: At five years, TARE was found to be cost-saving (saving $15,779 per person compared to cTACE) and produced 0.33 more QALYs per person than cTACE. TARE cost $13,696 more but produced 0.33 more QALYs than DEE-TACE, with an incremental cost-effectiveness ratio of $41,474 per QALY gained at five years. After accounting for parameter uncertainty, the likelihood of TARE being cost-effective was at least 90% against all comparators at a cost-effectiveness threshold of $100,000 per QALY gained. CONCLUSIONS: TARE produces more QALYs than cTACE and DEE-TACE, with a high probability of being cost-effective against both comparators.

The Barcelona Clinic Liver Cancer guideline recommends the use of transarterial radioembolization (TARE), conventional (cTACE), or drug-eluting bead transarterial chemoembolization (DEE-TACE) for treating hepatocellular carcinoma (HCC). This study evaluated the cost-effectiveness of TARE versus two alternative embolization treatments (cTACE and DEE-TACE) in treating patients with unresectable early- to intermediate-stage HCC.A cohort-based Markov model was developed to analyze the costs and benefits of these treatments from a US healthcare perspective within a 5-year time horizon. A 20-year time horizon was assessed as a scenario. In the model, patients were assigned to receive TARE, cTACE, or DEE-TACE and remained in the "watch and wait" stage for tumor downstaging. Data used in the model was taken from previous studies and in consultation with clinical experts. The benefits of the treatments were measured by considering the impact on the patient's quality of life. The costs associated with the treatments were obtained from various sources, including reports, publicly available databases, and published literature.The findings show that TARE is not only cost-saving compared to cTACE but also results in a higher number of quality-adjusted life years (QALYs) per person. While TARE was more expensive than DEE-TACE, it produced more QALYs, further indicating more favorable patient outcomes and overall treatment effectiveness. These findings could potentially impact resource allocation and decision-making for the treatment of HCC.

Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol.

Aim: This review provides a study protocol for a systematic review of peripheral artery disease (PAD) clinical trials to examine the eligibility criteria, demographic representation, and enrollment strategies among PAD patients undergoing lower extremity (LE) endovascular interventions. Methods: This systematic review will be conducted according to the Cochrane Collaboration methodology for systematic reviews and following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). Eligible studies will include randomized controlled trials (RCTs) between January 2012 and December 2022. The primary outcome will be a description and summary of the frequency of the reporting of demographic characteristics. The feasibility of a meta-analysis or meta-regression will be explored, but if determined to be infeasible, the Synthesis Without Meta-analysis (SWiM) reporting guideline will be followed for the reporting of findings. Discussion: The findings may help to quantify existing inequities in clinical trial participation that may be addressed through optimizing enrollment strategies for future PAD trials. Systematic review registration: PROSPERO (CRD42022378304).

Population-Based Disparities in Inferior Vena Cava Filter Procedures Among Medicare Enrollees With Acute Venous Thromboembolism.

PURPOSE: Venous thromboembolism (VTE) imposes a significant clinical and financial burden on patients and society. Inferior vena cava filters (IVCFs) are considered for patients with absolute contraindications or failures of anticoagulation. However, studies examining the population-based disparities of IVCF placement and retrieval are limited. The association between patient and clinical characteristics in the likelihood of and time to IVCF placement and retrievals in a nationally representative cohort was examined. METHODS: Medicare patients aged ≥65 years with index VTE claims between 2015 and 2018 were followed through 2019 to identify IVCF placements and retrievals. Rates were compared using survival analysis methods. RESULTS: Of the 516,978 patients with VTE diagnoses, 5,864 (1.1%) had IVCFs placed, and 1,884 (32.1%) of those underwent retrieval procedures. Placement and retrieval rates varied significantly by demographics, comorbidity burden, and geographic region. From Cox regression, older age (hazard ratio [HR], 1.26; P < .0001), higher baseline comorbidity (Elixhauser) score (HR, 1.07; P < .0001), and outpatient (vs inpatient) site of VTE service (HR, 2.11; P < .0001) were associated with increased frequency of IVCF placement. The rate of retrieval was significantly lower for men (HR, 0.83; P = .0393), patients with higher comorbidity scores (HR, 0.95; P = .0037), and those with outpatient (vs inpatient) VTE sites of service (HR, 0.77; P = .0173). Neither facility- nor county-level characteristics were significantly associated with placements or retrievals. CONCLUSIONS: This large cohort of Medicare beneficiaries with newly diagnosed VTE demonstrated inequities in IVCF placement and retrieval.

Tree-Related Injuries Associated With Response and Recovery From Hurricane Sandy, New Jersey, 2011-2014.

OBJECTIVES: Extreme weather events require extensive tree removal and disposal, tasks associated with severe injury risks among workers and residents. To help understand the risks of such activities, we evaluated the impact of a large and destructive storm (Hurricane Sandy in 2012) on the incidence of tree-related injuries. METHODS: We searched chief-complaint text fields for patients aged 18-65 from 2011-2014 emergency department visit records submitted by New Jersey hospitals through the state-based syndromic surveillance system. Tree-related keywords (eg, saw, branch, wood chip, woodchip, tree) identified possible injuries that we then reviewed to exclude unrelated cases and classify mechanisms of tree-related injury. We used Poisson regression analysis to evaluate changes in the rates of probable tree-related injuries, adjusting for total emergency department visits and seasonal variation. RESULTS: We identified 698 probable tree-related injuries from 2011-2014 among patients aged 18-65, including 104 (14.9%) falls, 241 (34.5%) machine-related injuries, 311 (44.6%) struck-by injuries, and 42 (6.0%) other tree-related injuries. Tree-related injuries increased significantly in the quarter immediately after Hurricane Sandy (November 2012-January 2013) compared with the same quarter the year before (rate ratio [RR] = 1.67; 95% confidence interval [CI], 1.13-2.47) and the year after (RR = 2.47; 95% CI, 1.62-3.78) Hurricane Sandy, especially for struck-by injuries compared with the year before (RR = 2.74; 95% CI, 1.47-5.12) and the year after (RR = 4.17; 95% CI, 2.09-8.32) Hurricane Sandy. More than one-third of the injuries (33.4%) involved chainsaws. CONCLUSIONS: A major hurricane was associated with an increase in tree-related injuries in emergency departments, especially for mechanisms consistent with handling downed and damaged trees. Further research should confirm these findings and evaluate opportunities for preventing tree-related injuries.