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ClinicoEconomics and Outcomes Research... 2024The 21-gene assay (the Oncotype DX Breast Recurrence Score test) estimates the 10-year risk of distant recurrence in hormone receptor positive (HR+) and human epidermal...
BACKGROUND AND OBJECTIVES
The 21-gene assay (the Oncotype DX Breast Recurrence Score test) estimates the 10-year risk of distant recurrence in hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) early-stage breast cancer to inform adjuvant chemotherapy decisions. The cost-effectiveness of the 21-gene assay compared against standard clinical-pathological risk tools alone for HR+/HER2- early-stage breast cancer was assessed using an economic model informed by evidence from randomized controlled trials.
MATERIALS AND METHODS
A cost-effectiveness model consisted of a decision-tree to stratify patients according to their Recurrence Score (RS) results and the use of adjuvant chemotherapy, followed by a Markov component to estimate the long-term costs and outcomes of the chosen treatment. Distributions of patients and distant recurrence probabilities were derived from the TAILORx (N0) and RxPONDER (N1) trials. The model was evaluated from a healthcare payer and societal perspective. Endocrine therapy and chemotherapy use were informed using clinical expert opinion to reflect US clinical practice and were combined with Medicare drug costs (2021) to estimate the cost of treatment. Societal costs included lost productivity and patient out-of-pocket costs obtained from literature.
RESULTS
The Oncotype DX test generated more quality-adjusted life-years (QALYs) (N0: 0.25; N1: 0.08) at a lower cost (N0: -$13,395; N1: -$2526) compared to clinical-pathological risk alone from a societal cost perspective. The overall conclusions from the model did not change when considering a payer perspective. The main cost drivers were avoidance of distant recurrence for N0 (-$12,578), and the cost of adjuvant chemotherapy for N1 (-$2133). Lost productivity had a major impact in the societal perspective analysis (N0: -$4607; N1: -$1586).
CONCLUSION
Adjuvant chemotherapy decisions based on the RS result led to more life year gains and lower healthcare costs (dominant) compared to using clinical-pathological risk factors alone among patients with HR+/HER2- N0 and N1 early-stage breast cancer.
PubMed: 38855430
DOI: 10.2147/CEOR.S449711 -
Journal of Pain Research 2024Evidence regarding the frequency and timing of treatment for lumbar spinal stenosis (LSS) fails to offer clear consensus. We describe the LSS care journey from initial...
BACKGROUND
Evidence regarding the frequency and timing of treatment for lumbar spinal stenosis (LSS) fails to offer clear consensus. We describe the LSS care journey from initial diagnosis to first surgical intervention.
METHODS
Using Medicare claims database from 2009 through 2020, we identified patients who were diagnosed with LSS. The use and timing of conservative and surgical treatments during the entire follow-up from the initial diagnosis were reported.
RESULTS
Of the 143,849 patients identified, 68% received conservative care within 8.4 months and 25.3% received a surgical or minimally invasive intervention over 5.7 years following initial diagnosis, with 12.6% undergoing open decompression alone, 10.2% undergoing open decompression with fusion, and 5.1% undergoing fusion surgery alone. Fewer than 1% were provided with interspinous spacers or a percutaneous image-guided lumbar decompression.
CONCLUSION
Approximately three-quarters of patients in the study received no surgical or non-invasive interventions for approximately six years following diagnosis with LSS.
PubMed: 38854929
DOI: 10.2147/JPR.S454887 -
MedRxiv : the Preprint Server For... May 2024Despite the availability of disease-modifying therapies, scalable strategies for heart failure (HF) risk stratification remain elusive. Portable devices capable of...
IMPORTANCE
Despite the availability of disease-modifying therapies, scalable strategies for heart failure (HF) risk stratification remain elusive. Portable devices capable of recording single-lead electrocardiograms (ECGs) can enable large-scale community-based risk assessment.
OBJECTIVE
To evaluate an artificial intelligence (AI) algorithm to predict HF risk from noisy single-lead ECGs.
DESIGN
Multicohort study.
SETTING
Retrospective cohort of individuals with outpatient ECGs in the integrated Yale New Haven Health System (YNHHS) and prospective population-based cohorts of UK Biobank (UKB) and Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).
PARTICIPANTS
Individuals without HF at baseline.
EXPOSURES
AI-ECG-defined risk of left ventricular systolic dysfunction (LVSD).
MAIN OUTCOMES AND MEASURES
Among individuals with ECGs, we isolated lead I ECGs and deployed a noise-adapted AI-ECG model trained to identify LVSD. We evaluated the association of the model probability with new-onset HF, defined as the first HF hospitalization. We compared the discrimination of AI-ECG against the pooled cohort equations to prevent HF (PCP-HF) score for new-onset HF using Harrel's C-statistic, integrated discrimination improvement (IDI), and net reclassification improvement (NRI).
RESULTS
There were 194,340 YNHHS patients (age 56 years [IQR, 41-69], 112,082 women [58%]), 42,741 UKB participants (65 years [59-71], 21,795 women [52%]), and 13,454 ELSA-Brasil participants (56 years [41-69], 7,348 women [55%]) with baseline ECGs. A total of 3,929 developed HF in YNHHS over 4.5 years (2.6-6.6), 46 in UKB over 3.1 years (2.1-4.5), and 31 in ELSA-Brasil over 4.2 years (3.7-4.5). A positive AI-ECG screen was associated with a 3- to 7-fold higher risk for HF, and each 0.1 increment in the model probability portended a 27-65% higher hazard across cohorts, independent of age, sex, comorbidities, and competing risk of death. AI-ECG's discrimination for new-onset HF was 0.725 in YNHHS, 0.792 in UKB, and 0.833 in ELSA-Brasil. Across cohorts, incorporating AI-ECG predictions in addition to PCP-HF resulted in improved Harrel's C-statistic (Δ=0.112-0.114), with an IDI of 0.078-0.238 and an NRI of 20.1%-48.8% for AI-ECG vs. PCP-HF.
CONCLUSIONS AND RELEVANCE
Across multinational cohorts, a noise-adapted AI model with lead I ECGs as the sole input defined HF risk, representing a scalable portable and wearable device-based HF risk-stratification strategy.
PubMed: 38854022
DOI: 10.1101/2024.05.27.24307952 -
BMC Primary Care Jun 2024As the U.S. population ages, family members increasingly act as informal caregivers, particularly for minority patients and those with limited English proficiency (LEP)....
BACKGROUND
As the U.S. population ages, family members increasingly act as informal caregivers, particularly for minority patients and those with limited English proficiency (LEP). However, physicians often do not identify or engage caregivers until there is a health crisis. This study aims to further our understanding of characteristics associated with having a caregiver present at a primary care visit, and better understand the specific roles family caregivers engage in to support older Chinese and Latino primary care patients.
METHODS
Primary care patients were surveyed by telephone in a study of language access and communication. Participants included Chinese and Latino primary care patients (≥ 65 years old) from an academic general medicine practice. We asked patients if anyone was in the room with them during their most recent primary care visit (yes = caregiver accompanied). We asked about caregiving support for various needs, and examined associations of patient and visit characteristics with being accompanied, and frequency of caregiver support roles overall and by caregiver accompaniment.
RESULTS
Among 906 participants, 80% preferred a non-English language, 64% were women, 88% had Medicare, and mean age was 76 years (range 65-97). 43% were accompanied to their most recent visit. Speaking English 'not at all' vs. 'very well' was associated with being caregiver accompanied (OR 3.5; 95% CI 1.3-9.7), as was older age ≥ 75 vs. 65-74 (OR 2.7; 95% CI 2.0-3.7). The most common roles being supported by caregivers included: transportation to medical appointments (63%), helping with medical decisions (60%), and talking with the doctor about the patient's medical care (54%). Even among unaccompanied patients, substantial proportions reported caregiver support with medical decisions (45%), talking with the doctor (33%), and medical needs at home (26%).
CONCLUSIONS
Opportunities for physicians to engage caregivers who have active support roles may be missed, especially if those caregivers are not present at the visit. Future interventions should aim to help physicians identify which patients have caregivers and for what needs, so they may effectively engage caregivers before a health crisis occurs.
Topics: Aged; Aged, 80 and over; Female; Humans; Male; Age Factors; Asian; Caregivers; Communication Barriers; Health Services Needs and Demand; Hispanic or Latino; Limited English Proficiency; Physician-Patient Relations; Primary Health Care; United States
PubMed: 38851670
DOI: 10.1186/s12875-024-02411-7 -
Journal of Comparative Effectiveness... Jun 2024Real-world healthcare resource use (HCRU) burden among patients with Parkinson's disease psychosis (PDP) treated with pimavanserin (PIM) versus other atypical...
Healthcare resource utilization among nursing home residents with Parkinson's disease psychosis: an analysis of Medicare beneficiaries treated with pimavanserin or other-atypical antipsychotics.
Real-world healthcare resource use (HCRU) burden among patients with Parkinson's disease psychosis (PDP) treated with pimavanserin (PIM) versus other atypical antipsychotics (other-AAPs) including quetiapine (QUE) in long term care (LTC) and nursing home (NH) settings are lacking. This analysis examines HCRU differences among residents in LTC/NH settings who initiate PIM versus QUE or other-AAPs. A retrospective analysis of LTC/NH residents with PDP from the 100% Medicare claims between 1 April 2015 and 31 December 2021 was conducted. Treatment-naive residents who initiated ≥6 months continuous monotherapy with PIM or QUE or other-AAPs between 04/01/16 and 06/30/2021 were propensity score matched (PSM) 1:1 using 31 variables (age, sex, race, region and 27 Elixhauser comorbidity characteristics). Post-index (i.e., 6 months) HCRU outcomes included: proportion of residents with ≥1 all-cause inpatient (IP) hospitalizations and emergency room (ER) visits. HCRU differences were assessed via log binomial regression and reported as relative risk ratios (RR) and 95% confidence intervals after controlling for dementia, insomnia and index year. From a total of PIM (n = 1827), QUE (n = 7770) or other-AAPs (n = 9557), 1:1 matched sample (n = 1827) in each cohort were selected. All-cause IP hospitalizations (PIM [29.8%]) versus QUE [36.7%]) and ER visits (PIM [47.3%] versus QUE [55.8%]), respectively, were significantly lower for PIM. PIM versus QUE cohort also had significantly lower RR for all-cause IP hospitalizations and ER visits, respectively, (IP hospitalizations RR: 0.82 [0.75. 0.9]; ER visits RR: 0.85 [0.8. 0.9]). PIM versus other-AAPs also had lower likelihood of HCRU outcomes. In this analysis, LTC/NH residents on PIM monotherapy (versus QUE) had a lower likelihood of all-cause hospitalizations (18%) and ER (15%) visits. In this setting, PIM also had lower likelihood of all-cause HCRU versus other-AAPs.
PubMed: 38850129
DOI: 10.57264/cer-2024-0038 -
Translational Psychiatry Jun 2024Treatment-resistant depression (TRD) affects approximately 2.8 million people in the U.S. with estimated annual healthcare costs of $43.8 billion. Deep brain stimulation...
Treatment-resistant depression (TRD) affects approximately 2.8 million people in the U.S. with estimated annual healthcare costs of $43.8 billion. Deep brain stimulation (DBS) is currently an investigational intervention for TRD. We used a decision-analytic model to compare cost-effectiveness of DBS to treatment-as-usual (TAU) for TRD. Because this therapy is not FDA approved or in common use, our goal was to establish an effectiveness threshold that trials would need to demonstrate for this therapy to be cost-effective. Remission and complication rates were determined from review of relevant studies. We used published utility scores to reflect quality of life after treatment. Medicare reimbursement rates and health economics data were used to approximate costs. We performed Monte Carlo (MC) simulations and probabilistic sensitivity analyses to estimate incremental cost-effectiveness ratios (ICER; USD/quality-adjusted life year [QALY]) at a 5-year time horizon. Cost-effectiveness was defined using willingness-to-pay (WTP) thresholds of $100,000/QALY and $50,000/QALY for moderate and definitive cost-effectiveness, respectively. We included 274 patients across 16 studies from 2009-2021 who underwent DBS for TRD and had ≥12 months follow-up in our model inputs. From a healthcare sector perspective, DBS using non-rechargeable devices (DBS-pc) would require 55% and 85% remission, while DBS using rechargeable devices (DBS-rc) would require 11% and 19% remission for moderate and definitive cost-effectiveness, respectively. From a societal perspective, DBS-pc would require 35% and 46% remission, while DBS-rc would require 8% and 10% remission for moderate and definitive cost-effectiveness, respectively. DBS-pc will unlikely be cost-effective at any time horizon without transformative improvements in battery longevity. If remission rates ≥8-19% are achieved, DBS-rc will likely be more cost-effective than TAU for TRD, with further increasing cost-effectiveness beyond 5 years.
Topics: Humans; Deep Brain Stimulation; Cost-Benefit Analysis; Depressive Disorder, Treatment-Resistant; Quality-Adjusted Life Years; Male; Female; United States; Middle Aged; Quality of Life; Health Care Costs; Monte Carlo Method
PubMed: 38849334
DOI: 10.1038/s41398-024-02951-7 -
Medical Care Jul 2024Hospitals are resurrecting the outdated "team nursing" model of staffing that substitutes lower-wage staff for registered nurses (RNs).
BACKGROUND
Hospitals are resurrecting the outdated "team nursing" model of staffing that substitutes lower-wage staff for registered nurses (RNs).
OBJECTIVES
To evaluate whether reducing the proportion of RNs to total nursing staff in hospitals is in the best interest of patients, hospitals, and payers.
RESEARCH DESIGN
Cross-sectional, retrospective.
SUBJECTS
In all, 6,559,704 Medicare patients in 2676 general acute-care US hospitals in 2019.
MEASURES
Patient outcomes: in-hospital and 30-day mortality, 30-day readmission, length of stay, and patient satisfaction. Avoidable Medicare costs associated with readmissions and cost savings to hospitals associated with shorter stays are projected.
RESULTS
A 10 percentage-point reduction in RNs was associated with 7% higher odds of in-hospital death, 1% higher odds of readmission, 2% increase in expected days, and lower patient satisfaction. We estimate a 10 percentage-point reduction in RNs would result in 10,947 avoidable deaths annually and 5207 avoidable readmissions, which translates into roughly $68.5 million in additional Medicare costs. Hospitals would forgo nearly $3 billion in cost savings annually because of patients requiring longer stays.
CONCLUSIONS
Reducing the proportion of RNs in hospitals, even when total nursing personnel hours are kept the same, is likely to result in significant avoidable patient deaths, readmissions, longer lengths of stay, and decreased patient satisfaction, in addition to excess Medicare costs and forgone cost savings to hospitals. Estimates represent only a 10 percentage-point dilution in skill mix; however, the team nursing model includes much larger reductions of 40-50 percentage-points-the human and economic consequences of which could be substantial.
Topics: Humans; Nursing Staff, Hospital; Cross-Sectional Studies; Retrospective Studies; Personnel Staffing and Scheduling; United States; Medicare; Patient Readmission; Length of Stay; Male; Female; Patient Satisfaction; Hospital Mortality; Aged
PubMed: 38848137
DOI: 10.1097/MLR.0000000000001990 -
JAMA Health Forum Jun 2024Dual Eligible Special Needs Plans (D-SNPs) are private managed care plans designed to promote Medicare and Medicaid integration for full-benefit, dually eligible...
IMPORTANCE
Dual Eligible Special Needs Plans (D-SNPs) are private managed care plans designed to promote Medicare and Medicaid integration for full-benefit, dually eligible beneficiaries. Currently, the highest level of D-SNP integration occurs in plans with exclusively aligned enrollment (EAE).
OBJECTIVE
To compare patient experience of care, out-of-pocket spending, and satisfaction among dually enrolled Medicaid beneficiaries in D-SNPs with EAE, those in D-SNPs without EAE, and those with traditional Medicare.
DESIGN, SETTING, AND PARTICIPANTS
This cross-sectional study included respondents to a mail survey fielded to a stratified random sample of full-benefit, community-dwelling, dual-eligible Medicaid beneficiaries who qualified for receipt of home and community-based services in the Virginia Medicaid Commonwealth Coordinated Care Plus program between March and October 2022.
EXPOSURE
Enrollment in a D-SNP with EAE or a D-SNP without EAE vs traditional Medicare.
MAIN OUTCOMES AND MEASURES
The main outcomes were self-reported measures of access and delays in receiving plan approvals, out-of-pocket spending, and satisfaction with health plans' customer service and choice of primary care and specialist physicians.
RESULTS
Of 7200 surveys sent, 2226 were completed (response rate, 30.9%). The analytic sample consisted of 1913 Medicaid beneficiaries with nonmissing data on covariates (mean [SD] age, 70.8 [15.6] years; 1367 [71.5%] female). Of these, 583 (30.5%) were enrolled in D-SNPs with EAE, 757 (39.6%) in D-SNPs without EAE, and 573 (30.0%) in traditional Medicare. Compared with respondents enrolled in D-SNPs without EAE, those in D-SNPs with the highest level of integration (EAE) were 6.77 percentage points (95% CI, 8.81-12.66 percentage points) more likely to report being treated with courtesy and respect and 5.83 percentage points (95% CI, 0.21-11.46 percentage points) more likely to know who to call when they had a health problem. No statistically significant differences were found between members in either type of D-SNP and between those in D-SNPs and traditional Medicare in terms of their difficulty accessing care, delays in care, and satisfaction with care coordination and physician choice.
CONCLUSIONS AND RELEVANCE
This cross-sectional study found some benefits of integrating administrative processes under Medicare and Medicaid but suggests that care coordination and access improvements under full integration require additional time and/or efforts to achieve.
Topics: Humans; United States; Cross-Sectional Studies; Female; Male; Medicare; Medicaid; Aged; Middle Aged; Patient Satisfaction; Virginia; Eligibility Determination; Managed Care Programs; Surveys and Questionnaires; Health Expenditures; Adult; Health Services Accessibility
PubMed: 38848088
DOI: 10.1001/jamahealthforum.2024.1383 -
JAMA Health Forum Jun 2024
Topics: Humans; United States; Prior Authorization; Health Information Interoperability; Health Care Reform; Electronic Health Records
PubMed: 38848086
DOI: 10.1001/jamahealthforum.2024.1193 -
Frontiers in Pharmacology 2024To investigate the risk of atrial fibrillation (AF) with sodium-glucose cotransporter-2 inhibitors (SGLT2is) compared to dipeptidyl peptidase-4 inhibitor (DPP4i) use in...
OBJECTIVES
To investigate the risk of atrial fibrillation (AF) with sodium-glucose cotransporter-2 inhibitors (SGLT2is) compared to dipeptidyl peptidase-4 inhibitor (DPP4i) use in older US adults and across diverse subgroups.
METHODS
We conducted a retrospective cohort analysis using claims data from 15% random samples of Medicare fee-for-service beneficiaries. Patients were adults with type 2 diabetes (T2D), no preexisting AF, and were newly initiated on SGLT2i or DPP4i. The outcome was the first incident AF. Inverse probability treatment weighting (IPTW) was used to balance the baseline covariates between the treatment groups including sociodemographics, comorbidities, and co-medications. Cox regression models were used to assess the effect of SGLT2i compared to DPP4i on incident AF.
RESULTS
Of the 97,436 eligible individuals (mean age 71.2 ± 9.8 years, 54.6% women), 1.01% (n = 983) had incident AF over a median follow-up of 361 days. The adjusted incidence rate was 8.39 (95% CI: 6.67-9.99) and 11.70 (95% CI: 10.9-12.55) per 1,000 person-years in the SGLT2i and DPP4i groups, respectively. SGLT2is were associated with a significantly lower risk of incident AF (HR 0.73; 95% CI, 0.57 to 0.91; = 0.01) than DPP4is. The risk reduction of incident AF was significant in non-Hispanic White individuals and subgroups with existing atherosclerotic cardiovascular diseases and chronic kidney disease.
CONCLUSION
Compared to the use of DPP4i, that of SGLT2i was associated with a lower risk of AF in patients with T2D. Our findings contribute to the real-world evidence regarding the effectiveness of SGLT2i in preventing AF and support a tailored therapeutic approach to optimize treatment selection based on individual characteristics.
PubMed: 38846094
DOI: 10.3389/fphar.2024.1379251