Search

Two blood-based brain biomarker tests such as the combination of glial fibrillary acidic protein and ubiquitin C-terminal hydrolase-L1 (GFAP+UCH-L1) or S100B have potential to reduce the need for head computed tomography (CT) scanning in patients with mild traumatic brain injury (mTBI). We assessed the clinical and economic impact of using GFAP+UCH-L1 versus CT scan and GFAP+UCH-L1 versus S100B to screen adults with suspected mTBI presenting to an emergency department (ED). A decision model was developed to estimate costs and health outcomes of GFAP+UCH-L1, CT scan, and S100B associated with these screening protocols. Model parameters were extracted from peer-reviewed articles, clinical guidelines, and expert opinion. Analysis was performed from a French health care system perspective (costs in 2020 euros). In the model, patients with a positive biomarker receive a CT scan to confirm the presence of intracranial lesions (ICLs). Depending on clinical state and biomarker and CT results, patients were discharged immediately, kept for observation in the ED, admitted for in-hospital stay and observation, or admitted for surgical management. Incorrect test results may lead to delayed treatment and poor outcomes or overtreatment. GFAP+UCH-L1 use was associated with an overall decrease in CT scans when compared with CT screening or S100B use (325.42 and 46.43 CTs per 1000 patients, respectively). The use of GFAP+UCH-L1 resulted in modest cost savings when compared with CT scanning and with S100B. In all cases, use of GFAP+UCH-L1 marginally improved quality-adjusted life-years (QALYs) and outcomes. Thus, screening with GFAP+UCH-L1 reduced the need for CT scans when compared with systematic CT scan screening or use of S100B while maintaining similar costs and health outcomes.

PREVENT-19, the pivotal phase 3 trial of the Novavax adjuvanted, recombinant spike protein COVID-19 vaccine (NVX-CoV2373) demonstrated that the vaccine was safe and efficacious (vaccine efficacy, VE= 90%) for the prevention of symptomatic COVID-19. In the trial, participants were randomly assigned in a 2:1 ratio to receive 2 doses of NVX-CoV2373 or placebo 21 days apart. Throughout the study, SARS-CoV-2 circulating variant was predominantly alpha, but other variants circulated (i.e., beta, gamma, epsilon, and iota). VE among the per-protocol efficacy analysis population was calculated according to pre-specified disease severity (mild, moderate, or severe) criteria, but the impact on the risk of COVID-19– associated hospitalization was not specifically investigated. During the placebo-controlled portion of the trial (January 25, 2021, to April 30, 2021), 4 hospitalizations occurred among the 77 events analyzed for the primary endpoint using the per-protocol population, 0 among vaccine recipients and 4 among placebo recipients, yielding a VE against hospitalization of 100% (95% CI: 28.8, 100). Among an expanded efficacy population, which included COVID-19–associated hospitalizations without a requirement for diagnostic polymerase chain reaction testing performed at the study central laboratory, 12 total hospitalizations were identified, 0 among vaccine recipients and 12 among placebo recipients, yielding apost hocVE against hospitalization of 100% (95% CI: 83.1, 100). These additional data from the PREVENT-19 trial provide relevant public health information concerning the attributes of NVX-CoV2373.

Background Large volume delayed sampling (LVDS) and pathogen reduction technology (PRT) are strategies for platelet processing to minimize transfusion of contaminated platelet components (PCs). This study holistically compares the economic and clinical impact of LVDS and PRT in the United States. Study design and methods A decision model was constructed to simulate collection, processing, and use of PCs and to compare processing strategies: PRT with 5-day shelf life, LVDS with 7-day shelf life (LVDS7), and LVDS with 5-day shelf life extended to 7 days with secondary testing (LVDS5/2). Target population was adults requiring two or more transfusions. Collection, processing, storage, and distribution data were obtained from the National Blood Collection and Utilization Survey and published literature. Patient outcomes associated with transfusions were obtained from AABB guidelines, meta-analyses, and other published clinical studies. Costs were obtained from reimbursement schedules and other published sources. Results Given 10,000 donated units, 9512, 9511, and 9651 units of PRT, LVDS5/2, and LVDS7 PCs were available for transfusion, respectively. With these units, 1502, 2172, and 2329 transfusions can be performed with similar levels of adverse events. Assuming 30 transfusions a day, a hospital would require 69,325, 47,940, and 45,383 units of PRT, LVDS5/2, and LVDS7 platelets to perform these transfusions. The mean costs to perform transfusions were significantly higher with PRT units. Conclusions Compared with PRT, LVDS strategies were associated with lower costs and higher PC availability while patients experienced similar levels of adverse events. Increased utilization of LVDS has the potential to improve efficiency, expand patient access to platelets, and reduce health care costs.

Previous cost-effectiveness models found ambulatory blood pressure monitoring (ABPM) to be a favorable strategy to diagnose hypertension; however, they mostly focused on older adults with a positive clinic blood pressure (BP) screen. We evaluated the cost-effectiveness of 3 methods of BP measurement for hypertension diagnosis in primary care settings among 14 age- and sex-stratified hypothetical cohorts (adults ≥21 years of age), accounting for the possibility of both false-positive (white-coat hypertension) and false-negative (masked hypertension) clinic measurements. We compared quality-adjusted life-years and lifetime costs ($US 2017 from the US healthcare perspective) associated with clinic BP measurement, home BP monitoring, and ABPM under 2 scenarios: positive and negative initial screen. Model parameters were obtained from published literature, publicly available data sources, and expert input. In the screen-positive scenario, ABPM was the dominant strategy among all age and sex groups. Compared with clinic BP measurement, ABPM was associated with cost-savings ranging from $77 (women 80 years of age) to $5013 (women 21 years of age). In the screen-negative scenario, ABPM was the dominant strategy in all men and women

Purpose: To evaluate the budget impact of adding a diagnostic test of tissue inhibitor of metalloproteinase 2 and insulin-like growth factor binding protein 7 ([TIMP-2]·[IGFBP7]), which identifies patients at risk of moderate-to-severe acute kidney injury (AKI), to the current standard of care (SOC) in a hospital setting. Materials and methods: A budget impact model (2017 USD) was developed from the perspective of a hypothetical US hospital system serving 10,000 inpatients annually. The model estimated the impact of assessing the risk of AKI using SOC vs a combination of SOC and the US Food and Drug Administration-approved assay [TIMP-2]·[IGFBP7] over a 1-year period. Potential cost implications were assessed using estimates for payer mix among patients, diagnostic efficacy, and patient healthcare resource utilization. The model also considered provider adoption rates and the estimated costs of [TIMP-2]·[IGFBP7]. Results: Compared to SOC alone, adding [TIMP-2]·[IGFBP7] to SOC was associated with a $1,855 reduction in uncompensated care per patient tested, which, after accounting for the additional costs of the test ($277), resulted in net savings of $1,578 per patient tested. The findings were robust to input parameter variations, as demonstrated by deterministic and probabilistic sensitivity analyses. In the probabilistic sensitivity analyses, net cost savings to the hospital ranged from $50,308–$3,971,514, or $101–$7,943 per tested patient (mean = $1,710; 95% confidence interval = $1,691–$1,729). Conclusions: The introduction of [TIMP-2]·[IGFBP7] as a novel tool in the identification of AKI risk may result in considerable cost savings from a hospital perspective under this model’s base-case assumptions. Further prospective studies are needed to confirm these findings in a real-world setting.Key points for decision makersAn economic model was constructed to determine the budget impact of adding a diagnostic test ([TIMP-2]·[IGFBP7]), which identifies patients at risk of moderate-to-severe acute kidney injury, to the current standard of care (SOC) in a hospital setting.According to the present model, the use of [TIMP-2]·[IGFBP7] to identify acute kidney injury risk may reduce costs for hospitals by ∼$1,578 per patient tested. An economic model was constructed to determine the budget impact of adding a diagnostic test ([TIMP-2]·[IGFBP7]), which identifies patients at risk of moderate-to-severe acute kidney injury, to the current standard of care (SOC) in a hospital setting. According to the present model, the use of [TIMP-2]·[IGFBP7] to identify acute kidney injury risk may reduce costs for hospitals by ∼$1,578 per patient tested.

Objective: To characterize mild traumatic brain injury (mTBI) patients in the USA, describing location of diagnosis, timing, and modality of imaging procedures, health-care resource utilization (HRU) and costs in the 12-month period post-diagnosis. Research Design: Retrospective claims analysis Methods: Anonymized data from the OptumHealth Care Solutions claims database (2006-2016). The index date was the first date with an mTBI diagnosis. HRU and costs (2016 USD) were assessed in the 12-month post-index period. Results: A total of 80,004 patients with mTBI were included: 60% were under 26 years and 54% were male. Mild TBI was most frequently diagnosed in an emergency department (ED) for all age groups, except patients aged 11-17 years, for whom the outpatient setting was the most frequent place of diagnosis. Almost half (47%) received brain imaging on the index date, with 98% of which receiving computed tomography. Mean follow-up health-care costs were $13,564 (SD = $41,071), primarily from inpatient ($4,675, SD = $29,982) and non-ED outpatient/physician office visits ($4,207, SD = $12,697). Older patients had greater HRU and higher health-care costs. Conclusions: The findings of this claims-based study show substantial HRU and costs associated with mTBI diagnosis during a 12-month follow-up period.

Previous cost-effectiveness models found ambulatory blood pressure monitoring (ABPM) to be a favorable strategy to diagnose hypertension; however, they mostly focused on older adults with a positive clinic blood pressure (BP) screen. We evaluated the cost-effectiveness of 3 methods of BP measurement for hypertension diagnosis in primary care settings among 14 age- and sex-stratified hypothetical cohorts (adults ≥21 years of age), accounting for the possibility of both false-positive (white-coat hypertension) and false-negative (masked hypertension) clinic measurements. We compared quality-adjusted life-years and lifetime costs ($US 2017 from the US healthcare perspective) associated with clinic BP measurement, home BP monitoring, and ABPM under 2 scenarios: positive and negative initial screen. Model parameters were obtained from published literature, publicly available data sources, and expert input. In the screen-positive scenario, ABPM was the dominant strategy among all age and sex groups. Compared with clinic BP measurement, ABPM was associated with cost-savings ranging from $77 (women 80 years of age) to $5013 (women 21 years of age). In the screen-negative scenario, ABPM was the dominant strategy in all men and women80 years of age with cost-savings ranging from $128 (women 70 years of age) to $2794 (women 21 years of age). Sensitivity analyses showed that results were sensitive to test specificity and antihypertensive medication costs. ABPM is recommended as the diagnostic strategy of choice for most adults in primary care settings regardless of initial screening results.

The aging population routinely has comorbid conditions requiring complicated medication regimens, yet nonadherence can preclude optimal outcomes. This study explored the association of adherence in the elderly with demographic, socioeconomic, and disease burden measures. Data were from the fifth visit (2011-2013) for 6,538 participants in the Atherosclerosis Risk in Communities Study, conducted in four communities. The Morisky–Green–Levine Scale measured self-reported adherence. Forty percent of respondents indicated some nonadherence, primarily due to poor memory. Logit regression showed, surprisingly, that persons with low reading ability were more likely to report being adherent. Better self-reported physical or mental health both predicted better adherence, but the magnitude of the association was greater for mental than for physical health. Compared with persons with normal or severely impaired cognition, mild cognitive impairment was associated with lower adherence. Attention to mental health measures in clinical settings could provide opportunities for improving medication adherence.

Background: Sexually transmitted infections (STIs) are among the most common causes of illness in the world and have far-reaching health, economic and social consequences for many countries. Failure to diagnose and treat STIs at an early stage may result in serious complications and sequels. Objective: This study aimed to determine the prevalence of Chlamydia trachomatis infection in patients who remain symptomatic after completion of their first episode of treatment for STI. Materials and Methods: We conducted a cross-sectional study on 49 patients suffering from symptoms or signs of sexually transmitted infections despite their first complete anti STI treatment. Conducting physical exam and smear preparation from vaginal discharge, diagnosis was confirmed by Polymerase chain reaction (PCR) method on every patient’s first-voided urine sample. Results: Among the etiologic factors investigated in this study, Chlamydia was reported in 17 patients. Trichomoniasis, Candidiasis, Gonorrhea and nonspecific germs were next organisms with 11, 9, 6 and 6 patients, respectively. Sixteen specimens were PCR positive (32.65%), while 33 patients had negative PCR results (67.34%) for Chlamydia trachomatis. Conclusion: Gonorrheal infection was the most prevalent infection in patients with completed treatment (6/10), which must be remembered in patients follow ups, because this prevalence warrants empirical therapy for Gonorrheain similar clinical conditions. Chlamydia trachomatis was the responsible organism in approximately a quarter of patients (17/75) who despite their full compliance on anti-Chlamydial treatment still suffered from signs and symptoms of STI. This rate also recommends empirical therapy for Chlamydia trachomatis in the similar clinical signs and symptoms.

Objectives To evaluate the reliability and factorial validity of the four-item Morisky Green Levine Medication Adherence Scale (MGLS) among Atherosclerosis Risk in Communities (ARIC) Study participants. Methods We used the cross-sectional visit 5 data from the ARIC Study to assess the measurement properties of the MGLS. We measured the internal consistency using Cronbach α (where α > 0.70 is considered reliable for group-level measurement), the response frequency, and the inter item correlation. Factor analysis of the MGLS and five other adherence items in the survey was conducted using a polychoric correlation matrix to examine the dimensionality that underlies the MGLS. A vanishing tetrad test was conducted to assess conformity with an effect indicator model. Results Among the ARIC visit 5 participants, 6,261 (96%) responded to the MGLS and other questions related to medication adherence in the survey (mean age 76 ± 5 years, 59% women). The Cronbach α for the MGLS was 0.47. The inter-item correlations ranged from 0.11 to 0.26. In the factor analysis of the medication adherence survey questions, a three-factor solution was used. One factor captured the extent of nonadherence, whereas other factors focused on the reasons for nonadherence. The MGLS items spread out across the factors that reflect the extent of as well as the reasons for nonadherence. The results of the vanishing tetrad test indicated that the MGLS consists of items other than effect indicators (P Conclusions The low reliability together with the factor analysis findings imply that the MGLS may reflect causes as well as the extent of medication adherence. The findings suggest that the MGLS, as presently used, lacks consistency in an elderly population.

Rationale, aims, and objectives Despite proven benefits for reducing incidence of major cardiac events, antihypertensive drug therapy remains underutilized in the United States. This analysis assesses antihypertensive drug adherence, utilization predictors, and associations between adherence and outcomes (a composite of cardiovascular events, Medicare inpatient payments, and inpatient days). Methods The sample consisted of Atherosclerosis Risk in Communities Study cohort participants reporting hypertension without prevalent cardiovascular disease during 2006 to 2007 annual follow-up calls. Atherosclerosis Risk in Communities records were linked to Medicare claims through 2012. Antihypertensive medication adherence was measured as more than 80% proportion days covered by using Medicare Part D claims. Standard and hierarchical regression models were used to evaluate adjusted associations between person characteristics and adherence and between adherence and outcomes. Results Among 1826 hypertensive participants with Part D coverage, 31.5% had no antihypertensive class with more than 80% proportion days covered in the 3 months preceding the report of hypertension in 2006 to 2007. After adjustment for confounders, positive predictors of use included female gender and diabetes; negative predictors were African-American race and current smoking. Adjusted association between receiving no therapy and a composite endpoint of cardiovascular outcomes through 2012 was not statistically significant (hazard ratio: 0.93; 95% confidence interval: 0.72, 1.22) nor was the adjusted association with Medicare inpatient days or payments (incremental difference at 48 months in payments: $1217; 95% CI: −$2030, $4463). Conclusions Despite having medical and prescription coverage, nearly a third of hypertensive participants were not adherent to antihypertensive drug therapy. Differences in clinical outcomes associated with nonadherence, though not statistically significant, were consistent with results from randomized trials. The approach provides a model framework for rigorous assessment of detailed data that are increasingly available through emerging sources.

Reperfusion times for ST-elevation myocardial infarction (STEMI) occurring in outpatients have improved significantly, but quality improvement efforts have largely ignored STEMI occurring in hospitalized patients (inpatient-onset STEMI).To define the incidence and variables associated with treatment and outcomes of patients who develop STEMI during hospitalization for conditions other than acute coronary syndromes (ACS).Retrospective observational analysis of STEMIs occurring between 2008 and 2011 as identified in the California State Inpatient Database.STEMIs were classified as inpatient onset or outpatient onset based on present-on-admission codes. Patients who had a STEMI after being hospitalized for ACS were excluded from the analysis.Regression models were used to evaluate associations among location of onset of STEMI, resource utilization, and outcomes. Adjustments were made for patient age, sex, comorbidities, and hospital characteristics. The analysis allowed for the location of inpatient STEMI to have a multiplicative rather than an additive effect for resource utilization since these measures were highly skewed.A total of 62,021 STEMIs were identified in 303 hospitals, of which 3068 (4.9%) occurred in patients hospitalized for non-ACS indications. Patients with inpatient-onset STEMI were older (mean, 71.5 [SD, 13.5] years vs 64.9 [SD, 14.1] years; P .001) and more frequently female (47.4% vs 32%; P .001) than those with outpatient-onset STEMI. Patients with inpatient-onset STEMI had higher in-hospital mortality (33.6% vs 9.2%; adjusted odds ratio (AOR), 3.05; 95% CI, 2.76-3.38; P .001), were less likely to be discharged home (33.7% vs 69.4%; AOR, 0.38; 95% CI, 0.34-0.42; P .001), and were less likely to undergo cardiac catheterization (33.8% vs 77.8%; AOR, 0.19; 95% CI, 0.16-0.21; P .001) or percutaneous coronary intervention (21.6% vs 65%; AOR, 0.23; 95% CI, 0.21-0.26; P .001). Length of stay and inpatient charges were higher for inpatient-onset STEMI (mean length of stay, 13.4 days [95% CI, 12.8-14.0 days] vs 4.7 days [95% CI, 4.6-4.8 days]; adjusted multiplicative effect, 2.51; 95% CI, 2.35-2.69; P .001; mean inpatient charges, $245,000 [95% CI, $235,300-$254,800] vs $129,000 [95% CI, $127,900-$130,100]; adjusted multiplicative effect, 2.09; 95% CI, 1.93-2.28; P .001).Patients who had a STEMI while hospitalized for a non-ACS condition, compared with those with onset of STEMI as an outpatient, were less likely to undergo invasive testing or intervention and had a higher in-hospital mortality rate.

Objectives To describe study design considerations and to simulate a trial of biomarker-guided sepsis management aimed to reduce acute kidney injury (acute kidney injury). Tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7 , urinary biomarkers of cell-cycle arrest, and indicators of kidney stress can detect acute kidney injury before clinical manifestations. We sought to determine the event rates for acute kidney injury as a function of serial measurements of urinary (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) in patients at risk of sepsis-associated acute kidney injury, so that an escalating series of kidney-sparing sepsis bundles based on international guidelines could be applied. Design We described the study protocol of "Limiting acute kidney injury Progression In Sepsis," a phase 4, multicenter, adaptive, randomized controlled trial. We performed simulations to estimate the rates for the trial's primary endpoint using patient-level data from two previous studies (Sapphire and Protocolized Care for Early Septic Shock). Setting Academic and community ICUs. Patients Critically ill patients with sepsis or septic shock, without evidence of stage 2/3 acute kidney injury at enrollment. Interventions None. Measurements and main results Our primary endpoint is progression of two or more stages of acute kidney injury, death, or dialysis within 72 hours after enrollment. In the Sapphire simulation, 45 of 203 patients (22%) with sepsis met the endpoint. In Protocolized Care for Early Septic Shock, 144 of 607 patients (24%) with septic shock met the endpoint. In both simulations, (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) patterns, suggested by Limiting acute kidney injury Progression In Sepsis protocol, stratified the risk for the endpoint from 6% (three negative tests) to 41% (for patients eligible for the highest level of kidney-sparing sepsis bundle) in Sapphire, and 14% (two negative tests) to 46% (for the highest level of kidney-sparing sepsis bundle) in Protocolized Care for Early Septic Shock. Conclusions Findings of our Limiting acute kidney injury Progression In Sepsis trial simulation confirmed that (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) could identify patients with different rates of progression to moderate/severe acute kidney injury, death, or dialysis in 72 hours. The Limiting acute kidney injury Progression In Sepsis protocol algorithm is therefore feasible in terms of identifying suitably high-risk individuals for kidney-sparing sepsis bundle.