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Objective: To investigate the cost-effectiveness of using artificial intelligence (AI) to screen for low ejection fraction (EF) in routine clinical practice using a pragmatic randomized controlled trial (RCT). Patients and Methods: In a post hoc analysis of the electrocardiogram (ECG) AI-guided screening for low ejection fraction trial, we developed a decision analytic model for patients aged 18 years and older without previously diagnosed heart failure and underwent a clinically indicated ECG between August 5, 2019, and March 31, 2020. In the previously published RCT, the intervention arm underwent an AI-guided targeted screening program for low EF with a workflow embedded into routine clinical practice—AI was applied to the ECG to identify patients at high-risk and recommended clinicians to order an ECG and the control arm received usual care without the screening program. We used results from the RCT for rates of low EF diagnosis and a lifetime Markov model to project the long-term outcomes. Quality-adjusted life years (QALYs), costs of intervention and treatment, disease event costs, incremental cost-effectiveness ratio (ICER), and cost for the number needed to screen. Multiple scenario and sensitivity analyses were performed. Results: Compared with usual care, AI-integrated ECG was cost effective, with an incremental cost-effectiveness ratio of $27,858/QALY. The program remained cost effective even with a change in patient age and follow-up time duration, although the specific ICER values varied for these parameters. The program was more cost effective in outpatient settings (ICER $1651/QALY) than in inpatient or emergency room settings. Conclusion: Implementing AI-guided targeted screening for low EF in routine clinical practice was cost effective.

Abstract The Adult Medical Care Coordination program (“the program”) was implemented at Mayo Clinic to promote patient self‐management and improve 30‐day unplanned readmission for patients with high risk for readmission after hospital discharge. This study aimed to evaluate the impact of the program compared to usual care using a pragmatic, stepped wedge cluster randomized trial (“stepped wedge trial”). However, several challenges arose including large differences between the study arms. Our goal is to describe the challenges and present lessons learned on how to overcome such challenges and generate evidence to support practice decisions. We describe the challenges encountered during the trial, the approach to addressing these challenges, and lessons learned for other learning health system researchers facing similar challenges. The trial experienced several challenges in implementation including several clinics dropping from the study and care disruptions due to COVID‐19. Additionally, there were large differences in the patient population between the program and usual care arms. For example, the mean age was 76.8 for the program and 68.1 for usual care. Due to these differences, we adapted the methods using the propensity score matching approach that is traditionally applied to observational designs and adjusted for differences in observable characteristics. When conducting pragmatic research, researchers will encounter factors beyond their control that may introduce bias. The lessons learned include the need to weigh the tradeoffs of pragmatic design elements and the potential value of adaptive designs for pragmatic trials. Applying these lessons would promote the successful generation of evidence that informs practice decisions.

Objective: Deterioration index (DI) is a computer-generated score at a specific frequency that represents the overall condition of hospitalized patients using a variety of clinical, laboratory and physiologic data. In this paper, a contrastive transfer learning method is proposed and validated for early prediction of adverse events in hospitalized patients using DI scores. Methods and procedures: An unsupervised contrastive learning (CL) model with a classifier is proposed to predict adverse outcome using a single temporal variable (DI scores). The model is pretrained on an unsupervised fashion with large-scale time series data and fine-tuned with retrospective DI score data. Results: The performance of this model is compared with supervised deep learning models for time series classification. Results show that unsupervised contrastive transfer learning with a classifier outperforms supervised deep learning solutions. Pretraining of the proposed CL model with large-scale time series data and fine-tuning that with DI scores can enhance prediction accuracy. Conclusion: A relationship exists between longitudinal DI scores of a patient and the corresponding outcome. DI scores and contrastive transfer learning can be used to predict and prevent adverse outcomes in hospitalized patients. Clinical impact: This paper successfully developed an unsupervised contrastive transfer learning algorithm for prediction of adverse events in hospitalized patients. The proposed model can be deployed in hospitals as an early warning system for preemptive intervention in hospitalized patients, which can mitigate the likelihood of adverse outcomes.

Objectives: To determine the cost of two surgical treatment approaches for vulvar Paget’s disease and model the cost-effectiveness considering differences in recurrence and reoperation over time. Methods: We assessed cost-effectiveness between excision guided by Mohs micrographic surgery (MMS-E) and traditional wide local excision (WLE). We examined billing data from patients with vulvar Paget’s disease who underwent MMS-E (cases, n = 24, 2018–2022) or WLE (controls, n = 64, 1990–2020). We created typical treatment bundles incorporating physician-administered services and facility costs standardized to Medicare reimbursements in 2022 United States Dollars (USD). The primary measure of effectiveness was disease-free years of life. A secondary analysis estimated quality-adjusted life years (QALY). A Markov model simulated treatment pathways over a 10-year time horizon. Transition probabilities were based on institutional recurrence rates (3-year RR 6.7 % for MMS-E vs 34.1 % for WLE). We used a willingness-to-pay threshold of 100,000 USD per QALY. Results: The cost of a single surgical episode was 34,664 USD for MMS-E and 14,969 USD for WLE. In the setting of lower recurrence rates with MMS-E, the incremental cost was 12,789 USD per disease-free year gained. A secondary analysis incorporating QALY showed an incremental cost of 72,820 USD per QALY. Conclusions: MMS-E appears to be a cost-effective treatment for vulvar Paget’s disease compared to historic standard of care. Our ability to estimate quality of life gained by avoiding disease recurrence was limited by scant data for this rare condition; thus, future studies incorporating health utility values are needed to facilitate a more comprehensive analysis.

Introduction: Using a digital process that leverages electronic health records (EHRs) can ease many of the challenges presented by the traditional enrollment process for clinical trials. We tested if automated batch enrollment using a technology-enabled subject recruitment system (TESRS) enhances recruitment while preserving representation of research subjects for the study population in our study setting. Methods: An ongoing community-based prospective adult cohort study was used to randomize 600 subjects who were eligible by age and residential address to TESRS (n = 300) and standard mailing method (n = 300), respectively, for 3 months. Then, TESRS was initiated and included automatic identification of patients’ preference for being contacted (online patient portal vs postal mail) from EHRs and automatic sending out of invitation letters followed by completion of a short online survey for checking eligibility and the digital consent process if eligible. We compared (1) median time to consent from invitation sent out per subject and total subjects recruited after a 3-month recruitment period, (2) the estimated study staff’s time, and (3) representation of sociodemographic characteristics (e.g., age, sex, race, SES measured by HOUSES index, and rural residence) between subjects recruited via TESRS and those via traditional mailing methods. Results: Median age of randomized subjects (n = 600) was 63 years with 52.0% female and 89.2% non-Hispanic White. Over a 3-month period, results showed consent rate via TESRS was 13% (39/297) similar to 11% (31/295) via standard mailing. However, recruitment was significantly faster with the TESRS approach (median 7 vs 26 days) given the study staff’s effort. Study staff’s time saved by using TESRS compared to standard mailing approach was estimated at 40 min per subject (equivalent to 200 h for 300 subjects). No significant differences in characteristics of research subjects from the study population were found. Conclusion: Our study demonstrated the utility of TESRS as a subject recruitment digital technology which significantly enhanced the recruitment effort while reducing the study staff burden of recruitment while maintaining the consistency of characteristics of recruited subjects. The strategy and support for implementing and testing TESRS in other study settings should be considered.

Background: Alaska Native and American Indian (ANAI) communities in Alaska are disproportionately affected by commercial tobacco use. Financial incentive interventions promote cigarette smoking cessation, but family-level incentives have not been evaluated. We describe the study protocol to adapt and evaluate the effectiveness and implementation of a remotely delivered, family-based financial incentive intervention for cigarette smoking among Alaskan ANAI people. Methods: The study has 3 phases: 1) qualitative interviews with ANAI adults who smoke, family members, and stakeholders to inform the intervention, 2) beta-test of the intervention, and 3) randomized controlled trial (RCT) evaluating intervention reach and effectiveness on verified, prolonged smoking abstinence at 6- and 12-months post-treatment. In the RCT, adult dyads (ANAI person who smokes [index participant] and family member) recruited throughout Alaska will be randomized to a no-incentives control condition (n = 328 dyads) or a 6-month incentive intervention (n = 328 dyads). All dyads will receive cessation support and family wellness materials. Smoking status will be assessed weekly for four weeks and at three and six months. Intervention index participants will receive escalating incentives for verified smoking abstinence at each time point (maximum $750 total); the family member will receive rewards of equal value. Results: A community advisory committee contributed input on the study design and methods for relevance to ANAI people, particularly emphasizing the involvement of families. Conclusion: Our study aligns with the strength and value AIAN people place on family. Findings, processes, and resources will inform how Indigenous family members can support smoking cessation within incentive interventions. Clinical Trials Registry: NCT05209451

Background: The risk of sudden cardiac death (SCD) after coronary revascularization in patients with left ventricular (LV) systolic dysfunction has not been characterized completely. This study aims to evaluate the incidence and time course of SCD after revascularization in such patients. The determinants of SCD within 3 months after revascularization were also assessed. Methods: A cohort study of patients with reduced ejection fraction (EF ≤40%), who underwent revascularization was performed. The incidence of SCD was estimated to account for the competing risk of deaths due to other causes. Results: 2317 patients were enrolled. With a median follow-up of 3.5 years, 162 (32.1%) of the 504 deaths were due to SCD. The risk of SCD was highest in the first 3 months after revascularization, with an incidence rate of 0.37%/month. The event rate decreased to 0.12%/month, 0.08%/month, 0.09%/month, 0.14%/month, and 0.19%/month at 3–6 months, 6–12 months, 1–3 years, 3–5 years, and 5–10 years, respectively. A history of ventricular tachycardia/ventricular fibrillation (hazard ratio [HR], 5.55; 95% confidence interval [CI], 1.33–23.19; p = 0.019) and triple vessel disease (HR, 3.90; 95% CI, 1.38–11.05; p = 0.010) were associated with the risk of SCD within 3 months. However, preoperative EF (in 5% increments) was not predictive (HR per 5% increase, 0.98; 95% CI, 0.62–1.55; p = 0.935). Conclusions: For patients with LV dysfunction, the risk of SCD was the highest during the first 3 months after revascularization. Further risk classification and treatment strategy are warranted. Clinical Trial Registration: The name of the registry: Coronary Revascularization in Patients with Ischemic Heart Failure and Prevention of Sudden Cardiac Death. Registration number: ChiCTR2100044378.

Abstract Background The anti-fibrotic medications nintedanib and pirfenidone were approved in the United States for use in patients with idiopathic pulmonary fibrosis several years ago. While there is a growing body of evidence surrounding their clinical effectiveness, these medications are quite expensive and no prior cost-effectiveness analysis has been performed in the United States. Methods A previously published Markov model performed in the United Kingdom was replicated using United States data to project the lifetime costs and health benefits of treating idiopathic pulmonary fibrosis with: (1) symptom management; (2) pirfenidone; or (3) nintedanib. For the cost-effectiveness analysis, strategies were ranked by increasing costs and then checked for dominating treatment strategies. Then an incremental cost-effectiveness ratio was calculated for the dominant therapy. Results The anti-fibrotic medications were found to cost more than $110,000 per year compared to $12,291 annually for symptom management. While pirfenidone was slightly more expensive than nintedanib and provided the same amount of benefit, neither medication was found to be cost-effective in this U.S.-based analysis, with an average cost of $1.6 million to gain one additional quality-adjusted life year over symptom management. Conclusions Though the anti-fibrotics remain the only effective treatment option for patients with idiopathic pulmonary fibrosis and the data surrounding their clinical effectiveness continues to grow, they are not considered cost-effective treatment strategies in the United States due to their high price.

Objectives To conduct comparative cost analysis of hospital care for critically ill patients with Limited English Proficiency (LEP) versus patients with English proficiency (controls). Patients and methods We conducted a historical cohort study using propensity matching at Mayo Clinic Rochester, a quaternary care academic center. We included hospitalized patients who had at least one admission to ICU during a 10-year period between 1/1/2008-12/31/2017. Results Due to substantial differences in baseline characteristics of the groups, propensity matching for the covariates age, sex, race, ethnicity, APACHE 3 score, and Charlson Comorbidity score was used, and we achieved the intended balance. The final cohort included 80,404 patients, 4,246 with LEP and 76,158 controls. Patients with LEP had higher costs during hospital admission to discharge, with a mean cost difference of $3861 (95% CI $822 to $6900, p = 0.013) and also higher costs during index ICU admission to hospital discharge, with a mean cost difference of $3166 (95% CI $231 to $6101, p = 0.035). A propensity matched cohort including only those that survived showed those with LEP had significantly greater mean costs for all outcomes. Sensitivity analysis revealed that international patients with LEP had significantly greater overall hospital costs of $9,240 than patients with LEP who resided in the US (95% CI $3341 to $15,140, p = 0.002). Conclusion This is the first study to demonstrate significantly higher costs for patients with LEP experiencing a critical illness. The causes for this may be increased healthcare utilization secondary to communication deficiencies that impede timely decision making about care.

Hypothesis/Background: Value-based healthcare delivery models are becoming increasingly common and are driving cost effectiveness initiatives. Rotator cuff repair (RCR) is a commonly performed procedure with some variations on the specific surgical technique. The purpose of this study was to perform a comprehensive analysis of the cost, complications, and readmission rates of 3 categories of RCR techniques (open [oRCR], combined arthroscopically assisted and mini-open [CRCR], and all arthroscopic [ARCR]) at a high-volume institution. Methods: All RCR procedures performed by 2 fellowship-trained shoulder surgeons at a single institution between 2012 and 2017 were retrospectively identified. These consisted of oRCR, CRCR, and ARCR repair techniques. One surgeon performed oRCR and CRCR, and the second surgeon performed ARCR. A cost analysis was designed to include a period of 60 days preoperatively, the index surgical hospitalization, and 90 days postoperatively, including costs of any readmission or reoperation. Results: The cohort consisted of 95 oRCR, 233 CRCR, and 287 ARCR. Median standardized costs were as follows: preoperative evaluation $486.03; index surgical hospitalization oRCR $9,343.10, CRCR $10,057.20, and ARCR $10,330.60; and postoperative care $875.02. Preoperative and postoperative costs did not vary based on the type of RCR performed. However, significant differences were observed among index surgical costs (P = .0008). The highest standardized cost for hospitalization for both the CRCR group and the ARCR group was related to the cost of the operating room and the implants. The 90-day complication, reoperation, and readmission rates were 1.1%, 1.1%, and 2.1% in the open group; 0.8%, 0.8%, and 1.7% in the combination group; 0%, 0%, and 1.7% in the all arthroscopic group, respectively. There were no significant differences among the 3 surgical procedures with respect to complication (P = .26), reoperation (P = .26), and readmission rates (P = .96). Discussion/Conclusions: In this investigation, the median standardized costs for RCR inclusive of 60-day workup and 90-day postoperative care were $10,704.15, $11,418.25, and $11,691.65 for oRCR, CRCR (average added cost $714.10), and ARCR (added cost $987.50), respectively. The group complication, reoperation, and readmission rate were 0.5%, 0.5%, and 1.8% with no significant differences between the varying techniques, respectively. This retrospective cost analysis and complication profile may serve as a useful reference as surgeons consider engaging in bundled payment for RCR. As value based initiatives continue to progress, implant cost may serve as an actionable area for cost reduction.

Abstract Background Real‐world data for patients with positive colorectal cancer (CRC) screening stool‐tests demonstrate that adenoma detection rates are lower when endoscopists are blinded to the stool‐test results. This suggests adenoma sensitivity may be lower for screening colonoscopy than for follow‐up to a known positive stool‐based test. Previous CRC microsimulation models assume identical sensitivities between screening and follow‐up colonoscopies after positive stool‐tests. The Colorectal Cancer and Adenoma Incidence and Mortality Microsimulation Model (CRC‐AIM) was used to explore the impact on screening outcomes when assuming different adenoma sensitivity between screening and combined follow‐up/surveillance colonoscopies. Methods Modeled screening strategies included colonoscopy every 10 years, triennial multitarget stool DNA (mt‐sDNA), or annual fecal immunochemical test (FIT) from 50 to 75 years. Outcomes were reported per 1000 individuals without diagnosed CRC at age 40. Base‐case adenoma sensitivity values were identical for screening and follow‐up/surveillance colonoscopies. Ranges of adenoma sensitivity values for colonoscopy performance were developed using different slopes of odds ratio adjustments and were designated as small, medium, or large impact scenarios. Results As the differences in adenoma sensitivity for screening versus follow‐up/surveillance colonoscopies became greater, life‐years gained (LYG) and reductions in CRC‐related incidence and mortality versus no screening increased for mt‐sDNA and FIT and decreased for screening colonoscopy. The LYG relative to screening colonoscopy reached >90% with FIT in the base‐case scenario and with mt‐sDNA in a “medium impact” scenario. Conclusions Assuming identical adenoma sensitivities for screening and follow‐up/surveillance colonoscopies underestimate the potential benefits of stool‐based screening strategies.

Objective: To assess the potential impact of Pharmacogenomic (PGx) variation in cytochrome P450 2D6 (CYP2D6) enzyme function, using loss in quality-adjusted life years (QALYs) associated with treatment problems, and the willingness to pay to avoid treatment problems from patients’ and payers’ perspectives. Patients and Methods: The study included patients prescribed tramadol or codeine, or both, between January 1, 2005, and December 31, 2017. Demographic information and adverse drug events, including adverse drug events and poor pain control, were collected from the electronic health records using natural language processing techniques and review by trained abstractors. Patients’ willingness to pay and QALY estimates were based on comprehensive literature review. The CYP2D6 phenotypes were divided into 4 groups: ultra-rapid metabolizers, normal metabolizers, intermediate metabolizers, and poor metabolizers. Results: Among the 2860 identified patients, 63 (2%) were ultrarapid metabolizers, 1449 (50%) were normal metabolizers, 1155 (40%) were intermediate metabolizers, and 193 (7%) were poor metabolizers. The patients’ average estimated willingness-to-pay value to avoid treatment problems was $23 per month; poor metabolizers developed problems with the highest estimated willingness-to-pay value ($32 per month). The mean QALY loss among all patients was 0.024 QALYs (8.8 healthy days); poor metabolizers had the highest loss (0.027 QALYs, 9.9 healthy days). Conclusion: Patients with various phenotypes developed different treatment problem profiles. Poor CYP2D6 metabolizers developed problems with highest willingness to pay, and they might potentially benefit most from PGx-guided treatment and problem prevention.

Screening colonoscopies for colorectal cancer (CRC) are typically covered without patient cost-sharing, whereas follow-up colonoscopies for positive stool-based screening tests often incur patient costs. The objective of this analysis was to estimate and compare the life-years gained (LYG) per average-risk screening colonoscopy and follow-up colonoscopy after a positive stool-based test to better inform CRC coverage policy and reimbursement decisions. CRC outcomes from screening and follow-up colonoscopies versus no screening were estimated using CRC-AIM in a simulated population of average-risk individuals screened between ages 45–75 years. The LYG/colonoscopy per 1000 individuals was 0.09 for screening colonoscopy and 0.29 for follow-up colonoscopy. 0.01 and 0.04 CRC cases and 0.01 and 0.02 CRC deaths were averted per screening and follow-up colonoscopies, respectively. Coverage policies should be revised to encourage individuals to complete recommended screening processes.

Abstract Background Transitioning care from hospital to home is associated with risks of adverse events and poor continuity of care. These transitions are even more challenging when new approaches to care, such as palliative care, are introduced before discharge. Family caregivers (FCGs) are expected to navigate these transitions while also managing care. In addition to extensive caregiving responsibilities, FCGs often have their own health needs that can inhibit their ability to provide care. Those living in rural areas have even fewer resources to meet their self-care and caregiving needs. The purpose of this study is to test the efficacy and cost-effectiveness of an intervention to improve FCGs’ health and well-being. The intervention uses video visits to teach, guide, and counsel FCGs in rural areas during hospital-to-home transitions. The intervention is based on evidence of transitional and palliative care principles, which are individualized to improve continuity of care, provide caregiver support, enhance knowledge and skills, and attend to caregivers’ health needs. It aims to test whether usual care practices are similar to this technology-enhanced intervention in (1) caregiving skills (e.g., caregiving preparedness, communication with clinicians, and satisfaction with care), (2) FCG health outcomes (e.g., quality of life, burden, coping skills, depression), and (3) cost. We describe the rationale for targeting rural caregivers, the methods for the study and intervention, and the analysis plan to test the intervention’s effect. Methods The study uses a randomized controlled trial design, with FCGs assigned to the control condition or the caregiver intervention by computer-generated lists. The intervention period continues for 8 weeks after care recipients are discharged from the hospital. Data are collected at baseline, 2 weeks, 8 weeks, and 6 months. Time and monetary costs from a societal perspective are captured monthly. Discussion This study addresses 2 independent yet interrelated health care foci—transitional care and palliative care—by testing an intervention to extend palliative care practice and improve transition management for caregivers of seriously ill patients in rural areas. The comprehensive cost assessment will quantify the commitment and financial burden of FCGs. Trial registration ClinicalTrials.gov NCT03339271 . Registered on 13 November 2017. Protocol version: 11.

Abstract Purpose The purpose of this analysis was to determine the cost‐effectiveness of a Collaborative Care Model (CCM)‐based, centralized telecare approach to delivering rehabilitation services to late‐stage cancer patients experiencing functional limitations. Methods Data for this analysis came from the Collaborative Care to Preserve Performance in Cancer (COPE) trial, a randomized control trial of 516 patients assigned to: (a) a control group (arm A), (b) tele‐rehabilitation (arm B), and (c) tele‐rehabilitation plus pharmacological pain management (arm C). Patient quality of life was measured using the EQ‐5D‐3L at baseline, 3‐month, and 6‐month follow‐up. Direct intervention costs were measured from the experience of the trial. Participants’ hospitalization data were obtained from their medical records, and costs associated with these encounters were estimated from unit cost data and hospital‐associated utilization information found in the literature. A secondary analysis of total utilization costs was conducted for the subset of COPE trial patients for whom comprehensive cost capture was possible. Results In the intervention‐only model, tele‐rehabilitation (arm B) was found to be the dominant strategy, with an incremental cost‐effectiveness ratio (ICER) of $15 494/QALY. At the $100 000 willingness‐to‐pay threshold, this tele‐rehabilitation was the cost‐effective strategy in 95.4% of simulations. It was found to be cost saving compared to enhanced usual care once the downstream hospitalization costs were taken into account. In the total cost analysis, total inpatient hospitalization costs were significantly lower in both tele‐rehabilitation (arm B) and tele‐rehabilitation plus pain management (arm C) compared to control (arm A), (P = .048). Conclusion The delivery of a CCM‐based, centralized tele‐rehabilitation intervention to patients with advanced stage cancer is highly cost‐effective. Clinicians and care teams working with this vulnerable population should consider incorporating such interventions into their patient care plans.

Introduction Since Friedman’s seminal publication on laboring women, numerous publications have sought to define normal labor progress. However, there is paucity of data on contemporary labor cervicometry incorporating both maternal and neonatal outcomes. The objective of this study is to establish intrapartum prediction models of unfavorable labor outcomes using machine-learning algorithms. Materials and methods Consortium on Safe Labor is a large database consisting of pregnancy and labor characteristics from 12 medical centers in the United States. Outcomes, including maternal and neonatal outcomes, were retrospectively collected. We defined primary outcome as the composite of following unfavorable outcomes: cesarean delivery in active labor, postpartum hemorrhage, intra-amniotic infection, shoulder dystocia, neonatal morbidity, and mortality. Clinical and obstetric parameters at admission and during labor progression were used to build machine-learning risk-prediction models based on the gradient boosting algorithm. Results Of 228,438 delivery episodes, 66,586 were eligible for this study. Mean maternal age was 26.95 ± 6.48 years, mean parity was 0.92 ± 1.23, and mean gestational age was 39.35 ± 1.13 weeks. Unfavorable labor outcome was reported in 14,439 (21.68%) deliveries. Starting at a cervical dilation of 4 cm, the area under receiver operating characteristics curve (AUC) of prediction models increased from 0.75 (95% confidence interval, 0.75–0.75) to 0.89 (95% confidence interval, 0.89–0.90) at a dilation of 10 cm. Baseline labor risk score was above 35% in patients with unfavorable outcomes compared to women with favorable outcomes, whose score was below 25%. Conclusion Labor risk score is a machine-learning–based score that provides individualized and dynamic alternatives to conventional labor charts. It predicts composite of adverse birth, maternal, and neonatal outcomes as labor progresses. Therefore, it can be deployed in clinical practice to monitor labor progress in real time and support clinical decisions.

Abstract Background The potential economic benefit in terms of reduced healthcare costs when patients quit smoking after hospital discharge has not been directly measured. The aim of this study was to compare the costs for hospital admission and six-month follow-up for a cohort of patients who self-reported abstinence from cigarettes at 6 months after hospital discharge and a matched group of patients who reported continued smoking. Materials and methods This was a secondary analysis of a recent population-based clinical trial cohort (ClinicalTrials.gov ID: NCT01575145), with cohort membership determined by self-reported 7 day point prevalence abstinence at 6 months after the index hospital discharge. Participants were admitted to Mayo Clinic Hospital, Rochester, MN, between May 5, 2012 and August 10, 2014 for any indication and lived in the areas covered by postal codes included in Olmsted County, MN. Propensity score matching was used to control for differences between groups other than smoking status, and any residual imbalance was adjusted through generalized linear model with gamma distribution for cost and log-link transformation. Results Of 600 patients enrolled in the clinical trial, 144 could be contacted and self-reported 7 day point prevalence abstinence at 6 months after hospital discharge. Of these patients, 99 were successfully matched for this analysis. The cost for the index hospitalization was significantly greater in patients who abstained compared to those that did not abstain (mean difference of $3042, higher for abstainers, 95% CI $170 to $5913, P = 0.038). However, there was no difference between mean 6-month follow-up costs, number of inpatient hospitalizations, or number of emergency room visits for abstainers versus non-abstainers. Conclusion There was no evidence to support the hypothesis that abstinence at 6 months after hospital discharge is associated with a decrease in health care costs or utilization over the first 6 months after hospital discharge.

Objectives: To investigate the association between diabetes mellitus (DM) and ejection fraction (EF) improvement following revascularization in patients with coronary artery disease (CAD) and left ventricular (LV) dysfunction.Background: Revascularization may improve outcomes of patients with LV dysfunction by improvement of EF. However, the determinants of EF improvement have not yet been investigated comprehensively.Method: A cohort study (No. ChiCTR2100044378) of patient with repeated EF measurements after revascularization was performed. All patients had baseline EF ≤40%. Patients who had EF reassessment 3 months after revascularization were enrolled. Patients were categorized into EF unimproved (absolute increase in EF ≤5%) and improved group (absolute increase in EF >5%).Results: A total of 974 patients were identified. 573 (58.8%) had EF improved. Patients with DM had greater odds of being in the improved group (odds ratio [OR], 1.42; 95% CI, 1.07–1.89; P = 0.014). 333 (34.2%) patients with DM had a greater extent of EF improvement after revascularization (10.5 ± 10.4 vs. 8.1 ± 11.2%; P = 0.002) compared with non-diabetic patients. The median follow-up time was 3.5 years. DM was associated with higher risk of overall mortality (hazard ratio [HR], 1.46; 95% CI, 1.02–2.08; P = 0.037). However, in EF improved group, the risk was similar between diabetic and non-diabetic patients (HR, 1.36; 95% CI, 0.80–2.32; P = 0.257).Conclusions: Among patients with reduced EF, DM was associated with greater EF improvement after revascularization. Revascularization in diabetic patients might partially attenuate the impact of DM on adverse outcomes. Our findings imply the indication for revascularization in patients with LV dysfunction who present with DM.

Background: The Comprehensive Care for Joint Replacement program implemented by the Centers for Medicare and Medicaid Services did not incorporate risk adjustment for lower extremity joint replacement (LEJR). Lack of adjustment places hospitals at financial risk and creates incentives for adverse patient selection. Objective: To identify patient-level risk factors associated with health care utilization and costs of patients undergoing LEJR. Methods: A comprehensive search of research databases from January 1, 1990, through January 31, 2016, was conducted. The databases included Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and SCOPUS and is reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. The search identified 2020 studies. Eligible studies focused on primary unilateral and bilateral LEJR. Independent reviewers determined study eligibility and extracted utilization and cost data. Results: Seventy-nine of 330 studies (24%) were included and were abstracted for analysis. Comorbidities, age, disease severity, and obesity were associated with increased costs. Increased number of comorbidities and age, presence of specific comorbidities, lower socioeconomic status, and female sex had evidence of increased length of stay. We found no significant association between indication for surgery and the likelihood of readmission. Conclusion: Developing a risk adjustment model for LEJR that incorporates clinical variables may serve to reduce the likelihood of adverse patient selection and enhance appropriate reimbursement aligned with procedural complexity.

Abstract Background Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. Methods This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12 months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask–Advise–Refer; (2) a digital (WEB + TXT) cessation intervention; or (3) a digital cessation intervention combined with tobacco treatment specialist (TTS) counseling (WEB + TXT + TTS). Discussion The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment. We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS. We expect that a combined digital/clinical intervention will yield higher quit rates than digital alone, but that it may not be as cost-effective or feasible for LCS programs to implement. This study is innovative in its use of interoperable, digital technologies to deliver a sustainable, scalable, high-impact cessation intervention and to facilitate its integration within clinical practice. It will add to the growing knowledge base about the overall effectiveness of digital interventions and their role in the healthcare delivery system. Trial registration ClinicalTrials.gov, NCT03084835 . Registered on 9 March 2017.

Abstract Background Research addressing value in healthcare requires a measure of cost. While there are many sources and types of cost data, each has strengths and weaknesses. Many researchers appear to create study-specific cost datasets, but the explanations of their costing methodologies are not always clear, causing their results to be difficult to interpret. Our solution, described in this paper, was to use widely accepted costing methodologies to create a service-level, standardized healthcare cost data warehouse from an institutional perspective that includes all professional and hospital-billed services for our patients. Methods The warehouse is based on a National Institutes of Research–funded research infrastructure containing the linked health records and medical care administrative data of two healthcare providers and their affiliated hospitals. Since all patients are identified in the data warehouse, their costs can be linked to other systems and databases, such as electronic health records, tumor registries, and disease or treatment registries. Results We describe the two institutions’ administrative source data; the reference files, which include Medicare fee schedules and cost reports; the process of creating standardized costs; and the warehouse structure. The costing algorithm can create inflation-adjusted standardized costs at the service line level for defined study cohorts on request. Conclusion The resulting standardized costs contained in the data warehouse can be used to create detailed, bottom-up analyses of professional and facility costs of procedures, medical conditions, and patient care cycles without revealing business-sensitive information. After its creation, a standardized cost data warehouse is relatively easy to maintain and can be expanded to include data from other providers. Individual investigators who may not have sufficient knowledge about administrative data do not have to try to create their own standardized costs on a project-by-project basis because our data warehouse generates standardized costs for defined cohorts upon request.

ABSTRACTObjective:To examine adherence to adalimumab (ADA) and etanercept (ETA) and health care costs in rheumatoid arthritis (RA) patients, and to explore the association between adherence, utilization and costs.Research design and methods:Using administrative claims data from a large managed health care plan, RA patients treated with etanercept or adalimumab during the period from 01/01/2005 through 12/31/2005 were identified. The first dispensing date was defined as the index date. Patient adherence and costs were assessed during the 1 year post-index period.Main outcome measures:Nonadherence (medication possession ratio <80) was modeled using logistic regression. Hazard ratios (HR) comparing time to discontinuation were estimated using Cox proportional hazard (PH) models. Propensity score matching with multivariate generalized linear modeling adjustment was done to assess cost difference between ADA and ETA.Results:Of 3829 eligible RA patients, 1292 (765 existing, 527 naïve) and 2537 (1834 existing, 703 naïve) patients used ADA and ETA, respectively. Compared with ADA users, ETA users had longer average treatment duration (316 vs. 291 days; p < 0.0001). Unadjusted adherence rates for naïve and existing users were 63 and 70 (ADA), and 65 and 73 (ETA). Logistic regression analysis indicated that compared with ETA users, ADA users were more likely to be nonadherent (OR, naïve 1.24; existing; 1.25). Cox PH models indicated that existing ADA users were more likely to discontinue (HR  1.11; p  0.06) their medication than existing ETA users. Compared with ADA users, ETA users had significantly lower RA-related pharmacy costs (naïve: 10,892 vs. 12,534, p < 0.01; existing: 12,192 vs. 13,752, p < 0.01) and RA-related total costs (naïve: 11,976.42 vs. 13,511.99, p < 0.05; existing: 14,031 vs. 15,454, p < 0.05).Conclusions:ETA users had longer treatment duration, were more likely to adhere to their medication regimen and had lower RA-related pharmacy and RA-related total costs compared with ADA users. These findings must be considered within the limitations of this database analysis. [ABSTRACT FROM AUTHOR]

Abstract Background Although inverse associations have been found between medication adherence and healthcare use and spending outcomes in many clinical settings, no studies to date have examined these relationships for patients with idiopathic pulmonary fibrosis (IPF) initiating nintedanib. We build on our prior study that used group-based trajectory modeling (GBTM) to compare inpatient hospitalization and medical care spending outcomes between groups of patients with different nintedanib adherence trajectories. Methods This analysis used 100% Medicare data and included beneficiaries with IPF who initiated nintedanib during 10/01/2014–12/31/2018. The sample consisted of community-dwelling older adults (≥ 66 years) with continuous coverage in Medicare Parts A (inpatient care), B (outpatient care) and D (prescription drugs) for one year before (baseline) and after (follow-up) initiating nintedanib. Patients were assigned to the GBTM-derived adherence trajectory group closest to their own nintedanib adherence experience. All-cause and IPF-related hospitalization events and total medical spending were measured during the follow-up period. Unadjusted and adjusted regression models were estimated to compare outcomes between patients in different nintedanib adherence trajectories. Results Among the 1,798 patients initiating nintedanib, the mean age was 75.4 years, 61.1% were male, and 91.1% were non-Hispanic white. The best-fitting GBTM had five adherence trajectories: high adherence, moderate adherence, high-then-poor adherence, delayed-poor adherence, and early-poor adherence. All-cause hospitalizations and total all-cause medical spending were higher among patients in the high-then-poor, delayed-poor and early-poor adherence trajectories than those in the high adherence trajectory. For example, adjusted total all-cause medical spending was $4,876 (95% CI: $1,470 to $8,282) higher in the high-then-poor adherence trajectory, $3,639 (95% CI: $1,322 to $5,955) higher in the delayed-poor adherence trajectory and $3,907 (95% CI: $1,658 to $6,156) higher in the early-poor adherence trajectory compared with the high adherence trajectory. IPF-related hospitalizations and medical care spending were higher among those in the high-then-poor adherence trajectory compared with those in the high adherence trajectory. Conclusions Poor adherence to nintedanib was associated with all-cause hospitalizations and medical costs. Therefore, improved adherence programs, such as support programs, can be implemented to reduce economic burden.

IntroductionTrue penicillin allergy is rare and is commonly incorrectly reported. In fact, less than five percent of patients who report a penicillin allergy will have a currently active clinically-significant IgE- or T-cell-mediated hypersensitivity when appropriately tested. Penicillin is the agent of choice for intrapartum antibiotic prophylaxis to reduce the risk of group B streptococcus early-onset disease in the newborn. Inaccurate penicillin allergy status may lead to inappropriate antibiotic use, as most alternative drugs are more expensive and broader spectrum than penicillin. Penicillin allergy testing has been found to be safe in pregnancy and cost-effective in other patient populations.ObjectiveTo evaluate the cost-effectiveness of penicillin allergy testing and appropriate antibiotic treatment (test then treat strategy) compared to usual care among pregnant women.MethodsWe developed a decision tree to evaluate the cost of providing appropriate care via a test then treat strategy for pregnant women who report a penicillin allergy, compared to usual care.ResultsUsing the test then treat strategy the additional cost to ensure appropriate care for all pregnant women who report a penicillin allergy, was $1122.38 per person. Adopting a test then treat strategy increased the number of appropriate antibiotic use from 7,843/10,000 to 10,000/10,000 simulations.ConclusionOur results show that a test then treat strategy for pregnant women who report a penicillin allergy is a good-value intervention.

Oral anticoagulant (OAC) therapy has been the main treatment approach for stroke prevention for decades. Warfarin is the most widely prescribed OAC in the United States, but is difficult to manage due to variability in dose requirements across individuals. Pharmacogenomics may mitigate risk concerns related to warfarin use by fostering the opportunity to facilitate individualized medicine approaches to warfarin treatment (e.g., genome-guided dosing). While various economic evaluations exist examining the cost-effectiveness of pharmacogenomics testing for warfarin, few observational studies exist to support these studies, with even fewer using genotype as the main exposure of interest. We examined a cohort of individuals initiating warfarin therapy between 2004 and 2017 and examined bleeding and cost outcomes for the year following initiation using Mayo Clinic's billing and administrative data, as well the Mayo Clinic Rochester Cost Data Warehouse. Analyses included descriptive summaries, comparison of characteristics across exposure groups, reporting of crude outcomes, and multivariate analyses. We included N = 1,143 patients for analyses. Just over a third of our study population (34.9%) carried a warfarin-sensitive phenotype. Sensitive individuals differed in their baseline characteristics by being of older age and having a higher number of comorbid conditions; myocardial infarction, diabetes, and cancer in particular. The occurrence of bleeding events was not significantly different across exposure groups. No significant differences across exposure groups existed in either the likelihood of incurring all-cause healthcare costs or in the magnitude of those costs. Warfarin-sensitive individuals were no more likely to utilize cardiovascular-related healthcare services; however, they had lower total and inpatient cardiovascular-related costs compared to warfarin-insensitive patients. No significant differences existed in any other categories of costs. We found limited evidence that warfarin-sensitive individuals have different healthcare spending than warfarin-insensitive individuals. Additional real-world studies are needed to support the traditional economic evaluations currently existing in the literature.

BackgroundReal-world adherence to colorectal cancer (CRC) screening strategies is imperfect. The CRC-AIM microsimulation model was used to estimate the impact of imperfect adherence on the relative benefits and burdens of guideline-endorsed, stool-based screening strategies.MethodsPredicted outcomes of multi-target stool DNA (mt-sDNA), fecal immunochemical tests (FIT), and high-sensitivity guaiac-based fecal occult blood tests (HSgFOBT) were simulated for 40-year-olds free of diagnosed CRC. For robustness, imperfect adherence was incorporated in multiple ways and with extensive sensitivity analysis. Analysis 1 assumed adherence from 0%-100%, in 10% increments. Analysis 2 longitudinally applied real-world first-round differential adherence rates (base-case imperfect rates = 40% annual FIT vs 34% annual HSgFOBT vs 70% triennial mt-sDNA). Analysis 3 randomly assigned individuals to receive 1, 5, or 9 lifetime (9 = 100% adherence) mt-sDNA tests and 1, 5, or 9 to 26 (26 = 100% adherence) FIT tests. Outcomes are reported per 1000 individuals compared with no screening.ResultsEach screening strategy decreased CRC incidence and mortality versus no screening. In individuals screened between ages 50-75 and adherence ranging from 10%a-100%, the life-years gained (LYG) for triennial mt-sDNA ranged from 133.1-300.0, for annual FIT from 96.3-318.1, and for annual HSgFOBT from 99.8-320.6. At base-case imperfect adherence rates, mt-sDNA resulted in 19.1% more LYG versus FIT, 25.4% more LYG versus HSgFOBT, and generally had preferable efficiency ratios while offering the most LYG. Completion of at least 21 FIT tests is needed to reach approximately the same LYG achieved with 9 mt-sDNA tests.ConclusionsAdherence assumptions affect the conclusions of CRC screening microsimulations that are used to inform CRC screening guidelines. LYG from FIT and HSgFOBT are more sensitive to changes in adherence assumptions than mt-sDNA because they require more tests be completed for equivalent benefit. At imperfect adherence rates, mt-sDNA provides more LYG than FIT or HSgFOBT at an acceptable tradeoff in screening burden.

Proton beam therapy is a commonly accepted treatment for intraocular melanomas, but the literature is lacking in descriptions of patient preferences of clinical outcomes and economic impact. In addition, no economic evaluations have been published regarding the incremental cost-effectiveness of proton beam therapy compared with enucleation or plaque brachytherapy, typical alternative treatments. We, therefore, conducted a cost-utility analysis of these three approaches for the treatment of intraocular melanomas.A Markov model was constructed. Model parameters were identified from the published literature and publicly available data sources. Cost-effectiveness of each treatment was calculated in 2011 US Dollars per quality-adjusted life-year. Incremental cost-effectiveness ratios were calculated assuming enucleation as reference. One-way sensitivity analyses were conducted on all model parameters. A decision threshold of $50,000/quality-adjusted life-year was used to determine cost-effectiveness.Enucleation had the lowest costs and quality-adjusted life-years, and plaque brachytherapy had the highest costs and quality-adjusted life-years. Compared with enucleation, the base-case incremental cost-effectiveness ratios for plaque brachytherapy and proton beam therapy were $77,500/quality-adjusted life-year and $106,100/quality-adjusted life-year, respectively. Results were highly sensitive to multiple parameters. All three treatments were considered optimal, and even dominant, depending on the values used for sensitive parameters.Base-case analysis results suggest enucleation to be optimal. However, the optimal choice was not robust to sensitivity analyses and, depending on the assumption, both plaque brachytherapy and proton beam therapy could be considered cost-effective. Future clinical studies should focus on generating further evidence with the greatest parameter uncertainty to inform future cost-effectiveness analyses.

Purpose Skeletal-related events (SREs) such as pathologic fracture, spinal cord compression, or the necessity for radiation or surgery to bone metastasis cause considerable morbidity, decrements in quality of life, and costs to the health care system. The results of a recent large randomized trial (Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology [CALGB/Alliance 70604]) showed that zoledronic acid (ZA) every 3 months was noninferior to monthly ZA in reducing the risks of SREs. We sought to determine the cost-effectiveness (CE) of monthly ZA, ZA every 3 months, and monthly denosumab in women with breast cancer and skeletal metastases. Methods Using a Markov model, costs per SRE avoided were calculated for the three treatments. Sensitivity analyses were performed where denosumab SRE probabilities were assumed to be 50%, 75%, and 90% lower than the ZA SRE probabilities. Quality-adjusted life-years were also calculated. The analysis was from the US payer perspective. Results The mean costs of the denosumab treatment strategy are nine-fold higher than generic ZA every 3 months. Quality-adjusted life-years were virtually identical in all the three treatment arms; hence, the optimal treatment would be ZA every 3 months because it was the least costly treatment. The sensitivity analyses showed that relative to ZA every 3 months, the incremental costs per mean SRE avoided for denosumab ranged from $162,918 to $347,655. Conclusion ZA every 3 months was more CE in reducing the risks of SRE than monthly denosumab. This analysis was one of the first to incorporate the costs of generic ZA and one of the first independent CE analyses not sponsored by either Novartis or Amgen, the makers of ZA and denosumab, respectively. ZA every 3 months is the more CE option and more reasonable alternative to monthly denosumab.