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BACKGROUND: Remdesivir is FDA-approved for the treatment of hospitalized patients with severe COVID-19. Many patients improve clinically to allow for hospital dismissal before completing the 5-day course. In a prior work, patients who continued remdesivir in an outpatient setting experienced better 28-day clinical outcomes. Here, we assessed patients' perspectives and the economic impact of this outpatient practice. METHODS: Hospitalized patients who received remdesivir for COVID-19 at Mayo Clinic, Rochester, from 11/6/2020 to 11/5/2021 and were dismissed to continue remdesivir in the outpatient setting were surveyed. The cost of care was compared between those who remained hospitalized versus those who were dismissed. RESULTS: 93 (19.8 %) among 470 eligible patients responded to the electronic survey. Responders were older than non-responders. The majority (70.5 %) had symptoms resolved by the time of the survey. Ten (11.4 %) patients had persistent symptoms attributed to long COVID-19. The majority were satisfied with the quality of care (82.3 %) and overall experience (76.0 %) in the infusion clinic. After adjusting for gender, comorbidity score, and WHO severity scale, the predicted costs for the groups were $16,544 (inpatient) and $9,097 (outpatient) per patient (difference of $7,447; p < .01). An estimate of 1,077 hospital bed-days were made available to other patients as a result of this transition to outpatient. CONCLUSION: An outpatient remdesivir program that allowed for early dismissal was perceived favorably by patients. The program resulted in significant cost and resource savings, the latter in terms of the availability of hospital beds for other patients needing critical services.
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OBJECTIVE: To examine the healthcare utilization of patients with non-English language preference (NELP) who utilized a professional language interpreter (PLI) in the intensive care unit (ICU) compared to similar patients with NELP who did not utilize a PLI in the ICU. METHODS: Single center cohort study of patients with NELP with at least one ICU admission a large academic medical center in the U.S. Midwest (1/1/2008-12/31/2022). The first model examined ICU length-of-stay (LOS) using a negative binomial and the second model examined whether a patient was readmitted to the ICU using a logistic regression with each model controlling for PLI utilization and covariates. RESULTS: Patients with NELP who utilized a PLI in the ICU had 0.87-days longer in the ICU (p < 0.01) and had a 46 % decreased odds of being readmitted to the ICU (p < 0.01) than a comparable patient with NELP who did not utilize a PLI in the ICU. CONCLUSION: Providing patients with NELP with access to a PLI in the ICU can improve patient outcomes and reduce language barriers. PRACTICE IMPLICATIONS: These results can provide the justification to potentially increase PLI staffing levels or increase the access to existing PLIs for more patients with NELP in ICUs.
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Cardiovascular disease (CVD) is the leading cause of death among people with type 2 diabetes1-5, most of whom are at moderate CVD risk6, yet there is limited evidence on the preferred choice of glucose-lowering medication for CVD risk reduction in this population. Here, we report the results of a retrospective cohort study where data for US adults with type 2 diabetes and moderate risk for CVD are used to compare the risks of experiencing a major adverse cardiovascular event with initiation of glucagon-like peptide-1 receptor agonists (GLP-1RA; n = 44,188), sodium-glucose cotransporter 2 inhibitors (SGLT2i; n = 47,094), dipeptidyl peptidase-4 inhibitors (DPP4i; n = 84,315) and sulfonylureas (n = 210,679). Compared to DPP4i, GLP-1RA (hazard ratio (HR) 0.87; 95% confidence interval (CI) 0.82-0.93) and SGLT2i (HR 0.85; 95% CI 0.81-0.90) were associated with a lower risk of a major adverse cardiovascular event, whereas sulfonylureas were associated with a higher risk (HR 1.19; 95% CI 1.16-1.22). Thus, GLP-1RA and SGLT2i may be the preferred glucose-lowering agents for cardiovascular risk reduction in patients at moderate baseline risk for CVD. ClinicalTrials.gov registration: NCT05214573.
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Background: Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models have important limitations, including reliance on data that may not be routinely available, narrow focus on primary prevention, limited patient populations, and longtime horizons for risk prediction. Objectives: The purpose of this study was to derive and internally validate a claims-based prediction model for 1-year risk of MACE in type 2 diabetes. Methods: Using medical and pharmacy claims for adults with type 2 diabetes enrolled in commercial, Medicare Advantage, and Medicare fee-for-service plans between 2014 and 2021, we derived and internally validated the annualized claims-based MACE estimator (ACME) model to predict the risk of MACE (nonfatal acute myocardial infarction, nonfatal stroke, and all-cause mortality). The Cox proportional hazards model was composed of 30 covariates, including patient age, sex, comorbidities, and medications. Results: The study cohort comprised 6,623,526 adults with type 2 diabetes, mean age 68.1 ± 10.6 years, 49.8% women, and 73.0% Non-Hispanic White. ACME had a concordance index of 0.74 (validation index range: 0.739-0.741). The predicted 1-year risk of the study cohort ranged from 0.4% to 99.9%, with a median risk of 3.4% (IQR: 2.3%-6.5%). Conclusions: ACME was derived in a large usual care population, relies on routinely available data, and estimates short-term MACE risk. It can support population risk stratification at the health system and payer levels, participant identification for decentralized clinical trials of cardiovascular disease, and risk-stratified observational studies using real-world data.
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INTRODUCTION: Alaska Native and American Indian (ANAI) peoples in Alaska currently experience a disproportionate burden of morbidity and mortality from tobacco cigarette use. Financial incentives for smoking cessation are evidence-based, but a family-level incentive structure has not been evaluated. We used a community-based participatory research and qualitative approach to culturally adapt a smoking cessation intervention with ANAI families. METHODS: We conducted individual, semi-structured telephone interviews with 12 ANAI adults who smoke, 12 adult family members, and 13 Alaska Tribal Health System stakeholders statewide between November 2022-March 2023. Through content analysis, we explored intervention receptivity, incentive preferences, culturally aligned recruitment and intervention messaging, and future implementation needs. RESULTS: Participants were receptive to the intervention. Involving a family member was viewed as novel and aligned with ANAI cultural values of commitment to community and familial interdependence. Major themes included choosing a family member who is supportive and understanding, keeping materials positive and encouraging, and offering cash and non-cash incentives for family members to choose (e.g., fuel, groceries, activities). Participants indicated that messaging should emphasize family collaboration and that cessation resources and support tips should be provided. Stakeholders also reinforced that program materials should encourage the use of other existing evidence-based cessation therapies (e.g., nicotine replacement, counseling). CONCLUSIONS: Adaptations, grounded in ANAI cultural strengths were made to the intervention and recruitment materials based on participant feedback. Next steps include a beta-test for feasibility and a randomized controlled trial for efficacy. IMPLICATIONS: This is the first study to design and adapt a financial incentives intervention promoting smoking cessation among Alaska Native or American Indian (ANAI) peoples and the first to involve the family system. Feedback from this formative work was used to develop a meaningful family-level incentive structure with ANAI people who smoke and family members and ensure intervention messaging is supportive and culturally aligned. The results provide qualitative knowledge that can inform future family-based interventions with ANAI communities, including our planned randomized controlled trial of the intervention.
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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.
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Fibrosis Pulmonar Idiopática , Medicare , Humanos , Masculino , Anciano , Estados Unidos , Femenino , Indoles/uso terapéutico , Atención a la Salud , Fibrosis Pulmonar Idiopática/tratamiento farmacológico , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
OBJECTIVE: This study aims to assess the costs of a Same-Day Discharge Enhanced Recovery Pathway (SDD) for diverting loop ileostomy closure compared to a standard institutional enhanced recovery protocol (ERP). SUMMARY BACKGROUND DATA: Every year, 50,155 patients in the United States undergo temporary stoma reversal. While ambulatory stoma closure has shown promise, widespread adoption remains slow. This study builds on previous research, focusing on the costs of a novel SDD protocol introduced in 2020. METHODS: A retrospective case-control study was conducted at Mayo Clinic, Rochester, Minnesota, and Mayo Clinic, Jacksonville, Florida, comparing patients undergoing same-day discharge diverting loop ileostomy closure (SDD) from August 2020 to February 2023 to those in a matched cohort receiving standard inpatient ERP. Patients were matched based on age, sex, ASA score, surgery period, and hospital. Primary outcomes included direct hospitalization and additional costs in the 30 days post-discharge. RESULTS: The SDD group (n=118) demonstrated a significant reduction in median index episode hospitalization and 30-day post-operative costs compared to the inpatient group (n=236), with savings of $4,827 per patient. Complication rates were similar, and so were readmission and reoperation rates. CONCLUSIONS: Implementation of the SDD for diverting loop ileostomy closure is associated with substantial cost savings without compromising patient outcomes. The study advocates for a shift towards same-day discharge protocols, offering economic benefits and potential improvements in healthcare resource utilization.
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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.
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The Deterioration Index (DI) is an automatic early warning system that utilizes a machine learning algorithm integrated into the electronic health record and was implemented to improve risk stratification of inpatients. Our pilot implementation showed superior diagnostic accuracy than standard care. A score >60 had a specificity of 88.5% and a sensitivity of 59.8% (PPV 0.1758, NPP 0.9817). However, acceptance in the clinical workflow was divided; nurses preferred standard care, while providers found it helpful.
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Algoritmos , Registros Electrónicos de Salud , Humanos , Pacientes Internos , Aprendizaje Automático , Flujo de TrabajoRESUMEN
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.
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Servicios de Laboratorio Clínico , Pacientes , Humanos , Estudios Retrospectivos , Algoritmos , Aprendizaje AutomáticoRESUMEN
Importance: Implementing multidisciplinary teams for treatment of complex brain tumors needing awake craniotomies is associated with significant costs. To date, there is a paucity of analysis on the cost utility of introducing advanced multidisciplinary standardized teams to enable awake craniotomies. Objective: To assess the cost utility of introducing a standardized program of awake craniotomies. Design, Setting, and Participants: A retrospective economic evaluation was conducted at Mayo Clinic Florida. All patients with single, unilateral lesions who underwent elective awake craniotomies between January 2016 and December 2021 were considered eligible for inclusion. The economic perspective of the health care institution and a time horizon of 1 year were considered. Data were analyzed from October 2022 to May 2023. Exposure: Treatment with an awake craniotomy before standardization (2016-2018) compared with treatment with awake craniotomy after standardization (2018-2021). Main Outcomes and Measures: Patient demographics, perioperative, and postoperative outcomes, including length of stay, intensive care (ICU) admission, extent of resection, readmission rates, and 1-year mortality were compared between patients undergoing surgery before and after standardization. Direct medical costs were estimated from Medicare reimbursement rates for all billed procedures. A cost-utility analysis was performed considering differences in direct medical costs and in 1-year mortality within the periods before and after standardization of procedures. Uncertainty was explored in probability sensitivity analysis. Results: A total of 164 patients (mean [SD] age, 49.9 [15.7] years; 98 [60%] male patients) were included in the study. Of those, 56 underwent surgery before and 108 after implementation of procedure standardization. Procedure standardization was associated with reductions in length of stay from a mean (SD) of 3.34 (1.79) to 2.46 (1.61) days (difference, 0.88 days; 95% CI, 0.33-1.42 days; P = .002), length of stay in ICU from a mean (SD) of 1.32 (0.69) to 0.99 (0.90) nights (difference, 0.33 nights; 95% CI, 0.06-0.60 nights; P = .02), 30-day readmission rate from 14% (8 patients) in the prestandardization cohort to 5% (5 patients) (difference, 9%; 95% CI, 19.6%-0.3%; P = .03), while extent of resection and intraoperative complication rates were similar between both cohorts. The standardized protocol was associated with mean (SD) savings of $7088.80 ($12â¯389.50) and decreases in 1-year mortality (dominant intervention). This protocol was found to be cost saving in 75.5% of all simulations in probability sensitivity analysis. Conclusions and Relevance: In this economic evaluation of standardization of awake craniotomy, there was a generalized reduction in length of stay, ICU admission time, and direct medical costs with implementation of an optimized protocol. This was achieved without compromising patient outcomes and with similar extent of resection, complication rates, and reduced readmission rates.
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Medicare , Vigilia , Estados Unidos , Humanos , Anciano , Masculino , Persona de Mediana Edad , Femenino , Estudios Retrospectivos , Instituciones de Atención Ambulatoria , CraneotomíaRESUMEN
BACKGROUND: Appropriate time for ejection fraction (EF) reassessment after revascularization in patients with left ventricular dysfunction has not been investigated comprehensively, although 3 months after revascularization is recommended to stratify the risk of sudden cardiac death (SCD). HYPOTHESIS: EF reassessed within different timeframe after revascularization may have incosistent contribution for risk stratification of SCD. METHODS: Patients who had EF ≤ 40% before revascularization and had EF reassessment at least once during follow-up were included. The role of early (<3 months) versus late (3-12 months) EF measurements in prediction of all-cause mortality and SCD were compared. RESULTS: A total of 1589 patients were identified. EF reassessed <3 months was lower than EF reassessed within 3-12 months (42.1 ± 9.7% vs. 45.8 ± 10.8%; p < .01). Among 1069 patients who had EF reassessed <3 months, EF ≤ 35% was associated with a higher risk of all-cause mortality (hazard ratio [HR], 1.67; 95% confidence interval [CI], 1.22-2.29; p < .01), but had no association with the risk of SCD (HR, 1.44; 95% CI, 0.84-2.48; p = .18). By contrast, among 595 patients who had EF reassessed within 3-12 months, EF ≤ 35% was associated with higher risks of both all-cause death (HR, 1.81; 95% CI, 1.06-3.10; p = .03) and SCD (HR, 2.71; 95% CI, 1.31-5.61; p < .01). The relative contribution of SCD to all-cause death was higher in patients with EF ≤ 35% than patients with EF > 35% when EF was reassessed within 3-12 months (p = .04). However, when EF was reassessed <3 months, the mode of death was similar in patients with EF ≤ 35% versus >35% (p = .85). CONCLUSIONS: 3 to 12 months after revascularization may be appropriate for cardiac function reassessment and SCD risk stratification.
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Desfibriladores Implantables , Disfunción Ventricular Izquierda , Humanos , Volumen Sistólico , Factores de Riesgo , Muerte Súbita Cardíaca/etiología , Muerte Súbita Cardíaca/prevención & control , Medición de Riesgo , Desfibriladores Implantables/efectos adversosRESUMEN
BACKGROUND: The Surgery in Early Metastatic Seminoma (SEMS) trial examined retroperitoneal lymph node dissection as first-line treatment for patients with isolated 1-3 cm retroperitoneal lymphadenopathy. To date, the standard of care for these patients has been either chemotherapy or radiotherapy. Herein, we evaluated the relative cost-effectiveness of these management strategies. METHODS: A microsimulation model assessed the cost-effectiveness of retroperitoneal lymph node dissection, chemotherapy, and radiotherapy for stage IIA seminoma. Sensitivity analyses were performed to evaluate model robustness. Retroperitoneal lymph node dissection recurrence probabilities were obtained from the SEMS trial. All other probability and utility values were obtained from published literature. Primary outcomes included costs from a commercial insurer's perspective, effectiveness (quality adjusted life-years [QALYs]), and incremental cost-effectiveness ratios using a willingness-to-pay threshold of $100â000/QALY. RESULTS: At a lifetime horizon, the mean costs per patient for retroperitoneal lymph node dissection, radiotherapy, and chemotherapy were $58â469, $98â783, and $104â096, and the mean QALYs were 40.61, 40.70, and 39.15, respectively. Retroperitoneal lymph node dissection was found to be the most cost-effective approach because of high costs and accrued disutility of chronic toxicities associated with radiotherapy (cost-effectiveness ratios = $433â845/QALY) and chemotherapy (dominated). On 1-way sensitivity analyses, retroperitoneal lymph node dissection was no longer cost-effective if the probabilities of infertility and cardiovascular toxicity after radiotherapy were less than 13% and 16%, respectively, or if the 2-year probability of progression after retroperitoneal lymph node dissection was more than 26%. CONCLUSIONS: Retroperitoneal lymph node dissection was the most cost-effective treatment approach for stage IIA seminoma. These findings support clinical guideline consideration of including retroperitoneal lymph node dissection as a treatment option for well-selected patients with stage IIA seminoma.
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Seminoma , Neoplasias Testiculares , Humanos , Masculino , Análisis Costo-Beneficio , Escisión del Ganglio Linfático , Seminoma/radioterapia , Seminoma/cirugía , Neoplasias Testiculares/radioterapia , Neoplasias Testiculares/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate and compare the financial burden of various surgical interventions for the management of benign prostatic hyperplasia (BPH). METHODS: We identified commercially insured men with a diagnosis of BPH who underwent a procedure of interest (simple prostatectomy (SP), transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HoLEP), photovaporization of the prostate (PVP), prostatic urethral lift (PUL), or water vapor thermal therapy (WVTT)) between 2015 and 2021 with the OptumLabs Data Warehouse. Primary outcome was total health care costs (THC) which included both patient out-of-pocket (OOP) and health plan paid costs for the index procedure and combined follow-up years 1-5. A generalized linear model was used to estimate adjusted costs controlling for demographic and clinical characteristics. Patients undergoing WVTT were excluded from extended follow-up analyses due to limited data. RESULTS: Among 25,407 patients with BPH, 10,117 (40%) underwent TURP, 6353 (25%) underwent PUL, 5411 (21%) underwent PVP, 1319 (5%) underwent SP, 1243 (5%) underwent WVTT, and 964 (4%) underwent HoLEP. Index procedure costs varied significantly with WVTT being the least costly [THC: $2637 (95% confidence interval (CI): $2513-$2761)], and SP being the costliest [THC: $14,423 (95% CI: $12,772-$16,075)]. For aggregate index and 5-year follow-up costs, HoLEP ($31,926 [95% CI: $29,704-$34,148]) was the least costly and PUL ($36,596 [95% CI: $35,369-37,823]) was the costliest. CONCLUSION: BPH surgical treatment is associated with significant system-level health care costs. The level of impact varies between procedures. Minimally invasive options, such as WVTT, may offer initial cost reductions; however, HoLEP and SP are associated with lower follow-up costs.
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Hiperplasia Prostática , Resección Transuretral de la Próstata , Masculino , Humanos , Gastos en Salud , Hiperplasia Prostática/cirugía , Próstata , Prostatectomía , VaporRESUMEN
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.
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Registros Electrónicos de Salud , Adulto , Humanos , Femenino , Persona de Mediana Edad , Masculino , Proyectos Piloto , Estudios de Cohortes , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
OBJECTIVES: Machine learning (ML)-based emulators improve the calibration of decision-analytical models, but their performance in complex microsimulation models is yet to be determined. METHODS: We demonstrated the use of an ML-based emulator with the Colorectal Cancer (CRC)-Adenoma Incidence and Mortality (CRC-AIM) model, which includes 23 unknown natural history input parameters to replicate the CRC epidemiology in the United States. We first generated 15,000 input combinations and ran the CRC-AIM model to evaluate CRC incidence, adenoma size distribution, and the percentage of small adenoma detected by colonoscopy. We then used this data set to train several ML algorithms, including deep neural network (DNN), random forest, and several gradient boosting variants (i.e., XGBoost, LightGBM, CatBoost) and compared their performance. We evaluated 10 million potential input combinations using the selected emulator and examined input combinations that best estimated observed calibration targets. Furthermore, we cross-validated outcomes generated by the CRC-AIM model with those made by CISNET models. The calibrated CRC-AIM model was externally validated using the United Kingdom Flexible Sigmoidoscopy Screening Trial (UKFSST). RESULTS: The DNN with proper preprocessing outperformed other tested ML algorithms and successfully predicted all 8 outcomes for different input combinations. It took 473 s for the trained DNN to predict outcomes for 10 million inputs, which would have required 190 CPU-years without our DNN. The overall calibration process took 104 CPU-days, which included building the data set, training, selecting, and hyperparameter tuning of the ML algorithms. While 7 input combinations had acceptable fit to the targets, a combination that best fits all outcomes was selected as the best vector. Almost all of the predictions made by the best vector laid within those from the CISNET models, demonstrating CRC-AIM's cross-model validity. Similarly, CRC-AIM accurately predicted the hazard ratios of CRC incidence and mortality as reported by UKFSST, demonstrating its external validity. Examination of the impact of calibration targets suggested that the selection of the calibration target had a substantial impact on model outcomes in terms of life-year gains with screening. CONCLUSIONS: Emulators such as a DNN that is meticulously selected and trained can substantially reduce the computational burden of calibrating complex microsimulation models. HIGHLIGHTS: Calibrating a microsimulation model, a process to find unobservable parameters so that the model fits observed data, is computationally complex.We used a deep neural network model, a popular machine learning algorithm, to calibrate the Colorectal Cancer Adenoma Incidence and Mortality (CRC-AIM) model.We demonstrated that our approach provides an efficient and accurate method to significantly speed up calibration in microsimulation models.The calibration process successfully provided cross-model validation of CRC-AIM against 3 established CISNET models and also externally validated against a randomized controlled trial.
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Adenoma , Neoplasias Colorrectales , Humanos , Incidencia , Calibración , Neoplasias Colorrectales/diagnóstico , Redes Neurales de la Computación , Adenoma/diagnósticoRESUMEN
STUDY OBJECTIVE: Increasing evidence suggests that hysterectomy to treat uterine fibroids (UFs), even with ovarian conservation (OC), is associated with a 33% increased risk of coronary artery disease (CAD). We sought to compare the cost-effectiveness of various treatment approaches for UFs to understand the trade-offs among development of CAD vs new fibroids. DESIGN: We developed a Markov model to include women with UFs who no longer desired pregnancy. The outcomes of interest were quality-adjusted life-years (QALYs) and total treatment costs. We conducted sensitivity analyses to test the effect of uncertain model inputs. SETTING: Health system perspective. PATIENTS: A hypothetical cohort of 10 000 40-year-old women. INTERVENTIONS: Myomectomy, hysterectomy with OC, and hysterectomy without OC. MEASUREMENTS AND MAIN RESULTS: Myomectomy was the best-value strategy, costing US$528 217 and providing 19.38 QALYs. Neither hysterectomy with OC nor hysterectomy without OC was found to be cost-effective, assuming a willingness-to-pay threshold of $100 000 per QALY gain as hysterectomy with OC provided more benefit than myomectomy at an average cost of $613 144 to gain one additional QALY. The sensitivity analyses showed that if the risk of new symptomatic UFs that required treatment after myomectomy was more than 13%, annually (base case, 3.6%), or the quality of life after myomectomy was less than 0.815 (base case, 0.834), then myomectomy would no longer be cost-effective, under a willingness-to-pay amount of US$100 000. CONCLUSION: Myomectomy is an optimal treatment of UFs compared with hysterectomy among women aged 40 years. The increased risk of CAD after hysterectomy and its associated costs and the effects on morbidity and quality of life made hysterectomy a costlier and less effective long-term strategy.
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Leiomioma , Embolización de la Arteria Uterina , Miomectomía Uterina , Neoplasias Uterinas , Embarazo , Humanos , Femenino , Miomectomía Uterina/efectos adversos , Análisis Costo-Beneficio , Neoplasias Uterinas/terapia , Calidad de Vida , Resultado del Tratamiento , Leiomioma/cirugía , Histerectomía/efectos adversos , Embolización de la Arteria Uterina/efectos adversosRESUMEN
PURPOSE: In response to the COVID-19 pandemic, many cancer practices rapidly adopted telehealth services. However, there is a paucity of data regarding ongoing telehealth visit utilization beyond this initial response. The purpose of this study was to assess changes in variables associated with telehealth visit utilization over time. METHODS: This is a cross-sectional, year-over-year, retrospective analysis of telehealth visits conducted across a multisite, multiregional cancer practice in the United States. Multivariable models examined the association of patient- and provider-level variables with telehealth utilization across outpatient visits conducted over three 8-week periods from July to August in 2019 (n = 32,537), 2020 (n = 33,399), and 2021 (n = 35,820). RESULTS: The rate of telehealth utilization increased from <0.01% (2019) to 11% (2020) to 14% (2021). The most significant patient-level factors associated with increased telehealth utilization included nonrural residence and age ≤65 years. Among patients residing in rural settings, video visit utilization rates were significantly lower and phone visit utilization rates were significantly higher compared with patients from nonrural residences. Regarding provider-level factors, widening differences in telehealth utilization were observed at tertiary versus community-based practice settings. Increased telehealth utilization was not associated with duplicative care as per-patient and per-physician visit volumes in 2021 remained consistent with prepandemic levels. CONCLUSION: We observed continuous expansion in telehealth visit utilization from 2020 to 2021. Our experiences suggest that telehealth can be integrated into cancer practices without evidence of duplicative care. Future work should examine sustainable reimbursement structures and policies to ensure accessibility of telehealth as a means to facilitate equitable, patient-centered cancer care.