Value in Health
○ Elsevier BV
Preprints posted in the last 90 days, ranked by how well they match Value in Health's content profile, based on 11 papers previously published here. The average preprint has a 0.01% match score for this journal, so anything above that is already an above-average fit.
Trigg, L. A.; Schmeising-Barnes, N.; Dix, C.; Angus, C.; Tsuchiya, A.
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Background Conventional cost-effectiveness analysis assumes societal indifference to the distribution of health gains across potential patients, yet evidence suggests public preferences vary between concentrating and dispersing benefits, depending on the size of health gain. The handful of Person Trade-Off (PTO) studies that explored this did not examine the cognitive mechanisms and rationales underlying the PTO tasks. Objectives To qualitatively investigate how individuals conceptualise and justify trade-off decisions within a PTO task designed to elicit distributional preferences regarding healthcare benefits. Methods Following a pilot phase (n=10), online cognitive debrief interviews (n=10) were conducted with UK adults using a think-aloud protocol and concurrent verbal probing. Participants completed an interactive, web-based PTO task that presented choices between concentrating larger health gains among fewer recipients or dispersing smaller gains across a larger population. Data were analysed using codebook thematic analysis. Results Six primary themes emerged across two categories: decision-making processes and decision drivers. Participants displayed varying degrees of moral discomfort, utilizing cognitive mechanisms ranging from strict mathematical logic (QALY maximisation) to emotion-driven heuristics. Key decision drivers included patient age, quality of survival, societal productivity, and strong death aversion. Participants frequently rejected pure QALY maximisation and held strong egalitarian preferences to give every patient a chance to receive treatment. Conclusion Public perspectives on benefit distribution are highly heterogeneous and shaped by complex normative values rather than pure health maximisation. Understanding these qualitative rationales is essential for isolating genuine distributional preferences from cognitive shortcuts, aiding health technology assessment bodies in evaluating equity weights.
Gomez-Guillen, D.; Fernandez-Lopez, D.; Cerquides, J.; Arcos, J. L.; Diaz, M.
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Background: Cost-effectiveness analyses (CEA) built on simulation models are usually delivered through project-specific scripts. Each new model, and often each new question, rebuilds the same scaffolding: parameter management, calibration, base-case analysis, sensitivity analysis and export. This is costly, and is where traceability between an estimate and the model version producing it is lost. We present THALASSA, a web application providing this infrastructure once, for any model satisfying a small programming contract. Methods: A simulation model is connected by one file implementing a fixed contract of R functions that determine its behaviour. THALASSA exposes the complete CEA workflow in a browser: a generated overview of the connected model, parameter editing, calibration, base-case comparison with the efficiency curve, and deterministic and probabilistic sensitivity analysis at a willingness-to-pay threshold, each with timestamped file export carrying the parameter values it was run with. Every session is bound to a repository version, so results carry their generating model version. Results: We demonstrate THALASSA on two public models of contrasting difficulty: a simple tutorial model and a generic cancer screening model with two competing natural-history pathways and a 21-dimensional calibration deliberately built to be more complex. Both ran on the same unmodified setup, implementing the same contract, with no code changes. Conclusions: Separating analysis infrastructure from model logic makes the CEA workflow reusable across projects and reproducible by construction. A modelling team can move from a versioned repository to audit-ready, exportable CEA outputs without writing analysis code. The integration effort does not grow with model size and one installation serves unrelated projects.
Han, S.; Starasvetskaya, N.; Terrero, G.; Hosein, P.; de Lima Lopes Junior, G.
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Abstract Introduction: Daraxonrasib is the first broad RAS-targeted medicine approved for metastatic pancreatic adenocarcinoma. In RASolute 302, it approximately doubled median overall survival in the prespecified RAS G12 population. The US wholesale acquisition cost (WAC) is $39,800 per 30-day supply. Contemporary oncology launch prices have risen substantially, and many recently launched drugs have been priced above value-based benchmarks. The value of a genuinely transformative oncology therapy at this price is uncertain. Objective: To estimate the cost-effectiveness of daraxonrasib compared with investigators-choice chemotherapy in previously treated metastatic pancreatic adenocarcinoma using publicly available clinical and economic data. Design, Setting, and Participants: Economic evaluation using a 3-state partitioned survival model informed by the international randomized phase 3 RASolute 302 trial. Published Kaplan-Meier curves and numbers at risk were used to reconstruct pseudo-individual patient data. The RAS G12 population (n=459), corresponding to the trials dual primary efficacy end points, was the primary economic population; the overall randomized population (n=500) was analyzed in parallel. Analyses were conducted in 2026 from a US health sector perspective. Exposures: Daraxonrasib 300 mg orally once daily versus investigators-choice chemotherapy, weighted to the observed trial regimen distribution. Main Outcomes and Measures: Incremental life-years, quality-adjusted life-years (QALYs), costs, incremental cost-effectiveness ratio (ICER), incremental net monetary benefit, and the 30-day daraxonrasib price consistent with willingness-to-pay thresholds of $100,000, $150,000, $200,000, and $255,000/QALY. Costs were expressed in 2026 US dollars and discounted at 3% annually. Results: In the RAS G12 population, daraxonrasib generated 0.652 additional life-years and 0.506 additional QALYs at an incremental cost of $253,171, yielding an ICER of $500,637/QALY. The corresponding overall-population ICER was $542,255/QALY. A 10-year horizon changed the RAS G12 ICER to $497,270/QALY; using curve-specific distributions selected by Akaike information criterion produced $493,895/QALY. In 5000 probabilistic simulations, the probability of cost-effectiveness was 0% at $150,000 and $200,000/QALY and 0.1% at $255,000/QALY. Threshold prices in the RAS G12 population were $14,060 per 30 days at $150,000/QALY and $17,730 at $200,000/QALY, reductions of 64.7% and 55.5% from WAC. An independent secondary implementation using separately digitized survival curves and piecewise-exponential extrapolation produced a higher ICER; after calibrating drug exposure to observed treatment duration, the estimate remained approximately $676,000/QALY, with most of the difference attributable to the extrapolated treatment-exposure tail. Conclusions and Relevance: Daraxonrasib nearly doubled median overall survival in previously treated metastatic pancreatic adenocarcinoma, in which median survival with standard chemotherapy was about 7 months, and should remain available to eligible patients. At WAC, daraxonrasib costs approximately $500,000 per QALY, well above conventional US benchmarks. Because actual net acquisition prices may reflect confidential discounts or rebates, the ICER based on WAC may exceed the ICER at the net price. Threshold list prices consistent with $150,000-$200,000/QALY were $14,060-$17,730 per 30 days (a 55%-65% reduction from WAC), offered as reference points for pricing and coverage discussions rather than recommended prices.
Creeden, J.; Olivecrona, M.; Benavent, N.; Hladun Alvaro, R.; Valero-Arrese, L.; Carolina Torres, A.; Soriano, A.
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Background. Comprehensive genomic reports in oncology contain complex molecular information that must be translated into concise summaries for treating clinicians. Manual summarisation is time-intensive, and robust evidence supporting AI-assisted summarisation systems remains limited. We evaluated whether AI-generated summaries were non-inferior to manually produced summaries in faithfully representing information from tertiary paediatric cancer genomics reports. Methods. QNOMX-VHIR-CPSP-001 Phase 1 was a single-site, non-interventional clinical performance study conducted at Vall d'Hebron Institut de Recerca under ISO 20916:2019. De-identified tertiary paediatric cancer genomics reports were summarised using both the AI-assisted system under evaluation and the standard manual workflow. Three qualified raters assessed both summary types against the source reports using the six-domain, five-point Quality Summary Index (QSI) in a blinded, counterbalanced crossover design with a minimum fourteen-day washout. Co-primary endpoints were composite content and presentation scores. Non-inferiority was assessed using a pre-specified Bayesian hierarchical model with a margin of 0.5 points and confirmed using a frequentist linear mixed model. Results. Thirty-seven of 38 planned cases contributed 74 paired evaluations. Mean content scores were similar between AI-generated and manual summaries (4.01 vs 3.97), whereas AI-generated summaries achieved higher presentation scores (4.39 vs 4.12). Non-inferiority was demonstrated for both co-primary endpoints: content +0.05 (95% CrI -0.18 to +0.28), presentation +0.28 (+0.10 to +0.47). Frequentist analyses were concordant. Accuracy was the only QSI dimension for which Bayesian non-inferiority was not concluded. Inter-rater reliability was low across all QSI domains. Conclusions. AI-generated summaries were non-inferior to manually produced summaries for both content and presentation endpoints in tertiary paediatric oncology genomics reports. Presentation scores were higher for AI-generated summaries, whereas content scores were comparable between approaches. Low inter-rater reliability limits confidence in the dimension-level estimates and is the main constraint on future validation studies. Clinical validity and workflow effect were not assessed.
Brodsky, S.; Matlin, O.
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Improving primary care is a long-standing strategy to constrain health care spending. Yet, evaluations of primary care models focused on payment reform have shown minimal effects on total cost of care. We report the results from a large-scale, real-world evaluation of an advanced primary care model that restructures access through same-day and next-day appointments, on-demand video visits, asynchronous clinician messaging, and extended hours. Using a stacked-cohort difference-in-differences design with entropy balancing and inverse probability of censoring weighting, we analyzed multi-payer claims covering April 2022 through March 2025. Advanced primary care use was associated with an 8.6% reduction in total cost of care (-$729 per patient per year; P = 0.004), driven by lower specialist cost (-$939/year; P < 0.001) and, to a lesser degree, by reductions in inpatient (-$134/year; P < 0.001), urgent care (-$70/year; P < 0.001), and emergency department cost (-$16/year; P = 0.02), partially offset by higher primary care cost (+$350/year; P < 0.001). The specialist reduction was concentrated in knowledge-based consultative encounters (-$663/year; P < 0.001), while procedural specialist cost was largely unchanged (-$276/year; P = 0.09). Cost differences emerged in the first post-index month. These findings suggest that advanced primary care may reduce total health care spending, with observed savings driven primarily by lower spending on consultative specialty care.
Shamim, F.; Hussain, R. A.
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Background: Extended-reality simulation is widely used for technical surgical training, yet immediate gains do not establish that skills persist once practice stops. Objective: To characterize delayed technical-skill outcomes after virtual, augmented, or mixed-reality training and estimate the comparative effect at the first eligible uncontaminated delayed assessment. Methods: PubMed/MEDLINE, Europe PMC, CENTRAL, ERIC, and ClinicalTrials.gov were searched from inception through May 5, 2026. Eligible studies enrolled surgical learners or practitioners, used virtual, augmented, or mixed reality for technical training, and measured objective performance at least seven days later. Pure retention was distinguished from maintenance and reacquisition. One endpoint per independent study family was selected. Standardized mean differences were expressed as Hedges' g, oriented so positive values favored extended reality. Paule-Mandel random effects with Hartung-Knapp confidence intervals were primary. Results: Thirty-four reports representing 33 studies (1,186 participants; 21 randomized trials) from 12 countries were included. Six studies (162 participants in selected arms) were pooled. The summary effect was g = 1.39 (95% CI -0.94 to 3.72; I2 = 88.0%;{tau} 2= 4.53); the 95% prediction interval was -5.04 to 7.81. Excluding the figure-derived estimate reduced the effect to g = 0.61 (95% CI -0.76 to 1.99). GRADE certainty for the primary outcome was very low. No pooled study assessed an interval of 90 days or longer. Conclusions: Delayed technical advantages after extended-reality simulation were observed in some settings, but the comparative evidence does not define a precise or generalizable retention effect. Substantial heterogeneity, sparse transfer and longer-term evidence, comparator differences, and influence from one figure-derived estimate warrant cautious interpretation. Keywords: augmented reality; extended reality; meta-analysis; mixed reality; skill retention; surgical simulation; virtual reality
Reza, L.; Arbai, Z.; Ward, H.; Payne, L.; Kinross, J.; Patel, V.
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Background Virtual hospital (VH) pathways support early discharge through remote monitoring, but limited evidence has hindered implementation in colorectal surgery. This study aimed to define patient- and carer-relevant outcomes and experiences of VH following colorectal surgery. Methodology A patient and public involvement and engagement (PPIE) consultation was conducted with 8 participants (7 patients, 1 carer; 4 women, 4 men) who had experienced VH following bowel resection at a high-volume robotic unit. Purposive sampling ensured that 50% of participants had experienced readmission. The 90-minute session was delivered via Microsoft Teams. Data were analysed using reflexive thematic analysis. Results Seven themes were identified: readmission, remote monitoring, carer burden, recovery, equity, readiness for discharge, and information delivery. Patients supported early discharge when remote monitoring enabled timely detection of complications and readmission pathways were efficient. Readmission was not perceived as failure but as appropriate escalation. Dissatisfaction with readmission was related to delays in emergency care. Remote monitoring provided psychological safety, with patients feeling held at home. Carers assumed substantial, often unrecognised, quasi-clinical roles. Recovery was defined by return to function rather than length of stay. Equity concerns were evident, with VH favouring those with adequate support at home, digital literacy, and language proficiency. Discharge readiness was both clinical and psychological. Information delivery at discharge was often poorly retained and requires reinforcement preoperatively at every encounter with patients and carers. Conclusions VH pathways are acceptable and valued. Readmission is a marker of system responsiveness rather than failure of early discharge on VH. Psychological preparedness, carer support, and equitable access are critical to successful and scalable implementation of early discharge using a virtual hospital.
Hamdan, M.; Harati, A.; Al-Bakheet, A.; Fuetterer, I.; Alshaer, I.
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Objective: To evaluate decision concordance between commercially available multimodal large language models (LLMs), resident doctors, and senior-surgeon ground truth for surgical indication and spinal level in degenerative lumbar spine disease. Methods: We retrospectively analyzed 147 consecutive patients. Each case included clinical documentation and MRI presented as two composite PNG images. Two resident doctors and three multimodal LLMs (GPT 5.5, Claude Sonnet 4.6, Gemini 3.1 Pro) independently assessed operative versus conservative management and, if operative, the surgical level. Analyses used Cochran's Q, McNemar tests with Holm correction, and Bayesian methods. Results: LLMs achieved higher therapy-decision accuracy (66.0%-68.0%; 97-100/147) than residents (54.4%; 80/147) but over-recommended surgery. Conditional level accuracy when surgery was correctly indicated was 71.4% (20/28) for residents versus 33.3%-41.1% for LLMs. Conclusion: Off-the-shelf multimodal LLMs approximate human performance for binary surgical indication but remain inferior for precise level localization. These results establish a practice-relevant baseline of spatial reasoning limitations for tools already used by patients and junior doctors.
Banerjee, J.; Chen, C.-C.; Styche, T.
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Background: CAMPs (cellular and acellular matrix products) can facilitate wound closure and improve clinical outcomes in patients with diabetic lower extremity ulcers (DLEU), however, there is a lack of comparative data between different CAMPs. The objective of this study was to use real-world evidence to compare the clinical and economic outcomes of hospital care for DLEU patients treated with a minimally manipulated human umbilical tissue (STRAVIX{lozenge}) or other acellular CAMPs. Methods: This retrospective analysis was conducted on patients with DLEU treated with the CAMPs using data from the Premier PINC AI Healthcare Database. Each patient's earliest inpatient encounter was designated as the index admission. The analysis groups included a cellular human umbilical tissue allograft (STRAVIX) and four different acellular CAMPs (aCAMPs). To balance baseline covariates, inverse probability of treatment weighting (IPTW) was applied. Subsequently, IPTW-adjusted generalized linear models were utilized to estimate healthcare-related outcomes and hospital-related costs. Results: 2,626 DLEUs patients with STRAVIX and 10,002 DLEUs patients with aCAMPs were identified. Compared to the patients treated with aCAMPs, the patients who had STRAVIX in addition to standard of care had significantly lower odds of having an infection reaction, dehiscence, minor and major amputations, after index admission discharge. The number of DLEU related follow-up visits was 17-23% lower, debridement related visits were 19-23% lower and the incidence of all-cause readmission was 22-25% lower in Stravix patients compared to aCAMP patients. The length of hospital stay days was 3% lower and the cost of all-cause visits was 20-25% lower in STRAVIX treated patients compared to aCAMP patients. Conclusion: This large data set demonstrates improved clinical outcomes in patients who had STRAVIX in addition to standard surgical management, when compared to certain acellular CAMPs.
Yin, C.; Wang, Y.; Jiang, L.; Huang, X.; Zhang, Z.; Jing, Z.
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Importance: Social connection is routinely recorded in surgical cohorts but rarely analyzed as an exposure, leaving its prognostic value unsummarized. Objective: To determine whether weaker preoperative social connection is associated with adverse postoperative outcomes. Data Sources: PubMed/MEDLINE, Embase, Scopus, Web of Science, CINAHL, PsycInfo, CENTRAL; inception to July 17, 2026; 33,301 records, 20,399 after deduplication. Study Selection: Studies of adults undergoing surgery with preoperatively ascertained social connection analyzed against a protocol-listed outcome; of 1,550 reports assessed, 454 reports of 445 studies were included. Data Extraction and Synthesis: PRISMA and MOOSE reporting; PROSPERO CRD420261449181. Estimate selection followed a frozen, direction-blind hierarchy; k denotes analysis weight units. Random-effects models used restricted maximum likelihood (REML) with modified Hartung-Knapp intervals; risk of bias, result-level Quality in Prognosis Studies (QUIPS); certainty, prognostic Grading of Recommendations Assessment, Development and Evaluation (GRADE). Artificial intelligence agents screened and extracted; 2 reviewers unblinded to their output confirmed all 39 principal-analysis estimate records. Main Outcomes and Measures: Postoperative all-cause survival (primary); early postoperative mortality, non-home discharge, unplanned readmission, any or major complications (secondary). Results: Poolable estimates came from 72 of 445 studies, mostly of marital status. Each principal analysis included up to 63,779 to 298,340 patients or procedures (upper bounds; cohorts recur across outcomes, so no overall total). For the primary outcome, postoperative survival, the confidence interval (CI) included 1 (9 units; hazard ratio, 1.37; 95% CI, 0.99-1.89; certainty very low). Weaker connection was associated with early postoperative mortality (8 units; odds ratio, 1.50; 95% CI, 1.12-2.01; certainty low) and non-home discharge (9 units; OR, 1.95; 95% CI, 1.35-2.81; certainty low). CIs included 1 for unplanned readmission (9 units; OR, 1.14; 95% CI, 0.98-1.33; certainty low) and complications (4 units; OR, 1.10; 95% CI, 0.96-1.25; certainty very low). All estimable prediction intervals included the null. No eligible study estimated the association with failure to rescue. Conclusions and Relevance: Preoperative social connection is a potential prognostic signal with substantial uncertainty. The largest association concerned discharge destination, partly shaped by the exposure itself, supporting early identification of support needs, not candidacy restriction. Whether changing social connection alters outcomes was not directly evaluated.
Leonhardt, C.; Birrer, D.; Stauffer, M. F.; Toti, J. M. A.; Gallagher, I. J.; Skipworth, R. J. E.; Laird, B.; Kuemmerli, C.
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Importance Non-inferiority trials are becoming increasingly popular in abdominal surgery. The non- inferiority margin is critical in the interpretation and conclusion of these trials. Objective This systematic review aims to assess the methodological and reporting quality of non- inferiority randomized controlled trials in abdominal surgery. Evidence Review Non-inferiority trials were systematically identified by searching Ovid Medline, Embase and the CENTRAL databases from 2006 until December 2025. Randomized controlled trials in adult patients with any type of abdominal surgical intervention in at least one trial arm and a sample size greater than or equal to 100 were eligible for inclusion. The primary outcome was the definition of the non- inferiority margin. Secondary outcomes were the reporting of the non-inferiority margin, the robustness of its estimation, the uncertainty of the point estimate and the adequacy of conclusions. Findings A total of 11 045 trials were identified, of which 101 were eligible, enrolling 44 370 patients. Most trials provided a rationale for the non-inferiority design, while six (5.9%) trials did not. Previous literature was commonly used (n=56; 55.4%), but the non-inferiority margin was most often based on a clinical fixed margin or on historical comparison of the treatment and the active comparator. Based on the margin, investigators tolerated substantially worse outcomes of the treatment compared to the comparator. Conclusions were appropriate based on the confidence interval and the predefined non- inferiority margin in 88 (87.1%) of trials. The clinical judgement of the conclusion was overall adequate. Confidence interval estimations were reported in 16 (15.8%) of trials. Simulation studies were limited by the reporting quality. Conclusions and Relevance Clinical fixed margins are commonly used in abdominal surgery non-inferiority randomized controlled trials, however, substantial shortcomings in reporting limit the interpretability and reproduction of study findings. Based on the findings of this study, guidance on surgical- specific non-inferiority margin definitions is needed.
Goodfellow, L.; Young, G. T. B.; van Leeuwen, E.; Lambach, P.; Jit, M.; Eggo, R. M.; Procter, S. R.
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Abstract Background Estimates of the healthcare costs associated with influenza treatment are essential for cost-effectiveness analyses that inform preventative and treatment strategies such as vaccination and non-pharmaceutical interventions. Existing evidence varies across treatment settings, age groups, and countries and there is little data from low- and middle-income settings. Methods We conducted an umbrella review of systematic reviews and meta-analyses reporting direct admitted and non-admitted hospitalisation costs of seasonal influenza treatment in children, adults, and older people. We supplemented an evidence gap with a systematised review of studies reporting adult non-admitted treatment costs. Costs were extracted and adjusted to 2023 USD. We fitted a Bayesian mixed-effects model to estimate influenza treatment costs using national economic indicators, age group, and treatment setting as a priori predictors. We predicted admitted and non-admitted treatment costs for children, adults, and older people in 195 countries and territories. Results Seven reviews were included in the umbrella review, supplemented by 17 primary studies for adult non-admitted care. Extracted data points most frequently described admitted treatment costs and came from high-income countries. The best-fitting model used healthcare expenditure per capita to predict treatment costs, with country-level random effects. Estimated costs increased with healthcare expenditure per capita, were higher for admitted than non-admitted care, and were highest for adults and lowest for children. Conclusions This study provides novel estimates of influenza-associated healthcare costs across age groups and treatment settings by synthesising the available global evidence. By extrapolating to settings without data, our estimates can inform future economic evaluation studies of influenza interventions worldwide.
Howran, J.; Sharma, A.; Andrews, K.; Pople McCord, D.; Salim, S. K.; Janka, D.; Ynoe Moraes, F.; Goldie, K.; Babiolakis, C.; Alkins, R.; Taslimi, S.; Pasarikovski, C.; Ebinu, J.; Cook, D. J.; Levy, R.; Purzner, J.; Purzner, T.
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Objective: To evaluate whether entrepreneurial methodologies applied to system-wide healthcare redesign were associated with improved survival, care timeliness, and rural-urban equity among patients with glioblastoma. Design: Non-randomized pre-post cohort study Setting: Tertiary neuro-oncology centre in Ontario, Canada Participants: Adults aged >18 years with histologically confirmed glioblastoma who underwent surgical resection between January 1, 2018, and February 28, 2025 Interventions: Implementation of the Integrative Brain Tumor Program (IBTP), a system-wide care intervention grounded in user-defined priorities and developed using a design thinking approach (empathize, define, ideate, prototype, test) integrated with operational frameworks adapted from early-stage innovation. System change was treated as a deliberate, deployable intervention that could be designed, launched, iteratively refined, and evaluated. Coordinated changes were embedded across healthcare services within existing infrastructure and resource constraints through a single centralized nurse navigator who standardized referrals, patient education, and real-time care coordination. Main Outcomes and Measures: Primary outcomes were one-year overall survival and time to postoperative MRI completion and radiotherapy initiation. Secondary outcomes assessed rural-urban equity in these measures. Associations were evaluated using Cox proportional hazards and Fine-Gray competing-risk models adjusted for age, sex, rurality, MGMT promoter methylation status, and calendar time. Results: Among 297 patients (244 pre-implementation, 53 post-implementation), baseline demographic and tumor characteristics were similar across cohorts. One-year overall survival was higher in the post-implementation cohort (60.4% vs 42.2%), corresponding to an adjusted hazard ratio of 0.61 (95% CI, 0.38-0.99). Postoperative MRI completion within 48 hours increased from 45.9% to 66.0% (adjusted cause-specific hazard ratio, 1.50; 95% CI, 1.05-2.14) with similar improvements observed at 7 days. Time to radiotherapy initiation did not differ between cohorts. Survival and MRI timeliness did not differ by rural or urban residence in either period, though rural radiotherapy delays were attenuated postimplementation. Conclusions: Systematic application of entrepreneurial methods to health system redesign was associated with clinically meaningful improvements in glioblastoma survival and care timeliness using minimal resources (single nurse navigator). These findings suggest that treating system change as an intervention grounded in user-defined priorities and oriented toward integrated systems rather than sequential process optimization can support sustainable transformation of complex, coordination-dependent care pathways and warrants evaluation in other disease settings.
Lee, F. G.; Choudhary, A.; Li-Han, L. Y.; Dale, E. L.; Bankes, A. C.; Varghese, C.; Anderson, S. S.; Habermann, E. B.; Etzioni, D. A.; McLaughlin, S. A.; Salehinejad, H.; Thiels, C. A.
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BackgroundEvaluating fairness in artificial intelligence (AI) is essential before clinical implementation to prevent unintended harm across diverse patient populations. This study assesses performance differences of an image-based surgical site infection (SSI) detection model across age, gender, geography, race, and skin color. MethodsModel development/validation study using retrospective, multicenter data across surgical subspecialties from adults who submitted an image of their incision via the electronic health record within 30 days of their procedure between 2019-2024. Area under receiver operating curve (AUROC) was compared by age (<55 vs. [≥]55 years old), gender (male vs. female), geography (Rochester, Minnesota vs. Jacksonville, Florida vs. Scottsdale, Arizona vs. regional Minnesota/Wisconsin areas), race (White/Caucasian vs. non-White/Caucasian), and skin color (Fitpatrick I-III vs. IV-VI and Monk A-E vs. F-J). ResultsTraining data contained 13,702 images from 4,274 patients between 2019-2022 (50.1% [≥]55 years old; 63.2% female; 91.6% White/Caucasian; 58.5% Rochester, 17.3% Florida, 10.5% Arizona; 96.3% light skin tone), of which 1,348 images (9.8%) had an SSI. No differences in SSI detection existed for age, gender, race, or skin color (AUROC 0.83-0.87, p>0.09), however geographical differences were significant: lowest AUROC 0.83 (95% CI 0.77-0.88) vs. highest AUROC 0.87 (95% CI 0.84-0.89, p=0.01). Temporal validation using 4,242 images from 1,353 patients between 2022-2023 showed intact fairness across subgroups ({Delta}AUROC [≤]0.06) except geography ({Delta}AUROC [≤]0.16). ConclusionsThe model behaved fairly across age, gender, race, and skin color, however geographical differences persisted. These findings have practical implications underscoring the importance of evaluating bias in clinical AI before deployment.
Kamine, T. H.; Townsend, J.; Fakhry, S. M.; Jabbour, N.; Kelly, E.
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Introduction: Hospitals face increasing financial pressures. Hospital reimbursement is tied to the Case Mix Index (CMI). The CMI is a measure of complexity of care provided by the hospital and the total reimbursement is the CMI multiplied by a base pay factor, multiplied by the total number of discharges from the hospital. The few studies in the literature have involved logistically complex attempts to improve documentation. We sought to determine whether limited, structured chart review by surgeons can improve CMI in a multihospital system. Methods: We performed a prospective, observational study in a four-hospital academic medical system on all surgical patients from 10/2022 to 7/2026. Two clinically busy trauma surgeons performed limited structured chart reviews for select surgical patients. In the limited intervention period (1/2024-9/2024) this focused only on the trauma division. In the full intervention period (10/2024-7/2026) expanded to all surgical patients across the system. The main outcome was surgical case mix index (CMI). Results: A total of 35,695 patients were included (13,811 pre-intervention, 9,337 limited intervention, 12,547 full intervention). CMI increased significantly among surgical patients across the whole system (2.68 (95%CI 2.65-2.71) to 2.87 (95%CI 2.82-2.92) to 2.97 (95%CI 2.93-3.01), ANOVA p <0.001). Overall length of stay was unchanged among surgical patients across the whole system. The estimated increase in revenue per patient attributable to this intervention was $3,912 in surgical patients across the system. Conclusion: Having trauma surgeons review targeted surgical patients for high value documentation capture significantly enhanced the CMI and estimated revenue of surgical services across a multi-hospital integrated health system. Such documentation reviews may represent a practical method to improve hospital documentation and revenue.
von Bechtolsheim, F.; Kolb, N.; Bodenstedt, S.; Speidel, S.; Merboth, F.; Hasanovic, J.; Weikert, L.; Radulova-Mauersberger, O.; Buck, N.; La Rosee, F.; Krause-Juettler, G.; Weitz, J.; Distler, M.; Oehme, F.
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Background: Robust evidence linking individual surgeon technical performance to patient outcomes in complex minimally invasive surgery remains scarce. Crowd-sourced video assessment offers a scalable alternative to expert review, but its clinical relevance in complex oncologic procedures such as robot-assisted minimally invasive esophagectomy (RAMIE) is unestablished. Methods: In this exploratory study, video recordings of 60 consecutive RAMIE procedures performed by 7 surgeons (2018-2023) were segmented into five representative surgical steps and rated by 93 blinded crowd-raters per segment using a modified GEARS instrument. Tertiles were used to compare top-performing operations and steps against the remaining two terciles for overall and step-specific performance, and associations with perioperative outcomes were analyzed. Results: Top-tercile overall performance was associated with significantly shorter operative time (abdominal, thoracic, and total) and less intraoperative blood loss (all p<0.05), without differences in postoperative outcomes. In exploratory step-specific analyses, top-tertile performance during infracarinal lymphadenectomy was associated with significantly fewer surgical complications (30.0% vs 60.0%; p=0.028), fewer severe surgical complications (25.0% vs 52.5%; p=0.043), and higher lymph node yield (22.8 vs 18.9; p=0.037), while the purse-string suture step showed the broadest operative-time benefit. These step-specific findings are hypothesis-generating and were not adjusted for multiple testing. Conclusion: Crowd-sourced video assessment enables scalable, step-specific evaluation of surgical performance in RAMIE associated with intraoperative blood loss and operative time. Exploratory analyses suggest that the relationship between technical performance and clinical outcomes might be step-specific, with infracarinal lymphadenectomy emerging as risky step linked to postoperative morbidity. These findings support further investigation of individualized performance assessment for quality improvement and risk stratification.
de Araujo, F. A. S.; Ikawa, J. N. R.; Lima, A. d. S.; Bernz, L. M.; CORREIA, L. R.
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Background: Lean Healthcare has been adopted as an approach to reducing waste, enhancing process efficiency, and optimizing clinical and administrative workflows. However, empirical evaluations aimed at establishing a causal relationship between Lean Healthcare interventions and outcomes remain limited. This evidence gap is particularly pronounced in the context of large-scale implementations in low- and middle-income countries, where more efficient allocation could yield substantial improvements in population health. Methods: We conducted an impact evaluation study employing a staggered difference-in-differences approach to estimate the effects of the Lean Healthcare in Emergency Departments (ED) initiative in the Brazilian context. The intervention was implemented between January 2017 and December 2025 across 309 hospitals. We analyzed hospital-level indicators of the number of hospitalizations and the average length of stay (in days) among patients admitted through urgent or emergency pathways. Results: Our estimates suggest that the intervention was associated with an average increase of 38.6 admissions per hospital per month (p = 0.033), corresponding to approximately a 5.9% increase relative to the monthly admission volume. We also observed a reduction of 0.184 days in the average length of stay (p = 0.058), equivalent to an approximately 3.0% decrease in hospitalization time. These effects exhibited distinct temporal dynamics: the effect on the number of hospitalizations emerged gradually and increased with the duration of the intervention, whereas the reduction in length of stay became evident earlier. Conclusion: This study provides evidence of a causal effect of Lean Healthcare implementation in emergency departments on operational performance. The simultaneous increase in admissions and reduction in length of stay suggests improved bed productivity and effective capacity without expanding physical infrastructure. These findings support the use of flow-management methodologies as an effective strategy for mitigating emergency department overcrowding while increasing service capacity.
Fust, K.; Beck, E.; Kohli, M.; Cartier, S.; Weinstein, M. C.; Van de Velde, N.; Joshi, K.
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Background/Objectives: Older adults are at high risk of influenza-related severe disease and complications. HD-IIV, currently recommended for adults [≥]65 years, is egg-based and may be subject to egg-adapted mutations. An mRNA-based vaccine for influenza, mRNA-1010, has been approved by the Food and Drug Administration. Given the clinical benefits observed in mRNA-1010 clinical trials and potential to avoid egg-adapted mutations, this analysis explores the clinical impact of mRNA-1010 compared to HD-IIV in those [≥]65 years in the United States. Methods: This study used a decision-analytic model of influenza infection and downstream outcomes to project influenza burden with each vaccine over a one-year timeframe. Vaccine coverage, HD-IIV vaccine effectiveness (VE) and influenza epidemiology was estimated based upon Centers for Disease Control and Prevention data. The relative VE (rVE) for mRNA-1010 vs. HD-IIV was modelled based on data from the clinical trial and published literature on the impact of egg adaptation. Results: The base-case analysis suggests mRNA-1010 may prevent an additional 232,200 symptomatic influenza infections, 130,000 outpatient cases, 21,100 influenza-related hospitalizations, and 2,200 influenza-related deaths compared to HD-IIV. The number needed to vaccination to prevent one hospitalization was 514 or mRNA-1010 vs no vaccine and 404 for HD-IIV versus no vaccine, for an incremental NNV of 110. Scenario and deterministic sensitivity analyses results indicate that clinical outcomes prevented by mRNA-1010 are most sensitive to influenza incidence and VE. Conclusions: mRNA-1010 may improve protection against influenza in US adults aged [≥]65 years, leading to meaningful reductions in the clinical influenza-related disease burden in older adults.
Cheerie, D.; Pan, A. Y.; Acker, M.; Amburgey, K.; Sidhu, J.; Buckley, L.; Gonorazky, H.; McKinnon, N. K.; McRae, L.; Reuter, M. S.; Vogt, L.; Zahavich, L.; Czarny, T.; Liston, E.; McFadyen, A.; Morgenstern, D. A.; Kalish, B. T.; Axford, M. M.; Deshwar, A. R.; Ivakine, Z.; Dowling, J. J.; Costain, G.
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PurposeTo describe the development of - and outcomes from - an institution-level initiative supporting access to innovative genetic medicines information and opportunities. MethodsWe developed and implemented a Genetic Medicines Patient Assessment Pathway for rare genetic conditions at a large public hospital, with multidisciplinary teams collaborating to evaluate a patients molecular and clinical amenability to experimental and/or to-be-developed genetic medicines (primarily nucleic acid therapeutics). A Genetic Medicines Consult Clinic operating in parallel offered no-cost specialized consultations and counseling to families regarding genetic medicines inquiries and Pathway outcomes. We retrospectively reviewed submissions, decisions, and outcomes over a >2-year period. ResultsA total of 63 submissions were reviewed in the Patient Assessment Pathway. Most submissions were classified as eligible or potentially eligible for at least one genetic medicines approach (42/63; 67%). Recommendations generated 87 discrete actions, such as outreach to potential collaborators (n = 28), offering participation in existing research studies (n = 23), or referral to the Consult Clinic (n = 19). Two patients have been approved for therapeutic program initiation or clinical trial enrolment. ConclusionFindings to date support feasibility and high uptake of a structured, multidisciplinary, medical genetics-led model for assessing patient-level opportunities for genetic medicines.
Rose, A.; Scherer, A.; Gedlinske, A.; Park, A.; Gidengil, C.; Askelson, N.; Lindley, M.; Gebremariam, A.; Pike, J.; Prosser, L.
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Background: While health system costs of COVID-19 are well documented, evidence on out-of-pocket costs to patients and families, including non-medical and time burden, is limited. This study aimed to estimate out-of-pocket medical, non-medical, and time burden of COVID-19 illness directly from patients and caregivers. Methods: Two cross-sectional surveys were fielded to national nonprobability samples of U.S. adults in Fall 2023: a personal burden survey (adult sample) and a caregiver burden survey (child sample). Surveys collected data on care setting, visit duration including travel and wait time, and medical and non-medical out-of-pocket costs. After applying quality-based exclusion criteria, 409 adult sample and 52 child sample responses were analyzed. Results: Over 87% of respondents were insured. Median out-of-pocket medical costs per visit were low, ranging from $5 (emergency department) to $10 (urgent care) in the adult sample, and from $0 (emergency department) to $75 (hospitalization) in the child sample. Median non-medical costs were $28 or less across care settings. Median time spent receiving care ranged from 90 minutes (primary care, child sample) to 300 minutes (emergency department, adult sample). Despite the relatively low reported out-of-pocket costs, COVID-related financial challenges were reported by 34% of the adult sample and 29% of the child sample, with the most common difficulty being paying non-medical bills (11% and 15%, respectively). Twelve percent in both groups reported problems paying COVID-19-related medical bills. Conclusions: In this post-pandemic non-probability sample, individual out-of-pocket costs for COVID-19 illness were relatively modest. However, time burden was substantial and one-third of respondents reported financial hardship. These estimates, including non-medical and time burden not captured in administrative data, can support more robust economic evaluations of COVID-19 prevention and treatment interventions.