Publications

@article{pmid38877668,

title = {Entorhinal vessel density correlates with phosphorylated tau and TDP-43 pathology},

author = {Josu\'{e} Llamas Rodr\'{i}guez and Andr\'{e} J W van der Kouwe and Jan Oltmer and Emma Rosenblum and Nathaniel Mercaldo and Bruce Fischl and Michael Marshall and Matthew P Frosch and Jean C Augustinack},

doi = {10.1002/alz.13896},

issn = {1552-5279},

year  = {2024},

date = {2024-07-01},

urldate = {2024-06-01},

journal = {Alzheimers Dement},

volume = {20},

number = {7},

pages = {4649-4662},

abstract = {INTRODUCTION: The entorhinal cortex (EC) and perirhinal cortex (PC) are vulnerable to Alzheimer\'s disease. A triggering factor may be the interaction of vascular dysfunction and tau pathology.nnMETHODS: We imaged post mortem human tissue at 100 μm with 7 T magnetic resonance imaging and manually labeled individual blood vessels (mean = 270 slices/case). Vessel density was quantified and compared per EC subfield, between EC and PC, and in relation to tau and TAR DNA-binding protein 43 (TDP-43) semiquantitative scores.nnRESULTS: PC was more vascularized than EC and vessel densities were higher in posterior EC subfields. Tau and TDP-43 strongly correlated with vasculature density and subregions with severe tau at the preclinical stage had significantly greater vessel density than those with low tau burden.nnDISCUSSION: These data impact cerebrovascular maps, quantification of subfield vasculature, and correlation of vasculature and pathology at early stages. The ordered association of vessel density, and tau or TDP-43 pathology, may be exploited in a predictive context.nnHIGHLIGHTS: Vessel density correlates with phosphorylated tau (p-tau) burden in entorhinal and perirhinal cortices. Perirhinal area 35 and posterior entorhinal cortex showed greatest p-tau burden but also the highest vessel density in the preclinical phase of Alzheimer\'s disease. We combined an ex vivo magnetic resonance imaging model and histopathology to demonstrate the 3D reconstruction of intracortical vessels and its spatial relationship to the pathology.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38858832,

title = {Emulator-Based Bayesian Calibration of the CISNET Colorectal Cancer Models},

author = {Carlos Pineda-Antunez and Claudia Seguin and Luuk A van Duuren and Amy B Knudsen and Barak Davidi and Pedro Nascimento de Lima and Carolyn Rutter and Karen M Kuntz and Iris Lansdorp-Vogelaar and Nicholson Collier and Jonathan Ozik and Fernando Alarid-Escudero},

doi = {10.1177/0272989X241255618},

issn = {1552-681X},

year  = {2024},

date = {2024-07-01},

urldate = {2024-07-01},

journal = {Med Decis Making},

volume = {44},

number = {5},

pages = {543-553},

abstract = {PURPOSE: To calibrate Cancer Intervention and Surveillance Modeling Network (CISNET)\'s SimCRC, MISCAN-Colon, and CRC-SPIN simulation models of the natural history colorectal cancer (CRC) with an emulator-based Bayesian algorithm and internally validate the model-predicted outcomes to calibration targets.nnMETHODS: We used Latin hypercube sampling to sample up to 50,000 parameter sets for each CISNET-CRC model and generated the corresponding outputs. We trained multilayer perceptron artificial neural networks (ANNs) as emulators using the input and output samples for each CISNET-CRC model. We selected ANN structures with corresponding hyperparameters (i.e., number of hidden layers, nodes, activation functions, epochs, and optimizer) that minimize the predicted mean square error on the validation sample. We implemented the ANN emulators in a probabilistic programming language and calibrated the input parameters with Hamiltonian Monte Carlo-based algorithms to obtain the joint posterior distributions of the CISNET-CRC models\' parameters. We internally validated each calibrated emulator by comparing the model-predicted posterior outputs against the calibration targets.nnRESULTS: The optimal ANN for SimCRC had 4 hidden layers and 360 hidden nodes, MISCAN-Colon had 4 hidden layers and 114 hidden nodes, and CRC-SPIN had 1 hidden layer and 140 hidden nodes. The total time for training and calibrating the emulators was 7.3, 4.0, and 0.66 h for SimCRC, MISCAN-Colon, and CRC-SPIN, respectively. The mean of the model-predicted outputs fell within the 95% confidence intervals of the calibration targets in 98 of 110 for SimCRC, 65 of 93 for MISCAN, and 31 of 41 targets for CRC-SPIN.nnCONCLUSIONS: Using ANN emulators is a practical solution to reduce the computational burden and complexity for Bayesian calibration of individual-level simulation models used for policy analysis, such as the CISNET CRC models. In this work, we present a step-by-step guide to constructing emulators for calibrating 3 realistic CRC individual-level models using a Bayesian approach.nnHIGHLIGHTS: We use artificial neural networks (ANNs) to build emulators that surrogate complex individual-based models to reduce the computational burden in the Bayesian calibration process.ANNs showed good performance in emulating the CISNET-CRC microsimulation models, despite having many input parameters and outputs.Using ANN emulators is a practical solution to reduce the computational burden and complexity for Bayesian calibration of individual-level simulation models used for policy analysis.This work aims to support health decision scientists who want to quantify the uncertainty of calibrated parameters of computationally intensive simulation models under a Bayesian framework.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38738534,

title = {The Impact of Model Assumptions on Personalized Lung Cancer Screening Recommendations},

author = {Kevin Ten Haaf and Koen de Nijs and Giulia Simoni and Andres Alban and Pianpian Cao and Zhuolu Sun and Jean Yong and Jihyoun Jeon and Iakovos Toumazis and Summer S Han and G Scott Gazelle and Chung Ying Kong and Sylvia K Plevritis and Rafael Meza and Harry J de Koning},

doi = {10.1177/0272989X241249182},

issn = {1552-681X},

year  = {2024},

date = {2024-07-01},

urldate = {2024-05-01},

journal = {Med Decis Making},

volume = {44},

number = {5},

pages = {497-511},

abstract = {BACKGROUND: Recommendations regarding personalized lung cancer screening are being informed by natural-history modeling. Therefore, understanding how differences in model assumptions affect model-based personalized screening recommendations is essential.nnDESIGN: Five Cancer Intervention and Surveillance Modeling Network (CISNET) models were evaluated. Lung cancer incidence, mortality, and stage distributions were compared across 4 theoretical scenarios to assess model assumptions regarding 1) sojourn times, 2) stage-specific sensitivities, and 3) screening-induced lung cancer mortality reductions. Analyses were stratified by sex and smoking behavior.nnRESULTS: Most cancers had sojourn times \<5 y (model range [MR]; lowest to highest value across models: 83.5%-98.7% of cancers). However, cancer aggressiveness still varied across models, as demonstrated by differences in proportions of cancers with sojourn times \<2 y (MR: 42.5%-64.6%) and 2 to 4 y (MR: 28.8%-43.6%). Stage-specific sensitivity varied, particularly for stage I (MR: 31.3%-91.5%). Screening reduced stage IV incidence in most models for 1 y postscreening; increased sensitivity prolonged this period to 2 to 5 y. Screening-induced lung cancer mortality reductions among lung cancers detected at screening ranged widely (MR: 14.6%-48.9%), demonstrating variations in modeled treatment effectiveness of screen-detected cases. All models assumed longer sojourn times and greater screening-induced lung cancer mortality reductions for women. Models assuming differences in cancer epidemiology by smoking behaviors assumed shorter sojourn times and lower screening-induced lung cancer mortality reductions for heavy smokers.nnCONCLUSIONS: Model-based personalized screening recommendations are primarily driven by assumptions regarding sojourn times (favoring longer intervals for groups more likely to develop less aggressive cancers), sensitivity (higher sensitivities favoring longer intervals), and screening-induced mortality reductions (greater reductions favoring shorter intervals).nnIMPLICATIONS: Models suggest longer screening intervals may be feasible and benefits may be greater for women and light smokers.nnHIGHLIGHTS: Natural-history models are increasingly used to inform lung cancer screening, but causes for variations between models are difficult to assess.This is the first evaluation of these causes and their impact on personalized screening recommendations through easily interpretable metrics.Models vary regarding sojourn times, stage-specific sensitivities, and screening-induced lung cancer mortality reductions.Model outcomes were similar in predicting greater screening benefits for women and potentially light smokers. Longer screening intervals may be feasible for women and light smokers.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38935989,

title = {Cost-Utility Analysis of Maintenance Pemetrexed Plus Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Non-Small Cell Lung Cancer in Jordan},

author = {Abeer Al Rabayah and Rawan Al Froukh and Razan Sawalha and Maali Al Shnekat and Beate Jahn and Uwe Siebert and Saad M Jaddoua},

doi = {10.1016/j.vhri.2024.101004},

issn = {2212-1102},

year  = {2024},

date = {2024-06-01},

journal = {Value Health Reg Issues},

volume = {43},

pages = {101004},

abstract = {OBJECTIVES: To assess the cost-effectiveness of maintenance pemetrexed plus best supportive care (BSC) in non-small cell lung cancer patients from a Jordanian healthcare system perspective.nnMETHODS: A Markov model with 4 health states was developed to estimate life years, quality-adjusted life-years (QALY), costs, and the incremental cost-utility ratio of pemetrexed plus BSC versus BSC. A lifelong time horizon was used in the base-case analysis. The transition probabilities were estimated from the PARAMOUNT trial, the utility weights were taken from published literature, and costs were based on data and unit costs at King Hussein Cancer Center and the Jordan Food and Drug Administration. Both costs and outcomes were discounted using a 3%. The parameter uncertainty was tested using deterministic and probabilistic sensitivity analyses.nnRESULTS: The base-case analysis showed that pemetrexed plus BSC increased QALYs and cost compared with BSC. Pemetrexed plus BSC leads to incremental 0.255 QALYs and incremental costs of US $30 826, resulting in an incremental cost-utility ratio of US $120 886/QALY. The results were sensitive to changes in the utility estimates during the progression-free health state, the progression health state, and the cost of postprogression medications The probabilistic sensitivity analysis showed that the probability of pemetrexed plus BSC being a cost-effective option compared with BSC is 0 at a threshold of $56 000.nnCONCLUSIONS: Maintenance pemetrexed for non-small cell lung cancer is not a cost-effective option compared with BSC from a healthcare system perspective based on the listed price at a threshold of $56 000/QALY.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38904957,

title = {Duration of New-Onset Depressive Symptoms During Medical Residency},

author = {Erin Kim and Brandy R Sinco and Joan Zhao and Yu Fang and Carrie Cunningham and Elena Frank and Srijan Sen and Amy Bohnert and Tasha M Hughes},

doi = {10.1001/jamanetworkopen.2024.18082},

issn = {2574-3805},

year  = {2024},

date = {2024-06-01},

journal = {JAMA Netw Open},

volume = {7},

number = {6},

pages = {e2418082},

abstract = {IMPORTANCE: The implications of new-onset depressive symptoms during residency, particularly for first-year physicians (ie, interns), on the long-term mental health of physicians are unknown.nnOBJECTIVE: To examine the association between and persistence of new-onset and long-term depressive symptoms among interns.nnDESIGN, SETTING, AND PARTICIPANTS: The ongoing Intern Health Study (IHS) is a prospective annual cohort study that assesses the mental health of incoming US-based resident physicians. The IHS began in 2007, and a total of 105 residency programs have been represented in this national study. Interns enrolled sequentially in annual cohorts and completed follow-up surveys to screen for depression using the 9-item Patient Health Questionnaire-9 (PHQ-9) throughout and after medical training. The data were analyzed from May 2023 to March 2024.nnEXPOSURE: A positive screening result for depression, defined as an elevated PHQ-9 score of 10 or greater (indicating moderate to severe depression) at 1 or more time points during the first postgraduate year of medical training (ie, the intern year).nnMAIN OUTCOMES AND MEASURES: The main outcomes assessed were mean PHQ-9 scores (continuous) and proportions of physicians with an elevated PHQ-9 score (≥10; categorical or binary) at the time of the annual follow-up survey. To account for repeated measures over time, a linear mixed model was used to analyze mean PHQ-9 scores and a generalized estimating equation (GEE) was used to analyze the binary indicator for a PHQ-9 score of 10 or greater.nnRESULTS: This study included 858 physicians with a PHQ-9 score of less than 10 before the start of their internship. Their mean (SD) age was 27.4 (9.0) years, and more than half (53.0% [95% CI, 48.5%-57.5%]) were women. Over the follow-up period, mean PHQ-9 scores did not return to the baseline level assessed before the start of the internship in either group (those with a positive depression screen as interns and those without). Among interns who screened positive for depression (PHQ-9 score ≥10) during their internship, mean PHQ-9 scores were significantly higher at both 5 years (4.7 [95% CI, 4.4-5.0] vs 2.8 [95% CI, 2.5-3.0]; P < .001) and 10 years (5.1 [95% CI, 4.5-5.7] vs 3.5 [95% CI, 3.0-4.0]; P < .001) of follow-up. Furthermore, interns with an elevated PHQ-9 score (≥10) demonstrated a higher likelihood of meeting this threshold during each year of follow-up.nnCONCLUSIONS AND RELEVANCE: In this cohort study of IHS participants, a positive depression screening result during the intern year had long-term implications for physicians, including having persistently higher mean PHQ-9 scores and a higher likelihood of meeting this threshold again. These findings underscore the pressing need to address the mental health of physicians who experience depressive symptoms during their training and to emphasize the importance of interventions to sustain the health of physicians throughout their careers.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38866410,

title = {ROBVALU: a tool for assessing risk of bias in studies about people's values, utilities, or importance of health outcomes},

author = {Samer G Karam and Yuan Zhang and Hector Pardo-Hernandez and Uwe Siebert and Laura Koopman and Jane Noyes and Jean-Eric Tarride and Adrienne L Stevens and Vivian Welch and Zuleika Saz-Parkinson and Brendalynn Ens and Tahira Devji and Feng Xie and Glen Hazlewood and Lawrence Mbuagbaw and Pablo Alonso-Coello and Jan L Brozek and Holger J Sch\"{u}nemann},

doi = {10.1136/bmj-2024-079890},

issn = {1756-1833},

year  = {2024},

date = {2024-06-01},

journal = {BMJ},

volume = {385},

pages = {e079890},

abstract = {People’s values are an important driver in healthcare decision making. The certainty of an intervention’s effect on benefits and harms relies on two factors: the certainty in the measured effect on an outcome in terms of risk difference and the certainty in its value, also known as utility or importance. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) working group has proposed a set of questions to assess the risk of bias in a body of evidence from studies investigating how people value outcomes. However, these questions do not address risk of bias in individual studies that, similar to risk-of-bias tools for other research studies, is required to evaluate such evidence. Thus, the Risk of Bias in studies of Values and Utilities (ROBVALU) tool was developed. ROBVALU has good psychometric properties and will be useful when assessing individual studies in measuring values, utilities, or the importance of outcomes. As such, ROBVALU can be used to assess risk of bias in studies included in systematic reviews and health guidelines. It also can support health research assessments, where the risk of bias of input variables determines the certainty in model outputs. These assessments include, for example, decision analysis and cost utility or cost effectiveness analysis for health technology assessment, health policy, and reimbursement decision making.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38851235,

title = {Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review},

author = {Erica Aranha Suzumura and Bruna de Oliveira Ascef and Fernando Henrique de Albuquerque Maia and Aline Frossard Ribeiro Bortoluzzi and Sidney Marcel Domingues and Natalia Santos Farias and Franciele Cordeiro Gabriel and Beate Jahn and Uwe Siebert and Patricia Coelho de Soarez},

doi = {10.1136/bmjopen-2024-086603},

issn = {2044-6055},

year  = {2024},

date = {2024-06-01},

journal = {BMJ Open},

volume = {14},

number = {6},

pages = {e086603},

abstract = {OBJECTIVES: To map the available methodological guidelines and documents for conducting and reporting benefit-risk assessment (BRA) during health technologies' life cycle; and to identify methodological guidelines for BRA that could serve as the basis for the development of a BRA guideline for the context of health technology assessment (HTA) in Brazil.nnDESIGN: Scoping review.nnMETHODS: Searches were conducted in three main sources up to March 2023: (1) electronic databases; (2) grey literature (48 HTA and regulatory organisations) and (3) manual search and contacting experts. We included methodological guidelines or publications presenting methods for conducting or reporting BRA of any type of health technologies in any context of the technology's life cycle. Selection process and data charting were conducted by independent reviewers. We provided a structured narrative synthesis of the findings.nnRESULTS: From the 83 eligible documents, six were produced in the HTA context, 30 in the regulatory and 35 involved guidance for BRA throughout the technology's life cycle. We identified 129 methodological approaches for BRA in the documents. The most commonly referred to descriptive frameworks were the Problem, Objectives, Alternatives, Consequences, Trade-offs, Uncertainty, Risk and Linked decisions and the Benefit-Risk Action Team. Multicriteria decision analysis was the most commonly cited quantitative framework. We also identified the most cited metric indices, estimation and utility survey techniques that could be used for BRA.nnCONCLUSIONS: Methods for BRA in HTA are less established. The findings of this review, however, will support and inform the elaboration of the Brazilian methodological guideline on BRA for HTA.nnTRIAL REGISTRATION NUMBER: https://doi.org/10.17605/OSF.IO/69T3V.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38845072,

title = {Characteristics of a cost-effective blood test for colorectal cancer screening},

author = {Pedro Nascimento De Lima and Rosita Van Den Puttelaar and Amy B Knudsen and Anne I Hahn and Karen M Kuntz and Jonathan Ozik and Nicholson Collier and Fernando Alarid-Escudero and Ann G Zauber and John M Inadomi and Iris Lansdorp-Vogelaar and Carolyn M Rutter},

doi = {10.1093/jnci/djae124},

issn = {1460-2105},

year  = {2024},

date = {2024-06-01},

journal = {J Natl Cancer Inst},

abstract = {BACKGROUND: Blood-based biomarker tests can potentially change the landscape of colorectal cancer (CRC) screening. We characterize the conditions under which blood test screening would be as effective and cost-effective as annual fecal immunochemical testing (FIT) or decennial colonoscopy.nnMETHODS: We used the three CISNET-Colon models to compare scenarios of no screening, annual FIT, decennial colonoscopy, and a blood test meeting CMS coverage criteria (74% CRC sensitivity and 90% specificity). We varied the sensitivity to detect CRC (74%-92%), advanced adenomas (AAs, 10%-50%), screening interval (1-3 years), and test cost ($25-$500). Primary outcomes included quality-adjusted life-years gained (QALYG) from screening and costs for an US average-risk 45-year-old cohort.nnRESULTS: Annual FIT yielded 125-163 QALYG per 1,000 at a cost of $3,811-5,384 per person, whereas colonoscopy yielded 132-177 QALYG at a cost of $5,375-7,031 per person. A blood test with 92% CRC sensitivity and 50% AA sensitivity yielded 117-162 QALYG if used every three years and 133-173 QALYG if used every year but would not be cost-effective if priced above $125 per test. If used every three years, a $500 blood test only meeting CMS coverage criteria yielded 83-116 QALYG, at a cost of $8,559-9,413 per person.nnCONCLUSION: Blood tests that only meet CMS coverage requirements should not be recommended to patients who would otherwise undergo screening by colonoscopy or FIT due to lower benefit. Blood tests need higher AA sensitivity (above 40%) and lower costs (below $125) to be cost-effective.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38470046b,

title = {The Need to Revise the Model for Face Validity},

author = {Elliot B Tapper and Jagpreet Chhatwal},

doi = {10.14309/ajg.0000000000002696},

issn = {1572-0241},

year  = {2024},

date = {2024-06-01},

journal = {Am J Gastroenterol},

volume = {119},

number = {6},

pages = {1205},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38830442,

title = {Modeling approaches to inform travel-related policies for COVID-19 containment: a scoping review and future directions},

author = {Satoshi Koiso and Eren Gulbas and Lotanna Dike and Nora M Mulroy and Andrea L Ciaranello and Kenneth A Freedberg and Mohammad S Jalali and Allison T Walker and Edward T Ryan and Regina C LaRocque and Emily P Hyle},

doi = {10.1016/j.tmaid.2024.102730},

issn = {1873-0442},

year  = {2024},

date = {2024-06-01},

journal = {Travel Med Infect Dis},

pages = {102730},

abstract = {BACKGROUND: Travel-related strategies to reduce the spread of COVID-19 evolved rapidly in response to changes in the understanding of SARS-CoV-2 and newly available tools for prevention, diagnosis, and treatment. Modeling is an important methodology to investigate the range of outcomes that could occur from different disease containment strategies.nnMETHODS: We examined 43 articles published from December 2019 through September 2022 that used modeling to evaluate travel-related COVID-19 containment strategies. We extracted and synthesized data regarding study objectives, methods, outcomes, populations, settings, strategies, and costs. We used a standardized approach to evaluate each analysis according to 26 criteria for modeling quality and rigor.nnRESULTS: The most frequent approaches included compartmental modeling to examine quarantine, isolation, or testing. Early in the pandemic, the goal was to prevent travel-related COVID-19 cases with a focus on individual-level outcomes and assessing strategies such as travel restrictions, quarantine without testing, social distancing, and on-arrival PCR testing. After the development of diagnostic tests and vaccines, modeling studies projected population-level outcomes and investigated these tools to limit COVID-19 spread. Very few published studies included rapid antigen screening strategies, costs, explicit model calibration, or critical evaluation of the modeling approaches.nnCONCLUSION: Future modeling analyses should leverage open-source data, improve the transparency of modeling methods, incorporate newly available prevention, diagnostics, and treatments, and include costs and cost-effectiveness so that modeling analyses can be informative to address future SARS-CoV-2 variants of concern and other emerging infectious diseases (e.g., mpox and Ebola) for travel-related health policies.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38737790,

title = {Functional hemodynamic imaging markers for the prediction of pathological outcomes in breast cancer patients treated with neoadjuvant chemotherapy},

author = {Bin Deng and Ailis Muldoon and Jayne Cormier and Nathaniel D Mercaldo and Elizabeth Niehoff and Natalie Moffett and Mansi A Saksena and Steven J Isakoff and Stefan A Carp},

doi = {10.1117/1.JBO.29.6.066001},

issn = {1560-2281},

year  = {2024},

date = {2024-06-01},

journal = {J Biomed Opt},

volume = {29},

number = {6},

pages = {066001},

abstract = {SIGNIFICANCE: Achieving pathologic complete response (pCR) after neoadjuvant chemotherapy (NACT) is a significant predictor of increased likelihood of survival in breast cancer patients. Early prediction of pCR is of high clinical value as it could allow personalized adjustment of treatment regimens in non-responding patients for improved outcomes.nnAIM: We aim to assess the association between hemoglobin-based functional imaging biomarkers derived from diffuse optical tomography (DOT) and the pathological outcome represented by pCR at different timepoints along the course of NACT.nnAPPROACH: Twenty-two breast cancer patients undergoing NACT were enrolled in a multimodal DOT and X-ray digital breast tomosynthesis (DBT) imaging study in which their breasts were imaged at different compression levels. Logistic regressions were used to study the associations between DOT-derived imaging markers evaluated after the first and second cycles of chemotherapy, respectively, with pCR status determined after the conclusion of NACT at the time of surgery. Receiver operating characteristic curve analysis was also used to explore the predictive performance of selected DOT-derived markers.nnRESULTS: Normalized tumor HbT under half compression was significantly lower in the pCR group compared to the non-pCR group after two chemotherapy cycles (). In addition, the change in normalized tumor  upon reducing compression from full to half mammographic force was identified as another potential indicator of pCR at an earlier time point, i.e., after the first chemo cycle (). Exploratory predictive assessments showed that AUCs using DOT-derived functional imaging markers as predictors reach as high as 0.75 and 0.71, respectively, after the first and second chemo cycle, compared to AUCs of 0.50 and 0.53 using changes in tumor size measured on DBT and MRI.nnCONCLUSIONS: These findings suggest that breast DOT could be used to assist response assessment in women undergoing NACT, a critical but unmet clinical need, and potentially enable personalized adjustments of treatment regimens.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38353447c,

title = {Society of Radiologists in Ultrasound Consensus Conference Recommendations for Incidental Gallbladder Polyp Management: Interreader Agreement Among 10 Radiologists},

author = {Mark A Anderson and Sarah Mercaldo and Jinjin Cao and Nayla Mroueh and Felipe S Furtado and Rory L Cochran and Ryan Chung and Reece J Goiffon and Madeleine Sertic and Theodore T Pierce and Aoife Kilcoyne and Amirkasra Mojtahed and Anuradha S Shenoy-Bhangle and Onofrio A Catalano and Avinash Kambadakone},

doi = {10.2214/AJR.23.30720},

issn = {1546-3141},

year  = {2024},

date = {2024-05-01},

journal = {AJR Am J Roentgenol},

volume = {222},

number = {5},

pages = {e2330720},

abstract = { The 2022 Society of Radiologists in Ultrasound (SRU) consensus conference recommendations for small gallbladder polyps support management that is less aggressive than earlier approaches and may help standardize evaluation of polyps by radiologists.  The purpose of the present study was to assess the interreader agreement of radiologists in applying SRU recommendations for management of incidental gallbladder polyps on ultrasound.  This retrospective study included 105 patients (75 women and 30 men; median age, 51 years) with a gallbladder polyp on ultrasound (without features highly suspicious for invasive or malignant tumor) who underwent cholecystectomy between January 1, 2003, and January 1, 2021. Ten abdominal radiologists independently reviewed ultrasound examinations and, using the SRU recommendations, assessed one polyp per patient to assign risk category (extremely low risk, low risk, or indeterminate risk) and make a possible recommendation for surgical consultation. Five radiologists were considered less experienced (< 5 years of experience), and five were considered more experienced (≥ 5 years of experience). Interreader agreement was evaluated. Polyps were classified pathologically as nonneoplastic or neoplastic.  For risk category assignments, interreader agreement was substantial among all readers (k = 0.710), less-experienced readers (k = 0.705), and more-experienced readers (k = 0.692). For surgical consultation recommendations, inter-reader agreement was substantial among all readers (k = 0.795) and more-experienced readers (k = 0.740) and was almost perfect among less-experienced readers (k = 0.811). Of 10 readers, a median of 5.0 (IQR, 2.0-8.0), 4.0 (IQR, 2.0-7.0), and 0.0 (IQR, 0.0-0.0) readers classified polyps as extremely low risk, low risk, and indeterminate risk, respectively. Across readers, the percentage of polyps classified as extremely low risk ranged from 32% to 72%; as low risk, from 24% to 65%; and as indeterminate risk, from 0% to 8%. Of 10 readers, a median of zero change to 0 (IQR, 0.0-1.0) readers recommended surgical consultation; the percentage of polyps receiving a recommendation for surgical consultation ranged from 4% to 22%. Of a total of 105 polyps, 102 were nonneo-plastic and three were neoplastic (all benign). Based on readers' most common assessments for nonneoplastic polyps, the risk category was extremely low risk for 53 polyps, low risk for 48 polyps, and indeterminate risk for one polyp; surgical consultation was recommended for 16 polyps.  Ten abdominal radiologists showed substantial agreement for polyp risk categorizations and surgical consultation recommendations, although areas of reader variability were identified.  The findings support the overall reproducibility of the SRU recommendations, while indicating opportunity for improvement.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38353447b,

title = {Society of Radiologists in Ultrasound Consensus Conference Recommendations for Incidental Gallbladder Polyp Management: Interreader Agreement Among 10 Radiologists},

author = {Mark A Anderson and Sarah Mercaldo and Jinjin Cao and Nayla Mroueh and Felipe S Furtado and Rory L Cochran and Ryan Chung and Reece J Goiffon and Madeleine Sertic and Theodore T Pierce and Aoife Kilcoyne and Amirkasra Mojtahed and Anuradha S Shenoy-Bhangle and Onofrio A Catalano and Avinash Kambadakone},

doi = {10.2214/AJR.23.30720},

issn = {1546-3141},

year  = {2024},

date = {2024-05-01},

journal = {AJR Am J Roentgenol},

volume = {222},

number = {5},

pages = {e2330720},

abstract = { The 2022 Society of Radiologists in Ultrasound (SRU) consensus conference recommendations for small gallbladder polyps support management that is less aggressive than earlier approaches and may help standardize evaluation of polyps by radiologists.  The purpose of the present study was to assess the interreader agreement of radiologists in applying SRU recommendations for management of incidental gallbladder polyps on ultrasound.  This retrospective study included 105 patients (75 women and 30 men; median age, 51 years) with a gallbladder polyp on ultrasound (without features highly suspicious for invasive or malignant tumor) who underwent cholecystectomy between January 1, 2003, and January 1, 2021. Ten abdominal radiologists independently reviewed ultrasound examinations and, using the SRU recommendations, assessed one polyp per patient to assign risk category (extremely low risk, low risk, or indeterminate risk) and make a possible recommendation for surgical consultation. Five radiologists were considered less experienced (< 5 years of experience), and five were considered more experienced (≥ 5 years of experience). Interreader agreement was evaluated. Polyps were classified pathologically as nonneoplastic or neoplastic.  For risk category assignments, interreader agreement was substantial among all readers (k = 0.710), less-experienced readers (k = 0.705), and more-experienced readers (k = 0.692). For surgical consultation recommendations, inter-reader agreement was substantial among all readers (k = 0.795) and more-experienced readers (k = 0.740) and was almost perfect among less-experienced readers (k = 0.811). Of 10 readers, a median of 5.0 (IQR, 2.0-8.0), 4.0 (IQR, 2.0-7.0), and 0.0 (IQR, 0.0-0.0) readers classified polyps as extremely low risk, low risk, and indeterminate risk, respectively. Across readers, the percentage of polyps classified as extremely low risk ranged from 32% to 72%; as low risk, from 24% to 65%; and as indeterminate risk, from 0% to 8%. Of 10 readers, a median of zero change to 0 (IQR, 0.0-1.0) readers recommended surgical consultation; the percentage of polyps receiving a recommendation for surgical consultation ranged from 4% to 22%. Of a total of 105 polyps, 102 were nonneo-plastic and three were neoplastic (all benign). Based on readers' most common assessments for nonneoplastic polyps, the risk category was extremely low risk for 53 polyps, low risk for 48 polyps, and indeterminate risk for one polyp; surgical consultation was recommended for 16 polyps.  Ten abdominal radiologists showed substantial agreement for polyp risk categorizations and surgical consultation recommendations, although areas of reader variability were identified.  The findings support the overall reproducibility of the SRU recommendations, while indicating opportunity for improvement.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38805733,

title = {Effects of Low-Level Light Therapy on Resting-State Connectivity Following Moderate Traumatic Brain Injury: Secondary Analyses of a Double-blinded Placebo-controlled Study},

author = {Suk-Tak Chan and Nathaniel Mercaldo and Maria G Figueiro Longo and Jonathan Welt and Arman Avesta and Jarone Lee and Michael H Lev and Eva-Maria Ratai and Michael R Wenke and Blair A Parry and Lynn Drake and Richard R Anderson and Terry Rauch and Ramon Diaz-Arrastia and Kenneth K Kwong and Michael Hamblin and Benjamin J Vakoc and Rajiv Gupta},

doi = {10.1148/radiol.230999},

issn = {1527-1315},

year  = {2024},

date = {2024-05-01},

journal = {Radiology},

volume = {311},

number = {2},

pages = {e230999},

abstract = {Background Low-level light therapy (LLLT) has been shown to modulate recovery in patients with traumatic brain injury (TBI). However, the impact of LLLT on the functional connectivity of the brain when at rest has not been well studied. Purpose To use functional MRI to assess the effect of LLLT on whole-brain resting-state functional connectivity (RSFC) in patients with moderate TBI at acute (within 1 week), subacute (2-3 weeks), and late-subacute (3 months) recovery phases. Materials and Methods This is a secondary analysis of a prospective single-site double-blinded sham-controlled study conducted in patients presenting to the emergency department with moderate TBI from November 2015 to July 2019. Participants were randomized for LLLT and sham treatment. The primary outcome of the study was to assess structural connectivity, and RSFC was collected as the secondary outcome. MRI was used to measure RSFC in 82 brain regions in participants during the three recovery phases. Healthy individuals who did not receive treatment were imaged at a single time point to provide control values. The Pearson correlation coefficient was estimated to assess the connectivity strength for each brain region pair, and estimates of the differences in Fisher -transformed correlation coefficients (hereafter,  differences) were compared between recovery phases and treatment groups using a linear mixed-effects regression model. These analyses were repeated for all brain region pairs. False discovery rate (FDR)-adjusted  values were computed to account for multiple comparisons. Quantile mixed-effects models were constructed to quantify the association between the Rivermead Postconcussion Symptoms Questionnaire (RPQ) score, recovery phase, and treatment group. Results RSFC was evaluated in 17 LLLT-treated participants (median age, 50 years [IQR, 25-67 years]; nine female), 21 sham-treated participants (median age, 50 years [IQR, 43-59 years]; 11 female), and 23 healthy control participants (median age, 42 years [IQR, 32-54 years]; 13 male). Seven brain region pairs exhibited a greater change in connectivity in LLLT-treated participants than in sham-treated participants between the acute and subacute phases (range of  differences, 0.37 [95% CI: 0.20, 0.53] to 0.45 [95% CI: 0.24, 0.67]; FDR-adjusted  value range, .010-.047). Thirteen different brain region pairs showed an increase in connectivity in sham-treated participants between the subacute and late-subacute phases (range of  differences, 0.17 [95% CI: 0.09, 0.25] to 0.26 [95% CI: 0.14, 0.39]; FDR-adjusted  value range, .020-.047). There was no evidence of a difference in clinical outcomes between LLLT-treated and sham-treated participants (range of differences in medians, -3.54 [95% CI: -12.65, 5.57] to -0.59 [95% CI: -7.31, 8.49];  value range, .44-.99), as measured according to RPQ scores. Conclusion Despite the small sample size, the change in RSFC from the acute to subacute phases of recovery was greater in LLLT-treated than sham-treated participants, suggesting that acute-phase LLLT may have an impact on resting-state neuronal circuits in the early recovery phase of moderate TBI. ClinicalTrials.gov Identifier: NCT02233413 © RSNA, 2024 },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38709852,

title = {Challenges of COVID-19 Case Forecasting in the US, 2020-2021},

author = {Velma K Lopez and Estee Y Cramer and Robert Pagano and John M Drake and Eamon B O'Dea and Madeline Adee and Turgay Ayer and Jagpreet Chhatwal and Ozden O Dalgic and Mary A Ladd and Benjamin P Linas and Peter P Mueller and Jade Xiao and Johannes Bracher and Alvaro J Castro Rivadeneira and Aaron Gerding and Tilmann Gneiting and Yuxin Huang and Dasuni Jayawardena and Abdul H Kanji and Khoa Le and Anja M\"{u}hlemann and Jarad Niemi and Evan L Ray and Ariane Stark and Yijin Wang and Nutcha Wattanachit and Martha W Zorn and Sen Pei and Jeffrey Shaman and Teresa K Yamana and Samuel R Tarasewicz and Daniel J Wilson and Sid Baccam and Heidi Gurung and Steve Stage and Brad Suchoski and Lei Gao and Zhiling Gu and Myungjin Kim and Xinyi Li and Guannan Wang and Lily Wang and Yueying Wang and Shan Yu and Lauren Gardner and Sonia Jindal and Maximilian Marshall and Kristen Nixon and Juan Dent and Alison L Hill and Joshua Kaminsky and Elizabeth C Lee and Joseph C Lemaitre and Justin Lessler and Claire P Smith and Shaun Truelove and Matt Kinsey and Luke C Mullany and Kaitlin Rainwater-Lovett and Lauren Shin and Katharine Tallaksen and Shelby Wilson and Dean Karlen and Lauren Castro and Geoffrey Fairchild and Isaac Michaud and Dave Osthus and Jiang Bian and Wei Cao and Zhifeng Gao and Juan Lavista Ferres and Chaozhuo Li and Tie-Yan Liu and Xing Xie and Shun Zhang and Shun Zheng and Matteo Chinazzi and Jessica T Davis and Kunpeng Mu and Ana Pastore Y Piontti and Alessandro Vespignani and Xinyue Xiong and Robert Walraven and Jinghui Chen and Quanquan Gu and Lingxiao Wang and Pan Xu and Weitong Zhang and Difan Zou and Graham Casey Gibson and Daniel Sheldon and Ajitesh Srivastava and Aniruddha Adiga and Benjamin Hurt and Gursharn Kaur and Bryan Lewis and Madhav Marathe and Akhil Sai Peddireddy and Przemyslaw Porebski and Srinivasan Venkatramanan and Lijing Wang and Pragati V Prasad and Jo W Walker and Alexander E Webber and Rachel B Slayton and Matthew Biggerstaff and Nicholas G Reich and Michael A Johansson},

doi = {10.1371/journal.pcbi.1011200},

issn = {1553-7358},

year  = {2024},

date = {2024-05-01},

journal = {PLoS Comput Biol},

volume = {20},

number = {5},

pages = {e1011200},

abstract = {During the COVID-19 pandemic, forecasting COVID-19 trends to support planning and response was a priority for scientists and decision makers alike. In the United States, COVID-19 forecasting was coordinated by a large group of universities, companies, and government entities led by the Centers for Disease Control and Prevention and the US COVID-19 Forecast Hub (https://covid19forecasthub.org). We evaluated approximately 9.7 million forecasts of weekly state-level COVID-19 cases for predictions 1-4 weeks into the future submitted by 24 teams from August 2020 to December 2021. We assessed coverage of central prediction intervals and weighted interval scores (WIS), adjusting for missing forecasts relative to a baseline forecast, and used a Gaussian generalized estimating equation (GEE) model to evaluate differences in skill across epidemic phases that were defined by the effective reproduction number. Overall, we found high variation in skill across individual models, with ensemble-based forecasts outperforming other approaches. Forecast skill relative to the baseline was generally higher for larger jurisdictions (e.g., states compared to counties). Over time, forecasts generally performed worst in periods of rapid changes in reported cases (either in increasing or decreasing epidemic phases) with 95% prediction interval coverage dropping below 50% during the growth phases of the winter 2020, Delta, and Omicron waves. Ideally, case forecasts could serve as a leading indicator of changes in transmission dynamics. However, while most COVID-19 case forecasts outperformed a na\"{i}ve baseline model, even the most accurate case forecasts were unreliable in key phases. Further research could improve forecasts of leading indicators, like COVID-19 cases, by leveraging additional real-time data, addressing performance across phases, improving the characterization of forecast confidence, and ensuring that forecasts were coherent across spatial scales. In the meantime, it is critical for forecast users to appreciate current limitations and use a broad set of indicators to inform pandemic-related decision making.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38713084,

title = {Recent and projected incidence trends and risk of anal cancer among people with HIV in North america},

author = {Ashish A Deshmukh and Yueh-Yun Lin and Haluk Damgacioglu and Meredith Shiels and Sally B Coburn and Raynell Lang and Keri N Althoff and Richard Moore and Michael J Silverberg and Alan G Nyitray and Jagpreet Chhatwal and Kalyani Sonawane and Keith Sigel},

doi = {10.1093/jnci/djae096},

issn = {1460-2105},

year  = {2024},

date = {2024-05-01},

journal = {J Natl Cancer Inst},

abstract = {BACKGROUND: Anal cancer risk is elevated among people with HIV (PWH). Recent anal cancer incidence patterns among PWH in the United States (US) and Canada remain unclear. It is unknown how the incidence patterns may evolve in future years.nnMETHODS: Using data from the North American AIDS Cohort Collaboration on Research and Design, we investigated absolute anal cancer incidence and incidence trends in the US, Canada, and different US regions. We further estimated relative risk compared with persons without HIV, relative risk among various subgroups, and projected future anal cancer burden among US PWH.nnRESULTS: During 2001-2016, in the US, age-standardized anal cancer incidence declined 2.2%/year (95%CI=-4.4% to -0.1%), particularly in the Western region (-3.8%/year [95%CI=-6.5% to -0.9%]. In Canada, incidence remained stable. Considerable geographic variation in risk was observed by US regions (eg, over four-fold risk in the Midwest and Southeast compared to the Northeast among men who have sex with men [MSM] with HIV). Anal cancer risk increased with a decrease in nadir CD4 count and was elevated among those with opportunistic illnesses. Anal cancer burden among US PWH is expected to decrease in future years (through 2035), but >70% of cases will continue to occur in MSM with HIV and people with AIDS.nnCONCLUSION: Geographic variation in anal cancer risk and trends may reflect underlying differences in screening practices and HIV epidemic. MSM with HIV and PWH with AIDS will continue to bear most anal cancer burden, highlighting the importance of precision prevention.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38697678,

title = {Efficacy of dual checkpoint inhibitors in a patient with a mixed hepatocellular cholangiocarcinoma},

author = {Santiago Sucre and Andrea Bullock and Mary Linton Peters},

doi = {10.1136/bcr-2023-255003},

issn = {1757-790X},

year  = {2024},

date = {2024-05-01},

journal = {BMJ Case Rep},

volume = {17},

number = {5},

abstract = {A woman in her 60s was diagnosed with a metastatic, unresectable rare histological type of liver cancer; combined hepatocellular cholangiocarcinoma. She had palliative chemotherapy, initially with gemcitabine and cisplatin, and then with oxaliplatin, L-folinic acid and fluorouracil. Both treatment strategies demonstrated disease progression, and somatic mutation profiling revealed no actionable mutations. The patient was started on immuno-oncology (IO) with nivolumab and ipilimumab, followed by maintenance nivolumab. She has achieved a sustained ongoing partial response since the start of this therapy for at least 12 months. The outcome in this patient is in keeping with the growing evidence of the role that IO agents have in metastatic biliary tract cancer and also serves to highlight their importance in mixed histology liver tumours.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38369282,

title = {Acceptability of using Real-World Data to Estimate Relative Treatment Effects in Health Technology Assessments: Barriers and Future Steps},

author = {Manuel Gomes and Alex J Turner and Cormac Sammon and Dalia Dawoud and Sreeram Ramagopalan and Alex Simpson and Uwe Siebert},

doi = {10.1016/j.jval.2024.01.020},

issn = {1524-4733},

year  = {2024},

date = {2024-05-01},

urldate = {2024-05-01},

journal = {Value Health},

volume = {27},

issue = {5},

pages = {623-632},

abstract = {OBJECTIVES: Evidence about the comparative effects of new treatments is typically collected in randomized controlled trials (RCTs). In some instances, RCTs are not possible, or their value is limited by an inability to capture treatment effects over the longer-term or in all relevant population subgroups. In these cases, non-randomized studies (NRS) using real-world data (RWD) are increasingly used to complement trial evidence on treatment effects for health technology assessment (HTA). However, there have been concerns over a lack of acceptability of this evidence by HTA agencies. This paper aims to identify barriers to the acceptance of NRS and steps that may facilitate increases in the acceptability of NRS in the future.nnMETHODS: Opinions of the authorship team based on their experience in real-world evidence research in academic, HTA, and industry settings, supported by a critical assessment of existing studies.nnRESULTS: Barriers were identified that are applicable to key stakeholder groups including HTA agencies (e.g., the lack of comprehensive methodological guidelines for using RWD), evidence-generators (e.g., avoidable deviations from best practices), and external stakeholders (e.g., data controllers providing timely access to high-quality RWD). Future steps that may facilitate future acceptability of NRS include improvements in the quality, integration, and accessibility of RWD, wider use of demonstration projects to highlight the value and applicability of non-randomized designs, living and more detailed HTA guidelines, and improvements in HTA infrastructure relating to RWD.nnCONCLUSION: NRS can represent a crucial source of evidence on treatment effects for use in HTA when RCT evidence is limited.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38607627,

title = {Semaglutide vs Endoscopic Sleeve Gastroplasty for Weight Loss},

author = {Muhammad Haseeb and Jagpreet Chhatwal and Jade Xiao and Pichamol Jirapinyo and Christopher C Thompson},

doi = {10.1001/jamanetworkopen.2024.6221},

issn = {2574-3805},

year  = {2024},

date = {2024-04-01},

journal = {JAMA Netw Open},

volume = {7},

number = {4},

pages = {e246221},

abstract = {IMPORTANCE: Obesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making.nnOBJECTIVE: To assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity.nnDESIGN, SETTING, AND PARTICIPANTS: This economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life.nnINTERVENTIONS: Strategies included treatment with semaglutide and ESG.nnMAIN OUTCOMES AND MEASURES: Costs (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100 000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed.nnRESULTS: The model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595 532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33 583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13 618, would need to be $3591.nnCONCLUSIONS AND RELEVANCE: This study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38336533,

title = {The assessment of quality of care of patients with type 2 diabetes mellitus in a population-based cohort in the District of Landeck in Austria},

author = {Mag Veronika Haslwanter and Ursula Rochau and L\'{a}ra R Hallsson and Uwe Siebert and Hans-Robert Sch\"{o}nherr and Monika Lechleitner and Willi Oberaigner},

doi = {10.1016/j.pcd.2024.01.011},

issn = {1878-0210},

year  = {2024},

date = {2024-04-01},

urldate = {2024-02-01},

journal = {Prim Care Diabetes},

volume = {18},

number = {2},

pages = {163-168},

abstract = {INTRODUCTION: Structured diabetes care based on evidence-based guidelines is one of the main strategies to improve glycemic control and to reduce long-term complications in diabetes mellitus.nnMETHODS: This study is based on the "Diabetes-Landeck Cohort", a population-based cohort of patients with diabetes mellitus type 2 (T2DM). We assessed the quality of diabetes care and compared it between three groups of care units, that is, general practitioners (GP), diabetes specialists in private practice (DSPP), and hospitals (HOSP).nnRESULTS: The total study population comprised 1616 patients with T2DM, including 378 patients of GP, 281 of DSPP, and 957 from HOSP. We identified statistically significant differences: DSPP showed the highest percentage of structured training, sufficient training, eye examinations and foot examinations. The group HOSP showed the highest proportion for increased HbA1c≥ 7.5 and almost all long-term complications surveyed, that is, nephropathy (23.2%), neuropathy (14.4%), diabetic foot (5.1%), and cerebrovascular diseases (10.9%).nnCONCLUSION: This population-based cohort study on patients with T2DM in Austria showed significant differences in important quality-of-care process and outcome parameters across different groups of care units. Future research should also include prediction modeling for early warning and monitoring systems as well as adjustment for patient characteristics and duration and severity of disease.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38492923,

title = {Hepatitis C Elimination in Rwanda: Progress, Feasibility, and Economic Evaluation},

author = {Huaiyang Zhong and Alec Aaron and Lindsey Hiebert and Janvier Serumondo and Yueran Zhuo and Madeline Adee and Gallican N Rwibasira and John W Ward and Jagpreet Chhatwal},

doi = {10.1016/j.jval.2024.03.005},

issn = {1524-4733},

year  = {2024},

date = {2024-03-14},

urldate = {2024-03-01},

journal = {Value Health},

volume = {27},

number = {7},

pages = {918-925},

abstract = {OBJECTIVE: In 2018, Rwanda launched a national program to eliminate the hepatitis C virus (HCV). We aim to assess the impact of the program to date and identify strategies to achieve the World Health Organization\'s HCV elimination goals by 2030.nnMETHODS: We developed a microsimulation model to simulate Rwanda\'s HCV epidemic from 2015 through 2050 and evaluated temporal trends in HCV infection, prevalence, mortality, and the total cost of care for scenarios that could achieve HCV elimination by 2030.nnRESULTS: Between 2018 and 2022, over 7 million people were screened for HCV, and 60,000 were treated. The study projected that Rwanda could achieve HCV elimination as early as 2027. A feasible strategy of an annual screening rate of 15% and a treatment rate of 100% would achieve all WHO elimination goals by 2028, requiring screening an additional 4 million people and treating 23,900 patients by 2030. The elimination strategy costs $25 million for screening and diagnosis and $21 million for treatment from 2015 to 2050. The national program would avert 4,900 hepatocellular carcinoma cases and 6,700 HCV-related deaths and save the health system $25.33 million from 2015 to 2050.nnCONCLUSIONS: Rwanda is poised to become one of the first countries in the world to eliminate HCV. Rwanda\'s program serves as a blueprint for other countries in the African region. By rapid screening and treatment scale-up (e.g., by leveraging HIV platforms) and by drug price negotiations, HCV elimination is not only feasible but can be cost-saving in low-income settings.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38552671,

title = {Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening With a Blood Test That Meets the Centers for Medicare \& Medicaid Services Coverage Decision},

author = {Rosita van den Puttelaar and Pedro Nascimento de Lima and Amy B Knudsen and Carolyn M Rutter and Karen M Kuntz and Lucie de Jonge and Fernando Alarid Escudero and David Lieberman and Ann G Zauber and Anne I Hahn and John M Inadomi and Iris Lansdorp-Vogelaar},

doi = {10.1053/j.gastro.2024.02.012},

issn = {1528-0012},

year  = {2024},

date = {2024-03-01},

journal = {Gastroenterology},

abstract = {BACKGROUND \& AIMS: A blood-based colorectal cancer (CRC) screening test may increase screening participation. However, blood tests may be less effective than current guideline-endorsed options. The Centers for Medicare \& Medicaid Services (CMS) covers blood tests with sensitivity of at least 74% for detection of CRC and specificity of at least 90%. In this study, we investigate whether a blood test that meets these criteria is cost-effective.nnMETHODS: Three microsimulation models for CRC (MISCAN-Colon, CRC-SPIN, and SimCRC) were used to estimate the effectiveness and cost-effectiveness of triennial blood-based screening (from ages 45 to 75 years) compared to no screening, annual fecal immunochemical testing (FIT), triennial stool DNA testing combined with an FIT assay, and colonoscopy screening every 10 years. The CMS coverage criteria were used as performance characteristics of the hypothetical blood test. We varied screening ages, test performance characteristics, and screening uptake in a sensitivity analysis.nnRESULTS: Without screening, the models predicted 77-88 CRC cases and 32-36 CRC deaths per 1000 individuals, costing $5.3-$5.8 million. Compared to no screening, blood-based screening was cost-effective, with an additional cost of $25,600-$43,700 per quality-adjusted life-year gained (QALYG). However, compared to FIT, triennial stool DNA testing combined with FIT, and colonoscopy, blood-based screening was not cost-effective, with both a decrease in QALYG and an increase in costs. FIT remained more effective (+5-24 QALYG) and less costly (-$3.2 to -$3.5 million) than blood-based screening even when uptake of blood-based screening was 20 percentage points higher than uptake of FIT.nnCONCLUSION: Even with higher screening uptake, triennial blood-based screening, with the CMS-specified minimum performance sensitivity of 74% and specificity of 90%, was not projected to be cost-effective compared with established strategies for colorectal cancer screening.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38537159,

title = {Pack-Year Smoking History: An Inadequate and Biased Measure to Determine Lung Cancer Screening Eligibility},

author = {Alexandra L Potter and Nuo N Xu and Priyanka Senthil and Deepti Srinivasan and Hang Lee and G Scott Gazelle and Lydia Chelala and Wei Zheng and Florian J Fintelmann and Lecia V Sequist and Jessica Donington and Julie R Palmer and Chi-Fu Jeffrey Yang},

doi = {10.1200/JCO.23.01780},

issn = {1527-7755},

year  = {2024},

date = {2024-03-01},

journal = {J Clin Oncol},

pages = {JCO2301780},

abstract = {PURPOSE: Pack-year smoking history is an imperfect and biased measure of cumulative tobacco exposure. The use of pack-year smoking history to determine lung cancer screening eligibility in the current US Preventive Services Task Force (USPSTF) guideline may unintentionally exclude many high-risk individuals, especially those from racial and ethnic minority groups. It is unclear whether using a smoking duration cutoff instead of a smoking pack-year cutoff would improve the selection of individuals for screening.nnMETHODS: We analyzed 49,703 individuals with a smoking history from the Southern Community Cohort Study (SCCS) and 22,126 individuals with a smoking history from the Black Women's Health Study (BWHS) to assess eligibility for screening under the USPSTF guideline versus a proposed guideline that replaces the ≥20-pack-year criterion with a ≥20-year smoking duration criterion.nnRESULTS: Under the USPSTF guideline, only 57.6% of Black patients with lung cancer in the SCCS would have qualified for screening, whereas a significantly higher percentage of White patients with lung cancer (74.0%) would have qualified ( < .001). Under the proposed guideline, the percentage of Black and White patients with lung cancer who would have qualified for screening increased to 85.3% and 82.0%, respectively, eradicating the disparity in screening eligibility between the groups. In the BWHS, using a 20-year smoking duration cutoff instead of a 20-pack-year cutoff increased the percentage of Black women with lung cancer who would have qualified for screening from 42.5% to 63.8%.nnCONCLUSION: Use of a 20-year smoking duration cutoff instead of a 20-pack-year cutoff greatly increases the proportion of patients with lung cancer who would qualify for screening and eliminates the racial disparity in screening eligibility between Black versus White individuals; smoking duration has the added benefit of being easier to calculate and being a more precise assessment of smoking exposure compared with pack-year smoking history.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38199940b,

title = {Implementation of a comprehensive clinical risk management system in a university hospital},

author = {Wolfgang Buchberger and Marten Schmied and Michael Schomaker and Anca Del Rio and Uwe Siebert},

doi = {10.1016/j.zefq.2023.11.008},

issn = {2212-0289},

year  = {2024},

date = {2024-03-01},

journal = {Z Evid Fortbild Qual Gesundhwes},

volume = {184},

pages = {18--25},

abstract = {BACKGROUND: Adverse events during hospital treatment are common and can lead to serious harm. This study reports the implementation of a comprehensive clinical risk management system in a university hospital and assesses the impact of clinical risk management on patient harms.nnMETHODS: The clinical risk management system was rolled out over a period of eight years and consisted of a training of interdisciplinary risk management teams, external and internal risk audits, and the implementation of a critical incident reporting system (CIRS). The risks identified during the audits were analyzed according to the type, severity, and implementation of preventive measures. Other key figures of the risk management system were obtained from the annual risk reports. The number of liability cases was used as primary outcome measurement.nnRESULTS: Of the 1,104 risks identified during the risk audits, 56.2% were related to organization, 21.3% to documentation, 15.3% to treatment, and 7.2% to patient information and consent. The highest proportion of serious risks was found in the category organization (22.7%), the lowest in the category documentation (13.6%). Critical incident reporting identified between 241 and 370 critical incidents per year, for which in 79.5% to 83% preventive measures were implemented within twelve months. The frequency of incident reports per department correlated with the number of active risk managers and risk team meetings. Compared with the years prior to the introduction of the clinical risk management system, an average annual reduction of harms by 60.1% (95% CI: 57.1; 63.1) was observed two years after the implementation was completed. On average, the rate of harms dropped by 5% per year for each 10% increase in roll-out of the clinical risk management system (incidence rate ratio: 0.95; 95% CI: 0.93; 0.97) .nnCONCLUSION: The results of this project demonstrate the effectiveness of clinical risk management in detecting treatment-related risks and in reducing harm to patients.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38470046,

title = {The Need to Revise the Model for Face Validity},

author = {Elliot B Tapper and Jagpreet Chhatwal},

doi = {10.14309/ajg.0000000000002696},

issn = {1572-0241},

year  = {2024},

date = {2024-03-01},

journal = {Am J Gastroenterol},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38290142,

title = {Comparative Analysis of Instrumental Variables on the Assignment of Buprenorphine/Naloxone or Methadone for the Treatment of Opioid Use Disorder},

author = {Fahmida Homayra and Benjamin Enns and Jeong Eun Min and Megan Kurz and Paxton Bach and Julie Bruneau and Sander Greenland and Paul Gustafson and Mohammad Ehsanul Karim and P Todd Korthuis and Thomas Loughin and Malcolm MacLure and Lawrence McCandless and Robert William Platt and Kevin Schnepel and Hitoshi Shigeoka and Uwe Siebert and Eugenia Socias and Evan Wood and Bohdan Nosyk},

doi = {10.1097/EDE.0000000000001697},

issn = {1531-5487},

year  = {2024},

date = {2024-03-01},

journal = {Epidemiology},

volume = {35},

number = {2},

pages = {218--231},

abstract = {BACKGROUND: Instrumental variable (IV) analysis provides an alternative set of identification assumptions in the presence of uncontrolled confounding when attempting to estimate causal effects. Our objective was to evaluate the suitability of measures of prescriber preference and calendar time as potential IVs to evaluate the comparative effectiveness of buprenorphine/naloxone versus methadone for treatment of opioid use disorder (OUD).nnMETHODS: Using linked population-level health administrative data, we constructed five IVs: prescribing preference at the individual, facility, and region levels (continuous and categorical variables), calendar time, and a binary prescriber's preference IV in analyzing the treatment assignment-treatment discontinuation association using both incident-user and prevalent-new-user designs. Using published guidelines, we assessed and compared each IV according to the four assumptions for IVs, employing both empirical assessment and content expertise. We evaluated the robustness of results using sensitivity analyses.nnRESULTS: The study sample included 35,904 incident users (43.3% on buprenorphine/naloxone) initiated on opioid agonist treatment by 1585 prescribers during the study period. While all candidate IVs were strong (A1) according to conventional criteria, by expert opinion, we found no evidence against assumptions of exclusion (A2), independence (A3), monotonicity (A4a), and homogeneity (A4b) for prescribing preference-based IV. Some criteria were violated for the calendar time-based IV. We determined that preference in provider-level prescribing, measured on a continuous scale, was the most suitable IV for comparative effectiveness of buprenorphine/naloxone and methadone for the treatment of OUD.nnCONCLUSIONS: Our results suggest that prescriber's preference measures are suitable IVs in comparative effectiveness studies of treatment for OUD.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37991182,

title = {Unspoken Truths: Mental Health Among Academic Surgeons},

author = {Reagan A Collins and Tianna Herman and Rebecca A Snyder and Krista L Haines and Anne Stey and Tania K Arora and Sunil K Geevarghese and Joseph D Phillips and Diego Vicente and Cornelia L Griggs and Imani E McElroy and Anji E Wall and Tasha M Hughes and Srijan Sen and Jaber Valinejad and Andres Alban and J Shannon Swan and Nathaniel Mercaldo and Mohammad S Jalali and Jagpreet Chhatwal and G Scott Gazelle and Erika Rangel and Chi-Fu Jeffrey Yang and Karen Donelan and Jessica A Gold and Colin P West and Carrie Cunningham},

doi = {10.1097/SLA.0000000000006159},

issn = {1528-1140},

year  = {2024},

date = {2024-03-01},

urldate = {2024-03-01},

journal = {Ann Surg},

volume = {279},

issue = {3},

pages = {429-436},

abstract = {OBJECTIVE: To characterize the current state of mental health within the surgical workforce in the United States (US).nnSUMMARY BACKGROUND DATA: Mental illness and suicide is a growing concern in the medical community; however, the current state is largely unknown.nnMETHODS: Cross-sectional survey of the academic surgery community assessing mental health, medical error, and suicidal ideation. The odds of suicidal ideation adjusting for sex, prior mental health diagnosis, and validated scales screening for depression, anxiety, post-traumatic stress disorder (PTSD), and alcohol use disorder were assessed.nnRESULTS: Of 622 participating medical students, trainees, and surgeons (estimated response rate=11.4-14.0%), 26.1% (141/539) reported a previous mental health diagnosis. 15.9% (83/523) of respondents screened positive for current depression, 18.4% (98/533) for anxiety, 11.0% (56/510) for alcohol use disorder, and 17.3% (36/208) for PTSD. Medical error was associated with depression (30.7% vs. 13.3%, P\<0.001), anxiety (31.6% vs. 16.2%, P=0.001), PTSD (12.8% vs. 5.6%, P=0.018), and hazardous alcohol consumption (18.7% vs. 9.7%, P=0.022). 13.2% (73/551) of respondents reported suicidal ideation in the past year and 9.6% (51/533) in the past two weeks. On adjusted analysis, a previous history of a mental health disorder (aOR: 1.97, 95% CI: 1.04-3.65, P=0.033), and screening positive for depression (aOR: 4.30, 95% CI: 2.21-8.29, P\<0.001) or PTSD (aOR: 3.93, 95% CI: 1.61-9.44, P=0.002) were associated with increased odds of suicidal ideation over the past 12 months.nnCONCLUSIONS: Nearly 1 in 7 respondents reported suicidal ideation in the past year. Mental illness and suicidal ideation are significant problems among the surgical workforce in the US.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37814499,

title = {Intracranial arteriosclerosis and the risk of dementia: A population-based cohort study},

author = {Tim C van den Beukel and Frank J Wolters and Uwe Siebert and Wilko Spiering and M Arfan Ikram and Meike W Vernooij and Pim A de Jong and Daniel Bos},

doi = {10.1002/alz.13496},

issn = {1552-5279},

year  = {2024},

date = {2024-02-20},

urldate = {2023-10-01},

journal = {Alzheimers Dement},

volume = {20},

issue = {2},

pages = {869-879},

abstract = {BACKGROUND: The impact of intracranial arteriosclerosis on dementia remains largely unclear.nnMETHODS: In 2339 stroke-free and dementia-free participants (52.2% women, mean age 69.5 years) from the general population, we assessed intracranial carotid artery calcification (ICAC) and vertebrobasilar artery calcification (VBAC) as proxy for arteriosclerosis. Associations with dementia were assessed using Cox models. In addition, indirect effects through cerebral small vessel disease (cSVD) and subcortical brain structure volumes were assessed using causal mediation analyses.nnRESULTS: During a median of 13.4 years (25th-75th percentiles 9.9-14.5) of follow-up, 282 participants developed dementia. Both ICAC presence (hazard ratio [HR]: 1.53, 95% confidence interval [CI]: 1.00-2.32]) and volume (HR per standard deviation: 1.19, 95% CI: 1.01-1.40) increased dementia risk. For VBAC, severe calcifications increased dementia risk (HR for third vs first volume tertile: 1.89, 95% CI: 1.00-3.59). These effects were mediated partly through increased cSVD (percentage mediated for ICAC: 13% and VBAC: 24%).nnDISCUSSION: Intracranial arteriosclerosis increases the risk of dementia.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37463414,

title = {The Rising Costs of Alcohol-associated Liver Disease in the United States},

author = {Jovan Julien and Turgay Ayer and Elliot B Tapper and Jagpreet Chhatwal},

doi = {10.14309/ajg.0000000000002405},

issn = {1572-0241},

year  = {2024},

date = {2024-02-05},

urldate = {2023-07-01},

journal = {Am J Gastroenterol},

volume = {119},

issue = {2},

pages = {270-277},

abstract = {INTRODUCTION: Alcohol-associated liver disease (ALD) is rising in the United States because of an increase in high-risk drinking, but population-level ALD cost is unknown. Our aim was to project the direct and indirect costs associated with ALD in the US population through 2040.nnMETHODS: We utilized a previously validated microsimulation model of alcohol consumption and ALD with model parameters estimated from publicly available data sources, including the National Epidemiologic Survey Alcohol and Related Conditions-III, the Center for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research, the Bureau of Labor Statistics, and published studies informing the impact of alcohol consumption on ALD severity in the United States resident population. The simulated scenario included current and projected ALD-associated costs.nnRESULTS: From 2022-2040, the ALD is projected to cost $880 billion; $355 billion in direct healthcare- related costs and $525 billion in lost labor and economic consumption. The annual cost of ALD is projected to increase from $31 billion in 2022 to $66 billion (118% increase) in 2040. While the female population makes up 29% of these costs in 2022, by 2040 on a per annum basis, female costs would be 43% of the total annual expenditure.nnDISCUSSION: Increased consumption of alcohol in the US population, especially in females, will cause a steep rise in the economic burden of alcohol-associated liver disease in the United States. These findings highlight the need for planners and policymakers to plan for the increased impact of liver disease in the United States.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38353447,

title = {Society of Radiologists in Ultrasound Consensus Conference Recommendations for Incidental Gallbladder Polyp Management: Interreader Agreement Among Ten Radiologists},

author = {Mark A Anderson and Sarah Mercaldo and Jinjin Cao and Nayla Mroueh and Felipe S Furtado and Rory L Cochran and Ryan Chung and Reece J Goiffon and Madeleine Sertic and Theodore T Pierce and Aoife Kilcoyne and Amirkasra Mojtahed and Anuradha S Shenoy-Bhangle and Onofrio A Catalano and Avinash Kambadakone},

doi = {10.2214/AJR.23.30720},

issn = {1546-3141},

year  = {2024},

date = {2024-02-01},

journal = {AJR Am J Roentgenol},

abstract = { The 2022 Society of Radiologists in Ultrasound (SRU) consensus conference recommendations support less-aggressive management of small gallbladder polyps on ultrasound versus earlier approaches and may help standardize polyp evaluation by radiologists.  To assess radiologists' interreader agreement in applying the SRU recommendations for management of incidental gallbladder polyps on ultrasound.  This retrospective study included 105 patients (median age, 52 years; 75 women, 27 men) with a gallbladder polyp on ultrasound (without features highly suspicious for invasive or malignant tumor) who underwent cholecystectomy between January 1, 2003 and January 1, 2021. Ten abdominal radiologists independently reviewed ultrasound examinations and, using SRU recommendations, assessed one polyp per patient for risk category (extremely low-risk, low-risk, or indeterminate risk) and possible recommendation for surgical consultation. Five radiologists were considered less-experienced (<5 years), and five more-experienced (≥5 years). Interreader agreement was evaluated. Polyps were classified pathologically as nonneoplastic or neoplastic.  For risk category assignments, interreader agreement was substantial among all readers (k=0.710), less-experienced readers (k=0.705), and more-experienced readers (k=0.692). For surgical consultation recommendations, interreader agreement was substantial among all readers (k=0.795) and more-experienced readers (kappa=0.740), and almost perfect among less-experienced readers (k=0.811). Of ten readers, a median of 5 (IQR, 2-8), 4 (IQR, 2-7), and 0 (IQR, 0-0) classified polyps as extremely low risk, low risk, and indeterminate risk, respectively. Across readers, the fraction of polyps classified as extremely low risk ranged from 32-72%, as low risk from 24-65%, and as indeterminate risk from 0-8%. Of ten readers, a median of 0 (IQR, 0-1) recommended surgical consultation; the fraction of polyps receiving a surgical consultation recommendation ranged from 4-22%. A total of 102/105 polyps were nonneoplastic; 3/105 were neoplastic (all benign). Based on readers' most-common assessments for the nonneoplastic polyps, the risk category was extremely low risk in 53, low risk in 48, and indeterminate risk in 1; surgical consultation was recommended in 16.  Ten abdominal radiologists showed substantial agreement for polyp risk categorizations and surgical consultation recommendations, although areas of reader variability were identified.  The findings support overall reproducibility of the SRU recommendations, while indicating opportunity for improvement.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38086003,

title = {Cost-Effectiveness Analysis of Screening for Pancreatic Cancer Among High-Risk Populations},

author = {Mary Linton B Peters and Andrew Eckel and Claudia L Seguin and Barak Davidi and David H Howard and Amy B Knudsen and Pari V Pandharipande},

doi = {10.1200/OP.23.00495},

issn = {2688-1535},

year  = {2024},

date = {2024-02-01},

urldate = {2024-02-01},

journal = {JCO Oncol Pract},

volume = {20},

issue = {2},

pages = {278-290},

abstract = {PURPOSE: We evaluated the potential cost-effectiveness of combined magnetic resonance imaging (MRI) and endoscopic ultrasound (EUS) screening for pancreatic ductal adenocarcinoma (PDAC) among populations at high risk for the disease.nnMETHODS: We used a microsimulation model of the natural history of PDAC to estimate the lifetime health benefits, costs, and cost-effectiveness of PDAC screening among populations with specific genetic risk factors for PDAC, including  and , , , Lynch syndrome, , , and . For each high-risk population, we simulated 29 screening strategies, defined by starting age and frequency. Screening included MRI with follow-up EUS in a subset of patients. Costs of tests were based on Medicare reimbursement for MRI, EUS, fine-needle aspiration biopsy, and pancreatectomy. Cancer-related cost by stage of disease and phase of treatment was based on the literature. For each high-risk population, we performed an incremental cost-effectiveness analysis, assuming a willingness-to-pay (WTP) threshold of $100,000 US dollars (USD) per quality-adjusted life year (QALY) gained.nnRESULTS: For men with relative risk (RR) 12.33 () and RR 28 (), annual screening was cost-effective, starting at age 55 and 40 years, respectively. For women, screening was only cost-effective for those with RR 28 (), with annual screening starting at age 45 years.nnCONCLUSION: Combined MRI/EUS screening may be a cost-effective approach for the highest-risk populations (among mutations considered, those with RR \>12). However, for those with moderate risk (RR, 5-12), screening would only be cost-effective at higher WTP thresholds (eg, $200K USD/QALY) or with once-only screening.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38191430,

title = {Planning, implementing and governing systems-based co-creation: the DISCOVER framework},

author = {Niamh Smith and Michail Georgiou and Mohammad S Jalali and Sebastien Chastin},

doi = {10.1186/s12961-023-01076-5},

issn = {1478-4505},

year  = {2024},

date = {2024-01-08},

urldate = {2024-01-01},

journal = {Health Res Policy Syst},

volume = {22},

number = {1},

pages = {6},

abstract = {BACKGROUND: Increasingly, public health faces challenges requiring complex, multifaceted and multi-sectoral responses. This calls for systems-based approaches that facilitate the kind of collective and collaborative thinking and working required to address complexity. While the literature on systems thinking, system dynamics and the associated methodologies is extensive, there remains little clear guidance on how to plan, govern and implement participatory systems approaches within a co-creation process.nnMETHODS: We used a three-step process to develop DISCOVER, a framework for implementing, and governing systems-based co-creation: Stage 1: We conducted a literature analysis of key texts to identify well-documented methods and phases for co-creation using a systems approach, as well as areas where gaps existed. Stage 2: We looked for the most appropriate methods and approaches to fill the gaps in the knowledge production chain. Stage 3: We developed the framework, identifying how the different tools and approaches fit together end-to-end, from sampling and recruiting participants all the way through to responding with an action plan.nnRESULTS: We devised DISCOVER to help guide researchers and stakeholders to collectively respond to complex social, health and wider problems. DISCOVER is a strategic research planning and governance framework that provides an actionable, systematic way to conceptualise complex problems and move from evidence to action, using systems approaches and co-creation. In this article, we introduce the eight-step framework and provide an illustrative case study showcasing its potential. The framework integrates complementary approaches and methods from social network analysis, systems thinking and co-creation literature. The eight steps are followed sequentially but can overlap.nnCONCLUSIONS: DISCOVER increases rigour and transparency in system approaches to tackling complex issues going from planning to action. It is being piloted in environmental health research but may be suitable to address other complex challenges and could be incorporated into research proposals and protocols for future projects.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid39831133,

title = {Participatory Modeling for High Complexity, Multi-System Issues: Challenges and Recommendations for Balancing Qualitative Understanding and Quantitative Questions},

author = {Arielle R Deutsch and Leah Frerichs and Madeline Perry and Mohammad S Jalali},

doi = {10.1002/sdr.1765},

issn = {0883-7066},

year  = {2024},

date = {2024-01-01},

journal = {Syst Dyn Rev},

volume = {40},

number = {4},

abstract = {Community stakeholder participation can be incredibly valuable for the qualitative model development process. However, modelers often encounter challenges for participatory modeling projects focusing on high-complexity, synergistic interactions between multiple issues, systems, and granularity. The diverse stakeholder perspectives and volumes of information necessary for developing such models can yield qualitative models that are difficult to translate into quantitative simulation or clear insight for informed decision-making. There are few reccomended best practices for developing high-complexity, participatory models. We use an ongoing project as a case study to highlight three practical challenges for tackling high-complexity, multi-system issues with system dynamics tools. These challenges include balanced and respectful stakeholder engagement, defining boundaries and levels of variable aggregation, and timing and processes for qualitative/quantitative model integration. Our five recommendations to address these challenges serve as a foundation for further research on methods for developing translatable qualitative multi-system models for informing actions for systemic change.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid39028718,

title = {Cost-effectiveness of applying high-sensitivity troponin I to a score for cardiovascular risk prediction in asymptomatic population},

author = {Paul J\"{u}licher and Nataliya Makarova and Francisco Ojeda and Isabella Giusepi and Annette Peters and Barbara Thorand and Giancarlo Cesana and Torben J\orgensen and Allan Linneberg and Veikko Salomaa and Licia Iacoviello and Simona Costanzo and Stefan S\"{o}derberg and Frank Kee and Simona Giampaoli and Luigi Palmieri and Chiara Donfrancesco and Tanja Zeller and Kari Kuulasmaa and Tarja Tuovinen and Felicity Lamrock and Annette Conrads-Frank and Paolo Brambilla and Stefan Blankenberg and Uwe Siebert},

doi = {10.1371/journal.pone.0307468},

issn = {1932-6203},

year  = {2024},

date = {2024-01-01},

journal = {PLoS One},

volume = {19},

number = {7},

pages = {e0307468},

abstract = {INTRODUCTION: Risk stratification scores such as the European Systematic COronary Risk Evaluation (SCORE) are used to guide individuals on cardiovascular disease (CVD) prevention. Adding high-sensitivity troponin I (hsTnI) to such risk scores has the potential to improve accuracy of CVD prediction. We investigated how applying hsTnI in addition to SCORE may impact management, outcome, and cost-effectiveness.nnMETHODS: Characteristics of 72,190 apparently healthy individuals from the Biomarker for Cardiovascular Risk Assessment in Europe (BiomarCaRE) project were included into a discrete-event simulation comparing two strategies for assessing CVD risk. The standard strategy reflecting current practice employed SCORE (SCORE); the alternative strategy involved adding hsTnI information for further stratifying SCORE risk categories (S-SCORE). Individuals were followed over ten years from baseline examination to CVD event, death or end of follow-up. The model tracked the occurrence of events and calculated direct costs of screening, prevention, and treatment from a European health system perspective. Cost-effectiveness was expressed as incremental cost-effectiveness ratio (ICER) in € per quality-adjusted life year (QALYs) gained during 10 years of follow-up. Outputs were validated against observed rates, and results were tested in deterministic and probabilistic sensitivity analyses.nnRESULTS: S-SCORE yielded a change in management for 10.0% of individuals, and a reduction in CVD events (4.85% vs. 5.38%, p<0.001) and mortality (6.80% vs. 7.04%, p<0.001). S-SCORE led to 23 (95%CI: 20-26) additional event-free years and 7 (95%CI: 5-9) additional QALYs per 1,000 subjects screened, and resulted in a relative risk reduction for CVD of 9.9% (95%CI: 7.3-13.5%) with a number needed to screen to prevent one event of 183 (95%CI: 172 to 203). S-SCORE increased costs per subject by 187€ (95%CI: 177 € to 196 €), leading to an ICER of 27,440€/QALY gained. Sensitivity analysis was performed with eligibility for treatment being the most sensitive.nnCONCLUSION: Adding a person's hsTnI value to SCORE can impact clinical decision making and eventually improves QALYs and is cost-effective compared to CVD prevention strategies using SCORE alone. Stratifying SCORE risk classes for hsTnI would likely offer cost-effective alternatives, particularly when targeting higher risk groups.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid39024212,

title = {Health disparities in cervical cancer: Estimating geographic variations of disease burden and association with key socioeconomic and demographic factors in the US},

author = {Tara Castellano and Andrew K ElHabr and Christina Washington and Jie Ting and Yitong J Zhang and Fernanda Musa and Ezgi Berksoy and Kathleen Moore and Leslie Randall and Jagpreet Chhatwal and Turgay Ayer and Charles A Leath},

doi = {10.1371/journal.pone.0307282},

issn = {1932-6203},

year  = {2024},

date = {2024-01-01},

journal = {PLoS One},

volume = {19},

number = {7},

pages = {e0307282},

abstract = {BACKGROUND: Despite advances in cervical cancer (CC) prevention, detection, and treatment in the US, health disparities persist, disproportionately affecting underserved populations or regions. This study analyzes the geographical distribution of both CC and recurrent/metastatic CC (r/mCC) in the US and explores potential risk factors of higher disease burden to inform potential strategies to address disparities in CC and r/mCC.nnMETHODS: We estimated CC screening rates, as well as CC burden (number of patients with CC diagnosis per 100,000 eligible enrollees) and r/mCC burden (proportion of CC patients receiving systemic therapy not in conjunction with surgery or radiation), at the geographic level between 2017-2022 using administrative claims. Data on income and race/ethnicity were obtained from US Census Bureau's American Community Survey. Brachytherapy centers were proxies for guideline-conforming care for locally advanced CC. Associations among demographic, socioeconomic, and healthcare resource variables, with CC and r/mCC disease burden were assessed.nnRESULTS: Between 2017-2022, approximately 48,000 CC-diagnosed patients were identified, and approximately 10,000 initiated systemic therapy treatment. Both CC and r/mCC burden varied considerably across the US. Higher screening was significantly associated with lower CC burden only in the South. Lower income level was significantly associated with lower screening rates, higher CC and r/mCC burden. Higher proportion of Hispanic population was also associated with higher CC burden. The presence of ≥1 brachytherapy center in a region was significantly associated with a reduction in r/mCC burden (2.7%).nnCONCLUSION: CC and r/mCC disparities are an interplay of certain social determinants of health, behavior, and race/ethnicity. Our findings may inform targeted interventions for a geographic area, and further highlight the importance of guideline-conforming care to reduce disease burden.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37722825b,

title = {Aetiology, ejection fraction and mortality in chronic heart failure: a mediation analysis},

author = {Josef Fritz and Katrin Belovari and Hanno Ulmer and Marc-Michael Zaruba and Moritz Messner and Maria Ungericht and Uwe Siebert and Frank Ruschitzka and Axel Bauer and Gerhard Poelzl},

doi = {10.1136/heartjnl-2023-322803},

issn = {1468-201X},

year  = {2024},

date = {2024-01-01},

journal = {Heart},

volume = {110},

number = {4},

pages = {290--298},

abstract = {OBJECTIVE: Clinical decision making in chronic heart failure (CHF) is based primarily on left ventricular ejection fraction (LVEF), and only secondarily on aetiology of the underlying disease. Our aim was to investigate the mediating role of LVEF in the relationship between aetiology and mortality.nnMETHODS: Using data of 2056 Austrian patients with CHF (mean age 57.2 years; mean follow-up 8.8 years), effects of aetiology on LVEF and overall mortality were estimated using multivariable-adjusted linear and Cox regression models. In causal mediation analyses, we decomposed the total effect of aetiology on mortality into direct and indirect (mediated through LVEF) effects.nnRESULTS: For the analysed aetiologies (dilated (DCM, n=1009) and hypertrophic (HCM, n=89) cardiomyopathy; ischaemic (IHD, n=529) and hypertensive (HHD, n=320) heart disease; cardiac amyloidosis (CA, n=109)), the effect of LVEF on mortality was similar (HR=1.07, 95% CI 1.04 to 1.10; p=0.718). HCM and CA were associated with significantly higher, and IHD and DCM with significantly lower LVEF compared with other aetiologies. Compared with respective other aetiologies, the corresponding total effect HRs for mortality were 0.77 (95% CI 0.67 to 0.89), 0.47 (95% CI 0.25 to 0.88), 1.40 (95% CI 1.21 to 1.62), 0.79 (95% CI 0.67 to 0.95) and 2.36 (95% CI 1.81 to 3.08) for DCM, HCM, IHD, HHD and CA, respectively. CA had the highest mortality despite a HR of 0.74 (95% CI 0.65 to 0.83). For all other aetiologies, <20% of the total mortality effects were mediated through LVEF.nnCONCLUSIONS: The direct effect of aetiology on mortality dominates the indirect effect through LVEF. Therefore, clarification of aetiology is as important as measurement of LVEF.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38218784,

title = {Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project},

author = {Laura Coll-Planas and Aina Carb\'{o}-Carde\~{n}a and Anu Jansson and Vladimira Dost\'{a}lov\'{a} and Alzbeta Bartova and Laura Rautiainen and Annika Kolster and Montse Mas\'{o}-Aguado and Laia Briones-Buixassa and Sergi Blancafort-Alias and Marta Roqu\'{e}-Figuls and Ashby Lavelle Sachs and Cristina Casajuana and Uwe Siebert and Ursula Rochau and Sibylle Puntscher and Iva Holmerov\'{a} and Kaisu H Pitkala and Jill S Litt},

doi = {10.1186/s12889-023-17547-x},

issn = {1471-2458},

year  = {2024},

date = {2024-01-01},

journal = {BMC Public Health},

volume = {24},

number = {1},

pages = {172},

abstract = {BACKGROUND: The negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life.nnMETHODS: This article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN Trial in Barcelona (Spain) is targeting people 18+ from low socio-economic urban areas; the RECETAS-PRG Trial in Prague (Czech Republic) is addressing community-dwelling older adults over 60 years of age, and the RECETAS-HLSNK trial is reaching older people in assisted living facilities. Each trial will recruit 316 adults suffering from loneliness at least sometimes and randomize them to nature-based social interventions called "Friends in Nature" or to the control group. "Friends in Nature" uses modifications of the "Circle of Friends" methodology based on group processes of peer support and empowerment but including activities in nature. Participants will be assessed at baseline, at post-intervention (3 months), and at 6- and 12-month follow-up after baseline. Primary outcomes are the health-related quality-of-life according to 15D measure and The De Jong Gierveld 11-item loneliness scale. Secondary outcomes are health and psychosocial variables tailored to the specific target population. Nature exposure will be collected throughout the intervention period. Process evaluation will explore context, implementation, and mechanism of impact. Additionally, health economic evaluations will be performed.nnDISCUSSION: The three RECETAS trials will explore the effectiveness of nature-based social interventions among lonely people from various ages, social, economic, and cultural backgrounds. RECETAS meets the growing need of solid evidence for programs addressing loneliness by harnessing the beneficial impact of nature on enhancing wellbeing and social connections.nnTRIAL REGISTRATION: Barcelona (Spain) trial: ClinicalTrials.gov, ID: NCT05488496. Registered 29 July 2022. Prague (Czech Republic) trial: ClinicalTrials.gov, ID: NCT05522140. Registered August 25, 2022. Helsinki (Finland) trial: ClinicalTrials.gov, ID: NCT05507684. Registered August 12, 2022.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38199940,

title = {Implementation of a comprehensive clinical risk management system in a university hospital},

author = {Wolfgang Buchberger and Marten Schmied and Michael Schomaker and Anca Del Rio and Uwe Siebert},

doi = {10.1016/j.zefq.2023.11.008},

issn = {2212-0289},

year  = {2024},

date = {2024-01-01},

journal = {Z Evid Fortbild Qual Gesundhwes},

abstract = {BACKGROUND: Adverse events during hospital treatment are common and can lead to serious harm. This study reports the implementation of a comprehensive clinical risk management system in a university hospital and assesses the impact of clinical risk management on patient harms.nnMETHODS: The clinical risk management system was rolled out over a period of eight years and consisted of a training of interdisciplinary risk management teams, external and internal risk audits, and the implementation of a critical incident reporting system (CIRS). The risks identified during the audits were analyzed according to the type, severity, and implementation of preventive measures. Other key figures of the risk management system were obtained from the annual risk reports. The number of liability cases was used as primary outcome measurement.nnRESULTS: Of the 1,104 risks identified during the risk audits, 56.2% were related to organization, 21.3% to documentation, 15.3% to treatment, and 7.2% to patient information and consent. The highest proportion of serious risks was found in the category organization (22.7%), the lowest in the category documentation (13.6%). Critical incident reporting identified between 241 and 370 critical incidents per year, for which in 79.5% to 83% preventive measures were implemented within twelve months. The frequency of incident reports per department correlated with the number of active risk managers and risk team meetings. Compared with the years prior to the introduction of the clinical risk management system, an average annual reduction of harms by 60.1% (95% CI: 57.1; 63.1) was observed two years after the implementation was completed. On average, the rate of harms dropped by 5% per year for each 10% increase in roll-out of the clinical risk management system (incidence rate ratio: 0.95; 95% CI: 0.93; 0.97) .nnCONCLUSION: The results of this project demonstrate the effectiveness of clinical risk management in detecting treatment-related risks and in reducing harm to patients.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37925258,

title = {Association of patient-practitioner sex concordance with specialist referral in primary hyperparathyroidism},

author = {Jordan M Broekhuis and Maria P Cote and Reagan A Collins and Jorge L Gomez-Mayorga and Natalia Chaves and Benjamin C James},

doi = {10.1016/j.surg.2023.08.048},

issn = {1532-7361},

year  = {2024},

date = {2024-01-01},

urldate = {2023-11-01},

journal = {Surgery},

volume = {175},

issue = {1},

pages = {19-24},

abstract = {BACKGROUND: Prior research has demonstrated barriers to the workup and management of primary hyperparathyroidism. As recent data have suggested that patient and practitioner sex concordance is associated with lower surgical complications, we sought to evaluate the effect of sex concordance on referral for primary hyperparathyroidism.nnMETHODS: We queried an institutional database for patients with first-incident hypercalcemia and subsequent biochemical evidence of primary hyperparathyroidism between 2010 and 2018. Primary care practitioner and endocrinologist sex, laboratory values, and complications of primary hyperparathyroidism were collected. Sex concordance (male patient/male practitioner or female patient/female practitioner) was evaluated as a binary predictor of specialist evaluation using logistic regression and Cox proportional hazards modeling.nnRESULTS: Among 1,100 patients, mean age was 62.5 (standard deviation 13.6), and 74% were female sex. Primary care practitioner sex was 52% female, and 63% of patients had sex concordance with their primary care practitioner. Endocrinologist sex was 59% female, and 45% of patients had sex concordance with their endocrinologist. Patients with sex concordance with their primary care practitioner (70 vs 80%, P = .001) and endocrinologist (71 vs 82%, P \< .001) were less likely to be female sex compared to those with discordance. After adjusting for demographics and clinical covariates, those patients with primary care practitioner sex concordance had 32% higher odds of endocrinologist evaluation (odds ratio 1.32, 95% confidence interval 1.003-1.734, P = .047). Similarly, those patients with endocrinologist sex concordance had a 48% higher rate of surgeon evaluation (hazard ratio 1.48, confidence interval 1.1-2.0, P = .009). Stratified analysis revealed that sex discordance reduced the rate of surgeon referral for female patients (hazard ratio 0.63, confidence interval 0.44-0.89, P = .008) but not male patients (hazard ratio 1.06, CI 0.58-1.93, P = .861).nnCONCLUSION: Sex discordance between patients and their health care professionals may contribute to under-referral in primary hyperparathyroidism. Further evaluation of the effect of patient and practitioner identities on communication and decision-making in surgery are needed.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37872045,

title = {The impact of social determinants of health on thyroid cancer mortality and time to treatment},

author = {Reagan A Collins and Catherine McManus and Eric J Kuo and Rachel Liou and James A Lee and Jennifer H Kuo},

doi = {10.1016/j.surg.2023.04.062},

issn = {1532-7361},

year  = {2024},

date = {2024-01-01},

urldate = {2023-10-01},

journal = {Surgery},

volume = {175},

issue = {1},

pages = {57-64},

abstract = {BACKGROUND: Whereas racial disparities in thyroid cancer care are well established, the role of social determinants of health is less clear. We aimed to assess the individual and cumulative impact of social determinants of health on mortality and time to treatment among patients with thyroid cancer.nnMETHODS: We collected social determinants of health data from thyroid cancer patients registered in the National Cancer Database from 2004 to 2017. We created a count variable for patients in the lowest quartile of each social determinant of health (ie, low income, low education, and no insurance). We assessed the association of social determinants of health with mortality and time to treatment and the association between cumulative social determinants of health count and time to treatment using Cox regression.nnRESULTS: Of the 142,024 patients we identified, patients with longer time to treatment had greater mortality compared to patients treated within 90 days (90-180 days, adjusted hazard ratio 1.21 (95% confidence interval 1.13-1.29, P \< .001); \>180 days, adjusted hazard ratio 1.57 (95% confidence interval 1.41-1.76, (P \< .001). Compared to patients with no adverse social determinants of health, patients with 1, 2, or 3 adverse social determinants of health had a 10%, 12%, and 34%, respectively, higher likelihood of longer time to treatment (1 social determinant of health, hazard ratio 0.90, 95% confidence interval 0.89-0.92, P \< .001; 2 social determinants of health, hazard ratio 0.88, 95% confidence interval 0.87-0.90, P \< .001; 3 social determinants of health, hazard ratio 0.66, 95% confidence interval 0.62-0.71, P \< .001 for all). On subgroup analysis by race, each adverse social determinant of health was associated with an increased likelihood of a longer time to treatment for Black and Hispanic patients (P \< .05).nnCONCLUSION: A greater number of adverse social determinants of health leads to a higher likelihood of a longer time to treatment for patients with thyroid cancer, which, in turn, is associated with an increased risk for mortality.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}