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Technology plays a role in nearly every aspect of healthcare delivery. Health systems must continually invest in new and existing technology and analytics platforms to scale initiatives, enable innovation, and achieve interoperability to meet the needs and expectations of patients and clinicians while remaining focused on the organization's mission and strategic priorities. In this process, decision-makers must determine how to allocate technological resources to platforms that meet clinical and administrative needs while reducing the need for frequent replacement or reconfiguration. Advances in artificial intelligence and its capabilities add urgency and complexity to technology investment decisions. An important consideration during this process is when to build new technology infrastructure and when to partner with existing companies and buy technology solutions. This case study explores a major academic medical center's approach to that decision, including the factors that influenced it and the outcomes of two solutions that were developed in-house.
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Árvores de Decisões , Estudos de Casos Organizacionais , Humanos , Centros Médicos Acadêmicos/organização & administração , Inteligência Artificial , Estados Unidos , Tecnologia BiomédicaRESUMO
BACKGROUND. Abbreviated breast MRI (AB-MRI) achieves a higher cancer detection rate (CDR) than digital breast tomosynthesis when applied for baseline (i.e., first-round) supplemental screening of individuals with dense breasts. Limited literature has evaluated subsequent (i.e., sequential) AB-MRI screening rounds. OBJECTIVE. This study aimed to compare outcomes between baseline and subsequent rounds of screening AB-MRI in individuals with dense breasts who otherwise had an average risk for breast cancer. METHODS. This retrospective study included patients with dense breasts who otherwise had an average risk for breast cancer and underwent AB-MRI for supplemental screening between December 20, 2016, and May 10, 2023. The clinical interpretations and results of recommended biopsies for AB-MRI examinations were extracted from the EMR. Baseline and subsequent-round AB-MRI examinations were compared. RESULTS. The final sample included 2585 AB-MRI examinations (2007 baseline and 578 subsequent-round examinations) performed for supplemental screening of 2007 women (mean age, 57.1 years old) with dense breasts. Of 2007 baseline examinations, 1658 (82.6%) were assessed as BI-RADS category 1 or 2, 171 (8.5%) as BI-RADS category 3, and 178 (8.9%) as BI-RADS category 4 or 5. Of 578 subsequent-round examinations, 533 (92.2%) were assessed as BI-RADS category 1 or 2, 20 (3.5%) as BI-RADS category 3, and 25 (4.3%) as BI-RADS category 4 or 5 (p < .001). The abnormal interpretation rate (AIR) was 17.4% (349/2007) for baseline examinations versus 7.8% (45/578) for subsequent-round examinations (p < .001). For baseline examinations, PPV2 was 21.3% (38/178), PPV3 was 26.6% (38/143), and the CDR was 18.9 cancers per 1000 examinations (38/2007). For subsequent-round examinations, PPV2 was 28.0% (7/25) (p = .45), PPV3 was 29.2% (7/24) (p = .81), and the CDR was 12.1 cancers per 1000 examinations (7/578) (p = .37). All 45 cancers diagnosed by baseline or subsequent-round AB-MRI were stage 0 or 1. Seven cancers diagnosed by subsequent-round AB-MRI had a mean interval of 872 ± 373 (SD) days since prior AB-MRI and node-negative status at surgical axillary evaluation; six had an invasive component, all measuring 1.2 cm or less. CONCLUSION. Subsequent rounds of AB-MRI screening of individuals with dense breasts had lower AIR than baseline examinations while maintaining a high CDR. All cancers detected by subsequent-round examinations were early-stage node-negative cancers. CLINICAL IMPACT. The findings support sequential AB-MRI for supplemental screening in individuals with dense breasts. Further investigations are warranted to optimize the screening interval.
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Densidade da Mama , Neoplasias da Mama , Imageamento por Ressonância Magnética , Humanos , Feminino , Neoplasias da Mama/diagnóstico por imagem , Pessoa de Meia-Idade , Imageamento por Ressonância Magnética/métodos , Estudos Retrospectivos , Detecção Precoce de Câncer/métodos , Idoso , Adulto , Mama/diagnóstico por imagem , Mama/patologiaRESUMO
BACKGROUND AND PURPOSE: The slow adoption of new advanced imaging techniques into clinical practice has been a long-standing challenge. Principles of implementation science and the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework were used to build a clinical vessel wall imaging program at an academic medical center. MATERIALS AND METHODS: Six phases for implementing a clinical vessel wall MR imaging program were contextualized to the RE-AIM framework. Surveys were designed and distributed to MR imaging technologists and clinicians. Effectiveness was measured by surveying the perceived diagnostic value of vessel wall imaging among MR imaging technologists and clinicians, trends in case volumes in the clinical vessel wall imaging examination, and the number of coauthored vessel wall imaging-focused publications and abstracts. Adoption and implementation were measured by surveying stakeholders about workflow. Maintenance was measured by surveying MR imaging technologists on the value of teaching materials and online tip sheets. The Integration dimension was measured by the number of submitted research grants incorporating vessel wall imaging protocols. Feedback during the implementation phases and solicited through the survey is qualitatively summarized. Quantitative results are reported using descriptive statistics. RESULTS: Six phases of the RE-AIM framework focused on the following: 1) determining patient and disease representation, 2) matching resource availability and patient access, 3) establishing vessel MR wall imaging (VWI) expertise, 4) forming interdisciplinary teams, 5) iteratively refining workflow, and 6) integrating for maintenance and scale. Survey response rates were 48.3% (MR imaging technologists) and 71.4% (clinicians). Survey results showed that 90% of the MR imaging technologists agreed that they understood how vessel wall MR imaging adds diagnostic value to patient care. Most clinicians (91.3%) reported that vessel wall MR imaging results changed their diagnostic confidence or patient management. Case volumes of clinical vessel wall MR imaging performed from 2019 to 2022 rose from 22 to 205 examinations. Workflow challenges reported by MR imaging technologists included protocoling examinations and scan length. Feedback from ordering clinicians included the need for education about VWI indications, limitations, and availability. During the 3-year implementation period of the program, the interdisciplinary teams coauthored 27 publications and abstracts and submitted 13 research grants. CONCLUSIONS: Implementation of a clinical imaging program can be successful using the principles of the RE-AIM framework. Through iterative processes and the support of interdisciplinary teams, a vessel wall MR imaging program can be integrated through a dedicated clinical pipeline, add diagnostic value, support educational and research missions at an academic medical center, and become a center for excellence.
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Centros Médicos Acadêmicos , Imageamento por Ressonância Magnética , Humanos , Imageamento por Ressonância Magnética/métodos , Ciência da Implementação , Angiografia por Ressonância Magnética/métodosRESUMO
The objective of this study is to define CT imaging derived phenotypes for patients with hepatic steatosis, a common metabolic liver condition, and determine its association with patient data from a medical biobank. There is a need to further characterize hepatic steatosis in lean patients, as its epidemiology may differ from that in overweight patients. A deep learning method determined the spleen-hepatic attenuation difference (SHAD) in Hounsfield Units (HU) on abdominal CT scans as a quantitative measure of hepatic steatosis. The patient cohort was stratified by BMI with a threshold of 25 kg/m2 and hepatic steatosis with threshold SHAD ≥ - 1 HU or liver mean attenuation ≤ 40 HU. Patient characteristics, diagnoses, and laboratory results representing metabolism and liver function were investigated. A phenome-wide association study (PheWAS) was performed for the statistical interaction between SHAD and the binary characteristic LEAN. The cohort contained 8914 patients-lean patients with (N = 278, 3.1%) and without (N = 1867, 20.9%) steatosis, and overweight patients with (N = 1863, 20.9%) and without (N = 4906, 55.0%) steatosis. Among all lean patients, those with steatosis had increased rates of cardiovascular disease (41.7 vs 27.8%), hypertension (86.7 vs 49.8%), and type 2 diabetes mellitus (29.1 vs 15.7%) (all p < 0.0001). Ten phenotypes were significant in the PheWAS, including chronic kidney disease, renal failure, and cardiovascular disease. Hepatic steatosis was found to be associated with cardiovascular, kidney, and metabolic conditions, separate from overweight BMI.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Fígado Gorduroso , Hepatopatia Gordurosa não Alcoólica , Humanos , Doenças Cardiovasculares/complicações , Sobrepeso/complicações , Sobrepeso/diagnóstico por imagem , Diabetes Mellitus Tipo 2/complicações , Fígado Gorduroso/complicações , Tomografia Computadorizada por Raios X/métodos , Fenótipo , Hepatopatia Gordurosa não Alcoólica/complicaçõesRESUMO
Electronic consultations (e-consults) mediated through an electronic health record system or web-based platform allow synchronous or asynchronous physician-to-physician communication. E-consults have been explored in various clinical specialties, but relatively few instances in the literature describe e-consults to connect health care providers directly with radiologists.The authors outline how a radiology department can implement an e-consult service and review the development of such a service in a large academic health system. They describe the logistics, workflow, turnaround time expectations, stakeholder management, and pilot implementation and highlight challenges and lessons learned.
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Melhoria de Qualidade , Radiologia , Humanos , Encaminhamento e Consulta , Software , ComunicaçãoRESUMO
There is a growing emphasis on population health management (PHM) in the United States, in part because it has the worst health outcomes indices among high-income countries despite spending by far the most on health care. Successful PHM is expected to lead to a healthier population with reduced health care utilization and cost. The role of radiology in PHM is increasingly being recognized, including efforts in care coordination, secondary prevention, and appropriate imaging utilization, among others. To further discuss economic considerations for PHM, we must understand the evolving health care payer environment, which combines fee-for-service and increasingly, an alternative payment model framework developed by the Health Care Payment Learning and Action Network. In considering the term "value-based care," perceived value needs to accrue to those who ultimately pay for care, which is more commonly employers and the government. This perspective drives the design of alternative payment models and thus should be taken into consideration to ensure sustainable practice models.
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Gestão da Saúde da População , Radiologia , Estados Unidos , Mecanismo de Reembolso , Planos de Pagamento por Serviço Prestado , Atenção à SaúdeRESUMO
The integration of digital data from imaging, pathology, genomics, and other fields creates an opportunity to produce information-rich diagnoses, especially for complex patients. Technology exists today to create a "diagnostic cockpit" that can accept inputs from multiple sources, analyze them using artificial intelligence and other quantitative tools, and produce a precision diagnosis. Although barriers to creation and dissemination of such a cockpit exist, the metaphor provides a glimpse into the diagnostic processes of the future.
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PURPOSE: In the United States, the National Cancer Institute National Cancer Clinical Trials Network (NCTN) groups have conducted publicly funded oncology research for 50 years. The combined impact of all adult network group trials has never been systematically examined. METHODS: We identified randomized, phase III trials from the adult NCTN groups, reported from 1980 onward, with statistically significant findings for ≥ 1 clinical, time-dependent outcomes. In the subset of trials in which the experimental arm improved overall survival, gains in population life-years were estimated by deriving trial-specific hazard functions and hazard ratios to estimate the experimental treatment benefit and then mapping this trial-level benefit onto the US cancer population using registry and life-table data. Scientific impact was based on citation data from Google Scholar. Federal investment costs per life-year gained were estimated. The results were derived through December 31, 2020. RESULTS: One hundred sixty-two trials comprised of 108,334 patients were analyzed, representing 29.8% (162/544) of trials conducted. The most common cancers included breast (34), gynecologic (28), and lung (14). The trials were cited 165,336 times (mean, 62.2 citations/trial/year); 87.7% of trials were cited in cancer care guidelines in favor of the recommended treatment. These studies were estimated to have generated 14.2 million (95% CI, 11.5 to 16.5 million) additional life-years to patients with cancer, with projected gains of 24.1 million (95% CI, 19.7 to 28.2 million) life-years by 2030. The federal investment cost per life-year gained through 2020 was $326 in US dollars. CONCLUSION: NCTN randomized trials have been widely cited and are routinely included in clinical guidelines. Moreover, their conduct has predicted substantial improvements in overall survival in the United States for patients with oncologic disease, suggesting they have contributed meaningfully to this nation's health. These findings demonstrate the critical role of government-sponsored research in extending the lives of patients with cancer.
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Neoplasias , Adulto , Humanos , Feminino , Estados Unidos , National Cancer Institute (U.S.) , Neoplasias/terapia , Oncologia , Análise Custo-BenefícioRESUMO
OBJECTIVE: Evaluation of image characteristics at ultra-low radiation dose levels of a first-generation dual-source photon-counting computed tomography (PCCT) compared to a dual-source dual-energy CT (DECT) scanner. METHODS: A multi-energy CT phantom was imaged with and without an extension ring on both scanners over a range of radiation dose levels (CTDIvol 0.4-15.0 mGy). Scans were performed in different modes of acquisition for PCCT with 120 kVp and DECT with 70/Sn150 kVp and 100/Sn150 kVp. Various tissue inserts were used to characterize the precision and repeatability of Hounsfield units (HUs) on virtual mono-energetic images between 40 and 190 keV. Image noise was additionally investigated at an ultra-low radiation dose to illustrate PCCT's ability to remove electronic background noise. RESULTS: Our results demonstrate the high precision of HU measurements for a wide range of inserts and radiation exposure levels with PCCT. We report high performance for both scanners across a wide range of radiation exposure levels, with PCCT outperforming at low exposures compared to DECT. PCCT scans at the lowest radiation exposures illustrate significant reduction in electronic background noise, with a mean percent reduction of 74% (p value ~ 10-8) compared to DECT 70/Sn150 kVp and 60% (p value ~ 10-6) compared to DECT 100/Sn150 kVp. CONCLUSIONS: This paper reports the first experiences with a clinical dual-source PCCT. PCCT provides reliable HUs without disruption from electronic background noise for a wide range of dose values. Diagnostic benefits are not only for quantification at an ultra-low dose but also for imaging of obese patients. KEY POINTS: PCCT scanners provide precise and reliable Hounsfield units at ultra-low dose levels. The influence of electronic background noise can be removed at ultra-low-dose acquisitions with PCCT. Both spectral platforms have high performance along a wide range of radiation exposure levels, with PCCT outperforming at low radiation exposures.
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Tomografia Computadorizada por Raios X , Humanos , Tomografia Computadorizada por Raios X/métodos , Doses de Radiação , Imagens de FantasmasRESUMO
BACKGROUND AND PURPOSE: Imaging and autopsy studies show intracranial gadolinium deposition in patients who have undergone serial contrast-enhanced MRIs. This observation has raised concerns when using contrast administration in patients who receive frequent MRIs. To address this, we implemented a contrast-conditional protocol wherein gadolinium is administered only for multiple sclerosis (MS) patients with imaging evidence of new disease activity on precontrast imaging. In this study, we explore the economic impact of our new MRI protocol. METHODS: We compared scanner time and Medicare reimbursement using our contrast-conditional methodology versus that of prior protocols where all patients received gadolinium. RESULTS: For 422 patients over 4 months, the contrast-conditional protocol amounted to 60% decrease in contrast injection and savings of approximately 20% of MRI scanner time. If the extra scanner time was used for performing MS follow-up MRIs in additional patients, the contrast-conditional protocol would amount to net revenue loss of $21,707 (â¼3.7%). CONCLUSIONS: Implementation of a new protocol to limit contrast in MS follow-up MRIs led to a minimal decrease in revenue when controlled for scanner time utilized and is outweighed by other benefits, including substantial decreased gadolinium administration, increased patient comfort, and increased availability of scanner time, which depending on type of studies performed could result in additional financial benefit.
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Gadolínio , Esclerose Múltipla , Idoso , Meios de Contraste , Seguimentos , Humanos , Imageamento por Ressonância Magnética/métodos , Medicare , Esclerose Múltipla/diagnóstico por imagem , Estados UnidosRESUMO
In the technique presented here, dubbed 'qMRS', we quantify the change in 1H MRS signal following administration of 2H-labeled glucose. As in recent human DMRS studies, we administer [6,6'-2H2]-glucose orally to healthy subjects. Since 2H is not detectable by 1H MRS, the transfer of the 2H label from glucose to a downstream metabolite leads to a reduction in the corresponding 1H MRS resonance of the metabolite, even if the total concentration of both isoforms remains constant. Moreover, introduction of the deuterium label alters the splitting pattern of the proton resonances, making indirect detection of the deuterated forms- as well as the direct detection of the decrease in unlabeled form- possible even without a 2H coil. Because qMRS requires only standard 1H MRS acquisition methods, it can be performed using commonly implemented single voxel spectroscopy (SVS) and chemical shift imaging (CSI) sequences. In this work, we implement qMRS in semi-LASER based CSI, generating dynamic maps arising from the fitted spectra, and demonstrating the feasibility of using qMRS and qCSI to monitor dynamic metabolism in the human brain using a 7T scanner with no auxiliary hardware.
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Glucose , Imageamento por Ressonância Magnética , Deutério , Glucose/metabolismo , Humanos , Imageamento por Ressonância Magnética/métodos , Espectroscopia de Ressonância Magnética/métodos , Espectroscopia de Prótons por Ressonância MagnéticaRESUMO
Rationale: Lung-RADS classification was developed to standardize reporting and management of lung cancer screening using low-dose computed tomographic (LDCT) imaging. Although variation in Lung-RADS distribution between healthcare systems has been reported, it is unclear if this is explained by patient characteristics, radiologist experience with lung cancer screening, or other factors. Objectives: Our objective was to determine if patient or radiologist factors are associated with Lung-RADS score. Methods: In the Population-based Research to Optimize the Screening Process (PROSPR) Lung consortium, we conducted a study of patients who received their first screening LDCT imaging at one of the five healthcare systems in the PROSPR Lung Research Center from May 1, 2014, through December 31, 2017. Data on LDCT scans, patient factors, and radiologist characteristics were obtained via electronic health records. LDCT scan findings were categorized using Lung-RADS (negative [1], benign [2], probably benign [3], or suspicious [4]). We used generalized estimating equations with a multinomial distribution to compare the odds of Lung-RADS 3, and separately Lung-RADS 4, versus Lung-RADS 1 or 2 and estimated adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for the associations between Lung-RADS assignment and patient and radiologist characteristics. Results: Analyses included 8,556 patients; 24% were assigned Lung-RADS 1, 60% Lung-RADS 2, 10% Lung-RADS 3, and 5% Lung-RADS 4. Age was positively associated with Lung-RADS 3 (OR, 1.02; 95% CI, 1.01-1.03) and 4 (OR, 1.03; 95% CI, 1.01-1.05); chronic obstructive pulmonary disease (COPD) was positively associated with Lung-RADS 4 (OR, 1.78; 95% CI, 1.45-2.20); obesity was inversely associated with Lung-RADS 3 (OR, 0.70; 95% CI, 0.58-0.84) and 4 (OR, 0.58; 95% CI, 0.45-0.75). There was no association between sex, race, ethnicity, education, or smoking status and Lung-RADS assignment. Radiologist volume of interpreting screening LDCT scans, years in practice, and thoracic specialty were also not associated with Lung-RADS assignment. Conclusions: Healthcare systems that are comprised of patients with an older age distribution or higher levels of COPD will have a greater proportion of screening LDCT scans with Lung-RADS 3 or 4 findings and should plan for additional resources to support appropriate and timely management of noted positive findings.
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Detecção Precoce de Câncer , Neoplasias Pulmonares , Detecção Precoce de Câncer/métodos , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Programas de Rastreamento/métodos , Radiologistas , Tomografia Computadorizada por Raios X/métodosRESUMO
OBJECTIVE: The objective was to develop a fully automated algorithm for abdominal fat segmentation and to deploy this method at scale in an academic biobank. MATERIALS AND METHODS: We built a fully automated image curation and labeling technique using deep learning and distributive computing to identify subcutaneous and visceral abdominal fat compartments from 52,844 computed tomography scans in 13,502 patients in the Penn Medicine Biobank (PMBB). A classification network identified the inferior and superior borders of the abdomen, and a segmentation network differentiated visceral and subcutaneous fat. Following technical evaluation of our method, we conducted studies to validate known relationships with visceral and subcutaneous fat. RESULTS: When compared with 100 manually annotated cases, the classification network was on average within one 5-mm slice for both the superior (0.4 ± 1.1 slice) and inferior (0.4 ± 0.6 slice) borders. The segmentation network also demonstrated excellent performance with intraclass correlation coefficients of 1.00 (P < 2 × 10-16) for subcutaneous and 1.00 (P < 2 × 10-16) for visceral fat on 100 testing cases. We performed integrative analyses of abdominal fat with the phenome extracted from the electronic health record and found highly significant associations with diabetes mellitus, hypertension, and renal failure, among other phenotypes. CONCLUSIONS: This work presents a fully automated and highly accurate method for the quantification of abdominal fat that can be applied to routine clinical imaging studies to fuel translational scientific discovery.
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Aprendizado Profundo , Gordura Abdominal , Bancos de Espécimes Biológicos , Registros Eletrônicos de Saúde , Humanos , Tomografia Computadorizada por Raios XRESUMO
Severe acute respiratory syndrome coronavirus 2 has spread across the world since December 2019, infecting 100 million and killing millions. The impact on health care institutions during the coronavirus disease 2019 pandemic has been considerable, with exhaustion of institutional and personal protective equipment resources during local outbreaks and crushing financial consequences for many institutions. Establishing adaptive principles of leadership is necessary during crises, fostering quick decision-making and workflow modifications, while a rapid review of data must determine necessary course corrections. This report describes concepts of crisis leadership teams that can help maximize their effectiveness during the current and future pandemics.
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Comitês Consultivos , COVID-19/diagnóstico , COVID-19/terapia , Liderança , Serviço Hospitalar de Radiologia/organização & administração , Humanos , América do Norte , SARS-CoV-2 , Sociedades MédicasRESUMO
Background The Eastern Cooperative Oncology Group and American College of Radiology Imaging Network Cancer Research Group A6702 multicenter trial helped confirm the potential of diffusion-weighted MRI for improving differential diagnosis of suspicious breast abnormalities and reducing unnecessary biopsies. A prespecified secondary objective was to explore the relative value of different approaches for quantitative assessment of lesions at diffusion-weighted MRI. Purpose To determine whether alternate calculations of apparent diffusion coefficient (ADC) can help further improve diagnostic performance versus mean ADC values alone for analysis of suspicious breast lesions at MRI. Materials and Methods This prospective trial (ClinicalTrials.gov identifier: NCT02022579) enrolled consecutive women (from March 2014 to April 2015) with a Breast Imaging Reporting and Data System category of 3, 4, or 5 at breast MRI. All study participants underwent standardized diffusion-weighted MRI (b = 0, 100, 600, and 800 sec/mm2). Centralized ADC measures were performed, including manually drawn whole-lesion and hotspot regions of interest, histogram metrics, normalized ADC, and variable b-value combinations. Diagnostic performance was estimated by using the area under the receiver operating characteristic curve (AUC). Reduction in biopsy rate (maintaining 100% sensitivity) was estimated according to thresholds for each ADC metric. Results Among 107 enrolled women, 81 lesions with outcomes (28 malignant and 53 benign) in 67 women (median age, 49 years; interquartile range, 41-60 years) were analyzed. Among ADC metrics tested, none improved diagnostic performance versus standard mean ADC (AUC, 0.59-0.79 vs AUC, 0.75; P = .02-.84), and maximum ADC had worse performance (AUC, 0.52; P < .001). The 25th-percentile ADC metric provided the best performance (AUC, 0.79; 95% CI: 0.70, 0.88), and a threshold using median ADC provided the greatest reduction in biopsy rate of 23.9% (95% CI: 14.8, 32.9; 16 of 67 BI-RADS category 4 and 5 lesions). Nonzero minimum b value (100, 600, and 800 sec/mm2) did not improve the AUC (0.74; P = .28), and several combinations of two b values (0 and 600, 100 and 600, 0 and 800, and 100 and 800 sec/mm2; AUC, 0.73-0.76) provided results similar to those seen with calculations of four b values (AUC, 0.75; P = .17-.87). Conclusion Mean apparent diffusion coefficient calculated with a two-b-value acquisition is a simple and sufficient diffusion-weighted MRI metric to augment diagnostic performance of breast MRI compared with more complex approaches to apparent diffusion coefficient measurement. © RSNA, 2020 Online supplemental material is available for this article.
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Neoplasias da Mama/diagnóstico por imagem , Imagem de Difusão por Ressonância Magnética/métodos , Adulto , Idoso , Mama/diagnóstico por imagem , Diagnóstico Diferencial , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Sociedades Médicas , Adulto JovemRESUMO
Background The RESCUE (Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Noninvasive Examinations) trial was a randomized, controlled, multicenter, comparative efficacy outcomes trial designed to assess whether initial testing with coronary computed tomographic angiography (CCTA) is noninferior to single photon emission computed tomography (SPECT) myocardial perfusion imaging in directing patients with stable angina to optimal medical therapy alone or optimal medical therapy with revascularization. Methods and Results The end point was first major adverse cardiovascular event (MACE) (cardiac death or myocardial infarction), or revascularization. Noninferiority margin for CCTA was set a priori as a hazard ratio (HR) of 1.3 (95% CI=0, 1.605). One thousand fifty participants from 44 sites were randomized to CCTA (n=518) or SPECT (n=532). Mean follow-up time was 16.2 (SD 7.9) months. There were no cardiac-related deaths. In patients with a negative CCTA there was 1 acute myocardial infarction; in patients with a negative SPECT examination there were 2 acute myocardial infarctions; and for positive CCTA and SPECT, 1 acute myocardial infarction each. Participants in the CCTA arm had a similar rate of MACE or revascularization compared with those in the SPECT myocardial perfusion imaging arm, (HR, 1.03; 95% CI=0.61-1.75) (P=0.19). CCTA segment involvement by a stenosis of ≥50% diameter was a better predictor of MACE and revascularization at 1 year (P=0.02) than the percent reversible defect size by SPECT myocardial perfusion imaging. Four (1.2%) patients with negative CCTA compared with 14 (3.2%) with negative SPECT had MACE or revascularization (P=0.03). Conclusions There was no difference in outcomes of patients who had stable angina and who underwent CCTA in comparison to SPECT as the first imaging test directing them to optimal medical therapy alone or with revascularization. CCTA was a better predictor of MACE and revascularization. Registration Information URL: https://www.clinicaltrials.gov/. Identifier: NCT01262625.
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Angina Estável/terapia , Angiografia por Tomografia Computadorizada/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Imagem de Perfusão do Miocárdio/métodos , Tomografia Computadorizada de Emissão de Fóton Único/métodos , Adulto , Angina Estável/classificação , Angina Estável/diagnóstico , Doenças Cardiovasculares/epidemiologia , Angiografia por Tomografia Computadorizada/estatística & dados numéricos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/terapia , Morte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/epidemiologia , Imagem de Perfusão do Miocárdio/estatística & dados numéricos , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/estatística & dados numéricos , Tomografia Computadorizada de Emissão de Fóton Único/estatística & dados numéricosRESUMO
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