Differentiating Renal Neoplasms From Simple Cysts on Contrast-Enhanced CT on the Basis of Attenuation and Homogeneity.

OBJECTIVE: The purpose of this study is to compare the attenuation and homogeneity of renal neoplasms with those of cysts on contrast-enhanced CT. MATERIALS AND METHODS: A total of 129 renal neoplasms and 24 simple cysts were evaluated. Two readers determined whether each mass was qualitatively heterogeneous or homogeneous. Mean, minimum, and maximum attenuation values were measured. Statistical analysis was performed. RESULTS: A total of 116 heterogeneous renal cell carcinomas (RCCs) (99 clear cell, four papillary, four oncocytic, seven chromophobe, and two unclassified RCCs), 13 homogeneous RCCs (10 papillary, two oncocytic, and one chromophobe RCC), and 24 cysts (all of which were homogeneous) were evaluated. All homogeneous RCCs had mean attenuation values of more than 42 HU, whereas renal cysts had mean attenuation values of up to 30 HU (p < 0.001). Two readers qualitatively and identically categorized all RCCs as homogeneous or heterogeneous (κ = 1.0; p < 0.001). CONCLUSION: Homogeneous simple renal cysts can have mean attenuation values of up to 30 HU, as determined by contrast-enhanced CT, whereas homogeneous RCCs have mean attenuation values as low as 42 HU, with no overlap occurring between the two groups. These data suggest that further evaluation of a homogeneous renal mass with a mean attenuation value of 30 HU or less on a contrast-enhanced CT scan likely is unwarranted.

Tomosynthesis in the Diagnostic Setting: Changing Rates of BI-RADS Final Assessment over Time.

Purpose To evaluate the effect of tomosynthesis in diagnostic mammography on the Breast Imaging Reporting and Data System (BI-RADS) final assessment categories over time. Materials and Methods This retrospective study was approved by the institutional review board. The authors reviewed all diagnostic mammograms obtained during a 12-month interval before (two-dimensional [2D] mammography [June 2, 2010, to June 1, 2011]) and for 3 consecutive years after (tomosynthesis year 1 [2012], tomosynthesis year 2 [2013], and tomosynthesis year 3 [2014]) the implementation of tomosynthesis. The requirement to obtain informed consent was waived. The rates of BI-RADS final assessment categories 1-5 were compared between the 2D and tomosynthesis groups. The positive predictive values after biopsy (PPV3) for BI-RADS category 4 and 5 cases were compared. The mammographic features (masses, architectural distortions, calcifications, focal asymmetries) of lesions categorized as probably benign (BI-RADS category 3) and those for which biopsy was recommended (BI-RADS category 4 or 5) were reviewed. The χ(2) test was used to compare the rates of BI-RADS final assessment categories 1-5 between the two groups, and multivariate logistic regression analysis was performed to compare all diagnostic studies categorized as BI-RADS 3-5. Results There was an increase in the percentage of cases reported as negative or benign (BI-RADS category 1 or 2) with tomosynthesis (58.7% with 2D mammography vs 75.8% with tomosynthesis at year 3, P < .0001). A reduction in the percentage of probably benign (BI-RADS category 3) final assessments also occurred (33.3% with 2D mammography vs 16.4% with tomosynthesis at year 3, P < .0001). Although the rates of BI-RADS 4 or 5 assessments did not change significantly with tomosynthesis (8.0% with 2D mammography vs 7.8% with tomosynthesis at year 3, P = .2), there was a significant increase in the PPV3 (29.6% vs 50%, respectively; P < .0001). These trends increased during the 3 years of tomosynthesis use. Conclusion Tomosynthesis in the diagnostic setting resulted in progressive shifts in the BI-RADS final assessment categories over time, with a significant increase in the proportion of studies classified as normal, a continued decrease in the rate of studies categorized as probably benign, and improved diagnostic confidence in biopsy recommendations. (©) RSNA, 2016.

Cost-effectiveness of follow-up of pulmonary nodules incidentally detected on cardiac computed tomographic angiography in patients with suspected coronary artery disease.

BACKGROUND: Pulmonary nodules (PNs) are often detected incidentally during coronary computed tomographic (CT) angiography, which is increasingly being used to evaluate patients with chest pain symptoms. However, the efficiency of following up on incidentally detected PN is unknown. METHODS AND RESULTS: We determined demographic and clinical characteristics of stable symptomatic patients referred for coronary CT angiography in whom incidentally detected PNs warranted follow-up. A validated lung cancer simulation model was populated with data from these patients, and clinical and economic consequences of follow-up per Fleischner guidelines versus no follow-up were simulated. Of the 3665 patients referred for coronary CT angiography, 591 (16%) had PNs requiring follow-up. The mean age of patients with PNs was 59±10 years; 66% were male; 67% had ever smoked; and 21% had obstructive coronary artery disease. The projected overall lung cancer incidence was 5.8% in these patients, but the majority died of coronary artery disease (38%) and other causes (57%). Follow-up of PNs was associated with a 4.6% relative reduction in cumulative lung cancer mortality (absolute mortality: follow-up, 4.33% versus non-follow-up, 4.54%), more downstream testing (follow-up, 2.34 CTs per patient versus non-follow-up, 1.01 CTs per patient), and an average increase in quality-adjusted life of 7 days. Costs per quality-adjusted life-year gained were $154 700 to follow up the entire cohort and $129 800 per quality-adjusted life-year when only smokers were included. CONCLUSIONS: Follow-up of PNs incidentally detected in patients undergoing coronary CT angiography for chest pain evaluation is associated with a small reduction in lung cancer mortality. However, significant downstream testing contributes to limited efficiency, as demonstrated by a high cost per quality-adjusted life-year, especially in nonsmokers.

Coronary CT angiography versus standard evaluation in acute chest pain.

BACKGROUND: It is unclear whether an evaluation incorporating coronary computed tomographic angiography (CCTA) is more effective than standard evaluation in the emergency department in patients with symptoms suggestive of acute coronary syndromes. METHODS: In this multicenter trial, we randomly assigned patients 40 to 74 years of age with symptoms suggestive of acute coronary syndromes but without ischemic electrocardiographic changes or an initial positive troponin test to early CCTA or to standard evaluation in the emergency department on weekdays during daylight hours between April 2010 and January 2012. The primary end point was length of stay in the hospital. Secondary end points included rates of discharge from the emergency department, major adverse cardiovascular events at 28 days, and cumulative costs. Safety end points were undetected acute coronary syndromes. RESULTS: The rate of acute coronary syndromes among 1000 patients with a mean (±SD) age of 54±8 years (47% women) was 8%. After early CCTA, as compared with standard evaluation, the mean length of stay in the hospital was reduced by 7.6 hours (P<0.001) and more patients were discharged directly from the emergency department (47% vs. 12%, P<0.001). There were no undetected acute coronary syndromes and no significant differences in major adverse cardiovascular events at 28 days. After CCTA, there was more downstream testing and higher radiation exposure. The cumulative mean cost of care was similar in the CCTA group and the standard-evaluation group ($4,289 and $4,060, respectively; P=0.65). CONCLUSIONS: In patients in the emergency department with symptoms suggestive of acute coronary syndromes, incorporating CCTA into a triage strategy improved the efficiency of clinical decision making, as compared with a standard evaluation in the emergency department, but it resulted in an increase in downstream testing and radiation exposure with no decrease in the overall costs of care. (Funded by the National Heart, Lung, and Blood Institute; ROMICAT-II ClinicalTrials.gov number, NCT01084239.).

Examining the use of comparative and cost-effectiveness analyses in radiology.

OBJECTIVE: This article explores key principles of comparative effectiveness analysis--in particular, how radiologic comparative and cost-effectiveness studies differ from other clinical trials. Exemplary studies are reviewed to show how comparative effectiveness has been implemented in radiology and how future studies might be conducted. Finally, the article closes with a discussion of several additional key themes relevant to quality and value in clinical radiology going forward. CONCLUSION: Comparative effectiveness is likely to require a paradigm shift in thinking within the discipline. For new radiologic applications to be accepted, we will need to show at least a significant change in treatment planning and at best a meaningful change in patient outcomes. This shift will require a forward-thinking approach to robust evidence generation for new imaging modalities or indications and the inclusion of other modes of value demonstration such as clinical decision support and intelligent data mining.

Design of the Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography: a multicenter randomized comparative effectiveness trial of cardiac computed tomography versus alternative triage strategies in patients with acute chest pain in the emergency department.

Although early cardiac computed tomographic angiography (CCTA) might improve the management of emergency department (ED) patients with acute chest pain, it could also result in increased testing, costs, and radiation exposure. ROMICAT II was a randomized comparative effectiveness trial enrolling patients 40 to 74 years old without known coronary artery disease who presented to the ED with chest pain but without ischemic electrocardiographic (ECG) changes or elevated initial troponin and who required further risk stratification. Overall, 1000 patients at 9 sites within the United States were randomized to either CCTA as the first diagnostic test following serial biomarkers or to standard of care, which included no testing or functional testing such as exercise ECG, stress radionuclide imaging, or stress echocardiography. Test results were provided to ED physicians, yet patient management was not driven by a study protocol in either arm. Data were collected on diagnostic testing, cardiac events, and cost of medical care for the index hospitalization and during the following 28 days. The primary end point was length of hospital stay. Secondary end points were cumulative radiation exposure, resource utilization, and costs of competing strategies. Tertiary end points were institutional, physician, and patient characteristics associated with primary and secondary outcomes. Rate of missed acute coronary syndrome within 28 days was the safety end point. The ROMICAT II will provide rigorous data on whether CCTA is more efficient than standard of care in the management of patients with acute chest pain at intermediate risk for acute coronary syndrome.

Use of MRI and Ga-68 DOTATATE for the detection of neuroendocrine liver metastases.

PURPOSE: To compare detection rates of NET liver metastases of MRI and Ga-68-DOTATATE PET/CT to provide more clarity when selecting diagnostic imaging tests for NET staging. METHODS: In this IRB-approved single-institution retrospective study, all patients with pathology-proven NET who underwent Ga-68-DOTATATE and MRI scans within 8 weeks of each other (3/2017-2/2020) were reviewed. Number of metastases for each patient on diffusion-weighted imaging (DWI), dynamic contrast-enhanced (DCE) MRI, and Ga-68 DOTATATE were recorded by two blinded radiologists, followed by consensus review with two separate blinded readers for MRI and nuclear medicine. Per-lesion and -modality scoring at each lesion location were then performed in consensus. Per-patient linear regression was performed comparing MRI and Ga-68 DOTATATE detection rates for each reader and in consensus, and per-lesion-matched pair difference means were used to compare detection frequency between modalities. RESULTS: 32 patients (mean age 59 years, 59.4% male) and 90 liver metastases were analyzed. Intraclass coefficients (ICC) [95% CI] between the two readers were 0.97 [0.95, 0.99], 0.89 [0.82, 0.94], and 0.98 [0.97, 0.99] for Ga-68 DOTATATE, DWI, and DCE, respectively. Matched per-lesion mean differences were + 0.17 ± 0.07 (p = 0.01) and + 0.22 ± 0.06 (p = < 0.001) for DWI versus Ga-68 DOTATATE and DCE vs Ga-68 DOTATATE, respectively, favoring MRI. Case-based linear regressions estimate that DWI and DCE detect 1.28 [1.07, 1.49] and 1.33 [1.12, 1.54] lesions, respectively, for each one detected on Ga-68 DOTATATE. CONCLUSION: MRI detects more hepatic NET metastasis in comparison to Ga-68 DOTATATE. Liver MRI should be performed in concert with Ga-68 DOTATATE in NET staging.

Characterization of adrenal masses by using FDG PET: a systematic review and meta-analysis of diagnostic test performance.

PURPOSE: To perform a systematic review and meta-analysis of published data to determine the diagnostic utility of adrenal fluorine 18 fluorodeoxyglucose (FDG) positron emission tomography (PET) for distinguishing benign from malignant adrenal disease. MATERIALS AND METHODS: Data on FDG PET assessment in MEDLINE and other electronic databases (from inception to November 2009) and in subject matter-specific journals were evaluated and compared with histologic diagnoses and/or established clinical and imaging follow-up results. Methodologic quality was assessed by using Quality Assessment of Diagnostic Accuracy Studies criteria. Bivariate random-effects meta-analytical methods were used to estimate summary and subgroup-specific sensitivity, specificity, and receiver operating characteristic curves and to investigate the effects of study design characteristics and imaging procedure elements on diagnostic accuracy. RESULTS: A total of 1391 lesions (824 benign, 567 malignant) in 1217 patients from 21 eligible studies were evaluated. Qualitative (visual) analysis of 841 lesions (in 14 reports) and quantitative analyses based on standardized uptake values (SUVs) for 824 lesions (in 13 reports) and standardized uptake ratios (SURs) for 562 lesions (in eight reports) were performed. Resultant data were highly heterogeneous, with a model-based inconsistency index of 88% (95% confidence interval [CI]: 79%, 98%). Mean sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio values for differentiating between benign and malignant adrenal disease were 0.97 (95% CI: 0.93, 0.98), 0.91 (95% CI: 0.87, 0.94), 11.1 (95% CI: 7.5, 16.3), 0.04 (95% CI: 0.02, 0.08), and 294 (95% CI: 107, 805), respectively, with no significant differences in accuracy among the visual, SUV, and SUR analyses. CONCLUSION: Meta-analysis of combination PET-computed tomography (CT) reports revealed that FDG PET was highly sensitive and specific for differentiating malignant from benign adrenal disease. Diagnostic accuracy was not influenced by the type of imaging device (PET vs PET/CT), but specificity was dependent on the clinical status (cancer vs no cancer).

A simulation model of clinical and economic outcomes of cardiac CT triage of patients with acute chest pain in the emergency department.

OBJECTIVE: Uncertainty exists as to whether coronary CT angiography (CTA) compared with standard of care (SOC) is more effective and efficient in the triage of low-risk emergency department (ED) patients with acute chest pain. Our objective was to construct a simulation model to estimate clinical and economic outcomes. MATERIALS AND METHODS: We constructed a microsimulation model comparing SOC to coronary CTA-based triage of 1000 55-year-old patients (50% men) with acute chest pain, nonsignificant ECG changes, and initial negative cardiac markers. In SOC, patients were reevaluated with serial cardiac markers after 6-8 hours, followed by either nuclear stress imaging (SPECT) or stress echocardiography. In coronary CTA-based triage, patients were imaged immediately and, depending on the results, discharged, held for SPECT or stress echocardiography, or referred directly to invasive coronary angiography. RESULTS: Compared with SOC, coronary CTA-based triage reduced the number of patients referred for invasive coronary angiography from 406 (SPECT) or 370 (stress echocardiography) to 255 per 1000 and resulted in fewer "missed" cases of acute coronary syndrome overall (5 vs 18). Coronary CTA-based triage also resulted in fewer deaths (4 vs 6). Coronary CTA led to immediate discharge of 706 patients and produced average cost-savings in the ED of $851 (SPECT) or $462 (stress echocardiography) per patient. At 30 days after initial ED triage, coronary CTA-based management produced average savings of $283 (SPECT) and average costs of $292 (stress echocardiography) per patient triaged. CONCLUSION: Our model suggests that coronary CTA-based triage of low-risk patients with acute chest pain in the ED might reduce invasive catheterizations, could improve survival, and may save money.

Artificial intelligence to assess body composition on routine abdominal CT scans and predict mortality in pancreatic cancer- A recipe for your local application.

BACKGROUND: Body composition is associated with mortality; however its routine assessment is too time-consuming. PURPOSE: To demonstrate the value of artificial intelligence (AI) to extract body composition measures from routine studies, we aimed to develop a fully automated AI approach to measure fat and muscles masses, to validate its clinical discriminatory value, and to provide the code, training data and workflow solutions to facilitate its integration into local practice. METHODS: We developed a neural network that quantified the tissue components at the L3 vertebral body level using data from the Liver Tumor Challenge (LiTS) and a pancreatic cancer cohort. We classified sarcopenia using accepted skeletal muscle index cut-offs and visceral fat based its median value. We used Kaplan Meier curves and Cox regression analysis to assess the association between these measures and mortality. RESULTS: Applying the algorithm trained on LiTS data to the local cohort yielded good agreement [>0.8 intraclass correlation (ICC)]; when trained on both datasets, it had excellent agreement (>0.9 ICC). The pancreatic cancer cohort had 136 patients (mean age: 67 ± 11 years; 54% women); 15% had sarcopenia; mean visceral fat was 142 cm2. Concurrent with prior research, we found a significant association between sarcopenia and mortality [mean survival of 15 ± 12 vs. 22 ± 12 (p < 0.05), adjusted HR of 1.58 (95% CI: 1.03-3.33)] but no association between visceral fat and mortality. The detector analysis took 1 ± 0.5 s. CONCLUSIONS: AI body composition analysis can provide meaningful imaging biomarkers from routine exams demonstrating AI's ability to further enhance the clinical value of radiology reports.

Visceral Adiposity and Severe COVID-19 Disease: Application of an Artificial Intelligence Algorithm to Improve Clinical Risk Prediction.

BACKGROUND: Obesity has been linked to severe clinical outcomes among people who are hospitalized with coronavirus disease 2019 (COVID-19). We tested the hypothesis that visceral adipose tissue (VAT) is associated with severe outcomes in patients hospitalized with COVID-19, independent of body mass index (BMI). METHODS: We analyzed data from the Massachusetts General Hospital COVID-19 Data Registry, which included patients admitted with polymerase chain reaction-confirmed severe acute respiratory syndrome coronavirus 2 infection from March 11 to May 4, 2020. We used a validated, fully automated artificial intelligence (AI) algorithm to quantify VAT from computed tomography (CT) scans during or before the hospital admission. VAT quantification took an average of 2 ± 0.5 seconds per patient. We dichotomized VAT as high and low at a threshold of ≥100 cm2 and used Kaplan-Meier curves and Cox proportional hazards regression to assess the relationship between VAT and death or intubation over 28 days, adjusting for age, sex, race, BMI, and diabetes status. RESULTS: A total of 378 participants had CT imaging. Kaplan-Meier curves showed that participants with high VAT had a greater risk of the outcome compared with those with low VAT (P < .005), especially in those with BMI <30 kg/m2 (P < .005). In multivariable models, the adjusted hazard ratio (aHR) for high vs low VAT was unchanged (aHR, 1.97; 95% CI, 1.24-3.09), whereas BMI was no longer significant (aHR for obese vs normal BMI, 1.14; 95% CI, 0.71-1.82). CONCLUSIONS: High VAT is associated with a greater risk of severe disease or death in COVID-19 and can offer more precise information to risk-stratify individuals beyond BMI. AI offers a promising approach to routinely ascertain VAT and improve clinical risk prediction in COVID-19.

Three-Dimensional Neural Network to Automatically Assess Liver Tumor Burden Change on Consecutive Liver MRIs.

BACKGROUND: Tumor response to therapy is often assessed by measuring change in liver lesion size between consecutive MRIs. However, these evaluations are both tedious and time-consuming for clinical radiologists. PURPOSE: In this study, we sought to develop a convolutional neural network to detect liver metastases on MRI and applied this algorithm to assess change in tumor size on consecutive examinations. METHODS: We annotated a data set of 64 patients with neuroendocrine tumors who underwent at least two consecutive liver MRIs with gadoxetic acid. We then developed a 3-D neural network using a U-Net architecture with ResNet-18 building blocks that first detected the liver and then lesions within the liver. Liver lesion labels for each examination were then matched in 3-D space using an iterative closest point algorithm followed by Kuhn-Munkres algorithm. RESULTS: We developed a deep learning algorithm that detected liver metastases, co-registered the detected lesions, and then assessed the interval change in tumor burden between two multiparametric liver MRI examinations. Our deep learning algorithm was concordant in 91% with the radiologists' manual assessment about the interval change of disease burden. It had a sensitivity of 0.85 (95% confidence interval (95% CI): 0.77; 0.93) and specificity of 0.92 (95% CI: 0.87; 0.96) to classify liver segments as diseased or healthy. The mean DICE coefficient for individual lesions ranged between 0.73 and 0.81. CONCLUSIONS: Our algorithm displayed high agreement with human readers for detecting change in liver lesions on MRI, offering evidence that artificial intelligence-based detectors may perform these tasks as part of routine clinical care in the future.

Long-term health outcomes and cost-effectiveness of coronary CT angiography in patients with suspicion for acute coronary syndrome.

BACKGROUND: Randomized trials have shown favorable clinical outcomes for coronary CT angiography (CTA) in patients with suspected acute coronary syndrome (ACS). Our goal was to estimate the cost-effectiveness of coronary CTA as compared to alternative management strategies for ACP patients over lifetime. METHODS: Markov microsimulation model was developed to compare cost-effectiveness of competitive strategies for ACP patients: 1) coronary CTA, 2) standard of care (SOC), 3) AHA/ACC Guidelines, and 4) expedited emergency department (ED) discharge protocol with outpatient testing. ROMICAT-II trial was used to populate the model with low to intermediate risk of ACS patient data, whereas diagnostic test-, treatment effect-, morbidity/mortality-, quality of life- and cost data were obtained from the literature. We predicted test utilization, costs, 1-, 3-, 10-year and over lifetime cardiovascular morbidity/mortality for each strategy. We determined quality adjusted life years (QALY) and incremental cost-effectiveness ratio. Observed outcomes in ROMICAT-II were used to validate the short-term model. RESULTS: Estimated short-term outcomes accurately reflected observed outcomes in ROMICAT-II as coronary CTA was associated with higher costs ($4,490 vs. $2,513-$4,144) and revascularization rates (5.2% vs. 2.6%-3.7%) compared to alternative strategies. Over lifetime, coronary CTA dominated SOC and ACC/AHA Guidelines and was cost-effective compared to expedited ED protocol ($49,428/QALY). This was driven by lower cardiovascular mortality (coronary CTA vs. expedited discharge: 3-year: 1.04% vs. 1.10-1.17; 10-year: 5.06% vs. 5.21-5.36%; respectively). CONCLUSION: Coronary CTA in patients with suspected ACS renders affordable long-term health benefits as compared to alternative strategies.

Lymphotropic nanoparticle-enhanced MRI for independent prediction of lymph node malignancy: a logistic regression model.

OBJECTIVE: The purpose of this study was to determine whether use of lymphotropic nanoparticle-enhanced MRI can improve the ability to characterize lymph nodes as benign or malignant beyond size criteria alone. MATERIALS AND METHODS: The cases of 42 consecutively registered patients with a known primary malignant tumor of the genitourinary tract who underwent both lymphotropic nanoparticle-enhanced MRI and CT-guided biopsy of a lymph node at our institution from 2000 to 2005 were retrospectively identified. Lymphotropic nanoparticle-enhanced MRI included T2(*)-weighted gradient-recalled echo imaging before and 24-36 hours after i.v. administration of lymphotropic iron oxide nanoparticles. Two positivity criteria for lymph node malignancy were evaluated independently: lack of nanoparticle uptake at lymphotropic nanoparticle-enhanced MRI and short-axis length of 1 cm or greater. Sensitivity and specificity were calculated for each criterion with biopsy results as the standard of reference. Logistic regression analysis was used to determine the association (odds ratio) between lymphotropic nanoparticle-enhanced MRI findings and the presence of lymph node malignancy when controlling for short-axis length. RESULTS: Metastatic lesions were detected at histologic examination in 67% (28/42) of nodes. According to the lymphotropic nanoparticle-enhanced MRI criterion, sensitivity for malignancy was 100% (28/28 nodes), and specificity was 64% (9/14 nodes). According to the short-axis criterion, sensitivity was 79% (22/28 nodes), and specificity was 21% (3/14 nodes). In multivariate analysis, when controlling for short-axis length, the finding of malignancy at lymphotropic nanoparticle-enhanced MRI was an independent predictor of the presence of malignancy (odds ratio, 61.0; 95% CI, 8.0 to infinity; p < 0.0001). CONCLUSION: Use of lymphotropic nanoparticle-enhanced MRI may improve ability to characterize lymph nodes beyond size criteria alone. Our results emphasize the need to further assess lymphotropic nanoparticle-enhanced MRI in prospective large-scale studies with wider variation in the distribution of lymph node sizes and primary malignancies.

Clinical Decision Support for Ordering CTA-PE Studies in the Emergency Department-A Pilot on Feasibility and Clinical Impact in a Tertiary Medical Center.

PURPOSE: To determine the feasibility and impact of Clinical Decision Support for imaging ordering. METHODS: A survey of 231 emergency providers identified Computed tomography angiography (CTA)-Pulmonary embolism (PE) as an overutilized study. We developed an algorithm that combined established risk scores to stratify patients for PE work-up (recommendations: CTA, D-dimer or no further testing); the algorithm was integrated into the Epic Radiology Information Ordering System. RESULTS: Among 872 studies requested, 479 (55%) received a recommendation to change their order: 6 (1.3%) were cancelled; 13 (2.7%) changed to a D-dimer, and 460 (96%) proceeded with CTA. Of the 853 studies conducted, 8.2% were positive for PE. The algorithm had good discriminatory power with positivity rates of 12.0% (CT), 10.0% (D-dimer), and 2.6% (no further testing). Compliance with the recommendation ranged from 12%-68% (mean 45%) with 10% correlation between compliance and positivity rates. CONCLUSION: While the CDS algorithm was accurate, it had only a minimal impact on ordering practices, in part due to heterogeneity in physician adherence.

Hypertension and diabetes control along the HIV care cascade in rural South Africa.

INTRODUCTION: Participation in antiretroviral therapy (ART) programmes has been associated with greater utilization of care for hypertension and diabetes in rural South Africa. The objective of this study was to assess whether people living with HIV on ART with comorbid hypertension or diabetes also have improved chronic disease management indicators. METHODS: The Health and Aging in Africa: a longitudinal study of an INDEPTH Community in South Africa (HAALSI) is a cohort of 5059 adults >40 years old. Enrollment took place between November 2014 and November 2015. The study collected population-based data on demographics, healthcare utilization, height, weight, blood pressure (BP) and blood glucose as well as HIV infection, HIV-1 RNA viral load (VL) and ART exposure. We used regression models to determine whether HIV care cascade stage (HIV-negative, HIV+ /No ART, ART/Detected HIV VL, and ART/Undetectable VL) was associated with diagnosis or treatment of hypertension or diabetes, and systolic blood pressure and glucose among those with diagnosed hypertension or diabetes. ART use was measured from drug level testing on dried blood spots. RESULTS AND DISCUSSION: Compared to people without HIV, ART/Undetectable VL was associated with greater awareness of hypertension diagnosis (adjusted risk ratio (aRR) 1.18, 95% CI: 1.09 to 1.28) and treatment of hypertension (aRR 1.24, 95% CI: 1.10 to 1.41) among those who met hypertension diagnostic criteria. HIV care cascade stage was not significantly associated with awareness of diagnosis or treatment of diabetes. Among those with diagnosed hypertension or diabetes, ART/Undetectable VL was associated with lower mean systolic blood pressure (5.98 mm Hg, 95% CI: 9.65 to 2.32) and lower mean glucose (3.77 mmol/L, 95% CI: 6.85 to 0.69), compared to being HIV-negative. CONCLUSIONS: Participants on ART with an undetectable VL had lower systolic blood pressure and blood glucose than the HIV-negative participants. HIV treatment programmes may provide a platform for health systems strengthening for cardiometabolic disease.

Noninvasive Imaging of Endothelial Damage in Patients With Different HbA1c Levels: A Proof-of-Concept Study.

The aim of this study was to compare endothelial permeability, which is considered a hallmark of coronary artery disease, between patients with different HbA1c levels using an albumin-binding magnetic resonance (MR) probe. This cross-sectional study included 26 patients with clinical indication for X-ray angiography who were classified into three groups according to HbA1c level (<5.7% [<39 mmol/mol], 5.7-6.4% [39-47 mmol/mol], and ≥6.5% [48 mmol/mol]). Subjects underwent gadofosveset-enhanced coronary magnetic resonance and X-ray angiography including optical coherence within 24 h. Contrast-to-noise ratios (CNRs) were assessed to measure the probe uptake in the coronary wall by coronary segment, excluding those with culprit lesions in X-ray angiography. In the group of patients with HbA1c levels between 5.7 and 6.4%, 0.30 increased normalized CNR values were measured, compared with patients with HbA1c levels <5.7% (0.30 [95% CI 0.04, 0.57]). In patients with HbA1c levels ≥6.5%, we found 0.57 higher normalized CNR values compared with patients with normal HbA1c levels (0.57 [95% CI 0.28, 0.85]) and 0.26 higher CNR values for patients with HbA1c level ≥6.5% compared with patients with HbA1c levels between 5.7 and 6.4% (0.26 [95% CI -0.04, 0.57]). Additionally, late atherosclerotic lesions were more common in patients with high HbA1c levels (HbA1c ≥6.5%, n = 14 [74%]; HbA1c 5.7-6.4%, n = 6 [60%]; and HbA1c <5.7%, n = 10 [53%]). In conclusion, coronary MRI in combination with an albumin-binding MR probe suggests that both patients with intermediate and patients with high HbA1c levels are associated with a higher extent of endothelial damage of the coronary arteries compared with patients with HbA1c levels <5.7%.

Analytic approaches to establish the diagnostic accuracy of coronary computed tomography angiography as a tool for clinical decision making.

Although 64-slice multidetector coronary computed tomography angiography (CTA) has been reported to have excellent test characteristics for the detection of significant coronary artery disease, current analytic approaches may not appropriately reflect the process of clinical decision making. Thirty-seven patients (29 men; mean age 63 +/- 11 years) who underwent coronary CTA for clinical indications followed by invasive coronary angiography within 4 weeks were studied. Computed tomography angiograms were analyzed independently for the presence of significant coronary artery stenosis (>or=50% luminal narrowing) by 2 observers blinded to invasive coronary angiographic results. The diagnostic test performance of coronary CTA was determined with and without inclusion of unassessable segments. Because stenosis could not be excluded in unassessable segments, these segments were counted as positive for stenosis. Sensitivity, specificity, and positive (PPV) and negative predictive values of CTA for detecting significant stenoses on assessable segments were 85% (51 of 60, 95% confidence interval [CI] 76% to 94%), 99% (414 of 416, 95% CI 99 to 100), 96% (95% CI 51 of 53), and 98% (95% CI 414 of 423), respectively. Overall, 13% of coronary segments (70 of 546) were not assessable using CTA (heavy calcium in 48 segments). By including these segments, PPV decreased from 96% to 60% (74 of 123), whereas sensitivity improved from 85% to 89% (95% CI 74 of 83). In conclusion, the clinical utility of coronary CTA may be limited by a low PPV in patients with a high prevalence of coronary artery disease.

Lessons Learned from a Cross-Model Validation between a Discrete Event Simulation Model and a Cohort State-Transition Model for Personalized Breast Cancer Treatment.

OBJECTIVES: Breast cancer is the most common malignancy among women in developed countries. We developed a model (the Oncotyrol breast cancer outcomes model) to evaluate the cost-effectiveness of a 21-gene assay when used in combination with Adjuvant! Online to support personalized decisions about the use of adjuvant chemotherapy. The goal of this study was to perform a cross-model validation. METHODS: The Oncotyrol model evaluates the 21-gene assay by simulating a hypothetical cohort of 50-year-old women over a lifetime horizon using discrete event simulation. Primary model outcomes were life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). We followed the International Society for Pharmacoeconomics and Outcomes Research-Society for Medical Decision Making (ISPOR-SMDM) best practice recommendations for validation and compared modeling results of the Oncotyrol model with the state-transition model developed by the Toronto Health Economics and Technology Assessment (THETA) Collaborative. Both models were populated with Canadian THETA model parameters, and outputs were compared. RESULTS: The differences between the models varied among the different validation end points. The smallest relative differences were in costs, and the greatest were in QALYs. All relative differences were less than 1.2%. The cost-effectiveness plane showed that small differences in the model structure can lead to different sets of nondominated test-treatment strategies with different efficiency frontiers. We faced several challenges: distinguishing between differences in outcomes due to different modeling techniques and initial coding errors, defining meaningful differences, and selecting measures and statistics for comparison (means, distributions, multivariate outcomes). CONCLUSIONS: Cross-model validation was crucial to identify and correct coding errors and to explain differences in model outcomes. In our comparison, small differences in either QALYs or costs led to changes in ICERs because of changes in the set of dominated and nondominated strategies.

Diabetes diagnosis and care in sub-Saharan Africa: pooled analysis of individual data from 12 countries.

BACKGROUND: Despite widespread recognition that the burden of diabetes is rapidly growing in many countries in sub-Saharan Africa, nationally representative estimates of unmet need for diabetes diagnosis and care are in short supply for the region. We use national population-based survey data to quantify diabetes prevalence and met and unmet need for diabetes diagnosis and care in 12 countries in sub-Saharan Africa. We further estimate demographic and economic gradients of met need for diabetes diagnosis and care. METHODS: We did a pooled analysis of individual-level data from nationally representative population-based surveys that met the following inclusion criteria: the data were collected during 2005-15; the data were made available at the individual level; a biomarker for diabetes was available in the dataset; and the dataset included information on use of core health services for diabetes diagnosis and care. We first quantified the population in need of diabetes diagnosis and care by estimating the prevalence of diabetes across the surveys; we also quantified the prevalence of overweight and obesity, as a major risk factor for diabetes and an indicator of need for diabetes screening. Second, we determined the level of met need for diabetes diagnosis, preventive counselling, and treatment in both the diabetic and the overweight and obese population. Finally, we did survey fixed-effects regressions to establish the demographic and economic gradients of met need for diabetes diagnosis, counselling, and treatment. FINDINGS: We pooled data from 12 nationally representative population-based surveys in sub-Saharan Africa, representing 38 311 individuals with a biomarker measurement for diabetes. Across the surveys, the median prevalence of diabetes was 5% (range 2-14) and the median prevalence of overweight or obesity was 27% (range 16-68). We estimated seven measures of met need for diabetes-related care across the 12 surveys: (1) percentage of the overweight or obese population who received a blood glucose measurement (median 22% [IQR 11-37]); and percentage of the diabetic population who reported that they (2) had ever received a blood glucose measurement (median 36% [IQR 27-63]); (3) had ever been told that they had diabetes (median 27% [IQR 22-51]); (4) had ever been counselled to lose weight (median 15% [IQR 13-23]); (5) had ever been counselled to exercise (median 15% [IQR 11-30]); (6) were using oral diabetes drugs (median 25% [IQR 18-42]); and (7) were using insulin (median 11% [IQR 6-13]). Compared with those aged 15-39 years, the adjusted odds of met need for diabetes diagnosis (measures 1-3) were 2·22 to 3·53 (40-54 years) and 3·82 to 5·01 (≥55 years) times higher. The adjusted odds of met need for diabetes diagnosis also increased consistently with educational attainment and were between 3·07 and 4·56 higher for the group with 8 years or more of education than for the group with less than 1 year of education. Finally, need for diabetes care was significantly more likely to be met (measures 4-7) in the oldest age and highest educational groups. INTERPRETATION: Diabetes has already reached high levels of prevalence in several countries in sub-Saharan Africa. Large proportions of need for diabetes diagnosis and care in the region remain unmet, but the patterns of unmet need vary widely across the countries in our sample. Novel health policies and programmes are urgently needed to increase awareness of diabetes and to expand coverage of preventive counselling, diagnosis, and linkage to diabetes care. Because the probability of met need for diabetes diagnosis and care consistently increases with age and educational attainment, policy makers should pay particular attention to improved access to diabetes services for young adults and people with low educational attainment. FUNDING: None.