Evaluation of Socioeconomic Disparities in Follow-Up Completion for Incidental Pulmonary Nodules.

PURPOSE: The aim of this study was to evaluate the association between census tract-level measures of social vulnerability and residential segregation and incidental pulmonary nodule (IPN) follow-up. METHODS: This retrospective cohort study included patients with IPNs ≥6 mm in size or multiple subsolid or ground-glass IPNs <6 mm (with nonoptional follow-up recommendations) diagnosed between January 1, 2018, and December 30, 2019, at a large urban tertiary center and followed for ≥2 years. Geographic sociodemographic context was characterized by the 2018 Centers for Disease Control and Prevention Social Vulnerability Index (SVI) and the index of concentration at the extremes (ICE), categorized in quartiles. Multivariable binomial regression models were used, with a primary outcome of inappropriate IPN follow-up (late or no follow-up). Models were also stratified by nodule risk. RESULTS: The study consisted of 2,492 patients (mean age, 65.6 ± 12.6 years; 1,361 women). Top-quartile SVI patients were more likely to have inappropriate follow-up (risk ratio [RR], 1.24; 95% confidence interval [CI], 1.12-1.36) compared with the bottom quartile; risk was also elevated in top-quartile SVI subcategories of socioeconomic status (RR, 1.23; 95% CI, 1.13-1.34), Minority status and language (RR, 1.24; 95% CI, 1.03-1.48), housing and transportation (RR, 1.13; 95% CI, 1.02-1.26), and ICE (RR, 1.20; 95% CI, 1.11-1.30). Furthermore, top-quartile ICE was associated with greater risk for inappropriate follow-up among high-risk versus lower risk IPNs (RR, 1.33 [95% CI, 1.18-1.50] versus 1.13 [95% CI, 1.02-1.25]), respectively; P for interaction = .017). CONCLUSIONS: Local social vulnerability and residential segregation are associated with inappropriate IPN follow-up and may inform policy or interventions tailored for neighborhoods.

How to Perform Economic Evaluation in Implementation Studies: Imaging-Specific Considerations and Comparison of Financial Models.

Economic evaluation for implementation science merits unique considerations for a local context, including the main audience of local decision makers. This local context is in contrast with traditional methods for developing coverage policy for medical tests and interventions, which typically emphasize benefits and costs more broadly, for society. Regardless of the strength of evidence backing the efficacy or effectiveness of a clinical intervention, local context is paramount when implementing evidence-based practices. Understanding the costs throughout the processes of implementing a program will inform the decision of whether to plan for and adopt the program, how to sustain the program, and whether to scale up widely. To guide economic evaluation for implementation of evidence-based imaging practices, we describe approaches that consider local stakeholders' needs and connect these with outcomes of cost and clinical utility. Illustrative examples of implementation strategies and economic evaluation are explored in areas of cancer screening and care delivery.

Active Surveillance Strategies for Low-Grade Prostate Cancer: Comparative Benefits and Cost-effectiveness.

Background Active surveillance (AS) is the recommended treatment option for low-risk prostate cancer (PC). Surveillance varies in MRI, frequency of follow-up, and the Prostate Imaging Reporting and Data System (PI-RADS) score that would repeat biopsy. Purpose To compare the effectiveness and cost-effectiveness of AS strategies for low-risk PC with versus without MRI. Materials and Methods This study developed a mathematical model to evaluate the cost-effectiveness of surveillance strategies in a simulation of men with a diagnosis of low-risk PC. The following strategies were compared: watchful waiting, prostate-specific antigen (PSA) and annual biopsy without MRI, and PSA testing and MRI with varied PI-RADS thresholds for biopsy. MRI strategies differed regarding scheduling and use of PI-RADS score of at least 3, or a PI-RADS score of at least 4 to indicate the need for biopsy. Life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios were calculated by using microsimulation. Sensitivity analysis was used to assess the impact of varying parameter values on results. Results For the base case of 60-year-old men, all strategies incorporating prostate MRI extended QALYs and life-years compared with watchful waiting and non-MRI strategies. Annual MRI strategies yielded 16.19 QALYs, annual biopsy with no MRI yielded 16.14 QALYs, and watchful waiting yielded 15.94 QALYs. Annual MRI with PI-RADS score of at least 3 or of at least 4 as the biopsy threshold and annual MRI with biopsy even after MRI with negative findings offered similar QALYs and the same unadjusted life expectancy: 23.05 life-years. However, a PI-RADS score of at least 4 yielded 42% fewer lifetime biopsies. With a cost-effectiveness threshold of $100 000 per QALY, annual MRI with biopsy for lesions with PI-RADS scores of 4 or greater was most cost-effective (incremental cost-effectiveness ratio, $67 221 per QALY). Age, treatment type, risk of initial grade misclassification, and quality-of-life impact of procedural complications affected results. Conclusion The use of active surveillance (AS) with biopsy decisions guided by findings from annual MRI reduces the number of biopsies while preserving life expectancy and quality of life. Biopsy in lesions with PI-RADS scores of 4 or greater is likely the most cost-effective AS strategy for men with low-risk prostate cancer who are younger than 70 years. © RSNA, 2021 Online supplemental material is available for this article. An earlier incorrect version appeared online. This article was corrected on July 13, 2021.

Point-of-care characterization and risk-based management of oral lesions in primary dental clinics: A simulation model.

OBJECTIVES: Oral potentially malignant disorders (OPMDs) encompass histologically benign, dysplastic, and cancerous lesions that are often indistinguishable by appearance and inconsistently managed. We assessed the potential impact of test-and-treat pathways enabled by a point-of-care test for OPMD characterization. MATERIALS AND METHODS: We constructed a decision-analytic model to compare life expectancy of test-treat strategies for 60-year-old patients with OPMDs in the primary dental setting, based on a trial for a point-of-care cytopathology tool (POCOCT). Eight strategies of OPMD detection and evaluation were compared, involving deferred evaluation (no further characterization), prompt OPMD characterization using POCOCT measurements, or the commonly recommended usual care strategy of routine referral for scalpel biopsy. POCOCT pathways differed in threshold for additional intervention, including surgery for any dysplasia or malignancy, or for only moderate or severe dysplasia or cancer. Strategies with initial referral for biopsy also reflected varied treatment thresholds in current practice between surgery and surveillance of mild dysplasia. Sensitivity analysis was performed to assess the impact of variation in parameter values on model results. RESULTS: Requisite referral for scalpel biopsy offered the highest life expectancy of 20.92 life-years compared with deferred evaluation (+0.30 life-years), though this outcome was driven by baseline assumptions of limited patient adherence to surveillance using POCOCT. POCOCT characterization and surveillance offered only 0.02 life-years less than the most biopsy-intensive strategy, while resulting in 27% fewer biopsies. When the probability of adherence to surveillance and confirmatory biopsy was ≥ 0.88, or when metastasis rates were lower than reported, POCOCT characterization extended life-years (+0.04 life-years) than prompt specialist referral. CONCLUSION: Risk-based OPMD management through point-of-care cytology may offer a reasonable alternative to routine referral for specialist evaluation and scalpel biopsy, with far fewer biopsies. In patients who adhere to surveillance protocols, POCOCT surveillance may extend life expectancy beyond biopsy and follow up visual-tactile inspection.

Point-of-care oral cytology tool for the screening and assessment of potentially malignant oral lesions.

BACKGROUND: The effective detection and monitoring of potentially malignant oral lesions (PMOL) are critical to identifying early-stage cancer and improving outcomes. In the current study, the authors described cytopathology tools, including machine learning algorithms, clinical algorithms, and test reports developed to assist pathologists and clinicians with PMOL evaluation. METHODS: Data were acquired from a multisite clinical validation study of 999 subjects with PMOLs and oral squamous cell carcinoma (OSCC) using a cytology-on-a-chip approach. A machine learning model was trained to recognize and quantify the distributions of 4 cell phenotypes. A least absolute shrinkage and selection operator (lasso) logistic regression model was trained to distinguish PMOLs and cancer across a spectrum of histopathologic diagnoses ranging from benign, to increasing grades of oral epithelial dysplasia (OED), to OSCC using demographics, lesion characteristics, and cell phenotypes. Cytopathology software was developed to assist pathologists in reviewing brush cytology test results, including high-content cell analyses, data visualization tools, and results reporting. RESULTS: Cell phenotypes were determined accurately through an automated cytological assay and machine learning approach (99.3% accuracy). Significant differences in cell phenotype distributions across diagnostic categories were found in 3 phenotypes (type 1 ["mature squamous"], type 2 ["small round"], and type 3 ["leukocytes"]). The clinical algorithms resulted in acceptable performance characteristics (area under the curve of 0.81 for benign vs mild dysplasia and 0.95 for benign vs malignancy). CONCLUSIONS: These new cytopathology tools represent a practical solution for rapid PMOL assessment, with the potential to facilitate screening and longitudinal monitoring in primary, secondary, and tertiary clinical care settings.

Personalized Treatment for Small Renal Tumors: Decision Analysis of Competing Causes of Mortality.

Purpose To compare the effectiveness of personalized treatment for small (≤4 cm) renal tumors versus routine partial nephrectomy (PN), accounting for various competing causes of mortality. Materials and Methods A state-transition microsimulation model was constructed to compare life expectancy of management strategies for small renal tumors by using 1 000 000 simulations in the following ways: routine PN or personalized treatment involving percutaneous ablation for risk factors for worsening chronic kidney disease (CKD), and otherwise PN; biopsy, with triage of renal cell carcinoma (RCC) to PN or ablation depending on risk factors for worsening CKD; active surveillance for growth; and active surveillance when MRI findings are indicative of papillary RCC. Transition probabilities were incorporated from the literature. Effects of parameter variability were assessed in sensitivity analysis. Results In patients of all ages with normal renal function, routine PN yielded the longest life expectancy (eg, 0.67 years in 65-year-old men with nephrometry score [NS] of 4). Otherwise, personalized strategies extended life expectancy versus routine PN: in CKD stages 2 or 3a, moderate or high NS, and no comorbidities, MRI guidance for active surveillance extended life expectancy (eg, 2.60 years for MRI vs PN in CKD 3a, NS 10); and with Charlson comorbidity index of 1 or more, biopsy or active surveillance for growth extended life expectancy (eg, 2.70 years for surveillance for growth in CKD 3a, NS 10). CKD 3b was most effectively managed by using MRI to help predict papillary RCC for surveillance. Conclusion For patients with chronic kidney disease and small renal tumors, personalized treatment selection likely extends life expectancy. © RSNA, 2019 Online supplemental material is available for this article.

MRI screening for uterine leiomyosarcoma.

BACKGROUND: Uterine fibroids are a common benign tumor and can be symptomatic, necessitating resection. Surgical myomectomy is an effective treatment option with a risk of disseminating occult uterine leiomyosarcoma (LMS), creating a need for an effective presurgical screening protocol. Clinical collaboration with contrast-enhanced MRI including T2 and diffusion-weighted imaging (DWI) can be utilized as a screening exam. PURPOSE: To review the accuracy and feasibility of an interdisciplinary prospective contrast-enhanced MRI pelvis with DWI screening system for LMS prior to fibroid resection. STUDY TYPE: Retrospective cohort study. POPULATION: In all, 1960 adult female patients aged 18-87 undergoing screening MRI pelvis prior to uterine fibroid resection. FIELD STRENGTH/SEQUENCE: T1 and T2 -weighted imaging, DWI, and contrast-enhanced images were acquired at 1.5 T and 3.0 T. ASSESSMENT: Each radiologist at the time of clinical study prospectively designated a confidence level of presence of LMS in the impression, which was reviewed retrospectively. A separate retrospective evaluation of the histologically proven LMS and the false positives was performed for the presence of five MRI features of LMS including low ADC values, intermediate/high T2 signal intensity, irregular margins, hemorrhage, and necrosis. A preliminary cost-effectiveness analysis was performed, comparing the costs of treatment of uterine fibroids with vs. without a collaborative screening protocol using MRI. STATISTICAL TESTS: Sensitivity, specificity, positive predictive value, and negative predictive value were obtained from the prospective evaluations. Student's t-tests were used to compare demographics and apparent diffusion coefficient values between LMS and false-positive results. RESULTS: We prospectively identified LMS patients with 100% sensitivity and 97% specificity. Preliminary cost analysis demonstrated that the MR screening protocol increased life expectancy by 0.04 years at a cost of $12,937 per life-year gained. DATA CONCLUSION: MRI is an effective and potentially economic screening test, especially with standardized reporting and coordination with clinicians. LEVEL OF EVIDENCE: 3 Technical Efficacy Stage: 2 J. Magn. Reson. Imaging 2019.

Measuring the value of MRI: Comparative effectiveness & outcomes research.

Magnetic resonance imaging (MRI) now provides diagnostic assessment for numerous clinical indications, including lesion detection, characterization, functional assessment, and response to treatment. To maximize the potential to improve health through the use of MRI, it is critical to investigate the impact of MRI on outcomes, and to compare the effectiveness of MRI with existing standard diagnostic approaches. Outcomes of MRI can include survival but also intermediate steps such as potential reduction in unnecessary therapy, shorter time to the appropriate therapy, or shorter periods of hospital admission. To understand the effectiveness of an imaging test's sensitivity and specificity, the results' consequences are weighed, reflecting the disease type, severity, and treatment effects. In some instances, other modalities may be faster, more readily available, or less costly than MRI but additional disease-related information or better accuracy may translate to greater population level benefit. For health policy decisions and clinical guidelines, studies of comparative outcomes can lend depth to the strength of the evidence, the specific benefits vs. harms of using one test over another, and the most effective use of the test in terms of target population. Cost effectiveness then allows for a direct comparison of approaches in terms of the cost for the projected gain in life expectancy and/or quality adjusted life expectancy. Expanding the literature on improved efficiency, accessibility, clinical effectiveness, and cost effectiveness will support the directive for better quality and value in healthcare. Level of Evidence 5 Technical Efficacy Stage 5 J. Magn. Reson. Imaging 2019.

Volume and Coverage of Secondary Imaging Interpretation Under Medicare, 2003 to 2016.

PURPOSE: The aim of this study was to assess changing Medicare volumes of, and coverage for, secondary interpretations of diagnostic imaging examinations stratified by modality and body region service families. METHODS: Medicare Physician/Supplier Procedure Summary Master Files for 2003 to 2016 were obtained. Aggregate Part B fee-for-service claims frequency and payment data were isolated for noninvasive diagnostic imaging and stratified by service family. Using published Medicare payment rules, secondary interpretations were identified as studies billed using both modifiers 26 and 77. Billed and denied services volumes were calculated and compared across modality and body region service families. RESULTS: Seven service families showed a compound annual growth rate from 2003 to 2016 of >20% (an additional 12 service families, >10% growth). For select high-volume service families (chest radiography and fluoroscopy [R&F], brain MRI, and abdominal and pelvic CT), relative growth in billed secondary interpretation services exceeded that for primary interpretations. In 2016, body region and modality service families with the most billed secondary interpretations were chest R&F (674,124), abdominal and pelvic R&F (65,566), brain CT (45,642), extremity R&F (34,560), abdominal and pelvic CT (14,269), and chest CT (10,914). All service families had secondary interpretation denial rates <25% in 2016 (15 service families, <10%). CONCLUSIONS: Among Medicare beneficiaries, the frequency of billed secondary interpretation services for diagnostic imaging services increased from 2003 to 2016 across a broad range of modalities and body regions, often dramatically. Payment denial rates were consistently low across service families. As CMS continues to seek input on appropriate coverage for these services, these findings suggest increasing clinical demand for and payer acceptance of these value-added radiologist services.

Use of Breast Cancer Screening and Its Association with Later Use of Preventive Services among Medicare Beneficiaries.

Purpose To retrospectively assess whether there is an association between screening mammography and the use of a variety of preventive services in women who are enrolled in Medicare. Materials and Methods U.S. Medicare claims from 2010 to 2014 Research Identifiable Files were reviewed to retrospectively identify a group of women who underwent screening mammography and a control group without screening mammography in 2012. The screened group was divided into positive versus negative results at screening, and the positive subgroup was divided into false-positive and true-positive findings. Multivariate logistic regression models and inverse probability of treatment weighting were used to examine the relationship between screening status and the probabilities of undergoing Papanicolaou test, bone mass measurement, or influenza vaccination in the following 2 years. Results The cohort consisted of 555 705 patients, of whom 185 625 (33.4%) underwent mammography. After adjusting for patient demographics, comorbidities, geographic covariates, and baseline preventive care, women who underwent index screening mammography (with either positive or negative results) were more likely than unscreened women to later undergo Papanicolaou test (odds ratio [OR], 1.49; 95% confidence interval: 1.40, 1.58), bone mass measurement (OR, 1.70; 95% confidence interval: 1.63, 1.78), and influenza vaccine (OR, 1.45; 95% confidence interval: 1.37, 1.53). In women who had not undergone these preventive measures in the 2 years before screening mammography, use of these three services after false-positive findings at screening was no different than after true-negative findings at screening. Conclusion In beneficiaries of U.S. Medicare, use of screening mammography was associated with higher likelihood of adherence to other preventive guidelines, without a negative association between false-positive results and cervical cancer screening.

Supporting Imagers' VOICE: A National Training Program in Comparative Effectiveness Research and Big Data Analytics.

Provided methodologic training, more imagers can contribute to the evidence basis on improved health outcomes and value in diagnostic imaging. The Value of Imaging Through Comparative Effectiveness Research Program was developed to provide hands-on, practical training in five core areas for comparative effectiveness and big biomedical data research: decision analysis, cost-effectiveness analysis, evidence synthesis, big data principles, and applications of big data analytics. The program's mixed format consists of web-based modules for asynchronous learning as well as in-person sessions for practical skills and group discussion. Seven diagnostic radiology subspecialties and cardiology are represented in the first group of program participants, showing the collective potential for greater depth of comparative effectiveness research in the imaging community.

Risk-stratified versus Non-Risk-stratified Diagnostic Testing for Management of Suspected Acute Biliary Obstruction: Comparative Effectiveness, Costs, and the Role of MR Cholangiopancreatography.

Purpose To analyze the cost-effectiveness of the American Society for Gastrointestinal Endoscopy (ASGE) risk stratification guidelines versus magnetic resonance (MR) cholangiopancreatography-based treatment of patients with possible choledocholithiasis. Materials and Methods A decision-analytic model was constructed to compare cost and effectiveness of three diagnostic strategies for gallstone disease with possible choledocholithiasis: noncontrast MR cholangiopancreatography, contrast material-enhanced MR imaging/MR cholangiopancreatography, and ASGE risk stratification guidelines for diagnostic evaluation recommending endoscopy (high risk), MR cholangiopancreatography (intermediate risk), or no test (low risk). Analysis was performed from a U.S. health system perspective over 1-year and lifetime horizons. The model accounted for benign and malignant causes of biliary obstruction and procedural complications. Cost information was based on Medicare reimbursements. Sensitivity analysis assessed the impact of parameter variability on model results. Results Noncontrast MR cholangiopancreatography was most cost-effective in 45-55-year-old patients (less than $100 000 per quality-adjusted life-year [QALY] gained), while contrast-enhanced MR imaging was favored in younger adults. Risk-stratified testing was less costly than MR cholangiopancreatography, with long-term savings of $1870 and $2068 versus noncontrast and contrast-enhanced MR cholangiopancreatography, respectively, but was also less effective (-0.1814, -0.1831 QALY, respectively). The lifetime incremental cost per QALY for noncontrast MR cholangiopancreatography was $10 311. Contrast-enhanced MR imaging was favored with pretest probabilities of biliary stricture or malignancy 0%-73% for patients aged 20-44 years. For patients older than 55 years, ASGE guidelines maximized QALYs at the lowest cost. Conclusion Although adults older than 55 years of age are optimally evaluated by using ASGE guidelines, younger patients suspected of having acute biliary obstruction likely benefit from MR cholangiopancreatography rather than risk-stratified diagnostic imaging because of improved detection of choledocholithiasis and alternative causes of biliary obstruction. © RSNA, 2017 Online supplemental material is available for this article.

Tumor Anatomy Scoring and Renal Function for Nephron-Sparing Treatment Selection in Patients With Small Renal Masses: A Microsimulation-Based Decision Analysis.

OBJECTIVE: The purpose of this article is to compare the effectiveness of a treatment algorithm for small renal tumors incorporating the nephrometry score, a renal tumor anatomy scoring system developed by urologists, with the current standard of uniformly recommended partial nephrectomy in patients with mild-to-moderate chronic kidney disease (CKD). MATERIALS AND METHODS: We developed a state-transition microsimulation model to project life expectancy (LE) in hypothetic patients with baseline mild or moderate CKD undergoing treatment of small renal masses. Our model incorporated the nephrometry score, which is predictive of postsurgical renal function loss. The two tested strategies were uniform treatment with partial nephrectomy and selective treatment based on nephrometry score and CKD stage, including percutaneous ablation for CKD stages 2 or 3a and intermediate-to-high nephrometry score or stage 3b CKD and any nephrometry score; otherwise, partial nephrectomy was assumed for other CKD stages and nephrometry scores. The model accounted for benign and malignant lesions, renal function decline, recurrence, and metastatic disease rates specific to each treatment, mortality by CKD stage, and comorbidities. Sensitivity analysis tested the stability of results when varying key parameters. RESULTS: Selective treatment with partial nephrectomy resulted in an average LE benefit of 0.48 year (95% interpercentile range, 0.42-0.54 year) in 65-year-old men and 0.37 year (95% interpercentile range, 0.30-0.43 year) in 65-year-old women relative to nondiscriminatory surgery, due to worsening CKD and cardiovascular mortality associated with partial nephrectomy. Model results were most sensitive to the rate of renal function decline and CKD-related mortality. CONCLUSION: Nephron-sparing treatment selection for small renal masses based on nephrometry score may improve LE in patients with mild or moderate CKD.

Acute Appendicitis: Use of Clinical and CT Findings for Modeling Hospital Resource Utilization.

OBJECTIVE: The purpose of this study was to retrospectively investigate associations between baseline CT findings in suspected acute appendicitis and subsequent hospital resource utilization. MATERIALS AND METHODS: One hundred thirty-eight patients (76 male and 62 female patients; mean [± SD] age, 40 ± 21 years) who were admitted for suspected acute appendicitis and underwent baseline CT were included. A single radiologist reviewed CT examinations for appendiceal-related findings. Linear and logistic regressions were performed to identify independent predictors of payer and hospital resource utilization. Combined performance of identified independent factors for predicting outcomes was determined. RESULTS: Greater age, lower Charlson comorbidity index (CCI), lesser appendiceal wall thickness, absence of loculated fluid collection, and absence of periappendiceal fluid were significant independent predictors of inpatient surgery (joint sensitivity, 92.7%; specificity, 65.8%). Smaller appendiceal diameter, absence of periappendiceal fluid, and laparoscopic surgery were significant independent predictors of same-day discharge (joint sensitivity, 79.1%; specificity, 64.2%). Greater CCI, greater wall thickness, and presence of periappendiceal fluid were significant independent predictors of repeat abdominopelvic CT (joint sensitivity, 82.5%; specificity, 68.1%). Presence of an appendicolith was the only significant predictor of repeat emergency department visit within 30 days (sensitivity, 61.2%; specificity, 68.8%) and the only significant predictor of repeat inpatient admission within 30 days (sensitivity, 63.6%; specificity, 68.5%). Greater appendiceal diameter and presence of free air were significant predictors of inpatient costs, and predicted costs were as follows: $8047 + ($745 × appendiceal diameter) if free air was absent; and $-39,261 + ($4426 × appendiceal diameter) if free air was present. However, costs were poorly predicted when greater than $45,000. Sex, WBC count, and payer category were not independent predictors, relative to CT findings, of any outcome. CONCLUSION: Admission CT findings serve as independent predictors of hospital resource utilization in suspected acute appendicitis.