Risk-stratified versus Non-Risk-stratified Diagnostic Testing for Management of Suspected Acute Biliary Obstruction: Comparative Effectiveness, Costs, and the Role of MR Cholangiopancreatography
Kang, Stella K; Hoffman, David; Ferket, Bart; Kim, Michelle I; Braithwaite, R Scott
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. (c) RSNA, 2017 Online supplemental material is available for this article.
A Randomized Study of Patient Risk Perception for Incidental Renal Findings on Diagnostic Imaging Tests
Kang, Stella K; Scherer, Laura D; Megibow, Alec J; Higuita, Leslie J; Kim, Nathanael; Braithwaite, R Scott; Fagerlin, Angela
OBJECTIVE: The purpose of this study is to assess differences in patient distress, risk perception, and treatment preferences for incidental renal findings with descriptive versus combined descriptive and numeric graphical risk information. MATERIALS AND METHODS: A randomized survey study was conducted for adult patients about to undergo outpatient imaging studies at a large urban academic institution. Two survey arms contained either descriptive or a combination of descriptive and numeric graphical risk information about three hypothetical incidental renal findings at CT: 2-cm (low risk) and 5-cm (high risk) renal tumors and a 2-cm (low risk) renal artery aneurysm. The main outcomes were patient distress, perceived risk (qualitative and quantitative), treatment preference, and valuation of lesion discovery. RESULTS: Of 374 patients, 299 participated (79.9% response rate). With inclusion of numeric and graphical, rather than only descriptive, risk information about disease progression for a 2-cm renal tumor, patients reported less worry (3.56 vs 4.12 on a 5-point scale; p < 0.001) and favored surgical consultation less often (29.3% vs 46.9%; p = 0.003). The proportion choosing surgical consultation for the 2-cm renal tumor decreased to a similar level as for the renal artery aneurysm with numeric risk information (29.3% [95% CI, 21.7-36.8%] and 27.9% [95% CI, 20.5-35.3%], respectively). Patients overestimated the absolute risk of adverse events regardless of risk information type, but significantly more so when given descriptive information only, and valued the discovery of lesions regardless of risk information type (range, 4.41-4.81 on a 5-point scale). CONCLUSION: Numeric graphical risk communication for patients about incidental renal lesions may facilitate accurate risk comprehension and support patients in informed decision making.
Supporting Imagers' VOICE: A National Training Program in Comparative Effectiveness Research and Big DataÂ Analytics
Kang, Stella K; Rawson, James V; Recht, Michael P
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.
MRI Improves the Characterization of Incidental Adnexal Masses Detected at Sonography [Comment]
Lee, Susanna I; Kang, Stella K
MRI Evaluation of Uterine Masses for Risk of Leiomyosarcoma: A Consensus Statement
Hindman, Nicole; Kang, Stella; Fournier, Laure; Lakhman, Yulia; Nougaret, Stephanie; Reinhold, Caroline; Sadowski, Elizabeth; Huang, Jian Qun; Ascher, Susan
Laparoscopic myomectomy, a common gynecologic operation in premenopausal women, has become heavily regulated since 2014 following the dissemination of unsuspected uterine leiomyosarcoma (LMS) throughout the pelvis of a physician treated for symptomatic leiomyoma. Research since that time suggests a higher prevalence than previously suspected of uterine LMS in resected masses presumed to represent leiomyoma, as high as one in 770 women (0.13%). Though rare, the dissemination of an aggressive malignant neoplasm due to noncontained electromechanical morcellation in laparoscopic myomectomy is a devastating outcome. Gynecologic surgeons' desire for an evidence-based, noninvasive evaluation for LMS is driven by a clear need to avoid such harms while maintaining the availability of minimally invasive surgery for symptomatic leiomyoma. Laparoscopic gynecologists could rely upon the distinction of higher-risk uterine masses preoperatively to plan oncologic surgery (ie, potential hysterectomy) for patients with elevated risk for LMS and, conversely, to safely offer women with no or minimal indicators of elevated risk the fertility-preserving laparoscopic myomectomy. MRI evaluation for LMS may potentially serve this purpose in symptomatic women with leiomyomas. This evidence review and consensus statement defines imaging and disease-related terms to allow more uniform and reliable interpretation and identifies the highest priorities for future research on LMS evaluation.
Improving breast cancer diagnostics with deep learning for MRI
Witowski, Jan; Heacock, Laura; Reig, Beatriu; Kang, Stella K; Lewin, Alana; Pysarenko, Kristine; Patel, Shalin; Samreen, Naziya; Rudnicki, Wojciech; ÅuczyÅ„ska, ElÅ¼bieta; Popiela, Tadeusz; Moy, Linda; Geras, Krzysztof J
Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) has a high sensitivity in detecting breast cancer but often leads to unnecessary biopsies and patient workup. We used a deep learning (DL) system to improve the overall accuracy of breast cancer diagnosis and personalize management of patients undergoing DCE-MRI. On the internal test set (n = 3936 exams), our system achieved an area under the receiver operating characteristic curve (AUROC) of 0.92 (95% CI: 0.92 to 0.93). In a retrospective reader study, there was no statistically significant difference (P = 0.19) between five board-certified breast radiologists and the DL system (mean Î”AUROC, +0.04 in favor of the DL system). Radiologists' performance improved when their predictions were averaged with DL's predictions [mean Î”AUPRC (area under the precision-recall curve), +0.07]. We demonstrated the generalizability of the DL system using multiple datasets from Poland and the United States. An additional reader study on a Polish dataset showed that the DL system was as robust to distribution shift as radiologists. In subgroup analysis, we observed consistent results across different cancer subtypes and patient demographics. Using decision curve analysis, we showed that the DL system can reduce unnecessary biopsies in the range of clinically relevant risk thresholds. This would lead to avoiding biopsies yielding benign results in up to 20% of all patients with BI-RADS category 4 lesions. Last, we performed an error analysis, investigating situations where DL predictions were mostly incorrect. This exploratory work creates a foundation for deployment and prospective analysis of DL-based models for breast MRI.
An Evaluation of a Web-Based Decision Aid for Treatment Planning of Small Kidney Tumors: Pilot Randomized Controlled Trial
Fogarty, Justin; Siriruchatanon, Mutita; Makarov, Danil; Langford, Aisha; Kang, Stella
BACKGROUND:Surgery is the most common treatment for localized small kidney masses (SKMs) up to 4 cm, despite a lack of evidence for improved overall survival. Nonsurgical management options are gaining recognition, as evidence supports the indolence of most SKMs. Decision aids (DAs) have been shown to improve patient comprehension of the trade-offs of treatment options and overall decision quality, and may improve consideration of all major options according to individual health priorities and preferences. OBJECTIVE:This pilot randomized controlled trial (RCT) primarily aims to evaluate the impact of a new web-based DA on treatment decisions for patients with SKM; that is, selection of surgical versus nonsurgical treatment options. Secondary objectives include an assessment of decision-making outcomes: decisional conflict, decision satisfaction, and an understanding of individual preferences for treatment that incorporate the trade-offs associated with surgical versus nonsurgical interventions. METHODS:Three phases comprise the construction and evaluation of a new web-based DA on SKM treatment. In phase 1, this DA was developed in print format through a multidisciplinary design committee incorporating patient focus groups. Phase 2 was an observational study on patient knowledge and decision-making measures after randomization to receive the printed DA or institutional educational materials, which identified further educational needs applied to a web-based DA. Phase 3 will preliminarily evaluate the web-based DA: in a pilot RCT, 50 adults diagnosed with SKMs will receive the web-based DA or an existing web-based institutional website at urology clinics at a large academic medical center. The web-based DA applies risk communication and information about diagnosis and treatment options, elicits preferences regarding treatment options, and provides a set of options to consider with their doctor based on a decision-analytic model of benefits/harm analysis that accounts for comorbidity, age group, and tumor features. Questionnaires and treatment decision data will be gathered before and after viewing the educational material. RESULTS:This phase will consist of a pilot RCT from August 2022 to January 2023 to establish feasibility and preliminarily evaluate decision outcomes. Previous study phases from 2018 to 2020 supported the feasibility of providing the printed DA in urology clinics before clinical consultation and demonstrated increased patient knowledge about the diagnosis and treatment options and greater likelihood of favoring nonsurgical treatment just before consultation. This study was funded by the National Cancer Institute. Recruitment will begin in August 2022. CONCLUSIONS:A web-based DA has been designed to address educational needs for patients making treatment decisions for SKM, accounting for comorbidities and treatment-related benefits and risks. Outcomes from the pilot trial will evaluate the potential of a web-based DA in personalizing treatment decisions and in helping patients weigh attributes of surgical versus nonsurgical treatment options for their SKMs. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05387863; https://clinicaltrials.gov/ct2/show/NCT05387863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:PRR1-10.2196/41451.
Does histologic subtype impact overall survival in observed T1a kidney cancers compared with competing risks? Implications for biopsy as a risk stratification tool
Michael, Jamie; Velazquez, Nermarie; Renson, Audrey; Tan, Hung-Jui; Rose, Tracy L; Osterman, Chelsea K; Milowsky, Matthew; Kang, Stella K; Huang, William C; Bjurlin, Marc A
OBJECTIVES/OBJECTIVE:We sought to assess if adding a biopsy proven histologic subtype to a model that predicts overall survival that includes variables representing competing risks in observed, biopsy proven, T1a renal cell carcinomas, enhances the model's performance. METHODS:The National Cancer Database was assessed (years 2004-2015) for patients with observed T1a renal cell carcinoma who had undergone renal mass biopsy. Kaplan-Meier curves were utilized to estimate overall survival stratified by histologic subtype. We utilized C-index from a Cox proportional hazards model to evaluate the impact of adding histologic subtypes to a model to predict overall survival for each stage. RESULTS:Of 132â€‰958 T1a renal masses identified, 1614 had biopsy proven histology and were managed non-operatively. Of those, 61% were clear cell, 33% papillary, and 6% chromophobe. Adjusted Kaplan-Meier curves demonstrated a difference in overall survival between histologic subtypes (Pâ€‰=â€‰0.010) with greater median overall survival for patients with chromophobe (85.1â€‰months, hazard rate 0.45, Pâ€‰=â€‰0.005) compared to clear cell (64.8â€‰months, reference group). Adding histology to a model with competing risks alone did not substantially improve model performance (C-index 0.65 vs 0.64 respectively). CONCLUSIONS:Incorporation of histologic subtype into a risk stratification model to determine prognostic overall survival did not improve modeling of overall survival compared with variables representing competing risks in patients with T1a renal cell carcinoma managed with observation. These results suggest that performing renal mass biopsy in order to obtain tumor histology may have limited utility. Future studies should further investigate the overall utility of renal mass biopsy for observed T1a kidney cancers.
Development and Pilot Evaluation of a Decision Aid for Small Kidney Masses
Thomas, Shailin A; Siriruchatanon, Mutita; Albert, Stephanie L; Bjurlin, Marc; Hoffmann, Jason C; Langford, Aisha; Braithwaite, R Scott; Makarov, Danil V; Fagerlin, Angela; Kang, Stella K
OBJECTIVE:To develop and pilot test a patient decision aid (DA) describing small kidney masses and risks and benefits of treatment for the masses. METHODS:An expert committee iteratively designed a small kidney mass DA, incorporating evidence-based risk communication and informational needs for treatment options and shared decision making. After literature review and drafting content with the feedback of urologists, radiologists, and an internist, a rapid qualitative assessment was conducted using two patient focus groups to inform user-centered design. In a pilot study, 30 patients were randomized at the initial urologic consultation to receive the DA or existing institutional patient educational material (PEM). Preconsultation questionnaires captured patient knowledge and shared decision-making preferences. After review of the DA and subsequent clinician consultation, patients completed questionnaires on discussion content and satisfaction. Proportions between arms were compared using Fisher exact tests, and decision measures were compared using Mann-Whitney tests. RESULTS:Patient informational needs included risk of tumor growth during active surveillance and ablation, significance of comorbidities, and posttreatment recovery. For the DA, 84% of patients viewed all content, and mean viewing time was 20 min. Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, PÂ <Â .001). DA use also increased the proportion of patients discussing ablation (66.7% DA versus 18.2% PEM, PÂ = .02). Decision satisfaction measures were similar in both arms. DISCUSSION/CONCLUSIONS:Patients receiving a small kidney mass DA are likely to gain knowledge and preparedness to discuss all treatment options over standard educational materials.
Outcomes of Incidental Lung Nodules With Structured Recommendations and Electronic Tracking
Bagga, Barun; Fansiwala, Kush; Thomas, Shailin; Chung, Ryan; Moore, William H; Babb, James S; Horwitz, Leora I; Blecker, Saul; Kang, Stella K
OBJECTIVE:To evaluate the impact of structured recommendations on follow-up completion for incidental lung nodules (ILNs). METHODS:Patients with ILNs before and after implementation of structured Fleischner recommendations and electronic tracking were sampled randomly. The cohorts were compared for imaging follow-up. Multivariable logistic regression was used to assess appropriate follow-up and loss to follow-up, with independent variables including use of structured recommendations or tracking, age, gender, race, ethnicity, setting of the index test (inpatient, outpatient, emergency department), smoking history, and nodule features. RESULTS:In all, 1,301 patients met final inclusion criteria, including 255 patients before and 1,046 patients after structured recommendations or tracking. Baseline differences were found in the pre- and postintervention groups, with smaller ILNs and younger age after implementing structured recommendations. Comparing pre- versus postintervention outcomes, 40.0% (100 of 250) versus 29.5% (309 of 1,046) of patients had no follow-up despite Fleischner indications for imaging (PÂ = .002), and among the remaining patients, 56.6% (82 of 145) versus 75.0% (553 of 737) followed up on time (P < .001). Delayed follow-up was more frequent before intervention. Differences postintervention were mostly accounted for by nodules â‰¤ 8 mm in the outpatient setting (P < .001). In multivariable analysis, younger age, White race, outpatient setting, and larger nodule size showed significant association with appropriate follow-up completion (P < .015), but structured recommendations did not. Similar results applied for loss to follow-up. DISCUSSION/CONCLUSIONS:Consistent use of structured reporting is likely key to mitigate selection bias when benchmarking rates of appropriate follow-up of ILN. Emergency department patients and inpatients are at high risk of missed or delayed follow-up despite structured recommendations.