Branda, Megan

Background: Incidental thyroid nodules (ITNs) detected on nonthyroid imaging contribute to thyroid cancer overdiagnosis, largely through downstream evaluation initiated by thyroid ultrasound (TUS). However, TUS follow-up rates for ITNs and their drivers in routine practice remain unclear. We quantified TUS utilization after ITN detection and identified patient, imaging, nodule, and reporting factors associated with this first step in the diagnostic cascade. Methods: We conducted a retrospective cohort study of adults without prior thyroid disease who underwent imaging that incidentally captured the thyroid at Mayo Clinic sites (2017–2023). A validated natural language processing pipeline identified ITNs and extracted nodule characteristics from radiology reports across multiple imaging modalities. The main outcome was the rate of TUS within 180 days after ITN detection. Clinical outcomes, including thyroid biopsy, thyroidectomy, and thyroid cancer diagnosis, were compared between patients who underwent TUS and those who did not. Factors associated with TUS utilization were assessed using multivariable logistic regression with penalized variable selection. Results: Among 115,683 patients who underwent thyroid-capturing imaging, 8426 (7.3%) had an ITN. These patients were predominantly female (64.6%) and White (89.7%), with a mean age of 61.7 years (standard deviation 15.2). Most nodules were detected on computed tomography (80.8%), most commonly from chest imaging (52.3%). Overall, 1677 patients with ITNs (19.9%) underwent TUS. In multivariable analysis, TUS use was independently associated with higher body mass index (odds ratio [OR], 1.20 per 10-unit increase; confidence interval [CI] [1.08–1.33]), nodule size ≥1.5 cm (OR, 1.79; CI [1.52–2.10]), and a radiologist recommendation (OR, 2.51; CI [2.12–2.98]), whereas older age was associated with lower odds of TUS (OR, 0.89 per 10-year increase; CI [0.84–0.93]). Patients undergoing TUS had higher rates of thyroid biopsy, partial thyroidectomy, and total thyroidectomy compared with those without it. All detected thyroid cancers (103 cases) occurred in the TUS group, representing 6.1% of that cohort. Conclusions: One in five patients with ITNs underwent TUS, representing a critical gateway to downstream diagnostic procedures and thyroid cancer detection. Factors associated with TUS utilization highlight opportunities to better define appropriateness of ultrasound after incidental nodule detection and to reduce unnecessary testing and treatment.

Abstract Introduction Fetal growth restriction (FGR) is associated with an increased risk of neonatal morbidity and mortality. Current diagnostic criteria for FGR do not discriminate between constitutionally small and pathologically restricted fetuses. Following FGR diagnosis, umbilical artery (UA) Doppler is utilized to monitor fetal well‐being, but its limitations have increased interest in investigating growth velocity as an adjunctive tool. The objective of this study is to compare the predictive ability of UA Doppler studies and growth velocity for adverse neonatal outcomes in growth‐restricted fetuses. Methods This is a secondary analysis of a cohort of pregnancies delivered in a single healthcare network from August 2017 to December 2022, diagnosed antenatally with FGR. The cohort was restricted to those with baseline estimated fetal weight (EFW) between the 3rd and 50th percentiles. All subjects had growth velocity measured (defined as EFW percentile change per week between baseline and subsequent ultrasound). The primary outcome was a composite of neonatal morbidity (neonatal intensive care unit [NICU] admission, low 5‐min Appearance, Pulse, Grimace, Activity, Respiration score [<7], intraventricular hemorrhage, necrotizing enterocolitis, or metabolic acidosis) and severe adverse perinatal events (stillbirth or neonatal death, hypoxic ischemic encephalopathy, mechanical ventilation, or severe metabolic acidosis [pH < 7.0]). Neonatal morbidity and severe adverse perinatal events were analyzed separately as secondary outcomes. Independence between growth velocity and S/D ratio was evaluated. Univariate logistic regression models were then performed, with each outcome of interest as the dependent variable and S/D ratio and growth velocity as independent variables. Receiver operating characteristic (ROC) curves were generated to compare the performance of both tests. Results A total of 172 patients were included in the analysis. UA Doppler data were available for 165 patients, 15.3% of whom had S/D ratio >95th percentile; none demonstrated absent or reversed end‐diastolic flow. There was no correlation observed between S/D ratio percentile and growth velocity, suggesting independence. ROC analysis demonstrated that the discriminatory ability of growth velocity was higher across outcomes with areas under the curve (AUC) ranging from 0.65 to 0.69 while AUC for S/D ratio percentiles ranged from 0.51 to 0.53, approximating the performance of chance. Higher growth velocity was significantly associated with reduced odds of the composite outcome (odds ratio [OR], 0.79; 95% confidence interval [CI], 0.69–0.90), and neonatal morbidity (OR, 0.84; 95% CI, 0.73–0.95). S/D ratio percentile was not associated with these outcomes. Conclusion In pregnancies complicated by growth restriction with forward UA flow, growth velocity outperformed S/D ratio percentile in predicting adverse outcomes. The two tests were independent, indicating that growth velocity may reflect a component of fetal development not captured by UA Doppler. These results suggest that growth velocity could be used in addition to UA Doppler studies for fetal risk assessment, especially in fetuses with forward arterial flow.

Abstract Patients with hypertensive disorders of pregnancy (HDPs) are recommended to attend an early postpartum follow-up visit for blood pressure monitoring. Follow-up frequency for patients with HDPs can vary widely, with some patients requiring multiple office visits. We sought to determine factors associated with multiple postpartum blood pressure visits among patients with HDPs. We retrospectively identified patients with HDPs who delivered at our maternity center in 2019 and compared factors between patients who attended a single blood pressure follow-up appointment without requiring further clinical evaluation for hypertension and patients who required multiple postpartum clinical evaluations for persistent hypertension. Univariate logistic regression models were used to identify factors associated with increased odds of having multiple clinically indicated postpartum visits for blood pressure monitoring. We identified 328 patients with HDPs, of whom 260 (79.3%) attended an initial postpartum blood pressure follow-up appointment and were included in further analyses. Of the 260 patients, 70 (26.9%) had multiple blood pressure visits. Factors associated with multiple blood pressure visits included delivery between 34 and less than 37 weeks of gestation (odds ratio [OR], 3.62; 95% CI, 1.07–12.30), systolic blood pressure before discharge of 140 mm Hg or higher (OR, 5.02; 95% CI, 2.57–9.82), and discharge with blood pressure medication (OR, 3.42; 95% CI, 1.82–6.41). Patients with HDPs who deliver preterm, have persistent hypertension before discharge, or are discharged with antihypertensive medication require continued close postpartum observation and continuity of care.

Abstract Background The self-management of type 2 diabetes (T2D) typically requires enacting various lifestyle changes, which can challenge people living with T2D. Clinical encounters between people with T2D and their clinicians, however, are often focused on metabolic management, leaving less time available for other self-management topics. The QBSAFE cards help patients articulate aspects of their experience with diabetes and prioritize issues for discussion. Methods This report details secondary outcomes of a randomized controlled trial; primary outcomes are reported elsewhere. All data was collected at Fair Haven Community Health Care, a federally qualified primary care clinic. 11 clinicians were randomly assigned to provide either usual care or usual care with QBSAFE cards to 155 of their patients with type 2 diabetes and hemoglobin A1c >8%. All patient encounters were video recorded for analysis. Patients and clinicians were not blinded to arm allocation but were kept unaware of the specific aims of the trial. Encounter video reviewers were blinded to arm allocation, but not to specific aims of the trial. The outcomes of interest for this report were the extent to which the QBSAFE cards were used as intended, their effect on the topics of discussion, and whether they enabled clinicians to notice and respond to each patient’s situation; comparisons between arms were conducted by a linear mixed model with fixed effect of arm and cluster effect of clinician, analyzed in both intent-to-treat and per-protocol populations. Findings 12 patients were excluded post-randomization (A1c <8%). Of 143 eligible patients, 137 encounters (65 in the usual care arm, 72 in QBSAFE) yielded evaluable videos. QBSAFE was used as intended in 61 (85%) QBSAFE arm encounters. Conversations about burden of treatment related to non-pharmacological interventions (17 vs 33, p = 0·04) and taking medications (11 vs 33, p = 0·0008) and about the patient’s challenging environment (2 vs 10, p = 0·04) were more prevalent in the QBSAFE group. There was no difference in the rate of conversations about metabolic management or of new care plans as a result of conversations between groups. Interpretation While there was a difference in the types of conversations observed between the two study arms, this difference was small and only apparent in a few domains. Future work could aim to modify the QBSAFE cards to more effectively stimulate patient-centered discussions and to further prepare clinicians to respond to a variety of issues raised during the clinical visit. Funding This work was supported by funding from the National Institute of Diabetes and Digestive and Kidney Diseases (R01DK129616).

ABSTRACT Background Effective interventions are needed to support co-creation of diabetes care plans that fit patients’ lives. We evaluated the QBSafe agenda-setting kit (14 conversation cards) for its impact on care fit and glycemic control when added to usual primary care. Methods This single-center, clinician-level cluster-randomized, open-label trial was conducted at a federally qualified health center in New Haven, Connecticut ( ClinicalTrials.gov NCT05553912 ). Clinicians and their patients with type 2 diabetes and HbA1c >8% were randomized 1:1 to usual care with or without QBSafe cards. In the intervention arm, patients selected up to 3 cards highlighting concerns about life with diabetes prior to their visit. Primary outcomes were change at 6 months in care fit (Illness Intrusiveness Ratings Scale, IIRS) and HbA1c, analyzed by intention to treat. Secondary outcomes were treatment burden (Treatment Burden Questionnaire, TBQ) and diabetes distress (Diabetes Distress Scale, DDS), and satisfaction with visits. Results Between February 2023 and July 2024, 143 participants (mean age 56 years; 61% female; 73% Hispanic; mean HbA1c 10%) were enrolled: 74 received usual care with QBSafe, 69 usual care alone. At 6 months, there were no significant between-arm differences in changes in IIRS (−3.9 [95% CI -10.4, 2.6]), HbA1c (−0.2% [95% CI -0.9, 0.5]), TBQ (1.0 [95% CI -16.6, 18.6]), or DDS (−0.1 [95% CI -0.4, 0.2]). Clinicians reported greater satisfaction when using QBSafe. Patient satisfaction was high and did not differ across arms. Conclusions QBSafe cards improved clinician satisfaction but did not improve care fit or glycemic control. Future tools should focus on helping clinicians respond effectively to patient-identified challenges.

AbstractIntroductionShared decision‐making (SDM) is a method of care by which patients and clinicians work together to co‐create a plan of care. Electronic health record (EHR) integration of SDM tools may increase adoption of SDM. We conducted a “lightweight” integration of a freely available electronic SDM tool, CV Prevention Choice, within the EHRs of three healthcare systems. Here, we report how the healthcare systems collaborated to achieve integration.MethodsThis work was conducted as part of a stepped wedge randomized pragmatic trial. CV Prevention Choice was developed using guidelines for HTML5‐based web applications. Healthcare systems integrated the tool in their EHR using documentation the study team developed and refined with lessons learned after each system integrated the electronic SDM tool into their EHR. CV Prevention Choice integration populates the tool with individual patient data locally without sending protected health information between the EHR and the web. Data abstraction and secure transfer systems were developed to manage data collection to assess tool implementation and effectiveness outcomes.ResultsTime to integrate CV Prevention Choice in the EHR was 12.1 weeks for the first system, 10.4 weeks for the second, and 9.7 weeks for the third. One system required two 1‐hour meetings with study team members and two healthcare systems required a single 1‐hour meeting. Healthcare system information technology teams collaborated by sharing information and offering improvements to documentation. Challenges included tracking CV Prevention Choice use for reporting and capture of combination medications. Data abstraction required refinements to address differences in how each healthcare system captured data elements.ConclusionTargeted documentation on tool features and resource mapping supported collaboration of IT teams across healthcare systems, enabling them to integrate a web‐based SDM tool with little additional research team effort or oversight. Their collaboration helped overcome difficulties integrating the web application and address challenges to data harmonization for trial outcome analyses.

Background Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Shared decision making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.