Branda, Megan E.

Importance Effective interventions are needed to support the cocreation of diabetes care plans that are sensible, desirable, and feasible for the people living with diabetes (ie, care that fits). Objective To investigate whether an agenda-setting kit (ASK) added to usual primary care improves fit of care and glycemic control in adults with type 2 diabetes (T2D). Design, Setting, and Participants This single-center, clinician-level cluster randomized clinical trial was conducted from February 16, 2023, to July 26, 2024, with a 6-month follow-up, at a federally qualified health center in New Haven, Connecticut. Eligible clinicians were primary care physicians, nurse practitioners, and physician assistants who prescribed medication to treat patients with T2D. Eligible patients were English- or Spanish-speaking adults aged 18 years or older with T2D and hemoglobin (Hb) A 1c level greater than 8%. Patients were excluded if their clinician determined that an HbA 1c level 8% or lower was inconsistent with goals of care. Data were analyzed from November 7, 2024, to August 13, 2026. Intervention Clinicians were randomized 1:1 to the ASK plus usual primary care group (intervention group) or usual primary care only (control group). The ASK intervention consisted of 14 conversation cards about life with diabetes and its treatment. Prior to the clinical encounter, patients were asked to select 0 to 3 cards they wanted to prioritize for discussion. Main Outcomes and Measures The primary outcome was the 6-month change from baseline in illness intrusiveness measured with the Illness Intrusiveness Ratings Scale (IIRS; range: 13-91, with higher scores indicating greater intrusiveness) and HbA 1c level. Secondary outcomes included changes in treatment burden measured with the Treatment Burden Questionnaire (TBQ; range: 0-150, with higher scores indicating greater burden), diabetes distress measured with the 17-Item Diabetes Distress Scale (DDS-17; scores: indicate little or no distress [<2.0], moderate distress [2.0-2.9], and high distress [≥3.0]), and visit satisfaction. Results Eleven clinicians (6 [54.5%] female) were included in the trial along with 143 of their patients. The mean (SD) patient age was 56 (12) years; 87 participants (60.8%) were female and 88 (61.5%) reported Spanish as their primary language. Six-month survey data were available for 65 of 74 patients (87.8%) in the intervention group and 58 of 69 (84.0%) in the control group; data on HbA 1c level were available for 71 (95.9%) and 65 (94.2%), respectively. At 6 months, mean (SD) IIRS scores were 32.1 (15.1) and 37.1 (18.7) in the intervention and control groups (adjusted mean difference, −3.9; 95% CI, −10.4 to 2.6). The mean (SD) HbA 1c levels were 8.8% (1.8) in the intervention group and 9.1% (1.8) in the control group (adjusted mean difference, −0.2%; 95% CI, −0.9% to 0.5%). Mean (SD) TBQ scores in the intervention and control groups were 41.2 (44.8) and 46.8 (44.4) (adjusted mean difference, 1.0; 95% CI, −16.6 to 18.6), and mean (SD) DDS-17 scores were 2.0 (1.0) and 2.3 (1.0) (adjusted mean difference, −0.1; 95% CI, −0.4 to 0.2). Clinician-reported satisfaction was greater in the intervention group; patient satisfaction did not differ between groups. Conclusions and Relevance In this cluster randomized clinical trial of adults with T2D, use of the ASK with usual primary care was associated with greater clinician satisfaction but not with improvements in patients’ fit of care or glycemic control over 6 months. Larger studies should evaluate interventions that not only identify patients’ priorities and treatment burdens but also better support clinicians in addressing them. Trial Registration ClinicalTrials.gov Identifier: NCT05553912

ABSTRACT Objective Women carry disproportionate shares of caregiving and other life demands that may compound the work of diabetes self-management. We sought to examine gender differences in overall and digital treatment burden and their key contributors. Research Design and Methods Cross-sectional analysis of two cohorts of adults with type 1 or type 2 diabetes attending outpatient endocrinology visits who completed the Treatment Burden Questionnaire Plus Digital (TBQ+D) (n=472). Multivariable regression estimated gender differences in overall and digital treatment burden, ability to live a normal life, and sustainability of current self- care effort, adjusting for age, diabetes type, insulin intensity, HbA1c, and cohort. Item-level analyses identified contributors to observed differences. Results Compared to men, women reported higher median overall treatment burden (33 vs 20, adjusted mean difference 10.6 points, 95% CI 5.1–16.3; p <.0001) and digital treatment burden (13 vs 7, adjusted mean difference 3.5 points, 95% CI 1.1–6.1; p =.009). They also had higher odds of not living a normal life (OR 1.77, 95% CI 1.18–2.67; p =0.006) and difficulty sustaining current self-care efforts indefinitely (OR 2.01, 95% CI 1.10–3.66; p =0.023). Digital burden differences were concentrated in annoyance, precautions, and time and effort required to use digital medicine tools, whereas contributors to differences in overall burden varied, with relationships, self-monitoring, and injections contributing most. Conclusions After adjusting for treatment intensity and other factors, women living with diabetes were twice as likely to be overwhelmed by diabetes care than men. Their greater vulnerability to treatment burden demands healthcare service redesign and individualization of plans of care that minimally disrupt patients’ and caregivers’ lives. ARTICLE HIGHLIGHTS Why did we undertake this study? Women may experience greater treatment burden across chronic conditions, reflecting competing (caregiving) demands that reduce capacity for self-management. Gender differences in diabetes, especially digital burden, remain unclear. What is the specific question we wanted to answer? Do women with diabetes experience greater overall and digital treatment burden than men? What did we find? Women reported greater overall and digital burden and more difficulty living a normal life and sustaining care than men. Differences were larger for digital annoyance, precautions, and effort, plus relationships, self-monitoring, and injections. What are the implications? Treatment burden cannot be inferred from treatment intensity alone. Diabetes care should consider whether treatment work fits within each patient’s life and can be sustained. Women with diabetes may be particularly vulnerable to becoming overwhelmed by the work of diabetes care.

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.

Background: Pregnancies complicated by fetal growth restriction are at increased risk of fetal demise and adverse neonatal outcomes. Distinguishing growth-restricted fetuses from constitutionally small ones remains challenging. Given the variability in current diagnostic criteria and the importance of identifying at-risk fetuses, fetal growth velocity has emerged as a predictor of adverse neonatal outcomes. Objective: To evaluate whether percentile-based fetal growth velocity, defined as change in estimated fetal weight percentile per week, predicts adverse neonatal outcomes in pregnancies affected by fetal growth restriction or small-for-gestational-age neonates. The primary aim was to determine the relationship between growth velocity and a composite of adverse neonatal outcomes. Study Design: This was a retrospective cohort study of pregnant patients 18 - 45 years old who delivered between August 2017 to December 2022 in a single healthcare system. Patients were excluded who had fewer than 2 ultrasounds after 16 weeks gestation, genetic or anatomic abnormalities, or a multiple gestation. Results: 300 patients met all inclusion criteria, and most patients (n=199) delivered at the tertiary care center. Three had an intrauterine fetal demise at a mean gestational age of 35w3d. 74 neonates were admitted to the NICU with a mean length of stay of 8.5 days; 29 required respiratory support. No neonatal deaths occurred. In fetuses with initial estimated fetal weight <3rd percentile (n=33), the probability of composite outcome was increased (50%, 95% CI 44.8-55.2) compared to those >50th percentile (5%, 95% CI 3.7-6.6). In the 3-10th and 10 - 50th percentile subgroups with decelerated growth, composite outcome rates were also increased (56.2% and 44.1%) compared to those with neutral or increased growth velocity. Conclusion: Percentile-based fetal growth velocity is a simple calculation that correlates with adverse neonatal outcomes regardless of initial estimated fetal weight. As fetal growth velocity decreased, our cohort saw increased rates of adverse outcomes. Change in EFW percentile normalizes for gestational age and allows ease of clinical interpretation. Decelerated growth identified fetuses at highest risk, suggesting growth velocity as a useful metric in routine surveillance.

Abstract Background Lung cancer is the leading cause of cancer-related death, and the most common cancer diagnosed globally. Approximately 85% of lung cancer cases are non-small cell lung cancer (NSCLC). After initial surgical treatment, adjuvant therapy with conventional or targeted chemotherapy can help optimize survival. These treatments, however, must be tailored to each patients’ problematic situation, including cancer characteristics and goals of care. Shared decision making (SDM) is a method of care by which patients and clinicians work together to form plans of care that advance the patient’s problematic human situation. This method often requires evaluating alternative options, “trying them on” for fit given their practical demands and favorable and unfavorable effects. Tools used within the encounter can facilitate and support SDM conversations, yet none exist for considering care post-surgical treatment of NSCLC. Therefore, we aimed to evaluate the effectiveness of a novel encounter tool for SDM, NSCLC Choice, compared to usual care at improving SDM and reducing decisional conflict for patients with resected early-stage NSCLC considering adjuvant treatment. Methods We will conduct a parallel, patient-level randomized trial comparing NSCLC Choice with usual care. Patients will be eligible if they are adults with stage >1B NSCLC eligible for postsurgical adjuvant chemotherapy. Allocation will be central and post-consent. Patients will be blinded to our trial hypothesis, instead of being invited to evaluate an educational intervention. Our primary outcome is SDM quality, which we will assess using participant reported measures (patient SDM-Q-9) obtained immediately post-encounter and an observer measure estimated from video recording of trial encounters in both arms (OPTION12). With resources to conduct a 100-patient trial, we will have >80% power to detect a 12-point medium difference between arms in patient-reported SDM-Q-9. We will also assess the secondary outcomes of knowledge about the disease and the features of treatment options using an ad hoc questionnaire, decisional conflict using the Decisional Conflict Scale, and patient and clinician satisfaction using the metrics used in prior SDM intervention trials. We will also determine encounter length using video recordings. Discussion In testing NSCLC Choice, we seek to determine the extent to which this intervention can improve care for patients with NSCLC considering adjuvant therapy after surgery. In addition, we expect to determine whether this intervention is satisfactory to participants and feasible in practice. If successful, this study will result in an evidence-based tool for promoting patient-centered conversations around NSCLC and cancer care those fits. Trial Registration: NCT06122064 ClinicalTrials.gov

Abstract Context Incidental thyroid findings (ITFs) are increasingly detected on imaging performed for non-thyroid indications. Their prevalence, features, and consequences remain undefined. Objective To develop, validate, and deploy a natural language processing (NLP) pipeline to identify ITFs in radiology reports and assess their prevalence, features, and clinical outcomes. Design Retrospective cohort study. Setting Mayo Clinic sites (Rochester, Arizona, Florida, Mayo Clinic Health System). Participants Adults without prior thyroid disease undergoing thyroid-capturing imaging from July 1, 2017, to September 30, 2023. A transformer-based NLP pipeline identified ITFs and extracted nodule characteristics from image reports from multiple modalities and body regions. Outcomes ITF prevalence, downstream thyroid ultrasound, biopsy, thyroidectomy, and cancer diagnosis. Logistic regression identified demographic and imaging-related factors. Results Among 115 683 patients (mean age, 56.8 [SD 17.2]; 52.9% women), 9077 (7.8%) had an ITF (92.9% nodular). ITFs were more likely in women, older adults, higher BMI, and in imaging ordered by specialties different from Emergency Medicine. Compared with chest CT, ITFs were more likely via neck CT, PET, and nuclear medicine scans. Nodule characteristics were poorly documented, with size reported in 44% and other features in fewer than 15%. Compared with patients without ITFs, those with ITFs had higher odds of thyroid nodule diagnosis (OR 45, 95%CI 41.1-49.3), biopsy (OR 46.8, 95%CI 39.0-56.2) thyroidectomy (OR 55.8, 95%CI 31.3-99.3), and thyroid cancer diagnosis (OR 61.7, 95%CI 38.6-98.5). Most cancers were papillary (88.5%) and larger when detected after ITFs (2 cm SD 1.4) vs no ITF (1.3 cm SD 0.8). Conclusion ITFs were common and strongly associated with cascades leading to the detection of small, low-risk cancers, highlighting their role in overdiagnosis and the need for standardized reporting and more selective follow-up.

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.

ABSTRACT Advanced chronic diseases, or multicomplexity in older adults presents unique challenges. Transthyretin cardiac amyloidosis (ATTR‐CA) is one such scenario where heart failure is a common presentation, and management remains challenging. We describe the challenges involved in the diagnosis of ATTR‐CA in older adults, which has implications on treatment options. We discuss the application of comprehensive geriatric assessment (CGA) and shared decision making (SDM) in the context of these challenges. Based on geriatric medicine principles, an innovative framework for applying SDM in ATTR‐CA patients is proposed, including consideration of the patient priorities care approach. The proposed framework emphasizes assessing functionality, frailty, and life expectancy to help categorize risk. This framework can be applied in various advanced chronic diseases or multicomplexity. Based on risk categorization, treatment burden, and alignment with values and preferences, management pathways are suggested for each risk category. Incorporating CGA and SDM, the proposed framework supports patient‐centered care, ensuring that clinical recommendations are tailored to each older adult's unique needs and goals. In ATTR‐CA, a collaboration between cardiology and geriatric medicine provides significant value in managing older adults. The need to prevent age‐related bias in clinical decision‐making exists across all health conditions, and the proposed framework allows for a thorough evaluation of multimorbidity, frailty, disability, and patient preferences. While ATTR‐CA is used as a prototype, this integrated approach can be applied across all health conditions and is essential for delivering holistic care, improving communication, and aligning treatment plans with patient values.