Clinical Care Research Articles

Hospital 4Ms: Documentation and association with patient characteristics.

For the thousands of health systems recognized as Age-Friendly, considerable progress has been made to integrate 4Ms into clinical care. This study evaluated associations between 4Ms documentation and patient characteristics in an inpatient setting. In this prospective cohort, hospitalizations included were from patients in an Acute Care for Elders (ACE) unit where the 4Ms were adopted and implemented. Each M (What Matters, Medication, Mentation, and Mobility) was stratified into three categories (not documented, partly documented, and fully documented) reflecting "assessment" and "action" clinical care processes. Electronic health records were reviewed for patient and hospitalization characteristics. Descriptive statistics evaluated these characteristics across categories of each M. There were 620 hospital encounters (573 patients) included in the cohort. Patients had a median age of 80 years [IQR 76, 86] and 85% were White. Of all 4Ms, What Matters had the lowest documentation with 413 (67%) of encounters falling into the not documented group. Medication had the highest documentation with 453 (73%) of encounters in the fully documented group. Significant differences in documentation were associated with age and partlyversus fully documented Mobility (80 [76, 86] and 82 [77, 88] (p = 0.019)). Hospital length of stay was differentially associated with documentation of all 4M categories. Initial mobility scores were associated with not versus partly documented Medication (6 [2, 7] and 2 [2, 6] (p = 0.041)). We developed a structured way to categorize "assessment" and "action" 4Ms care processes reflective of three documentation categories in the hospital (not, partly, and fully) and identified important patient and hospital characteristics associated with each. These results offer opportunities for future improvement efforts and insight to which characteristics may be important to measure with wider 4Ms adoption and uptake.

Preventive oral healthcare for children: towards appropriate care

In recent decades, oral healthcare has shifted from curation to prevention. Preventive oral healthcare for children consists mainly of oral health education to improve health behaviors and clinical prevention such as fissure sealants, application of fluoride varnish, removal of supragingival plaque and dental polishing. In addition, the periodic clinical examination is an important preventive instrument. These 5 preventive interventions for children up to 12 years of age can be discussed using the principles of 'appropriate care'. Appropriate care is an approach of the Dutch government to ensure the accessibility, quality and affordability of care in the Netherlands. Central to the approach are the effectiveness, efficiency and patient-centeredness of care. This article describes to what extent preventive oral healthcare meets these principles based on literature, care consumption data and recommendations from the clinical guidelines 'Oral care for children: prevention and treatment of dental caries' and the 'Advice on Caries Prevention' by the Ivory Cross, a Dutch scientific association for oral health. Appropriate oral healthcare is best served by care that is tailored to both the individual oral disease burden of the patient and their risk of disease as well as to the wishes of the patient.

Opportunistic Screening for Low Bone Mineral Density in Adults with Cystic Fibrosis Using Low-Dose Computed Tomography of the Chest with Artificial Intelligence.

Background: Cystic fibrosis bone disease (CFBD) is a common comorbidity in adult people with cystic fibrosis (pwCF), resulting in an increased risk of bone fractures. This study evaluated the capacity of artificial intelligence (AI)-assisted low-dose chest CT (LDCT) opportunistic screening for detecting low bone mineral density (BMD) in adult pwCF. Methods: In this retrospective single-center study, 65 adult pwCF (mean age 30.1 ± 7.5 years) underwent dual-energy X-ray absorptiometry (DXA) of the lumbar vertebrae L1 to L4 to determine BMD and corresponding z-scores and completed LDCTs of the chest within three months as part of routine clinical care. A fully automated CT-based AI algorithm measured the attenuation values (Hounsfield units [HU]) of the thoracic vertebrae Th9-Th12 and first lumbar vertebra L1. The ability of the algorithm to diagnose CFBD was assessed using receiver operating characteristic (ROC) curves. Results: HU values of Th9 to L1 and DXA-derived BMD and the corresponding z-scores of L1 to L4 showed a strong correlation (all p < 0.05). The area under the curve (AUC) for diagnosing low BMD was highest for L1 (0.796; p = 0.001) and Th11 (0.835; p < 0.001), resulting in a specificity of 84.9% at a sensitivity level of 75%. The HU threshold values for distinguishing normal from low BMD were <197 (L1) and <212 (Th11), respectively. Conclusions: Routine LDCT of the chest with the fully automated AI-guided determination of thoracic and lumbar vertebral attenuation values is a valuable tool for predicting low BMD in adult pwCF, with the best results for Th11 and L1. However, further studies are required to define clear threshold values.

Demographics and Clinical Features Associated with Abnormal Small Bowel Motility in Systemic Sclerosis.

The small bowel is affected in up to 50% of systemic sclerosis (SSc) patients, and some patients experience severe complications. Our aim was to use specific statistical methods to compare demographic and clinical features of SSc patients with and without abnormal small bowel to better characterize patients at risk for this complication. SSc patients with gastrointestinal symptoms were prospectively enrolled and underwent a scintigraphy-based whole gut transit (WGT) study. A cross-sectional analysis was performed comparing clinical features between patients with and without abnormal small bowel transit by WGT. Univariate logistic regression models and multivariable models were used to examine the relationship between clinical features and abnormal small bowel transit. Of 130 patients enrolled in this study, 22 had abnormal small bowel transit. SSc patients with abnormal small bowel transit were more likely to be male [Odds Ratio(OR)=3.70, Confidence Interval(CI) 1.07-12.50, p= 0.038], and have more severe cardiac involvement (OR = 3.98, CI 1.10-14.38, p= 0.035), while they were less likely to have sicca symptoms (OR = 0.30, CI 0.10-0.94, p= 0.039). In multivariable analyses, sicca symptoms (OR = 0.28, CI 0.08-0.96, p= 0.043) remained negatively associated with abnormal small bowel transit. Additionally, SSc patients with abnormal small bowel transit had higher mortality than patients with normal small bowel transit [Hazard ratio(HR)=4.57, CI 1.58-13.24, p= 0.005]. These findings suggest that patients with abnormal small bowel transit in SSc are more likely to be male, have more severe cardiac involvement, higher mortality, and less sicca symptoms. Recognizing this patient subgroup is essential for risk stratification and optimizing clinical care.

Adherence to Evidence-Based Guidelines and ImplicationsWhen Designing Electronic Documentation for Urinary Catheters.

The aim of this study was to investigate the point prevalence and the rate of adherence to evidence-based guidelines for patients who had indwelling urinary catheters in three Australian acute care hospitals. A cross-sectional observational design was used. A multisite cross-sectional observational design was utilised in three acute hospitals across Australia. Data were collected from each site in a single day directly from observation of the patient, the bedside notes and medical records. The data collected included observations of clinical care and scrutiny of the documentation of the insertion details and catheter care using best practice guidelines. Of the 1730 patients audited, 47% were female. The mean point prevalence of catheters insitu across three sites was 12.9%. Correct documentation compliance was reported to be, on average, 40%. Documentation was significantly better when a template was available to guide information recorded: this was regardless of whether it was hard copy or electronic. Overall, clinical care compliance with best practices was 77%. Of note for improvement was the fixing of the urinary catheter to the thigh in highly dependent patients. It was identified that there is a need for improvement across all three sites: specifically regarding securement of the urinary catheter to the patient's thigh within the ICU. In addition, it was identified that there is a need for documentation of the urine bag change in ward areas. Documentation may be improved by incorporating templates into healthcare documentation systems in the future. Further work is needed to ensure nurses are aware of the adverse effects of urinary catheters and thus, the need to adhere to best practice guidelines. There has been no patient or public contribution. We have adhered to the STROBE guidelines for reporting.

Discordance Between Clinician and Person-With-Diabetes Perceptions Regarding Technology Barriers and Benefits.

The quality of clinician-patient relationship is integral to patient health and well-being. This article is a narrative review of published literature on concordance between clinician and patient perspectives on barriers to diabetes technology use. The goals of this manuscript were to review published literature on concordance and to provide practical recommendations for clinicians and researchers. In this review, we discuss the qualitative and quantitative methods that can be applied to measure clinician and patient concordance. There is variability in how concordance is defined, with some studies using questionnaires related to working alliance, while others use a dichotomous variable. We also explore the impact of concordance and discordance on diabetes care, barriers to technology adoption, and disparities in technology use. Published literature has emphasized that physicians may not be aware of their patients' perspectives and values. Discordance between clinicians and patients can be a barrier to diabetes management and technology use. Future directions for research in diabetes technology including strategies for recruiting and retaining representative samples, are discussed. Recommendations are given for clinical care, including shared decision-making frameworks, establishing social support groups optimizing clinician-patient communication, and using patient-reported outcomes to measure patient perspectives on outcomes of interest.

Survey of Emergency Department Clinicians on the Utility of the Guaiac Fecal Occult Blood Test.

Emergency department (ED) clinicians utilize the guaiac fecal occult blood test (gFOBT) in their assessment of suspected gastrointestinal bleeding or unexplained anemia despite supporting evidence. ED clinicians' ability to predict the gFOBT results and how the gFOBT results could affect ED patient disposition has not been previously studied. Methods: From October 16, 2019, through September 15, 2020, we conducted a single-site survey of ED clinicians before and after performing gFOBTs during routine clinical care. Survey data were collected and retrospectively evaluated with unadjusted and multivariable regression analyses. We examined a total of 133 combined pre-gFOBT and post-gFOBT surveys. ED clinicians accurately predicted gFOBT results with an area under the receiver operating characteristic curve of 0.75 (95%CI, 0.66-0.85). Of clinician-predicted certain or very probable positive gFOBT results, only 79% were actually positive. In multivariable analyses, decreased hematocrit level (odds ratio (OR), 0.31/10% increase; 95%CI, 0.14-0.61), decreased red blood cell count (OR, 0.41/1x1012/L increase; 95%CI, 0.21-0.75), and absence of firm stool consistency (OR, 0.09; 95%CI, 0.01-0.42) were associated with positive gFOBT results (allP<.006). The most common reason for performing gFOBTs was black stool or suspected melena, followed by decreased hemoglobin level, red blood in stool, and suspected upper gastrointestinal tract bleeding. Before performing gFOBT, 50.8% of clinicians responded that the test results would change patient disposition, which decreased to 30.5% after the gFOBT result. We found that ED clinicians cannot predict the gFOBT results with high accuracy. A suspected GI bleed is the main reason for performing the test in the ED.

12395 Continuous Glucose Monitoring In Pseudohypoparathyroidism Type 1a

Abstract Disclosure: J. Tamaroff: None. A.E. Lee: None. A.H. Shoemaker: None. Background: Pseudohypoparathyroidism type 1A (PHP1A), due to heterozygous mutations in GNAS, is a rare disorder that leads to multi-hormone resistance, cognitive impairment, and early-onset obesity. Individuals with PHP1A have dysglycemia on oral glucose tolerance tests and increased rates of type 2 diabetes (T2DM). Individuals with rare diseases, like PHP1A, may travel significant distances for specialized clinical or research care. Wearable technology may alleviate barriers and provide useful information for clinical care or for use as potential biomarkers. The objective of this study is to evaluate glycemia in individuals with PHP1A and feasibility of utilizing continuous glucose monitors (CGMs) in this population. Methods: Observational study of individuals with PHP1A (3R01DK118407-03S1). CGMs (Dexcom Pro, Dexcom Inc, San Diego, CA) were placed on participants’ abdomens, typically by a family member, over secure-video call with study staff. CGMs collected data every 5 minutes for up to 10 days. Results: Seven participants (all female) with PHP1A without a diagnosis of diabetes had available data. Median age was 17 years (IQR: 14, 19; range: 8-23). Body mass index (BMI) categories (by percent of the 95th percentile for those under 18 years and BMI for adults) spanned from overweight to class 3 obesity. In terms of feasibility, 1 individual had to replace a CGM sensor due to an upcoming MRI and 1 individual had a “sensor failure” of unclear etiology. Both were able to place new CGMs. Individuals participated across 5 states in the United States. Median length of wear was 9.8 days (IQR 8.6, 9.9). Participants had a median average glucose of 104mg/dL (IQR 102, 111) and COV of 16% (15, 21). Percent of glucose &amp;gt; 140mg/dL was 5.0% (IQR: 1.8, 10.9; range:1.2-19.4%). One individual had 3.2% of glucose values ≥ 200mg/dL despite a normal hemoglobin A1c (HbA1c) level (5.5%). This level of hyperglycemia is qualitatively higher than published CGM data in healthy individuals. One study found individuals (6-24 years of age) had median percent of glucose values over 140mg/dL ranging from 1.2 to 2.4% with IQR values ranging from 0.3 to 4.4%, based on age categories.1Conclusions: In females with PHP1A, with overweight or obesity, CGM placement at home is a feasible way to collect real-world data. Participants with rare diseases often must travel for clinical and research care and CGMs may provide insight into glycemia without requiring an in-person visit. This “real-world” data mirrors research data reporting glycemia with normal HbA1c levels. The rate of hyperglycemia is higher than expected in some individuals with PHP1A though more data is needed. Ongoing studies will evaluate matched control participants and assess drivers of glycemia including inactivity and decreased sleep duration, as measured by actigraphy.

12420 Effects Of A Continuous Glucose Monitoring (CGM) Optimization Program On Prescribing Behavior And Glycemic Outcomes

Abstract Disclosure: A. Sterbenz: None. J. Fuentes Rosales: None. S. Abraham: None. P. Siroya: None. R. Middelbeek: None. J. Mitri: None. F. Rossitto: None. E. Cabana: None. A. Gharse: None. L. Collins: None. L. Aliaga: None. A. Millan Ferro: None. J. Cifuni: None. A. Schwartz: None. E. Kelley: None. C. Gomez: None. M. Aballay: None. Introduction: Continuous glucose monitoring (CGM) improves glucose control in patients with diabetes, as demonstrated in clinical trials. There is limited information available on the real-world application of CGM adoption in a resource-limited setting or safety net outpatient hospital setting. This intervention's aim was to assess the impact of a multifaceted approach on improving CGM utilization and on glycemic control among patients with diabetes. Methods: Wyckoff Heights Medical Center, located in Brooklyn, NY is a resource-limited setting that in partnership with the Joslin Diabetes Center, Boston, MA launched a CGM Clinical Care Optimization Program. This quality improvement (QI) initiative included establishing a diabetes technology team (DTT) which met weekly (n=24 sessions) to establish a highly specialized interprofessional group. The DTT activities included: 1) Establishing a CGM workflow; 2) Expanding Medical Assistant responsibilities related to diabetes technology and training; 3) Creating five bilingual (English-Spanish) patient handouts; 4) Building CGM vendor relationships; 5) Developing a CGM manual for data download, billing and coding, and education to increase CGM knowledge across the system. Data were collected prior to CGM initiation and at most recent visit. Results: The intervention occurred between February and November 2023. Prior to this intervention, 49 patients had a CGM prescription. After 9 months, CGM prescriptions were written for 333 patients (680% increase) with the following baseline characteristics (mean ± SD): age (61.2 ± 14.7 yrs.); 56% female; 44% male; 71% Latino; Race: 67% Other (63% Hispanic or Latino), 25% Black or African American, 4% White, Asian 2%, American Indian or Alaska Native 2%; 38% Spanish-speaking, 59% English-Speaking, 3% Other; 81% government insurance (63% Medicaid, 18% Medicare), 19% commercial insurance. The majority of patients had been diagnosed with type 2 diabetes (91%) and 9% had type 1 diabetes. Baseline HbA1C was 9.7 ± 1.5%. Of note, prior to CGM, 34% of patients had A1C&amp;gt;9%. The impact of CGM use was evaluated on 116 patients that met the following criteria: baseline A1C value within 60 days before or up-to 30 days after prescription, and a A1C &amp;gt;90 days after. After an average duration of 154 days of CGM use, HbA1c decreased significantly by -0.51% (p=0.001), demonstrating improved glycemic control post-CGM use. In those with A1c &amp;gt;9%, HbA1c decreased from 10.5% to 8.8% (p&amp;lt;0.01). Conclusion: Creating a CGM optimization program in a resource-limited setting is critical in improving patient self-awareness and provider insight in glycemic control in patients diagnosed with type 1 and type 2 diabetes. These data demonstrate the feasibility of implementing a CGM optimization program in a resource-limited setting, which is critically important in improving clinical care for people with diabetes. Presentation: 6/2/2024

5066 Evolution And Evaluation Of A Longitudinal ECHO Program In Transgender Health

Abstract Disclosure: M.S. Rothman: None. A. Chippone: None. A. Clark: None. D. Saxon: None. D. Miller: None. K. Young: None. S.J. Iwamoto: None. Background: Providers often report a lack of training in the care of transgender and gender diverse(TGD) patients. Extension for Community Healthcare Outcomes(ECHO) programs have been developed around the world as a form of tele-mentoring. As gender-affirming care bans rise in the US, it is crucial for providers to have access to education in TGD patient health. ECHO Colorado(CO) launched “Comprehensive Care for Transgender Patients” in 2020 as an ongoing live monthly series for providers interested in improving care for TGD patients. Design/Methods: 40 sessions were held between 2/2020-9/2023. Topics spanned mental health, medical, and surgical care with didactic presentations followed by case discussions. Demographic data was collected at registration via Connect, an online portal, and evaluations were conducted quarterly using Qualtrics. Not all questions were required. Participants attending at least one session in the quarter were eligible to complete the survey. With multiple responses, the most recent survey was used in the analysis. Results: 257 individuals participated in at least one session. 164/255 (64.3%) respondents identified as clinical health care providers. The majority of the remainder identified as: behavior health professional(n=28), other(n=23) or health outreach/admin(n=17). Most participants (79.4%) practice in CO and the majority provide direct care for underserved populations. 110 attendees responded to at least one survey. 96% of all participants reported improved understanding of the subject matter. Of the prescribing providers, 80%(60/75) rated themselves as comfortable with continuing and 68%(51/75) were comfortable with initiating hormone therapy. In the most recent quarter, participants were asked to self-report levels of professional isolation before and after the series. 30%(8/27) reported feeling very or extremely isolated prior, while none(0/27) reported this since participating. Common barriers reported were obstacles to implementing care and scheduling conflicts preventing attendance. Conclusion: Participants with a variety of backgrounds are highly satisfied with this longitudinal program. ECHO learning may combat feelings of professional isolation. The majority of providers report comfort with initiating and providing hormone therapy, but future efforts should seek ways to improve comfort, competency and examine asynchronous educational opportunities. Interest from attendees outside of CO supports a need for a national collaborative of TGD focused ECHOs. Presentation: 6/1/2024

6869 Endocrinologist Perceptions of the Value of Digital Health Tools to Assist in the Management of Insulin Dosing

Abstract Disclosure: M.B. Davidson: Employee; Self; Eli Lilly &amp; Company. B. Liao: Employee; Self; Eli Lilly &amp; Company. C. Heckman: Employee; Self; Eli Lilly &amp; Company. Background and aims: Insulin management is complex for both people with diabetes (PwD) and the healthcare providers (HCP) who treat them. Digital tools, such as connected insulin pen (CIP) platforms may reduce burden and improve suboptimal insulin dosing, especially through automatic capture of insulin dose events and integration with glucose values. However, the acceptance and utilization of CIP platforms in clinical practice remains lower than expected, given this clinical care gap. This study attempted to ascertain beliefs of HCP leading to this finding. Methods: For this cross-sectional study, 190 members of The Endocrine Society who self-identified as “clinical endocrinologists who treat diabetes” completed a 10-question survey on their perception of digital health tools and their value in clinical practice. Results: In their patients using multiple daily injections (MDI), defined as three or more injections of insulin per day, documentation of insulin dosing data was identified as “important” or “very important’ to 81% of respondents. However, only 48% of respondents are “confident” or “very confident” in the reliability of manually captured insulin and glucose data. While 92% of respondents indicated that a digital platform that displays insulin and glucose data would be “beneficial” or “very beneficial” for making dosing recommendations, 60% have found that a CIP platforms had been “beneficial” or “very beneficial” in helping PwD improving their glycemic control. Conclusion: A group of almost 200 clinician members of the Endocrine Society, who actively treat PwD, indicated that in their PwD using MDI regimens, access to combined insulin and glucose data is important, and digital capture of this data would be beneficial. However, this data is often unavailable or unreliable. The survey revealed a gap between their belief that availability of glucose data and insulin dosing data can help them make dosing recommendations and their belief that these will translate into impacting glycemic control of patients. Further research would be helpful to determine how diabetes technology may better support these HCP and the PwD they treat in practice. Presentation: 6/1/2024

Visual Field Patterns in Optic Neuropathy

The optic nerve is susceptible to a wide variety of pathological processes. In optic neuropathy, quantitative visual field analysis using standard automated perimetry is critical in initial diagnosis, monitoring disease progression, and guiding treatment plans. While acquired visual field defects may progress rapidly, congenital visual field defects may not progress or may progress slowly. Although the most common defect in congenital or acquired optic neuropathy is the central defect, many defect types that are not pathognomonic to the disease can be seen. In ischemic optic neuropathy, which is common among optic neuropathies, arcuate defect and central defect are usually seen. In disc disorders with localized nerve damage, such as optic disc coloboma or optic pit, localized defects such as arcuate scotoma or cecocentral scotoma in which the fixation point is preserved may be observed. Papilledema causes peripapillary fluid accumulation and an enlarged blind spot in the perimetry. In compressive optic neuropathies, non-specific defects such as central and subtudinal defects may be observed, as well as quadrant defects such as hemianopsia and quadrionopsia. Studies show that the combined use of optical coherence tomography and standard automated perimetry to determine structure-function relationships improves clinical care in neuro-ophthalmic disorders.

7816 Implementation And Evaluation Of Clinical Care Structures For People With Differences Of Sex Development (DSD) In Germany

Abstract Disclosure: S.O. Hiort: None. M. Schnoor: None. U. Doehnert: None. M. Juergensen: None. J. Scherf: None. A. Heidenreich: None. M. Rapp: None. A. Katalinic: None. People with Differences of Sex Development (DSD) pose a challenge for healthcare. Lifelong holistic care requires a broad range of diagnostic approaches, qualified psychosocial, peer, fertility and sexual counselling, and structured therapeutic strategies including gonadal monitoring, hormone or surgical therapy. A quest has been taken to define centers of expertise for DSD and to substantiate and evaluate quality of care. Based on the criteria defined by the European Reference Network (ERN) for Rare Endocrine Conditions, 10 health care providers in Germany qualify for specialized DSD care. Quality indicators (QI) were developed through a Donabedian model to define structure, process and outcome quality mainly based on the German national guideline ”Differences of Sex Development”. Additionally, a consensus was reached though a structured process involving participating centers as well as patient organizations. Structural QIs are collected by an annual survey from the participating centers. Patient-related process and outcome data are recorded in a central registry. Patients and legal guardians receive questionnaires to collect patient-related outcome and experience measures after visits. These are measured by CHC-SUN/ YHC-SUN for treatment satisfaction and KIDDY KINDL, KIDSSCREEN 52, or WHOQOL-BREF for quality of life. An annual evaluation of all data results in a benchmarking of the participating centers. 24 indicators for structural quality were consented, 7 for process and 8 for outcome quality. Indicators of process quality comprise e.g. diagnostic procedures, case conferences, peer counseling or patient education. For structural quality there was an increase of centers fulfilling the QIs in 14 items including e.g. team composition and qualification during the study period from 2020 until 2022. Still very few centers had fixed standard operating procedures e.g. for gonadal monitoring or long-term follow up after surgery. 601 people with DSD were included into the registry from May 2021 until June 2023. In process quality there were considerable differences between centers both in QI compliance and data quality. The proportion of individuals with a genetic diagnosis varied by center from 44% to 96%. Information from questionnaires was available from 445 participants. Satisfaction with care was high. Parents reported in 86% to be very or highly satisfied with the visit, children and adolescents in 76%, and adults in 77%. Our approach allows for detailed evaluation of structural, process, and outcome quality. Health care insurers have secured appropriate funding for continuous evaluation of DSD care and the maintenance of the registry. This will allow for sustainability of the benchmarking and improvement of health care provision for people with DSD. Presentation: 6/1/2024

12204 Role Of [18F]FDG-PET/CT In Detection Of Immunotherapy-induced Hypophysitis - A Case-control Study

Abstract Disclosure: A. Fischer: None. J.M. Martinez Gomez: None. J. Mangana: None. R. Dummer: None. Z. Erlic: None. S. Nölting: None. F. Beuschlein: None. A. Maurer: None. M. Messerli: None. M.W. Huellner: None. S. Skawran: None. Adverse events related to immune-checkpoint inhibitor (ICI) therapy frequently affect endocrine organs. Depending on the type of ICI therapy, 0.5% to 10% of patients develop hypophysitis. Diagnosis relies on unspecific clinical symptoms and low serum cortisol level. On MRI, the diagnosis of ICI-induced hypophysitis is supported by enlargement of the pituitary gland and its stalk. However, pituitary MRI is negative in up to 2/3 of patients with hypophysitis on anti-PD-1 monotherapy. A delayed diagnosis increases the risk for life-threatening adrenal crisis. Consequently, there is a need for diagnostic tools that facilitate the early detection of ICI-induced hypophysitis. In this retrospective, single-center case-control-study, we investigated the diagnostic efficacy of [[1]8F]FDG positron emission tomography/computed tomography (FDG-PET/CT) in detecting ICI-induced hypophysitis. Fourteen patients with metastatic melanoma and ICI-induced hypophysitis were compared to a control group of 14 metastatic melanoma patients undergoing ICI treatment without evidence of hypophysitis, matched for age and sex. FDG-PET/CT scans were acquired as part of routine clinical care between 79 days before to 8 days after hypophysitis diagnosis (mean 26+/-29 days before diagnosis) in the case group. In the control group, FDG-PET/CT scans were obtained at a mean of 78+/-31 days after initiating ICI therapy. To mitigate inter-individual differences in standardized uptake value (SUV), the ratio of maximum SUV of the pituitary gland to the mean SUV of the blood pool (SUV-ratio pituitary/bloodpool) was calculated. Hypophysitis was diagnosed at a median of 83 (range: 65 - 98) days after the first ICI treatment; 9/14 (64.3%) patients received ipilimumab/nivolumab. Isolated cortisol deficiency was observed in 6/14 patients (42.9%), while 7/14 (50.0%) patients also displayed secondary hypothyroidism. Visual assessment of the distribution of the SUV-ratio pituitary/bloodpool demonstrated a positive correlation with decreasing proximity to the time of diagnosis. To evaluate diagnostic performance, only patients within 50 days before and 8 days after diagnosis (12/14) were included. The SUV-ratio pituitary/bloodpool was significantly higher in the case group compared to the control group (mean 3.57+/-3.24 vs. 1.69+/-0.41 respectively; p = 0.034). By optimizing the Youden index through area under the receiver operating characteristics curve (AUC) analysis, a sensitivity of 72.7% and a specificity of 90.9% were achieved at a threshold of 2.41 for the SUV-ratio pituitary/bloodpool (AUC = 0.769). In conclusion, our findings indicate that in patients undergoing ICI treatment for metastatic melanoma, an pituitary SUV-ratio pituitary/bloodpool in FDG-PET/CT of approximately 2.5 might indicate impending ICI-induced hypophysitis and should trigger close clinical monitoring. Presentation: 6/3/2024

6894 Disparities in Continuous Glucose Monitor Utilization and Real-Time Remote Sharing in Patients with Type 2 Diabetes Treated with Insulin on Medicare

Abstract Disclosure: K.L. Flint: None. T. Ting: None. K. Rivera: None. P. Tamang: None. C.A. Colling: None. J.H. Li: None. M.S. Putman: Consulting Fee; Self; Synspira Therapeutics. Research Investigator; Self; Dexcom. Other; Self; Vertex Pharmaceuticals Incorporated. Introduction: Continuous glucose monitors (CGM) are FDA-approved for the management of diabetes and have been shown to improve glycemic control. For optimal utilization, CGM can be connected to cloud-based clinic portals for real-time sharing of glycemic data with clinicians to guide clinical care. Although studies have previously identified disparities in access to CGM for patients who receive Medicare, limited data are available examining disparities in CGM utilization and data sharing. Hypothesis: We hypothesized that racial and socioeconomic disparities in CGM access exist both in utilization and in real-time remote sharing of CGM data. Methods: This was a retrospective cohort study examining patients with type 2 diabetes on insulin using Medicare as primary or secondary insurance in a single diabetes clinic affiliated with a tertiary care medical center. Clinical data extracted from the electronic health record (EHR) included age, self-reported race and ethnicity, sex, preferred language, education level, ZIP code-based median household income, and enrollment in the EHR-patient portal. The most recent diabetes clinic note for each patient as of October 2023 was reviewed to assess whether each patient was using CGM at the time of the visit. The clinic’s CGM portal accounts were reviewed to assess whether the patient was connected to and actively sharing CGM data with the clinic. Two sample t-tests and chi-square tests were used to evaluate continuous and categorical predictors of CGM use and real-time remote sharing, respectively. Results: Of the 847 patients who qualified for inclusion, 420 (49.6%) were using CGM and 213 (25.1%) were sharing CGM data in real-time. Compared to patients not using CGM (n=427), patients using CGM were younger (70.8 years vs 73.5 years, p&amp;lt;0.001) and more often enrolled in the EHR-based patient portal (91.9% vs 84.1%, p&amp;lt;0.001); however, there were no differences in racial, ethnic, or socioeconomic factors between the groups (p&amp;gt;0.05 for all). Of the patients using CGM, remote sharing of data was associated with younger age (69.5 years vs 72.3 years, p&amp;lt;0.01), identifying as White (74.2% vs 65.0%, p=0.04), using English as preferred language (92.5% vs 84.2%, p=0.02), higher levels of education (p=0.01), and using the EHR-based patient portal (97.2% vs 86.7%, p&amp;lt;0.001). Conclusions: In this cohort of patients with type 2 diabetes on insulin receiving Medicare, there were no significant socioeconomic disparities in CGM utilization. However, racial and socioeconomic disparities were pronounced in real-time remote sharing of CGM data, suggesting that patients from minoritized racial backgrounds, patients who do not use English as their preferred language, and patients with less education may benefit from additional support and training to connect and share their CGM with their providers. Presentation: 6/2/2024

Real-world pan-tumor comprehensive genomic profiling sample adequacy and success rates in tissue and liquid specimens.

Real-world success rate of liquid and tissue-based comprehensive genomic profiling (CGP) is unknown. We analyzed real-world pan-tumor cohorts that underwent CGP during clinical care via FoundationOne CDx (F1CDx) and FoundationOne Liquid CDx (F1LCDx) to determine tissue and liquid sample adequacy based on tumor type. Pan-tumor presequencing adequacy was high (>90%) by both tissue-based F1CDx (median: 92.3%; range: 88.2%-96.9%) and liquid-based F1LCDx (median: 94.8%; range: 86.6%-96.7%). Similarly, postsequencing analysis revealed that most tissue and liquid samples yielded successful sequencing results with a median sequencing success rate of 97.9% and 98.1% for F1CDx and F1LCDx, respectively. One exception is central nervous system (CNS) tumors, for which F1CDx had dramatically higher sample sufficiency (96.9%) and postsequencing success rate (97.0%) compared with F1LCDx (86.6% and 92.9%, respectively). The pan-tumor median sample-to-success rate was 90.4% (range: 84.8%-94.4%) for F1CDx. The equivalent rate for F1LCDx was slightly higher at 93.2% (range: 80.4%-95.7%). Conversely, when examining the prevalence of F1LCDx results with high tumor fraction (TF≥1%), the sample-to-high TF results rate was dramatically lower (median: 37.7%, range: 2.1% [CNS tumors]-46.0%). In conclusion, except in CNS tumors or when accounting for liquid TF, success rates of F1CDx and F1LCDx are equivalently high. These results may guide informed decision on when to pursue tissue vs liquid testing of patients with cancer.

Super-Resolution in Clinically Available Spinal Cord MRIs Enables Automated Atrophy Analysis.

Measurement of the mean upper cervical cord area (MUCCA) is an important biomarker in the study of neurodegeneration. However, dedicated high-resolution scans of the cervical spinal cord are rare in standard-of-care imaging due to timing and clinical usability. Most clinical cervical spinal cord imaging is sagittally acquired in 2D with thick slices and anisotropic voxels. As a solution, previous work describes high-resolution T1-weighted brain imaging for measuring the upper cord area, but this is still not common in clinical care. We propose using a zero-shot super-resolution technique, SMORE, already validated in the brain, to enhance the resolution of 2D-acquired scans for upper cord area calculations. To incorporate super-resolution in spinal cord analysis, we validate SMORE against high-resolution research imaging and in a real-world longitudinal data analysis. Super-resolved images reconstructed using SMORE showed significantly greater similarity to the ground truth than low-resolution images across all tested resolutions (p<0.001 for all resolutions in PSNR and MSSIM). MUCCA results from super-resolved scans demonstrate excellent correlation with high-resolution scans (r>0.973 for all resolutions) compared to low-resolution scans. Additionally, super-resolved scans are consistent between resolutions (r>0.969), an essential factor in longitudinal analysis. Compared to clinical outcomes such as walking speed or disease severity, MUCCA values from low-resolution scans have significantly lower correlations than those from high-resolution scans. Super-resolved results have no significant difference. In a longitudinal real-world dataset, we show that these super-resolved volumes can be used in conjunction with T1-weighted brain scans to show a significant rate of atrophy (-0.790, p=0.020 vs. -0.438, p=0.301 with low-resolution). Super-resolution is a valuable tool for enabling large-scale studies of cord atrophy, as low-resolution images acquired in clinical practice are common and available. MS=multiple sclerosis; MUCCA=mean upper cervical cord; HR=high-resolution; LR=low-resolution; SR=superresolved; CSC=cervical spinal cord; PMJ=pontomedullary junction; MSSIM=mean structural similarity; PSNR=peak signal-to-noise ratio; EDSS=expanded disability status scale.

Value of Pharmacogenetic Testing Assessed with Real-World Drug Utilization and Genotype Data.

Implementation of pharmacogenetic testing in clinical care has been slow and with few exceptions is hindered by the lack of real-world evidence on how to best target testing. In this retrospective register-based study, we analyzed a nationwide cohort of 1,425,000 patients discharged from internal medicine or surgical wards and a cohort of 2,178 university hospital patients for purchases and prescriptions of pharmacogenetically actionable drugs. Pharmacogenetic variants were obtained from whole genome genotype data for a subset (n = 930) of the university hospital patients. We investigated factors associated with receiving pharmacogenetically actionable drugs and developed a literature-based cost-benefit model for pre-emptive pharmacogenetic panel testing. In a 2-year follow-up, 60.4% of the patients in the nationwide cohort purchased at least one pharmacogenetically actionable drug, most commonly ibuprofen (25.0%) and codeine (19.4%). Of the genotyped subset, 98.8% carried at least one actionable pharmacogenetic genotype and 23.3% had at least one actionable gene-drug pair. Patients suffering from musculoskeletal or cardiovascular diseases were more prone to receive pharmacogenetically actionable drugs during inpatient episode. The cost-benefit model included frequently dispensed drugs in the university hospital cohort, comprising ondansetron (19.4%), simvastatin (7.4%), clopidogrel (5.0%), warfarin (5.1%), (es)citalopram (5.3%), and azathioprine (0.5%). For untargeted pre-emptive pharmacogenetic testing of all university hospital patients, the model indicated saving €17.49 in direct healthcare system costs per patient in 2 years without accounting for the cost of the test itself. Therefore, it might be reasonable to target pre-emptive pharmacogenetic testing to patient groups most likely to receive pharmacogenetically actionable drugs.

Impact of the COVID-19 Pandemic on Lifestyle Behavior and Clinical Care Pathway Management in Type 2 Diabetes: A Retrospective Cross-Sectional Study.

Background and Objectives: In Italy, as in the rest of the world, government restrictions aimed at containing the spread of COVID-19 primarily imposed limitations on social relationships and personal behavior. This situation significantly affected the management of chronic illnesses, including type 2 diabetes (T2D). The objective was to evaluate the perceptions of patients with T2D regarding the quality of care received during the COVID-19 pandemic and the impact on dietary and physical activity behaviors. Materials and Methods: We conducted a retrospective cross-sectional survey. Data were collected from June to July 2023 using the convenience sampling of patients with T2D, and the Patient Assessment of Chronic Illness Care (PACIC) and Medi-Lite questionnaires were administered. Results: During the research period, out of the 130 subjects who met all enrollment criteria, 103 patients were included in this study (79.23%). The results of the administered questionnaires were heterogeneous. The average scores from the PACIC Questionnaire for each question displayed significant variability, indicating a range of experiences in the quality of care. In the Medi-Lite survey, fruit, cereals, and olive oil showed the highest adherence levels, with mean scores ranging from 2.58 (SD ± 1.18) for fruit to 1.89 (SD ± 0.34) for olive oil and 1.97 (SD ± 0.17) for cereals. Patients who reported increased food intake during the lockdown attributed it to having more time to prepare meals. Physical activity levels remained unchanged for 48 patients, decreased for 45 patients, and only 9 patients managed to exercise more during the COVID-19 restrictions. Conclusions: Healthcare systems must prioritize comprehensive care plans for T2D that address not only physical health, but also emotional and social well-being. Post-pandemic, promoting healthier lifestyles and empowering patients to manage their condition is crucial. A multidisciplinary and multidimensional approach could support the care of vulnerable individuals, such as patients with T2D, especially during crises like pandemics or other dramatic events.

Strategies for Equitable Recruitment to Engage Underrepresented Youth and Their Families into Clinical Research: Findings from the BEAD-T1D Pilot Study.

To address disparities in clinical research, we present strategies to optimize recruitment of underrepresented families into the Building the Evidence to Address Disparities in Type 1 Diabetes (BEAD-T1D) study. A bilingual/bicultural Latino research assistant (RA) was hired to facilitate culturally congruent recruitment for pediatric type 1 diabetes families. The RA screened, approached, and consented families using their preferred language, time of contact, and answered personal concerns around research. Families were given the option to consent during outpatient clinic visits (in-person, or virtually via video/phone call) at a pace set by the parent/guardian to ensure understanding. 64 families (Hispanic-65%, Non-Hispanic White [NHW]- 17%, Non-Hispanic Black [NHB]-1%, and Other-4%) were eligible. Of 49 approached, 32 consented (397.9 years; female-81%; Hispanic-72%, NHW-28%, &lt;50K income-69%, Spanish-speaking-50%). Clinic approaches were important to successful consent: 87% of the clinic approaches resulted in consent. Barriers to clinic approaches for RA included late/no response from clinicians, care team ending visit, and bandwidth/connectivity issues. Facilitators to clinic approaches included collaborative clinic care teams, flexible RA hours, and patient screening days in advance. We exceeded our recruitment goals for surveys (31/30), focus groups/interviews (26/20), and advisory board (22/10). We identified that culturally and linguistically congruent staff, flexible recruitment practices, and prioritizing participant availability were solutions to recruit a diverse study cohort resulting exceeding recruitment goals. Cultural interpersonal relationships formed with families addressed barriers to research participation within and outside of the medical system. These strategies suggest equitable clinical trial recruitment is feasible in diabetes research.