Prospective randomized controlled trial of water exchange plus cap versus water exchange colonoscopy in unsedated veterans.

BACKGROUND AND AIMS: Water exchange (WE) and cap-assisted colonoscopy separately have been shown to reduce pain during insertion in unsedated patients. We hypothesized that compared with WE, WE cap-assisted colonoscopy (WECAC) could significantly lower real-time maximum insertion pain (RTMIP). METHODS: Veterans without escort were recruited, randomized, blinded, and examined at 3 U.S. Veterans Affairs sites. The primary outcome was RTMIP, defined as the highest segmental pain (0 = no pain, 10 = most severe pain) during insertion. RESULTS: Randomization (WECAC, 143; WE, 137) produced an even distribution of a racially diverse group of men and women of low socioeconomic status. The intention-to-treat analysis reported results of WECAC and WE for cecal intubation (93% and 94.2%, respectively), mean RTMIP (2.9 [standard deviation {SD}, 2.5] and 2.6 [SD, 2.4]), proportion of patients with no pain (28.7% and 27.7%), mean insertion time (18.6 minutes [SD, 15.6] and 18.8 minutes [SD, 15.9]), and overall adenoma detection rate (48.3% and 55.1%); all P values were >.05. When RTMIP was binarized as "no pain" (0) versus "some pain" (1-10) or "low pain" (0-7) versus "high pain" (8-10), different significant predictors of RTMIP were identified. CONCLUSIONS: Unsedated colonoscopy was appropriate for unescorted veterans. WE alone was sufficient. Adding a cap did not reduce RTMIP. Patient-specific factors and application of WE with insertion suction of infused water contributed to high and low RTMIP, respectively. For unescorted patients, selecting those with low anxiety, avoiding low body mass index, history of depression or self-reported poor health, and complying with the steps of WE can minimize RTMIP to ensure success of unsedated colonoscopy. (Clinical trial registration number: NCT03160859.).

Differences in Outcomes by Place of Origin among Hispanic Patients with Kidney Failure.

SIGNIFICANCE STATEMENT: Hispanic patients are known to have a higher risk of kidney failure and lower rates of home dialysis use and kidney transplantation than non-Hispanic White patients. However, it is unknown whether these outcomes differ within the Hispanic community, which is heterogeneous in its members' places of origins. Using United States Renal Data System data, the authors found similar adjusted rates of home dialysis use for patients originating from places outside the United States and US-born Hispanic patients, whereas the adjusted risk of mortality and likelihood of transplantation differed depending on place (country or territory) of origin. Understanding the heterogeneity in kidney disease outcomes and treatment within the Hispanic community is crucial in designing interventions and implementation strategies to ensure that Hispanic individuals with kidney failure have equitable access to care. BACKGROUND: Compared with non-Hispanic White groups, Hispanic individuals have a higher risk of kidney failure yet lower rates of living donor transplantation and home dialysis. However, how home dialysis, mortality, and transplantation vary within the Hispanic community depending on patients' place of origin is unclear. METHODS: We identified adult Hispanic patients from the United States Renal Data System who initiated dialysis in 2009-2017. Primary exposure was country or territory of origin (the United States, Mexico, US-Puerto Rico, and other countries). We used logistic regression to estimate differences in odds of initiating home dialysis and competing risk models to estimate subdistribution hazard ratios (SHR) of mortality and kidney transplantation. RESULTS: Of 137,039 patients, 44.4% were US-born, 30.9% were from Mexico, 12.9% were from US-Puerto Rico, and 11.8% were from other countries. Home dialysis rates were higher among US-born patients, but not significantly different after adjusting for demographic, medical, socioeconomic, and facility-level factors. Adjusted mortality risk was higher for individuals from US-Puerto Rico (SHR, 1.04; 95% confidence interval [CI], 1.01 to 1.08) and lower for Mexico (SHR, 0.80; 95% CI, 0.78 to 0.81) and other countries (SHR, 0.83; 95% CI, 0.81 to 0.86) compared with US-born patients. The adjusted rate of transplantation for Mexican or US-Puerto Rican patients was similar to that of US-born patients but higher for those from other countries (SHR, 1.22; 95% CI, 1.15 to 1.30). CONCLUSIONS: Hispanic people from different places of origin have similar adjusted rates of home dialysis but different adjusted rates of mortality and kidney transplantation. Further research is needed to understand the mechanisms underlying these observed differences in outcomes.

LUNAR: a randomized Phase 2 study of 177 Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (clinical trial protocol).

OBJECTIVE: To assess the efficacy of 177 Lu-PNT2002, a novel radiolabelled small molecule that binds with high affinity to prostate-specific membrane antigen (PSMA), in combination with stereotactic body radiotherapy (SBRT) to all sites of metastasis, vs SBRT alone, in men with oligorecurrent metastatic hormone-sensitive prostate cancer (mHSPC). PATIENTS AND METHODS: The 177 Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (LUNAR) trial is an open-label, randomized, stratified, two-arm, single-centre, Phase 2 trial to compare the efficacy and safety of neoadjuvant 177 Lu-PNT2002 plus SBRT vs SBRT alone in men with oligorecurrent mHSPC. Key eligibility criteria include one to five lesions identified on a PSMA positron emission tomography (PET)/computed tomography (CT) scan centrally reviewed by a board-certified nuclear medicine physician. Key exclusion criteria include castrate-resistant disease, de novo oligometastatic disease and receipt of androgen deprivation therapy (ADT) within 6 months of trial enrolment. The trial aims to enrol 100 patients who will be centrally randomized to one of the two treatment arms, in a 1:1 ratio. Patients in the control arm receive SBRT to all sites of disease. Patients in the experimental arm receive two cycles of neoadjuvant 177 Lu-PNT2002 (6.8 GBq) 6-8 weeks apart, followed by an interval PSMA PET/CT in 4-6 weeks and dose-adapted SBRT to all sites of disease 1-2 weeks later. The primary endpoint is progression-free survival. Secondary endpoints are radiographic and prostate-specific antigen-based progression, acute and late physician-scored toxicity, patient-reported quality of life, ADT-free survival, time to progression, overall survival, locoregional control, and duration of response. Enrolment in the study commenced in September 2022. RESULTS AND CONCLUSIONS: The addition of 177 Lu-PNT2002 to metastasis-directed therapy alone may potentially further forestall disease progression. The results of this Phase 2 trial will determine, for the first time in a randomized fashion, the added benefit of 177 Lu-PNT2002 to SBRT in patients with oligorecurrent mHSPC.

Pediatric risk to orthotopic heart transplant (PRO) score: Insights from United Network for Organ Sharing (UNOS) waitlist mortality findings.

BACKGROUND: Pediatric heart transplant candidates on the waitlist have the highest mortality rate among all solid organ transplants. A risk score incorporating a candidate's individual risk factors may better predict mortality on the waitlist and optimize organ allocation to the sickest of those awaiting transplant. METHODS: Using the United Network for Organ Sharing (UNOS) database, we evaluated a total of 5542 patients aged 0-18 years old on the waitlist for a single, first time, heart transplant from January 2010 to June 2019. We performed a univariate analysis on two-thirds (N = 3705) of these patients to derive the factors most associated with waitlist mortality or delisting secondary to deterioration within 1 year. Those with a p <0.2 underwent a multivariate analysis and the resulting factors were used to build a prediction model using the Fine-Grey model analysis. This predictive scoring model was then validated on the remaining one-third of the patients (N = 1852). RESULTS: The Pediatric Risk to OHT (PRO) scoring model utilizes the following unique patient variables: blood type, diagnosis of congenital heart disease, weight, presence of ventilator support, presence of inotropic support, extracorporeal membrane oxygenation (ecmo) status, creatinine level, and region. A higher score indicates an increased risk of mortality. The PRO score had a predictive strength of 0.762 as measured by area under the ROC curve at 1 year. CONCLUSION: The PRO score is an improved predictive model with the potential to better assess mortality for patients awaiting heart transplant.

Outcomes and Prognostic Factors of Pulmonary Hypertension Patients Undergoing Emergent Endotracheal Intubation.

Background: Emergent endotracheal intubations (ETI) in pulmonary hypertension (PH) patients are associated with increased mortality. Post-intubation interventions that could increase survivability in this population have not been explored. We evaluate early clinical characteristics and complications following emergent endotracheal intubation and seek predictors of adverse outcomes during this post-intubation period. Methods: Retrospective cohort analysis of adult patients with groups 1 and 3 PH who underwent emergent intubation between 2005-2021 in medical and liver transplant ICUs at a tertiary medical center. PH patients were compared to non-PH patients, matched by Charlson Comorbidity Index. Primary outcomes were 24-h post-intubation and inpatient mortalities. Various 24-h post-intubation secondary outcomes were compared between PH and control cohorts. Results: We identified 48 PH and 110 non-PH patients. Pulmonary hypertension was not associated with increased 24-h mortality (OR 1.32, 95%CI 0.35-4.94, P = .18), but was associated with inpatient mortality (OR 4.03, 95%CI 1.29-12.5, P = .016) after intubation. Within 24 h post-intubation, PH patients experienced more frequent acute kidney injury (43.5% vs. 19.8%, P = .006) and required higher norepinephrine dosing equivalents (6.90 [0.13-10.6] mcg/kg/min, vs. 0.20 [0.10-2.03] mcg/kg/min, P = .037). Additionally, the median P/F ratio (PaO2/FiO2) was lower in PH patients (96.3 [58.9-201] vs. 233 [146-346] in non-PH, P = .001). Finally, a post-intubation increase in PaCO2 was associated with mortality in the PH cohort (post-intubation change in PaCO2 +5.14 ± 16.1 in non-survivors vs. -18.7 ± 28.0 in survivors, P = .007). Conclusions: Pulmonary hypertension was associated with worse outcomes after emergent endotracheal intubation than similar patients without PH. More importantly, our data suggest that the first 24 hours following intubation in the PH group represent a particularly vulnerable period that may determine long-term outcomes. Early post-intubation interventions may be key to improving survival in this population.

Power doppler ultrasound signal predicts abnormal HDL function in patients with rheumatoid arthritis.

Active rheumatoid arthritis (RA) is associated with increased cardiovascular risk and impaired function of high-density lipoprotein (HDL). Previous work suggests that HDL may become dysfunctional through oxidative modifications within the RA joint. The current work evaluates an association of synovial power doppler ultrasound signal (PDUS) with HDL function and structure. Two open-label clinical therapeutic studies using PDUS as a disease outcome measure were included in this analysis, including a 12-month trial of subcutaneous abatacept in 24 RA patients and a 6-month trial of IV tocilizumab in 46 RA patients. Laboratory assays included assessments of HDL function and structure, HDL and total cholesterol levels, and a cytokine/chemokine panel. Patients with the highest baseline PDUS scores in both clinical studies, had worse HDL function, including suppression of paraoxonase 1 (PON1) activity as well as lower HDL-C levels. Associations between other disease assessments (DAS28 and CDAI) and HDL function/structure were noted but were generally of lesser magnitude and consistency than PDUS across the HDL profile. Treatment with tocilizumab for 6 months was associated with increases in cholesterol levels and improvements in the HDL function profile, which correlated with greater decreases in PDUS scores. Similar trends were noted following treatment with abatacept for 3 months. Higher baseline PDUS scores identified patients with worse HDL function. This data supports previous work suggesting a direct association of joint inflammation with abnormal HDL function.

Peripheral blood gene expression profiling shows predictive significance for response to mycophenolate in systemic sclerosis-related interstitial lung disease.

OBJECTIVES: To characterise the peripheral blood cell (PBC) gene expression changes ensuing from mycophenolate mofetil (MMF) or cyclophosphamide (CYC) treatment and to determine the predictive significance of baseline PBC transcript scores for response to immunosuppression in systemic sclerosis (SSc)-related interstitial lung disease (ILD). METHODS: PBC RNA samples from baseline and 12-month visits, corresponding to the active treatment period of both arms in Scleroderma Lung Study II, were investigated by global RNA sequencing. Joint models were created to examine the predictive significance of baseline composite modular scores for the course of forced vital capacity (FVC) per cent predicted measurements from 3 to 12 months. RESULTS: 134 patients with SSc-ILD (CYC=69 and MMF=65) were investigated. CYC led to an upregulation of erythropoiesis, inflammation and myeloid lineage-related modules and a downregulation of lymphoid lineage-related modules. The modular changes resulting from MMF treatment were more modest and included a downregulation of plasmablast module. In the longitudinal analysis, none of the baseline transcript module scores showed predictive significance for FVC% course in the CYC arm. In contrast, in the MMF arm, higher baseline lymphoid lineage modules predicted better subsequent FVC% course, while higher baseline myeloid lineage and inflammation modules predicted worse subsequent FVC% course. CONCLUSION: Consistent with the primary mechanism of action of MMF on lymphocytes, patients with SSc-ILD with higher baseline lymphoid module scores had better FVC% course, while those with higher myeloid cell lineage activation score had poorer FVC% course on MMF.

Impact of Payer Status on Delisting Among Liver Transplant Candidates in the United States.

Although socioeconomic disparities persist both pre- and post-transplantation, the impact of payer status has not been studied at the national level. We examined the association between public insurance coverage and waitlist outcomes among candidates listed for liver transplantation (LT) in the United States. All adults (age ≥18 years) listed for LT between 2002 and 2018 in the United Network for Organ Sharing database were included. The primary outcome was waitlist removal because of death or clinical deterioration. Continuous and categorical variables were compared using the Kruskal-Wallis and chi-square tests, respectively. Fine and Gray competing-risks regression was used to estimate the subdistribution hazard ratios (HRs) for risk factors associated with delisting. Of 131,839 patients listed for LT, 61.2% were covered by private insurance, 22.9% by Medicare, and 15.9% by Medicaid. The 1-year cumulative incidence of delisting was 9.0% (95% confidence interval [CI], 8.3%-9.8%) for patients with private insurance, 10.7% (95% CI, 9.9%-11.6%) for Medicare, and 10.7% (95% CI, 9.8%-11.6%) for Medicaid. In multivariable competing-risks analysis, Medicare (HR, 1.20; 95% CI, 1.17-1.24; P < 0.001) and Medicaid (HR, 1.20; 95% CI, 1.16-1.24; P < 0.001) were independently associated with an increased hazard of death or deterioration compared with private insurance. Additional predictors of delisting included Black race and Hispanic ethnicity, whereas college education and employment were associated with a decreased hazard of delisting. In this study, LT candidates with Medicare or Medicaid had a 20% increased risk of delisting because of death or clinical deterioration compared with those with private insurance. As more patients use public insurance to cover the cost of LT, targeted waitlist management protocols may mitigate the increased risk of delisting in this population.

AngioVac Aspiration Thrombectomy of Right Atrial Thrombus is Safe and Effective in Cancer Patients.

OBJECTIVES: The aim of this study was to test the hypothesis that endovascular aspiration thrombectomy of right atrial thrombus (RAT) using the AngioVac device is as safe and effective in patients with cancer as those without cancer. BACKGROUND: RAT is a uniquely challenging clinical presentation of venous thromboembolism due to its low incidence and historically high-risk of mortality due to thrombus propagation into the pulmonary arteries. There is a lack of consensus regarding management, particularly in high-risk cancer patients. Endovascular aspiration thrombectomy utilizing the AngioVac device is effective in removal of right atrial thrombus and may be a safer option for patients with cancer in whom avoidance of higher-risk intervention is preferred. METHODS: This was an institutional review board-approved retrospective single-center case control study of patients with RAT who underwent AngioVac aspiration thrombectomy between August 2013 and July 2020. Analysis of patient demographics and clinical characteristics, thrombus-related factors, and operative details was performed. Primary endpoints included survival, safety, and technical success. RESULTS: A total of 44 patients met inclusion criteria, 20 of whom with active malignancy. The oncology group had a significantly higher Charlson comorbidity index (P = 0.01). Comparative outcomes between the oncology and non-oncology group showed no difference in survival (P = 0.8) or technical success (OR 3, 95% CI 0.83-10.9). There were 9 complications, including 6 minor, 1 moderate, 1 severe, and 1 death. CONCLUSIONS: AngioVac aspiration thrombectomy of RAT is as safe and effective in patients with cancer as those without cancer.

Pediatric hematopoietic cell transplantation: Longitudinal trends in body mass index and outcomes.

Pediatric recipients of HCT may have a high susceptibility for overweight and obesity, and obesity may negatively impact post-transplant mortality and survival. This is a single-center retrospective analysis of 297 pediatric patients who received HCT between 2005 and 2018. Patients were classified as UW, NW, OW, or OB based on age-adjusted BMI. A mixed-effects linear regression model controlling for patient, disease, and transplant-related characteristics was used to trend weight longitudinally. Comparisons were made between weight category and post-transplant outcomes. In the pretransplant period, 5.4%, 54.5%, 22.2%, and 17.8% of patients were UW, NW, OW, and OB, respectively. Five years post-transplantation, those numbers were 10.6%, 48.2%, 16.5%, and 24.7%. Overall, BMI increased 0.00094 ± 0.0001 kg/m2 each day post-transplant (P < .001), with older individuals demonstrating greater rates of increase. Further, there was a larger BMI increase in patients without TBI compared with those who received TBI (1.29 ± 0.49, P = .008). Rates of acute GVHD, chronic GVHD, and viral infections, in addition to time to platelet and neutrophil engraftment and 5-year survival estimates, were not significantly different based on pretransplant BMI. Overweight and obese individuals had poorer 5-year survival based on 100-day post-transplant BMI (P = .02). Overall, pediatric HCT recipients are at risk of developing obesity, which is associated with decreased survival. Adolescents and young adults demonstrate the highest risk of weight gain, representing a vulnerable population that requires close monitoring, additional interventions, and further research.

Reliability, construct validity and responsiveness to change of the PROMIS-29 in systemic sclerosis-associated interstitial lung disease.

OBJECTIVES: PROMIS-29 is a generic health-related quality of life instrument. Our objective was to assess the reliability, construct validity, and responsiveness to change of PROMIS-29 in systemic sclerosis-associated interstitial lung disease (SSc-ILD). METHODS: Seventy-three participants with SSc-ILD were administered patient reported outcomes (PROs) at baseline and follow-up visits which included PROMIS-29 and other measures of generic health, dyspnea, and cough instruments. We assessed internal consistency reliability using Cronbach's α, an alpha of ≥ 0.70 was considered satisfactory. We assessed the responsiveness to change using linear regression models. RESULTS: Mean age of the participants was 51.9 years and the mean disease duration was 7.9 years after first non-Raynaud's symptom. Of the 73 participants, 56.2% were classified as diffuse SSc and 26% limited SSc. The baseline (mean ± SD) FVC % predicted was 73.9±15.5 with a DLCO % predicted of 57.7±21.1; 95.9% had fibrotic NSIP pattern on HRCT. PROMIS-29 scores were 0.2 to 0.9 SD below the US population. Cronbach's α reliability was acceptable for all domains (ranged from 0.77 to 0.98). All scales showed statistically significant correlations with hypothesised PROMIS-29 domains (p≤0.05 for all comparisons). PROMIS-29 showed none-to-small discriminatory ability in comparison with physiologic measures (FVC and DLCO). There was no significant relationship between the change in FVC versus the change in PROMIS-29 measures over time. CONCLUSIONS: PROMIS-29 has adequate reliability and construct validity for evaluation in SSc-ILD. It has moderate-to-large correlations with other PROs. The PROMIS-29 domains were not found to change over time in this cohort, likely due to stable nature of the observational cohort.

Reliability and minimal clinically important differences of forced vital capacity: Results from the Scleroderma Lung Studies (SLS-I and SLS-II).

OBJECTIVES: To assess the reliability and the minimal clinically important differences (MCID) for FVC% predicted in the Scleroderma Lung Study I and II. METHODS: Using data from SLS I and II (N=300), we evaluated the test-retest reliability for FVC% predicted (FVC%; screening vs. baseline) using intra-class correlation (ICC). MCID estimates at 12 months were calculated in the pooled cohort (SLS-I and II) using 2 anchors: Transition Dyspnea Index (≥change of 1.5 units for improvement and worsening, respectively) and the SF-36 Health Transition question: "Compared to one year ago, how would you rate your health in general now?", where "somewhat better" or "somewhat worse" were defined as the MCID estimates. We next assessed the association of MCID estimates for improvement and worsening of FVC% with patient reported outcomes (PROs) and computer-assisted quantitation of extent of fibrosis (QLF) and of total ILD (QILD) on HRCT. RESULTS: Reliability of FVC%, assessed at a mean of 34 days, was 0.93 for the pooled cohort. The MCID estimates for the pooled cohort at 12 months for FVC% improvement ranged from 3.0 % to 5.3% and for worsening from -3.0% to -3.3%. FVC% improvement by ≥MCID was associated with either statistically significant or numerical improvements in some PROs, QILD, and QLF, while FVC% worsening ≥MCID was associated with statistically significant or numerical worsening of PROs, QILD, and QLF. CONCLUSION: FVC% has acceptable test-retest reliability, and we have provided the MCID estimates for FVC% in SSc-ILD based changes at 12 months from baseline in two clinical trials. Clinical trial registration available at www.clinicaltrials.gov, IDs NCT00004563 and NCT00883129.

Association of Citizenship Status With Kidney Transplantation in Medicaid Patients.

BACKGROUND: Although individuals classified as nonresident aliens, including undocumented immigrants, are entitled to receive emergency dialysis in the United States regardless of their ability to pay, most states do not provide them with subsidized care for maintenance dialysis or kidney transplantation. We explored whether nonresident aliens have similar outcomes to US citizens after receiving kidney transplants covered by Medicaid, a joint federal and state health insurance program. STUDY DESIGN: Retrospective observational cohort study. SETTING & PARTICIPANTS: All adult Medicaid patients in the US Renal Data System who received their first kidney transplant from 1990 to 2011. PREDICTOR: Citizenship status, categorized as US citizen, nonresident alien, or permanent resident. OUTCOME: All-cause transplant loss. MEASUREMENTS: HRs and 95% CIs estimated by applying Cox proportional hazards frailty models with transplantation center as a random effect. RESULTS: Of 10,495 patients, 8,660 (82%) were US citizens, 1,489 (14%) were permanent residents, and 346 (3%) were nonresident aliens, whom we assumed were undocumented immigrants. Nonresident aliens were younger, healthier, receiving dialysis longer, and more likely to have had a living donor. 71% underwent transplantation in California, and 61% underwent transplantation after 2005. Nonresident aliens had a lower unadjusted risk for transplant loss compared with US citizens (HR, 0.48; 95% CI, 0.35-0.65). Results were attenuated but still significant when adjusted for demographics, comorbid conditions, dialysis, and transplant-related factors (HR, 0.67; 95% CI, 0.46-0.94). LIMITATIONS: Citizenship status was self-reported, possible residual confounding. CONCLUSIONS: Our study suggests that the select group of insured nonresident aliens who undergo transplantation with Medicaid do just as well as US citizens with Medicaid. Policymakers should consider expanding coverage for kidney transplantation in nonresident aliens, including undocumented immigrants, given the associated high-quality outcomes in these patients.

Risk Factors for Food Insecurity among Early Childhood Education Providers: Time for a Solution.

The COVID-19 pandemic exacerbated challenges in the child care industry, leading to closures and financial strain. Early care and education (ECE) providers faced reduced income, increased debt, and material hardships such as food insecurity. Using survey data collected through the Child Care Resource Center (CCRC), this study examines the association between food insecurity risk, sociodemographic factors, and pandemic-related service changes among ECE providers in California. The results showed that income, race, and increased food costs were significantly associated with a higher risk of food insecurity among ECE providers. Compared to incomes greater than USD 60,000, those earning USD 40,000-USD 49,999 and USD 50,000-USD 59,999 had higher odds of food insecurity (OR: 1.94, 95% CI: 0.683-1.86; OR: 2.12, 95% CI: 0.623-1.81, respectively). Black (OR: 1.89, 95% CI: 1.21-2.94) and multi-racial respondents (OR: 1.71, 95% CI: 1.1-2.65) had higher odds of food insecurity than white respondents. Lastly, respondents experiencing increased food costs had greater odds of food insecurity (OR: 4.52, 95% CI: 2.74-7.45). These findings suggest the need for policies and interventions aimed at increasing food access among vulnerable ECE providers. Such interventions will better protect them from financial shocks and the risk of food insecurity, and will support their crucial role in healthy child growth and development.

Assessing readiness: the impact of an experiential learning entrustable professional activity-based residency preparatory course.

As medical schools move to integrate the Core Entrustable Professional Activities for Entering Residency (EPAs) into curricula and address the transition from student to resident, residency preparatory courses have become more prevalent. The authors developed an experiential learning EPA-based capstone course for assessment to determine impact on learner self-assessed ratings of readiness for residency and acquisition of medical knowledge. All fourth-year students from the classes of 2018-2020 completed a required course in the spring for assessment of multiple EPAs, including managing core complaints, performing basic procedures, obtaining informed consent, and providing patient handoffs. Learners selected between three specialty-based parallel tracks - adult medicine, surgery, or pediatrics. Students completed a retrospective pre-post questionnaire to provide self-assessed ratings of residency preparedness and comfort in performing EPAs. Finally, the authors studied the impact of the course on knowledge acquisition by comparing student performance in the adult medicine track on multiple choice pre- and post-tests. Four hundred and eighty-one students were eligible for the study and 452 (94%) completed the questionnaire. For all three tracks, there was a statistically significant change in learner self-assessed ratings of preparedness for residency from pre- to post-course (moderately or very prepared: adult medicine 61.4% to 88.6% [p-value < 0.001]; surgery 56.8% to 81.1% [p-value < 0.001]; pediatrics 32.6% to 83.7% [p-value 0.02]). A similar change was noted in all tracks in learner self-assessed ratings of comfort from pre- to post-course for all studied EPAs. Of the 203 students who participated in the adult medicine track from 2019-2020, 200 (99%) completed both the pre- and post-test knowledge assessments. The mean performance improved from 65.0% to 77.5% (p-value < 0.001). An experiential capstone course for the assessment of EPAs can be effective to improve learner self-assessed ratings of readiness for residency training and acquisition of medical knowledge.

Impact of Telemedicine Versus In-Person Pediatric Outpatient Type 1 Diabetes Visits on Immediate Glycemic Control: Retrospective Chart Review.

BACKGROUND: Children and adolescents with type 1 diabetes require frequent outpatient evaluation to assess glucose trends, modify insulin doses, and screen for comorbidities. Continuous glucose monitoring (CGM) provides a detailed glycemic control assessment. Telemedicine has been increasingly used since the COVID-19 pandemic. OBJECTIVE: To investigate CGM profile parameter improvement immediately following pediatric outpatient diabetes visits and determine if visit modality impacted these metrics, completion of screening laboratory tests, or diabetic emergency occurrence. METHODS: A dual-center retrospective review of medical records assessed the CGM metrics time in range and glucose management indicator for pediatric outpatient diabetes visits during 2021. Baseline values were compared with those at 2 and 4 weeks post visit. Rates of completion of screening laboratory tests and diabetic emergencies following visits were determined. RESULTS: A total of 269 outpatient visits (41.2% telemedicine) were included. Mean time in range increased by 1.63% and 1.35% at 2 and 4 weeks post visit (P=.003 and .01, respectively). Mean glucose management indicator decreased by 0.07% and 0.06% at 2 and 4 weeks post visit (P=.003 and .02, respectively). These improvements in time in range and glucose management indicator were seen across both telemedicine visits and in-person visits without a significant difference. However, patients seen in person were 2.69 times more likely to complete screening laboratory tests (P=.03). Diabetic emergencies occurred too infrequently to analyze. CONCLUSIONS: Our findings demonstrate an immediate improvement in CGM metrics following outpatient visits, regardless of modality. While statistically significant, the magnitude of these changes was small; hence, multiple visits over time would be required to achieve clinically relevant improvement. However, completion of screening laboratory tests was found to be more likely after visits occurring in person. Therefore, we suggest a hybrid approach that allows patient convenience with telemedicine but also incorporates periodic in-person assessment.

Duration and Frequency of Spirometry Needed to Accurately Reflect Annualized Change of FEV1 in COPD.

RATIONALE: The slope of FEV1 decline is commonly used to reflect the rate of disease progression for descriptive studies and therapeutic trials in COPD. Frequency and duration of spirometric testing needed to report the true slope is unknown. OBJECTIVE: To define the minimum frequency and follow-up duration needed to accurately describe the annualized rate of FEV1 change among patients with moderate-to-very severe COPD. METHODS: We performed a post-hoc analysis of the annualized rate of FEV1 change among 4412 subjects previously enrolled in the four-year UPLIFT trial of tiotropium versus placebo. Slope estimates were modeled for different iterations of semiannual or annual testing over a variable duration up to four years. All models were compared to a reference of semiannual spirometry for four years. MEASUREMENTS AND MAIN RESULTS: The overall rate of post-bronchodilator FEV1 decline measured semi-annually for four years (44.6 ml; 95% CI:42.5-46.6) did not differ significantly from annual spirometry over the same period (43.7 ml; 95% CI:41.3-46.1) or semiannual spirometry over the first two years (44.3 ml; 95% CI:41.1-47.5). Agreement was consistent for two follow-up values as far as 24 months apart (43.3ml; 95% CI:39.9-46.8). Models based on less than two follow-up values or duration less than 18 months were characterized by relative underestimation of the slope. CONCLUSIONS: In a large cohort of patients with moderate-to-very severe COPD, the annualized rate of change in FEV1 was accurately represented by a minimum of two follow-up measurements over 18 months compared to semiannual testing over four years.

Preliminary Investigation: Pilot Study of Program Directors' Perceptions of Wellness and Suicide Prevention for Student Registered Nurse Anesthetists.

The purpose of this pilot study was to investigate wellness and student suicidality in nurse anesthesia programs. Graduate students such as student registered nurse anesthetists (SRNAs) are at increased risk of suicide from environmental and educational stressors. Wellness interventions may help. An observational, anonymous online survey of all program directors (PDs) was conducted. Identical responses on a simultaneous pilot SRNA study were compared. Quantitative data were analyzed using Wilcoxon rank sum and Fisher's exact tests. Three PDs reported student suicides. Anxiety, depression, and emotional lability were warning signs. Student and PD responses to wellness program assessments were varied, with PD responses more positive and students more negative. PDs were as stressed as students and struggled to meet their own wellness needs. Most PDs reported no or insufficient training in suicide risk and prevention. Suggestions for improving wellness initiatives included to improve and standardize activities and make initiatives more accessible and seek innovative solutions to fit more content into an overcrowded curriculum. PDs and SRNAs need suicide prevention training and improved wellness efforts at local and national levels. Approaches are needed to counter stigma and reluctance to discuss mental health challenges. Suicide is multidimensional, but with proactive awareness, it may be preventable.

Development and Validation of a Trauma-Informed Care Communication Skills Assessment Tool.

BACKGROUND: Trauma-informed care (TIC) is growing in medical education as health care systems recognize trauma's impact on health outcomes. TIC acknowledges and responds to the effects of trauma on physical, psychological, and emotional health. As TIC trainings are developed and delivered to health care professionals across the learner continuum, curricula need evaluation beyond learner satisfaction and knowledge to better assess changes in skills. We developed the Gap Kalamazoo Communication Skills Assessment Form for Trauma-Informed Care (GKCSAF-TIC) to evaluate pediatric trainees' communication skills in TIC. We describe the development and validity evidence of the GKCSAF-TIC in assessing pediatric residents' TIC skills during standardized patient encounters. METHODS: We developed and implemented the TIC communication skills assessment tool in a one-year prospective cohort study involving pediatric residents. We conducted simulated patient encounters conducted before and after TIC training, with two pediatric faculty attendings assessing each encounter. We gathered validity evidence using Messick's framework, focusing on content, response process, internal structure, and relationship with other variables. RESULTS: We analyzed 57 standardized patient encounters with 33 pediatric interns, including 23 pre-post matched pairs. The development process and rater training supported content and response process validity. Internal consistency, measured by Cronbach's alpha, ranged from 0.93 to 0.96, while inter-rater reliability, measured by intraclass correlations, ranged from 0.80 to 0.83. There was a significant improvement in scores from pre-training to post-training (3.7/5 to 4.05/5; P < 0.05). CONCLUSION: The GKCSAF-TIC demonstrated strong preliminary validity and offers educators a valuable means to assess and provide formative feedback to pediatric trainees about TIC.