Prognostic Value of the 2019 EULAR/American College of Rheumatology Systemic Lupus Erythematosus Classification Criteria to Renal Response One Year After Treatment in a Cohort With Childhood-Onset Lupus Nephritis.

OBJECTIVE: In 2019, the EULAR/American College of Rheumatology developed classification criteria for systemic lupus erythematosus (SLE). A positive correlation between summary score at diagnosis and SLE disease activity at five years has been noted in adult patients with lupus, but little is known among the pediatric population. We evaluated the prognostic value of higher summary scores and number of extrarenal domains at diagnosis (low/moderate number [1-5] vs high number [6-9]) to renal outcomes after one year of treatment in pediatric patients with lupus nephritis (LN). METHODS: This retrospective, single-center cohort study included 74 pediatric patients with LN. Published pediatric renal response definitions were used for our outcome measure (no, partial, and complete response). Descriptive statistics were reported, and an ordinal logistic regression estimated adjusted odds ratios (ORs) for renal response including 95% confidence intervals (CIs). RESULTS: Patients with high extrarenal domains had OR 1.47 (95% CI 0.55-2.91) of having a complete renal response compared to patients with low/moderate domains. Patients with a summary score <30 had OR 1.31 (95% CI 0.50-3.44) of having a complete renal response relative to a summary score ≥30, though a larger proportion of patients with a summary score of ≥30 had no renal response after one year of treatment. CONCLUSION: More extrarenal domains at diagnosis did not have a statistically significant impact on renal response at one year, nor did a higher summary score. However, a larger portion of patients with a summary score <30 achieved complete renal response compared to patients with a score ≥30.

Air Medical Transport for Acute Ischemic Stroke Patients: A Retrospective Cohort Study of National Trends Over an 8-Year Period.

OBJECTIVE: Optimal management of ischemic stroke is time dependent. An understanding of patterns of air medical transport may identify disparities that could affect patient care. METHODS: In this 8-year (2007-2014) observational, retrospective, cohort study, we abstracted a 20% national sample of Medicare data from patients ≥ 66 years of age hospitalized with a primary diagnosis of acute ischemic stroke who presented to the emergency department by ambulance (air or ground). RESULTS: Among 149,751 hospitalized stroke patients who arrived by ambulance, the mean age was 81.6 years (standard deviation = 8.0 years), 62.1% were female (n = 93,007), and 86.3% were White (n = 129,268). Of these, 5,534 patients (3.7%) used any form of air ambulance. Air ambulance use (2007: 2.5%, 2014: 4.9%; P < .001) and arrival at certified stroke centers (2007: 40.3%, 2014: 63.2%; P < .001) increased over time. Air ambulance use was less likely among older patients (76-85 years and >85 years vs. 66-75 years; odds ratio [OR] = 0.68; 95% confidence interval [CI], 0.64-0.72 and OR = 0.34; 95% CI, 0.32-0.37, respectively) and all racial minorities except American Natives (OR = 2.07; 95% CI, 1.57-2.73) and more likely among sicker patients (Charlson Comorbidity Index ≥ 2 vs. 1, OR = 1.23; 95% CI, 1.09-1.38) and rural residents (OR = 1.34; 95% CI, 1.09-1.64). After adjustment for covariates, air ambulance use was associated with higher odds of thrombolysis (adjusted OR = 2.57; 95% CI, 2.38-2.79). CONCLUSION: Air ambulance use is independently associated with increased thrombolysis use for stroke, but disparities exist in both air ambulance and thrombolysis use. Further research into underlying causes for these disparities would be beneficial for systems and public health-based interventions for improving outcomes for ischemic stroke.

Impact of Comprehensive Health Insurance on Quality of Life in Low-Income Hispanic Men with Prostate Cancer.

OBJECTIVE: To evaluate the effect of the transition from IMPACT, a disease-focused treatment program, to comprehensive health insurance under Medicaid through the Affordable Care Act (ACA) on general and prostate cancer-specific quality of life (QoL) on a cohort of previously uninsured low-income men. We hypothesize that general QoL would improve and prostate cancer-specific QoL would remain the same after the transition to comprehensive health insurance. METHODS: We assessed and compared general QoL using the RAND SF-12v2™ (12-Item Short Form Survey, version 2) and prostate cancer-specific QoL using the UCLA PCI (Prostate Cancer Index) one year before, at, and one year after the transition between 30 men who transitioned to comprehensive insurance (newly insured/Medicaid group) and 54 men who remained in the prostate cancer program (uninsured/IMPACT group). We assessed the independent effects of Medicaid coverage on QoL outcomes using repeated-measures regression. RESULTS: Our cohort was composed primarily of Hispanic men (82%). At transition, patient demographics and clinical characteristics were similar between the groups. General and prostate cancer-specific QoL did not differ between the groups and remained stable over time, Radical prostatectomy as primary treatment and shorter time since treatment were associated with worse urinary and sexual function across both groups and over all three time points. CONCLUSION: Those who transitioned to full-scope insurance and those who remained in the free prostate cancer-focused treatment program had stable general and prostate cancer-specific QoL. High-touch navigation aspects of a disease-focused program may have contributed to stability in outcomes.

Someone Like Me: An Examination of the Importance of Race-Concordant Mentorship in Urology.

OBJECTIVE: To describe differences in urology mentorship exposure for medical students across race/ethnicity and to explore how much potential mentees valued the importance of race-concordant mentorship. METHODS: All medical students at UCLA received a cross-sectional survey. Dependent variables were perceived quality of mentorship in urology and association between race-concordant mentorship and perceived importance of race-concordant mentorship. Mentors were self-selected by medical students. Variables were compared across race/ethnicity using descriptive statistics and multivariate analyses. Subset analyses looking at race-concordance between mentor and student was performed using stratified Cochran-Mantel-Haenszel tests. This was performed to determine if there were differences, across race/ethnicity, in rating of importance of having a race-concordant mentor. RESULTS: The likelihood of having a urologist as a mentor was similar across race/ethnicity. Under-Represented in Medicine (URiM) students were more likely to report that having a mentor of the same race/ethnicity was extremely important (Asian 9%, Black 58%, Latinx 55% and White 3%, P < .001) compared to their non-URiM peers who were more likely to rate having a race-concordant mentor as not at all important (Asian 34%, Black 5%, Latinx 8%, White 79%, P < .001). URiM students with race-concordant mentors were still more likely to rate having a mentor of the same race/ethnicity as extremely/very important (73%) compared to their non-URiM peers (9%, P = .001). URiM students with race-discordant mentors also rated importance of mentors of the same race/ethnicity as extremely/very important (67%) compared to their non-URiM peers (11%, P = .006). CONCLUSION: URiM medical students regard race-concordant mentorship as extremely important. Interventions addressing mentor racial/ethnic concordance and those promoting culturally responsive mentorship may optimize recruitment of URiM students into urology.

Role of left atrial hypertension in pulmonary hypertension associated with bronchopulmonary dysplasia.

Left atrial hypertension (LAH) may contribute to pulmonary hypertension (PH) in premature infants with bronchopulmonary dysplasia (BPD). Primary causes of LAH in infants with BPD include left ventricular diastolic dysfunction or hemodynamically significant left to right shunt. The incidence of LAH, which is definitively diagnosed by cardiac catheterization, and its contribution to PH is unknown in patients with BPD-PH. We report the prevalence of LAH in an institutional cohort with BPD-PH with careful examination of hemodynamic contributors and impact on patient outcomes. This single-center, retrospective cohort study examined children <2 years of age with BPD-PH who underwent cardiac catheterization at Lucile Packard Children's Hospital Stanford. Patients with unrepaired simple shunt congenital heart disease (CHD) and pulmonary vein stenosis (only 1 or 2 vessel disease) were included. Patients with complex CHD were excluded. From April 2010 to December 2021, 34 patients with BPD-PH underwent cardiac catheterization. We define LAH as pulmonary capillary wedge pressure (PCWP) or left atrial pressure (LAP) of at least 10 mmHg. In this cohort, median PCWP was 8 mmHg, with LAH present in 32% (n = 11) of the total cohort. A majority (88%, n = 30) of the cohort had severe BPD. Most patients had some form of underlying CHD and/or pulmonary vein stenosis: 62% (n = 21) with an atrial septal defect or patent foramen ovale, 62% (n = 21) with patent ductus arteriosus, 12% (n = 4) with ventricular septal defect, and 12% (n = 4) with pulmonary vein stenosis. Using an unadjusted logistic regression model, baseline requirement for positive pressure ventilation at time of cardiac catheterization was associated with increased risk for LAH (odds ratio 8.44, 95% CI 1.46-48.85, p = 0.02). Small for gestational age birthweight, sildenafil use, and CHD were not associated with increased risk for LAH. LAH was associated with increased risk for the composite outcome of tracheostomy and/or death, with a hazard ratio of 6.32 (95% CI 1.72, 22.96; p = 0.005). While the etiology of BPD-PH is multifactorial, LAH is associated with PH in some cases and may play a role in clinical management and patient outcomes.

Intraoperative Laparoscopic Ultrasound Increases Fibroid Detection During Laparoscopic Myomectomy.

Objective: To assess the utility of intraoperative laparoscopic ultrasound in detecting additional fibroids during laparoscopic myomectomy (LM). Methods: Forty-two patients were enrolled in this prospective cohort study. All cases were performed by the same surgeon at a university affiliated hospital between April 1, 2019 and February 29, 2020. Following routine laparoscopic myomectomy, the laparoscopic ultrasound was then introduced, and ultrasonography was performed directly on the uterus. Any additional fibroids discovered were enucleated. Results: Using the laparoscopic ultrasound, an additional 54 fibroids among 27 (64%) of the 42 patients were found, with a median of 2 additional fibroids per patient (interquartile range [IQR] 1,3). Median fibroid size detected by laparoscopic ultrasound was 1.5 centimeters (IQR 1-3) and the most common types were FIGO grades 3 and 2 (43% and 33% respectively). The median surgical time was longer among patients in whom additional fibroids were found (170 minutes (IQR 137-219) vs 150 minutes (IQR 120-193), p = .044). When ≥ 2 fibroids were removed by usual methods, the laparoscopic ultrasound found additional fibroids 80% of the time, compared to 25% when < 2 fibroids were removed by usual methods (p < .001). Conclusion: Intraoperative laparoscopic ultrasonography is a useful tool in detecting additional fibroids that would have otherwise been missed. It is particularly helpful in identifying smaller intramural fibroids and in patients with multiple fibroids. By detecting additional fibroids, laparoscopic ultrasonography can help maximize the effectiveness of laparoscopic myomectomy and help decrease the rates of residual fibroids.

Comprehension, utility, and preferences of prostate cancer survivors for visual timelines of patient-reported outcomes co-designed for limited graph literacy: meters and emojis over comics.

OBJECTIVE: Visual timelines of patient-reported outcomes (PRO) can help prostate cancer survivors manage longitudinal data, compare with population averages, and consider future trajectories. PRO visualizations are most effective when designed with deliberate consideration of users. Yet, graph literacy is often overlooked as a design constraint, particularly when users with limited graph literacy are not engaged in their development. We conducted user testing to assess comprehension, utility, and preference of longitudinal PRO visualizations designed for prostate cancer survivors with limited literacy. MATERIALS AND METHODS: Building upon our prior work co-designing longitudinal PRO visualizations with survivors, we engaged 18 prostate cancer survivors in a user study to assess 4 prototypes: Meter, Words, Comic, and Emoji. During remote sessions, we collected data on prototype comprehension (gist and verbatim), utility, and preference. RESULTS: Participants were aged 61-77 (M = 69), of whom half were African American. The majority of participants had less than a college degree (95%), had inadequate health literacy (78%), and low graph literacy (89%). Among the 4 prototypes, Meter had the best gist comprehension and was preferred. Emoji was also preferred, had the highest verbatim comprehension, and highest rated utility, including helpfulness, confidence, and satisfaction. Meter and Words both rated mid-range for utility, and Words scored lower than Emoji and Meter for comprehension. Comic had the poorest comprehension, lowest utility, and was least preferred. DISCUSSION: Findings identify design considerations for PRO visualizations, contributing to the knowledge base for visualization best practices. We describe our process to meaningfully engage patients from diverse and hard-to-reach groups for remote user testing, an important endeavor for health equity in biomedical informatics. CONCLUSION: Graph literacy is an important design consideration for PRO visualizations. Biomedical informatics researchers should be intentional in understanding user needs by involving diverse and representative individuals during development.

Delivery Timing and Associated Outcomes in Pregnancies With Maternal Congenital Heart Disease at Term.

Background Current recommendations for delivery timing of pregnant persons with congenital heart disease (CHD) are based on expert opinion. Justification for early-term birth is based on the theoretical concern of increased cardiovascular stress. The objective was to evaluate whether early-term birth with maternal CHD is associated with lower adverse maternal or neonatal outcomes. Methods and Results This is a retrospective cohort study of pregnant persons with CHD who delivered a singleton after 37 0/7 weeks gestation at a quaternary care center with a multidisciplinary cardio-obstetrics care team between 2013 and 2021. Patients were categorized as early-term (37 0/7 to 38 6/7 weeks) or full-term (≥39 0/7) births and compared. Multivariable logistic regression was conducted to calculate the adjusted odds ratio for the primary outcomes. The primary outcomes were composite adverse cardiovascular, maternal obstetric, and adverse neonatal outcome. Of 110 pregnancies delivering at term, 55 delivered early-term and 55 delivered full-term. Development of adverse cardiovascular and maternal obstetric outcome was not significantly different by delivery timing. The rate of composite adverse neonatal outcomes was significantly higher in early-term births (36% versus 5%, P<0.01). After adjusting for confounding variables, early-term birth remained associated with a significantly increased risk of adverse neonatal outcomes (adjusted odds ratio 11.55 [95% CI, 2.59-51.58]). Conclusions Early-term birth for pregnancies with maternal CHD was associated with an increased risk of adverse neonatal outcomes, without an accompanying decreased rate in adverse cardiovascular or obstetric outcomes. In the absence of maternal or fetal indications for early birth, induction of labor before 39 weeks for pregnancies with maternal CHD should be reserved for routine obstetrical indications.

Health Care Disparities Among Latina Patients Presenting With Pelvic Organ Prolapse.

IMPORTANCE: This study identifies barriers, including language and insurance status, Latina patients may face in accessing urogynecology care. OBJECTIVE: The aim of the study was to determine differences in objective prolapse severity at the time of presentation between Latina and non-Latina patients and the effect socioeconomic disparities may have on these differences. STUDY DESIGN: This is a retrospective cohort study of patients visiting urogynecology clinics at 2 academic institutions (1 private, 1 public). Patients with symptomatic > stage II prolapse were included. Initial Pelvic Organ Prolapse Quantification examinations, leading edge of prolapse, and demographic data were extracted. We evaluated several socioeconomic factors for associations with prolapse severity in a multivariable analysis. RESULTS: Three hundred forty-two patients were included (36% Latina). Twenty-eight percent were non-English speaking and 54% had public or no insurance. Using leading edge as the outcome, there was no objective difference in prolapse severity between the Latina and non-Latina patients. A higher proportion of patients with public insurance had more advanced prolapse compared with those with private insurance (odds ratio, 2.78; 95% confidence interval, 1.40-5.55; P < 0.01) and a higher proportion of non-English speaking had more advanced prolapse compared with English speakers (odds ratio, 2.44; 95% confidence interval, 1.12-5.34; P = 0.03). CONCLUSIONS: Latina ethnicity was not a risk factor for more advanced prolapse at the time of initial evaluation in a urogynecology clinic. Rather, patients who were non-English speaking and had public insurance were more likely to present with more advanced prolapse. Our data suggest that language barriers and lower socioeconomic status are health care disparities for patients seeking care for prolapse.

Racial and Ethnic Differences in Medical Student Timing and Perceived Quality of Exposure to Urology.

OBJECTIVE: To contextualize the low representation of Under-Represented in Medicine (URiM) in urology, we examine differences in timing and perceived quality of urology clinical and research exposures for medical students across race/ethnicity. METHODS: A cross-sectional survey was distributed to all medical students at University of California, Los Angeles. Dependent variables were timing of urology exposure and perceived quality of urology exposure. Descriptive statistics and multivariate analyses were used to compare variables across race/ethnicity. Logistic regression was used to determine odds of early exposure to urology across race/ethnicity. RESULTS: Black and Latinx students were significantly less likely to discover urology before MS3 (P <.001). Although URiM students were more likely to recall receiving a urology interest group invitation (Asian 46%, Black 53%, Latinx 67%, White 48%, P = .03), they were less likely to attend an event (Asian 23%, Black 4%, Latinx 3% and White 15%, P <.001) despite being more likely to be interested in urology (Asian 32%, Black 38%, Latinx 50%, White 28%, P = .01). Black students were more likely to gain exposure via family/friend with a urological diagnosis. Black and Latinx students were twice as dissatisfied with timing and method of medical school exposure to urology versus their peers. There were differences across race/ethnicity for whether or not a student had engaged in urology research (Asian 10%, Black 5%, Latinx 2%, White 2%, P = .01). CONCLUSION: Racial/ethnic disparities exist in early exposure to urology, involvement in urology interest group, access to research, and satisfaction with exposure to urology. Interventions addressing the timing and quality of urology exposures may optimize recruitment of URiM students into urology.

Risk Factors for Measles Nonimmunity in Rubella-Immune Pregnant Patients.

OBJECTIVES: Measles immunity testing, unlike that for rubella, is not currently part of prenatal screening even though immunity to both is conferred by the measles-mumps-rubella (MMR) vaccine. Although endemic transmission of measles was declared eliminated in the United States in 2001, outbreaks have continued to occur. Given the risks associated with measles infection during pregnancy, we sought to identify risk factors for measles nonimmunity (MNI) in rubella-immune (RI) pregnant individuals. METHODS: We performed a retrospective observational cross-sectional study of patients receiving prenatal care and delivering at two university hospitals and a county hospital in Southern California from April 1, 2019 to February 1, 2021. Inclusion criteria were pregnant individuals ≥18 years old who had serological testing for rubella and measles during pregnancy. Demographic data were extracted from electronic medical records, including results of serological testing and chronic medical conditions. All subjects were rubella immune, and we compared measles-immune (MI) with MNI groups. RESULTS: In total, 1,813 RI individuals were identified, with 1,467 (81%) MI and 346 (19%) MNI individuals. Variables associated with an increased risk of MNI included having public health insurance (adjusted relative risk [aRR]: 1.56; 95% confidence interval [CI]: 1.24, 1.97) and Hispanic ethnicity (aRR: 1.37; 95% CI: 1.06, 1.78). Black race was associated with a decreased risk of MNI (aRR: 0.52; 95% CI: 0.29, 0.91). Birth year before 1989 demonstrated a trend toward increased risk of MNI, but this did not reach statistical significance (aRR 1.23; 95% CI: 1.00, 1.52). No differences were seen between the two groups for medical comorbidities. CONCLUSION: Our study is the first to demonstrate risk factors for measles MNI in patients with documented rubella immunity. In the absence of universal measles serological screening recommendations, the risk factors identified could help guide clinicians in selective screening for those at risk of needing postpartum MMR vaccination. KEY POINTS: · The rate of measles nonimmunity is higher than previously reported.. · Hispanic ethnicity and use of public insurance are risk factors for measles nonimmunity.. · The current recommendation for history-based screening for measles immunity is likely insufficient..

Community-Based Health Care Navigation's Impact on Access to Primary Care for Low-Income Latinos.

INTRODUCTION: Despite the Affordable Care Act's insurance expansion, low-income Latinos are less likely to have a primary care provider compared with other racial/ethnic and income groups. We examined if community-based health care navigation could improve access to primary care in this population. METHODS: We surveyed adult clients of a community-based navigation program serving predominantly low-income Latinos throughout Los Angeles County in 2019. We used multivariable logistic regression models, adjusting for sociodemographic characteristics, to calculate odds ratios for differences in access to primary care and barriers to care between clients who had experienced approximately 1 year of navigation services (intervention group) and clients who were just introduced to navigation (comparison group). RESULTS: Clients in the intervention group were more likely to report having a primary care clinic than the comparison group (Adjusted Odds Ratio [aOR] 3.0, 95%CI: 1.7, 5.4). The intervention group was also significantly less likely to experience several barriers to care, such as not having insurance, not being able to pay for a visit, and not having transportation. CONCLUSIONS: Community-based navigation has the potential to reduce barriers and improve access to primary care for low-income Latinos. In addition to expanding insurance coverage, policymakers should invest in health care navigation to reduce disparities in primary care.

Comparison of Pelvic Floor Physical Therapy Attendance Based on Referring Provider Specialty.

OBJECTIVE: The objective of this study was to determine whether pelvic floor physical therapy (PFPT) attendance differs based on referring provider specialty and identify factors related to PFPT initiation and completion. METHODS: This was an institutional review board-approved retrospective cohort study examining referrals from female pelvic medicine and reconstructive surgery (FPMRS) and non-FPMRS providers at a single academic medical center to affiliated PFPT clinics over a 12-month period. Demographics, referring specialty and diagnoses, prior treatment, and details regarding PFPT attendance were collected. Characteristics between FPMRS and non-FPMRS referrals were compared and multivariate logistic regression analyses were performed to identify factors associated with PFPT initiation and completion. RESULTS: A total of 497 referrals were placed for PFPT. Compared with non-FPMRS referrals, FPMRS referrals were for patients who were older (54.7 years vs 35.6 years), and had higher parity; more were postmenopausal (56% vs 18%) and had Medicare insurance (22% vs 10%) (all P < 0.001). Most FPMRS referrals were for patients with urinary incontinence (69% vs 31%), whereas non-FPMRS referrals were for patients with pelvic pain (70% vs 27%) (both P < 0.0001). Pelvic floor physical therapy attendance was similar in both groups when comparing rates of initiation (47% vs 45%) and completion (13% vs 16%). In multivariate analysis, factors associated with initiation were age 65 years or older, additional therapy provided at referring visit, private insurance, Asian race, pregnant or postpartum at time of referral, and more than 1 referring diagnosis (all P < 0.05). No factors were associated with completion. CONCLUSIONS: Less than half of the patients referred to PFPT initiate therapy, and only 15% complete PFPT. The populations referred by FPMRS and non-FPMRS providers are different, but ultimately PFPT utilization is similar.

Favorable Simplified Bishop Score after cervical ripening associated with decreased cesarean birth rate.

BACKGROUND: A favorable Simplified Bishop Score (>5) before the induction of labor is associated with successful vaginal birth. Patients with an unfavorable Simplified Bishop Score (≤5) undergo cervical ripening before the administration of oxytocin. However, data are limited regarding the utility of the Simplified Bishop Score after cervical ripening. OBJECTIVE: The objective of this study was to determine if the Simplified Bishop Score before oxytocin induction but after cervical ripening is associated with cesarean delivery. STUDY DESIGN: We conducted a retrospective cohort study on patients undergoing induction of labor from the Consortium on Safe Labor. The patients with a singleton term pregnancy who initially underwent cervical ripening were included. Those with a history of cesarean delivery were excluded. The outcomes of patients with a favorable Simplified Bishop Score after cervical ripening were compared with those with an unfavorable Simplified Bishop Score. The primary outcome was the mode of birth. A log-binomial regression was performed to calculate the relative risk and control for confounders such as admission Simplified Bishop Score and parity. RESULTS: A total of 5807 patients met the criteria to be included in the study. 4235 (73%) patients had a favorable cervix, and 1572 (27%) patients had an unfavorable cervix after cervical ripening. The favorable group had a decreased rate of cesarean delivery than the unfavorable group (risk ratio, 0.35; 95% confidence interval, 0.30-0.40). Both the groups had low rates of maternal chorioamnionitis, though the patients with an unfavorable cervix were at a higher risk. There was no significant difference in the rates of postpartum hemorrhage or neonatal intensive care unit admission. Lower rates of cesarean delivery among the favorable group persisted when stratifying by parity (nulliparous: risk ratio, 0.37; 95% confidence interval, 0.31-0.43; multiparous: risk ratio, 0.22; 95% confidence interval, 0.14-0.36). After controlling for maternal age, prepregnancy body mass index, parity, gestational age, and Simplified Bishop Score at admission, a favorable cervix remained significantly associated with fewer cesarean births (risk ratio, 0.55; 95% confidence interval, 0.46-0.66). CONCLUSION: In women undergoing labor induction, a favorable Simplified Bishop Score after cervical ripening and before the start of oxytocin is associated with a decreased rate of cesarean delivery, even after adjusting for parity and Simplified Bishop Score at admission. Moreover, the Simplified Bishop Score assigned after cervical ripening could be used to inform the timing of oxytocin initiation. However, further research is necessary to determine the ideal endpoint of cervical ripening.

Multi-Institutional Practice-Patterns in Fetal Congenital Heart Disease Following Implementation of a Standardized Clinical Assessment and Management Plan.

Background Prenatal diagnosis of congenital heart disease has been associated with early-term delivery and cesarean delivery (CD). We implemented a multi-institutional standardized clinical assessment and management plan (SCAMP) through the University of California Fetal-Maternal Consortium. Our objective was to decrease early-term (37-39 weeks) delivery and CD in pregnancies complicated by fetal congenital heart disease using a SCAMP methodology to improve practice in a high-risk and clinically complex setting. Methods and Results University of California Fetal-Maternal Consortium site-specific management decisions were queried following SCAMP implementation. This contemporary intervention group was compared with a University of California Fetal-Maternal Consortium historical cohort. Primary outcomes were early-term delivery and CD. A total of 496 maternal-fetal dyads with prenatally diagnosed congenital heart disease were identified, 185 and 311 in the historical and intervention cohorts, respectively. Recommendation for later delivery resulted in a later gestational age at delivery (38.9 versus 38.1 weeks, P=0.01). After adjusting for maternal age and site, historical controls were more likely to have a CD (odds ratio [OR],1.8; 95% CI, 2.1-2.8; P=0.004) and more likely (OR, 2.1; 95% CI, 1.4-3.3) to have an early-term delivery than the intervention group. Vaginal delivery was recommended in 77% of the cohort, resulting in 61% vaginal deliveries versus 50% in the control cohort (P=0.03). Among pregnancies with major cardiac lesions (n=373), vaginal birth increased from 51% to 64% (P=0.008) and deliveries ≥39 weeks increased from 33% to 48% (P=0.004). Conclusions Implementation of a SCAMP decreased the rate of early-term deliveries and CD for prenatal congenital heart disease. Development of clinical pathways may help standardize care, decrease maternal risk secondary to CD, improve neonatal outcomes, and reduce healthcare costs.

Randomized control trial of postpartum visits at 2 and 6 weeks.

BACKGROUND: The postpartum period is critical, and women are at highest risk of perinatal complications; however, patient attendance at postpartum clinic visits is low. OBJECTIVE: This study aimed to determine whether decreasing the time to an initial postpartum visit from 6 weeks to 2 weeks can increase the attendance rates of patients in routine postpartum visits. STUDY DESIGN: We conducted a parallel, randomized, nonblinded trial at a publicly insured clinic comparing a single 6-week postpartum visit (control) with 2 visits at 2 and 6 weeks after delivery (intervention). The primary outcome was attendance at 1 or more routine postpartum visits. Secondary outcomes were emergency department visits within 30 days after delivery and nonroutine clinic visits. Multivariable regression was performed to identify predictors of clinic nonattendance. To demonstrate a significant increase from the baseline clinic attendance rate of 70% to 85%, 250 participants were needed. RESULTS: Between November 2018 and March 2020, 250 patients were randomized and analyzed. The patient population had multiple comorbidities, notably obesity (53%), diabetes mellitus (30%), mental health disorders (22%), and hypertensive disorders (21%). The attendance at 1 or more postpartum visits was not significantly different among the control and intervention arms (58% vs 70%; P=.065). The 2-week visit had an attendance rate of 41% (51 of 125), and the 6-week visit had an attendance rate of 60% (151 of 250). After adjusting for confounders, significant predictors of postpartum visit nonattendance included younger age, multiparity, and being a patient from the high-risk obstetrical clinic. The rate of emergency department visits was similar between the control and intervention arms (8% vs 6%; P=.635). However, more patients in the control arm come to the clinic for nonroutine visits (30% vs 16%; P=.010). In response to a patient satisfaction survey on the optimal timing of the postpartum visit, most respondents (59%) would have preferred both the 2- and 6-week visits. CONCLUSION: The addition of a 2-week postpartum visit to the 6-week postpartum visit did not increase the likelihood of attendance of patients in a routine visit but did decrease the number of urgent clinic visits.

Differences in Implementation Outcomes of a Shared Decision-Making Program for Men with Prostate Cancer between an Academic Medical Center and County Health Care System.

BACKGROUND: Shared decision making (SDM) has long been advocated as the preferred way for physicians and men with prostate cancer to make treatment decisions. However, the implementation of formal SDM programs in routine care remains limited, and implementation outcomes for disadvantaged populations are especially poorly described. We describe the implementation outcomes between academic and county health care settings. METHODS: We administered a decision aid (DA) for men with localized prostate cancer at an academic center and across a county health care system. Our implementation was guided by the Consolidated Framework for Implementation Research and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. We assessed the effectiveness of the DA through a postappointment patient survey. RESULTS: Sites differed by patient demographic/clinical characteristics. Reach (DA invitation rate) was similar and insensitive to implementation strategies at the academic center and county (66% v. 60%, P = 0.37). Fidelity (DA completion rate) was also similar at the academic center and county (77% v. 80%, P = 0.74). DA effectiveness was similar between sites, except for higher academic center ratings for net promoter for the doctor (77% v. 37%, P = 0.01) and the health care system (77% v. 35%, P = 0.006) and greater satisfaction with manner of care (medians 100 v. 87.5, P = 0.04). Implementation strategies (e.g., faxing of patients' records and meeting patients in the clinic to complete the DA) represented substantial practice changes at both sites. The completion rate increased following the onset of reminder calls at the academic center and the creation of a Spanish module at the county. CONCLUSIONS: Successful DA implementation efforts should focus on patient engagement and access. SDM may broadly benefit patients and health care systems regardless of patient demographic/clinical characteristics.

21 Code of Federal Regulations Part 11-Compliant Digital Signature Solution for Cancer Clinical Trials: A Single-Institution Feasibility Study.

PURPOSE: Inefficiencies in the clinical trial infrastructure result in protracted trial completion timelines, physician-investigator turnover, and a shrinking skilled labor force and present obstacles to research participation. Taken together, these barriers hinder scientific progress. Technological solutions to improve clinical trial efficiency have emerged, yet adoption remains slow because of concerns with cost, regulatory compliance, and implementation. METHODS: A prospective pilot study that compared regulatory-compliant digital and traditional wet ink paper signatures was conducted over a 6.5-month period in a hospital-based health system. Staff time and effort, error rate, costs, and time to completion were measured. Wilcoxon rank sum tests were used to compare staff time and time to completion. A value analysis was conducted. A survey was administered to measure user satisfaction. RESULTS: There where 96 participants (47 digital, 49 paper), 132 studies included (31 digital, 101 paper), and 265 documents processed (156 digital, 109 paper). A moderate reduction in staff time required to prepare documents for signature was observed (P < .0001). Error rates were reported in 5.1% of digital and 2.8% of paper documents, but this difference was not significant. Discrepancies requiring revisions included incomplete mandatory fields, inaccurate information submitted, and technical issues. A value analysis demonstrated a 19% labor savings with the use of digital signatures. Survey response rate was 57.4% (n = 27). Most participants (85.2%) preferred digital signatures. The time to complete documents was faster with digital signatures compared with paper (P = .0241). CONCLUSION: The use of digital signatures resulted in a decrease in document completion time and regulatory burden as represented by staff hours. Additional cost and time savings and information liquidity could be realized by integrating digital signatures and electronic document management systems.