Use of Popular Opinion Leader Models to Disseminate Information About Clinical Trials to Black Individuals With Lupus in Two US Cities.

OBJECTIVE: Clinical trials for systemic lupus erythematosus ("lupus") under enroll Black individuals despite higher disease prevalence, morbidity, and mortality among Black compared to White individuals. To begin to address this disparity, we leveraged community-academic partnerships in 2 US cities (Boston and Chicago) to train popular opinion leaders (POLs) to disseminate information about clinical trials in predominantly Black communities. METHODS: The team of community and academic partners collaboratively developed a 5-module curriculum about clinical trials, barriers, facilitators, and structural racism in research. We enrolled POLs in Boston and Chicago to participate virtually in the curriculum and assessed knowledge gained by comparing pre- and post-test scores. We described the POLs' ability to disseminate information about clinical trials through their communities. RESULTS: We enrolled 19 POLs in Boston and 16 in Chicago; overall, 71% reported a lupus diagnosis, 94% were female, and 80% self-identified as Black or African American. The program was adapted to virtual formats due to the COVID-19 pandemic. POLs demonstrated significant improvement comparing pre/post scores for the conduct of clinical trials and history of racism in clinical research. Fifteen POLs (43%) reported their dissemination of information about clinical trials. Information reached 425 community members in Boston (90% virtually) and 1,887 in Chicago (95% virtually). CONCLUSION: By leveraging community-academic partnerships, we developed and implemented a curriculum to promote familiarity with clinical trials, leading to information dissemination by POLs in predominantly Black communities that are underrepresented in lupus clinical trials. The program successfully transitioned to a virtual model during the COVID-19 pandemic.

Trajectories of Depressive and Anxiety Symptoms Across Pregnancy and Postpartum in Selective Serotonin Reuptake Inhibitor-Treated Women.

Objective: Tracking perinatal mood and anxiety disorders is championed by the American Psychiatric Association and the International Marcé Society for Perinatal Mental Health. We conducted this study to examine trajectories of monthly depressive and anxiety symptoms through pregnancy and postpartum. Methods: This is a prospective longitudinal observational cohort study of pregnant women interviewed at baseline (≤18th gestational week), every four weeks through delivery and at 6 and 14 weeks postpartum at three urban academic medical centers (N = 85) and a single rural health center (N = 3) from 2016 to 2020. Pregnant women had at least one prior episode of major depressive disorder, were not in a current episode, and were treated with sertraline, fluoxetine, citalopram, or escitalopram. Of 192 women screened, 88 (46%) women enrolled, and 77 (88%) women completed the postpartum follow-up. Symptom trajectories were generated with scores from the Edinburgh Postnatal Depression Scale, the Quick Inventory of Depressive Symptoms, the Generalized Anxiety Disorder Scale, 7-item, and the Patient-Reported Outcomes Measurement Information System Global Health measure. A semi-parametric, group-based mixture model (trajectory analysis) was applied. Results: Three relatively stable depression trajectories emerged, described as Minimal, Mild, and Subthreshold, in each group across pregnancy. Two of the four anxiety trajectories were stable, including Asymptomatic and Minimal, while the third, termed Breakthrough, was ascending with increasing symptoms and the fourth trajectory, described as Mild, had descending symptoms. Conclusions: Screening for anxiety with depression for pregnant women will yield a comprehensive view of psychiatric symptoms and treatment targets in perinatal women.

Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study.

BACKGROUND: Use of prophylactic antibiotics after stented hypospadias repair is very common, but most research has not identified any clinical benefits of this practice. Only one study has found that postoperative prophylaxis reduces symptomatic urinary tract infections (UTIs). Data from the same trial suggested that prophylaxis may also reduce urethroplasty complications. No studies on this subject have been placebo-controlled. OBJECTIVE: We performed a randomized, double-blind, placebo-controlled study to evaluate the effect of postoperative prophylactic antibiotics on the incidence of infection or urethroplasty complications after stented repair of midshaft-to-distal hypospadias. STUDY DESIGN: Boys were eligible for this multicenter trial if they had a primary, single-stage repair of mid-to-distal hypospadias with placement of an open-drainage urethral stent for an intended duration of 5-10 days. Participants were randomized in a double-blind fashion to receive oral trimethoprim-sulfamethoxazole or placebo twice daily for 10 days postoperatively. The primary outcome was a composite of symptomatic UTI, surgical site infection (SSI), and urethroplasty complications, including urethrocutaneous fistula, meatal stenosis, and dehiscence. Secondary outcomes included each component of the primary outcome as well as acute adverse drug reactions (ADRs) and C. difficile colitis. RESULTS: Infection or urethroplasty complications occurred in 10 of 45 boys (22%) assigned to receive antibiotic prophylaxis as compared with 5 of 48 (10%) who received placebo (relative risk [RR], 2.1; 95% confidence interval [CI], 0.8 to 5.8; p = 0.16). There were no significant differences between groups in symptomatic UTIs, SSIs, or any urethroplasty complications. Mild ADRs occurred in 3 of 45 boys (7%) assigned to antibiotics as compared with 5 of 48 (10%) given placebo (RR, 0.6; 95% CI, 0.2 to 2.5; p = 0.72). There were no moderate-to-severe ADRs, and no patients developed C. difficile colitis. CONCLUSIONS: In this placebo-controlled trial of 93 patients, prophylactic antibiotics were not found to reduce infection or urethroplasty complications after stented mid-to-distal hypospadias repair. The study did not reach its desired sample size and was therefore underpowered to independently support a conclusion that prophylaxis is not beneficial. However, the result is consistent with most prior research on this subject. GOV IDENTIFIER: NCT02096159.

Assessing the Concordance of Clinical Classification Criteria for Lupus Between Electronic Health Records and a Physician Curated Registry.

We developed a computable phenotype for systemic lupus erythematosus (SLE) based on the Systemic Lupus International Collaborative Clinics clinical classification criteria set for SLE. We evaluated the phenotype over registry and EHR data for the same patient population to determine concordance of criteria detected in both datasets and to assess which types of structured data detected individual classification criteria. We identified a concordance of 68% between registry and EHR data relying solely on structured data.

Addressing Lupus Health Disparities: The MONARCAS Community and Academic Collaborative Program.

Purpose: The Centers for Disease Control (CDC) Popular Opinion Leader (POL) model was implemented in a lupus education program (MONARCAS) for the Latino community. The program aim was to increase lupus awareness by training high school students, community health workers, and parents. Methods: A curriculum was developed training POLs to disseminate concepts about lupus signs and symptoms. Pre- and post-program questions assessed lupus knowledge and message dissemination. Results: POL groups represented distinct demographic characteristics with Spanish or English language dominance. POLs reported increased lupus knowledge and program satisfaction. Conclusions: Future program goals should aim to increase understanding and improving access to care for Latino communities affected by lupus.

Disease Outcomes and Care Fragmentation Among Patients With Systemic Lupus Erythematosus.

OBJECTIVE: To examine the impact of care fragmentation across multiple health care institutions on disease outcomes in patients with systemic lupus erythematosus (SLE). METHODS: Using the Chicago HealthLNK Data Repository, an assembly of electronic health records from 6 institutions, we identified patients with SLE, using International Classification of Diseases, Ninth Revision (ICD-9) codes, whose care was delivered at more than 1 organization. We examined whether patients had severe infections or comorbidities (ICD-9 code defined) that indicated SLE-induced damage. T-tests and chi-square tests were used to examine differences between fragmentation groups. Logistic regression was used to assess factors contributing to the occurrence of disease outcomes. RESULTS: We identified 4,276 patients with SLE. A total of 856 (20%) received care from more than 1 health care institution. African American patients and patients with public insurance were more likely to experience care fragmentation compared to white and private insurance patients (odds ratio [OR] 1.66, 95% confidence interval [95% CI] 1.44-1.97 and OR 1.63, 95% CI 1.42-1.95). We identified increased risk of infections (OR 1.57, 95% CI 1.30-1.88), cardiovascular disease (OR 1.51, 95% CI 1.23-1.86), end-stage renal disease (OR 1.34, 95% CI 1.05-1.70), nephritis (OR 1.28, 95% CI 1.07-1.54), and stroke (OR 1.28, 95% CI 1.01-1.62) among patients with fragmented care, adjusted for age, sex, race, insurance status, length of followup time, and total visit count. CONCLUSION: In this cross-site cohort of SLE patients, care fragmentation is associated with increased risk of severe infection and comorbidities. These results suggest that improved health information exchange could positively impact outcomes for SLE patients.