Demographic and Socioeconomic Factors in Prospective Retina-Focused Clinical Trial Screening and Enrollment.

Historically marginalized populations are disproportionately affected by many diseases that commonly affect the retina, yet they have been traditionally underrepresented in prospective clinical trials. This study explores whether this disparity affects the clinical trial enrollment process in the retina field and aims to inform future trial recruitment and enrollment. Age, gender, race, ethnicity, preferred language, insurance status, social security number (SSN) status, and median household income (estimated using street address and zip code) for patients referred to at least one prospective, retina-focused clinical trial at a large, urban, retina-based practice were retrospectively extracted using electronic medical records. Data were collected for the 12-month period from 1 January 2022, through 31 December 2022. Recruitment status was categorized as Enrolled, Declined, Communication (defined as patients who were not contacted, were contacted with no response, were waiting for a follow-up, or were scheduled for screening following a clinical trial referral.), and Did Not Qualify (DNQ). Univariable and multivariable analyses were used to determine significant relationships between the Enrolled and Declined groups. Among the 1477 patients, the mean age was 68.5 years old, 647 (43.9%) were male, 900 (61.7%) were White, 139 (9.5%) were Black, and 275 (18.7%) were Hispanic. The distribution of recruitment status was: 635 (43.0%) Enrolled, 232 (15.7%) Declined, 290 (19.6%) Communication, and 320 (21.7%) DNQ. In comparing socioeconomic factors between the Enrolled and Declined groups, significant odds ratios were observed for age (p < 0.02, odds ratio (OR) = 0.98, 95% confidence interval (CI) [0.97, 1.00]), and between patients who preferred English versus Spanish (p = 0.004, OR = 0.35, 95% CI [0.17, 0.72]. Significant differences between the Enrolled and Declined groups were also observed for age (p < 0.05), ethnicity (p = 0.01), preferred language (p < 0.05), insurance status (p = 0.001), and SSN status (p < 0.001). These factors may contribute to patient participation in retina-focused clinical trials. An awareness of these demographic and socioeconomic disparities may be valuable to consider when attempting to make clinical trial enrollment an equitable process for all patients, and strategies may be useful to help address these challenges.

A randomized trial of home versus clinic-based sexually transmitted disease screening among men.

BACKGROUND: Preventing sexually transmitted diseases (STD) such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) remains a public health challenge. The U.S. Preventive Services Task Force suggests STD screening among men will likely lead to a decrease in infection rates of women. However, innovative approaches are necessary to increase the traditionally low rates of male screening. The purpose of this study is to compare the acceptability and effectiveness of home-based versus clinic-based urine screening for CT and GC in men. METHODS: We conducted a randomized clinical trial of 200 men aged 18 to 45 years who reside in St. Louis, MO. Men were enrolled via telephone and randomly assigned to receive a free urine CT/GC screening kit either in-person at the research clinic or to have it mailed to the participant's preferred address. Participants completed questionnaires at baseline and 10 to 12 weeks postenrollment. The primary outcome was whether STD screening was completed. RESULTS: Sixty percent (120/200) completed STD screening. Men assigned to home-based screening were 60% more likely to complete screening compared with clinic-based screening (72% vs. 48%, RRadj = 1.6, 95% CI = 1.3, 2.00). We identified 4 cases of CT or GC in the home-based group compared with 3 cases of CT in the clinic group. Men who completed screening were significantly more likely to be white, younger, and college educated. CONCLUSIONS: Home-based screening for CT and GC among men is more acceptable than clinic-based screening and resulted in higher rates of screening completion. Incorporating home-based methods as adjuncts to traditional STD screening options shows promise in improving STD screening rates in men.

Discussion: 'placental dysfunction disorders across generations' by Wikström et al.

In the roundtable that follows, clinicians discuss a study published in this issue of the Journal in light of its methodology, relevance to practice, and implications for future research. Article discussed: Wikström A-K, Svensson T, Kieler H, et al. Recurrence of placental dysfunction disorders across generations. Am J Obstet Gynecol 2011;205:454.e1-8.

Multi-modal intervention for the inpatient management of sickle cell pain significantly decreases the rate of acute chest syndrome.

INTRODUCTION: Pain in children with sickle cell disease (SCD) is the leading cause of acute care visits and hospitalizations. Pain episodes are a risk factor for the development of acute chest syndrome (ACS), contributing to morbidity and mortality in SCD. Few strategies exist to prevent this complication. METHODS: We performed a before-and-after prospective multi-modal intervention. All children with SCD admitted for pain during the 2-year study period were eligible. The multi-modal intervention included standardized admission orders, monthly house staff education, and one-on-one patient and caregiver education. RESULTS: A total of 332 admissions for pain occurred during the study period; 159 before the intervention and 173 during the intervention. The ACS rate declined by 50% during the intervention period 25% (39 of 159) to 12% (21 of 173); P = 0.003. Time to ACS development increased from 0.8 days (0.03-5.2) to 1.7 days (0.03-5.8); P = 0.047. No significant difference was found in patient demographics, intravenous fluid amount administered, frequency of normal saline bolus administration, or cumulative opioid amount delivered in the first 24 hr. Patient controlled analgesia-use was more common after the intervention 52% (82 of 159) versus 73% (126 of 173; P = 0.0001) and fewer patients required changes in analgesic dosing within the first 24 hr after admission (26%, 42 of 159 vs. 16%, 28 of 173; P = 0.015). CONCLUSIONS: A multi-modal intervention to educate and subsequently change physician's behavior likely decreased the rate of ACS in the setting of a single teaching hospital.

Circulating monocyte chemoattractant protein-1 in heart transplant recipients with cardiac allograft vasculopathy.

OBJECTIVE: To evaluate serum Monocyte Chemoattractant Protein-1 (MCP-1) as a biologic marker of cardiac allograft vasculopathy (CAV) in heart transplant recipients (HTR). DESIGN AND METHODS: Serum levels of MCP-1 were measured in 49 HTR with and without CAV. RESULTS: HTR exhibited significantly higher serum MCP-1 levels than controls. However, no difference was observed according to the existence of CAV. CONCLUSION: Serum MCP-1 levels do not constitute a marker of the CAV occurring after heart transplantation.