Citations

Objectives/Goals: As a priority area in translational science, rural health research can benefit from informatics methods for conducting thematic and environment scans. This study demonstrates an efficient approach to gaining insights about the rural health research literature by automated bibliometrics analysis. Methods/Study Population: We developed an automated pipeline to retrieve the 1972–2023 PubMed publications indexed with the MeSH terms “Rural Health” and “United States”. The article metadata in XML format were downloaded and parsed, including title, year, journal, author institutions, and MeSH terms. Each institution address was augmented by Google Maps API to obtain the county and latitude/longitude coordinates. Summary statistics were computed for the publication years, journals, author departments, and locations. A topic network was generated from the frequent co-occurring MeSH terms. The institutions were linked to Rural-Urban Continuum Codes and labeled on a map to visualize their geographic distribution. Results/Anticipated Results: A total of 4564 articles on rural health were analyzed. Two salient peaks of publications were revealed, one around 1978 and the other around 1993. The top author departments include Family Medicine, Nursing, Pediatrics, and Epidemiology. The five leading institutions reside in Chapel Hill, Minneapolis, Iowa City, Seattle, and Atlanta. The geographic distribution shows few institutions that reside in deep rural areas are well published on rural health, although the most scholarly productive institutions do seem adjacent to some moderately rural pockets. The frequently identified topics pertain to age group, study design, and specific concepts such as health services accessibility. Discussion/Significance of Impact: The two publication peaks in history were likely linked to certain policy milestone or seminal publication. Primary care and epidemiology departments have been most active in rural health research. Of concern, the geographic distribution of authors suggests under-investment in rural institutions.

Objectives/Goals: The operation of a clinical trials unit involves multifaceted tasks and stakeholders. A competent information system is critical to daily operations while ensuring smooth conduct of clinical research. We share 15 years of experience in the design and implementation of such a system at Mayo Clinic to inform other institutions with similar interests. Methods/Study Population: The Informatics team collaborated closely with nurse leaders and elicited input from additional stakeholders including nurse unit coordinators, lab managers, schedulers, investigators, study coordinators, and regulatory specialists throughout the phases of system design, development and continuous enhancements, and expansion. The stakeholders offered insights on the corresponding requirements throughout the study life cycle, from engaging with the study sponsor, operational review for protocol execution, development of study budgets, human subject protection and risk mitigation, data management and integration, to outcome monitoring, and regulatory reporting. The activities were then translated into functional components and implemented as a seamless and effective solution. Results/Anticipated Results: Patient safety, scientific rigor, operation automation, efficiency, and regulatory requirements were all considered in developing an integrated system, or the clinical research trials unit (CRTU) Tools. Our institution has leveraged the system for essential tasks from the study start-up, visit scheduling and execution, specimen collection and tracking, to individual protocol metrics and billing. We adopted a measure-as-we-go methodology so that data such as visit census, resource usage, and protocol deviation are tracked and collected during routine use of the system. Specifically, an issues/concerns/exceptions (ICE) tool is used for quality control and patient safety. Moreover, data quality greatly benefits from a task dictionary, standardizing the study activities that can be ordered and executed. Discussion/Significance of Impact: The implementation of a well-rounded clinical trials unit information system not only improves the operation efficiency and team productivity but also ensures scientific rigor and contributes to patient safety. We believe the experience can be informative to other institutions. More details will be shared in the poster.

Précis: 240-degree and 360-degree goniotomy (GT) demonstrated similar efficacy in intraocular pressure (IOP) reduction, both outperforming 120-degree GT in patients with juvenile open angle glaucoma (JOAG) at postoperative 6-month follow-up. Objective: To compare the surgical efficacy and safety of 120-degree, 240-degree, and 360-degree GT for patients with JOAG. Patients and Methods: This multicenter retrospective study included 102 eyes of 102 patients with JOAG, who underwent GT with a follow-up of at least 6 months. Patients were categorized into 3 groups: (1) 120-degree GT, (2) 240-degree GT, and (3) 360-degree GT. IOP, glaucoma medications, and complications were recorded at baseline and the final visit. Complete success and qualified success were defined as a postoperative IOP ≤21 mm Hg without and with medications, respectively. Results: Mean age of the participants was 24.4 ± 7.9 years. After a mean follow-up of 8.1 ± 2.7 months, complete success rates were similar between the 240-degree GT (45.2%) and the 360-degree GT (63.2%; P = 0.135), and both were superior to 120-degree GT (18.2%; P < 0.05). Qualified success rates among patients in the 120-degree, 240-degree, and 360-degree GT groups were 93.9%, 96.8%, and 100%, respectively, and showed no statistically significant difference (P = 0.292). 360-degree GT required fewer medications than 240-degree GT and 120-degree GT (P < 0.05), with no significant difference in medications between 120-degree GT and 240-degree GT (P > 0.05). Hyphema was the most common postoperative complication, with a significantly higher incidence in the 360-degree GT (68.4%) compared with the 240-degree GT (41.9%) and 120-degree GT (33.3%; P < 0.05). Conclusions: 240-degree and 360-degree GT showed similar efficacy in IOP reduction and were superior to 120-degree GT. More extensive GT may provide better outcomes in JOAG.

Importance Semaglutide, a glucagonlike peptide-1 receptor agonist (GLP-1RA), has recently been implicated in cases of nonarteritic anterior ischemic optic neuropathy (NAION), raising safety concerns in the treatment of type 2 diabetes (T2D). Objective To investigate the potential association between semaglutide and NAION in the Observational Health Data Sciences and Informatics (OHDSI) network. Design, Setting, and Participants This was a retrospective study across 14 databases (6 administrative claims and 8 electronic health records). Included were adults with T2D taking semaglutide, other GLP-1RA (dulaglutide, exenatide), or non–GLP-1RA medications (empagliflozin, sitagliptin, glipizide) from December 1, 2017, to December 31, 2023. The incidence proportion and rate of NAION were calculated. Association between semaglutide and NAION was assessed using 2 approaches: an active-comparator cohort design comparing new users of semaglutide with those taking other GLP-1RAs and non–GLP-1RA drugs, and a self-controlled case-series (SCCS) analysis to compare individuals’ risks during exposure and nonexposure periods for each drug. The cohort design used propensity score–adjusted Cox proportional hazards models to estimate hazard ratios (HRs). The SCCS used conditional Poisson regression models to estimate incidence rate ratios (IRRs). Network-wide HR and IRR estimates were generated using a random-effects meta-analysis model. Exposures GLP-1RA and non–GLP-1RAs. Main Outcomes and Measures NAION under 2 alternative definitions based on diagnosis codes: one more inclusive and sensitive, the other more restrictive and specific. Results The study included 37.1 million individuals with T2D, including 810 390 new semaglutide users. Of the 43 620 new users of semaglutide in the Optum’s deidentified Clinformatics Data Mart Database, 24 473 (56%) were aged 50 to 69 years, and 26 699 (61%) were female. The incidence rate of NAION was 14.5 per 100 000 person-years among semaglutide users. The HR for NAION among new users of semaglutide was not different compared with that of the non–GLP-1RAs using the sensitive NAION definition—empagliflozin (HR, 1.44; 95% CI, 0.78-2.68; P = .12), sitagliptin (HR, 1.30; 95% CI, 0.56-3.01; P = .27), and glipizide (HR, 1.23; 95% CI, 0.66-2.28; P = .25). The risk was higher only compared with patients taking empagliflozin (HR, 2.27; 95% CI, 1.16-4.46; P = .02) using the specific definition. SCCS analysis of semaglutide exposure showed an increased risk of NAION (meta-analysis IRR, 1.32; 95% CI, 1.14-1.54; P &amp;lt; .001). Conclusions and Relevance Results of this study suggest a modest increase in the risk of NAION among individuals with T2D associated with semaglutide use, smaller than that previously reported, and warranting further investigation into the clinical implications of this association.