Characteristics of Ophthalmology Trials Registered in ClinicalTrials.gov, 2007-2018.

PURPOSE: To perform a comprehensive analysis of characteristics of ophthalmology trials registered in ClinicalTrials.gov. DESIGN: Cross-sectional study. METHODS: All 4,203 ophthalmologic clinical trials registered on ClinicalTrials.gov between October 1, 2007, and April 30, 2018, were identified by using medical subject headings (MeSH). Disease condition terms were verified by manual review. Trial characteristics were assessed through frequency calculations. Hazard ratios and 95% confidence intervals were determined for characteristics associated with early discontinuation. RESULTS: The majority of trials were multiarmed (73.6%), single-site (69.4%), randomized (64.8%), and had <100 enrollees (66.3%). A total of 33% used a data-monitoring committee (DMC), and 50.6% incorporated blinding. Other groups (51.6%) were funded by industry, whereas 2.6% were funded by the US National Institutes of Health (NIH). NIH trials were significantly more likely to address oncologic (NIH = 15.5%, Other = 3%, Industry = 1.5%; P < 0.001) or pediatric disease (NIH = 20.9%, Other = 5.9%, Industry = 1.4%; P < 0.001). Industry-sponsored trials (69.6% of phase 3 trials) were significantly more likely to be randomized (Industry = 68.7%, NIH = 58.9%, Other = 60.8%; P < 0.001) and blinded (Industry = 57.2%, NIH = 42.7%, Other = 43.5%; P < 0.001). A total of 359 trials (8.5%) were discontinued early, and 530 trials (12.6%) had unknown status. Trials were less likely to be discontinued if funded by sources other than industry (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.55-0.95; P = 0.021) and/or had a DMC (HR, 0.71; 95% CI, 0.55-0.92; P = 0.010). CONCLUSIONS: Ophthalmology trials in the past decade reveal heterogeneity across study funding sources. NIH trials were more likely to support historically underfunded subspecialties, whereas Industry trials were more likely to face early discontinuation. These trends emphasize the importance of carefully monitored and methodologically sound trials with deliberate funding allocation.

Resident Wellness in US Ophthalmic Graduate Medical Education: The Resident Perspective.

Importance: Wellness programs have become important strategies to combat burnout and depression among residents. However, the resident perspective on wellness in ophthalmic graduate medical education has not been solicited on a national level. Objectives: To report on residents' views of wellness initiatives in ophthalmic graduate medical education and identify potential strategies for promoting resident wellness. Design, Setting, and Participants: In this national survey of ophthalmology residents in the United States, conducted from September 21 to November 3, 2017, all 1048 ophthalmology residents listed on the websites of ophthalmology residency programs accredited by the Accreditation Council for Graduate Medical Education were emailed an anonymous online survey consisting of 12 multiple-choice questions with options for free-text answers. Residents also received a mailed letter with a survey link and a $1 incentive, as well as 2 reminder emails. Survey responses were analyzed using descriptive statistics, and the free-text answers were categorized. Main Outcomes and Measures: Main outcomes include residents' reports regarding their personal experiences with wellness during residency, support systems provided by their programs, and opportunities for improving wellness in ophthalmic graduate medical education. Results: Of 1048 residents, 241 (23.0%) responded to the survey. Most respondents (121 of 177 [68.4%]) reported that their programs faced an issue involving depression, burnout, or suicide among residents within the past year; 26.3% of respondents (61 of 232) reported being involved in a case when resident fatigue, burnout, or depression adversely affected a medical outcome or judgment. Fewer than half of the respondents (110 of 241 [45.6%]) reported that their residency programs placed moderate or major emphasis on promoting a culture of resident wellness, and only 26.7% (63 of 236) reported that their department had a formal resident wellness program. The most commonly cited barrier to resident wellness (59 of 236 [25.0%]) was a lack of time to attend wellness programs. Conclusions and Relevance: These results suggest that there is a substantial burden of burnout and depression among US ophthalmology residents and that there are opportunities to boost wellness in ophthalmic graduate medical education by making wellness curricula more accessible to residents and ensuring that residents have time to attend wellness programs.

Assessing and Promoting the Wellness of United States Ophthalmology Residents: A Survey of Program Directors.

OBJECTIVE: To report on the status of residency-based wellness initiatives in ophthalmic graduate medical education and identify strategies for promoting ophthalmology resident wellness by surveying US ophthalmology program directors (PDs). DESIGN: The PDs were each sent an e-mail containing a link to an anonymous online 15-question survey. The PDs also received a letter with the survey link and a $1 incentive. After 2 weeks, nonresponders received 2 weekly reminder e-mails and phone calls. Descriptive statistics were used to analyze the multiple choice responses and categorize the free response answers. SETTING: National survey. PARTICIPANTS: All 111 US ophthalmology PDs were invited to participate. RESULTS: Of 111 PDs, 56 (50%) responded; 14 (26%) of 53 respondents reported that their programs faced an issue involving resident depression, burnout, or suicide within the last year; 25 (45%) of 56 reported that their department had a resident wellness program. Respondents without wellness programs reported a shortage of time (19/30; 63%) and lack of training and resources (19/30; 63%) as barriers to instituting these programs. Respondents reported that the Accreditation Council for Graduate Medical Education could better promote resident wellness by providing training resources for burnout and depression screening (35/53; 66%), resilience skills building (38/53; 72%), and wellness program development (36/53; 68%). CONCLUSIONS: This survey suggests that there is a substantial burden of burnout and depression among residents in ophthalmic graduate medical education and that this burden can be addressed by promoting the training of educators to recognize the signs of burnout and depression, and providing resources to develop and expand formal wellness programs.