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TOPIC: Sympathetic ophthalmia (SO) is a rare bilateral granulomatous panuveitis that can present after trauma or intraocular surgery (IOS). The incidence of SO after IOS varies among studies. The purpose of this review was to determine the incidence proportion of SO after IOS. CLINICAL RELEVANCE: The incidence proportion of SO after IOS can provide physicians and patients with information on the risk of SO during the consent process before surgery. METHODS: In this systematic review and meta-analysis, MEDLINE, EMBASE, and Cochrane databases were searched from inception to January 1, 2023 for population-based studies of SO after IOS. Two reviewers independently screened the results. Random-effects meta-analyses calculated incidence proportion. Subgroup analysis assessed SO incidence based on IOS type and technological advancements. Study quality and bias were assessed using the Newcastle-Ottawa scale and the Grades of Recommendation, Assessment, Development, and Evaluation framework. RESULTS: The final meta-analyses included 19 studies, with 118 cases of SO occurring after 505 178 inciting events. The estimated overall incidence proportion of SO after IOS was 0.061% (95% confidence interval [CI], 0.033%-0.111%; I2 = 83%), and the estimated incidence rate was 9.24 cases per 100 000 person-years (95% CI, 4.03-21.19; I2 = 88%). The average study duration across these studies was 10.8 years. Within the reviewed literature, SO after glaucoma and vitreoretinal IOS was studied most, with 9 and 6 studies, respectively. Observed differences in incidence between glaucoma (0.098%; 95% CI, 0.042%-0.232%; I2 = 40%) and vitreoretinal (0.043%; 95% CI, 0.022%-0.085%; I2 = 88%) IOS were not statistically significant (P = 0.14). Also, no significant difference was found in the incidence proportion before and after 1975, when modern intraocular surgical techniques emerged (0.060% vs. 0.058%; P = 0.98). The outcome measures showed low-certainty Grades of Recommendation, Assessment, Development, and Evaluation evidence. DISCUSSION: Sympathetic ophthalmia after IOS is rare and might not have changed over the past 5 decades. The estimated incidence proportion of SO may be useful during the consent process before surgery. Also, no significant difference may exist in the incidence of SO between glaucoma and vitreoretinal IOS, based on low-certainty evidence. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
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Oftalmía Simpática , Humanos , Oftalmía Simpática/epidemiología , Oftalmía Simpática/etiología , Incidencia , Complicaciones Posoperatorias/epidemiología , Procedimientos Quirúrgicos Oftalmológicos/efectos adversosRESUMEN
BACKGROUND: Patient education in ophthalmology poses a challenge for physicians because of time and resource limitations. ChatGPT (OpenAI, San Francisco) may assist with automating production of patient handouts on common neuro-ophthalmic diseases. METHODS: We queried ChatGPT-3.5 to generate 51 patient education handouts across 17 conditions. We devised the "Quality of Generated Language Outputs for Patients" (QGLOP) tool to assess handouts on the domains of accuracy/comprehensiveness, bias, currency, and tone, each scored out of 4 for a total of 16. A fellowship-trained neuro-ophthalmologist scored each passage. Handout readability was assessed using the Simple Measure of Gobbledygook (SMOG), which estimates years of education required to understand a text. RESULTS: The QGLOP scores for accuracy, bias, currency, and tone were found to be 2.43, 3, 3.43, and 3.02 respectively. The mean QGLOP score was 11.9 [95% CI 8.98, 14.8] out of 16 points, indicating a performance of 74.4% [95% CI 56.1%, 92.5%]. The mean SMOG across responses as 10.9 [95% CI 9.36, 12.4] years of education. CONCLUSIONS: The mean QGLOP score suggests that a fellowship-trained ophthalmologist may have at-least a moderate level of satisfaction with the write-up quality conferred by ChatGPT. This still requires a final review and editing before dissemination. Comparatively, the rarer 5% of responses collectively on either extreme would require very mild or extensive revision. Also, the mean SMOG score exceeded the accepted upper limits of grade 8 reading level for health-related patient handouts. In its current iteration, ChatGPT should be used as an efficiency tool to generate an initial draft for the neuro-ophthalmologist, who may then refine the accuracy and readability for a lay readership.
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Neurología , Oftalmología , Humanos , Esmog , Educación del Paciente como Asunto , BecasRESUMEN
BACKGROUND: Bilateral transverse venous sinus stenosis (TVSS) or stenosis of a dominant venous sinus has been found to be very sensitive radiological findings in patients with intracranial hypertension (IH), yet there is still an ongoing debate whether they constitute reversible or permanent phenomena. Thus, the purpose of this study was to investigate the reversibility of TVSS in patients with IH, including conservatively treated patients with signs of IH as defined by the presence of papilledema. METHODS: This was a retrospective chart review of all patients diagnosed with IH between 2016 and 2022, assessed from 2 tertiary university-affiliated neuro-ophthalmology practices. Inclusion criteria were the presence of papilledema, as quantified by optical coherence tomography, and bilateral TVSS, which is considered typical of IH on neuroimaging. During follow-up, included patients must have had confirmation of papilledema resolution as well as subsequent neuroimaging after conservative treatment or cerebrospinal fluid flow diversion. Patients with dural sinus vein thrombosis or intrinsic stenosis from sinus trabeculations or significant arachnoid granulations were excluded from the study. Either CT venography or MRI/MR venography was reviewed by a fellowship-trained neuroradiologist, and the degree of stenosis was scored through the combined conduit score (CCS), as described by Farb et al. The primary outcome was to assess TVSS changes after resolution or improvement of papilledema. RESULTS: From 435 patients, we identified a subset of 10 who satisfied all inclusion criteria. Our cohort comprised entirely women with a median age of 29.5 years and a median BMI of 32.5 kg/m2. Treatment consisted of acetazolamide in 7 patients, of which 1 had additional topiramate and 2 underwent cerebrospinal fluid flow diversion. Furthermore, 6 patients demonstrated significant weight loss during follow-up. For the primary outcome, 5 of 10 patients exhibited no appreciable TVSS change, and 5 patients demonstrated significant improvement in TVSS, of which 4 received conservative treatment only. Papilledema resolution or improvement was statistically significantly associated with increasing average CCS, TVSS diameter, and grade. CONCLUSIONS: We were able to demonstrate that TVSS can be both irreversible and reversible in patients with resolved papilledema. The finding of TVSS reversibility from conservative treatment alone is novel and has important implications to optimize patient care. Future studies should work to identify factors associated with irreversible TVSS for subsequent targeted intervention and prevention.
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Herpes Zoster (HZ) or shingles is the reactivation of the Varicella Zoster Virus (VZV), usually along a single sensory nerve, but can affect both sensory and motor cranial nerves. Major risk factors for HZ include immunosuppressed status and age older than 60 years. In the United States, the lifetime risk of HZ is approximately 30%. Worldwide, the median incidence of HZ is 4-4.5 per 1000 person-years across the Americas, Eurasia, and Australia. HZ ophthalmicus, occurring in 10-20% of patients, is an ophthalmic emergency characterized by VZV reactivation along the V1 branch of the trigeminal nerve. Approximately half of this patient subgroup will go on to develop ocular manifestations, requiring prompt diagnosis and management. While anterior segment complications are more common, neuro-ophthalmic manifestations are rarer and can also occur outside the context of overt HZ ophthalmicus. Neuro-ophthalmic manifestations include optic neuropathy, acute retinal necrosis or progressive outer retinal necrosis, cranial neuropathy (isolated or multiple), orbitopathy, and CNS manifestations. Although typically a clinical diagnosis, diagnosis may be aided by neuroimaging and laboratory (e.g., PCR and serology) studies. Early antiviral therapy is indicated as soon as a presumptive diagnosis of VZV is made and the role of corticosteroids remains debated. Generally, there is wide variation of prognosis with neuro-ophthalmic involvement. Vaccine-mediated prevention is recommended. In this review, we summarize neuro-ophthalmic manifestations of VZV.
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Antivirales , Herpes Zóster Oftálmico , Herpesvirus Humano 3 , Humanos , Herpes Zóster Oftálmico/diagnóstico , Herpes Zóster Oftálmico/tratamiento farmacológico , Antivirales/uso terapéutico , Infecciones Virales del Ojo/diagnóstico , Infecciones Virales del Ojo/virología , Herpes Zóster/diagnóstico , Factores de Riesgo , Neurología , Oftalmología , Enfermedades de los Nervios Craneales/virología , Enfermedades de los Nervios Craneales/diagnósticoRESUMEN
Functional vision disorder (FVD) is a relatively common diagnosis in ophthalmic practice which can be difficult to make because of clinician's apprehension to miss organic pathology. We review the diagnostic approach to patients with FVD, organic mimics of FVD, its diagnostic and management strategies and associated cost burden. Patients with FVD typically present with visual acuity and/or field loss. Diagnostic work-up should include patient observation, detailed history, pupillary examination, dilated ophthalmoscopy, visual field testing and ganglion cell analysis of the macular complex. Most common organic mimickers of FVD are amblyopia, cortical blindness, retrobulbar optic neuritis, cone dystrophy and chiasmal tumours; however, all could be ruled out by structured diagnostic approach. For patients with unilateral visual loss, bottom-up refraction, fogging of the well-seeing eye in the phoropter, convex lens and base-down prism tests could aid in diagnosis. For patients claiming binocular vision loss, checking for eye movement during the mirror test or nystagmus elicited by an optokinetic drum can be helpful. Effective management of FVD involves reassurance, stress reduction and, if agreed on, management of comorbid anxiety and/or depression. The social cost of FVD is predominately economic as patients typically meet several healthcare providers over multiple visits and often undergo several neuroimaging studies before neuro-ophthalmology referral. Further, inappropriate granting of disability benefits confers additional stigma to patients with organic vision loss.
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BACKGROUND/OBJECTIVES: Experimental investigation. Bing Chat (Microsoft) integration with ChatGPT-4 (OpenAI) integration has conferred the capability of accessing online data past 2021. We investigate its performance against ChatGPT-3.5 on a multiple-choice question ophthalmology exam. SUBJECTS/METHODS: In August 2023, ChatGPT-3.5 and Bing Chat were evaluated against 913 questions derived from the Academy's Basic and Clinical Science Collection collection. For each response, the sub-topic, performance, Simple Measure of Gobbledygook readability score (measuring years of required education to understand a given passage), and cited resources were collected. The primary outcomes were the comparative scores between models, and qualitatively, the resources referenced by Bing Chat. Secondary outcomes included performance stratified by response readability, question type (explicit or situational), and BCSC sub-topic. RESULTS: Across 913 questions, ChatGPT-3.5 scored 59.69% [95% CI 56.45,62.94] while Bing Chat scored 73.60% [95% CI 70.69,76.52]. Both models performed significantly better in explicit than clinical reasoning questions. Both models performed best on general medicine questions than ophthalmology subsections. Bing Chat referenced 927 online entities and provided at-least one citation to 836 of the 913 questions. The use of more reliable (peer-reviewed) sources was associated with higher likelihood of correct response. The most-cited resources were eyewiki.aao.org, aao.org, wikipedia.org, and ncbi.nlm.nih.gov. Bing Chat showed significantly better readability than ChatGPT-3.5, averaging a reading level of grade 11.4 [95% CI 7.14, 15.7] versus 12.4 [95% CI 8.77, 16.1], respectively (p-value < 0.0001, ρ = 0.25). CONCLUSIONS: The online access, improved readability, and citation feature of Bing Chat confers additional utility for ophthalmology learners. We recommend critical appraisal of cited sources during response interpretation.
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Comprensión , Evaluación Educacional , Oftalmología , Humanos , Evaluación Educacional/métodos , Internet , LecturaRESUMEN
OBJECTIVE: Motor neuron disease (MND) is a group of neurological diseases, the majority being amyotrophic lateral sclerosis (ALS), with varying clinical presentations across demographics. Clinical trial enrollment reflecting global disease burden improves understanding of diverse presentations and aids personalized therapy development. We assessed the sex, racial, and ethnic composition of MND/ALS clinical trial participants relative to global disease burdens. METHODS: We searched 'motor neuron disease OR amyotrophic lateral sclerosis' on ClinicalTrials.gov from 02/2000-04/2024. We extracted trial (start year, study site, sponsor location, phase, masking, intervention) and demographic data (sex, race, ethnicity) from randomized interventional studies. We obtained sex-based MND/ALS disease burden estimates from the Global Burden of Disease database. For females, we calculated pooled participation-to-prevalence ratio (PPR) with 95% confidence intervals (CIs), with PPR of 0.8-1.2 indicating adequate enrollment. We used Kruskal-Wallis tests to compare demographic groups across trial characteristics. RESULTS: Of 85 trials, females comprised 37.47% (n = 5011) of 13,372 participants; the pooled female PPR was 0.97 (95% CI: 0.77-1.16). Of 41 trials (9340 participants) reporting race, 121 (1.30%) participants were Black or African American, 16 (0.17%) American Indian or Alaskan Native, and 6 (0.06%) Native Hawaiian or Other Pacific Islander. 24 trials (595 participants) reported ethnicity, with a minority of Hispanic participants (n = 153; 2.57%). CONCLUSIONS: MND/ALS clinical trials had adequate female enrollment relative to global disease burdens. Race and ethnicity data were underreported. However, there were enrollment disparities of racial and ethnic groups. Increased trial leadership diversity, equitable enrollment policies, and addressing barriers to participation could improve enrollment diversity.
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Importance: As critical determinants of scientific rigor, reproducibility, and equity, sex and gender should be considered in clinical trial design and reporting. Objective: To evaluate the accuracy of sex and gender reporting and extent of sex- and gender-based analysis in clinical trials associated with US Food and Drug Administration (FDA) drug approvals between January 1, 1995, and December 31, 2022. Design, Setting, and Participants: In this cross-sectional study of participants enrolled in FDA ophthalmology trials, the following trial documents were reviewed by pairs of independent reviewers in decreasing order of priority: peer-reviewed publication, ClinicalTrials.gov report, and FDA medical and statistical reviews. Trial protocols and supplementary materials were also reviewed. Main Outcome and Measures: The proportion of trials that correctly applied sex and gender terminology, reported the method of assessing sex or gender, and conducted sex- or gender-based data analysis; incorrect application of sex and gender terminology was defined as interchangeable use of sex- and gender-related terms without a clear justification. Results: Between 1995 and 2022, 34 ophthalmic drugs corresponding to 85 trials (34â¯740 participants) received FDA approval, of which 16 drugs (47.1%) corresponding to 32 trials (18â¯535 participants [37.6%]) were associated with peer-reviewed publications. Sixteen trials used sex and gender terminology correctly (19.5%). No trial reported how sex and gender were collected nor enrolled participants from sexual and gender identity minority populations. Most trials reported sex- and gender-disaggregated demographic data (96.5%), but few conducted sex- or gender-based analysis for data on dropout (1.2%), primary outcomes (28.2%), secondary outcomes (2.4%), and adverse events (9.4%). Erroneous sex and gender reporting was associated with later publication year (2008.5 vs 2001.0; median difference, 7.5; 95% CI, -6.0 to 11.0; P < .001) and higher journal influence metrics, including 2022 journal impact factor (13.7 vs 5.9; median difference, 7.8; 95% CI, -1.4 to 152.4, P < .001) and 2022 journal citation indicator (4.9 vs 2.1; median difference, 2.9; 95% CI, 0-20.0, P < .001). Conclusions and Relevance: In this observational study, over three-quarters of ophthalmology trials associated with FDA drug approvals conflated sex and gender and over two-thirds lacked sex- and gender-based analyses. More rigorous integration of sex and gender appears warranted for FDA, and presumably other trials, to improve their validity, reproducibility, and equity.
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Oftalmología , Estados Unidos , Humanos , Masculino , Femenino , Estudios Transversales , United States Food and Drug Administration , Reproducibilidad de los Resultados , Identidad de GéneroRESUMEN
PURPOSE: To investigate sex, racial, and ethnic disparities in patient enrollment across cataract trials registered in the United States. SETTING: Participants enrolled in high-quality (reduced risk of bias), U.S.-registered (on ClinicalTrials.gov ), cataract-related randomized controlled trials (RCTs). RCTs must be completed, have used double or greater masking, and have published results through the registry or a scholarly journal. DESIGN: Cross-sectional database study. METHODS: Trial (study sponsor country, study site location, trial initiation year, study phase, and study masking) and demographic data (sex, race, and ethnicity according to U.S. reporting guidelines) were collected. The Global Burden of Disease database provided sex-based cataract disease burdens. Pooled participation-to-prevalence ratios (PPRs) with 95% CIs were calculated for female sex, with values between 0.8 and 1.2 constituting sufficient study enrollment. Kruskal-Wallis tests (α = 0.05) with subsequent post hoc comparisons were used to evaluate demographic representations stratified by trial characteristics. RESULTS: From 864 records, 100 clinical trials (N = 67 874) were identified, of which 97 (N = 67 697) reported sex demographics with a pooled female PPR of 0.89 (95% CI, 0.85-0.94). Of the 67 697 total participants, the absolute female enrollment was 19 062 (28.16%). Ethnicity and race were reported in 9 (N = 1792) and 26 trials (N = 23 181), respectively. Among trials that reported race, most were White (N = 19 574; 84.44%). CONCLUSIONS: High-quality, U.S.-registered, cataract trials enrolled acceptable proportions of women. However, the absolute number of female and racialized participants was low. Race and ethnicity were underreported. Disparity trends predominately held across secondary variables. To promote generalizability, future trials should pursue equitable demographic enrollment.
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Importance: Workforce diversity is integral to optimal function within health care teams. Objective: To analyze gender, race, and ethnicity trends in rank and leadership among US full-time academic ophthalmology faculty and department chairs between 1966 and 2021. Design, Setting, and Participants: This cohort study included full-time US academic ophthalmology faculty and department chairs registered in the Association of American Medical Colleges. Study data were analyzed in September 2023. Exposure: Identifying with an underrepresented in medicine (URiM) group. Main Outcomes and Measures: The main outcome measures were demographic (ie, gender, race, and ethnicity) changes among academic faculty and department chairs, assessed in 5-year intervals. The term minoritized race refers to any racial group other than White race. Results: There were 221 academic physicians in 1966 (27 women [12.2%]; 38 minoritized race [17.2%]; 8 Hispanic, Latino, or Spanish [3.6%]) and 3158 academic faculty by 2021 (1320 women [41.8%]; 1298 minoritized race [41.1%]; 147 Hispanic, Latino, or Spanish ethnicity [4.7%]). The annual proportional change for women, minoritized race, and Hispanic, Latino, or Spanish ethnicity was +0.63% per year (95% CI, 0.53%-0.72%), +0.54% per year (95% CI, 0.72%-0.36%), and -0.01% (95% CI, -0.03% to 0%), respectively. Women were underrepresented across academic ranks and increasingly so at higher echelons, ranging from nonprofessor/instructor roles (period-averaged mean difference [PA-MD], 19.88%; 95% CI, 16.82%-22.94%) to professor (PA-MD, 81.33%; 95% CI, 78.80%-83.86%). The corpus of department chairs grew from 77 in 1977 (0 women; 7 minoritized race [9.09%]; 2 Hispanic, Latino, or Spanish ethnicity [2.60%]) to 104 by 2021 (17 women [16.35%]; 22 minoritized race [21.15%]; 4 Hispanic, Latino, or Spanish ethnicity [3.85%]). For department chairs, the annual rate of change in the proportion of women, minoritized race, and Hispanic, Latino, or Spanish ethnicity was +0.32% per year (95% CI, 0.20%-0.44%), +0.34% per year (95% CI, 0.19%-0.49%), and +0.05% per year (95% CI, 0.02%-0.08%), respectively. In both faculty and department chairs, the proportion of URiM groups (American Indian or Alaska Native, Black or African American, Hispanic, and Native Hawaiian or Other Pacific Islander) grew the least. Intersectionality analysis suggested that men and non-URiM status were associated with greater representation across ophthalmology faculty and department chairs. However, among ophthalmology faculty, URiM women and men did not significantly differ across strata of academic ranks, whereas for department chairs, no difference was observed in representation between URiM men and non-URiM women. Conclusion & Relevance: Results of this cohort study revealed that since 1966, workforce diversity progressed slowly and was limited to lower academic ranks and leadership positions. Intersectionality of URiM status and gender persisted in representation trends. These findings suggest further advocacy and intervention are needed to increase workforce diversity.
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Etnicidad , Docentes Médicos , Liderazgo , Oftalmología , Humanos , Femenino , Estados Unidos , Masculino , Docentes Médicos/estadística & datos numéricos , Etnicidad/estadística & datos numéricos , Grupos Raciales/estadística & datos numéricos , Centros Médicos Académicos , Diversidad Cultural , Distribución por Sexo , Médicos Mujeres/estadística & datos numéricos , Estudios RetrospectivosRESUMEN
PURPOSE: This cross-sectional study evaluated the prevalence of inclusive author submission guidelines across ophthalmology journals. METHODS: Journals were identified from the 2021 Journal Citations Report (Clarivate Analytics). Independent reviewers rated each author submission guideline as "inclusive" for satisfying at-least one of six criteria: i) included examples of gender inclusive language; ii) recommended the use of gender-inclusive language; iii) distinguished between sex and gender; iv) provided educational resources on gender-inclusive language; v) provided a policy permitting name changes (e.g., in case of gender and name transition); and/or vi) provided a statement of commitment to inclusivity. The primary objective was to investigate the proportion of journals with "gender-inclusive" author submission guidelines and the elements of the gender-inclusive content within these guidelines. A secondary objective was to review the association between "gender-inclusivity" in author submission guidelines with publisher, origin country, and journal/source/influence metrics (Clarivate Analytics). RESULTS: Across 94 journals, 29.8% journals were rated as inclusive. Inclusive journals had significantly higher relative impact factor, citations, and article influence scores compared to non-inclusive journals. Of the 29.8% of inclusive journals, the three most common domains were inclusion of an inclusivity statement (71.4% of inclusive journals), distinguishing between sex and gender (67.9%), and provision of additional educational resources on gender reporting for authors (60.7%). CONCLUSION: A minority of ophthalmology journals have gender-inclusive author submission guidelines. Ophthalmology journals should update their submission guidelines to advance gender equity of both authors and study participants and promote the inclusion of gender-diverse communities.
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BACKGROUND: Atrial fibrillation (AF) is one of the most common complications after cardiac surgery. New-onset post-operative AF may signal an elevated risk of AF and associated outcomes in long-term follow-up. We aimed to estimate the rate of AF recurrence as detected by an implantable loop recorder (ILR) in patients experiencing post-operative AF within 30 days after cardiac surgery. METHODS: We searched MEDLINE, Embase and Cochrane CENTRAL to April 2023 for studies of adults who did not have known AF, experienced new-onset AF within 30 days of cardiac surgery and received an ILR. We pooled individual participant data on timing of AF recurrence using a random-effects model with a frailty model applied to a Cox proportional hazard analysis. RESULTS: From 8671 citations, 8 single-centre prospective cohort studies met eligibility criteria. Data were available from 185 participants in 7 studies, with a median follow-up of 1.7 (IQR: 1.3-2.8) years. All included studies were at a low risk of bias. Pooled AF recurrence rates following 30 post-operative days were 17.8% (95% CI 11.9%-23.2%) at 3 months, 24.4% (17.7%-30.6%) at 6 months, 30.1% (22.8%-36.7%) at 12 months and 35.3% (27.6%-42.2%) at 18 months. CONCLUSIONS: In patients who experience new-onset post-operative AF after cardiac surgery, AF recurrence lasting at least 30 s occurs in approximately 1 in 3 in the first year after surgery. The optimal frequency and modality to use for monitoring for AF recurrence in this population remain uncertain.
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Fibrilación Atrial , Procedimientos Quirúrgicos Cardíacos , Electrocardiografía Ambulatoria , Complicaciones Posoperatorias , Recurrencia , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/etiología , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Electrocardiografía Ambulatoria/instrumentaciónRESUMEN
PURPOSE: The demographic proportions of plastic surgery trials approximating real-world disease have not well been studied. Judicious trial representation is essential in evaluation of treatments across diverse patient populations. Herein, we investigate sex, racial, and ethnic disparities in patient enrollment across burn trials. METHODS: Cross-sectional analysis of participants enrolled in high-quality, with reduced risk of bias, randomized controlled trials (RCT) on burns registered on clinicaltrials.gov under the query "burn." Completed RCTs reporting at least two demographic groups, employing double masking or greater, and with results accessible through the registry or publications were included. Trial characteristics (sponsor country, site location, initiation year, study phase, masking) and demographic data (sex, race, ethnicity per US reporting guidelines) were collected. The Global Burden of Disease database provided sex-based burn disease burdens. The primary outcome was the population-to-prevalence ratio of enrolled female participants. Secondary outcomes included representation of racial and ethnic populations as related to study blinding, phase, and study/sponsor locations. RESULTS: Of 546 records, 39 trials met the inclusion criteria (2919 participants). All trials reported sex demographics, with females comprising 37.02% of all participants (PPR = 0.71, 95% CI [0.59, 0.82], likely indicating underrepresentation against their empiric disease burden). Only 7 and 9 trials reported ethnicity and race, respectively, although not comprehensively. Among trials reporting race or ethnicity, Caucasians and Black persons comprised 57.52% and 21.80% of participants, respectively, while only 9.80% had Hispanic/Latino ethnicity. Severe underreporting of race and ethnicity precluded much of secondary significance testing across study variables. CONCLUSIONS: Females are likely underrepresented in high-quality, US-registered burn trials, unreflective of their real-world disease burden. Further, severe underreporting of race and ethnicity was noted. Future trials should enroll diverse demographics and equitable populations for promotion of study generalizability.