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1.
Ophthalmology ; 131(7): 836-844, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38215990

RESUMO

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.


Assuntos
Oftalmia Simpática , Humanos , Oftalmia Simpática/epidemiologia , Oftalmia Simpática/etiologia , Incidência , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Oftalmológicos/efeitos adversos
2.
J Neuroophthalmol ; 2024 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-38373047

RESUMO

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.

3.
J Neuroophthalmol ; 44(1): 119-124, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38175720

RESUMO

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.


Assuntos
Neurologia , Oftalmologia , Humanos , Smog , Educação de Pacientes como Assunto , Bolsas de Estudo
4.
Ophthalmology ; 130(2): 129-136, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36195254

RESUMO

TOPIC: The term "papilledema" is often misused in different ways when describing nonintracranial pressure-related optic disc edema (ODE) or on fundoscopic examination. However, the extent of these errors is unknown among case reports. CLINICAL RELEVANCE: "Papilledema" refers to ODE secondary to raised intracranial pressure (ICP). Papilledema is a leading reason for referral to neuro-ophthalmologists. In any specialty setting, papilledema must be distinguished from other causes of ODE because it implies a unique pathophysiology and management strategy. If managed inappropriately, papilledema may cause permanent vision loss. METHODS: Cross-sectional evidence-based study with protocol registered on Open Science Framework (digital object identifier: 10.17605/OSF.IO/BUQS3). From Ovid MEDLINE and EMBASE, we included case reports with "papilledema" in their title, abstract, or article keywords between January 2011 and March 2022. Studies were graded for the following errors: type 1 (using "papilledema" without evidence of elevated ICP), type 2 (declaring "papilledema" on examination before finding evidence of elevated ICP), type 3 (both errors type 1 and 2), or no error. RESULTS: Among 722 case reports, there was a total of 482 errors (66.8%). There were 12 type 1 errors, 360 type 2 errors, 110 type 3 errors, and 240 studies with no errors. Ophthalmology, neurology, and neurosurgery were the most represented fields, yet only ophthalmology had a low prevalence of errors among all specialties. Regardless, all specialties with at least 10 included reports had a high error prevalence (>30%). Reduced error prevalence was significantly associated with higher impact factor journals, non-open-access publication models, and origin countries with an English official language. Error prevalence was not significantly associated with publication year. Also, the relationship between article citation counts and the prevalence of any type of error did not reach significance. Risk of bias analysis indicated that error occurrence was unrelated to the quality of case report study design. CONCLUSION: "Papilledema" is widely misused even among ophthalmology case reports. When allowed to propagate, this error can mislead care delivery to patients with ODE. Our results, although limited to case reports, indicate a need for more thorough peer-review standards and neuro-ophthalmology exposure in medical education.


Assuntos
Hipertensão Intracraniana , Medicina , Neurologia , Papiledema , Humanos , Papiledema/diagnóstico , Papiledema/etiologia , Estudos Transversais
5.
Can J Neurol Sci ; : 1-5, 2023 Aug 04.
Artigo em Inglês | MEDLINE | ID: mdl-37539690

RESUMO

With virtual interviews for residency applications, residency program websites have become increasingly important resources for applicants. We evaluated the comprehensiveness of US and Canadian neurology residency program website, comparing this to published rankings of the best neurology and neurosurgery hospitals (for US programs) and number of residency positions (for US and Canadian programs). US program websites were found to be largely more comprehensive than Canadian websites, more extensive websites were associated with better program rankings and fewer residency seats in the US, and US regional differences in comprehensiveness were present. We recommend standardized guidelines to increase website comprehensiveness across programs.

6.
J Neuroophthalmol ; 43(4): 525-530, 2023 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-37307081

RESUMO

BACKGROUND: Papilledema must be managed distinctly from other causes of optic disc edema (ODE) due to its basis in raised intracranial pressure (ICP). However, evidence indicates that the term "papilledema" is widely misused across specialties to describe ODE without raised ICP. Sources of this misconception remain undiscerned. Because all physicians consult medical databases, our objective was to evaluate whether nonspecific "papilledema" subject heading definitions misleadingly associate articles on other conditions with papilledema proper. METHODS: Systematic review of case reports, prospectively registered on PROSPERO (CRD42022363651). MEDLINE and Embase were searched to July 2022 for any full-length case report indexed to the "papilledema" subject heading. Studies were graded for incorrect indexing, defined as cases lacking evidence for raised ICP. Nonpapilledema diagnoses were assigned to a predefined set of diseases and pathophysiological mechanisms for subsequent comparison. RESULTS: Incorrect indexing occurred in 40.67% of 949 included reports. Embase-derived studies were misindexed significantly less than MEDLINE-derived studies ( P < 0.01). There was also significant heterogeneity in incorrect indexing among specific diseases ( P = 0.0015) and mechanisms ( P = 0.0003). The most commonly misindexed diseases were uveitis (21.24% of errors), optic neuritis (13.47%), and instances with no mention of ODE (13.99%). The most commonly misindexed mechanisms were inflammation (34.97%), other mechanism (e.g., genetic; 25.91%), and ischemia (20.47%). CONCLUSIONS: Database subject headings, especially from MEDLINE, do not adequately distinguish between true papilledema and other causes of ODE. Inflammatory diseases were most often incorrectly indexed among other diseases and mechanisms. Current "papilledema" subject headings should be revised to reduce the probability of misinformation.


Assuntos
Hipertensão Intracraniana , Neurite Óptica , Papiledema , Humanos , Inflamação , Hipertensão Intracraniana/diagnóstico , Neurite Óptica/diagnóstico , Papiledema/diagnóstico , Papiledema/etiologia , Relatos de Casos como Assunto
7.
J Neuroophthalmol ; 2023 Dec 13.
Artigo em Inglês | MEDLINE | ID: mdl-38088882

RESUMO

BACKGROUND: Person-first language (PFL) is a linguistic prescription, which places a person before their disease. It is considered an important tool to reduce stigma. However, PFL is not routinely used across the scientific literature, particularly in patients with overweight or obesity. Patients with idiopathic intracranial hypertension (IIH) face various stigmas through high rates of poverty, female gender, and frequent rates of comorbidities. Non-PFL language use intersects and worsen the health inequities faced by these patients. METHODS: A systematic review of case reports. MEDLINE and EMBASE were searched for all case reports with "pseudotumor cerebri" [MESH] OR "Idiopathic Intracranial Hypertension" as key word between January 1974 and August 2022. The primary criterion was the article's inclusion of patients with overweight or obesity. The secondary criterion was the article's discussion regarding obesity as risk factor. Articles not meeting primary or secondary criteria were excluded. RESULTS: Approximately 514/716 (71.8%) articles used non-PFL language. The publication year was predictive of non-PFL language: 1976-1991 (82.3%) vs 1992-2007 (72.3%, P = 0.0394) and 2008-2022 (68.3%, P = 0.0056). Non-PFL was significantly higher in obesity compared with other medical conditions (60.3% vs 7.3%, P < 0.001). The patient gender (P = 0.111) and ethnicity (P = 0.697), author's specialty (P = 0.298), and primary English-speaking status (P = 0.231), as well as the journal's impact factor (P = 0.795), were not predictive of non-PFL. CONCLUSIONS: Most literature focused on IIH use non-PFL when discussing overweight or obesity, regardless of the patient's gender and ethnicity, journal's impact factor, senior author's specialty, and English-speaking status. Non-PFL use is much more common when discussing obesity compared with other medical conditions. Appropriate use of PFL can decrease stigma and, more importantly, decrease the intersectionality of health stigma faced by patients with IIH.

8.
Women Health ; 63(2): 143-149, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36593567

RESUMO

Despite efforts toward equity, diversity, and inclusion in academic ophthalmology faculties, gender disparity continues to exist. Current evidence indicates that female ophthalmologists consistently hold lower academic ranks and receive less funding from the National Institutes of Health compared to their male colleagues. The extent of this disparity is unknown in the Canadian context. We sought to characterize the gender gap in Canadian Institutes of Health Research funding among ophthalmologists. From inception, funding decision data were collected from the official Canadian Institutes of Health Research website database hosted by the Government of Canada. Measures including gender, number of grants held over the study period, number of simultaneous grants, and total funding were collected. Female ophthalmologists were consistently awarded fewer grants (21.43 percent) compared to male counterparts and were less likely to hold multiple grants since 2008. An over five-fold disparity was found in total funding for female compared to male ophthalmologists. As well, females were less likely than males to hold a grant in each particular year except in 2020. Female ophthalmologists continue to face barriers to attaining academic support from Canadian Institute of Health Research funds. Continued action to mitigate this gender gap may improve gender-based parity in federal research funding.


Assuntos
Distinções e Prêmios , Oftalmologistas , Estados Unidos , Humanos , Masculino , Feminino , Canadá , National Institutes of Health (U.S.)
9.
15.
Semin Ophthalmol ; 39(2): 123-128, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37695018

RESUMO

PURPOSE: This review analyzed the top 100 most-cited thyroid eye disease (TED) papers. METHODS: In November 2022, Scopus was searched for the most highly cited TED works since inception. For each paper, journal of origin and impact factor, corresponding author country and specialty affiliation, citation count, publication year, database-affirmed study funding, and open-access status were extracted. RESULTS: A total of 76 primary and 24 secondary articles were published between 1969 and 2021 across 29 journals, with a median (range) of 186.5 (133-930) citations. The most cited journal was Journal of Clinical Endocrinology and Metabolism (25 articles; 5126 citations). The most cited article was 'Graves' ophthalmopathy' (Bahn 2010; New England Journal of Medicine; 930 citations). Articles hailed from 10 countries, with most from the United States (38 articles; 9194 citations). Endocrinology (n = 59) and ophthalmology (n = 26) were the most common corresponding authors. Nineteen first authors contributed multiple articles. Only journal impact factor was significantly associated with citation count (p = .0002; ρ = 0.45). CONCLUSION: A variety of medical disciplines, Western countries, and study personnel contributed to highly cited thyroid eye disease research. Thus, this research area is not exceedingly informed by any singular perspective. Further, it can be interpreted with increased confidence for their generalizability of results to patients globally.


Assuntos
Oftalmopatia de Graves , Humanos , Estados Unidos , Bibliometria , Fator de Impacto de Revistas
16.
Br J Ophthalmol ; 2024 Feb 02.
Artigo em Inglês | MEDLINE | ID: mdl-38307720

RESUMO

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.

17.
Eye (Lond) ; 2024 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-38538778

RESUMO

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.

18.
Eye (Lond) ; 38(10): 1897-1902, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38509182

RESUMO

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.


Assuntos
Compreensão , Avaliação Educacional , Oftalmologia , Humanos , Avaliação Educacional/métodos , Internet , Leitura
19.
Artigo em Inglês | MEDLINE | ID: mdl-38835201

RESUMO

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.

20.
JAMA Ophthalmol ; 142(2): 123-130, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38236588

RESUMO

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 (34 740 participants) received FDA approval, of which 16 drugs (47.1%) corresponding to 32 trials (18 535 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.


Assuntos
Oftalmologia , Estados Unidos , Humanos , Masculino , Feminino , Estudos Transversais , United States Food and Drug Administration , Reprodutibilidade dos Testes , Identidade de Gênero
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