Sociodemographic disparities in ophthalmological clinical trials.

Nakayama, Luis Filipe; Mitchell, William Greig; Shapiro, Skyler; Santiago, Alvina Pauline D; Phanphruk, Warachaya; Kalua, Khumbo; Celi, Leo Anthony; Regatieri, Caio Vinicius Saito

Nakayama, Luis Filipe; Mitchell, William Greig; Shapiro, Skyler; Santiago, Alvina Pauline D; Phanphruk, Warachaya; Kalua, Khumbo; Celi, Leo Anthony; Regatieri, Caio Vinicius Saito.

Afiliación

Nakayama LF; Laboratory for Computational Physiology, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA luisnaka@mit.edu.
Mitchell WG; Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Brazil.
Shapiro S; Ophthalmology, The Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.
Santiago APD; Laboratory for Computational Physiology, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Phanphruk W; Cornell University, Ithaca, New York, USA.
Kalua K; Department of Ophthalmology and Visual Sciences, Philippine General Hospital, Manila, Metro Manila, Philippines.
Celi LA; Ophthalmology, Khon Kaen University, Nai Mueang, Khon Kaen, Thailand.
Regatieri CVS; Ophthalmology, Kamuzu University of Health Sciences, Blantyre, Southern Region, Malawi.

BMJ Open Ophthalmol ; 8(1)2023 02.

Article en En | MEDLINE | ID: mdl-37278426

RESUMEN

INTRODUCTION: In ophthalmology, clinical trials (CTs) guide the treatment of diseases such as diabetic retinopathy, myopia, age-related macular degeneration, glaucoma and keratoconus with distinct presentations, pathological characteristics and responses to treatment in minority populations.Reporting gender and race and ethnicity in healthcare studies is currently recommended by National Institutes of Health (NIH) and Food and Drug Administration (FDA) guidelines to ensure representativeness and generalisability; however, CT results that include this information have been limited in the past 30 years.The objective of this review is to analyse the sociodemographic disparities in ophthalmological phases III and IV CT based on publicly available data. METHODS: This study included phases III and IV complete ophthalmological CT available from clinicaltrials.org, and describes the country distribution, race and ethnicity description and gender, and funding characteristics. RESULTS: After a screening process, we included 654 CTs, with findings that corroborate the previous CT reviews' findings that most ophthalmological participants are white and from high-income countries. A description of race and ethnicity is reported in 37.1% of studies but less frequently included within the most studied ophthalmological specialty area (cornea, retina, glaucoma and cataracts). The incidence of race and ethnicity reporting has improved during the past 7 years. DISCUSSION: Although NIH and FDA promote guidelines to improve generalisability in healthcare studies, the inclusion of race and ethnicity in publications and diverse participants in ophthalmological CT is still limited. Actions from the research community and related stakeholders are necessary to increase representativeness and guarantee generalisability in ophthalmological research results to optimise care and reduce related healthcare disparities.

Asunto(s)

Catarata; Glaucoma; Oftalmología; Estados Unidos/epidemiología; Humanos; Etnicidad; Grupos Minoritarios; Glaucoma/diagnóstico

Palabras clave

Clinical Trial; Epidemiology; Public health

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oftalmología / Catarata / Glaucoma Tipo de estudio: Diagnostic_studies / Guideline / Qualitative_research Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: BMJ Open Ophthalmol Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

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