Common data elements for observational studies in ocular toxoplasmosis: a Delphi consensus

William Rojas-Carabali; Carlos Cifuentes-González; Kerry Goetz; Maria Vittoria Cicinelli; Zheng Xian Thng; Sally L. Baxter; Edmund Tsui; Padmamalini Mahendradas; Jyotirmay Biswas; Sofia Androudi; Cristina Muccioli; Andre Luiz Land Curi; Su Ling HO; Alfredo Adán; Rina La Distia Nora; Claudio Silveira; Heloisa Nascimento; João M. Furtado; Germán Mejía-Salgado; URZUA SALINAS, CRISTHIAN

doi:10.1186/s12348-025-00525-2

Common data elements for observational studies in ocular toxoplasmosis: a Delphi consensus

Journal

Journal of Ophthalmic Inflammation and Infection

ISSN

1869-5760

Date Issued

2025-09-24

Author(s)

William Rojas-Carabali

Carlos Cifuentes-González

Kerry Goetz

Maria Vittoria Cicinelli

Zheng Xian Thng

Sally L. Baxter

Edmund Tsui

Padmamalini Mahendradas

Jyotirmay Biswas

Sofia Androudi

Cristina Muccioli

Andre Luiz Land Curi

Su Ling HO

Alfredo Adán

Rina La Distia Nora

Claudio Silveira

Heloisa Nascimento

João M. Furtado

Germán Mejía-Salgado

URZUA SALINAS, CRISTHIAN

Facultad de Medicina Clínica Alemana Universidad del Desarrollo

Justus G. Garweg

Ariel Schlaen

Xin Wei

Sivaraman Balamurugan

Ranju Kharel Sitaula

Ikhwanuliman Putera

Marcelo Rudzinski

Kalpana Babu

Mark Westcott

Rubens Belfort

Justine R. Smith

Jorge Gomez-Marin

Quan Dong Nguyen

Vishali Gupta

Rupesh Agrawal

Alejandra de-la-Torre

Type

journal-article

DOI

10.1186/s12348-025-00525-2

URL

https://hdl.handle.net/123456789/11552

URL Institutional Repository

https://hdl.handle.net/11447/10875

Abstract

PurposeOcular toxoplasmosis (OT) is the most common cause of posterior uveitis globally, with a significant risk of visual impairment. However, the lack of standardized data collection hinders meaningful comparisons across studies. This study aimed to develop a consensus-based set of Common Data Elements (CDEs) for observational studies in OT using a Delphi approach.DesignA set of CDEs was developed through a combination of a comprehensive literature review, a hybrid workshop, and a Delphi consensus process. This effort was led by an international panel of experts in OT to define a standardized CDE set for research and clinical purposes.MethodsA multidisciplinary steering committee identified an initial list of candidate CDEs through a targeted literature review. A panel of 30 international experts participated in a structured, one-round Delphi process to evaluate and refine these CDEs. Consensus was determined based on predefined thresholds for inclusion, exclusion, and modification.ResultsA total of 139 CDEs were categorized across nine domains: Demographic and Background Information, Medical and Ocular History, Clinical Presentation, Clinical Findings, Lesion Characteristics, Diagnostics, Imaging Findings, Treatment and Interventions, and Outcomes. All 139 CDEs met the inclusion criteria, with 79.8% rated as "very important". The consensus underscores the importance of a comprehensive, standardized dataset for OT research.ConclusionsThis study establishes the first expert-derived standardized dataset requested for reporting OT outcomes, providing a framework to standardize data collection for future observational studies. Adopting these CDEs will enhance data comparability, improve meta-analyses, and strengthen the evidence base for clinical decision-making in OT. Future work will focus on real-world validation and refinement of this dataset.

Cite this document

Rojas-Carabali, W., Cifuentes-González, C., Goetz, K., Cicinelli, M. V., Thng, Z. X., Baxter, S. L., Tsui, E., Mahendradas, P., Biswas, J., Androudi, S., Curi, A. L. L., Ho, S. L., Adán, A., La Distia Nora, R., Silveira, C., Nascimento, H., Furtado, J. M., Muccioli, C., Mejía-Salgado, G., … de-la-Torre, A. (2025). Common data elements for observational studies in ocular toxoplasmosis: A Delphi consensus. Journal of Ophthalmic Inflammation and Infection, 15(1), 68. https://doi.org/10.1186/s12348-025-00525-2