AUTHOR=Solebo Ameenat Lola , Kellett Salomey , Rahi Jugnoo , Pattani Reshma , Edelsten Clive , Dick Andrew D. , Denniston Alastair , The Pediatric Ocular Inflammation UNICORN Study Group , Solebo Ms Ameenat Lola , Kellett Ms Salomey , Dick Professor Andrew D , Rahi Professor Jugnoo , Denniston Professor Alastair , Yeo Mr Damien C.M. , Gonzalez-Martin Mr Jose , McLoone Ms Eibhlin , Pilling Prof Rachel , Bradbury Mr John , Ramanan Prof Athimalaipet V , Guly Ms Catherine , Muthusamy Ms Brinda , Watts Mr Patrick , Twomey Ms Christine , Pattani Ms Reshma , Edelsten Mr Clive , Pharoah Mr Daniel , Long Mr Vernon , Bates Mr Adam , Scoppettuolo Ms Elisabetta , Ashworth Prof Jane , Steeples Ms Laura , Petrushkin Mr Harry , Thomas Ms Dhanes , Connor Mr Alan John , O'Colmain Dr Una , Injarie Mr Anas , Puvanachandra Mr Narman , Pradeep Ms Archana , Sharma Ms Srilakshmi , Schmoll Dr Conrad , Millar Dr Eoghan , Bush Mrs Kate , Reddy Mr M. Ashwin , Choi Ms Jessy , Cooper Ms Gisella , May Ms Kristina , Hughes Mr Ed , Ritchie Ms Ailsa TITLE=Development of a Nationally Agreed Core Clinical Dataset for Childhood Onset Uveitis JOURNAL=Frontiers in Pediatrics VOLUME=10 YEAR=2022 URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.881398 DOI=10.3389/fped.2022.881398 ISSN=2296-2360 ABSTRACT=Background

Childhood onset uveitis comprises a group of rare inflammatory disorders characterized by clinical heterogeneity, chronicity, and uncertainties around long term outcomes. Standardized, detailed datasets with harmonized clinical definitions and terminology are needed to enable the clinical research necessary to stratify disease phenotype and interrogate the putative determinants of health outcomes. We aimed to develop a core routine clinical collection dataset for clinicians managing children with uveitis, suitable for multicenter and national clinical and experimental research initiatives.

Methods

Development of the dataset was undertaken in three phases: phase 1, a rapid review of published datasets used in clinical research studies; phase 2, a scoping review of disease or drug registries, national cohort studies and core outcome sets; and phase 3, a survey of members of a multicenter clinical network of specialists. Phases 1 and 2 provided candidates for a long list of variables for the dataset. In Phase 3, members of the UK's national network of stakeholder clinicians who manage childhood uveitis (the Pediatric Ocular Inflammation Group) were invited to select from this long-list their essential items for the core clinical dataset, to identify any omissions, and to support or revise the clinical definitions. Variables which met a threshold of at least 95% agreement were selected for inclusion in the core clinical dataset.

Results

The reviews identified 42 relevant studies, and 9 disease or drug registries. In total, 138 discrete items were identified as candidates for the long-list. Of the 41 specialists invited to take part in the survey, 31 responded (response rate 78%). The survey resulted in inclusion of 89 data items within the final core dataset: 81 items to be collected at the first visit, and 64 items at follow up visits.

Discussion

We report development of a novel consensus core clinical dataset for the routine collection of clinical data for children diagnosed with non-infectious uveitis. The development of the dataset will provide a standardized approach to data capture able to support observational clinical studies embedded within routine clinical care and electronic patient record capture. It will be validated through a national prospective cohort study, the Uveitis in childhood prospective national cohort study (UNICORNS).