Development of the Advised Protocol for OCT Study Terminology and Elements Anterior Segment OCT extension reporting guidelines: APOSTEL-AS

Abstract

Background Anterior segment optical coherence tomography (AS-OCT) is emerging as a valuable diagnostic, monitoring and predictive tool across a range of disorders. Clinical utility of quantitative information derived from AS-OCT has been suggested for ophthalmic disorders such as glaucoma, corneal disease and uveitis, which taken together comprise the majority of the blinding conditions affecting working age individuals. The current absence of guidelines for reporting OCT studies which quantitatively assess the anterior segment is an obstacle to reproducibility and interoperability. In order to provide this guidance, we aim to extend the existing Advised Protocol for OCT Study Terminology and Elements (APOSTEL) guidelines, to enable inclusion of items applicable to AS-OCT.

Methods The guideline will be developed through a staged consensus process involving literature review and Delphi consensus exercise across an international multi-disciplinary stakeholder committee. A systematic scoping review will be used to generate candidate items for the guideline extension, and to form the expert membership base (eye healthcare professionals, patients, methodologists, statisticians, computer scientists, industry representatives, health informaticists, and journal editors) of the consensus group. The candidate reporting items will be presented to consensus group members, alongside the existing APOSTEL items, in a Delphi consensus exercise. Members will be asked to vote on each item using a 9-point scale, and to provide explanatory notes. Aggregated responses will be presented at the second Delphi round, and anonymous electronic voting will be used to include or exclude existing, reworded or amended, or newly suggested items. Items achieving consensus (>80%) will be included. Any item not achieving consensus but which is approved by the majority (51-80% inclusive) will be considered for further amendment or refinement and representation in a subsequent round. The resultant APOSTEL-AS guideline will undergo piloting, with feedback from this pilot used to produce the final version.

Discussion AS-OCT is increasingly being used to derive quantitative data from images of normal physiology and for disease involving the anterior segment of the eye. Through APOSTEL-AS, we seek to provide timely support for researchers to ensure future standardisation, interoperability and reproducibility of reported work.

Competing Interest Statement

Alex Huang: 1)Abbvie: Consultant; 2)Amydis: Medical advisory board); 3)Celanese: consultant; 4)Diangosys: research support; 5)Equinox: consultant; 6)Glaukos: consultant; 7)Heidelberg Engineering: research support;8)QLARIS: scientific advisory board; 9)Santen: consultant; 10)Topcon: consultant

Funding Statement

AL Solebo is supported by an NIHR Clinician Scientist award CS-2018-18-ST2-005)

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee/IRB of University College London will grant ethical approval for this proposed work

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

All data produced in the present study are available upon reasonable request to the authors

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