Development of a core outcome set for patients with epiretinal membranes: a Delphi consensus study

Area of Science:

• Ophthalmology
• Clinical Trials
• Patient-Reported Outcomes

Background:

• Idiopathic epiretinal membrane (iERM) impacts vision significantly, necessitating comprehensive assessment beyond visual acuity.
• Macular pucker secondary to iERMs requires standardized evaluation methods for effective management.
• Current assessment practices for iERM may not fully capture the patient's visual experience and functional impact.

Purpose of the Study:

• To develop a Core Outcome Set (COS) for patients undergoing surgery for macular pucker caused by iERMs.
• To establish a standardized set of outcomes for use in both clinical practice and clinical trials related to iERM.
• To ensure that patient-centered outcomes are prioritized in the evaluation of iERM treatments.

Main Methods:

• A modified Delphi technique involving literature review, stakeholder workshops, and two-round Delphi surveys was employed.
• Health professionals and patients rated outcome importance using a 9-point Likert scale.
• Consensus was achieved for outcomes rated 'very important' by at least 80% of stakeholders.

Main Results:

• An initial list of 62 outcomes was considered, reduced through consensus voting and discussion.
• A final list of 13 core outcomes was established, categorized into six domains: visual function, symptoms, adverse events, functional ability, quality of life, and anatomical findings.
• The developed COS provides a minimum set of outcomes for iERM management.

Conclusions:

• A minimum Core Outcome Set (COS) for idiopathic epiretinal membrane (iERM) has been generated.
• Further research is required to determine specific assessment methods and time points for COS implementation.
• The COS has the potential to enhance clinical practice and inform future clinical trials for iERM.