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

BACKGROUND/AIMS: Idiopathic epiretinal membrane (iERM) can affect vision in complex ways, requiring assessment beyond visual acuity. We developed a core outcome set (COS) for patients undergoing surgery for macular pucker secondary to iERMs for use in both clinical practice and clinical trials. METHODS: An online modified Delphi technique was used, incorporating literature review, stakeholder workshops and two-round Delphi survey, each followed by a hybrid consensus meeting. Stakeholders, including health professionals and patients rated the importance of each outcome on a 9-point Likert scale (1-3, not important; 4-6, important; 7-9, very important). Outcomes scored as 'very important' by ≥80% of stakeholders were included in the COS. RESULTS: Sixty-two outcomes were initially included. Only one outcome reached consensus after the first vote, a further 10 after the second vote and five in the final vote. After discussion and considering clinical relevance and patient importance, the initial list of 17 outcomes was reduced to 13 core outcomes, grouped into six overarching domains: measured visual function, symptoms, adverse events, functional ability, quality of life and other, including objective measurements of anatomical findings. CONCLUSION: A minimum COS for iERMS comprising 13 outcomes covering six domains was generated by the modified Delphi process. The COS is not yet ready for use as the methods of assessment and the time points remain to be determined before it can be used in practice. Future research will test the implementation of the COS in clinical practice and its' potential incorporation into future trials.