Minimum set of outcome measures for non-advanced age-related macular degeneration: a Delphi consensus statement by the TRACER (intermediate age-related macular degeneration) study group.

Abstract

<h4>Background</h4>The purpose of this study was to define a minimum set of outcome measures for patients affected by non-advanced age-related macular degeneration (AMD).<h4>Methods</h4>A structured Delphi consensus process was conducted by a panel of worldwide experts in treatment outcome registries, imaging, nutrition and other AMD aspects. The experts answered anonymously to a series of surveys, each followed by a face-to-face meeting to discuss the pooled results. Supporting literature was shared among the group members by a facilitator before each round. Finally, all the results were discussed and the consensus document was created based on the level of agreement between experts.<h4>Results</h4>Six rounds were conducted until a formal consensus was achieved. Five main sections were identified: demographic characteristics, health factors, functional, imaging and clinical outcomes. A minimum set of 28 outcome measures was subsequently developed and approved by all members. Based on the priority of various items, 24 fields were designated as mandatory, while the remaining were deemed optional. Five items are required only at baseline, 12 are to be assessed annually for changes and the remaining 0 1must be collected at each clinical assessment.<h4>Conclusion</h4>This newly defined minimum set of outcome measures for non-advanced AMD could be employed in future real-world data collection registries aimed at gathering comprehensive and longitudinally extensive clinical data on a global scale. This may help to elucidate the natural progression of non-advanced AMD and its response to new therapies.