Prototype master protocol for benchmarking of real-world follow-up data in glaucoma.

Purpose: The purpose of this study was to create a prototype master protocol for benchmarking glaucoma real-world data (RWD). Benchmarking is part of the digital innovation strategy of the Finnish aces-rwm ecosystem (automation of care and evaluation of the system with real-world monitoring).

Methods: We collected glaucoma RWD in 2012-17 at Tampere University Hospital (Tays) and compared them to six published RWD sets (one in Sweden and five in England). Visual field (VF) data at Tays were retrieved from the perimeter, and clinical RWD were collected manually. At baseline, VF data were available in 2511 of 4121 glaucoma patients (61%), of whom 1413 patients (56%) had 5 years of VF follow-up by 2017 (34% of all 4121 patients). Mean deviation (MD) data were analysed in multiple ways, considering also age and intraocular pressure (IOP).

Results: In most data sets, higher age was related to faster progression. At Tays, the distributions of progression rates were similar in better and worse eyes. The proportions of eyes at Tays with the medium rate of MD progression (17% for 0.5-1.5 dB/year) and the fast rate (6% for >1.5 dB/year) were similar to the published RWD trial in England. The published datasets show significant variability in how their findings were reported.

Conclusions: This study represents a first step toward the development of a master protocol for real-world benchmarking of glaucoma care. Further refinement of the protocol will encourage and require national and international collaboration in order to produce comprehensive and comparable real-world EHR data sets.