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REGISTRIES IN OPHTHALMOLOGY
Although the recent trend in registries is towards analysing ever-larger data sets, there is also value to be found in focusing on specific questions relating to less common diseases, points out MarieJosé Tassignon MD, PhD, FEBO, who is spearheading the European Registry for Childhood Cataract Surgery (EuReCCa). “Because paediatric cataract is a rare disease, it makes administration of the database and transcription and validation of patient data much easier. We hope through the registry to obtain a better understanding of the mechanism of emmetropisation in infants and children. We also have some sub questions that will be addressed as well, such as the target of the IOL lens power implanted depending on the underlying cause of the cataract and the age of the patient,” she said. EuReCCa is currently in the early stage of development, but has benefited greatly from the experience of Dr Lundström and EUREQUO in getting the registry up and running, said Dr Tassignon. This included navigating the complexity of the new European General Data Protection Regulation (GDPR), which came into effect in 2018 and which has wide-reaching implications for any clinical data registry dealing with European citizens. In essence, the new rules require all registries to ensure that patient consents are aligned with the GDPR as well as with national requirements that allow sharing of aggregated and anonymised patient-level data for research or regulatory purposes. As Dr Nuijts sees it, this is one of the most critical issues facing clinical data registries today. “We need to be able to assure doctors and patients that their data is handled according to the legal requirements. To increase the potential of registries it would be worthwhile to include the retrospective data of existing registries, as was done with the ECCTR, but this needs adjustment to the current GDPR legislation,” he said. Although the complexity of such regulatory legislation is daunting, Dr Tassignon said that everything is currently on track with EuReCCa. “We have had a lot of interest from parties interested in contributing. It is quite challenging to bring all the various components together, to harmonise electronic health records (ERH) from different countries and respect all the various regulatory requirements, especially bearing in mind the new EU rules concerning GDPR. We are fortunate EUROTIMES | MAY 2019
We need to be able to assure doctors and patients that their data is handled according to the legal requirements Rudy Nuijts, MD, PHD
to be able to draw on Dr Lundström’s expertise to help meet all these challenges,” she said.
FUTURE DEVELOPMENTS Going forward, there is scope in the future to harness artificial intelligence applications and deep learning algorithms to delve deeper into the massive clinical datasets now available. There is also the challenge of continually refining the data collection to reflect evolving practice and ensure the relevance of the information contained therein. Dr Lundström also sees potential to use large databases to describe risk factors for rare events. “This means describing risk factors for rare complications and also outcomes when rare baseline characteristics are present. For instance, we can use the database to describe risk factors for a poor refractive outcome. The probable outcome for combinations of preoperative characteristics such as age, gender, preoperative visual acuity and ocular comorbidities can also be described,” he said. The current EUREQUO forms can also be used as Case Report Forms that could be utilised in future clinical studies, added Dr Lundström. “If needed, new parameters can be included that suit the research question being posed. To set up such a system from scratch is expensive and the EUREQUO system can be used by ESCRS scientists for free. The system is also updated to make it easier for clinics and surgeons to transfer data without double entry. I want to acknowledge the board of the ESCRS for its foresight in support of registries,” he said. Ophthalmology could also take inspiration from cardiology and oncology in using low-cost registrybased randomised
trials to guide clinical practice, suggests Dr Dickman. He cited the example of the Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial, in which investigators designed a large-scale trial to answer an important clinical question and carried it out at remarkably low cost by building on the platform of an already-existing highquality observational registry. “There is no reason why we cannot do the same for ophthalmology, whether in cataract, corneal surgery or paediatric cataract, to make better use of these wonderful data platforms that already exist and capture information about surgical techniques or innovative therapies,” Dr Lundström concluded. Mats Lundström: mats.lundstrom@ karlskrona.mail.telia.com Rudy Nuijts: rudy.nuijts@mumc.nl Marie-José Tassignon: Marie-Jose.Tassignon@uza.be Mor Dickman: mor.dickman@mumc.nl To join EUREQUO contact: lucia.brocato@escrs.org