A treasure trove of invaluable data
In an era of advanced computing power and digital technology, it is no surprise that registries comprising medical data play an increasingly important role in healthcare and research. Clinical data registries are organised systems that collect data on patients diagnosed with a disease or condition or who undergo a certain procedure.
Although clinical data registries have been around since at least 1856, when Norway established the National Leprosy Registry, the world’s first national patient register for any disease , it is only in recent decades that large population-based health administrative databases and clinical registries have come to the fore as a vital resource for clinical benchmarking and health research.
Several factors lie behind the robust growth of registries in recent years including advances in information technology, increasing use of electronic health records and growing demand for accountability in quality of care.
The United Kingdom currently has 50-plus clinical audit programmes, the United States has more than 110 federally qualified registries and Sweden, an acknowledged pioneer in the domain, has more than 100 registries, covering a broad spectrum of medical conditions and procedures from birth to old age.
Although priority conditions such as cancer and cardiovascular disease have traditionally led the pack in registries development, ophthalmology has also played its part in advancing the cause of clinical registries to improve quality and cost-efficiency in medical care. Registry-based studies have been used to study real-world clinical outcomes and shape the development of new guidelines and standards in areas such as cataract surgery, corneal transplantation, glaucoma and macular degeneration.
A recent meta-analysis of the PUBMED database listed at least 97 clinical eye registries worldwide, with significant growth noted in the past four decades. Most of those registries originate in the European region, North America and Australia, and nine of them have multinational coverage.
The American Academy of Ophthalmology’s IRIS Registry, with data on more than 225 million patient visits, claims to be the largest clinical data registry in the world for any specialty. It enables clinicians to look at large patient populations, rare diseases, prevalence data and differences in practice patterns geographically or disparities in practice among certain patient populations.
In Europe, the ESCRS actively supports three major pan-national registers: the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO), the European Cornea and Cell Transplantation Registry (ECCTR) and the European Registry for Childhood Cataract Surgery (EuReCCA).
Treasure trove of valuable data
The oldest of these registers, EUREQUO, started in 2008 as a European Union-funded project and now has almost 3 million cataract extraction surgeries in its database. This treasure trove of surgical data has already yielded tangible results in terms of improving cataract outcomes, providing evidence-based practice guidelines and generating research.
Studies based on EUREQUO have helped to shape clinical practice through a wide range of recommendations on second-eye surgery, outpatient procedures, pre- and postoperative visual tests, refractive outcomes, managing co-morbidities and complex cases, anaesthesia, IOL lens type and materials and other key aspects of surgical technique. The database also supported the largest study to date comparing visual, refractive and safety outcomes of patients undergoing femtosecond laser cataract surgery (FLACS) versus conventional phaco cataract surgery.
Mats Lundström MD, PhD, the pioneer and driving force behind the Swedish National Cataract Registry and EUREQUO, notes that registries for diseases and/or interventions serve two main goals.
“The first purpose is to offer comparison and benchmarking to initiate clinical improvement work for clinics and surgeons. The second purpose is scientific, which means to improve knowledge of real-world outcomes and stimulate analyses and studies,” he told EuroTimes.
Even though the principal purpose of EUREQUO is to offer benchmarking and serve as the basis of clinical improvement work, the utility of such a registry is still underestimated by many surgeons, regrets Dr Lundström.
“I think the purpose of registries is often poorly understood by our colleagues. For the clinician, EUREQUO gives them knowledge of their own results, what needs to be improved for better outcomes as well as expected outcomes given the patient’s characteristics. For the patient, it provides information about expected outcomes and risks, helps them to set realistic expectations and gives them confidence in a provider that prioritises quality control,” he said.
With national health authorities, payers and other stakeholders placing ever-greater emphasis on quality control and value-based healthcare, ophthalmologists can no longer afford to ignore the relentless drive towards evidence-based medicine.
“I really feel our profession is not as focused on the benefit of registries as it should be,” said Mor Dickman MD, PhD, who is steering group member of the Dutch National Organ Transplantation Registration (NOTR), EUREQUO, ECCTR and EuReCCa.
There is increasing demand in healthcare from all stakeholders for robust performance measures, noted Dr Dickman.
“In that context, it is imperative for every practitioner to know what his or her results are and to communicate that also to the patient. When I ask many top surgeons what their outcomes in terms of how predictable their refractive results are, their rates of posterior capsular rupture, the performance of their residents and so forth they simply do not know the answer because they do not look at it. Registries allow us to benchmark our performance starting at the single surgeon level and working up to clinic, national and European levels and are an invaluable resource for any medical practitioner,” he said.
Corneal transplantation data
The capacity of registries to inform and guide current clinical practice is also manifest in the field of corneal transplantation, points out Rudy Nuijts MD, PhD, one of the key figures in ECCTR, a three-year registry programme co-funded by the EU and the ESCRS to assess the safety, quality and efficacy of ophthalmic donor tissue transplantations and cell-based therapies.
“Registries are very important in terms of evidence-based medicine and are an important complement to randomised clinical trials in measuring the effect of specific interventions and raising standards of patient care. We saw this first-hand with our national transplant registry in the Netherlands, which showed that many factors influence outcomes such as surgical learning curve in Descemet’s Stripping Endothelial Keratoplasy (DMEK) and also indications for transplantation, where we see differences in graft survival,” he said.
With more than 4,000 surgeries in its database, and more expected as the project nears completion in 2019, the ECCTR web-based registry is expected to provide a wealth of useful information concerning corneal transplantation for academics, health professionals and health authorities.
Expected outcomes of the project include the development of key objective performance indicators to increase the quality of corneal transplant surgeries, validation of patient-related outcome measures (PROMs), development of evidence-based guidelines for good clinical practice and innovative benchmarks that will enable healthcare practitioners to better inform patients about expected outcomes.
Based on the Dutch experience, the expectation is that a European registry will also help to illuminate some fundamental questions relating to corneal transplantation as techniques continue to evolve, said Dr Dickman.
“We need to develop and evolve with the times. A few years ago we had only penetrating keratoplasty (PK) and now we have Descemet’s Stripping Automated Endothelial Keratoplasty (DSAEK), DMEK and limbal stem cell transplantation. The landscape of corneal transplant surgery has transformed dramatically, and will continue to develop as more advanced therapy medicinal products (ATMPs) become available. We need to ask ourselves if we want the data about these treatments guided by companies, or do we want to collect this data ourselves and have a real picture of how these perform in the real world on a wide variety of patients and in the long term?” he said.
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 Marie-José 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 to be able to draw on Dr Lundström’s expertise to help meet all these challenges,” she said.
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 registry-based 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 high-quality 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: email@example.com
Rudy Nuijts: firstname.lastname@example.org
Marie-José Tassignon: Marie-Jose.Tassignon@uza.be
Mor Dickman: email@example.com
To join Eurequo contact: firstname.lastname@example.org