Opportunities and challenges for clinical registries
We appreciate the insightful comments from Bacchi et al.1 on the Save Sight Registries (SSR) and our SSR-study2 which explored the quality of life (QoL) impact of eye diseases and highlighted the complex relationship between visual acuity and QoL. Patient-centred outcomes, including patient-reported outcomes, have always remained a focus of the SSR since its inception.3 In this letter, we share our experience and perspectives on important issues raised by Bacchi et al. We highlight opportunities for and challenges in establishing and maintaining high-quality clinical registries and strategies for engaging clinicians.
Efficient clinical quality registries are cost-effective tools to track patient outcomes, including rare adverse events, over a long period but their development, operation, and sustainability can be challenging. Registries may fail, as seen with the National Eyecare Outcomes Network (NEON) cataract surgery registry, if these challenges are not addressed.4
Use of registries in everyday clinical practice can be facilitated in a variety of ways. At SSR, only a minimum, essential, patient-centred outcome set is collected to reduce the clinician load for entering data and simplify analysis. Clinicians can not only track their patients’ outcomes but also easily generate clinical audit and benchmarking reports and compare treatment patterns and their patient outcomes with those of their peers in a deidentified manner in real time enhancing reflective routine clinical practice.3, 4 The registries enhance patient education as they display a patient’s entire treatment journey at each visit.4 Clinicians and scientists are motivated to participate in research leading to new knowledge and advances in clinical practice. The use of registries for audit and reflection has been accredited as an approved Continuing Professional Development activity in Australia.3, 4 Participation is free of charge to participating clinicians. Identifying a group of committed individuals, mostly clinicians, who will act proactively to advance the project, providing reassurance on privacy, and establishing a democratic system where everybody feels they control their own data are crucial for multi-site engagement. An administrative team is needed to manage ethics, privacy considerations and user engagement.
Registries yield knowledge that complements randomised clinical trials (RCTs) which may have generalisability and applicability issues due to their controlled testing conditions and strict participant selection criteria even if they are the ‘gold standard’ method for determining treatment efficacy.3, 4 Real-world registry studies are more generalisable and cost-effective. Bacchi et al.1 discussed beyond this; conducting registry-embedded RCTs as they may offer the benefits of both RCTs and registries as they are scientifically robust, generalisable, enable collection of patient-reported outcome data and can provide long-term follow-up data. The registries can either feed patients into RCTs or they can be used to actually conduct RCTs.
The SSR modules have received support from unrestricted grants from industry, and grants from not-for-profits and philanthropic organisations, but it is crucial to obtain more sustainable and independent funding to ensure long-term success. Governmental funding agencies may provide support but are generally looking for hypothesis-driven research. Industry are more likely to be interested in and support a registry if there has been success demonstrated through publications and presentations at meetings and if the data generated aligns with their interests.
Recent evidence shows that eye disease and vision impairment are associated with a high cost to the health system and the SSR data has shown that the registries are crucial for improving patient outcomes. Unfortunately, the Australian government has not placed ophthalmic registries on their priority list even though aflibercept is the most expensive drug to the government across all medicine, which was supposed to be one of the main criteria. Political lobbying may influence the priority a registry is given by the government, the SSR has not had success in this area.5 To increase support for ophthalmic registries the profession should lobby federal government support for research based registries and clinical quality registries in ophthalmology on behalf of our patients.