Development of a new standard set of core outcomes to improve health outcomes for patients receiving vitreoretinal surgery: The Finesse Study.

Most cases of retina conditions that require surgery (vitreoretinal surgery) rely on visual acuity charts to measure success but for some conditions eye charts fail to fully capture patient's symptoms. This is particularly true for conditions such as epiretinal membrane (ERM) or macula pucker; these are scar tissues that grow as a result of ageing on the surface of the central part of the retina. They are very common and are present in about a quarter of all people over 60 years. In about 1 in 20 people, ERM affects the very central bit of the retina called the macula and can contract and pull the retina out of shape. This can result in reduced and distorted vision. Surgeons commonly remove the ERM with an operation called vitrectomy and membrane peeling. This operation is usually successful in removing the scar tissue but exactly how much the vision improves is variable. The operation also carries some risk and usually causes cataracts.
Often the affected eye can be improved as measured by the number of lines read on the chart but vision in the treated eye may constantly interfere with the good vision in the other eye. Distortion is not something that can be easily quantified, but can be so troublesome that it often severely affects the patient's quality of life. There are also a host of other symptoms including micropsia (objects are perceived smaller) and diplopia (double vision).
This can happen to the extent that some patients need to wear a patch to cover the good eye. Quality of life is currently measured mainly on visual function and less on patients' reports of their own well-being so we need to determine which outcomes patients value most. Patient-reported outcomes are important to them. Patient-reported outcome measures (PROMs) are increasingly being used to measure the success or failure of treatment, how to manage a patients' treatment and care, and are also part of how healthcare is funded. PROM-tools are a series of standardised and validated questions to gain patients perspectives of their own health. A recent review by our group found that there were no specific PROMS available for retina surgery.
This research will bring together clinicians and patients (including carers of those with significant impairments) to meet face-to-face and on a virtual platform to reach consensus on what outcomes are important to measure and what tools, are already available to measure these outcomes. We will ask patients if these tools are specific enough to measure their experiences or if specific PROMS need to be developed.
We will set up a working group with 20 participants, the majority from different centres in the UK, including patients, nurses and doctors, but a few international consultants will also attend. The group will meet for discussions via teleconferences but there will be the option to dial in or join in by video to make it inclusive to all patients. Clinicians and patients will meet separately to make a list of outcomes important to be measured when patients present with this condition. Once it is drawn up, the list will be refined through 2 rounds of independent voting (online survey) and group discussions. We will also set up 2 focus groups with patients from St Paul's Eye Department to encourage open discussions on the PROMS that are available to measure patient-reported outcomes (for example quality of life) and see if we need to develop any new questionnaires in another project.
This set of outcomes will reflect agreement by all participants. This research will produce recommendations for measures to be used by vitreoretinal surgeons and researchers and it will ultimately help to improve clinical practice, patient pathways and outcomes. Pilot studies will then follow to test strategies to relay data back to clinical teams and patients. Having these measures will also help more accurately quantify and compare the benefits of different treatment options
at a global scale.

Aim: To define a minimum standard set of core outcomes, including patient-centred outcomes, for patients with vitreoretinal interface (VRI) disorders.
Methods: To establish a working group of 20 healthcare professionals (HCPs) (consultants, junior VR surgeons, Eye Clinic Liaison Officer (ECLO), nurses) and 8 VR-surgery patients for the modified Delphi process. Six teleconferences (on-line/dial-in, based on participant preference) will take place over an 18-month period. Initially separate HCPs and patient meetings will take place to generate a comprehensive 'long-list' of outcomes to enable 'the patient voice' to be heard and incorporated with outcomes identified and supported by the literature review. This list will be refined through group discussions and at least 2 rounds of independent voting (on-line survey) to reach consensus (80%+ agreement) on outcomes to include in the final standard set. Sixteen patients from vitreoretinal clinics at St. Paul's Unit, Liverpool, will independently complete the validated patient-reported outcome measures (PROMs) (identified by the modified Delphi process) to determine if they adequately capture the patient-reported outcomes (PROs) of patients with VRI disorders, given that there are no VRI-specific PROMs currently available. They will be split into two focus groups (n=8 per group), with cognitive interviewing facilitated by two HCPs, to discuss their responses to the PROMs and determine if development of a new VR-specific PROM is required.
Outcome: To implement collection of the newly developed standard set of core outcomes into clinical practice, nationally and internationally, to determine the impact of VR surgery on patient's health outcomes and identify good practice and areas for improvement.