Setting the Standard

Refractive surgery is functional. It reduces dependence on spectacles and contact lenses, and allows patients to engage in a more active lifestyle, with clearly documented gains in quality of life. However, like cosmetic surgery, refractive surgery is elective – and, as such, self-funded – for most patients. As a result, the provision of routine refractive surgery is dominated by a competitive marketplace and an independent healthcare sector.

New standards

The need for better regulation was first highlighted by the 2013 Keogh Report in the wake of the Poly Implant Prosthèse (PIP) breast implant scandal. Keogh condemned irresponsible advertising and inconsistent care standards, calling for improvements in three key areas: patient information, quality of care and support when things go wrong.

By 2015, public and professional perceptions of refractive surgery had been damaged by the imbalanced press coverage and suboptimal delivery of care of previous years. Refractive surgery was under-represented in training curricula, treated with suspicion by many eye care professionals and presented to the public with little consideration of the balance of risks with contact lens wear – the main alternate choice for patients seeking an active lifestyle.

In response, the Royal College of Ophthalmologists formed the Refractive Surgery Standards Working Group (RSSWG), on which I serve as chairman. The group was intended to build on the foundations laid by the GMC and the Royal College of Surgeons, downstream of the Keogh report.

Beyond simply updating existing standards, we aimed to increase engagement with the wider ophthalmic community, promote a more balanced discourse, and restore public and professional confidence in refractive surgery. Understandably, there were challenges along the way.

A matter of form

The RSSWG was faced with a small – but highly vocal – campaign against refractive surgery on one side (propagated through social media and the press) and, on the other, aggressive, litigious major providers. Steering change was no easy task. It required commitment and hard work from the panel of stakeholders – including optometric, scientific and lay input, layers of professional and public consultation – and strong support from the administrative team at the Royal College.

Keogh’s first call was for an informed and empowered public, centered on advertising and consent. We were keen to get away from the current situation, whereby patients were pulled in by glossy marketing, then disquieted on the day of surgery by a consent form reading like a disclaimer. The GMC is clear that consent is a process.

Any information given to patients must be consistent from first contact to discharge. Not only that, the tone and content of marketing information should be consistent with other patient information documents. Written consent forms should simply comprise procedure information – which should be available to the patient throughout – and a short consent statement.

We developed standardized documents for each of the main refractive modalities: laser vision correction, phakic intraocular lens implant and refractive lens exchange. Each document was based on a framework developed by the Royal College of Surgeons to identify the points that mattered most to patients. Our aim was to produce evidence-based material in simple language. A particular learning point for me in this was how much a first draft can be improved by lay input.

Without this feedback, it is easy to include impenetrable jargon or technical terms that are meaningless to a non-expert reader. The standardized information documents we produced are available on the Royal College website (www.rcophth.ac.uk) and can be customized with individual provider branding and information, provided it does not contradict our guidelines. Any claims for superior results should be independently verifiable.

In practice

Prior to the publication of our standards in 2017, it was possible to practice refractive surgery with no ophthalmic specialist training. Although some practitioners with an established revalidation record of good practice in refractive surgery were grandfathered in, there was no real debate about the need to ensure that refractive surgeons were both Cert LRS-qualified and on the specialist register.

Making the Cert LRS examination a requirement called into question the blurred boundary between refractive lens exchange and cataract surgery. When does a cataract surgeon become a refractive surgeon and, therefore, need to sit the exam? Should you have to sit the exam to use toric and multifocal lenses? Is it logical to restrict treatment of astigmatism during cataract surgery to refractive surgeons?

Clearly there is some crossover, and the form of words we settled on in the end reflects this: our guidance (and the need to sit the Cert LRS exam) applies wherever “the primary purpose of surgery is to reduce reliance on spectacles and contact lenses and the patient has a normal cornea and a normal lens in both eyes.”

Another issue we addressed was models of care. Refractive surgery – laser refractive surgery, in particular – is so safe and effective that models of care have evolved around minimizing cost, through surgeons delegating to lower paid staff. Teamwork and good quality support from non-surgical eye health care professionals are essential in refractive surgery and our outputs emphasise this, but the operating surgeon remains responsible for patient care throughout.

Models in which the surgeon only meets the patient on the day of surgery are problematic, both from the point of view of procedure choice and consent before surgery, and timely interception of problems afterwards. The clash between traditional models of private surgical care, in which the operating surgeon takes charge of every consultation, and the high-street approach in which the surgeon is treated as a technician, appearing on the day of surgery only, was one of the hardest fought areas in developing updated Professional Standards.

The eventual compromise was that the operating surgeon would have to be present to advise on procedure choices at the pre-operative consultation, but postoperative care could be delegated, provided that clear lines of communication with the operating surgeon remain in place. The operating surgeon or a suitably qualified colleague should also remain available to perform revision interventions when required.

Note that the Professional Standards are minimum standards, and that end-to-end continuity of care, in which the surgeon, backed up by a strong clinical team, sees the patient at every visit, remains the gold standard for refractive surgical care.

The main determinant of practice volume in refractive surgery hinges on reaching patients effectively. Traditional channels include word of mouth referrals, research publications, teaching and clear patient information. But direct marketing now dominates and one of our key objectives was to steer this away from damaging and unethical practice.

Sheraz Daya led on this and did a great job pulling together what are now our Advertising and Marketing Standards. Key recommendations include ensuring that any incentive to refer is transparent to patients, keeping cost information clear, avoiding time-limited deals and inducements, and keeping marketing and consent information consistent.

No matter how successful a surgeon becomes, there will always be problem cases. Although most can be resolved satisfactorily through good continuity of care, patients who lose confidence in their surgical provider in the self-pay sector may feel that they are left staring down the barrel of an open-ended financial commitment in seeking revision care elsewhere. Keogh highlighted this and called for better mechanisms of redress.

Great expectations

Specialist refractive surgical revision care is available free of charge in some NHS centres, including Moorfields Eye Hospital, but the real cause of unhappiness is often simply a breakdown in communication or an unrealistic set of expectations. This, in part, is why it is so important that surgeons themselves should take charge of the pre-operative consultation and, where possible, postoperative consultations, too.

Even with the best practice, problems in communication can arise, and “alternative dispute resolution” (ADR) mediation services are currently being explored as an effective alternative to litigation when in-house complaint resolution does not bring closure. ADR provision for refractive surgery remains a work in progress but has high success rates in other sectors, such as optometry and dentistry.

Other work downstream of the Professional Standards is centered on the development of a National data registry. The emergence of electronic healthcare record systems offers some really exciting possibilities for automatic data extraction and pooling, artificial intelligence guidance for nomogram development and procedure choices, and data mining to answer important research questions. The National Ophthalmology Database in Cataract Surgery has already demonstrated the potential for this approach in the UK.

Seeking to emulate this, a new working group was convened to agree the Clinical Dataset for Refractive Surgery, published in 2018. This is a common set of outcome measures and timepoints that should be easy to implement in routine clinical practice, and will form the basis for the data fields to be extracted from EHR systems and pooled for analysis.   

My hope is that the outputs from the Refractive Surgery Standards Working Group will, in time, impact positively on public confidence in refractive surgery procedures, which must surely be amongst the most effective healthcare interventions available. Whilst the Royal College can set standards and has called for legislative back-up, enforcement is currently a matter for the regulators: the General Medical Council, the Care Quality Commission, the Advertising Standards Agency and equivalent bodies in devolved areas of the UK.

However, it is in all of our interests to practise to a high standard and to strive constantly to chip away at the small percentage of patients whose outcome from refractive surgery does not match or exceed expectations. So, don’t wait for the regulator to call. Re-read the Standards and try to ensure that your own practice stays ahead of them.