Putting Glaucoma Patients Front and Center

With a glaucoma patient from the UK

Andrew Tatham, cataract and glaucoma surgeon, consultant at Princess Alexandra Eye Pavilion and The Edinburgh Clinic, Edinburgh, UK

Phil Graves, behavioral psychology expert, based in Cambridge, UK 

Jean-Sebastien Garrigue, Vice President, Research & Development (R&D), EMEA, Santen, based in Paris, France

Nobody is better placed than patients to explain the burden of their disease or to contribute to effective clinical management strategies. And few are better equipped to help companies develop the products, services and support that people truly need. Data firmly support this “nothing about us, without us” concept – but how are patient-centric approaches translated into ophthalmology and with what effect?

“Managing glaucoma is as much a mental achievement as a physical one.” Glaucoma patient from the UK

The importance of the patient perspective
Today, industry recognizes that, if it is to develop relevant and efficacious products, it must seek patient insights and experiences, and then act on them. This philosophy is rapidly becoming embedded in the healthcare sector, and is more than just fine words; the concept makes perfect clinical sense, not least in glaucoma. “The patient perspective is essential in choosing treatments and determining their success,” says Andrew Tatham, ophthalmic surgeon, consultant at Princess Alexandra Eye Pavilion and The Edinburgh Clinic in the UK. “The point of glaucoma treatment is to avoid progression that patients experience as reduced quality of life,” he adds. Failure to remember this – for example, by emphasizing markers invisible to the patient, such as intraocular pressure (IOP), visual field indices, and retinal nerve fiber layer thickness – can lead to us failing the patient. “A clinician may deem a treatment a success by virtue of IOP control – but for the patient, it may be unacceptable due to poor tolerability.” Indeed, patients are increasingly aware of these issues – and expect to play an active role in management of their disease. As Jean-Sebastien Garrigue, Vice President, R&D, EMEA, Santen, says, “we perceive patients as key stakeholders – they are at the forefront of everything Santen does.”

“Switching from preserved eye-drops to preservative-free medication eliminated my itchy, dry, red eyes overnight – I wish somebody had told me about the preservative-free option a long time ago!” Glaucoma patient from the UK

Looking at glaucoma through a patient-centric lens may dramatically improve outcomes. Topical glaucoma therapy is famous for poor adherence rates – 37 percent for prostaglandin analogs versus 60 percent for bisphosphonates (1). Tatham suggests that poor self-medication rates, and consequent sub-optimal outcomes, could be improved by patient-centric dialogs: “Adherence is influenced by patients’ individual experiences: someone with a blind parent may have very different perceptions of glaucoma compared to one with no family history of glaucoma.” Lifestyle factors may also be important; for example, patients who work irregular shifts may struggle to optimize medication timing. These issues can all be addressed through meaningful dialog with the patient, says Tatham: “When choosing clinical strategies, we must consider patients’ individual experiences, habits and preferences; patients who are involved in clinical decisions tend to become more invested in their own care.” Paternalistic healthcare attitudes, says Tatham, belong in the past; shared decision-making – patient centricity – is the future (see “Shared decision making: a collaborative process”).

"We perceive patients as key stakeholders – they are at the forefront of everything Santen does." Jean-Sebastien Garrigue

Shared decision making: a collaborative process

• Help patients reach decisions about their care based on evidence and personal, informed preferences, past experiences with other medications and tolerability issues, health beliefs, and values (2)

• Ensure patients have good understanding of risks, benefits, and possible consequences of different options; empower patients to make informed decisions about their treatment (3)

• Contribute to patient autonomy (a key pillar of medical ethics) equivalent to the principles of beneficence, non-maleficence and justice (4)

Patient centricity may also support the efficacy of existing products, in particular by improving regime adherence. “Given the association between medication adherence and visual field preservation, improved adherence could significantly improve visual outcomes,” says Tatham, who cites data, based on a study of 48 patients, showing that a personalized glaucoma support and education program improved adherence in 95 percent of poorly adherent patients (5). He also pointed to evidence that patients are more likely to comply with treatment if they are aware both of the permanent nature of glaucoma-associated vision loss – about a third are not (based on a survey of 105 patients) (6) – and of treatment side effects. The potential impact of this type of patient education is suggested by a self-reporting study of 307 patients that predicted visual field loss over eight years was only 0.62 dB in regime-adherent glaucoma patients, compared with losses of 2.23 dB in poorly-compliant patients (7).

“Involving patients in healthcare decisions leads to better adherence, improved treatment efficacy, and reductions in more costly and invasive treatments.” Andrew Tatham

Real-world evidence
In glaucoma management, at least, seeking the patient perspective contributes to invaluable real-world evidence (RWE) on product efficacy. Garrigue expands: “With RWE, we can better appreciate treatment compliance and outcomes strategies for combatting glaucoma. RWE is increasingly important in bridging the gap between the gold standard of clinical trials – which often do not reflect the population or the challenges of everyday management of the disease – and the routine clinical setting.”

This view is supported by careful studies. Phil Graves, a behavioral psychologist based in Cambridge, UK, has developed a methodology that recognizes that much human behavior is driven by unconscious mental processes (8). Rather than simply asking glaucoma patients why they behave as they do, Graves emphasizes the importance of studying each participant’s behavior to understand how glaucoma patients’ experiences impact on their condition both directly and indirectly (see “How do patient beliefs and behavior affect the management of their condition?”).

“Patients’ explanations of their own behavior are often driven by post-rationalizations that reflect how they think they think, not how they actually think!”  Phil Graves

How do patient beliefs and behavior affect the management of their condition?

• Subjects: Glaucoma patients from Germany, Italy, Spain, UK; 55-80 years; being treated with eye-drops; n=32
   

• Findings:

  • Medication side effects can have an impact on therapy adherence, with patients more likely to skip treatment if they experience side effects from some eye drops, such as red, stinging, dry eyes. This, together with potential vision loss from glaucoma, may cause patients to feel the lack of benefit from administering drops, which in turn can further negatively impact on adherence. 

  • Patients with consistent daily routines and good understanding of their condition are more likely to adhere to treatment

  • Patient lifestyles, experiences, and knowledge gained through consultations can empower them to take control of their condition

  • If HCP consultations are time-constrained or heavily IOP-focused, patients may not appreciate the intangible/volatile nature of IOP and how it is impacted by behavior. This may result in patients being falsely encouraged by apparent IOP control and lead to poor adherence.

  • Time-constrained consultations also may prevent patients discussing difficulties with eye-drop administration
     

• Conclusion: Patients should be offered detailed, effective consultations, preferably including observation of their eye-drop administration technique as well as in depth discussions around tolerability and adherence.

Graves emphasizes three key take-home messages for glaucoma management, based on a qualitative survey of 32 glaucoma patients in Germany, Italy, Spain, and the UK:

• Try to be clear about the risk of blindness at the first diagnosis. The more this is emphasized at the starting point, the more likely patients are to adhere to medication regimes

• Don’t overprescribe – try to limit the number of medications and doses. The more daily doses a patient is prescribed, the more likely they are to omit one (with a rationalization of having at least taken some medication that day)

• Talk to patients about setting routines – for example, taking their medication first thing in the morning or last thing at night – this results in better adherence.
  More practical tips on how to talk to your patients are available through Santen’s resources.

But perhaps the most significant issue Graves identified was this: “Patients take comfort from hearing that their IOP is ‘stable’ and infer from this that they can continue whatever they have done up to that point – which may include missing doses!” 

Note too that Graves’ approach also revealed unique challenges of glaucoma management. Firstly, when diagnosed, most patients have no subjective symptoms; medication therefore provides only discomfort for some patients, not relief.  Secondly, medication adherence may conflict with life goals; for example, hyperaemia can make patients dissatisfied with their appearance.

“It’s very difficult to go into a professional environment when your eyes look red all the time.” Glaucoma patient from the UK

For Garrigue, the importance of this kind of study is evident. “Even patients with regular routines and a good understanding of blindness risk may miss doses if medication side effects interfere with daily life.” Worse, patients may ‘compensate’ for missed doses by taking drops immediately prior to a consultation – thereby normalizing their IOP on the day and giving the impression of IOP control despite day-to-day non-adherence. This, says Tatham, may lead patients to falsely correlate irregular dosing with disease control.

Real-world impacts
What is the real-world result of putting patients front and center? The impact on products designed with patients and clinicians in mind is clear, according to Garrigue. “On hearing that eye-drop instillation can be challenging in elderly patients or those with neck pain or arthritis, Santen made eye-drop bottles easier to squeeze, and developed eye-drop assistance devices for patients with weak or unsteady fingers or hands.” Similarly, Santen is developing digital products based on patient feedback, adds Garrigue. These include specially-designed smartphone reminders about administering eye-drops, and an online test that simulates vision loss due to glaucoma and aims to raise awareness of the importance of early detection and ongoing management.

CASE STUDIES – Tatham clinic

Case study 1: Clinicians should carefully consider how their communication influences patient perceptions!

• Patient: moderate primary open angle glaucoma, IOP of 16 mmHg

• Previous treatment: one eye-drop

• Situation: Deteriorating visual fields

• Recommendation: Additional treatment to lower IOP and reduce risk of further vision loss

• Reaction: Patient reluctant to accept further treatment, as IOP was controlled by existing regime, and previous doctor had said, “They would be fine if they kept IOP below 21 mmHg.”

• Conclusion: Focusing discussion on patient-relevant outcomes, such as visual field preservation, may improve patients’ understanding of the aims of treatment.

Case study 2: The benefits of a holistic approach

• Patient: marked conjunctival hyperaemia

• Previous treatment: two eye-drop medications

• Initial questioning: patient reported no problems since last review

• Further questioning: when directly asked about hyperaemia, patient stated that this was normal; keeping eyes comfortable required lubricant administration six times per day – and, to reduce discomfort, they only administered glaucoma medications every other day!

• Conclusion: Consider all needs of each patient, including direct effects of medication on quality of life and indirect effects arising from poor adherence (reduced treatment efficacy and increased progression).

“Reaching target IOP to reduce risk of symptomatic vision loss should not involve a compromise between treatment efficacy and tolerability.” Andrew Tatham

Patient-centric glaucoma management today
We are getting better at listening to patients, but there is still room for improvement. Tatham points to the new European Glaucoma Society guidelines – see “Recommended questions for patients,” (9): “These provide excellent suggestions to help understand the patient perspective.” Furthermore, says Tatham, reports suggest the advantages of this approach flow in both directions, enabling clinician and patient alike to better understand what is important to the other (3).

Recommended questions for patients (9)

• How do you think your eyes are doing?

• What do you think about your diagnosis?

• If you’re having any problems with your drops, what are they?

• If you’re worried about your sight, what are your worries?

• How have you been using your eye drops, comparing it with your prescribed treatment?

“I’d like to be able to tell someone in the clinic if I am having a really tough time with a particular drug.” Glaucoma patient from the UK

The nub of the matter: how do we make patient-centricity work?
To embed the patient voice within our industry, we must first listen to it. This, says Garrigue, requires establishment of long-term relationships with patients via panels, advisory boards, focus groups, surveys, seminars, advocacy groups, and even social media monitoring. Such tools must be used in ethical and compliant ways, ideally with medical anthropologists or psychologists alongside to advise on how best to listen to patients and understand their needs and expectations.

Santen has embraced this new mindset. “We’ve always been a patient-focused company; now we are taking that to the next level,” says Garrigue. “Patients are equal partners in our development of innovative products and services.” Thus, Santen prioritizes the patient voice at the earliest stages of the value chain. “Patient insights can transform R&D,” asserts Garrigue. “Understanding patient needs dramatically affects product design.” But the patient dialog, he says, must be maintained throughout the product life cycle to identify gaps in the whole ecosystem. Garrigue continues: “Patient feedback enables Santen to design research according to unmet needs, develop relevant patient-reported outcomes, update clinical trial protocols and logistics for successful trials completion, and develop patient educational material.” This evolving attitude is not limited to pharma, Garrigue adds: “Other stakeholders, including regulators and payers, are increasingly involving patients in their activities and decision-making processes.”

Santen’s range of innovative technologies to bring the “Best Vision Experience” to patients includes:

• cell therapy research programs, such as a key partnership with JCyte to develop progenitor retinal cells for patients with retinitis pigmentosa

• research into digital and connected objects via a joint venture with Verily, a sister company of Google

• community initiatives, such as a telemedicine collaboration with Orbis International to support training for ophthalmology professionals, and the company’s assistance with WHO and ITU digital initiatives to help prevent and manage ocular conditions.

Even as industry grasps the opportunities offered by patient insights and novel technologies, it must grapple with new challenges: COVID-19 is changing what is possible and currently desirable in glaucoma management. Nevertheless, even the pandemic cloud may have a silver lining (see “Patient centricity in pandemic times”); it seems that although COVID-19 is limiting HCP-patient interaction time, HCP consultations are changing for the better – and to ensure patients receive the support necessary to manage their disease.

Patient centricity during and after the pandemic

COVID-19 has resulted in constraints. . .

• non-urgent consultations and surgeries have been postponed, canceled, or will be conducted by phone or digital methods

• appointments may be less frequent than normal

• demands of social distancing reduce clinic capacity

• virtual clinics are associated with communication challenges: how can a patient’s voice be heard when they are not seeing their healthcare professional face to face?

“Virtual clinics must have systems to allow patients to report concerns and continue disease awareness education.” Andrew Tatham

 . . . But necessity is the mother of invention

• the digital transformation of healthcare is accelerating along with patient-centricity

• development of remote monitoring tools and patient-reported outcomes to support continuation of clinical trials while minimizing hospital and clinic visits

• increased use of teleophthalmology: self-tonometry, home perimetry, and smartphone-mediated visual acuity tests (10, 11); ongoing development of home-based visual field testing

• development of virtual clinics: patients are seen by a technician who performs remote clinical tests including tonometry, perimetry, and imaging

• sharing results of virtual clinics via video consultations, rather than by letter, provide a more effective clinician-patient dialog (test results are available for discussion during the consultation)
  For more information, see a blog series: Telemedicine: balancing innovative digital solutions with traditional consultations in ophthalmology and Learning from COVID-19 to broaden horizons in ophthalmology

“Self-measured parameters, obtained with self-monitoring, can give patients direct feedback on treatment effects – and this may help improve patient engagement.” Andrew Tatham

Conclusion
In glaucoma, the consensus is that real-world experiences, habits, and preferences of patients are critical guides to their treatment. Garrigue is convinced that the patient-HCP dialog should be continued and reinforced. “That requires respect, humbleness, curiosity, active listening, and the recognition that patients are equal partners,” he notes.  Tatham agrees, pointing out that patients are uniquely placed to understand the impact of disease, and therefore it is essential that we listen to their voices (12). In the sector as a whole, says Garrigue, the importance of real-world data continues to affect stakeholders across the entire healthcare value chain, including physicians, providers, payers, regulators, and industry – all of whom are using real-world evidence to guide their decisions.

In glaucoma, at least, this sea-change is partly driven by the understanding that disease control demands sustained and consistent adherence to eye-drop treatment, and this in turn requires patient buy-in and cooperation, which can be massively enhanced by effective HCP communication. To maximize treatment efficacy, says Tatham, healthcare professionals should holistically account for patient preferences, not least regarding treatment tolerability and impact on quality of life. When patients with chronic diseases are more involved in treatment choice, better treatment adherence follows (13).

Tatham’s final words: “We should not blame patients for poor adherence; adherence is also influenced by clinician communication and by treatment complexity and tolerability.”

NP-No product-EMEA-0105

Date of preparation: April 2021