Consensus group redefines nonadherence, nonpersistence in neovascular AMD treatment
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A group of retina specialists developed and published a new consensus-based classification system for nonadherence and nonpersistence to anti-VEGF therapies in neovascular age-related macular degeneration.
The study provides the framework for more consistent assessment, reporting and comparison of real-world patient engagement and outcomes of therapy.
“We also proposed a classification of factors affecting nonadherence and nonpersistence. Studies often group patients together and don’t look at their specific reasons, which cover a wide range from lack of response to the treatment to other health problems, lack of transportation or family support. We wanted to make sure we captured all possible scenarios of why people continue or not continue treatment,” Mali Okada, MMed, a vitreoretinal surgeon at the Royal Victorian Eye and Ear Hospital in Melbourne, Australia, said in an interview with Healio/OSN.
The project started from the observation that uniform criteria to define nonadherence in the context of neovascular AMD were lacking.
“While doing a literature review of the extent of nonadherence to establish how much this was an issue in our patients, we found that the terminology varied a lot between studies, and because of that, there was no way to critically assess how much this affected our patient population,” Okada said.
A uniform language to be used on a global level across different health care systems and contexts is needed for research to compare and develop common strategies aimed at improving adherence and persistence to therapies, she said.
“Several studies have shown that the outcomes of anti-VEGF treatment in the real world are far below the standards of clinical trials. Our project started before the pandemic, and then COVID-19 put even more the spotlight on this issue. Many nAMD patients worldwide have had and will have their treatment interrupted during this crisis. We need a consistent terminology also to assess the effect of the pandemic on patient outcomes,” Okada said.
A modified Delphi method
The project was undertaken by the nAMD Barometer Leadership Coalition, an international group of 14 retina experts, using a modified Delphi method. The first step was a systematic literature review by a subcommittee, from which the first definitions for nonadherence and nonpersistence were drafted.
“The terms adherence/nonadherence and persistence/nonpersistence are preferred today to synonyms such as compliance/noncompliance or absenteeism that put a lot of the blame on the patients,” Okada said.
Through several subsequent rounds, these definitions were submitted to consensus validation by the full leadership coalition. Each member gave a score from 1 to 10 to indicate their level of agreement. When the mean score was less than 7.5, the definition was amended and re-sent for a further round of evaluation. When full consensus was reached, the definitions were sent for endorsement to the Vision Academy, a larger group of more than 80 international experts.
“We used a rigorous, multistep, scientific method to derive consensus rather than relying on just a group of people sitting and saying, ‘We agree,’” Okada said.
The new definitions
The number of missed visits rather than the number of missed injections within a time frame of 12 months was used as a criterion for the definition of adherence/nonadherence, considering that different treatment regimens are used.
“Many physicians use T&E, some do PRN, and fixed regimens can be monthly or bimonthly, so we wanted to make sure these definitions could be used across different treatment paradigms,” Okada said.
The term adherence was subdivided into full adherence, indicating the ideal scenario of 100% attendance to visits, and adherence, which reflects the most likely scenario of medical practice in which 80% is used as the cutoff value for good adherence to medications. In the context of anti-VEGF treatment for AMD, this led to a definition of adherence as no more than one missed appointment in 12 months.
Considering again the different treatment paradigms, nonpersistence was defined as missed treatment or monitoring for 6 months. Two additional terms, planned discontinuation and transfer of care, were added to indicate cases in which the treatment cessation is intentional and not due to nonpersistence and cases in which treatment is continued at a different clinic and details are not known.
Knowing risk factors to plan interventions
The WHO classifies the reasons for nonadherence and nonpersistence to therapies in the five categories of patient-associated, condition-associated, therapy-associated, health system-associated and social-economic reasons.
“Within these categories, we introduced subcategories specific to intravitreal injections for AMD. This resulted in a tailored list, which we are currently using as the basis for two other projects. The first is an observational, qualitative study in which we interview patients, carers and physicians to identify barriers to adherence and assess their association with the visual outcomes of anti-VEGF therapy. The second is a more in-depth quantitative survey, a much larger study involving many countries to have a broad picture of what comes in the way of adherence to therapies in different health care systems and socioeconomic contexts,” Okada said.
A deeper understanding of the risk factors for nonadherence and nonpersistence to anti-VEGF therapy will hopefully help improve the outcomes of treatment in the future.
“Identifying risk factors for nonadherence should become part of triaging patients because if we know what the problems are, we can look for solutions and proactively modify the behavior of patients before they become nonadherent,” Okada said. “Strategies might involve home monitoring, liaison nurse services, personal telephone reminders, investing in community transports and many other possible interventions. But first we need to identify who is at risk and why because reasons are different, and we cannot always apply a blanket solution. We need interventions that are tailored to the patients, the health care system and the environment they live in.”
For more information:
Mali Okada, MMed, can be reached at Royal Victorian Eye and Ear Hospital, 32 Gisborne St. E, Melbourne, VIC 3002, Australia; email: mali.okada@eyeandear.org.au.
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