Consensus group redefines non-adherence and non-persistence in the treatment of neovascular AMD


September 24, 2021

4 minutes to read

Source / Disclosures

Disclosures: Okada reports receiving in-kind support from Bayer Travel during the conduct of the study and personal costs from Bayer outside of the submitted work.

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A group of retinal specialists have developed and published a new consensus classification system for non-adherence and non-persistence to anti-VEGF therapies in age-related neovascular macular degeneration.

The study provides the framework for a more consistent assessment, reporting and comparison of real-world patient engagement and therapy outcomes.

“We have also proposed a classification of factors affecting non-adherence and non-persistence. Studies often group patients together and do not look at their specific reasons, which cover a wide range from lack of response to treatment to other health issues, to lack of transportation or family support. We wanted to make sure that we captured all possible scenarios as to why people continue treatment or not ”, Mali Okada, MMean, a vitreoretinal surgeon from the Royal Victorian Eye and Ear Hospital in Melbourne, Australia, said in an interview with Healio / OSN.

The project started from the observation that there was a lack of uniform criteria to define non-adherence in the context of neovascular AMD.

“In doing a review of the literature on the extent of nonadherence to establish how much of a problem this was in our patients, we found that the terminology varied a lot between studies, and because of this, it there was no way to critically assess how much this affected our patient population, ”Okada said.

Consistent language to be used globally in different healthcare systems and settings is needed for research to compare and develop common strategies to improve adherence and persistence to therapies, she said.

“Several studies have shown that the results of anti-VEGF treatment in the real world are well below clinical trial standards. Our project started before the pandemic, then COVID-19 put even more emphasis on this issue. Many patients with nAMD around the world have had and will have their treatment interrupted during this crisis. We also need consistent terminology 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 retinal experts, using a modified Delphi method. The first step was a systematic review of the literature by a subcommittee, from which the first definitions of non-adherence and non-persistence have been drafted.

“The terms adherence / non-adherence and persistence / non-persistence are preferred today over synonyms such as compliance / non-compliance or absenteeism which put a lot of the blame on the patients,” Okada said.

Over the course of several subsequent cycles, these definitions were subjected to consensus validation by the entire coalition of leaders. Each member assigned a score from 1 to 10 to indicate their level of agreement. When the mean score was less than 7.5, the definition was changed and sent back for a new round of assessments. When full consensus was reached, the definitions were sent for approval to Vision Academy, a larger group of over 80 international experts.

“We used a rigorous, multi-step scientific method to build consensus rather than just relying on a group of people sitting down and saying, ‘We agree,’” Okada said.

The new definitions

The number of missed visits rather than the number of missed injections over a 12 month period was used as a criterion for defining adherence / non-adherence, since different treatment regimens are used.

“A lot of doctors use T&E, some do PRN, and the fixed regimens can be monthly or bi-weekly, so we wanted to make sure these definitions could be used in different treatment paradigms,” Okada said.

The term membership has been subdivided into full adherence, indicating the ideal scenario of 100% visitation attendance, and adherence, which reflects the most likely scenario in medical practice where 80% is used as the cut-off for good medication adherence . As part of anti-VEGF treatment for AMD, this has led to a definition of adherence because no more than one missed appointment in 12 months.

Looking again at the different treatment paradigms, non-persistence was defined as missed treatment or monitoring for 6 months. Two additional terms, planned discontinuation and transfer of care, have been added to indicate cases in which discontinuation of treatment is intentional and not due to non-persistence and cases in which treatment is continued at a different clinic and details are not known.

Know the risk factors to plan interventions

The WHO classifies the reasons for non-adherence and non-persistence to therapy in the five categories of reasons associated with the patient, disease, therapy, health system and socio-economic.

“Within these categories, we have introduced specific subcategories of intravitreal injections for AMD. This resulted in a bespoke list, which we are currently using as the basis for two other projects. The first is a qualitative observational study in which we interview patients, caregivers, and physicians to identify barriers to adherence and assess their association with visual outcomes of anti-VEGF therapy. The second is a more in-depth quantitative survey, a much larger study involving many countries to gain an overview of what hinders adherence to therapies in different health systems and socio-economic contexts, ”Okada said.

A better understanding of the risk factors for non-adherence and non-persistence of anti-VEGF therapy will hopefully help improve treatment outcomes in the future.

“Identifying risk factors for non-adherence should be part of triage of patients, because if we know the issues, we can seek solutions and proactively change patient behavior before they become non-adherents. “Okada said. “Strategies can involve home monitoring, liaison nurse services, personal phone reminders, investing in community transportation, and many other possible interventions. But first we need to identify who is at risk and why, because the reasons are different, and we can’t always apply a comprehensive solution. We need interventions tailored to patients, the healthcare system and the environment in which they live.

For more information:

Mali Okada, MMean, can be reached at the Royal Victorian Eye and Ear Hospital, 32 Gisborne St. E, Melbourne, VIC 3002, Australia; email: [email protected]

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