A study to assess the feasibility of undertaking a randomized controlled trial of adherence with eye drops in glaucoma patients

Abstract

BackgroundAdherence with therapy could influence the progression of glaucoma and ultimately affect the onset of visual impairment in some individuals. This feasibility study evaluated the measures to be used for a future randomized controlled trial assessing the effects of group-based education on adherence with eye drops.MethodsPeople diagnosed with glaucoma within the previous 12 months attending a regional ophthalmology clinic in the North West of England were recruited. A two-session education program delivered one week apart had been devised as part of a previous project. A combined adult learning and health needs approach to education was taken. Outcomes measured were knowledge of glaucoma, self-report of adherence, illness perception, beliefs about medicines, patient enablement, and general health (Short Form-12). Adherence was also measured objectively using a Medical Events Monitoring System device.ResultsTwenty-six participants consented to undertake the educational program and 19 produced analyzable data. Knowledge of glaucoma, illness perception, beliefs about medicine, and patient enablement all showed statistically significant improvements after education. Mean adherence with eye drops was maintained above 85% before and for 3 months after attendance at the educational program. Self-report exaggerated adherence by at least 10% when compared with the objective Medical Events Monitoring System data, and in fact the kappa agreement was zero.ConclusionAll questionnaires other than the Short Form-12 were considered to be valuable measures and use of a Medical Events Monitoring System device was considered to be an objective surrogate measure for adherence with eye drops. A multicenter, randomized, controlled equivalence trial of group versus individualized education using adherence as the primary outcome is the next step.

Predictors of Adherence to Glaucoma Treatment in a Multisite Study

“…Reliability of the measure is supported by a low rate of technical errors (26) and validity is supported by correlations between MEMS and adherence-linked physiological outcomes such as viral load in HIV (30). Although MEMS are widely used to measure adherence, they may create a reactive measurement effect: In one glaucoma study the use of MEMS was associated with higher than normal adherence (27); in another a 2-week run-in period was used to rule out reactive measurement effects (28). In our own prior research we observed a return to baseline adherence 6–8 weeks after patients started using MEMS (26).…”

The Impact of Glaucoma Medications on Corneal Wound Healing

“…The side effects of antiglaucoma drugs are known to reduce drug adherence and therefore could influence the progression of glaucoma. 1 Local side effects include ocular discomfort upon instillation, tear film instability, conjunctival inflammation, subconjunctival fibrosis, conjunctival epithelium changes, eyelid dermatitis, and corneal surface and endothelial impairment. 2 Therefore, it is important to study the compounds of these water-based solutions.…”

Systematic review of educational interventions to improve glaucoma medication adherence: an update in 2015

“…Richardson and colleagues 30 conducted a quasi-experimental pre-post analysis of a group based education program for patients in England on monotherapy for open-angle glaucoma or ocular hypertension and measured its effect on adherence. A glaucoma trained nurse lead a 2.5 hour group based education session that allowed time for patients to describe their experience with glaucoma and ask questions.…”

“…14,22,23,30,32 Scripted education sessions 14,22 did not improve medication adherence and satisfaction was not measured with these interventions, so we do not know if patients were satisfied with this scripted information. The three interventions tested in RCTs that were really successful in improving adherence 17,26 used an individualized approach to supporting patients' health care needs and beliefs.…”