PSS45 - A MULTI-STAKEHOLDER MULTICRITERIA DECISION ANALYSIS IN DIABETIC MACULAR EDEMA. MULTIDEX-EMD STUDY.

To determine the most relevant criteria in decision-making for the management of diabetic macular edema (DME) from the perspective of physicians, pharmacists, psychologist, health management experts, national/local health authorities and patients in Spain. Nineteen stakeholders (7 physicians, 4 pharmacists, 5 health authorities and health management experts, 1 psychologist and 2 patients’ representatives) participated in the project. The study was developed in three phases: phase A, an Advisory Board defined all the criteria (each of them characterised by several levels) that could influence the DME patients’ treatment decision-making. In phase B, the previously defined criteria were screened, by using an electronic questionnaire based on a discrete choice experiment (DCE). A multinomial logit model was fitted to analyse the questionnaire responses applying the back-forward algorithm, considering as relevant the criteria with p-values<0.05. Phase C was a deliberative process to discuss the DCE results. Thirty-one criteria were initially defined in phase A grouped in 5 categories: efficacy/effectiveness, safety, organisational and economic impact, Patient-Reported Outcomes (PRO), and persistence and others. The DCE results (phase B) established as relevant 10 out of 31 criteria in decision-making for a 50-65 year old standard DME patient: mean change in best corrected visual acuity (p-value<0.001), percentage of patients with an improvement ≥15 letters (p-value<0.001), effect duration per administration (p-value=0.008), retinal detachment (p-value<0.001), endophthalmitis (p-value=0.012), myocardial infarction (p-value<0.001), intravitreal haemorrhage (p-value=0.021), annual treatment cost per patient (p-value=0.001), Health-Related Quality of life (HRQL) (p-value=0.004) and disability level (p-value=0.021). From a multi-stakeholder perspective, the selection of an appropriate treatment for DME patients should guarantee the patient safety and maximize the improvement in visual acuity with the longest treatment effect. Furthermore, it should contribute to the system sustainability with an affordable treatment cost. Finally, it should assure a positive impact in HRQL and prevent from disability.