Sabrina Müller1, Sophia Junker2, Thomas Wilke3, Albrecht Lommatzsch4, Alexander K Schuster5, Hakan Kaymak6, Christoph Ehlken7, Focke Ziemssen8. 1. IPAM e.v, University of Wismar, University of Applied Sciences, Alter Holzhafen 19, 23966, Wismar, Germany. sabrina.mueller@ipam-wismar.de. 2. Ingress-Health HWM GmbH, Alter Holzhafen 19, 23966, Wismar, Germany. 3. IPAM e.v, University of Wismar, University of Applied Sciences, Alter Holzhafen 19, 23966, Wismar, Germany. 4. Augenzentrum Am St. Franziskus-Hospital Münster, Hohenzollerning 74, 48145, Münster, Germany. 5. MORE Reading Center, Augenklinik Und Poliklinik Universitätsmedizin Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. 6. Augenchirugie Clinic, Theo-Champion-Str. 1, 40549, Düsseldorf, Germany. 7. Universitaetsklinikum Schleswig-Holstein Kiel, Arnold-Heller-Straße 3, 24105, Kiel, Germany. 8. Universitäts-Augenklinik Tübingen, Elfriede-Aulhorn-Straße 7, 72076, Tübingen, Germany.
Abstract
OBJECTIVE: To develop and validate a questionnaire for the investigation of non-adherence (NA) barriers in patients receiving intravitreal injection (IVT). DESIGN: Questionnaire development and cross-sectional patient survey combined with a retrospective medical chart review. PARTICIPANTS: German patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) receiving anti-vascular endothelial growth factor (anti-VEGF) treatment via IVT. METHODS: The previously validated (indications: atrial fibrillation, human immunodeficiency virus, chronic inflammatory lung disease) Adherence Barriers Questionnaire (ABQ) was revised according to specifications of IVT, within the framework of an expert panel. The ABQ-IVT, which initially consisted of 24 items formulated as statements (4-point-Likert-scale ranging from "strongly agree" to "strongly disagree"), was applied in a cross-sectional survey. Evaluation of the questionnaire included an assessment of internal consistency and factor analysis. The occurrence of potential barriers in the patient sample was evaluated using descriptive statistics. To identify patient subpopulations, hierarchical cluster analysis was performed using ABQ-IVT answers as predictors. Due to difficulties in capturing NA as an external criterion, the evaluation of the questionnaire was limited to its internal validity and reliability. MAIN OUTCOME MEASURES: Patients' answers to the ABQ-IVT questionnaire and interviews. RESULTS: Of 253 patients, 234 (92%) were able to complete the ABQ-IVT questionnaire. Within the reliability analysis, the ABQ-IVT was reduced to 17 items. The condensed questionnaire demonstrated good internal consistency (Cronbach's alpha = 0.78), and factor analysis showed no evidence for subscales of the questionnaire. Nearly half of the patients (49%) reported being affected by at least three different barriers. On average, a patient was affected by 3.1 barriers. The most frequently reported barriers were "Challenge due to time commitment of physician visits" (45% of the patients), "Depression" (29%) and "Travel and opportunity costs" (27%). Cluster analysis identified six patient subpopulations, each affected by different sets of barriers and differed regarding their patient characteristics. CONCLUSIONS: The ABQ-IVT is a practical and reliable instrument for identifying patient-specific barriers to IVT treatment adherence. In practice, the questionnaire may be useful in assessing whether individual patients are at higher risk of NA due to specific adherence barriers. Aside from better awareness, this allows earlier interventions, though these still need to be validated. Patient subpopulations face different barriers and may, therefore, need distinct preventative care.
OBJECTIVE: To develop and validate a questionnaire for the investigation of non-adherence (NA) barriers in patients receiving intravitreal injection (IVT). DESIGN: Questionnaire development and cross-sectional patient survey combined with a retrospective medical chart review. PARTICIPANTS: German patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) receiving anti-vascular endothelial growth factor (anti-VEGF) treatment via IVT. METHODS: The previously validated (indications: atrial fibrillation, human immunodeficiency virus, chronic inflammatory lung disease) Adherence Barriers Questionnaire (ABQ) was revised according to specifications of IVT, within the framework of an expert panel. The ABQ-IVT, which initially consisted of 24 items formulated as statements (4-point-Likert-scale ranging from "strongly agree" to "strongly disagree"), was applied in a cross-sectional survey. Evaluation of the questionnaire included an assessment of internal consistency and factor analysis. The occurrence of potential barriers in the patient sample was evaluated using descriptive statistics. To identify patient subpopulations, hierarchical cluster analysis was performed using ABQ-IVT answers as predictors. Due to difficulties in capturing NA as an external criterion, the evaluation of the questionnaire was limited to its internal validity and reliability. MAIN OUTCOME MEASURES: Patients' answers to the ABQ-IVT questionnaire and interviews. RESULTS: Of 253 patients, 234 (92%) were able to complete the ABQ-IVT questionnaire. Within the reliability analysis, the ABQ-IVT was reduced to 17 items. The condensed questionnaire demonstrated good internal consistency (Cronbach's alpha = 0.78), and factor analysis showed no evidence for subscales of the questionnaire. Nearly half of the patients (49%) reported being affected by at least three different barriers. On average, a patient was affected by 3.1 barriers. The most frequently reported barriers were "Challenge due to time commitment of physician visits" (45% of the patients), "Depression" (29%) and "Travel and opportunity costs" (27%). Cluster analysis identified six patient subpopulations, each affected by different sets of barriers and differed regarding their patient characteristics. CONCLUSIONS: The ABQ-IVT is a practical and reliable instrument for identifying patient-specific barriers to IVT treatment adherence. In practice, the questionnaire may be useful in assessing whether individual patients are at higher risk of NA due to specific adherence barriers. Aside from better awareness, this allows earlier interventions, though these still need to be validated. Patient subpopulations face different barriers and may, therefore, need distinct preventative care.
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