Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction

BMC Ophthalmology

Study Protocol

Stine Bolme¹  Tora Sund Morken²  Dordi Austeng³  Turid Follestad⁴  Vidar Halsteinli⁵ 

[1] Department of Ophthalmology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway;Department of Ophthalmology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway;Department of Laboratory Medicine, Children’s and Women’s Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway;Department of Ophthalmology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway;Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, Norway;Department of Public Health and General Practice, Norwegian University of Science and Technology (NTNU), Trondheim, Norway;Regional Center for Healthcare Improvement, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway;

关键词: Anti-VEGF;    Intravitreal injection;    Nurse;    Randomized controlled trial;    Age-related macular degeneration;    Retinal vein occlusion;    Diabetic macular edema;   

DOI  :  10.1186/s12886-016-0348-4

 received in 2016-01-21, accepted in 2016-06-24,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundIntravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) now improve or stabilize visual acuity in a number of previously untreatable eye diseases, of which the main are age-related macular degeneration, retinal vein occlusion and diabetic macular edema. Most patients require multiple injections over lengthy periods of time and the prevalence of treatable conditions is increasing. Anti-VEGF IVI normally administered by physicians, therefore represent a considerable workload on ophthalmologic clinics and will continue to do so in the near future. Nurse-administered IVI may relieve this workload, but the safety, cost and patient satisfaction of such an extended role for nurses in ophthalmologic clinics has not earlier been investigated. To investigate these outcomes following independent anti-VEGF IVI by trained nurses, a noninferiority randomized controlled trial is being conducted.Methods/DesignPatients eligible for anti-VEGF treatment, minimum 304, are recruited and randomized to IVI administration by either trained nurses or physicians. The primary outcome is safety, measured by difference in mean change in visual acuity between the two groups during an observation period of 12 months. Secondary outcomes are incidence of ocular adverse events, cost per patient and patient satisfaction.DiscussionThis study protocol describes the design of the first randomized controlled trial of nurse-administered IVI of anti-VEGF. The study is designed to examine safety, cost and patient satisfaction during 12 months follow-up.Trial registrationClinicalTrials.gov NCT02359149. Registered February 4, 2015.

【 授权许可】

CC BY   
© The Author(s). 2016