title: Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction.
abstract: BACKGROUND
  Intravitreal 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
  Patients 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02359149 . Registered February 4, 2015.
authors.affiliation: Department of Ophthalmology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. dordi.austeng@ntnu.no.|Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. dordi.austeng@ntnu.no.
authors.forename: Dordi
authors.initials: D
authors.lastname: Austeng
authors.affiliation: 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.
authors.forename: Tora Sund
authors.initials: TS
authors.lastname: Morken
authors.affiliation: Department of Ophthalmology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
authors.forename: Stine
authors.initials: S
authors.lastname: Bolme
authors.affiliation: Department of Public Health and General Practice, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
authors.forename: Turid
authors.initials: T
authors.lastname: Follestad
authors.affiliation: Regional Center for Healthcare Improvement, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
authors.forename: Vidar
authors.initials: V
authors.lastname: Halsteinli
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D058449:Intravitreal Injections / Q000451:nursing*; D008297:Male; D061214:Patient Safety; D017060:Patient Satisfaction; D057184:Practice Patterns, Nurses'; D011446:Prospective Studies; D012164:Retinal Diseases / Q000188:drug therapy* / Q000451:nursing; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors*; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D042461:Vascular Endothelial Growth Factor A
keywords: Age-related macular degeneration; Anti-VEGF; Diabetic macular edema; Intravitreal injection; Nurse; Randomized controlled trial; Retinal vein occlusion