title: Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL).
abstract: OBJECTIVE
  Patient-reported outcome (PRO) measures for laser in situ keratomileusis (LASIK) are needed.
  
  
  OBJECTIVE
  To develop PRO measures to assess satisfaction, eye-related symptoms, and their effect on functioning and well-being following LASIK based on patient and expert input.
  
  
  METHODS
  The Patient-Reported Outcomes With LASIK (PROWL) studies were prospective observational studies of patients undergoing LASIK surgery for myopia, hyperopia, or astigmatism. PROWL-1 was a single-center study of active-duty US Navy personnel and PROWL-2 was a 5-center study of civilians. PROWL-1 enrolled 262 active-duty service personnel and PROWL-2 enrolled 312 civilians 21 years or older who spoke English; 241 individuals in PROWL-1 and 280 in PROWL-2 completed a baseline questionnaire before surgery. The analytic sample included those also completing 1 or more follow-up questionnaires: 240 (99.6%) of those in PROWL-1 and 271 (94.4%) of those in PROWL-2. Questionnaires were self-administered through the internet preoperatively and at 1 and 3 months postoperatively in both studies and at 6 months postoperatively in PROWL-1. PROWL-1 began in August 2011 and was completed May 30, 2014; PROWL-2 began in July 2012 and was completed June 27, 2014. Data were analyzed from June 28, 2014, to October 24, 2016.
  
  
  METHODS
  Scales assessing visual symptoms (double images, glare, halos, and starbursts), dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery. Items from the National Eye Institute (NEI) Refractive Error Quality of Life Instrument (NEI-RQL-42), NEI Visual Function Questionnaire (NEI-VFQ), and the Ocular Surface Disease Index (OSDI) were included. All scales are scored on a 0 to 100 possible range. Construct validity and responsiveness to change were evaluated (comparing scores before and after surgery).
  
  
  RESULTS
  The median age of the 240-person PROWL-1 analytic sample was 27 years (range, 21-52 years); 49 were women (20.4%). The median age of the 271-person PROWL-2 analytic sample was 30 years (range, 21-57 years); 147 were women (54.2%). Internal consistency reliabilities for the 4 visual symptom scales ranged from 0.96 to 0.98 in PROWL-1 and from 0.95 to 0.97 in PROWL-2. The median (interquartile range) test-retest intraclass correlation was 0.69 (0.57-0.79) and 0.76 (0.68-0.84) in PROWL-1 and PROWL-2, respectively. Product-moment correlations of satisfaction with surgery with visual symptom scales at follow-up evaluations ranged from r = 0.24 to r = 0.49. Measures improved from baseline to follow-up, with effect sizes of 0.14 to 1.98, but scores on the NEI-RQL-42 glare scale worsened at the 1-month follow-up. Hours of work did not change significantly from baseline to 1-month follow-up, with the mean number (mean [SD] difference) in PROWL-1 of 41.7 vs 40.9 hours (-0.8 [18.7]) and in PROWL-2 of 38.8 vs 38.2 hours (-0.6 [17.1]).
  
  
  CONCLUSIONS
  The results of these studies support the reliability and validity of visual symptom scales to evaluate the effects of LASIK surgery in future studies.
authors.affiliation: Department of Medicine, UCLA (University of California, Los Angeles) 2Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Ron D
authors.initials: RD
authors.lastname: Hays
authors.affiliation: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Tarver
authors.affiliation: Department of Medicine, UCLA (University of California, Los Angeles).
authors.forename: Karen L
authors.initials: KL
authors.lastname: Spritzer
authors.affiliation: Department of Psychology, UCLA.
authors.forename: Steve
authors.initials: S
authors.lastname: Reise
authors.affiliation: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Gene
authors.initials: G
authors.lastname: Hilmantel
authors.affiliation: Department of Ophthalmology, Navy Refractive Surgery Center, Naval Medical Center San Diego, San Diego, California.
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Hofmeister
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Keri
authors.initials: K
authors.lastname: Hammel
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Jeanine
authors.initials: J
authors.lastname: May
authors.affiliation: Division of Epidemiology and Clinical Applications, National Eye Institute, Bethesda, Maryland7Viewpoint Editor, JAMA Ophthalmology.
authors.forename: Frederick
authors.initials: F
authors.lastname: Ferris
authors.affiliation: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Malvina
authors.initials: M
authors.lastname: Eydelman
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D020731:Keratomileusis, Laser In Situ / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D011446:Prospective Studies; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D055815:Young Adult