Patient satisfaction - innovations in the ophthalmic market reflected in patient reported outcome measures Jesper Hjortdal Department of Ophthalmology Aarhus University Hospital, Denmark Financial disclosures: Research support from Carl Zeiss Meditec to AUH
The Challenge “ Perfect ” clinical and objective result But … Unhappy patient
Objective versus Patient Reported Outcomes • Many years ago FDA became aware that some patients were experiencing debilitating ocular and visual symptoms affecting their quality of life following laser-assisted in situ keratomileusis (LASIK). • While all FDA-approved lasers for LASIK undergo extensive nonclinical and clinical data evaluation prior to approval, the impact of the symptoms on the patients ’ daily lives was not previously collected or reported to FDA by the health care community or manufacturers. • In 2009, FDA partnered with the National Institutes of Health to conduct the LASIK Quality of Life Collaboration Project (LQOLCP) to develop a valid,web-based questionnaire capturing the patient ’ s experience following LASIK surgery with the ultimate goal of quantifying these patient reported outcomes in the LASIK population Eydelmann et al. JAMA Ophthalmology 2017
Patient-Reported Outcomes With LASIK (PROWL) • PROWL-1 was conducted at the Navy Medical Center, San Diego US • US-state-of-the-art laser platforms, • the patient population was motivated, • the clinical staff conducted extensive screening for eligible patients, • the “ profit motive ” was absent from the patient selection process • PROWL-2 was designed to assess the generalizability of the measurement properties of this newly developed questionnaire to the civilian population • 5 clinical centres • a prospective, multicentre study evaluating the measurement properties of the PROWL questionnaire prior to surgery and 3 months after surgery Eydelmann et al. JAMA Ophthalmology 2017
PROWL-1 • On-line web-based questionnaire • Assessment of the Psychometric Properties of PROWL ; Scales tested: • Visual symptoms (double images, glare, halos, and starbursts), • Dry eye symptoms, • Satisfaction with vision, • Satisfaction with LASIK, • Items from the NEI Refractive Error Quality of Life Instrument (NEI-RQL-42), NEI Visual Function Questionnaire (NEI-VFQ), • Ocular Surface Disease Index (OSDI) • The results of these studies supported the reliability and validity of visual symptom scales to evaluate the effects of LASIK surgery in future studies Eydelmann et al. JAMA Ophthalmology 2017
PROWL-1 and -2 Results • Participants with no visual symptoms at baseline, • 46% reported a new visual symptom at 3 months. • The most common were halos and starbursts. • Participants with visual symptoms at baseline, • 34% reported no visual symptoms at 3 months. • Visual symptom scores at 3 and 6 months had low correlations with optical aberrations, postoperative UCVA, postoperative cylinder, and magnitude of spherical equivalent refraction in preoperative myopes • Some correlation with OSDI scores • While visual symptoms were common following LASIK surgery, few participants reported a substantial impact from those symptoms . Eydelmann et al. JAMA Ophthalmology 2017
PROWL-1 and -2 Results Overall, for each visual symptom, worse visual symptom scores (more severe visual symptoms) were modestly associated with increasing OSDI severity
PROWL-1 and -2 Results Eydelmann et al. JAMA Ophthalmology 2017
PROWL - Conclusions • PROWL questionnaire available on-line • Would need validation if translated to other languages • Future studies have to document whether preoperative PROWL scores can predict post-operative scores • Could be helpful in informing patients and selecting the best patients to offer refractive surgery
PROM in Aarhus after SMILE for myopia @ 3 month Since 2011: Simple, routine PROM after refractive surgery • Overall satisfaction • Dry eye discomfort • Very satisfied • None • Satisfied • Mild • Somewhat satisfied • Somewhat • Not satisfied • Severe • Night vision disturbances • None • Mild • Somewhat • Severe
PROM in Aarhus after SMILE for myopia @ 3 month 2025 patients, 1680 patients completed PROM (80%) • Overall satisfaction • Dry eye discomfort • Very satisfied • None 86% 76% • Satisfied • Mild 10% 21% • Somewhat satisfied • Somewhat 3% 3% • Not satisfied • Severe 1% 0.2% • Night vision disturbances • None 77% • Mild 20% • Somewhat 3% • Severe 0.4%
PROM in Aarhus after SMILE for myopia @ 3 month Predictors for low overall satisfaction (Multiple logistic regression) Pre-operative factors • Patients with age above 50 years are significantly less satisfied • No predictive significant effect on PROM of: • Gender • Type of pre-op correction • Pre-op spherical or astigmatic refraction • Expected post-op refraction
PROM in Aarhus after SMILE for myopia @ 3 month Predictors for low overall satisfaction (Multiple logistic regression) Post-operative factors @ 3 months: • Poor UCVA • Night vision disturbances • No predictive significant effect of: • Lower BSCVA • Prediction error (difference between achieved and expected) • Dry eye discomfort
Conclusions • Overall very high patient satisfaction with SMILE surgery (>95%) • Few severe night vision disturbances and dry eye complaints (<1%) • Pre-operatively, higher age (>50 years) is associated with lower satisfaction after SMILE • Post-operatively, poor uncorrected distance visual acuity is associated with lower satisfaction after SMILE • Good standard of care to incorporate patient reported outcome in daily clinical practice
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