Patient satisfaction - innovations in the ophthalmic market - - PowerPoint PPT Presentation

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
• ptical 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

• Overall satisfaction
• Very satisfied
• Satisfied
• Somewhat satisfied
• Not satisfied
• Dry eye discomfort
• None
• Mild
• Somewhat
• Severe
• Night vision disturbances
• None
• Mild
• Somewhat
• Severe

Since 2011: Simple, routine PROM after refractive surgery

PROM in Aarhus after SMILE for myopia @ 3 month

• Overall satisfaction
• Very satisfied

86%

• Satisfied

10%

• Somewhat satisfied

3%

• Not satisfied

1%

2025 patients, 1680 patients completed PROM (80%)

• Dry eye discomfort
• None

76%

• Mild

21%

• Somewhat

3%

• Severe

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