Development of the Presbyopia Impact and Coping Questionnaire

Area of Science:

• Ophthalmology
• Patient-Reported Outcomes
• Psychometrics

Background:

• Presbyopia is an age-related condition impacting near vision, affecting daily function and quality of life.
• Patient-reported outcome instruments are crucial for assessing the real-world effects of visual conditions and treatments.

Purpose of the Study:

• To develop and validate the Presbyopia Impact and Coping Questionnaire (PICQ) as a patient-reported outcome measure.
• To assess the psychometric properties of the PICQ for use in clinical trials and practice.

Main Methods:

• Concept elicitation interviews and cognitive debriefing were used for item development.
• Psychometric analyses, including confirmatory factor analysis (CFA), reliability, and validity testing, were performed on data from a phase 2 clinical trial.
• Anchor-based and distribution-based methods were employed to establish meaningful change thresholds.

Main Results:

• The PICQ demonstrated good model fit with two domain scores: Coping and Impact.
• High internal consistency (Cronbach's alpha: 0.89 for Coping, 0.84 for Impact) and acceptable test-retest reliability were observed.
• The questionnaire showed good construct validity and responsiveness, with effect sizes indicating meaningful changes in relation to clinical measures.

Conclusions:

• The PICQ is a valid and reliable instrument for measuring presbyopia impacts and coping behaviors.
• PICQ scores are relevant for assessing the outcomes of presbyopia treatments.
• The established responder thresholds aid in interpreting within-patient changes in presbyopia impact and coping.