Purpose
To validate the Ocular Pain Assessment Survey (OPAS), specifically designed to measure ocular pain and quality of life for use by eye care practitioners and researchers.
Design
A single-center, cohort study was conducted in patients with and without corneal and ocular surface pain at initial and follow-up visits over a 6-month period. The content of the OPAS was guided by literature review, a body of experts, and incorporating conceptual frameworks from existing pain questionnaires. The Wong-Baker FACES® Pain Rating Scale served as the gold standard for measuring intensity of ocular pain.
Subjects
102 patients aged 18 to 80 years completed the OPAS at the initial visit. 21 patients were followed up post-treatment.
Methods and Statistical Analysis
Indices of validity and internal consistency (Spearman’s rank-order, rs, or Pearson’s correlation coefficients, rp), and coefficient of reliability (Cronbach’s α) were determined in addition to equivalence testing, exploratory factor analysis (EFA) and diagnostic analysis.
Main outcome measures
Eye pain intensity was the primary outcome measure, while interference with quality of life (QoL), aggravating factors, associated factors, associated non-eye pain intensity and self-reported symptomatic relief were the secondary outcome measures.
Results
The OPAS had criterion validity at both initial (rs= 0.71, n= 102, P<0.01) and follow-up visits (rs= 0.97, n= 21, P<0.01). Equivalence tests yielded OPAS and gold standard equivalence for both the initial and follow-up visits. EFA supported 6 sub-scales (eye pain intensity 24 h and 2 weeks, non-eye pain intensity, quality of life, aggravating factors, and associated factors) confirming multi-dimensionality. Cronbach’s α >0.83 for all sub-scales established strong internal consistency, which correlated with the gold standard, including 24-hour eye pain intensity and QoL interference scores (rp = 0.81, 0.64, P< 0.001). At follow-up, reduction in pain scores was accompanied by improvement in all dimensions of the OPAS. Percent change in QoL correlated to percent change in the gold standard (rp = 0.53, P<0.05). The OPAS was sensitive (94%), specific (81%) and accurate (91%) with a diagnostic odds ratio greater than 50.
Conclusions
The OPAS is a valid, reliable and responsive tool with strong psychometric and diagnostic properties in the multi-dimensional quantification of corneal and ocular surface pain intensity, and quality of life.