Development of a New Patient Reported Outcome (PRO) Measure for Refractive Surgery Patients as Part of the National Dataset in Refractive Surgery

Specific aims of the study The investigators aim to take a novel PRO questionnaire from the conceptual framing stage through a well-defined validation pathway including cognitive interviews, field data collection in the target population, and Rasch modification. Secondary aims are to take the modified instrument through prospective studies of repeatability and sensitivity to change. The investigators´ ultimate goal is to develop a concise, screen based, self-administered, self-archiving and self-scoring PRO instrument for use as part of the National Dataset in Refractive Surgery.

Study Design

Step 1. Conceptual framing and draft development Conceptual framing and draft development for the questionnaire is complete. This was based on a comprehensive literature review, patient and surgeon feedback during RCOphth Refractive Surgery Standards development consultation, and advice from a panel of expert collaborators.

The investigators began with a literature review of existing refractive error specific questionnaires, including the following: (1) National Eye Institute Refractive Quality of Life (NEI-RQL), (2) Refractive Status and Vision Profile (RSVP), (3) Quality of Life Impact of Refractive Correction (QIRC), (4) Quality of Vision (QoV), (5) Canadian Refractive Surgery Research Group Quality of Vision Questionnaire (QVQ), (6) PERK Study Questionnaire, (7) Multidimensional Quality of Life for Myopia (MQLM) Scale, (8) Myopia-Specific Quality of Life Questionnaire (MQLQ), (9) Subjective Vision Questionnaire (SVQ), (10) Refractive Error Quality of Life Scale (REQ-Thai), (11) The Freedom from Glasses Value Scale (FGVS), (12) Near Activity Visual Questionnaire (NAVQ), Catquest questionnaire (CatQuest 9SF), and ocular comfort index (OCI).

Those questionnaires have been identified as refractive error specific in a recent review article published in JRS. The ocular comfort index (OCI) addresses ocular surface irritation. Unlike previous instruments designed to measure eye comfort such as the widely used ocular surface disease index (OSDI), it is unidimensional and was developed using Rasch fitting.