A Systematic Review of patient-reported Outcomes Instruments Relevant to Glaucoma

Précis: A minority (13 of 91) of patient-reported outcome measures for adult glaucoma meet rigorous quality standards for development. Others, despite limited evidence describing development, have been validated in glaucoma populations and should be used judiciously. Purpose: To identify, characterize and assess the quality of existing patient-reported outcome measures (PROMs) relevant to adult glaucoma patients, focusing on development and validation. Methods: We searched multiple databases for studies reporting development, validation, adaptation, or extension of vision-related PROMs in adults with glaucoma. Eligible reports were grouped by instrument for assessment using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) Risk of Bias checklist’s “Standards for evaluating the quality of PROM development.” Results: Among 91 instruments represented by 140 reports, 57 were developed for use in glaucoma patients; the remainder were validated in glaucoma patients. The instruments vary in length and complexity and evaluate domains within several constructs: vision-related QoL, health-related QoL, glaucoma knowledge, disease symptoms, vision-related activity limitation, treatment preferences, treatment side effects, patient satisfaction, and psychological status. According to COSMIN criteria, “adequate” development was documented for just 17 of 91 instruments, with descriptions of constructs, population(s) and context(s) for use, and published studies in the target population. Among these 17, concept elicitation was described for 13, of which 7 were developed since 2021. Conclusions: Thirteen instruments stand out in rigorous quality analysis based on the COSMIN Risk of Bias checklist. Other instruments without evidence of sound development have nevertheless been rigorously validated. PROMs we commonly use should be understood in the context of what they were designed to do, what they do well, their efficiency and limitations. It behooves us to follow and document best practices for developing and validating novel instruments.