Assessment of patient-reported outcome measures used in corneal transplantation: a systematic review.

The aim of this study was to review all the articles that have implemented patient-reported outcome measures (PROMs) to evaluate the quality of life (QoL) in corneal transplantation and discuss quality assessments of the PROMs. An extensive literature review was undertaken to identify all the studies that used PROMs to assess the QoL in corneal transplantation. Non-original or review articles, articles on other subject area and articles on cost-effectiveness/utility without PROM data/results were excluded. Each PROM was assessed against the following criteria: content development (item identification and item selection), psychometric properties, validity, reliability, and responsiveness. 425 articles were identified of which 35 articles were included in the final review. PROMs in corneal transplantation were used to (a) evaluate the QoL after surgery, (b) compare the QoL scores between different surgical techniques and (c) determine the relationship between QoL and objective measures such as visual acuity, visual field and stereoacuity. A total of 17 PROMs were used to assess QoL in corneal transplantation. Whilst this search did not produce any PROMs that were specifically designed to assess corneal transplantation, most studies were found to have employed the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ 25). The Visual Function Index 14 (VF 14) performed better in the present quality assessment criteria compared to other PROMs, however, the NEI VFQ 25 and the VF 14 PROMs were not specifically developed for corneal transplantation and therefore the QoL assessment made using these PROMs may be incomplete. As improvements in various forms of lamellar transplantation surgery techniques such as UT-DSAEK and FT-DSAEK have resulted in better visual outcomes, improved graft survival and reduced complications, a corneal transplantation specific PROM will be useful in clinical settings to compare the outcomes of different surgical techniques from the patient perspective.

Development and Psychometric Assessment of Novel Item Banks for Hereditary Retinal Diseases.

SIGNIFICANCE: This study develops psychometrically valid item banks across 10 areas of quality of life (QoL) specific to people with hereditary retinal diseases, which will enable clinicians and researchers to explore the impact of hereditary retinal diseases across all aspects of QoL. PURPOSE: The purpose of this study was to assess the psychometric properties of hereditary retinal disease QoL item banks using Rasch analysis and demonstrate the effectiveness of a computerized adaptive testing (CAT) system in obtaining precise measurement of QoL using only a few items. METHODS: The hereditary retinal disease item banks were answered by 233 participants (median age, 58 years; range, 18 to 94 years; female participants, 59%). The hereditary retinal disease item banks cover 10 QoL domains: activity limitation, mobility, emotional, social, convenience, economic, health concerns, visual symptoms, ocular comfort symptoms, and general symptoms. Rasch analysis assessed the psychometric properties of the 10 item banks and provided item calibrations for the development of CAT. Computerized adaptive testing simulations were performed to calculate the average number of items required to gain precise measurement of each QoL domain. RESULTS: The convenience, economic, visual symptoms, and the social domains formed unidimensional scales. However, the activity limitation and health concerns domains demonstrated multidimensionality and required major modifications to resolve this, which resulted in four new QoL domains, namely, reading, driving, lighting, and concerns about the disease progression. In total, 10 item banks underwent CAT simulation testing, which indicated that 8 to 12 items were required to gain precise measurement of each QoL domain. CONCLUSIONS: We have developed 10 psychometrically valid item banks to measure the QoL domains relevant to people with hereditary retinal diseases. On average, only 5 and 10 items were required to gain measurement at moderate and high precision, respectively.

Assessment of patient-reported outcomes in retinal diseases: a systematic review.

Advances in the understanding of the genetic, molecular, and cellular biology of retinal diseases have led to the development of new treatments. These expanding treatment options demand appropriate outcome measures for studies of treatment benefit including patient-reported outcomes (PROs). A plethora of PRO instruments assess impacts of retinal diseases from the patients' perspectives. We review all the studies that implemented PRO assessment in retinal diseases and also discuss quality assessment of the PRO instruments. We also include qualitative studies that explored quality of life impact on people with retinal diseases. Most studies used PRO instruments not specifically developed for retinal diseases (non-disease specific), nor have they undergone comprehensive validation in this disease group. A few retina-specific PRO instruments are available, but they suffer from limited content coverage of quality of life. Finally, we discuss the need for a new comprehensive and technologically advanced PRO instrument to assess quality of life impacts in retinal diseases.