Evaluation of item candidates for a diabetic retinopathy quality of life item bank

We are developing an item bank assessing the impact of diabetic retinopathy (DR) on quality of life (QoL) using a rigorous multi-staged process combining qualitative and quantitative methods. We describe here the first two qualitative phases: content development and item evaluation. After a comprehensive literature review, items were generated from four sources: (1) 34 previously validated patient-reported outcome measures; (2) five published qualitative articles; (3) eight focus groups and 18 semi-structured interviews with 57 DR patients; and (4) seven semi-structured interviews with diabetes or ophthalmic experts. Items were then evaluated during 3 stages, namely binning (grouping) and winnowing (reduction) based on key criteria and panel consensus; development of item stems and response options; and pre-testing of items via cognitive interviews with patients. The content development phase yielded 1,165 unique items across 7 QoL domains. After 3 sessions of binning and winnowing, items were reduced to a minimally representative set (n = 312) across 9 domains of QoL: visual symptoms; ocular surface symptoms; activity limitation; mobility; emotional; health concerns; social; convenience; and economic. After 8 cognitive interviews, 42 items were amended resulting in a final set of 314 items. We have employed a systematic approach to develop items for a DR-specific QoL item bank. The psychometric properties of the nine QoL subscales will be assessed using Rasch analysis. The resulting validated item bank will allow clinicians and researchers to better understand the QoL impact of DR and DR therapies from the patient's perspective.