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Purpose: To compare the results from a simulated computerized adaptive test (CAT) for the 28-item Impact of Vision Impairment (IVI) questionnaire and the original paper-pencil version in terms of efficiency (main outcome), defined as percentage item reduction., Methods: Using paper-pencil IVI data from 832 participants across the spectrum of vision impairment, item calibrations of the 28-item IVI instrument and its associated 20-item vision-specific functioning (VSF) and 8-item emotional well-being (EWB) subscales were generated with Rasch analysis. Based on these calibrations, CAT simulations were conducted on 1000 cases, with 'high' and 'moderate' precision stopping rules (standard error of measurement [SEM] 0.387 and 0.521, respectively). We examined the average number of items needed to satisfy the stopping rules and the corresponding percentage item reduction, level of agreement between person measures estimated from the full IVI item bank and from the CAT simulations, and item exposure rates (IER)., Results: For the overall IVI-CAT, 5 or 9.7 items were required, on average, to obtain moderate or high precision estimates of vision-related quality of life, corresponding to 82.1 and 65.4% item reductions compared to the paper-pencil IVI. Agreement was high between the person measures generated from the full IVI item bank and the IVI-CAT for both the high precision simulation (mean bias, - 0.004 logits; 95% LOA - 0.594 to 0.587) and moderate precision simulation (mean bias, 0.014 logits; 95% LOA - 0.828 to 0.855). The IER for the IVI-CAT in the moderate precision simulation was skewed, with six EWB items used > 40% of the time., Conclusion: Compared to the paper-pencil IVI instrument, the IVI-CATs required fewer items without loss of measurement precision, making them potentially attractive outcome instruments for implementation into clinical trials, healthcare, and research. Final versions of the IVI-CATs are available.

Importance: Previous work has reported a link between diabetic retinopathy/diabetic macular edema (DR/DME) and psychosocial functioning, although the extent and direction of the association remains uncertain., Objective: To determine the relationship between DR/DME and psychosocial functioning, the latter an umbrella term used to capture the emotional and social aspects of functioning which may include, for example, depression; depressive disorder; anxiety; vision-specific distress; diabetes-specific distress and emotional and social well-being., Evidence Review: PubMed, Embase, Medline and the Cochrane Central register were systematically searched for relevant interventional and observational quantitative studies using standardised criteria. Studies with DR/DME and psychosocial functioning as exposures or outcomes were accepted. Study quality was evaluated using the modified Newcastle-Ottawa scale for observational studies, and the modified Down's and Black checklist for interventional studies., Findings: Of 1827 titles initially identified, 42 were included in the systematic review. They comprised of four interventions (one RCT, three non-RCTs) and 38 observational studies (33 cross sectional, five prospective). In studies with DR/DME as the exposure (n = 28), its severity and related vision impairment were consistently associated with poor psychosocial outcomes, mostly higher incidence of depression and depressive symptoms. Baseline depression and depressive symptoms were also associated with greater DR incidence and progression of DR. Medical intervention strategies showed significant improvement in psychosocial outcomes in patients with DR, such as significant improvements in mental health domain scores of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ 25)., Conclusion and Relevance: Severity of DR, DME and associated vision loss are significantly associated with poor psychosocial outcomes. Aspects of depression and its symptoms show a bi-directional association, with increased incidence and progression of DR significant in those with baseline depression or depressive symptoms. Based on these findings, we propose two areas that may benefit from targeted interventions: (1) Prevention of development of poor psychological outcomes by preventing and delaying progression of DR/DME; and (2) Improved detection and management of poor psychological functioning by improving screening tools and multidisciplinary care for patients. Subsequent longitudinal studies can further help establish the underlying relationship between the two measures.

Purpose: The purpose of this study was to assess the psychometric properties of diabetic retinopathy (DR) and diabetic macular edema (DME) quality-of-life (QoL) item banks and determine the utility of the final calibrated item banks by simulating a computerized adaptive testing (CAT) application., Methods: In this clinical, cross-sectional study, 514 participants with DR/DME (mean age ± SD, 60.4 ± 12.6 years; 64% male) answered 314 items grouped under nine QoL item pools: Visual Symptoms (SY); Ocular Comfort Symptoms (OS); Activity Limitation (AL); Mobility (MB); Emotional (EM); Health Concerns (HC); Social (SC); Convenience (CV); and Economic (EC). The psychometric properties of the item pools were assessed using Rasch analysis, and CAT simulations determined the average number of items administered at high and moderate precision levels., Results: The SY, MB, EM, and HC item pools required minor amendments, mainly involving removal of six poorly worded, highly misfitting items. AL and CV required substantial modification to resolve multidimensionality, which resulted in two new item banks: Driving (DV) and Lighting (LT). Due to unresolvable psychometric issues, the OS, SC, and EC item pools were not pursued further. This iterative process resulted in eight operational item banks that underwent CAT simulations. Correlations between CAT and the full item banks were high (range, 0.88-0.99). On average, only 3.6 and 7.2 items were required to gain measurement at moderate and high precision, respectively., Conclusions: Our eight psychometrically robust and efficient DR/DME item banks will enable researchers and clinicians to accurately assess the impact and effectiveness of treatment therapies for DR/DME in all areas of QoL.

Purpose: 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., Methods: 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., Results: 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., Conclusions: 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.

Purpose: Assessing the efficacy of treatment modalities for diabetic retinopathy (DR) from the patient's perspective is restricted due to a lack of a comprehensive patient-reported outcome measure. We are developing a DR-specific quality of life (QoL) item bank, and we report here on the qualitative results from the first phase of this project., Methods: Eight focus groups and 18 semi-structured interviews were conducted with 57 patients with DR. The sessions were transcribed verbatim and iteratively analysed using the constant comparative method and NVIVO software., Results: Participants had a median age of 58 years (range 27-83 years). Twenty-seven (47%) participants had proliferative DR in the better eye, and 14 (25%) had clinically significant macular oedema. Nine QoL domains were identified, namely visual symptoms, ocular surface symptoms, vision-related activity limitation, mobility, emotional well-being, health concerns, convenience, social, and economic. Participants described many vision-related activity limitations, particularly under challenging lighting conditions; however, socioemotional issues were equally important. Participants felt frustrated due to their visual restrictions, concerned about further vision loss and had difficulty coping with this uncertainty. Restrictions on driving were pervasive, affecting transport, social life, relationships, responsibilities, work and independence., Conclusions: Patients with DR experience many socioemotional issues in addition to vision-related activity limitations. Data from this study will be used to generate data for a DR-specific QoL item bank.

Purpose: To assess and re-engineer the Vision Core Measure 1 (VCM1) questionnaire in low vision (LV) and cataract participants using Rasch analysis., Methods: 295 participants drawn from a low vision clinic and 181 from a cataract surgery waiting list completed the 10-item VCM1. Unidimensionality, item fit to the model, response category performance, differential item functioning (DIF) and targeting of items to patients were assessed. Category collapsing and item removal were considered to improve the questionnaire., Results: The initial fit of the VCM1 (combined populations) to the Rasch model showed lack of fit (chi2 = 83.3, df = 50, p = 0.002). There was evidence of DIF between the two populations which could not be resolved. Consequently, each population was assessed separately. Irrespective of the population, disordering of response category thresholds was evident. However, collapsing categories produced ordered thresholds and resulted in fit to the Rasch model for the LV (Total chi2 = 41.6, df = 30; p = 0.08) and cataract population (Total chi2 = 17.9, df = 20, p = 0.59). Overall, the VCM1 behaved as a unidimensional scale for each population and no item showed evidence of DIF. Item targeting to patients was however sub-optimal particularly for the cataract population., Conclusion: The VCM1 questionnaire could be improved by shortening the response scale, although different response categories are required for cataract and LV populations. Calibration of items also differed across populations. While the VCM1 performs well within the Rasch model, in line with its initial purpose, it requires the addition of items to satisfactorily target low vision and cataract populations.

Purpose: To assess if the Impact of Vision Impairment (IVI) is a valid instrument to measure participation in daily activities and rehabilitation in patients with age-related macular degeneration (AMD) and varying levels of visual impairment., Methods: Participants, recruited from a public eye hospital and low vision centers, completed the IVI questionnaire. The IVI and its three subscales were assessed for fit to the Rasch model. Unidimensionality, item fit, response category performance, and targeting of items to patients were assessed. Confirmatory factor analysis (CFA) was used to assess the three-factor model of the IVI in this sample of AMD patients., Results: 219 patients (mean +/- SD age = 83.5 +/- 7.4 yr) were recruited. Of these, 22%, 55% and 23% had mild (< 6/12-6/18), moderate (< 6/18-6/60) and severe (< 6/60) vision loss, respectively. The IVI total and three subscales displayed discrete thresholds indicating that the respondents understood the response categories. The IVI items fitted the scale and unidimensionality was established. Person separation reliability for the IVI score was substantial (0.94) indicating that the scale can discriminate between several groups of AMD patients. The IVI items were significantly targeted to the AMD patients with the means of the two distributions shown to be very close (0.0 and 0.1, respectively). Substantial targeting was also evident for the subscales. Poorer visual acuity was significantly associated (ANOVA; F (2, 216) = 23.4; p < 0.001) with greater restriction of participation suggesting that the IVI has substantial construct validity. CFA supported the IVI three-factor model which includes items from the "emotional well-being, "reading and accessing information" and "mobility and independence" subscales., Conclusions: Clinicians and researchers can reliably use the IVI to assess the impact on daily life and the effectiveness of clinical trials and rehabilitation interventions in patients with AMD across a range of vision loss.

Purpose: To determine if the impact of Visual Impairment Instrument (IVI) and Glaucoma Symptom Scale (GSS) are valid instruments to assess participation in daily living and ophthalmic complaints, respectively, in a glaucoma population., Methods: Patients with glaucoma were recruited from private and public clinics and completed the IVI and GSS questionnaires. The two scales were assessed for fit to the Rasch model. Unidimensionality, individual item and person fit to the model, response category performance (how respondents differentiate between the response options), differential item functioning (how subgroups, despite equal levels of the underlying trait, respond differently to an individual item), and targeting of items to patients (good spread of items across the full range of patients' scores) were assessed., Results: One hundred seventy-five participants (mean age = 71 year) were recruited. The majority (65%) had primary open angle glaucoma and good presenting visual acuity >or=6/9 in the better eye (87%). Only one-third of the participants had severe visual field loss in both eyes. Disordered thresholds were evident across all GSS items, indicating that the categories were difficult to discriminate and required category collapsing (5 to 3 categories). There was no evidence of person and item misfit, differential item functioning, and multidimensionality. However, both scales displayed ineffective person-item targeting as a large number of participants demonstrated little difficulty with the most difficult items., Conclusions: Because of unsatisfactory targeting, The IVI and GSS are suboptimal scales to assess patients with glaucoma but relatively good vision. It is likely that items could be added to optimize the performance of both instruments. There may however be a need to develop a glaucoma-specific instrument to assess Quality of Life in this population.

Purpose: To evaluate the effectiveness of a multidisciplinary low-vision rehabilitation program on quality of life evaluated by the Impact of Vision Impairment (IVI) instrument., Methods: First-time referrals to low-vision clinics were assessed before and after rehabilitation (3-6 months). Rasch analysis was used to estimate the three IVI subscale and overall values on an interval scale. A mixed between-within subjects ANOVA was used to identify whether presenting visual acuity had an interaction effect with rehabilitation change. Cohen d values were used to estimate the magnitude of the change and the standardized response mean (SRM) procedure was selected to determine the clinical significance of the rehabilitation-induced changes., Results: One hundred twenty-four women and 68 men (mean age, 80.3 years) completed the rehabilitation. Most had age-related macular degeneration (62%, 119) and were moderately to severely vision impaired (<6/18; 78%, 149). After rehabilitation, significant improvements were recorded for the overall IVI score (P = 0.006) and two subscales: reading and accessing information and emotional well-being (P = 0.007 and 0.009, respectively). No significant improvement was found on the mobility and independence subscale (P = 0.07). The magnitude of the post-intervention improvement was found to be relatively moderate (Cohen d = 0.17-0.30) and clinically modest (SRM = 0.22-0.42)., Conclusions: Significant improvements in overall quality of life and two specific areas of daily living in people with low vision were found, although the magnitude and clinical significance of the rehabilitation-induced gains were modest. Further investigation in other models of low-vision rehabilitation is needed to optimize quality of life gains in people with low vision.

A bstract People with vision-threatening diabetic retinopathy are likely to experience enhanced social and emotional strain. Critically, those with both vision-threatening diabetic retinopathy and psychosocial problems may have significantly reduced levels of functioning compared with psychologically healthy counterparts. This can cause inadequate compliance, increased strain on family functioning, worse diabetes control, increased progression of diabetic retinopathy and, consequently, further psychosocial stress resulting in a number of concerning implications for disease management, clinical outcomes and healthcare costs. However, the emotional and social health consequences of diabetic retinopathy have not yet been systematically explored. This information is crucial as it allows for a targeted approach to treatment and prevention and avoidance of the potentially detrimental implications described above. Therefore, this paper reviews the current qualitative and quantitative evidence regarding the social and emotional impact of diabetic retinopathy and identifies directions for future research. Key search terms were applied to the electronic databases Pubmed, ISI Web of Science and Embase and the bibliographies of relevant papers were systematically reviewed for additional references. Overall, the evidence suggests that diabetic retinopathy and associated vision loss have several debilitating effects, including disruption of family functioning, relationships and roles; increased social isolation and dependence; and deterioration of work prospects resulting in increased financial strain. Adverse emotional responses include fear, anxiety, vulnerability, guilt, loss of confidence, anger, stress and self-perception issues. However, the research to date is largely qualitative in nature, with most quantitative studies being small, cross-sectional and somewhat outdated. Similarly, the outcome measures used in many studies to date are suboptimal in terms of content and validity. Therefore, this review identifies the need for improved outcome measures to provide valid, meaningful measurement of the social and emotional impact of diabetic retinopathy and discusses potential directions for future research such as item banking and computer adaptive testing. [ABSTRACT FROM AUTHOR]