Measuring patient activation: the utility of the Patient Activation Measure administered in an interview setting.

BACKGROUND: Patient activation is an emerging field in healthcare research concerning knowledge, skills, and confidence of patients in managing their health. This is particularly important for patients with chronic diseases, who often require more complex care management and self-care skills. However, due to temporary or longer-lasting visual impairments, certain patient groups cannot answer a questionnaire independently. The main objective is to investigate the psychometric properties of the German Patient Activation Measure® (PAM) survey in an everyday clinical setting where it has to be read aloud. METHODS: Outpatients with macular edema participated in this questionnaire-based cross-sectional study. The study assessed patient activation by the PAM® survey, self-rated health, self-efficacy, quality of life, and general mood. Interviewers read questionnaires aloud to patients. Psychometric properties of the PAM® survey were investigated by item response theory (IRT), Cronbach's α and trait-trait correlations. RESULTS: The analysis included N = 554 patients. Median age was 69 (IQR 62.0-76.0) years and mean overall activation score 74.1 (SD 13.7). All items showed ceiling effects. Empirical reliability from the IRT model and Cronbach's α were 0.75. The PAM® survey showed a Spearman correlation of 0.54 with self-efficacy, 0.51 with quality of life and 0.34 with general mood. CONCLUSION: The read-aloud PAM® survey has been shown to provide to adequate measurement precision and convergent validity to be used as a screening tool in an everyday clinical setting. Objective assessment in an interview setting with the PAM® survey is possible. PAM® items are good in distinguishing lower to middle activated patients, but not patients with high activation. Further, issues with structural validity need more investigation.

Expectations and fears of patients with diabetes and macular edema treated by intravitreal injections.

AIMS: Clinical outcomes of diabetic macular edema (DME) have been widely described, but data on diabetic retinopathy perceptions by diabetes patients are limited. The aim of this survey was to explore the lived experience, knowledge, fears and expectations about disease, and treatment in patients with diabetes and macular edema treated with intravitreal injections (IVTI) and to characterize patient profiles. METHODS: Cross-sectional survey including a preliminary qualitative phase (20 patients with DME, treated or treatment-naive, 5 female and 15 male, age 36-74 years) followed by a quantitative survey (116 patients treated with IVTI for DME). Data ASKIA Analyze (version 5.3.3.5) was used for descriptive statistics, and R software (version 3.4.1) for multiple correspondence analysis. RESULTS: The qualitative phase identified the wording used by patients and information helpful to propose modalities of response in the quantitative phase. In the quantitative survey (116 patients, mean age 66.6 years), most patients were treated with anti-vascular endothelial growth factor. Overall, 71.9% reported that the disease negatively affected their daily activities and 33.1% considered that regular visits to the ophthalmologist were disrupting their life. Treatment expectations differed significantly between patients in terms of disease experience (visit and injection schedules), fears and feelings, and relationship with physicians, allowing three patient profiles to be identified: "Worried" patients (n = 45) felt isolated and were worried about the need for repeated treatment and possible side effects. They were mainly active men aged < 60 with type I diabetes (T1D) and DME diagnosed for > 2 years; "Curious" patients (n = 21) experienced insufficient support and requested more information on their disease and existing treatments. They were mainly single women aged 60-69 years; "Passive" patients (n = 50) felt sufficiently informed by their ophthalmologist and were not concerned by DME. They were older (mean age: 70 years) and mainly type 2 diabetic men. CONCLUSIONS: Patients with diabetes and macular edema treated with IVTI form a heterogeneous group regarding fears and expectations. Different patient profiles were identified and need to be confirmed in larger studies. A better understanding of psychological profiles may optimize compliance of diabetic patients.

Quality of life in children suffering from juvenile idiopathic arthritis-associated uveitis.

Uveitis (JIA-U), the most common extra-articular manifestation in juvenile idiopathic arthritis (JIA), may cause severe impairment of vision in children and affect their quality of life (QoL). Considering the lack of uveitis-related QoL assessment questionnaire, and multidimensional nature of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR), commonly used for monitoring and assessing the health status of children with JIA, we performed a cross-sectional study to investigate the potential of the JAMAR in estimation of QoL in children suffering from JIA-U. The study included 42 children with JIA, 21 of whom had JIA-U. Both children and their parents completed the JAMAR. We compared two groups of children (JIA-U and JIA without uveitis) and their parents against five extracted questionnaires items (QoL, functional ability, pain level, disease activity estimation, and current emotional state of the child) using the independent-samples t test to verify the differences and the Pearson correlation coefficient to measure the strength of a linear association between variables. No significant statistical difference in any of the examined variables was found between the two groups of children. In the groups of parents, current emotional state of children with JIA-U was assessed to be significantly worse (t = 2.05, p < 0.05) and the overall level of functioning significantly lower (t = 2.03, p < 0.05) than children without uveitis. Our results suggest the need for adding the uveitis-specific questionnaires items to JAMAR to improve its sensitivity and specificity in the assessment of QoL in children suffering from JIA-U, as well as designing a second assessment tool such as uveitis-specific questionnaires.

Psychological, social and everyday visual impact of diabetic macular oedema and diabetic retinopathy: a systematic review.

AIMS: To synthesize the evidence on the impact of diabetic retinopathy and diabetic macular oedema from the patient perspective. METHODS: A systematic literature review was conducted using MEDLINE Complete, PsycINFO, EMBASE and AMED. We included articles investigating the impact of the condition on quality of life, symptoms, visual functioning, activities of daily living, well-being, social functioning, and financial status. The studies evaluated were observational, including cross-sectional, prospective cohort and retrospective cohort designs. Outcome data were extracted and synthesized. RESULTS: Searches yielded 5114 publications. After screening, 85 studies were included, measuring the following outcomes: visual functioning (n=46); quality of life (n=22); well-being (n=16); functional status (n=5); work (n=4); and visual task performance (n=2). Diabetic retinopathy has a considerable impact on visual functioning and this is greater in people with greater disease severity. Diabetic retinopathy significantly limits activities including working, driving, walking and reading, and has the potential to have a negative impact on psychological well-being. CONCLUSIONS: Diabetic retinopathy is associated with poor self-reported visual functioning, well-being, and health-related quality of life. Ability to perform basic everyday tasks appears to diminish with disease severity. Some studies suggest impaired mobility and problems with work, but there are gaps in this evidence.

Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study.

PURPOSE: To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY). DESIGN: AQUA was a multicenter, open-label, single-arm, phase 4 study. PARTICIPANTS: Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME. METHODS: Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks. MAIN OUTCOME MEASURES: The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated. RESULTS: A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 µm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was -175.38 µm (SD, 132.62 µm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related. CONCLUSIONS: Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept.

The relationship between diabetic retinopathy and psychosocial functioning: a systematic review.

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.

Diabetic Retinopathy and Macular Edema Quality-of-Life Item Banks: Development and Initial Evaluation Using Computerized Adaptive Testing.

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.

Vision-related quality of life in patients receiving intravitreal ranibizumab injections in routine clinical practice: baseline data from the German OCEAN study.

BACKGROUND: Vision-related quality of life (vrQoL) is advancing more and more into the focus of interest in ophthalmological clinical research. However, to date only little information is available about vrQoL from large non-interventional studies in terms of "real-world evidence". The purpose of this investigation was to describe baseline VFQ-25 visual function scores, to evaluate whether they differ from previous phase III clinical trials, to determine which contributing factors (e.g. indication, age, gender) affect VFQ-25 scores and to identify its impact on driving. METHODS: The non-interventional OCEAN study (Observation of treatment patterns with LuCEntis and real life ophthalmic monitoring, including optional OCT in Approved iNdications) is the largest ophthalmic study conducted in Germany, to evaluate the real world situation of patients treated with ranibizumab (NCT02194803). The NEI-VFQ-25 questionnaire was conducted at baseline, months 4, 12 and 24. Descriptive statistics was used to analyse the baseline data. ANOVA was performed to evaluate the impact of various contributing factors on composite and selected subscale scores. RESULTS: Overall, 4844 (84.1 %) of all 5760 OCEAN patients completed the VFQ-25 questionnaire at baseline. Thereof, 3414 treatment-naïve patients were further analysed. Overall, the VFQ subscore general health was most affected by the ocular disease, followed by general vision. No major differences were detected in comparison to corresponding VFQ-25 scores of previous phase III clinical trials, except in DME patients, or with respect to possible contributing factors. A tendency towards a more decreased VFQ-25 composite score was observed for nAMD, for elderly patients ≥75 years of age, for female patients, for patients with low baseline visual acuity (VA; <50 letters) and for those with statutory health insurance. Indication, age, gender, baseline VA (all p <0.01) and the interaction of age and indication, as well as baseline VA and indication (p <0.01 each) had a significant impact on composite, general vision and distance vision scores (ANOVA). About 10 % of patients gave up driving due to eyesight issues. CONCLUSIONS: The knowledge of a patient's subjective disease burden is crucial to understanding anxieties and mental anguish. Additionally, the understanding of the impact of various contributing factors on the VFQ-25 scores and the extent to which they can be influenced help to optimize patient care. It demonstrates the need for medical and mental support by all medical staff, to encourage patients' compliance with a comprehensive anti-VEGF therapy, to increase BCVA and, consecutively, VFQ-25 scores. TRIAL REGISTRATION: NCT02194803.

Visual functioning and health-related quality of life in diabetic patients about to undergo anti-vascular endothelial growth factor treatment for sight-threatening macular edema.

PURPOSE: To examine patient-reported outcome (PRO) in a selected group of Swedish patients about to receive anti-vascular endothelial growth factor (VEGF) treatment for diabetic macular edema (DME). MATERIAL AND METHODS: In this cross-sectional study, 59 patients with diabetes mellitus, who regularly visited the outpatient eye-clinics, were included. Sociodemographic and clinical data were collected and the patients completed PRO measures before starting anti-VEGF treatment. PRO measures assessed eye-specific outcomes (NEI-VFQ-25) and generic health-related quality of life (SF-36). RESULTS: The participants consisted of 30 men and 29 women (mean age, 68.5years); 54 (92%) patients had type 2 diabetes; 5 (9%) patients had moderate or severe visual impairment; 28 (47%) were classified as having mild visual impairment. Some of the patients reported overall problems in their daily lives, such as with social relationships, as well as problems with impaired sight as a result of reduced distance vision. CONCLUSIONS: Further studies are needed to investigate PRO factors related to low perceived general health in this patient population. It is important to increase our understanding of such underlying mechanisms to promote improvements in the quality of patient care.

The use of weighted health-related Quality of Life scores in people with diabetic macular oedema at baseline in a randomized clinical trial.

AIMS: To examine the relationship between visual acuity in each eye and Quality of Life (QoL) outcomes in people with diabetic macular oedema. METHODS: Cross sectional retrospective analysis of data collected at baseline in 289 people entered into a randomized clinical trial with diabetic macular oedema which investigated the safety and efficacy of a vascular endothelial growth factor inhibitor, pegaptanib sodium. At the baseline visit, visual acuity was measured through refraction and using retro-illuminated modified Early Treatment Diabetic Retinopathy Study Log MAR charts, and patient health-related QoL was determined using the European Quality of Life EQ-5D-3L and the Visual Functioning Questionnaire-25 (NEI-VFQ25). A regression analysis with QoL score from each vision-related domain as the dependent variable was fitted using linear and quadratic terms of the better and worse eye, age, gender, adjusted for number of concurrent conditions, ethnicity and level of diabetes control. RESULTS: For all vision-related QoL domains from NEI-VFQ25 and EQ-5D-3L except ocular pain, both visual acuity in the better-seeing and the worse-seeing eye gave a significant increase in correlation coefficient over that obtained from clinical and demographic data. The NEI-VFQ25 correlation was most closely associated with a weighted visual acuity measure of 0.75 in the better and 0.25 in the worse eye or 0.60 in the better and 0.40 in the worse eye. CONCLUSIONS: We recommend that a weighted visual acuity measure from both eyes is considered in future diabetic macular oedema trials.

Vision-related quality of life and visual function following intravitreal bevacizumab injection for persistent diabetic macular edema after vitrectomy.

PURPOSE: To investigate the vision-related quality of life (VR-QOL) and visual function in patients undergoing intravitreal injection of bevacizumab (IVB) for persistent diabetic macular edema (DME) after vitrectomy. METHODS: This institutional study enrolled 20 consecutive patients (20 eyes) who had received 1.25 mg IVB for persistent macular edema after vitrectomy for DME at least 3 months previously. Visual function and VR-QOL were measured before, and 1 and 3 months after IVB. Measurements included the logarithm of the minimum angle of resolution (logMAR), best corrected visual acuity (BCVA), letter contrast sensitivity, severity of metamorphopsia using M-CHARTS, central retinal thickness using optical coherence tomography, and VR-QOL with the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25). RESULTS: One month after IVB, statistically significant improvements were observed in central retinal thickness, letter contrast sensitivity, and the VFQ-25 "mental health" subscale score (P < 0.05, Dunnett test). LogMAR BCVA, metamorphopsia, and the VFQ-25 composite score did not improve significantly. Three months after IVB, there were no significant improvements in any parameters examined. CONCLUSIONS: Intravitreal bevacizumab injection for persistent DME after vitrectomy temporarily improved central retinal thickness, contrast sensitivity, and the psychometric aspect of the VR-QOL, but these effects did not last for over 3 months.

Fluocinolone acetonide intravitreal implant for the treatment of diabetic macular edema.

Diabetic macular edema (DME) remains one of the leading causes of moderate to severe vision loss. Although laser photocoagulation was the standard of care for several years, few patients achieved significant improvements in visual acuity. As a result, several pharmacotherapies and surgeries have been investigated. The fluocinolone acetonide devices are one of the latest therapies considered for the treatment of DME. Despite bringing significant improvements in visual acuity, fluocinolone devices are associated with cataract formation, increased intraocular pressure (IOP), and surgery to lower IOP. Due to the risk of complications, fluocinolone acetonide devices should be considered only in cases refractive to first-line therapies. In this review, we evaluate current and emerging therapies for DME, with special emphasis on fluocinolone acetonide intravitreal devices.

Ranibizumab: the first vascular endothelial growth factor inhibitor approved for the treatment of diabetic macular edema.

OBJECTIVE: To review the pharmacology, efficacy, and safety data available for ranibizumab and compare the drug to other therapeutic options for diabetic macular edema (DME) to determine its likely role in therapy. DATA SOURCES: A PubMed search was initially used to identify all trials pertaining to the use of ranibizumab for DME. This search was conducted in February 2013 without a time frame for exclusion of older trials (all references included were published between January 1987 and February 2013). Following a review of the references of these articles, additional sources were obtained from PubMed, the manufacturer's website, and clinicaltrials.gov. STUDY SELECTION AND DATA EXTRACTION: Trials conducted in animals and those written in a language other than English were excluded. Abstracts of remaining trials were reviewed for determination of relevance to this review. Preference was given to randomized controlled trials. Additional information sources were obtained from a review of references as deemed necessary by the authors. DATA SYNTHESIS: Six Phase 2 or 3 randomized controlled trials studying the effects of ranibizumab in patients with DME were identified. Within these trials, ranibizumab consistently produced significantly greater gains in mean best corrected visual acuity than focal/grid laser photocoagulation or sham (7.4-12.5 letter improvement with ranibizumab vs 0.5-3 letters following focal/grid laser photocoagulation monotherapy) with a favorable safety and tolerability profile. Ranibizumab was also studied in combination with focal/grid laser photocoagulation, showing no additional gains in vision versus ranibizumab monotherapy. CONCLUSIONS: The identified trials provide support for the safety and efficacy of ranibizumab in the treatment of vision loss due to DME and present a strong case for the shift to first-line treatment with vascular endothelial growth factor inhibitors from focal/grid laser photocoagulation, the standard of care since the Early Treatment Diabetic Retinopathy Study of 1985.

Psychometric validation of the Visual Function Questionnaire-25 in patients with diabetic macular edema.

BACKGROUND: Diabetic Macular Edema (DME) is a common cause of impaired vision and blindness amongst diabetics. If not detected and treated early, the resulting vision loss can lead to considerable health costs and decreased health-related quality of life (HRQoL). The aim of this study was to provide evidence of the psychometric properties of the National Eye Institute - Visual Functioning Questionnaire (VFQ-25) for use in a cohort of DME patients who participated in a clinical efficacy and safety trial of pegaptinib sodium (Macugen). METHODS: A phase 2/3 randomised, double masked trial evaluated pegaptanib injection versus sham injection in patients with DME. The analysis was conducted using baseline HRQoL data of the VFQ-25 and the EQ-5D, on a modified intent-to-treat sample of 235 patients. These measures were administered by a trained interviewer by telephone in all but one of the study countries, where face-to-face interviews were conducted in the clinic. The measures were completed in the week prior to baseline, and after 54 weeks of treatment. Distance visual acuity, measured according to the Early Treatment Diabetic Retinopathy Study (ETDRS), was assessed at all time points. Psychometric properties of the VFQ-25 assessed included domain structure, reliability, concurrent and construct validity, responsiveness. RESULTS: The VFQ-25 was found to consist of 11 domains slightly different than those proposed. Nevertheless, none of the eight established multi-item scales met the criterion for further splitting and the VFQ-25 was scored as in the developers' instructions. Internal consistency reliability was demonstrated for six out of the eight original multi-item scales, with Cronbach's alpha ranging from 0.58 (Distance Activities) to 0.85 (Vision Specific: Dependency). The VFQ-25 domains generally showed a low to moderate correlation with EQ-5D visual analogue scale (range 0.16-0.43) and with the visual acuity score (range 0.10-0.41). Construct validity was upheld with higher VFQ-25 scores for patients who saw more letters according to the ETDRS. Almost all scales were shown to be responsive with Guyatt's statistic ranging from 0.10 to 0.56 at 54 weeks. CONCLUSIONS: The VFQ-25 has evidence to support its validity and reliability for measuring HRQoL in DME. However, some operating characteristics of the instrument need further consideration and discussion in the case of DME patients. Further research is therefore warranted in this indication.

Assessing disutility associated with diabetic retinopathy, diabetic macular oedema and associated visual impairment using the Vision and Quality of Life Index.

BACKGROUND: Use of generic multi-attribute utility instruments (MAUI) to assess the impact of diabetic retinopathy (DR) on health-related quality of life (HRQoL) has produced inconsistent findings. Therefore, we assessed the impact of DR, diabetic macular oedema (DME) and associated visual impairment on vision-related QoL (VRQoL) using a vision-specific MAUI. METHODS: In this cross-sectional study, 203 diabetic patients were recruited from specialised eye clinics in a Melbourne tertiary eye hospital. Severity of combined DR/DME was categorised as: no DR/no DME, mild non-proliferative DR (NPDR) and/or mild DME; moderate NPDR and/or moderate DME and vision-threatening DR (severe NPDR or proliferative DR (PDR) and/or severe DME) in the worse eye. Visual impairment was categorised as: none (up to 0.18 logMAR); mild (from 0.18 to 0.3 logMAR); moderate (from 0.3 to 0.48 logMAR); severe (from 0.48 to 0.78 logMAR); and profound (worse than 0.78 logMAR). The Vision and Quality of Life Index (VisQoL) vision-specific MAUI was the main outcome measure. As the distribution of the utilities was skewed, independent associations with covariates were explored using multivariable quantile regression models (five groups: 15(th) , 30(th) , 45(th) , 60(th) and 75(th) percentiles) ranging from poorest to highest VRQoL. RESULTS: Participants' median age was 65 years (range: 27 to 90 years). Of the 203 participants, 50 (24.6 per cent) had no DR/DME, 24 (11.8 per cent) had mild NPDR/DME, 47 (23.2 per cent) had moderate NPDR/DME and 82 (40.4 per cent) had vision-threatening DR. After adjusting for relevant covariables, only profound visual impairment was independently associated with VisQoL utilities (ß= -0.297 ± 0.098 p < 0.01). Severity of DR/DME was not significantly associated with any group of VisQoL utilities. CONCLUSION: The variation in VisQoL utilities was attributed to profound visual impairment but not mild, moderate or severe visual impairment or DR/DME severity. These findings support the use of vision-specific MAUI to capture the impact of profound visual impairment associated with DR and DME. A DR-specific MAUI might be required to assess the specific utility deficits associated with DR/DME across the spectrum of the condition.

The impact of diabetic retinopathy and diabetic macular edema on health-related quality of life in type 1 and type 2 diabetes.

PURPOSE: To assess the impact of diabetic retinopathy (DR) and diabetic macular edema (DME) on health-related quality of life (HRQoL) in type 1 and type 2 diabetes using the EuroQoL EQ-5D generic multi-attribute utility instrument (MAUI). METHODS: In this cross-sectional study, 577 patients with diabetes were recruited from specialized eye clinics in Melbourne, Australia. Each patient underwent clinical, biochemical, and anthropometric assessments. The severity of combined DR and DME (no DR/DME; mild NPDR [nonproliferative DR (NPDR)] and/or mild DME; moderate NPDR and/or moderate DME; and vision-threatening DR (VTDR) (severe NPDR or PDR and/or severe DME) in the worse eye was calculated. EQ-5D utility measures were the main outcome. Because the distribution of the utility measures was skewed, independent associations were explored using multivariate quantile regression models (five quintiles, namely 15th, 30th, 45th, 60th, 75th) ranging from poorest to highest HRQoL. RESULTS: Median age of the participants was 66 years (range, 26-90 years). Of the 577 participants, 223 (38.7%) had no DR/DME, 35 (6.1%) had mild NPDR/DME, 127 (22.0%) had moderate NPDR/DME, and 192 (33.3%) had VTDR. In adjusted models, neither presence nor severity of DR/DME was significantly associated with any quantile of the EQ-5D. In contrast, the presence of diabetic complications (other than DR) (ß = -0.153; SE = 0.052; P < 0.001), other nonocular comorbidities (ß = -0.115; SE = 0.038; P < 0.01), and higher body mass index (ß = -0.007; SE = 0.002; P < 0.001) were all associated with worse HRQoL. CONCLUSIONS: Using a generic MAUI, the EQ-5D, the authors found that the presence or severity of DR/DME and concomitant vision loss were not associated with any quantile of HRQoL. These findings suggest that the EQ-5D lacks sensitivity in assessing the impact of the severity of DR/DME on HRQoL parameters and that condition-specific instruments may better capture the full impact of the association.

Diabetic retinopathy and health-related quality of life.

OBJECTIVE: To describe the impact of co-morbidities, visual acuity, diabetic retinopathy (DR) grade, and macular edema (ME) on the health-related quality of life (HRQOL) among patients with diabetic retinopathy. METHODS: Analysis of data of 207 patients with diabetic retinopathy from Germany in 2003. HRQOL assessment was done using the generic (SF-12) questionnaire. It was hypothesized that exogenous variables (co-morbidities, visual acuity impairment, DR, and ME) would have an impact on HRQOL. Using a structural equation modelling procedure, the effects of exogenous variables on endogenous variables physical component summaries (PSC) and mental component summaries (MCS) reflecting HRQOL were tested. RESULTS: The number of co-morbidities had a negative effect on visual acuity (b = -0.26, standardized) and a similar negative effect on PCS (b = -0.27). DR grade had a negative effect on visual acuity (b = -0.19) and a positive effect on the variable ME (b = 0.44). ME displayed a negative effect on visual acuity (b = -0.58) and also on MCS (b = -0.29). Visual acuity had a positive effect (b = 0.48) on PCS. CONCLUSIONS: Presence of DR and ME, visual acuity impairment and patient co-morbidities lead to significant impairment of both the physical and mental components of HRQOL.

Vision-related quality of life in patients with diabetic macular oedema.

AIMS: The aim of this study was to determine the impact of diabetic macular oedema (DME) on the quality of life (QOL) in patients with type 2 diabetes mellitus. METHODS: The study was a prospective, consecutive, non-comparative case series. An observational study evaluated the quality of vision and vision-specific QOL using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Mean VFQ-25 subscale scores in type 2 diabetic study patients were compared with mean VFQ-25 subscale score in groups of patients with type 1 diabetic retinopathy (T1DR) and varying degrees of age-related macular degeneration (ARMD), glaucoma and cataracts and in reference populations. RESULTS: Thirty-three patients completed the NEI VFQ-25. The mean age of the study population was 64 years. When performing a comparison of those patients with DME versus those with isolated T1DR we found that for the general health subscale, the DME versus T1DR group means were 42+/-4.4 versus 61+/-1.0 respectively. The DME versus T1DR quality of vision categorical mean scores were 69+/-4.1 versus 93+/-3.9. The DME versus T1DR VR-QOL categorical mean scores were 62+/-5.0 versus 93+/-1.0. The DME group was significantly worse in each of these three categories compared with the T1DR group (p<0.01). An additional analysis was performed to examine the differences in VR-QOL in the DME group versus varying common ocular diseases, including age-related macular degeneration (ARMD), glaucoma, cataracts and disease-free reference groups. The mean values of VFQ-25 subscale in the DME group were significantly lower then the glaucoma group in ten of 12 subscales, the cataract group in 11 of 12 subscales, and the reference group in 12 of 12 subscales. However, the mean values of VFQ-25 subscale in the DME group were only significantly different from the ARMD group in three of 12 subscales. CONCLUSIONS: Type 2 diabetes patients with macular oedema experience a decreased VR-QOL compared with type 1 diabetic patients with diabetic retinopathy, glaucoma or cataracts. However, VR-QOL in type 2 diabetic patients with macular oedema was similar to those individuals with ARMD.

Patients' preferences in choosing therapy for retinal vein occlusions.

PURPOSE: The purpose of this study was to assess preference values for vein occlusions with macular edema and to determine how this may affect patient perceptions of potential treatments. METHODS: The Submacular Surgery Trials Vision Preference Value Scale and questions regarding enthusiasm for potential treatments were administered to 153 patients with vein occlusion. Univariate analyses identified predictors of preference values, followed by adjustment for potential confounders using multivariate linear regression. Relationships between preference values and enthusiasm for potential treatments were assessed. RESULTS: The mean preference values +/- SD were similar for patients with branch vein occlusions and central vein occlusions (0.65 +/- 0.20). Lower preference values were associated with duration of occlusion of >2 years (P=0.03) and poorer last-recorded visual acuity (P=0.02). Approximately one half of patients were moderately or very enthusiastic about undergoing intravitreal injection. Sixty-nine percent of branch vein occlusion patients were moderately or very enthusiastic about the standard of care, laser photocoagulation; only one third of central vein occlusion patients were moderately or very enthusiastic about standard observation. CONCLUSIONS: These data suggest that vein occlusion with macular edema has a significant impact on quality of life. Most patients were willing to undergo potentially invasive treatment.

The impact of diabetic retinopathy on health-related quality of life.

PURPOSE OF REVIEW: To review recent evidence evaluating the effect of diabetic retinopathy and diabetic macular edema on health-related quality of life. RECENT FINDINGS: A search of PubMed was conducted according to a strategy that combined the text words 'diabetic retinopathy' and 'quality of life' (n = 91; November 11, 2004) and 'diabetic macular edema' and 'quality of life' (n = 6; November 22, 2004). The Methods sections of all abstracts were reviewed for valid generic or disease-specific instruments used to evaluate health-related quality of life. In addition, abstracts were reviewed to ensure that the study sample was made up predominantly of diabetic individuals. Recent data suggest that persons with diabetic retinopathy are willing to trade off significant time to eliminate their ocular condition (mean time tradeoff score = 0.77-0.8) and that laser photocoagulation can improve health-related quality of life (significant improvement noted in 8 of 11 domains in the National Eye Institute Visual Function Questionnaire). In addition, recent research has noted that health-related quality of life can become affected in persons with diabetic retinopathy prior to visual loss, primarily because of anxiety about the future and emotional reaction to diagnosis and treatment. SUMMARY: From a search of the literature, several recent articles could be identified that demonstrated both a qualitative and a quantitative reduction in health-related quality of life in persons with diabetic retinopathy. With many novel treatments being explored for the management of diabetic retinopathy and diabetic macular edema, measuring health-related quality of life will likely play an important role both in the decision to offer treatment and in monitoring relevant health gains that may be derived from intervention.