Ophthalmology (Eye & Ear Hospital) - Research Publications
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ItemStudy methodology and diabetes control in patients from the non-English diabetes management project (NEDMP)(WILEY, 2017-03)BACKGROUND: To describe the clinical characteristics of non-English speaking patients from the Diabetes Management Project (NEDMP), and compare their diabetes management and severity of diabetic retinopathy (DR) with the English-speaking DMP sample (EDMP). DESIGN: A prospective study was conducted on non-English speaking adults with diabetes who attended the Royal Victorian Eye and Ear Hospital. PARTICIPANTS: 136 (90.1%) non-English speaking adults were assessed, with a mean age of 72.2 years (range: 50-88 years); 74 (54.4%) were male. METHODS: Participants completed interviewer-administered questionnaires and underwent visual acuity, fundus photography, optical coherence tomography, biochemistry and anthropometric measurements. The EDMP assessed 609 patients in 2009 using a similar protocol. MAIN OUTCOME MEASURES: Type and duration of diabetes, diabetes control and diabetic retinopathy. RESULTS: A total of 127 (93.4%) and 8 (5.9%) participants reported having type 2 and type 1 diabetes, respectively, with a median (IQR) duration of 17 (14) years. The proportion of patients with poor diabetes control (HbA1c ≥ 7%) in the NEDMP was similar to the EDMP (64.0% and 68.2%, respectively; P = 0.411). A significantly higher proportion of patients with DR in the NEDMP were found to have poor diabetes control (HbA1c ≥ 7%) compared to those without DR (80.9% vs. 50.0%, P = 0.003). Almost two-thirds of NEDMP patients (74/118) had DR and 23% (27/115) had diabetic macular edema. The prevalence of DR was similar between the NEDMP and EDMP studies, ranging from 25-30% and 28-29%. CONCLUSIONS: The clinical characteristics, diabetes control, and DR severity of English and non-English-speaking patients were similar. The high proportion of poor diabetes management in non-English speaking patients with DR suggests educational and behavioural interventions to improve glycaemic control are warranted.
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ItemLate referral for diabetic retinopathy screening in general practice(WILEY-BLACKWELL, 2016-12)
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ItemFactors Associated with Knowledge of Diabetes in Patients with Type 2 Diabetes Using the Diabetes Knowledge Test Validated with Rasch Analysis(PUBLIC LIBRARY SCIENCE, 2013-12-03)OBJECTIVE: In patients with Type 2 diabetes, to determine the factors associated with diabetes knowledge, derived from Rasch analysis, and compare results with a traditional raw scoring method. RESEARCH DESIGN & METHODS: Participants in this cross-sectional study underwent a comprehensive clinical and biochemical assessment. Diabetes knowledge (main outcome) was assessed using the Diabetes Knowledge Test (DKT) which was psychometrically validated using Rasch analysis. The relationship between diabetes knowledge and risk factors identified during univariate analyses was examined using multivariable linear regression. The results using raw and Rasch-transformed methods were descriptively compared. RESULTS: 181 patients (mean age±standard deviation = 66.97±9.17 years; 113 (62%) male) were included. Using Rasch-derived DKT scores, those with greater education (β = 1.14; CI: 0.25,2.04, p = 0.013); had seen an ophthalmologist (β = 1.65; CI: 0.63,2.66, p = 0.002), and spoke English at home (β = 1.37; CI: 0.43,2.31, p = 0.005) had significantly better diabetes knowledge than those with less education, had not seen an ophthalmologist and spoke a language other than English, respectively. Patients who were members of the National Diabetes Service Scheme (NDSS) and had seen a diabetes educator also had better diabetes knowledge than their counterparts. Higher HbA1c level was independently associated with worse diabetes knowledge. Using raw measures, access to an ophthalmologist and NDSS membership were not independently associated with diabetes knowledge. CONCLUSIONS: Sociodemographic, clinical and service use factors were independently associated with diabetes knowledge based on both raw scores and Rasch-derived scores, which supports the implementation of targeted interventions to improve patients' knowledge. Choice of psychometric analytical method can affect study outcomes and should be considered during intervention development.
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ItemCombined poor diabetes control indicators are associated with higher risks of diabetic retinopathy and macular edema than poor glycemic control alone(PUBLIC LIBRARY SCIENCE, 2017-06-29)PURPOSE: To examine the association of individual and combined indicators of diabetes control with diabetic retinopathy and diabetic macular edema. MATERIALS AND METHODS: In this clinical, cross-sectional study, 613 adults with type 2 diabetes (372 any diabetic retinopathy; 183 any diabetic macular edema) were examined. Diabetic retinopathy was assessed from fundus photographs; diabetic macular edema from Ocular Coherence Tomography scans; and HbA1c and serum lipid values from fasting blood samples. Poor glucose control was defined as HbA1c≥7%; poor blood pressure control as SBP≥130/DBP≥80; and poor lipid control as total cholesterol:HDL ratio≥4.0. The association of poor glucose control, poor blood pressure control and poor lipid control alone and in combination (poor glucose & blood pressure control; poor glucose & lipid control; poor blood pressure & lipid control; and poor glucose, blood pressure & lipid control) with diabetic retinopathy/diabetic macular edema was examined using multiple logistic regression models. RESULTS: Patients' mean±standard deviation age was 64.9±11.6 years (57% male). In adjusted models, compared to those with good control of all indicators (n = 99, 18.3%), the odds ratio (95% Confidence Interval) of having any diabetic retinopathy was 2.44 (1.34-4.46), 3.75 (1.75-8.07), 4.64 (2.13-10.12) and 2.28 (1.01-5.16) for poor glucose control only; poor glucose & blood pressure control; poor glucose & lipid control; and poor glucose, blood pressure & lipid control, respectively. Correspondingly for diabetic macular edema, they were 3.19 (1.55-6.59); 3.60 (1.58-8.22); 2.76 (1.18-6.44); and 3.01 (1.18-7.67), respectively. Odds were not significantly increased for other indicators. DISCUSSION: Compared to individual indicators of poor diabetes control, risk of diabetic retinopathy and diabetic macular edema increased three to fourfold with a combination of these indicators. Targeting combined diabetes control indicators is important to reduce risk of diabetic retinopathy/diabetic macular edema.
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ItemProblem-solving therapy for adults with diabetic retinopathy and diabetesspecific distress: a pilot randomized controlled trial(BMJ PUBLISHING GROUP, 2017-01)OBJECTIVE: To provide preliminary evidence for the impact of problem-solving therapy for diabetes (PST-D) in adults with diabetic retinopathy (DR) and diabetes distress. RESEARCH DESIGN AND METHODS: In a pilot randomized controlled trial, 40 participants with DR and diabetes distress were allocated to the PST-D or control groups. Diabetes distress (DDS), depressive symptoms (PHQ-9), self-care activities (SDSCA), and HbA1c were assessed at baseline, and 3 and 6-month follow-ups. RESULTS: At the 6-month follow-up, the PST-D group showed significant improvements relative to the control group, in 'regimen-related distress' (PST-D: -1.3±1.4; control: -0.4±1.1), depressive symptoms (PST-D: -4.3±6.1; control: -0.3±4.6), and HbA1c (PST-D: -1.2%±1.01; control: 0.2%±1.2%) (all p<0.05). In multiple regression analysis, adjusting for baseline values and sociodemographic factors, PST-D was associated with significant improvement in 'regimen-related distress', depressive symptoms, and HbA1c at the 6-month follow-up (p<0.05). CONCLUSIONS: PST-D is a promising intervention for improving psychological outcomes and glycemic control. A fully powered study is required to confirm these findings and examine mechanisms of change in HbA1c. TRIAL REGISTRATION NUMBER: ACTRN12616001010482; results.
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ItemCalibrating the Impact of Vision Impairment (IVI): Creation of a Sample-Independent Visual Function Measure for Patient-Centered Outcomes Research(ASSOC RESEARCH VISION OPHTHALMOLOGY INC, 2018-12)PURPOSE: Provide item calibrations estimated for the Impact of Vision Impairment (IVI) questionnaire by pooling data from several studies of people with vision impairment (VI) representing a variety of countries and causes of VI. METHODS: Eight data sets from six principal investigators representing responses to IVI items from 2867 VI patients were pooled for analysis. Eligible patients were 18 years or older and from Australia, India, and the United States. Rasch analysis, using the Andrich Rating Scale Model (Winsteps version 3.65), was performed on preintervention IVI responses to estimate item and person measures, reliability coefficients, and response category thresholds. Differential item functioning (DIF) analysis and analysis of variance (ANOVA) were used to examine the effects different data sets and covariates on item estimates. RESULTS: Patient age range was 18 to 103 years (median 62 years); 55% were male. Visual acuity ranged from 20/20 to no light perception and primary diagnosis was macular degeneration in 29% of patients. Item measure estimates showed good separation reliability (R 2 = 0.99). DIF magnitude did not preclude use of all IVI-28 data. ANOVA showed VA (P < 0.001) and gender (P < 0.002) were predictors of visual ability. CONCLUSIONS: Analysis from pooled data support the provision of calibrated IVI item measures for researchers and clinicians to use, thus better enabling direct comparisons of patients with VI. TRANSLATIONAL RELEVANCE: Validity testing of the IVI show that we can combine disparate data sets of patient responses to calibrate item measures and response category thresholds, and provide to others for use in comparing patients across clinical trials and on an individual basis.
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ItemImproving eye care in residential aged care facilities using the Residential Ocular Care (ROC) model: study protocol for a multicentered, prospective, customized, and cluster randomized controlled trial in Australia(BMC, 2018-11-26)BACKGROUND: Older adults in residential aged care facilities have unnecessarily high levels of vision impairment (VI) which are largely treatable or correctable. However, no current comprehensive eye health service model exists in this setting in Australia. We aimed to determine the clinical, person-centered, and economic effectiveness of a novel eye care model, the Residential Ocular Care (ROC). METHODS/DESIGN: This protocol describes a multicentered, prospective, randomized controlled trial. A total of 395 participants with distance vision < 6/12 (0.30 LogMAR) and/or near vision N8 (1.00 M) or worse will be recruited from 38 urban and rural aged care facilities across Victoria, Australia. Aged care facilities will be randomized (1:1) to one of two parallel groups. Participants in the ROC group will receive a comprehensive and tailored eye care pathway that includes, as necessary, refraction and spectacle provision, cataract surgery, low vision rehabilitation, and/or a referral to an ophthalmologist for funded treatment. Usual care participants will be referred for an evaluation to the eye care service associated with the facility or an eye care provider of their choice. The primary outcome will be presenting near and distance vision assessed at the two- and six-month follow-up visits, post baseline. Secondary outcomes will include vision-specific quality of life, mobility, falls, depression, and eye care utilization at two and six months. An incremental cost-effectiveness analysis will also be undertaken. DISCUSSION: The ROC study is the first multicentered, prospective, customized, and cluster randomized controlled trial in Australia to determine the effectiveness of a comprehensive and tailored eye care model for people residing in aged care facilities. Results from this trial will assist health and social care planners in implementing similar innovative models of care for this growing segment of the population in Australia and elsewhere. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12615000587505 . Registered on 4 June 2015 - retrospectively registered.
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ItemEvaluation of item candidates for a diabetic retinopathy quality of life item bank(SPRINGER, 2013-09)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.
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ItemThe impact of diabetic retinopathy on quality of life: qualitative findings from an item bank development project(SPRINGER, 2012-12)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.
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ItemNo Preview AvailableDiabetic Retinopathy and Macular Edema Quality-of-Life Item Banks: Development and Initial Evaluation Using Computerized Adaptive Testing(ASSOC RESEARCH VISION OPHTHALMOLOGY INC, 2017-12)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.