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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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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ItemComparing the effectiveness of selective laser trabeculoplasty with topical medication as initial treatment (the Glaucoma Initial Treatment Study): study protocol for a randomised controlled trial(BMC, 2015-09-11)BACKGROUND: Glaucoma is the leading cause of irreversible blindness in the world. Estimated to affect 60 million people worldwide, this figure is expected to rise to 80 million by 2020. Untreated, glaucoma leads to visual decay and eventually to blindness, and can significantly reduce quality of life. First-line treatment in patients with primary open-angle glaucoma and exfoliative glaucoma is topical medical therapy with ocular hypotensives as eye drops. However, eye drops have several disadvantages including cost, possible local and systemic side effects, and adherence and perseverance issues. Randomised controlled trials have demonstrated that selective laser trabeculoplasty is equally as effective in lowering intraocular pressure as eye drops. However, the impact of these two treatment modalities from the patient and economic perspectives has not been adequately determined. Thus, it remains unclear whether topical medical therapy or selective laser trabeculoplasty should be recommended as first-line treatment for glaucoma. METHODS/DESIGN: This protocol describes an international, multi-centre, randomised controlled trial to determine the optimum first-line therapy for people with primary open-angle glaucoma and exfoliative glaucoma. This study will compare the effect of selective laser trabeculoplasty and topical medication with respect to patients' generic and glaucoma-specific quality of life. The trial will also provide a detailed cost-effectiveness analysis and compare the clinical effectiveness with respect to the degree of intraocular pressure lowering and rates of treatment failure. Research coordinators in each centre will identify and recruit previously untreated patients with primary open-angle glaucoma and exfoliative glaucoma. Those who meet the eligibility criteria will be invited to enter a randomised controlled trial with either selective laser trabeculoplasty or topical ocular hypotensive therapy, according to a stepped regimen. Outcome assessment will be measured at 6 weeks and at 6, 12, and 24 months post-treatment. Regular clinic follow-ups will continue as clinically indicated between study outcome visits. DISCUSSION: The Glaucoma Initial Treatment Study is the first multi-centred RCT to determine the optimum first-line therapy for people with glaucoma. Our trial will have an unprecedented capacity to meaningfully transform the treatment and management of glaucoma in Australia and overseas. TRIAL REGISTRATION: ACTRN12611000720910; Date registered: 11 July 2011.
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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.