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Effectiveness of Teleretinal Imaging-Based Hospital Referral Compared With Universal Referral in Identifying Diabetic Retinopathy: A Cluster Randomized Clinical Trial.
Joseph, S, Kim, R, Ravindran, RD, Fletcher, AE, Ravilla, TD
JAMA ophthalmology. 2019;(7):786-792
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Abstract
IMPORTANCE Studies in high-income countries provide limited evidence from randomized clinical trials on the benefits of teleretinal screening to identify diabetic retinopathy (DR). OBJECTIVE To evaluate the effectiveness of teleretinal-screening hospital referral (TR) compared with universal hospital referral (UR) in people with diabetes. DESIGN, SETTING, AND PARTICIPANTS A cluster randomized clinical trial of 8 diabetes clinics within 10 km from Aravind Eye Hospital (AEH), Madurai, India, was conducted. Participants included 801 patients older than 50 years. The study was conducted from May 21, 2014, to February 7, 2015; data analysis was performed from March 12 to June 16, 2015. INTERVENTIONS In the TR cohort, nonmydriatic, 3-field, 45° retinal images were remotely graded by a retinal specialist and patients with DR, probable DR, or ungradable images were referred to AEH for a retinal examination. In the UR cohort, all patients were referred for a retinal examination at AEH. MAIN OUTCOMES AND MEASURES Hospital-diagnosed DR. RESULTS Of the 801 participants, 401 were women (50.1%) (mean [SD] age, 60.0 [7.3] years); mean diabetes duration was 8.6 (6.6) years. In the TR cohort, 96 of 398 patients (24.1%) who underwent teleretinal imaging were referred with probable DR (53 [13.3%]) or nongradable images (43 [10.8%]). Hospital attendance at AEH was proportionately higher with TR (54 of 96 referred [56.3%]) compared with UR (150 of 400 referred [37.5%]). The intention-to-treat analysis based on all patients eligible for referral in each arm showed that proportionately more patients with TR (36 of 96 [37.5]%) were diagnosed with DR compared with UR (50 of 400 [12.5%]) (unadjusted risk ratio [RR], 3.00; 95% CI, 2.01-4.48). These results were little changed by inclusion of covariates (RR, 2.72; 95% CI, 1.90-3.91). The RR was lower in the per-protocol analysis based on all patients who adhered to referral (covariate-adjusted RR, 1.75; 95% CI, 1.12-2.74). Diagnoses of DR were predominantly mild or moderate nonproliferative DR (36 in TR and 43 in UR). In the UR arm, there were 4 cases of severe nonproliferative DR and 2 cases of proliferative DR. Age (RR, 0.98; 95% CI, 0.95-0.99), female sex (RR, 0.79; 95% CI, 0.64-0.98), and hypertension diagnosis (RR, 0.81; 95% CI, 0.68-0.95) were factors associated with lower attendance. Those with higher secondary educational level or more were twice as likely to attend (RR, 2.00; 95% CI, 1.32-3.03). CONCLUSIONS AND RELEVANCE The proportionate yield of DR cases was higher in the TR arm, confirming the potential benefit, at least in the setting of eye hospitals in India, of a targeted referral approach using teleretinal screening to identify patients with DR. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02085681.
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Prospective evaluation of integrated device diagnostics for heart failure management: results of the TRIAGE-HF study.
Virani, SA, Sharma, V, McCann, M, Koehler, J, Tsang, B, Zieroth, S
ESC heart failure. 2018;(5):809-817
Abstract
AIMS: The primary aim of the TRIAGE-HF trial was to correlate cardiac implantable electronic device-generated heart failure risk status (HFRS) with signs, symptoms, and patient behaviours classically associated with worsening heart failure (HF). METHODS AND RESULTS TRIAGE-HF enrolled 100 subjects with systolic HF implanted with a Medtronic high-performance device and followed up at three Canadian HF centres. Study follow-up was up to 8 months. The HFRS assigned each subject's overall risk of HF hospitalization in the next 30 days and also highlighted abnormal device parameters contributing to a patient's risk status at the time of remote data transmission. Subjects with a high HFRS were contacted by telephone to assess symptoms, and compliance with prescribed therapies, nutrition, and exercise. Clinician-assessed risk and HFRS-calculated risk were correlated at both study baseline and exit. Twenty-four high HFRS occurrences were observed among 100 subjects. Device parameters associated with increased risk of HF hospitalization included OptiVol index (n = 20), followed by low patient activity (n = 18) and elevated night heart rate (n = 12). High HFRS was associated with symptoms of worsening HF in 63% of cases (n = 15) increasing to 83% of cases (n = 20) when non-compliance with pharmacological therapies and lifestyle was considered. CONCLUSIONS TRIAGE-HF is the first study to provide prospective data on the distribution of abnormal device parameters contributing to high HFRS. High HFRS has good predictive accuracy for patient-reported signs, symptoms, and behaviours associated with worsening HF status. As such, HFRS may be a useful tool for ambulatory HF monitoring to improve both patient-centred and health system level outcomes.
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Clinical presentation and treatment outcome of retinoblastoma in children of South Western China.
Gao, J, Zeng, J, Guo, B, He, W, Chen, J, Lu, F, Chen, D
Medicine. 2016;(42):e5204
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To study the clinical presentation and treatment outcome among children in South Western China with retinoblastoma (RB) and to determine factors predictive of poor outcome.A retrospective review of children diagnosed with RB from 2006 to 2015 at West China Hospital was undertaken. Demographic and clinical characteristics and treatment outcomes were studied.A total of 253 patients (unilateral 80.2%, bilateral 19.8%) were studied. Twenty six patients (10.3%) were from minority ethnic groups of China. The median onset age was 21 months. Leukocoria was the most common presenting sign (71%). Tumors were intraocular in 91.3% cases, extraocular in 8.7% cases. Extraocular RB patients had a longer median lag period than intraocular patients (9 months vs 2 months, P < 0.0001). In the intraocular group, 89.5% were advanced group D or E diseases. Enucleation was the major treatment for intraocular RB. However, over 10 years, the enucleation rate decreased constantly while more patients received chemotherapy. The Kaplan-Meier survival probability was 87.8%, 81.4%, and 74.8% at 3 years, 5 years, and 10 years, respectively. On Cox regression analysis, extraocular RB (P = 0.0008) and treatment abandonment (P < 0.0001) were associated with poor outcome; bilateral RB (P = 0.0116) and advanced pathological grade pT4 (P = 0.0011) were associated with poor outcome of intraocular RB.Most RB patients from South Western China were diagnosed at advanced clinical stage. Delayed presentation is related to extraocular RB which is a risk factor for poor outcome. Chemotherapy increased the eye salvage but had no effects to overall survival. Education for parents and general physicians for the early signs of RB (such as leukocoria), therapeutic strategy and treatment outcomes of RB may promote early diagnosis, improve the compliance, and outcome.
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Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial.
Fayad, ZA, Mani, V, Woodward, M, Kallend, D, Abt, M, Burgess, T, Fuster, V, Ballantyne, CM, Stein, EA, Tardif, JC, et al
Lancet (London, England). 2011;(9802):1547-59
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Abstract
BACKGROUND Dalcetrapib modulates cholesteryl ester transfer protein (CETP) activity to raise high-density lipoprotein cholesterol (HDL-C). After the failure of torcetrapib it was unknown if HDL produced by interaction with CETP had pro-atherogenic or pro-inflammatory properties. dal-PLAQUE is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints. METHODS In this phase 2b, double-blind, multicentre trial, patients (aged 18-75 years) with, or with high risk of, coronary heart disease were randomly assigned (1:1) to dalcetrapib 600 mg/day or placebo for 24 months. Randomisation was done with a computer-generated randomisation code and was stratified by centre. Patients and investigators were masked to treatment. Coprimary endpoints were MRI-assessed indices (total vessel area, wall area, wall thickness, and normalised wall index [average carotid]) after 24 months and (18)F-fluorodeoxyglucose ((18)F-FDG) PET/CT assessment of arterial inflammation within an index vessel (right carotid, left carotid, or ascending thoracic aorta) after 6 months, with no-harm boundaries established before unblinding of the trial. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00655473. FINDINGS 189 patients were screened and 130 randomly assigned to placebo (66 patients) or dalcetrapib (64 patients). For the coprimary MRI and PET/CT endpoints, CIs were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group. MRI-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after 24 months; absolute change from baseline relative to placebo was -4·01 mm(2) (90% CI -7·23 to -0·80; nominal p=0·04). The PET/CT measure of index vessel most-diseased-segment target-to-background ratio (TBR) was not different between groups, but carotid artery analysis showed a 7% reduction in most-diseased-segment TBR in the dalcetrapib group compared with the placebo group (-7·3 [90% CI -13·5 to -0·8]; nominal p=0·07). Dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups. INTERPRETATION Dalcetrapib showed no evidence of a pathological effect related to the arterial wall over 24 months. Moreover, this trial suggests possible beneficial vascular effects of dalcetrapib, including the reduction in total vessel enlargement over 24 months, but long-term safety and clinical outcomes efficacy of dalcetrapib need to be analysed. FUNDING F Hoffmann-La Roche Ltd.