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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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Maternal microcirculation and sidestream dark field imaging: a prospective assessment of the association between labour pain and analgesia on the microcirculation of pregnant women.
George, RB, DesRoches, J, Abdo, I, Lehmann, C
Clinical hemorheology and microcirculation. 2015;(4):389-95
Abstract
BACKGROUND Pregnancy places significant demands on the cardiovascular system leading to measurable changes in the macrocirculation and potentially the microcirculation. During labour, both uterine contractions and labour pain can further impact cardiovascular status. The objective of this observational study was to compare sublingual microcirculation in labouring parturients before and after epidural analgesia. METHODS Healthy pregnant, labouring women requesting epidural analgesia were approached to participate. Participants with cardiovascular disease, diabetes, obesity, smoking or caffeine intake were excluded. The sidestream dark field device was applied to the sublingual mucosa obtaining images of at least 20 seconds in 5 visual fields before and after epidural analgesia. Video clips were analyzed randomly and blindly. The primary outcome was mean microvascular flow index (MFI). RESULTS Twelve participants completed this study. The results demonstrate no statistically significant difference in the MFI during labour pain (2.9±0.1) compared to after epidural analgesia (3.0±0.04, p = 0.31). Furthermore, there were no statistically significant differences in any secondary outcomes. CONCLUSION Our findings indicate that epidural analgesia may not impact sublingual microcirculation in labouring women. This agrees with literature supporting epidural analgesia as a safe, appropriate method of pain relief during labour with limited impact on peripheral macro or microcirculation.
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Can neutrophil gelatinase-associated lipocalin help depict early contrast material-induced nephropathy?
Lacquaniti, A, Buemi, F, Lupica, R, Giardina, C, Murè, G, Arena, A, Visalli, C, Baldari, S, Aloisi, C, Buemi, M
Radiology. 2013;(1):86-93
Abstract
PURPOSE To evaluate the utility of serum and urinary neutrophil gelatinase-associated lipocalin (NGAL) in depicting an event of contrast material-induced nephropathy (CIN) in patients who received iodinated contrast media, gadoterate meglumine, or radiopharmaceutical technetium-99m ((99m)Tc) and to evaluate the protective effect exerted by isotonic saline infusion, sodium bicarbonate administration, or N-acetylcysteine administration. MATERIALS AND METHODS Institutional ethics committee approval was given, and informed consent was obtained. One hundred twenty patients were enrolled in a prospective study and divided into three groups: iomeprol group, magnetic resonance (MR) imaging group (gadoterate meglumine), and renal scintigraphy group ((99m)Tc). They randomly received N-acetylcysteine, physiologic saline, or sodium bicarbonate. Receiver operating characteristic (ROC) analysis, Kaplan-Meier curves, and Cox proportional hazard regression analysis were used. RESULTS In the MR imaging and renal scintigraphy groups, there were significant changes in serum creatinine and NGAL levels, and there were no cases of CIN. In the iomeprol group, an early rise in NGAL was found, while serum creatinine level changes occurred 24 hours after contrast material administration. At ROC analysis, NGAL showed high sensitivity and specificity (serum NGAL area under the curve, 0.995; 95% confidence interval [CI]: 0.868, 0.992; urinary NGAL area under the curve, 0.992; 95% CI: 0.925, 1.000) in identifying CIN 8 hours after iomeprol administration. Regression analysis showed that NGAL independently predicted CIN. Administration of N-acetylcysteine, sodium bicarbonate, or physiologic saline did not influence NGAL level. CONCLUSION NGAL depicted CIN in patients who received iodinated contrast material within 8 hours of contrast material administration. SUPPLEMENTAL MATERIAL http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12120578/-/DC1.
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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.
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Reply to 'Evaluation of the effect of JPEG and JPEG2000 image compression on the detection of diabetic retinopathy'.
Atan, D, Foy, C, Scanlon, PH
Eye (London, England). 2008;(3):471; author reply 473