糖尿病患病率的增加以及针对其主要视觉威胁并发症(糖尿病性黄斑水肿[DME]和增生性糖尿病性视网膜病变[PDR])的新疗法的出现,这需要频繁的终身随访,医院需求明显增加。随后患者评估和治疗的延误导致视力丧失。迫切需要提高能力的战略。视网膜病变(EMERALD)研究测试了诊断准确性,可接受性,以及以前治疗过DME或PDR的人的新医疗保健途径的成本。
预期,多中心,大小写引用,横截面,在英国13家医院进行的诊断准确性研究。
先前成功治疗DME或PDR的1型或2型糖尿病成人,在入学时,患有活动性或非活动性疾病。
涉及多模态成像的新医疗保健途径(DME的谱域OCT,和7场早期治疗糖尿病视网膜病变研究[ETDRS]和PDR的超宽场[UWF]眼底图像)由训练有素的非医务人员(眼科分级人员)解释以检测疾病的再激活,并与当前的标准护理(面对面)进行了比较。
主要结果:新通路的敏感性。
特异性;途径之间的一致性;成本;可接受性;需要后续眼科医生评估的比例,无法进行成像,图像不足或不确定的发现。
新的途径显示出97%的敏感性(95%置信区间[CI],92%-99%)和31%(95%CI,23%-40%)的特异性来检测DME。对于PDR,使用7场ETDRS图像的敏感性和特异性(85%[95%CI,77%-91%]和48%[95%CI,41%-56%],分别)或UWF图像(83%[95%CI,75%-89%]和54%[95%CI,46%-61%],分别)具有可比性。为了检测高风险的PDR,使用UWF图像时的敏感性和特异性更高(87%[95%CI,78%-93%]和49%[95%CI,42%-56%],分别,UWF与80%[95%CI,69-88%]和40%[95%CI,34%-47%],分别,对于7场ETDRS图像)。参与者更喜欢眼科医生的评估;在他们缺席的情况下,他们更喜欢评分者的即时反馈,保持定期的眼科医生评估。与当前的护理标准相比,新路径每100例DME就诊可节省1390英镑,每100例PDR就诊可节省461至1189英镑.
新的途径具有可接受的灵敏度并且将释放资源。用户建议应指导实施。
The increasing diabetes prevalence and advent of new treatments for its major visual-threatening complications (diabetic macular edema [
DME] and proliferative diabetic retinopathy [PDR]), which require frequent life-long follow-up, have increased hospital demands markedly. Subsequent delays in patient\'s evaluation and treatment are causing sight loss. Strategies to increase capacity are needed urgently. The retinopathy (EMERALD)
study tested diagnostic accuracy, acceptability, and costs of a new health care pathway for people with previously treated
DME or PDR.
Prospective, multicenter, case-referent, cross-sectional, diagnostic accuracy
study undertaken in 13 hospitals in the United Kingdom.
Adults with type 1 or 2 diabetes previously successfully treated DME or PDR who, at the time of enrollment, had active or inactive disease.
A new health care pathway entailing multimodal imaging (spectral-domain OCT for DME, and 7-field Early Treatment Diabetic Retinopathy
Study [ETDRS] and ultra-widefield [UWF] fundus images for PDR) interpreted by trained nonmedical staff (ophthalmic graders) to detect reactivation of disease was compared with the current standard care (face-to-face examination by ophthalmologists).
Primary outcome: sensitivity of the new pathway.
specificity; agreement between pathways; costs; acceptability; proportions requiring subsequent ophthalmologist assessment, unable to undergo imaging, and with inadequate images or indeterminate findings.
The new pathway showed sensitivity of 97% (95% confidence interval [CI], 92%-99%) and specificity of 31% (95% CI, 23%-40%) to detect DME. For PDR, sensitivity and specificity using 7-field ETDRS images (85% [95% CI, 77%-91%] and 48% [95% CI, 41%-56%], respectively) or UWF images (83% [95% CI, 75%-89%] and 54% [95% CI, 46%-61%], respectively) were comparable. For detection of high-risk PDR, sensitivity and specificity were higher when using UWF images (87% [95% CI, 78%-93%] and 49% [95% CI, 42%-56%], respectively, for UWF versus 80% [95% CI, 69-88%] and 40% [95% CI, 34%-47%], respectively, for 7-field ETDRS images). Participants preferred ophthalmologists\' assessments; in their absence, they preferred immediate feedback by graders, maintaining periodic ophthalmologist evaluations. When compared with the current standard of care, the new pathway could save £1390 per 100 DME visits and between £461 and £1189 per 100 PDR visits.
The new pathway has acceptable sensitivity and would release resources. Users\' suggestions should guide implementation.