由于糖尿病患病率的增加,与糖尿病性黄斑水肿和增生性糖尿病性视网膜病变相关的工作量正在增加,使医院眼科服务难以满足需求。
目的是评估诊断性能,使用眼科分级人员解释的多模式成像来检测先前治疗过的患者中糖尿病性黄斑水肿/增生性糖尿病视网膜病变的再激活的新路径的成本效益和可接受性。
这是一个前景,大小写引用,横断面诊断研究。
设置是13家NHS医院的眼科诊所。
患有1型或2型糖尿病的成年人,先前成功治疗过糖尿病性黄斑水肿/增生性糖尿病性视网膜病变,在入学时,糖尿病性黄斑水肿/增生性糖尿病性视网膜病变可为活动性或非活动性。
对于眼科分级器途径,回顾光谱域光学相干断层扫描扫描以检测糖尿病性黄斑水肿,和七场早期治疗糖尿病视网膜病变研究/超宽视野眼底图像检测增殖性糖尿病视网膜病变,由受过训练的眼科分级员。对于当前的标准护理途径(参考标准),眼科医生通过裂隙灯生物显微镜面对面检查患者的增生性糖尿病视网膜病变,此外,糖尿病性黄斑水肿的谱域光学相干断层扫描成像。
主要结果指标是眼科分级者途径检测活动性糖尿病性黄斑水肿/增生性糖尿病性视网膜病变的敏感性。次要结果是特异性,途径之间的协议,成本后果,可接受性和需要后续眼科医生评估的患者比例,无法进行成像和图像质量不足/不确定的结果。对于主要分析,假设所有分级者诊断为活动性疾病或“不确定”或图像为“无法分级”的患者都需要眼科医生进行检查。
患有活动性和非活动性糖尿病性黄斑水肿的合格参与者(152名和120名参与者,分别)和活动性和非活动性增生性糖尿病视网膜病变(111和170名参与者,分别)被招募。在主要分析下,分级者检测糖尿病性黄斑水肿的敏感性为97%(142/147)(95%置信区间92%~99%),特异性为31%(35/113)(95%置信区间23%~40%).对于增生性糖尿病视网膜病变,使用七场早期治疗糖尿病视网膜病变研究,分级者具有相似的敏感性和特异性[敏感性85%(87/102),95%置信区间77%至91%;特异性48%(77/160),95%置信区间41%至56%]或超宽场成像[灵敏度83%(87/105),95%置信区间75%至89%;特异性54%(86/160),95%置信区间46%至61%]。参加焦点小组的参与者表示更喜欢眼科医生的面对面评估。在眼科医生缺席的情况下,患者表示需要在分级者的评估后立即反馈,保持眼科医生的定期评估。分级医生和眼科医生支持新的途径。当与参考标准(当前标准途径)比较时,在对糖尿病性黄斑水肿患者的审查中,新的分级者途径可以节省每100名患者1390英镑,根据所使用的成像模式,在增殖性糖尿病视网膜病变患者的审查中,每100名患者为461英镑至1189英镑。
对于糖尿病性黄斑水肿患者,眼科分级器途径似乎安全且节省成本。新的途径检测活动性增生性糖尿病视网膜病变的敏感性较低,但对于之前接受过激光治疗的增生性糖尿病视网膜病变患者,仍可接受.如果引入新的途径以确保其对用户的可接受性,则应考虑焦点小组讨论的建议。
缺乏荧光素眼底血管造影来确认活动性增殖性糖尿病视网膜病变的诊断。
改善新的途径能否提高其检测增殖性糖尿病视网膜病变的敏感性?人工智能能否用于该先前治疗过的人群的图像自动读取?
当前对照试验ISRCTN10856638和ClinicalTrials.govNCT03490318。
该项目由国家卫生研究所(NIHR)卫生技术评估计划资助,并将在《卫生技术评估卷》中全文发表。25号32.有关更多项目信息,请参阅NIHR期刊库网站。
越来越多的人患上糖尿病。糖尿病性黄斑水肿和增生性糖尿病视网膜病变是糖尿病的并发症,这可能会导致失明。因此,患有糖尿病性黄斑水肿和增生性糖尿病视网膜病变的患者需要及时治疗,并在临床上进行终生检查。世界人口正在老龄化。因此,有更多的人患有眼部疾病。现在也有更多的治疗眼病的人。医院的工作量越来越大,使NHS难以应对需求。没有足够的眼科医生(眼科医生)照顾病人。延迟预约和治疗意味着患者可能会失明。EMERALD(多模式成像在糖尿病性视网膜病变中评估视网膜水肿和新膀胱的有效性)的目标是观察治疗且稳定的糖尿病性黄斑水肿或增生性糖尿病性视网膜病变的患者是否可以随访“眼科分级者”,他们不是医生,但接受过诊断糖尿病性黄斑水肿和增生性糖尿病性视网膜病变的培训。在EMERALD,受过训练的眼科分级人员检查了患有糖尿病性黄斑水肿和增生性糖尿病性视网膜病变的人的眼睛后部的照片。他们检查了糖尿病性黄斑水肿和增生性糖尿病性视网膜病变是否仍然不活跃。如果是,患者可以继续接受眼科分级者的随访.如果糖尿病性黄斑水肿或增生性糖尿病性视网膜病变活跃,分级人员会立即将患者转介给眼科医生。EMERALD发现分级人员在检测糖尿病性黄斑水肿方面表现出色,这可以让眼科医生有时间去看其他病人。分级者在检测活动性增生性糖尿病视网膜病变方面表现不佳。然而,考虑到病人已经接受了治疗,这可能还是安全的.参加焦点小组讨论的患者提到他们更愿意去看眼科医生,这样他们就可以询问他们的眼睛状况。如果这是不可能的,他们希望从分级者那里得到立竿见影的结果,并且仍然不时地看到眼科医生。
Owing to the increasing prevalence of diabetes, the workload related to diabetic macular oedema and proliferative diabetic retinopathy is rising, making it difficult for hospital eye services to meet demands.
The objective was to evaluate the diagnostic performance, cost-effectiveness and acceptability of a new pathway using multimodal imaging interpreted by ophthalmic graders to detect reactivation of diabetic macular oedema/proliferative diabetic retinopathy in previously treated patients.
This was a prospective, case-referent, cross-sectional diagnostic
study.
The setting was ophthalmic clinics in 13 NHS hospitals.
Adults with type 1 or type 2 diabetes with previously successfully treated diabetic macular oedema/proliferative diabetic retinopathy in one/both eyes in whom, at the time of enrolment, diabetic macular oedema/proliferative diabetic retinopathy could be active or inactive.
For the ophthalmic grader pathway, review of the spectral domain optical coherence tomography scans to detect diabetic macular oedema, and seven-field Early Treatment Diabetic Retinopathy
Study/ultra-wide field fundus images to detect proliferative diabetic retinopathy, by trained ophthalmic graders. For the current standard care pathway (reference standard), ophthalmologists examined patients face to face by slit-lamp biomicroscopy for proliferative diabetic retinopathy and, in addition, spectral domain optical coherence tomography imaging for diabetic macular oedema.
The primary outcome measure was sensitivity of the ophthalmic grader pathway to detect active diabetic macular oedema/proliferative diabetic retinopathy. The secondary outcomes were specificity, agreement between pathways, cost-consequences, acceptability and the proportion of patients requiring subsequent ophthalmologist assessment, unable to undergo imaging and with inadequate quality images/indeterminate findings. It was assumed for the main analysis that all patients in whom graders diagnosed active disease or were \'unsure\' or images were \'ungradable\' required examination by an ophthalmologist.
Eligible participants with active and inactive diabetic macular oedema (152 and 120 participants, respectively) and active and inactive proliferative diabetic retinopathy (111 and 170 participants, respectively) were recruited. Under the main analysis, graders had a sensitivity of 97% (142/147) (95% confidence interval 92% to 99%) and specificity of 31% (35/113) (95% confidence interval 23% to 40%) to detect diabetic macular oedema. For proliferative diabetic retinopathy, graders had a similar sensitivity and specificity using seven-field Early Treatment Diabetic Retinopathy
Study [sensitivity 85% (87/102), 95% confidence interval 77% to 91%; specificity 48% (77/160), 95% confidence interval 41% to 56%] or ultra-wide field imaging [sensitivity 83% (87/105), 95% confidence interval 75% to 89%; specificity 54% (86/160), 95% confidence interval 46% to 61%]. Participants attending focus groups expressed preference for face-to-face evaluations by ophthalmologists. In the ophthalmologists\' absence, patients voiced the need for immediate feedback following grader\'s assessments, maintaining periodic evaluations by ophthalmologists. Graders and ophthalmologists were supportive of the new pathway. When compared with the reference standard (current standard pathway), the new grader pathway could save £1390 per 100 patients in the review of people with diabetic macular oedema and, depending on the imaging modality used, between £461 and £1189 per 100 patients in the review of people with proliferative diabetic retinopathy.
For people with diabetic macular oedema, the ophthalmic grader pathway appears safe and cost saving. The sensitivity of the new pathway to detect active proliferative diabetic retinopathy was lower, but may still be considered acceptable for patients with proliferative diabetic retinopathy previously treated with laser. Suggestions from focus group discussions should be taken into consideration if the new pathway is introduced to ensure its acceptability to users.
Lack of fundus fluorescein angiography to confirm diagnosis of active proliferative diabetic retinopathy.
Could refinement of the new pathway increase its sensitivity to detect proliferative diabetic retinopathy? Could artificial intelligence be used for automated reading of images in this previously treated population?
Current Controlled Trials ISRCTN10856638 and ClinicalTrials.gov NCT03490318.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology AssessmentVol. 25, No. 32. See the NIHR Journals Library website for further project information.
More and more people are developing diabetes. Diabetic macular oedema and proliferative diabetic retinopathy are complications of diabetes, which could cause blindness. Thus, people with diabetic macular oedema and proliferative diabetic retinopathy need to be treated in a timely manner and reviewed in clinic for life. The population in the world is ageing. As a result, there are more people with eye diseases. There are also more treatments now for people with eye diseases. The workload in hospitals is increasing, making it difficult for the NHS to cope with the demand. There are not enough ophthalmologists (eye doctors) to look after patients. Delayed appointments and treatment mean that patients may lose sight. The goal of EMERALD (Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy) was to see if patients with treated and stable diabetic macular oedema or proliferative diabetic retinopathy could be followed by ‘ophthalmic graders’, who are not doctors but are trained to diagnose diabetic macular oedema and proliferative diabetic retinopathy. In EMERALD, trained ophthalmic graders examined photographs of the back of the eye of people with diabetic macular oedema and proliferative diabetic retinopathy. They checked if diabetic macular oedema and proliferative diabetic retinopathy remain inactive. If so, patients could continue follow-up with the ophthalmic graders. If diabetic macular oedema or proliferative diabetic retinopathy were active, graders would immediately refer patients to ophthalmologists. EMERALD found that graders were excellent at detecting diabetic macular oedema, and this could give ophthalmologists time to see other patients. Graders were not quite as good at detecting active proliferative diabetic retinopathy. However, considering that patients had already had treatment, this may still be safe. Patients participating in focus group discussions mentioned that they would prefer to see ophthalmologists, so they could ask questions about their eye condition. If this was not possible, they would like to have immediate results from graders and still see the ophthalmologist from time to time.