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远程医疗在提供糖尿病视网膜病变筛查检查方面的长期比较效果:一项随机临床试验。

Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial.

机构信息

Devers Eye Institute/Discoveries in Sight, Legacy Health, Portland, Oregon2Department of Public Health and Preventive Medicine, Oregon Health & Science University, Portland.

Devers Eye Institute/Discoveries in Sight, Legacy Health, Portland, Oregon.

出版信息

JAMA Ophthalmol. 2015 May;133(5):518-25. doi: 10.1001/jamaophthalmol.2015.1.

Abstract

IMPORTANCE

Minimal information exists regarding the long-term comparative effectiveness of telemedicine to provide diabetic retinopathy screening examinations.

OBJECTIVE

To compare telemedicine to traditional eye examinations in their ability to provide diabetic retinopathy screening examinations.

DESIGN, SETTING, AND PARTICIPANTS: From August 1, 2006, through September 31, 2009, 567 participants with diabetes were randomized and followed up to 5 years of follow-up (last date of patient follow-up occurred on August 6, 2012) as part of a multicenter randomized clinical trial with an intent to treat analysis. We assigned participants to telemedicine with a nonmydriatic camera in a primary care medical clinic (n = 296) or traditional surveillance with an eye care professional (n = 271). Two years after enrollment, we offered telemedicine to all participants.

MAIN OUTCOMES AND MEASURES

Percentage of participants receiving annual diabetic retinopathy screening examinations, percentage of eyes with worsening diabetic retinopathy during the follow-up period using a validated scale from stage 0 (none) to stage 4 (proliferative diabetic retinopathy), and percentage of telemedicine participants who would require referral to an eye care professional for follow-up care using a cutoff of moderate diabetic retinopathy or worse, the presence of macular edema, or an unable-to-determine result for retinopathy or macular edema.

RESULTS

The telemedicine group was more likely to receive a diabetic retinopathy screening examination when compared with the traditional surveillance group during the 6-month or less (94.6% [280/296] vs 43.9% [119/271]; 95% CI, 46.6%-54.8%; P < .001) and greater than 6-month through 18-month (53.0% [157/296] vs 33.2% [90/271]; 95% CI, 16.5%-23.1%; P < .001) time bins. After we offered telemedicine to both groups, we could not identify a difference between the groups in the percentage of diabetic retinopathy screening examinations. Diabetic retinopathy worsened by 2 stages or more in 35 (8.6%) of 409 participants (95% CI, 5.8%-11.2%) and improved by 2 stages or more in 5 (1.2%) of 409 participants (95% CI, 0.1%-2.3%) during the 4-year period. The percent of telemedicine participants requiring referral ranged from 19.2% (52/271) to 27.9% (58/208).

CONCLUSIONS AND RELEVANCE

Telemedicine increased the percentage of diabetic retinopathy screening examinations, most participants did not require referral to an eye care professional, and diabetic retinopathy levels were generally stable during the study period. This finding suggests that primary care clinics can use telemedicine to screen for diabetic retinopathy and monitor for disease worsening over a long period.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01364129.

摘要

重要性

关于远程医疗提供糖尿病视网膜病变筛查检查的长期比较效果,相关信息非常有限。

目的

比较远程医疗和传统眼科检查在提供糖尿病视网膜病变筛查检查方面的效果。

设计、地点和参与者:从 2006 年 8 月 1 日至 2009 年 9 月 31 日,共有 567 名患有糖尿病的参与者被随机分组并随访 5 年(最后一次患者随访时间为 2012 年 8 月 6 日),这是一项多中心随机临床试验,采用意向治疗分析。我们将参与者分配到初级保健医疗诊所的远程医疗(使用非散瞳相机)组(n=296)或传统监测的眼科专业护理组(n=271)。在登记后两年,我们向所有参与者提供远程医疗。

主要结果和测量

每年接受糖尿病视网膜病变筛查检查的参与者比例、在随访期间使用经过验证的量表(从 0 期(无)到 4 期(增生性糖尿病视网膜病变))评估的糖尿病视网膜病变恶化的眼睛比例,以及需要转介到眼科专业护理进行随访的远程医疗参与者比例,转介标准为中度糖尿病视网膜病变或更严重、黄斑水肿、或视网膜病变或黄斑水肿无法确定的结果。

结果

与传统监测组相比,远程医疗组在 6 个月或更短时间(94.6%[280/296]与 43.9%[119/271];95%CI,46.6%-54.8%;P<0.001)和 6 个月至 18 个月(53.0%[157/296]与 33.2%[90/271];95%CI,16.5%-23.1%;P<0.001)时间间隔内更有可能接受糖尿病视网膜病变筛查检查。在我们为两组都提供了远程医疗之后,我们无法在糖尿病视网膜病变筛查检查的比例上发现两组之间的差异。在 4 年期间,409 名参与者中有 35 名(8.6%)糖尿病视网膜病变恶化了 2 个或更多阶段(95%CI,5.8%-11.2%),5 名(1.2%)参与者(95%CI,0.1%-2.3%)糖尿病视网膜病变改善了 2 个或更多阶段。需要转介的远程医疗参与者比例为 19.2%(52/271)至 27.9%(58/208)。

结论和相关性

远程医疗增加了糖尿病视网膜病变筛查检查的比例,大多数参与者不需要转介到眼科专业护理,并且在研究期间糖尿病视网膜病变水平总体稳定。这一发现表明,初级保健诊所可以使用远程医疗来筛查糖尿病视网膜病变,并在较长时间内监测疾病的进展。

试验注册

clinicaltrials.gov 标识符:NCT01364129。

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