風險分類可減少糖尿病患不必要的眼科檢查


  【24drs.com】一篇新研究認為,可能可以將糖尿病患分成視網膜病變低風險與高風險,然後根據病患的風險類別建議篩檢間隔。
  
  蘇格蘭Dundee Ninewells醫院與醫學院的Graham P Leese醫師等人,在12月18日的糖尿病照護期刊線上發表對超過35萬名患者的多中心觀察結果。
  
  研究者表示,英國目前建議所有12歲以上的糖尿病患每年要至少檢查一次視網膜,美國糖尿病協會表示,如果單眼或雙眼檢查沒有視網膜病變,可以考慮每兩年檢查一次,但如果已經有任何程度的視網膜病變,要增加檢查頻率。
  
  該研究包括了英國的七個糖尿病視網膜篩檢計畫,開始時或一年後沒有視網膜病變者,在四年時發生可治療的眼科疾病的比率不到1% ,開始時與一年後有雙側背基型視網膜病變者,比率則是高達6.4%。
  
  Leese醫師表示,目前的資訊指出,每兩年篩檢一次對於那些開始時沒有視網膜病變者是安全的,至於視網膜病變高風險者,增加篩檢頻率是適當的。他指出,對病患進行後續研究,將可以計算個人的篩檢間隔。
  
  麻州波士頓哈佛醫學院眼科醫師Paolo Antonio S Silva醫師受邀發表評論時表示,這篇報告為美國糖尿病協會的建議提供額外支持,研究的強度是:樣本數夠大、當代人口、標準化的視網膜評估方法。
  
  不過,身兼波士頓Joslin糖尿病中心、Beetham眼科研究院、遠距醫療副總的Silva醫師也指出,缺乏有關HbA1c、血壓、其他相關臨床因素的資料—在視網膜篩檢轉診時缺乏—是這項研究的固有限制。
  
  研究樣本總共是354,549名在2005-2012年間至少進行過三次視網膜病變篩檢和分級的病患,在前兩次沒有可參考的糖尿病視網膜病變。
  
  可參考的定義為:中度非增殖性糖尿病視網膜病變、靜脈出血、靜脈重疊、視網膜內微血管異常、多處深部圓點或斑塊出血、增殖性視網膜病變,或顯著黃斑部病變(各中心有不同的定義);需要立即治療之眼科疾病的定義,是及早治療糖尿病視網膜病變研究(ETDRS)分數61分以上的增殖性視網膜病變。
  
  根據在開始時或一年時,單眼或雙眼有或沒有背基型視網膜病變,將病患分組,總共分成九組。
  
  九組中的三組納入分析,低風險定義為連續兩次篩檢都沒有糖尿病視網膜病變;中等風險定義為兩次篩檢有任一次有一眼有輕微非增殖性視網膜病變;高風險定義為兩次篩檢時兩眼都有輕微非增殖性視網膜病變。
  
  16,196例有可參考的視網膜病變,兩年時相對於開始時的視網膜惡化率為:低風險組0.3%–1.3% (因各中心而異) ,中等風險組2%–9%、高風險組13%–29% 。
  
  英國目前每年進行眼科檢查者有3%轉診進行後續檢查,這個數據遠遠高出低風險組的視網膜惡化百分比。
  
  Leese醫師等人指出,低風險組病患約占英國視網膜篩檢人口的一半到三分之二。
  
  他們報告指出,兩年時可治療之眼科疾病的比率,兩個低風險組都小於0.3%,高風險組為0.5% -4.1%,四年時,比率增加到0.9%- 6.4%。
  
  Leese醫師表示,在英國,要實施不同的篩檢間隔很棘手;改變政策是大事,因為它是已進行數十年的根深蒂固實務,釐清哪些病患最適用也很重要。
  
  他也指出,要成功的話,需要良好的通知與再通知的系統,可即時因應病患的篩檢要求的變化,也需要良好的品質保證系統。
  
  但在報告中,他們表示,將大部份低風險者延長篩檢間隔,把資源集中在高風險者的更頻繁篩檢,這可能要證明在經濟上是有利的,需要進一步的經濟分析,以瞭解對健康照護體系費用的整體影響。
  
  此外,他們指出,可能會中斷追蹤,是另一個需要注意的問題。
  
  實際上,美國也面臨相同問題,Silva醫師表示,這篇研究的方法是對所有糖尿病患進行系統性評估,報告指出英國的視網膜檢查率超過90%,在美國,估計約為60%,這個比率甚至比資源有限者更低。
  
  Silva醫師指出,不是以人口為基礎,而是以機率方式進行的視網膜篩檢計畫中,可以掌握到一樣多的病患,因為在這樣的設計下,不可能每年重複篩檢。
  
  他結論表示,要將這些研究結果應用到幾乎所有糖尿病患,還需要更進一步的研究。
  
  資料來源:http://www.24drs.com/professional/list/content.asp?x_idno=7152&x_classno=0&x_chkdelpoint=Y
  

Risk Stratification Cuts Unnecessary Eye Exams in Diabetes

By Miriam E Tucker
Medscape Medical News

It may be possible to stratify diabetes patients into lower- and higher-risk categories for retinopathy and then tailor the recommended screening intervals based on individual risk, a new study suggests.

Results from the observational multicenter trial of more than 350,000 patients were published online December 18 in Diabetes Care by Dr Graham P Leese (Ninewells Hospital and Medical School, Dundee, Scotland) and colleagues.

Current UK recommendations call for retinal exams at least annually for all people with diabetes aged 12 years and older, the researchers say. The American Diabetes Association says that tests every 2 years "may be considered" if there is no evidence of retinopathy for one or more eye exams but calls for more frequent screening in those who already have any degree of retinopathy.

In the study's seven diabetes retinal screening programs across the United Kingdom, less than 1% of patients with no retinopathy at baseline or 1 year later had developed treatable eye disease at 4 years, compared with up to 6.4% of those with bilateral background retinopathy at baseline and 1 year.

Dr Leese told Medscape Medical News, "Current information indicates that [screening every 2 years] may be safe for those with no baseline retinopathy, and increased frequency of screening [may be appropriate] for those with high-risk retinopathy."

And "It may be possible to calculate an individualized screening interval for patients following further research," he added.

Asked to comment on the findings, ophthalmologist Dr Paolo Antonio S Silva (Harvard Medical School, Boston, Massachusetts) told Medscape Medical News, "This present paper adds substantial support to [the ADA's] recommendation," adding that "the study's strengths are the large sample size, contemporary population, and standardized means for retinal evaluation."

However, Dr Silva, who is also assistant chief of telemedicine, Beetham Eye Institute, Joslin Diabetes Center, in Boston, also pointed out that the lack of data on HbA1c, blood pressure, and other relevant clinical factors — unavailable in the retinal screening referral setting — is "an inherent limitation" of the study.

Stratifying Risk by Baseline Condition

The study sample included a total 354,549 patients who had undergone retinopathy screening and grading at least three times from 2005 to 2012, with no referable diabetic retinopathy during the first two episodes.

"Referable" was defined as moderate nonproliferative diabetic retinopathy, venous bleeding, venous reduplication, intraretinal microvascular abnormality, multiple deep round or blot hemorrhages, proliferative retinopathy, or significant maculopathy (with differing definitions by center).

Eye disease requiring immediate treatment was defined as proliferative retinopathy with an Early Treatment of Diabetic Retinopathy Study (ETDRS) scale score of 61 or greater.

Patients were placed into a total of nine subgroups based on the presence or absence of background retinopathy in one or both eyes at baseline and at year 1.

Three of the nine groups were used for the analysis, with "low" risk defined as no diabetic retinopathy at either of the two successive screenings, "medium" risk as mild nonproliferative diabetic retinopathy in one eye at each of the two screenings, and "high" risk" as mild nonproliferative diabetic retinopathy in both eyes on the two screenings.

There were 16,196 cases of referable retinopathy, with the rate of progression at 2 years related to the baseline retinal findings: 0.3%–1.3% (varying by center) for the low-risk group, 2%–9% for the intermediate risk group, and 13%–29% for the high risk group.

Currently in the United Kingdom, 3% of people undergoing eye exams every year are referred for further investigation, a figure that is well above the percentage of patients experiencing progression of retinopathy in the "low-risk" group.

"This low-risk group of patients accounts for between one-half and two-thirds of patients within these UK retinal screening populations," Dr Leese and colleagues point out.

Rates of treatable eye disease at 2 years were less than 0.3% in the two lower-risk groups and 0.5% to 4.1% in the high-risk group. At 4 years, those proportions had increased to 0.9% and 6.4%, they report.

How to Put Findings Into Practice?

Dr. Leese acknowledges that in the United Kingdom, implementing variable screening intervals might prove tricky.

"It is a big step to change policy, as it is engrained in common practice and has been for decades. It is also important to try to identify which patients this is most applicable to," he told Medscape Medical News.

And he noted that, in order to succeed, "it requires a good call-recall system to be sensitive to the changing screening requirements of patients. It also requires a good quality-assurance system."

But in the paper, he and his colleagues say that extending the screening interval for the large proportion of low-risk people and concentrating resources on more frequent screening for the smaller proportion at higher risk might prove economically advantageous.

"Further economic modeling is required to understand the overall impact on healthcare-system costs," they write.

The potential loss to follow-up is another issue that would need to be addressed, they point out.

Indeed, that is an issue in the United States as well, Dr Silva told Medscape Medical News, noting that "this study was conducted using a program that performs a systematic evaluation of all patients with diabetes. The reported retinal evaluation rate in the UK is over 90%, in contrast to the US setting, which is estimated at about 60%. This rate is likely even lower in populations with limited resources."

Dr Silva added, "In retinal screening programs that are not population-based but rather opportunistic in approach, it is essential to capture as many patients, since yearly repeated examinations in this setting may not be possible.

"The applicability of the findings outside a setting with the resources to perform a systematic evaluation of nearly all patients with diabetes needs to be further evaluated," he concluded.

The study was supported by the National Health Service Diabetic Eye Screening Programme, a National Institutes for Health research grant, and the Scottish Diabetes Retinal Screening Programme. Dr Leese and coauthors report no relevant financial relationships, as does Dr Silva.

Diabetes Care. Published online December 18, 2014.

    
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