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基于证据的指南是否反映在临床实践中?意大利甲状腺癌观察站前瞻性收集数据的分析。

Are Evidence-Based Guidelines Reflected in Clinical Practice? An Analysis of Prospectively Collected Data of the Italian Thyroid Cancer Observatory.

机构信息

1 Department of Internal Medicine and Medical Specialties, University of Rome Sapienza , Rome, Italy .

2 Center for Outcomes Research and Clinical Epidemiology , Pescara, Italy .

出版信息

Thyroid. 2017 Dec;27(12):1490-1497. doi: 10.1089/thy.2017.0299. Epub 2017 Nov 10.

Abstract

OBJECTIVES

The goal of evidence-based practice guidelines is to optimize the management of emerging diseases, such as differentiated thyroid cancer (DTC). The aim of this study was to assess therapeutic approaches for DTC in Italy and to see how closely these practices conformed to those recommended in the 2009 American Thyroid Association (ATA) guidelines.

METHODS

The Italian Thyroid Cancer Observatory was established to collect data prospectively on thyroid cancers consecutively diagnosed in participating centers (uniformly distributed across the nation). Data on the initial treatment of all pathologically confirmed DTC cases present in the database from January 1, 2013 (database creation) to January 31, 2016, were analyzed.

RESULTS

A total of 1748 patients (77.2% females; median age 48.1 years [range 10-85 years]) were enrolled in the study. Most (n = 1640; 93.8%) were papillary carcinomas (including 84 poorly differentiated/aggressive variants); 6.2% (n = 108) were follicular and Hürthle cell carcinomas. The median tumor diameter was 11 mm (range 1-93 mm). Tumors were multifocal in 613 (35%) and presented extrathyroidal extension in 492 (28%) cases. Initial treatments included total thyroidectomy (involving one or two procedures; n = 726; 98.8%) and lobectomy (n = 22; 1.2%). A quarter of the patients who underwent total thyroidectomy had unifocal, intrathyroidal tumors ≤1 cm (n = 408; 23.6%). Neck dissection was performed in 40.4% of the patients (29.5% had central compartment dissection). Radioiodine remnant ablation (RRA) was performed in 1057 (61.2%) of the 1726 patients who underwent total thyroidectomy: 460 (41.2%) of the 983 classified by 2009 ATA guideline criteria as low-risk, 570 (87.1%) of the 655 as intermediate-risk, and 82 (93.1%) of the 88 as high-risk patients (p < 0.001). RRA was performed in 44% of the cases involving multifocal DTCs measuring ≤1 cm.

CONCLUSIONS

The treatment approaches for DTCs used in Italy display areas of inconsistency with those recommended by the 2009 ATA guidelines. Italian practices were characterized by underuse of thyroid lobectomy in intrathyroidal, unifocal DTCs ≤1 cm. The use of RRA was generally consistent with risk-stratified recommendations. However, its frequent use in small DTCs (≤1 cm) that are multifocal persists, despite the lack of evidence of benefit. These data provide a baseline for future assessments of the impact of international guidelines on DTC management in Italy. These findings also illustrate that the dissemination and implementation of guideline recommendations, and the change in practice patterns, require ongoing education and time.

摘要

目的

循证实践指南的目标是优化新兴疾病(如分化型甲状腺癌[DTC])的管理。本研究旨在评估意大利 DTC 的治疗方法,并观察这些方法与 2009 年美国甲状腺协会(ATA)指南推荐的方法的吻合程度。

方法

为了前瞻性地收集参与中心(全国均匀分布)连续诊断的甲状腺癌数据,成立了意大利甲状腺癌观察站。对数据库创建之日(2013 年 1 月 1 日)至 2016 年 1 月 31 日数据库中存在的所有经病理证实的 DTC 病例的初始治疗数据进行了分析。

结果

共有 1748 例患者(77.2%为女性;中位年龄 48.1 岁[范围 10-85 岁])入组研究。大多数(n=1640;93.8%)为乳头状癌(包括 84 种低分化/侵袭性变异);6.2%(n=108)为滤泡状和 Hurthle 细胞癌。肿瘤的中位直径为 11mm(范围 1-93mm)。613 例(35%)肿瘤多灶性,492 例(28%)肿瘤有甲状腺外侵犯。初始治疗包括全甲状腺切除术(涉及一次或两次手术;n=726;98.8%)和甲状腺叶切除术(n=22;1.2%)。全甲状腺切除术的患者中有四分之一(n=408;23.6%)为单发、甲状腺内、≤1cm 的肿瘤。40.4%的患者进行了颈部淋巴结清扫术(29.5%进行中央区淋巴结清扫术)。在接受全甲状腺切除术的 1726 例患者中,有 1057 例(61.2%)进行了放射性碘残留消融(RRA):460 例(41.2%)根据 2009 年 ATA 指南标准被归类为低危,570 例(87.1%)为中危,88 例(93.1%)为高危(p<0.001)。有 44%的多灶性、≤1cm 的 DTC 进行了 RRA。

结论

意大利使用的 DTC 治疗方法与 2009 年 ATA 指南推荐的方法存在不一致之处。意大利的做法特点是在≤1cm 的甲状腺内、单发 DTC 中过度使用甲状腺叶切除术。RRA 的使用总体上符合风险分层建议。然而,尽管缺乏获益证据,RRA 仍频繁用于≤1cm 的多灶性小 DTC。这些数据为未来评估国际指南对意大利 DTC 管理的影响提供了基线。这些发现还表明,指南推荐的传播和实施以及实践模式的改变需要持续的教育和时间。

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