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内科甲状腺功能减退症的管理:患者特征和 FADOI TIAMO 研究中群组随机对照教育项目的影响。

Management of Hypothyroidism in Internal Medicine: Patient Profile and Effects of an Educational Programme in the Cluster-Randomized FADOI TIAMO Study.

机构信息

Internal Medicine Department, Ospedale Civile di Partinico, Palermo, Italy.

Department of Clinical Medicine and Surgery, School of Medicine and Surgery, University of Naples Federico II, Naples, Italy.

出版信息

Front Endocrinol (Lausanne). 2022 Jun 13;13:839300. doi: 10.3389/fendo.2022.839300. eCollection 2022.

Abstract

BACKGROUND AND AIMS

There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP).

METHODS

A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization. Four EBGs and 39 CPRs provided the basis on which 22 treatment management indicators were identified (7 referring to the time of hospital admission, 15 to post-admission).

RESULTS

The 21 participating centres recruited 587 hospitalized patients with hypothyroidism, 421 of which were females (71.7%, mean age 74.1 + 14.4 yrs): 318 in phase 1 and 269 in phase 3. The cause of hypothyroidism was unknown in 282 patients (48%). Evaluation at the time of admission identified satisfactory adherence to CPRs (>50%) for 63.6% of the indicators. In the phase 3, TG centres showed significant improvement vs CG in 4 of the 15 post-admission indicators, while 1 out of 15 was significantly worse.

CONCLUSIONS

The EP based on outreach visits significantly improved some indicators in the management of patients with hypothyroidism, with specific reference to appropriateness of TSH dosage and levothyroxine (LT4) treatment modality.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, identifier NCT05314790.

摘要

背景与目的

关于在意大利内科(IM)病房住院的甲状腺功能减退症患者的临床特征和治疗适宜性,目前仍知之甚少。本研究旨在评估:1)患者的特征以及与基于证据的指南(EBG)中循证医学实践推荐(CPR)的可能偏差;2)通过标准化教育计划(EP)改善患者管理。

方法

本研究是一项全国性多中心研究,包括两个回顾性调查(第 1 阶段和第 3 阶段)的重复,并在一半的中心进行了 EP(第 2 阶段),而另一半中心则没有 EP。EP 基于外展访问。通过聚类随机化将中心分配到研究的两个臂,分别标记为培训组(TG)和对照组(CG)。4 个 EBG 和 39 个 CPR 为确定 22 个治疗管理指标提供了依据(7 个与入院时间有关,15 个与入院后有关)。

结果

21 个参与中心共招募了 587 名住院甲状腺功能减退症患者,其中 421 名女性(71.7%,平均年龄 74.1+14.4 岁):第 1 阶段 318 名,第 3 阶段 269 名。282 名患者(48%)的甲状腺功能减退症病因不明。入院时的评估发现,63.6%的指标符合 CPR 要求(>50%)。在第 3 阶段,TG 中心在 15 个入院后指标中有 4 个与 CG 相比有显著改善,而 15 个中有 1 个明显恶化。

结论

基于外展访问的 EP 显著改善了甲状腺功能减退症患者管理中的一些指标,特别是 TSH 剂量和左甲状腺素(LT4)治疗方式的适宜性。

临床试验注册

ClinicalTrials.gov,标识符 NCT05314790。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0437/9235396/71446053bed0/fendo-13-839300-g001.jpg

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