Estudio del impacto de la inclusión de la valoración global del dolor y la capacidad funcional en la definición de remisión y su mantenimiento en la artritis reumatoide. Objetivos y metodología

IF 1.2 Q4 RHEUMATOLOGY

Reumatologia Clinica Pub Date : 2025-05-01 DOI:10.1016/j.reuma.2025.501895

Alejandro Balsa , Daniel Seoane-Mato , Marta Domínguez-Álvaro , Mercedes Alperi , Virginia Ruiz-Esquide , Javier Bachiller-Corral , Federico Díaz-González , en representación del Grupo del estudio Remisión-AR

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Abstract

Background and objective

The SUMAR project established a definition for remission that includes the patient's perspective (global assessment of pain and HAQ) in the definition of remission in rheumatoid arthritis (RA). This new definition needs to be assessed on clinical practice. The main objective of the RA-Remission study is to estimate the proportion of patients in sustained remission according to SUMAR definition through 2-year follow-up, among patients in SUMAR remission at baseline. This manuscript describes the objectives and methodology of the study.

Materials and methods

This is a longitudinal, prospective, observational and multicentre study, involving 10 centres. Patients with RA who have achieved clinical remission in accordance to their attending rheumatologist clinical judgement within the last 6 months will be included. Follow-up visits will take place at 3, 6, 12, 12, 18 and 24 months. Ultrasound assessment of the power Doppler (PD) signal for 30 joints and 6 tendon regions will be performed at each participating centre by an expert blinded to all other study findings. Definitions of remission according to SUMAR, PD and activity indices will be used. Sustained remission will be considered for each of the definitions when the patient in remission at the baseline visit maintains it during all follow-up visits. To estimate the proportion of patients maintaining remission at two years with an accuracy of at least 6%, 180 patients will need to be recruited.

Discussion and conclusions

The main strength of the design is the use of ultrasound assessment as the gold standard for assessing inflammatory activity.

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研究将疼痛和功能的整体评估纳入缓解定义及其在类风湿关节炎中的维持的影响。目标和方法

背景和目的：SUMAR项目建立了缓解的定义，包括患者的视角（疼痛和HAQ的整体评估）来定义类风湿关节炎（RA）的缓解。这个新的定义需要在临床实践中进行评估。ra -缓解研究的主要目的是通过2年随访，估计基线时SUMAR缓解的患者中根据SUMAR定义持续缓解的患者比例。这份手稿描述了研究的目的和方法。材料和方法这是一项纵向、前瞻性、观察性和多中心研究，涉及10个中心。根据其主治风湿病医生的临床判断，在过去6个月内达到临床缓解的RA患者将被包括在内。随访将在3、6、12、12、18和24个月进行。每个参与中心将由一名不知道其他研究结果的专家对30个关节和6个肌腱区域的功率多普勒（PD）信号进行超声评估。根据SUMAR、PD和活动指数来定义缓解。当患者在基线访视时处于缓解状态，并在所有随访期间保持缓解状态时，将考虑每一种定义的持续缓解。为了估计在两年内保持缓解的患者比例，且准确性至少为6%，需要招募180名患者。讨论与结论本设计的主要优点是使用超声评估作为评估炎症活动的金标准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Reumatologia Clinica RHEUMATOLOGY-

CiteScore

2.40

自引率

6.70%

发文量

105

审稿时长

54 days

期刊介绍： Una gran revista para cubrir eficazmente las necesidades de conocimientos en una patología de etiología, expresividad clínica y tratamiento tan amplios. Además es La Publicación Oficial de la Sociedad Española de Reumatología y del Colegio Mexicano de Reumatología y está incluida en los más prestigiosos índices de referencia en medicina.