低疾病活动度类风湿关节炎患者的护士主导咨询：一项随机非劣效性试验。

Nurse-Led Consultation for Patients With Rheumatoid Arthritis at Low Disease Activity: A Randomized Noninferiority Trial.

作者信息

Kwok Suet-Kei, Tang Lai-Man, Tsang Hoi-Lun, Chung Ho-Yin, Chung Man-Ho, Ho Carmen T K, Lau Chak-Sing, Cheung Tommy T

机构信息

Queen Mary Hospital, Hong Kong, China.

The University of Hong Kong, Hong Kong, China.

出版信息

Arthritis Care Res (Hoboken). 2022 Oct;74(10):1736-1744. doi: 10.1002/acr.24625. Epub 2022 Aug 4.

DOI:10.1002/acr.24625

PMID:33973407

Abstract

OBJECTIVE

To determine the effectiveness of nurse-led consultations in patients with stable rheumatoid arthritis (RA) in Hong Kong.

METHODS

The present work was a single-center, randomized, open-label, noninferiority trial. Patients who had rheumatoid arthritis (RA) with low disease activity (LDA) were randomized at a 1:1 ratio to attend a nurse-led consultation or rheumatologist follow-up visit for 2 years. The primary end point was the proportion of patients whose RA remained at LDA. Secondary end points included the proportion of patients with RA in disease remission and the scores recorded on the Leeds Satisfaction Questionnaire at 2 years, changes from baseline on the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP), modified Sharp/van der Heijde score (SHS), Health Assessment Questionnaire disability index (HAQ DI), Short Form 36 (SF-36) physical component score, and 19-item Compliance Questionnaire for Rheumatology (CQR-19) score.

RESULTS

Among 280 patients who were randomized equally to either attend nurse-led consultations or rheumatologist follow-up visits, 267 patients completed the study. In the nurse-led consultation and rheumatologist follow-up groups, 92.1% and 91.4% patients, respectively, remained at LDA at 2 years. The 95% confidence intervals (95% CIs) of the adjusted treatment difference were within the predefined noninferiority margin in both the intention-to-treat analysis (95% CI 5.75, 7.15) and the per-protocol analysis (95% CI 1.67, 7.47). Although the changes in DAS28-CRP score over 2 years were significantly different between the 2 treatment groups (P < 0.001), there were no significant changes from baseline in SHS, HAQ DI, SF-36 physical component scores, and CQR-19 scores. At the end of the study, more patients expressed satisfaction with nurse-led consultations.

CONCLUSION

Nurse-led consultations were not inferior to rheumatologist follow-up visits in patients with stable RA.

摘要

目的

确定香港地区护士主导的会诊对稳定期类风湿关节炎（RA）患者的有效性。

方法

本研究为单中心、随机、开放标签、非劣效性试验。将疾病活动度低（LDA）的类风湿关节炎（RA）患者按1:1比例随机分组，分别接受护士主导的会诊或风湿科医生的随访，为期2年。主要终点是RA仍处于LDA状态的患者比例。次要终点包括疾病缓解的RA患者比例、2年时利兹满意度问卷的得分、基于C反应蛋白水平的28个关节疾病活动评分（DAS28-CRP）较基线的变化、改良Sharp/van der Heijde评分（SHS）、健康评估问卷残疾指数（HAQ DI）、简明健康调查问卷36项（SF-36）身体成分得分以及19项风湿病依从性问卷（CQR-19）得分。

结果

在280例被随机平均分配到接受护士主导的会诊或风湿科医生随访的患者中，267例患者完成了研究。在护士主导的会诊组和风湿科医生随访组中，分别有92.1%和91.4%的患者在2年时仍处于LDA状态。在意向性分析（95%置信区间[CI] 5.75，7.15）和符合方案分析（95% CI 1.67，7.47）中，调整后的治疗差异的95% CI均在预先定义的非劣效界值范围内。尽管2个治疗组在2年期间DAS28-CRP评分的变化有显著差异（P < 0.001），但SHS、HAQ DI、SF-36身体成分得分和CQR-19得分较基线均无显著变化。在研究结束时，更多患者对护士主导的会诊表示满意。