National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, P.O. Box 23 Vinderen, N-0319, Oslo, Norway.
Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
BMC Musculoskelet Disord. 2020 Apr 13;21(1):236. doi: 10.1186/s12891-020-03235-z.
To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model.
The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group.
Two hundred eighty-four intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (OR 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders.
The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers.
Clinicaltrials.gov identifier: NCT02333656. Registered 7. January 2015.
为了解决髋关节和膝关节骨关节炎（OA）治疗建议与当前临床实践之间存在的有据可查的差距，我们开发了一种结构化的 OA 综合护理模式，并在一项阶梯式楔形集群随机对照试验中对其进行了评估。本研究使用次要结局指标，通过在接受结构化 OA 护理模式与常规护理的患者中，在 3 个月和 6 个月时使用风湿病临床疗效评价指标（OMERACT-OARSI）应答标准（应答者标准），评估治疗的临床重要应答。其次，本研究旨在调查在干预组中，对模型中固有的运动方案的依从性是否会影响应答者的比例。
本研究在挪威的 6 个市的初级保健中进行。全科医生和物理治疗师接受了 OA 治疗建议和使用结构化模型的培训。干预组参加了物理治疗师主导的 OA 教育计划，并进行了 8-12 周的个体化锻炼。对照组接受常规护理。使用 11 点数字评定量表（NRS 0-10）评估患者在过去一周的疼痛、功能和疾病活动的总体评估。这些分数用于计算 OMERACT-OARSI 应答者的比例。使用两水平混合逻辑回归模型来调查干预组和对照组之间应答者的差异。
在挪威的 6 个市的初级保健中招募了 284 名接受髋关节和膝关节 OA 治疗的干预组患者和 109 名对照组患者。共有 47%的干预组和 35%的对照组患者在 3 个月或 6 个月时同时成为应答者；显示出不确定的组间差异（OR 1.38（95%CI 0.41，4.67）。在干预组中，有 184 名参与者完成了运动方案（每周至少运动 2 次，持续至少 8 周），其中 55%被归类为应答者。相比之下，86 名未完成者中有 28%被归类为应答者。
在 3 个月和 6 个月时，干预组和对照组之间 OMERACT-OARSI 应答者的比例差异不确定。在干预组中，与未完成者相比，运动完成者中应答者的比例更大。
ClinicalTrials.gov 标识符：NCT02333656。注册于 2015 年 1 月 7 日。
