IMPACT 研究：一项评估轴向脊柱关节炎转诊算法效果的聚类随机对照试验。
The IMPACT study: A clustered randomized controlled trial to assess the effect of a referral algorithm for axial spondyloarthritis.
机构信息
Department of Rheumatology and Clinical Immunology, Maasstad Hospital, Rotterdam, The Netherlands.
Department of Rheumatology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands.
出版信息
PLoS One. 2020 Jan 28;15(1):e0227025. doi: 10.1371/journal.pone.0227025. eCollection 2020.
BACKGROUND
A substantial number of patients with chronic low back pain (CLBP) have axial spondyloarthritis (axSpA), but early recognition of these patients is difficult for general practitioners (GPs). The Case Finding Axial Spondyloarthritis (CaFaSpA) referral strategy has shown to be able to identify patients with CLBP at risk for axSpA, but its impact on clinical daily practice is yet unknown.
OBJECTIVE
To assess the effect of the CaFaSpA referral strategy on pain caused by disability in primary care patients with CLBP.
METHODS
Within this clustered randomized controlled trial 93 general practices were randomized to either the CaFaSpA referral model (intervention) or usual primary care (control). In each group primary care patients between 18 and 45 years with CLBP were included. The primary outcome was disability caused by CLBP, measured with the Roland Morris Disability Questionnaire (RMDQ) at baseline and four months. Secondary outcome was the frequency of new axSpA diagnosis. Descriptive analyses were performed, and a linear mixed-effects model was used.
RESULTS
In total 679 CLBP patients were included of which 333 patients were allocated to the intervention group and 346 to the control group. Sixty-four percent were female and mean age was 36.2 years. The mean RMDQ score at baseline was 8.39 in the intervention group and 8.61 in the control group. At four months mean RMDQ score was 7.65 in the intervention group and 8.15 in the control group. This difference was not statistically significant (p = 0.50). Six (8%) out of the 75 finally referred patients, were diagnosed with axSpA by their rheumatologist.
CONCLUSIONS
The CaFaSpA referral strategy for axSpA did not have an effect on disability after four months caused by CLBP. However, the strategy is able to detect the axSpA patient within the large CLBP population sufficiently. Trial registration number: NCT01944163, Clinicaltrials.gov.
背景
大量慢性下背痛（CLBP）患者患有中轴型脊柱关节炎（axSpA），但全科医生（GPs）很难早期识别这些患者。病例发现中轴型脊柱关节炎（CaFaSpA）转诊策略已被证明能够识别 CLBP 患者中存在 axSpA 风险的患者，但该策略对临床日常实践的影响尚不清楚。
目的
评估 CaFaSpA 转诊策略对 CLBP 初级保健患者疼痛导致残疾的影响。
方法
在这项聚类随机对照试验中，93 家全科诊所被随机分为 CaFaSpA 转诊模型（干预组）或常规初级保健（对照组）。在每组中，均纳入 18 至 45 岁的 CLBP 初级保健患者。主要结局是 CLBP 导致的残疾，使用 Roland Morris 残疾问卷（RMDQ）在基线和四个月时进行测量。次要结局是新 axSpA 诊断的频率。进行描述性分析，并使用线性混合效应模型。
结果
共纳入 679 例 CLBP 患者，其中 333 例分配至干预组，346 例分配至对照组。64%为女性，平均年龄为 36.2 岁。干预组基线时的平均 RMDQ 评分为 8.39，对照组为 8.61。四个月时，干预组的平均 RMDQ 评分为 7.65，对照组为 8.15。差异无统计学意义（p = 0.50）。最终转诊的 75 例患者中，有 6 例（8%）被风湿病医生诊断为 axSpA。
结论
axSpA 的 CaFaSpA 转诊策略在四个月后对 CLBP 引起的残疾没有影响。然而，该策略能够在大量的 CLBP 人群中充分发现 axSpA 患者。
试验注册号
NCT01944163，Clinicaltrials.gov。
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