Department of Rheumatology, Acute Rheumatology Center Rhineland-Palatinate, Kaiser-Wilhelm-Str. 9-11, 55543, Bad Kreuznach, Germany.
Department of Internal Medicine I, Division of Rheumatology and Clinical Immunology, Johannes Gutenberg University Medical Center, Mainz, Germany.
Arthritis Res Ther. 2024 Sep 20;26(1):165. doi: 10.1186/s13075-024-03400-y.
The aims of this study were to suggest patient-adjusted optical spectral transmission (OST) cut-off values for the first time and to develop clinical models that predict the probability of an early rheumatoid arthritis (RA) diagnosis based on OST findings and the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria as a reference standard.
OST examinations were performed in newly diagnosed RA patients and healthy controls by the HandScan device. Moreover, RA patients underwent a full clinical [tender/swollen joint counts (TJC/SJC), disease activity score-28 (DAS28)] and laboratory evaluation. OST confounding factors were examined via logistic multivariate regression analyses and patient-adjusted OST-cut-offs were subsequently determined. Furthermore, statistical models to calculate the probability of an RA diagnosis, based on the measured OST values and the presence of OST influencing factors, were developed. Finally, correlations of OST with RA activity parameters were assessed.
1.584 joints of 72 early RA patients were examined via OST and compared to 2.200 joints of 100 healthy controls and 1.166 joints of 53 patients with non-inflammatory arthralgia (NIA), respectively. Overall OST diagnostic performance was excellent in the whole cohort between RA- and healthy control-group [Area-Under-the-Curve (AUC): 0.810 (95%CI: 0.746-0.873); p < 0.0001], and further improved in RA-patients with ≥ 1 swollen wrist/finger joint(s) [AUC: 0.841 (95%CI: 0.773-0.908); p < 0.0001]. Comparison between RA patients and patients with non-inflammatory arthralgia showed similar results by an AUC of 0.788 (95%-CI: 0.709-0.867; p < 0.0001), and further improved in RA patients with ≥ 1 swollen wrist/finger joint(s) [AUC: 0.822 (95%CI: 0.74-0.90); p < 0.0001]. For the assessment of an adjusted RA diagnosis probability, two gender-specific statistical models were developed, based on OST values and patient age. OST cut-off values of 11.2 and 18.21 were calculated for female and male patients with active disease (sensitivity 93% and 67%; specificity 71.2% and 90%), respectively. Among RA patients, OST was associated moderately/significantly with DAS28 (r = 0.42,p < 0.001) and swollen joint count (rho = 0.355,p = 0.002).
The development of patient-adjusted OST cut-off values and the suggested statistical models significantly enhance OST's diagnostic performance, supporting its utility in differentiating between RA and non-inflammatory conditions. Future research should include a broader spectrum of arthritis types to validate OST's comprehensive diagnostic utility also across various inflammatory arthritides.
DRKS00016752 (German Registry of Clinical Trials).
本研究旨在首次提出患者调整的光学生物测量(OST)截断值,并基于 OST 发现和 2010 年美国风湿病学会/欧洲抗风湿病联盟(ACR/EULAR)分类标准作为参考标准,开发预测早期类风湿关节炎(RA)诊断概率的临床模型。
使用 HandScan 设备对新诊断的 RA 患者和健康对照者进行 OST 检查。此外,RA 患者接受了全面的临床[压痛/肿胀关节计数(TJC/SJC)、疾病活动评分-28(DAS28)]和实验室评估。通过逻辑多元回归分析检查 OST 混杂因素,随后确定患者调整的 OST 截断值。此外,还开发了基于测量的 OST 值和 OST 影响因素存在的情况下计算 RA 诊断概率的统计模型。最后,评估了 OST 与 RA 活动参数之间的相关性。
对 72 例早期 RA 患者的 1.584 个关节和 100 例健康对照者的 2.200 个关节以及 53 例非炎性关节炎(NIA)患者的 1.166 个关节分别进行了 OST 检查。在整个队列中,RA 组和健康对照组之间的 OST 总体诊断性能非常出色[曲线下面积(AUC):0.810(95%CI:0.746-0.873);p<0.0001],在≥1 个肿胀腕/指关节的 RA 患者中进一步提高[AUC:0.841(95%CI:0.773-0.908);p<0.0001]。RA 患者与非炎性关节炎患者之间的比较结果相似,AUC 为 0.788(95%CI:0.709-0.867;p<0.0001),在≥1 个肿胀腕/指关节的 RA 患者中进一步提高[AUC:0.822(95%CI:0.74-0.90);p<0.0001]。为了评估调整后的 RA 诊断概率,基于 OST 值和患者年龄,开发了两个性别特异性统计模型。为患有活动性疾病的女性和男性患者计算了 11.2 和 18.21 的 OST 截断值(灵敏度分别为 93%和 67%,特异性分别为 71.2%和 90%)。在 RA 患者中,OST 与 DAS28(r=0.42,p<0.001)和肿胀关节计数(rho=0.355,p=0.002)中度/显著相关。
患者调整的 OST 截断值和建议的统计模型的发展显著提高了 OST 的诊断性能,支持其在区分 RA 和非炎性疾病方面的效用。未来的研究应包括更广泛的关节炎类型,以验证 OST 在各种炎性关节炎中的综合诊断效用。
DRKS00016752(德国临床试验注册处)。