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)

中文翻译：

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通过使用患者调整的截止分数提高早期类风湿性关节炎的光谱传输的预测价值


本研究的目的是首次建议患者调整的光谱透射 (OST) 截止值，并开发临床模型，根据 OST 研究结果和 2010 年预测早期类风湿性关节炎 (RA) 诊断的概率。以美国风湿病学会/欧洲抗风湿病联盟（ACR/EULAR）分类标准作为参考标准。通过 HandScan 设备对新诊断的 RA 患者和健康对照进行 OST 检查。此外，RA 患者接受了完整的临床[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 截止值。此外，还开发了基于测量的 OST 值和 OST 影响因素的存在来计算 RA 诊断概率的统计模型。最后，评估了 OST 与 RA 活性参数的相关性。通过 OST 检查了 72 名早期 RA 患者的 1.584 个关节，并分别与 100 名健康对照者的 2.200 个关节和 53 名非炎症性关节痛 (NIA) 患者的 1.166 个关节进行了比较。整个队列中 RA 组和健康对照组的总体 OST 诊断性能均非常出色 [曲线下面积 (AUC)：0.810 (95% CI：0.746–0.873)； p < 0.0001]，并且在 ≥ 1 个腕/指关节肿胀的 RA 患者中进一步改善 [AUC：0.841（95%CI：0.773–0.908）； p< 0.0001]。 RA 患者与非炎症性关节痛患者的比较结果相似，AUC 为 0.788（95%-CI：0.709-0.867；p < 0.0001），并且在 ≥ 1 个腕/指关节肿胀的 RA 患者中进一步改善（ s）[曲线下面积：0。822（95%CI：0.74–0.90）； p< 0.0001]。为了评估调整后的 RA 诊断概率，根据 OST 值和患者年龄，开发了两种特定性别的统计模型。对于患有活动性疾病的女性和男性患者，计算出的 OST 截止值分别为 11.2 和 18.21（敏感性 93% 和 67%；特异性 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/显着相关。患者调整的 OST 截止值和建议的统计模型的开发显着增强了 OST 的诊断性能，支持其区分 RA 和非炎症性疾病的实用性。未来的研究应包括更广泛的关节炎类型，以验证 OST 对各种炎症性关节炎的综合诊断效用。DRKS00016752（德国临床试验注册处）