Department of Rheumatology, 53141Aalborg University Hospital, Aalborg, Denmark.
Department of Clinical Medicine, 1004Aalborg University, Aalborg, Denmark.
Lupus. 2021 Nov;30(13):2124-2134. doi: 10.1177/09612033211051641. Epub 2021 Oct 31.
Patient-reported outcome measures (PROMs) are evaluated in randomized controlled trials (RCTs) in patients with systemic lupus erythematosus (SLE), but not widely used in clinical practice. However, interest in incorporating PROMs into the management of SLE is increasing as PROMs provide a unique insight into the patient's perception of lupus disease activity. The objective was to assess agreement in PROMs answered using a web app versus an outpatient touchscreen among patients with SLE.
In a crossover RCT, SLE patients answered the following PROMs in a random order using the web app and the outpatient touchscreen: Systemic Lupus Erythematosus Activity Questionnaire (SLAQ) Global Health, SLAQ Symptom, SLAQ Total, SLAQ Worsening, Pain Visual Analog Scale (VAS), Fatigue VAS, Patient Global Health VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Acceptable Symptom State (PASS), and an Anchoring Question. Equivalence between the two device types was demonstrated if the 95% confidence interval (95% CI) of the difference in PROM scores was within the prespecified equivalence margin. Agreement between the two device types was assessed using mixed linear models.
Thirty-four patients with SLE were included. Equivalence was demonstrated between the two device types for SLAQ Global Health with a difference of -0.21 (95% CI: -0.65 to 0.23). Moreover, equivalence was also found for HAQ-DI, Pain VAS, and Fatigue VAS whereas only comparability within the limits of the Minimal Clinically Important Difference (MCID) was demonstrated for VAS Patient Global Health. Statistical comparability was demonstrated for SLAQ Total, SLAQ Worsening, PASS, and Anchoring Question (no predefined MCID/equivalence margins available). However, a statistically significant difference between device types was observed for the SLAQ Symptom of -0.56 (95% CI: -1.10 to -0.01). The difference was, however, very small when considering the scale range of 0-24; thus, it was not judged to be of clinical relevance. Preference for the web app was very high (91.2%).
For the first time ever, equivalence and comparability between two electronic device types for various PROMs were demonstrated among patients with SLE. Implementation of the device is expected to improve the management of SLE.
患者报告结局测量（PROMs）在系统性红斑狼疮（SLE）患者的随机对照试验（RCT）中进行评估，但尚未广泛用于临床实践。然而，随着 PROMs 提供了对狼疮疾病活动患者独特的认知，将 PROMs 纳入 SLE 管理的兴趣正在增加。本研究旨在评估 SLE 患者使用网络应用程序和门诊触摸屏回答 PROMs 的一致性。
在一项交叉 RCT 中，SLE 患者以随机顺序使用网络应用程序和门诊触摸屏回答以下 PROMs：系统性红斑狼疮活动问卷（SLAQ）整体健康、SLAQ 症状、SLAQ 总分、SLAQ 恶化、疼痛视觉模拟量表（VAS）、疲劳 VAS、患者整体健康 VAS、健康评估问卷残疾指数（HAQ-DI）、患者可接受症状状态（PASS）和锚定问题。如果 PROM 评分差异的 95%置信区间（95%CI）在预设的等效区间内，则证明两种设备类型之间具有等效性。使用混合线性模型评估两种设备类型之间的一致性。
纳入了 34 名 SLE 患者。两种设备类型之间在 SLAQ 整体健康方面具有等效性，差异为-0.21（95%CI：-0.65 至 0.23）。此外，在 HAQ-DI、疼痛 VAS 和疲劳 VAS 方面也发现了等效性，而 VAS 患者整体健康仅在最小临床重要差异（MCID）范围内具有可比性。在 SLAQ 总分、SLAQ 恶化、PASS 和锚定问题方面也证明了统计学可比性（没有预定义的 MCID/等效性范围）。然而，在 SLAQ 症状方面观察到两种设备类型之间存在统计学显著差异，为-0.56（95%CI：-1.10 至 -0.01）。然而，考虑到 0-24 的量表范围，差异非常小；因此，不认为其具有临床意义。对网络应用程序的偏好非常高（91.2%）。
这是首次在 SLE 患者中证明两种电子设备类型对各种 PROMs 的等效性和可比性。预计设备的实施将改善 SLE 的管理。
