Tacchino Andrea, Di Giovanni Rachele, Grange Erica, Spirito Maria Marcella, Ponzio Michela, Battaglia Mario Alberto, Brichetto Giampaolo, Solaro Claudio Marcello
Italian Multiple Sclerosis Foundation (FISM), Scientific Research Area, Via Operai, 40, 16149, Genoa, Italy.
CRRF "Mons. L. Novarese", Moncrivello (VC), Italy.
Neurol Sci. 2024 Mar;45(3):1155-1162. doi: 10.1007/s10072-023-07103-1. Epub 2023 Oct 12.
The mobile device diffusion has increasingly highlighted the opportunity to collect patient-reported outcomes (PROs) through electronic patient-reported outcomes measurements (ePROMs) during the clinical routine. Despite the ePROMs promises and advantages, the equivalence when a PRO measure is moved from the original paper-and-pencil to the electronic version is still little investigated. This study aims at evaluating equivalence between PROMs and ePROMs self-administration in people with multiple sclerosis (PwMS); in addition, preference of self-administration type was evaluated.
The Manual Ability Measure-36 (MAM-36) and Fatigue Severity Scale (FSS) were selected for the equivalence test. The app ABOUTCOME was developed through a user-centered design approach to administer the questionnaires on tablet. Both paper-and-pencil and electronic versions were randomly self-administered. Intrarater reliability between both versions was evaluated through the intraclass correlation coefficient (ICC, excellent for values ≥ 0.75).
Fifty PwMS (35 females) participated to the study (mean age: 54.7±11.0 years, disease course: 27 relapsing-remitting and 23 progressive; mean EDSS: 4.7±1.9; mean disease duration: 13.3±9.5 years). No statistically significant differences were found for the means total scores of MAM-36 (p = 0.61) and FSS (p = 0.78). The ICC value for MAM-36 and FSS was excellent (0.98 and 0.94, respectively). Most of participants preferred the tablet version (84%).
The results of the study provide evidence about the equivalence between the paper-and-pencil and electronic versions of PROs administration. In addition, PwMS prefer electronic methods rather than paper because the information can be provided more efficiently and accurately. The results could be easily extended to other MS PROs.
移动设备的普及日益凸显了在临床常规过程中通过电子患者报告结局测量（ePROMs）收集患者报告结局（PROs）的机会。尽管ePROMs有诸多前景和优势，但当一个PRO测量工具从原始的纸笔形式转换为电子版本时，其等效性仍鲜少被研究。本研究旨在评估多发性硬化症患者（PwMS）中PROs与ePROMs自我管理的等效性；此外，还评估了自我管理类型的偏好。
选择手动能力测量-36（MAM-36）和疲劳严重程度量表（FSS）进行等效性测试。通过以用户为中心的设计方法开发了应用程序ABOUTCOME，用于在平板电脑上管理问卷。纸笔版和电子版均随机进行自我管理。通过组内相关系数（ICC，值≥0.75为优秀）评估两个版本之间的评分者内信度。
50名PwMS（35名女性）参与了研究（平均年龄：54.7±11.0岁，病程：27例复发缓解型和23例进展型；平均扩展残疾状态量表[EDSS]：4.7±1.9；平均疾病持续时间：13.3±9.5年）。MAM-36（p = 0.61）和FSS（p = 0.78）的平均总分未发现统计学上的显著差异。MAM-36和FSS的ICC值均为优秀（分别为0.98和0.94）。大多数参与者更喜欢平板电脑版本（84%）。
该研究结果为PROs管理的纸笔版和电子版之间的等效性提供了证据。此外，PwMS更喜欢电子方式而非纸质方式，因为信息可以更高效、准确地提供。这些结果可以很容易地推广到其他MS PROs。
