Patient-Reported Outcome Information Collected from Lupus Patients Using a Mobile Application: Compliance and Validation.

Patient-Reported Outcome Information Collected from Lupus Patients Using a Mobile Application: Compliance and Validation.
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DOI:
10.1002/acr2.11370
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发表时间:
2022-03
影响因子:
3.4
通讯作者:
Lipsky PE
Lipsky PE
中科院分区:
其他
文献类型:
--
作者:
Bell K;Dykas C;Muckian B;Williams B;Rainey H;Comberg M;Mora M;Owen KA;Lipsky PE

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患者报告的结果 (PRO) 可以提供有关疾病对个人影响的关键信息。以电子格式 (ePRO) 收集 PRO 数据的移动技术允许在个人的常规环境中进行频繁评估。本研究的目的是评估系统性红斑狼疮 (SLE) 患者对手机应用程序 (app) 的依从性并验证 ePRO 信息。开发了一款智能手机应用程序,可以从各种临床仪器收集 ePRO 数据。作为多中心随机介入临床试验的一部分,信息是通过 ePRO 和纸质给药仪器收集的,试验对象是符合美国风湿病学会 (ACR) SLE 分类标准的患者。为了确定以不同格式收集的 PRO 信息之间的一致性,评估了组内相关系数 (ICC)、配对学生 t 检验和 Bland-Altman 图。合规性和克朗巴赫阿尔法也被评估为调查可靠性的衡量标准。对于来自不同祖先背景的 62 名受试者,ePRO 完成的依从性很高(超过 75%)。 PRO 的 Cronbach α 值表明调查可靠性为中等到高。绝大多数 (73.4%) ICC 值表明测量方法之间具有良好至极好的可靠性。 Bland-Altman 图验证了方法的一致性,并且 87% 的配对 t 检验在使用不同管理方法收集的信息之间产生了微不足道的差异。纸质收集的数据与电子方法收集的数据之间的良好依从性和高度一致性表明该应用程序提供了一种可靠的方法来对 SLE 患者 PRO 的实时变化进行分类。
Patient‐reported outcomes (PROs) can provide critical information concerning the impact of a disease on an individual. Mobile technology to collect PRO data in an electronic format (ePRO) allows for frequent assessment in the person's regular environment. The goal of this study was to assess the compliance with a phone application (app) and validate ePRO information in individuals with systemic lupus erythematosus (SLE). A smartphone app that collects ePRO data from various clinical instruments was developed. Information was collected by both an ePRO and a paper‐administered instrument as part of a multicenter randomized interventional clinical trial of patients meeting American College of Rheumatology (ACR) criteria for the classification of SLE. To determine agreement between PRO information collected in the different formats, intraclass correlation coefficients (ICCs), paired Student's t tests, and Bland–Altman plots were evaluated. Compliance and Cronbach's alpha were also assessed as a measure of survey reliability. For the 62 subjects from diverse ancestral backgrounds, compliance with ePRO completion was high (more than 75%). Cronbach alpha values for PROs indicated moderate to high survey reliability. The vast majority (73.4%) of ICC values were indicative of good to excellent reliability between measurement methods. Bland–Altman plots verified method agreement, and 87% of pairwise t tests yielded an insignificant difference between information collected with the different administration methods. The excellent compliance and the high level of consistency between data collected by paper and that collected by electronic methods indicate that the app provides a reliable means of cataloging real‐time changes in PROs in SLE patients.
DOI: 10.11613/bm.2015.015
发表时间: 2015
期刊: Biochemia medica
影响因子: 3.3
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影响因子: 2.5
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发表时间: 2017-09-01
影响因子: 4.7
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