Graf Joachim, Moreno Beatrice, Wallwiener Markus, Menzel Karina, Brucker Sara Y, Simoes Elisabeth
Department für Frauengesundheit, Universitätsklinikum Tübingen, Tübingen.
Forschungsinstitut für Frauengesundheit, Universitätsklinikum Tübingen, Tübingen.
Gesundheitswesen. 2018 Nov;80(11):953-962. doi: 10.1055/s-0044-100037. Epub 2018 Feb 27.
E-health-based technologies also play an increasing role in the collection of patient- reported outcomes (ePRO). However, it remains unclear how feasible and powerful e-health applications are in the collection of PRO. Therefore, it should be examined to what extent the requirements for the use of technology-based PRO instruments has already been explored in order to allow its broad use in the "e-health world". Specifically, the research focus is on practicability, capability and technical implementation of ePRO. The design of the basic legal requirements for the conduct of PRO interviews and how the challenges of ePRO have already been harmonized here need to be examined.Methods Literature study: selective literature research in Pubmed as well as in the databases of DIMDI, G-BA, FDA and EMA.
Current scientific knowledge about hurdles, acceptance and usefulness in relation to sociodemografic factors, health status and technical skills as well as about technical implementation is low. The legal standards for ePRO are restricted only to the composition of the survey instrument and methodology quality criteria. There are no prerequisites for a broad use of ePRO, which is why therapeutic measures should not be based on them.
The standards of the legislators must be specified and adapted to the requirements of ePRO. Because the design of the tool surface and the rate of usability can influence the response behavior of the patients, the focus should be on the reliability and validity of ePRO surveys in the context of their implementation in relation to the patients, disease, questionnaire and ePRO-specific variables, which determine the response behavior, in order not to endanger the meaningfulness of PRO surveys.
基于电子健康的技术在患者报告结局(ePRO)收集方面也发挥着越来越重要的作用。然而,电子健康应用在PRO收集方面的可行性和有效性仍不明确。因此,应研究基于技术的PRO工具的使用要求在多大程度上已得到探索,以便其能在“电子健康领域”广泛应用。具体而言,研究重点在于ePRO的实用性、能力和技术实施。需要研究进行PRO访谈的基本法律要求的设计以及在此如何协调ePRO的挑战。
文献研究:在PubMed以及DIMDI、G-BA、FDA和EMA的数据库中进行选择性文献检索。
目前关于社会人口统计学因素、健康状况和技术技能方面的障碍、接受度和有用性以及技术实施的科学知识较少。ePRO的法律标准仅局限于调查问卷的构成和方法学质量标准。不存在广泛使用ePRO的先决条件,因此治疗措施不应基于这些标准。
立法者的标准必须明确并适应ePRO的要求。由于工具表面的设计和可用性比率会影响患者的反应行为,重点应放在ePRO调查在针对患者、疾病、问卷和决定反应行为的ePRO特定变量的实施背景下的可靠性和有效性上,以免危及PRO调查的意义。