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A Grounded Procedure for Managing Data and Sample Size of a Home Medical Device Assessment

机译：用于管理家用医疗器械评估数据和样本量的扎实程序

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The selection of participants for usability assessment, together with the minimum number of subjects required to obtain a set of reliable data, is a hot topic in Human Computer Interaction (HCI). Albeit, prominent contributions through the application of different p estimation models argued that five users provide a good benchmark when seeking to discover interaction problems a lot of studies have complained this five-user assumption. The sample size topic is today a central issue for the assessment of critical-systems, such as medical devices, because lacks in usability and, moreover, in the safety in use of these kind of products may seriously damage the final users. We argue that rely on one-size-fits-all solutions, such as the five-user assumption (for websites) or the mandated size of 15 users for major group (for medical device) lead manufactures to release unsafe product. Nevertheless, albeit there are no magic numbers for determining "a priori" the cohort size, by using a specific procedure it is possible to monitoring the sample discovery likelihood after the first five users in order to obtain reliable information about the gathered data and determine whether the problems discovered by the sample have a certain level of representativeness (i.e., reliability). We call this approach "Grounded Procedure" (GP). The goal of this study is to present the GP assumptions and steps, by exemplifying its application in the assessment of a home medical device.
机译：选择可用性评估参与者以及获得一组可靠数据所需的最少主题数，是人机交互（HCI）的热门话题。尽管通过应用不同的p估计模型做出了突出贡献，但他们指出，五个用户在寻求发现交互问题时提供了一个很好的基准，许多研究都抱怨这个五用户假设。如今，样本量主题是评估关键系统（例如医疗设备）的中心问题，因为缺乏可用性，此外，使用此类产品的安全性可能严重损害最终用户。我们认为，要依靠一刀切的解决方案，例如五用户假设（针对网站）或法定人数（主要群体为15个用户）（针对医疗设备）的铅生产商释放不安全的产品。尽管如此，尽管没有魔术数字可以确定“先验”队列规模，但是通过使用特定过程，可以监视前五个用户之后的样本发现可能性，以便获得有关所收集数据的可靠信息并确定是否样本发现的问题具有一定程度的代表性（即可靠性）。我们称这种方法为“地面程序”（GP）。这项研究的目的是通过举例说明GP在评估家用医疗设备中的应用，从而提出GP的假设和步骤。

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