Title
With how many users should you test a medical infusion pump? Sampling strategies for usability tests on high-risk systems.
Abstract
Usability testing is recognized as an effective means to improve the usability of medical devices and prevent harm for patients and users. Effectiveness of problem discovery in usability testing strongly depends on size and representativeness of the sample. We introduce the late control strategy, which is to continuously monitor effectiveness of a study towards a preset target. A statistical model, the LNB(zt) model, is presented, supporting the late control strategy. We report on a case study, where a prototype medical infusion pump underwent a usability test with 34 users. On the data obtained in this study, the LNB(zt) model is evaluated and compared against earlier prediction models. The LNB(zt) model fits the data much better than previously suggested approaches and improves prediction. We measure the effectiveness of problem identification, and observe that it is lower than is suggested by much of the literature. Larger sample sizes seem to be in order. In addition, the testing process showed high levels of uncertainty and volatility at small to moderate sample sizes, partly due to users' individual differences. In reaction, we propose the idiosyncrasy score as a means to obtain representative samples. Statistical programs are provided to assist practitioners and researchers in applying the late control strategy.
Year
DOI
Venue
2013
10.1016/j.jbi.2013.04.007
Journal of Biomedical Informatics
Keywords
Field
DocType
ergonomics,medical infusion pump,high-risk system,infusion pump,earlier prediction model,case study,sampling strategy,sample size,larger sample size,usability,testing process,representative sample,late control strategy,moderate sample size,usability test,patient safety,user testing,statistical model,usability testing,usability engineering,hazard ratio,patient monitoring,sample sizes,sampling,geometry,awareness,safety testing,biology,quality control
Data mining,Usability engineering,Computer science,Usability,Representativeness heuristic,Usability goals,Statistical model,Cognitive walkthrough,Usability inspection,Sample size determination
Journal
Volume
Issue
ISSN
46
4
1532-0480
Citations 
PageRank 
References 
4
0.44
32
Authors
3
Name
Order
Citations
PageRank
Martin Schmettow1598.53
Wendy Vos240.44
Jan Maarten Schraagen313013.99