Titre :

Estimating the number of usability problems affecting medical devices: modelling the discovery matrix.

Auteur(s) :

Vandewalle, Vincent [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Caron, Alexandre [Auteur]
Delettrez, C. [Auteur]
CHU Lille - Direction de la recherche et de l’innovation
Périchon, Renaud [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Pelayo, Sylvie [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Duhamel, Alain [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
DERVAUX, Benoit [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Titre de la revue :

BMC Med Res Methodol

Nom court de la revue :

BMC Med Res Methodol

Numéro :

20

Pagination :

234

Date de publication :

2020-09-18

ISSN :

1471-2288

Mot(s)-clé(s) :

Usability testing
Medical device
Missing data
Bayesian statistics
Maximum likelihood

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Background Usability testing of medical devices are mandatory for market access. The testings’ goal is to identify usability problems that could cause harm to the user or limit the device’s effectiveness. In practice, ...
Lire la suite >Background Usability testing of medical devices are mandatory for market access. The testings’ goal is to identify usability problems that could cause harm to the user or limit the device’s effectiveness. In practice, human factor engineers study participants under actual conditions of use and list the problems encountered. This results in a binary discovery matrix in which each row corresponds to a participant, and each column corresponds to a usability problem. One of the main challenges in usability testing is estimating the total number of problems, in order to assess the completeness of the discovery process. Today’s margin-based methods fit the column sums to a binomial model of problem detection. However, the discovery matrix actually observed is truncated because of undiscovered problems, which corresponds to fitting the marginal sums without the zeros. Margin-based methods fail to overcome the bias related to truncation of the matrix. The objective of the present study was to develop and test a matrix-based method for estimating the total number of usability problems. Methods The matrix-based model was based on the full discovery matrix (including unobserved columns) and not solely on a summary of the data (e.g. the margins). This model also circumvents a drawback of margin-based methods by simultaneously estimating the model’s parameters and the total number of problems. Furthermore, the matrix-based method takes account of a heterogeneous probability of detection, which reflects a real-life setting. As suggested in the usability literature, we assumed that the probability of detection had a logit-normal distribution. Results We assessed the matrix-based method’s performance in a range of settings reflecting real-life usability testing and with heterogeneous probabilities of problem detection. In our simulations, the matrix-based method improved the estimation of the number of problems (in terms of bias, consistency, and coverage probability) in a wide range of settings. We also applied our method to five real datasets from usability testing. Conclusions Estimation models (and particularly matrix-based models) are of value in estimating and monitoring the detection process during usability testing. Matrix-based models have a solid mathematical grounding and, with a view to facilitating the decision-making process for both regulators and device manufacturers, should be incorporated into current standards.Lire moins >

Langue :

Anglais

Comité de lecture :

Oui

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Date de dépôt :

2023-11-15T08:08:14Z
2023-11-30T21:36:40Z