title: The STEP database through the end-users eyes--USABILITY STUDY.
abstract: OBJECTIVE
  The user-designed database of Safety and Toxicity of Excipients for Paediatrics ("STEP") is created to address the shared need of drug development community to access the relevant information of excipients effortlessly. Usability testing was performed to validate if the database satisfies the need of the end-users.
  
  
  METHODS
  Evaluation framework was developed to assess the usability. The participants performed scenario based tasks and provided feedback and post-session usability ratings. Failure Mode Effect Analysis (FMEA) was performed to prioritize the problems and improvements to the STEP database design and functionalities.
  
  
  RESULTS
  The study revealed several design vulnerabilities. Tasks such as limiting the results, running complex queries, location of data and registering to access the database were challenging. The three critical attributes identified to have impact on the usability of the STEP database included (1) content and presentation (2) the navigation and search features (3) potential end-users.
  
  
  CONCLUSIONS
  Evaluation framework proved to be an effective method for evaluating database effectiveness and user satisfaction. This study provides strong initial support for the usability of the STEP database. Recommendations would be incorporated into the refinement of the database to improve its usability and increase user participation towards the advancement of the database.
authors.affiliation: Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, London, United Kingdom. Electronic address: S.Salunke@ucl.ac.uk.
authors.forename: Smita
authors.initials: S
authors.lastname: Salunke
authors.affiliation: Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, London, United Kingdom.
authors.forename: Catherine
authors.initials: C
authors.lastname: Tuleu
mesh_terms: D002626:Chemistry, Pharmaceutical; D002648:Child; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D005079:Excipients / Q000009:adverse effects*; D006801:Humans; D014584:User-Computer Interface
chemical_list: D005079:Excipients
keywords: Additives; Adverse effects; Children; Excipients; Information resource; Neonates; Paediatrics; STEP database; Safety; Toxicity