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Keywords:

  • adverse drug reaction;
  • patient;
  • pharmacovigilance;
  • reporting;
  • thinking aloud;
  • usability testing

Abstract

Objectives  The aim of this study, which was part of the first independent evaluation of patient reporting of adverse drug reactions (ADRs) to the Yellow Card Scheme, was to observe the three reporting systems (paper, internet and telephone) ‘in use’ in a simulated setting to identify aspects which facilitated or hindered reporting.

Methods  Forty adult participants were recruited from the general public using posters in pharmacies and a press article, and from a pool of volunteer simulated patients maintained by University of Nottingham medical and pharmacy schools. The participants, in seven groups that met at different times, were asked to ‘think aloud,’ as they were individually observed completing the reporting process for the paper and internet system, highlighting their thoughts and any issues encountered. They were asked to talk about their experience of reporting immediately after they had reported by telephone. Data from the field notes were analysed thematically and supplemented with relevant information from digital audio recordings.

Conclusions  Usability testing using the ‘think aloud’ approach worked well and identified areas of the Yellow Card reporting system which could be improved. Whilst the three methods of reporting available to the public are all reasonably ‘fit for purpose’, there were many suggestions identified for improving ease of completion and data quality, especially for the internet system. When systems for reporting of ADRs are designed, they should be tested by potential users before they are launched, so that potential problems are identified in advance.