title: Designing an Adverse Drug Event Reporting System to Prevent Unintentional Reexposures to Harmful Drugs: Study Protocol for a Multiple Methods Design.
abstract: BACKGROUND
  Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs.
  
  
  OBJECTIVE
  We aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada.
  
  
  METHODS
  To develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting.
  
  
  RESULTS
  This is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation and communication of ADEs.
  
  
  CONCLUSIONS
  We take this approach with the recognition that information technology-based solutions in health care often fall short of expectations as a result of designers' failure to account for organizational and work practice considerations, and the needs of end-users. We describe how integrating qualitative methods into an iterative participatory design process (planned in partnership with end-users) will allow us to address specific clinical needs, conceptualize linkages between systems, integrate the reporting system into clinicians' workflow, and design the system to optimize its uptake into practice.
authors.affiliation: Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada. dpeddie@sfu.ca.
authors.forename: David
authors.identifier: http://orcid.org/0000-0001-5571-2302
authors.initials: D
authors.lastname: Peddie
authors.forename: Serena S
authors.identifier: http://orcid.org/0000-0003-3627-9042
authors.initials: SS
authors.lastname: Small
authors.forename: Katherin
authors.identifier: http://orcid.org/0000-0002-5415-7236
authors.initials: K
authors.lastname: Badke
authors.forename: Maeve E
authors.identifier: http://orcid.org/0000-0003-0693-2223
authors.initials: ME
authors.lastname: Wickham
authors.forename: Chantelle
authors.identifier: http://orcid.org/0000-0002-2221-8647
authors.initials: C
authors.lastname: Bailey
authors.forename: Adam
authors.identifier: http://orcid.org/0000-0002-8796-8182
authors.initials: A
authors.lastname: Chruscicki
authors.forename: Christine
authors.identifier: http://orcid.org/0000-0003-0149-4009
authors.initials: C
authors.lastname: Ackerley
authors.forename: Ellen
authors.identifier: http://orcid.org/0000-0003-2094-7907
authors.initials: E
authors.lastname: Balka
authors.forename: Corinne M
authors.identifier: http://orcid.org/0000-0002-9210-7838
authors.initials: CM
authors.lastname: Hohl
keywords: action research; adverse drug event; adverse drug reaction reporting systems; focus groups; health services research; methods; qualitative research; systematic review; user-centered design