title: Pilot-testing an adverse drug event reporting form prior to its implementation in an electronic health record.
abstract: BACKGROUND
  Adverse drug events (ADEs), harmful unintended consequences of medication use, are a leading cause of hospital admissions, yet are rarely documented in a structured format between care providers. We describe pilot-testing structured ADE documentation fields prior to integration into an electronic medical record (EMR).
  
  
  METHODS
  We completed a qualitative study at two Canadian hospitals. Using data derived from a systematic review of the literature, we developed screen mock-ups for an ADE reporting platform, iteratively revised in participatory workshops with diverse end-user groups. We designed a paper-based form reflecting the data elements contained in the mock-ups. We distributed them to a convenience sample of clinical pharmacists, and completed ethnographic workplace observations while the forms were used. We reviewed completed forms, collected feedback from pharmacists using semi-structured interviews, and coded the data in NVivo for themes related to the ADE form.
  
  
  RESULTS
  We completed 25 h of clinical observations, and 24 ADEs were documented. Pharmacists perceived the form as simple and clear, with sufficient detail to capture ADEs. They identified fields for omission, and others requiring more detail. Pharmacists encountered barriers to documenting ADEs including uncertainty about what constituted a reportable ADE, inability to complete patient follow-up, the need for inter-professional communication to rule out alternative diagnoses, and concern about creating a permanent record.
  
  
  CONCLUSIONS
  Paper-based pilot-testing allowed planning for important modifications in an ADE documentation form prior to implementation in an EMR. While paper-based piloting is rarely reported prior to EMR implementations, it can inform design and enhance functionality. Piloting with other groups of care providers and in different healthcare settings will likely lead to further revisions prior to broader implementations.
authors: Faculty of Medicine, Queen's University, 15 Arch Street, Kingston, ON K7L 3N8 Canada.
authors: Adam
authors: A
authors: Chruscicki
authors: Department of Emergency Medicine, University of British Columbia, 855 West 12th Avenue, Vancouver, BC V5Z 1M9 Canada.
authors: Katherin
authors: K
authors: Badke
authors: School of Communication, Simon Fraser University, 8888 University Drive, Burnaby, BC V5A 1A6 Canada.
authors: David
authors: D
authors: Peddie
authors: School of Communication, Simon Fraser University, 8888 University Drive, Burnaby, BC V5A 1A6 Canada.
authors: Serena
authors: S
authors: Small
authors: School of Communication, Simon Fraser University, 8888 University Drive, Burnaby, BC V5A 1A6 Canada ; Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, 828 West 10th Ave, Vancouver, BC V5Z 1M9 Canada.
authors: Ellen
authors: E
authors: Balka
authors: Department of Emergency Medicine, University of British Columbia, 855 West 12th Avenue, Vancouver, BC V5Z 1M9 Canada ; Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, 828 West 10th Ave, Vancouver, BC V5Z 1M9 Canada.
authors: Corinne M
authors: CM
authors: Hohl
keywords: Adverse drug events; Electronic medical records; Pilot-testing; Reporting