title: A pilot randomised controlled trial to assess the utility of an e-learning package that trains users in adverse drug reaction causality.
abstract: OBJECTIVE
  Causality assessment of adverse drug reactions (ADRs) by healthcare professionals is often informal which can lead to inconsistencies in practice. The Liverpool Causality Assessment Tool (LCAT) offers a systematic approach. An interactive, web-based, e-learning package, the Liverpool ADR Causality Assessment e-learning Package (LACAeP), was designed to improve causality assessment using the LCAT. This study aimed to (1) get feedback on usability and usefulness on the LACAeP, identify areas for improvement and development, and generate data on effect size to inform a larger scale study; and (2) test the usability and usefulness of the LCAT.
  
  
  METHODS
  A pilot, single-blind, parallel-group, randomised controlled trial hosted by the University of Liverpool was undertaken. Participants were paediatric medical trainees at specialty training level 1+ within the Mersey and North-West England Deaneries. Participants were randomised (1 : 1) access to the LACAeP or no training. The primary efficacy outcome was score by correct classification, predefined by a multidisciplinary panel of experts. Following participation, feedback on both the LCAT and the LACAeP was obtained, via a built in survey, from participants.
  
  
  RESULTS
  Of 57 randomised, 35 completed the study. Feedback was mainly positive although areas for improvement were identified. Seventy-four per cent of participants found the LCAT easy to use and 78% found the LACAeP training useful. Sixty-one per cent would be unlikely to recommend the training. Scores ranged from 4 to 13 out of 20. The LACAeP increased scores by 1.3, but this was not significant.
  
  
  CONCLUSIONS
  Improving the LACAeP before testing it in an appropriately powered trial, informed by the differences observed, is required. Rigorous evaluation will enable a quality resource that will be of value in healthcare professional training.
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool.
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Conroy
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool.
authors.forename: Jamie J
authors.initials: JJ
authors.lastname: Kirkham
authors.affiliation: Research and Development, Alder Hey Children's NHS Foundation Trust, Liverpool.
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Bellis
authors.affiliation: Research and Development, Alder Hey Children's NHS Foundation Trust, Liverpool.
authors.forename: Matthew
authors.initials: M
authors.lastname: Peak
authors.affiliation: Institute of Child Health, University College London, London.
authors.forename: Rosalind L
authors.initials: RL
authors.lastname: Smyth
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool.
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
authors.affiliation: Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool.
authors.forename: Munir
authors.initials: M
authors.lastname: Pirmohamed
mesh_terms: D015984:Causality; D002648:Child; D003194:Computer-Assisted Instruction / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D004739:England; D005246:Feedback; D006282:Health Personnel / Q000193:education*; D006801:Humans; D020407:Internet; D010372:Pediatrics; D010865:Pilot Projects; D016037:Single-Blind Method
keywords: RCT; adverse drug reactions; clinical pharmacy; decision aids; evidence-based practice