title: Linking NHS data for pediatric pharmacovigilance: Results of a Delphi survey.
abstract: BACKGROUND
  Adverse drug events are a major cause of patient safety incidents. Current systems of pharmacovigilance under-report adverse drug reactions (ADRs), especially in children, leading to delays in their identification. This is of particular concern, as children especially have an increased vulnerability to ADRs.
  
  
  OBJECTIVE
  The objective was to seek consensus among healthcare professionals (HCPs) about barriers and facilitators to the linkage of routinely collected health data for pediatric pharmacovigilance in Scotland.
  
  
  METHODS
  A Delphi survey was conducted with a random sample of HCPs including nurses, pharmacists and doctors, working in primary or secondary care, in Scotland. Participants were identified from sampling frames of the target professionals such as an NHS workforce list for general practitioners and recruited by postal invitation. A total of 819 HCPs were invited to take part. Those agreeing to participate were given the option of completing the questionnaires online or as hard copy. Reminders were sent twice at a fortnightly interval. Questions content included description of professional role as well as testing for the willingness to support the proposed project and was informed by the Theoretical Domains Framework of Behavior Change (TDF) and earlier qualitative work. Three Delphi rounds were administered, including a first round for item generation.
  
  
  RESULTS
  121 of those invited agreed to take part (15%). The first round of the Delphi study included 21 open questions and generated over a 1000 individual statements from 61 participants that returned the questionnaires (50.4%). These were rationalized to 149 items for the second round in which participants rated their views on the importance (or not) of each item on a 9-point Likert scale (strongly disagree - strongly agree). After the third round, there was consensus on items that focused on professional standards, and practical requirements, overall there was support for data linkage and a multi-professional approach.
  
  
  CONCLUSIONS
  It would be acceptable to stakeholders to introduce a data linkage system for pharmacovigilance as long as identified concerns are addressed. Concerns included adherence to current professional, legal and ethical standards, as well resolving practical issues.
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. Electronic address: yvonne.hopf@med.uni-muenchen.de.
authors.forename: Y M
authors.initials: YM
authors.lastname: Hopf
authors.affiliation: School of Health Sciences, City University London, Northampton Square, London EC1V 0HB, UK.
authors.forename: J
authors.initials: J
authors.lastname: Francis
authors.affiliation: Child Health, University of Aberdeen, Royal Aberdeen Children's Hospital, Westburn Road, Aberdeen AB25 2ZG, UK.
authors.forename: P J
authors.initials: PJ
authors.lastname: Helms
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
authors.forename: J
authors.initials: J
authors.lastname: Haughney
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
authors.forename: C
authors.initials: C
authors.lastname: Bond
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D001291:Attitude of Health Personnel; D002648:Child; D005260:Female; D006282:Health Personnel; D006801:Humans; D016247:Information Storage and Retrieval; D008297:Male; D008875:Middle Aged; D009313:National Health Programs; D060735:Pharmacovigilance; D012606:Scotland; D011795:Surveys and Questionnaires
keywords: Data linkage; Delphi; Mixed methods; Pharmacovigilance