Important issues with data linkage: A consensus seeking exercise

Yvonne Hopf, Jillian Joy Francis, Christine Margaret Bond, John Andrew Francis Haughney, Peter Joseph Benedict Helms

Research output: Contribution to conferencePosterpeer-review


Adverse drug events are a major cause of patient safety incidents. Current systems of pharmacovigilance under-report adverse drug reactions (ADRs), especially for paediatric medicines. This is of particular concern due to the widespread use of off-label medicines in children and their resultant increased vulnerability to ADRs. The inclusion of the community health index in the recording of all NHS contacts in Scotland provides the opportunity to link data and thereby identify ADRs by linking prescribing and health utilization data. The aim of this study was to assess the views of Health Care Professionals (HCPs) towards a paediatric pharmacovigilance system based on data linkage and to inform the optimal system design.
A three round Delphi survey was sent out to a random sample (using a random number generator (Stat Trek 2012)) of HCPs (nurses, pharmacists and doctors with an interest in paediatric medicine) in Scotland to refine facilitators and potential barriers to data linkage for paediatric pharmacovigilance. The sample was drawn from publicly available sampling frames of the target professions. Delphi surveys are an iterative consensus technique by which issues are progressively refined and reduced in number reflecting the view of the majority. The survey was informed by findings of earlier qualitative work and was constructed using the Theoretical Domains Framework of Behaviour Change (TDF) which categorises key beliefs and behaviours. The behaviours under investigation were those that would ‘facilitate the proposed data linkage’ and which were specified as three distinct actions: (1) continuing to record data as usual, (2) requesting consent and/or explaining opt-out, and (3) explaining the purpose of the linkage to patients/parents. Qualitative statements generated in Round 1 were subject to a standard item reduction and de-duplication process by constant comparison. The consensus percentage for the Delphi study was set at 66.7% or more for Round 2 and for 90% or more for Round 3. Ethical approval was granted by the North of Scotland Research Ethics Service.
The first round of the Delphi study included 21 questions inviting comments and generated over a 1000 individual statements from 61 participants. These were reduced to 149 statements for the second round with which participants were asked to rate their agreement. After the third round, the retained consensus items (n=13) focused on professional standards, requirements for linkage and the use and form of potential feedback. HCPs indicated confidence in and intention to facilitate the proposed data linkage albeit with some reservations. Some system requirements were identified that might be necessary to secure more active support from frontline HCPs for the proposed data linkage. Professional standards were identified as important, together with a need to adhere to multiple legal and ethical considerations.
HCPs indicated their confidence in and intention to facilitate the proposed data linkage. Three key requirements of system design were identified namely adherence to current legal and ethical standards, support for HCP time from higher level stakeholders in the NHS and associated employers, and central support for maintaining accurate and timely data linkage.
Original languageEnglish
Publication statusPublished - Apr 2014
EventHealth Services Research and Pharmacy Practice Conference - University of Aberdeen, Aberdeen, United Kingdom
Duration: 3 Apr 20144 Apr 2014


ConferenceHealth Services Research and Pharmacy Practice Conference
Country/TerritoryUnited Kingdom


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