Objectives The aim was to explore the views of professional stakeholders and healthcare professionals (HCPs) on the linkage of UK National Health Service (NHS) data for paediatric pharmacovigilance purposes and to make recommendations for such a system.
Methods A mixed methods approach including a literature review, interviews, focus groups and a three-round Delphi survey with HCPs in Scotland was followed by a triangulation process using a systematic protocol. The survey was structured using the Theoretical Domains Framework of behaviour change. Items retained after applying the matrix-based triangulation process were thematically coded. Ethical approval was granted by the North of Scotland Research Ethics Service.
Results Results from 18 papers, 23 interviewees, 23 participants of focus groups and 61 completed questionnaires in the Delphi survey contributed to the triangulation process. A total of 25 key findings from all four studies were identified during triangulation. There was good convergence; 21 key findings were agreed and remained to inform recommendations. The items were coded as practical/technical (eg, decision about the unique patient identifier to use), mandatory (eg, governed by statute), essential (consistently mentioned in all studies and therefore needed to ensure professional support) or preferable.
Conclusions The development of a paediatric linked database has support from professional stakeholders and HCPs in Scotland. The triangulation identified three sets of core requirements for a new system of data linkage. An additional fourth set of ‘preferable’ requirements might increase engagement of HCPs and their support for the new system.
- mixed methods research
- data linkage
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Contributors PJH was the chief investigator of the overall programme (Child Medical Records for Safer Medicines (CHIMES)), conceived the research and led writing of the proposal for funding. CB and JH were coinvestigators and led the writing of the work package which included the literature review and the empirical studies. YMH was responsible for the draft of the overall study protocol as well as the triangulation protocol, the daily study conduct and co-ordination, acquisition of data, analysis, producing tables and figures and interpretation of data. YMH drafted/co-led writing of the paper and incorporated feedback from coauthors on successive drafts. CB and JF contributed to study protocol design and subsequent analysis, and co-led the writing of the paper. All authors commented on the initial drafts of the paper and revision of successive drafts. The final version of the manuscript was approved by all authors.
Funding This work was supported by the Chief Scientist Office (CHIMES Applied Research Programme, grant number ARPG/07/4).
Competing interests None declared.
Ethics approval North of Scotland Research Ethics Service and NHS Research and Development.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Additional data such as the search strategy of the literature review, the study information sheets and consent forms for all studies, as well as the Delphi questionnaires or the interview and focus group topic guides, example of descriptive chart (interviews/focus groups), and examples for categorisation of statements in Delphi are available by emailing the corresponding author.
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