"It's a balancing act": Views of Caldicott guardians on data linkage

Introduction
Medications prescribed for children are often not licensed for this age group1 and are therefore used ‘off-label’ or ‘unlicensed’; such use is linked to an increased risk of the child suffering an adverse drug reaction (ADR)2. The UK Yellow Card Scheme (YCS) is central to medicine surveillance and identification of ADRs, but other methods have been suggested as useful adjuncts3. The recent inclusion of the community health index (CHI) in all records of NHS contacts in Scotland provides opportunities to link data and to identify ADRs by linking prescribing and health utilization data. Caldicott guardians (CGs) were introduced after the publication of the Caldicott report4 to ensure that only the minimum necessary patient identifiable information within NHS organisations was shared for justified reasons. The aim of this study was to identify the views and opinions of Scottish Caldicott Guardians on perceived advantages and barriers to this novel use of routinely acquired NHS data as well as the of governance structure that would be required for the data linkage and use of linked data.
Methods
Semi-structured interviews (n=17)were conducted with members of the Scottish Caldicott Guardian Network to capture views on pharmacovigilance, confidentiality/patient privacy, attitude to data linkage, acceptable and non-acceptable usage of linked data, and dissemination of findings. All interviews were audio recorded and fully transcribed. A framework approach was used to identify themes inductively, but any emergent themes were also captured. Ethical approval was obtained.
Results
Themes identified from preliminary analysis included attitude to and discussion of proposed linkage, beliefs on the usage of linked data, as well as application of Caldicott principles. The proposed data linkage is seen favourably: “I think it is a great proposal. A great plan of using linked data to improve care.” (A37). To receive support from the CGs certain requirements have to be fulfilled including complying with the relevant laws, introducing very strict access and security protocols, and providing a justification for the linkage. Perceived challenges included proof of causality and gaining support from professional bodies and the public: “There’s something about bringing them [=medical profession] on board because they’re the key I think to public perception.” (A25). Another issue was the need for and the feasibility of consent from patients, and opinions differed widely from ‘no consent required’ to a request of explicit consent with some participants suggesting that a research ethics committee should decide: “I think it obviously needs to go through your Ethics Committee and as long as it does that and it passes muster then that would be fine.” (A38).
Discussion
In general, the Scottish Caldicott Guardians viewed the proposed data linkage positively as long as requirements to information governance are adhered to. So far analysis has not shown any notable difference in opinions between this and a parallel study with a mixed cohort of Scottish health care related stakeholders. The results of the two interview studies will be further explored with health care professionals across Scotland using focus groups and a Delphi survey.
References
1McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off label prescribing of drugs in general practice. Arch. Dis. Child. 2000 December 1;83(6):498-501
2Ekins-Daukes S, Helms PJ, Simpson CR et al (2004). Off-label prescribing to children in primary care: retrospective observational study. Eur J Clin Pharmacol 2004; 60: 349-353
3UKCRC, 2007. UKCRC R&D Advisory Group to Connecting for Health: The report of the research simulations. Available at: www.ukcrc.org/publications/report [accessed 04/03/2010]
4Great Britain. Department of Health (1997). Report on the review of patient –identifiable Information (The Caldicott Report)[online]. Available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4068403 (Accessed 20/05/2011)