Abstract
Focal points
• This study explored the acceptability of linking routinely collected healthcare data to inform a new system for pharmacovigilance in children.
• A mixed methods approach was used to elicit the views of healthcare professionals in Scotland to the proposed data linkage.
• A range of issues including information governance and public approval were identified.
• Healthcare professionals in Scotland would be supportive of the new system if data security and confidentiality could be assured.
Introduction
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 medicines off-label in children and their resultant increased vulnerability to ADRs. The inclusion of the community health index (CHI) 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 work was to explore the acceptability to healthcare professionals (HCPs) of linking routinely collected healthcare data to inform the design of a new system for pharmacovigilance in children.
Methods
A mixed methods study was conducted. Semi-structured interviews with a purposive sample of professional stakeholders (n=35 invites send) and focus groups with selected frontline healthcare professionals using a combination of convenience (invitations issued n=111) and snowball sampling were used to identify concerns with and barriers to the proposed data linkage (all analysed using Framework analysis). A three-round Delphi survey with a random sample of healthcare professionals (nurses, pharmacists and doctors with an interest in paediatric medicine; invitations sent to n=825) in Scotland was conducted to get consensus on essential system components required for HCPs to accept the proposed data linkage. The survey was structured using the Theoretical Domains Framework1 of barriers to clinical behaviour change. Results were integrated across the three arms of the study using a triangulation protocol2. Ethical approval was granted by the North of Scotland Research Ethics Service.
Results
Interviews (n=23) identified issues with security, anonymisation and legal challenges that should be addressed prior to implementation. Recommendations included information to, and involvement of, the public as well as strict control of access to the data by vetting and imposing meaningful sanctions. Focus group participants (n=22, 6 groups) additionally identified potential issues with the feasibility of the planned data linkage as well as possible liability issues from dissemination of findings. Participants focused less on legal issues, anticipating that standard governance protocols and current laws would be satisfied. After three rounds, the retained consensus items in the Delphi study (n=121 consented to take part in Round 1, after three rounds eligible data available from 27 participants) focused on professional standards, requirements for linkage and the use and form of potential feedback. The proposed data linkage was perceived as positive and necessary, with participants highlighting the benefits for research and for patients.
Discussion
The development of a paediatric linked database has support from professional stakeholders and healthcare professionals in Scotland. The proposed data linkage was perceived as addressing a gap in current knowledge. No insurmountable issues were identified, but a range of issues and concerns should be addressed prior to implementation. Front-line health professionals, ultimately responsible for collecting the data, saw feedback as a strong motivator for engaging with the project. The data from this study will be supported by and cross-referenced to a parallel study investigating the views of the public.
References:
1Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care 2005;14:26-33
2O’Cathain A, Murphy E, Nicoll J, 2010. Three techniques for integrating data in mixed methods studies. BMJ 341: c3852
• This study explored the acceptability of linking routinely collected healthcare data to inform a new system for pharmacovigilance in children.
• A mixed methods approach was used to elicit the views of healthcare professionals in Scotland to the proposed data linkage.
• A range of issues including information governance and public approval were identified.
• Healthcare professionals in Scotland would be supportive of the new system if data security and confidentiality could be assured.
Introduction
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 medicines off-label in children and their resultant increased vulnerability to ADRs. The inclusion of the community health index (CHI) 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 work was to explore the acceptability to healthcare professionals (HCPs) of linking routinely collected healthcare data to inform the design of a new system for pharmacovigilance in children.
Methods
A mixed methods study was conducted. Semi-structured interviews with a purposive sample of professional stakeholders (n=35 invites send) and focus groups with selected frontline healthcare professionals using a combination of convenience (invitations issued n=111) and snowball sampling were used to identify concerns with and barriers to the proposed data linkage (all analysed using Framework analysis). A three-round Delphi survey with a random sample of healthcare professionals (nurses, pharmacists and doctors with an interest in paediatric medicine; invitations sent to n=825) in Scotland was conducted to get consensus on essential system components required for HCPs to accept the proposed data linkage. The survey was structured using the Theoretical Domains Framework1 of barriers to clinical behaviour change. Results were integrated across the three arms of the study using a triangulation protocol2. Ethical approval was granted by the North of Scotland Research Ethics Service.
Results
Interviews (n=23) identified issues with security, anonymisation and legal challenges that should be addressed prior to implementation. Recommendations included information to, and involvement of, the public as well as strict control of access to the data by vetting and imposing meaningful sanctions. Focus group participants (n=22, 6 groups) additionally identified potential issues with the feasibility of the planned data linkage as well as possible liability issues from dissemination of findings. Participants focused less on legal issues, anticipating that standard governance protocols and current laws would be satisfied. After three rounds, the retained consensus items in the Delphi study (n=121 consented to take part in Round 1, after three rounds eligible data available from 27 participants) focused on professional standards, requirements for linkage and the use and form of potential feedback. The proposed data linkage was perceived as positive and necessary, with participants highlighting the benefits for research and for patients.
Discussion
The development of a paediatric linked database has support from professional stakeholders and healthcare professionals in Scotland. The proposed data linkage was perceived as addressing a gap in current knowledge. No insurmountable issues were identified, but a range of issues and concerns should be addressed prior to implementation. Front-line health professionals, ultimately responsible for collecting the data, saw feedback as a strong motivator for engaging with the project. The data from this study will be supported by and cross-referenced to a parallel study investigating the views of the public.
References:
1Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care 2005;14:26-33
2O’Cathain A, Murphy E, Nicoll J, 2010. Three techniques for integrating data in mixed methods studies. BMJ 341: c3852
| Original language | English |
|---|---|
| Publication status | Published - 2012 |
| Event | Royal Pharmaceutical Society Annual Conference 2012 - Birmingham, United Kingdom Duration: 9 Sept 2012 → 10 Sept 2012 |
Conference
| Conference | Royal Pharmaceutical Society Annual Conference 2012 |
|---|---|
| Country/Territory | United Kingdom |
| City | Birmingham |
| Period | 9/09/12 → 10/09/12 |