Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK
Background Epilepsy is a common chronic disease of children that can be treated with anti-epileptic drugs (AEDs). AEDs, however, have significant side effects. Newer AEDs are thought to have fewer side effects. There have, however, been few comparative studies of AED toxicity. The aim is to compare...
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BMJ Publishing Group
2017
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| Online Access: | https://eprints.nottingham.ac.uk/51985/ |
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| author | Egunsola, Oluwaseun Sammons, Helen M. Ojha, Shalini Whitehouse, William P. Anderson, Mark Hawcutt, Dan Choonara, Imti |
| author_facet | Egunsola, Oluwaseun Sammons, Helen M. Ojha, Shalini Whitehouse, William P. Anderson, Mark Hawcutt, Dan Choonara, Imti |
| author_sort | Egunsola, Oluwaseun |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Background Epilepsy is a common chronic disease of children that can be treated with anti-epileptic drugs (AEDs). AEDs, however, have significant side effects. Newer AEDs are thought to have fewer side effects. There have, however, been few comparative studies of AED toxicity. The aim is to compare the safety profile of the most frequently used AEDs by performing a multicentre prospective cohort study. This protocol describes the planned study.
Design A multicentre prospective cohort study of children on AED treatment in hospitals across the UK. Ethical approval will be obtained.
Sample size Three thousand children on treatment for epilepsy will be recruited from paediatric clinics. It is expected that this sample size will have the potential to compare toxicity between the most frequently used AEDs.
Duration of study 24 months.
Outcome measure Adverse drug reactions (ADRs) to AEDs. These will be identified by the use of a validated questionnaire, the Paediatric Epilepsy Side Effect Questionnaire. They will be evaluated using the Naranjo algorithm. Preventability will be assessed using the Schumock and Thornton scale.
Discussion Toxicity of individual AEDs when given as monotherapy and polytherapy will be determined. Additionally, discontinuation rates due to ADRs will be determined. The data will assist clinicians in choosing AEDs with the least toxicity. |
| first_indexed | 2025-11-14T20:22:39Z |
| format | Article |
| id | nottingham-51985 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:22:39Z |
| publishDate | 2017 |
| publisher | BMJ Publishing Group |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-519852020-05-04T18:58:57Z https://eprints.nottingham.ac.uk/51985/ Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK Egunsola, Oluwaseun Sammons, Helen M. Ojha, Shalini Whitehouse, William P. Anderson, Mark Hawcutt, Dan Choonara, Imti Background Epilepsy is a common chronic disease of children that can be treated with anti-epileptic drugs (AEDs). AEDs, however, have significant side effects. Newer AEDs are thought to have fewer side effects. There have, however, been few comparative studies of AED toxicity. The aim is to compare the safety profile of the most frequently used AEDs by performing a multicentre prospective cohort study. This protocol describes the planned study. Design A multicentre prospective cohort study of children on AED treatment in hospitals across the UK. Ethical approval will be obtained. Sample size Three thousand children on treatment for epilepsy will be recruited from paediatric clinics. It is expected that this sample size will have the potential to compare toxicity between the most frequently used AEDs. Duration of study 24 months. Outcome measure Adverse drug reactions (ADRs) to AEDs. These will be identified by the use of a validated questionnaire, the Paediatric Epilepsy Side Effect Questionnaire. They will be evaluated using the Naranjo algorithm. Preventability will be assessed using the Schumock and Thornton scale. Discussion Toxicity of individual AEDs when given as monotherapy and polytherapy will be determined. Additionally, discontinuation rates due to ADRs will be determined. The data will assist clinicians in choosing AEDs with the least toxicity. BMJ Publishing Group 2017-08-04 Article PeerReviewed Egunsola, Oluwaseun, Sammons, Helen M., Ojha, Shalini, Whitehouse, William P., Anderson, Mark, Hawcutt, Dan and Choonara, Imti (2017) Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK. BMJ Paediatrics Open, 1 (1). 000116/1-000116/7. ISSN 2399-9772 http://bmjpaedsopen.bmj.com/content/1/1/e000116 doi:10.1136/bmjpo-2017-000116 doi:10.1136/bmjpo-2017-000116 |
| spellingShingle | Egunsola, Oluwaseun Sammons, Helen M. Ojha, Shalini Whitehouse, William P. Anderson, Mark Hawcutt, Dan Choonara, Imti Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK |
| title | Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK |
| title_full | Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK |
| title_fullStr | Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK |
| title_full_unstemmed | Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK |
| title_short | Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK |
| title_sort | protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the uk |
| url | https://eprints.nottingham.ac.uk/51985/ https://eprints.nottingham.ac.uk/51985/ https://eprints.nottingham.ac.uk/51985/ |