dc.contributor.author | Angus-Leppan, H | |
dc.contributor.author | Moghim, MM | |
dc.contributor.author | Cock, H | |
dc.contributor.author | Kinton, L | |
dc.contributor.author | Synnott Wells, M | |
dc.contributor.author | Shankar, R | |
dc.date.accessioned | 2020-04-09T08:54:53Z | |
dc.date.issued | 2020-02-18 | |
dc.description.abstract | Objectives: Annual completion of a Valproate Risk Acknowledgement Form (RAF) is mandated in the United Kingdom due to neurodevelopmental risks of in utero valproate exposure. The number of women of childbearing potential taking valproate, the uptake of the RAF within this population and their clinical outcomes is not known or monitored. This study surveyed responses of clinicians administering the RAF to women of childbearing potential taking valproate medications. Materials and Methods: Study design—national online survey distributed to clinical specialists throughout the United Kingdom via their national organizations. Participants—clinicians qualified to counsel and administer the valproate RAF (as defined by the Medicines and Healthcare products Regulatory Agency). Main outcome measures—quantitative and qualitative responses regarding identification, uptake, effects and reactions to the RAF. Trial registration—registered at the Clinical Governance and Audit Committee at Royal Free London NHS Foundation Trust Hospital. Results: 215 respondents covering more than 4775 patient encounters were captured. Most patients continued on valproate, 90% with epilepsy as the indication. Respondents reported that seizure control deteriorated when switched to levetiracetam (33%) and lamotrigine (43%), compared to 7% when continuing valproate (P <.001). Conclusions: 33%-43% of clinicians reported seizure control deterioration in women changed to alternatives to valproate. Informed consent requires women considering a change are given this information. Systematic capture of data automated through online RAFs and linked to patient outcomes is needed. There remains little data on valproate given for indications other than epilepsy. | en_GB |
dc.identifier.citation | Published online 18 February 2020 | en_GB |
dc.identifier.doi | 10.1111/ane.13231 | |
dc.identifier.uri | http://hdl.handle.net/10871/120629 | |
dc.language.iso | en | en_GB |
dc.publisher | Wiley | en_GB |
dc.rights.embargoreason | Under embargo until 18 February 2021 in compliance with publisher policy | en_GB |
dc.rights | © 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd | en_GB |
dc.subject | congenital malformations | en_GB |
dc.subject | informed consent | en_GB |
dc.subject | medicines and healthcare products regulatory agency (MHRA) | en_GB |
dc.subject | neurodevelopmental disability | en_GB |
dc.subject | risk acknowledgement form (RAF) | en_GB |
dc.subject | teratogenicity | en_GB |
dc.subject | valproate | en_GB |
dc.title | Valproate risk form - Surveying 215 clinicians involving 4775 encounters | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2020-04-09T08:54:53Z | |
dc.identifier.issn | 0001-6314 | |
dc.description | This is the author accepted manuscript. The final version is available from Wiley via the DOI in this record | en_GB |
dc.description | Data sharing statement:
Data will be made available in anonymised form to researchers on contacting the Corresponding Author. | en_GB |
dc.identifier.journal | Acta Neurologica Scandinavica | en_GB |
dc.rights.uri | http://www.rioxx.net/licenses/all-rights-reserved | en_GB |
dcterms.dateAccepted | 2020-02-11 | |
rioxxterms.version | AM | en_GB |
rioxxterms.licenseref.startdate | 2020-02-18 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2020-04-09T08:52:33Z | |
refterms.versionFCD | AM | |
refterms.panel | A | en_GB |