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A HDRUK and MHRA dataset: Assessing the use of Sodium Valproate in acute care

Population Size

77,223

People

Years

2018 - 2024

Associated BioSamples

None/not available

Geographic coverage

https://www.geonames.org/2634343/west-midlands.html

Lead time

1-2 months

Summary

A highly granular dataset of 77,223 acute admissions with epilepsy and bipolar disorder to study the use of Sodium Valproate, including demography, comorbidities, symptoms, serial physiology and investigations, medications (name, dose, route), outcomes.

Documentation

A dataset of 77,223 admissions curated with the MHRA and HDRUK Medicines Driver programme to study the use of sodium valproate in acute care settings. This includes its use in patients with epilepsy and bipolar disorders during acute admissions to hospital. The current dataset includes admissions from 2018 to 2024 but can be expanded to assess other timelines of interest. The data includes granular prescribing information, from drug prescription, indication, dose, route and duration of treatment. The dataset also includes all other prescribing and provides a detailed review of the care of patients admitted acutely for both epilepsy and bipolar disorders.

Geography: The West Midlands (WM) has a population of 6 million & includes a diverse ethnic & socio-economic mix. UHB is one of the largest NHS Trusts in England, providing direct acute services & specialist care across four hospital sites, with 2.2 million patient episodes per year, 2750 beds & > 120 ITU bed capacity. UHB runs a fully electronic healthcare record (EHR) (PICS; Birmingham Systems), a shared primary & secondary care record (Your Care Connected) & a patient portal “My Health”.

Data set availability: Data access is available via the PIONEER Hub for projects which will benefit the public or patients. This can be by developing a new understanding of disease, by providing insights into how to improve care, or by developing new models, tools, treatments, or care processes. Data access can be provided to NHS, academic, commercial, policy and third sector organisations. Applications from SMEs are welcome. There is a single data access process, with public oversight provided by our public review committee, the Data Trust Committee. Contact pioneer@uhb.nhs.uk or visit www.pioneerdatahub.co.uk for more details.

Available supplementary data: Matched controls; ambulance and community data. Unstructured data (images). We can provide the dataset in OMOP and other common data models and can build synthetic data to meet bespoke requirements.

Available supplementary support: Analytics, model build, validation & refinement; A.I. support. Data partner support for ETL (extract, transform & load) processes. Bespoke and “off the shelf” Trusted Research Environment (TRE) build and run. Consultancy with clinical, patient & end-user and purchaser access/ support. Support for regulatory requirements. Cohort discovery. Data-driven trials and “fast screen” services to assess population size.

Dataset type
Health and disease, Measurements/Tests, Lifestyle
Dataset sub-type
Not applicable
Dataset population size
77223

Keywords

Sodium Valproate, Epilepsy, Bipolar Disorder, Acute Admissions, MHRA, HDRUK Medicines Driver Programme, Granular Data, Prescribing Information (dose, route, duration), Comorbidities, Serial Physiology, Investigations, Clinical Outcomes, Intravenous (IV) Valproate, Oral Valproate, Regulatory Actions, Patient Safety, Unintended Impacts, Pregnancy Prevention Programme, Congenital Malformations, Neurodevelopmental Disorders, Male Fertility, Epigenetic Effects, Transgenerational Risks, Commission on Human Medicine (CHM), Seizure Control, SUDEP (Sudden Unexplained Death in Epilepsy), Reproductive System Side Effects, Acute Bipolar Disorder Presentations, Demographics, Inpatient, Outpatient, Intensive Care

Observations

Observed Node
Disambiguating Description
Measured Value
Measured Property
Observation Date

Persons

containing 77223 patients admitted to hospital with epilepsy or bipolar disorder

77223

Count

17 Jan 2025

Provenance

Purpose of dataset collection
Care
Source of data extraction
EPR
Collection source setting
Secondary care - Accident and Emergency, Secondary care - In-patients, Secondary care - Outpatients
Patient pathway description
Data is representative of the multi-ethnicity population within the West Midlands (42% non white). Data includes all patients admitted during this timeframe, with National data Opt Outs applied, and therefore is representative of admissions to secondary care. Data focuses on in-patient stay in hospital during the acute episode but can be supplemented on request to include previous and subsequent hospital contacts (including outpatient appointments) and ambulance, 111, 999 data.
Image contrast
Not stated
Biological sample availability
None/not available

Structural Metadata

Details

Publishing frequency
Quarterly
Version
1.0.0
Modified

06/02/2025

Distribution release date

30/04/2025

Citation Requirements
This publication uses data from PIONEER, an ethically approved database and analytical environment (East Midlands Derby Research Ethics 20/EM/0158)

Coverage

Start date

01/01/2018

End date

30/06/2024

Time lag
Less than 1 week
Maximum age range
150
Follow-up
0 - 6 Months

Accessibility

Language
en
Alignment with standardised data models
LOCAL
Controlled vocabulary
ICD10, SNOMED CT, OPCS4
Format
SQL, application

Data Access Request

Dataset pipeline status
Available
Time to dataset access
1-2 months
Access request cost
www.pioneerdatahub.co.uk/data/data-services-costs/
Access method category
TRE/SDE
Access service description

Trusted Research Environments (TRE) are built using Microsoft Azure services and hosted in the UK to provide research teams a safe, secure and agile environment which allows users to quickly analyse, interpret and form an enriched view of primary care information through a range of integrated datasets.

Health data collated from multiple sources is ingested into a secure data lake which will then allow subsets of data to be made available to research teams on approval of a data request. Once approved a customer specific TRE is made available with a standard set of leading analytical tools from Microsoft including Azure Databricks, Azure Machine Learning, Azure SQL and Azure Synapse (for large-scale data warehouses). Specific tools can be provided at an additional cost over the standard platform data access charge and the PIONEER team will work with you to determine your exact needs.

Access to the TRE is managed using the latest virtual desktop technology to provide a safe and secure end-user experience. By utilising leading edge design PIONEER are able to create TREs rapidly to enable us to service any customer requirement.

Jurisdiction
GB-ENG
Data use limitation
General research use
Data use requirements
Project-specific restrictions
Data Controller
University Hospitals Birmingham NHS Foundation Trust
Data Processor
NOT APPLICABLE

Dataset Types: Health and disease, Measurements/Tests, Lifestyle


Collection Sources: Secondary care - Accident and Emergency, Secondary care - In-patients, Secondary care - Outpatients