Using routinely recorded data in a UK RCT: a comparison to standard prospective data collection methods

Area of Science:

• Clinical Trials
• Health Informatics
• Epilepsy Research

Background:

• Electronic health records (EHRs) offer potential for informing randomized controlled trials (RCTs).
• However, accessing and ensuring the accuracy of routinely recorded data presents challenges.
• The Standard and New Antiepileptic Drugs II (SANAD II) trial in the UK serves as a case study.

Purpose of the Study:

• To assess the attributes and agreement of routinely recorded data against case report forms (CRFs) in an epilepsy RCT.
• To evaluate data quality for participant identification, baseline, and follow-up in the SANAD II trial.
• To compare routinely collected data with data gathered via CRFs in an antiepileptic drug trial.

Main Methods:

• Utilized data from the SANAD II trial, a pragmatic, UK multicenter RCT on antiepileptic drugs.
• Extracted routinely recorded secondary care data from NHS Digital Hospital Episode Statistics and primary/secondary care data from The Secure Anonymised Information Linkage Databank.
• Assessed data attributes (missingness) and agreement using Cohen's kappa for categorical data and Bland-Altman plots for continuous data.

Main Results:

• Significant missing data (15/20 variables) was found in routine records, including all clinical variables.
• Poor agreement was observed for seizure occurrence and adverse events; only 37% of participants had a date of first seizure recorded.
• Satisfactory agreement was noted for antiepileptic drug prescription dates and healthcare resource use episodes.

Conclusions:

• Current limitations in routinely recorded data hinder its use for participant identification and clinical outcome assessment in epilepsy RCTs.
• Further research is essential to evaluate the attributes, agreement, benefits, and cost-effectiveness of routinely recorded data.
• The optimal integration of routinely recorded data with standard CRF methods requires further investigation for epilepsy and other chronic conditions.