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

ABSTRACT:

Background

Routinely recorded data held in electronic health records can be used to inform the conduct of randomised controlled trials (RCTs). However, limitations with access and accuracy have been identified.

Objective

Using epilepsy as an exemplar condition, we assessed the attributes and agreement of routinely recorded data compared to data collected using case report forms in a UK RCT assessing antiepileptic drug treatments for individuals newly diagnosed with epilepsy.

Methods

The case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK multicentre RCT assessing the clinical and cost-effectiveness of antiepileptic drugs as treatments for epilepsy. Ninety-eight of 470 eligible participants provided consent for access to rout

SUBMITTER: Powell GA 

PROVIDER: S-EPMC8259387 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature