Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access.

ABSTRACT:

Background

In the UK, routinely recorded data may benefit prospective studies including randomised controlled trials (RCTs). In an on-going study, we aim to assess the feasibility of access and agreement of routinely recorded clinical and non-clinical data compared to data collected during a RCT using standard prospective methods. This paper will summarise available UK routinely recorded data sources and discuss our experience with the feasibility of accessing routinely recorded data for participants of a RCT before finally proposing recommendations for improving the access and implementation of routinely recorded data in RCTs.

Methods

Setting: the case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK, multicentre, phase IV RCT asses

SUBMITTER: Powell GA 

PROVIDER: S-EPMC5569524 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature