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<ns4:p>Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data.</ns4:p><ns4:p> Recently funded and ongoing RCTs were identified for inclusion by searching the National Institute for Health Research journals library. Trials that have a protocol available were assessed for inclusion and those that use or plan to use routinely collected health data for at least one outcome were included. Routinely collected data sources and outcome information were extracted.</ns4:p><ns4:p> A total of 279 studies were identified with 102 eligible for data extraction. An Electronic Health Record (EHR) was the sole source of outcome data for at least one outcome in 46 trials. The most frequent sources are Hospital Episode Statistics (HES) and Office for National Statistics (ONS), with the most common outcome data to be extracted being on mortality, hospital admission, and health service resource use.</ns4:p><ns4:p> Our study has found that around half of publicly funded trials in a UK cohort plan to collect outcome data from routinely collected data sources. This is much higher than the figure of 8% found in a cohort of 189 RCTs published since 2000, the majority of were carried out in North America (McCord <ns4:italic>et al</ns4:italic>., 2019).</ns4:p>

Original publication




Journal article




F1000 Research Ltd

Publication Date





323 - 323