Most clinical trials are pragmatic in nature and aim to assess the effectiveness of a new treatment against ‘treatment as usual’. When interpreting trial results, researchers tend to focus primarily on what treatment participants in different trial arms received. This may be difficult in the usual care arm, as this arm is often poorly defined, whereas the intervention arm is often clearly defined prior to the trial starting. In addition, this focus is very narrow. Treatment is a process and patients’ experiences of accessing and receiving care could also influence their treatment outcomes, and thus the trial’s results.
A paper recently published in Trials highlights that differences do exist between the experiences of participants randomised to usual care and intervention arms. These differences relate not only to what treatment participants receive, but also how they access and … Read more