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Objectives Clinical outcomes are an important component of randomised controlled trials (RCTs) and are often used to complement patient reported outcomes measures such as health-related quality of life. Although clinical outcomes were traditionally collected through clinical examination or laboratory results, routine data sources and self-reporting by patients are now being increasingly used. We describe patient reported clinical outcomes and the challenges associated with collection of data in this way.

Patient reported clinical outcomes: the challenges and implications for randomised controlled trials