Patient-reported outcomes as individual-level interrupted time series in observational studies

This was a workshop for chief investigators, trial managers, statisticians, patients and others with an interest in improving the quality of non-randomised healthcare evaluations.

This meeting shared the findings of the PROMiSe study (Patient Reported Outcome MeasureS using Electronic informed consent and data capture), funded by NIHR’s CTU Support Funding programme to develop a practical framework for collecting patient-reported outcomes as individual-level time series, which can subsequently be linked to clinical data on treatments received. The workshop aims to present some novel research methods, and to stimulate more general discussion of ways to bridge the gap between observational studies and clinical trials in areas such as surgery, where randomised trials can face challenges, for example around equipoise and recruitment.