Evaluating the effectiveness of a web‐based intervention to promote mental wellbeing in women and partners following miscarriage, using a modified patient preference trial design: an external pilot

Please cite this paper as: Klein S, Cumming G, Lee A, Alexander D, Bolsover D. Evaluating the effectiveness of a web‐based intervention to promote mental wellbeing in women and partners following miscarriage, using a modified patient preference trial design: an external pilot. BJOG 2012;119:762–767. This article describes an external pilot study of a modified ‘partially randomised patient preference’ trial comparing a web‐based intervention (designed to promote mental wellbeing) with standard care post‐miscarriage. Assessment comprised an online administration of baseline measures with follow‐up at 3 months following registration. Baseline data were obtained from 60 women (and seven partners) post‐discharge from one of two Early Pregnancy Assessment Units. ‘Intention to treat’ versus a ‘per protocol’ sensitivity analysis showed the effects of introducing a ‘preference’ option post‐randomisation, and highlights the benefits compared with a randomised controlled trial design to enable a robust evaluation of the website in promoting mental wellbeing after miscarriage.