title: 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.
abstract: 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.
authors.affiliation: Aberdeen Centre for Trauma Research, Institute for Health and Welfare Research, Robert Gordon University, Aberdeen, UK. s.klein@rgu.ac.uk
authors.forename: S
authors.initials: S
authors.lastname: Klein
authors.forename: G P
authors.initials: GP
authors.lastname: Cumming
authors.forename: A J
authors.initials: AJ
authors.lastname: Lee
authors.forename: D A
authors.initials: DA
authors.lastname: Alexander
authors.forename: D
authors.initials: D
authors.lastname: Bolsover
mesh_terms: D000022:Abortion, Spontaneous / Q000523:psychology*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020407:Internet; D008297:Male; D057240:Patient Preference; D010865:Pilot Projects; D011613:Psychotherapy / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards*; D018454:Spouses / Q000523:psychology*; D011795:Surveys and Questionnaires; D014930:Women / Q000523:psychology*