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

S. Klein*, G. P. Cumming, A. J. Lee, D. A. Alexander, D. Bolsover

*Corresponding author for this work

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)762-767
Number of pages6
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume119
Issue number6
Early online date20 Mar 2012
DOIs
Publication statusPublished - May 2012

Fingerprint

Patient Preference
Spontaneous Abortion
Random Allocation
Randomized Controlled Trials
Pregnancy

Keywords

  • External pilot
  • mental wellbeing
  • miscarriage
  • modified patient preference trial design
  • web-based intervention

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

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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.",
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AU - Cumming, G. P.

AU - Lee, A. J.

AU - Alexander, D. A.

AU - Bolsover, D.

N1 - Acknowledgements The authors are indebted to all the women and partners who participated in this external pilot study, and to the midwives for their invaluable contribution to recruitment.

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AB - 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.

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