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Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK

Khalifeh, H; Molyneaux, E; Brauer, R; Vigod, S; Howard, LM; (2019) Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK. BJGP Open 10.3399/bjgpopen19X101666. Green open access

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Abstract

BACKGROUND: Decision-making regarding antidepressant use in pregnancy is challenging, given the uncertain evidence base on the benefits and risks for women and their children. Patient decision aids (PDAs) can improve shared decision-making for complex health decisions but no evidence-based PDAs exist for antidepressant use in pregnancy. AIM: To assess the feasibility of a full-scale randomised controlled trial (RCT) to evaluate the efficacy of an electronic PDA on antidepressant use in pregnancy. DESIGN & SETTING: A UK-based pilot parallel-group RCT. METHOD: The study recruited women whose clinicians recommended an antidepressant for depression in a current or planned pregnancy, and who were uncertain about antidepressant use while pregnant. Women were recruited via clinician or self-referral, and randomised to online access to the PDA or online access to standard resource list, with primary follow-up at 4 weeks and longer-term follow-up. The primary outcome was protocol feasibility (recruitment target of 50 women and follow-up rate of 80%). Outcome measures for a future full-scale RCT included the decisional conflict scale (DCS). RESULTS: Fifty-one women were recruited with a follow-up rate of 90.2% at 4 weeks. The PDA received good overall satisfaction ratings (mean 4.2/5). Analysis of covariance (ANCOVA) indicated a small improvement in decisional conflict at 4 weeks, accounting for baseline scores (DCS regression coefficient = -3.5, 95% confidence intervals [CI = -12.6 to 5.6]). CONCLUSION: This pilot RCT for an electronic PDA on antidepressant use in pregnancy showed that the study protocol was feasible, with high rates of participant satisfaction among those randomised to the PDA.

Type: Article
Title: Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.3399/bjgpopen19X101666
Publisher version: https://doi.org/10.3399/bjgpopen19X101666
Language: English
Additional information: This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Keywords: antidepressants, depression, patient decision aid, pilot, pregnancy, randomised controlled trial
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Practice and Policy
URI: https://discovery.ucl.ac.uk/id/eprint/10090148
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