Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK
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 exis...
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| Format: | Article |
| Language: | English |
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Royal College of General Practitioners
2019-12-01
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| Series: | BJGP Open |
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| Online Access: | https://bjgpopen.org/content/3/4/bjgpopen19X101666 |
| _version_ | 1818434359475044352 |
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| author | Hind Khalifeh Emma Molyneaux Ruth Brauer Simone Vigod Louise M Howard |
| author_facet | Hind Khalifeh Emma Molyneaux Ruth Brauer Simone Vigod Louise M Howard |
| author_sort | Hind Khalifeh |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T16:35:44Z |
| format | Article |
| id | doaj.art-d31090195d884d29a4b18bb939358c63 |
| institution | Directory Open Access Journal |
| issn | 2398-3795 |
| language | English |
| last_indexed | 2024-12-14T16:35:44Z |
| publishDate | 2019-12-01 |
| publisher | Royal College of General Practitioners |
| record_format | Article |
| series | BJGP Open |
| spelling | doaj.art-d31090195d884d29a4b18bb939358c632022-12-21T22:54:29ZengRoyal College of General PractitionersBJGP Open2398-37952019-12-013410.3399/bjgpopen19X101666Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UKHind Khalifeh0Emma Molyneaux1Ruth Brauer2Simone Vigod3Louise M Howard4Senior Clinical Researcher and Consultant Perinatal Psychiatrist, Section of Women’s Mental Health, Institute of Psychiatry, Psychology and Neuroscience (IOPPN), King’s College London, London, UKResearch Associate and Honorary Lecturer, Section of Women’s Mental Health, Institute of Psychiatry, Psychology and Neuroscience (IOPPN), King’s College London, London, UKLecturer Pharmacoepidemiology, School of Pharmacy, University College London, London, UKAssociate Professor and Psychiatrist-in-Chief, Women’s College Hospital and Women’s College Research Institute, and Department of Psychiatry, University of Toronto, Toronto, CanadaProfessor of Women's Mental Health, Section of Women’s Mental Health, Institute of Psychiatry, Psychology and Neuroscience (IOPPN), King’s College London, London, UKBackground: 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.https://bjgpopen.org/content/3/4/bjgpopen19X101666pregnancydepressionantidepressantspatient decision aidpilotrandomised controlled trial |
| spellingShingle | Hind Khalifeh Emma Molyneaux Ruth Brauer Simone Vigod Louise M Howard Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK BJGP Open pregnancy depression antidepressants patient decision aid pilot randomised controlled trial |
| title | Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK |
| title_full | Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK |
| title_fullStr | Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK |
| title_full_unstemmed | Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK |
| title_short | Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK |
| title_sort | patient decision aids for antidepressant use in pregnancy a pilot randomised controlled trial in the uk |
| topic | pregnancy depression antidepressants patient decision aid pilot randomised controlled trial |
| url | https://bjgpopen.org/content/3/4/bjgpopen19X101666 |
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