Evidence map›Paper›PMID 41606350›Full record

Trial reportArchives of women's mental health2026

A randomized controlled trial of an electronic patient decision aid (PDA) for decision-making around antidepressant use in pregnancy.

Simone N Vigod, Cindy-Lee Dennis, Sophie Grigoriadis, Kelly Metcalfe, Tim F Oberlander, Maria Michalowska, Aysha Butt, Antara Chatterjee, Claire DeOliveira, Wanrudee Isaranuwatchai and 4 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Archives of women's mental health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. When caution becomes harm.Nature medicine · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Simone N VigodUniversity of Toronto, Toronto, Canada. simone.vigod@wchospital.ca.
Cindy-Lee DennisUniversity of Toronto, Toronto, Canada.
Sophie GrigoriadisUniversity of Toronto, Toronto, Canada.
Kelly MetcalfeUniversity of Toronto, Toronto, Canada.
Tim F OberlanderUniversity of British Columbia, Vancouver, Canada.
Maria MichalowskaWomen's College Hospital and Research Institute, Toronto, Canada.
Aysha ButtWomen's College Hospital and Research Institute, Toronto, Canada.
Antara ChatterjeeWomen's College Hospital and Research Institute, Toronto, Canada.
Claire DeOliveiraUniversity of Toronto, Toronto, Canada.
Wanrudee IsaranuwatchaiLi Ka Shing Research Institute, St. Michael's Hospital, Toronto, Canada.
Yutong LuUniversity of Toronto, Toronto, Canada.
Janet ParsonsLi Ka Shing Research Institute, St. Michael's Hospital, Toronto, Canada.
Donna E StewartUniversity of Toronto, Toronto, Canada.
Kevin E ThorpeUniversity of Toronto, Toronto, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDecisions about whether to use antidepressant medication in pregnancy can be complex for patients. When decisional conflict is high, this can negatively impact on decision-making and resultant clinical outcomes. We evaluated an electronic patient decision aid (PDA) around antidepressant use in pregnancy for its ability to improve patients’ decision-making experience and the clinical outcomes associated with their decisions.

methodsThis parallel-group trial (2018–2025) randomized preconception and pregnant Canadian participants with depression in a 1:1 ratio to an electronic PDA plus standard resources or standard resource control. Groups were compared on decisional conflict (measured using the Decisional Conflict Scale, DCS) at 4 weeks post-randomization. Those who were pregnant/became pregnant were evaluated for postpartum depression (PPD) at 3 months postpartum using the Structured Clinical Interview for DSM-5.

resultsOf n = 462 participants, n = 231 (mean age 32.4 +/- 4.0 years. 48.3% pregnant at baseline) were randomized to the PDA and n = 231 (mean age 32.5 +/- 4.2 years. 48.1% pregnant at baseline) to control. Between baseline and 4-weeks post-randomization, mean (SD) DCS score decreased from 48.3 (13.1) to 33.9 (14.9) in the PDA condition and 47.9 (14.5) to 40.1 (17.0) in controls, an adjusted mean difference of -6.34 (95%CI -8.92 to -3.79). PPD at 3 months postpartum was present in 7 (6.0%) PDA and 15 (12.9%) control participants, an absolute risk difference of -6.9% (95% CI -14.4% to 0.5%).

conclusionsCompared to standard resources alone, our PDA plus standard resources significantly reduced decisional conflict about the decision of whether or not to use antidepressant medication in pregnancy. PPD rates at 3 months postpartum were non-significantly lower in the PDA group as well. These results support dissemination of the PDA, and the evaluation of its utility with a wider audience.

Indexed as

Antidepressive AgentsDecision MakingDecision Support TechniquesDepressionDepression, PostpartumPatient ParticipationPregnancy ComplicationsAdultCanadaFemaleHumansPregnancyAntidepressive AgentsAntidepressive agentsDepressionPatient decision aidPregnancy

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.