Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK.
Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK.
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DOI：
10.3399/bjgpopen19x101666
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发表时间：
2019-12-10
期刊：
影响因子：
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通讯作者：
Howard, Louise M
中科院分区：
文献类型：
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作者：
Khalifeh, Hind;Molyneaux, Emma;Howard, Louise M
背景：考虑到对妇女及其子女的益处和风险的不确定证据基础，关于在怀孕期间使用抗抑郁药的决策是具有挑战性的。患者决策辅助工具(PDA)可以改善复杂健康决策的共享决策，但目前尚不存在基于证据的PDA在妊娠期间使用抗抑郁药物的证据。目的：评估一项全面随机对照试验(RCT)的可行性，以评估电子PDA在妊娠期间使用抗抑郁药物的有效性。设计与背景：一项位于英国的试点平行小组RCT。方法：该研究招募了临床医生建议在当前或计划怀孕期间使用抗抑郁药物，且不确定怀孕期间使用抗抑郁药物的妇女。通过临床医生或自我推荐招募女性，并随机在线访问PDA或在线访问标准资源列表，在4周内进行初步随访和长期随访。主要结果是方案的可行性(招募目标为50名妇女，随访率为80%)。结果：51名女性入选，4周时的随访率为90.2%。掌上电脑的整体满意度评分良好(平均4.2/5分)。协方差分析(ANCOVA)显示4周后决策冲突略有改善，考虑了基线分数(DCS回归系数=-3.5，95%可信区间[CI=-12.6至5.6])。结论：这项关于妊娠期间抗抑郁药物使用的电子PDA的试验性随机对照试验表明，研究方案是可行的，随机使用PDA的参与者满意率较高。
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.