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评估早期妊娠丢失决策辅助工具:宾夕法尼亚州费城的一项试点随机对照试验。

Evaluation of a decision aid for early pregnancy loss: A pilot randomized controlled trial in Philadelphia, Pennsylvania.

机构信息

Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.

Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.

出版信息

Contraception. 2023 Sep;125:110077. doi: 10.1016/j.contraception.2023.110077. Epub 2023 Jun 1.

DOI:10.1016/j.contraception.2023.110077
PMID:37270163
Abstract

OBJECTIVES

To evaluate the effect of a decision aid on decisional conflict scale in patients choosing management for early pregnancy loss.

STUDY DESIGN

We conducted a pilot randomized control trial to assess the effect of the Healthwise patient decision aid on decisional conflict scale in patients with early pregnancy loss as compared with a control website. Patients 18years and older were eligible if they had an early pregnancy loss between 5 and 12 completed weeks of gestation. Participants completed surveys at baseline, poststudy intervention, after consultation, and 1week postconsultation. Surveys assessed participant scores on the decisional conflict scale (scale 0-100), knowledge, assessment of shared decision-making, satisfaction, and decision regret. Our primary outcome was the poststudy-intervention decisional conflict scale score.

RESULTS

From July 2020 through March 2021 we randomized 60 participants. After the intervention, the median decisional conflict scale score for the control group was 10 [0-30] and 0 [0-20] for the intervention group (p = 0.17). When assessing the decisional conflict scale subscales postintervention, the informed subscale for the control group was 16.7 [0-33.3] as opposed to 0 [0] for the patient decision aid group (p = 0.003). Knowledge remained significantly higher in the experimental arm from the postintervention to the 1-week follow-up. We found no differences between groups when assessing our other metrics.

CONCLUSIONS

Use of a validated decision aid did not result in statistically significant differences in the total decisional conflict scale scores as compared with the control. Participants allocated to the intervention were more informed postintervention and had consistently higher knowledge scores.

IMPLICATIONS

Use of a validated decision aid prior to early pregnancy loss management consultation did not affect overall decisional conflict but resulted in improved knowledge.

摘要

目的

评估决策辅助工具对早孕流产患者管理选择的决策冲突量表的影响。

研究设计

我们进行了一项试点随机对照试验,以评估 Healthwise 患者决策辅助工具对早孕流产患者决策冲突量表的影响,与对照网站相比。18 岁及以上、妊娠 5-12 周完全妊娠的患者符合条件。参与者在基线、研究后干预、咨询后和咨询后 1 周完成调查。调查评估了参与者在决策冲突量表(量表 0-100)、知识、共同决策评估、满意度和决策后悔方面的得分。我们的主要结局是研究后干预的决策冲突量表评分。

结果

2020 年 7 月至 2021 年 3 月,我们随机分配了 60 名参与者。干预后,对照组决策冲突量表评分中位数为 10[0-30],干预组为 0[0-20](p=0.17)。在评估干预后决策冲突量表的子量表时,对照组的知情子量表为 16.7[0-33.3],而患者决策辅助工具组为 0[0](p=0.003)。从干预后到 1 周随访,实验组的知识得分仍然显著更高。在评估我们的其他指标时,我们没有发现组间差异。

结论

与对照组相比,使用经过验证的决策辅助工具并未导致决策冲突量表总分的统计学显著差异。干预组患者在干预后更知情,知识得分一直较高。

意义

在早孕流产管理咨询前使用经过验证的决策辅助工具不会影响总体决策冲突,但会提高知识水平。

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