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一项旨在确定视频演示是否能提高子宫切除术知情同意的随机对照试验。

A randomized controlled trial to determine whether a video presentation improves informed consent for hysterectomy.

机构信息

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, San Antonio Military Medical Center, Fort Sam Houston, TX.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, San Antonio Military Medical Center, Fort Sam Houston, TX.

出版信息

Am J Obstet Gynecol. 2018 Sep;219(3):277.e1-277.e7. doi: 10.1016/j.ajog.2018.06.016. Epub 2018 Jun 28.

DOI:10.1016/j.ajog.2018.06.016
PMID:29959929
Abstract

BACKGROUND

Informed consent is an integral part of the preoperative counseling process. It is important that we know the best way to relay this information to patients undergoing surgery, specifically, hysterectomy.

OBJECTIVE

We sought to determine whether supplementing normal physician counseling with a video presentation improves patient comprehension during the informed consent process for hysterectomy.

STUDY DESIGN

In a randomized, mixed factorial controlled trial, standard physician counseling (control arm) was compared to physician counseling plus video presentation (video arm) during the prehysterectomy informed consent process. Primary outcome was improvement in patient comprehension measured by assessments at baseline, postcounseling, day of surgery, and postsurgery. Patient satisfaction was measured by a validated questionnaire. Audiotaped patient-physician interactions were analyzed to determine time spent counseling, number of patient questions, and whether standard counseling included 11 predetermined critical components included in the video. A sample size of 60 per group (N = 120) was planned to compare both groups.

RESULTS

From May 2014 through June 2015, 120 patients were enrolled and 116 randomized: 59 to the video arm and 57 to the control arm. All characteristics were similar between groups. Video arm subjects demonstrated greater improvement in comprehension scores in both postcounseling (9.9% improvement; 95% confidence interval, 4.2-15.7%; P = .0009) and day-of-surgery questionnaires (7.2% improvement; 95% confidence interval, 0.96-13.4%; P = .02). Scores 4-6 weeks after surgery returned to baseline for both groups. Control subjects were less likely to be counseled about risk of thrombosis (P < .0001), colostomy (P < .0001), further medical/surgical therapy (P = .002), hormone replacement therapy (P < .0001), or postoperative expectations (P < .0001). Physicians spent more time counseling patients who did not watch the video (8 vs 12 minutes, P = .003) but number of questions asked by patients in each group was similar.

CONCLUSION

Enhancing prehysterectomy counseling with a video improves patient comprehension through day of surgery, increases thoroughness of counseling, and reduces physician time.

摘要

背景

知情同意是术前咨询过程的一个组成部分。我们需要了解向接受手术(特别是子宫切除术)的患者传达信息的最佳方式。

目的

我们旨在确定在子宫切除术的知情同意过程中,补充常规医生咨询与视频演示是否可以提高患者的理解能力。

研究设计

在一项随机、混合因子对照试验中,标准医生咨询(对照组)与术前子宫切除术知情同意过程中的医生咨询加视频演示(视频组)进行了比较。主要结果是通过基线、咨询后、手术当天和手术后的评估来衡量患者理解能力的提高。患者满意度通过经过验证的问卷进行衡量。分析了录音的医患互动,以确定咨询时间、患者问题数量以及标准咨询是否包含视频中的 11 个预定关键组成部分。计划每组招募 60 名患者(N=120)以比较两组。

结果

从 2014 年 5 月至 2015 年 6 月,共招募了 120 名患者,并对 116 名患者进行了随机分组:59 名患者分入视频组,57 名患者分入对照组。两组患者的所有特征均相似。视频组患者在咨询后(提高 9.9%;95%置信区间,4.2-15.7%;P=.0009)和手术当天的问卷(提高 7.2%;95%置信区间,0.96-13.4%;P=.02)中的理解得分均有更大的提高。两组患者术后 4-6 周的评分恢复至基线。对照组患者在血栓形成风险(P<.0001)、结肠造口术(P<.0001)、进一步的医疗/手术治疗(P=.002)、激素替代疗法(P<.0001)或术后预期(P<.0001)方面接受的咨询较少。未观看视频的患者的医生咨询时间更长(8 分钟对 12 分钟,P=.003),但两组患者的问题数量相似。

结论

在子宫切除术的术前咨询中增加视频可以提高患者的理解能力直至手术当天,提高咨询的全面性,并减少医生的时间。

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