Virtual Compared With In-Office Postoperative Visits After Urogynecologic Surgery: A Randomized Controlled Trial.

IF 8.3 2区 材料科学 Q1 MATERIALS SCIENCE, MULTIDISCIPLINARY
ACS Applied Materials & Interfaces Pub Date : 2024-10-01 Epub Date: 2024-08-08 DOI:10.1097/AOG.0000000000005694
Lannah L Lua-Mailland, Amy S Nowacki, Marie Fidela R Paraiso, Amy J Park, Shannon L Wallace, Cecile A Ferrando
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引用次数: 0

Abstract

Objective: To compare patient satisfaction, health care resource utilization, and adverse events among patients receiving a virtual video compared with in-office postoperative visit after urogynecologic surgery. We hypothesized that virtual video visits would be noninferior to in-office visits.

Methods: This was a randomized noninferiority clinical trial of patients undergoing surgery for pelvic organ prolapse and urinary incontinence at a single academic tertiary referral center. Participants were randomized to receive either a virtual video postoperative visit or a standard in-office postoperative visit. The primary outcome was patient satisfaction measured by the validated PSQ-18 (Patient Satisfaction Questionnaire-18) (noninferiority margin 5 points) at the 6-week postoperative visit. Secondary outcomes included PSQ-18 domain scores (noninferiority margin 0.5 points) and composite health care resource utilization and adverse events after the 6-week postoperative visit up to 12 weeks after surgery (noninferiority margin 10%). A sample size of 100 participants (50 per group) would allow 80% power to assess a 5-point noninferiority margin on the total PSQ-18 with an SD of 10 and α=0.05.

Results: From January 2023 to September 2023, 265 patients were screened for eligibility, and 104 were randomized. A total of 100 participants (50 per arm) completed the study and were included in the analysis. The mean±SD age of all participants was 57.0±13.2 years. The mean±SD PSQ-18 total score was 75.18±8.15 in the virtual group and 75.14±8.7 in the in-office group. The mean PSQ-18 total score was 0.04 points higher (ie, greater degree of satisfaction) in the virtual group, with a 95% CI of -2.75 to 2.83, which met the criterion for noninferiority. Between-group differences for all PSQ-18 domain scores likewise met criterion for noninferiority. Composite health care resource utilization was 14.0% lower in the virtual group than in the in-office group (20.0% vs 34.0%, 95% CI, -28.0% to 1.0%). For composite adverse events, the between-group difference was 2.0% (2.0% in virtual group vs 0.0% in in-office group, 95% CI,-3.0% to 8.0%).

Conclusion: Virtual video postoperative visits were noninferior to in-office visits with regard to patient satisfaction, health care resource utilization, and adverse events and can be offered as an alternative to in-office visits for postoperative follow-up after urogynecologic surgery.

Clinical trial registration: ClinicalTrials.gov , NCT05641077.

泌尿妇科手术术后虚拟访视与诊室访视的比较:随机对照试验。
目的比较泌尿妇科手术后接受虚拟视频和诊室术后访视的患者的满意度、医疗资源利用率和不良事件。我们假设虚拟视频访视的效果不劣于诊室访视:这是一项随机非劣效性临床试验,对象是在一家学术性三级转诊中心接受盆腔器官脱垂和尿失禁手术的患者。参与者被随机分配接受虚拟视频术后访视或标准诊室术后访视。主要结果是患者在术后6周就诊时通过有效的PSQ-18(患者满意度问卷-18)测量的满意度(非劣效差5分)。次要结果包括 PSQ-18 领域得分(非劣效差值为 0.5 分)以及术后 6 周访视后至术后 12 周的综合医疗资源利用率和不良事件(非劣效差值为 10%)。100名参与者(每组50名)的样本量将使80%的力量能够评估PSQ-18总分5分的非劣效差,SD为10,α=0.05.结果:从 2023 年 1 月到 2023 年 9 月,共筛选出 265 名符合条件的患者,并对 104 名患者进行了随机分组。共有 100 名参与者(每组 50 人)完成研究并纳入分析。所有参与者的平均(±SD)年龄为 57.0±13.2 岁。虚拟组 PSQ-18 总分的平均值(±SD)为 75.18±8.15,诊室组为 75.14±8.7。虚拟组的 PSQ-18 总分平均值高出 0.04 分(即满意度更高),95% CI 为 -2.75 至 2.83,符合非劣效性标准。所有 PSQ-18 领域得分的组间差异同样符合非劣效标准。虚拟组的综合医疗资源利用率比诊室组低 14.0%(20.0% vs 34.0%,95% CI,-28.0% 至 1.0%)。综合不良事件方面,组间差异为 2.0%(虚拟组为 2.0%,诊室组为 0.0%,95% CI,-3.0% 至 8.0%):在患者满意度、医疗资源利用率和不良事件方面,虚拟视频术后随访并不比诊室随访差,可以作为诊室随访的替代方案用于泌尿妇科手术后的术后随访:临床试验注册:ClinicalTrials.gov,NCT05641077。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
ACS Applied Materials & Interfaces
ACS Applied Materials & Interfaces 工程技术-材料科学:综合
CiteScore
16.00
自引率
6.30%
发文量
4978
审稿时长
1.8 months
期刊介绍: ACS Applied Materials & Interfaces is a leading interdisciplinary journal that brings together chemists, engineers, physicists, and biologists to explore the development and utilization of newly-discovered materials and interfacial processes for specific applications. Our journal has experienced remarkable growth since its establishment in 2009, both in terms of the number of articles published and the impact of the research showcased. We are proud to foster a truly global community, with the majority of published articles originating from outside the United States, reflecting the rapid growth of applied research worldwide.
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