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

IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Obstetrics and gynecology Pub 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
{"title":"Virtual Compared With In-Office Postoperative Visits After Urogynecologic Surgery: A Randomized Controlled Trial.","authors":"Lannah L Lua-Mailland, Amy S Nowacki, Marie Fidela R Paraiso, Amy J Park, Shannon L Wallace, Cecile A Ferrando","doi":"10.1097/AOG.0000000000005694","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, NCT05641077.</p>","PeriodicalId":19483,"journal":{"name":"Obstetrics and gynecology","volume":null,"pages":null},"PeriodicalIF":5.7000,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Obstetrics and gynecology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/AOG.0000000000005694","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
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.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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。
求助全文
约1分钟内获得全文 去求助
来源期刊
Obstetrics and gynecology
Obstetrics and gynecology 医学-妇产科学
CiteScore
11.10
自引率
4.20%
发文量
867
审稿时长
1 months
期刊介绍: "Obstetrics & Gynecology," affectionately known as "The Green Journal," is the official publication of the American College of Obstetricians and Gynecologists (ACOG). Since its inception in 1953, the journal has been dedicated to advancing the clinical practice of obstetrics and gynecology, as well as related fields. The journal's mission is to promote excellence in these areas by publishing a diverse range of articles that cover translational and clinical topics. "Obstetrics & Gynecology" provides a platform for the dissemination of evidence-based research, clinical guidelines, and expert opinions that are essential for the continuous improvement of women's health care. The journal's content is designed to inform and educate obstetricians, gynecologists, and other healthcare professionals, ensuring that they stay abreast of the latest developments and best practices in their field.
期刊最新文献
False-Positive Human Immunodeficiency Virus-1 Test Results With Rapid Seroreversion After Third-Trimester Tdap Booster Vaccination. Compliance Rate With Triage Test and Treatment for Participants Screening Positive in Cervical Cancer Screening Programs: A Systematic Review and Meta-analysis. Effects of Antihypertensive Therapy During Pregnancy on Postpartum Blood Pressure Control. Management of Vulvovaginal Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Navigating the Legal Landscape of Reproductive Rights and Medical Training After LePage v. Mobile Infirmary Clinic.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1