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加强基于文本的远程医疗在术后护理中的证据:一项关于南非自愿男性包皮环切术后双向、基于文本的随访范围和效果的实用性研究。

Strengthening evidence for text-based telehealth in post-operative care: A pragmatic study of the reach and effectiveness of two-way, text-based follow-up after voluntary medical male circumcision in South Africa.

作者信息

Feldacker Caryl, Fabens Isabella, Dong Tracy, Moyo Khumbulani, Makhele Calsile, Phohole Motshana, Igaba Nelson, Hlongwane Sizwe, Pienaar Jacqueline, Sardini Maria, Ndebele Felex, Tweya Hannock, Holec Marrianne, Waweru Evelyn, Setswe Geoffrey

出版信息

medRxiv. 2024 Dec 8:2024.12.05.24317906. doi: 10.1101/2024.12.05.24317906.

Abstract

Building upon evidence of safety and efficiency gains from a randomized control trial (RCT) in South Africa, we further scaled implementation of two-way, short message service (SMS), text-based (2wT) follow-up after voluntary medical male circumcision (VMMC). We aimed to determine if gains in adverse event (AE) identification and reduced follow-up visits could be maintained when 2wT was implemented in routine VMMC settings. A pragmatic, stepped wedge design (SWD) study was implemented across three districts in South Africa. Men ages 15 and older could opt into the 2wT telehealth follow-up approach when their facility was in the intervention period. Men in routine periods were offered the standard of care (SoC): in-person post-operative visits on days 2 and 7 as per national VMMC guidelines. 2wT participants were not required to attend any postoperative visits but could return for care if desired or referred. Two quality of care markers, safety (AE ascertainment rate) and efficiency (# in-person follow-up visits), were compared between groups. We aimed for at least 200 men per step to have 80% power to detect a change in AE rate from before to after 2wT was implemented. Secondary analysis explored response rates; client and site uptake; and AE details. Among 6842 clients in the intervention period, 2856 opted into 2wT (37.8%) across three intervention waves and two platforms (SMS or WhatsApp). Among those with post-operative follow-up, the AE ascertainment rate was higher among 2wT (0.60%) than SoC (0.13%) clients (p = 0.0018), demonstrating safety gains. On average, 2wT participants had 2.1 fewer visits compared to SoC clients (p<0.001), demonstrating gains in follow-up efficiency. Among 2wT men, 2069/2586 (80%) responded via 2wT over 14 days, demonstrating engagement in post-operative care. Of all intervention clients, 93 2wT (3.6%) and 342 (8.0%) SoC were considered lost to follow-up. In this expansion trial, we provided additional evidence that the 2wT approach maintains the quality of post-operative care for adult VMMC clients. 2wT should be scaled to augment in-person, post-operative visits after VMMC for eligible, interested males ages 15 and older. To achieve potential impact, effort is needed to improve access and uptake to 2wT among providers and sites, expanding the 2wT approach for other acute follow-up care especially among men.

摘要

基于南非一项随机对照试验(RCT)所取得的安全性和效率提升证据,我们进一步扩大了自愿男性包皮环切术(VMMC)后双向短消息服务(SMS)文本形式(2wT)随访的实施规模。我们旨在确定在常规VMMC环境中实施2wT时,不良事件(AE)识别方面的提升以及随访次数的减少是否能够得以维持。在南非的三个地区开展了一项实用的阶梯楔形设计(SWD)研究。15岁及以上的男性在其所在机构处于干预期时可以选择加入2wT远程医疗随访方式。处于常规时期的男性接受标准护理(SoC):按照国家VMMC指南在术后第2天和第7天进行面对面随访。2wT参与者无需参加任何术后随访,但如有需要或被转诊可回来接受护理。对两组之间的两个护理质量指标,即安全性(AE确定率)和效率(面对面随访次数)进行了比较。我们的目标是每一步至少有200名男性,以便有80%的把握检测到2wT实施前后AE率的变化。二次分析探讨了回复率、客户和机构的接受情况以及AE细节。在干预期的6842名客户中,在三个干预波次和两个平台(SMS或WhatsApp)上,有2856人选择加入2wT(37.8%)。在有术后随访的人群中,2wT客户的AE确定率(0.60%)高于SoC客户(0.13%)(p = 0.0018),表明安全性有所提升。平均而言,2wT参与者的随访次数比SoC客户少2.1次(p<0.001),表明随访效率有所提高。在2wT男性中,2069/2586(80%)在14天内通过2wT进行了回复,表明他们参与了术后护理。在所有干预客户中,93名2wT客户(3.6%)和342名SoC客户(8.0%)被视为失访。在这项扩展试验中,我们提供了更多证据表明2wT方法能够维持成年VMMC客户术后护理的质量。对于15岁及以上符合条件且感兴趣的男性,应扩大2wT的规模以增加VMMC术后的面对面随访。为实现潜在影响,需要努力提高提供者和机构对2wT的可及性和接受度,将2wT方法扩展到其他急性随访护理,尤其是针对男性的护理。

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