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远程医疗服务在药物流产中的应用。

The use of telemedicine services for medical abortion.

作者信息

Cleeve Amanda, Lavelanet Antonella, Gemzell-Danielsson Kristina, Endler Margit

机构信息

Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.

Karolinska University Hospital, Stockholm, Sweden.

出版信息

Cochrane Database Syst Rev. 2025 Jun 4;6(6):CD013764. doi: 10.1002/14651858.CD013764.pub2.

Abstract

RATIONALE

Telemedicine models for medical abortion are service delivery models where care is provided by a health worker using telecommunications to support the abortion process. Existing evidence suggests that telemedicine for medical abortion is safe, effective, and acceptable to women compared to when care is provided in-clinic. However, the available data are often constrained by several factors. We sought to strengthen the evidence base by comparing telemedicine models for medical abortion with medical abortion provided in-clinic.

OBJECTIVES

To assess the safety, success rate, and acceptability of telemedicine models for medical abortion, according to which phase or phases (pre-abortion, abortion, and/or post-abortion) telecommunications were used as the primary means of service delivery, compared to in-clinic care for medical abortion in the corresponding phase/phases.

SEARCH METHODS

We searched CENTRAL (Ovid EBM Reviews), MEDLINE ALL (Ovid), Embase.com, CINAHL (EBSCOhost), LILACS, Global Health (Ovid), Scopus, Google Scholar, and grey literature sources from the inception of the database to 13 August 2024. We screened the references of included studies and contacted authors to identify additional data or enquire about ongoing studies.

ELIGIBILITY CRITERIA

We included randomised controlled trials (RCTs) and non-randomised studies (NRS) of telemedicine models compared with in-clinic care (standard care) for medical abortion. We only included studies that used an interactive type of telecommunication and studies where telemedicine services were provided by a health worker.

OUTCOMES

Critical: successful abortion (a terminated pregnancy without the need for surgical intervention to complete the abortion within 42 days of the abortion). Important: continuing pregnancy, blood transfusion, hospitalisation, emergency visits, satisfaction, adherence.

RISK OF BIAS

We used the RoB 2 and ROBINS-I tools to assess the risk of bias in the included RCTs and NRS, respectively.

SYNTHESIS METHODS

Two review authors (AC and ME) independently screened and extracted data in Covidence. We grouped interventions according to which abortion phase or phases (pre-abortion, abortion, post-abortion) telecommunications were used to deliver care. We graded the certainty of the evidence using the GRADE approach.

INCLUDED STUDIES

We included 22 studies: six RCTs and 16 NRS, comprising a total of 131,278 individuals undergoing medical abortion up to 12 weeks' gestation. Studies were conducted across five high-income and four middle-income countries. Due to the heterogeneity among included NRS, we performed meta-analyses only for comparisons where we had RCTs.

SYNTHESIS OF RESULTS

Main intervention: Pre- to post-abortion care telemedicine models for medical abortion versus in-clinic care In these telemedicine models, various forms of synchronous and asynchronous telecommunications were used to deliver care from the pre- to post-abortion phase, up to 12 weeks' gestation. Any in-clinic testing was done to complement, rather than to replace, service delivery in the pre-abortion phase. Five out of nine studies did not perform routine ultrasounds as part of the eligibility screening. Pre- to post-abortion telemedicine models probably result in little to no difference in successful abortion (RR 0.99, 95% CI 0.97 to 1.01; 2 RCTs, 837 participants; moderate-certainty evidence). This finding was supported by NRS results (Aiken 2021; 99% versus 98%; adjusted P value = 0.268; 7 NRS, 83,061 participants; moderate-certainty evidence). Further, pre- to post-abortion telemedicine models probably result in little to no difference in rates of continued pregnancy (Aiken 2021: 0.5% versus 1%; adjusted P value = 0.268; 5 NRS, 74,269 participants; moderate-certainty evidence) and may result in little to no difference in blood transfusions (Aiken 2021: 0.02% versus 0.03%, adjusted P value = 0.557; 5 NRS, 83,651 participants; low-certainty evidence). The effect of the intervention on hospitalisation is uncertain (RR 1.45, 95% CI 0.24 to 8.61; 2 RCTs, 846 participants; very low-certainty evidence). This intervention may result in little to no difference in emergency visits (RR 1.15, 95% CI 0.36 to 3.75; 2 RCTs, 847 participants; low-certainty evidence) and satisfaction (RR 1.01, 95% CI 1.00 to 1.02; 2 RCTs, 832 participants; low-certainty evidence), and probably results in little to no difference in adherence to the medical abortion regimen (RR 0.99, 95% CI 0.96 to 1.02; 1 RCT, 732 participants; moderate-certainty evidence). No deaths were reported in this review. Sub-interventions: Pre-abortion/abortion telemedicine models for medical abortion versus in-clinic; Post-abortion telemedicine models versus in-clinic Four NRS compared pre-abortion/abortion telemedicine models with in-clinic care; all outcomes had very low-certainty evidence. Four RCTs and five NRS compared post-abortion telemedicine models with in-clinic follow-up. Post-abortion telemedicine models likely result in little to no difference in successful abortion (RR 1.0, 95% CI 0.99 to 1.01; 4 RCTs, 5069 participants; moderate-certainty evidence). They may result in little to no difference in continuing pregnancy (RR 0.81, 95% CI 0.48 to 1.36; 4 NRS, 5069 participants; low-certainty evidence) and likely result in higher rates of adherence to follow-up procedures (RR 1.15, 95% CI 1.13 to 1.18; 4 RCTs, 5235 participants; moderate-certainty evidence). The effects of post-abortion telemedicine models on blood transfusion, hospitalisation, emergency visits, and satisfaction are uncertain.

AUTHORS' CONCLUSIONS: Pre- to post-abortion telemedicine models probably result in little to no difference in successful abortion, continuing pregnancy, and adherence to the medical abortion regimen, with moderate-certainty evidence. We found low-certainty evidence that this intervention may result in little to no difference in rates of blood transfusions, emergency visits, and satisfaction, but we are uncertain about the effect on hospitalisation. Post-abortion telemedicine models likely result in higher rates of adherence to follow-up procedures, with moderate-certainty evidence. We downgraded studies mainly due to serious risk of bias or imprecision, with some outcomes being rare events. Altogether, the findings indicate that telemedicine models for medical abortion in early pregnancy may result in similar outcomes in terms of safety, effectiveness, and acceptability when compared to in-clinic provision. Most studies were conducted in high-resource settings and data were limited to gestational ages above nine weeks. Future studies should investigate telemedicine models for medical abortion in lower-resourced settings and in gestational ages above nine weeks, compare different kinds of telecommunications, and assess models that omit testing (ultrasounds, physical exams, or blood tests).

FUNDING

None REGISTRATION: DOI: 10.1002/14651858.CD013764.

摘要

理论依据

药物流产的远程医疗模式是一种服务提供模式,即医护人员利用电信技术支持流产过程。现有证据表明,与在诊所提供护理相比,药物流产的远程医疗对女性来说是安全、有效且可接受的。然而,现有数据往往受到多种因素的限制。我们试图通过比较药物流产的远程医疗模式与诊所提供的药物流产来加强证据基础。

目的

评估药物流产的远程医疗模式的安全性、成功率和可接受性,根据使用电信作为主要服务提供方式的流产阶段(流产前、流产中和/或流产后),与相应阶段的诊所药物流产护理进行比较。

检索方法

我们检索了Cochrane系统评价数据库(Ovid循证医学综述)、MEDLINE ALL(Ovid)、Embase.com、护理学与健康领域数据库(EBSCOhost)、拉丁美洲及加勒比地区卫生科学数据库、全球健康(Ovid)、Scopus、谷歌学术以及从数据库建立至2024年8月13日的灰色文献来源。我们筛选了纳入研究的参考文献,并联系作者以识别其他数据或询问正在进行的研究。

纳入标准

我们纳入了将药物流产的远程医疗模式与诊所护理(标准护理)进行比较的随机对照试验(RCT)和非随机研究(NRS)。我们仅纳入使用交互式电信类型的研究以及由医护人员提供远程医疗服务的研究。

结局指标

关键指标:流产成功(终止妊娠,无需手术干预即可在流产后42天内完成流产)。重要指标:持续妊娠、输血、住院、急诊就诊、满意度、依从性。

偏倚风险

我们分别使用RoB 2和ROBINS-I工具评估纳入的RCT和NRS中的偏倚风险。

综合方法

两位综述作者(AC和ME)在Covidence中独立筛选和提取数据。我们根据使用电信提供护理的流产阶段(流产前、流产中和流产后)对干预措施进行分组。我们使用GRADE方法对证据的确定性进行分级。

纳入研究

我们纳入了22项研究:6项RCT和16项NRS,共有131278名妊娠12周以内的女性接受药物流产。研究在5个高收入国家和4个中等收入国家进行。由于纳入的NRS之间存在异质性,我们仅对有RCT的比较进行荟萃分析。

结果综合

主要干预措施:流产前至流产后的药物流产远程医疗模式与诊所护理 在这些远程医疗模式中,使用了各种形式的同步和异步电信技术,在流产前至流产后阶段提供护理,直至妊娠12周。任何诊所检查都是为了补充而不是取代流产前阶段的服务提供。9项研究中有5项未将常规超声检查作为资格筛查的一部分。流产前至流产后的远程医疗模式在流产成功方面可能几乎没有差异(RR=0.99,95%CI 0.97至1.01;2项RCT,837名参与者;中等确定性证据)。这一发现得到了NRS结果的支持(Aiken 2021;99%对98%;调整后P值=0.268;7项NRS,83061名参与者;中等确定性证据)。此外,流产前至流产后的远程医疗模式在持续妊娠率方面可能几乎没有差异(Aiken 2021:0.5%对1%;调整后P值=0.268;5项NRS,74269名参与者;中等确定性证据),在输血方面可能几乎没有差异(Aiken 2021:0.02%对0.03%,调整后P值=0.557;5项NRS,83651名参与者;低确定性证据)。干预措施对住院的影响尚不确定(RR=1.45,95%CI 0.24至8.61;2项RCT,846名参与者;极低确定性证据)。这种干预措施在急诊就诊(RR=1.15,95%CI 0.36至3.75;2项RCT,847名参与者;低确定性证据)和满意度(RR=1.01,95%CI 1.00至1.02;2项RCT,832名参与者;低确定性证据)方面可能几乎没有差异,在药物流产方案的依从性方面可能几乎没有差异(RR=0.99,95%CI 0.96至1.02;1项RCT,732名参与者;中等确定性证据)。本综述中未报告死亡病例。子干预措施:药物流产的流产前/流产中远程医疗模式与诊所护理;流产后远程医疗模式与诊所护理 4项NRS将流产前/流产中远程医疗模式与诊所护理进行了比较;所有结局指标的证据确定性都非常低。4项RCT和5项NRS将流产后远程医疗模式与诊所随访进行了比较。流产后远程医疗模式在流产成功方面可能几乎没有差异(RR=1.0,95%CI 0.99至1.01;4项RCT,5069名参与者;中等确定性证据)。它们在持续妊娠方面可能几乎没有差异(RR=0.81,95%CI 0.48至1.36;4项NRS,5069名参与者;低确定性证据),并且可能导致更高的随访程序依从率(RR=1.15,95%CI 1.13至1.18;4项RCT,5235名参与者;中等确定性证据)。流产后远程医疗模式对输血、住院、急诊就诊和满意度的影响尚不确定。

作者结论

流产前至流产后的远程医疗模式在流产成功、持续妊娠和药物流产方案的依从性方面可能几乎没有差异,证据确定性为中等。我们发现低确定性证据表明,这种干预措施在输血率、急诊就诊和满意度方面可能几乎没有差异,但我们不确定其对住院的影响。流产后远程医疗模式可能导致更高的随访程序依从率,证据确定性为中等。我们对研究进行降级主要是由于存在严重的偏倚风险或不精确性,一些结局是罕见事件。总体而言,研究结果表明,与诊所提供的服务相比,早期妊娠药物流产的远程医疗模式在安全性、有效性和可接受性方面可能产生相似的结果。大多数研究在资源丰富的环境中进行,数据仅限于妊娠9周以上的孕周。未来的研究应调查资源较少环境中妊娠9周以上的药物流产远程医疗模式,比较不同类型的电信技术,并评估省略检查(超声、体格检查或血液检查)的模式。

资金来源

注册信息

DOI:10.1002/14651858.CD013764

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f935/12135146/2bc0715900fc/tCD013764-FIG-01.jpg

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