Barnard Sharmani, Kim Caron, Park Min Hae, Ngo Thoai D
Research Monitoring and Evaluation, Marie Stopes International, 1 Conway Street, 4 Fitzroy Square, London, UK, W1T 6LP.
Cochrane Database Syst Rev. 2015 Jul 27;2015(7):CD011242. doi: 10.1002/14651858.CD011242.pub2.
The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system. Training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct first trimester aspiration abortions and manage medical abortions has been proposed as a way to increase women's access to safe abortion procedures.
To assess the safety and effectiveness of abortion procedures administered by mid-level providers compared to doctors.
We searched the CENTRAL Issue 7, MEDLINE and POPLINE databases for comparative studies of doctor and mid-level providers of abortion services. We searched for studies published in any language from January 1980 until 15 August 2014.
Randomised controlled trials (RCTs) (clustered or not clustered), prospective cohort studies or observational studies that compared the safety or effectiveness (or both) of any type of first trimester abortion procedure, administered by any type of mid-level provider or doctors, were eligible for inclusion in the review.
Two independent review authors screened abstracts for eligibility and double-extracted data from the included studies using a pre-tested form. We meta-analysed primary outcome data using both fixed-effect and random-effects models to obtain pooled risk ratios (RR) with 95% confidence intervals (CIs). We carried out separate analyses by study design (RCT or cohort) and type of abortion procedure (medical versus surgical).
Eight studies involving 22,018 participants met our eligibility criteria. Five studies (n = 18,962) assessed the safety and effectiveness of surgical abortion procedures administered by mid-level providers compared to doctors. Three studies (n = 3056) assessed the safety and effectiveness of medical abortion procedures. The surgical abortion studies (one RCT and four cohort studies) were carried out in the United States, India, South Africa and Vietnam. The medical abortion studies (two RCTs and one cohort study) were carried out in India, Sweden and Nepal. The studies included women with gestational ages up to 14 weeks for surgical abortion and nine weeks for medical abortion.Risk of selection bias was considered to be low in the three RCTs, unclear in four observational studies and high in one observational study. Concealment bias was considered to be low in the three RCTs and high in all five observational studies. Although none of the eight studies performed blinding of the participants to the provider type, we considered the performance bias to be low as this is part of the intervention. Detection bias was considered to be high in all eight studies as none of the eight studies preformed blinding of the outcome assessment. Attrition bias was low in seven studies and high in one, with over 20% attrition. We considered six studies to have unclear risk of selective reporting bias as their protocols had not been published. The remaining two studies had published their protocols. Few other sources of bias were found.Based on an analysis of three cohort studies, the risk of surgical abortion failure was significantly higher when provided by mid-level providers than when procedures were administered by doctors (RR 2.25, 95% CI 1.38 to 3.68), however the quality of evidence for this outcome was deemed to be very low. For surgical abortion procedures, we found no significant differences in the risk of complications between mid-level providers and doctors (RR 0.99, 95% CI 0.17 to 5.70 from RCTs; RR 1.38, 95% CI 0.70 to 2.72 from observational studies). When we combined the data for failure and complications for surgical abortion we found no significant differences between mid-level providers and doctors in both the observational study analysis (RR 1.36, 95% CI 0.86 to 2.14) and the RCT analysis (RR 3.07, 95% CI 0.16 to 59.08). The quality of evidence of the outcome for RCT studies was considered to be low and for observational studies very low. For medical abortion procedures the risk of failure was not different for mid-level providers or doctors (RR 0.81, 95% CI 0.48 to 1.36 from RCTs; RR 1.09, 95% CI 0.63 to 1.88 from observational studies). The quality of evidence of this outcome for the RCT analysis was considered to be high, although the quality of evidence of the observational studies was considered to be very low. There were no complications reported in the three medical abortion studies.
AUTHORS' CONCLUSIONS: There was no statistically significant difference in the risk of failure for medical abortions performed by mid-level providers compared with doctors. Observational data indicate that there may be a higher risk of abortion failure for surgical abortion procedures administered by mid-level providers, but the number of studies is small and more robust data from controlled trials are needed. There were no statistically significant differences in the risk of complications for first trimester surgical abortions performed by mid-level providers compared with doctors.
世界卫生组织建议，可在医疗保健系统的最低级别提供堕胎服务。有人提议培训中级医疗服务提供者，如助产士、护士和其他非医生医疗服务提供者，使其能够实施孕早期负压吸宫流产手术并管理药物流产，以此增加妇女获得安全堕胎程序的机会。
评估与医生相比，中级医疗服务提供者实施堕胎手术的安全性和有效性。
我们检索了Cochrane系统评价数据库第7期、医学期刊数据库和人口与健康数据库，以查找有关医生和中级堕胎服务提供者的比较研究。我们检索了1980年1月至2014年8月15日期间以任何语言发表的研究。
随机对照试验（RCTs）（聚类或非聚类）、前瞻性队列研究或观察性研究，比较了由任何类型的中级医疗服务提供者或医生实施的任何类型孕早期堕胎手术的安全性或有效性（或两者），均符合纳入本综述的条件。
两名独立的综述作者筛选摘要以确定其是否符合条件，并使用预先测试的表格从纳入研究中双重提取数据。我们使用固定效应模型和随机效应模型对主要结局数据进行荟萃分析，以获得合并风险比（RR）及95%置信区间（CIs）。我们按研究设计（RCT或队列）和堕胎手术类型（药物流产与手术流产）进行了单独分析。
八项研究涉及22,018名参与者，符合我们的入选标准。五项研究（n = 18,962）评估了与医生相比，中级医疗服务提供者实施手术流产手术的安全性和有效性。三项研究（n = 3056）评估了药物流产的安全性和有效性。手术流产研究（一项RCT和四项队列研究）在美国、印度、南非和越南进行。药物流产研究（两项RCT和一项队列研究）在印度、瑞典和尼泊尔进行。这些研究纳入了孕龄长达14周的手术流产妇女和孕龄长达9周的药物流产妇女。三项RCT的选择偏倚风险被认为较低，四项观察性研究的选择偏倚风险不明确，一项观察性研究的选择偏倚风险较高。三项RCT的隐蔽偏倚被认为较低，所有五项观察性研究的隐蔽偏倚被认为较高。尽管八项研究中没有一项对参与者隐瞒提供者类型，但我们认为执行偏倚较低，因为这是干预措施的一部分。八项研究中的所有研究均被认为检测偏倚较高，因为八项研究中没有一项对结局评估进行盲法处理。七项研究的失访偏倚较低，一项研究的失访偏倚较高，失访率超过20%。我们认为六项研究的选择性报告偏倚风险不明确，因为它们的研究方案未发表。其余两项研究发表了其研究方案。几乎未发现其他偏倚来源。基于三项队列研究的分析，中级医疗服务提供者实施手术流产失败的风险显著高于医生实施手术流产的风险（RR 2.25，95%CI 1.38至3.68），然而该结局的证据质量被认为非常低。对于手术流产手术，我们发现中级医疗服务提供者和医生之间并发症风险没有显著差异（来自RCT的RR 0.99，95%CI 0.17至5.70；来自观察性研究的RR 1.38，95%CI 0.70至2.72）。当我们合并手术流产失败和并发症的数据时，我们发现在观察性研究分析（RR 1.36，95%CI 0.86至2.14）和RCT分析（RR 3.07，95%CI 0.16至59.08）中，中级医疗服务提供者和医生之间均无显著差异。RCT研究结局的证据质量被认为较低，观察性研究结局的证据质量被认为非常低。对于药物流产手术，中级医疗服务提供者和医生的失败风险没有差异（来自RCT的RR 0.81，95%CI 0.48至1.36；来自观察性研究的RR 1.09，95%CI 0.63至1.88）。RCT分析该结局的证据质量被认为较高，尽管观察性研究的证据质量被认为非常低。三项药物流产研究均未报告并发症。
与医生相比，中级医疗服务提供者实施药物流产的失败风险无统计学显著差异。观察性数据表明，中级医疗服务提供者实施手术流产手术的失败风险可能更高，但研究数量较少，需要来自对照试验的更有力数据。与医生相比，中级医疗服务提供者实施孕早期手术流产的并发症风险无统计学显著差异。
