Quality of care, risk management, and technology in obstetrics to reduce hospital-based maternal mortality in Senegal and Mali (QUARITE): a cluster-randomised trial

Quality of care, risk management, and technology in obstetrics to reduce hospital-based maternal mortality in Senegal and Mali (QUARITE): a cluster-randomised trial
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DOI:
10.1016/s0140-6736(13)60593-0
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发表时间:
2013-07-13
期刊:
影响因子:
168.9
通讯作者:
Fraser, William D.
Fraser, William D.
中科院分区:
医学1区
文献类型:
--
作者:
Dumont, Alexandre;Fournier, Pierre;Fraser, William D.

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西非的孕产妇死亡率高于大多数工业化国家,因此开发和验证有效的干预措施至关重要。我们做了一项试验,以评估多方面的干预措施,以促进产妇死亡审查和现场培训的产科急诊转诊医院在塞内加尔和马里的孕产妇死亡率高的影响。方法我们做了一个务实的集群随机对照试验,与医院作为单位的随机化和患者作为单位的分析。46家公立一级和二级转诊医院,每年超过800例分娩,按国家和医院类型分层,并随机分配到干预组(n=23)或无外部干预的对照组(n=23)。所有在基线和干预后期间在每个参与机构分娩的妇女都被纳入其中。干预措施在医院一级实施了两年,包括最初的互动讲习班和每季度面向临床的教育性循证外联访问,重点是孕产妇死亡审查和最佳做法的实施。主要结局是降低住院死亡风险。通过意向治疗进行分析,并依赖于logistic回归模型的广义估计方程扩展,以解释医院内妇女的聚集。该研究在ClinicalTrials.gov注册,编号ISRCTN 46950658。研究结果分析了在参与医院分娩的191167例患者(干预组95931例,对照组95236例)。总体而言,干预医院的死亡率降低显著高于对照医院(比值比[OR] 0.85,95%CI 0.73-0.98,p=0.0299),但这种影响仅限于首都和地区医院,这些医院在本试验中主要作为一级转诊医院。在首都以外的二级转诊(区域)医院中没有影响(OR 1.02,95% CI 0.79-1.31,p=0.89)。无医院失访。全面实施具体行动,以提高干预医院的护理质量。口译训练有素的外部协调员定期访问和现场培训可以为医疗保健专业人员提供知识和信心,以便在审计会议期间提出质量改进建议。孕产妇死亡审查与最佳做法的实施相结合,可有效降低一级转诊医院的住院死亡率。还需要进一步的研究来确定干预措施的益处是否可以推广到二级转诊医院。
Background Maternal mortality is higher in west Africa than in most industrialised countries, so the development and validation of effective interventions is essential. We did a trial to assess the effect of a multifaceted intervention to promote maternity death reviews and onsite training in emergency obstetric care in referral hospitals with high maternal mortality rates in Senegal and Mali.Methods We did a pragmatic cluster-randomised controlled trial, with hospitals as the units of randomisation and patients as the unit of analysis. 46 public first-level and second-level referral hospitals with more than 800 deliveries a year were enrolled, stratified by country and hospital type, and randomly assigned to either the intervention group (n=23) or the control group with no external intervention (n=23). All women who delivered in each of the participating facilities during the baseline and post-intervention periods were included. The intervention, implemented over a period of 2 years at the hospital level, consisted of an initial interactive workshop and quarterly educational clinically-oriented and evidence-based outreach visits focused on maternal death reviews and best practices implementation. The primary outcome was reduction of risk of hospital-based mortality. Analysis was by intention-to-treat and relied on the generalised estimating equations extension of the logistic regression model to account for clustering of women within hospitals. This study is registered with ClinicalTrials.gov, number ISRCTN46950658.Findings 191 167 patients who delivered in the participating hospitals were analysed (95 931 in the intervention groups and 95 236 in the control groups). Overall, mortality reduction in intervention hospitals was significantly higher than in control hospitals (odds ratio [OR] 0.85, 95% CI 0.73-0.98, p=0.0299), but this effect was limited to capital and district hospitals, which mainly acted as first-level referral hospitals in this trial. There was no effect in second-level referral (regional) hospitals outside the capitals (OR 1.02, 95% CI 0.79-1.31, p=0.89). No hospitals were lost to follow-up. Concrete actions were implemented comprehensively to improve quality of care in intervention hospitals.Interpretation Regular visits by a trained external facilitator and onsite training can provide health-care professionals with the knowledge and confidence to make quality improvement suggestions during audit sessions. Maternal death reviews, combined with best practices implementation, are effective in reducing hospital-based mortality in first-level referral hospitals. Further studies are needed to determine whether the benefits of the intervention are generalisable to second-level referral hospitals.