Implementation strategies for WHO guidelines to prevent, detect, and treat postpartum hemorrhage.

IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Cochrane Database of Systematic Reviews Pub Date : 2025-02-26 DOI:10.1002/14651858.CD016223
Katherine Semrau, Ethan Litman, Rose L Molina, Megan Marx Delaney, Leslie Choi, Lindsay Robertson, Anna H Noel-Storr, Jeanne-Marie Guise
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The latest search date was 25 April 2024.</p><p><strong>Eligibility criteria: </strong>We included randomized controlled trials (RCTs), including cluster, pragmatic, and stepped-wedge designs, and non-randomized studies of interventions (NRSIs), including interrupted time series (ITS) studies, controlled before-after (CBA) studies, and follow-up (cohort) studies containing concurrent controls that focused on or described implementation strategies of WHO guidelines for the prevention, detection, and treatment of PPH. Participants were birth attendants and people giving birth in a hospital or healthcare facility. We excluded studies that did not implement a WHO PPH recommendation, had no comparator group, or did not report clinical/implementation outcomes.</p><p><strong>Outcomes: </strong>Our critical outcomes were: adherence to WHO-recommended guidelines for PPH prevention, detection, and treatment; PPH ≥ 500 mL; PPH ≥ 1000 mL; additional uterotonics within 24 hours after birth; blood transfusions; maternal death; severe morbidities (major surgery; admission to intensive care unit [ICU]); and adverse effects (variable and related to the clinical intervention) during hospitalization for birth. Our important outcomes were: breastfeeding at discharge; implementation outcomes such as acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability of the implementation strategy; and health professional outcomes such as knowledge and skill.</p><p><strong>Risk of bias: </strong>We used the RoB 2 and ROBINS-I tools to assess risk of bias in RCTs and NRSIs, respectively.</p><p><strong>Synthesis methods: </strong>Two review authors independently selected studies, performed data extraction, and assessed risk of bias and trustworthiness. Due to the nature of the data, we reported relevant results for each comparison and outcome but did not attempt quantitative synthesis. We used GRADE to assess the certainty of evidence.</p><p><strong>Included studies: </strong>We included 13 studies (9 cluster-RCTs and 4 NRSIs) with a total of 1,027,273 births and more than 4373 birth attendants. The included studies were conducted in 17 different countries. Most trials were conducted in resource-limited settings. None of the included studies reported data on the use of additional uterotonics within 24 hours after birth or adverse effects.</p><p><strong>Synthesis of results: </strong>Single-component implementation strategies versus usual care for PPH prevention, detection, and treatment We do not know if single-component implementation strategies have any effect on adherence to WHO PPH prevention recommendations, PPH ≥ 500 mL, PPH ≥ 1000 mL, or blood transfusion (very low-certainty evidence). Low-certainty evidence suggests that single-component implementation strategies may have little to no effect on maternal death (86,788 births, 3 trials); may increase severe morbidity related to ICU admission (26,985 births, 1 trial); and may reduce severe morbidity related to surgical outcomes (26,985 births, 1 trial). No trials in this comparison measured the effect on adherence to WHO treatment guidelines. Multicomponent implementation strategies versus usual care for PPH prevention, detection, and treatment We do not know if multicomponent implementation strategies have any effect on adherence to WHO PPH treatment recommendations, PPH ≥ 500 mL, blood transfusion, or severe morbidity relating to surgical outcomes (very low-certainty evidence). Multicomponent implementation strategies may have little to no effect on maternal death (274,008 births, 2 trials; low-certainty evidence) compared to usual care. No trials in this comparison measured the effect on adherence to WHO PPH prevention recommendations, PPH ≥ 1000 mL, or severe morbidity (outcomes related to ICU admission). Multicomponent implementation strategies versus enhanced usual care for PPH prevention, detection, and treatment Low-certainty evidence suggests that multicomponent implementation strategies may improve adherence to WHO PPH prevention recommendations (14,718 births, 2 trials) and adherence to WHO PPH treatment recommendations (356,913 births, 2 trials) compared to enhanced usual care. Multicomponent implementation strategies probably have little to no effect on maternal death (224,850 births, 2 trials; moderate-certainty evidence), severe morbidity related to ICU admission (224,850 births, 2 trials; moderate-certainty evidence), and surgical morbidity (210,132 births, 1 trial; moderate-certainty evidence) compared to enhanced usual care. We do not know if multicomponent implementation strategies affect PPH ≥ 500 mL, PPH ≥ 1000 mL, or blood transfusion (very low-certainty evidence).</p><p><strong>Authors' conclusions: </strong>Multicomponent implementation strategies may improve adherence to WHO PPH prevention and treatment recommendations, but they probably result in little to no difference in ICU admissions, surgical morbidity, or maternal death. The majority of available evidence is of low to very low certainty, thus we cannot draw any robust conclusions on the effects of implementation strategies for WHO guidelines to prevent, detect, and treat PPH. While all included studies used the implementation strategy of 'train and educate,' the effects seem to be limited when used as a single strategy. Additional research using pragmatic, hybrid effectiveness-implementation study designs that measure implementation outcomes simultaneously alongside clinical outcomes would be beneficial to understand contextual factors, barriers, and facilitators that affect implementation.</p><p><strong>Funding: </strong>This Cochrane review had no dedicated external funding. Dr Rose Molina, who is employed by Beth Israel Deaconess Medical Center, received funding from Ariadne Labs (Harvard T.H. Chan School of Public Health, Brigham and Women's Hospital) for her time. As a funder, Ariadne Labs had no involvement in the development of the protocol or conduct of the review. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of Ariadne Labs.</p><p><strong>Registration: </strong>Registration: PROSPERO (CRD42024563802) available via https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024563802.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD016223"},"PeriodicalIF":8.8000,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11863301/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cochrane Database of Systematic Reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/14651858.CD016223","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

Abstract

Rationale: Despite World Health Organization (WHO) guidelines for preventing, detecting, and treating postpartum hemorrhage (PPH), effective implementation has lagged.

Objectives: To evaluate the clinical benefits and harms of implementation strategies used to promote adherence to WHO clinical guidelines for the prevention, detection, and treatment of PPH.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and two trial registries, along with reference checking, citation searching, and contact with study authors. The latest search date was 25 April 2024.

Eligibility criteria: We included randomized controlled trials (RCTs), including cluster, pragmatic, and stepped-wedge designs, and non-randomized studies of interventions (NRSIs), including interrupted time series (ITS) studies, controlled before-after (CBA) studies, and follow-up (cohort) studies containing concurrent controls that focused on or described implementation strategies of WHO guidelines for the prevention, detection, and treatment of PPH. Participants were birth attendants and people giving birth in a hospital or healthcare facility. We excluded studies that did not implement a WHO PPH recommendation, had no comparator group, or did not report clinical/implementation outcomes.

Outcomes: Our critical outcomes were: adherence to WHO-recommended guidelines for PPH prevention, detection, and treatment; PPH ≥ 500 mL; PPH ≥ 1000 mL; additional uterotonics within 24 hours after birth; blood transfusions; maternal death; severe morbidities (major surgery; admission to intensive care unit [ICU]); and adverse effects (variable and related to the clinical intervention) during hospitalization for birth. Our important outcomes were: breastfeeding at discharge; implementation outcomes such as acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability of the implementation strategy; and health professional outcomes such as knowledge and skill.

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

Synthesis methods: Two review authors independently selected studies, performed data extraction, and assessed risk of bias and trustworthiness. Due to the nature of the data, we reported relevant results for each comparison and outcome but did not attempt quantitative synthesis. We used GRADE to assess the certainty of evidence.

Included studies: We included 13 studies (9 cluster-RCTs and 4 NRSIs) with a total of 1,027,273 births and more than 4373 birth attendants. The included studies were conducted in 17 different countries. Most trials were conducted in resource-limited settings. None of the included studies reported data on the use of additional uterotonics within 24 hours after birth or adverse effects.

Synthesis of results: Single-component implementation strategies versus usual care for PPH prevention, detection, and treatment We do not know if single-component implementation strategies have any effect on adherence to WHO PPH prevention recommendations, PPH ≥ 500 mL, PPH ≥ 1000 mL, or blood transfusion (very low-certainty evidence). Low-certainty evidence suggests that single-component implementation strategies may have little to no effect on maternal death (86,788 births, 3 trials); may increase severe morbidity related to ICU admission (26,985 births, 1 trial); and may reduce severe morbidity related to surgical outcomes (26,985 births, 1 trial). No trials in this comparison measured the effect on adherence to WHO treatment guidelines. Multicomponent implementation strategies versus usual care for PPH prevention, detection, and treatment We do not know if multicomponent implementation strategies have any effect on adherence to WHO PPH treatment recommendations, PPH ≥ 500 mL, blood transfusion, or severe morbidity relating to surgical outcomes (very low-certainty evidence). Multicomponent implementation strategies may have little to no effect on maternal death (274,008 births, 2 trials; low-certainty evidence) compared to usual care. No trials in this comparison measured the effect on adherence to WHO PPH prevention recommendations, PPH ≥ 1000 mL, or severe morbidity (outcomes related to ICU admission). Multicomponent implementation strategies versus enhanced usual care for PPH prevention, detection, and treatment Low-certainty evidence suggests that multicomponent implementation strategies may improve adherence to WHO PPH prevention recommendations (14,718 births, 2 trials) and adherence to WHO PPH treatment recommendations (356,913 births, 2 trials) compared to enhanced usual care. Multicomponent implementation strategies probably have little to no effect on maternal death (224,850 births, 2 trials; moderate-certainty evidence), severe morbidity related to ICU admission (224,850 births, 2 trials; moderate-certainty evidence), and surgical morbidity (210,132 births, 1 trial; moderate-certainty evidence) compared to enhanced usual care. We do not know if multicomponent implementation strategies affect PPH ≥ 500 mL, PPH ≥ 1000 mL, or blood transfusion (very low-certainty evidence).

Authors' conclusions: Multicomponent implementation strategies may improve adherence to WHO PPH prevention and treatment recommendations, but they probably result in little to no difference in ICU admissions, surgical morbidity, or maternal death. The majority of available evidence is of low to very low certainty, thus we cannot draw any robust conclusions on the effects of implementation strategies for WHO guidelines to prevent, detect, and treat PPH. While all included studies used the implementation strategy of 'train and educate,' the effects seem to be limited when used as a single strategy. Additional research using pragmatic, hybrid effectiveness-implementation study designs that measure implementation outcomes simultaneously alongside clinical outcomes would be beneficial to understand contextual factors, barriers, and facilitators that affect implementation.

Funding: This Cochrane review had no dedicated external funding. Dr Rose Molina, who is employed by Beth Israel Deaconess Medical Center, received funding from Ariadne Labs (Harvard T.H. Chan School of Public Health, Brigham and Women's Hospital) for her time. As a funder, Ariadne Labs had no involvement in the development of the protocol or conduct of the review. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of Ariadne Labs.

Registration: Registration: PROSPERO (CRD42024563802) available via https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024563802.

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世卫组织预防、发现和治疗产后出血指南的实施战略。
理由:尽管世界卫生组织(WHO)制定了预防、检测和治疗产后出血(PPH)的指导方针,但有效实施滞后。目的:评估用于促进遵守世卫组织预防、检测和治疗PPH临床指南的实施战略的临床利弊。检索方法:我们检索了Cochrane中央对照试验注册库(Central)、MEDLINE、Embase、CINAHL和两个试验注册库,同时进行了参考文献检查、引文检索和与研究作者的联系。最近一次搜索日期是2024年4月25日。入选标准:我们纳入了随机对照试验(rct),包括聚类、实用和楔形设计,以及干预措施的非随机研究(NRSIs),包括中断时间序列(ITS)研究、前后对照(CBA)研究和包含并发对照的随访(队列)研究,这些研究关注或描述了世卫组织预防、检测和治疗PPH指南的实施策略。参与者是助产士和在医院或医疗机构分娩的人。我们排除了没有实施WHO PPH推荐、没有比较组或没有报告临床/实施结果的研究。结果:我们的关键结果是:遵守世卫组织推荐的PPH预防、检测和治疗指南;PPH≥500 mL;PPH≥1000 mL;出生后24小时内进行子宫强张;输血;孕产妇死亡;严重的发病率(大手术;入住重症监护病房[ICU]);分娩住院期间的不良反应(可变且与临床干预有关)。我们的重要结果是:出院时母乳喂养;实施结果,例如实施策略的可接受性、采纳度、适当性、可行性、保真度、实施成本、渗透程度和可持续性;健康专业成果,如知识和技能。偏倚风险:我们分别使用rob2和ROBINS-I工具来评估rct和nrsi的偏倚风险。综合方法:两位综述作者独立选择研究,进行数据提取,评估偏倚风险和可信度。由于数据的性质,我们报告了每个比较和结果的相关结果,但没有尝试定量综合。我们使用GRADE来评估证据的确定性。纳入的研究:我们纳入了13项研究(9项集群随机对照试验和4项NRSIs),共1,027,273例分娩和超过4373名助产士。纳入的研究在17个不同的国家进行。大多数试验是在资源有限的环境中进行的。纳入的研究均未报告出生后24小时内额外使用子宫强直剂或不良反应的数据。我们不知道单组分实施策略是否对遵守世卫组织PPH预防建议、PPH≥500 mL、PPH≥1000 mL或输血(极低确定性证据)有任何影响。低确定性证据表明,单一组成部分的实施策略可能对孕产妇死亡几乎没有影响(86,788例分娩,3项试验);可能增加与ICU入院相关的严重发病率(26,985例新生儿,1项试验);并可能降低与手术结果相关的严重发病率(26,985例分娩,1项试验)。在这一比较中,没有试验衡量对遵守世卫组织治疗指南的影响。我们不知道多成分实施策略是否对遵守世卫组织PPH治疗建议、PPH≥500 mL、输血或与手术结果相关的严重发病率(极低确定性证据)有任何影响。多成分实施战略可能对孕产妇死亡影响不大或没有影响(274,008例分娩,2项试验;低确定性证据)与常规护理相比。在这项比较中,没有试验测量对遵守世卫组织PPH预防建议、PPH≥1000 mL或严重发病率(与ICU住院相关的结局)的影响。低确定性证据表明,与增强的常规护理相比,多成分实施策略可以提高对世卫组织PPH预防建议(14,718例分娩,2项试验)和对世卫组织PPH治疗建议(356,913例分娩,2项试验)的依从性。 多成分实施战略可能对孕产妇死亡影响很小或没有影响(224,850例分娩,2项试验;中度确定性证据),重症发病率与ICU入院相关(224,850例出生,2项试验;中等确定性证据)和手术发病率(210,132例新生儿,1项试验;中等确定性证据)与增强的常规护理相比。我们不知道多组分实施策略是否影响PPH≥500 mL、PPH≥1000 mL或输血(非常低确定性的证据)。作者的结论:多成分实施策略可能会提高对世卫组织PPH预防和治疗建议的依从性,但它们可能在ICU入院、手术发病率或孕产妇死亡方面几乎没有差异。大多数现有证据的确定性低至极低,因此我们无法就世卫组织预防、发现和治疗PPH指南实施战略的效果得出任何强有力的结论。虽然所有纳入的研究都使用了“培训和教育”的实施策略,但当作为单一策略使用时,效果似乎有限。使用实用的、混合的有效性-实施研究设计,同时测量实施结果和临床结果,将有助于了解影响实施的背景因素、障碍和促进因素。资助:Cochrane综述没有专门的外部资助。罗斯·莫利纳博士受雇于贝斯以色列女执事医疗中心,获得了阿里阿德涅实验室(哈佛大学公共卫生学院、布里格姆妇女医院)的资助。作为资助者,阿里阿德涅实验室没有参与协议的制定或审查的进行。其中表达的观点和意见是评论作者的观点和意见,并不一定反映阿里阿德涅实验室的观点和意见。报名:报名:普洛斯彼罗(CRD42024563802)可通过https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024563802获得。
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来源期刊
CiteScore
10.60
自引率
2.40%
发文量
173
审稿时长
1-2 weeks
期刊介绍: The Cochrane Database of Systematic Reviews (CDSR) stands as the premier database for systematic reviews in healthcare. It comprises Cochrane Reviews, along with protocols for these reviews, editorials, and supplements. Owned and operated by Cochrane, a worldwide independent network of healthcare stakeholders, the CDSR (ISSN 1469-493X) encompasses a broad spectrum of health-related topics, including health services.
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