Engaging women to set the research agenda for assisted vaginal birth.

INTRODUCTION: Public and patient involvement can provide crucial insights to optimise research by enhancing relevance and appropriateness of studies. The World Health Organization (WHO) engaged in an inclusive process to ensure that both technical experts and women had a voice in defining the research gaps and needs to increase or reintroduce the use of assisted vaginal birth (AVB) in settings where this intervention is needed but unavailable or underused. METHODS: We describe the methods and outcomes of online workshops led by WHO to obtain women representatives' perspectives about AVB research gaps and needs. RESULTS: After technical experts created a list of research questions based on various evidence syntheses, WHO organised four online workshops with 31 women's representatives from 27 mostly low- and middle-income (LMIC) countries. Women rated the importance and priority of the research questions proposed by the technical experts, improving and broadening some of them, added new questions, and voiced their main concerns and views about AVB. Women helped to put the research questions into context in their communities, highlighted neglected factors/dimensions that influence practices and affect women's experience during labour and childbirth, underscored less salient consequences of AVB, and highlighted the main concerns of women about research on AVB. The consolidated vision of technical experts and women's representatives resulted in a technical brief published by WHO. The technical brief is expected to stimulate global research and action closely aligned with women's priorities. CONCLUSIONS: We describe a successful experience of engaging women, mostly from LMICs, in the identification of research gaps and needs to reintroduce AVB use. This process contributed to better aligning research questions with women's views, concerns, and priorities. Given the scarcity of reports about engaging women from LMICs to optimise research, this successful experience can serve as an inspiration for future work. PATIENT OR PUBLIC CONTRIBUTION: Women representatives were involved at every stage of the workshops described in full in this manuscript.

A research agenda to improve incidence and outcomes of assisted vaginal birth.

Access to emergency obstetric care, including assisted vaginal birth and caesarean birth, is crucial for improving maternal and childbirth outcomes. However, although the proportion of births by caesarean section has increased during the last few decades, the use of assisted vaginal birth has declined. This is particularly the case in low- and middle-income countries, despite an assisted vaginal birth often being less risky than caesarean birth. We therefore conducted a three-step process to identify a research agenda necessary to increase the use of, or reintroduce, assisted vaginal birth: after conducting an evidence synthesis, which informed a consultation with technical experts who proposed an initial research agenda, we sought and incorporated the views of women's representatives of this agenda. This process has allowed us to identify a comprehensive research agenda, with topics categorized as: (i) the need to understand women's perceptions of assisted vaginal birth, and provide appropriate and reliable information; (ii) the importance of training health-care providers in clinical skills but also in respectful care, effective communication, shared decision-making and informed consent; and (iii) the barriers to and facilitators of implementation and sustainability. From women's feedback, we learned of the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if necessary. The promotion and/or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth.

L'accès aux soins obstétriques d'urgence, y compris l'accouchement vaginal assisté et la césarienne, est essentiel pour améliorer les effets de la maternité et de l'accouchement. Toutefois, bien que la proportion de césariennes ait augmenté ces dernières décennies, le recours à l'accouchement vaginal assisté a diminué. C'est particulièrement le cas dans les pays à revenu faible ou intermédiaire, bien que l'accouchement vaginal assisté soit souvent moins risqué qu'une césarienne. Nous avons donc mené un processus en trois étapes afin d'imaginer un programme de recherche qui permettrait d'augmenter le recours à l'accouchement vaginal assisté ou de le réintroduire. Après avoir réalisé une synthèse des données probantes, qui a servi de base à une consultation avec des experts techniques qui ont proposé un programme de recherche initial, nous avons sollicité et incorporé les avis des représentantes des femmes pour ce programme. Ce processus nous a permis d'imaginer un programme de recherche complet, avec des sujets classés comme suit: (i) la nécessité de comprendre la perception qu'ont les femmes de l'accouchement vaginal assisté et de fournir des informations appropriées et fiables; (ii) l'importance de la formation des prestataires de soins de santé en matière de compétences cliniques, mais aussi de respect dans les soins de santé, de communication efficace, de prise de décision partagée et de consentement éclairé; ou (iii) les obstacles à la mise en œuvre et à la durabilité et les facteurs qui les facilitent. Les réactions de femmes nous ont appris qu'il était urgent de reconnaître que l'accouchement, la naissance et le post-partum sont des processus humains intrinsèquement physiologiques et dignes au cours desquels les interventions ne devraient être mises en œuvre qu'en cas de nécessité. La promotion et/ou la réintroduction de l'accouchement vaginal assisté dans les régions à faibles ressources nécessitent que les pouvoirs publics, les décideurs politiques et les administrations d'hôpitaux soutiennent les prestataires de soins de santé qualifiés, qui pourront à leur tour soutenir respectueusement les femmes pendant l'accouchement.

El acceso a la atención obstétrica de emergencia, incluido el parto vaginal asistido y el parto por cesárea, es crucial para mejorar los resultados de la maternidad y el parto. No obstante, aunque el porcentaje de partos por cesárea ha aumentado en las últimas décadas, el uso del parto vaginal asistido ha disminuido. Esto ocurre especialmente en los países de ingresos bajos y medios, a pesar de que un parto vaginal asistido suele ser menos arriesgado que un parto por cesárea. Por lo tanto, llevamos a cabo un proceso de tres pasos para identificar un programa de investigación necesario para aumentar el uso del parto vaginal asistido o volver a incorporarlo: tras realizar una síntesis de la evidencia, que sirvió de base para una consulta con expertos técnicos que propusieron un programa de investigación inicial, buscamos e integramos las opiniones de las representantes de las mujeres sobre este programa. Este proceso nos ha permitido identificar un programa de investigación exhaustivo, con temas categorizados como: (i) la necesidad de comprender las percepciones de las mujeres sobre el parto vaginal asistido, y proporcionar información adecuada y fiable; (ii) la importancia de formar a los profesionales sanitarios en habilidades clínicas, pero también en atención respetuosa, comunicación efectiva, toma de decisiones compartida y consentimiento informado; o (iii) las barreras y los facilitadores de la implementación y la sostenibilidad. A partir de las opiniones de las mujeres, nos enteramos de la urgente necesidad de reconocer las experiencias del parto, el alumbramiento y el posparto como procesos humanos inherentemente fisiológicos y dignos, en los que las intervenciones solo deben aplicarse si son necesarias. La promoción o la reincoporación del parto vaginal asistido en regiones de escasos recursos exige que los gobiernos, los responsables de formular políticas y los administradores de hospitales apoyen a los profesionales sanitarios capacitados que, a su vez, pueden ayudar a las mujeres en el trabajo de parto y el alumbramiento de manera respetuosa.

Educational interventions targeting pregnant women to optimise the use of caesarean section: What are the essential elements? A qualitative comparative analysis.

BACKGROUND: Caesarean section (CS) rates are increasing globally, posing risks to women and babies. To reduce CS, educational interventions targeting pregnant women have been implemented globally, however, their effectiveness is varied. To optimise benefits of these interventions, it is important to understand which intervention components influence success. In this study, we aimed to identify essential intervention components that lead to successful implementation of interventions focusing on pregnant women to optimise CS use. METHODS: We re-analysed existing systematic reviews that were used to develop and update WHO guidelines on non-clinical interventions to optimise CS. To identify if certain combinations of intervention components (e.g., how the intervention was delivered, and contextual characteristics) are associated with successful implementation, we conducted a Qualitative Comparative Analysis (QCA). We defined successful interventions as interventions that were able to reduce CS rates. We included 36 papers, comprising 17 CS intervention studies and an additional 19 sibling studies (e.g., secondary analyses, process evaluations) reporting on these interventions to identify intervention components. We conducted QCA in six stages: 1) Identifying conditions and calibrating the data; 2) Constructing truth tables, 3) Checking quality of truth tables; 4) Identifying parsimonious configurations through Boolean minimization; 5) Checking quality of the solution; 6) Interpretation of solutions. We used existing published qualitative evidence synthesis to develop potential theories driving intervention success. RESULTS: We found successful interventions were those that leveraged social or peer support through group-based intervention delivery, provided communication materials to women, encouraged emotional support by partner or family participation, and gave women opportunities to interact with health providers. Unsuccessful interventions were characterised by the absence of at least two of these components. CONCLUSION: We identified four key essential intervention components which can lead to successful interventions targeting women to reduce CS. These four components are 1) group-based delivery, 2) provision of IEC materials, 3) partner or family member involvement, and 4) opportunity for women to interact with health providers. Maternal health services and hospitals aiming to better prepare women for vaginal birth and reduce CS can consider including the identified components to optimise health and well-being benefits for the woman and baby.

Interventions targeting healthcare providers to optimise use of caesarean section: a qualitative comparative analysis to identify important intervention features.

BACKGROUND: Rapid increases in caesarean section (CS) rates have been observed globally; however, CS rates exceeding 15% at a population-level have limited benefits for women and babies. Many interventions targeting healthcare providers have been developed to optimise use of CS, typically aiming to improve and monitor clinical decision-making. However, interventions are often complex, and effectiveness is varied. Understanding intervention and implementation features that likely lead to optimised CS use is important to optimise benefits. The aim of this study was to identify important components that lead to successful interventions to optimise CS, focusing on interventions targeting healthcare providers.  METHODS: We used Qualitative Comparative Analysis (QCA) to identify if certain combination of important intervention features (e.g. type of intervention, contextual characteristics, and how the intervention was delivered) are associated with a successful intervention as reflected in a reduction of CS. We included 21 intervention studies targeting healthcare providers to reduce CS, comprising of 34 papers reporting on these interventions. To develop potential theories driving intervention success, we used existing published qualitative evidence syntheses on healthcare providers' perspectives and experiences of interventions targeted at them to reduce CS. RESULTS: We identified five important components that trigger successful interventions targeting healthcare providers: 1) training to improve providers' knowledge and skills, 2) active dissemination of CS indications, 3) actionable recommendations, 4) multidisciplinary collaboration, and 5) providers' willingness to change. Importantly, when one or more of these components are absent, dictated nature of intervention, where providers are enforced to adhere to the intervention, is needed to prompt successful interventions. Unsuccessful interventions were characterised by the absence of these components. CONCLUSION: We identified five important intervention components and combinations of intervention components which can lead to successful interventions targeting healthcare providers to optimise CS use. Health facility managers, researchers, and policy-makers aiming to improve providers' clinical decision making and reduce CS may consider including the identified components to optimise benefits.

Prevalence of and reasons for women's, family members', and health professionals' preferences for cesarean section in Iran: a mixed-methods systematic review.

BACKGROUND: Cesarean section (CS) rates have been increasing globally. Iran has one of the highest CS rates in the world (47.9%). This review was conducted to assess the prevalence of and reasons for women's, family members', and health professionals' preferences for CS in Iran. METHODS AND FINDINGS: In this mixed-methods systematic review, we searched MEDLINE/PubMed, Embase, CINAHL, POPLINE, PsycINFO, Global Health Library, Google scholar; as well as Iranian scientific databases including SID, and Magiran from 1 January 1990 to 8th October 2019. Primary quantitative, qualitative, and mixed-methods studies that had been conducted in Iran with Persian or English languages were included. Meta-analysis of quantitative studies was conducted by extracting data from 65 cross-sectional, longitudinal, and baseline measurements of interventional studies. For meta-synthesis, we used 26 qualitative studies with designs such as ethnography, phenomenology, case studies, and grounded theory. The Review Manager Version 5.3 and the Comprehensive Meta-Analysis (CMA) software were used for meta-analysis and meta-regression analysis. Results showed that 5.46% of nulliparous women (95% CI 5.38-5.50%; χ2 = 1117.39; df = 28 [p < 0.00001]; I2 = 97%) preferred a CS mode of delivery. Results of subgroup analysis based on the time of pregnancy showed that proportions of preference for CS reported by women were 5.94% (95% CI 5.86-5.99%) in early and middle pregnancy, and 3.81% (95% CI 3.74-3.83%), in late pregnancy. The heterogeneity was high in this review. Most women were pregnant, regardless of their parity; the risk level of participants were unknown, and some Persian publications were appraised as low in quality. A combined inductive and deductive approach was used to synthesis the qualitative data, and CERQual was used to assess confidence in the findings. Meta-synthesis generated 10 emerging themes and three final themes: 'Women's factors', 'Health professional factors', andex 'Health organization, facility, or system factors'. CONCLUSION: Despite low preference for CS among women, CS rates are still so high. This implies the role of factors beyond the individual will. We identified a multiple individual, health facility, and health system factors which affected the preference for CS in Iran. Numerous attempts were made in recent years to design, test and implement interventions to decrease unnecessary CS in Iran, such as mother-friendly hospitals, standard protocols for labor and birth, preparation classes for women, midwives, and gynaecologists, and workshops for specialists and midwives through the "health sector evolution policy". Although these programs were effective, high rates of CS persist and more efforts are needed to optimize the use of CS.

Reducing unnecessary caesarean sections: scoping review of financial and regulatory interventions.

BACKGROUND: Caesarean sections (CS) are increasing worldwide. Financial incentives and related regulatory and legislative factors are important determinants of CS rates. This scoping review examines the evidence base of financial, regulatory and legislative interventions intended to reduce CS rates. METHODS: We searched MEDLINE, EMBASE, CINAHL and two trials registers in June 2019. Both experimental and observational intervention studies were eligible for inclusion. Primary outcome measures were: CS, spontaneous vaginal and instrumental birth rates. We assessed quality of evidence using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. RESULTS: We identified 9057 articles and assessed 65 full-texts. We included 16 observational studies. Most of the studies were conducted in high-income countries. Three studies assessed payment methods for health workers: equalising physician fees for vaginal and caesarean delivery reduced CS rates in one study; however, little or no difference in CS rates was found in the remaining two studies. Nine studies assessed payment methods for health organisations: There was no difference in CS rates between diagnosis-related group (DRG) payment system compared to fee-for-service system in one study. However, DRG system was associated with lower odds for CS in another study. There was little or no difference in CS rates following implementation of global budget payment (GBP) system in two studies. Vaginal birth after caesarean section (VBAC) increased after implementation of a case-based payment system in one study. Caesarean section increased while VBAC rates decreased following implementation of a cap-based payment system in another study. Financial incentive for providers to promote vaginal delivery combined with free vaginal delivery policy was found to reduce CS rates in one study. Studied regulatory and legislative interventions (comprising legislatively imposed practice guidelines for physicians in one study and multi-faceted strategy which included policies to control CS on maternal request in another study) were found to reduce CS rates. The GRADE quality of evidence varied from very low to low. CONCLUSIONS: Available evidence on the effects of financial and regulatory strategies intended to reduce unnecessary CS is inconclusive given inconsistency in effects and low quality of the available evidence. More rigorous studies are needed.

Interventions to reduce unnecessary caesarean sections in healthy women and babies.

Optimising the use of caesarean section (CS) is of global concern. Underuse leads to maternal and perinatal mortality and morbidity. Conversely, overuse of CS has not shown benefits and can create harm. Worldwide, the frequency of CS continues to increase, and interventions to reduce unnecessary CSs have shown little success. Identifying the underlying factors for the continuing increase in CS use could improve the efficacy of interventions. In this Series paper, we describe the factors for CS use that are associated with women, families, health professionals, and health-care organisations and systems, and we examine behavioural, psychosocial, health system, and financial factors. We also outline the type and effects of interventions to reduce CS use that have been investigated. Clinical interventions, such as external cephalic version for breech delivery at term, vaginal breech delivery in appropriately selected women, and vaginal birth after CS, could reduce the frequency of CS use. Approaches such as labour companionship and midwife-led care have been associated with higher proportions of physiological births, safer outcomes, and lower health-care costs relative to control groups without these interventions, and with positive maternal experiences, in high-income countries. Such approaches need to be assessed in middle-income and low-income countries. Educational interventions for women should be complemented with meaningful dialogue with health professionals and effective emotional support for women and families. Investing in the training of health professionals, eliminating financial incentives for CS use, and reducing fear of litigation is fundamental. Safe, private, welcoming, and adequately resourced facilities are needed. At the country level, effective medical leadership is essential to ensure CS is used only when indicated. We conclude that interventions to reduce overuse must be multicomponent and locally tailored, addressing women's and health professionals' concerns, as well as health system and financial factors.

Optimising the use of caesarean section: a generic formative research protocol for implementation preparation.

BACKGROUND: Caesarean section rates are rising across all geographical regions. Very high rates for some groups of women co-occur with very low rates for others. Both extremes are associated with short and longer term harms. This is a major public health concern. Making the most effective use of caesarean section is a critical component of good quality, sustainable maternity care. In 2018, the World Health Organization published evidence-based recommendations on non-clinical interventions to reduce unnecessary caesarean section. The guideline identified critical research gaps and called for formative research to be conducted ahead of any interventional research to define locally relevant determinants of caesarean birth and factors that may affect implementation of multifaceted optimisation strategies. This generic formative research protocol is designed as a guide for contextual assessment and understanding for anyone planning to take action to optimise the use of caesarean section. METHODS: This formative protocol has three main components: (1) document review; (2) readiness assessment; and (3) primary qualitative research with women, healthcare providers and administrators. The document review and readiness assessment include tools for local mapping of policies, protocols, practices and organisation of care to describe and assess the service context ahead of implementation. The qualitative research is organized according to twelve identified interventions that may optimise use of caesarean section. Each intervention is designed as a "module" and includes a description of the intervention, supporting evidence, theory of change, and in-depth interview/focus group discussion guides. All study instruments are included in this protocol. DISCUSSION: This generic protocol is designed to underpin the formative stage of implementation research relating to optimal use of caesarean section. We encourage researchers, policy-makers and ministries of health to adapt and adopt this design to their context, and share their findings as a catalyst for rapid uptake of what works.

Non-clinical interventions for reducing unnecessary caesarean section.

BACKGROUND: Caesarean section rates are increasing globally. The factors contributing to this increase are complex, and identifying interventions to address them is challenging. Non-clinical interventions are applied independently of a clinical encounter between a health provider and a patient. Such interventions may target women, health professionals or organisations. They address the determinants of caesarean births and could have a role in reducing unnecessary caesarean sections. This review was first published in 2011. This review update will inform a new WHO guideline, and the scope of the update was informed by WHO's Guideline Development Group for this guideline. OBJECTIVES: To evaluate the effectiveness and safety of non-clinical interventions intended to reduce unnecessary caesarean section. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers in March 2018. We also searched websites of relevant organisations and reference lists of related reviews. SELECTION CRITERIA: Randomised trials, non-randomised trials, controlled before-after studies, interrupted time series studies and repeated measures studies were eligible for inclusion. The primary outcome measures were: caesarean section, spontaneous vaginal birth and instrumental birth. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures recommended by Cochrane. We narratively described results of individual studies (drawing summarised evidence from single studies assessing distinct interventions). MAIN RESULTS: We included 29 studies in this review (19 randomised trials, 1 controlled before-after study and 9 interrupted time series studies). Most of the studies (20 studies) were conducted in high-income countries and none took place in low-income countries. The studies enrolled a mixed population of pregnant women, including nulliparous women, multiparous women, women with a fear of childbirth, women with high levels of anxiety and women having undergone a previous caesarean section.Overall, we found low-, moderate- or high-certainty evidence that the following interventions have a beneficial effect on at least one primary outcome measure and no moderate- or high-certainty evidence of adverse effects.Interventions targeted at women or familiesChildbirth training workshops for mothers alone may reduce caesarean section (risk ratio (RR) 0.55, 95% confidence interval (CI) 0.33 to 0.89) and may increase spontaneous vaginal birth (RR 2.25, 95% CI 1.16 to 4.36). Childbirth training workshops for couples may reduce caesarean section (RR 0.59, 95% CI 0.37 to 0.94) and may increase spontaneous vaginal birth (RR 2.13, 95% CI 1.09 to 4.16). We judged this one study with 60 participants to have low-certainty evidence for the outcomes above.Nurse-led applied relaxation training programmes (RR 0.22, 95% CI 0.11 to 0.43; 104 participants, low-certainty evidence) and psychosocial couple-based prevention programmes (RR 0.53, 95% CI 0.32 to 0.90; 147 participants, low-certainty evidence) may reduce caesarean section. Psychoeducation may increase spontaneous vaginal birth (RR 1.33, 95% CI 1.11 to 1.61; 371 participants, low-certainty evidence). The control group received routine maternity care in all studies.There were insufficient data on the effect of the four interventions on maternal and neonatal mortality or morbidity.Interventions targeted at healthcare professionalsImplementation of clinical practice guidelines combined with mandatory second opinion for caesarean section indication slightly reduces the risk of overall caesarean section (mean difference in rate change -1.9%, 95% CI -3.8 to -0.1; 149,223 participants). Implementation of clinical practice guidelines combined with audit and feedback also slightly reduces the risk of caesarean section (risk difference (RD) -1.8%, 95% CI -3.8 to -0.2; 105,351 participants). Physician education by local opinion leader (obstetrician-gynaecologist) reduced the risk of elective caesarean section to 53.7% from 66.8% (opinion leader education: 53.7%, 95% CI 46.5 to 61.0%; control: 66.8%, 95% CI 61.7 to 72.0%; 2496 participants). Healthcare professionals in the control groups received routine care in the studies. There was little or no difference in maternal and neonatal mortality or morbidity between study groups. We judged the certainty of evidence to be high.Interventions targeted at healthcare organisations or facilitiesCollaborative midwifery-labourist care (in which the obstetrician provides in-house labour and delivery coverage, 24 hours a day, without competing clinical duties), versus a private practice model of care, may reduce the primary caesarean section rate. In one interrupted time series study, the caesarean section rate decreased by 7% in the year after the intervention, and by 1.7% per year thereafter (1722 participants); the vaginal birth rate after caesarean section increased from 13.3% before to 22.4% after the intervention (684 participants). Maternal and neonatal mortality were not reported. We judged the certainty of evidence to be low.We studied the following interventions, and they either made little or no difference to caesarean section rates or had uncertain effects.Moderate-certainty evidence suggests little or no difference in caesarean section rates between usual care and: antenatal education programmes for physiologic childbirth; antenatal education on natural childbirth preparation with training in breathing and relaxation techniques; computer-based decision aids; individualised prenatal education and support programmes (versus written information in pamphlet).Low-certainty evidence suggests little or no difference in caesarean section rates between usual care and: psychoeducation; pelvic floor muscle training exercises with telephone follow-up (versus pelvic floor muscle training without telephone follow-up); intensive group therapy (cognitive behavioural therapy and childbirth psychotherapy); education of public health nurses on childbirth classes; role play (versus standard education using lectures); interactive decision aids (versus educational brochures); labourist model of obstetric care (versus traditional model of obstetric care).We are very uncertain as to the effect of other interventions identified on caesarean section rates as the certainty of the evidence is very low. AUTHORS' CONCLUSIONS: We evaluated a wide range of non-clinical interventions to reduce unnecessary caesarean section, mostly in high-income settings. Few interventions with moderate- or high-certainty evidence, mainly targeting healthcare professionals (implementation of guidelines combined with mandatory second opinion, implementation of guidelines combined with audit and feedback, physician education by local opinion leader) have been shown to safely reduce caesarean section rates. There are uncertainties in existing evidence related to very-low or low-certainty evidence, applicability of interventions and lack of studies, particularly around interventions targeted at women or families and healthcare organisations or facilities.

A comparative evaluation of PDQ-Evidence.

BACKGROUND: A strategy for minimising the time and obstacles to accessing systematic reviews of health system evidence is to collect them in a freely available database and make them easy to find through a simple 'Google-style' search interface. PDQ-Evidence was developed in this way. The objective of this study was to compare PDQ-Evidence to six other databases, namely Cochrane Library, EVIPNet VHL, Google Scholar, Health Systems Evidence, PubMed and Trip. METHODS: We recruited healthcare policy-makers, managers and health researchers in low-, middle- and high-income countries. Participants selected one of six pre-determined questions. They searched for a systematic review that addressed the chosen question and one question of their own in PDQ-Evidence and in two of the other six databases which they would normally have searched. We randomly allocated participants to search PDQ-Evidence first or to search the two other databases first. The primary outcomes were whether a systematic review was found and the time taken to find it. Secondary outcomes were perceived ease of use and perceived time spent searching. We asked open-ended questions about PDQ-Evidence, including likes, dislikes, challenges and suggestions for improvements. RESULTS: A total of 89 people from 21 countries completed the study; 83 were included in the primary analyses and 6 were excluded because of data errors that could not be corrected. Most participants chose PubMed and Cochrane Library as the other two databases. Participants were more likely to find a systematic review using PDQ-Evidence than using Cochrane Library or PubMed for the pre-defined questions. For their own questions, this difference was not found. Overall, it took slightly less time to find a systematic review using PDQ-Evidence. Participants perceived that it took less time, and most participants perceived PDQ-Evidence to be slightly easier to use than the two other databases. However, there were conflicting views about the design of PDQ-Evidence. CONCLUSIONS: PDQ-Evidence is at least as efficient as other databases for finding health system evidence. However, using PDQ-Evidence is not intuitive for some people. TRIAL REGISTRATION: The trial was prospectively registered in the ISRCTN registry 17 April 2015. Registration number: ISRCTN12742235 .

Financial arrangements for health systems in low-income countries: an overview of systematic reviews.

BACKGROUND: One target of the Sustainable Development Goals is to achieve "universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all". A fundamental concern of governments in striving for this goal is how to finance such a health system. This concern is very relevant for low-income countries. OBJECTIVES: To provide an overview of the evidence from up-to-date systematic reviews about the effects of financial arrangements for health systems in low-income countries. Secondary objectives include identifying needs and priorities for future evaluations and systematic reviews on financial arrangements, and informing refinements in the framework for financial arrangements presented in the overview. METHODS: We searched Health Systems Evidence in November 2010 and PDQ-Evidence up to 17 December 2016 for systematic reviews. We did not apply any date, language, or publication status limitations in the searches. We included well-conducted systematic reviews of studies that assessed the effects of financial arrangements on patient outcomes (health and health behaviours), the quality or utilisation of healthcare services, resource use, healthcare provider outcomes (such as sick leave), or social outcomes (such as poverty, employment, or financial burden of patients, e.g. out-of-pocket payment, catastrophic disease expenditure) and that were published after April 2005. We excluded reviews with limitations important enough to compromise the reliability of the findings. Two overview authors independently screened reviews, extracted data, and assessed the certainty of evidence using GRADE. We prepared SUPPORT Summaries for eligible reviews, including key messages, 'Summary of findings' tables (using GRADE to assess the certainty of the evidence), and assessments of the relevance of findings to low-income countries. MAIN RESULTS: We identified 7272 reviews and included 15 in this overview, on: collection of funds (2 reviews), insurance schemes (1 review), purchasing of services (1 review), recipient incentives (6 reviews), and provider incentives (5 reviews). The reviews were published between 2008 and 2015; focused on 13 subcategories; and reported results from 276 studies: 115 (42%) randomised trials, 11 (4%) non-randomised trials, 23 (8%) controlled before-after studies, 51 (19%) interrupted time series, 9 (3%) repeated measures, and 67 (24%) other non-randomised studies. Forty-three per cent (119/276) of the studies included in the reviews took place in low- and middle-income countries. Collection of funds: the effects of changes in user fees on utilisation and equity are uncertain (very low-certainty evidence). It is also uncertain whether aid delivered under the Paris Principles (ownership, alignment, harmonisation, managing for results, and mutual accountability) improves health outcomes compared to aid delivered without conforming to those principles (very low-certainty evidence). Insurance schemes: community-based health insurance may increase service utilisation (low-certainty evidence), but the effects on health outcomes are uncertain (very low-certainty evidence). It is uncertain whether social health insurance improves utilisation of health services or health outcomes (very low-certainty evidence). Purchasing of services: it is uncertain whether increasing salaries of public sector healthcare workers improves the quantity or quality of their work (very low-certainty evidence). Recipient incentives: recipient incentives may improve adherence to long-term treatments (low-certainty evidence), but it is uncertain whether they improve patient outcomes. One-time recipient incentives probably improve patient return for start or continuation of treatment (moderate-certainty evidence) and may improve return for tuberculosis test readings (low-certainty evidence). However, incentives may not improve completion of tuberculosis prophylaxis, and it is uncertain whether they improve completion of treatment for active tuberculosis. Conditional cash transfer programmes probably lead to an increase in service utilisation (moderate-certainty evidence), but their effects on health outcomes are uncertain. Vouchers may improve health service utilisation (low-certainty evidence), but the effects on health outcomes are uncertain (very low-certainty evidence). Introducing a restrictive cap may decrease use of medicines for symptomatic conditions and overall use of medicines, may decrease insurers' expenditures on medicines (low-certainty evidence), and has uncertain effects on emergency department use, hospitalisations, and use of outpatient care (very low-certainty evidence). Reference pricing, maximum pricing, and index pricing for drugs have mixed effects on drug expenditures by patients and insurers as well as the use of brand and generic drugs. Provider incentives: the effects of provider incentives are uncertain (very low-certainty evidence), including: the effects of provider incentives on the quality of care provided by primary care physicians or outpatient referrals from primary to secondary care, incentives for recruiting and retaining health professionals to serve in remote areas, and the effects of pay-for-performance on provider performance, the utilisation of services, patient outcomes, or resource use in low-income countries. AUTHORS' CONCLUSIONS: Research based on sound systematic review methods has evaluated numerous financial arrangements relevant to low-income countries, targeting different levels of the health systems and assessing diverse outcomes. However, included reviews rarely reported social outcomes, resource use, equity impacts, or undesirable effects. We also identified gaps in primary research because of uncertainty about applicability of the evidence to low-income countries. Financial arrangements for which the effects are uncertain include external funding (aid), caps and co-payments, pay-for-performance, and provider incentives. Further studies evaluating the effects of these arrangements are needed in low-income countries. Systematic reviews should include all outcomes that are relevant to decision-makers and to people affected by changes in financial arrangements.

Governance arrangements for health systems in low-income countries: an overview of systematic reviews.

BACKGROUND: Governance arrangements include changes in rules or processes that determine authority and accountability for health policies, organisations, commercial products and health professionals, as well as the involvement of stakeholders in decision-making. Changes in governance arrangements can affect health and related goals in numerous ways, generally through changes in authority, accountability, openness, participation and coherence. A broad overview of the findings of systematic reviews can help policymakers, their technical support staff and other stakeholders to identify strategies for addressing problems and improving the governance of their health systems. OBJECTIVES: To provide an overview of the available evidence from up-to-date systematic reviews about the effects of governance arrangements for health systems in low-income countries. Secondary objectives include identifying needs and priorities for future evaluations and systematic reviews on governance arrangements and informing refinements of the framework for governance arrangements outlined in the overview. METHODS: We searched Health Systems Evidence in November 2010 and PDQ Evidence up to 17 December 2016 for systematic reviews. We did not apply any date, language or publication status limitations in the searches. We included well-conducted systematic reviews of studies that assessed the effects of governance arrangements on patient outcomes (health and health behaviours), the quality or utilisation of healthcare services, resource use (health expenditures, healthcare provider costs, out-of-pocket payments, cost-effectiveness), healthcare provider outcomes (such as sick leave), or social outcomes (such as poverty, employment) and that were published after April 2005. We excluded reviews with limitations that were important enough to compromise the reliability of the findings of the review. Two overview authors independently screened reviews, extracted data and assessed the certainty of evidence using GRADE. We prepared SUPPORT Summaries for eligible reviews, including key messages, 'Summary of findings' tables (using GRADE to assess the certainty of the evidence) and assessments of the relevance of findings to low-income countries. MAIN RESULTS: We identified 7272 systematic reviews and included 21 of them in this overview (19 primary reviews and 2 supplementary reviews). We focus here on the results of the 19 primary reviews, one of which had important methodological limitations. The other 18 were reliable (with only minor limitations).We grouped the governance arrangements addressed in the reviews into five categories: authority and accountability for health policies (three reviews); authority and accountability for organisations (two reviews); authority and accountability for commercial products (three reviews); authority and accountability for health professionals (seven reviews); and stakeholder involvement (four reviews).Overall, we found desirable effects for the following interventions on at least one outcome, with moderate- or high-certainty evidence and no moderate- or high-certainty evidence of undesirable effects. Decision-making about what is covered by health insurance- Placing restrictions on the medicines reimbursed by health insurance systems probably decreases the use of and spending on these medicines (moderate-certainty evidence). Stakeholder participation in policy and organisational decisions- Participatory learning and action groups for women probably improve newborn survival (moderate-certainty evidence).- Consumer involvement in preparing patient information probably improves the quality of the information and patient knowledge (moderate-certainty evidence). Disclosing performance information to patients and the public- Disclosing performance data on hospital quality to the public probably encourages hospitals to implement quality improvement activities (moderate-certainty evidence).- Disclosing performance data on individual healthcare providers to the public probably leads people to select providers that have better quality ratings (moderate-certainty evidence). AUTHORS' CONCLUSIONS: Investigators have evaluated a wide range of governance arrangements that are relevant for low-income countries using sound systematic review methods. These strategies have been targeted at different levels in health systems, and studies have assessed a range of outcomes. Moderate-certainty evidence shows desirable effects (with no undesirable effects) for some interventions. However, there are important gaps in the availability of systematic reviews and primary studies for the all of the main categories of governance arrangements.

Implementation strategies for health systems in low-income countries: an overview of systematic reviews.

BACKGROUND: A key function of health systems is implementing interventions to improve health, but coverage of essential health interventions remains low in low-income countries. Implementing interventions can be challenging, particularly if it entails complex changes in clinical routines; in collaborative patterns among different healthcare providers and disciplines; in the behaviour of providers, patients or other stakeholders; or in the organisation of care. Decision-makers may use a range of strategies to implement health interventions, and these choices should be based on evidence of the strategies' effectiveness. OBJECTIVES: To provide an overview of the available evidence from up-to-date systematic reviews about the effects of implementation strategies for health systems in low-income countries. Secondary objectives include identifying needs and priorities for future evaluations and systematic reviews on alternative implementation strategies and informing refinements of the framework for implementation strategies presented in the overview. METHODS: We searched Health Systems Evidence in November 2010 and PDQ-Evidence up to December 2016 for systematic reviews. We did not apply any date, language or publication status limitations in the searches. We included well-conducted systematic reviews of studies that assessed the effects of implementation strategies on professional practice and patient outcomes and that were published after April 2005. We excluded reviews with limitations important enough to compromise the reliability of the review findings. Two overview authors independently screened reviews, extracted data and assessed the certainty of evidence using GRADE. We prepared SUPPORT Summaries for eligible reviews, including key messages, 'Summary of findings' tables (using GRADE to assess the certainty of the evidence) and assessments of the relevance of findings to low-income countries. MAIN RESULTS: We identified 7272 systematic reviews and included 39 of them in this overview. An additional four reviews provided supplementary information. Of the 39 reviews, 32 had only minor limitations and 7 had important methodological limitations. Most studies in the reviews were from high-income countries. There were no studies from low-income countries in eight reviews.Implementation strategies addressed in the reviews were grouped into four categories - strategies targeting:1. healthcare organisations (e.g. strategies to change organisational culture; 1 review);2. healthcare workers by type of intervention (e.g. printed educational materials; 14 reviews);3. healthcare workers to address a specific problem (e.g. unnecessary antibiotic prescription; 9 reviews);4. healthcare recipients (e.g. medication adherence; 15 reviews).Overall, we found the following interventions to have desirable effects on at least one outcome with moderate- or high-certainty evidence and no moderate- or high-certainty evidence of undesirable effects.1.Strategies targeted at healthcare workers: educational meetings, nutrition training of health workers, educational outreach, practice facilitation, local opinion leaders, audit and feedback, and tailored interventions.2.Strategies targeted at healthcare workers for specific types of problems: training healthcare workers to be more patient-centred in clinical consultations, use of birth kits, strategies such as clinician education and patient education to reduce antibiotic prescribing in ambulatory care settings, and in-service neonatal emergency care training.3. Strategies targeted at healthcare recipients: mass media interventions to increase uptake of HIV testing; intensive self-management and adherence, intensive disease management programmes to improve health literacy; behavioural interventions and mobile phone text messages for adherence to antiretroviral therapy; a one time incentive to start or continue tuberculosis prophylaxis; default reminders for patients being treated for active tuberculosis; use of sectioned polythene bags for adherence to malaria medication; community-based health education, and reminders and recall strategies to increase vaccination uptake; interventions to increase uptake of cervical screening (invitations, education, counselling, access to health promotion nurse and intensive recruitment); health insurance information and application support. AUTHORS' CONCLUSIONS: Reliable systematic reviews have evaluated a wide range of strategies for implementing evidence-based interventions in low-income countries. Most of the available evidence is focused on strategies targeted at healthcare workers and healthcare recipients and relates to process-based outcomes. Evidence of the effects of strategies targeting healthcare organisations is scarce.

Delivery arrangements for health systems in low-income countries: an overview of systematic reviews.

BACKGROUND: Delivery arrangements include changes in who receives care and when, who provides care, the working conditions of those who provide care, coordination of care amongst different providers, where care is provided, the use of information and communication technology to deliver care, and quality and safety systems. How services are delivered can have impacts on the effectiveness, efficiency and equity of health systems. This broad overview of the findings of systematic reviews can help policymakers and other stakeholders identify strategies for addressing problems and improve the delivery of services. OBJECTIVES: To provide an overview of the available evidence from up-to-date systematic reviews about the effects of delivery arrangements for health systems in low-income countries. Secondary objectives include identifying needs and priorities for future evaluations and systematic reviews on delivery arrangements and informing refinements of the framework for delivery arrangements outlined in the review. METHODS: We searched Health Systems Evidence in November 2010 and PDQ-Evidence up to 17 December 2016 for systematic reviews. We did not apply any date, language or publication status limitations in the searches. We included well-conducted systematic reviews of studies that assessed the effects of delivery arrangements on patient outcomes (health and health behaviours), the quality or utilisation of healthcare services, resource use, healthcare provider outcomes (such as sick leave), or social outcomes (such as poverty or employment) and that were published after April 2005. We excluded reviews with limitations important enough to compromise the reliability of the findings. Two overview authors independently screened reviews, extracted data, and assessed the certainty of evidence using GRADE. We prepared SUPPORT Summaries for eligible reviews, including key messages, 'Summary of findings' tables (using GRADE to assess the certainty of the evidence), and assessments of the relevance of findings to low-income countries. MAIN RESULTS: We identified 7272 systematic reviews and included 51 of them in this overview. We judged 6 of the 51 reviews to have important methodological limitations and the other 45 to have only minor limitations. We grouped delivery arrangements into eight categories. Some reviews provided more than one comparison and were in more than one category. Across these categories, the following intervention were effective; that is, they have desirable effects on at least one outcome with moderate- or high-certainty evidence and no moderate- or high-certainty evidence of undesirable effects. Who receives care and when: queuing strategies and antenatal care to groups of mothers. Who provides care: lay health workers for caring for people with hypertension, lay health workers to deliver care for mothers and children or infectious diseases, lay health workers to deliver community-based neonatal care packages, midlevel health professionals for abortion care, social support to pregnant women at risk, midwife-led care for childbearing women, non-specialist providers in mental health and neurology, and physician-nurse substitution. Coordination of care: hospital clinical pathways, case management for people living with HIV and AIDS, interactive communication between primary care doctors and specialists, hospital discharge planning, adding a service to an existing service and integrating delivery models, referral from primary to secondary care, physician-led versus nurse-led triage in emergency departments, and team midwifery. Where care is provided: high-volume institutions, home-based care (with or without multidisciplinary team) for people living with HIV and AIDS, home-based management of malaria, home care for children with acute physical conditions, community-based interventions for childhood diarrhoea and pneumonia, out-of-facility HIV and reproductive health services for youth, and decentralised HIV care. Information and communication technology: mobile phone messaging for patients with long-term illnesses, mobile phone messaging reminders for attendance at healthcare appointments, mobile phone messaging to promote adherence to antiretroviral therapy, women carrying their own case notes in pregnancy, interventions to improve childhood vaccination. Quality and safety systems: decision support with clinical information systems for people living with HIV/AIDS. Complex interventions (cutting across delivery categories and other health system arrangements): emergency obstetric referral interventions. AUTHORS' CONCLUSIONS: A wide range of strategies have been evaluated for improving delivery arrangements in low-income countries, using sound systematic review methods in both Cochrane and non-Cochrane reviews. These reviews have assessed a range of outcomes. Most of the available evidence focuses on who provides care, where care is provided and coordination of care. For all the main categories of delivery arrangements, we identified gaps in primary research related to uncertainty about the applicability of the evidence to low-income countries, low- or very low-certainty evidence or a lack of studies.

The need for pragmatic clinical trials in low and middle income settings - taking essential neonatal interventions delivered as part of inpatient care as an illustrative example.

BACKGROUND: Pragmatic randomized trials aim to examine the effects of interventions in the full spectrum of patients seen by clinicians who receive routine care. Such trials should be employed in parallel with efforts to implement many interventions which appear promising but where evidence of effectiveness is limited. We illustrate this need taking the case of essential interventions to reduce inpatient neonatal mortality in low and middle income countries (LMIC) but suggest the arguments are applicable in most clinical areas. DISCUSSION: A set of basic interventions have been defined, based on available evidence, that could substantially reduce early neonatal deaths if successfully implemented at scale within district and sub-district hospitals in LMIC. However, we illustrate that there remain many gaps in the evidence available to guide delivery of many inpatient neonatal interventions, that existing evidence is often from high income settings and that it frequently indicates uncertainty in the magnitude or even direction of estimates of effect. Furthermore generalizing results to LMIC where conditions include very high patient staff ratios, absence of even basic technologies, and a reliance on largely empiric management is problematic. Where there is such uncertainty over the effectiveness of interventions in different contexts or in the broad populations who might receive the intervention in routine care settings pragmatic trials that preserve internal validity while promoting external validity should be increasingly employed. Many interventions are introduced without adequate evidence of their effectiveness in the routine settings to which they are introduced. Global efforts are needed to support pragmatic research to establish the effectiveness in routine care of many interventions intended to reduce mortality or morbidity in LMIC. Such research should be seen as complementary to efforts to optimize implementation.

Subsidising artemisinin-based combination therapy in the private retail sector.

BACKGROUND: Malaria causes ill health and death in Africa. Treating illness promptly with artemisinin-based combination therapy (ACT) is likely to cure people and avoid the disease progressing to more severe forms and death. In many countries, ACT use remains low. Part of the problem is that most people seek treatment from the retail sector where ACTs are expensive; this expense is a barrier to their use.The Global Fund and other international organisations are subsidising the cost of ACTs for private retail providers to improve access to ACTs. The subsidy was initially organised through a stand-alone initiative, called the Affordable Medicines Facility-malaria (AMFm), but has since been integrated into the Global Fund core grant management and financial processes. OBJECTIVES: To assess the effect of programmes that include ACT price subsidies for private retailers on ACT use, availability, price and market share. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 1, The Cochrane Library, including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register); MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL (EbscoHost), EconLit (ProQuest), Global Health (OvidSP), Regional Indexes (Global Health Library, WHO), LILACS (Global Health Library, WHO), Science Citation Index and Social Sciences Citation Index (ISI Web of Science) and Health Management (ProQuest). All databases were searched February 2015, except for Health Management which was searched November 2013, without any date, language or publication status restrictions. We also searched the International Clinical Trials Registry Platform (ICTRP; WHO), ClinicalTrials.gov (NIH) and various grey literature sources. We also conducted a cited reference search for all included studies in ISI Web of Knowledge, checked references of identified articles and contacted authors to identify additional studies. SELECTION CRITERIA: Randomised trials, non-randomised trials, controlled before-after studies and interrupted-time-series studies that compared the effects of ACT price subsidies for private retailers to no subsidies or alternative ACT financing mechanisms were eligible for inclusion. Two authors independently screened and selected studies for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data, assessed study risk of bias and confidence in effect estimates (certainty of evidence) using Grading of Recommendations, Assessment, Development and Evaluation (GRADE). MAIN RESULTS: We included four trials (two cluster-randomised trials reported in three articles and two non-randomised cluster trials). Three trials assessed retail sector ACT subsidies combined with supportive interventions (retail outlet provider training, community awareness and mass media campaigns). One trial assessed vouchers provided to households to purchase subsidised ACTs. Price subsidies ranged from 80% to 95%. One trial enrolled children under five years of age; the other three trials studied people of all age groups. The studies were done in rural districts in East Africa (Kenya, Uganda and Tanzania).In this East Africa setting, these ACT subsidy programmes increased the percentage of children under five years of age receiving ACTs on the day, or following day, of fever onset by 25 percentage points (95% confidence interval (CI) 14.1 to 35.9 percentage points; 1 study, high certainty evidence). This suggests that in practice, among febrile children under five years of age with an ACT usage rate of 5% without a subsidy, subsidy programmes would increase usage by between 19% and 41% over a one year period.The ACT subsidy programmes increased the percentage of retail outlets stocking ACTs for children under five years of age by 31.9 percentage points (95% CI 26.3 to 37.5 percentage points; 1 study, high certainty evidence). Effects on ACT stocking for patients of any age is unknown because the certainty of evidence was very low.The ACT subsidy programmes decreased the median cost of ACTs for children under five years of age by US$ 0.84 (median cost per ACT course without subsidy: US$ 1.08 versus with subsidy: US$ 0.24; 1 study, high certainty evidence).The ACT subsidy programmes increased the market share of ACTs for children under five years of age by between 23.6 and 63.0 percentage points (1 study, high certainty evidence).The ACT subsidy programmes decreased the use of older antimalarial drugs (such as amodiaquine and sulphadoxine-pyrimethamine) among children under five years of age by 10.4 percentage points (95% CI 3.9 to 16.9 percentage points; 1 study, high certainty evidence).None of the three studies of ACT subsidies reported the number of patients treated who had confirmed malaria.Vouchers increased the likelihood that an illness is treated with an ACT by 16 to 23 percentage points; however, vouchers were associated with a high rate of over-treatment of malaria (only 56% of patients taking ACTs from the drug shop tested positive for malaria under the 92% subsidy; 1 study, high certainty evidence). AUTHORS' CONCLUSIONS: Programmes that include substantive subsidies for private sector retailers combined with training of providers and social marketing improved use and availability of ACTs for children under five years of age with suspected malaria in research studies from three countries in East Africa. These programmes also reduced prices of ACTs, improved market share of ACTs and reduced the use of older antimalarial drugs among febrile children under five years of age. The research evaluates drug delivery but does not assess whether the patients had confirmed (parasite-diagnosed) malaria. None of the included studies assessed patient outcomes; it is therefore not known whether the effects seen in the studies would translate to an impact on health.

In-service training for health professionals to improve care of seriously ill newborns and children in low-income countries.

BACKGROUND: A variety of in-service emergency care training courses are currently being promoted as a strategy to improve the quality of care provided to seriously ill newborns and children in low-income countries. Most courses have been developed in high-income countries. However, whether these courses improve the ability of health professionals to provide appropriate care in low-income countries remains unclear. This is the first update of the original review. OBJECTIVES: To assess the effects of in-service emergency care training on health professionals' treatment of seriously ill newborns and children in low-income countries. SEARCH METHODS: For this update, we searched the Cochrane Database of Systematic Reviews, part of The Cochrane Library (www.cochranelibrary.com); MEDLINE, Ovid SP; EMBASE, Ovid SP; the Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library (www.cochranelibrary.com) (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register); Science Citation Index and Social Sciences Citation Index, Institute for Scientific Information (ISI) Web of Knowledge/Science and eight other databases. We performed database searches in February 2015. We also searched clinical trial registries, websites of relevant organisations and reference lists of related reviews. We applied no date, language or publication status restrictions when conducting the searches. SELECTION CRITERIA: Randomised trials, non-randomised trials, controlled before and after studies and interrupted-time-series studies that compared the effects of in-service emergency care training versus usual care were eligible for inclusion. We included only hospital-based studies and excluded community-based studies. Two review authors independently screened and selected studies for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed study risk of bias and confidence in effect estimates (certainty of evidence) for each outcome using GRADE (Grades of Recommendation, Assessment, Development and Evaluation). We described results and presented them in GRADE tables. MAIN RESULTS: We identified no new studies in this update. Two randomised trials (which were included in the original review) met the review eligibility criteria. In the first trial, newborn resuscitation training compared with usual care improved provider performance of appropriate resuscitation (trained 66% vs usual care 27%, risk ratio 2.45, 95% confidence interval (CI) 1.75 to 3.42; moderate certainty evidence) and reduced inappropriate resuscitation (trained mean 0.53 vs usual care 0.92, mean difference 0.40, 95% CI 0.13 to 0.66; moderate certainty evidence). Effect on neonatal mortality was inconclusive (trained 28% vs usual care 25%, risk ratio 0.77, 95% CI 0.40 to 1.48; N = 27 deaths; low certainty evidence). Findings from the second trial suggest that essential newborn care training compared with usual care probably slightly improves delivery room newborn care practices (assessment of breathing, preparedness for resuscitation) (moderate certainty evidence). AUTHORS' CONCLUSIONS: In-service neonatal emergency care courses probably improve health professionals' treatment of seriously ill babies in the short term. Further multi-centre randomised trials evaluating the effects of in-service emergency care training on long-term outcomes (health professional practice and patient outcomes) are needed.

Chlorhexidine skin or cord care for prevention of mortality and infections in neonates.

BACKGROUND: Affordable, feasible and efficacious interventions to reduce neonatal infections and improve neonatal survival are needed. Chlorhexidine, a broad spectrum topical antiseptic agent, is active against aerobic and anaerobic organisms and reduces neonatal bacterial colonisation and may reduce infection. OBJECTIVES: To evaluate the efficacy of neonatal skin or cord care with chlorhexidine versus routine care or no treatment for prevention of infections in late preterm or term newborn infants in hospital and community settings. SEARCH METHODS: We searched CENTRAL, latest issue of The Cochrane Library, MEDLINE (1966 to November 2013), EMBASE (1980 to November 2013), and CINAHL (1982 to November 2013). Ongoing trials were detected by searching the following databases: www.clinicaltrials.gov and www.controlled-trials.com. SELECTION CRITERIA: Cluster and individual patient randomised controlled trials of chlorhexidine use (for skin care, or cord care, or both) in term or late preterm neonates in hospital and community settings were eligible for inclusion. Three authors independently screened and selected studies for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data, and assessed study risk of bias. The quality of evidence for each outcome was assessed using GRADE. We calculated pooled risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CIs), and presented results using GRADE 'Summary of findings' tables. MAIN RESULTS: We included 12 trials in this review. There were seven hospital-based and five community-based studies. In four studies maternal vaginal wash with chlorhexidine was done in addition to neonatal skin and cord care. Newborn skin or cord cleansing with chlorhexidine compared to usual care in hospitalsLow-quality evidence from one trial showed that chlorhexidine cord cleansing compared to dry cord care may lead to no difference in neonatal mortality (RR 0.11, 95% CI 0.01 to 2.04). Moderate-quality evidence from two trials showed that chlorhexidine cord cleansing compared to dry cord care probably reduces the risk of omphalitis/infections (RR 0.48, 95% CI 0.28 to 0.84).Low-quality evidence from two trials showed that chlorhexidine skin cleansing compared to dry cord care may lead to no difference in omphalitis/infections (RR 0.88, 95% CI 0.56 to 1.39). None of the studies in this comparison reported effects of the treatments on neonatal mortality. Newborn skin or cord cleansing with chlorhexidine compared to usual care in the communityHigh-quality evidence from three trials showed that chlorhexidine cord cleansing compared to dry cord care reduces neonatal mortality (RR 0.81, 95% CI 0.71 to 0.92) and omphalitis/infections (RR 0.48, 95% CI 0.40 to 0.57).High-quality evidence from one trial showed no difference between chlorhexidine skin cleansing and usual skin care on neonatal mortality (RR 1.03, 95% CI 0.87 to 1.23). None of the studies in this comparison reported effects of the treatments on omphalitis/infections. Maternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention (sterile saline solution) in hospitalsModerate-quality evidence from one trial showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on neonatal mortality (RR 0.98, 95% CI 0.67 to 1.42). High-quality evidence from two trials showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on the risk of infections (RR 0.93, 95% CI 0.82 to 1.16).Findings from one trial showed that maternal vaginal cleansing in addition to total body cleansing results in increased risk of hypothermia (RR 1.33, 95% CI 1.19 to 1.49). Maternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention (sterile saline solution) in the communityLow-quality evidence from one trial showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on neonatal mortality (RR 0.20, 95% CI 0.01 to 4.03). Moderate-quality evidence from one trial showed that maternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention probably reduces the risk of neonatal infections (RR 0.69, 95% CI 0.49 to 0.95). These studies did not report effect on omphalitis. AUTHORS' CONCLUSIONS: There is some uncertainty as to the effect of chlorhexidine applied to the umbilical cords of newborns in hospital settings on neonatal mortality. The quality of evidence for the effects on infection are moderate for cord application and low for application to skin. There is high-quality evidence that chlorhexidine skin or cord care in the community setting results in a 50% reduction in the incidence of omphalitis and a 12% reduction in neonatal mortality. Maternal vaginal chlorhexidine compared to usual care probably leads to no difference in neonatal mortality in hospital settings. Maternal vaginal chlorhexidine compared to usual care results in no difference in the risk of infections in hospital settings. The uncertainty over the effect of maternal vaginal chlorhexidine on mortality outcomes reflects small sample sizes and low event rates in the community settings.