A case for updating the WHO Safe Childbirth Checklist to improve newborn care: Experience from seven Asia and Pacific countries.

The WHO Safe Childbirth Checklist (the SCC) is a clinical tool developed to help health workers follow evidence-based maternal and perinatal care practices at childbirth. Newborn delivery care practices at facilities in seven countries in East Asia and the Pacific were compared to practices checked by the SCC. The analysis found that the SCC does not incorporate several key evidence-based practices around birth demonstrated to prevent newborn morbidity or mortality, or harmful practices associated with increased risks. A revision of the standard SCC is needed to maximise its potential to improve newborn outcomes. This can be initiated under the coordinating umbrella of WHO, but must ensure that the realities of labour and childbirth practices in low- and middle-income countries are considered and addressed.

Appraisal of the methodological quality of clinical practice guidelines in the Philippines.

PURPOSE: The Republic of the Philippines has recently enacted the Universal Health Care Law, which mandates the Philippines Department of Health (DOH) to operationalize evidence-based clinical practice guideline (CPG) development. As a baseline to the foregoing task, the aim of this study was to appraise the methodological quality of CPGs previously developed and currently being disseminated in the Philippines. A multimethod search for CPGs was implemented. CPGs were independently evaluated using a modified version of the Knowledge Management Plus CPG appraisal tool. FINDINGS: Eighty-seven CPGs were included in the appraisal. Majority implemented processes to ensure validity, ie, consideration for patient groups, management options, benefits, and harms (99%), and indicated strength of their recommendations (89%). Seventy-seven CPGs (89%) evaluated the evidence for local applicability. Of the 87 CPGs, 20 CPGs (23%) considered equity in the development process. The development process differed among CPGs with varying degrees of utilization of GRADE methodology (52%), disclosure of funding sources (72%), and engagement of technical support external to the development body (3%). Mean duration of CPG development was 1 year (SD 5.9 months), and mean interval between updates was 6 years and 1 month (SD 37.8 months). CONCLUSION: Although most of the CPGs fulfilled essential criteria for quality recommendations (validity and applicability), equity considerations were limited. Furthermore, only half used the GRADE approach and development and dissemination practices differed substantially between CPGs. Thus, it is recommended that a standard CPG development process be made available by the DOH to be utilized by CPG developers in the Philippines.

Improving immediate newborn care practices in Philippine hospitals: impact of a national quality of care initiative 2008-2015.

OBJECTIVE: To determine whether intrapartum and newborn care practices improved in 11 large hospitals between 2008 and 2015. DESIGN: Secondary data analysis of observational assessments conducted in 11 hospitals in 2008 and 2015. SETTING: Eleven large government hospitals from five regions in the Philippines. PARTICIPANTS: One hundred and seven randomly sampled postpartum mother-baby pairs in 2008 and 106 randomly sampled postpartum mothers prior to discharge from hospitals after delivery. INTERVENTIONS: A national initiative to improve quality of newborn care starting in 2009 through development of a standard package of intrapartum and newborn care services, practice-based training, formation of multidisciplinary hospital working groups, and regular assessments and meetings in hospitals to identify actions to improve practices, policies and environments. Quality improvement was supported by policy development, health financing packages, health facility standards, capacity building and health communication. MAIN OUTCOME MEASURES: Sixteen intrapartum and newborn care practices. RESULTS: Between 2008 and 2015, initiation of drying within 5 s of birth, delayed cord clamping, dry cord care, uninterrupted skin-to-skin contact, timing and duration of the initial breastfeed, and bathing deferred until 6 h after birth all vastly improved (P<0.001). The proportion of newborns receiving hygienic cord handling and the hepatitis B birth dose decreased by 11-12%. Except for reduced induction of labor, inappropriate maternal care practices persisted. CONCLUSIONS: Newborn care practices have vastly improved through an approach focused on improving hospital policies, environments and health worker practices. Maternal care practices remain outdated largely due to the ineffective didactic training approaches adopted for maternal care.

Maternal and perinatal health research priorities beyond 2015: an international survey and prioritization exercise.

BACKGROUND: Maternal mortality has declined by nearly half since 1990, but over a quarter million women still die every year of causes related to pregnancy and childbirth. Maternal-health related targets are falling short of the 2015 Millennium Development Goals and a post-2015 Development Agenda is emerging. In connection with this, setting global research priorities for the next decade is now required. METHODS: We adapted the methods of the Child Health and Nutrition Research Initiative (CHNRI) to identify and set global research priorities for maternal and perinatal health for the period 2015 to 2025. Priority research questions were received from various international stakeholders constituting a large reference group, and consolidated into a final list of research questions by a technical working group. Questions on this list were then scored by the reference working group according to five independent and equally weighted criteria. Normalized research priority scores (NRPS) were calculated, and research priority questions were ranked accordingly. RESULTS: A list of 190 priority research questions for improving maternal and perinatal health was scored by 140 stakeholders. Most priority research questions (89%) were concerned with the evaluation of implementation and delivery of existing interventions, with research subthemes frequently concerned with training and/or awareness interventions (11%), and access to interventions and/or services (14%). Twenty-one questions (11%) involved the discovery of new interventions or technologies. CONCLUSIONS: Key research priorities in maternal and perinatal health were identified. The resulting ranked list of research questions provides a valuable resource for health research investors, researchers and other stakeholders. We are hopeful that this exercise will inform the post-2015 Development Agenda and assist donors, research-policy decision makers and researchers to invest in research that will ultimately make the most significant difference in the lives of mothers and babies.

Early versus Delayed Refeeding for Children with Acute Diarrhoea.

BACKGROUND: Acute diarrhoea is one of the principal causes of morbidity and mortality among children in low-income countries.  The cornerstone of treatment is oral rehydration therapy and dietary management.  However, there is a lack of data and studies on both the timing and type of feeding that should be adopted during the course of the illness. OBJECTIVES: To compare the efficacy and safety of early and late reintroduction of feeding in children with acute diarrhoea. SEARCH STRATEGY: In May 2011, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2011, Issue 1), MEDLINE, EMBASE, LILACS, and mRCT. We also contacted researchers and organizations, and searched reference lists. SELECTION CRITERIA: Randomized controlled trials of early versus late refeeding among children less than 10 years old with acute diarrhoea.  Early refeeding was defined as within 12 hours of start of rehydration and late refeeding was defined as more than 12 hours after start of rehydration.  DATA COLLECTION AND ANALYSIS: Two authors independently assessed the search results and the risk of bias, and extracted data. We present risk ratios for dichotomous outcomes and mean differences for continuous outcomes. We combined the results of the trials using meta-analysis when heterogeneity was not substantial. MAIN RESULTS: Twelve trials involving 1283 participants wereincluded; 1226 participants were used in the analysis (724 in the early refeeding group and 502 in the late refeeding group). Nine trials described their allocation sequence, but only two used concealed allocation. One trial reported single-blinding but did not clearly identify the person who was blinded. Early refeeding meant intake during or immediately after start of rehydration, while late refeeding meant intake only 20 hours to 48 hours after start of rehydration. Significant heterogeneity was noted in the data for the duration of diarrhoea. There was no significant difference between the two refeeding groups in the number of participants who needed unscheduled intravenous fluids (six trials with 813 participants), who experienced episodes of vomiting (five trials with 466 participants), and who developed persistent diarrhoea (four trials with 522 participants). The mean length of hospital stay was also similar (two trials with 246 participants). AUTHORS' CONCLUSIONS: There was no evidence that early refeeding increases the risk of unscheduled intravenous fluid use, episodes of vomiting, and development of persistent diarrhoea. No conclusion could be made regarding the duration of diarrhoea.

Immediate newborn care practices delay thermoregulation and breastfeeding initiation.

AIM: A deadly nosocomial outbreak in a Philippine hospital drew nationwide attention to neonatal sepsis. Together with specific infection control measures, interventions that protect newborns against infection-related mortality include drying, skin-to-skin contact, delayed cord clamping, breastfeeding initiation and delayed bathing. This evaluation characterized hospital care in the first hours of life with the intent to drive policy change, strategic planning and hospital reform. METHODS: Trained physicians observed 481 consecutive deliveries in 51 hospitals using a standardized tool to record practices and timing of immediate newborn care procedures. RESULTS: Drying, weighing, eye care and vitamin K injections were performed in more than 90% of newborns. Only 9.6% were allowed skin-to-skin contact. Interventions were inappropriately sequenced, e.g. immediate cord clamping (median 12 sec), delayed drying (96.5%) and early bathing (90.0%). While 68.2% were put to the breast, they were separated two minutes later. Unnecessary suctioning was performed in 94.9%. Doctors trained in neonatal resuscitation were 2.5 (1.1-5.7) times more likely to unnecessarily suction vigorous newborns. Two per cent died and 5.7% developed sepsis/pneumonia. CONCLUSIONS: This minute-by-minute observational assessment revealed that performance and timing of immediate newborn care interventions are below WHO standards and deprive newborns of basic protections against infection and death.

Scaling up kangaroo mother care in the Philippines using policy, regulatory and systems reform to drive changes in birth practices.

The WHO recommends kangaroo mother care (KMC) for stable preterm and low birthweight babies because it has been demonstrated to reduce mortality by up to half compared with conventional incubator-based care. Uptake of KMC in low/middle-income countries has been limited, despite its suitability for low-resource environments. This paper reviews factors that contributed to the adoption and expansion of KMC in the Philippines. Early introduction began in 1999 but national scale-up was slow until 2014 after which a significant improvement in national adoption was observed. The proportion of target hospitals implementing KMC rose from 3% to 43% between 2014 and 2019, with 53% of preterm and low birthweight babies receiving KMC by the end of this period. Expansion was led by the government which committed resources and formed partnerships with development partners and non-governmental organisations. Scale-up of KMC was built on the introduction of evidence-based newborn care practices around birth. Practice changes were promoted and supported by consensus-based policy, protocol, regulatory and health insurance changes led by multidisciplinary teams. A new approach to changing and sustaining clinical practice used hospital teams to conduct on-the-job clinical coaching and use local data to make environmental changes to support practices. Institutionalisation of early skin-to-skin contact, non-separation of mother and newborn and early initiation of exclusive breast feeding, with increased responsibility given to mothers, drove a cultural change among staff and families which allowed greater acceptance and uptake of KMC. Financial and programmatic support must be sustained and expanded to address ongoing challenges including staffing gaps, available space for KMC, willingness of some staff to adopt new practices and lack of resources for clinical coaching and follow-up.

Guidelines in Low and Middle Income Countries Paper 3: Appraisal of Philippine Clinical Practice Guidelines using Appraisal of Guidelines for Research and Evaluation II: improvement needed for rigor, applicability, and editorial independence.

BACKGROUND AND OBJECTIVE: High-quality clinical practice guidelines (CPGs) are needed to guide practitioners, policy makers, and other stakeholders to provide optimal health care. This study aims to appraise the CPGs developed in the Philippines using the AGREE II instrument. METHODS: Ninety-one CPGs were appraised independently by two health-care professionals. CPGs were considered acceptable if they garnered an overall mean score of at least 75.0% for all 6 domains and a domain score of at least 75.0% for rigor of development. A mean score of <75.0% on either of the criteria implied that the CPG needed revision. RESULTS: Overall mean scores of the CPGs ranged from 8.4% to 79.2%, with a mean of 43.9% (standard deviation = 13.4%). In general, CPGs scored better for the domains of clarity of presentation, scope and purpose, and stakeholder involvement. Lowest scores were obtained for the domains of rigor of development, applicability, and editorial independence. Only 1 (1.1%) CPG qualified as acceptable. CONCLUSION: AGREE II is a practical and useful guide in appraising the quality of CPGs. Strengthening technical capacity in various medical fields is essential to improve the quality of CPGs. Rigor of development, applicability issues, and editorial independence should be emphasized in CPG capacity-building activities.

Remdesivir for severe covid-19: a clinical practice guideline.

CLINICAL QUESTION: What is the role of remdesivir in the treatment of severe covid-19? This guideline was triggered by the ACTT-1 trial published in the New England Journal of Medicine on 22 May 2020. CURRENT PRACTICE: Remdesivir has received worldwide attention as a potentially effective treatment for severe covid-19. After rapid market approval in the US, remdesivir is already being used in clinical practice. RECOMMENDATIONS: The guideline panel makes a weak recommendation for the use of remdesivir in severe covid-19 while recommending continuation of active enrolment of patients into ongoing randomised controlled trials examining remdesivir. HOW THIS GUIDELINE WAS CREATED: An international panel of patients, clinicians, and methodologists produced these recommendations in adherence with standards for trustworthy guidelines using the GRADE approach. The recommendations are based on a linked systematic review and network meta-analysis. The panel considered an individual patient perspective and allowed contextual factors (such as resources) to be taken into account for countries and healthcare systems. THE EVIDENCE: The linked systematic review (published 31 Jul 2020) identified two randomised trials with 1300 participants, showing low certainty evidence that remdesivir may be effective in reducing time to clinical improvement and may decrease mortality in patients with severe covid-19. Remdesivir probably has no important effect on need for invasive mechanical ventilation. Remdesivir may have little or no effect on hospital length of stay. UNDERSTANDING THE RECOMMENDATION: Most patients with severe covid-19 would likely choose treatment with remdesivir given the potential reduction in time to clinical improvement. However, given the low certainty evidence for critical outcomes and the fact that different perspectives, values, and preferences may alter decisions regarding remdesivir, the panel issued a weak recommendation with strong support for continued recruitment in randomised trials.

Association between early essential newborn care and breastfeeding outcomes in eight countries in Asia and the Pacific: a cross-sectional observational -study.

OBJECTIVE: To explore the association between early essential newborn care (EENC) policy, practice and environmental interventions and breastfeeding outcomes. DESIGN: Cross-sectional observational study. SETTING: 150 national, provincial and district hospitals implementing EENC in eight countries in East Asia and the Pacific. PARTICIPANTS: 1383 maternal interviews, chart reviews and environmental assessments during 2016 and 2017. MAIN OUTCOME MEASURES: Exclusive breastfeeding (EBF), that is, feeding only breastmilk without other food or fluids since birth and before discharge, and, early breastfeeding initiation, that is, during skin-to-skin contact (SSC) with the mother without separation. RESULTS: Fifty-nine per cent of newborns initiated breastfeeding early and 83.5% were EBF. Duration of SSC showed a strong dose-response relationship with early breastfeeding initiation. SSC of at least 90 min was associated with 368.81 (95% CI 88.76 to 1532.38, p<0.001) times higher early breastfeeding. EBF was significantly associated with SSC duration of 30-59 min (OR 3.54, 95% CI 1.88 to 6.66, p<0.001), 60-89 min (OR 5.61, 95% CI 2.51 to 12.58, p<0.001) and at least 90 min (OR 3.78, 95% CI 2.12 to 6.74, p<0.001) regardless of delivery mode. Non-supine position (OR 2.80, 95% CI 1.90 to 4.11, p<0.001), rooming-in (OR 5.85, 95% CI 3.46 to 9.88, p<0.001), hospital breastfeeding policies (OR 2.82, 95% CI 1.97 to 4.02, p<0.001), quality improvement mechanisms (OR 1.63, 95% CI 1.07 to 2.49, p=0.02) and no formula products (OR 17.50, 95% CI 5.92 to 51.74, p<0.001) were associated with EBF. CONCLUSION: EENC policy, practice and environmental interventions were associated with breastfeeding outcomes. To maximise the likelihood of early and EBF, newborns, regardless of delivery mode, should receive immediate and uninterrupted SSC for at least 90 min.

Controversy and debate on dengue vaccine series-paper 1: review of a licensed dengue vaccine: inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs.

Severe life-threatening dengue fever usually occurs when a child is infected by dengue virus a second time. This is caused by a phenomenon called antibody-dependent enhancement (ADE). Since dengue vaccines can mimic a first infection in seronegative children (those with no previous infection), a natural infection later in life could lead to severe disease. The possibility that dengue vaccines can cause severe dengue through ADE has led to serious concern regarding the safety of mass vaccination programs. A published meta-analysis addressed this safety issue for a new vaccine against dengue fever-Dengvaxia. The trials in this meta-analysis have been used to campaign for mass vaccination programs in developing countries. We discuss the results of this paper and point out problems in the analyses. Reporting the findings in an Asian trial (CYD14), the authors show a sevenfold rise in one outcome-hospitalization for dengue fever in children <5 years old. However, they fail to point out two signals of harm for another outcome-hospitalization for severe dengue fever (as confirmed by an independent data monitoring committee): 1. In children younger than 9 years, the relative risk was 8.5 (95% confidence interval [CI]: 0.5, 146.8), and 2. In the overall study group, the relative risk was 5.5 (95% CI: 0.9, 33). The authors conduct a subgroup analysis to support claims that the vaccine is probably safe among children aged 9 years or more. This subgroup analysis has limited credibility because: (1) it was a post hoc analysis; (2) it was one of a large number of subgroup analyses; (3) the test of interaction was not reported, but was insignificant (P = 0.14); and (4) there is no biological basis for a threshold age of 9 years. The more likely explanation for the higher risk in younger children is ADE, that is, more frequent seronegativity, rather than age itself. The selective reporting and inappropriate subgroup claims mask the potential harm of dengue mass vaccination programs. Countries planning public use of the vaccine must conduct diligent postmarketing surveillance, secure informed consent from parents of potential recipients, and closely monitor the results of ongoing long-term follow-up of clinical trial participants.

Rubella and Congenital Rubella Syndrome in the Philippines: A Systematic Review.

Background. As part of regional elimination efforts, rubella-containing vaccines (RCV) have recently been introduced in the Philippines, yet the true burden of rubella and congenital rubella syndrome (CRS) in the country is largely unknown. Objective. To provide baseline information on rubella and CRS prior to routine vaccine introduction in the Philippines. Methods. We conducted a systematic literature review on rubella and CRS in the Philippines, including a cross-sectional study conducted in 2002 among 383 pregnant women attending the obstetric outpatient clinic of the Philippine General Hospital to assess rubella susceptibility of women of childbearing age. Results. 15 locally published and unpublished studies were reviewed. Susceptibility to rubella among women of childbearing age was higher in rural communities. Retrospective reviews revealed congenital heart diseases, cataracts, and hearing impairments to be most common presentations in children of CRS. In the cross-sectional study, 59 (15.4%) of the 383 pregnant women enrolled were seronegative for rubella IgG. Conclusion. Similar to other countries introducing RCV, it was only recently that surveillance for rubella has been established. Previous studies show substantial disabilities due to CRS and a substantial proportion of susceptible women who are at risk for having babies affected with CRS. Establishment of CRS surveillance and enhanced awareness on rubella case detection should be prioritized.

Drugs that affect the fetus and newborn infant via the placenta or breast milk.

In general, drugs that are taken by a mother during pregnancy or after birth may be transferred to the fetus or the infant (through breast milk). Many factors are involved that determine the amount of drugs that are transferred and their potential effects on the fetus or infant. A careful assessment of the risk versus benefit is necessary and should be individualized. In the breastfed infant, many measures can be undertaken further so that the amount of drug transferred to the infant is minimized.

Trade-off between benefit and harm is crucial in health screening recommendations. Part II: evidence summaries.

Evidence on the effectiveness of health screening strategies may be direct (i.e., studies on screening vs. no screening) or indirect (i.e., studies that separately evaluate the screening test[s], the confirmatory test, or the treatment). Critical trade-offs in the balance between harm and benefit for many screening strategies mandate that advocates of health screening adhere to the ethical precepts of nonmaleficence, autonomy, confidentiality, and equity. In our first article, we pointed out five prerequisites to justifying a health screening program: (1) the burden of illness should be high, (2) the screening and confirmatory tests should be accurate, (3) early treatment (or prevention) must be more effective than late treatment, (4) the tests and the treatment(s) must be safe, and (5) the cost of the screening strategy must be commensurate with the potential benefit. As can be gleaned from these criteria, recommendations on screening must be tailored to specific populations. Recommendations in one country, no matter how authoritative, cannot be generalized to apply to all other countries. Although accuracy, effectiveness, and safety data may be global (criteria 2-4), burden of illness and efficiency (criteria 1 and 5) will always vary from country to country. Rather than review various national guidelines, in this last article of our two-part series, we present evidence summaries to illustrate health screening. Our examples were selected to address special issues related to four situations-screening for cancer, risk factors for disease, genetic disorders, and infectious diseases.

Trade-off between benefit and harm is crucial in health screening recommendations. Part I: general principles.

Health screening is defined as the use of a test or a series of tests to detect unrecognized health risks or preclinical disease in apparently healthy populations to permit prevention and timely intervention. A health screening strategy consists of the sequence of a screening test, confirmatory test(s), and finally, treatment(s) for the condition detected. The potential benefits of health screening are easy to understand, but the huge potential for physical and psychological harm is less well recognized. Thus, health screening should only be recommended when five criteria are satisfied: (1) the burden of illness should be high, (2) the tests for screening and confirmation should be accurate, (3) early treatment (or prevention) must be more effective than late treatment, (4) the test(s) and treatment(s) must be safe, and (5) the cost of the screening strategy must be commensurate with potential benefit. Direct evidence from screening trials is subject to less bias. In some instances, indirect evidence may be acceptable, e.g., when the condition screened for is a risk factor for a disease rather than the disease itself.