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.

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.

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.

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.

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.