Medical device regulation and oversight in African countries: a scoping review of literature and development of a conceptual framework.

Regulatory and other governance arrangements influence the introduction of medical devices into health systems and are essential for ensuring their effective and safe use. Challenges with medical device safety, quality and use are documented globally, with evidence suggesting these are linked to poor governance. Yet, medical device regulation and oversight remain inadequately defined and described, particularly in low-income and middle-income settings. Through this review, we sought to examine the literature available on regulatory and oversight processes for medical devices in African countries.Following a systematic approach, we searched academic databases including PubMed, Embase (Ovid) and MEDLINE (Ovid), supplemented by search for grey literature and relevant organisational websites, for documents describing medical device regulation and oversight in African countries. We summarised the data to present key actors, areas for regulation and oversight and challenges.A total of 39 documents reporting regulation and oversight of medical devices were included for analysis. Regulatory and oversight guidelines and processes were reported as inadequate, including limited pre-market testing, reliance on international certifications and limited processes for post-market monitoring and reporting of adverse events. Challenges for regulation and oversight reported included inadequate funding, personnel and technical expertise to perform regulatory functions. The literature highlighted gaps in guidelines for donated medical devices and in information on governance processes at the national level.The current literature provides a general overview of medical device regulatory guidelines and limited evidence on the implementation of regulatory/oversight processes at national and especially subnational levels. We recommend further research to elucidate existing governance arrangements for medical devices within African countries and propose a conceptual framework to inform future studies. The framework provides entry points for careful examination of governance and oversight in policy and practice, the exploration of governance realities across the health system and the influence of wider system dynamics.

Institutionalizing the Management of Sick Young Infants: Kenya's Experience in Revising National Guidelines on Integrated Management of Newborn and Childhood Illnesses.

INTRODUCTION: In 2015, the World Health Organization (WHO) developed guidelines for the management of sick young infants (SYIs) with possible serious bacterial infection (PSBI) where referral is not feasible. The Ponya Mtoto project was designed as an implementation research project to demonstrate how to adopt the WHO PSBI guidelines in the Kenyan context. PONYA MTOTO PROJECT DESCRIPTION: Between October 2017 and June 2021, Ponya Mtoto was implemented in 4 Kenyan counties with higher infant and newborn mortality rates than the national mean. A total of 48 health facilities stratified by level of services were selected as study sites. IMPLEMENTATION APPROACH: The following activities were done to institutionalize the management of SYIs with PSBI where referral is not feasible in Kenya's health system: (1) participating in a cocreation workshop and development of a theory of change; (2) revising the national integrated management of newborn and childhood illnesses guidelines to incorporate the management of PSBI where referral is not feasible; (3) improving availability of essential commodities; (4) strengthening provider confidence in the management of SYIs; (5) strengthening awareness about PSBI services for SYIs at the community level; and (6) harmonizing the national integrated management of newborn and childhood illnesses guidelines to address discrepancies in the content on the management of PSBI. In addition, the project focused on strengthening quality of care for SYIs and using implementation research to track progress in achieving project targets and outcomes. CONCLUSION: Using an implementation research approach to introduce new WHO guidelines on PSBI where referral is not feasible into Kenya's health care service was critical to fostering engagement of a diverse range of stakeholders, monitoring provider skills and confidence-building, strengthening provision of key commodities for managing SYIs with PSBI, and sustaining community-facility linkages.

Characterising Kenyan hospitals' suitability for medical officer internship training: a secondary data analysis of a cross-sectional study.

OBJECTIVE: To characterise the capacity of Kenya internship hospitals to understand whether they are suitable to provide internship training for medical doctors. DESIGN: A secondary data analysis of a cross-sectional health facility assessment (Kenya Harmonized Health Facility Assessment (KHFA) 2018). SETTING AND POPULATION: We analysed 61 out of all 74 Kenyan hospitals that provide internship training for medical doctors. OUTCOME MEASURES: Comparing against the minimum requirement outlined in the national guidelines for medical officer interns, we filtered and identified 166 indicators from the KHFA survey questionnaire and grouped them into 12 domains. An overall capacity index was calculated as the mean of 12 domain-specific scores for each facility. RESULTS: The average overall capacity index is 69% (95% CI 66% to 72%) for all internship training centres. Hospitals have moderate capacity (over 60%) for most of the general domains, although there is huge variation between hospitals and only 29 out of 61 hospitals have five or more specialists assigned, employed, seconded or part-time-as required by the national guideline. Quality and safety score was low across all hospitals with an average score of 40%. As for major specialties, all hospitals have good capacity for surgery and obstetrics-gynaecology, while mental health was poorest in comparison. Level 5 and 6 facilities (provincial and national hospitals) have higher capacity scores in all domains when compared with level 4 hospitals (equivalent to district hospitals). CONCLUSION: Major gaps exist in staffing, equipment and service availability of Kenya internship hospitals. Level 4 hospitals (equivalent to district hospitals) are more likely to have a lower capacity index, leading to low quality of care, and should be reviewed and improved to provide appropriate and well-resourced training for interns and to use appropriate resources to avoid improvising.

WHO preferred product characteristics for monoclonal antibodies for passive immunization against respiratory syncytial virus (RSV) disease in infants - Key considerations for global use.

World Health Organization (WHO) preferred product characteristics describe preferences for product attributes that would help optimize value and use to address global public health needs, with a particular focus on low- and middle-income countries. Having previously published preferred product characteristics for both maternal and paediatric respiratory syncytial virus (RSV) vaccines, WHO recently published preferred product characteristics for monoclonal antibodies to prevent severe RSV disease in infants. This article summarizes the key attributes from the preferred product characteristics and discusses key considerations for future access and use of preventive RSV monoclonal antibodies.

Devolved health system capacity in the provision of care for sick newborns and young infants in four counties serving vulnerable populations in Kenya.

Possible severe bacterial infections (PSBI) is one of the three leading causes of newborn and young infant mortality globally that can be prevented by timely diagnosis and treatment using suitable antibiotics. High impact interventions such as use of out-patient injectable gentamicin and dispersible Amoxicillin with community-based follow up have been shown to reduce mortality in clinical trials. The objective of this study was to assess the health systems' preparedness and organizational gaps that may impact execution in providing care for newborns and sick young infants. This formative research study was embedded within a three-year implementation research project in 4 Counties in Kenya. The indicators were based on facility audits for existing capacity to care for newborns and young infants as well as County organizational capacity assessment. The organizational capacity assessment domains were derived from the World Health Organization's Health Systems Building blocks for health service delivery. The scores were computed by adding average scores in each domain and calculated against the total possible scores to generate a percentage outcome. Statistical analyses were descriptive with adjustment for clustering of data. Overall, the Counties have inadequate organizational capacity for management of sick young infants with Organizational Capacity Index scores of between 61-64%. Among the domains, the highest score was in Health Management Information System and service delivery. The lowest scores were in monitoring and evaluation (M&E). Counties scored relatively low scores in human resources for health and health products and commodities with one scoring poorly for both areas while the rest scored average performance. The four counties revealed varying levels of organizational capacity deficit to effectively manage sick young infants. The key underlying issues for the below par performance include poor coordination, low funding, inadequate supportive supervision, and M&E to enable data utilisation for quality improvement. It was evident that newborn and young infant health services suffer from inadequate infrastructure, equipment, staffing, and coordination. As Kenya, continuously rolls out the guidelines on management of sick young infants, there is need to focus attention to these challenges to enhance sustainable adoption and reduction of young infant morbidity and mortality.

Neonatal mortality in Kenyan hospitals: a multisite, retrospective, cohort study.

BACKGROUND: Most of the deaths among neonates in low-income and middle-income countries (LMICs) can be prevented through universal access to basic high-quality health services including essential facility-based inpatient care. However, poor routine data undermines data-informed efforts to monitor and promote improvements in the quality of newborn care across hospitals. METHODS: Continuously collected routine patients' data from structured paper record forms for all admissions to newborn units (NBUs) from 16 purposively selected Kenyan public hospitals that are part of a clinical information network were analysed together with data from all paediatric admissions ages 0-13 years from 14 of these hospitals. Data are used to show the proportion of all admissions and deaths in the neonatal age group and examine morbidity and mortality patterns, stratified by birth weight, and their variation across hospitals. FINDINGS: During the 354 hospital months study period, 90 222 patients were admitted to the 14 hospitals contributing NBU and general paediatric ward data. 46% of all the admissions were neonates (aged 0-28 days), but they accounted for 66% of the deaths in the age group 0-13 years. 41 657 inborn neonates were admitted in the NBUs across the 16 hospitals during the study period. 4266/41 657 died giving a crude mortality rate of 10.2% (95% CI 9.97% to 10.55%), with 60% of these deaths occurring on the first-day of admission. Intrapartum-related complications was the single most common diagnosis among the neonates with birth weight of 2000 g or more who died. A threefold variation in mortality across hospitals was observed for birth weight categories 1000-1499 g and 1500-1999 g. INTERPRETATION: The high proportion of neonatal deaths in hospitals may reflect changing patterns of childhood mortality. Majority of newborns died of preventable causes (>95%). Despite availability of high-impact low-cost interventions, hospitals have high and very variable mortality proportions after stratification by birth weight.

How to do no harm: empowering local leaders to make care safer in low-resource settings.

In a companion paper, we showed how local hospital leaders could assess systems and identify key safety concerns and targets for system improvement. In the present paper, we consider how these leaders might implement practical, low-cost interventions to improve safety. Our focus is on making immediate safety improvements both to directly improve patient care and as a foundation for advancing care in the longer-term. We describe a 'portfolio' approach to safety improvement in four broad categories: prioritising critical processes, such as checking drug doses; strengthening the overall system of care, for example, by introducing multiprofessional handovers; control of known risks, such as only using continuous positive airway pressure when appropriate conditions are met; and enhancing detection and response to hazardous situations, such as introducing brief team meetings to identify and respond to immediate threats and challenges. Local clinical leaders and managers face numerous challenges in delivering safe care but, if given sufficient support, they are nevertheless in a position to bring about major improvements. Skills in improving safety and quality should be recognised as equivalent to any other form of (sub)specialty training and as an essential element of any senior clinical or management role. National professional organisations need to promote appropriate education and provide coaching, mentorship and support to local leaders.

The paediatrician workforce and its role in addressing neonatal, child and adolescent healthcare in Kenya.

OBJECTIVE: To examine the availability of paediatricians in Kenya and plans for their development. DESIGN: Review of policies and data from multiple sources combined with local expert insight. SETTING: Kenya with a focus on the public, non-tertiary care sector as an example of a low-income and middle-income country aiming to improve the survival and long-term health of newborns, children and adolescents. RESULTS: There are 305 practising paediatricians, 1.33 per 100 000 individuals of the population aged <19 years which in total numbers approximately 25 million. Only 94 are in public sector, non-tertiary county hospitals. There is either no paediatrician at all or only one paediatrician in 21/47 Kenyan counties that are home to over a quarter of a million under 19 years of age. Government policy is to achieve employment of 1416 paediatricians in the public sector by 2030, however this remains aspirational as there is no comprehensive training or financing plan to reach this target and health workforce recruitment, financing and management is now devolved to 47 counties. The vast majority of paediatric care is therefore provided by non-specialist healthcare workers. DISCUSSION: The scale of the paediatric workforce challenge seriously undermines the ability of the Kenyan health system to deliver on the emerging survive, thrive and transform agenda that encompasses more complex health needs. Addressing this challenge may require innovative workforce solutions such as task-sharing, these may in turn require the role of paediatricians to be redefined. Professional paediatric communities in countries like Kenya could play a leadership role in developing such solutions.

Lessons from a Health Policy and Systems Research programme exploring the quality and coverage of newborn care in Kenya.

There are global calls for research to support health system strengthening in low-income and middle-income countries (LMICs). To examine the nature and magnitude of gaps in access and quality of inpatient neonatal care provided to a largely poor urban population, we combined multiple epidemiological and health services methodologies. Conducting this work and generating findings was made possible through extensive formal and informal stakeholder engagement linked to flexibility in the research approach while keeping overall goals in mind. We learnt that 45% of sick newborns requiring hospital care in Nairobi probably do not access a suitable facility and that public hospitals provide 70% of care accessed with private sector care either poor quality or very expensive. Direct observations of care and ethnographic work show that critical nursing workforce shortages prevent delivery of high-quality care in high volume, low-cost facilities and likely threaten patient safety and nurses' well-being. In these challenging settings, routines and norms have evolved as collective coping strategies so health professionals maintain some sense of achievement in the face of impossible demands. Thus, the health system sustains a functional veneer that belies the stresses undermining quality, compassionate care. No one intervention will dramatically reduce neonatal mortality in this urban setting. In the short term, a substantial increase in the number of health workers, especially nurses, is required. This must be combined with longer term investment to address coverage gaps through redesign of services around functional tiers with improved information systems that support effective governance of public, private and not-for-profit sectors.

Does respiratory syncytial virus lower respiratory illness in early life cause recurrent wheeze of early childhood and asthma? Critical review of the evidence and guidance for future studies from a World Health Organization-sponsored meeting.

Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) and hospitalization in infants and children globally. Many observational studies have found an association between RSV LRTI in early life and subsequent respiratory morbidity, including recurrent wheeze of early childhood (RWEC) and asthma. Conversely, two randomized placebo-controlled trials of efficacious anti-RSV monoclonal antibodies (mAbs) in heterogenous infant populations found no difference in physician-diagnosed RWEC or asthma by treatment group. If a causal association exists and RSV vaccines and mAbs can prevent a substantial fraction of RWEC/asthma, the full public health value of these interventions would markedly increase. The primary alternative interpretation of the observational data is that RSV LRTI in early life is a marker of an underlying predisposition for the development of RWEC and asthma. If this is the case, RSV vaccines and mAbs would not necessarily be expected to impact these outcomes. To evaluate whether the available evidence supports a causal association between RSV LRTI and RWEC/asthma and to provide guidance for future studies, the World Health Organization convened a meeting of subject matter experts on February 12-13, 2019 in Geneva, Switzerland. After discussing relevant background information and reviewing the current epidemiologic evidence, the group determined that: (i) the evidence is inconclusive in establishing a causal association between RSV LRTI and RWEC/asthma, (ii) the evidence does not establish that RSV mAbs (and, by extension, future vaccines) will have a substantial effect on these outcomes and (iii) regardless of the association with long-term childhood respiratory morbidity, severe acute RSV disease in young children poses a substantial public health burden and should continue to be the primary consideration for policy-setting bodies deliberating on RSV vaccine and mAb recommendations. Nonetheless, the group recognized the public health importance of resolving this question and suggested good practice guidelines for future studies.

Effect of enhancing audit and feedback on uptake of childhood pneumonia treatment policy in hospitals that are part of a clinical network: a cluster randomized trial.

BACKGROUND: The World Health Organization (WHO) revised its clinical guidelines for management of childhood pneumonia in 2013. Significant delays have occurred during previous introductions of new guidelines into routine clinical practice in low- and middle-income countries (LMIC). We therefore examined whether providing enhanced audit and feedback as opposed to routine standard feedback might accelerate adoption of the new pneumonia guidelines by clinical teams within hospitals in a low-income setting. METHODS: In this parallel group cluster randomized controlled trial, 12 hospitals were assigned to either enhanced feedback (n = 6 hospitals) or standard feedback (n = 6 hospitals) using restricted randomization. The standard (network) intervention delivered in both trial arms included support to improve collection and quality of patient data, provision of mentorship and team management training for pediatricians, peer-to-peer networking (meetings and social media), and multimodal (print, electronic) bimonthly hospital specific feedback reports on multiple indicators of evidence guideline adherence. In addition to this network intervention, the enhanced feedback group received a monthly hospital-specific feedback sheet targeting pneumonia indicators presented in multiple formats (graphical and text) linked to explicit performance goals and action plans and specific email follow up from a network coordinator. At the start of the trial, all hospitals received a standardized training on the new guidelines and printed booklets containing pneumonia treatment protocols. The primary outcome was the proportion of children admitted with indrawing and/or fast-breathing pneumonia who were correctly classified using new guidelines and received correct antibiotic treatment (oral amoxicillin) in the first 24 h. The secondary outcome was the proportion of correctly classified and treated children for whom clinicians changed treatment from oral amoxicillin to injectable antibiotics. RESULTS: The trial included 2299 childhood pneumonia admissions, 1087 within the hospitals randomized to enhanced feedback intervention, and 1212 to standard feedback. The proportion of children who were correctly classified and treated in the first 24 h during the entire 9-month period was 38.2% (393 out of 1030) and 38.4% (410 out of 1068) in the enhanced feedback and standard feedback groups, respectively (odds ratio 1.11; 95% confidence interval [CI] 0.37-3.34; P = 0.855). However, in exploratory analyses, there was evidence of an interaction between type of feedback and duration (in months) since commencement of intervention, suggesting a difference in adoption of pneumonia policy over time in the enhanced compared to standard feedback arm (OR = 1.25, 95% CI 1.14 to 1.36, P < 0.001). CONCLUSIONS: Enhanced feedback comprising increased frequency, clear messaging aligned with goal setting, and outreach from a coordinator did not lead to a significant overall effect on correct pneumonia classification and treatment during the 9-month trial. There appeared to be a significant effect of time (representing cumulative effect of feedback cycles) on adoption of the new policy in the enhanced feedback compared to standard feedback group. Future studies should plan for longer follow-up periods to confirm these findings. TRIAL REGISTRATION: US National Institutes of Health-ClinicalTrials.gov identifier (NCT number) NCT02817971 . Registered September 28, 2016-retrospectively registered.

Developing a seasonal influenza vaccine recommendation in Kenya: Process and challenges faced by the National Immunization Technical Advisory Group (NITAG).

BACKGROUND: In 2014 the Kenya National Immunization Technical Advisory Group (KENITAG) was asked by the Ministry of Health to provide an evidence-based recommendation on whether the seasonal influenza vaccine should be introduced into the national immunization program (NIP). METHODS: We reviewed KENITAG manuals, reports and meeting minutes generated between June 2014 and June 2016 in order to describe the process KENITAG used in arriving at that recommendation and the challenges encountered. RESULTS: KENITAG developed a recommendation framework to identify critical, important and non-critical data elements that would guide deliberations on the subject. Literature searches were conducted in several databases and the quality of scientific articles obtained was assessed using the Critical Appraisal Skills Programme tool. There were significant gaps in knowledge on the national burden of influenza disease among key risk groups, i.e., pregnant women, individuals with co-morbidities, the elderly and health care workers. Insufficient funding and limited work force hindered KENITAG activities. In 2016 KENITAG recommended introduction of the annual seasonal influenza vaccine among children 6 to 23 months of age. However, the recommendation was contingent on implementation of a pilot study to address gaps in local data on the socio-economic impact of influenza vaccination programs, strategies for vaccine delivery, and the impact of the vaccination program on the healthcare workforce and existing immunization program. KENITAG did not recommend the influenza vaccine for any other risk group due to lack of local burden of disease data. CONCLUSION: Local data are a critical element in NITAG deliberations, however, where local data and in particular burden of disease data are lacking, there is need to adopt scientifically acceptable methods of utilizing findings from other countries to inform local decisions in a manner that is valid and acceptable to decision makers.

Mechanisms associated with maternal adverse childhood experiences on offspring's mental health in Nairobi informal settlements: a mediational model testing approach.

BACKGROUND: Adverse childhood experiences (ACEs) is a significant public health and social welfare problem in low-and middle income countries (LMICs). However, most ACEs research is based on developed countries, and little is known about mechanisms of early ACEs on adulthood health and offspring's wellbeing for populations in LMICs. This area is needed to guide social welfare policy and intervention service planning. This study addresses these research gaps by examining patterns of ACEs and understanding the role of ACEs on adulthood health (i.e., physical, mental health, experience of underage pregnancy) and offspring's mental health in Kenya. The study was guided by an Integrated Family Stress and Adverse Childhood Experiences Mediation Framework. METHODS: Three hundred ninety four mothers from two informal communities in Kariobangi and Kangemi in Nairobi were included in this study. The Adverse Childhood Experiences International Questionnaire (ACE-IQ), the Kessler Psychological Distress Scale (K10), Overall Health and Quality of Life items, and Child Behavior Checklist were used to study research questions. Data was gathered through a one-time interview with mothers. Structural Equational Modeling (SEM) was applied for mediational mechanism testing. RESULTS: Among 13 ACE areas, most mothers experienced multiple adversity during their childhood (Mean (SD) = 4.93 (2.52)), with household member treated violently (75%) as the most common ACE. SEM results showedthat all domains of ACEs were associated with some aspects of maternal health, and all three domains of maternal health (maternal mental health, physical health, and adolescent pregnancy) were significantly associated with development of offspring's mental health problems. CONCLUSION: ACEs are highly prevalent in Kenyan informal settlements. Consistent with cross cultural literature on family stress model, maternal ACEs are robust predictors for poor child mental health. Preventive interventions for child mental health need to address maternal adverse childhood traumatic experiences as well as their current health in order to effectively promote child mental health.

Complementary Feeding: Beyond Nutrition.

In this article, we will summarize the key non-nutritional aspects of the introduction of complementary feeding. Intestinal maturation related to starch digestion is relatively complete by the time complementary feeding is recommended to be initiated. A much more complex maturation is needed, however, from the neurodevelopmental standpoint as the infants need to be able to hold their head and trunk and be able to coordinate tongue movement followed by swallowing. Issues can arise in infants with a history of medical problems as well as when caretakers cannot handle the initial difficulties or want to impose certain rigidity to the learning process. The introduction of complementary feedings is also part of the early steps in introduction to human socialization. In that regard, it sets up the infant to internalize and accept the diversity of food textures and food choices. Early refusal of some food items is common and should not be interpreted as being disliked. Multiple attempts should be made to incorporate new food items. To accomplish these dynamics, caregivers need comprehensive education and relevant information.

The past, present, and future of immunization in the Americas

The Pan American Journal of Public Health recognizes with appreciation the contributions of the members of the Editorial Committee, and authors of the Overview article. Their contributions and dedication to this issue on immunization in the Region of the Americas were extraordinary and helped make the manuscripts more interesting, more accurate, and more useful to our readers and all others who work to improve the health of the peoples of the Americas. The Journal would like to give special thanks to the General Coordination of the National Immunization Program, Department of Transmissible Disease Surveillance, Health Surveillance Secretariat, Ministry of Health, Brazil, whose financial and programmatic contributions were essential to the publication of this special issue.

Improving skills and institutional capacity to strengthen adolescent immunisation programmes and health systems in African countries through HPV vaccine introduction.

Several African countries have recently introduced or are currently introducing the HPV vaccine, either nationwide or through demonstration projects, while some countries are planning for introduction. A collaborative project was developed to strengthen country adolescent immunisation programmes and health systems in the African Region, addressing unique public health considerations of HPV vaccination: adolescents as the primary target group, delivery platforms (e.g. school-based and facility based), socio-behavioural issues, and the opportunity to deliver other health interventions alongside HPV vaccination. Following a successful "taking-stock" meeting, a training programme was drafted to assist countries to strengthen the integration of adolescent health interventions using HPV vaccination as an entry point. Two workshops were conducted in the Eastern and Southern African Regions. All countries reported on progress made during a final joint symposium. Of the 20 countries invited to participate in either of the workshops and/or final symposium, 17 countries participated: Angola, Botswana, Ethiopia, Kenya, Malawi, Mauritius, Mozambique, Namibia, Rwanda, Seychelles, South Africa, South Sudan, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe. Countries that are currently implementing HPV vaccination programmes, either nationally or through demonstration projects, reported varying degrees of integration with other adolescent health interventions. The most commonly reported adolescent health interventions alongside HPV vaccination include health education (including sexually transmitted infections), deworming and delivering of other vaccines like tetanus toxoid (TT) or tetanus diphtheria (Td). The project has successfully (a) established an African-based network that will advocate for incorporating the HPV vaccine into national immunisation programmes; (b) created a platform for experience exchange and thereby contributed to novel ideas of revitalising and strengthening school-based health programmes as delivery platform of adolescent immunisation services and other adolescent health interventions, as well as identifying ways of reaching out-of-school girls through facility and community based programmes; and (c) laid a foundation for incorporating future adolescent vaccination programmes.

Correlates of isoniazid preventive therapy failure in child household contacts with infectious tuberculosis in high burden settings in Nairobi, Kenya - a cohort study.

BACKGROUND: Sub-Saharan Africa continues to document high pediatric tuberculosis (TB) burden, especially among the urban poor. One recommended preventive strategy involves tracking and isoniazid preventive therapy (IPT) for children under 5 years in close contact with infectious TB. However, sub-optimal effectiveness has been documented in diverse settings. We conducted a study to elucidate correlates to IPT strategy failure in children below 5 years in high burden settings. METHODS: A prospective longitudinal cohort study was done in informal settlings in Nairobi, where children under 5 years in household contact with recently diagnosed smear positive TB adults were enrolled. Consent was sought. Structured questionnaires administered sought information on index case treatment, socio-demographics and TB knowledge. Contacts underwent baseline clinical screening exclude TB and/or pre-existing chronic conditions. Contacts were then put on daily isoniazid for 6 months and monitored for new TB disease, compliance and side effects. Follow-up continued for another 6 months. RESULTS: At baseline, 428 contacts were screened, and 14(3.2%) had evidence of TB disease, hence excluded. Of 414 contacts put on IPT, 368 (88.8%) completed the 1 year follow-up. Operational challenges were reported by 258(70%) households, while 82(22%) reported side effects. Good compliance was documented in 89% (CI:80.2-96.2). By endpoint, 6(1.6%) contacts developed evidence of new TB disease and required definitive anti-tuberculosis therapy. The main factor associated with IPT failure was under-nutrition of contacts (p = 0.023). CONCLUSION: Under-nutrition was associated with IPT failure for child contacts below 5 years in high burden, resource limited settings. IPT effectiveness could be optimized through nutrition support of contacts.

Mortality among 5-17 year old children in Kenya.

INTRODUCTION: Global mortality trends have changed over time and are expected to continue changing with a reduction in communicable diseases and an increase of non-communicable disease. Increased survival of children beyond five years may change mortality patterns for these children. There are few studies in Africa that explore the causes of mortality in children over five years. The objective of this study was to determine the mortality rate and clinical profiles of children aged 5-17 years who died in six Kenyan hospitals in 2013. METHODS: Retrospective review of patients' medical records to abstract data on diagnosis for those who died in year 2013. Data was analysed to provide descriptive statistics and explored differences in mortality rates between age groups and gender. RESULTS: We retrieved 4,520 patient records. The in-hospital mortality rate was 3.5% (95%CI 3.0-4.1) with variations in deaths between the ages and gender. Among the deaths, 60% suffered from communicable diseases, maternal and nutritional causes; 41.3% suffered from non-communicable diseases. A further 11.9% succumbed to traumatic injuries. The predominant clinical diagnoses among patients who died were HIV/AIDS, respiratory tract infections and malaria. CONCLUSION: Infectious causes had the highest proportion of diagnoses among children aged 5-17 years who died.

Developing guidelines in low-income and middle-income countries: lessons from Kenya.

There are few examples of sustained nationally organised, evidence-informed clinical guidelines development processes in Sub-Saharan Africa. We describe the evolution of efforts from 2005 to 2015 to support evidence-informed decision making to guide admission hospital care practices in Kenya. The approach to conduct reviews, present evidence, and structure and promote transparency of consensus-based procedures for making recommendations improved over four distinct rounds of policy making. Efforts to engage important voices extended from government and academia initially to include multiple professional associations, regulators and practitioners. More than 100 people have been engaged in the decision-making process; an increasing number outside the research team has contributed to the conduct of systematic reviews, and 31 clinical policy recommendations has been developed. Recommendations were incorporated into clinical guideline booklets that have been widely disseminated with a popular knowledge and skills training course. Both helped translate evidence into practice. We contend that these efforts have helped improve the use of evidence to inform policy. The systematic reviews, Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approaches and evidence to decision-making process are well understood by clinicians, and the process has helped create a broad community engaged in evidence translation together with a social or professional norm to use evidence in paediatric care in Kenya. Specific sustained efforts should be made to support capacity and evidence-based decision making in other African settings and clinical disciplines.