Otitis media at 6-monthly assessments of Australian First Nations children between ages 12-36 months: Findings from two randomised controlled trials of combined pneumococcal conjugate vaccines.

OBJECTIVES: In remote communities of northern Australia, First Nations children with hearing loss are disproportionately at risk of poor school readiness and performance compared to their peers with no hearing loss. The aim of this trial is to prevent early childhood persisting otitis media (OM), associated hearing loss and developmental delay. To achieve this, we designed a mixed pneumococcal conjugate vaccine (PCV) schedule that could maximise immunogenicity and thereby prevent bacterial otitis media (OM) and a trajectory of educational and social disadvantage. METHODS: In two sequential parallel, open-label, randomised controlled trials, eligible infants were first allocated 1:1:1 to standard or mixed PCV primary schedules at age 28-38 days, then at age 12 months to a booster dose (1:1) of 13-valent PCV, PCV13 (Prevenar13®, +P), or 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine, PHiD-CV10 (Synflorix®, +S). Here we report findings of standardised ear assessments conducted six-monthly from age 12-36 months, by booster dose. RESULTS: From March 2013 to September 2018, 261 children were allocated to booster + P (n = 131) or + S (n = 130). There were no significant differences in prevalence of any OM diagnosis by booster dose or when stratified by primary schedule. We found high, almost identical prevalence of OM in both boost groups at each age (for example 88% of 129 and 91% of 128 children seen, respectively, at primary endpoint age 18 months, difference -3% [95% Confidence Interval -11, 5]). At each age prevalence of bilateral OM was 52%-78%, and tympanic membrane perforation was 10%-18%. CONCLUSION: Despite optimal pneumococcal immunisation, the high prevalence of OM persists throughout early childhood. Novel approaches to OM prevention are needed, along with improved early identification strategies and evaluation of expanded valency PCVs.

Trajectories of otitis media and association with health determinants among Indigenous children in Australia: the Longitudinal Study of Indigenous Children.

OBJECTIVES: Indigenous children in Australia experience high burden of persistent otitis media (OM) from very early age. The aim was to identify distinct trajectories of OM in children up to age 10-12 years and examine the association with socio-economic determinants. STUDY DESIGN: A multistage clustered national panel survey. METHODS: The study analysed the birth cohort of the Longitudinal Study of Indigenous Children from 2008 to 2018, comprising 11 study waves. Group-based trajectory modelling was used to identify different trajectories of OM outcome. Multinomial logistic regression was applied to examine the relationship between trajectories and individual, household and community-level socio-economic determinants. RESULTS: This analysis included 894 children with at least three responses on OM over the 11 waves, and the baseline mean age was 15.8 months. Three different trajectories of OM were identified: non-severe OM prone, early/persistent severe OM and late-onset severe OM. Overall, 11.4% of the children had early/persistent severe OM from birth to 7.5 to nine years, while late-onset severe OM consisted of 9.8% of the children who had first OM from age 3.5 to five years. Children in communities with middle and the highest socio-economic outcomes have lower relative risk of early/persistent severe OM (adjusted relative risk ratio = 0.39, 95% confidence interval = 0.22-0.70 and adjusted relative risk ratio = 0.22, 95% confidence interval = 0.09-0.52, respectively) compared to children in communities with lowest socio-economic outcomes. CONCLUSION: Efforts to close the gap in the quality of life of Indigenous children must prioritise strategies that prevent severe ear disease (runny ears and perforation), including improved healthcare access, reduced household crowding, and better education, and more employment opportunities.

Overweight and obesity among non-pregnant women of reproductive age in Nigeria: findings from the 2008-2018 Nigerian Demographic and Health Survey.

OBJECTIVES: Overweight and obesity are known risk factors for diabetes, heart disease, certain cancers and pregnancy-related problems. This study aimed to determine the prevalence and change in prevalence of overweight and obesity among non-pregnant women of reproductive age and relationship with individual- and community-level factors over a decade. STUDY DESIGN: This was a cross-sectional survey with two-stage probability sampling design. METHODS: Data sets were pooled from the 2008, 2013 and 2018 Nigerian Demographic and Health Survey - a cross-sectional, nationally representative sample of the entire Nigerian population aged 15-49 years. Body mass index (BMI) was used to classify overweight and obesity. Multilevel logistic regression was used to assess associations between overweight (25.0-29.9 kg/m2), obesity (≥30.0 kg/m2) and individual and community factors. RESULTS: There were 76,729 non-pregnant women (38.0% in 2008, 44.5% in 2013 vs 17.5% in 2018) with a mean age of 29.0 years and a BMI of 23.0 kg/m2 across the three survey periods. Overweight and obesity prevalence were 16.0% and 6.2% in 2008, 17.2% and 7.5% in 2013 and 18.1% and 9.9% in 2018, respectively. There was 76% (95% confidence interval: 44% to twofold) increased odds of obesity in 2018 compared with 2008 in adjusted analysis. Older women with at least primary education living in urban areas, ever married and from wealthier households are at a greater odd of being overweight and obese. CONCLUSION: Over a decade, overweight and obesity prevalence increased among non-pregnant women of reproductive age in Nigeria. There is an urgent need for public health strategies and interventions to improve on deficient knowledge and low awareness about healthy foods and physical activity at individual and community levels especially in urban areas.

Nasopharyngeal carriage of otitis media pathogens in infants receiving 10-valent non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10), 13-valent pneumococcal conjugate vaccine (PCV13) or a mixed primary schedule of both vaccines: A randomised controlled trial.

BACKGROUND: Aboriginal children in Northern Australia have a high burden of otitis media, driven by early and persistent nasopharyngeal carriage of otopathogens, including non-typeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae (Spn). In this context, does a combined mixed primary series of Synflorix and Prevenar13 provide better protection against nasopharyngeal carriage of NTHi and Spn serotypes 3, 6A and 19A than either vaccine alone? METHODS: Aboriginal infants (n = 425) were randomised to receive Synflorix™ (S, PHiD-CV10) or Prevenar13™ (P, PCV13) at 2, 4 and 6 months (_SSS or _PPP, respectively), or a 4-dose early mixed primary series of PHiD-CV10 at 1, 2 and 4 months and PCV13 at 6 months of age (SSSP). Nasopharyngeal swabs were collected at 1, 2, 4, 6 and 7 months of age. Swabs of ear discharge were collected from tympanic membrane perforations. FINDINGS: At the primary endpoint at 7 months of age, the proportion of nasopharyngeal (Np) swabs positive for PCV13-only serotypes 3, 6A, or 19A was 0%, 0.8%, and 1.5% in the _PPP, _SSS, and SSSP groups respectively, and NTHi 55%, 52%, and 52% respectively, and no statistically significant vaccine group differences in other otopathogens at any age. The most common serotypes (in order) were 16F, 11A, 10A, 7B, 15A, 6C, 35B, 23B, 13, and 15B, accounting for 65% of carriage. Ear discharge swabs (n = 108) were culture positive for NTHi (52%), S. aureus (32%), and pneumococcus (20%). CONCLUSIONS: Aboriginal infants experience nasopharyngeal colonisation and tympanic membrane perforations associated with NTHi, non-PCV13 pneumococcal serotypes and S. aureus in the first months of life. Nasopharyngeal carriage of pneumococcus or NTHi was not significantly reduced in the early 4-dose combined SSSP group compared to standard _PPP or _SSS schedules at any time point. Current pneumococcal conjugate vaccine formulations do not offer protection from early onset NTHi and pneumococcal colonisation in this high-risk population.

Prediabetes and cardiovascular complications study (PACCS): international collaboration 4 years' summary and future direction.

OBJECTIVE: The prediabetes and cardiovascular complications studies proposes to develop a screening protocol for diabetes cardiovascular risk, and strategies for holistic management amongst others. Over 500 participants were recruited in the first 2 years of rural community research screening. Specific for this report, various published findings were reviewed. The objective is to summarize research outcomes and itemize limitations as they constitute basis of future directions. RESULTS: Affordability and availability are major confounding behavioural change wheel factors in the rural community. 4.9% prevalence of prediabetes, which may be lower or non-significantly different in urban areas. Hyperglycaemia co-morbidity with dyslipidaemia (5.0%), obesity (3.1%) and hypertension (1.8%) were observed. Limitation of the study includes participants being mostly over 60 years old, which has created impetus for the Global Alliance on Chronic Diseases agenda on vulnerability of older adults to diabetes being a new direction of the collaboration. Other directions in Australia and Nepal focus on patients with chronic kidney disease with or without cardiovascular complications. This report highlights the need to translational research.

Anthropometric indices: How they compare in screening of cardio- metabolic risks in a Nigerian sub-population.

BACKGROUND: The current anthropometric indices used for diagnosis of cardio-metabolic syndrome (CMS) in sub-Saharan Africa are those widely validated in the western world. We hereby aim to compare the sensitivity and specificity of these tools in identifying risk factors for CMS. METHOD: The study assessed body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR). Statistical analyses were performed to determine the sensitivity and specificity of WHtR in comparison with WC cut-off points recommended by the International Diabetes Federation (IDF) and the Third Adult Treatment Panel (ATPIII) as well as BMI cut-offs prescribed by the World Health Organisation (WHO). RESULT: WHtR had the highest area under the receiver operating characteristic (ROC) curve in screening CMS. WHtR >0.5 also showed highest sensitivity in both genders in identifying CMS and clusters of >2 CMS risk factors, but with lowest specificity and positive likelihood ratio (LR+). ATPIII WC cut-off revealed lowest sensitivity and highest specificity in screening CMS and >2 CMS risk factors in males (p<0.000l). IDF WC-threshold had the more stable sensitivity and specificity in males (p<0.0001) but not in females. CONCLUSION: WHtR>0.5 is more sensitive than WC and BMI recommended values in screening for CMS, but with the least positive likelihood ratio. However, more studies in other nations of sub-Saharan Africa are needed to assure evaluation of different cut points that will yield optimal specificity and sensitivity. This will help curb the problem of over-diagnosis of CMS risk factors and increase better health outcome of the population.

Prevalence of cardio-metabolic syndrome in Nigeria: a systematic review.

OBJECTIVE: This is a systematic review of the distribution of cardiometabolic syndrome (CMS) in Nigeria, the clinical definitions widely used and how it affects the proposition of a national prevalence of CMS that will advise management interventions. STUDY DESIGN: Systematic review of literature. METHODS: To present a comprehensive report of the distribution of CMS in Nigeria, extensive searches was carried out on PubMed, African Journals Online (AJOL), SCOPUS, EBSCOhost (CINAHL Plus), Google Scholar and Science Direct using terms: Nigeria, metabolic syndrome, cardio-metabolic syndrome, syndrome X, World Health Organization, International Diabetic Federation, National Cholesterol Education Program Adult Treatment Panel III, European Group for study on Insulin Resistance, American Association of Clinical Endocrinologist, American Heart Association/National Heart, Lung and Blood Institute. All published data between January 2002 and December 2013 were collated into a database. Information gathered and recorded for each source were the population sampled, age and number of population, locality, clinical definition used, longitude and latitude, and period of the study. RESULTS: Out of 32 studies, 9 (28.1%) adopted the WHO classification, 19 (59.4%) used the ATPIII definition, while the remaining 10 (31.3%) studies used the IDF definitions. Twenty (62.5%) were hospital-based studies on diabetic, hypertensive, HIV, asthmatic and thyroid disorder patients. The remaining 12 (37.5%) studies were population-based studies in urban, suburb and rural settings. The mean overall prevalence of CMS in Nigeria is 31.7%, 27.9% and 28.1% according to the WHO, ATPIII and IDF definitions, respectively. Most of the studies were from the Southern region. Age groups mostly studied were those from ≥35 years. CONCLUSION: The report of this review provides an essential overview on the current distribution of CMS in Nigeria. It provides an insight to direct future studies such as the need to (1) study rural communities where lifestyles are not westernized as in the urban areas, and (2) young adults, as well as (3) develop a consensus on the definition of CMS among the Sub-Saharan African populations.

Metabolic syndrome and prediabetes in ndokwa community of Nigeria: preliminary study.

BACKGROUND: Global prevalence of metabolic syndrome (MS) and diabetes is increasing, but the reference ranges for MS indices have yet to be established for sub-Saharan African countries. As part of the international research collaboration agenda for Prediabetes and Cardiovascular Complications Study (PACCS), a pilot study was conducted in one of the Ndokwa communities of Nigeria in 2013. AIM: The study was to obtain preliminary indication of prevalence and reference values of MS in the rural communities of a low-mid income country. MATERIALS AND METHODS: Seventy-four volunteer participants were recruited, after public lectures in high schools and churches in the community. Body mass index (BMI), blood pressure and waist circumference (WC), blood glucoselevel, and lipid profile were measured. Percentage prevalence MS was determined using commonest three criteria (Third Adult Treatment Panel (ATP III) 2001, International Diabetes Federation (IDF) 2005, and World Health Organization (WHO) 1999). RESULTS: When individual indices of MS are considered separately; the males seem healthier than females. However, the prevalence of high-density lipoprotein (HDL) cholesterol was higher in males than in females. Equal 3% prevalence of MS was seen in both genders using the WHO standard. Other criteria show prevalence of 8% females and 11% males (ATP III), 5% females and 8% males (IDF 2005 European), and 14% females and 17% males (IDF 2005 Ethnic). CONCLUSION: The prevalence of MS is higher in males than females; and relative to ATP III 2001 criteria, either the IDF 2005 European may underestimate MS, or the ethnic specific could overestimate the prevalence. Hence, it is important to define the criteria to be used.