The conduct of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review

Objectives and importance of study: Values and ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (Values and ethics) describes key values that should underpin Aboriginal and Torres Strait Islander (Indigenous)-focused health research. It is unclear how research teams address this document in primary health care research. We systematically review the primary health care literature focusing on Indigenous social and emotional wellbeing (SEWB) to identify how Values and ethics and community preferences for standards of behaviour (local protocols) are addressed during research. Systematic review in accordance with PRISMA Guidelines and MOOSE Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies. We searched four databases and one Indigenous-specific website for qualitative, quantitative and mixed-method studies published since Values and ethics was implemented (2003). Included studies were conducted in primary health care services, focused on Indigenous SEWB and were conducted by research teams. Using standard data extraction forms, we identified actions taken (reported by authors or identified by us) relating to Values and ethics and local protocols. A total of 25 studies were included. Authors of two studies explicitly mentioned the Values and ethics document, but neither reported how their actions related to the document's values. In more than half the studies, we identified at least three actions relating to the values. Some actions related to multiple values, including use of culturally sensitive research processes and involving Indigenous representatives in the research team. Local protocols were rarely reported. Addressing Values and ethics appears to improve research projects. The academic community should focus on culturally sensitive research processes, relationship building and developing the Indigenous research workforce, to facilitate acceptable research that affects health outcomes. For Values and ethics to achieve its full impact and to improve learning between research teams, authors should be encouraged to report how the principles are addressed during research, including barriers and enablers that are encountered

The quality of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review

Objectives and importance of the study: Primary health care research focused on Aboriginal and Torres Strait Islander (Indigenous) people is needed to ensure that key frontline services provide evidence based and culturally appropriate care. We systematically reviewed the published primary health care literature to identify research designs, processes and outcomes, and assess the scientific quality of research focused on social and emotional wellbeing. This will inform future research to improve evidence based, culturally appropriate primary health care. Systematic review in accordance with PRISMA and MOOSE guidelines. Four databases and one Indigenous-specific project website were searched for qualitative, quantitative and mixed-method published research. Studies that were conducted in primary health care services and focused on the social and emotional wellbeing of Indigenous people were included. Scientific quality was assessed using risk-of-bias assessment tools that were modified to meet our aims. We assessed community acceptance by identifying the involvement of community governance structures and representation during research development, conduct and reporting. Data were extracted using standard forms developed for this review. We included 32 articles, which reported on 25 studies. Qualitative and mixed methods were used in 18 studies. Twelve articles were judged as high or unclear risk of bias, four as moderate and five as low risk of bias. Another four studies were not able to be assessed as they did not align with the risk-of-bias tools. Of the five articles judged as low risk of bias, two also had high community acceptance and both of these were qualitative. One used a phenomenological approach and the other combined participatory action research with a social-ecological perspective and incorporated 'two-way learning' principles. Of the 16 studies where a primary outcome was identified, eight aimed to identify perceptions or experiences. The remaining studies assessed resources, or evaluated services, interventions, programs or policies. We were unable to identify primary outcomes in eight studies. Conducting Indigenous-focused primary health care research that is scientifically robust, culturally appropriate and produces community-level outcomes is challenging. We suggest that research teams use participatory, culturally sensitive approaches and collaborate closely to plan and implement high-quality research that incorporates local perspectives. Research should result in beneficial outcomes for the communities involved

Poor food and nutrient intake among Indigenous and non-Indigenous rural Australian children

<p>Abstract</p> <p>Background</p> <p>The purpose of this study was to describe the food and nutrient intake of a population of rural Australian children particularly Indigenous children. Participants were aged 10 to 12 years, and living in areas of relative socio-economic disadvantage on the north coast of New South Wales.</p> <p>Methods</p> <p>In this descriptive cross-sectional study 215 children with a mean age of 11.30 (SD 0.04) years (including 82 Indigenous children and 93 boys) completed three 24-hour food recalls (including 1 weekend day), over an average of two weeks in the Australian summer of late 2005.</p> <p>Results</p> <p>A high proportion of children consumed less than the Australian Nutrient Reference Values for fibre (74-84% less than Adequate Intake (AI)), calcium (54-86% less than Estimated Average Requirement (EAR)), folate and magnesium (36% and 28% respectively less than EAR among girls), and the majority of children exceeded the upper limit for sodium (68-76% greater than Upper Limit (UL)). Energy-dense nutrient-poor (EDNP) food consumption contributed between 45% and 49% to energy. Hot chips, sugary drinks, high-fat processed meats, salty snacks and white bread were the highest contributors to key nutrients and sugary drinks were the greatest <it>per capita </it>contributor to daily food intake for all. <it>Per capita </it>intake differences were apparent by Indigenous status. Consumption of fruit and vegetables was low for all children. Indigenous boys had a higher intake of energy, macronutrients and sodium than non-Indigenous boys.</p> <p>Conclusions</p> <p>The nutrient intake and excessive EDNP food consumption levels of Australian rural children from disadvantaged areas are cause for concern regarding their future health and wellbeing, particularly for Indigenous boys. Targeted intervention strategies should address the high consumption of these foods.</p

Baseline Morbidity in 2,990 Adult African Volunteers Recruited to Characterize Laboratory Reference Intervals for Future HIV Vaccine Clinical Trials

BACKGROUND: An understanding of the health of potential volunteers in Africa is essential for the safe and efficient conduct of clinical trials, particularly for trials of preventive technologies such as vaccines that enroll healthy individuals. Clinical safety laboratory values used for screening, enrolment and follow-up of African clinical trial volunteers have largely been based on values derived from industrialized countries in Europe and North America. This report describes baseline morbidity during recruitment for a multi-center, African laboratory reference intervals study. METHODS: Asymptomatic persons, aged 18-60 years, were invited to participate in a cross-sectional study at seven sites (Kigali, Rwanda; Masaka and Entebbe, Uganda; Kangemi, Kenyatta National Hospital and Kilifi, Kenya; and Lusaka, Zambia). Gender equivalency was by design. Individuals who were acutely ill, pregnant, menstruating, or had significant clinical findings were not enrolled. Each volunteer provided blood for hematology, immunology, and biochemistry parameters and urine for urinalysis. Enrolled volunteers were excluded if found to be positive for HIV, syphilis or Hepatitis B and C. Laboratory assays were conducted under Good Clinical Laboratory Practices (GCLP). RESULTS AND CONCLUSIONS: Of the 2990 volunteers who were screened, 2387 (80%) were enrolled, and 2107 (71%) were included in the analysis (52% men, 48% women). Major reasons for screening out volunteers included abnormal findings on physical examination (228/603, 38%), significant medical history (76, 13%) and inability to complete the informed consent process (73, 13%). Once enrolled, principle reasons for exclusion from analysis included detection of Hepatitis B surface antigen (106/280, 38%) and antibodies against Hepatitis C (95, 34%). This is the first large scale, multi-site study conducted to the standards of GCLP to describe African laboratory reference intervals applicable to potential volunteers in clinical trials. Approximately one-third of all potential volunteers screened were not eligible for analysis; the majority were excluded for medical reasons

CLSI-Derived Hematology and Biochemistry Reference Intervals for Healthy Adults in Eastern and Southern Africa

BACKGROUND: Clinical laboratory reference intervals have not been established in many African countries, and non-local intervals are commonly used in clinical trials to screen and monitor adverse events (AEs) among African participants. Using laboratory reference intervals derived from other populations excludes potential trial volunteers in Africa and makes AE assessment challenging. The objective of this study was to establish clinical laboratory reference intervals for 25 hematology, immunology and biochemistry values among healthy African adults typical of those who might join a clinical trial. METHODS AND FINDINGS: Equal proportions of men and women were invited to participate in a cross sectional study at seven clinical centers (Kigali, Rwanda; Masaka and Entebbe, Uganda; two in Nairobi and one in Kilifi, Kenya; and Lusaka, Zambia). All laboratories used hematology, immunology and biochemistry analyzers validated by an independent clinical laboratory. Clinical and Laboratory Standards Institute guidelines were followed to create study consensus intervals. For comparison, AE grading criteria published by the U.S. National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) and other U.S. reference intervals were used. 2,990 potential volunteers were screened, and 2,105 (1,083 men and 1,022 women) were included in the analysis. While some significant gender and regional differences were observed, creating consensus African study intervals from the complete data was possible for 18 of the 25 analytes. Compared to reference intervals from the U.S., we found lower hematocrit and hemoglobin levels, particularly among women, lower white blood cell and neutrophil counts, and lower amylase. Both genders had elevated eosinophil counts, immunoglobulin G, total and direct bilirubin, lactate dehydrogenase and creatine phosphokinase, the latter being more pronounced among women. When graded against U.S. -derived DAIDS AE grading criteria, we observed 774 (35.3%) volunteers with grade one or higher results; 314 (14.9%) had elevated total bilirubin, and 201 (9.6%) had low neutrophil counts. These otherwise healthy volunteers would be excluded or would require special exemption to participate in many clinical trials. CONCLUSIONS: To accelerate clinical trials in Africa, and to improve their scientific validity, locally appropriate reference ranges should be used. This study provides ranges that will inform inclusion criteria and evaluation of adverse events for studies in these regions of Africa

Review of Short-Form Questions for the Evaluation of a Diet, Physical Activity, and Sedentary Behaviour Intervention in a Community Program Targeting Vulnerable Australian Children

Childhood obesity is associated with low socioeconomic status in developed countries, and community programs can deliver cost-effective obesity interventions to vulnerable children and adolescents at scale. Evaluating these programs in a low-cost, time-efficient, and culturally appropriate way with valid and reliable measures is essential to determining their effectiveness. We aimed to identify existing valid and reliable short-form instruments (&le;50 items for diet, &le;15 items for physical activity) suitable for the assessment of change in diet, physical activity, and sedentary behaviour in an Australian obesity intervention program for children and adolescents aged 7&ndash;13 years from low socioeconomic groups, with a focus on Aboriginal and Torres Strait Islander children. Relevant electronic databases were searched, with a focus on Australian literature. Validity and/or reliability studies using diet instruments (5), physical activity/sedentary behaviour instruments (12), and diet and physical activity/sedentary behaviour instruments used with Aboriginal and Torres Strait Islander (3) children were identified. Seven questions on diet, one question on physical activity, and no questions on sedentary behaviour were recommended. These questions can be used for evaluation in community-based obesity programs among Australian children and adolescents, including those from low socioeconomic groups and Aboriginal and Torres Strait Islander children

The reliability and validity of a short FFQ among Australian Aboriginal and Torres Strait Islander and non-Indigenous rural children

Objective: To determine the reproducibility and validity of a short FFQ (SFFQ) for Australian rural children aged 10 to 12 years, particularly Aboriginal and Torres Strait Islander children. Design: In this cross-sectional study participants completed the SFFQ on two occasions and three 24 h recalls. Concurrent validity was established by comparing results of the first SFFQ against food recalls; reproducibility was established by comparing the two SFFQ. Setting: The north coast of New South Wales in the Australian summer of late 2005. Subjects: Two hundred and forty-one children (ninety-two Aboriginal and Torres Strait Islander children and 100 boys) completed two SFFQ and were included in the reproducibility study; of these, 205 participants with a mean age of 10·8 (sd 0·7) years took part in the validity study.Results: The SFFQ showed moderate to good reproducibility among all children with kappa coefficients for repeated measures between 0·41 and 0·80. Eighteen of twenty-three questions demonstrated good validity against the mean of the 24 h recalls, with statistically significant increasing trends (P ≤ 0·05) for mean daily weight and/or frequency as survey response categories increased. A similar number of short questions showed good validity for Aboriginal and Torres Strait Islander children as for their non-Indigenous counterparts. Conclusions: Many short questions in this SFFQ are able to discriminate between different categories of food intake and provide information on relative intake within the given population. They can be used to monitor and/or evaluate population-wide health programmes, including those with rural Aboriginal and Torres Strait Islander children

Humoral Immune Response to mRNA COVID-19 Vaccination Among Children 5-11 in a Multisite Prospective Cohort study, September 2021-September 2022

Abstract Background The PROTECT study is a longitudinal cohort study initiated in July 2021 with weekly testing for SARS-CoV-2 in four states: Arizona, Florida, Texas, and Utah. This study aims to examine the protective effect of vaccine-elicited antibody response against post-vaccination SARS-CoV-2 infections. Methods Participants, children aged 5-11, had serum collected 14-59 days after second dose of monovalent Pfizer-BioNTech COVID-19 mRNA vaccine. Vaccine-elicited antibodies were measured by area under the curve (AUC) and endpoint titer by ELISA (RBD and S2) and surrogate neutralization (SN) assays against ancestral (WA1) and Omicron (BA.2). Results Among 79 vaccinated participants, (33 [41.7%] female; median age 8.8 [SD 1.9] years), 48 (60.8%) were from Tucson, Arizona, 64 (81.0%) were non-Hispanic white, 63 (80.8%) attended school in person, 68 (86.1%) did not have any chronic conditions, 56 (72.7%) did not take daily medications; and 47 (59.5%) were infected after vaccination. Uninfected children had higher AUCs after vaccination against WA1 (p = 0.0093) and Omicron (p = 0.018). The geometric mean SN titer above the limit of detection was 346.0 for WA1 and 39.7 for Omicron, an 8.7-fold decrease (p = <0.0001). After adjustment of covariates in the WA1-specific model, we observed a 47% reduction in the odds of a post-vaccination infection for every standard deviation increase of RBD AUC (aOR: 0.53, 95% CI: 0.29, 0.97) and a 69% reduction in the odds of infection for every three-fold increase in RBD end titer, (aOR: 0.31, 95% CI: 0.06, 1.57). Conclusion Children with higher antibody levels experienced lower incidence of post-vaccination SARS-CoV-2 infection