Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline.

BACKGROUND: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. METHODS: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. DISCUSSION: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

Interventions for treating neuropathic pain in people with sickle cell disease.

BACKGROUND: Pain is the hallmark of sickle cell disease (SCD) and it can be severe, frequent and unpredictable. Although nociceptive pain is more common, at times, people with SCD may have neuropathic pain. The latter can occur due to peripheral or central nerve injury. This review is focused on identifying treatment of only painful sensory neuropathy in people with SCD. OBJECTIVES: To determine the effectiveness and safety of any pharmacological or non-pharmacological therapies for treating neuropathic pain in people with SCD. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched trial registries, the reference lists of relevant articles and reviews and contacted experts in the field.Date of last search: 31 January 2019. SELECTION CRITERIA: Randomised controlled trials (RCTs) (parallel or cross-over in design), quasi-RCTs of pharmacological or non-pharmacological therapies for treating neuropathic pain in people with SCD compared to placebo or another intervention in any category (i.e. pharmacological or non-pharmacological). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed all trials identified by the searches and extracted relevant data. Two authors independently assessed the risk of bias in the selected trials using the Cochrane risk of bias tool. Two review authors independently rated the quality of the evidence for each outcome using the GRADE guidelines. MAIN RESULTS: One RCT of 22 participants with SCD, conducted in the USA was included in this review. Participants were randomly assigned to either pregabalin (n = 11) or placebo (n = 11). Oral pregabalin was administered at an initial dose of 75 mg twice daily. The drug was titrated at increments of 75 mg to a maximum of 600 mg daily or decreased by 75 mg per day if necessary, based on clinical presentation and pain level. Neuropathic pain was assessed using self-reports on the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS) scale and the Neuropathic Pain Symptom Inventory (NPSI), where higher scores were indicative of more pain. Outcomes included self-reported pain, quality of life and withdrawal due to adverse effects measured at baseline and monthly for three months post-intervention. The overall risk of bias was low with a high risk of bias due to attrition.In relation to this reviews primary outcomes, for self-reported neuropathic pain relief, given the paucity of data, we are very uncertain whether there is a difference between the pregabalin and placebo groups at the end of three months as measured by the S-LANSS scale, mean difference (MD) -2.00 (95% confidence interval (CI) -9.18 to 5.18), or the NPSI scale, MD -11.10 (95% CI -33.97 to 11.77) (very low-quality evidence). There was no report of 'Patient Global Impression of Change' in the included trial.Although the mean quality of life scores (Short Form-36) at three months showed small increases in seven of the eight domains post-intervention in the pregabalin group as compared to the placebo group, this was very low-quality evidence and we are very uncertain whether pregabalin increases quality of life. Neither of our pre-defined outcomes of 'time to improvement of symptoms' or 'changes in sleep quality', were measured in the included trial.While treatment-related adverse effects appeared higher in pregabalin group than the placebo group at three months, this was very low-quality evidence and we are very uncertain whether there is a difference, RR 1.33 (95% CI 0.39 to 4.62) (very low-quality evidence). There was one withdrawal for adverse effects in the pregabalin group while three people withdrew or dropped out from the placebo group due to adverse effects and complications and hospitalisation related to SCD. AUTHORS' CONCLUSIONS: The included trial provided very low-quality evidence. Self-reported pain relief was greater in the pregabalin group compared to the placebo control group but only using the S-LANSS scale and we are very unsure whether there is a difference. While the pregabalin group tended to have improved quality of life over the duration of the trial, this was very low-quality evidence and we are uncertain whether there is a difference. Adverse effects and withdrawals were similar across the treatment and placebo control group in trial. There are both insufficient trials addressing this review question and insufficient outcomes addressed in the single included RCT. Therefore, there is still a significant gap in evidence on interventions for neuropathic pain in people with SCD.

Educational health disparities in hypertension and diabetes mellitus among African descent populations in the Caribbean and the USA: a comparative analysis from the Spanish town cohort (Jamaica) and the Jackson heart study (USA).

BACKGROUND: Studies have suggested that social inequalities in chronic disease outcomes differ between industrialized and developing countries, but few have directly compared these effects. We explored inequalities in hypertension and diabetes prevalence between African-descent populations with different levels of educational attainment in Jamaica and in the United States of America (USA), comparing disparities within each location, and between countries. METHODS: We analyzed baseline data from the Jackson Heart Study (JHS) in the USA and Spanish Town Cohort (STC) in Jamaica. Participants reported their highest level of educational attainment, which was categorized as 'less than high school' (HS). Educational disparities in the prevalence of hypertension and diabetes were examined using prevalence ratios (PR), controlling for age, sex and body mass index (BMI). RESULTS: Analyses included 7248 participants, 2382 from STC and 4866 from JHS, with mean age of 47 and 54 years, respectively (p < 0.001). Prevalence for both hypertension and diabetes was significantly higher in the JHS compared to STC, 62% vs. 25% (p < 0.001) and 18% vs. 13% (p < 0.001), respectively. In bivariate analyses there were significant disparities by education level for both hypertension and diabetes in both studies; however, after accounting for confounding or interaction by age, sex and BMI these effects were attenuated. For hypertension, after adjusting for age and BMI, a significant education disparity was found only for women in JHS, with PR of 1.10 (95% CI 1.04-1.16) for < HS vs > HS and 1.07 (95% CI 1.01-1.13) for HS vs > HS. For diabetes; when considering age-group and sex specific estimates adjusted for BMI, among men: significant associations were seen only in the 45-59 years age-group in JHS with PR 1.84 (95% CI 1.16-2.91) for < HS vs > HS. Among women, significant PR comparing < HS to > HS was seen for all three age-groups for JHS, but not in STC; PR were 3.95 (95% CI 1.94-8.05), 1.53 (95% CI 1.10-2.11) and 1.32 (95% CI 1.06-1.64) for 25-44, 45-59 and 60-74 age-groups, respectively. CONCLUSION: In Jamaica, educational disparities were largely explained by age, sex and BMI, while in the USA these disparities were larger and persisted after accounting these variables.

Interventions for patients and caregivers to improve knowledge of sickle cell disease and recognition of its related complications.

BACKGROUND: Sickle cell disease is a group of genetic diseases which is especially prevalent in tropical and subtropical regions; however, forced migration and ongoing population movement have spread it throughout the world, with estimated birth rates reaching 0.49 per 1000 in the Americas, 0.07 per 1000 in Europe, 0.68 per 1000 in South and Southeast Asia, and 10.68 per 1000 in Africa. Life for individuals with sickle cell disease can be affected by repeated acute complications and compounded by progressive organ damage. Studies reveal that when people with chronic illness learn self-management, their clinical outcomes and quality of life improves; and they show lower dependence on healthcare services. There are, however, no reviews identifying which interventions improve knowledge and little is known about the impact of patient or care-giver knowledge on clinical and psychosocial outcomes in people with sickle cell disease. OBJECTIVES: 1. To determine the effectiveness of patient- and caregiver-centred educational interventions for changing knowledge and understanding of sickle cell disease among patients as well as caregivers of people with the disease.2. To assess the effectiveness and safety of patient- and caregiver-centred educational interventions and programs for the recognition of signs and symptoms of disease-related morbidity, adherence to treatment and healthcare utilization in patients with sickle cell disease. SEARCH METHODS: The authors searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Additional trials were sought from the reference lists of the trials and reviews identified by the search strategy.Date of last search: 11 April 2016. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials which evaluate the effectiveness of individual- and group-based interventions for either the patient with sickle cell disease or their caregivers, or both. Eligible interventions will aim to change knowledge, attitudes or skills, improve psychosocial aspects of the disease as well as treatment adherence and healthcare utilization. Trials evaluating the intervention versus no program, comparing two interventions and those which are part of a multi-faceted intervention to improve a range of sickle cell-related health outcomes are all eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials based on stated inclusion criteria and thereafter examined each selected report to extract data using a prepared, piloted, data collection form. A third author assisted in reaching consensus if there were any discrepancies. Similarly, risk of bias was assessed by two authors and verified by a third author. MAIN RESULTS: A total of 12 trials (11 randomized controlled trials and one quasi-randomized trial) of 563 people with HbSS, HbSC or HbSßthal, aged six to 35 years old, were included in the review; the majority of participants were African-American. Interventions ranged from a total of one hour to weekly sessions for eight weeks and the post-intervention assessments ranged from the end of the intervention period to 12 months after completion. The heterogeneity of the included trials, which encompasses setting, inclusion and exclusion criteria, interventional method and time of assessment, ranged from 'not important' to 'moderate to substantial' for different review outcomes. The overall risk of bias was low for selective reporting, unclear for random sequence generation, allocation concealment, blinding of participants and blinding of outcome assessment. Incomplete outcome reporting and blinding of personnel showed mixed bias representations.Patient knowledge was assessed by four trials (160 participants) with moderate to substantial heterogeneity. There was evidence that educational programs improved patient knowledge, standardised mean difference 0.87 points (95% confidence interval 0.28 to 1.45, moderate quality evidence), which improved further when a trial with high bias was removed in a sensitivity analysis. Caregiver knowledge, reported in a single trial of 20 families, also showed an improvement, standardised mean difference 0.52 points (95% confidence interval 0.03 to 1.00, moderate quality evidence). The effect on patient knowledge was sustained at longer follow-up periods, whereas the effect on caregiver knowledge was not sustained.There were two primary outcomes related to the effectiveness of educational programs on the recognition of signs and symptoms of disease-related morbidity. No comparative data were reported for patients or caregivers (or both) recognising signs and symptoms leading to self-management. Data from two trials were analysed for the utilization of health services and showed no evidence of an effect, mean difference 0.33 (95% confidence interval -0.57 to 1.23, moderate quality evidence).With regard to the review's secondary outcomes, depression showed a statistically significant decline in intervention groups, standardised mean difference -0.66 points (95% confidence interval -1.18, to -0.14, moderate quality evidence). Adherence to treatment was not assessed in any of the identified trials. No effects of interventions were seen on coping, family relationships or health-related quality of life of patients.The quality of evidence was low for positive coping and moderate for child knowledge, healthcare utilization and depression. This suggests that further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimates. AUTHORS' CONCLUSIONS: This review identifies important positive effects of educational interventions on improving patient knowledge of sickle cell disease and depression. Effects on patients' knowledge were maintained for longer than for caregivers. The effect on knowledge was significant but small and whether it offers any clinical benefit is uncertain. Significant factors limiting these effects could be trials being under powered as well as attrition rates. Effects were not statistically significant in assessments of secondary outcomes, possibly due to the paucity of the number of trials and patients and caregivers. Trials showed moderate to high heterogeneity which might impact the results. To better study effects on outcomes, further controlled trials are needed with rigorous attention given to improve recruitment and retention and to decrease bias. Predetermined protocols using similar measurements should be used across multiple sites.

Disparities in hypertension among black Caribbean populations: a scoping review by the U.S. Caribbean Alliance for Health Disparities Research Group (USCAHDR).

BACKGROUND: Despite the large body of research on racial/ethnic disparities in health, there are limited data on health disparities in Caribbean-origin populations. This scoping review aimed to analyze and synthesize published and unpublished literature on the disparities in hypertension and its complications among Afro-Caribbean populations. METHODS: A comprehensive protocol, including a thorough search strategy, was developed and used to identify potentially relevant studies. Identified studies were then screened for eligibility using pre-specified inclusion/exclusion criteria. An extraction form was developed to chart data and collate study characteristics including methods and main findings. Charted information was tagged by disparity indicators and thematic analysis performed. Disparity indicators evaluated include ethnicity, sex, socioeconomic status, disability, sexual orientation and geographic location. Gaps in the literature were identified and extrapolated into a gap map. RESULTS: A total of 455 hypertension related records, published between 1972 and 2012, were identified and screened. Twenty-one studies met inclusion criteria for detailed analysis. The majority of studies were conducted in the United Kingdom and utilized a cross-sectional study design. Overall, studies reported a higher prevalence of hypertension among Caribbean blacks compared to West African blacks and Caucasians. Hypertension and its related complications were highest in persons with low socioeconomic status. Gap analysis showed limited research data reporting hypertension incidence by sex and socioeconomic status. No literature was found on disability status or sexual orientation as it relates to hypertension. Prevalence and morbidity were the most frequently reported outcomes. CONCLUSION: The literature on hypertension health disparities in Caribbean origin populations is limited. Future research should address these knowledge gaps and develop approaches to reduce them.

Disparities in diabetes mellitus among Caribbean populations: a scoping review.

BACKGROUND: Despite the large body of research on racial/ethnic disparities in health, there are limited data on health disparities in Caribbean origin populations. This review aims to analyze and synthesize published literature on the disparities in diabetes mellitus (DM) and its complications among Afro-Caribbean populations. METHODS: A detailed protocol, including a comprehensive search strategy, was developed and used to identify potentially relevant studies. Identified studies were then screened for eligibility using pre-specified inclusion and exclusion criteria. An extraction form was developed to chart data and collate study characteristics including methods and main findings. Charted information was tagged by disparity indicators and thematic analysis performed. Disparity indicators evaluated include ethnicity, sex, age, socioeconomic status, disability and geographic location. Gaps in the literature were identified and extrapolated into a gap map. RESULTS: A total of 1009 diabetes related articles/manuscripts, published between 1972 and 2013, were identified and screened. Forty-three studies met inclusion criteria for detailed analysis. Most studies were conducted in the United Kingdom, Trinidad and Tobago and Jamaica, and used a cross-sectional study design. Overall, studies reported a higher prevalence of DM among Caribbean Blacks compared to West African Blacks and Caucasians but lower when compared to South Asian origin groups. Morbidity from diabetes-related complications was highest in persons with low socioeconomic status. Gap analysis showed limited research data reporting diabetes incidence by sex and socioeconomic status. No published literature was found on disability status or sexual orientation as it relates to diabetes burden or complications. Prevalence and morbidity were the most frequently reported outcomes. CONCLUSION: Literature on diabetes health disparities in Caribbean origin populations is limited. Future research should address these knowledge gaps and develop approaches to reduce them.

Oral protein calorie supplementation for children with chronic disease.

BACKGROUND: Poor growth and nutritional status are common in children with chronic diseases. Oral protein calorie supplements are used to improve nutritional status in these children. These expensive products may be associated with some adverse effects, e.g. the development of inappropriate eating behaviour patterns. This is a new update of a Cochrane review last updated in 2009. OBJECTIVES: To examine evidence that in children with chronic disease, oral protein calorie supplements alter daily nutrient intake, nutritional indices, survival and quality of life and are associated with adverse effects, e.g. diarrhoea, vomiting, reduced appetite, glucose intolerance, bloating and eating behaviour problems. SEARCH METHODS: Trials of oral protein calorie supplements in children with chronic diseases were identified through comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. Companies marketing these products were also contacted.Most recent search of the Group's Trials Register: 24 February 2015. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing oral protein calorie supplements for at least one month to increase calorie intake with existing conventional therapy (including advice on improving nutritional intake from food or no specific intervention) in children with chronic disease. DATA COLLECTION AND ANALYSIS: We independently assessed the outcomes: indices of nutrition and growth; anthropometric measures of body composition; calorie and nutrient intake (total from oral protein calorie supplements and food); eating behaviour; compliance; quality of life; specific adverse effects; disease severity scores; and mortality; we also assessed the risk of bias in the included trials. MAIN RESULTS: Four studies (187 children) met the inclusion criteria. Three studies were carried out in children with cystic fibrosis and one study included children with paediatric malignant disease. Overall there was a low risk of bias for blinding and incomplete outcome data.Two studies had a high risk of bias for allocation concealment. Few statistical differences were found in the outcomes we assessed between treatment and control groups, except change in total energy intake at six and 12 months, mean difference 304.86 kcal per day (95% confidence interval 5.62 to 604.10) and mean difference 265.70 kcal per day (95% confidence interval 42.94 to 485.46), respectively. However, these were based on the analysis of just 58 children in only one study. Only two chronic diseases were included in these analyses, cystic fibrosis and paediatric malignant disease. No other studies were identified which assessed the effectiveness of oral protein calorie supplements in children with other chronic diseases. AUTHORS' CONCLUSIONS: Oral protein calorie supplements are widely used to improve the nutritional status of children with a number of chronic diseases. We identified a small number of studies assessing these products in children with cystic fibrosis and paediatric malignant disease, but were unable to draw any conclusions based on the limited data extracted. We recommend a series of large, randomised controlled trials be undertaken investigating the use of these products in children with different chronic diseases. Until further data are available, we suggest these products are used with caution.

Food supplementation for improving the physical and psychosocial health of socio-economically disadvantaged children aged three months to five years.

BACKGROUND: Undernutrition contributes to five million deaths of children under five each year. Furthermore, throughout the life cycle, undernutrition contributes to increased risk of infection, poor cognitive functioning, chronic disease, and mortality. It is thus important for decision-makers to have evidence about the effectiveness of nutrition interventions for young children. OBJECTIVES: Primary objective1. To assess the effectiveness of supplementary feeding interventions, alone or with co-intervention, for improving the physical and psychosocial health of disadvantaged children aged three months to five years.Secondary objectives1. To assess the potential of such programmes to reduce socio-economic inequalities in undernutrition.2. To evaluate implementation and to understand how this may impact on outcomes.3. To determine whether there are any adverse effects of supplementary feeding. SEARCH METHODS: We searched CENTRAL, Ovid MEDLINE, PsycINFO, and seven other databases for all available years up to January 2014. We also searched ClinicalTrials.gov and several sources of grey literature. In addition, we searched the reference lists of relevant articles and reviews, and asked experts in the area about ongoing and unpublished trials. SELECTION CRITERIA: Randomised controlled trials (RCTs), cluster-RCTs, controlled clinical trials (CCTs), controlled before-and-after studies (CBAs), and interrupted time series (ITS) that provided supplementary food (with or without co-intervention) to children aged three months to five years, from all countries. Adjunctive treatments, such as nutrition education, were allowed. Controls had to be untreated. DATA COLLECTION AND ANALYSIS: Two or more review authors independently reviewed searches, selected studies for inclusion or exclusion, extracted data, and assessed risk of bias. We conducted meta-analyses for continuous data using the mean difference (MD) or the standardised mean difference (SMD) with a 95% confidence interval (CI), correcting for clustering if necessary. We analysed studies from low- and middle-income countries and from high-income countries separately, and RCTs separately from CBAs. We conducted a process evaluation to understand which factors impact on effectiveness. MAIN RESULTS: We included 32 studies (21 RCTs and 11 CBAs); 26 of these (16 RCTs and 10 CBAs) were in meta-analyses. More than 50% of the RCTs were judged to have low risk of bias for random selection and incomplete outcome assessment. We judged most RCTS to be unclear for allocation concealment, blinding of outcome assessment, and selective outcome reporting. Because children and parents knew that they were given food, we judged blinding of participants and personnel to be at high risk for all studies.Growth. Supplementary feeding had positive effects on growth in low- and middle-income countries. Meta-analysis of the RCTs showed that supplemented children gained an average of 0.12 kg more than controls over six months (95% confidence interval (CI) 0.05 to 0.18, 9 trials, 1057 participants, moderate quality evidence). In the CBAs, the effect was similar; 0.24 kg over a year (95% CI 0.09 to 0.39, 1784 participants, very low quality evidence). In high-income countries, one RCT found no difference in weight, but in a CBA with 116 Aboriginal children in Australia, the effect on weight was 0.95 kg (95% CI 0.58 to 1.33). For height, meta-analysis of nine RCTs revealed that supplemented children grew an average of 0.27 cm more over six months than those who were not supplemented (95% CI 0.07 to 0.48, 1463 participants, moderate quality evidence). Meta-analysis of seven CBAs showed no evidence of an effect (mean difference (MD) 0.52 cm, 95% CI -0.07 to 1.10, 7 trials, 1782 participants, very low quality evidence). Meta-analyses of the RCTs demonstrated benefits for weight-for-age z-scores (WAZ) (MD 0.15, 95% CI 0.05 to 0.24, 8 trials, 1565 participants, moderate quality evidence), and height-for-age z-scores (HAZ) (MD 0.15, 95% CI 0.06 to 0.24, 9 trials, 4638 participants, moderate quality evidence), but not for weight-for-height z-scores MD 0.10 (95% CI -0.02 to 0.22, 7 trials, 4176 participants, moderate quality evidence). Meta-analyses of the CBAs showed no effects on WAZ, HAZ, or WHZ (very low quality evidence). We found moderate positive effects for haemoglobin (SMD 0.49, 95% CI 0.07 to 0.91, 5 trials, 300 participants) in a meta-analysis of the RCTs.Psychosocial outcomes. Eight RCTs in low- and middle-income countries assessed psychosocial outcomes. Our meta-analysis of two studies showed moderate positive effects of feeding on psychomotor development (SMD 0.41, 95% CI 0.10 to 0.72, 178 participants). The evidence of effects on cognitive development was sparse and mixed.We found evidence of substantial leakage. When feeding was given at home, children benefited from only 36% of the energy in the supplement. However, when the supplementary food was given in day cares or feeding centres, there was less leakage; children took in 85% of the energy provided in the supplement. Supplementary food was generally more effective for younger children (less than two years of age) and for those who were poorer/ less well-nourished. Results for sex were equivocal. Our results also suggested that feeding programmes which were given in day-care/feeding centres and those which provided a moderate-to-high proportion of the recommended daily intake (% RDI) for energy were more effective. AUTHORS' CONCLUSIONS: Feeding programmes for young children in low- and middle-income countries can work, but good implementation is key.

Disparities in cardiovascular disease among Caribbean populations: a systematic literature review.

BACKGROUND: Cardiovascular diseases (CVD) are the predominant cause of death globally. The large health disparities in the distribution of the burden of disease seen in developed and developing countries are of growing concern. Central to this concern is the poor outcome which is seen disproportionately in socially disadvantaged groups and racial/ethnic minorities. The aim of the study was to conduct a systematic literature review to investigate the nature of cardiovascular disease health disparities among Afro-Caribbean origin populations and identify current knowledge gaps. METHODS: A systematic literature review including a detailed search strategy was developed to search MEDLINE and other research databases. Using an a priori protocol peer-reviewed publications and grey literature articles were retrieved and screened and relevant data extracted by two independent review authors. Thematic analysis was done according to CVD outcomes and measures of disparity including age, sex, ethnicity and socioeconomic status. RESULTS: The search retrieved 665 articles of which 22 met the inclusion criteria. Most studies were conducted in the United Kingdom and centered on the prevalence of CVD by ethnicity, age and sex. An important sub-theme identified was the disparities in health service utilization/hospital admission. Coronary Heart Disease (CHD) and Peripheral Arterial Disease (PAD) were less prevalent among Afro-Caribbeans compared to Caucasian and South East Asian ethnic groups. The prevalence of CHD ranged from 0-7% in Afro-Caribbean to 2-22% in Caucasians. Strokes were more common among Afro-Caribbeans. There are inadequate data on morbidity and mortality from CVD, particularly across the socio-economic gradient, in Afro-Caribbean populations. CONCLUSIONS: There are important differences in morbidity and mortality from CVD across ethnic groups. Important knowledge gaps remain in understanding the social determinants of these disparities in CVD. More research exploring these gaps by varying disparity indicators needs to be undertaken.

Centering Racial Health Equity in Systematic Reviews Paper 6: Engaging racially and ethnically diverse stakeholders in evidence syntheses.

OBJECTIVE: To inform methods for centering racial health equity in syntheses, we explored 1) how syntheses that assess health-related interventions and explicitly address racial health inequities have engaged interest holders and 2) guidance for engaging racially and ethnically diverse interest holders. STUDY DESIGN AND SETTING: We systematically identified evidence syntheses (searches limited to January 1, 2020, through January 25, 2023) and guidance documents (no search date limits) for this overview. From syntheses we extracted data on engagement rationale and processes and extracted approaches suggested from guidance documents. We summarized findings qualitatively. RESULTS: Twenty-nine of the 157 (18%) eligible syntheses reported using engagement. Syntheses typically lacked robust detail on why and how to use and structure engagement and outcomes/effects of engagement, though syntheses involving Indigenous populations typically included more detail. When reported, engagement typically occurred in early and later synthesis phases. We did not identify guidance documents that specifically intended to provide guidance for engaging racially/ethnically diverse individuals in syntheses; some related guidance described broader equity considerations or engagement in general. CONCLUSION: This review highlights gaps in understanding of the use of engagement in racial health equity-focused syntheses and in guidance specifically addressing engaging racially and ethnically diverse populations. Syntheses and guidance materials we identified reported limited data addressing the whys, hows, and whats (i.e., rationale for, approaches to, resources needed and effects of) of engagement, and we lack information for understanding whether engagement makes a difference to the conduct and findings of syntheses and when and how engagement of specific populations may contribute to centering racial health equity. A more informed understanding of these issues, facilitated by prospective and retrospective descriptions of engagement of diverse interest holders, may help advance actionable guidance and reviews.

Centering Racial Health Equity in Systematic Reviews Paper 5: A Methodological Overview of methods and interventions.

OBJECTIVE: We aim to 1) evaluate the methods used in systematic reviews of interventions focused on racialized populations to improve racial health equity, and 2) examine the types of interventions evaluated for advancing racial health equity in systematic reviews. STUDY DESIGN AND METHODS: We searched MEDLINE, Cochrane and Campbell databases for reviews evaluating interventions focused on racialized populations to mitigate racial health inequities, published from January 2020 to January 2023. RESULTS: We analyzed 157 reviews on racialized populations. Only 22 (14%) reviews addressed racism's role in driving racial health inequities related to the review question. Eleven percent (7) of reviews considered intersectionality when conceptualizing racial inequities. Two-thirds (105, 67%) provided descriptive summaries of included studies rather than synthesizing them. Among those that quantified effect sizes, 54% (21) used biased synthesis methods like vote counting. The most common method assessed was tailoring interventions to meet the needs of racialized populations. Reviews mainly focused on assessing interventions to reduce racial disparities rather than enhancing structural opportunities for racialized populations. CONCLUSIONS: Reviews for racial health equity could be improved by enhancing methodologic quality, defining the role of racism in the question, usingreliable analytical methods, and assessing process and implementation outcomes. More focus is needed on assessing structural interventions to improve opportunities for racialized populations and prioritize these issues in political and social agendas.

Centering Racial Health Equity in Systematic Reviews Paper 2: Themes from Semi-structured Interviews.

OBJECTIVE: In the context of profound and persistent racial health inequities, we sought to understand how to define racial health equity in the context of systematic reviews and how to staff, conduct, disseminate, sustain, and evaluate systematic reviews that address racial health equity. STUDY DESIGN AND SETTING: The study consisted of virtual, semi-structured interviews followed by structured coding and qualitative analyses using NVivo. RESULTS: Twenty-nine individuals, primarily US-based, including patients, community representatives, systematic reviewers, clinicians, guideline developers, primary researchers, and funders, participated in this study. These interest holders brought up systems of power, injustice, social determinants of health, and intersectionality when conceptualizing racial health equity. They also emphasized including community members with lived experience in review teams. They suggested making changes to systematic review scope, methods, and eligible evidence (such as adapting review methods to include racial health equity considerations in prioritizing topics for reviews, formulating key questions and searches, and specifying outcomes) and broadening evidence to include designs that address implementation and access. Interest holders noted that sustained efforts to center racial health equity in systematic reviews require resources, time, training, and demonstrating value to funders. CONCLUSION: Interest holders identified changes to the funding, staffing, conduct, dissemination, and implementation of systematic reviews to center racial health equity. Action on these steps requires clear standards for success, an evidence base to support transformative changes, and consensus among interest holders on the way forward.

Social support and ideal cardiovascular health in urban Jamaica: A cross-sectional study.

Recent studies have suggested that high levels of social support can encourage better health behaviours and result in improved cardiovascular health. In this study we evaluated the association between social support and ideal cardiovascular health among urban Jamaicans. We conducted a cross-sectional study among urban residents in Jamaica's south-east health region. Socio-demographic data and information on cigarette smoking, physical activity, dietary practices, blood pressure, body size, cholesterol, and glucose, were collected by trained personnel. The outcome variable, ideal cardiovascular health, was defined as having optimal levels of ≥5 of these characteristics (ICH-5) according to the American Heart Association definitions. Social support exposure variables included number of friends (network size), number of friends willing to provide loans (instrumental support) and number of friends providing advice (informational support). Principal component analysis was used to create a social support score using these three variables. Survey-weighted logistic regression models were used to evaluate the association between ICH-5 and social support score. Analyses included 841 participants (279 males, 562 females) with mean age of 47.6 ± 18.42 years. ICH-5 prevalence was 26.6% (95%CI 22.3, 31.0) with no significant sex difference (male 27.5%, female 25.7%). In sex-specific, multivariable logistic regression models, social support score, was inversely associated with ICH-5 among males (OR 0.67 [95%CI 0.51, 0.89], p = 0.006) but directly associated among females (OR 1.26 [95%CI 1.04, 1.53], p = 0.020) after adjusting for age and community SES. Living in poorer communities was also significantly associated with higher odds of ICH-5 among males, while living communities with high property value was associated with higher odds of ICH among females. In this study, higher level of social support was associated with better cardiovascular health among women, but poorer cardiovascular health among men in urban Jamaica. Further research should explore these associations and identify appropriate interventions to promote cardiovascular health.

Reporting of equity in observational epidemiology: A methodological review.

Background: Observational studies can inform how we understand and address persisting health inequities through the collection, reporting and analysis of health equity factors. However, the extent to which the analysis and reporting of equity-relevant aspects in observational research are generally unknown. Thus, we aimed to systematically evaluate how equity-relevant observational studies reported equity considerations in the study design and analyses. Methods: We searched MEDLINE for health equity-relevant observational studies from January 2020 to March 2022, resulting in 16 828 articles. We randomly selected 320 studies, ensuring a balance in focus on populations experiencing inequities, country income settings, and coronavirus disease 2019 (COVID-19) topic. We extracted information on study design and analysis methods. Results: The bulk of the studies were conducted in North America (n = 95, 30%), followed by Europe and Central Asia (n = 55, 17%). Half of the studies (n = 171, 53%) addressed general health and well-being, while 49 (15%) focused on mental health conditions. Two-thirds of the studies (n = 220, 69%) were cross-sectional. Eight (3%) engaged with populations experiencing inequities, while 22 (29%) adapted recruitment methods to reach these populations. Further, 67 studies (21%) examined interaction effects primarily related to race or ethnicity (48%). Two-thirds of the studies (72%) adjusted for characteristics associated with inequities, and 18 studies (6%) used flow diagrams to depict how populations experiencing inequities progressed throughout the studies. Conclusions: Despite over 80% of the equity-focused observational studies providing a rationale for a focus on health equity, reporting of study design features relevant to health equity ranged from 0-95%, with over half of the items reported by less than one-quarter of studies. This methodological study is a baseline assessment to inform the development of an equity-focussed reporting guideline for observational studies as an extension of the well-known Strengthening Reporting of Observational Studies in Epidemiology (STROBE) guideline.

Diabetes mellitus in Jamaica: sex differences in burden, risk factors, awareness, treatment and control in a developing country.

OBJECTIVE: The objective of this study was to provide valid estimates of the burden of and risk factors for diabetes mellitus by sex in Jamaica, a predominantly Black, middle-income and developing country. METHODS: The Jamaica Health and Lifestyle Survey 2008 examined a nationally representative sample of 2848 Jamaicans aged 15-74. Parameter estimates and 95% confidence intervals [CI] were weighted for non-response as well as age and sex of the source population. Sex differences in risk factors and diabetes prevalence, awareness, treatment and control were estimated in multivariable models. Population-attributable fractions (PAFs) of obesity on diabetes mellitus were estimated in both sexes. RESULTS: The prevalence of diabetes mellitus was 7.9% (95% CI: 6.7-9.1%), significantly higher in women than men 9.3% vs. 6.4% (P = 0.02) and increasing with age. Seventy-six percentage of persons with diabetes mellitus were aware of their status; urban women and rural men were less likely to be aware. Diabetes control (43% overall) was less common in higher-income men, but more common in higher-income women. Persons without health insurance were less likely to control their diabetes. The prevalence of diabetes risk factors was higher in women than men. Increased waist circumference (≥94 cm [men]/≥80 cm [women]), overweight/obesity (body mass index ≥ 25 kg/m(2)) and low physical activity/inactivity were associated with PAFs for diabetes mellitus of 27%, 37% and 15%, respectively, in men and 77%, 54% and 24%, respectively, in women. CONCLUSIONS: Prevalence of diabetes mellitus and its risk factors is high in Jamaica, especially among women, and national programmes to stem the diabetes mellitus epidemic should take these sex differences into consideration.

Dietary patterns as predictors of prostate cancer in Jamaican men.

Studies of diet and prostate cancer have focused primarily on food and nutrients; however, dietary patterns examine the overall diet, particularly foods eaten in combination, and risk of disease. We evaluated the association of dietary patterns and prostate cancer and low- and high-grade subgroups in Jamaican men. In a case-control study, we enrolled 243 incident cases and 273 urology controls in Jamaican clinics, March 2005-July 2007. Dietary patterns were identified using principal component analysis. Four food patterns were identified: a "vegetable and legume" pattern, a "fast food" pattern, a "meat" pattern, and a "refined carbohydrate" pattern. Men in the highest tertile for the refined carbohydrate pattern, characterized by high intakes of rice, pasta, sugar sweetened beverages, and sweet baked foods were at increased risk of total prostate cancer [odds ratio (OR) = 2.02; 95% confidence interval (CI) = 1.05-3.87 (Ptrend = 0.029)] and low-grade disease [OR = 2.91; 95% CI = 1.18-7.13 (Ptrend = 0.019)] compared with men in the lowest tertile. The vegetable and legumes pattern (healthy), meat pattern, or fast food pattern were not associated with prostate cancer risk. These data suggest a carbohydrate dietary pattern high in refined carbohydrates may be a risk factor for prostate cancer in Jamaican men.

Definitions, terminology, and related concepts of "racial health equity": a scoping review protocol.

BACKGROUND: In the USA, access to quality healthcare varies greatly across racial and ethnic groups, resulting in significant health disparities. A new term, "racial health equity" (RHE), is increasingly reported in the medical literature, but there is currently no consensus definition of the term. Additionally, related terms such as "health disparities," "health inequities," and "equality" have been inconsistently used when defining RHE. METHODS: The primary purpose of this scoping review is to investigate the current use and underlying concepts used to define racial health equity. The study will address two key questions: (1) "What terminology and definitions have been used to characterize RHE?" and (2) "What knowledge gaps and challenges are present in the current state of RHE research and theory?" The review will collect and analyze data from three sources: (1) websites from key national and international health organizations, (2) theoretical and narrative published articles, and (3) evidence synthesis studies addressing interventions targeting racial health equity and minority stakeholder engagement. DISCUSSION: Defining "racial health equity" and related terminology is the first step to advancing racial health equity within the USA. This review aims to offer an improved understanding of RHE constructs and definitions, bringing greater unity to national racial health equity research efforts across disciplines. SYSTEMATIC REVIEW REGISTRATION: This protocol is registered with the Open Science Framework at https://osf.io/7pvzq .

Adverse effects of biologics: a network meta-analysis and Cochrane overview.

BACKGROUND: Biologics are used for the treatment of rheumatoid arthritis and many other conditions. While the efficacy of biologics has been established, there is uncertainty regarding the adverse effects of this treatment. Since serious risks such as tuberculosis (TB) reactivation, serious infections, and lymphomas may be common to the biologics but occur in small numbers across the various indications, we planned to combine the results from biologics used in many conditions to obtain the much needed risk estimates. OBJECTIVES: To compare the adverse effects of tumor necrosis factor blocker (etanercept, adalimumab, infliximab, golimumab, certolizumab), interleukin (IL)-1 antagonist (anakinra), IL-6 antagonist (tocilizumab), anti-CD28 (abatacept), and anti-B cell (rituximab) therapy in patients with any disease condition except human immunodeficiency disease (HIV/AIDS). METHODS: Randomized controlled trials (RCTs), controlled clinical trials (CCTs) and open-label extension (OLE) studies that studied one of the nine biologics for use in any indication (with the exception of HIV/AIDS) and that reported our pre-specified adverse outcomes were considered for inclusion. We searched The Cochrane Library, MEDLINE, and EMBASE (to January 2010). Identifying search results and data extraction were performed independently and in duplicate. For the network meta-analysis, we performed mixed-effects logistic regression using an arm-based, random-effects model within an empirical Bayes framework. MAIN RESULTS: We included 163 RCTs with 50,010 participants and 46 extension studies with 11,954 participants. The median duration of RCTs was six months and 13 months for OLEs. Data were limited for tuberculosis (TB) reactivation, lymphoma, and congestive heart failure. Adjusted for dose, biologics as a group were associated with a statistically significant higher rate of total adverse events (odds ratio (OR) 1.19, 95% CI 1.09 to 1.30; number needed to treat to harm (NNTH) = 30, 95% CI 21 to 60) and withdrawals due to adverse events (OR 1.32, 95% CI 1.06 to 1.64; NNTH = 37, 95% CI 19 to 190) and an increased risk of TB reactivation (OR 4.68, 95% CI 1.18 to 18.60; NNTH = 681, 95% CI 143 to 14706) compared to control.The rate of serious adverse events, serious infections, lymphoma, and congestive heart failure were not statistically significantly different between biologics and control treatment. Certolizumab pegol was associated with significantly higher risk of serious infections compared to control treatment (OR 3.51, 95% CI 1.59 to 7.79; NNTH = 17, 95% CI 7 to 68). Infliximab was associated with significantly higher risk of withdrawals due to adverse events compared to control (OR 2.04, 95% CI 1.43 to 2.91; NNTH = 12, 95% CI 8 to 28). Indirect comparisons revealed that abatacept and anakinra were associated with a significantly lower risk of serious adverse events compared to most other biologics.  Although the overall numbers are relatively small, certolizumab pegol was associated with significantly higher odds of serious infections compared to etanercept, adalimumab, abatacept, anakinra, golimumab, infliximab, and rituximab; abatacept was significantly less likely than infliximab and tocilizumab to be associated with serious infections.  Abatacept, adalimumab, etanercept and golimumab were significantly less likely than infliximab to result in withdrawals due to adverse events. AUTHORS' CONCLUSIONS: Overall, in the short term biologics were associated with significantly higher rates of total adverse events, withdrawals due to adverse events and TB reactivation. Some biologics had a statistically higher association with certain adverse outcomes compared to control, but there was no consistency across the outcomes so caution is needed in interpreting these results.There is an urgent need for more research regarding the long-term safety of biologics and the comparative safety of different biologics. National and international registries and other types of large databases are relevant sources for providing complementary evidence regarding the short- and longer-term safety of biologics. 

Integrating a problem-solving intervention with routine care to improve psychosocial functioning among mothers of children with sickle cell disease: A randomized controlled trial.

OBJECTIVE: To assess the feasibility of a problem-solving skills training intervention in improving psychological outcomes in mothers of infants with sickle cell disease (SCD). DESIGN AND METHODS: This parallel randomized controlled trial recruited 64 babies with SCD, 6 to 12 months of age, and their mothers. Baseline measurements assessed mothers' coping and problem-solving skills, depression, and parental stress before random assignment to intervention or control groups (n = 32 each). Problem-solving skills intervention was delivered through 6 monthly sessions, when babies attended for routine penicillin prophylaxis. All measurements were repeated for both groups at the end of the intervention period. Intention to treat analysis used repeated measures mixed models with the restricted estimation maximum likelihood approach. RESULTS: The problem-solving intervention had no significant effect on mothers' problem-solving skills (adjusted treatment effect: -1.69 points (95% CI:-5.62 to 2.25)), coping behaviours (adjusted treatment effect: 0.65 points (95% CI:- -7.13 to 8.41)) or depressive symptoms (adjusted treatment effect: -0.41 (95% CI: -6.00 to 5.19)). It reduced mothers' level of difficulty in managing stressful events by 9.5 points (95% CI (-16.86 to -2.16); effect size: 0.21 SD). In the subgroup of mothers at risk of depression (n = 31 at baseline), the intervention reduced depression scores with treatment effect of 10.4 points (95%CI: -18.83 to -1.88; effect size: 0.67 SD). CONCLUSION: This problem-solving skills intervention study suggests feasibility and possible efficacy in improving some maternal outcomes. Further refinement and culturally appropriate adaptations of the intervention could lead to stronger effects.

Improving Social Justice in COVID-19 Health Research: Interim Guidelines for Reporting Health Equity in Observational Studies.

The COVID-19 pandemic has highlighted the global imperative to address health inequities. Observational studies are a valuable source of evidence for real-world effects and impacts of implementing COVID-19 policies on the redistribution of inequities. We assembled a diverse global multi-disciplinary team to develop interim guidance for improving transparency in reporting health equity in COVID-19 observational studies. We identified 14 areas in the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist that need additional detail to encourage transparent reporting of health equity. We searched for examples of COVID-19 observational studies that analysed and reported health equity analysis across one or more social determinants of health. We engaged with Indigenous stakeholders and others groups experiencing health inequities to co-produce this guidance and to bring an intersectional lens. Taking health equity and social determinants of health into account contributes to the clinical and epidemiological understanding of the disease, identifying specific needs and supporting decision-making processes. Stakeholders are encouraged to consider using this guidance on observational research to help provide evidence to close the inequitable gaps in health outcomes.