Background
The Food and Drug Administration Center for Biologics Evaluation and Research (CBER) established the Biologics Effectiveness and Safety (BEST) Initiative with several objectives, including ...the expansion and enhancement of CBER’s access to fit-for-purpose data sources, analytics, tools, and infrastructures to improve the understanding of patient experiences with conditions related to CBER-regulated products. Owing to existing challenges in data collection, especially for rare disease research, CBER recognized the need for a comprehensive platform where study coordinators can engage with study participants and design and deploy studies while patients or caregivers could enroll, consent, and securely participate as well.
Objective
This study aimed to increase awareness and describe the design, development, and novelty of the Survey of Health and Patient Experience (SHAPE) platform, its functionality and application, quality improvement efforts, open-source availability, and plans for enhancement.
Methods
SHAPE is hosted in a Google Cloud environment and comprises 3 parts: the administrator application, participant app, and application programming interface. The administrator can build a study comprising a set of questionnaires and self-report entries through the app. Once the study is deployed, the participant can access the app, consent to the study, and complete its components. To build SHAPE to be scalable and flexible, we leveraged the open-source software development kit, Ionic Framework. This enabled the building and deploying of apps across platforms, including iOS, Android, and progressive web applications, from a single codebase by using standardized web technologies. SHAPE has been integrated with a leading Health Level 7 (HL7®) Fast Healthcare Interoperability Resources (FHIR®) application programming interface platform, 1upHealth, which allows participants to consent to 1-time data pull of their electronic health records. We used an agile-based process that engaged multiple stakeholders in SHAPE’s design and development.
Results
SHAPE allows study coordinators to plan, develop, and deploy questionnaires to obtain important end points directly from patients or caregivers. Electronic health record integration enables access to patient health records, which can validate and enhance the accuracy of data-capture methods. The administrator can then download the study data into HL7® FHIR®–formatted JSON files. In this paper, we illustrate how study coordinators can use SHAPE to design patient-centered studies. We demonstrate its broad applicability through a hypothetical type 1 diabetes cohort study and an ongoing pilot study on metachromatic leukodystrophy to implement best practices for designing a regulatory-grade natural history study for rare diseases.
Conclusions
SHAPE is an intuitive and comprehensive data-collection tool for a variety of clinical studies. Further customization of this versatile and scalable platform allows for multiple use cases. SHAPE can capture patient perspectives and clinical data, thereby providing regulators, clinicians, researchers, and patient advocacy organizations with data to inform drug development and improve patient outcomes.
This study explores the association between cognitive ability in childhood and midlife and bone health outcomes in early old age; and the relationships of these bone measures with contemporaneous and ...subsequent cognitive ability in the MRC National Survey of Health and Development (NSHD). This British birth cohort assessed areal and volumetric bone mineral density (aBMD and vBMD) at age 60-64, derived from peripheral quantitative computed tomography and dual-energy X-ray absorptiometry, and cognitive performance from childhood to age 69, among 866 women and 792 men. Cognitive performance at age 15 was assessed using tests of verbal and non-verbal ability, and mathematics; and memory and search speed tasks were administered at ages 53, 60-64, and 69. Covariates included body size, pubertal timing, smoking, leisure time physical activity, socioeconomic circumstances and menopause timing. Multiple linear regression analyses showed that higher childhood cognitive ability was associated with higher hip aBMD, in women, and greater cortical and trabecular vBMD, in men. For women, there were positive associations between hip aBMD and total vBMD, and contemporaneous cognitive ability with associations also extending to subsequent cognitive ability for total vBMD. For men, some associations with trabecular and total vBMD emerged at ages 60-64 and 69 but only after adjusting for education, occupational class and health behaviors. Our findings highlight that higher cognitive ability in childhood is associated with BMD in early old age and these associations might be explained by social and behavioral pathways. The results suggest that individuals with greater cognitive ability in early life are more likely to engage in healthy behaviors (e.g., leisure time physical activity) in adulthood, which in turn are associated with greater BMD later in life. Associations between bone health and cognitive performance should be considered within a life course framework; and the potential role of smoking and physical activity should be addressed when advising adults at high future risk of osteoporosis and fracture.
Background: Previous work has shown little association between self-report and directly measured physical activity. The objective of this study was to investigate the relationships between ...self-reported and directly assessed measures of physical activity and sedentary time by weight status in Kenyan children.
Methods: Direct assessment of body weight, physical activity and sedentary time of 563 children was collected through anthropometry and accelerometry, while self-reported assessment was achieved by administering a questionnaire.
Results: Under/healthy weight children had significantly higher directly measured mean daily minutes of moderate-to-vigorous physical activity (MVPA) compared to overweight/obese children (39 vs 20 minutes); had lower mean weekend-day minutes of sedentary time (346 vs 365 minutes); had a higher proportion who met accepted physical activity guidelines (15.3% vs 2.6%); and a higher number reported using active transportation to/from school (49.2% vs 32.4%). Self-reported time spent outside before and after school and active transport to/from school were significantly associated with mean weekday minutes of MVPA (r-value range = 0.12-0.36), but only for the under/healthy weight children.
Conclusions: The results of this study found a number of differences in the accumulation of MVPA and sedentary time by weight status and weak-to-moderate correlations between self-report and direct measures of weekday and weekend-day physical activity among the under/healthy weight children.
In the era of double burden of infectious and non-communicable diseases in sub-Saharan Africa, the burden of multimorbidity is likely to be common. However, there is limited evidence on the burden ...and its associated factors in the sub-Saharan African context.
The aim of this study was to determine the levels and identify determinants of multimorbidity from chronic conditions in two urban slums in Nairobi.
Data collected from 2003 study participants aged 40-60 years in two urban slums of the Nairobi Urban Health and Demographic Surveillance System in 2015 were used. Using self-report, anthropometry and key biomarkers, data on 16 conditions including chronic diseases, behavioral disorders and metabolic abnormalities were gathered. Lifetime multimorbidity defined by the occurrence of at least two chronic conditions in an individual at any time during their life course was computed. Factors associated with lifetime multimorbidity were identified using multiple logistic regression.
A total of 2,081 chronic conditions were identified among 1,302 individuals. While 701 (35.0%) had no chronic condition, single morbidity was reported in 726 (36.2%) of the study population. The overall prevalence of lifetime multimorbidity was 28.7%. The prevalence of dyads and triads of simultaneous occurrences of conditions (episodic multimorbidity) was 20.8% and 6.1%, respectively. Single morbidity was positively associated with gender and alcohol consumption; and negatively associated with employment. Women, older people, the unemployed, current smokers and current alcohol consumers had higher levels of lifetime multimorbidity in the study population.
The findings of this study indicate that a considerable proportion of adults living in urban slums experience multimorbidity from chronic conditions. Further studies with a better rigor to establish temporal associations between socio-demographic factors and the occurrence of chronic conditions are needed to explore the impacts and implications on health status and health system.
Background: Normal-weight central obesity is associated with higher mortality than general obesity as defined by body mass index, particularly in the absence of central fat distribution.
Objective: ...The aim of this study was to examine the magnitude and predictors of normal-weight central obesity in an urban informal settlement setting in Kenya.
Methods: We used data from the AWI-Gen study, a cross-sectional survey targeting randomly selected consenting adults between the ages of 40-60 in two urban informal settlements of Nairobi between 2014 and 2016. Central obesity was determined using waist circumference, waist to hip ratio, visceral fat thickness, and subcutaneous fat thickness. General obesity was determined using body mass index (BMI).
Results: About 20.0% of participants in the study had general obesity. The prevalence of central obesity as measured by waist circumference was 52.0%, by waist-to-hip ratio was 53.5%, by visceral fat thickness was 32.4% and by subcutaneous fat thickness was 49.2%. The prevalence of normal-weight central obesity in the study population was highest when measured by waist to hip ratio (38.1%) and lowest when measured by visceral fat thickness (18.1%). Factors associated with normal-weight central obesity as assesses by waist circumference were being female, of older age, and in full-time employment. Older age was associated with normal-weight central obesity as assessed by waist to hip ratio.
Conclusion: The findings highlight a significant prevalence of normal-weight central obesity among adults in a poor urban setting in Kenya, pointing to women as a key target group for focused interventions. Longitudinal studies are needed to establish whether there is a link between normal-weight central obesity and mortality in such settings as has been found in other settings.
In humanitarian settings, timely access to care is essential for survivors of gender-based violence (GBV). Despite the existence of GBV support services, challenges still exist in maximising benefits ...for survivors. This study aimed to understand the characteristics of violence against women and explore barriers and facilitators to care-seeking for GBV by women in two camps within the Dadaab refugee complex in Kenya. A mixed-methods design was used to study women accessing comprehensive GBV services between February 2016 and February 2017. Women were recruited into a cohort study (n = 209) and some purposively selected for qualitative in-depth interviews (n = 34). Survivor characteristics were descriptively analysed from baseline measures, and interview data thematically assessed. A majority of women were Muslim, of Somali origin, had been residents in the camp for more than five years, with little or no formal education, and meagre or no monthly income. From the survey, 60.3% and 66.7% of women had experienced non-partner violence or intimate partner violence in their lifetime respectively. Facilitators to accessing GBV services by survivors included awareness of GBV services and self-perceived high severity of acts of violence. Barriers included stigma by family and the community, fear of further violence from perpetrators, feelings of helplessness and insecurity, and being denied entry to service provision premises by guards. Women in the Dadaab refugee camps face violence from intimate partners, family, and other refugees. There is an urgent need to address drivers of GBV and the barriers to disclosure and access to services for all survivors of GBV.
The report card presents available evidence on the physical activity (PA) and body weight status of Kenyan children and youth. It highlights areas where Kenya is succeeding and those in which more ...action is needed.
Comprehensive review and analysis of available data on core indicators for Kenyan children and youth 5-17 years were conducted. The grading system used was based on a set of specific criteria and existing grading schemes from similar report cards in other countries.
Of the 10 core indicators discussed, body composition was favorable (grade B) while overall PA levels, organized sport participation, and active play were assigned grades of C. Active transportation and sedentary behaviors were also favorable (grade B). Family/peers, school, governmental and nongovernmental strategies were graded C.
The majority of Kenyan children and youth have healthy body composition levels and acceptable sedentary time, but are not doing as well in attaining the World Health Organization (WHO) recommendation on PA. Although Kenya seems to be doing well in most indicators compared with some developed countries, there is a need for action to address existing trends toward unhealthy lifestyles. More robust and representative data for all indicators are required.
Despite evidence from other regions, researchers and policy-makers remain skeptical that women's disproportionate childcare responsibilities act as a significant barrier to women's economic ...empowerment in Africa. This randomized control trial study in an informal settlement in Nairobi, Kenya, demonstrates that limited access to affordable early childcare inhibits poor urban women's participation in paid work. Women who were offered vouchers for subsidized early childcare were, on average, 8.5 percentage points more likely to be employed than those who were not given vouchers. Most of these employment gains were realized by married mothers. Single mothers, in contrast, benefited by significantly reducing the time spent working without any loss to their earnings by shifting to jobs with more regular hours. The effects on other measures of women's economic empowerment were mixed. With the exception of children's health care, access to subsidized day care did not increase women's participation in other important household decisions. In addition, contrary to concerns that reducing the costs of childcare may elevate women's desire for more children, we find no effect on women's fertility intentions. These findings demonstrate that the impact of subsidized childcare differs by marital status and across outcomes. Nonetheless, in poor urban Africa, as elsewhere, failure to address women's childcare needs undermines efforts to promote women's economic empowerment.
ObjectivesTo investigate whether cross-sectional and longitudinal associations of body mass index (BMI) and waist circumference (WC) with back pain change with age and extend into later ...life.DesignBritish birth cohort study.SettingEngland, Scotland and Wales.ParticipantsUp to 3426 men and women from the MRC National Survey of Health and Development.Primary outcome measuresBack pain (sciatica, lumbago or recurring/severe backache all or most of the time) was self-reported during nurse interviews at ages 36, 43, 53 and 60–64 years and in a postal questionnaire using a body manikin at age 68.ResultsFindings from mixed-effects logistic regression models indicated that higher BMI was consistently associated with increased odds of back pain across adulthood. Sex-adjusted ORs of back pain per 1 SD increase in BMI were: 1.13 (95% CI: 1.01 to 1.26), 1.11 (95% CI: 1.00 to 1.23), 1.17 (95% CI: 1.05 to 1.30), 1.31 (95% CI: 1.15 to 1.48) and 1.08 (95% CI: 0.95 to 1.24) at ages 36, 43, 53, 60–64 and 68–69, respectively. Similar patterns of associations were observed for WC. These associations were maintained when potential confounders, including education, occupational class, height, cigarette smoking status, physical activity and symptoms of anxiety and depression were accounted for. BMI showed stronger associations than WC in models including both measures.ConclusionsThese findings demonstrate that higher BMI is a persistent risk factor for back pain across adulthood. This highlights the potential lifelong consequences on back pain of the rising prevalence of obesity within the population.
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