69832 research outputs found
Sort by
Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED.
Get PDFBACKGROUND: The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations.
METHODS: The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans.
RESULTS: Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months (P=0.003) but not in the RDN group (P=0.44).
CONCLUSIONS: Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775
Diagnostic accuracy of a three-gene Mycobacterium tuberculosis host response cartridge using fingerstick blood for childhood tuberculosis: a multicentre prospective study in low-income and middle-income countries.
Get PDFBACKGROUND: Childhood tuberculosis remains a major cause of morbidity and mortality in part due to missed diagnosis. Diagnostic methods with enhanced sensitivity using easy-to-obtain specimens are needed. We aimed to assess the diagnostic accuracy of the Cepheid Mycobacterium tuberculosis Host Response prototype cartridge (MTB-HR), a candidate test measuring a three-gene transcriptomic signature from fingerstick blood, in children with presumptive tuberculosis disease.
METHODS: RaPaed-TB was a prospective diagnostic accuracy study conducted at four sites in African countries (Malawi, Mozambique, South Africa, and Tanzania) and one site in India. Children younger than 15 years with presumptive pulmonary or extrapulmonary tuberculosis were enrolled between Jan 21, 2019, and June 30, 2021. MTB-HR was performed at baseline and at 1 month in all children and was repeated at 3 months and 6 months in children on tuberculosis treatment. Accuracy was compared with tuberculosis status based on standardised microbiological, radiological, and clinical data.
FINDINGS: 5313 potentially eligible children were screened, of whom 975 were eligible. 784 children had MTB-HR test results, of whom 639 had a diagnostic classification and were included in the analysis. MTB-HR differentiated children with culture-confirmed tuberculosis from those with unlikely tuberculosis with a sensitivity of 59·8% (95% CI 50·8-68·4). Using any microbiological confirmation (culture, Xpert MTB/RIF Ultra, or both), sensitivity was 41·6% (34·7-48·7), and using a composite clinical reference standard, sensitivity was 29·6% (25·4-34·2). Specificity for all three reference standards was 90·3% (95% CI 85·5-94·0). Performance was similar in different age groups and by malnutrition status. Among children living with HIV, accuracy against the strict reference standard tended to be lower (sensitivity 50·0%, 15·7-84·3) compared with those without HIV (61·0%, 51·6-69·9), although the difference did not reach statistical significance. Combining baseline MTB-HR result with one Ultra result identified 71·2% of children with microbiologically confirmed tuberculosis.
INTERPRETATION: MTB-HR showed promising diagnostic accuracy for culture-confirmed tuberculosis in this large, geographically diverse, paediatric cohort and hard-to-diagnose subgroups.
FUNDING: European and Developing Countries Clinical Trials Partnership, UK Medical Research Council, Swedish International Development Cooperation Agency, Bundesministerium für Bildung und Forschung; German Center for Infection Research (DZIF)
Correlates of Body Composition in Children with Stunting: A Cross-sectional Study in Uganda.
Get PDFBACKGROUND: Development of body composition (BC) may be disrupted in children with stunting. Such disruption may affect the later risk of excess adiposity and metabolic health, yet few studies have investigated correlates of BC in children with stunting. OBJECTIVES: We aimed to investigate nutritional status, infection and inflammation, breastfeeding behaviors, and other factors as correlates of BC in children with stunting. METHODS: Among Ugandan children with a height-for-age z-score <-2, BC was estimated using bioelectrical impedance analysis and compared with United Kingdom references. We used multiple linear regression analysis to identify correlates of fat mass (FM), fat-free mass (FFM), FM-index (FMI), and FFM index (FFMI) and height, adjusting for gender and age. RESULTS: In 750 children aged 1-5 y, FMI was 0.46 (95% confidence interval [CI]: 0.38, 0.54] and FFMI 0.18 [95% CI: 0.11, 0.26) z-scores lower than United Kingdom references. Elevated serum α1-acid glycoprotein was associated with 1.14 [0.76, 1.52] cm lower height, 0.50 [0.35, 0.65] kg/m2 less FFMI, and 0.48 [0.31, 0.66] kg/m2 greater FMI. Similar, weaker, associations for elevated serum C-reactive protein were detected. A positive malaria rapid test was associated with 0.64 [0.25, 1.02] cm shorter height, but 0.36 [0.18, 0.54] kg/m2 greater FMI. Anemia (according to hemoglobin) was associated with 0.20 [0.07, 0.33] kg less FFM in proportion to shorter height. Longer breastfeeding duration was associated with 0.03 [0.02, 0.04] kg greater FFM per month, in proportion to greater height. CONCLUSIONS: These children exhibited deficits in FM and FFM, proportionally to their stunted height, compared with United Kingdom references. Systemic inflammation correlated inversely with linear growth and FFM but positively with fatness, making it a possible target for intervention where fat-free tissue accretion is desirable. Longer breastfeeding may offer protection to lean linear growth, but findings for micronutrients were less clear. Longitudinal studies are warranted to support these findings. The study was registered at www.isrctn.com (Ref. ISRCTN13093195)
Exploring mechanisms and contexts in a Peer Education Project to improve mental health literacy in schools in England: a qualitative realist evaluation.
Get PDFPoor adolescent mental health calls for universal prevention. The Mental Health Foundation's 'Peer Education Project' equips older students ('peer educators') to teach younger students ('peer learners') about mental health. The peer-led lessons cover defining good and bad mental health, risk and protective factors, self-care, help-seeking and looking after one another. While previous pre-post evaluations have suggested effectiveness, the mechanisms through which the intervention improves mental health literacy remain unclear. We purposively recruited seven secondary schools across England from 2020 to 2022 and collected data through five observations, 12 staff interviews and 15 student focus groups (totalling 134 students; 46 peer educators aged 14-18 years and 88 peer learners aged 11-13 years). Our realist analysis adopted retroductive logic, intertwining deductive and inductive approaches to test the initial programme theory against insights arising from the data. We developed Context-Mechanisms-Outcome configurations related to four themes: (i) modelling behaviours and forming supportive relationships, (ii) relevant and appropriate content, (iii) peer educators feeling empowered and (iV) a school culture that prioritises mental health support. Our refined programme theory highlights key mechanisms, contexts conducive to achieving the outcomes and ways to improve training, recruitment and delivery to maximise effectiveness for similar peer-led initiatives
Trachoma Impact Survey Results from 31 Woredas in Tigray Region, Ethiopia.
Get PDFPURPOSE: Baseline surveys were conducted in Tigray region, Ethiopia, in 2013. Since then, rounds of azithromycin mass drug administration (MDA) have been delivered in-line with international guidance. The purpose of these surveys was to assess trachomatous inflammation-follicular (TF) prevalence following those treatments to enable the region to plan the next steps towards elimination of trachoma. METHODS: All surveys followed WHO recommendations for community-based cross-sectional survey design. Thirty-one woredas in six zones of Tigray region were surveyed. There were two survey series: all 31 woredas were surveyed in the first series, and 11 woredas were resurveyed in the second, due to having a TF prevalence between 5% and 9.9% in the first series. RESULTS: In the first series of 31 surveys, one woreda had an adjusted TF prevalence in 1-9-year-olds of <5.0%, 13 had a prevalence of 5.0-9.9% and 17 had a prevalence of 10.0-29.9%. In the second series of 11 surveys, the prevalence of TF was <5.0% in seven woredas and 5.0-9.9% in four woredas. The most recent adjusted prevalence of trachomatous trichiasis (TT) unknown to the health system in ≥15-year-olds was ≥.2% in 27 EUs. One-third of households visited had access to an improved drinking water source within a 30-minute return journey of their house, and 11% had an improved latrine. CONCLUSION: Eight woredas met the criteria to stop MDA for 2 years before the re-survey. However, further rounds of MDA, additional efforts to improve water and sanitation access and ongoing strengthening of surgical services for TT are needed across Tigray
Community boat service to promote institutional delivery in the Philippines: a mixed-methods study of a social innovation.
Get PDFBACKGROUND: Remote islands have limited access to institutional obstetric care, and these challenges are further exacerbated by climatic threats. A Health Service Boat Project was implemented in rural Philippines to provide free boats for pregnant people to deliver at facilities and facilitate prenatal outreach.
OBJECTIVE: To evaluate the impact of the boat project on institutional delivery rates and to explore the underlying mechanism.
METHODS: A sequential mixed-methods study was conducted in Zumarraga Municipality, Philippines. In the quantitative component, we analysed the data from nationally representative household surveys and governmental data to assess the institutional delivery rate before and after the boat project started in 2012. Linear difference-in-difference regression analysis was used to test the intervention effects of the boat project on institutional delivery. Weather information obtained from the Philippine Atmospheric, Geophysical and Astronomical Services Administration was used to compare the institutional delivery rate between cyclone-affected and non-cyclone-affected periods. In the qualitative component, we conducted two focus group discussions and two semistructured interviews to explore how the boat service may have improved the institutional delivery rate.
RESULTS: The institutional delivery rate significantly increased the year after the boat project started (B=0.38, p<0.001). The median institutional delivery rate during the cyclone-affected period was significantly lower than that during the non-cyclone-affected period but still remained high at 93.3%. Pregnant women who used the boat service to facilitate institutional delivery reported that they trusted the service, which was available regardless of economic status and political affiliations. The boat project also allowed community health workers to conduct more frequent prenatal check-ups in the community, leading to an improved rapport between health workers and women. The main challenge identified during the implementation was the limited budget for long-term maintenance of the boat.
CONCLUSION: The boat project not only facilitated transportation for pregnant people to the facility but also improved community-based prenatal services. In addition, the boat project may mitigate some of the effects of cyclones on access to health services for pregnant people
The Association Between COVID-19-related Discrimination and Probable Post-traumatic Stress Disorder Among Patients With COVID-19 in Sapporo, Japan.
Get PDFBACKGROUND: Disasters such as earthquakes, terrorism, and pandemics have triggered post-traumatic stress disorder (PTSD), and discrimination against the affected individuals has been linked to the development of PTSD. However, there is limited evidence regarding the association between discrimination against coronavirus disease 2019 (COVID-19) patients and probable PTSD in Japan. METHODS: We conducted a cross-sectional study utilizing a web-based questionnaire targeting individuals who had contracted the severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infection in Sapporo City. A total of 4,247 individuals with laboratory-confirmed SARS-CoV-2 infection spanning from February 2020 to February 2022 completed the questionnaire (response rate: 15.9%). Probable PTSD was measured using the three-item Posttraumatic Diagnostic Scale. The stratified exact logistic regression was applied to calculate the odds ratios (ORs) of probable PTSD for COVID-19-related discrimination with adjusted factors. RESULTS: This study included 3,626 patients who had a history of SARS-CoV-2 infection. Among them, 321 patients (8.9%) experienced COVID-19-related discrimination. The prevalence of probable PTSD was 19.6% (63/321) among the patients who experienced COVID-19-related discrimination, and 4.6% (152/3,305) among those who had not encountered such discrimination. The adjusted OR of COVID-19-related discrimination for probable PTSD was 4.68 (95% confidence interval [CI], 3.36-6.53). The population attributable fraction of probable PTSD attributable to COVID-19-related discrimination among COVID-19 patients was estimated to be 23.4% (95% CI, 21.5-25.3%). CONCLUSION: The comprehensive epidemiological survey of COVID-19 patients in Japan showed that COVID-19-related discrimination was associated with a higher prevalence of probable PTSD. Mitigating discrimination could be helpful to attenuate PTSD in future pandemics
Awareness of, willingness to use, and experiences with Pre-exposure prophylaxis among youth in Nigeria.
Get PDFBACKGROUND: Youth (ages 14-24) in Nigeria have disproportionately high rates of new HIV infection. Pre-exposure prophylaxis could substantially reduce new infections among youth but has not been scaled up. This cross-sectional study aimed to assess Pre-exposure prophylaxis awareness, willingness to use, and prior use of Pre-exposure prophylaxis among youth in Nigeria.
METHODS: This is a secondary analysis of cross-sectional data from a quasi-experimental pilot study (clinical trial NCT04070287). The analysis focused on Pre-exposure prophylaxis awareness, willingness to use, and prior use among 324 youth recruited between September 2019 to March 2020. Descriptive statistics were calculated as frequencies and percentages for categorical variables and means and standard deviations for continuous variables.
RESULTS: Of the 324 participants, the mean age and standard deviation were 21.17 (± 2.20) years. The majority were 20-24 years old (75.9%) and male (57.7%). Only 30.7% used condoms consistently over three months. Regarding Pre-exposure prophylaxis awareness and willingness, 62.6% had never heard of Pre-exposure prophylaxis, and 158 (50.1%) reported willingness to use Pre-exposure prophylaxis. Only 10 (3.2%) reported having used Pre-exposure prophylaxis.
CONCLUSION: Nigerian youth have low awareness of and prior use of Pre-exposure prophylaxis. Given the gap between prior use and willingness to use Pre-exposure prophylaxis, our findings suggest missed opportunities to prevent new HIV infections among youth in Nigeria. Efforts to increase awareness and uptake of Pre-exposure prophylaxis among this population should consider youth-led Pre-exposure prophylaxis outreach efforts and effectively communicate the benefits of Pre-exposure prophylaxis to this population.
TRIAL REGISTRATION: NCT04070287, the Date of registration of the trial is 20-07-2019
Study protocol: Comparison of different risk prediction modelling approaches for COVID-19 related death using the OpenSAFELY platform.
Get PDFOn March 11th 2020, the World Health Organization characterised COVID-19 as a pandemic. Responses to containing the spread of the virus have relied heavily on policies involving restricting contact between people. Evolving policies regarding shielding and individual choices about restricting social contact will rely heavily on perceived risk of poor outcomes from COVID-19. In order to make informed decisions, both individual and collective, good predictive models are required. For outcomes related to an infectious disease, the performance of any risk prediction model will depend heavily on the underlying prevalence of infection in the population of interest. Incorporating measures of how this changes over time may result in important improvements in prediction model performance. This protocol reports details of a planned study to explore the extent to which incorporating time-varying measures of infection burden over time improves the quality of risk prediction models for COVID-19 death in a large population of adult patients in England. To achieve this aim, we will compare the performance of different modelling approaches to risk prediction, including static cohort approaches typically used in chronic disease settings and landmarking approaches incorporating time-varying measures of infection prevalence and policy change, using COVID-19 related deaths data linked to longitudinal primary care electronic health records data within the OpenSAFELY secure analytics platform
Global burden of Alzheimer's disease and other dementias attributed to metabolic risks from 1990 to 2021: results from the global burden of disease study 2021.
Get PDFOBJECTIVE: The risk of Alzheimer's disease (AD) and other dementias increases with greater global exposure to metabolic risks, making this a crucial public health issue. This study aimed to report the metabolism-attributable global burden of AD and other dementias from 1990 to 2021.
METHODS: The Global Burden of Disease Study (GBD) 2021 collected data on the number of deaths and disability-adjusted life-years (DALYs) related to AD and other dementias caused by metabolic risks, including high fasting plasma glucose (FPG) and high body mass index (BMI). The analysis assessed the disease burden and temporal patterns worldwide, examining data by region, country, level of social development, age group, and sex.
RESULTS: Globally, the count of AD and other dementia-related deaths due to metabolic risks grew from 98,608 to 399,824, a 4.1-fold increase. For dementias related to high FPG and high BMI, the age-standardized mortality rates (ASMR) and age-standardized DALY rate (ASDR) increased with age and were higher in females than in males. In 2021, the highest burden was observed in high-income North America. The ASMR and ASDR have grown worldwide between 1990 and 2021. The burden of metabolism-related AD and other dementias was positively correlated with the Socio-Demographic Index (SDI), with higher ASMR and ASDR in high SDI regions but showing more pronounced increases in low and low-middle SDI regions.
CONCLUSIONS: Metabolism-related global burden of AD and other dementias is increasing, particularly among women and in high-income regions. Targeted prevention programs for dementia should be developed, along with early interventions for risk factors