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Increasing breastfeeding initiation and duration in women with a body mass index ≥ 30 kg/m 2: developing an intervention from theory to acceptability
Get PDFBackgroundBreastfeeding has many health benefits for both mother and child, but rates of initiation and duration amongst women with a BMI ≥ 30 kg/m2 are low. Few interventions aiming to increase breastfeeding in this group have been successful; likely because existing interventions do not target psychological factors. Therefore, this study aimed to design and explore the acceptability of a newly developed psychological intervention to increase breastfeeding initiation and duration in women with a BMI ≥ 30 kg/m2.MethodsThe Medical Research Council’s Complex Intervention Development Framework was followed to design the intervention. A ‘breastfeeding workbook’ was developed, based on literature and psychological theory, and filled with tailored information and activities. A Patient and Public Involvement group of women with a BMI ≥ 30 kg/m2 who had breastfed, health professionals and researchers were consulted throughout the process, selecting the intervention content, format and delivery methods. Thirteen women with a BMI ≥ 30 kg/m2 then reviewed the workbook and took part in in-depth qualitative interviews to assess its acceptability. Thematic analysis was conducted, informed by the Theoretical Framework of Acceptability version 2.ResultsThe findings reveal the intervention is acceptable to the target population; women believe the intervention shows promise for increasing breastfeeding initiation and duration, is representative of their experiences, is accessible, and aligns with their belief system. They valued that the intervention provided realistic expectations of breastfeeding, options to overcome the challenges of breastfeeding in the real-world and supported them to breastfeed without inducing stigma or shame regarding their weight or infant feeding practices. Suggestions for improvement are also included, such as incorporating audio and video content as alternatives to written text and translation options.ConclusionsAn acceptable, psychological intervention was developed to increase breastfeeding initiation and duration in women with BMIs ≥ 30 kg/m2. These findings can inform maternity and breastfeeding care, future research directions and intervention development.</p
A life that’s worth living – measuring health-related quality of life among people treated for tuberculosis in Viet Nam: a longitudinal EQ-5D-5L survey
Get PDFBackgroundIn many settings, Tuberculosis (TB) represents a catastrophic life event that substantially impairs a person’s Health-Related Quality of Life (HRQoL). We aimed to measure HRQoL among people with TB in Viet Nam at initiation and throughout treatment.MethodsThis study took place in four provinces from Oct-2020 to Sep-2022. Persons initiated on TB treatment were consecutively recruited across three pathways to access care: passive case finding (NTP); active case finding (ACF); and private sector engagement (PPM). We conducted the EuroQol–5-Dimension–5-Level (EQ-5D-5L) survey during the intensive, continuation, and post-treatment phase. We described participant characteristics, assessed the survey’s psychometric properties, and calculated utility indexes using a Vietnamese value set. We reported these alongside visual analog scale (EQ-VAS) scores and EQ-5D-5L dimensions by treatment stage, care pathway and other participant characteristics. Mixed-effect Tobit models were fitted to identify relevant associations with HRQoL, which we compared to general population benchmarks.ResultsWe recruited 585 participants (23.6% female) with a median age of 51 years. EQ-5D-5L dimensions at baseline showed that 53.8% experienced pain/discomfort and 35.0% felt anxiety/depression, while 33.8%, 30.4%, and 9.6% reported problems with carrying out usual activities, mobility, and self-care, respectively. The mean utility index was 0.83 (95% confidence interval: [0.82, 0.85]) and mean EQ-VAS was 67.1 (95%CI: [65.6, 68.6]). Post-treatment, HRQoL improved significantly on all dimensions and composite measures. While utility indexes were at parity with general population benchmarks (0.90; 95%CI: [0.89, 0.92] vs. 0.91), self-reported EQ-VAS scores remained significantly lower (79.4; 95%CI: [78.1, 80.6] vs. 87.4). HRQoL was higher at baseline in the ACF versus the NTP cohorts on utility index (0.87 vs. 0.82; p = 0.003) and EQ-VAS score (70.4 vs. 65.5; p = 0.015). The EQ-5D-5L tool demonstrated moderate to high validity on Cronbach’s alpha (0.75 ≤ α ≤ 0.84) and Spearman’s rho (0.4679 ≤ ρ0 ≤ 0.5651) across treatment stages and various known groups.ConclusionTB significantly impairs HRQoL among affected Vietnamese people. While treatment partially remedies these impairments, they may persist post-TB. Hence, physical, psychological and social rehabilitation during and after therapy should receive more attention. We found evidence that ACF may mitigate TB-related declines in HRQoL, but tailored studies are needed to substantiate these findings.</p
Endoscopic variceal ligation combined with carvedilol versus endoscopic variceal ligation combined with propranolol for the treatment of oesophageal variceal bleeding in cirrhosis: study protocol for a multicentre, randomised controlled trial
Get PDFIntroduction Liver cirrhosis and its severe complication, oesophageal variceal bleeding (EVB), pose significant health risks. Standard treatment for EVB combines non-selective beta-blockers (NSBB) with endoscopic variceal ligation (EVL). Carvedilol, an NSBB with additional benefits, is preferred for compensated cirrhosis. However, no randomised controlled trial (RCT) has compared carvedilol with propranolol, a conventional NSBB, in combination with EVL for secondary prophylaxis. This study aims to compare the effectiveness and safety of these treatments in preventing variceal rebleeding or death in patients with cirrhosis and EVB.Methods and analysis This multicentre, RCT is scheduled to begin in December 2024, with recruitment and follow-up continuing until December 2026. Eligible participants are patients with liver cirrhosis and EVB. Participants are randomly assigned in a 1:1 ratio to receive EVL combined with either carvedilol or propranolol. The primary endpoint is the incidence of variceal rebleeding or all-cause death. Secondary endpoints include all-cause death, liver-related death, each of the complications of portal hypertension (overt ascites, overt hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome, portal vein thrombosis), hepatocellular carcinoma, changes in liver function (assessed by Child-Pugh and Model for End-Stage Liver Disease scores), changes in liver stiffness, changes in spleen stiffness, and adverse events. Subgroup and sensitivity analyses will be conducted to evaluate the consistency and robustness of the treatment effects. A total sample size of 524 patients (262 per group) is required to detect a significant difference between the treatment arms.Ethics and dissemination The study protocol has been approved by the ethics committee of the First Hospital of China Medical University (No. 2024-656-2). The study will follow the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this trial will be disseminated through peer-reviewed publications, conference presentations and healthcare professionals to guide future clinical practice.</p
INCIDENCE AND MATERNAL-PERINATAL OUTCOMES OF UTERINE RUPTURE IN HIWOT FANA COMPREHENSIVE SPECIALIZED UNIVERSITY HOSPITAL: A RETROSPECTIVE CROSS-SECTIONAL STUDY: A RETROSPECTIVE CROSS-SECTIONAL STUDY
Get PDFBACKGROUND: Uterine rupture remains a significant public health concern in many developing countries, including Ethiopia. Understanding its incidence and associated maternal and perinatal outcomes is essential for developing effective prevention and management strategies. OBJECTIVE: To assess the incidence, trends, and maternal and perinatal outcomes of uterine rupture among women who gave birth at Hiwot Fana Comprehensive Specialized University Hospital. METHODS: A retrospective, facility-based cross-sectional study was conducted from October 1 to 31, 2023, including all women who gave birth at Hiwot Fana Comprehensive Specialized University Hospital between January 1, 2018, and December 31, 2022. Data were collected by reviewing medical records using a structured and pretested checklist. The information was coded, cleaned, and entered into EpiData version 4.6, then exported to SPSS version 26 for statistical analysis. The results were summarized and presented in tables and figures. RESULTS: Out of 24,608 deliveries recorded during the study period, 168 cases of uterine rupture were identified, corresponding to an incidence rate of 6.8 per 1,000 births. Over the five-year period, there were no significant changes in the trend of uterine rupture incidence. Among the 153 cases with complete information, there were 119 stillbirths (90.8%), 113 cases of severe hemorrhage (73.9%), 79 hysterectomies (51.6%), 13 bladder ruptures (8.5%), 9 cases of obstetric fistula (5.9%), and 5 maternal deaths (3.3%). CONCLUSION: Although relatively infrequent, uterine rupture is associated with substantial adverse maternal and perinatal outcomes. Regular audits to evaluate the timeliness and quality of obstetric care are essential to prevent such complications and maternal and perinatal deaths
Higher dose corticosteroids in hospitalised COVID-19 patients requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial: a randomised, controlled, open-label, platform trial
No full textBackground: Low dose corticosteroids (e.g., 6 mg dexamethasone) have been shown to reduce mortality for hypoxic COVID-19 patients. We have previously reported that higher dose corticosteroids cause harm in patients with clinical hypoxia but not receiving ventilatory support (the combination of non-invasive mechanical ventilation, including high-flow nasal oxygen, continuous positive airway pressure and bilevel positive airway pressure ventilation, and invasive mechanical ventilation or extra-corporeal membrane oxygenation), but the balance of efficacy and safety in patients receiving ventilatory support is uncertain. Methods: This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) assessed multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting adult patients receiving ventilatory support were randomly allocated (1:1) to either usual care with higher dose corticosteroids (dexamethasone 20 mg once daily for 5 days followed by 10 mg once daily for 5 days or until discharge if sooner) or usual standard of care alone (which includes dexamethasone 6 mg once daily for 10 days or until discharge if sooner). The primary outcome was 28-day mortality; secondary outcomes were duration of hospitalisation and (among participants not on invasive mechanical ventilation at baseline) the composite of invasive mechanical ventilation or death. Recruitment closed on 31 March 2024 when funding for the trial ended. The RECOVERY trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). Findings: Between 25 May 2021 and 9 January 2024, 477 COVID-19 patients receiving ventilatory support were randomly allocated to receive usual care plus higher dose corticosteroids vs. usual care alone (of whom 99% received corticosteroids during the follow-up period). Of those randomised, 221 (46%) were in Asia, 245 (51%) in the UK and 11 (2%) in Africa. 143 (30%) had diabetes mellitus. Overall, 86 (35%) of 246 patients allocated to higher dose corticosteroids vs. 86 (37%) of 231 patients allocated to usual care died within 28 days (rate ratio [RR] 0.87; 95% CI 0.64–1.18; p = 0.37). There was no significant difference in the proportion of patients discharged from hospital alive within 28 days (128 [52%] in the higher dose corticosteroids group vs. 120 [52%] in the usual care group; RR 1.04, 0.81–1.33]; p = 0.78). Among those not on invasive mechanical ventilation at baseline, there was no clear reduction in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (76 [37%] of 206 vs. 93 [45%] of 205; RR 0.79 [95% CI 0.63–1.00]; p = 0.05). Interpretation: In patients hospitalised for COVID-19 receiving ventilatory support, we found no evidence that higher dose corticosteroids reduced the risk of death compared to usual care, which included low dose corticosteroids. Funding: UK Research and Innovation ( Medical Research Council) and National Institute for Health Research (Grant ref: MC_PC_19056), and Wellcome Trust (Grant Ref: 222406/Z/20/Z)
Incidence of diabetes mellitus following hospitalisation for COVID-19 in the United Kingdom: A prospective observational study: A prospective observational study
No full textBackground: People hospitalised for coronavirus disease 2019 (COVID-19) have elevated incidence of diabetes. However, it is unclear whether this is due to shared risk factors, confounding or stress hyperglycaemia in response to acute illness. Methods: We analysed a multicentre prospective cohort study (PHOSP-COVID) of people ≥18 years discharged from NHS hospitals across the United Kingdom following COVID-19. Individuals were included if they attended at least one research visit with a HbA1c measurement within 14 months of discharge and had no history of diabetes at baseline. The primary outcome was new onset diabetes (any type), as defined by a first glycated haemoglobin (HbA1c) measurement ≥6.5% (≥48 mmol/mol). Follow-up was censored at the last HbA1c measurement. Age-standardised incidence rates and incidence rate ratios (adjusted for age, sex, ethnicity, length of hospital stay, body mass index, smoking, physical activity, deprivation, hypertension, hyperlipidaemia/hypercholesterolaemia, intensive therapy unit admission, invasive mechanical ventilation, corticosteroid use and C-reactive protein score) were calculated using Poisson regression. Incidence rates were compared with the control groups of published clinical trials in the United Kingdom by applying the same inclusion and exclusion criteria, where possible. Results: Incidence of diabetes was 91.4 per 1000 person-years and was higher in South Asian (incidence rate ratios [IRR] = 3.60; 1.77, 7.32; p < 0.001) and Black ethnic groups (IRR = 2.36; 1.07, 5.21; p = 0.03) compared with White ethnic groups. When restricted to similar characteristics, the incidence rates were similar to those in UK clinical trials data. Conclusion: Diabetes incidence following hospitalisation for COVID-19 is high, but it remains uncertain whether it is disproportionately higher than pre-pandemic levels
Transcutaneous auricular vagus nerve stimulation to treat narcolepsy type 1 (TARGET-NT1): A two-arm, randomised, sham-controlled trial: A two-arm, randomised, sham-controlled trial
Get PDFTo assess exploratorily the safety and efficacy of transcutaneous auricular vagus nerve stimulation (tVNS) as an adjunctive therapy in improving symptoms in patients with narcolepsy type 1 (NT1). The TARGET-NT1 trial, a two-arm, double-blinded, sham-controlled trial was conducted from April 2022, to June 2024 at Xijing Hospital in Xi'an, China. Participants were randomised to receive tVNS treatment or sham tVNS (stVNS) treatment. Both interventions were performed for two 30-min periods per day with the same stimulation parameters but different stimulation points, for 12 weeks. The primary outcome was the change in mean sleep onset latency of maintenance of wakefulness test (MWT) from baseline to week 12. Secondary outcomes included changes in Narcolepsy Severity Scale (NSS), Epworth Sleepiness Scale (ESS), 14-item Hamilton Anxiety Rating Scale (HAMA-14), 17-item Hamilton Depression Rating Scale (HAMD-17). Among 60 randomised participants (32 men [53.3 %] and 28 [46.7 %]; mean [SD] age, 29.9 [9.9] years), 56 were included in the modified intention-to-treat (mITT) analysis. From baseline to week 12, the difference in mean change in mean sleep onset latency of MWT was 3.09 (95 % CI, 1.00, 5.88; P = 0.0041) as compared with stVNS group. Significant improvements in NSS-EDS (−2.61 [95%CI, −4.07, −1.15; P = 0.0006]), NSS-SP (−1.11 [95%CI, −1.83, −0.38; P = 0.0030]), NSS-HH (−2.71 [95%CI, −3.36, −2.05; P < 0.0001]), NSS- DNS (−0.52 [95%CI, −0.87, −0.17; P = 0.0036]), ESS (−3.03 [95%CI, −4.30, −1.75; P < 0.0001]) and HAMD-17 (−2.50 [95%CI, −4.30, −0.70; P = 0.0069]) were observed in the tVNS group as compared with stVNS group. This exploratory study supported the efficacy and safety of tVNS in patients with NT1 and provided insights into the mechanisms underlying tVNS treatment for NT1. The findings highlight tVNS as a potential non-pharmacological adjunctive therapy for patients with NT1. This trial was registered with the Chinese Clinical Trial Registry, ChiCTR2400094550
Multi-omics analysis of SFTS virus infection in Rhipicephalus microplus cells reveals antiviral tick factors
Get PDFThe increasing prevalence of tick-borne arboviral infections worldwide necessitates advanced control strategies, particularly those targeting vectors, to mitigate the disease burden. However, the cellular interactions between arboviruses and ticks, especially for negative-strand RNA viruses, remain largely unexplored. Here, we employ a proteomics informed by transcriptomics approach to elucidate the cellular response of the Rhipicephalus microplus-derived BME/CTVM6 cell line to severe fever with thrombocytopenia syndrome virus (SFTSV) infection. We generate the de novo transcriptomes and proteomes of SFTSV- and mock-infected tick cells, identifying key host responses and regulatory pathways. Additionally, interactome analysis of the viral nucleoprotein (N) integrated host responses with viral replication and dsRNA-mediated gene silencing screen reveals two anti-SFTSV effectors: the N interacting RNA helicases DHX9 and UPF1. Collectively, our results provide insights into the antiviral responses of R. microplus vector cells and highlight critical SFTSV restriction factors, while enriching transcriptomic and proteomic resources for future research.</p
Paediatric anaemia in rural Kenya and the role of travel time to emergency care services
Get PDFBackground: Access to emergency care (EC) services is crucial for severe anaemia outcome. Limited information exists on the association between travel times to EC services and the presentation and severity of anaemia upon hospital admission. Here, we investigate the association between travel time and presentation of severe anaemia (compared to mild/moderate anaemia) at admission in western Kenya. Methods: Data from January 2020 to July 2023 from Busia County Referral Hospital were assembled for paediatric admissions aged 1–59 months residing in Busia County. Travel time from a patient's village to the hospital was calculated using a least cost path algorithm. Anaemia severity was categorised as mild (Hb ≥ 7–<10 g dl−1), moderate (Hb ≥ 5–<7 g dl−1) and severe (Hb < 5 g dl−1). We fitted a geostatistical model accounting for covariates to estimate the association between travel times to EC services and severe anaemia presentation. Results: Severe anaemia admissions had the highest median travel time of 36 min (IQR: 25,54) (p-value: <0.001). Compared to children living within a 30 min travel time to the hospital, the adjusted odds ratio (AOR) of severe anaemia presentation relative to mild/moderate anaemia was 2.44 (95% CI: 1.63–3.55) for those residing within 30-59 min. For travel times of 60–89 min, the AOR was 3.55 (95% CI: 1.86–6.10) and for ≥90 min, the AOR was 3.41 (95% CI: 1.49–7.67). Conclusion: Travel time is significantly associated with the severity of paediatric anaemia presentations at hospitals. Addressing disparities in travel times such as strategic bolstering of lower-level facilities to offer EC services, is crucial for implementing new interventions and optimizing existing hospital-linked interventions to enhance healthcare delivery.</p
Unwrapping the Global Financing Facility: understanding implications for women’s children’s and adolescent’s health through layered policy analysis
Get PDFThe Global Financing Facility (GFF), launched in 2015, aims to catalyse funding for reproductive, maternal, newborn, child, and adolescent health, and nutrition. Few independent assessments have evaluated its processes and impact. We conducted a multi-layered policy analysis of GFF documents–the Investment Cases (ICs) and the GFF-linked World Bank Project Appraisal Documents (PADs)–examining the content of GFF documents for 28 countries, comparing four tracer themes (maternal and newborn health, adolescent health, community health, and quality), and analysing the policy processes in four country studies (Burkina Faso, Mozambique, Tanzania, and Uganda). From 2015 to 2022, GFF-linked PADs reported US$ 14.5 billion of funding across 26 countries through 30 PADs, with GFF contributing 4% to this value. GFF investments primarily focused on service delivery, governance, and performance-based financing. Countries received more targeted investments for maternal and newborn health and adolescent health linked to their burden of these tracer themes. Attention to community health and quality varied. ICs were broader than PADs and more inclusive in their development. Local contexts shaped policy processes. GFF supported priority-setting and learning; however, translating priorities into resourced actions proved challenging. Power dynamics influenced country ownership, donor coordination and resource mobilisation. The GFF is a significant opportunity to advance health for vulnerable populations. Progress in transparency and data use is evident, but accountability gaps, power imbalances, and limited engagement with civil society and private sector hinder national ownership. Further research is needed to determine GFF’s attribution to catalytic resource mobilization.</p