Conectar
There is an urgent need for effective interventions to aid diabetes-related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.
Gestational diabetes mellitus (GDM) is an emerging public health concern in low and middle-income countries, including Nigeria, because of the associated pregnancy complications, increased healthcare costs and long-term health sequelae among women of reproductive age and their offspring. We determined the cumulative incidence, risk factors and pregnancy outcomes of GDM in Ibadan, Nigeria.
Prospective cohort study.
Ibadan, Southwest Nigeria.
721 pregnant women from the Ibadan Pregnancy Cohort Study participated in the one-step 75 g-oral glucose tolerance test at 24–28 weeks’ gestation.
The primary outcome of the study is the cumulative incidence of GDM. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups criteria. Secondary outcomes were pregnancy outcomes, which included modes of delivery (CS, spontaneous vaginal delivery), macrosomia (birth weight ≥4.0 kg), gestational age at delivery and birth asphyxia. The risk factors (exposures) examined included sociodemographic, obstetric, clinical, behavioural and lifestyle factors. Bivariate and multivariate Log-binomial regression models were used to identify the independent risk factors of GDM (adjusted for maternal age ≥35 years, income, maternal body mass index, history of pregnancy loss and congenital anomaly) and the associated pregnancy outcomes of GDM (adjusted for maternal age, income and maternal body mass index). Adjusted relative risk (aRR) and 95% CI, used to assess the strength of associations, were reported.
The cumulative incidence of GDM was 20.7%, 95% CI (17.9% to 23.9%). The mean time for the diagnosis of GDM is 25.4±1.42 weeks of gestation. After adjusting for other variables, maternal age ≥35 years: (aRR: 1.48). 95% CI (1.07 to 1.97) p=0.016), maternal obesity (aRR: 1.85, 95% CI (1.26 to 2.30) p=0.002) and a previous history of congenital anomaly (aRR: 2.83, 95% CI (1.97 to 4.07) p
The cumulative incidence of GDM is high among pregnant women in Ibadan. Maternal age ≥35 years, maternal obesity and a history of congenital anomaly were significant independent risk factors for GDM. These factors should be targeted for public health interventions, including lifestyle modification among pregnant women with obesity and early screening and diagnosis of GDM.
by Adedapo Olufemi Bashorun, Larry Kotei, Abdoulie F. Jallow, Ousubie Jawla, Emmanuel U. Richard-Ugwuadu, Muhammed Jagana, Lamin Bah, Amadou Tijan Bah, Karamo Conteh, Mamadou S.K. Jallow, Mehrab Karim, Bai Lamin Dondeh, Anne Segonds-Pichon, Gary M. Clifford, Iacopo Baussano, Bruno Pichon, David Jeffries, Ed Clarke
Human papillomavirus (HPV) infection is a primary cause of preventable deaths from cervical cancer, a condition of profound inequality with approximately 90% of deaths occurring in low- and middle-income countries, particularly in sub-Saharan Africa. In May 2018, the WHO Director-General declared a Joint Global Commitment to Cervical Cancer Elimination, highlighting the critical role of HPV vaccines in achieving this goal. However, there is a lack of systemically collected data on HPV prevalence in The Gambia, and impact data from high-income countries may not be reliably extrapolated to West African settings due to geographical variation in HPV types and distinct behavioural, biological, and sociodemographic exposures. The Gambia introduced a two-dose HPV vaccination schedule in 2019, but coverage has been very low, interrupted mainly by the COVID-19 pandemic. This presents a key opportunity to generate vital baseline data on HPV prevalence in the population before potential scale-up of vaccination efforts. The PHASE survey, a multi-stage cluster survey, aims to establish the baseline, population prevalence estimates of high-risk and low-risk, vaccine-type and non-vaccine-type HPV infection in 15- to 49-year-old females in The Gambia by measuring urinary HPV-DNA. The survey will also quantify the effects of various exposures on HPV prevalence, including sexual behaviour, the presence of other sexually-transmitted infections (STIs) - Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), syphilis, as well as blood borne viruses, human immunodeficiency virus (HIV), hepatitis B and hepatitis C; obstetric history, socio-demographic characteristics, and cervical cancer screening and/or treatment. Additionally, the study will provide important antimicrobial resistance (AMR) data for NG and MG in sub-Saharan Africa, a region poorly represented in global surveillance programs. This data is needed to guide regional treatment guidelines and advocate for new solutions, including gonococcal vaccines. The AMR data are expected to immediately influence recommendations regarding the appropriate choice of antibiotics for syndromic STI management in West Africa and hence to address an important driver of AMR in the sub-region. Leveraging on the Medical Research Council Unit The Gambia funded Health Demographic Surveillance system (HDSS) as its sampling frame, the survey will utilize validated diagnostic assays and culturally sensitive data collection methods, to ensure both scientific rigor and local relevance. Tools such as Audio Computer-Assisted Self-Interviewing (ACASI) technology, developed in consultation with local community advisory boards, are included to reduce social desirability bias in reporting sexual behaviour. This approach aims to maximize both the reliability and cultural appropriateness of the findings. This study directly addresses the critical need for baseline epidemiological data on HPV in a West African setting to accelerate vaccine impact and drive new interventions towards cervical cancer elimination. By understanding other factors that influence HPV (like other STIs, sexual behaviour, etc.), the study aims to ensure that, when the vaccine’s impact is measured later, changes in other confounding factors that may impact on HPV prevalence can be accounted for. The study will also establish the population prevalence of the measured STIs and their relationship to common symptoms and other adverse health outcomes related to STIs.Pre-eclampsia and fetal growth restriction (FGR) are two principal complications of pregnancy related to placental dysfunction. Nevertheless, knowledge of the underlying pathophysiological mechanisms remains inadequate, and only a few tools are available for in vivo assessment of placental perfusion. Contrast-enhanced ultrasound (CEUS) allows organ vascularisation evaluation via a strictly intravascular gas microbubble. The primary aim of this study is to compare placental vascularisation parameters obtained via CEUS between pregnancies with FGR and those without FGR.
This is a single-centre, prospective, comparative, non-randomised, feasible, open and interventional study. We will include 30 women with medical termination of pregnancy divided into two groups: one with severe FGR and the other without FGR. Severe FGR is defined as an estimated fetal weight below the third percentile for gestational age. Women will be informed and recruited in the fetal medicine unit over a period of 48 months. The primary goal of this study is to compare the placental contrast ultrasound parameter measurements according to group. The primary objective is to compare placental contrast ultrasound data in women who undergo medical termination of pregnancy at a gestational age of 16 weeks (38+6 days) between two groups: a group with FGR and a group without FGR. The secondary objectives are as follows: (1) to describe the placental vascularisation parameters measured by CEUS; (2) to describe the parameters for quantifying vascularisation at different gestational ages via CEUS; (3) to study the associations between CEUS data and placental histological data and (4) to establish a biological collection of placentas to increase our knowledge of the development and functions of the placenta during pregnancy. The statistical analysis will include descriptive analysis for all study patients, with quantitative data described by means±SDs, medians, IQRs, and extreme values and qualitative data reported as counts and percentages. Comparisons of placental contrast ultrasound parameters between the two groups will be performed via Student’s t-test or the Mann-Whitney U test on the basis of data normality. Associations between CEUS parameters and placental histology data will be analysed with Spearman or Pearson correlations. Qualitative associations will be studied via analysis of variance or the Kruskal-Wallis test. Box plot representations will be used when applicable. Analyses will be performed with R software, with significance set at p
This study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) SUD EST II – LYON – FRANCE, on 26 April 2024, with reference number 2023-506936-34-00, and the competent authority ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) authorised the study on 17 May 2024. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.
NCT06497959; EU CT number: 2023-506936-34-00.
To investigate the effects of active involvement of family caregivers in adult in-hospital care on patients' readmissions, complications, mortality, length of hospital stay, quality of life, psychological distress and activities of daily living, as well as on the satisfaction of patients, HCPs and family caregivers.
Systematic review.
Ovid Medline, Ovid Embase, EBSCO CINAHL, Cochrane Library (from inception to February 2024).
The PRISMA 2020 statement was followed. Prospective controlled studies focusing on active involvement of family caregivers in adult in-hospital care were included. Two independent teams of authors conducted study selection, quality assessment and data extraction.
Thirteen studies were included, comprising 11 randomised controlled trials. The clinical and methodological heterogeneity precluded a meta-analysis. Six of these studies were performed in stroke patients. Some studies reported statistically significant benefits of active family involvement on readmission rates, hospital LOS, ADL, psychological distress for patients and family members, QoL and satisfaction of family caregivers. However, others did not observe differences in these outcomes. For complication rates, mortality and satisfaction of patients and HCPs, no studies demonstrated significant differences between groups.
Further research is needed to provide a conclusive answer as to whether active family caregiver involvement improves outcomes of adult hospitalised patients.
Despite the inconclusive findings of this review, advocating for active involvement of family caregivers in adult in-hospital care fits the perspective of patient- and family-centred care.
As the care of hospitalised adults is shifting to a more family-centric approach, investigating the effects of an active role of family caregivers in adult in-hospital care is necessary. However, the small number of studies available and heterogeneity between studies included in this review hamper firm conclusions. Further evaluations through well-designed studies are required.
The National Family Health Survey-5 has reported an under-five mortality rate of 41.9 per 1000 live births in India. Pneumonia, one of the leading causes of under-five mortality, contributes substantially to this figure. The Indian government has made efforts through multiple national programmes, but pneumonia-specific mortality remains high. The Government of India revised their Childhood Pneumonia Management Guidelines in 2019 to improve under-five pneumonia prevention and management. This implementation study aims to achieve a high population-based coverage of pneumonia treatment for under 5 yearold children in the Palwal district of India.
This implementation study uses a quasi-experimental pre-post design and a mixed-methods approach, conducted in three phases: (i) formative research, (ii) model optimisation through iterative testing in a learning block and (iii) scale-up and concurrent evaluation. The study is set in Palwal district, Haryana, and the primary catchment/study area will be the Health and Wellness Centres, the most accessible public health facilities for the community. Approximately 4167 households will be surveyed to capture ~2400 under-five children, among whom about 120 pneumonia cases (based on an estimated 5% prevalence) will be included in the analysis of treatment coverage and outcomes. Quantitative data will be analysed using descriptive statistics and generalised linear models, while qualitative data from focus group discussions and in-depth interviews will be thematically analysed using NVivo software.
Ethical approval was granted by the ethical committees of the Society for Applied Studies (ERC/IR Pneumonia/2021), the Regional Ethics Committee of Western Norway (2022/531608) and the WHO(ERC.0003652). Additionally, this study has obtained the Government of Haryana state (Memo no. HSHRC/2022/505) and Health Ministry steering committee (approval date: 19 Dec 2022, proposal id 2022–17596) approvals. Informed consent will be obtained from all participants, including caregivers and healthcare workers, prior to data collection. Dissemination meetings in the study country will share results with stakeholders, including Ministry of Health officials, health managers, families of under-five children, community leaders and academia, to discuss national health programme implications. Results will also be shared regionally and globally, with publications and presentations encouraged in national and international forums.
Clinical Trials Registry – India, CTRI/2021/03/031622.
To evaluate the effects of exergaming on physical frailty in older adults.
Systematic review with meta-analysis.
Six electronic databases were searched for randomised controlled trials evaluating the effects of exergaming on frailty in older adults. Data were synthesised using narrative synthesis and meta-analysis. The risk of bias and the certainty of the evidence were assessed.
CINAHL, Cochrane Library, Embase, PubMed, Web of Science, and China Academic Journal Network Publishing Database were searched from their inception through February 2024.
Five studies (n = 391) were included. Exergaming, which was delivered in 20–36 sessions over 8–12 weeks, resulted in improvements in frailty scores and indices, frailty status, and frailty phenotypes, including exhaustion, low physical activity levels, gait speed, and muscle weakness over time. There was no effect on unintentional weight loss. Meta-analyses showed that the effects of exergaming were not significantly different from those observed in the control groups. The rate of adherence to the intervention of the exergaming group was slightly higher than that of the comparison group (87.3%–87.7% vs. 81.1%–85.4%). The overall risk of bias was high in all studies. The certainty of the evidence was very low.
Exergaming exerts effects on frailty comparable to those of conventional physical exercises. Participants appeared to have better adherence to exergaming. Future studies with robust designs are warranted.
With effects comparable to those of conventional physical exercises, exergaming could be considered in clinical settings to address frailty.
This review addressed the effects of exergaming on frailty instead of physical outcomes. Exergaming was comparable to conventional physical exercises in improving frailty scores and indices, frailty status, and four frailty phenotypes. The findings provide insights to healthcare providers on the design of exergames.
PRISMA guidelines.
PROSPERO number: CRD42023460495.
No Patient or Public Contribution.
Depressive symptoms are common among people with dementia (PWD). Exergaming consisting of combined cognitive and physical training in gaming is increasingly used to alleviate their depressive symptoms in research. With its potential synergistic neurobiological and psychosocial effects on reducing depressive symptoms among PWD, this review aimed to understand its effectiveness and contents.
This is a systematic review of the effectiveness of exergames on depressive symptoms among older adults with dementia. A search was conducted on 7 May 2024 of the online databases CINAHL, Embase, PsycINFO, PubMed and the China Academic Journal Network Publishing Database (CNKI). The methodological quality of randomised controlled trials (RCT) and quasi-experimental studies was assessed with RoB2 and ROBINS-I, respectively. A meta-analysis of the included RCTs was conducted.
Six studies consisting of four RCTs and two quasi-experimental studies involving 235 participants with various stages of dementia were included. The meta-analysis showed a significant overall improvement in depression with a large effect size (SMD = 1.46, 95% CI = −2.50, −0.43; p = 0.006). Despite high heterogeneity (I 2 = 91%), all studies demonstrated a trend of improvement in depression after the intervention. The exergames adopted in the included trials had the following elements: simultaneous motor-cognitive training, a scoring mechanism and a social play. The dose of exergames ranged from 15 to 60 min per session for at least 8 weeks, with a minimum of two sessions weekly. However, the included studies had a moderate-to-serious risk of bias. The certainty of the evidence was very low.
Exergames could be effective at improving the depressive symptoms of older adults with dementia. Yet, a moderate-to-severe risk of bias shows a rigorous study should be conducted in the future.
This study provides evidence for healthcare professionals and informal caregivers to use exergames to address depressive symptoms in PWD.
The review was registered on PROSPERO with the reference CRD42022372762.
This study aimed to review studies exploring the experiences and perceptions of healthcare students and providers regarding their personal choices for elective female fertility preservation and their recommendations of the same to patients.
Employing Pluye and Hong's convergent qualitative synthesis approach, a mixed-studies review was conducted. The appraisal of studies was performed using the Mixed Methods Appraisal Tool and data analysis utilised Thomas and Harden's thematic synthesis approach.
Six electronic databases (PubMed, Embase, CINAHL, PsycINFO, Scopus and Web of Science) were searched from their inception till November 2023.
About 24 studies were reviewed, uncovering four major themes: varied personal perspectives, knowledge gaps and role ambiguities, perceived temporal and financial constraints and apprehensions related to fear and stigma.
This review underscored the challenges faced by healthcare professionals and students in their personal pursuit of elective fertility preservation. Addressing these challenges demands the implementation of fertility navigators, culturally and religiously sensitive public health campaigns and staff training. Moreover, standardised guidelines, transparent cost and process reporting, evidence-based education, counselling on risks and success rates and governmental support in the form of subsidies can mitigate barriers, enhance cost-effectiveness and promote equitable access to care. Collaboration among stakeholders is imperative to ensure equitable access and maintain quality care in elective female fertility preservation.
This mixed studies review followed the reporting guidelines in the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement.
No Patient or Public Contribution.
Trial Registration: This review has been registered on the Prospective Register of Systematic Reviews (PROSPERO) database (CRD42023395406)
FreshRSS 