Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.
We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at
This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.
ClinicalTrials.gov, NCT05968794.
In recent years, the use of frozen embryo transfers (FET) has rapidly increased following the freeze-all strategy due to the advantages of increased maternal safety, improved pregnancy rates, lower ectopic pregnancy rates and better obstetric and neonatal outcomes. Currently, there is still no good scientific evidence to support when to perform FET following a stimulated in vitro fertilisation (IVF) cycle in the freeze-all strategy.
This will be a randomised controlled trial. A total of 828 women undergoing their first FET following their first stimulated IVF cycle in the freeze-all strategy will be enrolled and randomised into one of the following groups according to a computer-generated randomisation list: (1) the immediate group, in which FET will be performed in the first menstrual cycle following the stimulated IVF cycle; or (2) the delayed group, in which FET will be performed at least in the second menstrual cycle following the stimulated IVF cycle. The primary outcome will be live birth, which is defined as the delivery of any infants at ≥22 gestational weeks with heartbeat and breath.
Ethical approval was granted by the Ethics Committee of Assisted Reproductive Medicine at the Shanghai JiAi Genetics & IVF Institute (JIAI E2019-15). Written informed consent will be obtained from each woman before any study procedure is performed, according to good clinical practice. The results of this trial will be disseminated in a peer-reviewed journal.
This study aimed to assess the administration technique of eye medications, its determinants and disposal practices among ophthalmic outpatients.
An analytical cross-sectional study was conducted.
Brhan Aini Ophthalmic National Referral Hospital in Asmara, Eritrea.
Samples of ophthalmic outpatients aged
Data were collected from August 2021 to September 2021, using an interview-based questionnaire. The collected data were entered and analysed using CSPro (V.7.3) and SPSS (V.26), respectively. Descriptive statistics and independent samples t-test were performed. P-values less than 0.05 were considered as significant.
A total of 333 respondents with a mean age of 56.4 (SD: 18.76) years were recruited in the study. More than half of the respondents (57.4%) did not have any information on the time interval between two successive eye medications. However, only 16.5% of the respondents managed to close their tear ducts after the administration of eye medication. The mean (SD) score for proper administration of eye medication was 4.16 (1.07) out of 7.0. Female sex (p=0.002), the absence of glaucoma (p=0.035) and the presence of cataract (p=0.014) were significant determinants of the proper administration technique of eye medication. The most favoured disposal practice for unused and/or expired eye medications was disposing of regular garbage (79.9%).
This research revealed that there was an inappropriate administration technique and disposal practices of eye medications among ophthalmic outpatients. This requires immediate attention from policy-makers, programme managers and healthcare professionals to ensure the appropriate use of eye medications by the patients.
Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.
This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.
The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.
Amid the growing global concern about obesity, young adults in South Korea are particularly affected, with 30.8% of people aged 19–34 classified as obese. Given the urban-centric lifestyle of Korean youth, understanding the relationship between daily life activities and the urban environment holds great promise for effective interventions. This study aims to explore the daily life activities of young adults with obesity in Seoul, a city known for its highly accessible and compact environment. The research questions explore the interaction between daily life activities and the neighbourhood environment and consider weight management in an urban context.
This study uses an extended qualitative geographic information system approach to explore a district in Seoul with a highly accessible and compact urban environment. The sample comprises young adults with obesity (aged 19–34) residing in the study area, with recruitment targeting up to 51 participants for data saturation. A qualitative, multimethod approach combines descriptive and spatiotemporal data collection. Descriptive data are being collected, including in-depth interviews and photographs of daily food consumption. Spatial data collection involves field observations, cognitive mapping and mobile Global Positioning System tracking. Temporal data is gathered through participants drawing round timetables, detailing their daily schedules. Data analysis will entail thematic analysis of the interview data and content analysis of the spatiotemporal data. For the integrated analysis, pattern finding will be used to synthesise the data.
This study was approved by the institutional review board of Seoul National University on 11 July 2022. Data collection and curation are currently underway, and the results of the analysis will be shared with the scientific community at international conferences and peer-reviewed journals. We are planning an open seminar to share our research findings with relevant policy-makers, community organisations and health professionals.
To determine the community’s perception on the magnitude of Xeroderma pigmentosum (XP) disease and healthcare-seeking practices in Micheweni, Pemba in response to the public widespread information on the increased burden of the disease.
Mixed-methods cross-sectional study.
Micheweni district, Pemba.
211 male and female adults in the household survey, three caretakers/parents of patients with XP in the case study, 20 key community leaders/influential people and health workers in in-depth interviews and 50 community members and other leaders in six focus groups.
This study has revealed that XP disease exists in few families of which some of them have more than one child affected. The record review showed that there were a total of 17 patients who were diagnosed with the disease for the past 3 years, however only 10 were alive during the time of the survey. Findings from the community members revealed that several patients were believed to have XP disease and perceived causes include inheritance, food types, beliefs and other sociocultural practices. Stigma and discrimination were reported by caretakers and religious leaders. However, some cases believed to be XP were identified as other skin conditions when clinical examination was performed by the team of our researchers. There is a great confusion about XP and other skin diseases.
The study has shown that XP affects only few families, hence termed as concentrated rather than a generalised disease. Due to the rareness of the disease, majority of people in the district are unaware of the disease, hence confusing it with other skin conditions. There is a need for the government in collaboration with other stakeholders to provide educational programme to community members about the disease to address the misconception about the magnitude of the disease.
This systematic review and meta-analysis aimed to assess the magnitude and determinants of diabetic ketoacidosis (DKA) among patients with diabetes mellitus (DM) in Ethiopia.
Systematic review and meta-analysis.
Age 15 and above all patients with diabetes with the diagnosis of DKA in Ethiopia
PubMed/MEDLINE, Cochrane Library, Science Direct, HINARI, Google Scholar and grey literatures were accessed to find relevant articles. Studies that have been conducted and reported in English language, articles with an available full-text, and observational studies were included. The task of searching sources was carried out from all stated electronic databases performed during 15 April–29 April 2023.
Eligible studies were critically appraised by three independent reviewers for methodological quality in the review using standardised critical appraisal instruments from Joanna Briggs Institute (JBI) for observational studies. After the finally extracted studies were exported, systematic review and meta-analysis were conducted using Unified Management, Assessment and Review of Information (JBI SUMARI) (JBI, Adelaide, Australia) and STATA V.17 software. Sensitivity tests were done, and funnel plot inspections with Egger’s test were used to check for publication bias.
From a total of 19 studies with 6498 study participants, the pooled prevalence of DKA among patients with DM in Ethiopia was 30.92% (95% CI 29.96 to 31.89) with a significant statistical heterogeneity (I2=99.2, p=
This systematic review and meta-analysis revealed that the prevalence of DKA among patients with DM in Ethiopia was 30.92%. Besides, different behavioural and clinical determinants of DKA among patients with DM were identified. However, further studies should be conducted, particularly on the possible determinants of DKA, and different stakeholders should be engaged to minimise its burden.
Early sepsis treatment in the emergency department (ED) is crucial to improve patient survival. Despite international promulgation, the uptake of the Surviving Sepsis Campaign (SSC) Hour-1 Bundle (lactate measurement, blood culture, broad-spectrum antibiotics, 30 mL/kg crystalloid for hypotension/lactate ≥4 mmol/L and vasopressors for hypotension during/after fluid resuscitation within 1 hour of sepsis recognition) is low across healthcare settings. Delays in sepsis recognition and a lack of high-quality evidence hinder its implementation. We propose a novel sepsis care model (National Early Warning Score, NEWS-1 care), in which the SSC Hour-1 Bundle is triggered objectively by a high NEWS-2 (≥5). This study aims to determine the feasibility of a full-scale type 1 hybrid effectiveness-implementation trial on the NEWS-1 care in multiple EDs.
We will conduct a pilot type 1 hybrid trial and prospectively recruit 200 patients from 4 public EDs in Hong Kong cluster randomised in a stepped wedge design over 10 months. All study sites will start with an initial period of standard care and switch in random order at 2-month intervals to the NEWS-1 care unidirectionally. The implementation evaluation will employ mixed methods guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, which includes qualitative and quantitative data from focus group interviews, staff survey and clinical record reviews. We will analyse the 14 feasibility outcomes as progression criteria to a full-scale trial, including trial acceptability to patients and staff, patient and staff recruitment rates, accuracy of sepsis screening, protocol adherence, accessibility to follow-up data, safety and preliminary clinical impacts of the NEWS1 care, using descriptive statistics.
The institutional review boards of all study sites approved this study. This study will establish the feasibility of a full-scale hybrid trial. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities.
Rises in average life expectancy, increased comorbidities and frailty among older patients lead to higher admission rates to intensive care units (ICU). During an ICU stay, loss of physical and cognitive functions may occur, causing prolonged rehabilitation. Some functions may be lost permanently, affecting quality of life (QoL). There is a lack of understanding regarding how many variables are relevant to health-related outcomes and which outcomes are significant for the QoL of frail, elderly patients following discharge from the ICU. Therefore, this scoping review aims to identify reported variables for health-related outcomes and explore perspectives regarding QoL for this patient group.
The Joanna Briggs Institute guidelines for scoping reviews will be employed and original, peer-reviewed studies in English and Scandinavian languages published from 2013 to 2023 will be included. The search will be conducted from July 2023 to December 2023, according to the inclusion criteria in Embase, MEDLINE, PsycINFO and CINAHL. References to identified studies will be hand-searched, along with backward and forward citation searching for systematic reviews. A librarian will support and qualify the search strategy. Two reviewers will independently screen eligible studies and perform data extraction according to predefined headings. In the event of disagreements, a third reviewer will adjudicate until consensus is achieved. Results will be presented narratively and in table form and discussed in relation to relevant literature.
Ethical approval is unnecessary, as the review synthesises existing research. The results will be disseminated through a peer-reviewed publication in a scientific journal.
Patient-reported outcome measures (PROMs) are useful for trauma registries interested in monitoring patient outcomes and trauma care quality. PROMs had not previously been collected by the New Zealand Trauma Registry (NZTR). More than 2500 New Zealanders are admitted to hospital for major trauma annually. The Trauma Outcomes Project (TOP) collected PROMs postinjury from three of New Zealand’s (NZ’s) major trauma regions. This cohort profile paper aims to provide a thorough description of preinjury and 6 month postinjury characteristics of the TOP cohort, including specifically for Māori (Indigenous population in Aotearoa me Te Waipounamu/NZ).
Between July 2019 and June 2020, 2533 NZ trauma patients were admitted to one of 22 hospitals nationwide for major trauma and included on the NZTR. TOP invited trauma patients (aged ≥16 years) to be interviewed from three regions; one region (Midlands) declined to participate. Interviews included questions about health-related quality of life, disability, injury recovery, healthcare access and household income adequacy.
TOP recruited 870 participants, including 119 Māori. At 6 months postinjury, most (85%) reported that the injury still affected them, 88% reported problems with≥1 of five EQ-5D-5L dimensions (eg, 75% reported problems with pain or discomfort, 71% reported problems with usual activities and 52% reported problems with mobility). Considerable disability (World Health Organization Disability Assessment Schedule, WHODAS II, score ≥10) was reported by 45% of participants. The prevalence of disability among Māori participants was 53%; for non-Māori it was 44%. Over a quarter of participants (28%) reported trouble accessing healthcare services for their injury. Participation in paid work decreased from 63% preinjury to 45% 6 months postinjury.
The 12 and 24 month postinjury data collection has recently been completed; analyses of 12 month outcomes are underway. There is potential for longer-term follow-up interviews with the existing cohort in future. TOP findings are intended to inform the National Trauma Network’s quality improvement processes. TOP will identify key aspects that aid in improving postinjury outcomes for people experiencing serious injury, including importantly for Māori.