Climate change and climate-related disasters adversely affect mental health. Low- and middle-income countries (LMICs) are particularly vulnerable to the impacts of climate change and climate-related disasters and often lack adequate mental healthcare infrastructure. We used the scoping review methodology to determine how exposure to climate change and climate-related disasters influences the presence of mental disorders among those living in LMICs. We also aimed to recognise existing gaps in this area of literature.
This review followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist. To identify relevant studies, we searched five electronic databases (MEDLINE, EMBASE, Global Health, APA PsycInfo and Sociological Abstracts) from 1 January 2007 to 31 December 2019. We also searched the grey literature. Included studies had an adult-focused LMIC population, a climate change or climate-related disaster exposure and a mental disorder outcome. Relevant study information was extracted and synthesised.
Fifty-eight studies were identified, most of which (n=48) employed a cross-sectional design. The most commonly studied exposure–outcome combinations were flood-related post-traumatic stress disorder (PTSD) (n=28), flood-related depression (n=15) and storm-related PTSD (n=13). The majority of studies identified a positive exposure–outcome association. However, few studies included a baseline or comparator (ie, unexposed) group, thereby limiting our understanding of the magnitude or nature of this association. There was also great heterogeneity in this literature, making studies difficult to pool or compare. Several research gaps were identified including the lack of longitudinal studies and non-uniformity of geographic coverage.
To our knowledge, this was the first scoping review to investigate the relationship between climate change and climate-related disaster exposures and mental disorder outcomes in LMICs. Our findings support the need for further research, but also highlight that mental health should be a priority within LMIC climate change policy considerations.
Gastrointestinal recovery after surgery is of worldwide significance. Postoperative gastrointestinal dysfunction is multifaceted and known to represent a major source of postoperative morbidity, however, its significance to postoperative care across all surgical procedures is unknown. The complexity of postoperative gastrointestinal recovery is poorly defined within gastrointestinal surgery, and even less so outside this field. To inform the clinical care of surgical patients worldwide, this systematic review and meta-analysis will aim to characterise the duration of postoperative gastrointestinal recovery that can be expected across all surgical procedures and determine the associations between factors that may affect this.
MEDLINE, Embase, Cochrane Library and CINAHL will be searched for studies reporting the time to first postoperative passage of stool after any surgical procedure. We will screen records, extract data and assess risk of bias in duplicate. Forest plots will be constructed for time to postoperative gastrointestinal recovery, as assessed by various outcome measures. Because of potential heterogeneity, a random-effects model will be used throughout the meta-analysis. Funnel plots will be used to test for publication bias. Meta-regressions will be undertaken where the outcome is the mean time to first postoperative passage of stool, with potential predictors and confounders being patient characteristics, postoperative outcomes and surgical factors.
This study will not involve human or animal subjects and, thus, does not require ethics approval. The outcomes will be disseminated via publication in peer-reviewed scientific journal(s) and presentations at scientific conferences.
Despite current available treatment patients with bipolar disorder often experience relapses and decreased overall functioning. Furthermore, patients with bipolar disorder are often not treated medically or psychologically according to guidelines and recommendations. A Clinical Academic Group is a new treatment initiative bringing together clinical services, research, education and training to offer care and treatment that is based on reliable evidence backed up by research. The present Clinical Academic Group for bipolar disorder (the CAG Bipolar) randomised controlled trial (RCT) aims for the first time to investigate whether specialised outpatient treatment in CAG Bipolar versus generalised community-based treatment improves patient outcomes and clinician’s satisfaction with care in patients with bipolar disorder.
The CAG Bipolar trial is a pragmatic randomised controlled parallel-group trial undertaken in the Capital Region of Denmark covering a catchment area of 1.85 million people. Patients with bipolar disorder are invited to participate as part of their outpatient treatment in the Mental Health Services. The included patients will be randomised to (1) specialised outpatient treatment in the CAG Bipolar (intervention group) or (2) generalised community-based outpatient treatment (control group). The trial started 13 January 2020 and has currently included more than 600 patients. The outcomes are (1) psychiatric hospitalisations and cumulated number and duration of psychiatric hospitalisations (primary), and (2) self-rated depressive symptoms, self-rated manic symptoms, quality of life, perceived stress, satisfaction with care, use of medication and the clinicians’ satisfaction with their care (secondary). A total of 1000 patients with bipolar disorder will be included.
The CAG Bipolar RCT is funded by the Capital Region of Denmark and ethical approval has been obtained from the Regional Ethical Committee in The Capital Region of Denmark (H-19067248). Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets.
The Oslo Ischaemia Study was designed to investigate the prevalence and predictors of silent coronary disease in Norwegian middle-aged men, specifically validating exercise electrocardiography (ECG) findings compared with angiography. The study has been important in investigating long-term predictors of cardiovascular morbidity and mortality, as well as investigating a broad spectrum of epidemiological and public health perspectives.
In 1972–1975, 2014 healthy men, 40–59 years old, were enrolled in the study. Comprehensive clinical examination included an ECG-monitored exercise test at baseline and follow-ups. The cohort has been re-examined four times during 20 years. Linkage to health records and national health registries has ensured complete endpoint registration of morbidity until the end of 2006, and cancer and mortality until the end of 2017.
The early study results provided new evidence, as many participants with a positive exercise ECG, but no chest pain (‘silent ischaemia’), did not have significant coronary artery stenosis after all. Still, they were over-represented with coronary disease after years of follow-up. Furthermore, participants with the highest physical fitness had lower risk of cardiovascular disease, and the magnitude of blood pressure responses to moderate exercise was shown to influence the risk of cardiovascular disease and mortality. With time, follow-up data allowed the scope of research to expand into other fields of medicine, with the aim of investigating predictors and the importance of lifestyle and risk factors.
Recently, the Oslo Ischaemia Study has been found worthy, as the first scientific study, to be preserved by The National Archives of Norway. All the study material will be digitised, free to use and accessible for all. In 2030, the Oslo Ischaemia Study will be linked to the Norwegian Cause of Death Registry to obtain complete follow-up to death. Thus, a broad spectrum of additional opportunities opens.
Cardiovascular diseases (CVDs) are the single greatest contributor to global mortality. The successful introduction and scale-up of antiretroviral therapy (ART) delivered a reduction in HIV mortality. Consequently, an association was found between the scale-up of ART and an increased prevalence of comorbidities among people living with HIV (PLWH) such as hypertension and dyslipidaemia. A higher quality diet can delay the onset of comorbidities related to HIV infection. Diet quality and its methods of assessment are not fully established among PLWH. This review will identify the diet quality and food insecurity indices that have been used among PLWH and how these constructs are associated with risk of developing CVD.
The frameworks recommended by Arksey and O’Malley and the Joanna Briggs Institute’s manual for conducting scoping reviews will be adopted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines will be used for reporting. A search strategy was developed using keywords related to the topic. A preliminary MEDLINE (via PubMed) search was conducted on 11 November 2020 to develop a comprehensive search strategy. The final search will be conducted on PubMed, EbscoHost, Scopus, Web of Science and Cochrane Library databases. Titles and abstracts of retrieved records will be screened independently by two reviewers. Data will be extracted from records that meet the inclusion criteria using a predesigned charting tool. Discrepancies in decisions made by reviewers will be resolved by consensus or the decision of a third reviewer. Extracted data will be presented in tables or charts. A descriptive summary of the charts or tables will follow.
Ethical approval is not required for a scoping review. Findings will inform other studies currently underway and will be presented at conferences and published in peer-reviewed journals.
The increased reliance on digital technologies to deliver healthcare as a result of the COVID-19 pandemic has meant pre-existing disparities in digital access and utilisation of healthcare might be exacerbated in disadvantaged patient populations. The aim of this rapid review was to identify how this ‘digital divide’ was manifest during the first wave of the pandemic and highlight any areas which might be usefully addressed for the remainder of the pandemic and beyond.
Rapid review and narrative synthesis.
The major medical databases including PubMed and Embase and Google Scholar were searched alongside a hand search of bibliographies.
Original research papers available in English which described studies conducted during wave 1 of the COVID pandemic and reported between 1 March 2020 and 31 July 2021.
The search was described using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and identified nine studies. The results are presented within a refined framework describing the three key domains of the digital divide: (1) digital access, within which one study described continuing issues with internet connectivity among vulnerable patients in the UK; (2) digital literacy, where seven studies described how ethnic minorities and the elderly were less likely to use digital technologies in accessing care; (3) digital assimilation, where one study described how video technologies can reduce feelings of isolation and another how elderly black males were the most likely group to share information about COVID-19 on social media platforms.
During the early phase of the pandemic in the developed world, familiar difficulties in utilisation of digital healthcare among the elderly and ethnic minorities continued to be observed. This is a further reminder that the digital divide is a persistent challenge that needs to be urgently addressed when considering the likelihood that in many instances these digital technologies are likely to remain at the centre of healthcare delivery.
The prevalence of childhood obesity has risen dramatically in recent years. A proportion of this burden has been attributed to factors that occur during the first 1000 days of life such as genetic predisposition, breast feeding and complementary feeding. Although the mechanisms by which these factors affect weight and adiposity are less well understood, appetite and satiety regulation may be a key to understanding them. This cohort study aims to investigate the role of appetite and satiety regulation as a mediator in the association between infant feeding practices and genetic polymorphisms with children’s growth, adiposity and metabolic risk factors.
‘MAS-Lactancia’ (the first word means ‘more’ and is also an acronym in Spanish for ‘Appetite and Satiety Mechanisms’, the second word is ‘breastfeeding’) is an open, ongoing, prospective birth cohort that began the enrolment in 2016 of mother–child pairs affiliated to the Mexican Social Security Institute and that live in the city of Cuernavaca, Mexico. Pregnant women between 16-week and 22-week gestation are followed during the second half of their pregnancies, at birth and throughout their infant’s first 48 months of life (at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months and 48 months) at the clinic and at-home visits that include questionnaires, anthropometric measurements and biospecimen collection. The main exposure variables are infant feeding (breast feeding and complementary feeding) and genetic polymorphisms (fat mass and obesity-associated, leptin and adiponectin genes). Outcome variables include infant’s growth, adiposity and metabolic risk factors. We will conduct longitudinal models and path analyses to identify the potential mediating role of satiety and appetite indicators (leptin, adiponectin, insulin concentrations, appetite and satiety perception).
The study protocol, data collection instruments, consent forms and procedures were approved by the institutional review boards of the National Institute of Public Health and the Mexican Social Security Institute in Mexico. Findings will be disseminated through conferences, peer-reviewed publications and meetings with stakeholders.
Previous studies have investigated the association between socioeconomic characteristics and fractures among children, producing different results. In a population-based study, we previously found an increased risk of fractures among children living in an urban municipality compared with rural municipalities. This study aimed to evaluate the importance of socioeconomic variables for the incidence of fractures among 0–17 year olds.
We present a longitudinal, observational study of a population 0–17 years of age. Data from an injury database were linked with additional socioeconomic data for the population at risk. These were 55 758 individuals residing within the primary catchment area of a regional hospital in northern Sweden. Using the number of fractures as the outcome, we fitted a generalised linear mixed model for a Poisson response with socioeconomic variables at the family level as independent variables while controlling for age, sex and place of residence.
We found a significant association between higher levels of family income and the risk of fracture, rate ratio 1.40 (1.28–1.52) p
Our results indicate that children from families with higher income and with siblings are at greater risk of sustaining fractures.
To survey the healthcare professionals’ background and experiences from work with patients with COVID-19 in intensive care units (ICUs) during the first wave of the COVID-19 pandemic in Norway.
Observational cohort study.
COVID-ICUs in 27 hospitals across Norway.
Healthcare professionals (n=484): nurses (81%), medical doctors (9%) and leaders (10%), who responded to a secured, web-based questionnaire from 6 May 2020 to 15 July 2020.
Healthcare professionals’: (1) professional and psychological preparedness to start working in COVID-ICUs, (2) factors associated with high degree of preparedness and (3) experience of working conditions.
The age of the respondents was 44.8±10 year (mean±SD), 78% were females, 92% had previous ICU working experience. A majority of the respondents reported professional (81%) and psychological (74%) preparedness for working in COVID-ICU. Factors significantly associated with high professional preparedness for working in COVID-19-ICU in a multivariate logistic model were previous ICU work experience (p0.001) and participation in COVID-ICU simulation team training (p=0.042) and participation in COVID-ICU simulation team training (p=0.001). Working with new colleagues and new professional challenges were perceived as positive in a majority of the respondents, whereas 84% felt communication with coworkers to be challenging, 46% were afraid of being infected and 82% felt discomfort in denying access for patient relatives to the unit. Symptoms of sweating, tiredness, dehydration, headache, hunger, insecurity, mask irritation and delayed toilet visits were each reported by more than 50%.
Healthcare professionals working during the first wave of COVID-ICU patients in Norway were qualified and prepared, but challenges and potential targets for future improvements were present.
Our aim is to develop a novel approach to hyperkinetic movement disorder classification, that combines clinical information, electromyography, accelerometry and video in a computer-aided classification tool. We see this as the next step towards rapid and accurate phenotype classification, the cornerstone of both the diagnostic and treatment process.
The Next Move in Movement Disorders (NEMO) study is a cross-sectional study at Expertise Centre Movement Disorders Groningen, University Medical Centre Groningen. It comprises patients with single and mixed phenotype movement disorders. Single phenotype groups will first include dystonia, myoclonus and tremor, and then chorea, tics, ataxia and spasticity. Mixed phenotypes are myoclonus-dystonia, dystonic tremor, myoclonus ataxia and jerky/tremulous functional movement disorders. Groups will contain 20 patients, or 40 healthy participants. The gold standard for inclusion consists of interobserver agreement on the phenotype among three independent clinical experts. Electromyography, accelerometry and three-dimensional video data will be recorded during performance of a set of movement tasks, chosen by a team of specialists to elicit movement disorders. These data will serve as input for the machine learning algorithm. Labels for supervised learning are provided by the expert-based classification, allowing the algorithm to learn to predict what the output label should be when given new input data. Methods using manually engineered features based on existing clinical knowledge will be used, as well as deep learning methods which can detect relevant and possibly new features. Finally, we will employ visual analytics to visualise how the classification algorithm arrives at its decision.
Ethical approval has been obtained from the relevant local ethics committee. The NEMO study is designed to pioneer the application of machine learning of movement disorders. We expect to publish articles in multiple related fields of research and patients will be informed of important results via patient associations and press releases.
This study was conducted to explore the association between pneumoconiosis and pneumothorax.
Retrospective cohort study.
Nationwide population-based study using the Taiwan National Health Insurance Database.
A total of 2333 pneumoconiosis patients were identified (1935 patients for propensity score (PS)-matched cohort) and matched to 23 330 control subjects by age and sex (7740 subjects for PS-matched cohort).
The incidence and the cumulative incidence of pneumothorax.
Both incidence and the cumulative incidence of pneumothorax were significantly higher in the pneumoconiosis patients as compared with the control subjects (p
Our study revealed a higher risk of pneumothorax in pneumoconiosis patients and suggested potential risk factors in these patients. Clinicians should be aware about the risk of pneumothorax in pneumoconiosis patients.
This study aimed to evaluate the quality of life (QoL) and determine its association with various factors and social support among university students during the COVID-19 pandemic after the end of movement lockdown.
This online cross-sectional study recruited 316 participants. The inclusion criteria were students 18 years and above who were registered with the faculties of medicine at Malaysian public universities located in Klang Valley and in the states of Penang and Kelantan in Peninsular Malaysia. The exclusion criteria were those who presented with psychotic disorders, bipolar mood disorder or a history of illicit drugs.
Participants were administered a self-reported questionnaire to gather data on demographic, personal, clinical and psychological characteristics. The questionnaire comprised of the 21-item Depression, Anxiety and Stress Scale, the Multidimensional Scale of Perceived Social Support, and the WHO Quality of Life- Brief Version (WHOQoL-BREF).
The psychological and social QoL scores were lower than the non-pandemic norms of the general population, while the physical health and environmental QoL scores were comparable. After adjusting for relevant demographic, personal and clinical variables, religious coping, greater number of hours of online classes attended, and greater social support from family, friends and significant others were significantly associated with higher QoL among the participants. Frustration due to study disruption, living in areas with a high prevalence of COVID-19 cases, and a higher severity of depressive and stress symptoms were significantly associated with lower QoL.
COVID-19 impaired the QoL of university students even after the movement lockdown was lifted.
Almost 60% of antibiotics in frail elderly are prescribed for alleged urinary tract infections (UTIs). A substantial part of this comprises prescriptions in case of non-specific symptoms or asymptomatic bacteriuria, for which the latest guidelines promote restrictiveness with antibiotics. We aim to reduce inappropriate antibiotic use for UTIs through an antibiotic stewardship intervention (ASI) that encourages to prescribe according to these guidelines. To develop an effective ASI, we first need a better understanding of the complex decision-making process concerning suspected UTIs in frail elderly. Moreover, the implementation approach requires tailoring to the heterogeneous elderly care setting.
First, we conduct a qualitative study to explore factors contributing to antibiotic prescribing for UTIs in frail elderly, using semi-structured interviews with general practitioners, nursing staff, patients and informal caregivers. Next, we perform a pragmatic cluster randomised controlled trial in elderly care organisations. A multifaceted ASI is implemented in the intervention group; the control group receives care as usual. The ASI is centred around a decision tool that promotes restrictive antibiotic use, supported by a toolbox with educational materials. For the implementation, we use a modified participatory-action-research approach, guided by the results of the qualitative study. The primary outcome is the number of antibiotic prescriptions for suspected UTIs. We aim to recruit 34 clusters with in total 680 frail elderly residents ≥70 years. Data collection takes place during a 5-month baseline period and a 7-month follow-up period. Finally, we perform a process evaluation. The study has been delayed for 6 months due to COVID-19 and is expected to end in July 2021.
Ethical approvals and/or waivers were obtained from the ethical committees in Poland, the Netherlands, Norway and Sweden. The results will be disseminated through publication in peer-reviewed journals and conference presentations.
The atypical antipsychotic clozapine has shown superior efficacy compared with other antipsychotics and is the gold standard for treating otherwise treatment resistant schizophrenia. However, multiple studies have found that clozapine is underutilised in most parts of the world. A few reviews of literature addressing barriers to clozapine prescribing have been conducted. While there is some variation in the literature included in these reviews, a common feature of the studies included is that they primarily focus on clinical staff’s attitudes and perceived barriers for prescribing. Studies of patient perspectives are only sparsely included. A preliminary literature search revealed though, that additional literature on the subject exists, including literature on patient perspectives. It is therefore difficult to conclude if the formerly synthesised literature is representative of current evidence or if the topic has been adequately investigated to inform clinical practice. A scoping review is warranted in order to map and synthesise primary literature on patients’ and psychiatrists’ perspectives on clozapine treatment, and to identify gaps for future research.
The electronic databases Cochrane Library, CINAHL, Web of Science, Psychinfo, MEDLINE and EMBASE will be searched for relevant publications, supplied with searches of Google scholar, The Networked Digital Library of Theses and Dissertations and OpenGrey. Citation tracking of selected studies will furthermore be undertaken. Two researchers will independently screen and extract data. Data will be collated to provide a descriptive summary of the literature, along with a qualitative content analysis of key findings. Identified gaps in research will be accompanied by recommendations for future investigations.
Findings will be disseminated through a peer-reviewed journal and conference presentations. The scoping review does not require ethics approval.
Sharps injuries, including needlestick injuries and splash exposures, constitute serious occupational health problems for healthcare workers, carrying the risk of bloodborne infections. However, data on such occupational incidents and their risk factors in healthcare settings are scarce and not systematically summarised in the Arab countries.
The aim of this study is to conduct a systematic review and meta-analysis to review published literature about sharps injuries and splash exposures of healthcare workers in Arab countries, with the objectives to determine the incidence and/or prevalence of these events, their identified risk factors and the applied preventive and postexposure prophylactic measures.
The protocol is developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines. A comprehensive presearch developed in January to March 2021 in the database PubMed will be followed by a systematic search of six, core medical and health science databases: PubMed, EMBASE, Scopus, CINAHL, Web of Science and Africa-Wide Information in May 2021. The search will be performed without any filters or restrictions for publication years. Covidence systematic review tool will be used for document management, blinded screening and study selection. Two reviewers will independently screen the records, extract data and conduct risk of bias assessment. Results will be synthesised narratively in summary tables, and, if findings allow, meta-analysis will be conducted on the incidence and/or prevalence of sharps injuries and splash exposures, and on the effect size of risk factors.
The systematic review methodology does not require ethics approval due to the nature of the study design based only on published studies. The results of the systematic review will be published in a peer-reviewed journal, disseminated to stakeholders and made publicly available.
While the trend in smoking prevalence is decreasing worldwide, the number of male tobacco smokers is growing in Africa. This study compares the cigarette market in eight sub-Saharan African countries. This includes examining cigarette prices, pricing differentials, pack sizes and affordability at national and subnational levels.
A cross-sectional data analysis using data from the Data on Alcohol and Tobacco in Africa (DATA) Project. The DATA Project was centrally coordinated by project supervisors following a standardised protocol. University students were recruited to conduct data collection and a total of 22 347 retail cigarette price data points collected between June and August 2018 were analysed (including Botswana, Ethiopia, Lesotho, Namibia, Nigeria, South Africa, Zambia and Zimbabwe). Prices were converted to US$ and standardised to the price of a 20-cigarette pack.
This research found large price differentials within provinces/states, with the gap between medium and minimum prices per 20-cigarette pack exceeding 50% of the medium price in 18 out of 24 provinces/states. Single cigarettes were widely available, especially in Lesotho and Ethiopia. Results of multivariable regression suggest prices (per 20-cigarette pack) were lower for cigarettes sold in packs than single sticks (–US$0.27, 95% CI: –US$0.39 to –US$0.23) and lower in less populated areas (–US$0.28 in rural compared with urban settings, 95% CI: –US$0.41 to –US$0.15). Availability of cheaper single cigarettes (lower per unit price than packed cigarettes) were identified for Lesotho and South Africa.
These findings identify a varied picture in cigarette pricing in studied countries and suggest measures to tackle pricing differentials and availability of single sticks are warranted. These measures should counteract the potential health consequences of the increasing penetration of tobacco industry in these sub-Saharan African countries.
Achieving gross total resection and endocrine remission in pituitary neuroendocrine tumours (PitNET) can be challenging, especially in PitNETs with cavernous sinus (CS) invasion, defined as a Knosp grade of 3 or 4. A potential target to identify PitNET tissue is vascular endothelial growth factor A (VEGF-A), which expression is known to be significantly higher in PitNETs with CS invasion.
The aim of this non-randomised, non-blinded, single centre, feasibility and dose-finding phase 1 trial is to determine the feasibility of intraoperative fluorescence imaging detection of PitNET tissue during endoscopic transsphenoidal surgery using the VEGF-A targeting optical agent bevacizumab-800CW (4, 5, 10 or 25 mg). Nine to fifteen patients with a PitNET with a Knosp grade of 3 or 4 will be included. Secondary objectives are: (1) To identify the optimal tracer dose for imaging of PitNET tissue during transsphenoidal surgery for further development in a phase 2 fluorescence molecular endoscopy trial. (2) To quantify fluorescence intensity in vivo and ex vivo with multidiameter single-fibre reflectance, single-fibre fluorescence (MDSFR/SFF) spectroscopy. (3) To correlate and validate both the in vivo and ex vivo measured fluorescence signals with histopathological analysis and immunohistochemical staining. (4) To assess the (sub)cellular location of bevacizumab-800CW by ex vivo fluorescence microscopy. Intraoperative, three imaging moments are defined to detect the fluorescent signal. The tumour-to-background ratios are defined by intraoperative fluorescence in vivo measurements including MDSFR/SFF spectroscopy data and by ex vivo back-table fluorescence imaging. After inclusion of three patients in each dose group, an interim analysis will be performed to define the optimal dose.
Approval was obtained from the Medical Ethics Review Board of the University Medical Centre Groningen. Results will be disseminated through national and international journals. The participants and relevant patient support groups will be informed about the results.
Rapid sequence induction of anaesthesia is indicated in patients with an increased risk of pulmonary aspiration. The main objective of the technique is to reduce the critical time period between loss of airway protective reflexes and rapid inflation of the cuff of the endotracheal tube to minimise the chance of aspiration of gastric contents. The COVID-19 pandemic has reinforced the importance of first-pass intubation success to ensure patient and healthcare worker safety. The aim of this study is to compare the first-pass intubation success rate (FPS) using the videolaryngoscopy compared with conventional direct laryngoscopy in surgical patients with a high risk of pulmonary aspiration.
The LARA trial is a multicentre, patient-blinded, randomised controlled trial. Consecutive patients requiring tracheal intubation are randomly allocated to either the McGrath MAC videolaryngoscope or direct laryngoscopy using the Macintosh laryngoscope. The expected rate of FPS is 92% in the McGrath group and 82% in the Macintosh group. Each group must include a total of 500 patients to achieve 90% power for detecting a difference at the 5% significance level. Successful intubation with the FPS is the primary endpoint. The secondary endpoints are the time to intubation, the number of intubation attempts, the necessity of airway management alternatives, the visualisation of the glottis using the Cormack and Lehane Score and the Percentage Of Glottic Opening Score and definite adverse events.
The project is approved by the local ethics committee of the Medical Association of the Rhineland Palatine state (registration number: 2020–15502) and medical ethics committee of the University of Freiburg (registration number: 21–1303). The results of this study will be made available in form of manuscripts for publication and presentations at national and international meetings.
The prevalence of chronic, lifestyle-related diseases is increasing among adults and children from low-income and middle-income countries. Despite the effectiveness of community-based interventions to address this situation, the benefits thereof may disappear in the long term, due to a lack of maintenance, especially among disadvantaged and high-risk populations. The KaziBantu randomised controlled trial conducted in 2019 consisted of two school-based health interventions, KaziKidz and KaziHealth. This study will evaluate the long-term effectiveness and sustainability of these interventions in promoting positive lifestyle changes among children and educators in disadvantaged schools in Nelson Mandela Bay, South Africa, in the context of the COVID-19 pandemic.
This study has an observational, longitudinal, mixed-methods design. It will follow up educators and children from the KaziBantu study. All 160 educators enrolled in KaziHealth will be invited to participate, while the study will focus on 361 KaziKidz children (aged 10–16 years) identified as having an increased risk for non-communicable diseases. Data collection will take place 1.5 and 2 years postintervention and includes quantitative and qualitative methods, such as anthropometric measurements, clinical assessments, questionnaires, interviews and focus group discussions. Analyses will encompass: prevalence of health parameters; descriptive frequencies of self-reported health behaviours and quality of life; the longitudinal association of these; extent of implementation; personal experiences with the programmes and an impact analysis based on the Reach, Efficacy, Adoption, Implementation, Maintenance framework.
In settings where resources are scarce, sustainable and effective prevention programmes are needed. The purpose of this protocol is to outline the design of a study to evaluate KaziKidz and KaziHealth under real-world conditions in terms of effectiveness, being long-lasting and becoming institutionalised. We hypothesise that a mixed-methods approach will increase understanding of the interventions’ capacity to lead to sustainable favourable health outcomes amid challenging environments, thereby generating evidence for policy.
Neonates and young infants with diagnosed or highly suspected glaucoma require an examination under anaesthesia to achieve accurate intraocular pressure (IOP) measurements, since crying or squinting of the eyes may increase IOP and lead to falsely high values. IOP considerably depends on perioperative variables such as haemodynamic factors, anaesthetics, depth of anaesthesia and airway management. The aim of this paper is to report the design and baseline characteristics of EyeBIS, which is a study to develop a standardised anaesthetic protocol for the measurement of IOP under anaesthesia in childhood glaucoma, by investigating the link between the magnitude of IOP and depth of anaesthesia.
This is a single-centre, prospective cohort study in 100 children with diagnosed or highly suspected glaucoma all undergoing ophthalmological examination under general anaesthesia. 20 children, who undergo general anaesthesia for other reasons, are included as controls. The primary outcome measure is the establishment of a standardised anaesthetic protocol for IOP measurement in childhood glaucoma by assessing the relationship between IOP and depth of anaesthesia (calculated as an electroencephalography variable, the bispectral index), with special emphasis on airway management and haemodynamic parameters. The dependence of IOP under anaesthesia on airway management and haemodynamic parameters will be described, using a mixed linear model. Restricting the model to patients with healthy eyes will allow to determine a 95% reference region, in which 95% of the measurement values of patients with healthy eyes can be expected.
The study has been approved by the local ethics committee of the Medical Association of Rhineland-Palatine (Ethik-Kommisssion der Landesaerztekammer Rheinland-Pfalz), Germany (approval number: 2019-14207). This work will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at national and international scientific meetings and data sharing with other investigators.
ClinicalTrials.gov Registry (NCT03972852).