To evaluate the psychometric properties and performance of the 32‐item Thriving of Older People Assessment Scale (TOPAS) and to explore reduction into a short‐form.
The 32‐item TOPAS has been used in studies of place‐related well‐being as a positive measure in long‐term care to assess nursing home resident thriving; however, item redundancy has not previously been explored.
Staff members completed the 32‐item TOPAS as proxy raters for a random sample of Swedish nursing home residents (N = 4,831) between November 2013 ‐ September 2014. Reliability analysis, exploratory factor analysis and item response theory‐based analysis were undertaken. Items were systematically identified for reduction using statistical and theoretical analysis. Correlation testing, means comparison and model fit evaluation confirmed scale equivalence.
Psychometric properties of the 32‐item TOPAS were satisfactory and several items were identified for scale reduction. The proposed short‐form TOPAS exhibited a high level of internal consistency (α = 0.90) and strong correlation (r = 0.98) to the original scale, while also retaining diversity among items in terms of factor structure and item difficulties.
The 32‐item and short‐form TOPAS’ indicated sound validity and reliability to measure resident thriving in the nursing home context.
There is a lack of positive life‐world measures for use in nursing homes. The short‐form TOPAS indicated sound validity and reliability to measure resident thriving, providing a feasible measure with enhanced functionality for use in aged care research, assessments and care planning for health‐promoting purposes in nursing homes.
To synthesize the best available evidence on the experiences and perceptions of older people who identify as LGBTQ+ regarding their mental health needs and concerns.
A narrative review and critical appraisal of qualitative, quantitative and mixed methods studies.
A systematic search was undertaken across all of the databases including PsycINFO, MEDLINE, CINAHL and Sociological Abstracts. International studies published in academic journals in the English language, from January 1995 to January 2019 were appraised. Studies had to involve older people identifying as LGBTQ+ and who had experiences mental health issues.
Fourteen papers were selected for inclusion in the systematic review. A narrative analysis of the papers was used by synthesizing the key findings and organizing them into themes and concepts.
Following analysis of the data, the themes that emerged were: (i) LGBTQ+ identity issues (ii) risk and vulnerability factors, (iii) coping strategies and resilience, (iv) interventions and supports.
This review highlights key mental health‐related issues that need to be taken into account in the creation and provision of appropriate, responsive and inclusive supports and services.
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Our study investigates the influence of career facilitators and barriers on nurses' improvement of their professional capabilities and their professional turnover intention.
Reducing nurses' professional turnover intention could help alleviate the global nursing shortage. Nevertheless, little research has addressed how career facilitators and barriers, nurses' improvement of their professional capabilities and professional turnover intention are related, indicating a gap.
This study used a cross‐sectional design.
We surveyed 502 out of 2,660 full‐time nurses who worked for a medical centre in Taiwan between January and March 2018. Our items were adapted from Cunningham et al. and Teng et al. and had adequate reliability and validity. Structural equation modeling was used to test the study hypotheses.
Human capital, social capital and discrimination were positively related to intention to improve professional capabilities. Moreover, intention to improve professional capabilities was positively related to action to improve professional capabilities, which was negatively related to professional turnover intention.
Most of the career facilitators and even barriers, boost the improvement of professional capabilities and are useful for retaining nurses in the nursing profession.
Findings of this study should have an impact on nursing managers by offering them means to retain nurses, e.g., enhancing human capital and social capital among nurses to reduce their turnover intention.
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The Lone Star Stroke Consortium Telestroke Registry (LeSteR) currently consisting of 3 academic hub centres and 27 partner spokes is a statewide initiative organised by leading academic health centres in the State of Texas to understand practice patterns of acute stroke management via telestroke (TS) in Texas, a state with one of the largest rural populations in the USA.
All patients who had presumed stroke for whom a TS consultation has been obtained in the network are entered into a web-based, Health Insurance Portability and Accountability Act-compliant database from September 2013 to present. Spokes were enrolled into LeSteR in a staggered approach in two data collection phases: a retrospective phase and a prospective phase. Basic clinical, demographic data and relevant time metrics are collected in the retrospective phase. Starting 1 September 2015, additional outcome data including 90-day modified Rankin score, readmission and 90-day disposition are obtained by a standard phone interview. From the registry initiation to 31 December 2017, there are 8089 patients who had suspected stroke in the registry. Over 60% of patients enrolled after 1 September 2015 have reported outcome data. Enrolment is still active for this registry.
LeSteR is a statewide TS registry organised by academic health centres that will provide significant insight regarding the impact of TS in the State of Texas. Findings from LeSteR will provide data that can be analysed to improve the allocation of healthcare resources using TS to treat stroke in a state with one of the largest rural populations.
Paget’s disease of bone (PDB) is characterised by increased and disorganised bone remodelling affecting one or more skeletal sites. Complications include bone pain, deformity, deafness and pathological fractures. Mutations in sequestosome-1 (SQSTM1) are strongly associated with the development of PDB. Bisphosphonate therapy can improve bone pain in PDB, but there is no evidence that treatment alters the natural history of PDB or prevents complications. The Zoledronate in the Prevention of Paget’s disease trial (ZiPP) will determine if prophylactic therapy with the bisphosphonate zoledronic acid (ZA) can delay or prevent the development of PDB in people who carry SQSTM1 mutations.
People with a family history of PDB aged >30 years who test positive for SQSTM1 mutations are eligible to take part. At the baseline visit, participants will be screened for the presence of bone lesions by radionuclide bone scan. Biochemical markers of bone turnover will be measured and questionnaires completed to assess pain, health-related quality of life (HRQoL), anxiety and depression. Participants will be randomised to receive a single intravenous infusion of 5 mg ZA or placebo and followed up annually for between 4 and 8 years at which point baseline assessments will be repeated. The primary endpoint will be new bone lesions assessed by radionuclide bone scan. Secondary endpoints will include changes in biochemical markers of bone turnover, pain, HRQoL, anxiety, depression and PDB-related skeletal events.
The study was approved by the Fife and Forth Valley Research Ethics Committee on 22 December 2008 (08/S0501/84). Following completion of the trial, a manuscript will be submitted to a peer-reviewed journal. The results of this trial will inform clinical practice by determining if early intervention with ZA in presymptomatic individuals with SQSTM1 mutations can prevent or slow the development of bone lesions with an adverse event profile that is acceptable.
To assess the trends concerning utilisation of maternal and child health (MCH) services before, during and after the Ebola outbreak, quantifying the contribution of a reorganised referral system (RS).
A prospective observational study of MCH services.
Pujehun district in Sierra Leone, 77 community health facilities and 1 hospital from 2012 to 2017.
MCH utililization was evaluated by assessing: (1) institutional deliveries, Cesarean-sections, paediatric and maternity admissions and deaths, and major direct obstetric complications (MDOCs), at hospital level; (2) antenatal care (ANC) 1 and 4, institutional delivery and family planning, at community level. Contribution of a strengthened RS was also measured.
At hospital level, there is a significant difference between trends Ebola versus pre-Ebola for maternal admissions (7, 95% CI 4 to 11, p
A stronger health system compared with other districts in Sierra Leone and a strengthened RS enabled health facilities in Pujehun to maintain service provision and uptake during and after the Ebola epidemic.
To carry out a systematic review of the psychometric properties of international studies that have used the Hospital Survey on Patient Safety Culture (HSPSC).
Literature review and an analysis framework to review studies.
Hospitals and other healthcare settings in North and South America, Europe, the Near East, the Middle East and the Far East.
A total of 62 studies and 67 datasets made up of journal papers, book chapters and PhD theses were included in the review.
Psychometric properties (eg, internal consistency) and sample characteristics (eg, country of use, participant job roles and changes made to the original version of the HSPSC).
Just over half (52%) of the studies in our sample reported internal reliabilities lower than 0.7 for at least six HSPSC dimensions. The dimensions ‘staffing’, ‘communication openness’, ‘non-punitive response to error’, ‘organisational learning’ and ‘overall perceptions of safety’ resulted in low internal consistencies in a majority of studies. The outcomes from assessing construct validity were reported in 60% of the studies. Most studies took place in a hospital setting (84%); the majority of survey participants (62%) were drawn from nursing and technical staff. Forty-two per cent of the studies did not state what modifications, if any, were made to the original US version of the instrument.
While there is evidence of a growing worldwide trend in the use of the HSPSC, particularly within Europe and the Near/Middle East, our review underlines the need for caution in using the instrument. Future use of the HSPSC needs to be sensitive to the demands of care settings, the target population and other aspects of the national and local healthcare contexts. There is a need to develop guidelines covering procedures for using, adapting and translating the HSPSC, as well as reporting findings based on its use.
To test the association between use of medicines with anticholinergic or sedative properties and physical function, cognitive function, appetite and frailty.
This cross-sectional study analysed baseline data collected as part of the Australian Longitudinal Study of Ageing, a population-based cohort of 2087 participants aged 65 years or over living in South Australia.
Physical function was measured at baseline using measures including hand grip strength, walking speed, chair stands, activities of daily living and instrumental activities of daily living (IADL). Cognitive function was measured using Mini-Mental State Examination. Appetite was measured using Center for Epidemiologic Studies Depression question 2. Frailty was measured using frailty index. The association between use of anticholinergics or sedatives and physical or cognitive function, appetite, or frailty was assessed using analysis of covariance and ordinal or binary logistic regression.
Almost half of the population were using anticholinergics or sedatives (n=954, 45.7%). Use of anticholinergics was significantly associated with poorer grip strength, slower walking speed, poorer IADL and poorer appetite. Use of sedatives was significantly associated with poorer grip strength, slower walking speed and poorer IADL. We found no significant association between medicine use and cognitive function. Users of anticholinergics or sedatives were significantly more likely to be frail compared with non-users.
Use of medicines with anticholinergic or sedative properties is significantly associated with poorer physical function, poorer appetite and increased frailty. Early identification of signs and symptoms of deterioration associated with medicine use is particularly important in older people so that worsening frailty and subsequent adverse events are prevented.
The aim of this study was to systematically evaluate the quality of the clinical practice guidelines (CPGs) for diabetes mellitus published in China over the period of January 2007 to April 2017.
We searched the China National Knowledge Infrastructure, Chinese Biomedical Literature database, VIP database and WanFang databases and guideline websites for CPGs for diabetes mellitus published between January 2007 and April 2017 in China. Two reviewers independently screened the literature according to the inclusion and exclusion criteria and extracted data. We used the the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool (Canadian Institutes of Health Research, Ottawa, Canada) to evaluate the quality of the included guidelines, calculated the scores of each domain and evaluated the consistency among the assessors via use of the intragroup correlation coefficient. And then we compared the results with Chinese CPGs and international CPGs. We conducted a subgroup analysis based on different classification criteria and compared scores of each domain subgroup analyses.
A total of 98 guidelines were identified. The correlation coefficient within the group was 0.93, suggesting that the consistency between the evaluators was good. The scores of the six domains of AGREE II were described in median (IQR) as follows: scope and purpose 53.7 (50.0–59.7), stakeholder involvement 31.5 (27.3–37.0), rigour of development 19.1 (15.3–22.2), clarity of presentation 59.3 (50.0–64.8), applicability 18.1 (13.9–25.7) and editorial independence 0.0 (0.0–0.0). The mean score in each domain of quality of Chinese diabetes CPGs was lower than that of CPGs published worldwide but higher than the mean score of Chinese guidelines of all topics. A funding source, the updated version, organisation and publishers of the guidelines and target fields are all the factors influencing the quality of CPGs to a certain degree.
A large number of Chinese diabetes CPGs have been produced. Their quality remain unsatisfactorily low compared with CPGs worldwide, there is still room for improvement. Chinese guideline developers should pay more attention to the transparency of methodology, and use the AGREE II instrument to develop and report guidelines.
Knowledge of how physical activity (PA) and sport participation are related to mental health throughout adolescence is scarce. Our objective was to describe PA levels and sport participation in a population-based sample of adolescents, and to explore how they relate to mental health in different age groups.
A population-based cross-sectional study.
The adolescent part of the Nord-Trøndelag Health Study, a Norwegian population-based health survey, conducted from 2006 to 2008. Of 10 464 invited participants (age 13–19 years), 7619 (73%) participated, of whom 3785 (50%) were boys.
Mental health outcomes included psychological distress assessed using a short version of the Hopkins Symptom Check List Five items, self-esteem assessed using a short version of the Rosenberg Self-Esteem Scale and life satisfaction assessed with a single-item satisfaction with life measure.
Logistic regression models were used to estimate the likelihood of psychological distress, low self-esteem and low life satisfaction, according to self-reported PA level and type of sport participation, stratified by gender and school level (junior vs senior high school).
Fewer senior high school students participated in team sports compared with junior high school students (p
A high PA level was favourably associated with various dimensions of mental health, especially for adolescents in senior high school. Team sport participation may have a positive impact on mental health and should, therefore, be encouraged.
To explore health-worker perspectives on security, improving safety, managing constrained resources and handling mass casualties during besiegement in Syria.
A qualitative study using semi-structured key informant interviews, conducted remotely over WhatsApp and Skype, and analysed thematically using inductive coding.
Secondary and tertiary health facilities affected by besiegement in Aleppo (from July to December 2016) and Rural Damascus (from August 2013 to February 2018).
Twenty-one male Syrian health-workers and service-users who had experienced besiegement and targeting of their health facilities.
Participants described four related challenges of: (i) conflict-related responses, particularly responding to mass casualties; (ii) targeted attack responses, particularly preventing/surviving facility bombings; (iii) besiegement responses, particularly mitigating severe resource constraints; and (iv) chronic risk responses, particularly maintaining emotional resilience. Mass casualty response involved triage and training to prioritise mortality reduction and available resources, for example those with greatest need and likelihood of survival. Targeting response was largely physical, including fortification, working underground, reducing visibility and services dispersal. Besiegement response required resource conservation, for example, controlling consumption, reusing consumables, low-technology equipment, finding alternative supply routes, stockpiling and strengthening available human resources through online trainings and establishing a medical school in Ghouta. Risk responses included managing safety worries, finding value in work and maintaining hope.
Besieged health-workers were most affected by severe resource constraints and safety concerns while responding to overwhelming mass casualty events. Lessons for targeting/besiegement planning include training staff and preparing for: (i) mass casualties, through local/online health-worker training in triage, emergency response and resource conservation; allowing task-shifting; and providing access to low-technology equipment; (ii) attacks, through strengthened facility security, for example, protection and deterrence through fortification, working underground and reducing visibility; and (iii) besiegement, through ensuring access to internet, electricity and low-technology/reusable equipment; securely stockpiling fuel, medicines and supplies; and establishing alternative supply routes.
Musculoskeletal care pathways are variable and inconsistent. The aim of this systematic review was to evaluate the evidence for the clinical and/or cost effectiveness of current care pathways for adults with hip and/or knee pain referred for specialist opinion.
Electronic database searches were carried out in MEDLINE, MEDLINE In-Process, Cumulative Index of Nursing and Allied Health Literature, Embase, PEDro, PubMed, Web of Science, Cochrane Central and Health Management Information Consortium without language restriction from 1990 onwards. Websites were reviewed for grey literature.
All study designs and documents that considered care pathways for adults with musculoskeletal hip and/or knee pain referred for specialist opinion were screened by two reviewers. Risk of bias was assessed using The Critical Appraisal Skills Programme checklist for randomised controlled trials and the Joanna Briggs Institute checklists.
Data extraction and quality assessment were performed by one reviewer and checked by a second. Findings are reported narratively.
The titles and abstracts of 1248 articles were screened and 140 full-text articles retrieved. 19 papers reporting 17 studies met the study inclusion criteria. Quality was low due to study design and methodological flaws. Most of the outcomes relate to organisational process at the ‘meso’ level of a whole systems approach.
It can be concluded that the pathway is not linear, containing variations and activity loops. The available evidence suggests that, from the point of referral for specialist opinion, a model is required that integrates the skills of all the different healthcare professionals and streamlining is required to ensure that individuals are seen by the healthcare professional that best meets their needs. There is very limited evidence of patient experience informing knee and hip care pathways.
The Global Burden of Disease 2010 study ranked osteoarthritis (OA) as a leading cause of years lived with disability. With an ageing population, increasing body weight and sedentary lifestyle, a substantial increase especially in knee OA (KOA) is expected. Management strategies for KOA include non-pharmacological, pharmacological and surgical interventions. Meanwhile, over-the-counter pain medications have been discredited as they are associated with several risks with long-term usage. By consequence, the use of exercise and all sorts of complementary and alternative medicine (CAM) for joint pain has increased. The available self-management strategies are plenty, but there is no overview of their use at a population level and whether they are used along with doctors’ prescriptions or replace these. The aim of this study is to estimate the population incidence of developing knee symptoms and analyse the association between (and impact of) the use of self-reported preventive measures and knee symptoms.
This prospective cohort study pragmatically recruits individuals from the municipality of Frederiksberg, Denmark. All citizens aged 60–69 years old will be contacted annually for 10 years and asked to participate in a web-based survey. The major outcomes are self-reported knee symptoms and their association with use of various management strategies, including use of non-pharmacological treatments and CAM. Secondary outcomes include the influence of treatments on use of healthcare system and surgical procedures. Descriptive and analytic statistics (eg, logistic regression) will be used to provide summaries about the sample and observations made and the associations between self-management and development of knee symptoms.
This study can be implemented without permission from the Health Research Ethics Committee. Permission has been obtained from the Danish Data Protection Agency. Study findings will be disseminated in peer-reviewed journals and presented at relevant conferences.
To describe the disposition and sociodemographic characteristics of medical students associated with inclusion of traditional and complementary medicine in medical school curricula in Uganda.
A cross-sectional study conducted during May 2017. A pretested questionnaire was used to collect data. Disposition to include principles of traditional and complementary medicine into medical school curricula was determined as proportion and associated factors determined through multivariate logistic regression.
Medical students in their second to fifth years at the College of Health Sciences, Makerere University, Uganda. Makerere University is the oldest public university in the East African region.
393 of 395 participants responded. About 60% (192/325) of participants recommended inclusion of traditional and complementary medicine principles into medical school curricula in Uganda. The disposition to include traditional and complementary medicine into medical school curricula was not associated with sex, age group or region of origin of the students. However, compared with the second year students, the third (OR 0.34; 95% CI 0.17 to 0.66) and fifth (OR 0.39; 95% CI 0.16 to 0.93) year students were significantly less likely to recommend inclusion of traditional and complementary medicine into the medical school curricula. Participants who hold positive attributes and believe in effectiveness of traditional and complementary medicine were statistically significantly more likely to recommend inclusion into the medical school curricula in Uganda.
Inclusion of principles of traditional and complementary medicine into medical school curricula to increase knowledge, inform practice and research, and moderate attitudes of physicians towards traditional medicine practice is acceptable by medical students at Makerere University. These findings can inform review of medical schools’ curricula in Uganda.
Most people suffering from depression and anxiety disorders are entirely treated in primary care. Due to growing challenges in ageing societies, for example, patients’ immobility and multimorbidity, the transition to specialised care becomes increasingly difficult. Although the co-location of general practitioners and mental health specialists improves the access to psychosocial care, integrated in-person approaches are not practical for rural and single-doctor practices with limited personnel and financial resources. Treating primary care patients via internet-based video consultations by remotely located mental health specialists bears the potential to overcome structural barriers and provide low-threshold care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing of mental health specialist video consultations in primary care practices.
Fifty primary care patients with significant depression and/or anxiety symptomatology will be randomised in two groups receiving either the treatment as usual as provided by their general practitioner or up to five video consultations conducted by a mental health specialist. The video consultations focus on (1) systematic diagnosis plus proactive monitoring using validated clinical rating scales, (2) the establishment of an effective working alliance and (3) a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices’ workflows, feasibility of the data collection and clinical parameters.
This trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-634/2018). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial.
Smoking among persons with a mental health disorder is associated with inequitable health, social and economic burden. Randomised controlled trials (RCTs) are considered the gold standard design for the assessment of healthcare intervention efficacy/effectiveness. However, many RCTs of smoking interventions for persons with a mental health disorder lack rigour due to low participant retention. No systematic review has pooled retention rates in randomised trials of smoking interventions for persons with a mental health disorder or explored associated factors. The aims of the systematic review will therefore be to: (1) summarise overall rates of participant retention in smoking cessation and reduction trials involving persons with a mental health disorder (including for experimental and control groups separately) and (2) determine if retention rates vary according to participant, environmental, researcher and study factors.
PsycINFO, EMBASE, MEDLINE, CENTRAL and The Cochrane Tobacco Addiction Review Group Specialised Register will be searched for reports of RCTs of outpatient smoking cessation or reduction interventions for adults with a mental health disorder. The search terms will include MeSH terms and free text words, and there will be no language or date restrictions. All databases will be searched from inception to present. Data will be analysed using the Mantel-Haenszel fixed-effect model, and where substantial heterogeneity (I2 >50%) is detected, DerSimonian & Laird inverse-variance random effects model. Pooled estimates and 95% CIs will be calculated for overall participant retention rates and for intervention and control trial arms separately. Associations between participant retention and participant, environmental, researcher and study factors will be assessed via subgroup analyses and, where sufficient data are obtained, meta-regression.
This study does not require ethical approval. The findings of this review will be disseminated via publication in a peer-reviewed open access medical journal and presentations at international scientific meetings.
Although cardiovascular disease (CVD) is of growing importance in low- and middle-income countries (LMICs), there are conflicting views regarding CVD as a major public health problem for the urban poor, including those living in slums. We examine multivariable risk prediction in a slum population and assess the number of cardiovascular related deaths within 10 years of application of the tool.
We use data from the Nairobi Urban Health and Demographic Surveillance System (NUHDSS) population (residents of two slum communities) between May 2008 and April 2009.
This is a secondary data analysis from a cross-sectional survey. We use the WHO/International Society of Hypertension (WHO/ISH) cardiovascular risk prediction tool to examine 10-year risk of major CVD events in a slum population. CVD deaths in the cohort, reported up until June 2018 and identified through verbal autopsy are also presented.
3063 men and women aged over 40 years with complete data for variables needed for the WHO/ISH risk prediction tool were eligible to take part.
The majority of study members (2895, 94.5%) were predicted to have ‘low’ risk (20% were identified as dying of CVD.
This study shows that there is a low risk profile of CVD in this slum population in Nairobi, Kenya, in comparison to results from application of multivariable risk prediction tools in other LMIC populations. This has implications for health service planning in these contexts.
To examine the impact of caesarean section on breastfeeding indicators—early initiation of breastfeeding, exclusive breastfeeding under 6 months and children ever breastfed (at least once)—in sub-Saharan Africa.
Secondary analysis of Demographic and Health Surveys (DHS).
Thirty-three low-income and middle-income countries with a survey conducted between 2010 and 2017/2018.
Women aged 15–49 years with a singleton live last birth during the 2 years preceding the survey.
We analysed the DHS data to examine the impact of caesarean section on breastfeeding indicators using the modified Poisson regression models for each country adjusted for potential confounders. For each breastfeeding indicator, the within-country adjusted prevalence ratios (aPR) were pooled in random-effects meta-analysis.
The within-country analyses showed, compared with vaginal birth, caesarean section was associated with aPR for early initiation of breastfeeding that ranged from 0.24 (95% CI 0.17 to 0.33) in Tanzania to 0.89 (95% CI 0.78 to 1.00) in South Africa. The aPR for exclusive breastfeeding under 6 months ranged from 0.58 (95% CI 0.34 to 0.98) in Angola to 1.93 (95% CI 0.46 to 8.10) in Cote d'Ivoire, while the aPR for children ever breastfed ranged from 0.91 (95% CI 0.82 to 1.02) in Gabon to 1.02 (95% CI 0.99 to 1.04) in Gambia. The meta-analysis showed caesarean section was associated with a 46% lower prevalence of early initiation of breastfeeding (pooled aPR, 0.54 (95% CI 0.48 to 0.60)). However, meta-analysis indicated little association with exclusive breastfeeding under 6 months (pooled aPR, 0.94 (95% CI 0.88 to 1.01)) and children ever breastfed (pooled aPR, 0.98 (95% CI 0.98 to 0.99)) among caesarean versus vaginally born children.
Caesarean section had a negative influence on early initiation of breastfeeding but showed little difference in exclusive breastfeeding under 6 months and children ever breastfed in sub-Saharan Africa.
Biannual mass azithromycin distribution to children aged 1–59 months has been shown to reduce all-cause mortality. Children under 28 days of age were not treated in studies evaluating mass azithromycin distribution for child mortality due to concerns related to infantile hypertrophic pyloric stenosis (IHPS). Here, we report the design of a randomised controlled trial to evaluate the efficacy and safety of administration of a single dose of oral azithromycin during the neonatal period.
The Nouveaux-nés et Azithromycine: une Innovation dans le Traitement des Enfants (NAITRE) study is a double-masked randomised placebo-controlled trial designed to evaluate the efficacy of a single dose of azithromycin (20 mg/kg) for the prevention of child mortality. Newborns (n=21 712) aged 8–27 days weighing at least 2500 g are 1:1 randomised to a single, directly observed, oral dose of azithromycin or matching placebo. Participants are followed weekly for 3 weeks after treatment to screen for adverse events, including IHPS. The primary outcome is all-cause mortality at the 6-month study visit.
This study was approved by the Institutional Review Boards at the University of California, San Francisco in San Francisco, USA (Protocol #18-25027) and the Comité National d’Ethique pour la Recherche in Ouagadougou, Burkina Faso (Protocol #2018-10-123). The findings of this trial will be presented at local, regional and international meetings and published in open access peer-reviewed journals.
Although substantial progress in the treatment of stable angina pectoris (sAP) has been made, little is known about the functional status and quality of life (QoL) of patients in different healthcare systems.
We undertook a survey using the Seattle Angina Questionnaire (SAQ) (five domains scored form 0—worst assessment to 100—best assessment) to assess symptoms, QoL (including limitation of activities), demographics, geographic distribution and individual disease data in patients with stable coronary artery disease in Austrian cardiology practices.
A total of 660 patients with sAP with a mean age of 69.2 years were included. SAQ scores were 67.5±24.4 for physical limitation, 65.5±26.6 for angina stability, 79.3±23.2 for angina frequency, 86.3±16.2 for treatment satisfaction and 63.7±24.2 for overall QoL. Multiple regression identified male gender, but also female gender, Eastern Austrian residence and high body mass index as predictive factors for SAQ scoring. A total of 35.6% of the patients reported at least one desirable activity that was limited through AP symptoms.
Activity and QoL assessments are in accordance with published literature: The number and the diversity of desired activities indicate the need to focus on patient’s individual activity level to improve symptom management.