To examine whether cost-free (CF) smoking cessation medication was more effective than a prescription for cessation medication in patients after transient ischaemic attack (TIA) or stroke.
Two-site randomised trial.
Stroke prevention clinics (SPCs) in Ontario, Canada.
Smokers with TIA or stroke, willing to quit smoking.
Smoking status was assessed in SPC attendees. Smokers were advised to quit smoking and received recommendations for cessation medication and counselling. Consenting participants were randomly assigned (1:1) to either a CF medication group or a prescription-only (Rx) group. CF participants immediately received a 12-week supply of cessation medication. Rx participants were given a prescription for 12 weeks of cessation medication. Follow-up counselling was provided for 26 weeks.
The primary outcome was 40-week continuous abstinence verified using a carbon monoxide breath test at 52-week follow-up. Secondary outcomes included abstinence at intermediate timepoints, medication adherence and serious adverse events.
Hundred and ninety-four participants were randomised and 131 (67.5%) completed the trial. The 40-week continuous abstinence rate at 52-week follow-up was 15.5% in the CF group versus 14.0% in the Rx group (OR=1.13; 95% CI 0.51 to 2.53). The 14-week continuous abstinence rate at 26-week follow-up was 18.6% in the CF group versus 16.8% in the Rx group (OR=1.20; 95% CI 0.56 to 2.55). Seven-day point-prevalence abstinence at 12 weeks was 38.1% in the CF group versus 26.9% in the Rx group (OR=1.76; 95% CI 0.94 to 3.28). Medication adherence was higher in the CF group versus the Rx group (47.4%±41.2% vs 25.5±36.8%, p
Our findings were inconclusive; we failed to meet our recruitment target and the effect size was smaller than anticipated. CF medication improved medication adherence.
NCT00962988; ClinicalTrials.gov Identifier.
Measures to mitigate the COVID-19 outbreak in the migrant worker dormitories in Singapore included lockdown and isolation of residents for prolonged periods. In this paper, we explore efforts to ease tensions and support mental health under these conditions.
Case study of dormitory residents under lockdown from April to August 2020 comprises a nested mixed-method approach using an online questionnaire (n=175) and semistructured interviews (n=23) of migrant workers sampled from the survey (August to September 2020). Logistic regression models were used to analyse survey data. Semistructured interviews were analysed using applied thematic analysis.
Survey and interview data showed that mental health was largely protected despite initial rising tensions over restrictions during lockdown. Sources of tension negatively affecting low stress responses included job related worries, OR=0.07 (95% CI 0.03 to 0.18, p
Interviewees shared how their adaptive capability played a pivotal protective role alongside social support and solidarity; aided by regular use of messaging applications, which supported mental health, OR=4.81 (95% CI 1.54 to 15.21, p
Tensions are mapped to protective solutions informing guidelines for future outbreak stress management response.
To examine long-term effectiveness of rehabilitation services on physical function, pain severity and post-traumatic stress disorder (PTSD) in earthquake survivors over a 4-year period.
Prospective cohort study with early and late intervention and geographical control group.
Three counties of Sichuan Province, China.
591 survivors of the 2008 Wenchuan earthquake were followed-up over a 4-year period ranging from 2008 to 2012.
In Mianzhu county, a comprehensive hospital-based and community-based rehabilitation programme was implemented in September 2008; in Anxian county, the same programme was implemented 1 year later; in Shifang county, the programme was not implemented and survivors from this county served as a control group.
Physical function was measured using Modified Barthel Index (MBI), pain severity with Visual Analogue Scale and PTSD with the PTSD Checklist-Civilian Version. All outcomes were assessed at three time points (baseline from 2008 to 2009, 2010 and 2012) and analysed with mixed effects regression.
400 patients completed all assessments. In all groups, physical function and pain severity improved over time. MBI improvement per month as compared with control was greater in the late rehabilitation (b=1.69, 95% CI 1.20 to 2.19) than the early rehabilitation group (b=0.96, 95% CI 0.68 to 1.24). This rehabilitation effect was however marginally decreasing over time. Superior improvement as compared with control with regard to pain was only found in the early rehabilitation group (b=–0.05, 95% CI –0.09 to –0.02). PTSD symptoms decreased over time, but the observed differences could not be specifically linked to the rehabilitation intervention.
Physical rehabilitation of earthquake survivors appears to be effective in improving physical function and, if delivered early, pain. Effects on mental health are less clear and need further examination using more consistent and frequent assessments of relevant outcomes and determinants.
Initial reports suggest people experiencing homelessness (PEH) are at high risk for SARS-CoV-2 infection and associated morbidity and mortality. However, there have been few longitudinal evaluations of the spread and impact of COVID-19 among PEH. This study will estimate the prevalence and incidence of COVID-19 infections in a cohort of PEH followed prospectively in Toronto, Canada. It will also examine associations between individual-level and shelter-level characteristics with COVID-19 infection, adverse health outcomes related to infection and vaccination. Finally, the data will be used to develop and parameterise a mathematical model to characterise SARS-CoV-2 transmission dynamics, and the transmission impact of interventions serving PEH.
Ku-gaa-gii pimitizi-win will follow a random sample of PEH from across Toronto (Canada) for 12 months. 736 participants were enrolled between June and September 2021, and will be followed up at 3-month intervals. At each interval, specimens (saliva, capillary blood) will be collected to determine active SARS-CoV-2 infection and serologic evidence of past infection and/or vaccination, and a detailed survey will gather self-reported information, including a detailed housing history. To examine the association between individual-level and shelter-level characteristics on COVID-19-related infection, adverse outcomes, and vaccination, shelter and healthcare administrative data will be linked to participant study data. Healthcare administrative data will also be used to examine long-term (up to 5 years) COVID-19-related outcomes among participants.
Ethical approval was obtained from the Unity Health Toronto and University of Toronto Health Sciences Research Ethics Boards (# 20-272). Ku-gaa-gii pimitizi-win was designed in collaboration with community and service provider partners and people having lived experience of homelessness. Findings will be reported to groups supporting Ku-gaa-gii pimitizi-win, Indigenous and other community partners and service providers, funding bodies, public health agencies and all levels of government to inform policy and public health programs.
Camrelizumab is a selective, humanised, high-affinity IgG4 kappa monoclonal antibody against programmed cell death 1 that shows effective antitumour activity with acceptable toxicity in multiple tumour types. The CameL trial demonstrated that camrelizumab plus chemotherapy (CC) significantly prolonged the median progression-free survival and median overall survival versus chemotherapy alone (CA) in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Our study was conducted to investigate the cost-effectiveness of the two strategies in chemotherapy-naive patients with advanced non-squamous NSCLC.
A Markov simulation model was generated based on the CameL trial. The two simulated treatments included CC and CA.
Utility was derived from published literature, and costs were calculated based on those at our hospital in Chengdu, China. Incremental cost-effectiveness ratios (ICERs) were calculated to compare the cost-effectiveness of the two treatment arms.
In the overall population, the total costs were $27 223.40 and $13 740.10 for CC and CA treatment, respectively. The CC treatment produced 1.37 quality-adjusted life years (QALYs), and the CA treatment produced 1.17 QALYs. Hence, patients who were in the CC group spent an additional $13 483.30 and generated an increase of 0.20 QALYs, resulting in an ICER of $67 416.50 per QALY.
For chemotherapy-naive patients with advanced non-squamous NSCLC, CC is not considered a cost-effective treatment versus CA in China when considering a willingness-to-pay threshold of $31 500 per QALY.
Knee osteoarthritis is a leading cause of disability, resulting in pain and reduced quality of life. Exercise is the cornerstone of conservative management but effects are, at best, moderate. Early evidence suggests that repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (M1) may improve the effect of exercise in knee osteoarthritis. This pilot study aims to (1) determine the feasibility, safety and participant-rated response to an intervention adding M1 rTMS to exercise in knee osteoarthritis; (2) elucidate physiological mechanisms in response to the intervention; (3) provide data to conduct a sample size calculation for a fully powered trial.
This is a pilot randomised, assessor-blind, therapist-blind and participant-blind, sham-controlled trial. Thirty individuals with painful knee osteoarthritis will be recruited and randomly allocated to receive either: (1) active rTMS+exercise or (2) sham rTMS+exercise intervention. Participants will receive 15 min of either active or sham rTMS immediately prior to 30 min of supervised muscle strengthening exercise (2x/week, 6 weeks) and complete unsupervised home exercises. Outcome measures of feasibility, safety, pain, function and physiological mechanisms will be assessed before and/or after the intervention. Feasibility and safety will be analysed using descriptive analysis. Within-group and between-group comparisons of pain and function will be conducted to examine trends of efficacy.
This study has been approved by the University of New South Wales Human Research Ethics Committee (HC210954). All participants will provide written informed consent. The study results will be submitted for peer-reviewed publication.
To assess costs, health outcomes and cost-effectiveness of interventions that aim to improve quality of diet and level of physical activity in adolescents.
A Markov model was developed to assess four potential benefits of healthy behaviour for adolescents: better mental health (episodes of depression and generalised anxiety disorder), higher earnings and reduced incidence of type 2 diabetes and adverse pregnancy outcomes (in terms of preterm delivery). The model parameters were informed by published literature. The analysis took a societal perspective over a 20-year period. One-way and probabilistic sensitivity analyses for 10 000 simulations were conducted.
A hypothetical cohort of 100 adolescents with a mean age of 13 years.
An exemplar school-based, multicomponent intervention that was developed by the Engaging Adolescents for Changing Behaviour programme, compared with usual schooling.
Incremental cost-effectiveness ratio (ICER) as measured by cost per quality-adjusted life-year (QALY) gained.
The exemplar dietary and physical activity intervention was associated with an incremental cost of £123 per adolescent and better health outcomes with a mean QALY gain of 0.0085 compared with usual schooling, resulting in an ICER of £14 367 per QALY. The key model drivers are the intervention effect on levels of physical activity, quality-of-life gain for high levels of physical activity, the duration of the intervention effects and the period over which effects wane.
The results suggested that such an intervention has the potential to offer a cost-effective use of healthcare-resources for adolescents in the UK at a willingness-to-pay threshold of £20 000 per QALY. The model focused on short-term to medium-term benefits of healthy eating and physical activity exploiting the strong evidence base that exists for this age group. Other benefits in later life, such as reduced cardiovascular risk, are more sensitive to assumptions about the persistence of behavioural change and discounting.
The term frontotemporal dementia (FTD) refers to a heterogeneous group of neurodegenerative disorders affecting the frontal and temporal lobes. Cognitively, impairment of executive function and social cognition predominates across the FTD spectrum, although other domains can be affected. Traditionally, cognition is tested through standard ‘pen and paper’ tasks in FTD. However, recent attempts have been made across other neurodegenerative disorders such as Alzheimer’s disease to develop computerised batteries that allow more accurate and sensitive detection of cognitive impairment.
This paper describes the development of a novel battery of tests for a tablet computer, particularly focused on FTD. It consists of 12 different tasks which aim to tap into information processing speed, various aspects of executive function, social cognition, semantic knowledge, calculation and visuospatial skills. Future studies will focus on validating the battery in a healthy control cohort, comparing it against a standard ‘pen and paper’ psychometric battery, and finally testing it within an FTD cohort, including those with genetic forms of FTD where we will be able to assess its ability to detect very early cognitive deficits prior to the onset of symptoms.
Normative data will be produced in the initial validation study (approved by the UCL Ethics Committee, project ID 17691/002) and will be made available online.
The aim of the study was to estimate the prevalence and correlates of cardiovascular disease (ischaemic heart disease and/or stroke (IHDS)) in Mongolia.
National community-based sample of people aged 15–69 years in Mongolia.
6654 people (15–69 years, mean 41.3) who participated in the 2019 Mongolia STEPS survey.
Self-reported prevalence of IHDS and biological and social covariates. Determinants of IHDS were estimated with logistic regression.
The prevalence of IHDS was 14.0%, 15.6% among women and 12.3% among men. Older age (45–69 years), being married or cohabiting, and urban residence were positively associated, and male sex was negatively associated, with IHDS. Additionally, experience of threats, hypertension, current tobacco use, passive smoking, sedentary behaviour and high physical activity were positively associated with IHDS.
Almost one in seven people aged 15–69 years had IHDS in Mongolia. Several factors amenable to public health intervention for IHDS were identified, including experience of threats, hypertension, current tobacco use, passive smoking and sedentary behaviour.
At the very start of medical residency training, entrustment of clinical tasks may be a major challenge, on which current scientific knowledge is scarce. This study therefore aimed to gain insight into the process of supervisors’ decision making underlying the entrustment of clinical tasks at the start of one-on-one supervisor–trainee working relationships.
This study was performed in a general practice (GP) training department in the Netherlands.
For this study, we recruited supervisor–trainee pairs who were just about to start the first year of GP residency training. Of 10 eligible supervisor–trainee pairs, 4 participated.
We used a qualitative, social-constructivist research approach. Data from naturalistic non-participant observations and semistructured interviews with supervisors in four GP practices were triangulated and analysed using a thematic analysis approach.
Supervisors’ early entrustment decisions were based on generic trainee qualities such as self-reflexivity, knowing one’s limitations and asking for help in time, rather than on task-specific performance. At the start of residency training, supervisors’ primary concern was to create a safe working and learning environment in which trainees could and would ask for timely supervision while being entrusted with challenging tasks. Supervisors used idiosyncratic entrustment strategies that were influenced by their propensity to trust, previous experiences with trainees, and their perspective on learning and teaching.
Entrustment decisions require high levels of safety for all stakeholders involved. Especially at the beginning of supervisor–trainee relationships, establishing an educational alliance in which entrustment is the subject of ongoing trainee–supervisor conversations is essential to achieve and maintain and optimal balance between trainee learning and patient safety. Additional research may further our understanding of early entrustment decision making and the role of generic trainee qualities in different settings.