Early phase cell therapy trials face many barriers to successful, timely completion. To optimise the conduct of a planned clinical trial of mesenchymal stem cell (MSC) therapy for chronic stroke, we sought patient and physician views on possible barriers and enablers that may influence their participation.
Semistructured interview study.
Patients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling.
Thirteen chronic stroke patients (patients who had experienced a stroke at least 3 months prior; 10 male, 3 female) and 15 physicians (stroke physiatrists; 9 male, 6 female) participated in our interview study. Data adequacy was reached after 13 patient interviews and 13 physician interviews.
Interview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified.
Most patients were optimistic about participating in an MSC therapy clinical trial, and many expressed interest in participating, even if it was a randomised controlled trial with the possibility of being allocated to a placebo group. However, the method of administration of cells (intravascular preferred to intracerebral) and goal of the trial (efficacy preferred to safety) may influence their intention to participate. All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial. Physicians also identified several time-related barriers and the need for resources to ensure feasibility.
This novel application of the TDF helped identify key potential barriers and enablers prior to conducting a clinical trial of MSC therapy for stroke. This will be used to refine the design and conduct of our trial. A similar approach may be adopted by other investigators considering early phase cell therapy trials.
Discrepancies in outcome reporting (DOR) between protocol and published studies include inclusions of new outcomes, omission of prespecified outcomes, upgrade and downgrade of secondary and primary outcomes, and changes in definitions of prespecified outcomes. DOR can result in outcome reporting bias (ORB) when changes in outcomes occur after knowledge of results. This has potential to overestimate treatment effects and underestimate harms. This can also occur at the level of systematic reviews when changes in outcomes occur after knowledge of results of included studies. The prevalence of DOR and ORB in systematic reviews is unknown in systematic reviews published post-2007.
To estimate the prevalence of DOR and risk of ORB in all Cochrane reviews between the years 2007 and 2014.
A stratified random sampling approach was applied to collect a representative sample of Cochrane systematic reviews from each Cochrane review group. DOR was assessed by matching outcomes in each systematic review with their respective protocol. When DOR occurred, reviews were further assessed if there was a risk of ORB (unclear, low or high risk). We classified DOR as a high risk for ORB if the discrepancy occurred after knowledge of results in the systematic review.
150 of 350 (43%) review and protocol pairings contained DOR. When reviews were further scrutinised, 23% (35 of 150) of reviews with DOR contained a high risk of ORB, with changes being made after knowledge of results from individual trials.
In our study, we identified just under a half of Cochrane reviews with at least one DOR. Of these, a fifth were at high risk of ORB. The presence of DOR and ORB in Cochrane reviews is of great concern; however, a solution is relatively simple. Authors are encouraged to be transparent where outcomes change and to describe the legitimacy of changing outcomes in order to prevent suspicion of bias.
The world’s older population continues to grow at an unprecedented rate. An ageing population poses a great challenge to our healthcare system that requires new tool to tackle the complexity of health services as well as the increasing expenses. Mobile health applications (mHealth app) is seen to have the potential to address these challenges, alleviating burdens on the healthcare system and enhance the quality of life for older adults. Despite the numerous benefits of mHealth apps, relatively little is known about whether older adults perceive that these apps confer such benefits. Their perspectives towards the use of mobile applications for health-related purposes have also been little studied. Therefore, in this paper, we outline our scoping review protocol to systematically review literature specific to older adults’ willingness, perceived barriers and motivators towards the use of mobile applications to monitor and manage their health.
Arksey and O’Malley’s scoping review methodology framework will guide the conduct of this scoping review. The search strategy will involve electronic databases including PubMed, Excerpta Medica Database, Cumulative Index of Nursing and Allied Health Literature, Cochrane Library, Google Scholar and ScienceDirect, in addition to grey literature sources and hand-searching of reference lists. Two reviewers will independently screen all abstracts and full-text studies for inclusion. Data will be charted and sorted through an iterative process by the research team. The extracted data will undergo a descriptive analysis and simple quantitative analysis will be conducted using descriptive statistics. Engagement with relevant stakeholders will be carried out to gain more insights into our data from different perspectives.
Since the data used are from publicly available sources, this study does not require ethical approval. Results will be disseminated through academic journals, conferences and seminars. We anticipate that our findings will aid technology developers and health professionals working in the area of ageing and rehabilitation.
To investigate associations of dual use of e-cigarettes and cigarettes with subsequent quitting activity (smoking reduction, quit attempts and use of evidence-based cessation aids). To overcome potential confounding by factors associated with use of pharmacological support, we selected dual use of over-the-counter nicotine replacement therapy (OTC NRT) and cigarettes as a behavioural control.
Prospective cohort study with 6-month follow-up.
413 current smokers participating in the Smoking Toolkit Study, a representative survey of adults in England, who reported current use of e-cigarettes or OTC NRT and provided data at 6-month follow-up.
The exposure was dual use of e-cigarettes or OTC NRT at baseline. Outcomes were change in cigarette consumption, quit attempts and use of evidence-based cessation aids during quit attempts over 6-month follow-up. Relevant sociodemographic and smoking characteristics were included as covariates.
After adjustment for covariates, dual e-cigarette users smoked two fewer cigarettes per day at follow-up than at baseline compared with dual OTC NRT users (B=2.01, 95% CI –3.62; –0.39, p=0.015). While dual e-cigarette users had 18% lower odds than dual OTC NRT users to make a quit attempt at follow-up (risk ratio (RR) 0.82, 95% CI 0.67 to 1.00, p=0.049), the groups did not differ in use of cessation aids (RR 1.06, 95% CI 0.93 to 1.21, p=0.388).
Dual use of e-cigarettes is associated with a greater reduction in cigarette consumption than dual use of OTC NRT. It may discourage a small proportion of users from making a quit attempt compared with dual OTC NRT use but it does not appear to undermine use of evidence-based cessation aids.
by Ida Derish, Jeremy K. H. Lee, Melanie Wong-King-Cheong, Sima Babayeva, Jillian Caplan, Vicki Leung, Chloe Shahinian, Michel Gravel, Michael R. Deans, Philippe Gros, Elena TorbanPlanar cell polarity (PCP) pathway is crucial for tissue morphogenesis. Mutations in PCP genes cause multi-organ anomalies including dysplastic kidneys. Defective PCP signaling was postulated to contribute to cystogenesis in polycystic kidney disease. This work was undertaken to elucidate the role of the key PCP gene, Vangl2, in embryonic and postnatal renal tubules and ascertain whether its loss contributes to cyst formation and defective tubular function in mature animals. We generated mice with ubiquitous and collecting duct-restricted excision of Vangl2. We analyzed renal tubules in mutant and control mice at embryonic day E17.5 and postnatal days P1, P7, P30, P90, 6- and 9-month old animals. The collecting duct functions were analyzed in young and adult mutant and control mice. Loss of Vangl2 leads to profound tubular dilatation and microcysts in embryonic kidneys. Mechanistically, these abnormalities are caused by defective convergent extension (larger tubular cross-sectional area) and apical constriction (cuboidal cell shape and a reduction of activated actomyosin at the luminal surface). However, the embryonic tubule defects were rapidly resolved by Vangl2-independent mechanisms after birth. Normal collecting duct architecture and functions were found in young and mature animals. During embryogenesis, Vangl2 controls tubular size via convergent extension and apical constriction. However, rapidly after birth, PCP-dependent control of tubular size is switched to a PCP-independent regulatory mechanism. We conclude that loss of the Vangl2 gene is dispensable for tubular elongation and maintenance postnatally. It does not lead to cyst formation and is unlikely to contribute to polycystic kidney disease.
by Verena H. Menec, Nancy E. Newall, Corey S. Mackenzie, Shahin Shooshtari, Scott NowickiBackground
Although a large body of research has focused on social isolation and loneliness, few studies have examined social isolation and loneliness together. The objectives of this study were to examine: 1) the relationship between four groups derived from combining social isolation and loneliness (socially isolated and lonely; only socially isolated; only lonely; neither socially isolated nor lonely) and the desire for more social participation, and social support; and 2) the relationship between the four groups and psychological distress.Methods
The study was based on the Comprehensive Cohort of the Canadian Longitudinal Study on Aging. Using CLSA baseline data (unweighted N = 30,079), ordinary and logistic regression analysis was used to examine the cross-sectional relationship between the four social isolation/loneliness groups and desire for more social participation and four types of social support (tangible, positive interaction, affection, and emotional support). Prospective logistic regression analysis was possible for psychological distress, which was derived from the Maintaining Contact Questionnaire administered about 18 months after the baseline questionnaire (unweighted N = 28,789).Results
Findings indicate that being socially isolated and lonely was associated with the most social support gaps; this group also had an increased likelihood of psychological distress, relative to those who were neither socially isolated nor lonely. Participants who were only socially isolated, and those only lonely also perceived some social support gaps. In addition, the only lonely group was more likely to be psychologically distressed than the only socially isolated group and the neither isolated nor lonely group.Conclusion
Examining the four social isolation/loneliness was useful, as it provided more nuanced risk profiles than would have been possible had we examined social isolation and loneliness separately. Findings may suggest avenues for interventions tailored to the unique needs of at-risk individuals.
Assess the outcome of a standardised protocol for the treatment of post‐operative wound infection in patients undergoing deformity correction for neuro‐muscular scoliosis (NMS). Retrospective review of 443 consecutive patients with a minimum 18 months’ follow‐up, following a primary posterior deformity correction for NMS. In patients who developed a wound complication, the patient demographic and comorbidities, causative pathogen, number of re‐operations, length of stay (LOS), rate of cure, and complications were analysed. Forty‐four patients (9.9%) developed a wound infection. Marginally more infections were mono‐microbial (23) than poly‐microbial (21). Coagulase negative staphylococcus and Staphylococcus aureus were the most commonly cultured pathogens. Seventeen patients were treated with antibiotics alone, while 27 patients also required surgical debridement. The average LOS for those treated with antibiotics alone was 12 days (range: 9‐15 days), in contrast to those requiring debridement, which was 35 days (range: 35‐70 days). All patients were cured from their infection and ultimately achieved fusion. Infection is common in NMS deformity correction. This is marginally more common as a mono‐microbial than poly‐microbial infection with most pathogens being staphylococcal in origin. Our defined treatment strategy resulted in a cure for all patients and capacity for all patients to achieve fusion.
To describe the extent to which different categories of anaesthesia provider are used in humanitarian surgical projects and to explore the volume and nature of their surgical workload.
Descriptive analysis using 10 years (2008–2017) of routine case-level data linked with routine programme-level data from surgical projects run exclusively by Médecins Sans Frontières-Operational Centre Brussels (MSF-OCB).
Projects were in contexts of natural disaster (ND, entire expatriate team deployed by MSF-OCB), active conflict (AC) and stable healthcare gaps (HG). In AC and HG settings, MSF-OCB support pre-existing local facilities. Hospital facilities ranged from basic health centres with surgical capabilities to tertiary referral centres.
The full dataset included 178 814 surgical cases. These were categorised by most senior anaesthetic provider for the project, according to qualification: specialist physician anaesthesiologists, qualified nurse anaesthetists and uncertified anaesthesia providers.
Volume and nature of surgical workload of different anaesthesia providers.
Full routine data were available for 173 084 cases (96.8%): 2518 in ND, 42 225 in AC, 126 936 in HG. Anaesthesia was predominantly led by physician anaesthesiologists (100% in ND, 66% in AC and HG), then nurse anaesthetists (19% in AC and HG) or uncertified anaesthesia providers (15% in AC and HG). Across all settings and provider groups, patients were mostly healthy young adults (median age range 24–27 years), with predominantly females in HG contexts, and males in AC contexts. Overall intra-operative mortality was 0.2%.
Our findings contribute to existing knowledge of the nature of anaesthetic provision in humanitarian settings, while demonstrating the value of high-quality, routine data collection at scale in this sector. Further evaluation of perioperative outcomes associated with different models of humanitarian anaesthetic provision is required.
To describe paediatric postdischarge concerns manifesting in the first 96 hr after hospital discharge.
Analysis of nursing documentation generated as part of a randomized controlled trial evaluating the effect of a nurse home visit on healthcare re‐use.
We analysed home visit records of 651 children (age <18) hospitalized at a large Midwestern children's hospital in 2015 and 2016 who were enrolled in the trial. Registered nurses documented concerns in structured fields and free‐text notes in visit records. Descriptive statistics were used to summarize visit documentation. Free‐text visit notes were reviewed and exemplars illustrative of quantitative findings were selected.
Overall, nurses documented at least one concern in 56% (N = 367) of visits. Most commonly, they documented concerns about medication safety (15% or 91 visits). Specifically, in 11% (N = 58) of visits nurses were concerned that caregivers lacked a full understanding of medications and in 8% (N = 49) of visits families did not have prescribed discharge medications. Pain was documented as present in 9% of all visits (N = 56). Nurses completed referrals to other providers/services in 12% of visits (N = 78), most frequently to primary care providers. In 13% of visits (N = 85) nurses documented concerns considered beyond the immediate scope of the visit related to social needs such as housing and transportation.
Inpatient and community nurses and physicians should be prepared to reconcile and manage discharge medications, assess families’ medication administration practices and anticipate social needs after paediatric discharge.
Little empirical data are available describing concerns manifesting immediately after paediatric hospital discharge.
Concerns about medication safety were most frequent followed by concerns related to housing and general safety.
The results are important for clinicians preparing children and families for discharge and for community clinicians caring for discharged children.
To enhance understanding of the bodily and lifestyle effects of ageing with cerebral palsy (CP) for women, with a particular focus on experiences with sexual and reproductive healthcare (SRH) services in the UK and North America.
A qualitative study underpinned by feminist disability theory and drawing on digital ethnographies to capture health and healthcare experiences for women with CP.
A global community of 140 women with CP, who are members of the closed international Facebook group, Women Ageing with Cerebral Palsy (WACP).
Forty-five members of WACP who were based in the UK and North America. The women were aged between 21 and 75.
Messages posted on WACP between January 2018 and October 2018 were collated and underwent thematic analysis to identify themes relating to effects of ageing and experiences of SRH for women with CP at different points over the female life course.
The breadth of experiences in relation to the effects of ageing and access to reproductive and sexual healthcare for women with CP can be divided into three themes: (1) bodily effects of ageing; (2) lifestyle effects of ageing; (3) experiences of reproductive and sexual healthcare.
Giving women with CP a platform to ‘speak for themselves’ in relation to effects of ageing and SRH provides health professionals with an informed knowledge base on which to draw. This might improve treatment for this growing adult patient community whose experiences have not received attention in health discourse or services. Including these experiences in public medical and social discourse can also bring a new knowledge to girls with CP about what ageing could mean for them so plans can be put in place for their future.
Automated continuous ambulatory monitoring may provide an alternative to intermittent manual vital signs monitoring. This has the potential to improve frequency of measurements, timely escalation of care and patient safety. However, a major barrier to the implementation of these wearable devices in the ward environment is their uncertain reliability, efficiency and data fidelity. The purpose of this study is to test performance of selected devices in a simulated clinical setting including during movement and low levels of peripheral oxygen saturation.
This is a single centre, prospective, controlled, cross-sectional, diagnostic accuracy study to determine the specificity and sensitivity of currently available ambulatory vital signs monitoring equipment in the detection of hypoxia and the effect of movement on data acquisition. We will recruit up to 45 healthy volunteers who will attend a single study visit; starting with a movement phase and followed by the hypoxia exposure phase where we will gradually decrease saturation levels down to 80%. We will simultaneously test one chest patch, one wrist worn only and three wrist worn with finger probe devices against ‘clinical standard ‘and ‘gold standard’ references. We will measure peripheral oxygen saturations, pulse rate, heart rate and respiratory rate continuously and arterial blood gases intermittently throughout the study.
This study has received ethical approval by the East of Scotland Research Ethics Service REC 2 (19/ES/0008). The results will be broadly distributed through conference presentations and peer-reviewed publications.
ISRCTN61535692 registered on 10/06/2019.
Primary care physicians have an opportunity to support healthy dietary behaviours of patients by providing nutrition care. However, it is unclear whether primary care physicians in the Kingdom of Saudi Arabia (KSA) are sufficiently competent in nutrition. This study aimed to assess the nutrition competence of primary care physicians in KSA and identify whether nutrition competence is associated with the provision of nutrition care to patients living with diet-related chronic disease.
A cross-sectional study.
Chronic disease clinics across 48 primary care centres under the Ministry of Health in the city of Jeddah, KSA.
90 primary care physicians completed the survey (response rate: 98%). General practitioners and family medicine residents, specialists, and consultants actively working in chronic disease clinics between February and May 2019 were included.
Primary outcome measure was nutrition competence of primary care physicians measured via the validated NUTCOMP (nutrition competence) questionnaire.
Primary care physicians perceived themselves as competent in nutrition care but their reported provision of nutrition care was limited. Confidence in their nutrition knowledge and skills elicited the lowest mean scores of 25.8 (±5.4) out of 35 and 29 (±5.2) out of 40, respectively. The reported provision of nutrition care was closely correlated with physicians’ confidence in their nutrition knowledge (r=0.57) and communication (r=0.52). Three factors were identified as predicting whether physicians provide nutrition care to patients: confidence in counselling about nutrition (p
Primary care physicians felt confident in providing nutrition care to patients living with diet-related chronic disease. Primary care physicians would benefit from higher levels of nutrition knowledge and skills to effectively support patients to improve their dietary behaviours and health conditions, leading to a positive impact on public health.
by Andreas Leha, Kristian Hellenkamp, Bernhard Unsöld, Sitali Mushemi-Blake, Ajay M. Shah, Gerd Hasenfuß, Tim SeidlerBackground
Machine learning (ML) is a powerful tool for identifying and structuring several informative variables for predictive tasks. Here, we investigated how ML algorithms may assist in echocardiographic pulmonary hypertension (PH) prediction, where current guidelines recommend integrating several echocardiographic parameters.Methods
In our database of 90 patients with invasively determined pulmonary artery pressure (PAP) with corresponding echocardiographic estimations of PAP obtained within 24 hours, we trained and applied five ML algorithms (random forest of classification trees, random forest of regression trees, lasso penalized logistic regression, boosted classification trees, support vector machines) using a 10 times 3-fold cross-validation (CV) scheme.Results
ML algorithms achieved high prediction accuracies: support vector machines (AUC 0.83; 95% CI 0.73–0.93), boosted classification trees (AUC 0.80; 95% CI 0.68–0.92), lasso penalized logistic regression (AUC 0.78; 95% CI 0.67–0.89), random forest of classification trees (AUC 0.85; 95% CI 0.75–0.95), random forest of regression trees (AUC 0.87; 95% CI 0.78–0.96). In contrast to the best of several conventional formulae (by Aduen et al.), this ML algorithm is based on several echocardiographic signs and feature selection, with estimated right atrial pressure (RAP) being of minor importance.Conclusions
Using ML, we were able to predict pulmonary hypertension based on a broader set of echocardiographic data with little reliance on estimated RAP compared to an existing formula with non-inferior performance. With the conceptual advantages of a broader and unbiased selection and weighting of data our ML approach is suited for high level assistance in PH prediction.
Since the Singapore Mental Health Study in 2010 which reported a 16.0% prevalence rate for current smokers and 4.5% for nicotine dependence, new anti-smoking strategies have been implemented. The aim of this study was to compare smoking trends from the 2010 study with the second Singapore Mental Health Study in 2016 (SMHS 2016).
A survey of 6126 individuals aged 18 years and above randomly selected among Singapore residents was conducted using the same methodology as the 2010 study. The measures used in this analysis were sociodemographic questions, the Composite International Diagnostic Interview which assessed for psychiatric disorders, the Fagerstrom Test for Nicotine Dependence and a list of chronic physical conditions that were prevalent in Singapore. Logistic regression analyses were used to test for associations between smoking/nicotine-dependence and other measures.
In the SMHS 2016, 16.1% were current smokers and 3.3% were nicotine-dependent. As compared with non-smokers, current smokers were more likely to be younger, male gender, of ethnic minority and had lower/vocational education level. Younger age, male gender, lower/vocational education and psychiatric disorders (major depression, bipolar disorder and alcohol use disorders) predicted nicotine dependence. No associations were found between nicotine dependence and any of the chronic conditions.
The prevalence of current smokers in the population has plateaued while that of nicotine dependence has decreased from 2010. However, the study did not investigate the use of e-cigarettes. Inequalities in smoking and nicotine dependence continue to pervade the population particularly among those of ethnic minority, lower/vocational education and the mentally ill.
To compare necrotising enterocolitis (NEC) prevention practices and NEC associated factors between units from eight countries of the International Network for Evaluation of Outcomes of Neonates, and to assess their association with surgical NEC rates.
Prospective unit-level survey combined with retrospective cohort study.
Neonatal intensive care units in Australia/New Zealand, Canada, Finland, Israel, Spain, Sweden, Switzerland and Tuscany (Italy).
Extremely preterm infants born between 240 to 286 weeks’ gestation, with birth weights
NEC prevention practices (probiotics, feeding, donor milk) using responses of an on-line pre-piloted questionnaire containing 10 questions and factors associated with NEC in literature (antenatal steroids, c-section, indomethacin treated patent ductus arteriosus and sepsis) using cohort data.
Surgical NEC rates and death following NEC using cohort data.
The survey response rate was 91% (153 units). Both probiotic provision and donor milk availability varied between 0%–100% among networks whereas feeding initiation and advancement rates were similar in most networks. The 9792 infants included in the cohort study to link survey results and cohort outcomes, revealed similar baseline characteristics but considerable differences in factors associated with NEC between networks. 397 (4.1%) neonates underwent NEC surgery, ranging from 2.4%–8.4% between networks. Standardised ratios for surgical NEC were lower for Australia/New Zealand, higher for Spain, and comparable for the remaining six networks.
The variation in implementation of NEC prevention practices and in factors associated with NEC in literature could not be associated with the variation in surgical NEC incidence. This corroborates the current lack of consensus surrounding the use of preventive strategies for NEC and emphasises the need for research.
To examine the prevalence of, and sociodemographic and smoking-related characteristics associated with, long-term e-cigarette use compared with long-term nicotine replacement therapy (NRT) use.
Cross-sectional and prospective survey, the Smoking Toolkit Study, with baseline data collected between September 2014 and September 2016 and follow-ups at 6 and 12 months.
Population representative sample of 40 933 adults aged 16+ years.
Prevalence of long-term (≥12 months) use of e-cigarettes and NRT by retrospective self-report among baseline respondents (all adults, n=40 933; smokers, n=8406) and current use at baseline, 6 months and 12 months in a subsample of smokers who responded to follow-up (n=733).
Of baseline respondents, 1.5% (95% CI 1.4% to 1.6%, n=604) of adults and 3.9% (95% CI 3.5% to 4.3%, n=327) of smokers were long-term e-cigarette users and 0.5% (95% CI 0.4% to 0.6%, n=205) of adults and 1.3% (95% CI 1.1% to 1.5%, n=112) of smokers were long-term NRT users. Assessed prospectively, 13.4% (95% CI 10.9% to 15.9%, n=100) of smokers were long-term e-cigarette users and 1.9% (95% CI 0.9% to 2.9%, n=14) were long-term NRT users. Among all adults, long-term use by never smokers of either e-cigarettes (0.1%, n=27) or NRT (0.0%, n=7) was rare. Among past-year smokers, long-term e-cigarette and NRT use was higher among older smokers compared with those who were 16–34 years old (OR range=1.55–5.21). Long-term e-cigarette use only was lower in smokers who were less educated (OR=0.63, 95% CI 0.49 to 0.81), from social grades C2DE (OR=0.66, 95% CI 0.52 to 0.84) and with children in the household (OR=0.66, 95% CI 0.51 to 0.85). Long-term e-cigarette use and long-term NRT use were higher among smokers more motivated to quit (OR=2.05, 95% CI 1.63 to 2.60 and OR=2.33, 95% CI 1.57 to 3.46).
In the adult population in England, long-term use of e-cigarettes and long-term use of NRT are almost exclusively by current or ex-smokers. Only a minority of past-year smokers retrospectively report long-term e-cigarette or NRT use, but this figure may be an underestimate, especially for e-cigarette use, which is more than threefold higher when assessed prospectively.
An increasing proportion of fetuses are exposed to antenatal corticosteroids (ACS). Despite their immediate beneficial effects, the long-term safety of ACS has been an ongoing source of concern. In the current study, we assessed the likelihood of neurodevelopmental problems among term infants exposed to ACS earlier in pregnancy compared with non-exposed term infants.
Retrospective cohort study (2006–2011). Median duration of follow-up was 7.8 (IQR 6.4–9.2) years.
Population-based study, Ontario, Canada.
All live singleton infants born at term (≥370/7 weeks gestation) (n=529 205).
ACS during pregnancy.
A composite of diagnostic or billing codes reflecting proven or suspected neurodevelopmental problems during childhood including audiometry testing, visual testing or physician service claim with a diagnosis code related to a suspected neurocognitive disorder.
At 5 years of age, the cumulative rate for the primary outcome was higher among infants exposed to ACS compared with non-exposed infants: 61.7% (3346/5423) vs 57.8% (302 520/523 782), respectively (p
We found an association among term infants between exposure to ACS during pregnancy and healthcare utilisation during childhood related to suspected neurocognitive and neurosensory disorders.
Loneliness is an emerging public health problem that is associated with social, emotional, mental and physical health issues. The application of digital technology (DT) interventions to reduce loneliness has significantly increased in the recent years. The effectiveness of DT interventions needs to be assessed systematically.
Aim: To undertake a systematic review and meta-analysis on the effectiveness of DT interventions to reduce loneliness among adults.
Design: Systematic review and meta-analysis.
Data sources: PubMed, Medline, CINAHL, EMBASE and Web of Science.
Publication period: 1 January 2010 to 31 July 2019.
Inclusion criteria: Primary studies involving the application of DT interventions to reduce loneliness, involving adult participants (aged ≥18 years), follow-up period ≥3 months and published in the English language.
Synthesis and meta-analysis: A narrative summary of the characteristics of included studies, findings by the type of DT intervention, and the age, gender and ethnicity of participants. A meta-analysis by the study design and duration of follow-up and determination of random effects size using the RevMan V.5 software.
Quality of evidence and bias: Quality of evidence assessed the RoB V.2.0 (revised tool for Risk of Bias in randomized trials) and ROBINS-I (Risk Of Bias in Non-randomized Studies—of Interventions) tools for randomised control trials and non-randomised studies, respectively. Heterogeneity between studies will be determined by the I2 and Cochran’s Q statistics and publication bias checked with funnel plots and the Egger’s test.
Ethics approval was not required for this protocol. The findings will be disseminated through journal articles and conference presentations.