Management of newly diagnosed type 1 diabetes (T1D) in children and adolescents is challenging for patients, families and healthcare professionals. The objective of this study is to determine whether continued intensive metabolic control using hybrid closed-loop (CL) insulin delivery following diagnosis of T1D can preserve C-peptide secretion, a marker of residual beta-cell function, compared with standard multiple daily injections (MDI) therapy.
The study adopts an open-label, multicentre, randomised, parallel design, and aims to randomise 96 participants aged 10–16.9 years, recruited within 21 days of diagnosis with T1D. Following a baseline mixed meal tolerance test (MMTT), participants will be randomised to receive 24 months treatment with conventional MDI therapy or with CL insulin delivery. A further 24-month optional extension phase will be offered to all participants to continue with the allocated treatment. The primary outcome is the between group difference in area under the stimulated C-peptide curve (AUC) of the MMTT at 12 months post diagnosis. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are between group differences in time spent in target glucose range (3.9–10 mmol/L), glycated haemoglobin (HbA1c) and time spent in hypoglycaemia (
Ethics approval has been obtained from Cambridge East Research Ethics Committee. The results will be disseminated by peer-reviewed publications and conference presentations.
Despite research support, evidence‐based practices (EBPs) are inconsistently implemented throughout the United States. Facilitation is one implementation strategy to speed adoption in clinical settings. Facilitation has not been previously described in the literature as an implementation strategy within neonatal care.
The purpose of this study was to categorize and describe essential features of facilitation in the context of implementing an EBP using perspectives elicited from neonatal clinicians and external facilitators (EFs).
In this qualitative descriptive study, semistructured interviews were conducted with a purposive sample of neonatal clinicians and EFs. Participants shared their experiences related to the strategy of facilitation while implementing an EBP during the California Perinatal Quality Care Antibiotic Stewardship Collaborative. Interviews were transcribed, coded, and analyzed using directed content analysis.
Five categories emerged to address facilitation as an implementation strategy: (a) facilitated change management, (b) unit and organization receptivity, (c) evaluation strategies, (d) supportive culture, and (e) facilitator stewardship.
Implementing EBP is complex and multifactorial. Results from this study provide insights into influencing barriers and drivers as experienced by internal and external facilitators, and context factors that impacted the success of implementation.
Haemophilia A is an X linked inherited bleeding disorder, caused by a decrease in coagulation factor VIII. Persons with haemophilia experience repeated musculoskeletal bleeding, which can lead to decreased range of motion, irreversible joint damage, low bone mineral density (BMD), and are at greater risk for osteoporosis. Women heterozygous for this mutation, also known as haemophilia A carriers, can have bleeding symptoms and even experience joint bleeding evidenced by radiological soft tissue and osteochondral changes. The prevalence of low BMD as a risk factor for osteoporosis has never been evaluated in carriers of haemophilia, and given the recent findings which suggest subclinical musculoskeletal bleeding in carrier women, we hypothesise that they too are at risk of impaired bone health.
This is a national multicentre prospective matched-cohort study to compare BMD T-scores among symptomatic haemophilia A carriers, 50 years of age or older, with age-matched and body mass index-matched non-carriers (1:1). A total of 40 symptomatic carriers and 40 matched non-carriers will be recruited from St. Michael’s Hospital, Kingston General Hospital in Ontario, Canada and Foothills Medical Centre in Alberta, Canada. Multivariable linear regression models will be used to estimate the effect of haemophilia carriership on BMD T-scores, adjusting for age, body mass index and other relevant covariates.
The protocol was designed and will be conducted in compliance with applicable laws, rules and regulations. Research ethics approval was obtained from St. Michael’s Hospital, Foothills Medical Centre, and Kingston General Hospital. Findings will be presented at international venues such as the American Society of Haematology and the World Federation of Haemophilia World Congress. The authors of this study will seek publication in journals such as Blood, Journal of Thrombosis and Haemostasis, American Journal ofHematology and British Journal ofHaematology.
An increasing proportion of cancer surgeries are ambulatory procedures requiring a stay of 1 day or less in the hospital. Providing patients and their caregivers with ongoing, real-time support after discharge aids delivery of high-quality postoperative care in this new healthcare environment. Despite abundant evidence that patient self-reporting of symptoms improves quality of care, the most effective way to monitor and manage this self-reported information is not known.
This is a two-armed randomised, controlled trial evaluating two approaches to the management of patient-reported data: (1) team monitoring, symptom monitoring by the clinical team, with nursing outreach if symptoms exceed normal limits, and (2) enhanced feedback, real-time feedback to patients about expected symptom severity, with patient-activated care as needed.
Patients with breast, gynaecologic, urologic, and head and neck cancer undergoing ambulatory cancer surgery (n=2750) complete an electronic survey for up to 30 days after surgery that includes items from a validated instrument developed by the National Cancer Institute, the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Information provided to patients in the Enhanced Feedback group is procedure-specific and based on updated PRO-CTCAE data from previous patients. Qualitative interviews are also performed. The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden).
This study is approved by the Institutional Review Board at Memorial Sloan Kettering Cancer Center. The relationships between the study team and stakeholders will be leveraged to disseminate study findings. Findings will be relevant in designing future coordinated care models targeting improved healthcare quality and patient experience.
The aim of this work was to train machine learning models to identify patients at end of life with clinically meaningful diagnostic accuracy, using 30-day mortality in patients discharged from the emergency department (ED) as a proxy.
Retrospective, population-based registry study.
Swedish health services.
All cause 30-day mortality.
Electronic health records (EHRs) and administrative data were used to train six supervised machine learning models to predict all-cause mortality within 30 days in patients discharged from EDs in southern Sweden, Europe.
The models were trained using 65 776 ED visits and validated on 55 164 visits from a separate ED to which the models were not exposed during training.
The outcome occurred in 136 visits (0.21%) in the development set and in 83 visits (0.15%) in the validation set. The model with highest discrimination attained ROC–AUC 0.95 (95% CI 0.93 to 0.96), with sensitivity 0.87 (95% CI 0.80 to 0.93) and specificity 0.86 (0.86 to 0.86) on the validation set.
Multiple models displayed excellent discrimination on the validation set and outperformed available indexes for short-term mortality prediction interms of ROC–AUC (by indirect comparison). The practical utility of the models increases as the data they were trained on did not require costly de novo collection but were real-world data generated as a by-product of routine care delivery.
Hospitals in the UK are under increasing clinical and financial pressures. Following introduction of childhood rotavirus vaccination in the UK in 2013, rotavirus gastroenteritis (RVGE) hospitalisations reduced significantly. We evaluated changes in ‘hospital pressures’ (demand on healthcare resources and staff) following rotavirus vaccine introduction in a paediatric setting in the UK.
Retrospective hospital database analysis between July 2007 and June 2015.
A large paediatric hospital providing primary, secondary and tertiary care in Merseyside, UK.
Hospital admissions aged
Hospital pressures were compared before and after rotavirus vaccine introduction: these included bed occupancy, hospital-acquired infection rate, unplanned readmission rate and outlier rate (medical patients admitted to surgical wards due to lack of medical beds). Interrupted time-series analysis was used to evaluate changes in bed occupancy.
There were 116 871 admissions during the study period. Lower bed occupancy in the rotavirus season in the postvaccination period was observed for RVGE (–89%, 95% CI 73% to 95%), acute gastroenteritis (–63%, 95% CI 39% to 78%) and any infection (–23%, 95% CI 15% to 31%). No significant overall reduction in bed occupancy was observed (–4%, 95% CI –1% to 9%). No changes were observed for the other outcomes.
Rotavirus vaccine introduction was not associated with reduced hospital pressures. A reduction in RVGE hospitalisation without change in overall bed occupancy suggests that beds available were used for a different patient population, possibly reflecting a previously unmet need.
To assess the proportion of Australian children aged 0–15 years that received care in line with clinical practice guidelines (CPGs) for upper respiratory tract infections (URTIs).
Retrospective medical record review using a multistage sampling strategy.
General practices, hospital emergency departments and hospital inpatient service providers in three Australian states.
Children aged up to 15 years who received care for URTI in 2012 and 2013.
The primary assessment was estimated adherence with 14 indicators of appropriate care as documented in medical records. Indicators were extracted from national and international CPGs and ratified by experts. Secondary assessment was adherence to two bundles of indicators (diagnostic symptoms and medical history taking), where all indicators must be adherent for the bundle to be scored as adherent.
There were 1653 children with one or more assessments of URTI care to CPG adherence. Over half of the children were under 3 years of age, with roughly equal numbers of males and females. Three indicators had fewer than 25 visits so were not reported. Overall adherence ranged from 0.5% for ‘documented advice around antibiotics’ to 88.3% for ‘documentation of medical history’. Adherence with Bundle A (documentation of all three definitive symptoms) was 43.1% (95% CI 32.8% to 54.0%) and Bundle B (documentation of all four indicators of medical history) was 30.2% (95% CI 20.9% to 40.9%).
URTIs in children are common, usually self-limiting, conditions that are allocated considerable resources. The results suggest that there may be a need for more thorough holistic assessment of the patient and improved documentation. Since inappropriate prescription of antibiotics for URTIs is still a known problem in Australia, there is a need for consistent, clear communication around antibiotics’ lack of impact on symptoms and a high association with undesirable side effects.
A theory-based, task-oriented, community walking programme can increase outdoor walking activity among older adults to optimise functional independence, social participation and well-being. The study objective is to determine if there is a difference in the change in outdoor walking activity from baseline to 10 weeks, 5.5 months and 12 months after receiving a 1-day interactive workshop and outdoor walking programme (Getting Older Adults Outdoors (GO-OUT)) compared with the workshop and weekly reminders (WR) in older adults with difficulty walking outdoors.
A randomised controlled trial is being conducted in four urban Canadian communities. We will stratify 240 individuals by site and participant type (ie, individual vs spousal/friend pair) and randomise to either the GO-OUT or WR intervention. The GO-OUT intervention involves a 1-day workshop, where participants complete eight interactive stations to build knowledge and skills to walk outside, followed by a 10-week group outdoor walking programme (two 1-hour sessions/week) led by a physiotherapist or kinesiologist in parks. The WR intervention consists of the same workshop and 10 weekly telephone reminders to facilitate outdoor walking. The primary outcome measure is mean outdoor walking time in minutes/week derived from accelerometry and global positioning system data. GO-OUT is powered to detect an effect size of 0.4, given α=0.05, β=0.20, equal number of participants/group and a 20% attrition rate. Secondary outcomes include physical activity, lifespace mobility, participation, health-related quality of life, balance, leg strength, walking self-efficacy, walking speed, walking distance/endurance and mood.
GO-OUT has received ethics approval at all sites. A Data Safety Monitoring Board will monitor adverse events. We will disseminate findings through lay summaries, conference presentations and journal articles.
The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea.
To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8–18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months’ follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months’ follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea.
Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands.
Worldwide, emergency healthcare systems are under intense pressure from ever-increasing demand and evidence is urgently needed to understand how this can be safely managed. An estimated 10%–43% of emergency department patients could be treated by primary care services. In England, this has led to a policy proposal and £100 million of funding (US$130 million), for emergency departments to stream appropriate patients to a co-located primary care facility so they are ‘free to care for the sickest patients’. However, the research evidence to support this initiative is weak.
Rapid realist literature review.
Articles describing general practitioners working in or alongside emergency departments.
To develop context-specific theories that explain how and why general practitioners working in or alongside emergency departments affect: patient flow; patient experience; patient safety and the wider healthcare system.
Ninety-six articles contributed data to theory development sourced from earlier systematic reviews, updated database searches (Medline, Embase, CINAHL, Cochrane DSR & CRCT, DARE, HTA Database, BSC, PsycINFO and SCOPUS) and citation tracking. We developed theories to explain: how staff interpret the streaming system; different roles general practitioners adopt in the emergency department setting (traditional, extended, gatekeeper or emergency clinician) and how these factors influence patient (experience and safety) and organisational (demand and cost-effectiveness) outcomes.
Multiple factors influence the effectiveness of emergency department streaming to general practitioners; caution is needed in embedding the policy until further research and evaluation are available. Service models that encourage the traditional general practitioner approach may have shorter process times for non-urgent patients; however, there is little evidence that this frees up emergency department staff to care for the sickest patients. Distinct primary care services offering increased patient choice may result in provider-induced demand. Economic evaluation and safety requires further research.
Recognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn’s skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.
Research protocol for diagnosis, singlegroup, singleblinding and singlearm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case–control study.
Each local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.
The CareTrack study found that a wide range of appropriateness of care (ie, care in line with evidence-based or consensus-based guidelines) was delivered across many health conditions in Australia. This study therefore aimed to demonstrate the feasibility of using the CareTrack method (a retrospective onsite record review) to measure the appropriateness of eye care delivery.
Cross-sectional feasibility study.
Two hundred and thirteen patient records randomly selected from eight optometry and ophthalmology practices in Australia, selected through a combination of convenience and maximum variation sampling.
Retrospective record review designed to assess the alignment between eye care delivered and 93 clinical indicators (Delphi method involving 11 experts) extracted from evidence-based clinical practice guidelines.
Number of eligible patient records, sampling rates and data collection time. This feasibility study also tested the ability of 93 clinical indicators to measure percentage appropriate eye care for preventative, glaucoma and diabetic eye care. A secondary outcome was the percentage of practitioner–patient encounters at which appropriate eye care was received.
A median of 20 records (range 9 to 63) per practice were reviewed. Data collection time ranged from 3 to 5.5 hours (median 3.5). The most effective sampling strategy involved random letter generation followed by sequential sampling. The appropriateness of care was 69% (95% CI 67% to 70%) for preventative eye care, 60% (95% CI 56% to 58%) for glaucoma and 63% (95% CI 57% to 69%) for diabetic eye care.
Appropriateness of eye care can be measured effectively using retrospective record review of eye care practices and consensus-based care indicators.
Evidence on the economic costs of physical inactivity and the cost-effectiveness of physical activity interventions in low-income and middle-income countries (LMICs) is sparse, and fragmented where they are available. This is the first review aimed to summarise available evidence on economics of physical activity in LMICs, identify potential target variables for policy, and identify and report gaps in the current knowledge on economics of physical activity in LMICs.
Peer-reviewed journal articles of observational, experimental, quasi-experimental and mixed-method studies on economics of physical activity in LMICs will be identified by a search of electronic databases; Scopus, Web of Science and SPORTDiscus. Websites of WHO, the National Institute for Health and Care Excellence international, World Bank and reference lists of included studies will be searched for relevant studies. The study selection process will be a two-stage approach; title and abstract screen for inclusion, followed by a review of selected full-text articles by two independent reviewers. Disagreements will be resolved by consensus and discussion with a third reviewer. Data will be extracted using standardised piloted data extraction forms. Risk of bias will be critically appraised using standard checklists based on study designs. Descriptive synthesis of data is planned. Where relevant, summaries of studies will be classified according to type of economic analysis, country or country category, population, intervention, comparator, outcome and study design. Meta-analysis will be performed where appropriate. This protocol for systematic review is prepared according to the Preferred Reporting Items for Systematic review and Meta-analysis for Protocols –2015 statement.
Ethical approval is not obtained as original data will not be collected as part of this review. The completed review will be submitted for publication in a peer-reviewed journal and presented at conferences.