by Olivia R. Stockly, Audrey E. Wolfe, Gretchen J. Carrougher, Barclay T. Stewart, Nicole S. Gibran, Steven E. Wolf, Kara McMullen, Alyssa M. Bamer, Karen Kowalske, William G. Cioffi, Ross Zafonte, Jeffrey C. Schneider, Colleen M. RyanIntroduction
Inhalation injuries carry significant acute care burden including prolonged ventilator days and length of stay. However, few studies have examined post-acute outcomes of inhalation injury survivors. This study compares the long-term outcomes of burn survivors with and without inhalation injury.Methods
Data collected by the Burn Model System National Database from 1993 to 2019 were analyzed. Demographic and clinical characteristics for adult burn survivors with and without inhalation injury were examined. Outcomes included employment status, Short Form-12/Veterans Rand-12 Physical Composite Score (SF-12/VR-12 PCS), Short Form-12/Veterans Rand-12 Mental Composite Score (SF-12/VR-12 MCS), and Satisfaction With Life Scale (SWLS) at 24 months post-injury. Regression models were used to assess the impacts of sociodemographic and clinical covariates on long-term outcome measures. All models controlled for demographic and clinical characteristics.Results
Data from 1,871 individuals were analyzed (208 with inhalation injury; 1,663 without inhalation injury). The inhalation injury population had a median age of 40.1 years, 68.8% were male, and 69% were White, non-Hispanic. Individuals that sustained an inhalation injury had larger burn size, more operations, and longer lengths of hospital stay (p Conclusions
Burn survivors with inhalation injury were significantly less likely to be employed at 24 months post-injury compared to survivors without inhalation injury. However, other health-related quality of life outcomes were similar between groups. This study suggests distinct long-term outcomes in adult burn survivors with inhalation injury which may inform future resource allocation and treatment paradigms.
Although several imaging options are available for diagnosing syndesmotic injury, a fundamental question that guides treatment remains unanswered. Syndesmotic instability is still challenging to diagnose correctly, and syndesmotic disruption and true syndesmotic instability should be differentiated. Currently, imaging tests quickly diagnose severe syndesmotic instability but have difficulty in diagnosing mild and moderate cases. This study aims to investigate which strategy among an existing CT index test and two new add-on CT index tests with stress manoeuvres more accurately diagnoses syndesmotic instability. The secondary objective is to investigate the participants’ disability outcomes by applying the Foot and Ankle Ability Measure questionnaire.
This study of a diagnostic accuracy test will consecutively select individuals older than 18 years with a clinical diagnosis of a suspected acute syndesmotic injury. Three strategies of the CT index test (one in the neutral position and two with stress) will examine the accuracy using MRI as the reference standard. The external rotation and dorsiflexion of the ankle will guide the stress manoeuvres. A comparison of measurements between the injured syndesmosis and the uninjured contralateral side of the same individual will investigate the syndesmotic instability, by evaluating the rotational and translational relationships between the fibula and tibia. Sensitivity, specificity, area under the receiver operating characteristic curve and likelihood analyses will compare the diagnostic accuracies of the strategies.
The Internal Review Board and the Einstein Ethics Committee approved this study (registered number 62100016.5.0000.0071). All participants will receive an oral description of the study’s aim, and the choice to participate will be free and voluntary. Participants will be enrolled after they sign the written informed consent form, including the terms of confidentiality. The results will be presented at national and international conferences and published in peer-reviewed journals and social media.
ClinicalTrials.gov Registry (NCT04095598; preresults).
To assess if 12 novel circulating biomarkers, when added to ‘standard predictors’ available in general practice, could improve the 10-year prediction of cardiovascular events and mortality in patients with stable coronary heart disease.
The patients participated as placebo receiving patients in the randomised clarithromycin for patients with stable coronary artery disease (CLARICOR) trial at a random time in their disease trajectory.
Five Copenhagen University cardiology departments and a coordinating centre.
1998 participants with stable coronary artery disease.
Death and composite of myocardial infarction, unstable angina pectoris, cerebrovascular disease and death.
When only ‘standard predictors’ were included, 83.4% of all-cause death predictions and 68.4% of composite outcome predictions were correct. Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors. Adding the remaining 10 biomarkers (high-sensitive assay cardiac troponin T; neutrophil gelatinase-associated lipocalin; osteoprotegerin; N-terminal pro-B-type natriuretic peptide; tumour necrosis factor receptor 1 and 2; pregnancy-associated plasma protein A; endostatin; YKL40; cathepsin-B), which were all individually significantly associated with the prediction of the two outcomes, increased the figures to 84.7% and 69.7%.
When ‘standard predictors’ routinely available in general practices are used for risk assessment in consecutively sampled patients with stable coronary artery disease, the addition of 10 novel biomarkers to the prediction model improved the correct prediction of all-cause death and the composite outcome by
This study assessed whether concussion affects subsequent baseline performance in professional rugby players. Annual baseline screening tests are used to guide return-to-play decisions and concussion diagnosis during subsequent screens. It is important that baseline performances are appropriate and valid for the duration of a season and unaffected by factors unrelated to the current head impact event. One such factor may be a concussion following baseline assessment.
The World Rugby concussion management database for global professional Rugby Union.
501 professional rugby players with two baseline Sports Concussion Assessment Tools (SCATs) and an intervening concussion (CONC) were compared with 1190 control players with successive annual SCAT5s and no diagnosed concussion (CONT).
Symptom endorsement, cognitive and balance performance during annual SCAT baseline assessments.
Players with a diagnosed concussion (CONC) endorsed fewer symptoms (change –0.42, 95% CI –0.75 to –0.09), and reported lower symptom severity scores during their second assessment (T2, p
Reduced symptom endorsement and improved cognitive performance after concussion may be the result of differences in the motivation of previously concussed players to avoid exclusion from play, leading to under-reporting of symptoms and greater effort in cognitive tests. Improved cognitive performance may be the result of familiarity with the tests as a result of greater exposure to concussion screening. The changes are small and unlikely to have clinical significance in most cases, though clinicians should be mindful of possible reasons, possibly repeating sub-modes and investigating players whose baseline scores change significantly after concussion. The findings do not necessitate a change in the sport’s concussion management policy.
The Oxford Parkinson’s Disease Centre (OPDC) Discovery Cohort MRI substudy (OPDC-MRI) collects high-quality multimodal brain MRI together with deep longitudinal clinical phenotyping in patients with Parkinson’s, at-risk individuals and healthy elderly participants. The primary aim is to detect pathological changes in brain structure and function, and develop, together with the clinical data, biomarkers to stratify, predict and chart progression in early-stage Parkinson’s and at-risk individuals.
Participants are recruited from the OPDC Discovery Cohort, a prospective, longitudinal study. Baseline MRI data are currently available for 290 participants: 119 patients with early idiopathic Parkinson’s, 15 Parkinson’s patients with pathogenic mutations of the leucine-rich repeat kinase 2 or glucocerebrosidase (GBA) genes, 68 healthy controls and 87 individuals at risk of Parkinson’s (asymptomatic carriers of GBA mutation and patients with idiopathic rapid eye movement sleep behaviour disorder-RBD).
Differences in brain structure in early Parkinson’s were found to be subtle, with small changes in the shape of the globus pallidus and evidence of alterations in microstructural integrity in the prefrontal cortex that correlated with performance on executive function tests. Brain function, as assayed with resting fMRI yielded more substantial differences, with basal ganglia connectivity reduced in early Parkinson’sand RBD. Imaging of the substantia nigra with the more recent adoption of sequences sensitive to iron and neuromelanin content shows promising results in identifying early signs of Parkinsonian disease.
Ongoing studies include the integration of multimodal MRI measures to improve discrimination power. Follow-up clinical data are now accumulating and will allow us to correlate baseline imaging measures to clinical disease progression. Follow-up MRI scanning started in 2015 and is currently ongoing, providing the opportunity for future longitudinal imaging analyses with parallel clinical phenotyping.
Data on race and ethnic disparities for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are limited. We analysed sociodemographic factors associated with higher likelihood of SARS-CoV-2 infection and explore mediating pathways for race and ethnic disparities in the SARS-CoV-2 pandemic.
This is a cross-sectional analysis of the COVID-19 Surveillance and Outcomes Registry, which captures data for a large healthcare system, comprising one central tertiary care hospital, seven large community hospitals and an expansive ambulatory/emergency care network in the Greater Houston area. Nasopharyngeal samples for individuals inclusive of all ages, races, ethnicities and sex were tested for SARS-CoV-2. We analysed sociodemographic (age, sex, race, ethnicity, household income, residence population density) and comorbidity (Charlson Comorbidity Index, hypertension, diabetes, obesity) factors. Multivariable logistic regression models were fitted to provide adjusted OR (aOR) and 95% CI for likelihood of a positive SARS-CoV-2 test. Structural equation modelling (SEM) framework was used to explore three mediation pathways (low income, high population density, high comorbidity burden) for the association between non-Hispanic black (NHB) race, Hispanic ethnicity and SARS-CoV-2 infection.
Among 20 228 tested individuals, 1551 (7.7%) tested positive. The overall mean (SD) age was 51.1 (19.0) years, 62% were females, 22% were black and 18% were Hispanic. NHB and Hispanic ethnicity were associated with lower socioeconomic status and higher population density residence. In the fully adjusted model, NHB (vs non-Hispanic white; aOR, 2.23, CI 1.90 to 2.60) and Hispanic ethnicity (vs non-Hispanic; aOR, 1.95, CI 1.72 to 2.20) had a higher likelihood of infection. Older individuals and males were also at higher risk of infection. The SEM framework demonstrated a significant indirect effect of NHB and Hispanic ethnicity on SARS-CoV-2 infection mediated via a pathway including residence in densely populated zip code.
There is strong evidence of race and ethnic disparities in the SARS-CoV-2 pandemic that are potentially mediated through unique social determinants of health.
This systematic review aims to assess the quality of literature supporting surgical interventions for paediatric extravasation injury and to determine whether there is sufficient evidence to support invasive techniques in children.
We performed a systematic review by searching Ovid MEDLINE and EMBASE as well as AMED, CINAHL, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and clinicaltrials.gov from inception to February 2019. Studies other than case reports were eligible for inclusion if the population was younger than 18 years old, if there was a surgical intervention aimed at treating extravasation injury and if they reported on outcomes. Study quality was graded according to the National Institutes of Health study quality assessment tools.
26 studies involving 728 children were included—one before-and-after study and 25 case series. Extravasation injuries were mainly confined to skin and subcutaneous tissues but severe complications were also encountered, including amputation (one toe and one below elbow). Of the surgical treatments described, the technique of multiple puncture wounds and instillation of saline and/or hyaluronidase was the most commonly used. However, there were no studies in which its effectiveness was tested against another treatment or a control and details of functional and aesthetic outcomes were generally lacking.
Surgical management is commonly reported in the literature in cases where there is significant soft tissue injury but as there are no comparative studies, it is unclear whether this is optimal. Further observational and experimental research evaluating extravasation injuries, including a centralised extravasation register using a universal grading scheme and core outcome set with adequate follow-up, are required to provide evidence to guide clinician decision-making.
Universal health coverage (UHC) includes the dimensions of equity in access, quality services that improve health and protection against financial hardship. Cataract continues to be the leading cause of blindness globally, despite cataract surgery being an efficacious intervention. The aim of this scoping review is to map the nature, extent and global distribution of data on cataract services for UHC in terms of equity, access, quality and financial protection.
The search will be constructed by an Information Specialist and undertaken in MEDLINE, Embase and Global Health databases. We will include all published non-interventional primary research studies and systematic reviews that report a quantitative assessment of access, equity, quality or financial protection of cataract surgical services for adults at the subnational, national, regional or global level from population-based surveys or routinely collected health service data since 1 January 2000 and published through to February 2020.
Screening and data charting will be undertaken using Covidence systematic review software. Titles and abstracts of identified studies will be screened by two authors independently. Full-text articles of potentially relevant studies will be obtained and reviewed independently by two authors against the inclusion criteria. Any discrepancies between the authors will be resolved by discussion, and with a third author as necessary. A data charting form will be developed and piloted on three studies by three authors and amendments made as necessary. Data will be extracted by two reviewers independently and summarised narratively and using maps.
Ethical approval was not sought as the scoping review will only use published and publicly accessible data. The review will be published in an open access peer-reviewed journal. A summary of the results will be developed for website posting, stakeholder meetings and inclusion in the ongoing Lancet Global Health Commission on Global Eye Health.
To investigate short-term and long-term effectiveness of simulation training to acquire a structured Airway Breathing Circulation Disability Exposure (ABCDE) approach for medical emergencies; and to examine which skills were learnt and maintained best.
An observational study with a 3–4 months follow-up.
Skills center of the University Medical Center Groningen.
Thirty voluntary participants (21 females and 9 males; 27±2.77 years) of a simulation-based course.
A 2-day ABCDE-teaching course for residents and non-residents. The course encompasses 24 simulations in which participants perform primary assessments of acute ill patients. Video recordings were taken of each participant performing a primary assessment, before (T1), directly after (T2) and 3–4 months after the intervention (T3).
Physicians’ performance in the ABCDE primary assessment at T1, T2 and T3. Two observers scored the primary assessments, blinded to measurement moment, using an assessment form to evaluate the performance with regard to skills essential for a structured ABCDE approach. The Friedman and Wilcoxon signed-rank test were used to compare physicians’ performances on the subsequent measurement moments.
The mean ranks on the total primary assessment at T1, T2 and T3 were 1.14, 2.62 and 2.24, respectively, and were significantly different, (p
The mean ranks on the total primary assessment directly after the course (T2 vs T1 p
A course using simulation training is an effective educational tool to teach physicians the ABCDE primary assessment. Certain CRM skills decrease over time, so we recommend organising refresher courses, simulation team training or another kind of simulation training with a focus on CRM skills.
Since the WHO declared COVID-19 as a pandemic, the spread of the new coronavirus has been the focus of attention of scientists, governments and populations. One of the main concerns is the impact of this pandemic on health outcomes, mainly on mental health. Even though there are a few empirical studies on COVID-19 and mental health, so far, there is no systematic review about the impact of COVID-19 on mental health of young people and adults yet. We aim to critically synthesise the scientific evidence about the impact of the COVID-19 pandemic on the mental health of young people and adults.
A systematic review will be performed through eight databases: MEDLINE (Medical Literature Analysis and Retrieval System Online), ISI-of-Knowledge, CENTRAL (Cochrane Central Register of Controlled Trials), EMBASE (Excerpta Medica Database), SCOPUS, LILACS (Latin American and Caribbean Health Sciences Literature), PsycINFO (Psychology Information) and CNKI (Chinese National Knowledge Infrastructure), from inception until 30 June 2020. No restriction regarding the publication date, setting or languages will be considered. Preliminary search strategies were carried out on 29 March 2020 and will be updated in June 2020. The primary outcomes will be the prevalence and the severity of psychological symptoms in young people and adults (>18 years old) resulting from the impact of COVID-19 pandemic. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Pooled standardised mean differences and 95% CIs will be calculated. The risk of bias of the observational studies will be assessed through the Methodological Index for Non-Randomised Studies (MINORS). Additionally, if sufficient data are available, a meta-analysis will be conducted. Heterogeneity between the studies will be determined by the I2 statistics. Subgroup analyses will also be performed. Publication bias will be checked with funnel plots and Egger’s test. Heterogeneity will be explored by random-effects analysis.
Ethical assessment was not required. Findings will be disseminated through peer-reviewed publication and will be presented at conferences related to this field.
Two oral targeted therapies, gefitinib and erlotinib, were first approved and then launched into the market for treatment of late-stage non-small cell lung cancer (NSCLC) in Taiwan in 2003 and 2006, respectively. The aim of this study were to determine the trends in lung cancer burden and examine changes in lung cancer-related survival rates and mortality following the launch of these new drugs.
Yearly lung cancer-related data (1994–2013), including incidence, number of newly diagnosed patients, survival rate and mortality, were retrieved from the Taiwan Cancer Registry Database.
Using a time series design with autoregressive integrated moving average model, we investigated and projected trends in the incidence and early diagnosis of lung cancer in Taiwan. We also estimated the changes in survival rates and mortality following the launch of targeted therapies using interrupted time series and segmented regression models.
The age-standardised incidence of lung cancer increased from 22.53 per 100 000 people in 1994 to 34.09 in 2013, and it was projected to reach 38.98 by 2020. The rate of early-stage NSCLC at diagnosis increased from 12.63% in 2004 to 23.99% in 2013, and it was projected to reach 32.95% by 2020. The 2-year lung cancer survival increased by 19.81% (95% CI 14.90% to 24.71%) 3 years following the launch of gefitinib. Lung cancer mortality declined by 5.97% (95% CI –8.20% to –3.73%) 3 years following the launch of gefitinib.
Lung cancer survival rate increased and mortality decreased significantly following the launch of gefitinib and erlotinib in Taiwan.
Older adults who fall recurrently (i.e., >1 fall/year) are at risk for functional decline and mortality. Key risk factors for recurrent falls in community-dwelling older adults are not well established due to methodological limitations, such as recall bias. A better understanding of the risk factors for recurrent falls will aid in refining clinical practice guidelines for secondary fall prevention strategies. The primary objective of this systematic review with meta-analysis is to examine the risk factors for recurrent falls in prospective studies among community-dwelling older adults.
A comprehensive search for articles indexed in MEDLINE, EMBASE, PsycINFO and CINAHL databases as well as grey literature was conducted on April 25, 2019. We will use MeSH and keyword search terms around the following topics: falls, recurrence, fall-risk, ageing and prospective studies. Prospective studies with monthly falls monitoring for 12 months, investigating risk factors for recurrent falls in older adults will be included. One author will complete the search. Two authors will remove duplicates and screen the titles and abstracts for their potential inclusion against the eligibility criteria. Two authors will screen the full texts and extract the data using a piloted extraction sheet. Included studies will be evaluated for the risk of bias with the Joanna Briggs Institute Prevalence Critical Appraisal tools. The quality of reporting will be determined with the Strengthening the Reporting of OBservational studies in Epidemiology. The data extraction will include study characteristics as well as sociodemographic, balance and mobility, sensory and neuromuscular, psychological, medical, medication and environmental factors. The results will be presented via figures, summary tables, meta-analysis (when possible) and narrative summaries.
No ethics approval will be required. Findings will be disseminated through publication and media.
Management of diet-related chronic diseases may benefit from improved nutrition education of medical students. This study aims to investigate the effects of a nutrition education course on nutritional knowledge and intentions towards nutritional counselling in Dutch medical students.
This is a pre–post intervention study with a comparison group. Participants completed self-reported questionnaires on nutritional knowledge and intentions towards nutritional counselling.
In total, 118 medical students (64.4% undergraduate, 73.2% women) were recruited from two medical schools in the Netherlands (n=66 intervention group, n=52 comparison group).
The intervention group completed a 25-hour course in nutritional counselling (the Students Experienced in Lifestyle and Food (SELF) course) in addition to the standard medical curriculum. The comparison group followed the standard medical curriculum.
Self-reported nutritional knowledge and intentions towards nutritional counselling, including attitude, self-efficacy and social support.
Nutritional knowledge (B: 2.42, 95% CI 1.81 to 3.02), attitude in men (B: 0.50, 95% CI 0.13 to 0.87) and self-efficacy (B: 0.78, 95% CI 0.62 to 0.95) significantly increased in the intervention group compared with the comparison group. No significant differences were found for social support (B: 0.20, 95% CI –0.02 to 0.43) and attitude in women (B: 0.08, 95% CI –0.24 to 0.31) between the two groups.
The SELF course increased medical students’ nutritional knowledge and stimulated their intentions towards nutritional counselling. Future research is needed to evaluate the long-term impact of nutrition education interventions on physician practice patterns and patient outcomes.
To describe the risk and frequency of challenges in acute care nursing, and the practice priorities in Australian hospital wards based upon expert consensus.
Health care is facing increasing demands that are negatively impacting upon the safety and quality of nursing care.
A three‐round electronic Delphi method was used to collect and synthesise expert consensus opinion of 30 participants in Rounds One and Two of the survey, and 12 participants in Round Three. The study was carried out from July to December 2016. This study complied with the STROBE checklist.
High patient acuity or complexity, as well as inadequate bed space on wards, are “very high” risks that occur “often” and “very often,” respectively. The pressure to admit patients, delayed medical review and patient boarding are all “high” risks that occur “often.” Though only occurring “sometimes,” inadequate numbers and skill mix of staff, suboptimal communication and early or inappropriate discharge all pose a “very high” risk to patient care.
The key practice priorities for nurse managers should include the design, implementation and evaluation of sustainable system‐wide frameworks, processes and models of care that address patient boarding, communication and discharge processes, job satisfaction, staffing numbers and expertise.
This study provides a description of the challenges that face acute care nursing in the provision of safe and high‐quality care.
Diabetic foot ulcers (DFUs) have significant clinical impact and carry a substantial economic burden. Patients with DFUs that are refractory to standard wound care are at risk for major complications, including infection and amputation and have an increased risk of mortality. This study evaluated the safety and preliminary efficacy of a novel decellularised purified reconstituted bilayer matrix (PRBM) in treating DFUs. Ten diabetic patients with refractory wounds that failed to heal after at least 4 weeks of standard wound care were studied in this Institutional Review Board approved trial. Ten consecutive wounds were treated weekly with the PRBM for up to 12 weeks. At each weekly visit, the wound was evaluated, photographed, and cleaned, followed by application of new graft if not completely epithelialised. Assessment included measurement of the wound area and inspection of the wound site for signs of complications. The primary outcome measure was wound closure, as adjudicated by independent reviewers. Secondary outcomes included assessment of overall adverse events, time to closure, percent area reduction, and the cost of product(s) used. Nine of 10 patients achieved complete wound closure within 4 weeks, and 1 did not heal completely within 12 weeks. The mean time to heal was 2.7 weeks. The mean wound area reduction at 12 weeks was 99%. No adverse events nor wound complications were observed. These early clinical findings suggest that the PRBM may be an effective tool in the treatment of diabetic foot ulcers.
by Axel J. Chu, Eric Jiahua Zhao, Mu Chiao, Chinten James LimVarious types of stem cells and non-stem cells have been shown to differentiate or transdifferentiate into cardiomyocytes by way of co-culture with appropriate inducer cells. However, there is a limited demonstration of a co-culture induction system utilizing stem cell-derived cardiomyocytes as a stimulatory source for cardiac reprogramming (of stem cells or otherwise). In this study, we utilized an inductive co-culture method to show that previously differentiated induced pluripotent stem (iPS) cell-derived cardiomyocytes (iCMs), when co-cultivated with iPS cells, constituted a sufficient stimulatory system to induce cardiac differentiation. To enable tracking of both cell populations, we utilized GFP-labeled iPS cells and non-labeled iCMs pre-differentiated using inhibitors of GSK and Wnt signaling. Successful differentiation was assessed by the exhibition of spontaneous self-contractions, structural organization of α-actinin labeled sarcomeres, and expression of cardiac specific markers cTnT and α-actinin. We found that iCM-iPS cell-cell contact was essential for inductive differentiation, and this required overlaying already adherent iPS cells with iCMs. Importantly, this process was achieved without the exogenous addition of pathway inhibitors and morphogens, suggesting that ‘older’ iCMs serve as an adequate stimulatory source capable of recapitulating the necessary culture environment for cardiac differentiation.
Natural experiments are considered a priority for examining causal associations between the built environment (BE) and physical activity (PA) because the randomised controlled trial design is rarely feasible. Few natural experiments have examined the effects of walking and cycling infrastructure on PA and active transport in adults, and none have examined the effects of such changes on PA and active transport to school among adolescents. We conducted the Built Environment and Active Transport to School (BEATS) Study in Dunedin city, New Zealand, in 2014–2017. Since 2014, on-road and off-road cycling infrastructure construction has occurred in some Dunedin neighbourhoods, including the neighbourhoods of 6 out of 12 secondary schools. Pedestrian-related infrastructure changes began in 2018. As an extension of the BEATS Study, the BEATS Natural Experiment (BEATS-NE) (2019–2022) will examine the effects of BE changes on adolescents’ active transport to school in Dunedin, New Zealand.
The BEATS-NE Study will employ contemporary ecological models for active transport that account for individual, social, environmental and policy factors. The published BEATS Study methodology (surveys, accelerometers, mapping, Geographic Information Science analysis and focus groups) and novel methods (environmental scan of school neighbourhoods and participatory mapping) will be used. A core component continues to be the community-based participatory approach with the sustained involvement of key stakeholders to generate locally relevant data, and facilitate knowledge translation into evidence-based policy and planning.
The BEATS-NE Study has been approved by the University of Otago Ethics Committee (reference: 17/188). The results will be disseminated through scientific publications and symposia, and reports and presentations to stakeholders.
Residency is a stressful phase associated with high prevalence of mental distress. Besides impaired personal health, mental distress in residents has an impact on the quality of patient care and produces economic costs. Therefore, there is demand for interventions that improve resident physicians’ mental health. The aim of the present study is to examine the effects of a mindfulness-based intervention that has been tailored to residents’ needs. Specifically, mindfulness has been supplemented by a focus on the concept of Muße.
This study applies a randomised controlled multimethod design. Residents assigned to the intervention group will participate in an 8-week mindfulness course followed by a 4-month maintenance phase, whereas residents assigned to the control group will read text-based information about mindfulness on a weekly basis for the duration of 8 weeks. The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents’ self-care as well as on building empathic relationships. Participants will be assessed before, directly after the intervention, after the maintenance phase as well as at follow-up 6 months after the intervention group completes the intervention. Assessments will consist of self-report measures, physiological data, qualitative interviews, third-party reports as well as implicit and projective measures and will focus on both psychopathology and salutogenesis. The primary outcome will be burnout. Data will be analysed using linear mixed modelling.
The study was approved by the ethics committee of the Medical Center - University of Freiburg and is funded by the German Research Foundation as part of the interdisciplinary Collaborative Research Center ‘SFB Muße 1015’. The results of this study will be published in scientific journals and disseminated through the study’s website, and conferences.
Pain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.
This will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.
This trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.
International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme ‘isPO’ is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost–consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare.
The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study.
The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations.