To identify theoretical and technical aspects regarding treatment, prevention of spread and protection of staff to inform the development of a comprehensive training curriculum on COVID-19 management.
Nine hospitals caring for patients with COVID-19 in Wuhan, China.
134 Chinese healthcare professionals (74 doctors and 60 nurses) who were deployed to Wuhan, China during the COVID-19 epidemic were included. A two-round Delphi process was initiated between March and May 2020. In the first round, the participants identified knowledge, technical and behavioural (ie, non-technical) skills that are needed to treat patients, prevent spread of the virus and protect healthcare workers. In round 2, the participants rated each item according to its importance to be included in a training curriculum on COVID-19. Consensus for inclusion in the final list was set at 80%.
Knowledge, technical and behavioural (ie, non-technical) skills that could form the basis of a training curriculum for COVID-19 management.
In the first round 1398 items were suggested by the doctors and reduced to 67 items after content analysis (treatment of patients: n=47; infection prevention and control: n=20). The nurses suggested 1193 items that were reduced to 70 items (treatment of patients: n=49; infection prevention and control: n=21). In round 2, the response rates were 82% in doctors and 93% in nurses. Fifty-eight items of knowledge, technical and behavioural skills were agreed on by the doctors to include in the final list. For the nurses, 58 items were agreed on.
This needs assessment process resulted in a comprehensive list of knowledge, technical and behavioural skills for COVID-19 management. Educators can use these to guide decisions regarding content of training curricula not only for COVID-19 management but also in preparation for future viral pandemic outbreaks.
To explore parents’ experience of transition in the period between the palliative cardiac surgeries (i.e., the interstage period) of an infant with single ventricle congenital heart disease.
We conducted an exploratory naturalistic inquiry using a qualitative descriptive approach.
A purposive sample of 11 parents of children with single ventricle disease was selected among families that participated in an interstage‐period parental home monitoring program during the past 2 years. Interviews and field observations were conducted September–October 2019, and data were analyzed for themes. Analysis of data was inductive, although study questions and the interpretation of results were informed by Meleis’ transition theory.
Parents described the experience of transition in interstage as a striving for normality, a theme that was clustered in subthemes of home, self, and infant.
Parents' experiences of striving for normality indicated a need for more targeted efforts to address parents’ psychosocial needs during the highly stressful interstage transition.
This research underscored the complexity of parents’ psychosocial support needs on returning home after their child's first palliative surgery. The findings also suggest need for examination of the transition following the second palliative heart surgery, when the home monitoring program is withdrawn. Understanding parent needs will help guide healthcare teams in developing ways to support parents as they adjust to home, self, and child.
The COVID-19 epidemic grows and there are clinical trials of antivirals. There is an opportunity to complement these trials with investigation of angiotensin II type 1 receptor blockers (ARBs) because an ARB (losartan) was effective in murine influenza pneumonia.
Our innovative design includes: ARBs; alignment with the WHO Ordinal Scale (primary endpoint) to align with other COVID-19 trials; joint longitudinal analysis; and predictive biomarkers (angiotensins I, 1–7, II and ACE1 and ACE2). Our hypothesis is: ARBs decrease the need for hospitalisation, severity (need for ventilation, vasopressors, extracorporeal membrane oxygenation or renal replacement therapy) or mortality of hospitalised COVID-19 infected adults. Our two-pronged multicentre pragmatic observational cohort study examines safety and effectiveness of ARBs in (1) hospitalised adult patients with COVID-19 and (2) out-patients already on or not on ARBs. The primary outcome will be evaluated by ordinal logistic regression and main secondary outcomes by both joint longitudinal modelling analyses. We will compare rates of hospitalisation of ARB-exposed versus not ARB-exposed patients. We will also determine whether continuing ARBs or not decreases the primary outcome. Based on published COVID-19 cohorts, assuming 15% of patients are ARB-exposed, a total sample size of 497 patients can detect a proportional OR of 0.5 (alpha=0.05, 80% power) comparing WHO scale of ARB-exposed versus non-ARB-exposed patients.
This study has core institution approval (UBC Providence Healthcare Research Ethics Board) and site institution approvals (Health Research Ethics Board, University of Alberta; Comite d’etique de la recerche, CHU Sainte Justine (for McGill University and University of Sherbrook); Conjoint Health Research Ethics Board, University of Calgary; Queen’s University Health Sciences & Affiliated Hospitals Research Ethics Board; Research Ethics Board, Sunnybrook Health Sciences Centre; Veritas Independent Research Board (for Humber River Hospital); Mount Sinai Hospital Research Ethics Board; Unity Health Toronto Research Ethics Board, St. Michael’s Hospital). Results will be disseminated by peer-review publication and social media releases.
Commentary on: Lin CP, Evans CJ, Koffman J, et al. What influences patients' decisions regarding palliative care in advance care planning discussions? Perspectives from a qualitative study conducted with advanced cancer patients, families and healthcare professionals. Palliat Med 2019; Epub ahead of print Aug 1. doi:10.1177/0269216319866641.
More evidence is needed to understand the cultural aspects of palliative care. Paying attention to and acting on cultural context facilitate better culturally sensitive, person-centred advance care planning and palliative care.
More evidence is needed to understand the cultural aspects of palliative care.
Paying attention to and acting on cultural context facilitate better culturally sensitive, person-centred advance care planning and palliative care.
Advance care planning is largely derived from Western countries,
Providing effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An ‘underfeeding syndrome’ can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15–25 years), hospitalised with AN.
The study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.
The protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.
Australian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.
To explore (1) the extent to which a multicomponent intervention addressed determinants of the desired behaviours (ie, adherence to cardiac rehabilitation (CR) and cardiovascular medications), (2) the associated mechanism(s) of action and (3) how future interventions might be better designed to meet the needs of this patient population.
A qualitative evaluation embedded within a multicentre randomised trial, involving purposive semistructured interviews.
Nine cardiac centres in Ontario, Canada.
Potential participants were stratified according to the trial’s primary outcomes of engagement and adherence, resulting in three groups: (1) engaged, adherence outcome positive, (2) engaged, adherence outcome negative and (3) did not engage, adherence outcome negative. Participants who did not engage but had positive adherence outcomes were excluded. Individual domains of the Theoretical Domains Framework were applied as deductive codes and findings were analysed using a framework approach.
Thirty-one participants were interviewed. Participants who were engaged with positive adherence outcomes attributed their success to the intervention’s ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences. The behaviour of those with negative adherence outcomes was driven by beliefs about consequences, emotions and identity. As currently designed, the intervention failed to target these determinants for this subset of participants, resulting in partial engagement and poor adherence outcomes.
The intervention facilitated CR adherence through reinforcement, behavioural regulation, the provision of knowledge and social influence. To reach a broader and more diverse population, future iterations of the intervention should target aberrant beliefs about consequences, memory and decision-making and emotion.
ClinicalTrials.gov registry; NCT02382731
Immunomodulators such as thiopurines (azathioprine (AZA)/6-mercaptopurine (6MP)), methotrexate (MTX) and biologics such as adalimumab (ADA) are well established for maintenance of remission within paediatric Crohn’s disease (CD). It remains unclear, however, which maintenance medication should be used first line in specific patient groups.
To compare the efficacy of maintenance therapies in newly diagnosed CD based on stratification into high and low-risk groups for severe CD evolution; MTX versus AZA/6MP in low-risk and MTX versus ADA in high-risk patients. Primary end point: sustained remission at 12 months (weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation.
REDUCE-RISK in CD is an international multicentre open-label prospective randomised controlled trial funded by EU within the Horizon2020 framework (grant number 668023). Eligible patients (aged 6–17 years, new-onset disease receiving steroids or EEN for induction of remission for luminal ± perianal CD are stratified into low and high-risk groups based on phenotype and response to induction therapy. Participants are randomised to one of two treatment arms within their risk group: low-risk patients to weekly subcutaneous MTX or daily oral AZA/6MP, and high-risk patients to weekly subcutaneous MTX or fortnightly ADA. Patients are followed up for 12 months at prespecified intervals. Electronic case report forms are completed prospectively. The study aims to recruit 312 participants (176 low risk; 136 high risk).
ClinicalTrials.gov Identifier: (NCT02852694), authorisation and approval from local ethics committees have been obtained prior to recruitment. Individual informed consent will be obtained prior to participation in the study. Results will be published in a peer-reviewed journal with open access.
Patients with paediatric-onset inflammatory bowel disease (PIBD) may develop a complicated disease course, including growth failure, bowel resection at young age and treatment-related adverse events, all of which can have significant and lasting effects on the patient’s development and quality of life. Unfortunately, we are still not able to fully explain the heterogeneity between patients and their disease course and predict which patients will respond to certain therapies or are most at risk of developing a more complicated disease course. To investigate this, large prospective studies with long-term follow-up are needed. Currently, no such European or Asian international cohorts exist. In this international cohort, we aim to evaluate disease course and which patients are most at risk of therapy non-response or development of complicated disease based on patient and disease characteristics, immune pathology and environmental and socioeconomic factors.
In this international prospective observational study, which is part of the PIBD Network for Safety, Efficacy, Treatment and Quality improvement of care (PIBD-SETQuality), children diagnosed with inflammatory bowel disease
Medical ethical approval has been obtained prior to patient recruitment for all sites. The results will be disseminated through peer-reviewed scientific publications.
To explore the healthcare professionals (HCP) experience of providing care coordination to people living with multimorbidity.
There is increasing interest in improving care of people living with multimorbidity who need care coordination to help manage their health. Little is known about the experiences of HCP working with people living with multimorbidity.
Phenomenological approach to understanding the experiences of HCP.
We interviewed 18 HCP, including 11 registered nurses, working in care coordination in Melbourne, Australia. We used interpretative phenomenological analysis to identify themes from descriptions of providing care, identifying and responding to a person’s needs, and the barriers and facilitators to providing person‐centred care.
We identified four themes as follows: (a) Challenge of focusing on the person; (b) “Hear their story,” listening to and giving time to clients to tell their story; (c) Strategies for engagement in the programme; and, (d) “See the bigger picture,” looking beyond the disease to the needs of a person. Our results are reported using COREQ.
The HCP experienced challenges to a traditional approach to care when focusing on the person. They described providing care that was person‐centred, and acknowledged that optimal, guideline‐oriented care might not be achieved. They took the necessary time to hear the story and see the context of the person’s life, to help the person manage their health.
For registered nurses in care coordination programmes, focusing on the client may challenge traditional approaches to care. Providing care involves developing a relationship with the client to optimise health outcomes. Experienced registered nurses appear to use skills in reflective practice and accept the parameters of care to improve the client’s health and well‐being.
To describe the evolution of the burden of chronic kidney disease (CKD) in Mexico by states, sex and subtypes from 1990 to 2017.
Secondary data analysis based on the Global Burden of Disease Study (GBD) 2017.
Mexico and its 32 states. Data were publicly available and de-identified and individuals were not involved.
We analysed age-standardised mortality rates, years of life lost (YLL) due to premature death, years lived with disability (YLD) and disability-adjusted life years (DALY), as well as the percentage of change of these indicators between 1990 and 2017.
From 1990 to 2017, the number of deaths, YLL, YLD and DALY due to CKD increased from 12 395 to 65 033, from 330 717 to 1 544 212, from 86 416 to 210 924 and from 417 133 to 1 755 136, respectively. Age-standardised rates went from 28.7 to 58.1 for deaths (% of change 102.3), from 601.2 to 1296.7 for YLL (% of change 115.7), from 158.3 to 175.4 for YLD (% of change 10.9) and from 759.4 to 1472.2 for DALY (% of change 93.8). The highest burden of CKD was for Puebla and the lowest for Sinaloa. It was also greater for men than women. By subtypes of CKD, diabetes and hypertension were the causes that contributed most to the loss of years of healthy life in the Mexican population.
Mexico has experienced exponential and unprecedented growth in the burden of CKD with significant differences by states, sex and subtypes. Data from the GBD are key inputs to guide decision-making and focus efforts towards the reduction of inequities in CKD. These results should be considered a valuable resource that can help guide the epidemiological monitoring of this disease and prioritise the most appropriate health interventions.
Gout is a painful form of inflammatory arthritis associated with several comorbidities, particularly cardiovascular disease. Cherries, which are rich in anti-inflammatory and antioxidative bioactive compounds, are proposed to be efficacious in preventing and treating gout, but recommendations to patients are conflicting. Cherry consumption has been demonstrated to lower serum urate levels and inflammation in several small studies. One observational case cross-over study reported that cherry consumption was associated with reduced risk of recurrent gout attacks. This preliminary evidence requires substantiation. The proposed randomised clinical trial aims to test the effect of consumption of tart cherry juice on risk of gout attacks.
This 12-month, parallel, double-blind, randomised, placebo-controlled trial will recruit 120 individuals (aged 18–80 years) with a clinical diagnosis of gout who have self-reported a gout flare in the previous year. Participants will be randomly assigned to an intervention group, which will receive Montmorency tart cherry juice daily for a 12-month period, or a corresponding placebo group, which will receive a cherry-flavoured placebo drink. The primary study outcome is change in frequency of self-reported gout attacks. Secondary outcome measures include attack intensity, serum urate concentration, fractional excretion of uric acid, biomarkers of inflammation, blood lipids and other markers of cardiovascular risk. Other secondary outcome measures will be changes in physical activity and functional status. Statistical analysis will be conducted on an intention-to-treat basis.
This study has been granted ethical approval by the National Research Ethics Service, Yorkshire and The Humber—Leeds West Research Ethics Committee (ref: 18/SW/0262). Results of the trial will be submitted for publication in a peer-reviewed journal.
To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.
Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.
11 diabetes clinics in England and Wales.
Between February 2010 and August 2011, we validly randomised 308 children aged 6–18 years; 201 received the intervention.
We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment.
Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use.
Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=–4.68; SE=1.74; 95%CI from –8.10 to –1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=–3.20; SE=1.33; 95% CI from –5.73 to –0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.
Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents.
Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes.
by Russell A. Cohen Hoffing, Nina Lauharatanahirun, Daniel E. Forster, Javier O. Garcia, Jean M. Vettel, Steven M. ThurmanPupil size modulations have been used for decades as a window into the mind, and several pupillary features have been implicated in a variety of cognitive processes. Thus, a general challenge facing the field of pupillometry has been understanding which pupil features should be most relevant for explaining behavior in a given task domain. In the present study, a longitudinal design was employed where participants completed 8 biweekly sessions of a classic mental arithmetic task for the purposes of teasing apart the relationships between tonic/phasic pupil features (baseline, peak amplitude, peak latency) and two task-related cognitive processes including mental processing load (indexed by math question difficulty) and decision making (indexed by response times). We used multi-level modeling to account for individual variation while identifying pupil-to-behavior relationships at the single-trial and between-session levels. We show a dissociation between phasic and tonic features with peak amplitude and latency (but not baseline) driven by ongoing task-related processing, whereas baseline was driven by state-level effects that changed over a longer time period (i.e. weeks). Finally, we report a dissociation between peak amplitude and latency whereby amplitude reflected surprise and processing load, and latency reflected decision making times.
Venous leg ulcers (VLUs) have a significant impact on approximately 3% of the adult population worldwide, with a mean NHS wound care cost of £7600 per VLU over 12 months. The standard care for VLUs is compression therapy, with a significant number of ulcers failing to heal with this treatment, especially with wound size being a risk factor for non‐healing. This multicentre, prospective, randomised trial evaluated the safety and effectiveness of autologous skin cell suspension (ASCS) combined with compression therapy compared with standard compression alone (Control) for the treatment of VLUs. Incidence of complete wound closure at 14 weeks, donor site closure, pain, Health‐Related Quality of Life (HRQoL), satisfaction, and safety were assessed in 52 patients. At Week 14, VLUs treated with ASCS + compression had a statistically greater decrease in ulcer area compared with the Control (8.94 cm2 versus 1.23 cm2, P = .0143). This finding was largely driven by ulcers >10 to 80 cm2 in size, as these ulcers had a higher mean percentage of reepithelialization at 14 weeks (ASCS + compression: 69.97% and Control: 11.07%, P = .0480). Additionally, subjects treated with ASCS + compression experienced a decrease in pain and an increase in HRQoL compared with the Control. This study indicates that application of ASCS + compression accelerates healing in large venous ulcers.
Aspects of the built environment that support physical activity are associated with better population health outcomes. Few experimental data exist to support these observations. This protocol describes the study of the creation of urban trials on cardiovascular disease (CVD)-related morbidity and mortality in a large urban centre.
Between 2008 and 2010, the city of Winnipeg, Canada, built four, paved, multiuse (eg, cycling, walking and running), two-lane trails that are 5–8 km long and span ~60 neighbourhoods. Linking a population-based health data with census and environmental data, we will perform an interrupted time series analysis to assess the impact of this natural experiment on CVD-related morbidity and mortality among individuals 30–65 years of age residing within 400–1200 m of the trail. The primary outcome of interest is a composite measure of incident major adverse CVD events (ie, CVD-related mortality, ischaemic heart disease, stroke and congestive heart failure). The secondary outcome of interest is a composite measure of incident CVD-related risk factors (ie, diabetes, hypertension and dyslipidaemia). Outcomes will be assessed quarterly in the 10 years before the intervention and 5 years following the intervention, with a 4-year interruption. We will adjust analyses for differences in age, sex, ethnicity, immigration status, income, gentrification and other aspects of the built environment (ie, greenspace, fitness/recreation centres and walkability). We will also assess trail use and trail user profiles using field data collection methods.
Ethical approvals for the study have been granted by the Health Research Ethics Board at the University of Manitoba and the Health Information Privacy Committee within the Winnipeg Regional Health Authority. We have adopted an integrated knowledge translation approach. Information will be disseminated with public and government partners.
To explore recent research on care coordination interventions for people living with multimorbidity, from the perspective of the person receiving care.
Care coordination interventions for people living with multimorbidity show some effectiveness in improving management of their health and reducing potentially preventable hospitalisations. The experience of people enrolled in care coordination interventions requires further exploration.
A review was guided by the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) checklist where five databases (The Cochrane Library, PsycINFO, Scopus, CINAHL and MEDLINE) were searched for qualitative sources published from January 2008–March 2019. Two additional databases focused on multimorbidity and integrated care were included in the search. Titles, abstracts and full texts were screened using inclusion criteria. Reference lists of the included articles were hand‐searched. Summary tables were developed for data extraction, and the data were mapped to the research question.
Eighteen primary research articles were included. Three themes of participant experience were identified: (a) relationships built on trust, (b), a sense of safety and security and (c) feeling cared for and respected.
The contribution of qualitative approaches to evaluating the experiences of care for people living with multimorbidity is growing. Participants’ describe a focus on relationships formed with healthcare professionals during care coordination. Further research incorporating lived experiences of participants could illuminate these concepts further.
People living with multimorbidity who require assistance via care coordination value trusting relationships with healthcare professionals, who respect their needs and provide a sense of security. Understanding participant experiences is important to shape care coordination interventions that incorporate person‐centred approaches.
Commentary on: Collier A, Hodgins M, Crawford G, et al. What does it take to deliver brilliant home-based palliative care? Using positiveorganisational scholarship and video reflexive ethnography to explore the complexities of palliative care at home. Palliat Med 2018:269216318807835. doi: 10.1177/0269216318807835.
Presents credible arguments that good practice is reinforced and encouraged through making everyday interactions visible. Explains and demonstrates the research methodology of Positive Organisational Scholarship in Healthcare (POSH, study of that which is positive, flourishing and life-giving in organisations) and video-reflexive ethnography (VRE) to support generalisability of these methods for research.
Presents credible arguments that good practice is reinforced and encouraged through making everyday interactions visible.
Explains and demonstrates the research methodology of Positive Organisational Scholarship in Healthcare (POSH, study of that which is positive, flourishing and life-giving in organisations) and video-reflexive ethnography (VRE) to support generalisability of these methods for research.
Despite the increasing number of people worldwide requiring palliative care at home, there is limited evidence on how such care is best practised. Care can improve symptom management, quality of life and prevent hospitalisation at the end of life. There is significant variation in how it is delivered....
To estimate the effect of deprivation on the demand for calls to National Health Service Direct Wales (NHSDW) controlling for confounding factors.
Study of routine data on over 400 000 calls to NHSDW using multiple regression to analyse the logarithms of ward-specific call rates across Wales by characteristics of call, patient and ward, notably the Welsh Index of Multiple Deprivation.
810 electoral wards with average population of 3300, defined by 1998 administrative boundaries.
All calls to NHSDW between January 2002 and June 2004.
We used ward populations as denominators to calculate the rates of three categories of calls: calls seeking advice, calls seeking information and all calls combined.
Confounding variables explained 31% of variation in advice call rates, but only 14% of variation in information call rates and in all call rates (all significant at 0.1% level). However, deprivation was only a statistically significant predictor of information call rates. The proportion of the ward population categorised as ‘white’ was a highly significant predictor of all three call rates. For advice calls and combined calls, rates decreased highly significantly with the proportion of those who called the service for themselves. Information call rates were higher on weekdays and highest on Mondays, while advice call rates were highest on Sundays.
Deprivation had no consistent effect on demand for the service and the relationship needs further exploration. While our data may have underestimated the ‘need’ of deprived patients, they yield no evidence that policy-makers should seek to improve demand from those patients. However, we found differences in the way callers use advice and information calls. Previously unexplored variables that help to predict ward-specific call rates include: ethnicity, day of the week and whether patients made the calls themselves.