In low-income and middle-income countries, pneumonia remains the leading cause of illness and death in children
Approximately 10 000 paediatric chest X-ray images are currently being collected from an ongoing WHO-supported surveillance study in Bangladesh. Each image will be read by two trained clinicians/radiologists for the presence or absence of primary endpoint pneumonia (PEP) in each lung, as defined by the WHO. Images whose PEP labels are discordant in either lung will be reviewed by a third specialist and the final assignment will be made using a majority vote. Convolutional neural networks will be used for lung segmentation to align and scale the images to a reference, and for interpretation of the images for the presence of PEP. The model will be evaluated against an independently collected and labelled set of images from the WHO. The study outcome will be an automated method for the interpretation of chest radiographs for diagnosing paediatric pneumonia.
All study protocols were approved by the Ethical Review Committees of the Bangladesh Institute of Child Health, Bangladesh. The study sponsor deemed it unnecessary to attain ethical approval from the Academic and Clinical Central Office for Research and Development of University of Edinburgh, UK. The study uses existing X-ray images from an ongoing WHO-coordinated surveillance. All findings will be published in an open-access journal. All X-ray labels and statistical code will be made openly available. The model and images will be made available on request.
This double-blind, randomised controlled trial (RCT) aims to estimate the effect of a physiotherapist-led intervention with targeted strengthening compared with a physiotherapist-led intervention with standardised stretching, on hip-related quality of life (QOL) or perceived improvement at 6 months in people with femoroacetabular impingement (FAI) syndrome. We hypothesise that at 6 months, targeted strengthening physiotherapist-led treatment will be associated with greater improvements in hip-related QOL or greater patient-perceived global improvement when compared with standardised stretching physiotherapist-led treatment.
We will recruit 164 participants with FAI syndrome who will be randomised into one of the two intervention groups, both receiving one-on-one treatment with the physiotherapist over 6 months. The targeted strengthening physiotherapist-led treatment group will receive a personalised exercise therapy and education programme. The standardised stretching physiotherapist-led treatment group will receive standardised stretching and personalised education programme. Primary outcomes are change in hip-related QOL using International Hip Outcome Tool-33 and patient-perceived global improvement. Secondary outcomes include cost-effectiveness, muscle strength, range of motion, functional task performance, biomechanics, hip cartilage structure and physical activity levels. Statistical analyses will make comparisons between both treatment groups by intention to treat, with all randomised participants included in analyses, regardless of protocol adherence. Linear mixed models (with baseline value as a covariate and treatment condition as a fixed factor) will be used to evaluate the treatment effect and 95% CI at primary end-point (6 months).
The study protocol was approved (La Trobe University Human Ethics Committee (HEC17-080)) and prospectively registered with the Australian New Zealand Clinical Trials Registry. The findings of this RCT will be disseminated through peer reviewed scientific journals and conferences. Patients were involved in study development and will receive a short summary following the completion of the RCT.
A cohort of 12 000 children in the Philippines who had enrolled in a 2000–2004 (current ages 16 to 20 years) Phase 3 11-valent pneumococcal conjugate vaccine for the prevention of radiographically confirmed pneumonia are now being asked to participate in a separate study (expected completion date September 2021) to assess the cohort’s current long-term audiometric and otologic status. This new study would allow assessments of the utility of the pneumococcal vaccine in conferring its protective effects on the long-term sequelae of otitis media (OM), if any. Lack of trained local healthcare providers in otolaryngology/audiology and testing equipment in Bohol, Philippines, necessitates the development of a distinct methodology that would lead to meaningful data analysis.
Reliable data collection and transfer are achieved by a US otolaryngologist/audiologist team training local nurses on all procedures in a didactic and hands-on process. An assortment of portable otolaryngologic and audiologic equipment suitable for field testing has been acquired, including an operating otoscope (Welch-Allyn), a video-otoscope (JedMed), a tympanometer with distortion product otoacoustic emission measurements (Path Sentiero) and a screening audiometer (HearScreen). Data will then be uploaded to a Research Electronic Data Capture database in the USA.
Tympanometric and audiologic data will be codified through separate conventional algorithms. A team of paediatric otolaryngology advanced practice providers (APPs) have been trained and validated in interpreting video otoscopy. The protocol for classification of diagnostic outcome variables based on video otoscopy and tympanometry has been developed and is being used by APPs to evaluate all otoscopy data.
The study was approved by the Research Institute of Tropical Medicine, Alabang, Manila, Philippines, and the institutional review board and the Colorado Multiple Institutional Review Board of the University of Colorado School of Medicine, Aurora, Colorado, USA.
Research results will be made available to children and their caregivers with abnormal audiologic outcomes, the funders and other researchers.
ISRCTN 62323832; Post-results.
In patients with septic shock, low levels of circulating immunoglobulins are common and their kinetics appear to be related to clinical outcome. The pivotal role of immunoglobulins in the host immune response to infection suggests that additional therapy with polyclonal intravenous immunoglobulins may be a promising option in patients with septic shock. Immunoglobulin preparations enriched with the IgM component have largely been used in sepsis, mostly at standard dosages (250 mg/kg per day), regardless of clinical severity and without any dose adjustment based on immunoglobulin serum titres or other biomarkers. We hypothesised that a personalised dose of IgM enriched preparation based on patient IgM titres and aimed to achieve a specific threshold of IgM titre is more effective in decreasing mortality than a standard dose.
The study is designed as a multicentre, interventional, randomised, single-blinded, prospective, investigator sponsored, two-armed study. Patients with septic shock and IgM titres
The study protocol was approved by the ethics committees of the coordinating centre (Comitato Etico dell’Area Vasta Emilia Nord) and collaborating centres. The results of the trial will be published within 12 months from the end of the study and the steering committee has the right to present them at public symposia and conferences.
The trial protocol and information documents have received a favourable opinion from the Area Vasta Emilia Nord Ethical Committee on 12 September 2019. The trial protocol has been registered on EudraCT (2018-001613-33) on 18 April 2018 and on ClinicalTrials.gov (NCT04182737) on 2 December 2019.
Children, pregnant women and the elderly at a global level are all being dangerously exposed to tobacco use in the household (HH). However, there is no understanding of the familial and socio-cultural factors that provide barriers to ensuring tobacco-free homes in Bangladesh either in urban or rural areas (U&RAs). This study therefore investigates those barriers to help enable a move towards tobacco-free homes in Bangladesh.
Comparative cross-sectional study.
Data were collected from both urban and rural settings in Bangladesh.
A probability proportional sampling procedure was used to select 808 participants in U&RAs out of a total of 3715 tobacco users. Semi-structured interviews through the use of a questionnaire were conducted with the participants followed by a multivariate logistic regression analysis of the data in order to explore the familial and socio-cultural factors associated with tobacco use at home.
The prevalence of tobacco use at home was 25.7% in urban areas and 47.6% in rural areas. In urban areas: marital status (adjusted OR (AOR)=3.23, 95% CI 1.37 to 6.61), education (AOR=2.14, 95% CI 1.15 to 3.99), the smoking habits of elderly family members (AOR=1.81, 95% CI 0.91 to 2.89), offering tobacco as a traditional form of leisure activity at home (AOR=1.85, 95% CI 0.94 to 2.95) and lack of religious practices (AOR=2.39, 95% CI 1.27 to 4.54) were identified as significant socio-cultural predictors associated with tobacco use at home. In rural areas: age (AOR=5.11, 95% CI 2.03 to 12.83), extended family (AOR=3.08, 95% CI 1.28 to 7.38), lack of religious practices (AOR=4.23, 95% CI 2.32 to 7.72), using children to buy or carry tobacco (AOR=3.33, 95% CI 1.11 to 9.99), lack of family guidance (AOR=4.27, 95% CI 2.45 to 7.42) and offering tobacco as a traditional form of leisure activity at home (AOR=3.81, 95% CI 2.23 to 6.47) were identified as significant determinants for tobacco use at home.
This study concludes that socio-cultural traditions and familial norms in Bangladesh provide significant barriers for enabling tobacco-free homes. The identification of these barriers can aid policymakers and programme planners in Bangladesh in devising appropriate measures to mitigate the deadly consequences of tobacco use in the home. The consequences also include the dangers involved in family members being exposed to secondhand smoke.
We conducted a cross-sectional survey to assess the extent and to identify the determinants of food insecurity and coping strategies in urban and rural households of Bangladesh during the month-long, COVID-19 lockdown period.
Selected urban and rural areas of Bangladesh.
106 urban and 106 rural households.
Household food insecurity status and the types of coping strategies were the outcome variables for the analyses. Multinomial logistic regression analyses were done to identify the determinants.
We found that around 90% of the households were suffering from different grades of food insecurity. Severe food insecurity was higher in urban (42%) than rural (15%) households. The rural households with mild/moderate food insecurity adopted either financial (27%) or both financial and food compromised (32%) coping strategies, but 61% of urban mild/moderate food insecure households applied both forms of coping strategies. Similarly, nearly 90% of severely food insecure households implemented both types of coping strategies. Living in poorest households was significantly associated (p value
Both urban and rural households suffered from moderate to severe food insecurity during the month-long lockdown period in Bangladesh. But, poorest, poorer and even the richer households adopted different coping strategies that might result in long-term economic and nutritional consequences.
Social distancing and lockdown measures are among the main government responses to the COVID-19 pandemic. These measures aim to limit the COVID-19 infection rate and reduce the mortality rate of COVID-19. Given we are likely to see local lockdowns until a treatment or vaccine for COVID-19 is available, and their effectiveness depends on public acceptability, it is important to understand public preference for government responses.
Using a discrete choice experiment (DCE), this study will investigate the public’s preferences for pandemic responses in the UK. Attributes (and levels) are based on: (1) lockdown measures described in policy documents; (2) literature on preferences for lockdown measures and (3) a social media analysis. Attributes include: lockdown type; lockdown length; postponement of usual non-urgent medical care; number of excess deaths; number of infections; impact on household spending and job losses. We will prepilot the DCE using virtual think aloud interviews with respondents recruited via Facebook. We will collect preference data using an online survey of 4000 individuals from across the four UK countries (1000 per country). We will estimate the relative importance of the attributes, and the trade-offs individuals are willing to make between attributes. We will test if respondents’ preferences differ based on moral attitudes (using the Moral Foundation Questionnaire), socioeconomic circumstances (age, education, economic insecurity, health status), country of residence and experience of COVID-19.
The University of Aberdeen’s College Ethics Research Board (CERB) has approved the study (reference: CERB/2020/6/1974). We will seek CERB approval for major changes from the developmental and pilot work. Peer-reviewed papers will be submitted, and results will be presented at public health and health economic conferences nationally and internationally. A lay summary will be published on the Health Economics Research Unit blog.
Pancreatic ductal adenocarcinoma (PDAC) has a dismal prognosis with an overall 5-year survival of approximately 8%. The success in reducing the mortality rate of PDAC is related to the discovery of new therapeutic agents, and to a significant extent to the development of early detection and prevention programmes. Patients with new-onset diabetes mellitus (DM) represent a high-risk group for PDAC as they have an eightfold higher risk of PDAC than the general population. The proposed screening programme may allow the detection of PDAC in the early, operable stage. Diagnosing more patients in the curable stage might decrease the morbidity and mortality rates of PDAC and additionally reduce the burden of the healthcare.
This is a prospective, multicentre observational cohort study. Patients ≥60 years old diagnosed with new-onset (≤6 months) diabetes will be included. Exclusion criteria are (1) Continuous alcohol abuse; (2) Chronic pancreatitis; (3) Previous pancreas operation/pancreatectomy; (4) Pregnancy; (5) Present malignant disease and (6) Type 1 DM. Follow-up visits are scheduled every 6 months for up to 36 months. Data collection is based on questionnaires. Clinical symptoms, body weight and fasting blood will be collected at each, carbohydrate antigen 19–9 and blood to biobank at every second visit. The blood samples will be processed to plasma and analysed with mass spectrometry (MS)-based metabolomics. The metabolomic data will be used for biomarker validation for early detection of PDAC in the high-risk group patients with new-onset diabetes. Patients with worrisome features will undergo MRI or endoscopic ultrasound investigation, and surgical referral depending on the radiological findings. One of the secondary end points is the incidence of PDAC in patients with newly diagnosed DM.
The study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (41085-6/2019). We plan to disseminate the results to several members of the healthcare system includining medical doctors, dietitians, nurses, patients and so on. We plan to publish the results in a peer-reviewed high-quality journal for professionals. In addition, we also plan to publish it for lay readers in order to maximalise the dissemination and benefits of this trial.
To explore reasons, thoughts, motives, and influencing factors regarding the use or non‐use of Personal Safety Alerting Devices (PSADs) in the daily lives of community‐dwelling older persons.
A qualitative descriptive study design was used.
Six focus groups were conducted with a total of 32 older persons between February–August 2016. Data analysis followed the Qualitative Analysis Guide of Leuven.
The participants described the use or non‐use of PSADs as a decision resulting from a “legitimation process”. This process implies that a person needs to perceive the necessity for a PSAD and then determine the right moment at which to start using it. During this process, each person weighs her or his “ageing self” and “perception of technology” then decides whether to start using a device or to delay its use. “Critical events” initiate this process, compelling the person to consider their own safety and their possible need for assistance.
The legitimation process suggests that the initiation of PSAD use represents a turning point in life. Using a PSAD is not simply a matter of obtaining one. It is a complex decision‐making process establishing legitimation for its use, which is interwoven with one's individual ageing, self‐perception, and the meaning attributed to the device.
Older persons need to be supported; in particular, they require time to go through the legitimation process for PSAD use. Nurses can empower them in this process, such that they perceive using a PSAD as a means to restore their frailty balance and feel enabled to (re)gain control over their own life and thus to preserve their independence.
To compare the prevalence of work-related potential traumatic events (PTEs), support protocols and mental health symptoms across Dutch gynaecologists, orthopaedic surgeons and paediatricians.
Cross-sectional study, supplementary analysis of combined data.
Nationwide survey between 2014 and 2017.
An online questionnaire was sent to all Dutch gynaecologists, orthopaedic surgeons and paediatricians, including resident physicians (4959 physicians). 1374 questionnaires were eligible for analysis, corresponding with a response rate of 27.7%.
Primary outcome measures were the prevalence of work-related PTEs, depression, anxiety, psychological distress and traumatic stress, measured with validated screening instruments (Hospital Anxiety and Depression Scale, Trauma Screening Questionnaire). Secondary outcomes were the association of mental health and defensive practice to traumatic events and support protocols.
Of the respondents, 20.8% experienced a work-related PTE at least 4 weeks ago. Prevalence rates indicative of depression, anxiety or post-traumatic stress disorder (PTSD) were 6.4%, 13.6% and 1.5%, respectively. Depression (9.2% vs 5.2%, p=0.019), anxiety (18.2% vs 8.2%, p
Physicians are frequently exposed to PTEs with high emotional impact over the course of their career. Lacking a support protocol after adverse events was associated with more post-traumatic stress. Adverse events were associated with considering to quit medical practice and a more defensive practice. More awareness must be created for the mental health of physicians as well as for the implementation of a well-organised support system after PTEs.
The overuse of antibiotics is causing worldwide spread of antimicrobial resistance (AMR). Compared with other countries, Italy has both high antibiotic consumption rates and high rates of AMR. Due to the fact that around 90% of antibiotics are prescribed by general practitioners (GPs), this study aims to measure the impact of knowledge, attitudes and sociodemographic and workplace-related factors on the quality of antibiotic prescriptions filled by GPs in the Italian Region of Sardinia.
Knowledge, attitude, sociodemographic and workplace-related factors deemed to influence physicians prescribing behaviour will be evaluated in a cross-sectional study conducted among all GPs of the Italian Region of Sardinia (n=1200). A knowledge and attitudes questionnaire (Knowledge and Attitudes on Antibiotics and Resistance - Italian version: ITA-KAAR) accompanied by a sociodemographic form will be linked to drug prescription data reimbursed by the National Health System. European Surveillance of Antibiotic Consumption quality indicators for outpatient antibiotic use will be calculated from drug prescription records. Every GP will be deemed to have demonstrated an adequate quality of prescriptions of antibiotics if half of the indicator score plus one is better than the median of the region. A multivariate Poisson regression model with robust variance estimation will be used to evaluate the impact of the determinants of antibiotic prescriptions on the actual prescribing quality of each physician.
The project has been approved by the ethics committee of the Regional Health Trust of Sardinia (176/2019/CE, 24 September 2019). The results will be useful to inform evidence-based interventions to tackle irrational antibiotic use in the community.
The first objective of this study was to describe the age-specific prevalence of chronic diseases and multimorbidity among unemployed and employed persons. The second objective was to examine associations of employment status and sociodemographic characteristics with chronic diseases and multimorbidity.
Data linkage of cross-sectional nationwide registries on employment status, medication use and sociodemographic characteristics in 2016 was applied.
Register-based data covering residents in the Netherlands.
5 074 227 persons aged 18–65 years were selected with information on employment status, medication use and sociodemographic characteristics.
Multiple logistic regression analysis and descriptive statistics were performed to examine associations of employment and sociodemographic characteristics with the prevalence of chronic diseases and multimorbidity. The age-specific prevalence of six common chronic diseases was described, and Venn diagrams were applied for multimorbidity among unemployed and employed persons.
Unemployed persons had a higher prevalence of psychological disorders (18.3% vs 5.4%), cardiovascular diseases (20.1% vs 8.9%), inflammatory diseases (24.5% vs 15.8%) and respiratory diseases (11.7% vs 6.5%) than employed persons. Unemployed persons were more likely to have one (OR 1.30 (1.29–1.31)), two (OR 1.74 (1.73–1.76)) and at least three chronic diseases (OR 2.59 (2.56–2.61)) than employed persons. Among unemployed persons, psychological disorders and inflammatory conditions increased with age but declined from middle age onwards, whereas a slight increase was observed among employed persons. Older persons, women, lower educated persons and migrants were more likely to have chronic diseases.
Large differences exist in the prevalence of chronic diseases and multimorbidity among unemployed and employed persons. The age-specific prevalence follows a different pattern among employed and unemployed persons, with a relatively high prevalence of psychological disorders and inflammatory conditions among middle-aged unemployed persons. Policy measures should focus more on promoting employment among unemployed persons with chronic diseases.
To explore the patient view of competencies essential for doctors to provide good collaboration at the primary–secondary care interface.
We used a qualitative research approach. Focus groups with patients were conducted to explore their opinions of doctors’ competencies to provide good collaboration between primary and secondary care doctors. Transcripts were analysed using thematic analysis.
Dutch primary–secondary care interface.
Sixteen participants took part in five focus groups. Patients treated in both primary and secondary care, defined as having a minimum of two contacts with their general practitioner and two contacts with a medical specialty in the last 6 months, were included. Psychiatric patients and children were excluded from this study.
Three groups of competencies were identified: (1) relationship building, both with patients and with other doctors; (2) transparent collaborating: be able to provide clarity on the process of collaboration and on roles and responsibilities of those involved and (3) reflective practising: to be willing to acknowledge mistakes, give and receive feedback and act as a lifelong learner.
This focus group study enhances our understanding of the patient perspective on doctors’ collaborative competencies at the primary–secondary care interface. With this information, doctors can improve their collaborative skills to a level that would meet their patients’ needs. Patients expect doctors to be able to build relationships and act as reflective practitioners. Including patients in the collaborative process by giving them a role that is appropriate to their abilities and by making collaboration more explicit could help to improve collaboration between general practitioners and medical specialists.
This study aimed to identify significant work stressors associated with stress symptoms, job satisfaction, intention to leave and health‐related outcomes among health professionals.
The workforce shortage of health professionals is a current concern, and a reduction of work‐related stress is thus essential for retaining health professionals. Studies on the extent of work‐related stress in different health professions are limited.
The research was conducted with a cross‐sectional study encompassing 26 randomly selected acute care and rehabilitation hospitals. The sample consisted of 3,398 health professionals. The study was undertaken in accordance with the STROBE checklist for observational studies.
Work–private life conflicts were significantly associated with health professionals' stress symptoms, job satisfaction, intention to leave the organisation and profession, their general health status, burnout symptoms and quality of sleep. Also, opportunities for development and the behaviour of the direct line manager (e.g. quality of leadership, unfair behaviour, rewards given) along with various profession‐specific stressors were the important predictors revealed.
This study shows the high relevance of preventing and reducing work–private life conflicts, enhancing leadership qualities as well as opportunities for development among health professionals working in acute care and rehabilitation hospitals. Also, differences between health professions should be taken into consideration in developing strategies for reducing stress at work.
The results of this study are particularly relevant for health professional leaders and reveal the urgent need in hospital practice for effective strategies to improve health professionals' work–private life balance, opportunities for development and quality of leadership.
by I. M. Wagensveld, A. C. Weustink, J. A. Kors, B. M. Blokker, M. G. M. Hunink, J. W. OosterhuisObjectives
Autopsy rates worldwide have dropped significantly over the last five decades. Imaging based autopsies are increasingly used as alternatives to conventional autopsy (CA). The aim of this study was to investigate the effect of the introduction of minimally invasive autopsy, consisting of CT, MRI and tissue biopsies on the overall autopsy rate (of CA and minimally invasive autopsy) and the autopsy rate among different ethnicities.Methods
We performed a prospective single center before-after study. The intervention was the introduction of minimally invasive autopsy as an alternative to CA. Minimally invasive autopsy consisted of MRI, CT, and CT-guided tissue biopsies. Autopsy rates over time and the effect of introducing minimally invasive autopsy were analyzed with a linear regression model. We performed a subgroup analysis comparing the autopsy rates of two groups: a group of western-European ethnicity versus a group of other ethnicities.Results
Autopsy rates declined from 14.0% in 2010 to 8.3% in 2019. The linear regression model showed a significant effect of both time and availability of minimally invasive autopsy on the overall autopsy rate. The predicted autopsy rate in the model started at 15.1% in 2010 and dropped approximately 0.1% per month (β = -0.001, p Conclusions
The introduction of the minimally invasive autopsy had a small, but significant effect on the overall autopsy rate. Furthermore, the minimally invasive autopsy appears to be more acceptable than CA among people with an ethnicity other than western-European.
Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.
The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0–12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study’s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.
The study protocol was approved by the institutional review board (IRB) at Children’s Hospital of Philadelphia (CHOP) on 3 October 2014 (14–0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.
Poorly differentiated (PD), extrapulmonary (EP), neuroendocrine carcinomas (NECs) are rare but aggressive neuroendocrine neoplasms. First-line treatment for advanced disease is an etoposide and platinum-based chemotherapy combination. There is no established second-line treatment for patients with PD-EP-NEC, and this is an area of unmet need.
NET-02 is a UK, multicentre, randomised (1:1), parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI)/5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive PD-EP-NEC. One hundred and two eligible participants will be randomised to receive either nal-IRI/5-FU/folinic acid or docetaxel. The primary objective is to determine the 6-month progression-free survival (PFS) rate. The secondary objectives of this study are to determine PFS, overall survival, objective response rate, toxicity, quality of life and whether neuron-specific enolase is predictive of treatment response. If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial. If both treatments meet this target, prespecified selection criteria will be applied to establish which treatment to take forward.
This study has ethical approval from the Greater Manchester Central Research Ethics Committee (reference no. 18/NW/0031) and clinical trial authorisation from the Medicine and Healthcare Products Regulatory Agency. Results will be published in peer-reviewed journals and uploaded to the European Union Clinical Trials Register.
Coronary artery bypass grafting (CABG) surgery is known to improve vascular function and cardiac-related mortality rates; however, it is associated with high rates of postoperative cognitive decline and delirium. Previous attempts to prevent post-CABG cognitive decline using pharmacological and surgical approaches have been largely unsuccessful. Cognitive prehabilitation and rehabilitation are a viable yet untested option for CABG patients. We aim to investigate the effects of preoperative cognitive training on delirium incidence, and preoperative and postoperative cognitive training on cognitive decline at 4 months post-CABG.
This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia. Those in the intervention group will complete 1–2 weeks of CCT preoperatively (45–60 min sessions, 3.5 sessions/week) and 12 weeks of CCT postoperatively (commencing 1 month following surgery, 45–60 min sessions, 3 sessions/week). All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1 year. The primary delirium outcome variable will be delirium incidence (presence vs absence); the primary cognitive decline variable will be at 4 months (significant decline vs no significant decline/improvement from baseline). Logistic regression modelling will be used, with age and gender as covariates. Secondary outcomes include cognitive decline from baseline to discharge, and at 6 months and 1 year post-CABG.
Ethics approval was obtained from the Central Adelaide Local Health Network Human Research Ethics Committee (South Australia, Australia) and the University of South Australia Human Ethics Committee, with original approval obtained on 13 December 2017. It is anticipated that approximately two to four publications and multiple conference presentations (national and international) will result from this research.
This clinical trial is registered with the Australian New Zealand Clinical Trials Registry and relates to the pre-results stage. Registration number: ACTRN12618000799257.
To assess cost-effectiveness of enhanced recovery pathways following total hip and knee arthroplasties. Secondary objectives were to report on quality of studies and identify research gaps for future work.
Systematic review of cost–utility analyses.
Ovid MEDLINE, Embase, the National Health Service Economic Evaluations Database and EconLit, January 2000 to August 2019.
English-language peer-reviewed cost–utility analyses of enhanced recovery pathways, or components of one, compared with usual care, in patients having total hip or knee arthroplasties for osteoarthritis.
Data extracted by three reviewers with disagreements resolved by a fourth. Study quality assessed using the Consensus on Health Economic Criteria list, the International Society for Pharmacoeconomics and Outcomes Research and Assessment of the Validation Status of Health-Economic decision models tools; for trial-based studies the Cochrane Collaboration’s tool to assess risk of bias. No quantitative synthesis was undertaken.
We identified 17 studies: five trial-based and 12 model-based studies. Two analyses evaluated entire enhanced recovery pathways and reported them to be cost-effective compared with usual care. Ten pathway components were more effective and cost-saving compared with usual care, three were cost-effective, and two were not cost-effective. We had concerns around risk of bias for all included studies, particularly regarding the short time horizon of the trials and lack of reporting of model validation.
Consistent results supported enhanced recovery pathways as a whole, prophylactic systemic antibiotics, antibiotic-impregnated cement and conventional ventilation for infection prevention. No other interventions were subject of more than one study. We found ample scope for future cost-effectiveness studies, particularly analyses of entire recovery pathways and comparison of incremental changes within pathways. A key limitation is that standard practices have changed over the period covered by the included studies.
To examine the predictive properties of the brief Dutch National Safety Management Program for the screening of frail hospitalised older patients (VMS) and to compare these with the more extensive Maastricht Frailty Screening Tool for Hospitalised Patients (MFST‐HP).
Screening of older patients during admission may help to detect frailty and underlying geriatric conditions. The VMS screening assesses patients on four domains (i.e. functional decline, delirium risk, fall risk and nutrition). The 15‐item MFST‐HP assesses patients on three domains of frailty (physical, social and psychological).
Retrospective cohort study.
Data of 2,573 hospitalised patients (70+) admitted in 2013 were included, and relative risks, sensitivity and specificity and area under the receiver operating characteristic (AUC) curve of the two tools were calculated for discharge destination, readmissions and mortality. The data were derived from the patients nursing files. A STARD checklist was completed.
Different proportions of frail patients were identified by means of both tools: 1,369 (53.2%) based on the VMS and 414 (16.1%) based on the MFST‐HP. The specificity was low for the VMS, and the sensitivity was low for the MFST‐HP. The overall AUC for the VMS varied from 0.50 to 0.76 and from 0.49 to 0.69 for the MFST‐HP.
The predictive properties of the VMS and the more extended MFST‐HP on the screening of frailty among older hospitalised patients are poor to moderate and not very promising.
The VMS labels a high proportion of older patients as potentially frail, while the MFST‐HP labels over 80% as nonfrail. An extended tool did not increase the predictive ability of the VMS. However, information derived from the individual items of the screening tools may help nurses in daily practice to intervene on potential geriatric risks such as delirium risk or fall risk.