Recent evidence suggests that ethnic minority groups are disproportionately at increased risk of hospitalisation and death from SARS-CoV-2 infection. Population-based evidence on potential explanatory factors across minority groups and within subgroups is lacking. This study aims to quantify the association between ethnicity and the risk of hospitalisation and mortality due to COVID-19.
This is a retrospective cohort study of adults registered across a representative and anonymised national primary care database (QResearch) that includes data on 10 million people in England. Sociodemographic, deprivation, clinical and domicile characteristics will be summarised and compared across ethnic subgroups (categorised as per 2011 census). Cox models will be used to calculate HR for hospitalisation and COVID-19 mortality associated with ethnic group. Potential confounding and explanatory factors (such as demographic, socioeconomic and clinical) will be adjusted for within regression models. The percentage contribution of distinct risk factor classes to the excess risks seen in ethnic groups/subgroups will be calculated.
The study has undergone ethics review in accordance with the QResearch agreement (reference OX102). Findings will be disseminated through peer-reviewed manuscripts, presentations at scientific meetings and conferences with national and international stakeholders.
COVID‐19 has infected millions of patients and impacted healthcare workers worldwide. Personal Protective Equipment (PPE) is a key component of protecting frontline clinicians against infection. The benefits of PPE far outweigh the risks, nonetheless, many clinicians are exhibiting skin injury caused by PPE worn incorrectly. These skin injuries, ranging from lesions to open wounds are concerning because they increase the susceptibility of viral infection and transmission to other individuals. Early into the COVID‐19 pandemic (April 2020), the U.S. National Pressure Injury Advisory Panel (NPIAP) developed a series of position statements to improve wear‐ability of PPE and protect healthcare professionals and their patients as safe from harm as possible under the circumstances. The NPIAP positions, which were formed by conducting a systematic review of what was known at the time, include: (1) Prepare skin before and after wearing PPE with skin sealants, barrier creams and moisturizers; (2) Frequent PPE offloading to relieve pressure and shear applied to skin; (3) treat visible skin injuries immediately caused by PPE to minimize future infection; (4) non‐porous dressings may provide additional skin protection, but lack evidence; (5) health systems should take care to educate clinicians about placement and personal hygiene related to handling PPE. Throughout all of these practices, handwashing remains a top priority to handle PPE. These NPIAP positions provided early guidance to reduce the risk of skin injury caused by PPE based on available research regarding PPE injuries, a cautious application of evidence‐based recommendations on prevention of device related pressure injuries in patients and the expert opinion of the NPIAP Board of Directors. Clinicians who adhere to these recommendations reduce the prospects of skin damage and long‐term effects (e.g. scarring). These simple steps to minimize the risk of skin injury and reduce the risk of coronavirus infection from PPE can help.
The majority of female street-based sex workers (SSWs) are dependent on illicit drugs and sell sex to fund their drug use. They typically face multiple traumatic experiences, starting at a young age, which continue through sex work involvement. Their trauma-related symptoms tend to increase when drug use is reduced, hindering sustained reduction. Providing specialist trauma care to address post-traumatic stress disorder (PTSD) alongside drug treatment may therefore improve treatment outcomes. Aims to (1) evaluate recruitment and retention of participants; (2) examine intervention experiences and acceptability; and (3) explore intervention costs using a mixed methods feasibility study.
Female SSW charity premises in a large UK inner city.
Females aged 18 years or older, who have sold sex on the street and used heroin and/or crack cocaine at least once a week in the last calendar month.
Female SSW-only drug treatment groups in a female SSW-only setting delivered by female staff. Targeted PTSD screening then treatment of positive diagnoses with eye movement desensitisation and reprocessing (EMDR) therapy by female staff from a specialist National Health Service trauma service.
(1) Of 125 contacts, 11 met inclusion criteria and provided informed consent, 4 reached the intervention final stage, (2) service providers said working in collaboration with other services was valuable, the intervention was worthwhile and had a positive influence on participants. Participants viewed recruitment as acceptable and experienced the intervention positively. The unsettled nature of participant’s lives was a key attendance barrier. (3) The total cost of the intervention was £11 710, with staff costs dominating.
Recruitment and retention rates reflected study inclusion criteria targeting women with the most complex needs. Two participants received EMDR demonstrating that the three agencies working together was feasible. Staff heavy costs highlight the importance of supporting participant attendance to minimise per participant costs in a future trial.
Lower urinary tract reconstruction in paediatric urology represents a physiologically stressful event that is associated with high complication rates, including readmissions and emergency room visits. Enhanced recovery after surgery (ERAS) protocol is a set of multidisciplinary, perioperative strategies designed to expedite surgical recovery without adversely impacting readmission or reoperation rates. Early paediatric urology data demonstrated ERAS reduced complications in this population.
In 2016, a working group of paediatric urologists and anaesthesiologists convened to develop an ERAS protocol suitable for patients undergoing lower urinary tract reconstruction and define study process measures, patient-reported outcomes and clinically relevant outcomes in paediatric and adolescent/young adult patients. A multicentre, prospective, propensity-matched, case–control study design was chosen. Each centre will enrol five pilot patients to verify implementation. Subsequent enrolled patients will be propensity matched to historical controls. Eligible patients must be aged 4–25 years and undergoing planned operations (bladder augmentation, continent ileovesicostomy or appendicovesicostomy, or urinary diversion). 64 ERAS patients and 128 controls will be needed to detect a decrease in mean length of stay by 2 days. Pilot phase outcomes include attainment of ≥70% mean protocol adherence per patient and reasons for protocol deviations. Exploratory phase primary outcome is ERAS protocol adherence, with secondary outcomes including length of stay, readmissions, reoperations, emergency room visits, 90-day complications, pain scores, opioid usage and differences in Quality of Recovery 9 scores.
This study has been registered with authors’ respective institution review boards and will be published in peer-reviewed journals. It will provide robust insight into the feasibility of ERAS in paediatric urology, determine patient outcomes and allow for iteration of ERAS implementations as new best practices and evidence for paediatric surgical care arise. We anticipate this study will take 4 years to fully accrue with completed follow-up.
Vasodilatory hypotension is common among intensive care unit (ICU) patients; vasopressors are considered standard of care. However, optimal mean arterial pressure (MAP) targets for vasopressor titration are unknown. The objective of the Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65) trial is to ascertain the effect of permissive hypotension (vasopressor titration to achieve MAP 60–65 mm Hg) versus usual care on biomarkers of organ injury in hypotensive patients aged ≥65 years.
OVATION-65 is an allocation-concealed randomised trial in 7 Canadian hospitals. Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12 hours to maintain MAP ≥65 mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours. Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise. Patients are randomised to permissive hypotension versus usual care for up to 28 days. The primary outcome is high-sensitivity troponin T, a biomarker of cardiac injury, on day 3. Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months). Assessors of biomarkers, mortality and cognitive function are blinded to allocation.
This protocol has been approved at all sites. Consent is obtained from the eligible patient, the substitute decision-maker if the patient is incapable, or in a deferred fashion where permitted. End-of-grant dissemination plans include presentations, publications and social media platforms and discussion forums.
The Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on ‘healthful’ improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study.
The overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing ‘healthful’ behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.
The MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences.
Most cardiovascular disease (CVD)-related events could be prevented or substantially delayed with improved diet and lifestyle. Providing information on structural vascular disease may improve CVD risk factor management, but its impact on lifestyle change remains unclear. This study aims to determine whether providing visualisation and pictorial representation of structural vascular disease (abdominal aortic calcification (AAC)) can result in healthful diet and lifestyle change.
This study, including men and women aged 60–80 years, is a 12-week, two-arm, multisite randomised controlled trial. At baseline, all participants will have AAC assessed from a lateral spine image captured using a bone densitometer. Participants will then be randomised to receive their AAC results at baseline (intervention group) or a usual care control group that will receive their results at 12 weeks. All participants will receive information about routinely assessed CVD risk factors and standardised (video) diet and lifestyle advice with three simple goals: (1) increase fruit and vegetable (FV) intake by at least one serve per day, (2) improve other aspects of the diet and (3) reduce sitting time and increase physical activity. Clinical assessments will be performed at baseline and 12 weeks.
The primary outcome is a change in serum carotenoid concentrations as an objective measure of FV intake. The study design, procedures and treatment of data will adhere to Standard Protocol Items for Randomized Trials guidelines.
Ethics approval for this study has been granted by the Edith Cowan University and the Deakin University Human Research Ethics Committees (Project Numbers: 20513 HODGSON and 2019-220, respectively). Results of this study will be published in peer-reviewed academic journals and presented in scientific meetings and conferences. Information regarding consent, confidentiality, access to data, ancillary and post-trial care and dissemination policy has been disclosed in the participant information form.
Australian New Zealand Clinical Trial Registry (ACTRN12618001087246).
Driving is one of the main modes of transport with safe driving requiring a combination of visual, cognitive and physical skills. With population ageing, the number of people living with vision impairment is set to increase in the decades ahead. Vision impairment may negatively impact an individual’s ability to safely drive. The association between vision impairment and motor vehicle crash involvement or driving participation has yet to be systematically investigated. Further, the evidence for the effectiveness of vision-related interventions aimed at decreasing crashes and driving errors has not been synthesised.
A search will be conducted for relevant studies on Medline (Ovid), EMBASE and Global Health from their inception to March 2020 without date or geographical restrictions. Two investigators will independently screen abstracts and full texts using Covidence software with conflicts resolved by a third investigator. Data extraction will be conducted on all included studies, and their quality assessed to determine the risk of bias using the Joanna Briggs Institute Critical Appraisal Tools. Outcome measures include crash risk, driving cessation and surrogate measures of driving safety (eg, driving errors and performance). The results of this review will be reported using the Preferred Reporting Items for Systematic Review and Meta-Analysis guideline. Meta-analysis will be undertaken for outcomes with sufficient data and reported following the Meta-analyses of Observational Studies in Epidemiology guideline. Where statistical pooling is not feasible or appropriate, narrative summaries will be presented following the Synthesis Without Meta-analysis in systematic reviews guideline.
This review will only report on published data thus no ethics approval is required. Results will be included in the Lancet Global Health Commission on Global Eye Health, published in a peer-reviewed journal and presented at relevant conferences.
This paper presents findings from a hermeneutical study which sought to explore how registered nurses experienced and perceived their professional accountability in clinical settings.
Professional accountability encompasses the ideals and standards of nursing practice. Nurses are accountable for their actions under civil, criminal and contract law to their; employing organisation, their regulatory body and the patients for whom they care.
This paper reports on a Heideggerian hermeneutical study involving seven registered nurses, working in clinical practice in the National Health Service in the United Kingdom.
The study adopted purposive sampling, collecting data by means of in‐depth interviews. Data were analysed using the hermeneutic circle. COREQ checklist was used as a reporting guideline for this study.
The findings suggest that professional accountability in nursing practice is a complex phenomenon, which can be compromised by many factors which are historically, socially or politically driven
Participants experienced challenges through a lack of resources and poor managerial support, which compromised their ability to deliver high‐quality patient care. However, collegiality strongly impacted upon resilience and positively influenced their well‐being.
Amid the challenges of the clinical workplace, a positive workplace culture with visible managerial support is a fundamental requirement in supporting professional accountability, development and retention of nurses. Findings highlight the view that leadership should be seen as a collective responsibility, which empowers staff to positively change the practice environment.
Commentary on: Khan JS, Hah JM, Mackey SC. Effects of smoking on patients with chronic pain: a propensity-weighted analysis on the Collaborative Health Outcomes Information Registry. Pain 2019;160:2374–9.
Active smokers should be educated about the complex bidirectional relationship between smoking and pain. Studies are required to identify targeted interventions to encourage smoking cessation and improve outcomes for smokers with persistent pain.
Active smokers should be educated about the complex bidirectional relationship between smoking and pain.
Studies are required to identify targeted interventions to encourage smoking cessation and improve outcomes for smokers with persistent pain.
The association between cigarette smoking and lung cancer was described in epidemiological studies in 1950. Smoking remains a public health issue with a strong association between demographic and socioeconomic factors. Chronic pain is also related to working, socioeconomic and educational status.
In order to avoid unnecessary hospital admission and associated complications, there is an urgent need to improve the early detection of infection in nursing home residents. Monitoring signs and symptoms with checklists or aids called decision support tools may help nursing home staff to detect infection in residents, particularly during the current COVID-19 pandemic.
We plan to conduct a survey exploring views and experiences of how infections are detected and managed in practice by nurses, care workers and managers in nursing homes in England and Sweden.
An international cross-sectional descriptive survey, using a pretested questionnaire, will be used to explore nurses, care workers and managers views and experiences of how infections are detected and managed in practice in nursing homes. Data will be analysed descriptively and univariate associations between personal and organisational factors explored. This will help identify important factors related to awareness, knowledge, attitudes, belief and skills likely to affect future implementation of a decision support tool for the early detection of infection in nursing home residents.
This study was approved using the self-certification process at the University of Surrey and Linköping University ethics committee (Approval 2018/514-32) in 2018. Study findings will be disseminated through community/stakeholder/service user engagement events in each country, publication in academic peer-reviewed journals and conference presentations. A LAY summary will be provided to participants who indicate they would like to receive this information.
This is the first stage of a plan of work to revise and evaluate the Early Detection of Infection Scale (EDIS) tool and its effect on managing infections and reducing unplanned hospital admissions in nursing home residents. Implementation of the EDIS tool may have important implications for the healthcare economy; this will be explored in cost–benefit analyses as the work progresses.
To measure the use of healthcare services and assistive devices by centenarians in five countries.
Cross-sectional study using a survey questionnaire.
Community-dwelling and institutionalised centenarians living in Japan, France, Switzerland, Sweden and Denmark.
1253 participants aged 100 or in their 100th year of life, of whom 1004 (80.1%) were female and 596 (47.6%) lived in institutions.
Recent use of medical visits, nursing care at home, home-delivered meals, acute care hospital stays overnight, professional assessments such as sight tests, mobility aids and other assistive devices. A set of national healthcare system indicators was collected to help interpret differences between countries.
There was considerable variability in the healthcare services and assistive devices used by centenarians depending on their country and whether they were community-dwelling or institutionalised. In contrast to the relatively homogeneous rates of hospitalisation in the past year (around 20%), community-dwelling centenarians reported widely ranging rates of medical visits in the past 3 months (at least one visit, from 32.2% in Japan to 86.6% in France). The proportion of community-dwellers using a mobility device to get around indoors (either a walking aid or a wheelchair) ranged from 48.3% in Japan to 79.2% in Sweden. Participants living in institutions and reporting the use of a mobility device ranged from 78.6% in Japan to 98.2% in Denmark.
Our findings suggest major differences in care received by centenarians across countries. Some may result from the characteristics of national healthcare systems, especially types of healthcare insurance coverage and the amounts of specific resources available. However, unexplored factors also seem to be at stake and may be partly related to personal health and cultural differences.
There has been increased interest in screening for atrial fibrillation (AF) with commissioned pilot schemes, ongoing large clinical trials and the emergence of inexpensive consumer single-lead ECG devices that can be used to detect AF. This qualitative study aimed to explore patients’ views and understanding of AF and AF screening to determine acceptability and inform future recommendations.
A single primary care practice in Hampshire, UK.
15 participants (11 female) were interviewed from primary care who had taken part in an AF screening trial. A semistructured interview guide was used flexibly to enable the interviewer to explore any relevant topics raised by the participants. Interviews were recorded, transcribed verbatim and analysed using inductive thematic analysis.
Participants generally had an incomplete understanding of AF and conflated it with other heart problems or with raised blood pressure. With regards to potential drawbacks from screening, some participants considered anxiety and the cost of implementation, but none acknowledged potential harms associated with screening such as side effects of anticoagulation treatment or the risk of further investigations. The screening was generally well accepted, and participants were generally in favour of engaging with prolonged screening.
Our study highlights that there may be poor understanding (of both the nature of AF and potential negatives of screening) among patients who have been screened for AF. Further work is required to determine if resources including decision aids can address this important knowledge gap and improve clinical informed consent for AF screening.
The objective for this work was to assess clinical experts’ and patients’ opinions on the benefits and risks of sharing patients’ diagnostic radiological images with them.
This study was conducted outside of the primary and secondary care settings. Clinical experts were recruited at a UK national imaging and oncology conference, and patients were recruited via social media.
121 clinical experts and 282 patients completed the study. A further 73 patient and 10 clinical expert responses were discounted due to item non-response. Individuals were required to be a minimum of 18 years of age at the time of participation.
This study was exploratory in nature. As such, the outcomes to be measured for demonstration of the successful completion of this study were generated organically through the process of the investigation itself. These were: (1) the delineation of the benefits available from, and the risks posed by, widening access to diagnostic radiological images; (2) establishment of the level and nature of demand for access to diagnostic radiological images; and (3) the identification of stakeholder requirements for accessing available benefit from diagnostic radiological images.
403 usable questionnaires were returned consisting of responses from clinical experts (n=121) and patients (n=282). Both groups acknowledge the potential benefits of this practice. Examples included facilitating communication, promoting patient engagement and supporting patients in accepting health information shared with them. However, both groups also recognised risks associated with image sharing, such as the potential for patients to be upset or confused by their images.
There is a demand from patients for access to their diagnostic radiological images alongside acknowledgement from clinical experts that there may be benefits available from this. However, due to the acknowledged risks, there is also a need to carefully manage this interaction.
Commentary on: Derry S, Bell RF, Straube S, et al. Pregabalin for neuropathic pain in adults. Cochrane Database Syst Rev 2019:CD007076. doi: 10.1002/14651858.CD007076.pub3.
There is moderate quality evidence that pregabalin is more effective than placebo for postherpetic neuralgia, painful diabetic neuropathy and post-traumatic neuropathic pain. There is no evidence to support its use in HIV neuropathy nor central neuropathic pain. Future studies require greater sample sizes and clearer methodology. There is a need to identify patients who would benefit from pregabalin therapy.
There is moderate quality evidence that pregabalin is more effective than placebo for postherpetic neuralgia, painful diabetic neuropathy and post-traumatic neuropathic pain.
There is no evidence to support its use in HIV neuropathy nor central neuropathic pain.
Future studies require greater sample sizes and clearer methodology.
There is a need to identify patients who would benefit from pregabalin therapy.
Pregabalin is licensed to treat neuropathic pain which is defined as pain caused by a lesion or disease of the somatosensory nervous system.
Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. There is a need for adjuvant, targeted therapies to improve outcomes. Broccoli sprout extract, rich in the antioxidant sulforaphane, reduces oxidative stress and placental secretion of the antiangiogenic factors that contribute to vascular dysfunction in preeclampsia. We propose a phase III trial investigating broccoli sprout extract. We will assess broccoli sprout extract in women with early onset (
A double-blind, placebo-controlled randomised trial will be conducted at Monash Health, Melbourne, Australia. One hundred and eighty women (45 each arm of each stratum) with early onset preeclampsia (defined as per Society for Obstetric Medicine of Australia and New Zealand guidelines) will be recruited. Consenting women will be randomised to receive an oral dose of either broccoli sprout extract (24 mg of activated sulforaphane) or identical placebo, twice daily until delivery. Maternal blood will be collected antenatally for measurement of biomarkers of preeclampsia, including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF), soluble endoglin (sEng) and activin A, as well as circulating sulforaphane metabolites. Maternal and perinatal outcomes will be monitored throughout. All clinical care decisions, including the timing of delivery, will be made by the treating team, blinded to treatment allocation. Participation in this trial will not affect routine care. At delivery, maternal and cord blood and placentae will be collected to measure sulforaphane metabolites and sFlt-1, PlGF, sEng and activin A.
Approval to conduct the trial has been granted by Monash Health Human Research and Ethics Committee (RES-18-0000-109A). Deidentified data will be published in peer-reviewed journals and presented at learnt society conferences, both nationally and internationally. This study has not yet commenced and is pre-results.
Trial registration number
To explore doctors’ knowledge, willingness, concerns and the countermeasures to the most stringent antimicrobial stewardship regulations of China which implemented in August 2012.
Cross-sectional survey. A pretested 32-point structured questionnaire was distributed to doctors by sending a web link via the mobile phone application WeChat through snowball sampling methods and email groups of medical academic societies.
The questionnaire inquired about the doctors’ experiences, knowledge, willingness, concerns and the countermeasures to the stewardship policies.
Total of persons in the groups was 19 791, among them 1194 submitted the answers, within them, 807 were doctors. Doctors had a mean age of 39.0 years. The majority (78.9% in 2012, 89.1% in 2016) reported that they were willing or very willing to accept the regulations. Almost all respondents (93.2%) felt the stewardship regulations had the potential to adversely affect the prognosis of patients who would have been prescribed antimicrobials before they were implemented, and >65% (65.7% in 2012, 66.9% in 2016) of doctors were often or always concerned about the prognosis of these patients. In 2012, 32% of doctors prescribed restricted antimicrobials or suggested patient self-medication with restricted antimicrobials to address doctors’ concerns, and this number decreased to 22.6% in 2016. Although compulsory antimicrobial stewardship training was frequent, less than half of respondents (46.8%) responded correctly to all three knowledge questions.
Antimicrobial stewardship regulations had some positive effect on rational antimicrobial use. Willingness and practice of doctors towards the regulations improved from 2012 to 2016. Knowledge about rational antimicrobial use was still lacking. Doctors found ways of accessing restricted antibiotics to address their concerns about the prognosis of patients, which undermined the implementation of the stewardship regulations.
This paper explores what aspects of a multicomponent intervention were deemed strengths and weaknesses by teenagers and the local council when promoting physical activity to young people.
Qualitative findings at 12 months from a mixed method randomised control trial.
Active Children Through Incentive Vouchers—Evaluation (ACTIVE) gave teenagers £20 of activity enabling vouchers every month for a year. Peer mentors were also trained and a support worker worked with teenagers to improve knowledge of what was available. Semistructured focus groups took place at 12 months to assess strengths and weaknesses of the intervention. Eight focus groups (n=64 participants) took place with teenagers and one additional focus group was dedicated to the local council’s sport development team (n=8 participants). Thematic analysis was used to analyse the data.
Teenagers used the vouchers on three main activities: trampolining, laser tag or the water park. These appeal to both genders, are social, fun and require no prior skill or training. Choice and financial support for teenagers in deprived areas was considered a strength by teenagers and the local council. Teenagers did not engage with a trained peer mentor but the support worker was considered helpful.
The ACTIVE Project’s delivery had both strengths and weakness that could be used to underpin future physical activity promotion. Future interventions should focus on improving access to low cost, fun, unstructured and social activities rather than structured organised exercise/sport. The lessons learnt from this project can help bridge the gap between what is promoted to teenagers and what they actually want from activity provision.