Evaluation of Hospital Antimicrobial Stewardship Programs: Implementation, Process, Impact, and Outcomes, Review of Systematic Reviews.

Antimicrobial Stewardship Programs (ASP) were introduced in healthcare as a public health priority to promote appropriate prescribing of antimicrobials, to reduce adverse events related to antimicrobials, as well as to control the escalating challenges of antimicrobial resistance. To deliver aimed outcome objectives, ASPs involve multiple connected implementation process measures. A systematic review was conducted to evaluate both concepts of ASPs. Guided by PRISMA frames, published systematic reviews (SR) focusing on ASPs restricted to secondary and tertiary healthcare were evaluated over the past 10 years involving all age groups. Out of 265 identified SR studies, 63 met the inclusion criteria. The majority were conducted in Europe and North America, with limited studies from other regions. In the reviewed studies, all age groups were examined, although they were conducted mainly on adults when compared to children and infants. Both process and outcomes measures of ASPs were examined equally and simultaneously through 25 different concepts, dominated by efficacy, antimicrobial resistance, and economic impact, while information technology as well as role of pharmacy and behavioral factors were equally examined. The main broad conclusions from the review were that, across the globe, ASPs demonstrated effectiveness, proved efficacy, and confirmed efficiency, while focused evaluation advocated that developed countries should target medium- and small-sized hospitals while developing countries should continue rolling ASPs across healthcare facilities. Additionally, the future of ASPs should focus on embracing evolving information technology to bridge the gaps in knowledge, skills, and attitude, as well as to enhance appropriate decision making.

Contribution of high-technology procedures to public healthcare expenditures: the case of ischemic heart disease in Portugal, 2002-2015.

The magnitude of the impact of technological innovations on healthcare expenditure is unclear. This paper estimated the impact of high-technology procedures on public healthcare expenditure for patients with ischemic heart disease (IHD) in Portugal. The Blinder-Oaxaca decomposition method was applied to Portuguese NHS administrative data for IHD discharges during two periods, 2008-2015 vs. 2002-2007 (N = 434,870). We modelled per episode healthcare expenditures on the introduction of new technologies, adjusting for GDP, patient age, and comorbidities. The per episode healthcare expenditure was significantly higher in 2008-2015 compared to 2002-2007 for IHD discharges. The increase in the use of high-technology procedures contributed to 28.6% of this growth among all IHD patients, and to 18.4%, 6.8%, 11.1%, and 29.2% for acute myocardial infarction, unstable angina, stable angina, and other IHDs, respectively. Changes in the use of stents and embolic protection and/or coronary brachytherapy devices were the largest contributors to expenditure growth. High-technology procedures were confirmed as a key driver of public healthcare expenditure growth in Portugal, contributing to more than a quarter of this growth.

"What Works" to Support LGBTQ+ Young People's Mental Health: An Intersectional Youth Rights Approach.

Despite overwhelming international evidence of elevated rates of poor mental health in LGBTQ+ youth compared to their cis-heterosexual peers, we know relatively little about effective mental health services for this population group. This study aims to produce the first early intervention model of "what works" to support LGBTQ+ youth with emerging mental health problems. Utilizing a mixed method case study, we collected data across 12 UK mental health service case study sites that involved: (a) interviews with young people, parents, and mental health practitioners (n = 93); (b) documentary analysis; (c) nonparticipant observation. The data analysis strategy was theoretical using the "explanation-building" analytical technique. Our analysis suggests an intersectional youth rights approach with 13 principles that must be enacted to provide good mental health services as advocated by the United Nations Convention on the Rights of the Child and World Health Organization. This approach should address the multiple forms of marginalization and stigmatization that LGBTQ+ youth may experience, enable informed independent decision-making, and uphold the right to freedom of safe self-expression. A rights-based approach to mental health services for LGBTQ+ young people is not prominent. This needs to change if we are to tackle this mental health inequality and improve the mental well-being of LGBTQ+ youth worldwide.

A Systematic Review of Methodologies Used in Models of the Treatment of Diabetes Mellitus.

BACKGROUND: Diabetes mellitus is a chronic and complex disease, increasing in prevalence and consequent health expenditure. Cost-effectiveness models with long time horizons are commonly used to perform economic evaluations of diabetes' treatments. As such, prediction accuracy and structural uncertainty are important features in cost-effectiveness models of chronic conditions. OBJECTIVES: The aim of this systematic review is to identify and review published cost-effectiveness models of diabetes treatments developed between 2011 and 2022 regarding their methodological characteristics. Further, it also appraises the quality of the methods used, and discusses opportunities for further methodological research. METHODS: A systematic literature review was conducted in MEDLINE and Embase to identify peer-reviewed papers reporting cost-effectiveness models of diabetes treatments, with time horizons of more than 5 years, published in English between 1 January 2011 and 31 of December 2022. Screening, full-text inclusion, data extraction, quality assessment and data synthesis using narrative synthesis were performed. The Philips checklist was used for quality assessment of the included studies. The study was registered in PROSPERO (CRD42021248999). RESULTS: The literature search identified 30 studies presenting 29 unique cost-effectiveness models of type 1 and/or type 2 diabetes treatments. The review identified 26 type 2 diabetes mellitus (T2DM) models, 3 type 1 DM (T1DM) models and one model for both types of diabetes. Fifteen models were patient-level models, whereas 14 were at cohort level. Parameter uncertainty was assessed thoroughly in most of the models, whereas structural uncertainty was seldom addressed. All the models where validation was conducted performed well. The methodological quality of the models with respect to structure was high, whereas with respect to data modelling it was moderate. CONCLUSIONS: Models developed in the past 12 years for health economic evaluations of diabetes treatments are of high-quality and make use of advanced methods. However, further developments are needed to improve the statistical modelling component of cost-effectiveness models and to provide better assessment of structural uncertainty.

Patient preferences and cost-benefit of hypertension and hyperlipidemia collaborative management model between pharmacies and primary care in Portugal: A discrete choice experiment alongside a trial (USFarmácia®).

BACKGROUND: Little is known about patient preferences and the value of pharmacy-collaborative disease management with primary care using technology-driven interprofessional communication under real-world conditions. Discrete Choice Experiments (DCEs) are useful for quantifying preferences for non-market services. OBJECTIVES: 1) To explore variation in patient preferences and estimate willingness-to-accept annual cost to the National Health Service (NHS) for attributes of a collaborative intervention trial between pharmacies and primary care using a trial exit DCE interview; 2) to incorporate a DCE into an economic evaluation using cost-benefit analysis (CBA). METHODS: We performed a DCE telephone interview with a sample of hypertension and hyperlipidemia trial patients 12 months after trial onset. We used five attributes (levels): waiting time to get urgent/not urgent medical appointment (7 days/45 days; 48 hrs./30 days; same day/15 days), model of pharmacy intervention (5-min. counter basic check; 15-min. office every 3 months for BP and medication review of selected medicines; 30-min. office every 6 months for comprehensive measurements and medication review of all medicines), integration with primary care (weak; partial; full), chance of having a stroke in 5 years (same; slightly lower; much lower), and annual cost to the NHS (0€; 30€; 51€; 76€). We used an experimental orthogonal fractional factorial design. Data were analyzed using conditional logit. We subtracted the estimated annual incremental trial costs from the mean WTA (Net Benefit) for CBA. RESULTS: A total of 122 patients completed the survey. Waiting time to get medical appointment-on the same day (urgent) and within 15 days (non-urgent)-was the most important attribute, followed by 30-minute pharmacy intervention in private office every 6 months for point-of-care measurements and medication review of all medicines, and full integration with primary care. The cost attribute was not significant. Intervention patients were willing to accept the NHS annual cost of €877 for their preferred scenario. The annual net benefit per patient is €788.20 and represents the monetary value of patients' welfare surplus for this model. CONCLUSIONS: This study is the first conducted in Portugal alongside a pharmacy collaborative trial, incorporating DCE into CBA. The findings can be used to guide the design of pharmacy collaborative interventions with primary care with the potential for reimbursement for uncontrolled or at-risk chronic disease patients informed by patient preferences. Future DCE studies conducted in community pharmacy may provide additional contributions. TRIAL REGISTRATION: Current Controlled Trials (ISRCTN): ISRCTN13410498, retrospectively registered on 12 December 2018.

'Thank goodness you're here'. Exploring the impact on patients, family carers and staff of enhanced 7-day specialist palliative care services: A mixed methods study.

BACKGROUND: Healthcare usage patterns change for people with life limiting illness as death approaches, with increasing use of out-of-hours services. How best to provide care out of hours is unclear. AIM: To evaluate the effectiveness and effect of enhancements to 7-day specialist palliative care services, and to explore a range of perspectives on these enhanced services. DESIGN: An exploratory longitudinal mixed-methods convergent design. This incorporated a quasi-experimental uncontrolled pre-post study using routine data, followed by semi-structured interviews with patients, family carers and health care professionals. SETTING/PARTICIPANTS: Data were collected within specialist palliative care services across two UK localities between 2018 and 2020. Routine data from 5601 unique individuals were analysed, with post-intervention interview data from patients (n = 19), family carers (n = 23) and health care professionals (n = 33; n = 33 time 1, n = 20 time 2). RESULTS: The mean age of people receiving care was 73 years, predominantly white (90%) and with cancer (42%). There were trends for those in the intervention (enhanced care) period to stay in hospital 0.16 days fewer, but be hospitalised 2.67 more times. Females stayed almost 3.5 more days in the hospital, but were admitted 2.48 fewer times. People with cancer had shorter hospitalisations (4 days fewer), and had two fewer admission episodes. Themes from the qualitative data included responsiveness (of the service); reassurance; relationships; reciprocity (between patients, family carers and staff) and retention (of service staff). CONCLUSIONS: Enhanced seven-day services provide high quality integrated palliative care, with positive experiences for patients, carers and staff.

Costs of incident non-hip osteoporosis-related fractures in postmenopausal women from a payer perspective.

Osteoporosis-related fractures lead to high morbidity, mortality, and healthcare costs among post-menopausal women. This study showed that incident non-hip osteoporosis-related fractures are frequent among women aged 50 + in Portugal, leading to excessive healthcare costs of €74 million per year, in a conservative scenario. PURPOSE: This study aimed to estimate the costs of incident non-hip osteoporosis-related fractures among postmenopausal women living in Portugal from a payer perspective. METHODS: The study includes women ≥ 50 years old who participated in the baseline assessment (2011-2013) and the first follow-up wave (2013-2015) of the Epidemiology of Chronic Diseases cohort, a Portuguese community-based longitudinal prospective study (n = 2,762). Incident non-hip osteoporosis-related fractures were defined as any self-reported low impact non-hip fractures since baseline. Healthcare resource utilization during the year following fracture was obtained from an informal panel of experts. The amounts of resources used were multiplied by the national tariffs practiced in the National Health Service (NHS) to obtain the cost per patient in the year following a wrist, vertebral, or other site fracture, which was subsequently multiplied by the estimated annual number of incident fractures to obtain the total annual cost of incident non-hip osteoporosis-related fractures among postmenopausal women. RESULTS: Each year approximately 5,000 wrist, 3,500 vertebral, and 39,000 other-site osteoporosis-related fractures occur in women aged 50 + in Portugal. Healthcare costs per patient in the year following fracture vary from €2,709.52 for vertebral fractures to €3,096.35 for other fractures. Non-hip incident osteoporosis-related fractures among 50 + women cost approximately €74 million per year. Among all healthcare services, physiotherapy represents the bulk of costs. CONCLUSIONS: This study pinpoints the relevance of preventing non-hip osteoporosis-related fractures, as these cost about €74 million per year in direct healthcare costs, a substantial impact on the budget of the Portuguese NHS.

The economic burden experienced by carers of children who had a critical deterioration at a tertiary children's hospital in the United Kingdom (the DETECT study): an online survey.

BACKGROUND: Unplanned critical care admissions following in-hospital deterioration in children are expected to impose a significant burden for carers across a number of dimensions. One dimension relates to the financial and economic impact associated with the admission, from both direct out-of-pocket expenditures, as well as indirect costs, reflecting productivity losses. A robust assessment of these costs is key to understand the wider impact of interventions aiming to reduce in-patient deterioration. This work aims to determine the economic burden imposed on carers caring for hospitalised children that experience critical deterioration events. METHODS: Descriptive study with quantitative approach. Carers responded to an online survey between July 2020 and April 2021. The survey was developed by the research team and piloted before use. The sample comprised 71 carers of children admitted to a critical care unit following in-patient deterioration, at a tertiary children's hospital in the UK. The survey provides a characterisation of the carer's household and estimates of direct non-medical costs grouped in five different expenditure categories. Productivity losses can also be estimated based on the reported information. RESULTS: Most carers reported expenditures associated to the child's admission in the week preceding the survey completion. Two-thirds of working carers had missed at least one workday in the week prior to the survey completion. Moreover, eight in ten carers reported having had to travel from home to the hospital at least once a week. These expenditures, on average, amount to £164 per week, grouped in five categories (38% each to travelling costs and to food and drink costs, with accommodation, childcare, and parking representing 12%, 7% and 5%, respectively). Additionally, weekly productivity losses for working carers are estimated at £195. CONCLUSION: Unplanned critical care admissions for children impose a substantial financial burden for carers. Moreover, productivity losses imply a subsequent cost to society. Even though subsidised hospital parking and on-site accommodation at the hospital contribute to minimising such expenditure, the overall impact for carers remains high. Interventions aiming at reducing emergency critical care admissions, or their length, can be crucial to further contribute to the reduction of this burden. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61279068, date of registration 07/06/2019, retrospectively registered.

Real-World Effectiveness in Hypertension and Hyperlipidemia Collaborative Management between Pharmacies and Primary Care in Portugal: A Multicenter Pragmatic Controlled Trial (USFarmácia®).

There is evidence of the efficacy of collaborative health interventions with pharmacies and primary care providers but little of its real-world effectiveness. We aimed to assess the effectiveness and discuss the design and challenges of hypertension and hyperlipidemia management between pharmacies and primary care providers using real-world data exchange between providers and experimental bundled payment. This was a pragmatic, quasi-experimental controlled trial. We collected patient-level data from primary care prescription claims and Electronic Medical Record databases, a pharmacy claims database, and patient telephone surveys at several time points. The primary outcomes were changes in blood pressure and total cholesterol. We used matched controls with difference-in-differences estimators in a Generalized Linear Model (GLM) and controlled interrupted time series (CITS). We collected additional data for economic and qualitative studies. A total of 6 Primary Care Units, 20 pharmacies, and 203 patients entered the study. We were not able to observe significant differences in the effect of intervention vs. control. We experienced challenges that required creative strategies. This real-world trial was not able to show effectiveness, likely due to limitations in the primary care technology which affected the sample size. It offers, however, valuable lessons on methods, strategies, and data sources, paving the way for more real-world effectiveness trials to advance value-based healthcare.

Using technology to reduce critical deterioration (the DETECT study): a cost analysis of care costs at a tertiary children's hospital in the United Kingdom.

BACKGROUND: Electronic early warning systems have been used in adults for many years to prevent critical deterioration events (CDEs). However, implementation of similar technologies for monitoring children across the entire hospital poses additional challenges. While the concept of such technologies is promising, their cost-effectiveness is not established for use in children. In this study we investigate the potential for direct cost savings arising from the implementation of the DETECT surveillance system. METHODS: Data were collected at a tertiary children's hospital in the United Kingdom. We rely on the comparison between patients in the baseline period (March 2018 to February 2019) and patients in the post-intervention period (March 2020 to July 2021). These provided a matched cohort of 19,562 hospital admissions for each group. From these admissions, 324 and 286 CDEs were observed in the baseline and post-intervention period, respectively. Hospital reported costs and Health Related Group (HRG) National Costs were used to estimate overall expenditure associated with CDEs for both groups of patients. RESULTS: Comparing post-intervention with baseline data we found a reduction in the total number of critical care days, driven by an overall reduction in the number of CDEs, however without statistical significance. Using hospital reported costs adjusted for the Covid-19 impact, we estimate a non-significant reduction of total expenditure from £16.0 million to £14.3 million (corresponding to £1.7 million of savings - 11%). Additionally, using HRG average costs, we estimated a non-significant reduction of total expenditure from £8.2 million to £ 7.2 million (corresponding to £1.1 million of savings - 13%). DISCUSSION AND CONCLUSION: Unplanned critical care admissions for children not only impose a substantial burden on patients and families but are also costly for hospitals. Interventions aimed at reducing emergency critical care admissions can be crucial to contribute to the reduction of these episodes' costs. Even though cost reductions were identified in our sample, our results do not support the hypothesis that reducing CDEs using technology leads to a significant reduction on hospital costs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61279068, date of registration 07/06/2019, retrospectively registered.

Healthcare use and healthcare costs for patients with advanced cancer; the international ACTION cluster-randomised trial on advance care planning.

BACKGROUND: Advance care planning supports patients to reflect on and discuss preferences for future treatment and care. Studies of the impact of advance care planning on healthcare use and healthcare costs are scarce. AIM: To determine the impact on healthcare use and costs of an advance care planning intervention across six European countries. DESIGN: Cluster-randomised trial, registered as ISRCTN63110516, of advance care planning conversations supported by certified facilitators. SETTING/PARTICIPANTS: Patients with advanced lung or colorectal cancer from 23 hospitals in Belgium, Denmark, Italy, the Netherlands, Slovenia and the UK. Data on healthcare use were collected from hospital medical files during 12 months after inclusion. RESULTS: Patients with a good performance status were underrepresented in the intervention group (p< 0.001). Intervention and control patients spent on average 9 versus 8 days in hospital (p = 0.07) and the average number of X-rays was 1.9 in both groups. Fewer intervention than control patients received systemic cancer treatment; 79% versus 89%, respectively (p< 0.001). Total average costs of hospital care during 12 months follow-up were €32,700 for intervention versus €40,700 for control patients (p = 0.04 with bootstrap analyses). Multivariable multilevel models showed that lower average costs of care in the intervention group related to differences between study groups in country, religion and WHO-status. No effect of the intervention on differences in costs between study groups was observed (p = 0.3). CONCLUSIONS: Lower care costs as observed in the intervention group were mainly related to patients' characteristics. A definite impact of the intervention itself could not be established.

How do hospital characteristics and ties relate to the uptake of second-generation biosimilars? A longitudinal analysis of Portuguese NHS hospitals, 2015-2021.

BACKGROUND: There is limited evidence on within-country discrepancies in biosimilar uptake. This study analyzes differences in timing and diffusion of biosimilar uptake across Portuguese NHS hospitals and explores possible determinants. RESEARCH DESIGN AND METHODS: We analyzed publicly accessible consumption data of originator biologic and biosimilar drugs for adalimumab, etanercept, infliximab, rituximab, and trastuzumab, by hospital and month for the years 2015-2021 (N = 9,467). We modeled the time to biosimilar adoption using survival regression models and the share of biosimilar consumption using generalized estimated equations with random hospital effects. RESULTS: Academic hospitals were characterized by a quicker uptake of adalimumab and infliximab biosimilars but lower shares for other drugs. A higher total consumption of biologics was related to a lower share of biosimilar uptake. A stronger participation in randomized controlled trials was linked to higher biosimilar shares and quicker uptake, except for rituximab. If all NHS hospitals had biosimilar shares equal to the highest ones, potential annual savings could reach 13.9 million euros. CONCLUSION: The findings suggest a need for capacity-building on biosimilar prescribing, including for doctors of academic hospitals and those working in settings where high biosimilar use would be expected.

Cost-effectiveness and cost-utility of hypertension and hyperlipidemia collaborative management between pharmacies and primary care in portugal alongside a trial compared with usual care (USFarmácia®).

Background: There is little experience in the economic evaluation of pharmacy/primary care collaborative health interventions using interprofessional technology-driven communication under real-world conditions. This study aimed to conduct cost-effectiveness and cost-utility analyses of a collaborative care intervention in hypertension and hyperlipidemia management between pharmacies and primary care versus usual (fragmented) care alongside a trial. Methods: An economic evaluation was conducted alongside a 6-month pragmatic quasi-experimental controlled trial. Data sources included primary care clinical software; pharmacy dispensing software; patient telephone surveys; and published literature. The target population was adult patients on hypertension and/or lipid-lowering medication. The perspective was societal. We collected patient-level data on resource use to estimate trial costs. Effect outcomes included blood pressure (BP) and quality-adjusted life years (QALYs). Bootstrapping was used to estimate uncertainty around the incremental cost-effectiveness and cost-utility ratios. Cost-effectiveness planes and acceptability curves were estimated. Results: The intervention was not shown to have reasonable levels of cost-effectiveness or cost-utility when compared to usual care as denoted by the levels of uncertainty expressed in wide confidence intervals. The probability of the intervention being cost-effective is 28% at the threshold of €20,000 per QALY gained and 57% at the threshold of €500 per mmHg systolic BP decrease. Conclusion: Considering the limitations of the trial which affected effectiveness and economic outcomes, our results are not generalizable for community pharmacy and primary care in Portugal. This research offers, however, valuable lessons on methods and strategies that can be used in future economic evaluations of collaborative public health interventions with the potential for reimbursement. Clinical trial registration: https://www.isrctn.com/ISRCTN13410498, identifier ISRCTN13410498.

Systematic voiding programme in adults with urinary incontinence following acute stroke: the ICONS-II RCT.

BACKGROUND: Urinary incontinence affects around half of stroke survivors in the acute phase, and it often presents as a new problem after stroke or, if pre-existing, worsens significantly, adding to the disability and helplessness caused by neurological deficits. New management programmes after stroke are needed to address urinary incontinence early and effectively. OBJECTIVE: The Identifying Continence OptioNs after Stroke (ICONS)-II trial aimed to evaluate the clinical effectiveness and cost-effectiveness of a systematic voiding programme for urinary incontinence after stroke in hospital. DESIGN: This was a pragmatic, multicentre, individual-patient-randomised (1 : 1), parallel-group trial with an internal pilot. SETTING: Eighteen NHS stroke services with stroke units took part. PARTICIPANTS: Participants were adult men and women with acute stroke and urinary incontinence, including those with cognitive impairment. INTERVENTION: Participants were randomised to the intervention, a systematic voiding programme, or to usual care. The systematic voiding programme comprised assessment, behavioural interventions (bladder training or prompted voiding) and review. The assessment included evaluation of the need for and possible removal of an indwelling urinary catheter. The intervention began within 24 hours of recruitment and continued until discharge from the stroke unit. MAIN OUTCOME MEASURES: The primary outcome measure was severity of urinary incontinence (measured using the International Consultation on Incontinence Questionnaire) at 3 months post randomisation. Secondary outcome measures were taken at 3 and 6 months after randomisation and on discharge from the stroke unit. They included severity of urinary incontinence (at discharge and at 6 months), urinary symptoms, number of urinary tract infections, number of days indwelling urinary catheter was in situ, functional independence, quality of life, falls, mortality rate and costs. The trial statistician remained blinded until clinical effectiveness analysis was complete. RESULTS: The planned sample size was 1024 participants, with 512 allocated to each of the intervention and the usual-care groups. The internal pilot did not meet the target for recruitment and was extended to March 2020, with changes made to address low recruitment. The trial was paused in March 2020 because of COVID-19, and was later stopped, at which point 157 participants had been randomised (intervention, n = 79; usual care, n = 78). There were major issues with attrition, with 45% of the primary outcome data missing: 56% of the intervention group data and 35% of the usual-care group data. In terms of the primary outcome, patients allocated to the intervention group had a lower score for severity of urinary incontinence (higher scores indicate greater severity in urinary incontinence) than those allocated to the usual-care group, with means (standard deviations) of 8.1 (7.4) and 9.1 (7.8), respectively. LIMITATIONS: The trial was unable to recruit sufficient participants and had very high attrition, which resulted in seriously underpowered results. CONCLUSIONS: The internal pilot did not meet its target for recruitment and, despite recruitment subsequently being more promising, it was concluded that the trial was not feasible owing to the combined problems of poor recruitment, poor retention and COVID-19. The intervention group had a slightly lower score for severity of urinary incontinence at 3 months post randomisation, but this result should be interpreted with caution. FUTURE WORK: Further studies to assess the effectiveness of an intervention starting in or continuing into the community are required. TRIAL REGISTRATION: This trial is registered as ISRCTN14005026. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 31. See the NIHR Journals Library website for further project information.

Urinary incontinence affects around half of stroke survivors. It causes embarrassment and distress, affecting patients' ability to take part in rehabilitation. It also has a major impact on families and may determine whether or not patients are able to return home. Finding the underlying cause and addressing it can prevent, cure or reduce problems. Doing this in a systematic way for everyone with incontinence problems as early as possible after the stroke, while they are still in hospital, may work best. We also wanted to avoid using catheters in the bladder to drain the urine away, as these are often unnecessary and can cause urinary tract infections. This study aimed to test whether or not continence problems and the use of urinary catheters could be reduced if everyone with incontinence was fully assessed and given the right management and support early after hospital admission. We also wanted to find out if the benefits outweighed the costs. We planned to involve 1024 men and women with incontinence from 18 stroke units in the study, with 512 people receiving the intervention and 512 receiving usual care. However, the trial was paused because of COVID-19, at which time only 157 participants had been recruited. When we were thinking about restarting the study and looked at its progress, we found that not enough people had agreed to take part and, of those who had agreed, many had not returned their outcome questionnaires. This indicated that the trial was not feasible and should not restart. We could not make any firm conclusions about whether or not the intervention worked, as not enough people were involved. We found that stays in hospital after stroke are shorter than they were in the past. This suggests that future studies investigating ways of treating incontinence should consider interventions with management and support for incontinence that continue after patients leave the hospital.

A comparison between thoracic epidural analgesia and rectus sheath catheter analgesia after open midline major abdominal surgery: randomized clinical trial.

BACKGROUND: Rectus sheath catheter analgesia (RSCA) and thoracic epidural analgesia (TEA) are both used for analgesia following laparotomy. The aim was to compare the analgesic effectiveness of RSCA with TEA after laparotomy for elective colorectal and urological surgery. METHODS: Patients undergoing elective midline laparotomy were randomized in a non-blinded fashion to receive RSCA or TEA for postoperative analgesia at a single UK teaching hospital. The primary quantitative outcome measure was dynamic pain score at 24 h after surgery. A nested qualitative study (reported elsewhere) explored the dual primary outcome of patient experience and acceptability. Secondary outcome measures included rest and movement pain scores over 72 h, functional analgesia, analgesia satisfaction, opiate consumption, functional recovery, morbidity, safety, and cost-effectiveness. RESULTS: A total of 131 patients were randomized: 66 in the RSCA group and 65 in the TEA group. The median (interquartile range; i.q.r.) dynamic pain score at 24 h was significantly lower after TEA than RSCA (33 (11-60) versus 50.5 (24.50-77.25); P = 0.018). Resting pain score at 72 h was significantly lower after RSCA (4.5 (0.25-13.75) versus 12.5 (2-13); P = 0.019). Opiate consumption on postoperative day 3 (median (i.q.r.) morphine equivalent 17 (10-30) mg versus 40 (13.25-88.50) mg; P = 0.038), hypotension, or vasopressor dependency (29.7 versus 49.2 per cent; P = 0.023) and weight gain to day 3 (median (i.q.r.) 0 (-1-2) kg versus 1 (0-3) kg; P = 0.046) were all significantly greater after TEA, compared with RSCA. There were no significant differences between groups in other secondary outcomes, although more participants experienced serious adverse events after TEA compared with RSCA, which was also the more cost-effective. CONCLUSIONS: TEA provided superior initial postoperative analgesia but only for the first 24 h. By 72 hours RSCA provides superior analgesia, is associated with a lower incidence of unwanted effects, and may be more cost-effective.

Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial.

INTRODUCTION: Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children. METHODS AND ANALYSIS: Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic. ETHICS AND DISSEMINATION: The trial protocol was approved by the HRA and NHS REC (North West Liverpool East REC reference 18/NW/0100). We will publish the results in international peer-reviewed journals and present at scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN11369832.

Explaining effective mental health support for LGBTQ+ youth: A meta-narrative review.

This meta-narrative review on mental health early intervention support for LGBTQ+ â€‹youth aimed to develop a theoretical framework to explain effective mental health support. Using the RAMESES standards for meta-narrative reviews, we identified studies from database searches and citation-tracking. Data extraction and synthesis was conducted through conceptual coding in Atlas.ti. in two stages: 1) conceptual mapping of the meta-narratives; 2) comparing the key concepts across the meta-narratives to produce a theoretical framework. In total, 2951 titles and abstracts were screened and 200 full papers reviewed. 88 studies were included in the final review. Stage 1 synthesis identified three meta-narratives - psychological, psycho-social, and social/youth work. Stage 2 synthesis resulted in a non-pathological theoretical framework for mental health support that acknowledged the intersectional aspects of LGBTQ+ â€‹youth lives, and placed youth at the centre of their own mental health care. The study of LGBTQ+ â€‹youth mental health has largely occurred independently across a range of disciplines such as psychology, sociology, public health, social work and youth studies. The interdisciplinary theoretical framework produced indicates that effective early intervention mental health support for LGBTQ+ â€‹youth must prioritise addressing normative environments that marginalises youth, LGBTQ+ â€‹identities and mental health problems.

Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): protocol for a feasibility randomised controlled trial.

INTRODUCTION: Exercise and physical activity (PA) are fundamental to the treatment of type 2 diabetes. Current exercise and PA strategies for newly diagnosed individuals with type 2 diabetes are either clinically effective but unsuitable in routine practice (supervised exercise) or suitable in routine practice but clinically ineffective (PA advice). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and PA advice, enabling patients to engage in regular long-term physically active lifestyles. This feasibility randomised controlled trial (RCT) will evaluate the use of mHealth technology when incorporated into a structured home-based exercise and PA intervention, in those recently diagnosed with type 2 diabetes. METHODS AND ANALYSIS: This feasibility multicentre, parallel group RCT will recruit 120 individuals with type 2 diabetes (diagnosis within 5-24 months, aged 40-75 years) in the UK (n=60) and Canada (n=60). Participants will undertake a 6-month structured exercise and PA intervention and be supported by an exercise specialist (active control). The intervention group will receive additional support from a smartwatch and phone app, providing real-time feedback and enabling improved communication between the exercise specialist and participant. Primary outcomes are recruitment rate, adherence to exercise and loss to follow-up. Secondary outcomes include a qualitative process evaluation and piloting of potential clinical outcome measures for a future RCT. ETHICS AND DISSEMINATION: The trial was approved in the UK by the South East Scotland Research Ethics Committee 01 (20/SS/0101) and in Canada by the Clinical Research Ethics Board of the University of British Columbia (H20-01936), and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings. TRIAL REGISTRATION NUMBERS: ISRCTN14335124; ClinicalTrials.gov: NCT04653532.

The utilisation of tools to facilitate cross-border communication during international food safety events, 1995-2020: a realist synthesis.

Efficient communication and coordination are needed between countries to prevent, detect and respond to international food safety events. While communication tools, networks and systems exist, current evidence suggests that they are only useful within particular contexts and several only target specific geographic areas. There is a need to unpack and explore the mechanisms of how and in what context such communication tools and their components are effective at facilitating international communication and coordination to keep food safe and mitigate the burden of foodborne disease around the world.A realist synthesis was undertaken to understand how and why certain processes and structures of communication tools, used during international food safety events, influence their utility and effectiveness according to different contextual factors. The focus of this review was explanatory and aimed to develop and refine theory regarding how contextual factors trigger specific processes and mechanisms to produce outcomes. Using the realist context-mechanism-outcome configuration of theory development, a range of sources was used to develop an initial programme theory, including the authors' experience, a scoping review of published papers and grey literature and input from an expert reference committee. Literature was then systematically located and synthesised from several databases with input from the expert reference committee to refine the programme theory.The programme theory developed indicates that when a country has interests in food import or export, has the technical infrastructure to detect and respond to food safety events, and is governed in accordance with regional and/or global laws and regulations relating to food control and global health security, then specific mechanisms will facilitate various outcomes. Mechanisms include trust, experience, support, awareness, understanding, a sense of community, standardisation and intersectoral collaboration. The outcomes include using communication tools to relay information abroad and the prevention of foodborne diseases, among others.Components of such communication tools may be adapted according to different contextual factors to promote, support and improve their use. Improving international coordination and communication during international food safety events is in the interest of global health security and can mitigate the global burden of foodborne disease.