Search Results for: Gestione del dolore post-operatorio

Introduction
Obesity combined with metabolic syndrome is a major global public health problem. This trial aims to investigate the therapeutic effects of low-frequency transcutaneous electrical nerve stimulation (Lo-TENS) in individuals with obesity and coexisting metabolic syndrome. The study will also delve into the underlying mechanisms through which Lo-TENS may mitigate the symptoms of metabolic syndrome, providing insights into its potential as a novel treatment approach.

Methods and analysis
This randomised controlled trial will enrol 63 individuals with obesity and metabolic syndrome, and randomly assign them to one of the three groups: (1) peripheral stimulation group, (2) central stimulation group and (3) sham stimulation group. Each participant will receive a 30 min daily session of their assigned stimulation, conducted 5 days a week for a duration of 12 weeks. The primary outcomes of interest are body mass index and fasting blood glucose, with secondary outcomes encompassing blood pressure, triglyceride levels and various metabolic biomarkers. Comprehensive assessments will be performed at baseline, immediately post intervention, and followed by a 12-week follow-up evaluation to monitor long-term effects and sustainability of potential benefits.

Ethics and dissemination
The trial has been granted ethical approval by the ethics committee of the Second People’s Hospital of Kunming (approval number: 202305001). The study’s findings will be disseminated through peer-reviewed journal publications and international conference presentations.

Trial registration number
Chinese Clinical Trial Registry Platform: www.chictr.org.cn (No. ChiCTR2400089104).

Stroke, Ahead of Print. BACKGROUND:It is unknown whether computed tomographic perfusion (CTP) parameters predict ischemic stroke in patients with symptomatic chronic carotid or middle cerebral artery occlusion.METHODS:A post hoc analysis of medically treated patients enrolled in the CMOSS trial (Carotid or Middle Cerebral Artery Occlusion Surgery Study; REGISTRATION: URL:https://www.clinicaltrials.gov; Unique identifier: NCT01758614), a randomized controlled trial conducted at 13 centers in China between June 2013 and March 2018. It aimed to compare extracranial-intracranial bypass surgery to medical therapy in patients with symptomatic carotid or middle cerebral artery occlusion and hemodynamic insufficiency. CTP-derived mean transit time and relative cerebral blood flow were collected. The primary outcome was defined as ischemic stroke in the territory of the qualifying artery within 2 years after randomization. The predictive value of CTP for the primary outcome was analyzed by a Cox regression model. Receiver operating characteristic curves were used to calculate optimal cutoff values of CTP parameters.RESULTS:All 165 per-protocol patients (median age=53.7 years, 81.2% males) treated with medical treatment alone were analyzed. Sixteen (9.7%) patients suffered the primary outcome during the 2-year follow-up. Cutoff values of mean transit time >6.5 seconds (symptomatic side) and relative cerebral blood flow ≤0.5 were associated with recurrent stroke. In multivariate Cox regression, mean transit time (adjusted hazard ratio, 3.50 [95% CI, 1.19–10.30];P=0.02) and relative cerebral blood flow (adjusted hazard ratio, 7.36 [95% CI, 2.27–23.85];P=0.001) were independently associated with the primary outcome.CONCLUSIONS:CTP-based hemodynamic parameters are predictive of recurrent ischemic stroke in symptomatic patients with chronic carotid or middle cerebral artery occlusion. CTP could be used in patient selection for stratified secondary prevention of stroke in future studies.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT01758614.

Introduction
Transition of care from hospital is a period when the risks of medication errors and adverse events are high, with 50% of adults discharged having at least one medication-related problem. Pharmacist-led medication reviews can reduce medication errors and unplanned readmission when completed promptly post-discharge; however, they are underutilised. A Transition of Care Stewardship pharmacist has been proposed to facilitate and coordinate a patient’s discharge process and facilitate a timely post-discharge medication review. Access to pharmacist medication review in rural and regional areas can be limited. This protocol describes a randomised controlled trial (RCT) to determine whether a virtual Transition of Care Stewardship pharmacist reduces medication-related harm in rural and regional Australia.

Method and analysis
Multicentre RCT involving patients at high risk of medication-related harm discharged from regional and rural hospitals to a domiciliary residence. Eligible patients must be aged≥18 years, admitted under a medical specialty, be discharged to a domiciliary setting, have a regular general practitioner (GP) or be willing to visit a GP or an Aboriginal Medical Service after discharge for medical follow-up, have a Medicare card and be at high risk of readmission. High risk of readmission is defined as either a previous admission to the hospital or Emergency Department (ED) presentation in the past 6 months AND≥three regular medications OR on at least ONE high-risk medication. A total of 922 participants will be recruited into the study. Enrolled participants will be randomised to the intervention or control (usual care). The intervention will include a virtual Transition Of Care Stewardship pharmacist to ensure that patients receive discharge medication reconciliation, medication counselling, medication list and communicate directly with primary care providers to facilitate a timely post-discharge medication review. Usual care will include informing the patient’s clinical inpatient treating team that the patient is at high risk of medication misadventure and may benefit from a post-discharge Home Medicines Review (a GP-referred pharmacist medication review funded by the Australian Government).
Data analysis will be performed on a modified intent-to-treat basis. The primary outcome assessed is a composite of a first unplanned medication-related hospitalisation or ED presentation within 30 days of hospital discharge. Comparisons between the intervention and usual care groups for the primary outcome will be made using a mixed-effects logistic regression model, adjusting for site-level clustering as a random effect.

Ethics and dissemination
This study is approved to be conducted at the Western New South Wales Local Health District via the Research Ethics and Governance Information System (approval number: 2023/ETH00978). To ensure the needs of Aboriginal and Torres Strait Islander patients are appropriately addressed, ethics for this study were submitted and approved by the Aboriginal Health and Medical Research Council (approval number: 2148/23). Manuscripts resulting from this trial will be submitted to peer-reviewed journals. Results may also be disseminated at scientific conferences and meetings with key stakeholders.

Trial registration number
ACTRN12623000727640.

Introduction
Concurrent with infants’ progression in dietary complexity and gut microbiome diversity, infants gradually change their defecation patterns during the first year of life. However, the links between bowel habits, the gut microbiota and early life nutrition remain unclear. The primary outcome is to characterise the gut microbiome development from birth to 1 year of age. Second, to investigate how bowel habits and nutrition in early life relate to the gut microbiome and metabolome during this period of life, and to explore how the development of the gut microbiome associates with host development.

Methods and analysis
The MOTILITY Mother-Child Cohort (MOTILITY) is a Danish prospective longitudinal cohort study enrolling up to 125 mother–infant dyads. Assessments occur at 36 weeks gestation (visit 1), birth (screening of infant) and 3, 6, 9 and 12 months (±2 weeks) post partum (visits 2–5). At visit 1, maternal anthropometrics, self-collected faecal and urine samples, and questionnaires on bowel habits and lifestyle are obtained. Between visits, infant faecal (biweekly), urine (monthly) and maternal breast milk (monthly until 6 months of age) samples are collected at home, and bowel habits and dietary intake are assessed biweekly by self-reported questionnaires. At visits 2–5, infant blood and saliva samples are collected, and anthropometric measurements are obtained. In addition, dietary intake is recorded thrice throughout the study period for mother and infant, respectively, and infant whole-gut transit time is estimated by sweet corn tests at 9 and 12 months of age. Birth, growth, motor development, sleep patterns, tooth development, overall health and well-being are assessed using questionnaires. Univariate and multivariate statistics will be applied to identify associations between the gut microbiome, early life nutrition and host physiology including bowel habits during the first year of life.

Ethics and dissemination
The MOTILITY study has been approved by the Research Ethics Committee for the Capital Region of Denmark (reference number: H-21063016). Selected results will be made available to the participants in the form of a summary document. Results will be published in peer-review journals and by means of national and international conferences.

Trial registration number
NCT05491161.

Introduction
Balance and gait disorders represent the most frequent and disabling sequelae after stroke. Impaired body orientation with respect to gravity (lateropulsion) is one of the primary underlying mechanisms, increasingly investigated. After hemisphere stroke, lateropulsion is caused by an impaired internal representation of verticality, for which developing rehabilitation techniques has become a priority. Among various approaches, virtual reality appears to be a promising tool for modulating spatial reference frame. The objective of this study is to investigate the effects of immersion in virtual tilted reality (VTR) on the postural vertical (PV) as a primary outcome, as well as main secondary outcomes on the visual vertical (VV) and the active standing posture (body orientation with respect to gravity and weight-bearing (WB) distribution on lower limbs), both in healthy individuals and individuals exhibiting lateropulsion at the subacute phase after a hemispheric stroke. The cumulative effect of the VTR on the post-stroke lateropulsion will also be analysed.

Methods and analysis
This pilot study is a single-centre, within-person randomised trial conducted in the department of Physical and Rehabilitation Medicine of the University Hospital of Grenoble-Alpes (France). We will include 40 individuals from 18 to 85 years old, 20 healthy individuals and 20 individuals with lateropulsion tested 0.5 on the Scale for Contraversive Pushing), the study lasts 4 weeks: W1 for inclusion, randomisation, planning and conventional rehabilitation; W2 and W4 to collect clinical data and conventional rehabilitation; and W3 for the VTR intervention over four consecutive mornings at the same time: 2 to test the VTR effects on verticality perception (PV and VV) and 2 to test the VTR effects on active standing (body orientation and WB distribution on lower limbs). Immediate effects and post-effects of the VTR immersion are analysed by comparing results of the following time points: for verticality perception baseline, during and after VTR and for active standing at only baseline and during VTR immersion. Linear mixed-effect models will be run with different factors/covariates according to objectives. We will analyse the proportion and features of responders (PV modulation ≥2°). The cumulative effect of the 4 days of VTR sessions will be analysed by comparing scores of the SCAle for LAteropulsion assessed at the end of every week.

Ethics and dissemination
The study was approved by an institutional review board at the national level (Comité de Protection des Personnes Ile de France X; 2020-A02941-38, amendment 2024). All participants will provide written informed consent before enrolment. Findings will be submitted to peer-reviewed journals related to rehabilitation, stroke or neuroscience.

Trial registration number
ClinicalTrials.gov, NCT04911738.

Objective
To investigate the epidemiological characteristics and temporal-spatial distribution of Mycoplasma pneumoniae (MP) infections among paediatric inpatients with respiratory tract infections in Tianjin, China, across three distinct phases: pre-pandemic (2017–2019), pandemic (2020–2022) and post-pandemic (2023–2024). The primary hypothesis is that the COVID-19 pandemic altered the epidemiology of MP infections in children.

Design
Retrospective, single-centre study.

Setting
Secondary care paediatric hospital in a metropolitan area.

Participants
A total of 60 213 paediatric patients hospitalised with respiratory infections between January 2017 and December 2024 were included. The study population consisted of children aged 0–18 years, with a male-to-female ratio of 1.22:1.00. Selection criteria included children admitted with a diagnosis of respiratory infection, while those with incomplete clinical data or non-respiratory infections were excluded.

Primary and secondary outcome measures
The primary outcome was the overall positive detection rate of MP-RNA. Secondary outcomes included annual and seasonal variations in MP-RNA detection rates, differences by sex and age group, and the impact of the COVID-19 pandemic on MP epidemiology. All statistical methods, including those used to control for confounding, involved the use of ² tests for comparing positive rates between groups.

Results
The overall positive detection rate of MP-RNA among children hospitalised for respiratory infections during the study period was 36.58% (22 023/60 213). The annual MP-RNA-positive detection rates from 2017 to 2024 were as follows: 50.74% (411/810) in 2017, 36.28% (1150/3170) in 2018, 27.41% (1459/5323) in 2019, 10.18% (222/2181) in 2020, 11.42% (928/8129) in 2021, 13.27% (579/4364) in 2022, 28.97% (3064/10575) in 2023 and 55.38% (14 210/25 661) in 2024. The highest annual positivity rate was observed in 2024 (55.38%, 14 210/25 661), while the lowest rate occurred in 2020 (10.18%, 222/2181). Statistical analysis revealed significant differences in MP-RNA detection rates across different years (²=8331.511, p

Objectives
Investigate determinants of post-COVID-19 condition (PCC) clinic attendance among participants not hospitalised versus hospitalised during the SARS-CoV-2 infection.

Design
Retrospective cohort study.

Setting
Six population-based registers with high coverage to cover all adults residing in Stockholm County, Sweden.

Participants
Adults residing in Stockholm County on 31 January 2020, with a SARS-CoV-2 infection through 30 November 2022, who did not die or move out of Stockholm County within 90 days.

Primary outcome measures
PCC clinic attendance from 90 days after the SARS-CoV-2 test until date of death, date of moving out, or 30 November 30,2023.

Results
Of non-hospitalised and hospitalised participants, 737 of 464 674 (0.2%) and 433 of 23 374 (1.9%), respectively, attended a PCC clinic. A total of 75 878 (16.3%) of non-hospitalised participants and 6190 (26.5%) of hospitalised participants presented with new-onset symptoms that could indicate PCC in primary care. The strongest determinants of attendance among non-hospitalised participants were mental health disorder (adjusted risk ratio (aRR) 2.57, 95% CI 2.21 to 2.98), asthma (2.39, 1.97–2.92) and >4 PCC symptoms in 2019 (2.27, 1.60–3.24), and among hospitalised participants were >31 sick days in 2019 (1.94, 1.47–2.56), 1–30 sick days in 2019 (1.56, 1.06–2.29) and obesity (1.51, 1.19–1.93). The most common clinical presentation was fatigue (n=526, 71.4%) among non-hospitalised and dyspnoea (n=148, 34.2%) among hospitalised participants.

Conclusions
PCC clinic attendance characteristics differed between non-hospitalised and hospitalised participants. Distinguishing PCC from conditions with overlapping symptoms and determining the appropriate level of care may be challenging, with risk of resource displacement effects and inappropriate care.

Introduction
Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to inperson treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure – Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth.

Methods and analysis
A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12–25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60–90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

Ethics and dissemination
This study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number
ACTRN12624000776505.

Protocol version
V.2.3, 20 March 2025.

Introduction
Postoperative delirium (POD) is a common and serious complication in older adult patients undergoing cardiovascular surgery. Esketamine is known for its anti-inflammatory and neuroprotective properties. While it has shown preventive effects on POD in those not undergoing cardiovascular surgery, its efficacy in older adult patients undergoing cardiovascular surgery remains uncertain. Therefore, we herein aimed to evaluate the preventive effect of intraoperative subanaesthetic esketamine on POD in this specific population.

Methods and analysis
This single-centre, randomised, double-blind, placebo-controlled trial will enrol 778 patients aged 60–80 years undergoing open-heart cardiovascular surgery in China, from September 2023 to December 2025. The participants will be randomly assigned in a 1:1 ratio to the following groups: the esketamine group and the control group. In the esketamine group, esketamine (2 mg/mL) will be administered intravenously at a dosage of 0.3 mg/kg over 10 min following tracheal intubation, followed by a continuous infusion at 0.15 mg/kg/h until the end of the surgery. Patients in the control group will receive a placebo following the same dosage and regimen. The incidence of POD will be the primary outcome and will be assessed twice daily from the first to the seventh postoperative day. The postoperative sleep quality, duration of postoperative mechanical ventilation, and length of hospital and intensive care unit stay will be the secondary outcomes.

Ethics and dissemination
Ethical approval was obtained from the Institutional Review Board of Fuwai Central China Cardiovascular Hospital (No. 2023068). Public disclosure is guaranteed post-trial, and the results will be published in a peer-reviewed scientific journal.

Trial registration number
ChiCTR2300074395.

While the adenoma detection rate (ADR) is associated with post-colonoscopy colorectal cancer (PCCRC) risk, it is unknown to what extent this reflects missed colorectal cancer (CRC) versus missed pre-cancerous lesions. We evaluated the association between physician ADR and prevalent CRC detection during colonoscopy.

Stroke, Ahead of Print. BACKGROUND:Neuronal plasticity after stroke occurs predominantly within the first few months. However, its persistence and distribution in the chronic phase remain unclear. This study investigated longitudinal changes in cortical gray matter and corticospinal tract integrity beyond 6 months poststroke and their associations with chronic upper limb motor outcomes.METHODS:We conducted a retrospective cohort study at St. Vincent’s Hospital (Suwon, Republic of Korea) between 2015 and 2022, including patients with first-ever unilateral stroke who underwent at least 2 magnetic resonance imaging scans ≥6 months post-onset. Gray matter volume in cerebral and cerebellar cortices was assessed using 3-dimensional T1-weighted imaging and corticospinal tract integrity via diffusion tensor tractography. Hemispheres were classified as affected or unaffected based on anatomic connectivity to the lesion. Upper limb motor score was measured using a 5-stage ordinal scale and grouped into 3 categories by hand function: poor (no movement), partial (limited movement), and good (fully functional use). Ordinal logistic regression identified structural predictors of motor outcomes, adjusting for age, sex, lesion volume, and baseline impairment.RESULTS:Among 62 patients, structural plasticity persisted beyond 6 months in a subset of patients. Imaging was conducted at an average of 51 months poststroke (range, 13–137 months). Increases in affected cerebellar gray matter were associated with better motor outcomes (odds ratio, 0.67 [95% CI, 0.48–0.92];P=0.01). The odds ratio

Objectives
To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.

Design
We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1:1 allocation ratio, using convergent mixed methods.

Setting
Home-based care without 24/7 paid care provision, in three UK sites.

Participants
Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before the approach, including a known history of substance abuse or carer ability to be trained to competency.

Intervention
Intervention-group carers received training by local nurses using a manualised training package.

Primary outcome measures
Quantitative data were collected at baseline and 6–8 weeks post-bereavement and via carer diaries. Interviews with carers and healthcare professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.

Secondary outcome measures
The secondary outcome measure was time to symptom relief, calculated using data items from the carer diary, after the patient had died.

Results
In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting >30% of eligible dyads. The expected recruitment target (50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced (30% (6/20) usual care and 80% (16/20) intervention). The feasibility criterion of >40% retention was, therefore, considered not met. A total of 12 carers (intervention, n=10; usual care, n=2) and 20 healthcare professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The intervention group had a considerably shorter time to medication administration than the usual-care group (median time to administer medication in intervention=5 min, usual-care=105 min). Intervention group carers felt confident in administering medication. Healthcare professional support was sought by intervention group carers in 24 out of 147 (16.3%) medication administration entries. The context of the feasibility study was not ideal, as district nurses were overstretched, unfamiliar with research methods and possibly not in equipoise. A disparity in readiness to consider the intervention was demonstrated between carers, who were uniformly enthusiastic, and healthcare professionals who were not. Findings confirmed methodological and ethics issues pertaining to researching the last days of life care.

Conclusion
The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring healthcare professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.

Trial registration number
ISRCTN11211024.

Introduction
Diabetes during pregnancy poses significant health risks for both mothers and their offspring and requires comprehensive management throughout pregnancy and the postpartum period. The increasing global prevalence of diabetes during pregnancy requires effective and efficient management. The current healthcare system can be challenging because of need for frequent hospital visits and limited availability of gestational diabetes (GDM) specialists.
This study investigates the impact of a digital-based management system designed to support women with diabetes from pregnancy through the first year post partum. This system includes a mobile application (MomStart) that allows users to log health data, receive tailored educational content and communicate with healthcare providers. The primary objective of this study is to compare pregnancy outcomes with historical data. We will also investigate the usability of the MomStart application.

Methods and analysis
The study will enrol over 100 pregnant women with diabetes from two hospitals in South Korea for the main study and an additional 500 women from across the country for a supplementary usability study. Data will be collected and analysed to assess neonatal and maternal outcomes and the app’s retention and satisfaction rates.

Ethics and dissemination
The protocol was approved by the Institutional Review Board of the Catholic University of Korea (XC23OIDI0012). We will present our findings in a national conference and in peer-reviewed medical journals.

Clinical study registration number
This study was registered in Korea’s Clinical Research Information Service system (KCT0008483).

Objectives
To evaluate the impact and acceptability of a tailored, gender-responsive behavioural activation (BA) intervention for improving depression and anxiety in male National Health Service (NHS) frontline workers.

Design
Pre-post intervention study.

Setting
Three NHS organisations in the North of England.

Participants
45 men aged ≥18 years working in a frontline NHS role scoring in the subclinical range (5–14) on the Patient Health Questionnaire-9 (PHQ-9) (depression) and/or the Generalised Anxiety Disorder-7 (GAD-7) (anxiety) at baseline.

Interventions
A tailored BA treatment programme consisting of up to eight telephone support sessions over a period of 4–6 weeks, accompanied by a BA self-help manual.

Main outcome measures
Self-reported symptom severity of depression, assessed by PHQ-9, and anxiety, assessed by GAD-7, at baseline and 4 and 6 months. Acceptability from the perspectives of male study participants and coaches who delivered the intervention was assessed in a nested qualitative study using the theoretical framework of acceptability (TFA).

Results
PHQ-9 and GAD-7 scores decreased from baseline to 4 months on both the PHQ-9 and GAD-7. While scores increased from 4 months to 6 months, the 6-month scores remained below those of the baseline scores. Acceptability of the intervention was high across all constructs of the TFA. The practical and action-oriented strategies of the intervention, and the confidential, flexible, convenient mode of delivery, worked to support men’s engagement with the intervention.

Conclusions
Delivery of a tailored, gender-responsive BA intervention was appealing to, and beneficial for, men working in frontline NHS roles with less severe depression and anxiety. The BALM intervention offers promise as a tailored workplace mental health programme that is aligned with men’s needs and preferences and can help overcome a reticence to engage with mental health support in NHS staff and beyond.

Trial registration number
ISRCTN48636092.