Risultati per: Gestione del dolore post-operatorio

I delegati si riuniranno martedì a Ginevra per perfezionare il testo e dare la loro approvazione definitiva

Background
Low-dose amitriptyline, a tricyclic antidepressant (TCA), was superior to placebo for irritable bowel syndrome (IBS) in the AmitripTyline at Low-dose ANd Titrated for Irritable bowel syndrome as Second-line treatment (ATLANTIS) trial.

Objective
To perform post hoc analyses of ATLANTIS for predictors of response to, and tolerability of, a TCA.

Design
ATLANTIS randomised 463 adults with IBS to amitriptyline (232) or placebo (231). We examined the effect of baseline demographic and disease-related patient characteristics on response to amitriptyline and the effect of amitriptyline on individual symptoms and side effects by subtype.

Results
There was a quantitative difference in amitriptyline effectiveness in those ≥50 years vs

Stroke, Ahead of Print. BACKGROUND:The prevalence of cerebral small vessel disease (CSVD) imaging markers is high, yet their influence on stroke prognosis remains unclear. This study aimed to estimate the effects of CSVD on the efficacy and safety of clopidogrel+aspirin versus aspirin among patients with minor stroke or high-risk transient ischemic attack.METHODS:This was a post hoc subgroup analysis of the INSPIRES trial (Intensive Statin and Antiplatelet Therapy for Acute High-Risk Intracranial or Extracranial Atherosclerosis), which was a double-blind, placebo-controlled, 2×2 factorial, and randomized clinical trial conducted at 222 centers in China from September 2018 to October 2022. Patients were classified into CSVD score 0 to 2 and CSVD score ≥3 groups based on a modified CSVD burden score without microbleeds. The primary efficacy and safety outcomes were stroke recurrence and moderate-to-severe bleeding risk within 90-day follow-up. We used Cox proportional hazards models to test the treatment-by-CSVD group interaction for stroke and bleeding risk.RESULTS:A total of 5126 patients (median age, 65 [57–71] years; 3915 [64.2%] males) were enrolled and 2131 (41.57%) had a modified CSVD score ≥3. Patients with CSVD score ≥3 had numerically higher stroke recurrence rate (9.10% versus 8.05%) and lower risk of moderate-to-severe bleeding (0.56% versus 0.80%) than those with CSVD score 0 to 2 within 90 days. Clopidogrel+aspirin versus aspirin reduced stroke recurrence to a similar relative degree in both CSVD score 0 to 2 (adjusted hazard ratio, 0.78 [95% CI, 0.61–1.01];P=0.06) and CSVD score ≥3 groups (adjusted hazard ratio, 0.82 [95% CI, 0.62–1.09];P=0.12) with no evidence of statistical interaction (P=0.84). Clopidogrel+aspirin versus aspirin increased bleeding risk to a similar relative degree in both CSVD score 0 to 2 (adjusted hazard ratio, 2.83 [95% CI, 1.52–5.27];P=0.03) and CSVD score ≥3 groups (adjusted hazard ratio, 2.13 [95% CI, 1.08–4.19];P=0.22) with no statistical interaction (P=0.68).CONCLUSIONS:In this post hoc subgroup analysis, no significant interaction effect was observed between the antiplatelet treatment and the modified CSVD score, suggesting that clopidogrel+aspirin may not provide a significantly different benefit-risk profile across patients with CSVD score 0 to 2 versus CSVD score ≥3.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03635749.

Objective
To assess HIV testing and status disclosure rates and explore their associated predictors among young adolescents (10–17 years) who received health education through the Orphans and Vulnerable Children programme in Nimule, South Sudan.

Design
A pre–post evaluation study with data collected at baseline (December 2020) and at the endline (December 2022).

Setting
The study was conducted in Nimule, a densely populated periurban town characterised by high HIV prevalence and substantial cross-border movement between Uganda and South Sudan, making it a relevant setting for an HIV prevention project.

Intervention
The primary intervention was HIV risk education delivered through forty peer-led health clubs. Adolescents were screened for HIV risk factors and referred for HIV and other sexually transmitted infection testing at health facilities.

Participants
The study included young adolescents aged 10–17 years recruited from HIV-affected households within 17 neighbourhoods in Nimule periurban town. Informed consent was obtained from both caregivers and adolescents.

Primary and secondary outcome measures
The primary outcome was self-reported HIV testing and status disclosure. Binary logistic regression was used to assess the association between the study outcome variables and associated sociodemographic factors.

Results
A total of 557 (73.0%) of the 768 enrolled adolescents were surveyed at baseline and endline, including 301 (54.0%) females and 276 (46.0%) males. The median age was 14 years (IQR: 11–16) at baseline and 15 years (IQR: 12–17) at endline.
HIV testing increased from 315 (56.7%) at baseline to 557 (100%). The odds of undisclosed HIV status were 49% lower at endline adjusted OR (aOR) 0.51 (95% CI 0.92, 0.67; p

Introduction
Each year in the UK, 140 000 patients are discharged from intensive care units (ICUs) to general hospital wards, almost all with complex rehabilitation needs. 84% of patients still require nutritional support and 98% are not physically independent. Despite this, many are discharged from ICU without a nutrition plan, and failure to recognise malnutrition is common. Consequently, malnutrition persists in the ward environment, leading to poor outcomes and acting as a barrier to successful physical rehabilitation. This transition from intensive care to the ward represents a key stage in the recovery journey, and a window for optimising physical independence prior to hospital discharge, decreasing the need for support in the community. However, uncertainty as to how best to provide ongoing rehabilitation which combines adequate nutrition and exercise on the general ward has driven widespread variation in practice.
We have previously shown the benefits of delivering a structured rehabilitation strategy in the ICU. However, the ward environment poses different challenges to the development of an integrated rehabilitation pathway. There is a need to evaluate the clinical and cost-effectiveness of structured rehabilitation strategies when delivered outside the ICU.

Methods and analysis
Physiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness is a bi-centre, mixed methods feasibility randomised controlled trial (RCT). 60 patients will be recruited from ICUs at two acute National Health Service Trusts and randomised on a 1:1 basis to receive either individualised physiotherapy and optimised nutrition post discharge from ICU (intervention) or standard care. The primary objective is to assess the acceptability of the intervention and feasibility of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semistructured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.

Ethics and dissemination
Ethical approval has been obtained through the Wales Research and Ethics Committee 2 (24/WA/0050). We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.

Trial registration number
NCT06159868. Prospectively registered on 28 November 2023.

Introduction
Each year in the UK, 140 000 patients are discharged from intensive care units (ICUs) to general hospital wards, almost all with complex rehabilitation needs. 84% of patients still require nutritional support and 98% are not physically independent. Despite this, many are discharged from ICU without a nutrition plan, and failure to recognise malnutrition is common. Consequently, malnutrition persists in the ward environment, leading to poor outcomes and acting as a barrier to successful physical rehabilitation. This transition from intensive care to the ward represents a key stage in the recovery journey, and a window for optimising physical independence prior to hospital discharge, decreasing the need for support in the community. However, uncertainty as to how best to provide ongoing rehabilitation which combines adequate nutrition and exercise on the general ward has driven widespread variation in practice.
We have previously shown the benefits of delivering a structured rehabilitation strategy in the ICU. However, the ward environment poses different challenges to the development of an integrated rehabilitation pathway. There is a need to evaluate the clinical and cost-effectiveness of structured rehabilitation strategies when delivered outside the ICU.

Methods and analysis
Physiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness is a bi-centre, mixed methods feasibility randomised controlled trial (RCT). 60 patients will be recruited from ICUs at two acute National Health Service Trusts and randomised on a 1:1 basis to receive either individualised physiotherapy and optimised nutrition post discharge from ICU (intervention) or standard care. The primary objective is to assess the acceptability of the intervention and feasibility of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semistructured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.

Ethics and dissemination
Ethical approval has been obtained through the Wales Research and Ethics Committee 2 (24/WA/0050). We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.

Trial registration number
NCT06159868. Prospectively registered on 28 November 2023.

Introduction
Effective chronic obstructive pulmonary disease (COPD) interventions require intensive and repetitive exercises, yet their monotonous nature can reduce adherence. Innovative rehabilitation devices that are safe, user-friendly, engaging and cost-effective are crucial. This study introduces a digital gamification-based approach to pursed lip breathing (PLB) exercises, guided by the Behaviour Change Wheel (BCW) framework. The digital platform transforms traditional PLB into an interactive and enjoyable experience, enhancing motivation and adherence. Using a pre-post study design, this feasibility trial aims to assess the safety, feasibility and acceptability of the digital gamification PLB intervention protocol driven by the BCW framework installed on WeChat (DT-PLB) for home-based COPD management.

Methods and analysis
The methodology of this study is divided into two phases. Phase 1 refers to the development of the DT-PLB system based on research evidence, behavioural analysis from the insight of the BCW and stakeholders’ perspectives, and phase 2 points to present the pre-post trial design for the DT-PLB system consisting of five smartphone-based software interface modules: Ranking, Report, Daily PLB Tasks, Social Community and Mine. Eligible patients with COPD will be recruited from a university hospital in Sichuan Province, Mainland China. The DT-PLB will be conducted in non-hospital settings for patients with COPD for 10 min per session, three times a day on a daily basis for 8 weeks. Data collection will be conducted at two time points: baseline and post-intervention.
Demographic data (eg, age, gender and marital status) will be collected only at baseline. The primary outcome measures in this study will be a series of feasibility outcomes involving participant recruitment and completion of the DT-PLB intervention. Additionally, several clinical outcomes in terms of the effects of the DT-PLB intervention on dyspnoea, exercise capability, quality of life, and pulmonary function index will be evaluated as secondary outcomes.

Ethics and dissemination
This study has received Manchester Metropolitan University ethical approval (REC reference 56631) and the Affiliated Hospital of Southwest Medical University ethical approval (REC reference KY2023105). The findings from DT-PLB will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, DT-PLB will be directly applied to the Affiliated Hospital of Southwest Medical University to manage PLB exercises.

Trial registration number
NCT06063733.

Introduction
Effective chronic obstructive pulmonary disease (COPD) interventions require intensive and repetitive exercises, yet their monotonous nature can reduce adherence. Innovative rehabilitation devices that are safe, user-friendly, engaging and cost-effective are crucial. This study introduces a digital gamification-based approach to pursed lip breathing (PLB) exercises, guided by the Behaviour Change Wheel (BCW) framework. The digital platform transforms traditional PLB into an interactive and enjoyable experience, enhancing motivation and adherence. Using a pre-post study design, this feasibility trial aims to assess the safety, feasibility and acceptability of the digital gamification PLB intervention protocol driven by the BCW framework installed on WeChat (DT-PLB) for home-based COPD management.

Methods and analysis
The methodology of this study is divided into two phases. Phase 1 refers to the development of the DT-PLB system based on research evidence, behavioural analysis from the insight of the BCW and stakeholders’ perspectives, and phase 2 points to present the pre-post trial design for the DT-PLB system consisting of five smartphone-based software interface modules: Ranking, Report, Daily PLB Tasks, Social Community and Mine. Eligible patients with COPD will be recruited from a university hospital in Sichuan Province, Mainland China. The DT-PLB will be conducted in non-hospital settings for patients with COPD for 10 min per session, three times a day on a daily basis for 8 weeks. Data collection will be conducted at two time points: baseline and post-intervention.
Demographic data (eg, age, gender and marital status) will be collected only at baseline. The primary outcome measures in this study will be a series of feasibility outcomes involving participant recruitment and completion of the DT-PLB intervention. Additionally, several clinical outcomes in terms of the effects of the DT-PLB intervention on dyspnoea, exercise capability, quality of life, and pulmonary function index will be evaluated as secondary outcomes.

Ethics and dissemination
This study has received Manchester Metropolitan University ethical approval (REC reference 56631) and the Affiliated Hospital of Southwest Medical University ethical approval (REC reference KY2023105). The findings from DT-PLB will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, DT-PLB will be directly applied to the Affiliated Hospital of Southwest Medical University to manage PLB exercises.

Trial registration number
NCT06063733.

Introduction
Arm weakness after stroke is one of the leading causes of adult-onset disability. Invasive vagus nerve stimulation (VNS) paired with rehabilitation has been shown to improve arm recovery in chronic stroke. Small studies of non-invasive or transcutaneous VNS (tVNS) suggest it is safe and tolerable. However, it is not known whether tVNS paired with rehabilitation is effective in promoting arm recovery in chronic stroke and what the mechanisms of action are.

Methods and analysis
TRICEPS is a UK multicentre, double-blinded, superiority, parallel-group, three-arm two-stage with an option to select promising arm(s) at 50% accrual, individually randomised, sham-controlled trial. Up to 243 participants will be randomised (1:1:1) using minimisation via a restricted, web-based centralised system. tVNS will be delivered by a movement-activated tVNS system (TVNS Technologies), which delivers stimulation during repetitive task practice. Rehabilitation will consist of repetitive task training for 1 hour a day, 5 days per week for 12 weeks. Participants will be adults with anterior circulation ischaemic stroke between 6 months and 10 years prior with moderate-severe arm weakness. The primary outcome measure will be the change in Upper Limb Fugl-Meyer total motor score at 91 days after the start of treatment. Secondary outcome measures include the Wolf Motor Function Test, the Modified Ashworth Scale to assess spasticity in the affected arm and the Stroke-Specific Quality of Life Scale. A mechanistic substudy including 40 participants will explore the mechanisms of active versus sham tVNS using multimodal MRI and serum inflammatory cytokine levels. Participant recruitment started on 30 November 2023.

Ethics and dissemination
The study has received ethical approval from the Cambridge Central Research Ethics Committee (REC reference: 22/NI/0134). Dissemination of results will be via publications in scientific journals, meetings, written reports and articles in stakeholder publications.

Trial registration number
ISRCTN20221867.

Introduction
Myosteatosis, characterised by altered muscle composition detectable by muscle radiodensity attenuation on CT scans, has been associated with increased mortality in patients with cirrhosis. However, standard attenuation cut-offs, derived primarily from oncology populations, may not be appropriate for patients with cirrhosis. This study protocol aims to address this diagnostic gap by validating the Ebadi cut-offs, which are based on a retrospective cohort and have not been extensively validated in a cirrhotic population. The aim of the study is to refine these cut-offs for more accurate prediction of mortality in patients with cirrhosis using two independent patient cohorts (retrospective and prospective).

Methods and analysis
This post hoc validation study analyses muscle weakness cut-offs in patients with cirrhosis using data from two independent cohorts. A total of 1537 patients will be analysed. The study will assess interobserver variability to ensure robust results by analysing random samples of 60 patients from the two cohorts. Statistical methods will be used to determine the accuracy and relevance of current cut-offs in predicting patient mortality. The analysis will also examine the relationship between muscle wasting and clinical outcomes in cirrhosis and the relationship with muscle mass loss.

Ethics and dissemination
Ethical approval for this study has been obtained from the relevant institutional review boards. The results will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. The results of the study are expected to contribute to improved diagnostic criteria for myosteatosis in cirrhosis, providing clinicians with more tailored and accurate tools for cirrhosis prognosis.

Trial registration number
NCT06593015.

91% interventi oncologici A in tempi previsti in primi 2 mesi’25

Objective
The study assessed the knowledge, awareness and perception of NaProTechnology as well as the effect of an educational video intervention among pharmacy undergraduate students.

Design
The study design was a pre-post educational video intervention using a cross-sectional questionnaire-based survey.

Participants and setting
The study was done among undergraduate students of a school of pharmacy in South-eastern Nigeria.

Intervention and outcome measures
At baseline, the knowledge, awareness and perception of the students were assessed using a 17-item questionnaire: five questions for knowledge, five questions for awareness and seven questions for perception, followed by the administration of an educational video on NaProTechnology which was prepared by one of the authors, a gynaecologist and also an expert in NaProTechnology. A post-intervention survey was done with the same pre-intervention questionnaire to assess the effect of the educational intervention. The correct (knowledge) or positive (awareness and perception) responses for each question were reported as percentages.

Results
There were 410 and 350 students in the pre- and post-intervention surveys, respectively, with a relatively equal number of males and females. The majority were between 18 and 29 years old. The average proportion of the participants with correct responses on the knowledge assessment of NaProTechnology was 13.2% and 75.7% in the pre- and post-intervention surveys, respectively (p

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