Risultati per: La nevralgia post-erpetica

Introduction
Graft-versus-host disease (GvHD) remains a major complication of allogeneic stem cell transplantation (allo-SCT), affecting 30–70% of patients (representing 800 new patients per year in the UK). The risk is higher in patients undergoing unrelated allo-SCT. About 1 in 10 patients die as a result of GvHD or through complications of its treatment. In patients who survive GvHD and or the complications of treatment, about 1 in 3 patients develop chronic GvHD which has a negative impact on quality of life (QoL). Many transplant protocols use alemtuzumab or anti-thymocyte globulin (ATG) in combination with a calcineurin inhibitor (CNI) and mycophenolate mofetil as GvHD prophylaxis; however, the outcomes of these treatments are complicated by high rates of infection and therefore the development of improved GvHD prophylaxis strategies represents a major unmet need.

Methods and analysis
The Methods of T-Cell Depletion trial is a prospective, multicentre, adaptive randomised trial in patients undergoing reduced intensity-conditioned unrelated donor allo-SCT. The trial will compare the novel GvHD prophylaxis regimens post-transplant cyclophosphamide (PTCy) in combination with a CNI or sirolimus (PTCy-CNI or PTCy-sirolimus, respectively) to a current standard-of-care GvHD prophylaxis involving the use of Thymoglobulin (a specific brand of ATG containing rabbit polyclonal antibodies). The primary outcome measure is GvHD-free, relapse-free survival at 1 year. Secondary outcomes include cumulative incidence of acute grade II-IV GvHD at 1 year, cumulative incidence of moderate and severe chronic GvHD at 1 year, overall survival at 1 year and cumulative incidence of non-relapse mortality at 1 year.

Ethics and dissemination
The protocol was approved by the West Midlands, Edgbaston Research Ethics Committee (20/WM/0195); initial approval was received on 11 September 2020, current protocol version (V.4.0) approval on 25 July 2023. The Medicines and Healthcare products Regulatory Authority also approved all protocol versions. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number
EudraCT Number: 2019-002419-24.
ISRCTN Number: 50290131.

Circulation, Ahead of Print. Background: In patients with post-thrombotic syndrome (PTS), stent recanalization of iliofemoral veins or the inferior vena cava can restore venous patency and improve functional outcomes. The risk of stent thrombosis is particularly increased during the first 6 months after intervention. The ARIVA trial tested whether daily aspirin 100 mg plus rivaroxaban 20 mg is superior to rivaroxaban 20 mg alone to prevent stent thrombosis within 6 months after stent placement for PTS.Methods: In this multinational, academic, open-label, independently adjudicated trial, patients with a Villalta score >4 points, a stenosis or occlusion of the inferior vena cava, iliac veins, or common femoral vein, successfully treated with venous stent placement, were randomized in a 1:1 fashion to the study groups. Key exclusion criteria included age 75 years, contraindications to anticoagulant use or acute venous thrombosis

Stroke, Ahead of Print.

Introduction
Knee osteoarthritis (OA) is a chronic condition affecting joint function. Regular physical activity can enhance functional capacity and reduce pain. However, there is a scarcity of studies relating to knee OA during the COVID-19 pandemic, particularly its impact on symptoms and quality of life.

Methods
This analytic cross-sectional study design will recruit participants aged 40 and above from Metro Manila with knee pain and COVID-19 history. The Filipino version of the Knee Injury and Osteoarthritis Outcome Score and International Physical Activity Questionnaire-Short Form will be used to assess the mediating variables.

Analysis
The study will employ descriptive and regression analyses for data analysis and follow the Strengthening the Reporting of Observational Studies in Epidemiology statement for reporting the data.

Ethics and dissemination
This study has received ethical approval from the Ethics Review Committee of the College of Rehabilitation Sciences. Study results will be disseminated through peer-reviewed journal publications and conference presentations to ensure accessibility to healthcare professionals and stakeholders, contributing to the advancement of knee OA management in post-COVID settings.

Introduction
The incidence of post-traumatic stress disorder (PTSD) in emergency trauma surgery patients is 24%, emphasising the urgent need for effective early interventions and treatments. Transauricular vagus nerve stimulation (ta-VNS) modulates the autonomic nervous system by stimulating the nucleus tractus solitarius while affecting PTSD-related neural networks, including the prefrontal cortex, hippocampus and amygdala, potentially offering new options for PTSD prevention and treatment. This study aims to evaluate the efficacy and safety of ta-VNS in preventing PTSD in emergency trauma surgery patients.

Methods and analysis
This multicentre, double-blind, randomised controlled study aims to evaluate the incidence of PTSD in emergency trauma surgery patients receiving either ta-VNS or sham stimulation. A total of 350 participants will be randomly assigned to receive either active or sham stimulation. The active group will undergo electrical stimulation of the left cymba conchae at 30 Hz with a pulse width of 250 µs, using a 30 s on/30 s off cycle. The intensity will start at 0.4 V, increasing in 0.4 V increments until a tingling sensation is detected, and will be adjusted to the highest tolerable level without causing pain. The initial intervention will begin once informed consent is obtained and randomisation is completed in the preoperative preparation room, continuing until the surgery is finished. For the four postoperative days, the intervention will be administered two times per day in 2-h sessions each morning and evening. The sham stimulation group will follow a similar procedure without actual stimulation. The primary outcome is the incidence of PTSD evaluated on postoperative day 30, with secondary outcomes including recovery quality, sleep quality, and adverse events.

Ethics and dissemination
The protocol received approval from Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine, on 15 October 2024 (approval number: 20240562). The study will adhere to the Declaration of Helsinki guidelines, and written informed consent will be obtained from all participants. Results will be submitted to a peer-reviewed journal for publication.

Trial registration number
China Clinical Trial Registration Center (ChiCTR2400080342). Trial details: https://www.chictr.org.cn/showproj.html?proj=217809

Background
Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk.

Objective
To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement.

Design
This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up.

Results
Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality.

Conclusion
This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement.

Trial registration number
NL5130.

Objectives
To search the literature systematically in order to map and identify gaps in research investigating patient and family member psychoeducation needs regarding post-stroke cognition.

Design
Scoping review conducted in line with Joanna Briggs Institute (JBI) recommendations and PRISMA-ScR checklist.

Methods
MEDLINE, PsycINFO, Embase, CINAHL and Scopus were searched on 25 August 2023 for peer-reviewed studies conducted in a high-income country, describing cognition-related psychoeducation needs in stroke survivors and/or family members aged ≥18 years (≥50% of the study population). Two reviewers independently screened titles, abstracts and then full-text articles. One reviewer extracted pre-defined study characteristics and findings. These data were verified by a second reviewer. Synthesis involved descriptive statistics and thematic analysis.

Results
Searches identified 8115 articles, of which 30 were included. Articles were published between 1996 and 2023. Studies were conducted in Australia (n=7), USA (n=6), UK (n=5), Canada (n=3), New Zealand (n=3), Ireland (n=2), Netherlands (n=2), South Korea (n=1) and Sweden (n=1). Most studies (n=21) used an exclusively qualitative approach but six combined qualitative and quantitative methods. The post-stroke period under investigation varied, including the acute/subacute stage (n=10) and the chronic stage (n=3), though many articles did not state the timepoint explicitly. Research was conducted with stroke survivors only (n=7), family members only (n=12) and both stroke survivors and family members (n=11). Qualitative analysis suggested participants wanted psychoeducation about cognitive impairment, including recovery expectations, treatment/therapy options and signposting to services/resources available. Hopeful information was important. Factors potentially impacting cognition-related psychoeducation needs were identified as time since stroke and family member relationship. Most articles focused on aphasia with very few studies considering other cognitive domains (eg, memory, attention, executive function).

Conclusions
The need for psychoeducation regarding cognition is well evidenced throughout the post-stroke care continuum, though most research has focused on language impairments. Further research investigating other cognitive impairments (eg, impairments in memory, attention and executive function) is required.

Prophylactic respiratory support for patients after extubation is effective in improving their outcomes and prognosis. However, the optimal post-extubation respiratory support for different populations and disease types of mechanically ventilated patients remains controversial, and there is a lack of detailed, multidisciplinary, evidence-based recommendations for clinical application.
Methods and Analysis
This protocol strictly follows the development process outlined in the WHO Handbook for Guideline Development and Guidelines 2.0, as well as the guidelines for the development of relevant methodological standards. Key steps in developing the guideline include: (1) establishing the guideline working groups, (2) defining the scope of guideline application, (3) selecting the priority clinical questions, (4) retrieving and screening evidence, (5) grading the quality of evidence, (6) forming recommendations and (7) conducting an external review.

Ethics and dissemination
Ethical approval has been granted by Changzhi People’s Hospital (2023K023). Findings from this study will be disseminated through peer-reviewed publications.

Guideline registration
PREPARE-2023CN418.

Objective
To evaluate the relationship between infarct pattern, inferred stroke mechanism and risk of recurrence in patients with ischaemic stroke. The question is clinically relevant to optimise secondary stroke prevention investigations and treatment.

Design
We conducted a retrospective analysis of the dabigatran treatment of acute stroke II (DATAS II) trial (ClinicalTrials.gove NCT NCT02295826), in which patients underwent diffusion-weighted imaging (DWI) at baseline and 30 days after randomisation to one of two antithrombotic therapies. Patients were classified as embolic, isolated small subcortical infarcts or transient ischaemic attack TIA (no infarct) at baseline and day 30. Stroke mechanism was determined by traditional and modified (based on DWI lesion findings) Trial of Org 10 172 in Acute Stroke Treatment (TOAST) criteria (DWI-TOAST).

Setting
Multicentre (6) tertiary acute stroke treatment hospitals.

Participants
305 adults with minor ischaemic stroke (National Institutes of Health Stroke Scale (NIHSS) score≤9).

Results
Of 305 patients, 148 had embolic pattern infarcts, 93 were isolated small subcortical infarcts and 64 had no infarct on baseline MRI (TIA). In the absence of DWI, TOAST classification indicated the mechanism was cryptogenic in 147 patients (48.2%), and small-vessel occlusion in 127 (41.6%). Using, DWI-TOAST, the number of cryptogenic strokes decreased to 123 (40.3%), and the number of small-vessel occlusion strokes increased to 151 (49.5%). Recurrent infarcts were seen in 13% of patients with an MRI-defined embolic infarct pattern and cryptogenic mechanism on DWI-TOAST. The relative risk of recurrent infarction in patients with undetermined aetiology was increased compared with other categories (standardised coefficient=1.0 (0.1, 1.9), p=0.029). The topography of recurrent infarcts was most often embolic (60.9%), but in 39.1% an isolated small subcortical infarct was seen.

Conclusions
Definitive identification of infarct topography with DWI has a significant impact on infarct mechanism classification. The variable relationship between baseline infarct patterns, clinical presentation and recurrent infarct distribution is a challenge to both the lacunar and embolic stroke of uncertain source (ESUS) concepts. Irrespective of aetiological classification, patients with MRI-defined cryptogenic embolic pattern infarcts are at high risk for recurrent events.

Trial registration number
Linked to the DATAS II trial. ClinicalTrials.gov ID NCT02295826.

Objective
Many individuals exposed to SARS-CoV-2 experience long-term symptoms as part of a syndrome called post-COVID condition (PCC). Research on PCC is still emerging but is urgently needed to support diagnosis, clinical treatment guidelines and health system resource allocation. In this study, we developed a method to identify PCC cases using administrative health data and report PCC prevalence and predictive factors in Manitoba, Canada.

Design
Cohort study.

Setting
Manitoba, Canada.

Participants
All Manitobans who tested positive for SARS-CoV-2 during population-wide PCR testing from March 2020 to December 2021 (n=66 365) and were subsequently deemed to have PCC based on International Classification of Disease-9/10 diagnostic codes and prescription drug codes (n=11 316). Additional PCC cases were identified using predictive modelling to assess patterns of health service use, including physician visits, emergency department visits and hospitalisation for any reason (n=4155).

Outcomes
We measured PCC prevalence as % PCC cases among Manitobans with positive tests and identified predictive factors associated with PCC by calculating odds ratios with 95% confidence intervals, adjusted for sociodemographic and clinical characteristics (aOR).

Results
Among 66 365 Manitobans with positive tests, we identified 15 471 (23%) as having PCC. Being female (aOR 1.64, 95% CI 1.58 to 1.71), being age 60–79 (aOR 1.33, 95% CI 1.25 to 1.41) or age 80+ (aOR 1.62, 95% CI 1.46 to 1.80), being hospitalised within 14 days of COVID-19 infection (aOR 1.95, 95% CI 1.80 to 2.10) and having a Charlson Comorbidity Index of 1+ (aOR 1.95, 95% CI 1.78 to 2.14) were predictive of PCC. Receiving 1+ doses of the COVID-19 vaccine (one dose, aOR 0.80, 95% CI 0.74 to 0.86; two doses, aOR 0.29, 95% CI 0.22 to 0.31) decreased the odds of PCC.

Conclusions
This data-driven approach expands our understanding of the prevalence and epidemiology of PCC and may be applied in other jurisdictions with population-based data. The study provides additional insights into risk and protective factors for PCC to inform health system planning and service delivery.

Introduction
The SARS-CoV-2 pandemic has caused global devastations in social, economic and health systems of every nation, but disproportionately of nations in Africa. In addition to its grave effects on the global systems, there is continuation or development of new symptoms among individuals who have contracted the virus, with the potential to further stress the health systems on the continent. Therefore, the aim of this scoping review was to collate and summarise the existing research evidence on the prevalence and health effects of post–COVID-19 conditions in Africa.

Methods and analysis
Five main databases were thoroughly searched from 1 September 2023 to 10 May 2024 for eligible articles based on the pre-established inclusion and exclusion criteria. These databases included PubMed, Central, Scopus, Dimensions AI and JSTOR. A total of 17 papers were included in the review. The protocol for this review is already published in BMJ Open; doi:10.1136/bmjopen-2023-082519.

Results
The prevalence of post–COVID-19 conditions in Africa ranged from 2% to as high as 94.7%. Fatigue, dyspnoea and brain fog were among the commonly reported symptoms of post–COVID-19 conditions. Reduced functional status as well as physical and psychosocial disorders were the main health effects reported by the studies reviewed, but no study yet reported the effects of post–COVID-19 conditions on the health systems in Africa.

Conclusions
There is an evidence of high prevalence of post–COVID-19 conditions in the African setting. However, there is limited evidence of the health effects of the post–COVID-19 conditions on patients and health systems in Africa.

Ethics and dissemination
This scoping review involved analysis of secondary data; therefore, no ethical approval was needed. Dissemination of the result is being done through international journals and may also be presented at available research conferences.

Objectives
To evaluate the cost-utility of botulinum toxin A (BoNT-A) for treating upper limb (UL) and lower limb (LL) post-stroke spasticity.

Design
Using a Markov model, adopting a societal perspective and a lifetime horizon with a 3% annual discount rate, the cost-utility analysis was conducted to compare BoNT-A combined with standard of care (SoC) with SoC alone. Costs, utilities, transitional probabilities and treatment efficacy were derived from 5-year retrospective data from tertiary hospitals and meta-analysis. Uncertainty analyses were performed.

Setting
Tertiary hospitals in Thailand.

Participants
Cohort of post-stroke patients aged 55 years with UL or LL spasticity and a Modified Ashworth Scale score ≥1+.

Interventions
BoNT-A (abobotulinumtoxinA: aboBoNT-A, onabotulinumtoxinA: onaBoNT-A or prabotulinumtoxinA: praBoNT-A) combined with SoC versus SoC alone.

Primary outcome measures
Expected life years, quality-adjusted life years (QALYs), costs and incremental cost-effectiveness ratios (ICERs), considering a cost-effectiveness threshold of 160 000 THB (US$4468) per QALY gained.

Results
The combination of aboBoNT-A and SoC yielded the highest QALYs gained (0.013 for UL and 0.11 for LL), followed by onaBoNT-A and SoC and praBoNT-A and SoC. The additional costs for treating UL and LL cases were highest for onaBoNT-A US$75 and US$95, respectively, followed by aboBoNT-A and praBoNT-A. ICER values for treating UL with aboBoNT-A, onaBoNT-A and praBoNT-A ranged from US$4669 to US$7541 per QALY. For LL treatments, aboBoNT-A and onaBoNT-A had ICER values ranging from US$7072 to US$15 182 per QALY. Integrating BoNT-A treatment delivery into the healthcare system would require a budget outlay of approximately US$413 246–US$966 103 that may vary annually by an additional US$50 260–US$335 064.

Conclusion
BoNT-A effectively reduces focal spasticity and improves quality of life in post-stroke patients. However, its cost-effectiveness in Thailand necessitates price negotiations as a condition for inclusion in the pharmaceutical reimbursement list.

Introduction
Chronic post-thoracotomy pain (CPTP) is a persistent and disabling condition affecting a significant proportion of patients after thoracotomy and posing a challenge for clinicians, despite advances in surgical and pain management strategies. Esketamine, the S-enantiomer of ketamine, has emerged as a promising therapeutic agent for various pain conditions, with evidence for its effectiveness in alleviating acute and chronic pain. This systematic review and meta-analysis will be conducted to assess the efficacy of esketamine in treating CPTP, and evaluate its effectiveness in reducing pain intensity, improving functional outcomes, and reducing opioid consumption, as well as its adverse effects.

Methods and analysis
Computer-based literature retrieval in the PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang database and China Science and Technology Journal Database (VIP) for randomised controlled trials will be conducted from database inception to April 2024, with no restrictions on the language of publication. Eligible trials will be those focused on esketamine use to prevent and treat CPTP in adult patients; trial groups will have received esketamine and control groups will have been treated with placebo, standard treatment or other non-esketamine medications. Primary outcome measures can include the incidence of CPTP at 3 months, 6 months or 12 months postoperatively. Secondary outcome measures will encompass Visual Analogue Scale and Numerical Rating Scale Scores for rest and movement at different postoperative timepoints, the total number and effective number of patient-controlled analgesia button presses, total consumption of sufentanil, rate of rescue analgesia, and the occurrence of postoperative adverse reactions. Two researchers will independently screen the literature, evaluate its quality and extract the data. Meta-analysis will be performed on literature meeting the quality criteria using Review Manager V.5.3 software.

Ethics and dissemination
This review does not require ethical approval. On completion, the results of the review will be submitted to a peer-reviewed journal for publication and/or presented at an academic conference.

Trial registration number
PROSPERO, CRD42024526945.

Da 4 anni rifiuta intervento e vaccini ma scatena una polemica

Da 4 anni rifiuta intervento e vaccini ma scatena una polemica

Background
Following the COVID-19 pandemic, there was an increase in teenage pregnancies nationally, however, limited data exists regarding the same among girls living in refugee settlements.

Objectives
We evaluated the prevalence of teenage pregnancy and associated factors in Palorinya and Bidi Bidi refugee settlements in Obongi and Yumbe districts of northern Uganda, in the post-COVID-19 era.

Design
We conducted a cross-sectional study.

Setting
Refugee settlements in northern Uganda.

Participants
We included 385 teenage girls aged 15–19 years.

Methods
We used convenience sampling techniques between March and May 2023. Prevalence of teenage pregnancy was assessed by self-reported pregnancies between January 2020 and May 2023 among participants. We conducted Pearson’s 2 and Fisher’s exact tests for bivariate analysis. All variables with a p value