Risultati per: La nevralgia post-erpetica

Circulation, Ahead of Print. This scientific statement presents a conceptual framework for the pathophysiology of post–cardiac arrest brain injury, explores reasons for previous failure to translate preclinical data to clinical practice, and outlines potential paths forward. Post–cardiac arrest brain injury is characterized by 4 distinct but overlapping phases: ischemic depolarization, reperfusion repolarization, dysregulation, and recovery and repair. Previous research has been challenging because of the limitations of laboratory models; heterogeneity in the patient populations enrolled; overoptimistic estimation of treatment effects leading to suboptimal sample sizes; timing and route of intervention delivery; limited or absent evidence that the intervention has engaged the mechanistic target; and heterogeneity in postresuscitation care, prognostication, and withdrawal of life-sustaining treatments. Future trials must tailor their interventions to the subset of patients most likely to benefit and deliver this intervention at the appropriate time, through the appropriate route, and at the appropriate dose. The complexity of post–cardiac arrest brain injury suggests that monotherapies are unlikely to be as successful as multimodal neuroprotective therapies. Biomarkers should be developed to identify patients with the targeted mechanism of injury, to quantify its severity, and to measure the response to therapy. Studies need to be adequately powered to detect effect sizes that are realistic and meaningful to patients, their families, and clinicians. Study designs should be optimized to accelerate the evaluation of the most promising interventions. Multidisciplinary and international collaboration will be essential to realize the goal of developing effective therapies for post–cardiac arrest brain injury.

Stroke, Volume 55, Issue 7, Page e234-e234, July 1, 2024.

We read with great interest the report in Gut by Hicks et al,1 which showed that transjugular intrahepatic portosystemic stent-shunt (TIPSS) was safe and efficacious in control of variceal rebleeding and refractory ascites, but carried a higher incidence of post-TIPSS hepatic encephalopathy (HE) than the current best estimations in 2020 British Society of Gastroenterology (BSG)-TIPSS guidelines.2 Interestingly, an adjuvant technique, simultaneous extrahepatic collateral embolisation (ECE) during TIPSS procedure may help to resolve this issue. However, the clinical benefits of TIPSS plus ECE, including embolisation of gastroesophageal varices and spontaneous splenorenal shunts/gastrorenal shunts, are still controversial. Indeed, previous studies yielded inconsistent results in terms of short-term or long-term clinical outcomes.3–6 Therefore, we conducted a meta-analysis to compare the clinical outcomes of TIPSS±ECE. Fifteen studies () including 1408 patients with cirrhosis and variceal bleeding (1252 (88.9%) for secondary prophylaxis,…

This Viewpoint describes the challenges for clinical research and participant protections following the US Supreme Court ruling in Dobbs v Jackson Women’s Health Organization.

Objective
To assess the potential associations between social determinants of health (SDH) and severe maternal outcomes (SMO), to better understand the social structural framework and the contributory, non-clinical mechanisms associated with SMO.

Study design
Prospective observational study.

Study setting
Tertiary referral centre in south-eastern region of India.

Participants
One thousand and thirty-three women with potentially life-threatening complications (PLTC) were identified using WHO criteria.

Risk factors assessed
Social Determinants of Health (SDH).

Primary outcomes
Severe maternal outcomes, which include maternal near-miss and maternal death.

Statistical analysis
Logistic regression to assess the association between SDH and clinical factors on SMO, expressed as adjusted ORs (aOR) with a 95% CI.

Results
Of the 37 590 live births, 1833 (4.9%) sustained PLTC, and 380 (20.7%) developed SMO. Risk of SMO was higher with increasing maternal age (adjusted OR (aOR) 1.04 (95% CI 1.01 to 1.07)), multiparity (aOR 1.44 (1.10 to 1.90)), medical comorbidities (aOR 1.50 (1.11 to 2.02)), obstetric haemorrhage (aOR 4.63 (3.10 to 6.91)), infection (aOR 2.93 (1.83 to 4.70)), delays in seeking care (aOR 3.30 (2.08 to 5.23)), and admissions following a referral (aOR 2.95 (2.21 to 3.93)). SMO was lower in patients from socially backward community (aOR 0.45 (0.33 to 0.61)), those staying more than 10 km from hospital (aOR 0.56 (0.36 to 0.78)), those attending at least four antenatal visits (aOR=0.53 (0.36 to 0.78)) and those referred from resource-limited facilities (aOR=0.62 (0.46 to 0.84)).

Conclusion
This study demonstrates the independent contribution of SDH to SMO among those sustaining PLTC in a middle-income setting, highlighting the need to formulate preventive strategies beyond clinical considerations.

Objective
The objective was to analyse how the pandemic affected primary care access and comprehensiveness in chronic disease management by comparing primary care patterns before and during the early COVID-19 pandemic.

Design
We conducted a quasi-experimental pre–post design cohort study and reported indicators for the 21 months before and after the onset of the COVID-19 pandemic.

Setting
We used electronic medical record data from primary care clinics enrolled in the Canadian Primary Care Sentinel Surveillance Network from 1 January 2018 to 31 December 2021.

Population
The study population included patients (n=919 928) aged 18 years or older with at least one primary care contact from 12 March 2018 to 12 March 2020, in Canada.

Outcome measures
The study indicators included three indicators measuring access to primary care (encounters, blood pressure measurements and lab tests) and three for comprehensiveness (diagnoses, non-COVID-19 vaccines administered and referrals).

Results
67.3% of the cohort was aged ≥40 years, 56.4% were female and 53.5% were from Ontario, Canada. Fewer patients received an encounter during the pandemic (91.5% to 81.5%), while the median (IQR) number of encounters remained the same (5 (2–1)) for those with access. Fewer patients received a blood pressure measurement (47.9% to 31.8%), and patients received fewer measurements during the pandemic (2 (1–4) to 1 (0–2)).

Conclusions
Encounters with primary care remained consistent during the pandemic, but in-person care, such as lab tests and blood pressure measurements, decreased. In-person care indicators followed temporally to national COVID-19 case counts during the pandemic.

Objective
People with post-stroke aphasia (language/communication impairment) and their supporters report mixed satisfaction with stroke and aphasia care. To date, however, their journey of care and the key service interactions that shape their experience have not been comprehensively explored. We aimed to investigate the lived experience of post-stroke aphasia care, across the continuum of care and by geographical location, to establish priorities for service design.

Design
This is the first stage of an experience-based co-design study. We purposively sampled people with aphasia (PWA) and significant others (SOs) across 21 hospital and health service sites, community groups and by self-referral. Participants shared experiences of care in online interviews and focus groups. Touchpoints (key moments that shape experience) and unmet needs were identified using qualitative thematic analysis. Priorities for service design were established using an adapted nominal group technique.

Setting
Sites spanned remote, regional and metropolitan areas in Queensland, Australia.

Participants
PWA (n=32; mild=56%; moderate=31%; severe=13%) and SOs (n=30) shared 124 experiences of acute, rehabilitation and community-based care in 23 focus groups and 13 interviews.

Results
Both positive and negative healthcare experiences occurred most frequently in hospital settings. Negative experiences regularly related to communication with health professionals, while positive experiences related to the interpersonal qualities of healthcare providers (eg, providing hope) for PWA, or witnessing good rapport between a PWA and their health professional for SOs. To improve services, PWA prioritised communicatively accessible education and information and SOs prioritised access to psychological and peer support.

Conclusions
We identified key aspects of post-stroke aphasia care that shape experience. The needs of PWA and SOs may be better met through health professional training in supported communication, increased service availability in regional and remote areas, communication-accessible hospital environments, increased access to psychological and peer support, and meaningful involvement of SOs in rehabilitation.

Introduction
Continuous theta burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), targeting the language network in the right hemisphere of post-stroke aphasia (PSA) patients shows promising results in clinical trials. However, existing PSA studies have focused on single-target rTMS, leaving unexplored the potential benefits of multitarget brain stimulation. Consequently, there is a need for a randomised clinical trial aimed to evaluate the efficacy and safety of cTBS targeting on multiple critical nodes in the language network for PSA.

Methods and analysis
This is a prospective, multicentre, double-blind, two-arm parallel-group, sham-controlled randomised trial. The study will include a total of 60 participants who will be randomly assigned in a 1:1 ratio to either the active cTBS group or the sham cTBS group. Using precision resting-state functional MRI for each participant, we will map personalised language networks and design personalised targets in the inferior frontal gyrus, superior temporal gyrus and superior frontal gyrus. Participants will undergo a 3-week cTBS intervention targeting the three personalised targets, coupled with speech and language therapy. The primary outcome is the change in the Western Aphasia Battery-Revised aphasia quotient score among participants after a 3-week treatment. Secondary outcomes include Boston Diagnostic Aphasia Examination severity ratings, Token Test and the Chinese-version of the Stroke and Aphasia Quality of Life Scale 39-generic version.

Ethics and dissemination
The study has been approved by the ethics committees of Affiliated Hospital of Hebei University, Hebei General Hospital and Affiliated Hospital of Chengde Medical University. The findings of this study will be reported in peer-reviewed scientific journals.

Trial registration number
The study has been registered on ClinicalTrials.gov (NCT05957445).

Introduction
Healthcare providers usually manage medication for patients during hospitalisation, although patients are expected to self-manage their medication after discharge. A lack of self-management competencies is found to be associated with low adherence levels and medication errors harming patients’ health. Currently, patients seldom receive support or education in medication self-management. When self-management is allowed during hospitalisation, it is rarely provided using a structured, evidence-based format. Therefore, an in-hospital medication self-management intervention (ie, SelfMED) was developed based on current evidence. To date, empirical data demonstrating the effect of SelfMED on medication adherence are lacking. This study primarily aims to evaluate the effect of the SelfMED intervention on medication adherence 2 months postdischarge in polypharmacy patients, as compared with usual care.

Methods and analysis
A multicentre pre–post intervention study will be conducted. The study will start with a control phase investigating usual care (ie, medication management entirely provided by healthcare providers), followed by an intervention period, investigating the effects of the SelfMED intervention. SelfMED consists of multiple components: (1) a stepped assessment evaluating patients’ eligibility for in-hospital medication self-management, (2) a monitoring system allowing healthcare providers to follow up medication management and detect problems and (3) a supportive tool providing healthcare providers with a resource to act on observed problems with medication self-management. Polymedicated patients recruited during the control and intervention periods will be monitored for 2 months postdischarge. A total of 225 participants with polypharmacy should be included in each group. Medication adherence 2 months postdischarge, measured by pill counts, will be the primary outcome. Secondary outcomes include self-management, medication knowledge, patient and staff satisfaction, perceived workload and healthcare service utilisation.

Ethics and dissemination
The ethics committee of the Antwerp University Hospital approved the study (reference no: B3002023000176). Study findings will be disseminated through peer-reviewed publications, conference presentations and summaries in layman’s terms.

Trial registration number
ISRCTN15132085.

Introduction
A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.

Methods and analysis
A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.

Ethics and dissemination
The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.

Trial registration number
NCT05430152.

Objectives
This study aimed to determine the potential profiles of self-psychological adjustment in patients with lung cancer undergoing chemotherapy, including sense of coherence (SOC) and positive cognitive emotion regulation (PCER). The relationship between these profiles with post-traumatic growth (PTG) and the relevant factors of self-psychological adjustment in different profiles was analysed.

Design
Cross-sectional study.

Setting
Patients with lung cancer undergoing chemotherapy in China.

Participants
A total of 330 patients with lung cancer undergoing chemotherapy were recruited out of which 321 completed the questionnaires effectively.

Methods
Latent profile analysis was used to identify self-psychological adjustment classes based on the two subscales of the Sense of Coherence Scale and Cognitive Emotion Regulation Questionnaire. One-way analysis of variance and multinomial logistic regression were performed to examine the subgroup association with characteristics and PTG.

Results
Three latent profiles of self-psychological adjustment were identified: low level (54.5%), high SOC-low PCER (15.6%) and high PCER (29.9%). The results of univariate analysis showed a significant difference in PTG scores among different self-psychological adjustment subgroups (F=11.55, p

Introduction
Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution.

Methods and analysis
The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery.

Ethics and dissemination
All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive.

Trial registration number
ClinicalTrials.gov Registry (NCT04850300).