Search Results for: Sviluppo di un test meno invasivo per la malattia infiammatoria intestinale

To the Editor In a recent trial, there were no differences in gastric cancer incidence or mortality between the 2 treatment groups at a median follow-up of 5.7 years (IQR, 4.9-6.5 years). The progression time from early asymptomatic to symptomatic gastric cancer is unknown and may be longer than the follow-up time of the trial. Presentation of cumulative incidence curves would be helpful to further gauge the effect of the intervention. Furthermore, the study excluded 4 patients with gastric cancer diagnosed on endoscopy after trial entry. While H pylori eradication may not have affected the development of cancer in these patients, excluding them creates bias because the control group was not exposed to gastroscopy with early detection of prevalent cancers. We suggest a recalculation of screening effects including the 4 patients who were excluded. Additionally, we are interested to know if more than 1 H pylori stool test was offered (for example, with subsequent FIT), which would provide information about reinfection and subsequent cancer risk.

To the Editor Dr Lee and colleagues conducted a randomized, population-based trial in Taiwan to assess whether the addition of the Helicobacter pylori stool antigen (HPSA) test to the standard fecal immunochemical test (FIT) could reduce gastric cancer incidence and mortality. The study reported no significant differences between the 2 groups in gastric cancer incidence (0.032% vs 0.037%; P = .23) or mortality (0.015% vs 0.013%; P = .57). Several points merit further discussion.

Introduction
Combining repetitive transcranial magnetic stimulation (rTMS) with robotic training could result in more significant improvements in motor function than either treatment alone. The efficacy of this combination may depend on the sequencing of the interventions. However, few studies have explored the possibility of interleaving or alternating between the two treatment modalities within a single session or over a shorter time frame. The objective of this study is to evaluate the efficacy of alternating rTMS and soft-hand rehabilitation robot therapy to enhance upper limb and hand function in patients with ischaemic stroke.

Methods and analysis
This multicentre study will be conducted as a single-blind, controlled, randomised trial, enrolling 132 post-stroke patients with a disease duration ranging from 1 week to 3 months. The study participants will be randomly assigned to group A (n=44), group B (n=44) and group C (n=44). All participants will undergo a 4-week neurological rehabilitation programme, which includes standardised physical and occupational therapy administered by experienced therapists. Group A will receive 10 Hz high-frequency rTMS (HF-rTMS) over the ipsilesional primary motor cortex (iM1) for 20 min, followed by 20 min of soft-hand rehabilitation robot training. Group B will receive 5 min of 10 Hz HF-rTMS over the iM1 followed by 5 min of soft-hand rehabilitation robot training, repeated four times. Group C will receive sham rTMS with other parameters identical to those of group A. The above treatments will be administered once daily, 5 days a week, for 4 weeks. The primary outcome measurement is the Fugl-Meyer assessment of upper extremity (FMA-UE). The secondary outcome measurements include the Hong Kong edition of Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK), the Modified Ashworth Scale (MAS), and the International Classification of Functioning, Disability and Health upper extremity entries (ICF-Upper Extremity Entries). Assessments will be conducted at baseline and after 4 weeks of treatment.

Ethics and dissemination
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2024-SR-515). The findings of this study will be spread through networks of scientists, professionals and the general public, as well as peer-reviewed scientific papers and presentations at pertinent conferences.

Trial registration number
ChiCTR2400089583.

Introduction
Sexual minority women represent one of the highest-risk groups for hazardous drinking and comorbid mental health problems (eg, depression, anxiety). Research has identified cognitive (eg, expectations of rejection), affective (eg, emotion dysregulation) and behavioural (eg, avoidant coping) pathways through which minority stress (eg, stigma) places sexual minority women at disproportionate risk of hazardous drinking and comorbid depression/anxiety; yet no evidence-based interventions have been tested to address these pathways in this population. This article describes the design of Project EQuIP (Empowering Queer Identities in Psychotherapy), a randomised controlled trial of a transdiagnostic lesbian, gay, bisexual, transgender, queer (LGBTQ)-affirmative cognitive-behavioural therapy intervention (CBT) designed to improve minority stress coping and reduce sexual minority women’s hazardous drinking and mental health comorbidities.

Methods and analysis
This two-arm randomised controlled trial, funded by the National Institute on Alcohol Abuse and Alcoholism, has two objectives: (1) test the efficacy of 10 sessions of LGBTQ-affirmative CBT compared with 10 sessions of supportive counselling for sexual minority women in the community (anticipated n=450) who report hazardous alcohol use and meet criteria for a Diagnostic and Statistical Manual of Mental Disorders – 5 diagnosis of a depression or anxiety disorder and (2) examine psychosocial mechanisms and demographic factors as potential mediators and moderators, respectively, of the treatment-outcome relationship. This study’s primary outcome is change in the proportion of heavy drinking days. Secondary outcomes are changes in depressive and anxious symptoms.

Ethics and dissemination
The Yale University Human Subjects Committee reviewed and approved the research protocol. Results of this study will be disseminated to researchers and practitioners through peer-review publications and conference presentations, and directly to study participants.

Trial registration number
Registered on 17 August 2022 (ClinicalTrials.gov identifier: NCT05509166).

Objectives
To investigate the prevalence and factors of COVID-19 infection in children aged 0–6 years within Hunan Province following the deregulation of epidemic control.

Design
This is an observational study in epidemiology, using an on-site questionnaire survey to investigate the current status of COVID-19 infection and its influencing factors in children aged 0–6 years in Hunan Province from 16 February to 24 March 2023.

Setting
Multi-stage stratified sampling method was applied in this study. The regions were categorised as developed, medium and underdeveloped. One municipality was selected from each category. In each municipality, one district and one county were chosen for cluster sampling.

Participants
Children aged 0–6 years in Hunan Province.

Results
A total of 78 115 children aged 0–6 years were enrolled in this study, of 30 659 (39.2%) had a confirmed positive SARS-CoV-2 test result or related clinical symptoms. The majority of COVID-19 infections in children were of mild type (92.0%), and very few were severe and critical (0.4% and 0.1%). The majority (74.6%–88.7%) of children had minimal lifestyle behavioural changes after infected with COVID-19. Parents of the child working as a staff member (OR=0.654, 95% CI: 0.603, 0.709) and civil servant (OR=0.865, 95% CI: 0.794, 0.941), living in a rural area (OR=0.384, 95% CI: 0.369, 0.400) and no COVID-19 exposure (OR=0.108, 95% CI: 0.104, 0.113) were protective factors for COVID-19 infection in children.

Conclusion
Children experienced a large number of COVID-19 infections following the deregulation, fewer severe cases and fewer changes in lifestyle. Easing epidemic control measures in the later stage of the pandemic did not aggravate the consequences of the epidemic.

‘fuoco di S.Antonio’ malattia pericolosa contrastabile

This prospective multicenter study including individuals with hematuria evaluates the performance of a urinary DNA methylation test in identifying patients with high-grade or invasive bladder cancer.

Objectives
The aim of this study was to determine the prevalence of risky alcohol consumption and regular binge drinking, and their associated factors, in Spanish college students.

Design
A cross-sectional study was conducted.

Setting
This study took place at a private university in a northern region of Spain.

Participants
A total of 330 Spanish undergraduate university students enrolled in the 2022–2023 academic year voluntarily agreed to participate in this investigation.

Primary and secondary outcome measures
Data collection included sociodemographic information and health-related behaviours. The Alcohol Use Disorders Identification Test was used to assess alcohol consumption. Logistic regression models were used to identify independent predictors for risky alcohol consumption and regular binge drinking.

Results
40.0% of participants reported risky alcohol consumption, and 26.7% were classified as regular binge drinkers. Factors associated with risky alcohol consumption included smoking (OR=3.54, 95% CI 2.03 to 6.14) and problematic internet use (OR=2.10, 95% CI 1.24 to 3.53). Conversely, being older than 30 years was associated with a lower likelihood (OR=0.22, 95% CI 0.08 to 0.60). Regular binge drinking was associated with living outside the family home (OR=2.78, 95% CI 1.56 to 4.95), smoking (OR=3.53, 95% CI 1.94 to 6.40) and problematic internet use (OR=2.19, 95% CI 1.23 to 3.89). In contrast, being female (OR=0.50, 95% CI 0.27 to 0.94) and being over 30 years old (OR=0.28, 95% CI 0.10 to 0.86) were inversely associated.

Conclusions
Risky alcohol consumption and binge drinking are relatively common among Spanish university students. Interventions to promote responsible alcohol consumption among this population should be implemented in collaboration with other stakeholders.

Introduction
Maxillary transverse deficiency (MTD) is a common type of malocclusion. For adult MTD patients with highly ossified midpalatal sutures, surgically assisted rapid palatal expansion (SARPE) has been the conventional method of maxillary expansion. However, SARPE has the disadvantages of significant trauma, high cost and a high incidence of adverse events. Therefore, we proposed a novel minimally invasive method for maxillary expansion, which is midpalatal suture osteotomy combined with microimplant-assisted rapid palatal expansion (MSO-MARPE). The results are expected to confirm MSO-MARPE as a novel minimally invasive alternative to SARPE in skeletally mature MTD patients.

Methods and analysis
A prospective, single-centre, parallel-group randomised controlled trial will be conducted, enrolling 20 adult MTD patients. Participants will be randomised equally to the control and experimental groups. The control group will undergo a Lefort I and median osteotomy and postoperative maxillary expansion with a tooth-borne Hyrax-type expander. The experimental group will undergo a midpalatal suture osteotomy and postoperative maxillary expansion with a microimplant-assisted expander. A series of linear and angular parameters will be measured in the pre- and post-coronal planes before treatment (T0), immediately after expansion (T1) and 6 months after expansion (T2) to evaluate the efficacy of skeletal expansion and dental side effects. The study aims to compare the clinical and cost-effectiveness of SARPE and that of MSO-MARPE. The primary outcome is the contribution of posterior midpalatal expansion immediately after expansion. The secondary outcomes include nasal, sutural, alveolar and dental expansion, pain intensity, operative time and treatment costs. The safety indicator will be the number and incidence of adverse events. The interaction between the control group and the experimental group will be analysed using two independent-sample t-tests or Mann–Whitney U test, and the paired data at different time points will be analysed using paired t-test.

Ethics and dissemination
The trial protocol (version 6.0 13 December 2024) has been approved by the Institutional Review Board of the Ninth People’s Hospital of Shanghai Jiao Tong University School of Medicine (approval number: SH9H-2023-T309-3). Results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Trial registration number
ChiCTR2400081545.

Objective
Targeted temperature management (TTM), through its physiological effects on intracranial pressure, may impede the progression to brain death (BD) in severe anoxic brain injury post-cardiac arrest (CA). We examined the potential association between the use of TTM and the occurrence of BD after CA.

Design
Monocentric, retrospective study.

Setting
Intensive care unit, Versailles Hospital, France.

Participants
Comatose survivors of CA who died from BD or postanoxic encephalopathy (PAE) after 24 hours.

Main outcome measures
PAE deaths corresponded to withdrawal of life-sustaining therapy (WLST) due to irreversible postanoxic coma or vegetative state according to prognostication guidelines. BD corresponded to the cessation of cerebral vascularisation secondary to intracranial hypertension. The diagnosis of BD was definite by clinical diagnosis of deep coma according to the Glasgow Coma Scale 3, loss of all brainstem reflexes and the demonstration of apnoea during a hypercapnia test. A cerebral omputed tomography (CT) scan or two isoelectric and unreactive electroencephalograms were used to confirm BD. To identify the independent association between TTM and BD, we conducted a multivariable logistic regression analysis.

Results
Out of 256 patients included between 2005 and 2021, 54.3% received TTM for at least 24 hours, and 56 patients (21.9%) died from BD. In the multivariable analysis, TTM for 24 hours or more was not associated with a decrease in BD (Odds Ratio 1.08, 95% CI 0.51 to 2.32). Factors associated with BD included a total duration of no-flow plus low-flow exceeding 30 min, CA due to neurological causes or hanging and a high arterial partial pressure of carbon dioxide between days 1 and 2 after admission.

Conclusions
This exploratory analysis of post-CA patients with severe anoxic brain injury did not find an association between TTM ≥24 hours and a reduction in BD. Further studies are needed to identify specific subgroups of post-CA patients for whom TTM may be especially futile or even harmful.

Introduction
Fibreoptic bronchoscopy (FOB) is a challenging procedure during mechanical ventilation (MV) as it considerably reduces the endotracheal tube’s internal diameter, causing a drastic increase in respiratory resistance, which may compromise the delivery of ventilatory assistance. According to respiratory physiology principles applied to MV, the reduction of inspiratory flow and tidal volume is likely to reduce airway pressure during the inspiratory phase when respiratory resistances increase. Based on this assumption, we propose new ventilator settings aimed at reducing airway pressure during FOB. This study represents the first investigation to test special ventilator settings in order to facilitate FOB during MV.

Methods and analysis
This is a single-centre randomised double-blind controlled trial, in which intubated patients undergoing an FOB will be assigned (1/1) either to receive the new ventilatory strategy or to stay on the ventilator settings previously selected by the attending physician. The intervention group will be applied the specific ventilator settings (inspiratory flow ≤25 L/min, tidal volume=5 mL/Kg, 1 s≤inspiratory time≤1.3 s, respiratory frequency=16 c/min, positive end-expiratory pressure=5 cm H2O). The primary endpoint will be the reduction of the occurrence of a serious adverse event (inability to deliver ventilatory support, significant arterial desaturation or haemodynamics instability) during FOB, prompting the interruption of the procedure. The primary endpoint will be validated a posteriori by an external adjudication committee. The sample size was estimated at a minimum of 42 patients to demonstrate a 50% reduction in the occurrence of such a serious adverse event with a power of 90% and an alpha risk of 0.05 (2 test). Considering the possibility of technical problems in 10% of cases, 46 patients will be included.

Ethics and dissemination
The study has been approved by the national ethics committee for the protection of the individuals (ID number: 2024-A00747-40). Written informed consent will be obtained from all patients. The results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT06562725.

Epidemia iniziata il 21 gennaio dopo che 3 bambini hanno mangiato un pipistrello

Objectives
We aimed to examine the predictive accuracy of functioning, relapse or remission among patients with psychotic disorders, using machine learning methods. We also identified specific features that were associated with these clinical outcomes.

Design
The methodology of this review was guided by the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy.

Data sources
CINAHL, EMBASE, PubMed, PsycINFO, Scopus and ScienceDirect were searched for relevant articles from database inception until 21 November 2024.

Eligibility criteria
Studies were included if they involved the use of machine learning methods to predict functioning, relapse and/or remission among individuals with psychotic spectrum disorders.

Data extraction and synthesis
Two independent reviewers screened the records from the database search. Risk of bias was evaluated using the Quality Assessment of Diagnostic Accuracy Studies tool from Cochrane. Synthesised findings were presented in tables.

Results
23 studies were included in the review, which were mostly conducted in the west (91%). Predictive summary area under the curve values for functioning, relapse and remission were 0.63–0.92 (poor to outstanding), 0.45–0.95 (poor to outstanding), 0.70–0.79 (acceptable), respectively. Logistic regression and random forest were the best performing algorithms. Factors influencing outcomes included demographic (age, ethnicity), illness (duration of untreated illness, types of symptoms), functioning (baseline functioning, interpersonal relationships and activity engagement), treatment variables (use of higher doses of antipsychotics, electroconvulsive therapy), data from passive sensor (call log, distance travelled, time spent in certain locations) and online activities (time of use, use of certain words, changes in search frequencies and length of queries).

Conclusion
Machine learning methods show promise in the prediction of prognosis (specifically functioning, relapse and remission) of mental disorders based on relevant collected variables. Future machine learning studies may want to focus on the inclusion of a broader swathe of variables including ecological momentary assessments, with a greater amount of good quality big data covering longer longitudinal illness courses and coupled with external validation of study findings.

PROSPERO registration number
The review was registered on PROSPERO, ID: CRD42023441108.