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

Introduction
Heavy alcohol use has the potential to derail progress towards UNAIDS 95-95-95 targets for countries in sub-Saharan Africa (SSA). Within couples, alcohol use is closely linked with factors such as intimate partner violence and economic insecurity and can result in poor adherence to antiretroviral therapy (ART) and HIV clinical outcomes. We hypothesise that a combined economic and relationship intervention for couples that builds on the prior success of standalone economic and relationship-strengthening interventions will be efficacious for improving HIV clinical outcomes and reducing alcohol use. The synergy of these interventions has not been assessed in SSA—specifically among people living with HIV who drink alcohol. To test this hypothesis, we will test Mlambe, an economic and relationship-strengthening intervention, found to be feasible and acceptable in a pilot study in Malawi. We will conduct a full-scale, randomised controlled trial (RCT) to evaluate the efficacy and cost-effectiveness of Mlambe.

Methods and analysis
We will enrol 250 adult married couples having at least one partner living with HIV and reporting heavy alcohol use. There will be two arms: Mlambe or an enhanced usual care control arm. Couples in the Mlambe arm will receive incentivised matched savings accounts and monthly sessions on financial literacy, relationship skills, and alcohol reduction education and counselling. Participants will be assessed at baseline, 11 months, 15 months and 20 months to examine effects on heavy alcohol use, HIV viral suppression, ART adherence and couple relationship dynamics. Study hypotheses will be tested using multilevel regression models, considering time points and treatment arms. Programmatic costs will be ascertained throughout the study and incremental cost-effectiveness ratios will be computed for each arm.

Ethics and dissemination
The RCT has been approved by the University of California, San Francisco (UCSF) (Human Research Protection Program; Protocol Number 23-40642), and the study has been approved by the National Health Sciences Research Committee (NHSRC; Protocol Number 24/05/4431) in Malawi. Adverse events and remedial actions will be reported to authorities both in Malawi and at UCSF. Results will be disseminated to study participants, local health officials and HIV policy makers and through presentations at conferences and publications in peer-reviewed journals.

Trial registration number
ClinicalTrials.gov Protocol Registration; NCT06367348 registered on 19 April 2024; https://register.clinicaltrials.gov/. Protocol Version 1.0: 22 October 2024.

Objectives
To test the feasibility and acceptability of a text-message-delivered behavioural intervention to promote and maintain physical activity and recovery after stroke rehabilitation.

Design
A single-arm acceptability and feasibility study.

Setting
Community rehabilitation services in two Health Board areas in Scotland.

Participants
People with stroke who could participate in physical activities and use a mobile phone were recruited during rehabilitation and community rehabilitation.

Intervention
Keeping Active with Texting after Stroke (KATS) is an automated text message-delivered intervention informed by behaviour change theory. It delivers a structured sequence of 103 messages over 14 weeks to support the uptake and maintenance of physical activities following stroke rehabilitation.

Outcomes
Data on recruitment, retention and satisfaction were collected. Semistructured interviews explored intervention acceptability. Preintervention and postintervention measures provided preliminary information on step count, functional independence, mental well-being, self-efficacy and quality of life.

Results
18 men and 13 women were recruited; three withdrew before intervention commencement. All 28 participants who received at least one text message completed the study, indicating 100% retention. Median satisfaction score was 23/25 (range 12–25). All but one participant read and responded to texts, indicating good engagement. Effect sizes (Cohen’s d; per cent change) were demonstrated in step count (0.2; 13%), extended activities of daily living (0.24; 8.3%) and mental well-being (0.35; 7%). Participants perceived KATS as acceptable, valuing messages and motivational prompts, but personalised tailoring was desired by some.

Conclusions
Recruitment, retention and outcome measure completion were feasible, and KATS was perceived as acceptable. Findings suggest some modifications of messages and goal-setting processes are required to accommodate participants with diverse physical activity capabilities before a definitive trial. Promising indicators of effects were detected, although interpretation must be cautious because the study was not powered to determine efficacy, and there was no control group. Based on these findings, KATS will be further optimised before evaluating effectiveness in a randomised controlled trial.

Trial registration number and protocol availability
ISRCTN 13704805 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/keeping-active-with-texting-after-stroke-kats/
Protocol available https://www.isrctn.com/ISRCTN13704805?q=13704805&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10

Objectives
Currently, there is no generally accepted consensus on how to translate strength of evidence into language. Against this background, we here investigated how widely used verbal descriptors of evidence grades and clinical practice recommendations, respectively, are understood, interpreted and transferred into intentions to treat. We explored differences between medical specialists and undergraduate medical students.

Design
Cross-sectional, anonymous online survey. Assessment was based on publicly available proposals for wording to characterise strength of evidence from randomised versus non-randomised trials and of clinical practice recommendations, respectively.

Setting
The online survey was conducted between September 2021 and March 2022 and promoted by several professional organisations in German-speaking European countries (Germany, Austria and Switzerland).

Participants
Medical students, trainees and medical specialist (open to all medical specialties).

Outcome
The survey was composed of two sections: (1) Aim of the first survey section was to assess if the linguistic differentiation between results from randomised versus non-randomised studies is correctly understood as put forward by the proponents. To this end, participants were asked to grade the relative weight of the expression for the results of a randomised trial versus two proposals for how to express the results of non-randomised studies. (2) Next, strong positive, weak positive, weak negative and strong negative clinical recommendations were presented, and participants were asked to answer in a forced-choice format if they would treat all/no patients, selected patients or only consider treatment. Additionally, the number of eligible patients who would be treated was assessed.

Results
N=1081 physicians and N=539 medical students completed the survey. (1) Less than half of the participants (48.5%) interpreted use of ‘associated with’ as linguistic differentiation between results from randomised versus non-randomised trials in a sense as put forward by the proponents. However, use of the subjunctive mood (‘could’) resulted in 87.3% correct differentiations. (2) Even with only four types of clinical practice recommendations (positive/negative and strong/weak), interpretation and translation into intention to treat, respectively, showed a heterogeneous picture: while the presentation of a strong clinical recommendation led to largely congruent responses, the interpretation of weak recommendations showed a high variability, with no clear response pattern for intentions to treat. Responses from physicians and medical students were largely comparable.

Conclusion
This study demonstrates limitations in the currently used linguistic expressions of strength of evidence and clinical practice recommendations and supports the need to prospectively test effects of language on intentions to treat prior to implementation of a certain wording. Study results cast doubt on that linguistic means alone will lead to optimally targeted intentions to treat.

Introduction
Pheochromocytoma/paraganglioma (PPGL) resection remains a high-risk surgical procedure owing to severe haemodynamic instability, which can lead to myocardial injury after non-cardiac surgery (MINS). MINS is the most common and easily overlooked cardiovascular complication and results in increased postoperative mortality and prolonged inpatient hospitalisation. We aimed to develop and validate a predictive model for MINS in patients undergoing laparoscopic PPGL resection.

Methods and analysis
The PPGL-MINS study is a single-centre, observational, ambispective cohort study that includes patients undergoing elective laparoscopic PPGL resection under general anaesthesia at the Peking Union Medical College Hospital (PUMCH) between 1 January 2013 and 31 May 2025. We expect to enrol 700 patients, including at least 550 patients retrospectively and 150 patients prospectively. A prediction model will be developed for the retrospective cohort (training cohort) of patients from 1 January 2013 to 31 December 2022. Possible clinically relevant variables, particularly intraoperative blood pressure and heart rate, will be selected as candidate predictors. Stepwise and least absolute shrinkage and selection operator regression will be used for predictor selection. Multivariate logistic regression will be used to develop the prediction model, which will be presented as a nomogram. The developed model will be used to assess discrimination with the receiver operating characteristic curve and area under the curve value, calibration with the Hosmer-Lemeshow test and calibration curve, and clinical usefulness with decision curve analysis. Internal validation will be assessed with bootstrap. For external validation, we will use an independent prospective cohort (validation cohort) of patients from 1 March 2023 to 31 May 2025.

Ethics and dissemination
The study protocol has been approved by the Research Ethics Committee of PUMCH (IRB-K2893). Written informed consent will be obtained from all participants in the prospective cohort before enrolment in the study. We aim to publish and disseminate the findings in peer-reviewed journals and at scientific conferences.

Trial registration number
NCT05752773.

Objective
Beneficiaries’ satisfaction with health insurance schemes is crucial for the success of these programmes, influencing their effective implementation and reducing dropout rates. This systematic review and meta-analysis aimed to assess the proportion of beneficiaries satisfied with health insurance and identify factors associated with their satisfaction in Sub-Saharan Africa (SSA).

Design
A systematic review and meta-analysis were conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis guidelines.

Data sources
PubMed/MEDLINE, African Journals Online, Cumulative Index to Nursing & Allied Health Literature and Google Scholar were searched up to 23 May 2024.

Eligibility criteria
Observational and quantitative studies conducted in SSA that reported the proportion of health insurance beneficiaries satisfied with the scheme and/or determined factors associated with satisfaction were included.

Data extraction and synthesis
Data were extracted using Microsoft Excel and analysed with STATA V.17 software. The quality of studies was assessed using Joanna Briggs Institute checklists. A random-effects model was employed to estimate pooled outcomes. Publication bias was evaluated with a funnel plot and Egger’s regression test, while heterogeneity was assessed using the I² statistic.

Result
The study included 29 primary studies with a total of 11,488 participants. Among the included studies, 17 (58.62%) were found to have a low risk of bias, while the remaining studies exhibited a moderate risk of bias. The findings suggested publication bias among the included studies. To address this, a trim-and-fill analysis imputed 10 hypothetical missing studies, resulting in a more symmetrical funnel plot. The pooled finding showed that 61.84% of beneficiaries were satisfied with their health insurance (95% CI: 55.14 to 68.55, (I2=98.6%, p

Ancona, caso senza precedenti di paziente con una rara malattia

Objective
Ampullary neoplastic lesions can be resected by endoscopic papillectomy (EP) or transduodenal surgical ampullectomy (TSA) while pancreaticoduodenectomy is reserved for more advanced lesions. We present the largest retrospective comparative study analysing EP and TSA.

Design
Of all patients in the database, lesions with prior interventions, benign histology advanced malignancy (T2 and more), patients with hereditary syndromes and those undergoing pancreatoduodenectomy were excluded. All remaining cases as well as a subgroup of them, after propensity-score matching (nearest-neighbour-method) based on age, gender, anthropometrics, comorbidities, size and histological subtype, were analysed. The median follow-up was 21 months (IQR 10–47) after the primary intervention. Primary outcomes were rates of complete resection (R0) and complications. Groups were compared by Fisher’s exact or 2 test, Mann-Whitney-U-test and log-rank test for survival.

Results
Of 1673 patients in the database, 1422 underwent EP and 251 TSA. Of them, 23.2% were excluded for missing or inconclusive data and 19.8% of patients for prior interventions or hereditary syndromes. Final histology showed in 24.2% of EP and 14.8% of TSA patients a histology other than adenoma or adenocarcinoma while advanced cancers were recorded in 10.9% of EP and 36.6% of TSA patients. Finally, 569 EP and 63 TSA were included in the overall analysis, with a higher rate of more advanced cases and higher R0 resection rates in the TSA groups (90.5% vs 73.1%; p

Introduction
The aim of this study is to investigate the effects of acute exercise on appetite control and whether this differs between morning and late afternoon in individuals with overweight/obesity with or without type 2 diabetes (T2D).

Methods and analysis
The hedonic and homeostatic appetite control in obesity and type 2 diabetes in the context of meal and exercise timing (TIMEX) study is a randomised, controlled, cross-over trial. Fifty-eight women and men (aged 18–75 years) with overweight or obesity (body mass index ≥25 kg/m2) with or without T2D will be recruited. All participants will complete a screening and baseline visit followed by four test visits: two morning visits and two late afternoon visits. The participants will arrive in the fasted state during the visits. During one morning visit and one late afternoon visit, the participants will engage in a 45-min bout of acute high-intensity interval exercise on an ergometer bicycle. The remaining two visits (one morning and one late afternoon visit) will include 45 min of rest. Fifteen minutes after the rest or exercise period, the participants will be presented with an ad libitum meal. Blood samples will be collected and subjective appetite will be assessed using Visual Analogue Scales in the fasted state before exercise/rest, immediately post-exercise/rest and at 15, 30, 45 and 60 min post-exercise/rest. Food reward and food preferences will be assessed using the validated diurnal version of the Steno Biometric Food Preference Task in the fasted state before exercise/rest and 15 min after the ad libitum meal (45 min post-exercise/rest). The primary outcome is the difference in ad libitum energy intake after exercise compared with rest. Secondary outcomes include eating rate; 24-hour energy intake; appetite-related metabolites and hormones, and circulating biomarkers assessed from proteomics, metabolomics and lipidomics analyses; food choice, food attention and reaction time, explicit and implicit liking and wanting for different food categories, subjective appetite; ratings of perceived exertion during exercise. All outcomes will be compared between morning and late afternoon and between participants with and without T2D.

Ethics and dissemination
The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-22019913) and the Capital Region of Denmark’s Research Register (Privacy). The study will be conducted in accordance with the Declaration of Helsinki. All results will be published in national and international peer-reviewed journals and will be disseminated at national and international conferences.

Trial registration number
NCT05768958.

Objectives
To investigate the relationship between sleep quality and perimenstrual symptoms among Japanese female students.

Design
Observational, cross-sectional, online survey

Setting
We used an online questionnaire to collate responses from Japanese female students on sleep quality and perimenstrual symptoms.

Participants
A total of 298 female students aged 18–25 years in Japan were included in this study.

Primary and secondary outcome measures
The Menstrual Distress Questionnaire (MDQ) was used to assess the severity of perimenstrual symptoms for three periods—premenstrual, menstrual and postmenstrual—and the Japanese version of the Pittsburgh Sleep Quality Index was used to assess sleep quality. The MDQ scores were compared between two groups (normal-sleep quality and low-sleep quality) using Mann-Whitney U test. In addition, multiple logistic regression analysis was performed, and the MDQ subscales that showed significant differences between the groups were used as independent variables. The MDQ subscale that was strongly associated with sleep quality was calculated.

Results
Of the female students, 160 were classified into the normal-sleep quality group and 138 into the low-sleep quality group. The total MDQ scores were significantly higher in the low-sleep quality group at all phases of the menstrual cycle (respectively p

Purpose
The prospective Viral load Cohort North-East Lesotho (VICONEL) aims to support clinical management and generate scientific evidence to inform HIV care. Specifically, VICONEL allows for the monitoring of HIV treatment outcomes and health system performance, encompasses a biobank for further research with routinely collected blood plasma samples of consenting participants and provides a valuable framework for nested observational and interventional studies.

Participants
VICONEL captures routine viral load test results alongside associated demographic and treatment information among people in care for HIV in Lesotho, southern Africa. As of December 2023, it encompasses all viral load testing from 24 healthcare facilities in two districts of Lesotho.

Findings to date
From January 2016 to December 2023, 137 660 viral load test results were available for 29 380 participants. At the time of the last viral load test, median age was 42 years (IQR: 33–53); 18 511 (63%) were adult women, 10 029 (34%) adult men and 835 (3%) children

Le testimonianze dopo la malattia, ora più innamorate della vita

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