Search Results for: Report aggiornato sulla qualità dell’aria in Europa (2015)

Introduction
Methamphetamine use disorder is a global public health concern with no approved pharmacotherapies for its treatment. One recent randomised controlled trial conducted in the USA examined a combination of bupropion and naltrexone not readily available globally. Here, we report a trial protocol for an oral formulation of combined naltrexone and bupropion.

Methods and analysis
This single-arm, open-label pilot study will assess the safety and feasibility of oral naltrexone and bupropion (40 mg/450 mg daily in divided doses) in adults with methamphetamine use disorder. Participants (n=20) will be outpatients of a stimulant treatment program at an inner-city hospital in Sydney, Australia. The primary endpoint is Day 84. Participants will attend weekly study visits from Baseline to Week 12 and a follow-up telephone visit at Week 16. All participants will receive treatment as usual, such as psychosocial therapy. Primary outcomes are safety (measured by treatment-emergent adverse events (AEs)/adverse reactions) and feasibility (measured by the time taken to recruit, the proportion of ineligible participants, retention in the study and study medication adherence). Secondary outcomes will assess methamphetamine use, craving and withdrawal; treatment goals and expectations; physical and psychological well-being; depression and anxiety; and treatment satisfaction. Qualitative interviews will assess the acceptability of the intervention and outcome measures.

Ethics and dissemination
This study received ethics approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00549). Results will be submitted to peer-reviewed journals and scientific conferences, and a video abstract will be created to ensure that the findings are accessible to participants and people who use methamphetamines.

Trial registration number
ANZCTR: ACTRN12623000866606 (protocol V.2.1 dated 08 April 2024).

Objectives
To investigate the association of individual patient health with their characteristics, including income deprivation, ethnicity and gender, with the size, quality and staffing of their general practices, and how these associations and income-related health inequality vary across chronic conditions, regions and age bands.

Design
Using observational pooled cross-sectional individual patient survey data linked with data on general practice clinical quality and staffing and deprivation at Lower-Layer Super Output Area level. Ordinary least-squares multiple regression models of patient health estimated on the full sample and on eight condition-specific, nine region-specific and six age-specific subsamples. Three concentration indices embodying different value judgements summarise income-related health inequality in the full sample and subsamples.

Setting
Primary care in England.

Participants
Over 1 million adult patients in 6426 general practices in 2015/2016 and 2016/2017.

Primary outcome measures
Patient-reported health (the 5-level EQ-5D version or EQ-5D-5L).

Results
Patients who are younger, male, more satisfied with their practice, have fewer chronic conditions and live in less-income or education-deprived areas report better health. White ethnicity is associated with worse health up to age 64 and better health from age 65, with better health in five of the eight chronic condition samples, and in the regional samples except for London and Yorkshire and Humber regions. Practice clinical quality is positively associated with health in the full sample but only in 4 of the 23 subsamples. Income-related health inequality is worst for patients with a mental health problem, residents in the northwest and northeast regions and is greatest for those aged 55–64. The three concentration indices are highly positively correlated across chronic condition and age-band samples. One index has a much weaker correlation relationship with the other two indices in the region-specific samples.

Conclusion
Income-related health inequality and the associations of health with patient and practice characteristics are heterogeneous by patients’ chronic condition, age and region.

Message Surgical removal is recommended for gastrointestinal stromal tumours (GISTs) larger than 3 cm due to their potential for malignancy but limited wedge resection is not possible in the proximal stomach. Endoscopic removal of larger lesions has been technically limited in complex anatomical regions such as cardia. We report two cases of large proximal (cardia/fundus) GIST tumours (51 and 60 mm) which were downsized (to 26 and 36 mm) by 3–7 months of imatinib therapy followed by transmural endoscopic resection. Follow-up of 23 and 16 months including endoscopy and CT was unremarkable. In more detail GISTs commonly occur in the stomach.1 2 Due to their malignant potential, surgery is generally recommended.3–5 Recently, endoscopic resection of submucosal tumours (SMTs) has made significant progress.6 The European Society of Gastrointestinal Endoscopy recommended endoscopic resection for gastric GISTs

Background and objectives
Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it. Secondary objectives: to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse.

Design
Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn’s disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn’s disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)). All patients maintained immunomodulators. Patients were followed-up until month 12 or up to clinical relapse.

Results
One-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA. The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%. The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 µg/g at the end of follow-up in the WA (p=0.01). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA).

Conclusion
Anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment.

Trial registration number
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10
https://clinicaltrials.gov/study/NCT02994836

Via a 2 fase del progetto Oms Europa coordinato in Italia da Iss

Introduction
Individuals with stroke are at risk of long-term overweight and obesity due to biopsychosocial factors. Being overweight and obese is associated with an increased risk of numerous chronic conditions, including recurrent stroke. Unfortunately, recommendations for nutritional interventions vary. The objective of this scoping review is to identify and map the body of literature on professional nutritional interventions aimed at preventing or reducing overweight and obesity during postacute stroke rehabilitation.

Methods and analysis
The review follows the Joanna Briggs Institute methodology for scoping reviews. A three-step librarian-assisted search strategy will be conducted using the bibliographic databases MEDLINE (PubMed), Embase, CINAHL and Web of Science. Indexed and grey literature in English and Scandinavian languages, from January 2010 to the present, will be considered for inclusion. The scoping review will include materials such as research articles, methodological papers and clinical guidelines that report on nutritional interventions aimed at preventing or reducing overweight and obesity among individuals with stroke (aged ≥18 years) from admission to rehabilitation hospitals. We will map and identify any kind of nutritional intervention in rehabilitation hospitals, nursing homes or their own environments in high-income countries. Two independent reviewers will conduct an iterative process for screening the identified literature, paper selection and data extraction. Disagreements will be resolved through discussion or with an additional reviewer. A data extraction form will be used to guide the data extraction.

Ethics and dissemination
This review will involve the collection and analysis of secondary sources that have been published and/or are publicly available. Therefore, ethical approval is not required. The results will be published in an international peer-reviewed journal, presented at scientific conferences and disseminated through digital science communication platforms.

Trial registration number
The protocol is registered in the Open Science Framework: https://osf.io/ga63n/view_only=ee07beace7bb48d6b9c82cbf79cf2e95.

Introduction
Efforts to increase engagement with diabetes prevention programmes largely focus on increasing diabetes awareness, with the logic that risk knowledge will motivate behaviour change. However, the salience of perceived risk as it relates to diabetes prevention is contested. The goal of this cross-sectional, embedded mixed-methods study was to examine the relationships between perceived risk, diabetes beliefs and prevention behaviours among adults at elevated risk of type 2 diabetes.

Methods
Data come from the Richmond Stress and Sugar Study (n=125). Diabetes beliefs (ie, internal, chance, powerful others) were assessed using the Multidimensional Health Locus of Control. Preventive behaviours (eg, changing diet, exercise, tobacco, alcohol) were measured by self-report. Perceived risk of developing diabetes was measured using a probability scale (0%–100%). Logistic and Poisson regression models quantified the relationships between beliefs, behaviours and perceived risk. Qualitative themes regarding challenges and facilitators to preventive behaviours were abstracted from open-ended questions and summarised using content analysis.

Results
Perceived risk of developing diabetes was low (median: 35% likelihood) and only 10% of participants had ever attended a prevention class. None of the diabetes belief domains were significantly associated with either engagement in preventive behaviours or perceived diabetes risk. Perceived diabetes risk was not associated with engagement in preventive behaviours; however, having a family history of diabetes was strongly related to perceived risk (OR: 3.35, 95% CI: 1.42 to 7.86). Qualitative facilitators and barriers of preventive behaviours reflected psychosocial factors (eg, determination, stress, preferences) and resources (eg, social support, time, overall health).

Conclusions
Perceptions of risk and health beliefs are not correlated with engagement in preventive behaviours among adults at clinically elevated risk of diabetes. Awareness campaigns may benefit from incorporating family health history information. Diabetes prevention programmes should address barriers beyond health beliefs to promote engagement in behaviour change.

Purpose
The Outcome Monitoring After Cardiac Surgery (OMACS) cohort study was set-up with the aim of establishing a rich source of biological samples and health status data from patients who undergo cardiac surgery. The objectives were to use these data to inform the design of new clinical studies and to provide samples and data to answer research questions.

Participants
Recruitment began on 23 May 2016 and ended 31 May 2022. Adult patients undergoing cardiac surgery at University Hospitals Bristol and Weston NHS Foundation Trust were screened and approached for consent. Participants could optionally consent to provide biological samples (urine, blood and waste tissue) in addition to data. A total of 4068 patients consented to participate in the study with 2027 consenting to donate samples. Participants were sent quality-of-life follow-up questionnaires at 3 and 12 months after surgery. The clinical data were collected from hospital records/databases.

Findings to date
The OMACS population appears to be representative of the wider cardiac surgery population with similar preoperative demography to those reported on the UK surgery population. To date, eight studies have been carried out by research teams using data from a total of 1165 OMACS participants. Two Studies Within A Trial have been performed by the OMACS study team. The format of the study patient information leaflet was not significantly associated with an increased recruitment rate, and an alternative theory-informed cover letter included with the 12-month follow-up questionnaires was not associated with an increase in questionnaire completion. Additional exploratory research carried out within the OMACS study has been presented at international conferences.

Future plans
The OMACS study is now closed. The cohort’s data and samples will be available to share with researchers, providing an opportunity to answer a variety of research questions (eg, evaluating predictors of adverse outcomes after cardiac surgery such as biomarkers, surgical methods and pre-existing conditions). The data and samples will be available for sharing in a linked anonymised format.

Trial registration number
ISRCTN90204321 (date assigned: 21 January 2015).

Pochi ospedali monitorano i sintomi dei pazienti. ‘Serve un cambio di passo’

A contemporary report describing the burden and expenditures of gastrointestinal (GI) diseases can be helpful for policy makers, administrators, and researchers. Using the most recent data, we estimated the burden and costs associated with GI diseases in the United States.

Objective
This study aimed to investigate the trends and factors associated with congenital anomalies (CAs) among newborns in Eastern Ethiopia from 2015 to 2022.

Design
Open cohort study.

Setting
The Kersa Health and Demographic Surveillance System (KHDSS), which is located in the Kersa district of the Oromia region in Eastern Ethiopia, covering 24 kebeles.

Population
Newborns registered at birth in the database of the KHDSS site in Eastern Ethiopia.

Methods
The KHDSS tracks demographic and health changes in the community. Newborn data were extracted using a checklist. Trends in CAs over time (in years) were analysed and the associated factors were identified through logistic regression analysis.

Outcome measure
Newborn CAs, which are structural or functional abnormalities present at birth, were assessed through thorough physical examinations and detailed interviews conducted by trained data collectors using a standardised questionnaire.

Results
Between 2015 and 2022, a total of 27 350 newborns were recorded in the KHDSS, 104 of whom had CAs. The overall rate of CAs was 3.83 per 1000 live births (95% CI 3.19, 4.61). There was a significant increase in the trend of CAs over the study period, with a Mantel-Haenszel 2 of 82.76 (p=0.001). Factors associated with CA included maternal age over 35 years (adjusted OR (AOR)=1.68, 95% CI 1.07, 2.62), place of birth (AOR=2.04, 95% CI 1.04, 4.02) and normal birth weight (AOR=0.14, 95% CI 0.04, 0.47).

Conclusion
The data from the KHDSS revealed a rising trend in CAs. CA was associated with factors such as the mother’s age, place of birth and the baby’s birth weight. It is crucial for healthcare providers and stakeholders to consider these factors in efforts to reduce the prevalence of CAs.

Circulation, Volume 151, Issue 5, Page 318-330, February 4, 2025. Representativeness in randomized clinical trials remains a critical concern, affecting the external validity of trial results, equitable access to the risks and benefits of research participation, and public trust in clinical research. Although representative participation by members of groups traditionally underrepresented in clinical trials is just a surrogate for true diversity, equity, inclusion, and belonging in clinical trials, it can be quantified, allowing stakeholders to add empirical rigor to diversity, equity, inclusion, and belonging efforts. Multiple ways to measure representativeness have been proposed, including the participation-to-prevalence ratio, raw participation proportions or numbers for relevant subgroups, and enrollment fraction for relevant subgroups. These methods have strengths and weaknesses and may be appropriate to report in certain circumstances, depending on why stakeholders seek to assess representativeness. Stakeholders—including regulatory agencies, journal editors, clinical trial investigators, and trial sponsors—may use quantitative measures of representativeness to establish trial enrollment standards, monitor equitable participation in ongoing trials, and condition funding or drug or device approval on achieving specific representativeness targets. However, using quantitative measures of representativeness in this way could have unintended consequences, including researchers “gaming” recruitment strategies to meet target numbers, overlooking nuanced variations within communities, and potentially incentivizing problematic and exploitative recruitment strategies. Although no single method of measuring representativeness offers a comprehensive solution for increasing diversity, equity, inclusion, and belonging in all randomized clinical trials, a carefully designed, multifaceted approach to measuring representativeness may provide stakeholders with useful perspectives for measuring progress in increasing the diversity of clinical trial participation. For stakeholders seeking a single number to assess the representativeness of a trial enrolling patients with a disease state with well-delineated demographics, the participation-to-prevalence ratio is ideal; however, for a more nuanced view of representativeness, the combination of enrollment fraction in subgroups of relevance plus a full report of the demographics of patients approached for enrollment may be more appropriate.

Introduction
Postpartum haemorrhage (PPH) negatively impacts women’s health. Preventing and managing PPH is important, and nurse-led interventions are needed. However, no systematic review has evaluated the effectiveness of non-invasive uterine massage for PPH prevention. Therefore, this systematic review aims to assess the efficacy of midwife/nurse-led intervention in managing PPH, serving as the best available evidence to develop further guidelines and recommendations in practice and policy-making.

Methods and analysis
This systematic review will follow the JBI methodology for systematic reviews of effectiveness. The search will be conducted in the MEDLINE (PubMed), CINAHL (EBSCO), BENTHUM Science, JBI, Cochrane, ThaiJo and Google Scholar databases. Studies will be included in English and Thai and published between 2015 and 2024. Two independent reviewers will conduct the review, with data extraction and quality evaluation. Studies will be pooled in a statistical meta-analysis using JBI System for the Unified Management, Assessment and Review of Information or other software where possible.

Ethics and dissemination
This systematic review does not require formal ethical approval because all data will be analysed anonymously. The results will provide an overall review and evidence of midwife/nurse-led non-invasive uterine massage intervention in preventing PPH. These findings will be disseminated through peer-reviewed publications.

PROSPERO registration number
CRD42024566382

La denuncia dei farmacisti, nel 68% dei casi interrotte o sospese le produzioni

This case report describes a man in his 60s with hypertension, deep vein thrombosis, and a recent diagnosis of HIV presented with low CD4 cell count after starting antiretroviral therapy with tenofovir alafenamide-emtricitabine-bictegravir.

This case report describes 2 older patients with refractory mogamulizumab-associated rash successfully treated with upadacitinib.