Search Results for: Standard di cura nel diabete 2024

The Original Investigation titled “Exploration-Exploitation and Suicidal Behavior in Borderline Personality Disorder and Depression,” published on October 2, 2024, was corrected to add a grant number to the Funding/Support section. This article was corrected online.

In the Original Investigation titled “Opioid Prescribing and Outcomes in Patients With Sickle Cell Disease Post–2016 CDC Guideline,” published online on March 11, 2024, and in the May 2024 issue, the study sample was inaccurately described. In the original article, the included study participants were referred to as individuals with sickle cell disease who were at least 1 year of age, had no cancer diagnosis, and had pharmacy coverage for the month of measurement. However, the participants included in the study were those who met these criteria and had at least 1 health care encounter (inpatient or outpatient) in the month. All data were reanalyzed using the sample described in the published article (ie, patients with sickle cell disease, regardless of their health care visit history). Corrections were made to the Key Points, Abstract, Results, Discussion, Table 2, Figures 1 to 3, eTables 3 to 7, and eFigures 2 and 4 to 6 in Supplement 1. The overall sample size remained unchanged, but the mean (range) number of patients included in each month was corrected, which impacted 4 outcomes that used monthly sample size as the denominator. In addition, the statistical significance of 2 outcomes shifted: the monthly opioid prescription rate lost statistical significance, and the monthly rate of pain-related emergency department visits gained statistical significance. The interpretations and conclusions of the study were not affected. The article was corrected online.

Piovella (Soi): ‘Dare ai pazienti il massimo della qualità”

George S, Lucero Y, Cabrera C, et al. Protocol for a randomised ‘screen-and-treat’ Helicobacter pylori eradication trial in 14–18-years-old adolescents residing in three regions of Chile: effectiveness and microbiological host implications. BMJ Open 2025;15:e084984. doi:10.1136/bmjopen-2024–0 84 984
This article has been corrected since it was published online. The funding information has been updated from “The funder has no influence on the study’s design, execution, analysis, or publication of results. The funder has no influence on the study’s design, execution, analysis, or publication of results. The funder has no influence on the study’s design, execution, analysis, or publication of results.” to “This trial has received funding from the National Fund for Scientific and Technological Development (Fondecyt 1 220 964 and 1190456). MO received partial funding from the grant ANID PIA AFB 230002. The funder has no influence on the study’s design, execution, analysis, or publication of results.”

Introduction
Diabetic retinopathy is one of the leading causes of vision impairment globally. Alongside the systemic control of diabetes and timely detection of diabetic retinopathy, the prompt initiation and completion of treatment is essential to prevent vision loss. Routine monitoring of access to retinal screening services for the detection of diabetic retinopathy is common, while monitoring of coverage of subsequent treatment services is far less common. When diabetic retinopathy treatment coverage is assessed, there is great variability in how it is defined and reported. If a definition of treatment coverage could be standardised, the monitoring of the quality of diabetes eye care could more readily be compared between settings and over time. The aim of this review is to summarise how diabetic retinopathy treatment coverage has been measured in published studies and the extent to which these have been disaggregated by population groups.

Methods and analysis
A search will be conducted on Medline and Embase without any language restrictions, for cohort and cross-sectional studies published from 1 January 2015 that report diabetic retinopathy treatment coverage for adults with diabetic retinopathy and/or macular oedema. We will include studies from any world region reporting diabetic retinopathy treatment coverage for one or more of: (1) laser photocoagulation; (2) intravitreal injections of antivascular endothelial growth factor agents; (3) intravitreal injections of corticosteroids; (4) vitrectomy. The PROGRESS framework (place of residence, race/ethnicity/culture/language, occupation, gender/sex, religion, education, socioeconomic status and social capital) will be used to assess disaggregation by population groups. Two investigators will independently screen studies and extract relevant data. Data will be synthesised descriptively to outline the full range of definitions of diabetic retinopathy treatment coverage in the literature and identify the common sources of data used.

Ethics and dissemination
This review will only include published data; thus, no ethical approval will be sought. The findings of this review will be published in a peer-reviewed journal and presented at relevant conferences. The findings will also be considered in conjunction with an ongoing review on retinal screening for diabetic retinopathy to develop indicators for monitoring of services along the diabetes eye care pathway, which may include an indicator of effective service coverage.

Registration
Open Science Framework registration 6/08/2024: https://osf.io/5b93m

Introduction
The introduction of perfusion technologies in kidney transplantation has the potential to improve graft function and survival and increase utilisation. Our previous work demonstrated that kidneys with an enhanced inflammatory and immune response during normothermic machine perfusion (NMP) had significant graft dysfunction after transplantation. The addition of a cytokine filter (CytoSorb) to the NMP circuit dramatically reduces both circulating inflammatory mediators and inflammatory gene expression, but this has not been trialled in clinical practice.

Methods and analysis
This is a randomised phase 1 pilot study to evaluate the safety and feasibility of using a CytoSorb filter in clinical NMP to remove inflammatory and immune mediators. Eligible kidney transplant recipients on the waiting list in the East of England will be approached for consent. A total of 20 patients will be recruited and randomised in a 1:1 ratio for the donor kidney to receive either NMP or NMP with a CytoSorb filter pre-transplantation. The kidney will be transplanted according to standard practice after NMP. The primary endpoint is inflammatory and immune gene expression measured in a cortical biopsy from the kidney 60 min post-transplant. Secondary endpoints include rates and duration of delayed graft function and graft function as assessed by change in creatinine clearance and estimated glomerular filtration rate 2 days, 5 days, 1 month and 3 months post-transplant. Additionally, inflammatory mediators and injury markers will be measured in peripheral blood and urine samples taken pre-operatively and on days 2 and 5 after transplant.

Ethics and dissemination
This study has been approved by the Health Research Authority Health and Care Research Wales Committee (REC 23/WM/0141) and by National Health Service (NHS) Blood and Transplant (Ref: Study 148). Findings will be published in a peer-reviewed journal and disseminated at scientific conferences. The dataset will be made available on request.

Trial registration
The study is prospectively registered on the ISCRTN registry (ID: 13698207).

Introduction
Over the past decades, there has been increasing recognition that assessing patients with cancer’s health-related quality of life (HRQoL) is pivotal to delivering optimal patient-centred healthcare. However, with the increasing number of patient-reported outcome measures (PROMs) available, it becomes more and more challenging to identify the most appropriate PROM to capture HRQoL. Therefore, the aim of this systematic review is to (1) identify all available PROMs assessing HRQoL across the European cancer continuum and (2) critically appraise, compare and summarise the psychometric properties of the identified PROMs.

Methods and analysis
Bibliographic databases MEDLINE and PubMed Central (through PubMed) and EMBASE (through Scopus) will be comprehensively searched from database inception until March 2024. Studies reporting on the measurement properties of PROMs assessing HRQoL throughout the European cancer continuum will be included. The evaluation of the psychometric properties, data extraction and data synthesis will be conducted according to the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology. Two reviewers will independently assess the methodological quality using the COSMIN risk of bias checklist and the COSMIN criteria for good measurement properties. Subsequently, findings will be qualitatively summarised. The Grading of Recommendations Assessment, Development and Evaluations (GRADE) guidelines will be used to grade and summarise the quality of the evidence.

Ethics and dissemination
Ethical clearance for this research is not required, as the systematic review will only use information from previously published research. The results of this review will be submitted for publication in a peer-reviewed journal and will be used to provide a set of evidence-based recommendations for a European project (EUonQOL), which aims at developing a new PROM (EUonQOL toolkit) to assess HRQoL across the European cancer continuum. Moreover, findings will be disseminated to a clinical audience and policymakers through conferences, supporting researchers and clinicians in choosing the best measure to evaluate HRQoL in patients with cancer and survivors in Europe.

PROSPERO registration number
CRD42023418616.

Objectives
Falls from heights are a leading cause of workplace injuries and fatalities. Ensuring worker fitness is crucial, yet many countries lack formal guidelines for fitness for work (FFW) assessments, posing safety and legal risks. This scoping review sought to identify and map the existing evidence on the assessment of fitness to work at heights.

Design
Scoping review following the Joanna Briggs Institute Scoping Review Methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.

Data sources
Searches were conducted in March 2024 across ProQuest Central, Google Scholar, PubMed, Scopus, ScienceDirect, Web of Science and PsycINFO. Grey literature was sourced from the websites of organisations including the International Labour Organisation, Safe Work Australia, Canadian Centre for Occupational Health and Safety, Health and Safety Executive (UK), Occupational Safety and Health Administration (USA), WHO, Centre for Construction Research and Training (USA), Institution of Occupational Safety and Health (UK), South African Society of Occupational Medicine, South African Society of Occupational Health Nursing and Institute for Work at Height (South Africa), in addition to general Google searches.

Eligibility criteria for selecting studies
Our inclusion criteria encompassed both peer-reviewed and grey literature that addressed either ‘fitness for work at heights’, ‘fitness for work in high-risk settings requiring work at heights’ or human risk factors associated with working at heights.

Data extraction and synthesis
A data extraction framework and guidance sheet were developed, piloted and refined through team discussions. An iterative review process was followed, with one author extracting and coding data while two authors conducted quality checks. Deductive qualitative content analysis was applied to the extracted data.

Results
68 articles met the inclusion criteria, but only 7 directly addressed fitness to work at heights, with the rest focusing on fitness to work in high-risk settings requiring work at heights or human risk factors associated with work at heights. This highlights a lack of peer-reviewed research specific to the topic. Key challenges included FFW assessments failing to reflect job demands, inconsistent application of FFW evaluations, lack of standardisation and inadequate stakeholder collaboration. Legal tensions between employer safety obligations and worker rights were also noted. Critical human risk factors—such as physical and mental limitations, adverse states, human error and rule violations—significantly affected worker safety, though evidence of their specific impact in this context remained limited. Findings on the economic implications of FFW assessments were also inconclusive.

Conclusion
Assessing FFW at heights is vital for worker safety, yet key challenges persist. This review highlights gaps in evidence on human risk factors and assessment methods. Findings emphasise the need for practice-based research, standardised fitness criteria and interdisciplinary protocols for preplacement assessment and ongoing monitoring.

Objectives
To explore the views of obstetrics and gynaecology (O&G) and general surgery (GS) trainees and consultants on the laparoscopic skills considered necessary to achieve the certificate of completion of training (CCT) and identify any mismatch between consultants and trainees in their expectations of these skills.

Design
A prospective nationwide cross-sectional study in the UK.

Setting
A national survey distributed through Health Education, England and national training bodies such as the Royal College of Obstetricians & Gynaecologists, British Society for Gynaecological Endoscopy and the Association of Surgeons of Great Britain and Ireland.

Participants
O&G and GS consultants and specialty trainees in O&G and GS. Specialty trainees below ST3 level and consultants performing open surgery or minor laparoscopic surgery only were excluded.

Interventions
Trainees completed a 27-item questionnaire on their training characteristics, rated their confidence and perceived importance of 10 laparoscopic skills required for CCT using a 5-point Likert scale. Consultants answered a 36-item questionnaire on their demographic details, their views on the importance of the same 10 laparoscopic skills, their confidence and the standard of laparoscopic skills they observed among trainees approaching CCT.

Results
345 participants responded to the questionnaire: 117 O&G trainees, 95 O&G consultants, 57 GS trainees and 76 GS consultants. O&G trainees and consultants expected similar laparoscopic skills required for CCT for all 10 skills (p >0.050), while GS consultants had higher expectations of GS trainees for use of endovascular devices (p

Introduction
Each year in the UK, 140 000 patients are discharged from intensive care units (ICUs) to general hospital wards, almost all with complex rehabilitation needs. 84% of patients still require nutritional support and 98% are not physically independent. Despite this, many are discharged from ICU without a nutrition plan, and failure to recognise malnutrition is common. Consequently, malnutrition persists in the ward environment, leading to poor outcomes and acting as a barrier to successful physical rehabilitation. This transition from intensive care to the ward represents a key stage in the recovery journey, and a window for optimising physical independence prior to hospital discharge, decreasing the need for support in the community. However, uncertainty as to how best to provide ongoing rehabilitation which combines adequate nutrition and exercise on the general ward has driven widespread variation in practice.
We have previously shown the benefits of delivering a structured rehabilitation strategy in the ICU. However, the ward environment poses different challenges to the development of an integrated rehabilitation pathway. There is a need to evaluate the clinical and cost-effectiveness of structured rehabilitation strategies when delivered outside the ICU.

Methods and analysis
Physiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness is a bi-centre, mixed methods feasibility randomised controlled trial (RCT). 60 patients will be recruited from ICUs at two acute National Health Service Trusts and randomised on a 1:1 basis to receive either individualised physiotherapy and optimised nutrition post discharge from ICU (intervention) or standard care. The primary objective is to assess the acceptability of the intervention and feasibility of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semistructured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.

Ethics and dissemination
Ethical approval has been obtained through the Wales Research and Ethics Committee 2 (24/WA/0050). We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.

Trial registration number
NCT06159868. Prospectively registered on 28 November 2023.

Background
Immunotherapies targeting the programmed death receptor-1/programmed death ligand-1(PD-1/PD-L1) checkpoint have a major impact on the treatment of both resectable and advanced non-small cell lung cancer (NSCLC). Additional blockade of the T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain (TIGIT)-receptor may synergistically foster the immune-related response. Several trials are currently investigating the combination of neoadjuvant platinum-based chemotherapy and dual checkpoint inhibition prior to curative surgery. The investigator-initiated NeoTRACK trial (EU CT number: 2022-501322-38-00; ClinicalTrials.gov identifier: NCT05825625; IKF056) aims to evaluate the feasibility and safety of perioperative anti-PD-L1 (by atezolizumab) and anti-TIGIT (by tiragolumab) treatment in combination with chemotherapy in patients with early stage NSCLC.

Methods and analysis
NeoTRACK is an open-label, single-arm, prospective, bicentric phase II trial. Patients with NSCLC in clinical stages II, IIIA and IIIB (only T3N2) will receive two cycles of standard platinum-based chemotherapy in combination with the anti-TIGIT antibody tiragolumab and the anti-PD-L1 antibody atezolizumab, followed by curative surgery. After surgery, patients without pathological complete response (pCR) will receive another two cycles of chemotherapy in combination with tiragolumab and atezolizumab, followed by tiragolumab/atezolizumab maintenance for up to 1 year (maximum 16 cycles). Patients with pCR will only receive dual immunotherapy. All patients will be followed-up for 30 months after the last study treatment. The clinical study will be aligned with a translational research programme to investigate treatment-naïve tumour tissues, surgical specimens and longitudinally collected blood samples. 35 patients are planned for enrolment. Patient recruitment started in August 2023, and treatment of the last patient is estimated to start 2.5 years thereafter.

Discussion
The NeoTRACK trial aims to assess the feasibility and efficacy of combining tiragolumab and atezolizumab as both neoadjuvant and adjuvant therapies in patients with resectable NSCLC. The concept of treatment personalisation based on postoperative pCR is of great clinical interest.

Ethics and dissemination
The trial obtained ethical and regulatory approval in Germany through the Clinical Trials Information System (CTIS, ID: 2022-501322-38-00) and the Paul Ehrlich Institute (PEI, competent authority for approval of clinical trials using medicinal products for human use in Germany, process number: PB00148) on 30 March 2023. A data safety and monitoring board will meet regularly to review ongoing treatment in terms of safety.
Study results will be published in peer-reviewed journals, presented at conferences and in the public registry of CTIS, following trial completion.

Trial registration number
NCT05825625.

Introduction
Palliative care (PC) improves quality of life (QOL). However, PC is currently delivered ‘too little, too late’ in heart failure (HF). Timely interventions to enable and reach patients with HF and their caregivers, with PC (TIER-HF-PC) is a novel, nurse coach-led model of PC that integrates PC into HF care. We will compare the effectiveness of TIER-HF-PC against usual care for improving patient and caregiver health outcomes. We will also evaluate implementation outcomes (such as care experience) of TIER-HF-PC.

Methods and analysis
In TIER-HF-PC, patients undergo regular distress screening. The intensity of PC treatments will be tiered based on the severity of problems detected. Minimally, all patients will receive PC education resources. Patients with moderate-intensity needs will receive PC health coaching. Patients with high-intensity needs will receive a PC physician consultation, on top of PC health coaching. Patients in usual care are not screened but can be referred to a PC physician based on cardiologist discretion.
We will recruit 240 English- or Mandarin-speaking patients with HF and up to 240 caregivers from 3 sites across 2 cardiac centres. Patients will be randomised in a 1:1 ratio to TIER-HF-PC or usual care. We will use an intention-to-treat approach for data analysis. Our primary outcome is patient QOL on the Kansas City Cardiomyopathy Questionnaire at 24 weeks. Secondary outcomes include patient healthcare utilisation, caregiver QOL and cost-effectiveness. All participants who received PC treatments will receive a service evaluation survey. Additionally, a sample of these participants and their treating healthcare staff will be purposively recruited for in-depth semistructured interviews on their TIER-HF-PC experience. Interviews will be thematically analysed. We will evaluate protocol fidelity through case notes and study process audits.

Ethics and dissemination
This study was approved by the SingHealth Institutional Ethics Review Board—review number: 2024–2213. Results of the study will be disseminated when data analysis is complete.

Trial registration number
NCT06244953.

Introduction
A national research priority for people living with bile acid diarrhoea (BAD) is effective treatment options to improve their quality of life. This study aims to evaluate the feasibility of conducting a randomised controlled trial (RCT) of a novel healthy dietary pattern (The 8×5 Diet) to inform a future, larger trial.

Methods and analysis
We plan to enrol 76 UK adults living with BAD and ongoing diarrhoea using self-selection sampling and digital technologies. Eligible participants will be assigned to groups using permuted block randomisation using 1:1 allocation to receive either 8 weeks of usual care or The 8×5 Diet using one-to-one, dietitian counselling via a video-conferencing platform and developed digital resources. Randomisation, consent, recruitment, retention and acceptability will be evaluated using data from the RCT and post-trial interviews conducted with those in the intervention group. Secondary outcome exploratory assessment will include health-related quality of life, symptom relief, diarrhoea, diet quality, nutrient intakes and diet satisfaction.

Ethics and dissemination
Ethical approval was granted by the University of Manchester Research Ethics Committee (2024-19094-33261; V1.7, last updated: 24/02/2025).
Findings will be disseminated through peer-reviewed publication, conference presentation and social media.

Trial registration number
NCT06259396.

Objective
Measuring the effectiveness of mass casualty incident (MCI) scenario training is challenging due to simultaneously assessing individual skills, team dynamics, decision-making under pressure and adaptability. Existing instruments often focus too narrowly on individual skills, overlooking the comprehensive range of skills needed for effective prehospital disaster response. This study aims to develop and validate a comprehensive self-assessment tool for prehospital disaster response skills during initial MCI scenario training.

Design
The instrument was developed and validated using a comprehensive methodology. This included literature reviews to identify the construct, ensuring content validity through expert evaluation and conducting field trials in MCI scenario training to evaluate the instrument under simulated conditions that approximated real-life incidents. The instrument’s psychometric properties were assessed using exploratory factor analysis (EFA) and Horn’s parallel analysis, as well as Cronbach’s α and item–total correlation analysis.

Setting
Two field trials conducted with participants in Sweden during 2023 and 2024.

Participants
75 students from a bachelor’s programme at a Swedish university were recruited to participate in the field trials. The programme featured one semester of comprehensive theoretical and practical training in disaster medicine, including MCI response and management. 88 instruments were collected during the field trials.

Results
Overall Cronbach’s α score was 0.86, indicating high internal consistency for the instrument. EFA and Horn’s parallel analysis revealed a five-factor model accounting for 52.3% of the total variance: incident control and management; systematic examination procedures; risk assessment and management; stress response and impact; and triage procedures. Cronbach’s α for all factors indicated good internal consistency (range: 0.74–0.85).

Conclusions
The instrument addresses a critical gap by offering a comprehensive self-evaluation tool for disaster response skills. The robust psychometric properties indicate its potential for practical implication. Future studies should explore its application in diverse training settings and populations to enhance its utility and generalisability.
A comprehensive development and validation methodology ensured the high content validity of the instrument.

Introduction
Palliative care (PC) improves quality of life (QOL). However, PC is currently delivered ‘too little, too late’ in heart failure (HF). Timely interventions to enable and reach patients with HF and their caregivers, with PC (TIER-HF-PC) is a novel, nurse coach-led model of PC that integrates PC into HF care. We will compare the effectiveness of TIER-HF-PC against usual care for improving patient and caregiver health outcomes. We will also evaluate implementation outcomes (such as care experience) of TIER-HF-PC.

Methods and analysis
In TIER-HF-PC, patients undergo regular distress screening. The intensity of PC treatments will be tiered based on the severity of problems detected. Minimally, all patients will receive PC education resources. Patients with moderate-intensity needs will receive PC health coaching. Patients with high-intensity needs will receive a PC physician consultation, on top of PC health coaching. Patients in usual care are not screened but can be referred to a PC physician based on cardiologist discretion.
We will recruit 240 English- or Mandarin-speaking patients with HF and up to 240 caregivers from 3 sites across 2 cardiac centres. Patients will be randomised in a 1:1 ratio to TIER-HF-PC or usual care. We will use an intention-to-treat approach for data analysis. Our primary outcome is patient QOL on the Kansas City Cardiomyopathy Questionnaire at 24 weeks. Secondary outcomes include patient healthcare utilisation, caregiver QOL and cost-effectiveness. All participants who received PC treatments will receive a service evaluation survey. Additionally, a sample of these participants and their treating healthcare staff will be purposively recruited for in-depth semistructured interviews on their TIER-HF-PC experience. Interviews will be thematically analysed. We will evaluate protocol fidelity through case notes and study process audits.

Ethics and dissemination
This study was approved by the SingHealth Institutional Ethics Review Board—review number: 2024–2213. Results of the study will be disseminated when data analysis is complete.

Trial registration number
NCT06244953.

Introduction
Each year in the UK, 140 000 patients are discharged from intensive care units (ICUs) to general hospital wards, almost all with complex rehabilitation needs. 84% of patients still require nutritional support and 98% are not physically independent. Despite this, many are discharged from ICU without a nutrition plan, and failure to recognise malnutrition is common. Consequently, malnutrition persists in the ward environment, leading to poor outcomes and acting as a barrier to successful physical rehabilitation. This transition from intensive care to the ward represents a key stage in the recovery journey, and a window for optimising physical independence prior to hospital discharge, decreasing the need for support in the community. However, uncertainty as to how best to provide ongoing rehabilitation which combines adequate nutrition and exercise on the general ward has driven widespread variation in practice.
We have previously shown the benefits of delivering a structured rehabilitation strategy in the ICU. However, the ward environment poses different challenges to the development of an integrated rehabilitation pathway. There is a need to evaluate the clinical and cost-effectiveness of structured rehabilitation strategies when delivered outside the ICU.

Methods and analysis
Physiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness is a bi-centre, mixed methods feasibility randomised controlled trial (RCT). 60 patients will be recruited from ICUs at two acute National Health Service Trusts and randomised on a 1:1 basis to receive either individualised physiotherapy and optimised nutrition post discharge from ICU (intervention) or standard care. The primary objective is to assess the acceptability of the intervention and feasibility of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semistructured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.

Ethics and dissemination
Ethical approval has been obtained through the Wales Research and Ethics Committee 2 (24/WA/0050). We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.

Trial registration number
NCT06159868. Prospectively registered on 28 November 2023.