Search Results for: Linee Guida GOLD (2019) sulla BPCO

Objectives
Elevated left ventricular end-diastolic pressure (LVEDP) in ST-segment elevation myocardial infarction (STEMI) has been studied in patients who received thrombolysis or who were treated early in the primary percutaneous coronary intervention (PCI) era; LVEDP was found to be a predictor of adverse outcomes in these retrospective post hoc analyses. The aim of the current analysis is to assess the prognostic value of the elevated LVEDP in STEMI patients undergoing primary PCI in current contemporary practice.

Design
Prospective, single-centre study.

Participants
Our study enrolled STEMI patients with elevated LVEDP undergoing primary PCI at John Hunter Hospital, Newcastle, Australia.

Primary outcome measure
The primary endpoint was the combination of 12-month all-cause mortality and heart failure admissions, comparing different quartiles of LVEDP.

Results
A total of 997 patients underwent primary PCI at our hospital during the 5-year study period (age: 64±13 years, males: 73%; n=728) from 1 January 2015 to 31 December 2019. The median LVEDP for the whole cohort was 27 mm Hg (IQR: 22–31 mm Hg). The median LVEDP was 17 mm Hg (IQR: 13–18 mm Hg) and 33 mm Hg (IQR: 30–36 mm Hg) for 1st and 4th quartiles respectively (p

Objective
This study aimed to evaluate the utility of optical sensor-based technology in mitigating the frequency and severity of peripheral intravenous infiltration and/or extravasation (PIVIE) in neonates.

Design
Single-centre, retrospective, observational cohort study.

Setting
Tertiary-level neonatal intensive care unit (NICU) (112 cots) at the Women’s Wellness and Research Centre (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar, January 2019–December 2022.

Participants
All neonates admitted to the NICU requiring intravenous therapy via a neonatal short peripheral intravenous catheter (n-SPC) were included. Participants were excluded if the insertion was unsuccessful, if they had incomplete data, or if they received intravenous therapy exclusively through alternative vascular access devices.

Interventions
The study analysed two cohorts representing different clinical practices over two distinct periods. In the conventional cohort (Phase 1, 2019–2020), PIVIE detection relied solely on periodic ‘Touch Look Compare (TLC)’ assessments. In the ivWatch cohort (Phase 2, 2021–2022), continuous optical sensor-based monitoring using the ivWatch system was implemented alongside TLC assessments. This sequential design allowed for a comparison of outcomes between the two phases.

Outcome measurements
The primary outcomes were the occurrence and severity of PIVIE. Secondary outcomes included the influence of patient demographics, vascular access characteristics, and management details on PIVIE incidence and severity.

Results
Over the 4-year data collection period, 32 713 peripheral intravenous catheters were analysed across two cohorts. PIVIE was the most common reason for unplanned device removal. In the conventional cohort (Phase 1, 2019–2020), 4941 infiltration events were reported (29.9%), compared with 4872 events (30.1%) in the ivWatch cohort (Phase 2, 2021–2022). However, severity measures using the Intravenous Extravasation Grading Scale (IEGS) revealed a marked reduction in severe PIVIE cases, with severe events decreasing from 243 (4.9%) in the conventional cohort to 54 (1.1%) in the ivWatch cohort (p

Introduction
Vaccine hesitancy remains a critical public health challenge, especially in high-income countries. Gender differences in vaccine hesitancy can significantly affect vaccination rates and public health outcomes. The aim of this research is performing an umbrella review and meta-analysis to systematically investigate gender disparities in vaccine hesitancy for COVID-19 in high-income countries, as well as the quality, potential biases and dependability of epidemiological evidence.

Methods and analysis
The study will systematically search, extract and analyse data from reported systematic reviews and meta-analyses that focus specifically on gender differences in vaccine hesitancy. The search will include CINAHL, Cochrane Library, PubMed/MEDLINE, EMBASE and Epistemonikos for studies published from 2019 onward. The inclusion criteria will encompass systematic reviews and meta-analyses of non-interventional studies conducted in high-income countries. The identified factors contributing to vaccine hesitancy will be categorised based on demographic, psychological, social and economic dimensions. The methodological quality of the included meta-analyses will be assessed using the “Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses” tool.

Ethics and dissemination
Ethical approval is not required for this umbrella review. These results will be published in a peer-reviewed journal.

PROSPERO registration number
CRD42024572978.

Objective
To evaluate any association of the presence and severity of nine major symptoms (pain, tiredness, drowsiness, nausea, appetite, breathlessness, depression, anxiety, and perceived well-being) with sleep quality and duration in elderly men.

Design and setting
Cross-sectional analysis within the population-based VAScular and Chronic Obstructive Lung disease study (VASCOL) conducted in southern Sweden in 2019.

Participants
A total of 838 older men aged 73 years.

Measures
Severity of the symptoms was self-reported between 0 and 10 on a numerical rating scale. Breathlessness was also assessed using the Multidimensional Dyspnoea Profile and Dyspnoea-12. Sleep quality was reported on a 5-point Likert scale from ‘very well’ to ‘very bad’and sleep duration on a 7-point scale from ‘less than 4 hours’ to ‘more than 10 hours’. Associations of each symptom score with having worse sleep quality (‘bad’ or ‘very bad’) and/or shorter sleep duration (

Introduction
Asthma is a major personal and public health problem worldwide, with a significant impact on patients’ quality of life and health systems. The prevalence of asthma in children is 9.1% and in adolescents is 11%. Greater literacy among children is related to better asthma control. There are many validated Patient-Reported Outcome Measures (PROMs) related to asthma, but there are only a few, and no gold standard, to measure children and adolescents’ knowledge of asthma. Therefore, the purpose of this systematic review is to evaluate the most suitable asthma self-knowledge PROMs for the paediatric population with asthma.

Methods and analysis
The inclusion criteria will be children and adolescents diagnosed with asthma (population), validated PROMs about asthma self-knowledge (intervention), between each PROM (comparison) and measurement properties (outcome) (validity, reliability, interpretability and responsiveness). The search process will be conducted in PubMed, Web of Science, EMBASE and SCOPUS. The risk of bias evaluation will be done independently by two authors with the COnsensus-based Standards for the selection of health Measurement INstruments risk of bias checklist, and the quality of evidence will be evaluated based on the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethics and dissemination
Ethics approval is not applicable for this study since the data that will be collected are secondary data and are already in the public domain. The results will be disseminated through peer-reviewed publication and conference presentations.

PROSPERO registration number
CRD42024577500.

La guida dell’Istituto sui cibi e le regole da rispettare

Background
The growing global burden of diabetes suggests a currently unrealised growth in prevalence of eye disease. This prospective observational study addresses gaps in evidence of blood sugar control as a risk factor for the diagnosis of glaucoma, diabetic eye disease, macular degeneration and cataract using waves 2–9 (2004–2019) of the English Longitudinal Study of Ageing.

Methods
Logistic regression modelling is used to predict the probability of self-reported diagnosis of four eye conditions separately over a 14-year period in a community-dwelling sample in England. Analysis of approximately 29 000 person observations over eight study waves from around 5600 participants for each eye disease is conducted with an average of 5.7 waves per participant. Participants’ baseline blood sugar control is categorised as non-diabetic (diabetes not previously diagnosed and glycated haemoglobin (HbA1c)

Introduction
Sepsis-induced left ventricular (LV) dysfunction participates in cardiovascular dysfunction and associated organ failure in patients with septic shock. The tested hypothesis is that dobutamine will reduce tissue hypoperfusion and secondary organ dysfunction in increasing oxygen delivery in fluid-filled patients with septic shock and associated symptomatic septic cardiomyopathy with documented low-flow state.

Methods and analysis
ADAPT–Dobutamine is a blinded, two parallel group, add-on, multicentre, randomised 1:1 and placebo-controlled trial. Patients will be included if hospitalised in the intensive care unit with septic shock (Sepsis-3 definition) and septic cardiomyopathy, identified using echocardiography (LV ejection fraction ≤40% and LV outflow tract velocity–time integral 130 bpm, severe ventricular arrhythmia, obstructive cardiomyopathy, severe aortic stenosis, ongoing acute coronary syndrome and indication for extracorporeal life support. Primary outcome will be the evolution of a modified Sequential Organ Failure Assessment score (excluding the neurologic system) during the initial intensive care unit stay encompassing screening (before randomisation), and from Day 1 to 3 after randomisation. Randomisation will be stratified on participating centres and previously documented heart failure (ejection fraction ≤40%). The use of open-labelled Dobutamine as a rescue therapy will be allowed in refractory shock based on strict clinical requirements. The use of alternative inotropes will not be allowed.

Ethics and dissemination
Approved by the Comité de Protection des Personnes Nord-Ouest IV from Lille (France) on 19 December 2019 (approval reference #19.04.05.36321). The results will be published in a peer-reviewed journal and presented in various congresses.

Trial registration number
NCT04166331.

Introduction
Drug-related problems (DRPs) associated with oral anticancer drugs are frequent and require a new healthcare organisation to manage them on an outpatient basis. The aim of this article is to present the study protocol of the Drug Related problems in Oncology Practice (DROP) randomised controlled trial (RCT), endorsed by the French Society for Oncology Pharmacy. The main objective of the DROP RCT is to measure the impact at 6 months of the DROP community/hospital pharmaceutical intervention programme, compared with usual treatment, on the mean number of DRP (ie, adverse effects, drug–drug interactions, medication errors) related to oral anticancer drugs in at-risk outpatients.

Methods and analysis
The DROP protocol is a prospective, multicentre controlled clinical trial, with individual randomisation, comparing in parallel and in open, two groups of outpatients treated with oral anticancer drugs. The interventional group benefits from the DROP multidisciplinary intervention on oral anticancer treatment. The control group receives usual care. The primary outcome of the DROP RCT is the number of DRP due to oral anticancer drugs, per patient, identified between the inclusion of the patient and 6 months after inclusion

Ethics and dissemination
Approval to conduct this study was obtained for all participating centres from an Ethics Committee (Comité de Protection des Personnes Sud-Méditerranée V) in August 2018 in accordance with French law. The trial results will be disseminated at clinical conferences and published in peer-reviewed journals.

Trial registration number
ClinicalTrials.gov: NCT03257969, recruitment started in June 2019. The current protocol version is V.9, 13 December 2023.

Stroke, Ahead of Print. BACKGROUND:The impact of covert cerebrovascular disease on falls in the general population is not well-known. Here, we determine the time to a first fall following incidentally detected covert cerebrovascular disease during a clinical neuroimaging episode.METHODS:This longitudinal cohort study assessed computed tomography (CT) and magnetic resonance imaging from 2009 to 2019 of patients aged >50 years registered with Kaiser Permanente Southern California which is a healthcare organization combining health plan coverage with coordinated medical services, excluding those with before stroke/dementia. We extracted evidence of incidental covert brain infarcts (CBI) and white matter hyperintensities/hypoattenuation (WMH) from imaging reports using natural language processing. We examined associations of CBI and WMH with falls requiring medical attention, using Cox proportional hazards regression models with adjustment for 12 variables including age, sex, ethnicity multimorbidity, polypharmacy, and incontinence.RESULTS:We assessed 241 050 patients, mean age 64.9 (SD, 10.42) years, 61.3% female, detecting covert cerebrovascular disease in 31.1% over a mean follow-up duration of 3.04 years. A recorded fall occurred in 21.2% (51 239/241 050) during follow-up. On CT, single fall incidence rate/1000 person-years (p-y) was highest in individuals with both CBI and WMH on CT (129.3 falls/1000 p-y [95% CI, 123.4–135.5]), followed by WMH (109.9 falls/1000 p-y [108.0–111.9]). On magnetic resonance imaging, the incidence rate was the highest with both CBI and WMH (76.3 falls/1000 p-y [95% CI, 69.7–83.2]), followed by CBI (71.4 falls/1000 p-y [95% CI, 65.9–77.2]). The adjusted hazard ratio for single index fall in individuals with CBI on CT was 1.13 (95% CI, 1.09–1.17); versus magnetic resonance imaging 1.17 (95% CI, 1.08–1.27). On CT, the risk for single index fall incrementally increased for mild (1.37 [95% CI, 1.32–1.43]), moderate (1.57 [95% CI, 1.48–1.67]), or severe WMH (1.57 [95% CI, 1.45–1.70]). On magnetic resonance imaging, index fall risk similarly increased with increasing WMH severity: mild (1.11 [95% CI, 1.07–1.17]), moderate (1.21 [95% CI, 1.13–1.28]), and severe WMH (1.34 [95% CI, 1.22–1.46]).CONCLUSIONS:In a large population with neuroimaging, CBI and WMH are independently associated with greater risks of an index fall. Increasing severities of WMH are associated incrementally with fall risk across imaging modalities.

Objective
There are no clearly defined family profiles with an overall view of the predictors of early childhood caries (ECCs). The aim of our study was to identify the profiles of families that are particularly affected by ECCs. We also examined the factors that can be acted on to promote oral health.

Design
In this single-centre cross-sectional study, the researchers examined the mouths of 300 children with caries and recorded the Decayed, Missing and Filled Teeth Index (dmft). These observations were supplemented by a questionnaire completed by the families, focusing in particular on their sociodemographic characteristics (e.g. age, parents’ professions and jobs, social assistance and family composition).

Setting
This work was conducted at Lille University Hospital between 2019 and 2024.

Participants
The participants included 300 caregiver-child dyads with children under the age of 6 years.

Primary and secondary outcome measures
Childhood Caries Index (dmft) and family characteristics associated with ECCs.

Statistical analyses
A multiple correspondence analysis was used, followed by a hierarchical clustering on principal components analysis, to identify the family profiles associated with ECC risk.

Result
Of the patients included in the study, 42% were girls, 58% were boys and their mean age was 4 years (±1.1 years). The mean dfmt index was 8.7 (±4.6); 77% of the participants had lesions on the smooth surfaces of the teeth, and 80% of the participants had a severe stage of caries disease. The analysis revealed three high-risk profiles based on the characteristics of the child’s mother and the family sibling composition. The first profile was larger families where the focal child was not the eldest. The second profile was families with foreign-born mothers and a low socioeconomic level. The third profile was families with mothers facing geographical and financial difficulties in accessing healthcare.

Conclusion
This study enabled us to identify the profiles of families at risk of caries. These at-risk profiles highlight the need to implement specific interventions acting at different levels and focused on oral health education in interprofessional practice during the key period of the first 1000 days of life. These factors could help to bridge the gap between oral health and general health, improve children’s oral health and reduce social health inequalities.

Ethics and dissemination
This human study has been ethically approved by the French Committee for the Protection of Individuals (N° 2019-A00827-50).

Trial registration number
The protocol is recorded on clinicaltrials.gov, with ID: NCT04195607.

Importance
Background rates are critical for contextualising safety signals arising from COVID-19-related interventions in investigational or real-world settings.

Objective
To estimate background rates of medical events of interest (MEI) for which COVID-19 infection and/or COVID-19 interventions may be risk factors in two US claims databases.

Design, setting and participants
This retrospective cohort study spans the pre-COVID-19 (2018–2019) and COVID-19 (2020–2021) periods. We constructed three cohorts, in each of Inovalon/HealthVerity (Inovalon/HV) and Optum databases: a COVID-19-positive adult cohort (2020–2021), a paediatric cohort (2018–2021) and a high-risk cohort (2018–2021) comprising patients at increased risk for severe COVID-19. Participants were indexed on the day they first qualified to enter each cohort during the study period. Background rates of 17 MEI were estimated per 1000 person-years (PY) with 95% CIs.

Main outcomes and measures
Annual incidence rates (IRs) of 17 MEI.

Results
Overall, 758 414 (COVID-19-positive adults; 57.8% women), 12 513 664 (high-risk adults; 56.8% women) and 8 510 627 (paediatric patients; 49.1% women) patients were identified in the HV database. IRs of MEI varied substantially by year, data source, study cohort and duration of follow-up. The IRs of MEI were highest among COVID-19-positive adults and lowest among paediatric patients. For example, IR of myocarditis/pericarditis per 1000 PY was 3.0 (95% CI: 2.6 to 3.4) in the COVID-19-positive adult cohort vs 0.36 (95% CI: 0.34 to 0.37) among high-risk adults and 0.05 (95% CI: 0.05 to 0.06) among paediatric patients. In the COVID-19-positive adult cohort, we observed higher IRs during 90-day follow-up (eg, IR of acute myocardial infarction (AMI) 26.5 (95% CI: 25.3 to 27.7)) vs 365-day follow-up (eg, IR of AMI 20.0 (95% CI: 9.2 to 20.8)) and during 2020 compared with 2021. IRs were higher in the high-risk adult and paediatric populations during the pre-COVID-19 period than during the COVID-19 pandemic.

Conclusions
Substantial variability was observed in IRs of MEI by study cohort, year, data source and follow-up duration. When generating background rates for contextualising safety signals from COVID-19 interventions, careful consideration must be given to the indicated subpopulation of interest, COVID-19-related temporal variations and data sources.

Introduction
Individual participant data meta-analysis (IPD-MA) is regarded as the gold standard for evidence synthesis. However, diverse recommendations and guidance on its conduct exist, and there is no consensus-based tool for the critical appraisal of a completed IPD-MA. We aim to close this gap by systematically identifying quality items and developing and validating a critical appraisal checklist for IPD-MA.

Methods and analysis
This study will comprise three phases, as follows:
Phase 1: a systematic methodology review to identify potential checklist domains and items; this will be conducted according to the Cochrane methods for systematic reviews and reported following the Preferred Reporting Items for Systematic Reviews and Meta-analysis 2020 guidance. We will include studies that address methodological guides and essential statistical requirements for IPD-MA. We will use the proposed items to prepare a preliminary checklist for the e-Delphi study.
Phase 2: at least two rounds of an e-Delphi survey will be conducted among panels with expertise in IPD-MA research, consensus development, healthcare providers, journal editors, healthcare policymakers, patients and public partners from diverse geographic locations with experience in IPD-MA. Participants will use Qualtrics software to rate items on a 5-point Likert scale. The Wilcoxon matched signed rank test will estimate response stability across rounds. Consensus on including an item will be achieved if ≥75% of the panel rates the item as ‘strongly agree’ or ‘agree’ and items will be excluded if ≥75% rates it as ‘strongly disagree’ or ‘disagree’. A convenience sample of 10 reviewers with experience in conducting an IPD-MA will pilot-test the checklist to provide practical feedback that will be used to refine the checklist.
Phase 3: critical appraisal checklist validation: to improve confidence in the tool’s uptake, a subset of the e-Delphi participants and graduate students of epidemiology and biostatistics will conduct content validity and reliability testing, respectively, per the Consensus-based Standards for the Selection of Health Measurement Instruments.

Ethics and dissemination
Ethics approval has been obtained from the Western University Health Science Research Ethics Board in Canada. The validated checklist will be published in a peer-reviewed open-access journal and shared across the networks of this study’s steering committee, Cochrane IPD-MA group and the institutions’ social media platforms.

Background
Angina, a major manifestation of ischaemic heart disease, affects 3–7% of adults and is a leading cause of cardiovascular morbidity. As an ambulatory care-sensitive condition, its outcomes can be improved through proactive outpatient management. However, the real-world impact of continuity of care (COC) and medication adherence, measured by the medication possession ratio (MPR)—on angina complications in South Korea remains poorly understood.

Objective
This study evaluated the effectiveness of COC and MPR in patients with angina using comprehensive national data and examined the outcomes at the hospital level.

Methods
This retrospective cohort study used data from the National Health Insurance Service of Korea between 2002 and 2019. We identified 11 127 patients aged >30 years newly diagnosed with angina, applying strict exclusion criteria to ensure cohort validity. COC was categorised as high (COC index=1.0) or low (

Objective
To estimate the prevalence of autism among adults living in Canada.

Design
A Monte Carlo simulation modelling approach was employed. Input parameters included adult population estimates and mortality rates; autism population all-cause mortality risk ratios; and autism prevalence estimates derived from child and youth data due to the lack of adult data. This approach was executed through 10 000 simulations, with each iteration generating a distinct data scenario. Prevalence estimates were reported as the mean with the 2.5th and 97.5th percentiles, corresponding to a 95% simulation interval (SI).

Setting
Where possible, Canadian data sources were used, including the 2019 Canadian Health Survey on Children and Youth and Statistics Canada mortality rates and population estimates.

Primary outcome measure
National prevalence estimates of autistic adults living in private dwellings in Canada, with variations in prevalence by sex at birth and province/territory considered.

Results
The findings suggest the prevalence of autism among adults in Canada to be 1.8% (95% SI 1.6%, 2.0%). National prevalence estimates by sex at birth were 0.7% (95% SI 0.6%, 0.9%) for females and 2.9% (95% SI 2.6%, 3.2%) for males. Provincial/territorial estimates ranged from 0.7% in Saskatchewan (95% SI 0.3%, 1.3%) to 3.6% in New Brunswick (95% SI 2.4%, 5.1%).

Conclusions
The limited availability of data on autistic adults constrains our ability to fully understand and address their unique needs. In this study, autism prevalence was estimated based on diagnosed cases, which excludes individuals without a formal diagnosis. Additionally, other factors such as data availability and methodological assumptions may influence the modelling of prevalence estimates. As a result, our findings should be interpreted within the context of these limitations. Nevertheless, this study provides a valuable reference point for understanding autism prevalence among adults in Canada.