Search Results for: Come si esegue la raccolta delle urine delle 24 ore

Objectives
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifying lung disease using HRCT. This study aimed to assess the change in QLF score associated with a minimum clinically important difference (MCID) of IPF symptoms and physiological lung function, and also determine the MCID of QLF change associated with all-cause mortality to serve as an imaging biomarker to confirm disease progression and response to therapy.

Design and study setting
We conducted post hoc analyses of prospective data from two IPF phase II studies of pamrevlumab, a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity.

Participants
Overall, 152 patients with follow-up visits after week 24.

Methods
We used the anchor-based Jaeschke’s method to estimate the MCID of the QLF score that corresponded with the already established MCID of St. George’s Respiratory Questionnaire (SGRQ) and percent-predicted forced vital capacity (ppFVC). We also conducted a Cox regression analysis to establish a sensitive and robust MCID of the QLF score in predicting all-cause mortality.

Results
QLF changes of 4.4% and 3.6% corresponded to the established MCID of a 5-point increase in SGRQ and a 3.4% reduction in ppFVC, respectively. QLF changes of 1% (HR=4.98, p=0.05), 2% (HR=4.04, p=0.041), 20 mL (HR=6.37, p=0.024) and 22 mL (HR=6.38, p=0.024) predicted mortality.

Conclusion
A conservative metric of 2% can be used as the MCID of QLF for predicting all-cause mortality. This may be considered in IPF trials in which the degree of structural fibrosis assessed via HRCT is an endpoint. The MCID of SGRQ and FVC corresponds with a greater amount of QLF and may reflect that a greater amount of change in fibrosis is required before there is functional change.

Trial registration number
NCT01262001, NCT01890265.

Objectives
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifying lung disease using HRCT. This study aimed to assess the change in QLF score associated with a minimum clinically important difference (MCID) of IPF symptoms and physiological lung function, and also determine the MCID of QLF change associated with all-cause mortality to serve as an imaging biomarker to confirm disease progression and response to therapy.

Design and study setting
We conducted post hoc analyses of prospective data from two IPF phase II studies of pamrevlumab, a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity.

Participants
Overall, 152 patients with follow-up visits after week 24.

Methods
We used the anchor-based Jaeschke’s method to estimate the MCID of the QLF score that corresponded with the already established MCID of St. George’s Respiratory Questionnaire (SGRQ) and percent-predicted forced vital capacity (ppFVC). We also conducted a Cox regression analysis to establish a sensitive and robust MCID of the QLF score in predicting all-cause mortality.

Results
QLF changes of 4.4% and 3.6% corresponded to the established MCID of a 5-point increase in SGRQ and a 3.4% reduction in ppFVC, respectively. QLF changes of 1% (HR=4.98, p=0.05), 2% (HR=4.04, p=0.041), 20 mL (HR=6.37, p=0.024) and 22 mL (HR=6.38, p=0.024) predicted mortality.

Conclusion
A conservative metric of 2% can be used as the MCID of QLF for predicting all-cause mortality. This may be considered in IPF trials in which the degree of structural fibrosis assessed via HRCT is an endpoint. The MCID of SGRQ and FVC corresponds with a greater amount of QLF and may reflect that a greater amount of change in fibrosis is required before there is functional change.

Trial registration number
NCT01262001, NCT01890265.

Introduction
Excessive bleeding after childbirth (postpartum haemorrhage, PPH) affects 5% of births and causes 75 000 maternal deaths worldwide annually. It is the leading cause of direct maternal deaths globally and continues to be a major cause of mortality in the UK. Oxytocin is the standard first-line treatment for atonic PPH. The PPH rate is increasing, and this may be partially related to the overuse of oxytocics in labour. Laboratory studies on myometrium suggest that repeated use of oxytocics leads to the saturation of oxytocin receptors and reduced therapeutic efficacy of oxytocin. Carboprost (a prostaglandin analogue) is usually reserved for second-line management of atonic PPH. A systematic review comparing the efficacy of carboprost and conventional uterotonics for PPH prophylaxis found that carboprost was associated with less blood loss, but around 15% of women experienced side effects. The study’s aim is to compare intramuscular carboprost with intravenous oxytocin for the initial treatment of PPH. In addition, to assess the cost-effectiveness of both treatments, participants’ views on the two treatments and the consent process.

Methods and analysis
COPE is a double-blind, double-dummy, randomised controlled trial that aims to recruit 2000 women (1:1 allocation, stratified by mode of birth) across 20 hospitals in the UK. Due to the emergency nature of PPH, COPE uses a research without prior consent (RWPC) model. Randomisation and treatment will occur if eligibility criteria are met once bleeding starts. Postnatal consent will be sought for disclosure of identifiable data and continued follow-up. Clinical efficacy outcomes will be collected at 24 and 48 hours or at hospital discharge, if sooner. Questionnaires will also be collected at 24 hours and 4 weeks postrandomisation. Cost-effectiveness will be based on the incremental cost per quality-adjusted life-year, calculated from the perspective of the NHS and personal social services.

Ethics and dissemination
This study has been approved by the Coventry and Warwickshire Research Ethics Committee (REC) (18/WM/0227) and the Health Research Authority. Results will be disseminated via peer-reviewed publications.

Trial registration number
ISRCTN16416766.

Introduction
The primary objective of this trial is to evaluate the effect of replenishing coagulation factor XIII (FXIII) in women with postpartum haemorrhage (PPH) on measured blood loss (MBL). Based on earlier research, we hypothesise that the administration of FXIII leads to a significant reduction in postpartum blood loss.

Methods and analysis
This is a randomised, controlled trial that will allocate eligible patients in the event of a PPH and after receiving tranexamic acid either to the treatment group, receiving FXIII, or to the control group (standard of care). The primary endpoint is the MBL within 24 hours using a standardised method. For the primary analysis, estimation of the OR under a proportional odds assumption is conducted simultaneously for all possible cut-off points. A corresponding estimate, along with a two-sided 95% CI and two-sided p value against the null hypothesis OR=1, is obtained from the Continuous Outcome Logistic Regression model. More than 7000 patients will be screened in order to include a total of 988 eligible patients into the trial. Secondary outcomes include the rate of adverse maternal outcomes related to PPH, the rate of women breastfeeding after PPH and the safety of the administration of FXIII in women with PPH. Dynamics of blood coagulation factors in women with PPH and their association with MBL will be assessed in specific centres. A preliminary overview on costs and potential savings through early treatment of PPH with FXIII is included in the analysis as well as a patient and public involvement report, asking for patients’ personal experience during PPH in the main study centre.

Ethics and dissemination
Ethics approval was granted by the central ethics committee (Kantonale Ethikkommission Zürich/Switzerland) on 16 June 2024, reference number: BASEC 2024-00374. Results will be disseminated via open-access publication in a relevant medical journal.

Trial registration number
ClinicalTrials.gov ID NCT06481995.

Introduction
The concept of generations and generational diversity in the workplace is a widely discussed phenomenon in popular culture, organisational articles and research studies. A number of non-medical and medical organisations have attempted to identify generational differences among their workforces and devise solutions to overcome this. The impact of generational differences among the medical workforce, specifically postgraduate doctors-in-training (PGDiTs), in the National Health Service (NHS) has not been studied.

Method and analysis
This qualitative study will use a pragmatic study methodology with components of grounded theory and interpretative phenomenological analysis to explore and understand the concept, perceptions, experiences and sources of generational diversity among PGDiTs working in the NHS. Six focus groups will be conducted with PGDiTs recruited from a single acute NHS Trust. Participants will be stratified according to their generation (ie, Generation X, Y or Z). Two focus groups will be conducted for each generation. If insufficient participants are recruited for a focus group, then one-to-one interviews will be offered. The data from the focus groups and one-to-one interviews will be analysed using an inductive thematic analysis method using NVivo software.

Ethics and dissemination
This study has received approval from the Health Research Authority and Care Research Wales (Reference: 24/HRA/0770). Ethics committee approval is not required as the study involves NHS staff as research participants. The findings from this study will report a number of higher level themes reflecting the views and experiences of the research participants. The findings will be disseminated via academic conferences and peer-reviewed publications.
NCT06446297.

Objectives
We aim to determine, using routinely collected data and common scoring systems, whether parameters seen at intensive care unit (ICU) discharge can be predictive of subsequent clinical deterioration.

Design/setting
A single-centre retrospective study located in a tertiary hospital in the south of England.

Participants
1868 patients who were admitted and discharged from ICU between 1 April 2023 and 31 March 2024 were screened for eligibility. A total of 1393 patients were included in the final analysis, including 122 patients who were classified in the ‘deteriorated’ subgroup.

Interventions
Assessment of vital signs, blood markers of infection and inflammation and three scoring systems (National Early Warning Score 2 (NEWS2), Acute Physiology and Chronic Health Evaluation II Score and Sequential Organ Failure Assessment (SOFA) score) taken within 24 hours prior to ICU discharge.

Primary outcomes
Assessment of predictors of deterioration after ICU discharge.

Secondary outcomes
Reasons for readmission to ICU, hospital mortality, ICU length of stay and time before readmission to ICU.

Results
Heart rate, conscious level (alert, voice, pain, unresponsive scale) and SOFA score were independent predictors of deterioration after ICU discharge (under the curve 0.85, CI 0.79 to 0.90, specificity 82.3%, sensitivity 79.7%) in multivariable models. Of these, a reduced level of consciousness was the most significant predictor of clinical deterioration (OR 19.6, CI 11.4 to 35.0). NEWS2 was an independent predictor for deterioration on univariable analysis. Mortality was significantly increased in patients who experienced deterioration after ICU discharge, as was ICU length of stay.

Conclusions
Predictive models may be useful in assisting clinicians with ICU discharge decisions. Further research is required to develop patient-tailored scoring systems that incorporate other factors that are needed for decisions around ICU discharge.

I read with interest the recent article of Wilkinson-Smith and colleagues on the assessment of colonic motility by means of MRI and high-resolution colonic manometry (HRCM),1 showing that patients with constipation and irritable bowel syndrome (IBS) may display some abnormalities when such investigated. I would like to make some observations on this study. Since HRCM probes were positioned 35 cm from the anal verge, I would be very cautious in claiming that those were ‘colonic’ studies, since (by considering the physiological bending of the large bowel) at the very best only a very limited colonic area was studied. Indeed, the authors in the methods reported that only the sigmoid colon was actually investigated in a systematic manner. Both MRI and HRCM were carried out as short-timed studies (respectively, 2 and 4 hours duration) conducted in a viscus that fully displays its motor activity over a 24-hour time span.

Background
Cyst size, its growth rate, and diameter of the main pancreatic duct (MPD) are all associated with pancreatic carcinoma prevalence in intraductal papillary mucinous neoplasms (IPMNs).

Objective
To examine the above factors in relation to future risk of incident pancreatic carcinoma in individuals with IPMNs harbouring no high-risk stigmata.

Design
In a prospective longitudinal cohort, we analysed 2549 patients with IPMNs. A multivariable cause-specific Cox proportional hazards regression model was built to estimate HRs for incident pancreatic carcinoma.

Results
IPMN size at baseline and its annual growth rate over 2 years of follow-up were associated with incident pancreatic carcinoma (ptrend

Introduction
Acute circulatory failure plays a major role in the development of sepsis-related organ dysfunction. Current ‘bundles’ of the Surviving Sepsis Campaign (SSC) include the administration of a fluid loading of 30 mL/kg in the presence of hypotension within the first hour of sepsis identification. The impact of haemodynamic assessment using echocardiography at the early phase of management of septic patients in the Emergency Department (ED) on patient-centred outcomes is unknown.

Methods and analysis
This is a two-parallel arm randomised trial with blinded assessment comparing early haemodynamic assessment using transthoracic echocardiography aimed at guiding therapeutic management to standard of care according to current SSC recommendations in septic patients during initial management in 13 French EDs. Patients with suspected or documented infection and a qualifying quick Sequential Organ Failure Assessment (qSOFA) score (haemodynamic criterion required: systolic blood pressure≤100 mm Hg) will be 1:1 randomised after 500 mL of fluid loading initiation. In the intervention group, echocardiography will allow identifying the haemodynamic profile at the origin of sepsis-induced circulatory failure and monitoring the efficacy and tolerance of fluid resuscitation, or of any other therapeutic intervention according to a predefined therapeutic algorithm. The control group will receive conventional 30 mL/kg fluid resuscitation (unless pulmonary venous congestion) according to SSC recommendations. Primary outcome will be the course of organ dysfunction assessed by the crude change in the modified SOFA score between baseline and 24 hours after randomisation. Secondary outcomes will be the nature of therapeutic interventions resulting from echocardiography (fluid loading, early initiation of vasopressor support or inotrope), the prevalence of the different haemodynamic profiles, the evolution of lactatemia, the safety of the initial therapeutic, the proportion of patients who develop secondarily septic shock, the orientation of patients after ED discharge and both day 7 and in-hospital mortality. We plan to randomise 312 patients.

Ethics and dissemination
Approved by the Ethics Committee CPP Ouest V on 18 January 2021 (ref: 20/075-2-20.10.16.57638). The dissemination plan includes presentations at scientific conferences and publication of results in a peer-reviewed journal.

Trial registration number
NCT04580888.

Introduction
To assess the effects of oral dydrogesterone on the recurrence rate of endometrial polyps (EPs) and abnormal uterine bleeding (AUB) symptoms after transcervical resection of polyps (TCRP).

Methods and analysis
A randomised, parallel, open-label, multicentre study will be conducted across 12 hospitals in China, including general and women’s specialty hospitals. In this study, we will recruit female patients aged 18–46 years diagnosed with EPs using transvaginal ultrasonography during two menstrual cycles. Eligible participants who have not received other oestrogen or progesterone treatments will be randomly assigned in a 1:1 ratio to either an intervention or control group. All participants will undergo TCRP, with the time between randomisation and surgery not exceeding 14 days. The intervention group will receive oral dydrogesterone for three menstrual cycles, whereas the control group will receive no hormonal treatment. The primary outcome is the recurrence rate of EPs, which will be evaluated using follow-up transvaginal ultrasonography at 1, 3, 6, 12, 18 and 24 months postsurgery. Secondary outcomes include assessment of AUB and menstrual status. For statistical analyses, a multivariate regression will be used to adjust for confounding factors.

Ethics and dissemination
This study protocol adheres to the Declaration of Helsinki and has been approved by the Women’s Hospital, School of Medicine, Zhejiang University (IRB-20240077-R). All participants in the trial will provide written informed consent. The study findings will be published in peer-reviewed journals and presented at academic conferences.

Trial registration number
ChiCTR2400083097.

Purpose
There is a need for diagnostic and prognostic biosignatures to improve long-term outcomes in inflammatory bowel disease (IBD). Here, we describe the establishment of the Swedish Inception Cohort in IBD (SIC-IBD) and demonstrate its potential for the identification of such signatures.

Participants
Patients aged ≥18 years with gastrointestinal symptoms who were referred to the gastroenterology unit due to suspected IBD at eight Swedish hospitals between November 2011 and March 2021 were eligible for inclusion.

Findings to date
In total, 367 patients with IBD (Crohn’s disease, n=142; ulcerative colitis, n=201; IBD-unclassified, n=24) and 168 symptomatic controls were included. In addition, 59 healthy controls without gastrointestinal symptoms were recruited as a second control group. Biospecimens and clinical data were collected at inclusion and in patients with IBD also during follow-up to 10 years. Levels of faecal calprotectin and high-sensitivity C-reactive protein were higher in patients with IBD compared with symptomatic controls and healthy controls. Preliminary results highlight the potential of serum protein signatures and autoantibodies, as well as results from faecal markers, to differentiate between IBD and symptomatic controls in the cohort. During the first year of follow-up, 37% (53/142) of the patients with Crohn’s disease, 24% (48/201) with ulcerative colitis and 4% (1/24) with IBD-U experienced an aggressive disease course.

Future plans
We have established an inception cohort enabling ongoing initiatives to collect and generate clinical data and multi-omics datasets. The cohort will allow analyses for translation into candidate biosignatures to support clinical decision-making in IBD. Additionally, the data will provide insights into mechanisms of disease pathogenesis.

Un webinar Fondazione Humanitas per promuovere cultura del sonno

Introduction
Adverse events during paediatric anaesthesia are common, with hypoxaemia during the induction period being a leading cause, as infants and children are particularly vulnerable to hypoxaemia during periods of apnoea. The administration of supplementary oxygen, referred to as apnoeic oxygenation, has been shown to prolong safe apnoea times and increase first-pass intubation success rates. Despite these benefits, apnoeic oxygenation is not routinely used in paediatric anaesthesia. Low-flow apnoeic oxygenation, delivered via a standard nasal cannula, is a simple approach to provide supplementary oxygen during paediatric airway management without requiring additional equipment. However, its efficacy in airway management during elective surgeries has not been adequately studied.

Methods and analysis
The ApOx-Pedi-Trial is a single-centre, cluster randomised, controlled clinical trial comparing the use of low-flow apnoeic oxygenation during the induction of general anaesthesia in infants and children up to 6 years of age undergoing elective surgery at the Department of Pediatric Surgery at Heidelberg University Hospital to standard of care (no apnoeic oxygenation). Randomisation is conducted using a weekly cluster randomisation method, where all patients presenting for surgery in a given week either receive apnoeic oxygenation or standard of care during the induction of general anaesthesia, based on the week’s group allocation.
The study population will consist of two independent, age-stratified cohorts (24 months to 6 years), each including 100 patients. Statistical analysis of study endpoints will be conducted separately for each cohort to allow for age-specific assessment of outcomes.
The primary objective of this trial is to evaluate whether apnoeic oxygenation can prevent a decrease in transcutaneous haemoglobin saturation (SpO2) during the induction of general anaesthesia in infants and children. The primary outcome measure will be the lowest recorded SpO2 value throughout the apnoeic period.

Ethics and dissemination
The ApOx-Pedi-Trial received permission from the local ethics committee (Ethics Committee of the medical faculty at Heidelberg University, Heidelberg, Germany) under the registration number S-074–2024. The study is following institutional Guidelines and the Declaration of Helsinki of 1975 in its most recent version. Trial results will be submitted to peer-reviewed journals and presented at national and international conferences.

Trial registration number
The trial is prospectively registered on ClinicalTrials.gov with the number NCT06576596.

Introduction
The objective of the Chinese Neonatal Follow-Up Network (CHNFUN) is to establish a standardised follow-up protocol for the assessment of high-risk preterm infants, and collaborative research aimed at improving early intervention and neurodevelopmental outcomes for preterm infants with gestational age less than 32 weeks in China. The CHNFUN is the first national neonatal follow-up network and has the largest geographically representative cohort from neonatal intensive care units (NICUs) in China.

Methods and analysis
A survey of neonatal follow-up clinics participating in CHNFUN was used to inform the development of a standardised protocol for the assessment of high-risk preterm infants in China. Training in the use of assessment tools and data collection was provided to all participating centres. Individual-level neurodevelopmental outcomes data from participating neonatal follow-up clinics will be collected at corrected age, 40 weeks, 3–4 months, 12 months, 18–24 months, 3 years and 6 years of age, using a unique database developed by the CHNFUN and linked to NICU outcomes data in the CHNN Database. Data will be prospectively collected on an ongoing basis from all surviving infants born at

Objectives
There is a lack of information about household factors associated with delayed measles, mumps and rubella (MMR) vaccination. We examined whether timeliness of first MMR (MMR1) receipt is associated with sharing a household with an older child with non-receipt of MMR1 independent of household composition and size.

Design
Longitudinal observational study using linked electronic health records.

Setting
North East London, UK.

Participants
The index cohort comprised 71 509 children (51.0% males) eligible to receive MMR1 between 1 January 2014 and 28 February 2020.

Methods
The primary outcome was MMR1 receipt between 12 months and 24 months of age. The explanatory variable was non-receipt of MMR1 between age 12 months and 24 months in the oldest child sharing the same household. We examined the likelihood of MMR1 receipt in index children sharing a household with an older child with non-receipt of MMR1 between 12 months and 24 months using logistic regression to estimate ORs and 95% CIs before and after adjustment for individual-level, household-level and area-level covariates. We carried out sensitivity analyses excluding households with an age interval between oldest and youngest child greater than 5 years.

Results
59 851 (83.6%) index children received MMR1 between 12 months and 24 months of age. After adjustment for household composition and size, MMR1 receipt was less likely in index children sharing a household with an older child with non-receipt of MMR1 between 12 months and 24 months of age: OR: 0.19 (95% CI: 0.18, 0.20). This association strengthened after excluding households with an age interval greater than 5 years: OR: 0.14 (0.13, 0.15).

Conclusions
There is strong concordance within households of delay in MMR1 receipt independent of household size and composition. Lack of timely protection within households increases the risk of measles outbreaks. There is a need for household-based interventions to improve MMR1 timeliness.

Purpose
Pharmacovigilance (PV) systems to assess the safety of antiretroviral treatment used periconception and during pregnancy are lacking in low-resource settings with high HIV burdens, and strategies to guide their implementation are limited. We implemented the Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO) study in Kenya to address these gaps.

Participants
In MANGO, we ascertained delivery outcomes for pregnant women living with HIV (WLH) and not living with HIV (WNLH) enrolled in care at Moi Teaching and Referral Hospital (MTRH) through two cohorts: C1, a prospective cohort of 1:1 matched WLH and WNLH attending antenatal clinic; and C2, a cross-sectional cohort of all deliveries, including among those who did not attend antenatal clinic at MTRH.

Findings to date
24 205 deliveries were recorded from October 2020 to September 2023 (853 in C1 and 23 352 in C2). Median maternal age was 32 years, 4.5% were WLH and 2.6% of deliveries were stillbirths. Among liveborn infants, 17.2% were preterm (