Search Results for: Terapia antibiotica: breve durata vs. lunga durata

This randomized clinical trial evaluates the efficacy and safety of first-line toripalimab vs placebo plus etoposide and platinum-based chemotherapy for treating patients with extensive-stage small cell lung cancer.

This Viewpoint discusses injuries among US children that are attributable to TikTok challenges, addresses the challenge of distinguishing between unintentional injuries and suicide attempts, and explores potential methods of prevention, treatment, and clinical disposition for such injuries.

Objective
To compare the neurological outcomes of out-of-hospital cardiac arrest due to anaphylaxis (OHCA-A) and cardiac causes (OHCA-C).

Design
Retrospective observational study.

Setting
Japanese nationwide dataset from 2012 to 2021.

Participants
In total, 153 890 patients were included in this study, of which 331 had OHCA-A and 153 559 had OHCA-C.

Outcome measures
The primary outcome was a favourable neurological outcome 1 month after cardiac arrest. The secondary outcome was survival at 1 month.

Results
Patients with OHCA-A had a significantly higher favourable neurological outcome rate (24.2% vs 11.7%, p

Objective
Infants are at a high risk of developing anaemia, which can arise from various causes, including inappropriate feeding practices. However, few infants attend anaemia screening programmes due to poor cooperation and being time-consuming. This study evaluated the accuracy of noninvasive total haemoglobin (Hb) spot-check monitoring as part of anaemia screening in healthy infants, compared with the conventional laboratory method.

Design
A cross-sectional study was conducted using a consecutive sampling technique.

Setting
The study was carried out at the Well-Child Clinic, Khon Kaen University, Thailand.

Participants
Healthy, full-term infants aged 6–12 months who were scheduled for vaccination. Spectrophotometric haemoglobin (SpHb) was measured using Masimo Rad-67 with Rainbow DCI-mini Sensor. These values were compared with conventional laboratory analysis (HbLab) performed on the same day.

Primary and secondary outcome
Differences between Hb values using the two methods were analysed using the Bland–Altman method. Sensitivity, specificity and positive and negative predictive values (PPV and NPV) for detecting anaemia were determined. Anaemia was defined as HbLab of

Ricoverato il 60%, il 13,5 in terapia intensiva, mortalità 10,6%

Introduction
Secondary spontaneous pneumothorax (SSP) is a medical emergency where the lung collapses in the presence of underlying chronic lung disease. Current international clinical guidelines advise intercostal drain (ICD) insertion for SSP. However, in a previous small study needle aspiration (NA) has been shown to reduce length of hospital stay (LOHS) and reduce complications. We are evaluating the clinical and cost-effectiveness of an initial NA approach to the management of patients with SSP in the United Kingdom.

Methods and analysis
The PRINCE-SSP (Pragmatic non-inferiority Randomised trial Investigating Needle aspiration vs ChEst drain for Secondary Spontaneous Pneumothorax) trial is a pragmatic, multicentre, open-label, parallel, two-group, randomised, non-inferiority trial to establish whether NA for SSP is non-inferior in terms of LOHS compared with ICD. We aim to recruit 110 patients from at least 15 UK NHS hospitals, over 18 months. Participants allocated to the intervention (NA) group will have an NA inserted at the presentation. Those allocated to the comparator (usual care) group will have an ICD inserted. Participants are followed up for 30 days. The primary outcome measure is initial LOHS, up to day 30 postrandomisation. Secondary outcomes include (but are not limited to) total LOHS including readmissions, complications, cost-effectiveness and patient-reported quality of life.

Ethics and dissemination
This trial received Health Research Authority (HRA) approval from Wales Research Ethics Committee seven ethics committee (23/WA/0085). Results will be submitted for publication in a peer-reviewed journal. A plain English summary of the trial results will be prepared and disseminated with the help of our patient advisory group, including via social media, and provided to trial participants via post or email according to their preference.

Trial registration number
ISRCTN12644940.

Objectives
To understand the competitive position of the UK in comparison to Europe and the USA for haematological cancer clinical research.

Design
Using commercially available databases, clinical trial numbers, their effectiveness and publication outputs were evaluated in two analyses: a macrodevelopment and a research activity and performance analysis.

Data sources
The following databases were used for this analysis: Organisation for Economic Co-operation and Development, Thomson Reuters Incidence and Prevalence, the Cortellis Clinical Trial Intelligence, the Clarivate Cortellis Innography Patent Intelligence, Thomson-Reuters Cortellis Regulatory Intelligence, Thomson Reuters Web of Science and data from the Centre for Medicine Research (CMR).

Eligibility criteria
European countries with comparable geography, healthcare standards and economies, as well as the USA, the largest country where research is conducted. All haematological oncology clinical trials from phase 1 to phase 3 were included.

Data extraction and synthesis
All data were retrieved in September 2017 and macroeconomic data were reviewed in 2022; haematological cancer data were restricted to leukaemias generally as a surrogate reference for haematological oncology indications; research output publication data were evaluated using specific MeSH/keyword search terms between 2010 and 2017. Key metrics explored included healthcare expenditure per capita, study experience across countries, comparative capability of each country for clinical trial implementation, clinical trials’ performance and impact of research as measured by impact factor and citation metrics of publications.

Results
Revenue for clinical studies is lower in the UK than European comparators. All studied countries had comparable leukaemia prevalence rates, but the UK spent least per capita on healthcare versus France, Germany, Spain and the USA. The number of clinical studies in the UK showed a decline compared with other European countries. Clinical trial implementation was lowest in the UK (n=380) versus Germany (n=665), France (n=643), Spain (n=632), Italy (n=538) and the USA (n=3254). Registered versus active clinical studies suggested the USA had the highest number underway (n=824), with the UK ranked fourth of five European countries (Germany=239, Italy=232, France=211, UK=177 and Spain=141). However, the UK had the highest completion rate of phase 3 studies it did initiate (n=154, 87%) and performance was comparable with Germany (n=188, 78.7%) and France (n=151, 71.6%). When analysed by phase, the UK was the second highest European performing country (n=121) for phase 2 study completion compared with Germany (n=182) both less than the USA (n=345). The UK completed the most phase 1 studies compared with other European countries, only second to the USA (n=31 vs n=126). However, the UK clinical trial performance metrics were negatively impacted for the UK compared with other European countries with respect to clinical trial application (CTA) process, timelines, ethics committee approvals, median time to start up and rate of non-enrolling sites. The UK was slower to initiate studies (median 186 days) vs Germany (92 days), France (141 days), Italy (122 days) and only marginally faster than Spain (195 days). While median enrolment rates were comparable across all countries, the UK had the highest proportion of sites that failed to enrol any patients (despite regulatory timings being comparable to Germany (90 days) and France (95 days)). However, publication of data following clinical trials in the UK was robust and of the highest quality compared with other countries, judged by journal placement and publication citations. The UK published high-quality, diverse research with citation rates (11.8) from clinical studies which was higher than every other country, including the USA who published fivefold more publications per year.

Conclusion
While research in the UK remains among the highest quality and value globally, the UK may be losing its position globally as an attractive destination for executing clinical trials. This may be a trend that is recognised by the UK Government, but it is vital to reverse the trend of clinical trial decline and to improve the economic outlook for the UK and patient early access to innovative cancer medicines.

Objective
Heart rate serves as a critical prognostic factor in heart failure (HF) patients. We hypothesise that elevated heart rate in critically ill HF patients on discharge from the intensive care unit (ICU) could be linked to adverse outcomes.

Design
A single-centre retrospective cohort study.

Setting
This study used data collected between 2008 and 2019 from the Medical Information Mart for Intensive Care IV (V.2.0) Database.

Participants
From the 76 943 ICU stays, we enrolled 2365 patients in this study.

Primary and secondary outcome measures
We observed correlations between in-hospital mortality and ICU discharge heart rate of 83.56±15.81 beats per minute (bpm) (survivors) vs 93.84±17.28 bpm (non-survivors, p

Objectives
The objectives of the study are to investigate infection risk in offspring born to women with systemic lupus erythematosus (SLE) compared with offspring born to women without SLE and examine the mediating role of preterm birth.

Design
This is a register-based cohort study.

Setting
Liveborn singletons born in Sweden, 2006–2021, were included in the study.

Participants
1248 infants born to mothers with SLE (≥2 International Classification of Diseases-coded visits in the National Patient Register (NPR) and Medical Birth Register, with ≥1 visit before pregnancy) and 34 886 infants born to women without SLE from the general population were included.

Primary and secondary outcome measures
The primary outcome was any visit for infection in the NPR or anti-infectives in the Prescribed Drug Register. The secondary outcome was hospitalised infection. Infection risks within 72 hours, within 1 month and within 1 year were estimated.

Results
SLE offspring had a higher risk of infection in the first 72 hours compared with non-SLE (2.1% vs 1.2%; risk ratios (RR) (95% CI) 1.62 (1.09 to 2.42)), the first month (5.2% vs 4.5%; RR 1.12 (0.88 to 1.43)) and first year of life (38.2% vs 37.2%; RR 1.09 (1.01 to 1.17)). The hospitalised infection risk for SLE offspring was similar to that of non-SLE (5.8% vs 5.5%, first year of life). The percentage of the total effect of maternal SLE on infant infection mediated through preterm birth was 86% for infection in the first 72 hours and 27% in the first year of life.

Conclusions
The risk of infection in SLE offspring is most increased in the first 3 days after birth, and a proportion of this association can be explained by preterm birth. To prevent early neonatal infections, maternal SLE could be considered as a risk factor before allowing early discharge from postnatal care.

To the Editor As noted by Dr Barnard and colleagues, existing evidence confirms that endometriosis is associated with an elevated risk of ovarian cancer with differences by histotype. However, despite the varying presentations of endometriosis—most notably 3 macrosurgically visualized subphenotypes (endometriomas, superficial peritoneal, and/or deep lesions)—identifying women with endometriosis who are at high risk remains elusive. To address this question, the investigators leveraged data from the Utah Population Database and defined endometriosis subphenotypes by International Classification of Diseases (ICD) codes documented from 1992 to 2019 in more than 450 000 women. A consistent challenge in registry-based studies has been the selection of a comparison group. As demonstrated by Hermens et al in the Dutch nationwide registry, women diagnosed with ovarian cancer may be concurrently diagnosed with endometriosis, biasing estimated risk compared with members of the general population, who typically have not had pelvic surgery and whose endometriosis is more likely to remain undetected, leading to an observed 29 (95% CI, 20.7-40.9) times greater risk of endometrioid ovarian cancer (incident rate per 100 000 person-years, 29.7) when they included concurrent endometriosis diagnosis, but a much lower 2.6 (95% CI, 1.5-4.5)–fold greater risk when they excluded endometriosis diagnosed within 1 year of a diagnosis of ovarian cancer (incident rate per 100 000 person-years, 4.1). Unfortunately, Barnard and colleagues did not exclude concurrent diagnoses of ovarian cancer and endometriosis (17% of endometriosis and ovarian cancer diagnoses were within 5 mm under the peritoneal surface). Furthermore, since deep lesions were combined with endometriomas, the reader is unable to distinguish the true ovarian cancer risk for women with endometriomas vs deep lesions. Ultimately, the results may encourage clinicians to advise women with endometriomas or deep endometriosis toward prophylactic bilateral oophorectomy based on an overestimation of the true risk. Such an approach disregards the growing evidence of harm caused by inducing early menopause unnecessarily, including elevated risk of cardiovascular disease, bone fracture, and Alzheimer disease. As this is an essential question for women’s health, a reanalysis of the data are needed to guide women and clinicians in understanding a realistic estimation of their ovarian cancer risk and valid attribution to an accurately defined endometriosis subtype.

In the Original Investigation “Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis: The BASIS Randomized Clinical Trial,” published Online First September 5, 2024, and in the October 1, 2024, print/online issue of JAMA, there were errors in Tables S2, S3, and S12 in the Supplement. The author has explained these errors and corrections needed in a Letter to the Editor and has confirmed that there are no other errors in the article.

This Special Communication analyzes and compares development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment costs of biologics with small-molecule drugs.

To the Editor On behalf of my coauthors, I write to address concerns raised by a reader regarding the data presented in the Supplement to our Original Investigation, “Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis: The BASIS Randomized Clinical Trial,” published online first on September 5, 2024, and in the October 1, 2024, print/online issue of JAMA. We value the feedback and have conducted a thorough review of the data, specifically supplemental Tables S2, S3, and S12.

Objective
To investigate the impact of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal and maternal outcomes and test the feasibility of a future large, randomised trial.

Design
A randomised, double-blind, pilot clinical trial from 16 March 2023 to 15 June 2023.

Setting
A tertiary-care hospital in Beijing, China.

Participants
200 women aged≥18 years who had full-term single pregnancy and were scheduled for vaginal delivery with epidural analgesia.

Interventions
Eligible participants were randomly assigned in a 1:1 ratio to receive self-controlled epidural labour analgesia using ropivacaine supplemented with either dexmedetomidine (0.45 µg/mL for induction and 0.36 µg/mL for maintenance) or sufentanil (0.45 µg/mL for induction and 0.36 µg/mL for maintenance).

Main outcomes and measures
The primary endpoint was a composite of neonatal morbidity, including 1- or 5 min Apgar score

Objective
To estimate the resource use of patients with obstructive hypertrophic cardiomyopathy (HCM), stratified by New York Heart Association (NYHA) class, in the English and Northern Irish healthcare systems via expert elicitation.

Design
Modified Delphi framework methodology.

Setting
UK HCM secondary care centres (n=24).

Participants
Cardiologists who actively treated patients with HCM were eligible, of whom 10 from English and Northern Irish centres participated. Recruitment of participants to the study was limited to one expert per site.

Methods
Responses were collected by electronic quantitative survey. Following the discussion of survey results in a virtual panel, aggregated responses from a final survey were analysed and stratified by NYHA class. Data were analysed without (base case) and with (scenario) interventional cardiologists who conduct septal reduction therapies (SRTs).

Results
Based on expert opinion, as NYHA class increased, so did the mean±95% CI number of primary care consultations (classes I–IV: 0.64±0.35; 1.07±0.33; 3.29±1.02; 6.00±2.46, respectively) per patient per annum. This was also observed across all types of secondary care consultations, such as mean±95% CI number of cardiovascular-related outpatient visits (classes I–IV: 0.69±0.26; 0.88±0.24; 2.13±0.78; 3.25±1.42, respectively) and inpatient admissions (classes I–IV: 0.01±0.01; 0.04±0.07; 0.94±0.39; 1.90±0.65, respectively) per annum. Patients in NYHA class III were most likely to undergo SRT in their lifetime (mean±95% CI proportion of patients:17.25%±7.19% or 26.30%±13.61% including interventionalists). Across NYHA, experts estimated that septal myectomy was more costly than alcohol septal ablation (mean±95% CI: £15 675±£10 556 vs £6750±£5900, respectively). Prescription of beta-blockers was higher than calcium channel blockers, irrespective of NYHA class.

Conclusions
Treatment of obstructive HCM is associated with a substantial clinical and economic burden in England and Northern Ireland; the burden of the disease increasing with NYHA class is driven by the need for intensive disease management, hospitalisations and the potential burden of undertaking SRTs.

Introduction
Lower diversity of the gut microbiome prior to allogeneic haematopoietic cell transplantation (HCT) correlates with reduced survival after the intervention. Most patients undergoing HCT for a haematological malignancy have previously received intensive chemotherapy, resulting in prolonged neutropenic episodes requiring broad-spectrum antibiotics; use of these has been linked to reduced microbiome diversity. Intestinal microbiota transplant (IMT) is a novel treatment approach that restores this diversity. We hypothesised that IMT performed prior to initiation of HCT conditioning restores microbiome diversity during the early stages of HCT, leading to decreased frequency of complications and improved outcomes of HCT.

Methods and analysis
50 adult patients receiving allogeneic HCT will be recruited into this phase IIa trial and randomised 1:1 to receive capsulised IMT or matched placebo shortly prior to initiation of HCT conditioning and followed for up to 12 months. The primary outcome will be to assess the increase in alpha diversity between pre-IMT and that measured at ~42 days after IMT administration (day +28 of HCT), comparing the difference between patients receiving IMT compared with placebo. Secondary outcomes will include tolerability, the dynamics of gut microbiome diversity metrics and taxonomy over all time points assessed, as well as clinical outcomes (including burden of invasive infections, days of fever, admission to intensive care, development of graft-vs-host disease and mortality).

Ethics and dissemination
This study was approved by a UK Research Ethics Committee (REC reference: 23/NE/0105). Dissemination of results will be in concert with patient and public involvement group input and is expected to be primarily via abstract presentation at conferences and manuscripts in peer-reviewed journals.

Trial registration numbers
NCT6355583; EudraCT: 2022-003617-10.