Assessing the Value of New Antimicrobials: Evaluations of Cefiderocol and Ceftazidime-Avibactam to Inform Delinked Payments by the NHS in England.

Objectives: The UK has recently established subscription-payment agreements for two antimicrobials: cefiderocol and ceftazidime-avibactam. This article summarises the novel value assessments that informed this process and lessons learned for future pricing and funding decisions.

Methods: The evaluations used decision modelling to predict population incremental net health effects (INHEs), informed by systematic reviews, evidence syntheses, national surveillance data and structured expert elicitation.

Innovative diagnostic technologies: navigating regulatory frameworks through advances, challenges, and future prospects.

Diagnostic tools are key to guiding patient management and informing public health policies to control infectious diseases. However, many diseases still do not have effective diagnostics and much of the global population faces restricted access to reliable, affordable testing. This limitation underscores the urgent need for innovation to enhance diagnostic availability and effectiveness.

Ongoing prospective studies on reirradiation: A systematic review of a clinical trials database.

Introduction: Reirradiation has gained increasing interest, as advances in systemic therapy increase the survival of patients with cancer, and modern radiation techniques allow more precise treatments. However, high-quality prospective evidence on the safety and efficacy of reirradiation to guide clinical practice remains scarce. This systematic review evaluates ongoing prospective studies on reirradiation to identify research gaps and priorities.

Eliciting the barriers and enablers towards anaesthetists giving penicillin-based antibiotic prophylaxis to low-risk patients who have had their penicillin allergy label removed as part of a preoperative delabelling process.

Background: Some penicillin allergy labels can be removed by non-allergy specialists by direct oral challenge, but there is reluctance amongst anaesthetists to give penicillin to these patients. We aimed to assess anaesthetist beliefs about giving penicillin to patients delabelled by direct oral challenge.

Methods: A survey, developed using the Theoretical Domains Framework, was circulated to anaesthetists within a regional research network in England.

Calcinosis in systemic sclerosis: An update on pathogenesis, related complications, and management: A heavy burden still waiting to be lifted off patients' hands.

In SSc, dystrophic calcinosis is one of the major clinical manifestations, characterized by the deposition of insoluble calcific substances in tissues, predominantly in the chemical form of calcium hydroxyapatite. Furthermore, calcinosis might lead to compressive neuropathies and severe pain. Current evidence suggests that tissue ischemia and repeated trauma are implicated in the development of calcinosis; however, there are still too many unknown areas that need to be investigated.

Embedding clinical research in pre-registration nursing and midwifery programmes.

Background: Within the UK, there is a goal that research is embedded into everyday healthcare practice. Currently education provided to students at pre-registration level is theoretical, with little focus on clinical research delivery.

Aims: The paper's aim is to report on the development and evaluation of a pre-registration clinical research resource for nursing and midwifery students with direct application to clinical settings and patient care outcomes.

A multicentre observational study to investigate feasibility of a direct oral penicillin challenge in de-labelling 'low risk' patients with penicillin allergy by non-allergy healthcare professionals (SPACE study): Implications for healthcare systems.

Objective: The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of 'point-of-care' tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling.

Outcomes of ankle joint distraction in a paediatric and young adult cohort presenting with symptomatic ankle arthritis.

Ankle arthritis in paediatric and young adult patients causes significant morbidity; therefore, joint-preserving procedures are preferable. Ankle joint distraction (AJD) is a technique that preserves the native joint. However, only short-term outcomes are reported in paediatric patients.

Mixed-methods evaluation of a behavioural intervention package to identify and amend incorrect penicillin allergy records in UK general practice.

Objectives: About 6% of the UK general practice population has a record of a penicillin allergy but fewer than 10% of these are likely to be truly allergic. In the ALABAMA (Allergy Antibiotics and Microbial resistance) feasibility trial, primary care patients with penicillin allergy were randomised to penicillin allergy assessment pathway or usual care to assess the effect on health outcomes. A behavioural intervention package was developed to aid delabelling.

Addressing the Challenges of Penicillin Allergy Delabeling With Electronic Health Records and Mobile Applications.

Allergy labels are common, often incorrect, and potentially harmful. There are many opportunities for clinical decision support (CDS) tools integrated in the electronic health record (EHR) and mobile apps to address the challenges with drug allergy management, including penicillin allergy delabeling (PADL). Effective delabeling solutions must consider multidisciplinary clinical workflow and multistep processes, including documentation, assessment, plan (eg, allergy testing and referral), record update, drug allergy alert management, and allergy reconciliation over time.

Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial.

Background: Geographic location and national income may influence access to innovation in healthcare. We aimed to study if geographical location and national income influenced the timelines to activate the global phase III APHINITY trial, evaluating adjuvant pertuzumab in patients with HER2-positive early breast cancer.

Methods: Time from regulatory authority (RA) submission to approval (RAA), time to Ethics Committee/Institutional Review Board (EC/IRB) approval, time from study approval by EC/IRB to first randomised patient and from first to last randomised patient were collected.

The European Code of Cancer Practice.

There are considerable disparities between the quality of cancer care and clinical outcomes for cancer patients in different European countries, regions, hospitals and communities. These have persisted despite the introduction of many European and National Cancer Plans, an extensive portfolio of clinical guidelines and the existence of evidence based guidelines for the good practice in planning cancer healthcare systems. We describe the European Code of Cancer Practice which is a citizen and patient-centred accessible widely disseminated statement of the core requirements for good clinical cancer practice.

Treatment With Etirinotecan Pegol for Patients With Metastatic Breast Cancer and Brain Metastases: Final Results From the Phase 3 ATTAIN Randomized Clinical Trial.

Importance: Patients with breast cancer and brain metastases (BM) have a poor prognosis and high clinical need for novel treatments; however, historically, studies have often excluded these patients. Although the BEACON study did not meet its primary end point, treatment with etirinotecan pegol vs chemotherapy of the physician's choice for patients with advanced breast cancer demonstrated a significant improvement in overall survival (OS) for the prespecified patient subgroup with preexisting, pretreated, and nonprogressive BM.

Objective: To compare clinical outcomes in patients with BM treated with etirinotecan pegol vs chemotherapy of the physician's choice in a confirmatory trial.

An open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones.

Background: DAV132 (colon-targeted adsorbent) has prevented antibiotic-induced effects on microbiota in healthy volunteers.

Objectives: To assess DAV132 safety and biological efficacy in patients.

Patients And Methods: An open-label, randomized [stratification: fluoroquinolone (FQ) indication] multicentre trial comparing DAV132 (7.

Quality-of-life methodology in hormone receptor-positive advanced breast cancer: Current tools and perspectives for the future.

Health-related quality of life (HRQOL) is increasingly recognized as important when evaluating cancer treatments. The use, reporting, and analysis of patient-reported outcome measures (PROMs), however, are not standardized in clinical trials and are often poorly implemented in clinical practice. We report the results of a systematic literature review (PubMed search: January 1, 2000 to August 15, 2020) of PROM use, reporting, and analysis in phase 3 clinical trials of hormone receptor-positive (HR+) advanced breast cancer (ABC).

Cancer Treatment: Preclinical & Clinical.

The first evidence that cannabinoids may have in vitro and in vivo antineoplastic activity against tumor cell lines and animal tumor models was published in the Journal of the National Cancer Institute nearly 50 years ago. Cannabinoids appear to induce apoptosis in rodent brain tumors by way of direct interaction with the cannabinoid receptor. They may inhibit angiogenesis and tumor cell invasiveness.

The Place of Chemotherapy in The Evolving Treatment Landscape for Patients With HR-positive/HER2-negative MBC.

Endocrine therapy (ET) for the treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive/HER2-negative) metastatic breast cancer (MBC) has changed markedly over recent years with the emergence of new ETs and the use of molecularly targeted agents. Cytotoxic chemotherapy continues, however, to have an important role in these patients and it is important to maximize its efficacy while minimizing toxicity to optimize outcomes. This review examines current HR-positive/HER2-negative MBC clinical guidelines and addresses key questions around the use of chemotherapy in the face of emerging therapeutic options.

Effectiveness of interventions that support penicillin allergy assessment and de-labeling of patients by non-allergy specialists: a systematic review protocol.

Objective: This review will systematically examine and synthesize the evidence evaluating the effectiveness and safety of interventions that enable non-allergy specialist health care workers to assess allergy risk in patients with reported penicillin allergies and subsequently remove erroneous allergy records.

Introduction: The potential benefits of removing erroneous penicillin allergy labels (de-labeling) are wide-ranging. Penicillin allergy assessment and de-labeling is an antibiotic stewardship priority.

Management of penicillin allergy in primary care: a qualitative study with patients and primary care physicians.

Background: Six percent of patients are allergic to penicillin according to their medical records. While this designation protects a small number of truly allergic patients from serious reactions, those who are incorrectly labelled may be denied access to recommended first line treatment for many infections. Removal of incorrect penicillin allergy may have positive health consequences for the individual and the general population.