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Summary of the National Advisory Committee on Immunization (NACI) Statement-Updated guidance on Imvamune in the context of a routine immunization program.

BACKGROUND: Mpox is a viral illness related to smallpox. It can cause flu-like symptoms and a rash, and in severe cases, can lead to hospitalization or death. The Imvamune® vaccine offers protection against mpox. Consistent with global trends, mpox cases in Canada have been reported primarily among men who have sex with men (MSM), with sexual contact as the predominantly reported mode of transmission. While the incidence of mpox in Canada has significantly declined since the fall of 2022, mpox remains an important public health concern with the potential for future resurgence. METHODS: The Na

Ensuring compliance: A review of EU regulations and standards for incorporating legume and legume by-product proteins in food formulations.

Consumers are increasingly seeking nutritionally enhanced products, unique flavours and packaging, and ethically sourced ingredients. Significant technological advancements and investments in product innovation by manufacturers are driving the overall market growth for plant-based protein alternatives. In Europe, this growth is largely due to the rising adoption of veganism and the flexitarian trend. During vegetable processing, certain activities generate large amounts of by-products, many of which are discarded by manufacturers. These legumes and their by-products contain substantial amounts

Efficacy of focal high-dose-rate brachytherapy in the treatment of patients diagnosed with low or favourable: intermediate-risk prostate cancer-a protocol for a randomised controlled trial.

INTRODUCTION: Prostate cancer (PCa) is men's second most predominant cancer worldwide. Because the prostate-specific antigen test is used in diagnostics, PCa is more often diagnosed in the early stages, making radical treatment of the disease possible. However, it is estimated that over a million men worldwide suffer from radical treatment-related complications. Thus, focal treatment has been proposed as a solution, which aims to destroy the predominant lesson that determines the progression of the disease. The main objective of our study is to compare the quality of life and efficacy of patie

Indications for involuntary hospitalization for refusal of treatment in severe anorexia nervosa: a survey of physicians and mental health care review board members in Japan.

BACKGROUND: When a patient with anorexia nervosa refuses treatment despite a physically critical condition, the therapist considers involuntary inpatient treatment under the Mental Health Law. However, ethical and practical problems arise from its application. In this study, a survey of treatment providers for eating disorders and psychiatric review board members was conducted regarding indications for involuntary hospitalization under the Mental Health Act for refusal of treatment for anorexia nervosa. METHODS: A survey of 212 physicians affiliated with the Japanese Society for Eating Disord

Patient relevant endpoints in oncology: current issues in the context of early benefit assessment in Germany.

UnlabelledThe German AMNOG healthcare reform includes a mandatory early-benefit-assessment (EBA) at launch. As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the Federal Joint Committee (G-BA). Current EBA decisions released have unveiled issues regarding the acceptance of some patient-relevant endpoints as G-BA and IQWiG are grading the endpoints, focusing on overall survival as the preferred endpoint in oncology.A taskforce of experienced German outcome

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… The European authorities (European Medical Agency, EMA), the higher federal authorities in Germany (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM, and Paul-Ehrlich-Institute, PEI, respectively) and ethics-committees in charge have defined specific requirements in this respect [ 2 - 4 ]. … Survival-related and other endpoints in oncology: an integrated view The selection of the primary endpoint in clinical trials in oncology and the cross-over question (Table 1 ) are typically the subject of intense discussion between researchers, study groups, regulatory bodies and ethics committees. …

Generative AI in the Care of Older Adults: A Position Statement From the American Geriatrics Society.

BACKGROUND: Generative artificial intelligence (GenAI), particularly large language models (LLMs), is being integrated into healthcare documentation, decision support, patient education, administrative workflows, and emerging agentic systems capable of initiating clinical and operational actions. While GenAI may reduce clinician burden and support person-centered care, it also introduces risks such as misinformation, algorithmic bias, privacy harms, errors of omission, and automation over-reliance. These risks may be amplified for older adults because core geriatrics care tasks, such as goals-

CROSS-CULTURAL ADAPTATION OF THE LIVER DISEASE UNDERNUTRITION SCREENING TOOL TO BRAZILIAN PORTUGUESE.

BACKGROUND: Chronic liver diseases represent a relevant public health problem, and undernutrition is one of their most frequent complications, being associated with higher morbidity and mortality in patients with cirrhosis. Early identification of undernutrition risk in outpatients with liver disease is fundamental; however, there is no nutritional screening tool culturally adapted for this population in Brazil. The Liver Disease Undernutrition Screening Tool (LDUST) is a simple and validated instrument for this purpose. OBJECTIVE: The objective of this study was to perform the cross-cultural

Incidence of Arterial Hypertension in People With Periodontitis and Characterization of the Oral and Subgingival Microbiome: A Study Protocol.

Cardiovascular diseases are the leading cause of morbidity and mortality worldwide. High blood pressure in particular, continues to increase throughout the global population at an increasingly fast pace. The relationship between arterial hypertension and periodontitis has been recently discussed in the context of its origins and implications. Particularly relevant is the role of the periodontal microbiome linked to persistent local and systemic inflammation, along with other risk factors and social determinants of health. The present protocol will investigate/assess the association between per

Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study.

INTRODUCTION: Antineoplastic drugs (AD) are potentially carcinogenic and/or reprotoxic molecules. Healthcare professionals are increasingly exposed to these drugs and can be potentially contaminated by them. Internal contamination of professionals is a key concern for occupational physicians in the assessment and management of occupational risks in healthcare settings. Objectives of this study are to report AD internal contamination rate in nursing staff and to identify factors associated with internal contamination. METHODS AND ANALYSIS: This trial will be conducted in two French hospital ce

Harmonizing mind acupuncture combined with nicotine replacement therapy for tobacco use disorder: a protocol for a pragmatic randomized controlled trial.

BACKGROUND: Tobacco use disorder (TUD) remains a leading cause of preventable morbidity and mortality worldwide. Although nicotine replacement therapy (NRT) is recommended as a first-line treatment, its effectiveness is limited by persistent craving and withdrawal symptoms, resulting in high relapse rates. Acupuncture has been investigated as an adjunctive therapy; however, existing evidence is inconsistent and limited by methodological heterogeneity. High-quality pragmatic randomized controlled trials are needed. The co-primary outcomes are nicotine craving reduction (VAS) and biochemically v

Comparison of oxycodone hydrochloride injection versus sufentanil for postoperative analgesia in patients undergoing minimally invasive cardiac valve replacement: study protocol for a single-centre, randomised, double-blind non-inferiority trial.

INTRODUCTION: With the advancement of the ERAS (Enhanced Recovery After Surgery) concept, minimally invasive heart valve replacement surgery has become widely performed due to its advantages of smaller trauma and fewer adverse reactions. However, postoperative pain management remains complex and traditional opioid analgesia is often associated with adverse side effects. Oxycodone, an opioid agonist, has strong analgesic effects with relatively few side effects. This study aims to explore the efficacy and safety of oxycodone hydrochloride injection in multimodal pain management following minima

Effectiveness of psychosocial counselling on treatment adherence among patients with a new tuberculosis diagnosis in primary care: a study protocol for a cluster-randomised controlled trial.

INTRODUCTION: Newly diagnosed tuberculosis (TB) patients frequently experience psychological distress, stigma, and concerns regarding treatment duration, side effects and social consequences, which may negatively affect adherence. Psychosocial counselling has been proposed as a patient-centred strategy to address these challenges; however, evidence regarding its effectiveness among newly diagnosed TB patients in primary care settings remains limited. This study aims to evaluate the effectiveness of a psychosocial counselling intervention in improving treatment adherence and psychosocial outcom

Protocol for the development and testing of a web-based patient decision aid for early-stage breast cancer patients within a cancer centre care: a mixed-method approach.

INTRODUCTION: Early breast cancer (BC) detection enhances survival, with treatment options influenced by cancer stage, pathological characteristics and patient preferences. Patient decision aids (PDAs) promote shared decision-making (SDM), enhancing patients' engagement, adherence to treatment and satisfaction. However, few PDAs for early-stage BC patients exist in the Italian context. METHODS AND ANALYSIS: A first developmental phase will include a systematic review on current PDAs and semistructured interviews with patients and healthcare professionals. Outcomes will be used to develop a fi

Learning from the experiences of midwifery students and recent graduates in humanitarian and conflict-affected settings: A prospective cohort study protocol.

BACKGROUND: Health workforce shortages are a serious impediment to the delivery of effective and person-centered care, particularly in conflict settings. Midwives are a critical cadre who can help avert maternal and child death, but face persistent barriers to education, employment, regulation, and professional development-challenges that are especially pronounced in conflict-affected areas. Few studies have systematically explored midwives' experiences in these settings. OBJECTIVES: The EQUAL midwifery cohort study was established to systematically examine midwives' educational and professio

PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in acute coronary syndromes (REPRESS): study protocol for a multicentre randomised controlled trial.

INTRODUCTION: The 'strike early and strike strong' lipid-lowering strategy emphasises rapid reduction of low-density lipoprotein cholesterol (LDL-C) in patients with acute coronary syndrome (ACS). Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are increasingly used alongside statins to achieve guideline-recommended LDL-C targets after ACS. However, despite substantial LDL-C reductions with early PCSK9i initiation, their effects on non-culprit coronary atherosclerotic plaques remain unclear. This study aims to assess the impact of early intensive LDL-C lowering with PCSK9i ad

Efficacy of artificial intelligence-based digital therapeutics versus traditional Schroth exercises for adolescent idiopathic scoliosis: protocol for a randomised controlled trial.

INTRODUCTION: Adolescent idiopathic scoliosis (AIS) requires long-term conservative management to prevent curve progression. While physiotherapeutic scoliosis-specific exercises, specifically the Schroth method, are considered the gold standard for conservative treatment, their clinical efficacy is often limited by accessibility barriers, high costs and suboptimal treatment adherence. This study aims to evaluate the efficacy of a novel artificial intelligence (AI)-based digital therapeutic system, which uses computer vision for remote, personalised posture analysis and adaptive exercise prescr

Effectiveness and cost-effectiveness of the Pain-at-Work Toolkit for improving work ability in adults with chronic pain: protocol for a cluster randomised controlled trial.

OBJECTIVES: Chronic pain affects around 28 million adults in the UK and is associated with impaired work ability, reduced productivity and increased sickness absence. Access to work-focused support within healthcare services is limited, and most employers do not routinely provide structured assistance for employees living with chronic pain. The Pain-at-Work Toolkit is a co‑created, web‑based intervention designed to improve work ability, self‑management, and workplace experiences for employees living with chronic pain. A feasibility trial demonstrated strong acceptability, exceptional recruitm

Co-development of a consensus-based pathway to improve access and outcomes for women seeking flat symmetry as an alternative to breast reconstruction after mastectomy for breast cancer: Protocol for the UK FLAME study.

INTRODUCTION: Up to 40% of women with breast cancer will require a mastectomy, and breast reconstruction is routinely offered to restore symmetry. While not all women want, or are suitable for, breast reconstruction, many want to be symmetrical following breast cancer surgery. For these women, contralateral mastectomy for 'flat symmetry' is a good alternative, but in the UK, access to contralateral 'symmetrising' mastectomy (CSM) is highly variable. Many women seeking this option describe feeling frustrated, unsupported and having to 'fight' to access care, while clinicians express concerns ab

Preventing the next stroke: nurse-led decision and adherence coaching to empower people with stroke (StrokeCompass) versus usual care - study protocol for a stepped-wedge pilot trial.

INTRODUCTION: Recurrent stroke prevention is important for people who have suffered a stroke or transient ischaemic attack (TIA), as they are at increased risk of having another stroke. Nevertheless, treatment adherence is often low. Therefore, the StrokeCompass project was initiated to enhance medication adherence by empowering individuals who have had a stroke to take an active role in recurrent stroke prevention and medication management. In accordance with the UK Medical Research Council (MRC) guidelines, a complex intervention was developed that integrated evidence-based decision aids and

Studying Early Life Live-Attenuated influenza virus immune Responses (STELLAR): study protocol for an exploratory observational study of the nasal mucosal and systemic immune response in healthy children given an intranasal live-attenuated influenza vaccine.

INTRODUCTION: The mechanisms generating immunity involved in nasal vaccination for children are likely to differ significantly from both adult immunity and animal models. A deeper understanding is necessary for the development of future paediatric mucosal vaccines. Live-attenuated influenza vaccines (LAIVs) are licensed mucosal vaccines which confer protection in children against severe influenza. Beyond individual protection, mucosal vaccines can also limit transmission and colonisation, offering broader public health benefits than parenteral vaccination. We describe a protocol for an explora