Search Results for: AGA: linee guida sulla de-prescrizione degli inibitori della pompa protonica

Science and medicine are dynamic, evolving areas of study and practice. Scientific journal publications reflect the rapidly shifting knowledge and paradigms set by the scientific community. This community produces and consumes journal content, impacted by multidimensional current and historical contexts. The paradigm-shifting events of 2020 amplified awareness and demand for scientific journals to more fully reflect the intersection of science, medicine, and health equity. From this demand came the inspiration to develop the Diversity, Equity, and Inclusion (DEI) Section in Gastroenterology in January 2022, and, soon after, a parallel DEI section in Clinical Gastroenterology and Hepatology (CGH) in July 2022, within the framework of the American Gastroenterological Association (AGA) Equity Project.

Introduction
While intensive protocols in onco-haematology have improved survival rates for patients with haematological malignancies, they have also resulted in an increased incidence of infection associated with therapy-induced immunosuppression (including chemotherapy-induced febrile neutropenia; FN). The occurrence of FN, associated with high morbidity and mortality, necessitates broad-spectrum antibiotic therapy, occasioning delayed chemotherapy and resulting in a loss of opportunity for the patient. Considering that without an identified pathogen, a 10% mortality rate can ensue, documentation is essential to the optimisation of antibiotic therapy. However, blood culture (the reference test) is limited for several reasons: such as fastidious culture, antibiotic treatment prior to sampling or insufficient sample volume. Sequencing technologies have led to the development of diagnostic approaches based on the detection of circulating DNA in blood. This study will aim to assess the clinical utility of metagenomic next-generation sequencing (mNGS)-DISQVER technology in detecting pathogenic microorganisms from blood samples of patients undergoing high-risk FN treatment.

Methods and analysis
This nationwide, prospective, multicentre, interventional, proof-of-concept clinical trial will enrol 200 patients. Will include patients≥18 years old, treated for malignancy, at high risk of FN (Multinational Association for Supportive Care in Cancer score≤21) with an expected duration of neutropenia≥7 days. Patients who received antibiotic treatment within 24 hours prior to enrolment, have previously participated and/or have enhanced protection will be excluded. The primary outcome will be determined by considering the microorganisms responsible for this FN, weighted by the assessment of an adjudication committee. Secondary outcomes will evaluate patient management depending on the arm. The second secondary outcome will be determined by the duration of conventional assessment, frequency of microorganisms detected during routine care and percentage distribution of theoretical adjustments made to anti-infective treatment based on microorganisms diagnosed using the mNGS-DISQVER tool as compared with conventional practices. Identifying the pathogens responsible for high-risk FN from a blood sample, using an unbiased technique, can provide microbiological documentation and may even reveal unexpected microorganisms in these profoundly immunocompromised patients.

Ethics and dissemination
The protocol received approval from the Comité de Protection des Personnes Sud-Méditerranée II. All participants will provide informed consent before participation. The trial has been registered on ClinicalTrials.gov (identifier NCT06075888). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Trial registration number
ClinicalTrials.gov NCT06075888.

Introduction
There is currently limited information regarding the association between the modified Nutrition Risk in Critically Ill (mNUTRIC) score, nutrition delivery and clinical outcomes in critically ill patients admitted to the intensive care unit (ICU) section.

Methods and analysis
The Isfahan-ICU study is a multicentre, prospective observational cohort study that will be conducted on critically ill adults treated in the trauma or medical ICU sections of six hospitals to investigate whether clinical outcomes, including length of ICU stay and 30-day survival, vary by the mNUTRIC score at admission or the 7-day nutrition delivery. This paper outlines the Isfahan-ICU study protocol approved by the ethics committee of Isfahan University of Medical Sciences, Iran. Patient confidentiality is ensured, and study results will be shared at conferences and in medical papers.

Ethics and dissemination
This study protocol was reviewed and approved by the ethics committee of the Isfahan University of Medical Sciences, Isfahan, Iran (IR.MUI.RESEARCH.REC.1401.184). The patient’s identity will be considered confidential and will not be revealed or published under any circumstances; all provisions of laws governing personal data protection will be observed. Patient data recorded in the electronic survey will be documented pseudonymously using de-identified patient ID codes, and authorised staff at each participating site will have access to only their identifiable data. Results from the study will be disseminated at national and international conferences and in medical papers.

Trial registration number
Ethics committee of the Isfahan University of Medical Sciences, Isfahan, Iran (IR.MUI.RESEARCH.REC.1401.184).

Introduction
The prevention of diabetic foot ulcer (DFU) involves the classification of risk, systemic care, regular examinations, foot care, therapeutic education and adjunct treatments. Photobiomodulation (PBM) has been successfully administered for the healing of DFU and its preventive effects have drawn the interest of researchers.

Methods and analysis
The purpose of the study is to assess the effect of PBM for the prevention of DFU through a randomised, controlled, double-blind, clinical trial. Individuals from 18 to 75 years of age of both sexes with type 2 diabetes mellitus (DM) at moderate to high risk of developing DFU will be randomly allocated to two groups of 32 participants each. The PBM group will wear a boot with 1344 light-emitting diodes (LEDs)—504 with a wavelength of 660 nm located on the sides of the boot (28.5 mW, 10 J per LED), 504 with a wavelength of 850 nm also on the sides of the boot (23 mW, 8 J per LED), 168 with a wavelength of 660 nm on the base of the boot (28.5 mW, 10 J per LED) and 168 with a wavelength of 850 nm also on the base of the boot (23 mW, 8 J per LED). The boot will be worn once a day for 6 min over 60 days and the participants will also receive therapeutic education. The control group will wear a non-therapeutic LED boot (sham) under the same conditions and will also receive therapeutic education. Assessments will be performed at the beginning of the study, after 30 days (clinical examination) and after 60 days (clinical examination, assessment of peripheral neuropathy (PN) and peripheral artery disease (PAD), blood and urine examinations and quality of life).

Ethics and dissemination
This protocol received approval from the Human Research Ethics Committee of Nove de Julho University and the Mandaqui Hospital Complex (certificate number: 66098522.0.3001.5511; final approval date: 22 June 2023). The findings will be published in a peer-reviewed journal.

Trial registration number
NCT06353568, ClinicalTrials.gov.

Introduction
Osteoarthritis, the most prevalent joint disease, poses a significant challenge due to its progressive nature and impact on the whole joint and periarticular structures. Although exercise is crucial for symptom improvement and progression slowdown, adherence to exercise programmes remains a concern. In response, we have developed a novel smartphone-based m-health application, ARTH-e, specifically designed to enhance adherence to adapted physical activity in individuals with knee osteoarthritis. We aim to perform a prospective,multicenter, randomized (1:1) controlled trial to compare the effectiveness of m-health application ARTH-e (intervention group) with standard care (control group) on exercise adherence in people with knee osteoarthritis. We hypothesise that adherence will be stronger among users of the ARTH-e application.

Methods and analysis
We will recruit 120 participants from 5 hospitals in France. The participants will undergo a comprehensive assessment, including the Exercise Adherence Rating Scale (EARS) at 2, 4 and 6 months, Knee Injury and Osteoarthritis Outcome Score, Evaluation of the Perception of Physical Activity, Tampa Scale of Kinesiophobia, European Quality of Life 5 Dimensions and 3 Lines and a Visual Analogue Scale rating of pain at baseline and 6 months. Adherence will be monitored using a connected bracelet. The intervention group will use the ARTH-e application for 6 months, while the control group will follow stay-active advice from their physician. The primary outcome will be the difference between groups in the evolution of the EARS score at 6 months.

Ethics and dissemination
The study has been approved by the medical ethics committee (Comité de Protection des Personnes) XI of Saint Germain en Laye (27 March 2024) (ID for ethics approval: 24.00330.000201). Eligible individuals will sign the informed consent form before enrolment. Study results will be reported in peer-reviewed publications and at scientific meetings.

Trial registration number
NCT06359171.

I recently read the American Gastroenterological Association clinical practice update on integrating potassium-competitive acid blockers into clinical practice.1 I believe the advice and data presented regarding the use of vonoprazan for the treatment of Helicobacter pylori infections are misleading. Vonoprazan triple therapy is recommended despite the US/European vonoprazan trial reporting that vonoprazan-based therapy failed to produce high, or even acceptable, cure rates in patients with both clarithromycin susceptible and resistant infections.

Inizio d’anno con un ‘tour de force’ al Bufalini

Objective
To identify specific subgroups of older patients at risk of repeated hospital readmissions and death.

Design
Prospective, multicentre, DAMAGE (Patient Outcomes After Hospitalization in Acute Geriatric Unit) cohort of adults aged 75 and over, discharged from an acute geriatric unit (AGU) and followed up for 12 months.

Setting
Six recruiting hospital centres in the Hauts-de-France and Normandie regions of France.

Main outcome measures
We performed a latent class analysis to identify subgroups at risk of repeated hospital readmissions and death, followed by a logistic regression analysis to determine the characteristics associated with the identified subgroups.

Results
3081 patients were included (mean (SD) age: 86.4 (5.5)) and two subgroups were identified. In subgroup 1 (n=2169, 70.4%), only 619 (28.5%) patients were readmitted to hospital once during the follow-up, and 495 (22.5%) died. In subgroup 2 (n=912, 29.6%), all patients were readmitted to hospital at least twice, and 523 (57.8%) died. Subgroup 2 accounted for 29.6% of patients but 74.4% of hospital readmissions, with longer lengths of stay, and 51.6% of deaths. A multivariate logistic regression analysis identified only four characteristics weakly associated with the risk of being in subgroup 2 (at least one hospital admission in the 6 months preceding the index hospital admission, cancer, polymedication and weight changes (gain or loss) during the index hospital admission). The area under the receiver operating characteristic curve was 63%.

Conclusion
A latent class analysis showed that a population of older adults hospitalised in an AGU is divided into two subgroups with regard to the postdischarge outcomes: one subgroup (70% of the individuals) will have a low rate of hospital readmission and a moderate death rate, whereas the other will have a high rate of hospital readmission and a very high death rate. There is a need for predictive scores for both events, with a view to better targeting at-risk patients.

Trial registration number
Trial registration number was approved by the local independent ethics committee (CPP Nord-Ouest IV, Lille, France) on 13 February 2015, with an amendment approved on 21 January 2016 (reference: IDRCB 2014 A01670 47, CNIL bxA15352514).

Irritable bowel syndrome (IBS) is a common condition characterized by recurrent abdominal pain associated with a change in stool form or frequency, which may be diarrhea-predominant (IBS-D), constipation-predominant (IBS-C), or marked by mixed bowel habits (IBS-M).1,2 Studies have shown substantial variation in the care of patients with IBS, often including extensive diagnostic testing leading to unnecessary health care expenditures without notable improvements in outcomes. In addition to the impact on quality of life, this leads to a considerable economic burden related to absenteeism and direct medical expenses.

Introduction
The TransEAsome project, funded by the Agence Nationale de la Recherche, aims to evaluate the long-term outcomes of patients with oesophageal atresia (OA) between 13 and 14 years old and establish multiomics profiles using data from the world’s biggest OA registry.

Methods and analysis
TransEAsome is a national multicentre population-based cohort study recruiting participants from all qualified French centres for OA surgery at birth. The primary objective is to assess the prevalence of gastro-oesophageal reflux disease in adolescence among patients with OA, with several secondary objectives including the identification of risk factors and multiomic profiles from oesophageal biopsies and blood samples collected between 13 and 14 years old, compared with a control group. This comprehensive characterisation of phenotype and omic profiles aims to enhance the understanding of disease evolution in patients with OA and inform tailored care management strategies.

Ethics and dissemination
The study, coconstructed with input from patients, parents and research-expert adolescents, has obtained approval from the ethics research committee: Comité de protection des personnes Est II. Findings will be disseminated to various target audiences, including the scientific community, research participants, the patient community, the general public, regulatory authorities and policymakers. Data will be made available in a Findable, Accessible, Interoperable, Reusable format on the France Cohortes platform on study completion.

Trial registration number
NCT05995171:Clinical trial

Introduction
MODY2 (maturity-onset diabetes of the young type 2, MIM125851) is a monogenic diabetes with an autosomal dominant transmission caused by a variant of the GCK gene. MODY2 is often confused with type 1 or type 2 diabetes, but despite a slightly elevated blood glucose level, it does not induce long-term vascular complications, nor does it require pharmacological treatment. Genetic testing for the diagnosis of MODY2 is currently reserved for genetic specialists and some physicians. Still, access to it by primary care healthcare professionals (HCPs), coupled with appropriate training, would improve the diagnosis and management of patients with MODY2. Thus, to evaluate the implementation in primary care of genetic testing for the screening of MODY2 (iMOgene study), an implementation pilot study has been designed supported by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework.

Method and analysis
Two primary care clinics will be involved in the region of Saguenay-Lac-Saint-Jean (Québec, Canada). An asynchronous online training on MODY2 and genetic testing, including pre/post questionnaires, will be provided to the HCPs. Satisfaction, adoption and maintenance indicators will be collected throughout the project for each clinic. Questionnaires for patients and professionals and focus groups with HCPs will be conducted to assess implementation. This study will document the implementation process of genetic testing in primary care by identifying facilitating and limiting factors to establish specifications for scaling up.

Ethics and dissemination
The present protocol has been approved by the research ethic committee of the ‘Centre intégré universitaire de santé et de services sociaux of Saguenay-Lac-Saint-Jean’ (CIUSSS-SLSJ) on 9 January 2024 and by the ‘Comité central d’éthique de la recherche’ (CCER) of the ‘Ministère de la Santé et des Services Sociaux’ of Quebec (Canada) on 30 January 2024. The informed consent of participants will be obtained orally. Dissemination of the study results will involve peer-review publications, presentations at major national and international scientific conferences.

Introduction
Several cardiovascular outcome trials have been conducted to assess the cardiovascular safety and efficacy of glucagon-like peptide-1 receptor agonists (GLP1-RAs) on cardiorenal outcomes in patients with type-2 diabetes (T2D). However, the strict requirements of randomised controlled trials to avoid most confounding factors are at the expense of external validity. Using national real-world data, we aimed to evaluate the effectiveness of GLP-1RAs in association with metformin especially on cardiovascular events, hospitalisation for heart failure and all-cause death in comparison with other diabetes treatment schemes using dipeptidyl peptidase IV inhibitors, sulfonylureas/glinides or insulin also associated with metformin. Sodium-glucose transport protein 2 inhibitors (SGLT-2i) will be excluded as comparators, as this class of oral hypoglycaemic agents just started in 2020 to be marketed in France.

Methods and analysis
The Système National des Données de Santé is a comprehensive nationwide administrative healthcare database in France that covers approximately 67 million people.
Several cohorts of adult patients with T2D initiating any GLP1-RA in dual or triple therapies, as recommended by the French Health authorities, will be identified in this database over the period 2016–2021. These cohorts will be defined by the combination of glucose-lowering drugs prescribed simultaneously with GLP1-RA and diabetes treatment received over a 6-month period before GLP1-RA initiation. They will be first matched with T2D controls (1:3 ratio) based on the year of drug initiation and treatment regimens before and simultaneously with GLP1-RA in the different selected cohorts. Comparative analyses will be conducted versus these control groups, adjusting for cardiovascular event history and a propensity score considering age, sex, area of residence, deprivation index, comorbidities, duration of diabetes, use of lipid-lowering drugs, anticoagulants, antiplatelet therapies and blood pressure-lowering therapies. Comparative analyses will be conducted versus these control groups, using a high-dimensional propensity scores method and fixed baseline characteristics. Treatment effects on the different outcomes measured will be estimated for each GLP1-RA group, through HR and their corresponding CIs (95% CI) using Cox regressions and/or competitive risk regressions when necessary.

Ethics and dissemination
The study has been approved by an independent ethics committee (Comité éthique et scientifique pour les recherches, les études et les évaluations dans le domaine de la santé, Paris, France; reference: 8699786, dated 2 June 2022) and has been registered with the French National Data Protection Commission (Commission Nationale de l’Informatique et des Libertés, Paris, France; reference: 922161, dated 26 June 2022). The findings of this study will be published in peer-reviewed scientific journals and presented at international conferences.

Trial registration number
F20220803152803.

Introduction
Glycated haemoglobin (HbA1c) is currently the gold standard for assessing glycaemic control in diabetes, given the established relationship with microvascular and macrovascular complications in this condition. However, HbA1c is affected by non-glycaemic factors, while also failing to provide data on hypoglycaemic exposure and glucose variability, which are associated with adverse vascular outcomes. Continuous glucose monitoring (CGM)-derived glucose metrics provide a more comprehensive assessment of glycaemia, but their role in predicting future vascular complications remains unclear. Here, we present the protocol for a real-world cohort study, aiming to establish the relationship between CGM-derived glycaemic metrics and the incidence of macrovascular and/or microvascular complications in people with diabetes.

Methods and analysis
This cohort study will use data from all CGM new users (FreeStyle Libre system) in France who uploaded their glycaemic values onto the LibreView cloud-based system, linked with data from the French nationwide Système National des Données de Santé claims database. The study is expected to include a minimum of 70 000 individuals with diabetes with a first date of glucose data upload to the LibreView platform after 1 January 2018 and with a 6-year follow-up period. The primary outcomes are the first occurrence of new macrovascular or microvascular complications, analysed as a composite outcome and separately. Secondary outcomes will include all-cause mortality and hospital admissions for any cause. This longitudinal study will provide key data on the relationship between CGM-derived glycaemic metrics and micro/macrovascular complications in diabetes. This will have an impact on routine clinical practice by setting targets for the different glycaemic markers, based on robust outcome data, thus helping to optimise glucose management in diabetes.

Ethics and dissemination
The study data-collection protocol is approved by the French National Commission for Informatics and Liberties, including approval from the Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé. This study complies with French and European regulations, including those relating to the General Data Protection Regulation. This study uses pseudonymous information, not requiring informed consent. Dissemination plans include full publication of the study outcomes in peer-reviewed journal(s) with open access and presentations at national and international diabetes and cardiovascular conferences.

Introduction
Alcohol use disorder (AUD) is a massive burden for the individual, relatives and society. Despite this, the treatment gap is wide compared with other mental health disorders. Treatment options are sparse, with only three Food and Drug Administration (FDA)-approved pharmacotherapies. Glucagon-like peptide-1 (GLP-1) receptor agonists have shown promising effects in reducing alcohol consumption in preclinical experiments, and clinical trials are in high demand to investigate these potentially beneficial effects in patients diagnosed with AUD.

Methods and analysis
The effects of the once-weekly GLP-1 receptor agonist semaglutide will be investigated in a 26-week, randomised, placebo-controlled, double-blinded clinical trial. 108 patients diagnosed with AUD and comorbid obesity (body mass index (BMI)≥30 kg/m2)) will be randomised to treatment with either semaglutide or placebo in combination with cognitive behavioural therapy. A subgroup of the patients will have structural, functional and neurochemical brain imaging performed at baseline and after 26 weeks of treatment. The primary endpoint is the reduction in heavy drinking days, defined as days with excess consumption of 48/60 g of alcohol per day (women and men, respectively). Secondary endpoints include changes from baseline to week 26 in alcohol consumption, smoking status, quality of life, fibrosis-4 score, plasma concentration of phosphatidylethanol, brain gamma-aminobutyric acid (GABA) levels, alcohol cue reactivity, functional connectivity and white matter tract integrity.

Status
Recruitment started in June 2023.

Ethics and dissemination
The study is approved by the Ethics Committee of the Capital Region of Denmark, the Danish Board of Health and the Danish Data Protection Agency. All patients will sign the written consent form before being included in the trial. Results will be disseminated through peer-reviewed publications and conference presentations. After the results are published, all de-identified data will be available in the Mendeley database.

Trial registration number
NCT05895643.