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

Background
Approximately 69%–89% of people with severe mental illnesses, particularly psychosis, experience a treatment gap in low- and middle-income countries (LMICs) due to factors such as low public spending on health and weak healthcare systems. The PIECEs project aims to assess the effectiveness and cost-effectiveness of a solution-focused resource-oriented approach (DIALOG+) for improving the quality of life and mental well-being of people with psychosis in India and Pakistan.

Methods
The research design of this analysis is an economic evaluation piggybacked on the PIECEs randomised control trial to test the feasibility of DIALOG+ in India and Pakistan. It implies a cost-utility analysis with a health system perspective. The costs include the cost of the intervention, the cost of healthcare providers and the cost to the household. The primary outcome will be quality-adjusted life years. Incremental cost, incremental effectiveness and incremental cost-effectiveness ratios will be calculated using linear regression models with a hierarchical data structure. A probabilistic sensitivity analysis will be carried out to test for the uncertainty surrounding the estimates of cost-effectiveness.

Discussion
This study will provide evidence of a patient-centred approach to improve the quality of community-based care for people with psychosis in India and Pakistan. The economic evaluation will support efforts to scale up low-cost healthcare interventions such as DIALOG+ to rural and unserved areas, which is otherwise challenging in the resource-constrained health systems in many LMICs.

Conclusion
The evidence on the cost-effectiveness of DIALOG+ will contribute to efforts to improve community-based care and the quality of life for millions of people suffering from mental health problems in India and Pakistan who experience psychosis.

Ethics and dissemination
This study is approved by the Queen Mary Ethics of Research Committee (UK), Institutional Ethics Committee of SCARF (India), IRD’s Independent Institutional Review Board (IRD_IRB_2021_01_005) (Pakistan), Karawan-e-Hayat Management Committee (Institutional Approval) (Pakistan), Jinnah Postgraduate Medical Centre Research Committee (NO.F.2-81/2021-GENL/60224/JPMC) (Pakistan), Aga Khan’s Ethics Research Committee (2021-5933-17533) (Pakistan) and National Bio-Ethics Committee, Pakistan (Ref: No.4–87/NBC-774/22/2037 Date: 17 May 2022).
The findings of this research will be widely disseminated through research publications and engagement with the communities and the healthcare providers in the public and not-for-profit sectors.

Trial registration number
ISRCTN13022816.

Introduction
Iron deficiency anaemia (IDA) and dental caries are prevalent diseases among Pakistani children. Limited research has been done to explore their association with permanent teeth. Given the caries susceptibility of permanent first molars and their role in the development of ideal occlusion, this study aimed to estimate caries frequency in these molars and assess its association with IDA in 7–12 year-old children.

Methods and analysis
This analytical cross-sectional study will include 141 children aged 7–12 years visiting physicians in the paediatric OPD of Dr. Ruth K.M. Pfau, Civil Hospital Karachi. Using consecutive sampling, children who met initial screening criteria were further evaluated to determine eligibility for the study. Data collection will involve physical examinations (including weight and height), oral examinations (including the relevant oral hygiene and caries assessments) and laboratory examinations (including the prescribed tests). In addition, questions will be asked about sociodemographic characteristics, history of IDA, oral hygiene habits, smokeless tobacco use and the frequency of cariogenic dietary consumption. Exposure variable will include the presence of IDA, assessed using complete blood count, C-reactive protein and ferritin tests and treated as a dichotomous variable. Outcome variable will include dental caries in at least one permanent first molar, assessed using the Decayed, Missing, and Filled Teeth index and also treated as a dichotomous variable. Analysis will include Poisson regression with robust variance, reporting prevalence ratios with 95% CIs for the association of IDA and dental caries in the permanent first molars. Frequency of children with carious permanent first molars with 95% CIs will also be reported.

Ethics and dissemination
This research has been approved by ethical review committee of Aga Khan University (Reference number: 2024-9692-30593) and the institutional review board of Dow University of Health Sciences (IRB Reference: IRB-3556/DUHS/Approval/2024/196) before participant recruitment. Results will be disseminated through seminars and peer-reviewed publications.

Introduction
The United Nations underlines the participation in all domains of daily living for people with intellectual and/or multiple disabilities in the Disability Rights Convention, which also includes medical services. In line with this, the German Federal Participation Act has further developed the relevant disability policy at the national level. This also implies access to comprehensive medical care. In 2015, Germany created a legal basis for the establishment of medical centres for adults with intellectual and/or multiple disabilities in order to ensure basic medical care for these patients. However, the medical centres cannot provide complex rehabilitation. Mobile rehabilitation can be another tool to address the underuse of medical rehabilitation for people with intellectual and/or multiple disabilities. Mobile rehabilitation refers to rehabilitation services provided in a patient’s home or local community, rather than in a traditional inpatient or outpatient rehabilitation facility. The advantages of mobile rehabilitation are its accessibility for patients with mobility problems, the comfort of a familiar environment, which can reduce stress, and the fact that rehabilitation can be tailored to the patient’s living conditions and daily routine. In Germany, mobile rehabilitation is currently only available in the field of geriatrics.
Within the framework of the feasibility study ‘Social space-oriented individualised medical rehabilitation for people with intellectual and/or multiple disabilities (SIMRE),’ a social space-oriented rehabilitation concept was developed to close the rehabilitation gap for people with intellectual and/or multiple disabilities. It is funded by the German Federal Ministry of Health. This study protocol describes the procedure of this feasibility study.

Methods
This study is a prospective mixed methods feasibility study. The rehabilitation concept combines outpatient and home-based rehabilitation, medical, and therapeutic care for people with intellectual and/or multiple disabilities.

Analysis
The primary target criteria are the feasibility and acceptance of the concept by participants, relatives, carers and the rehabilitation staff. Guided interviews with participants and their relatives and/or carers will be analysed using the content-structuring analysis according to Kuckartz. Quantitative analysis will include a cost-benefit analysis to provide information on the economic feasibility of the rehabilitation concept. Changes in individual participation, quality of life and rehabilitation goals will be assessed using a before-and-after comparison with questionnaires. The frequency and type of rehabilitation procedures used will be evaluated quantitatively.
The trial was prospectively registered in the German Clinical Trials Register on 17 August 2023. (https://www.drks.de/DRKS00032493).

Ethics and dissemination
Ethical approval was granted by the Ethics Committee of Hannover Medical School (reference number: 10985_BO_S_2023).
1. Publication: The results of the project will be made available to the public through open access publications. We plan to develop a treatment guideline for the treatment concept based on clinical experience.
2. Widespread implementation: If the project is continued and adequately staffed, the rehabilitative care concept could be implemented nationwide, and the University Hospital could be available as a reference clinic.

Trial registration number
German Clinical Trials Register (reference number: DRKS00032493).

Simg, “antibiotici da limitare, solo su prescrizione medica”

Introduction
The identification of type 1 diabetes at an early presymptomatic stage has clinical benefits. These include a reduced risk of diabetic ketoacidosis (DKA) at the clinical manifestation of the disease and a significant reduction in clinical symptoms. The European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception (EDENT1FI) represents a pioneering effort to advance early detection of type 1 diabetes through public health screening. With the EDENT1FI Master Protocol, the project aims to harmonise and standardise screening for early-stage type 1 diabetes and care.

Methods and analysis
Public health islet autoantibody screening is conducted in the Czech Republic, Denmark, Germany, Italy, Poland, Portugal, Sweden and the UK. Between November 2023 (start date) and October 2028 (planned end date), an estimated number of 200 000 children and adolescents aged 1–17 years are expected to be screened. Screening is performed in capillary blood, examining different islet autoantibodies (autoantibodies against insulin, glutamic acid decarboxylase-65, insulinoma-associated antigen-2 and/or zinc transporter-8). Positive screening results undergo confirmation through a second antibody method. A second (venous) blood sample is requested if at least two autoantibodies are detected, to confirm the autoantibody status. Children and adolescents with confirmed two or more autoantibodies are invited to metabolic staging (oral glucose tolerance test, haemoglobin A1c (HbA1c), random glucose, optionally continuous glucose monitoring); an educational programme and recommendations for monitoring are provided. The feasibility and acceptability of screening are evaluated by feedback questionnaires. Pseudonymised data is collated in the EDENT1FI Registry. Study outcomes include country-specific screening rates, prevalences of stage 1 and stage 2 type 1 diabetes, number in EDENT1FI Registry, proportion with DKA and symptoms at clinical diagnosis and median HbA1c.

Ethics and dissemination
Following the EDENT1FI Master Protocol, site-specific protocols are developed and approved by local ethics committees (Technical University of Munich, Medical Faculty, Nr. 70/14; Medizinische Hochschule Hannover, Nr. 9588_BO_S_2021; Technische Universität Dresden, Nr. BO-EK-356082020; Center for Sundhed Region Hovedstaden, Nr. H-22053116; Swedish Ethical Review Authority, Nr. 2023-00312-01; National Health Service Health Research Authority and Health Care Research Wales, IRAS (Integrated Research Application System) project ID 309252; Italian National Institute of Health, National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions, Prot. PRE BIO CE Nr. 0059835; Charles University in Prague, Ethics Committee for Multi-Centric Clinical Trials of the University Hopital Motol and 2nd Faculty of Medicine, Nr. 1271/23; Bioethics Committee at the Medical University of Warsaw, Nr. 21/2024 and KB/6/R/2024; Associacão Protectora dos Diabéticos de Portugal, Nr. 211/2024). Results are disseminated through peer-reviewed journals and conference presentations and will be shared openly.

Introduction
Canadian youth mental health (YMH) systems have the potential to urgently tackle the mental health treatment gap currently impacting young people, and stepped care (SC) is one model that can address this need. The adoption of SC models can guide the development of better-connected YMH systems by simplifying transitions and care pathways. To do so requires robust standards that are co-created across stakeholder groups, including with lived experience experts, to ensure the effective implementation of SC models.

Methods and analysis
This study aims to establish standards for implementing SC in Canadian child and YMH service settings by convening and developing a learning alliance (LA) of 65 individuals, translating guiding principles to standards via consensus methods (Delphi study), and operationalising and applying draft standards to three test ecosystems. Members of the LA will be recruited via snowball and purposive recruitment techniques to complete an e-Delphi study over three to four rounds until consensus is achieved. Participants will rank their agreement with including specific clause items in the final standard, and will be given opportunities to provide feedback and suggest revisions during each round. Comments will be analysed, scored and coded accordingly. Once consensus has been achieved, members of the LA will consider the application of these implementation standards in three settings that could benefit from SC. The protocol for this study was registered at Open Science Framework (https://doi.org/10.17605/OSF.IO/J5UNW).

Ethics and dissemination
The protocol has been approved by the Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l’Ouest-de-l’Île-de-Montréal—Mental Health and Neuroscience subcommittee. As part of the ethics approval, informed consent forms for all Delphi participants were created and distributed to participants ahead of the Delphi. This includes parental consent forms for all LA members participating in the study who are under the age of 18. On completion, the project will ultimately support the implementation of SC in diverse service systems and guide the development of a robust and connected mental health delivery system in Canada. The final standard will be shared with relevant government bodies and health planners and disseminated via academic and other platforms.

Introduction
Childhood early oral ageing syndrome (CEOAS) is a condition involving oral abnormalities resulting from systemic diseases of different origins that are related to the current lifestyle of the paediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the early loss of tooth structure at an accelerated pace, with negative impacts on function, aesthetics and quality of life. The aim of the study is to identify the prevalence of early tooth wear in childhood and its severity using the CEOAS index, which is a tool for the diagnosis of the condition and for epidemiological surveys, involving the investigation of abnormalities of the oral cavity in the paediatric population and possible factors associated with the severity of the condition.

Methods and analysis
Children aged 3–6 years will be recruited from the paediatric clinic of Universidade Nove de Julho. Children with amelogenesis imperfecta, dentinogenesis imperfecta and genetic syndromes, as well as those undergoing orthodontic treatment will be excluded. A questionnaire will be administered addressing general health, sleep quality, dietary habits, oral hygiene habits and parafunctional habits. Clinical examinations will then be performed using the novel CEOAS index to assess tooth wear (scores 0–3) and determine the occurrence of enamel defects (scores I–III). The vertical dimension of occlusion (VDO) will also be measured. The CEOAS scores will be computed for the deciduous dentition and analysed statistically, with the significance level set at 5% (p

Gastric cancer (GC) is a leading cause of preventable cancer and mortality in certain US populations. The most impactful way to reduce GC mortality is via primary prevention, namely Helicobacter pylori eradication, and secondary prevention, namely endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM). An emerging body of evidence supports the possible impact of these strategies on GC incidence and mortality in identifiable high-risk populations in the United States.

Rinviato a metà gennaio voto su piano revisione Rete oncologica

Introduction
Diabetic macular oedema (DMO), a serious ocular complication of diabetic retinopathy (DR), is a leading cause of vision impairment worldwide. If left untreated or inadequately treated, DMO can lead to irreversible vision loss and blindness. Intravitreal injections using antivascular endothelial growth factor (anti-VEGF) and laser are the current standard of treatment for DMO. These treatments are costly and invasive and must be repeated over several years with a high service load. Fenofibrate has been shown to reduce the progression of DR. However, there is a lack of high-quality data on the effects of fenofibrate on established DMO. This study aims to evaluate the effectiveness of oral fenofibrate for the treatment of DMO.

Methods and analysis
This randomised double-blind, placebo-controlled trial recruited 204 patients with DMO across three different clinics in Sydney. Participants will be randomly allocated in a 1:1 ratio to intervention and control groups. The intervention group will receive oral fenofibrate (145 mg) taken once daily for 24 months, while the control group will receive placebo tablets taken once daily for 24 months. Standard care with anti-VEGF injections, focal lasers or observation will also be provided to all participants regardless of their group allocation. The primary outcome is the reduction in DMO measured using central macular subfield thickness (CSMT) on optical coherence tomography imaging at 24 months. Secondary outcomes at 24 months include the proportion of eyes with CSMT

Objectives
Intensive care unit (ICU) clinicians stop antibiotics more often, with a negative infection: point-of-care test (PCR-POCT). Simulated cases of diagnostic uncertainty regarding infection resolution led clinicians to choose options such as procalcitonin (PCT) and/or PCR-POCTs +/– de-escalation to aid stop decisions. We hypothesised that a direct infection indicator, PCR-POCT, would influence stop judgements more than indirect PCT. Accordingly, we tested antibiotic-stop decisions when presented with a negative PCR-POCT despite borderline-positive PCT.

Designs
Observational prospective study.

Setting
ICU.

Participants
66 ICU clinicians from University hospitals.

Methods
Clinicians saw four scenarios of different clinico-biological trajectories: (1) clear improvement, (2) clear worsening, (3) discordant—clinically better/biologically worse and (4) discordant—clinically worse/biologically better. Participants gave an initial decision (stop/continue/continue–escalate/continue–de-escalate). Then PCR-POCT and/or PCT was offered (accept/decline). After a negative PCR-POCT and borderline-positive PCT result, a final antibiotic decision was taken.

Measures
Proportion of stop decisions before versus after test results per scenario. The association of the final decision with the clinician’s change in confidence, willingness to request the biomarker(s) and the case trajectory was determined.

Results
Fewer clinicians than expected stopped antibiotics versus baseline (36%, 94/264 vs 42%, 110/264, p=0.045). This was so in three of four scenarios, significantly less in the improvement (p

Introduction
Pre-eclampsia is a pregnancy-related complication estimated to affect up to 8% of pregnancies worldwide. It is associated with an increased risk of postpartum sustained hypertension, coronary artery disease, cerebrovascular disease, peripheral arterial disease and cardiovascular-related mortality. Nevertheless, these associations have seldom been addressed in younger women from sub-Saharan Africa (SSA). Hence, this study aims to assess the association between pre-eclampsia and cardiovascular impairment within the first year after delivery, among younger women in SSA.

Methods and analysis
This is a prospective cohort study conducted at Hospital Nacional Simão Mendes in Bissau, Guinea-Bissau. A total of 230 pregnant women aged below 25 years (115 diagnosed with pre-eclampsia and 115 normotensive age-matched pregnancies), will be enrolled after their 20th gestational week. Exclusion criteria include diabetes, hypertension or other serious maternal diseases present before pregnancy. Participants will be assessed at baseline (pre-labour period), 4 and 12 months after delivery; evaluations started in March 2023 and are expected to end in December 2026. At each follow-up assessment, the women will have their blood pressure measured with a digital sphygmomanometer and a 24-hour ambulatory blood pressure monitor. Cardiac and renal function will be assessed using echocardiography and laboratory testing, respectively. Primary outcomes include the mean differences in cardiovascular and renal parameters between women who had pre-eclampsia and those who had normotensive pregnancies. Age, parity, age at first pregnancy, family history of cardiovascular diseases, smoking habits, gestational diabetes diagnosed before pre-eclampsia, body mass index and labour complications will be considered a priori as potential confounders of the association between pre-eclampsia and postpartum cardiovascular impairment.

Ethics and dissemination
This study was approved by the Comité Nacional de Ética em Pesquisa na Saúde, Guinea-Bissau (008/CNES/INASA/2023), and participants provide written informed consent. Results will be disseminated among the scientific community and the public.