Publications by authors named "Germini F"

Given the suboptimal performance of Boolean searching to identify methodologically sound and clinically relevant studies in large bibliographic databases, exploring machine learning (ML) to efficiently classify studies is warranted. To boost the efficiency of a literature surveillance program, we used a large internationally recognized dataset of articles tagged for methodological rigor and applied an automated ML approach to train and test binary classification models to predict the probability of clinical research articles being of high methodologic quality. We trained over 12,000 models on a dataset of titles and abstracts of 97,805 articles indexed in PubMed from 2012-2018 which were manually appraised for rigor by highly trained research associates and rated for clinical relevancy by practicing clinicians.

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Background: It is uncertain whether prothrombin complex concentrate (PCC) improves hemostasis in patients on treatment with oral factor Xa-inhibitors (XaI) who require emergency surgery.

Objectives: To evaluate whether, in patients with therapeutic levels of oral XaI, preoperative PCC prevents excessive bleeding during and after emergency surgery and is not associated with thrombotic complications.

Methods: We conducted a prospective cohort study wherein a fixed 2000 IU dose of 4-factor PCC was given to patients taking oral XaI with plasma XaI levels of at least 75 ng/mL before the emergency surgery with an expected blood loss of at least 50 mL.

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Background: Recent enhancements in Large Language Models (LLMs) such as ChatGPT have exponentially increased user adoption. These models are accessible on mobile devices and support multimodal interactions, including conversations, code generation, and patient image uploads, broadening their utility in providing healthcare professionals with real-time support for clinical decision-making. Nevertheless, many authors have highlighted serious risks that may arise from the adoption of LLMs, principally related to safety and alignment with ethical guidelines.

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Study Objective: Computed tomography pulmonary angiogram (CTPA) is overused during pulmonary embolism (PE) testing in the emergency department (ED), whereas prediction rules and D-dimer are underused. We report the adherence, clinical benefit, and safety of a D-dimer-only strategy to guide need for PE imaging in the ED.

Methods: This was a prospective multicenter implementation study in 2 EDs with historical and external controls.

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Introduction: The Patient Reported Outcomes, Burdens, and Experiences (PROBE) questionnaire is a patient-reported outcome tool that assesses quality of life and disease burden in people with haemophilia (PWH).

Aim: To assesses the test-retest reliability of PROBE when completed using the mobile phone application.

Methods: We recruited PWH, including carriers, and individuals with no bleeding disorders who attended haemophilia-related workshops or via social media.

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Introduction: Damoctocog alfa pegol (BAY 94-9027, Jivi®) is an extended half-life recombinant factor (F)VIII replacement, indicated for the treatment of haemophilia A in patients aged ≥12 years. Following introduction of damoctocog alfa pegol in Canada in 2020, there have been no reports on routine clinical effectiveness and satisfaction, when switching from a previous FVIII product in Canada.

Aim: To report changes in pharmacokinetics, effectiveness, utilization and patient satisfaction when switching to damoctocog alfa pegol prophylaxis from previous standard half-life octocog alfa (BAY 81-8973, Kovaltry®) treatment.

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Background: The transition from in-hospital intravenous administration to subcutaneous therapies to treat inflammatory bowel disease (IBD) can raise some concerns among patients due to the self-administration concerns, the management of potential side effects and the overall worries related to a change of treatment. This study aimed at evaluating patients' opinion about the switch from intravenous to subcutaneous formulations and their knowledge on new available therapeutic options.

Methods: We conducted a survey using a questionnaire prepared by a team of gastroenterologists and nurses working at the IBD unit.

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Background: In the inflammatory bowel disease (IBD) multidisciplinary team, a key figure is the IBD care manager, usually an independent practice nurse, responsible for evidence-based assessment, care planning, treatment evaluation, and provision of practical information, health education, and emotional support to patients. The objective of this study was to evaluate the profile of this figure in Italy.

Methods: A team of experienced nurses created a questionnaire based on the Second N-ECCO declaration, which was administered to nurses who worked in an IBD unit for a period of at least 3 years.

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Background: Evidence on bleeding rates in people with congenital haemophilia A (PwcHA) without inhibitors on factor VIII (FVIII) replacement products is inconsistent.

Aim: This systematic literature review assessed bleeding outcomes in PwcHA using FVIII-containing products as prophylactic treatment.

Methods: A search was conducted using the bibliographic databases Medline, Embase and Cochrane Central Register of Controlled Trials on the Ovid platform.

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Background: Identifying practice-ready evidence-based journal articles in medicine is a challenge due to the sheer volume of biomedical research publications. Newer approaches to support evidence discovery apply deep learning techniques to improve the efficiency and accuracy of classifying sound evidence.

Objective: To determine how well deep learning models using variants of Bidirectional Encoder Representations from Transformers (BERT) identify high-quality evidence with high clinical relevance from the biomedical literature for consideration in clinical practice.

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Background: The Canadian Bleeding Disorders Registry (CBDR) is a source of real-world data for Canadian patients with hemophilia B. Nonacog beta pegol (N9-GP), an extended half-life (EHL) recombinant factor IX (FIX) concentrate, was awarded a Canadian Blood Services contract in 2018 and subsequently made available across Canada (except Québec) to adult patients. For most patients already on another EHL FIX treatment, a switch to N9-GP occurred.

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Importance: Improving methodological quality is a priority in the health research community. Finding appropriate methods guidance can be challenging due to heterogeneous terminology, poor indexing in medical databases, and variation in formats. The Library of Guidance for Health Scientists (LIGHTS) is a new searchable database for methods guidance articles.

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Study Objective: We prospectively assessed the diagnostic accuracy of YEARS and a modified age-adjusted clinical decision rule ("Adjust-Unlikely") for pulmonary embolism (PE) testing in the emergency department.

Methods: This study was conducted in tertiary care Canadian emergency departments. When the D-dimer was <500 ng/ml, PE was excluded.

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Background: The SARS-CoV-2 pandemic has affected also the school environment. Prolonged closures and the weakness of available data prevent a definitive answer to the question of school transmission. We report our experience of responding to COVID-19 cases in the school setting, presenting a case study of the management of an outbreak in a large school.

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Background: Knowledge about the risk for bleeding in patients with hemophilia (PWH) would be relevant for patients, stakeholders, and policy makers.

Objectives: To perform a systematic review of the literature on risk assessment models (RAMs) and risk factors for bleeding in PWH on regular prophylaxis.

Methods: We searched Medline, Embase, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews from inception through August 2019.

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Background: The Canadian Bleeding Disorders Registry (CBDR) captures data from 24 hemophilia treatment centers and patients directly. Nonacog beta pegol (N9-GP) was approved in Canada in 2018.

Objectives: To assess treatment outcomes following switching to N9-GP in a real-world setting.

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Predicting individual effects of switching from standard half-life (SHL) to extended half-life (EHL) FVIII/FIX concentrates is pivotal in clinical care, but large-scale individual data are scarce. The aim of this study was to assess individual changes in terminal half-life (THL) after switching to EHL concentrates and identifying determinants of a clinically relevant THL extension in people with severe hemophilia. Data from participants with pharmacokinetic studies on both SHL and EHL were extracted from the Web-Accessible Population Pharmacokinetics Service (WAPPS) database and stratified according to hemophilia type and age groups (children/adults).

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Objective: To systematically compare the effect of direct oral anticoagulants and low molecular weight heparin for thromboprophylaxis on the benefits and harms to patients undergoing non-cardiac surgery.

Design: Systematic review and network meta-analysis of randomised controlled trials.

Data Sources: Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL), up to August 2021.

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Background: The Patient-Reported Outcomes, Burdens, and Experiences (PROBE) questionnaire is a tool for assessing the quality of life and disease burden in people living with hemophilia.

Objective: The objectives of our study were (1) to assess the needs of relevant stakeholders involved in the use of PROBE, (2) to develop the software infrastructure needed to meet these needs, and (3) to test the usability of the final product.

Methods: We conducted a series of semistructured interviews of relevant stakeholders, including PROBE investigators, people with hemophilia, and representatives of the sponsor.

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Background: Numerous wrist-wearable devices to measure physical activity are currently available, but there is a need to unify the evidence on how they compare in terms of acceptability and accuracy.

Objective: The aim of this study is to perform a systematic review of the literature to assess the accuracy and acceptability (willingness to use the device for the task it is designed to support) of wrist-wearable activity trackers.

Methods: We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and SPORTDiscus for studies measuring physical activity in the general population using wrist-wearable activity trackers.

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