357 results match your criteria: "Centre d'epidemiologie clinique[Affiliation]"

Identifying patients who benefit from a treatment is a key aspect of personalized medicine, which allows the development of individualized treatment rules (ITRs). Many machine learning methods have been proposed to create such rules. However, to what extent the methods lead to similar ITRs, that is, recommending the same treatment for the same individuals is unclear.

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Objective: The timely initiation of renal replacement therapy (RRT) for acute kidney injury (AKI) requires sequential decision-making tailored to individuals' evolving characteristics. To learn and validate optimal strategies for RRT initiation, we used reinforcement learning on clinical data from routine care and randomized controlled trials.

Materials And Methods: We used the MIMIC-III database for development and AKIKI trials for validation.

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Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements.

J Clin Epidemiol

May 2024

Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK; Centre for Statistics in Medicine, University of Oxford, Oxford, UK. Electronic address:

Objectives: To describe, and explain the rationale for, the methods used and decisions made during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines.

Methods: We developed SPIRIT 2024 and CONSORT 2024 together to facilitate harmonization of the two guidelines, and incorporated content from key extensions. We conducted a scoping review of comments suggesting changes to SPIRIT 2013 and CONSORT 2010, and compiled a list of other possible revisions based on existing SPIRIT and CONSORT extensions, other reporting guidelines, and personal communications.

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Synthesis methods used to combine observational studies and randomised trials in published meta-analyses.

Syst Rev

February 2024

Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Hôpital Hôtel Dieu, 1 Place du Parvis Notre-Dame, 75004, Paris, France.

Background: This study examined the synthesis methods used in meta-analyses pooling data from observational studies (OSs) and randomised controlled trials (RCTs) from various medical disciplines.

Methods: We searched Medline via PubMed to identify reports of systematic reviews of interventions, including and pooling data from RCTs and OSs published in 110 high-impact factor general and specialised journals between 2015 and 2019. Screening and data extraction were performed in duplicate.

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Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trials.

EClinicalMedicine

March 2024

Département de Rhumatologie, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris, Université Paris Saclay, INSERM UMR 1184, Le Kremlin Bicêtre, France.

Article Synopsis
  • Immunomodulators, which are used to treat COVID-19, do not appear to improve outcomes for immunocompromised patients without increasing risks of secondary infections.
  • A review of eleven randomized controlled trials with 397 patients showed no significant differences in mortality or infection rates between those treated with immunomodulators and those receiving standard care.
  • The findings suggest that immunomodulators provide no clear benefit or harm for immunocompromised patients hospitalized due to COVID-19, according to the study conducted.
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National committee statement as a missed opportunity to acknowledge the relevance of a biopsychosocial approach in understanding long COVID.

J Psychosom Res

November 2024

Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Center for Research in Epidemiology and StatisticS (CRESS), Paris 75004, France; Service de Médecine interne, AP-HP, Hôpital Européen Georges-Pompidou, Paris 75015, France; Unité CASPer, AP-HP, Hôpital Hôtel-Dieu, Paris 75004, France. Electronic address:

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Introduction: The management of giant cell arteritis (GCA) has evolved with the arrival of tocilizumab (TCZ) and the use of PET/CT. Our objective is to describe the characteristics and followup of patients with recent diagnosis of GCA in current care.

Patients And Methods: The NEWTON cohort is a monocentric retrospective cohort based on data collected from 60 GCA patients diagnosed between 2017 and 2022 according to the ACR/EULAR 2022 criteria.

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Comparison of effect estimates between preprints and peer-reviewed journal articles of COVID-19 trials.

BMC Med Res Methodol

January 2024

Center for Research in Epidemiology and Statistics (CRESS-U1153), Université Paris Cité and Université Sorbonne Paris Nord, INRAE, Inserm, Hôpital Hôtel-Dieu, 1 Place du Parvis Notre-Dame, Paris, F-75004, France.

Article Synopsis
  • Preprints are becoming popular for sharing research, and this study looked at how consistent the effect estimates are between preprints and final journal articles for COVID-19 randomized controlled trials (RCTs).
  • The analysis included 109 RCTs, with an average delay of about 4 months from preprint to journal publication, and found that a significant number (80%) showed some concern regarding bias in their results.
  • Overall, most preprint and journal article pairs (81 out of 109) showed consistent outcomes, although 9 had discrepancies that slightly affected the reported effect estimates.
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Estimating the smallest worthwhile difference of antidepressants: a cross-sectional survey.

BMJ Ment Health

January 2024

Institute of Social and Preventive Medicine and Clinical Trials, University of Bern, Bern, Switzerland.

Background: Approximately 30% of patients experience substantial improvement in depression after 2 months without treatment, and 45% with antidepressants. The smallest worthwhile difference (SWD) refers to an intervention's smallest beneficial effect over a comparison patients deem worthwhile given treatment burdens (harms, expenses and inconveniences), but is undetermined for antidepressants.

Objective: Estimating the SWD of commonly prescribed antidepressants for depression compared to no treatment.

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Article Synopsis
  • The CORIPLASM trial aimed to assess whether covid-19 convalescent plasma is effective in treating hospitalized adults with moderate covid-19, including those with weakened immune systems.
  • Conducted across 19 hospitals in France, the trial included 120 participants randomly assigned to receive either convalescent plasma or usual care between April 2020 and April 2021.
  • Key outcomes measured included the proportion of patients experiencing worsening symptoms by day 4 and survival without needing assisted ventilation by day 14, while secondary outcomes assessed overall survival and recovery times.
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Our aim was to describe the research practices of doctoral students facing a dilemma to research integrity and to assess the impact of inappropriate research environments, i.e. exposure to (a) a post-doctoral researcher who committed a Detrimental Research Practice (DRP) in a similar situation and (b) a supervisor who did not oppose the DRP.

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Article Synopsis
  • Tobacco use is linked to poorer treatment outcomes in tuberculosis (TB), specifically showing increased rates of TB recurrence and higher mortality during treatment.
  • Research analyzed data from a variety of studies to assess these associations and highlighted variations in quality and participant characteristics.
  • Findings indicate that both current and former tobacco users are at a significantly greater risk of TB recurrence and increased mortality compared to non-tobacco users.
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No evidence of important difference in summary treatment effects between COVID-19 preprints and peer-reviewed publications: a meta-epidemiological study.

J Clin Epidemiol

October 2023

Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Center for Research in Epidemiology and Statistics (CRESS), F-75004 Paris, France; Centre d'Epidémiologie Clinique, AP-HP, Hôpital Hôtel Dieu, F-75004 Paris, France; Cochrane France, Paris, France.

Objectives: Preprints became a major source of research communication during the COVID-19 pandemic. We aimed to evaluate whether summary treatment effect estimates differ between preprint and peer-reviewed journal trials.

Study Design And Setting: A meta-epidemiological study.

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Completeness and Mismatch of Patient-Important Outcomes After Trauma.

Ann Surg Open

December 2022

Centre d'Epidémiologie Clinique, AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Hôtel Dieu, Paris, France.

Unlabelled: To assess the completeness of the collection of patient-important outcomes and the mismatch between outcomes measured in research and patients' important issues after trauma.

Summary Background Data: To date, severe trauma has mainly been assessed using in-hospital mortality. Yet, with 80 to 90% survivors discharged from hospital, it is critical to assess the collection of patient important long-term outcomes of trauma.

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Article Synopsis
  • This study evaluated the effectiveness and safety of second-line tyrosine kinase inhibitors (TKIs) in patients with advanced hepatocellular carcinoma (HCC) who previously progressed after treatment with atezolizumab and bevacizumab.
  • A total of 82 patients were analyzed, with those receiving regorafenib showing significantly better overall survival (OS) compared to other TKIs like sorafenib, lenvatinib, and cabozantinib.
  • Safety results indicated that 20% of patients experienced grade 3 adverse events, but there were no severe grade 4 or 5 events reported.
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Importance: Just-in-time interventions (JITIs) are a type of digital therapeutic intervention that combines remote monitoring tools and algorithms to personalize the delivery of specific interventions at the right time. The US Food and Drug Administration (FDA) regulatory approval documents are often the only available source of information on the effectiveness of therapeutic interventions based on these devices.

Objective: To systematically review the publicly available information from the FDA on all recently approved medical devices used in JITIs to (1) assess how they operate to deliver JITIs and (2) appraise the evidence supporting their performance and clinical effectiveness.

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Improving Diagnosis of Pulmonary Mucormycosis: Leads From a Contemporary National Study of 114 Cases.

Chest

November 2023

Infectious Diseases Department, Necker-Enfants Malades Hospital, Paris-Cité University, AP-HP, Paris, France; Institut Pasteur, Université Paris Cité, National Reference Center for Invasive Mycoses and Antifungals, Translational Mycology Research Group, Mycology Department, Paris, France. Electronic address:

Background: Pulmonary mucormycosis (PM) is a life-threatening invasive mold infection. Diagnosis of mucormycosis is challenging and often delayed, resulting in higher mortality.

Research Question: Are the disease presentation of PM and contribution of diagnosis tools influenced by the patient's underlying condition?

Study Design And Methods: All PM cases from six French teaching hospitals between 2008 and 2019 were retrospectively reviewed.

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What should be done and what should be avoided when comparing two treatments?

Best Pract Res Clin Haematol

June 2023

Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Center for Research in Epidemiology and StatisticS (CRESS), F-75004, Paris, France; Centre d'Épidémiologie Clinique, AP-HP, Hôpital Hôtel Dieu, F-75004, Paris, France. Electronic address:

The preferred approach to compare two treatments is a randomized controlled trial (RCT). Indeed, randomization ensures that the groups compared are similar. Well-designed and well-conducted RCTs thus allow to draw causal conclusions on the relative efficacy and safety of treatments compared.

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A methodological framework allows the identification of personomic markers to consider when designing personalized interventions.

J Clin Epidemiol

July 2023

Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Center for Research in Epidemiology and StatisticS (CRESS), F-75004 Paris, France; Centre d'Epidémiologie Clinique, AP-HP, Hôpital Hôtel-Dieu, Paris, France.

Objectives: To develop a methodological framework to identify and prioritize personomic markers (e.g., psychosocial situation, beliefs…) to consider for personalizing interventions and to test in smoking cessation interventions.

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Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials.

JAMA Netw Open

June 2023

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.

Importance: Numerous studies have shown that adherence to reporting guidelines is suboptimal.

Objective: To evaluate whether asking peer reviewers to check if specific reporting guideline items were adequately reported would improve adherence to reporting guidelines in published articles.

Design, Setting, And Participants: Two parallel-group, superiority randomized trials were performed using manuscripts submitted to 7 biomedical journals (5 from the BMJ Publishing Group and 2 from the Public Library of Science) as the unit of randomization, with peer reviewers allocated to the intervention or control group.

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[Medical start-ups: how to attract investors?].

Rev Prat

April 2023

Associée Elaia Partners, Paris . Service de gastroentérologie et nutrition, hôpital Saint-Antoine, AP-HP, Paris, et centre d'épidémiologie clinique, Hôtel-Dieu, AP-HP, Paris, France.

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Background: It has been reported that people with COVID-19 and pre-existing autoantibodies against type I interferons are likely to develop an inflammatory cytokine storm responsible for severe respiratory symptoms. Since interleukin 6 (IL-6) is one of the cytokines released during this inflammatory process, IL-6 blocking agents have been used for treating people with severe COVID-19.

Objectives: To update the evidence on the effectiveness and safety of IL-6 blocking agents compared to standard care alone or to a placebo for people with COVID-19.

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Purpose: To assess the completeness of reporting in abstracts of published randomized controlled trials (RCTs) assessing interventional radiology (IR) for liver disease; to assess whether publication of the 2017 CONSORT update for nonpharmacological treatments (NPT) resulted in changes in abstract reporting; and to identify factors associated with better reporting.

Material And Methods: MEDLINE and Embase were searched to identify RCTs of IR for liver disease (January 2015-September 2020). Two reviewers assessed the completeness of abstract reporting according to the CONSORT-NPT-2017-update.

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