Bruno Giraudeau

Bruno Giraudeau
University of Tours | UFR

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388
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Publications

Publications (388)
Article
Background: A non-completer is defined as a participant who leaves a trial before the end of the planned follow-up. Research in nursing homes is highly exposed to this problem because of high death rates. Objective: To assess the statistical management of non-completers in cluster randomized trials carried out in nursing homes. Study design and...
Article
Objective Randomized trials labelled as “pragmatic” are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS (PRagmatic Explanatory Continuum Indicator Summary)-2 domains). Study desi...
Article
Objective: We assessed whether general practitioner (GP) delivery of a vaginal self-sampling kit was non-inferior to home-mailed delivery on cervical cancer screening (CCS) participation. Methods: Two hundred and ten French GPs from Indre-et-Loire French department were randomized into two groups, and their unscreened women patients aged 30-65 were...
Article
Full-text available
Background Lingual microcystic lymphatic malformations (LMLMs) are rare congenital vascular malformations presenting as clusters of cysts filled with lymph fluid or blood. Even small well-limited lesions can be responsible for a heavy burden, inducing pain, aesthetic prejudice, or oozing, bleeding, infections. The natural history of LMLMs is progre...
Article
Full-text available
Objectives: The first COVID-19 lockdown led to a significantly reduced access to healthcare, which may have increased decompensations in frail patients with chronic diseases, especially older patients living with a chronic cardiovascular disease (CVD) or a mental health disorder (MHD). The objective of COVIQuest was to evaluate whether a general p...
Article
Introduction Est considéré comme « non-completers » tout participant qui quitte un essai avant la fin du suivi planifié, avec comme conséquence un recueil manquant concernant le/les critères de jugement. Les essais cliniques ciblant les résidents d’établissements d'hébergement pour personnes âgées dépendantes (EHPAD) sont exposés à cette problémati...
Article
Introduction Les anomalies vasculaires (AVs) superficielles rares représentent un large panel de maladies et sont classées par l'International Society for the Study of Vascular Anomalies dans le groupe des tumeurs vasculaires ou des malformations vasculaires. Leur prise en charge est difficile étant donné le large spectre de ces pathologies et le m...
Article
Introduction Les recommandations de bonne pratique destinées aux médecins généralistes (MG) sont très souvent établies à partir d'essais réalisés en soins secondaires ou tertiaires. Ces essais sont très souvent considérés par les MG comme n'étant pas applicable à une population de soins primaires. Aucune étude n'a comparé l'effet intervention estim...
Article
Full-text available
Introduction: Vaccination is an effective and safe strategy to prevent Human papillomavirus (HPV) infection and related harms. Despite various efforts by French authorities to improve HPV vaccine coverage (VC) these past few years, VC has remained far lower than in most other high-income countries. To improve it, we have coconstructed with stakeho...
Article
Objectives : To describe prevalence of multiple primary outcomes, changes in primary outcomes and target sample sizes between protocols and final reports, and how issues of multiplicity are addressed in pragmatic trials. Study Design and Setting : Individually randomised trials labelled as pragmatic, published 2014-2019 in MEDLINE and registered w...
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Background Nowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates. Patients’ adherence to both treatment and hygienic-dietary measures is mandatory to achieve these objectives. Adherence to immunosuppressive drugs is estimated to be o...
Article
Background Considering the increase in MDR Gram-negative bacteria (GNB), the choice of empirical antibiotic therapy is challenging. In parallel, use of broad-spectrum antibiotics should be avoided to decrease antibiotic selection pressure. Accordingly, clinicians need rapid diagnostic tools to narrow antibiotic therapy. Class 1–3 integrons, identif...
Article
Importance: Sirolimus is increasingly being used to treat various vascular anomalies, although evidence of its efficacy is lacking. Objective: To assess the efficacy and safety of sirolimus for children with slow-flow vascular malformations to better delineate the indications for treatment. Design, setting and participants: This multicenter, o...
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Full-text available
Overstating the impact of interventions through incomplete or inaccurate reporting can lead to inappropriate scale-up of interventions with low impact. Accurate reporting of the impact of interventions is of great importance in global health research to protect scarce resources. In global health, the cluster randomised trial design is commonly used...
Article
In cluster randomised trials, a measure of intracluster correlation such as the intraclass correlation coefficient (ICC) should be reported for each primary outcome. Providing intracluster correlation estimates may help in calculating sample size of future cluster randomised trials and also in interpreting the results of the trial from which they a...
Preprint
Full-text available
Background Lingual microcystic lymphatic malformations (LMLMs) are rare congenital vascular malformations presenting as clusters of cysts filled with lymph fluid or blood. Even small well-limited lesions can be responsible for a heavy burden, inducing pain, aesthetic prejudice, or oozing, bleeding, infections. The natural history of LMLMs is progre...
Article
Full-text available
Introduction International guidelines include early nutritional support (≤48 hour after admission), 20–25 kcal/kg/day, and 1.2–2 g/kg/day protein at the acute phase of critical illness. Recent data challenge the appropriateness of providing standard amounts of calories and protein during acute critical illness. Restricting calorie and protein intak...
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Introduction Fasting is frequently imposed to patients before extubation in the intensive care unit based on scheduled surgery guidelines. This practice has never been evaluated among critically ill patients and may delay extubation, increase nursing workload and reduce caloric intake. We are hypothesising that continuous enteral nutrition until ex...
Article
Randomized trials are frequently used in clinical research and considered the gold standard, but they are less common in population health intervention research (PHIR). We discuss issues that are sometimes shared and sometimes distinct between PHIR and clinical research, notably the randomization unit, design, standardization of the intervention, o...
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Full-text available
Background Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates wh...
Article
Full-text available
Background: A marked increase in frequency of acute acral eruptions (AAE) was observed in children during the COVID-19 pandemic in the spring period. Objectives: In this observational multicenter study, based on children with AAE, we aimed to assess the proportion of household members possibly infected by SARS-CoV-2. Methods: We collected data from...
Article
Introduction Les enfants semblent développer des manifestations systémiques moins fréquentes et moins sévères que l’adulte, et être moins contaminants. Une augmentation inédite des éruptions acrales aiguës a été observée durant la période de circulation intense du virus. Notre objectif a été de déterminer le degré de contamination intrafamiliale lo...
Article
Importance: Coronavirus disease 2019 (COVID-19) is associated with severe lung damage. Corticosteroids are a possible therapeutic option. Objective: To determine the effect of hydrocortisone on treatment failure on day 21 in critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory...
Article
Introduction Skin diseases are common, with an estimated overall prevalence of 27% to 55% [1], [2]. Topical treatments are commonly prescribed and are usually the first-line treatment. Patients may have a single lesion, multiple lesions or extensive body surface areas [3] Variability in the topography of the skin lesions offers different possibilit...
Article
Introduction: Fever is one of the most common reasons for consultation in the paediatric emergency department (ED). Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment. The aims of this study are to demonstrate that using a procalcitonin (PCT) rapid te...
Article
The Cape-Covid trial is an embedded clinical trial within the ongoing Cape-Cod trial. The Covid-19 pandemic appeared while we were conducting a randomized trial assessing the effectiveness of corticosteroids in severe community-acquired pneumonia. We took advantage of this ongoing trial to embed a sub-trial assessing hydrocortisone in SARS-CoV-2 in...
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Full-text available
Background: Suicide constitutes a cause of death which could be prevented by e-health programs accessible to the general population. Effective promotion has the potential to maximize the uptake of such programs. However, few e-health programs have been combined with promotion campaigns. The primary objective of this trial is to assess the effective...
Article
Full-text available
Controlling for confounding bias is crucial in causal inference. Distinct methods are currently employed to mitigate the effects of confounding bias. Each requires the introduction of a set of covariates, which remains difficult to choose, especially regarding the different methods. We conduct a simulation study to compare the relative performance...
Article
Aim: To assess whether a pharmacist intervention associating medication reconciliation at discharge with a link to the community pharmacist reduces drug-related problems (DRP) in adult patients during the 7 days after hospital discharge in 22 university or general hospitals in France. Methods: We conducted a cluster randomised cross-over superio...
Article
In cluster randomized trials, the intraclass correlation coefficient (ICC) is classically used to measure clustering. When the outcome is binary, the ICC is known to be associated with the prevalence of the outcome. This association challenges its interpretation and can be problematic for sample size calculation. To overcome these situations, Cresp...
Article
Full-text available
Background: Cutaneous microcystic lymphatic malformations (CMLMs) are rare conditions in children and adults. They present as clusters of vesicles full of lymph and blood to various extents, inducing maceration, esthetic impairment, pain, and impaired quality of life. The treatment is challenging. Sirolimus is an inhibitor of mammalian target of r...
Article
Introduction Les anti-histaminiques H1 (anti-H1) constituent la 1ère ligne de traitement pour l’urticaire chronique spontanée (UCS). En cas d’inefficacité (UCS dits « réfractaires »), l’omalizumab ou un traitement immunosuppresseur peuvent être proposés. L’objectif de cette étude était, en situation d’échec d’une monothérapie anti-H1, d’évaluer l’e...
Article
Background: Patients who are treated with targeted temperature management after out-of-hospital cardiac arrest with shockable rhythm are at increased risk for ventilator-associated pneumonia. The benefit of preventive short-term antibiotic therapy has not been shown. Methods: We conducted a multicenter, double-blind, randomized, placebo-controll...
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Background: Moderate therapeutic hypothermia is currently recommended to improve neurologic outcomes in adults with persistent coma after resuscitated out-of-hospital cardiac arrest. However, the effectiveness of moderate therapeutic hypothermia in patients with nonshockable rhythms (asystole or pulseless electrical activity) is debated. Methods:...
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Background: Nephrotoxic drug prescription may contribute to acute kidney injury (AKI) occurrence and worsening among critically ill patients and thus to associated morbidity and mortality. The objectives of this study were to describe nephrotoxic drug prescription in a large intensive-care unit cohort and, through a case-control study nested in th...
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Background Inappropriate staff behaviour during surgical procedures may disrupt the surgical performance and compromise patient safety. We developed an innovative monitoring and feedback system combined with an adaptive approach to optimise staff behaviour intraoperatively and prevent post-operative complications (POC) in orthopaedic surgery. Meth...
Article
Background: Systemic mammalian target of rapamycin (mTOR) inhibitors are currently used in many dermatologic indications. Their topical use is recent and poorly codified. Objective: To provide an overview of the topical use of mTOR inhibitors in dermatologic conditions and evaluate their efficacy and safety. Methods: A literature search was pe...
Article
Objectives: The Consolidated Standards of Reporting Trials extension for the stepped-wedge cluster randomized trial (SW-CRT) is a recently published reporting guideline for SW-CRTs. We assess the quality of reporting of a recent sample of SW-CRTs. Study Design and Setting: Quality of reporting was asssessed according to the 26 items in the new guid...
Article
Background: Although nebulizing beta 2-agonists during noninvasive ventilation (NIV) could prove helpful, this administration route has to date never been studied in unstable chronic obstructive pulmonary disease (COPD) patients. We sought to demonstrate that salbutamol could be nebulized through an NIV circuit in COPD exacerbation and improve forc...
Article
Introduction Le retard diagnostique est particulièrement long dans l’hidradénite suppurée (HS), 7 ans en moyenne, dans de nombreux pays. Les causes de ce délai ont rarement été explorées. L’objectif de cette étude était d’évaluer les connaissances des médecins généralistes sur l’HS et d’identifier les raisons du retard diagnostique important dans c...
Article
Full-text available
Background: Cluster (CRTs) and individually randomized trials (IRTs) are often pooled together in meta-analyses (MAs) of randomized trials. However, the potential systematic differences in intervention effect estimates between these two trial types has never been investigated. Therefore, we conducted a meta-epidemiological study comparing interven...
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Background: Institutional review boards must guarantee the ethical acceptability of a randomized controlled trial before it is conducted. However, some may regard an unbalanced randomization ratio as reflecting an absence of uncertainty between the groups being compared. The objective was to assess institutional review board members' perceptions o...
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Full-text available
Strategies for diets in chronic spontaneous urticaria (CSU) are controversial. This systematic review assessed the interest in diet for managing CSU. We searched for original reports in MEDLINE, EMBASE, CENTRAL and LILACS. Among the 278 reports screened, 20 were included, involving 1,734 patients. Reports described 3 types of systematic diet: pseud...
Article
Background: Chronic spontaneous urticaria (CSU) is not frequent in children. Management guidelines have been developed for adults and randomized controlled trials (RCTs) included teenagers aged 12 to 18, but data for children under age 12 are limited. We performed a systematic review to assess comorbidities in children < 12 years old with CSU and...
Article
BACKGROUND: Whether the route of early feeding affects outcomes of patients with severe critical illnesses is controversial. We hypothesised that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition. METHODS: In this randomised, controlled, multicentre, open-label, parallel-group study (NUTRIR...
Article
Background: Urate-lowering therapy (ULT) is associated with low rates of adherence, leading to a potential risk of relapse of gouty arthritis, tophi, or urolithiasis. Our main aim was to identify the recurrence of gouty arthritis, tophi, or urolithiasis after discontinuation of ULT. Secondary aims included an assessment of ULT reintroduction rates...
Article
Multistate models with interval-censored data, such as the illness-death model, are still not used to any considerable extent in medical research regardless of the significant literature demonstrating their advantages compared to usual survival models. Possible explanations are their uncommon availability in classical statistical software or, when...
Article
Background: Whether the route of early feeding affects outcomes of patients with severe critical illnesses is controversial. We hypothesised that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition. Methods: In this randomised, controlled, multicentre, open-label, parallel-group study (NUT...
Article
Full-text available
AIM To prospectively evaluate the performance of Doppler-ultrasonography (US) for the detection of transjugular intrahepatic portosystemic shunt (TIPS) dysfunction within a multicenter cohort of cirrhotic patients. METHODS This study was conducted in 10 french teaching hospitals. After TIPS insertion, angiography and liver Doppler-US were carried...
Article
Full-text available
Introduction Induction of labour for prolonged pregnancies (PP) when the cervix is unfavourable is a challenging situation. Cervical ripening by pharmacological or mechanical techniques before oxytocin administration is used to increase the likelihood of vaginal delivery. Both techniques are equally effective in achieving vaginal delivery but exces...
Article
Time-dependent receiver operating characteristic curves allow to evaluate the capacity of a marker to discriminate between subjects who experience the event up to a given prognostic time from those who are free of this event. In this article, we propose an inverse probability weighting estimator of a standardized and weighted time-dependent receive...