Bruno Giraudeau
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View article: Implementation evaluation of a school- and primary care-based multicomponent intervention to improve HPV vaccine coverage: Results from the PrevHPV randomized controlled trial
Implementation evaluation of a school- and primary care-based multicomponent intervention to improve HPV vaccine coverage: Results from the PrevHPV randomized controlled trial Open
Clinicaltrials.gov, NCT04945655. Registered 30 June 2021, https://clinicaltrials.gov/study/NCT04945655.
View article: Correspondence about the article “Effect of hydrocortisone on mortality in patients with severe community-acquired pneumonia. The REMAP-CAP corticosteroid domain randomized clinical trial”
Correspondence about the article “Effect of hydrocortisone on mortality in patients with severe community-acquired pneumonia. The REMAP-CAP corticosteroid domain randomized clinical trial” Open
View article: Improving human papillomavirus vaccination coverage in France: a need to act but not to rush
Improving human papillomavirus vaccination coverage in France: a need to act but not to rush Open
International audience
View article: Gaps in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: a citation analysis reveals a need for updated ethics guidelines
Gaps in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: a citation analysis reveals a need for updated ethics guidelines Open
Identifying 24 gaps reveals a need to update the Ottawa Statement. Alongside additional gaps identified in ongoing empirical work and through engagement with our patient and public partners, the gaps identified through this citation analys…
View article: Adjunctive dobutamine in patients with septic cardiomyopathy and tissue hypoperfusion: a blinded randomised controlled multicentre trial study protocol of the ADAPT-dobutamine trial
Adjunctive dobutamine in patients with septic cardiomyopathy and tissue hypoperfusion: a blinded randomised controlled multicentre trial study protocol of the ADAPT-dobutamine trial Open
Introduction Sepsis-induced left ventricular (LV) dysfunction participates in cardiovascular dysfunction and associated organ failure in patients with septic shock. The tested hypothesis is that dobutamine will reduce tissue hypoperfusion …
View article: Impact of early haemodynamic assessment by echocardiography on organ dysfunction and outcome of patients admitted to the emergency department with sepsis or septic shock: protocol of a multicentre randomised controlled trial (GENESIS)
Impact of early haemodynamic assessment by echocardiography on organ dysfunction and outcome of patients admitted to the emergency department with sepsis or septic shock: protocol of a multicentre randomised controlled trial (GENESIS) Open
Introduction Acute circulatory failure plays a major role in the development of sepsis-related organ dysfunction. Current ‘bundles’ of the Surviving Sepsis Campaign (SSC) include the administration of a fluid loading of 30 mL/kg in the pre…
View article: Correction: Identifying the needs of natural caregivers caring for a person with dementia: a mixed method study
Correction: Identifying the needs of natural caregivers caring for a person with dementia: a mixed method study Open
International audience
View article: Bevacizumab-based chemotherapy adaptive to pharmacokinetic of bevacizumab in first-line treatment of patients with unresectable metastatic colorectal cancer: A double-blind, multicenter, randomized phase III trial study (PHARBEVACOL trial)
Bevacizumab-based chemotherapy adaptive to pharmacokinetic of bevacizumab in first-line treatment of patients with unresectable metastatic colorectal cancer: A double-blind, multicenter, randomized phase III trial study (PHARBEVACOL trial) Open
Bevacizumab shows inter-individual pharmacokinetic variability, with an exposure-response relationship in metastatic colorectal cancer (mCRC) patients. This study explores whether a double dose of bevacizumab, compared to a standard dose, …
View article: Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials
Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials Open
Background Guidance exists to inform the content of statistical analysis plans in clinical trials. Though not explicitly stated, this guidance is generally focused on clinical trials in which the randomization units are individual patients…
View article: Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration
Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration Open
International audience
View article: Quilting Suture Without Drainage or Conventional Closure with Drainage for Breast Cancer Mastectomy: A Randomized Controlled Trial
Quilting Suture Without Drainage or Conventional Closure with Drainage for Breast Cancer Mastectomy: A Randomized Controlled Trial Open
View article: Oral Ivermectin Versus 5% Permethrin Cream to Treat Children and Adults with Classic Scabies: A Cluster-Randomised Clinical Trial
Oral Ivermectin Versus 5% Permethrin Cream to Treat Children and Adults with Classic Scabies: A Cluster-Randomised Clinical Trial Open
View article: Estimating an adjusted risk difference in a cluster randomized trial with individual-level analyses
Estimating an adjusted risk difference in a cluster randomized trial with individual-level analyses Open
In cluster randomized trials (CRTs) with a binary outcome, intervention effects are usually reported as odds ratios, but the CONSORT statement advocates reporting both a relative and an absolute intervention effect. With a simulation study…
View article: Six-month outcomes after a GP phone call during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial using medico-administrative databases
Six-month outcomes after a GP phone call during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial using medico-administrative databases Open
Objectives The first COVID-19 lockdown raised concerns about reduced access to primary care, especially for people with chronic diseases particularly at risk in the absence of follow-up. However, the COVIQuest trial, evaluating the impact …
View article: Implementation evaluation of a school-based intervention on HPV vaccination (the PrevHPV study)
Implementation evaluation of a school-based intervention on HPV vaccination (the PrevHPV study) Open
Background HPV vaccine coverage (VC) remains lower than expected in many countries, particularly France. We developed and evaluated the PrevHPV multicomponent intervention to improve HPV VC among French adolescents. We evaluated the implem…
View article: Effectiveness of a school- and primary care-based HPV vaccination intervention (the PrevHPV study)
Effectiveness of a school- and primary care-based HPV vaccination intervention (the PrevHPV study) Open
Background HPV vaccine coverage (VC) remains lower than expected in many countries, particularly France. We developed and evaluated the PrevHPV multicomponent intervention to improve HPV VC among French adolescents. The components were ‘ed…
View article: FIRE Stones: impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser—protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation
FIRE Stones: impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser—protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation Open
View article: Can Biomarkers Correctly Predict Ventilator-associated Pneumonia in Patients Treated With Targeted Temperature Management After Cardiac Arrest? An Exploratory Study of the Multicenter Randomized Antibiotic (ANTHARTIC) Study
Can Biomarkers Correctly Predict Ventilator-associated Pneumonia in Patients Treated With Targeted Temperature Management After Cardiac Arrest? An Exploratory Study of the Multicenter Randomized Antibiotic (ANTHARTIC) Study Open
IMPORTANCE: Ventilator-associated pneumonia (VAP) frequently occurs in patients with cardiac arrest. Diagnosis of VAP after cardiac arrest remains challenging, while the use of current biomarkers such as C-reactive protein (CRP) or procalc…
View article: Sample Size Calculation for an Individual Stepped‐Wedge Randomized Trial
Sample Size Calculation for an Individual Stepped‐Wedge Randomized Trial Open
In the individual stepped‐wedge randomized trial (ISW‐RT), subjects are allocated to sequences, each sequence being defined by a control period followed by an experimental period. The total follow‐up time is the same for all sequences, but…
View article: Effectiveness of a School- and Primary Care–Based HPV Vaccination Intervention
Effectiveness of a School- and Primary Care–Based HPV Vaccination Intervention Open
Importance The human papillomavirus (HPV) vaccine is safe and effective, yet vaccination coverage remains below public health objectives in many countries. Objective To examine the effectiveness of a 3-component intervention on HPV vaccina…
View article: Topical versus oral corticosteroids in moderate drug reaction with eosinophilia and systemic symptoms: A multicenter randomized clinical trial
Topical versus oral corticosteroids in moderate drug reaction with eosinophilia and systemic symptoms: A multicenter randomized clinical trial Open
View article: Optimizing Communication on HPV Vaccination to Parents of 11- to 14-Year-Old Adolescents in France: A Discrete Choice Experiment
Optimizing Communication on HPV Vaccination to Parents of 11- to 14-Year-Old Adolescents in France: A Discrete Choice Experiment Open
View article: Reporting of cluster randomised crossover trials 2023: extension of the CONSORT 2010 statement with explanation and elaboration
Reporting of cluster randomised crossover trials 2023: extension of the CONSORT 2010 statement with explanation and elaboration Open
In this report we present the Consolidated Standards of Reporting Trials (CONSORT) extension for the cluster randomised crossover (CRXO) trial. A CRXO trial involves randomisation of groups of individuals (‘clusters’) to different sequence…
View article: Do patients with type 2 diabetes mellitus included in randomised clinical trials differ from general-practice patients? A cross-sectional comparative study
Do patients with type 2 diabetes mellitus included in randomised clinical trials differ from general-practice patients? A cross-sectional comparative study Open
Objectives To compare the characteristics of patients with type 2 diabetes mellitus in general practice and those included in randomised controlled trials on which clinical practice guidelines are based. Design Cross-sectional comparative …
View article: FIRE Stones:Impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser: protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation.
FIRE Stones:Impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser: protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation. Open
Background Lithiasis is a common and recurrent disease. Flexible ureteroscopy (fURS) is the cornerstone of laser treatment of kidney stones. Kidney stones destruction requires its laser pulverization into small fragments in order to remove…
View article: Cluster randomized trials: statistical, practical and ethical issues
Cluster randomized trials: statistical, practical and ethical issues Open
View article: Why and when should we cluster randomize?
Why and when should we cluster randomize? Open
View article: Drug clustering to anticipate new aspects of drug safety profile: Application to gabapentinoids and other voltage‐gated calcium channel ligand drugs
Drug clustering to anticipate new aspects of drug safety profile: Application to gabapentinoids and other voltage‐gated calcium channel ligand drugs Open
Aims Gabapentin and pregabalin bind to α2‐δ subunit of voltage‐gated calcium channels (Ca v ). Other drugs targeting Ca v include cardiovascular calcium channel blockers (CCBs) and anticonvulsants (levetiracetam, ethosuximide and zonisamid…
View article: Designs used in published therapeutic studies of rare superficial vascular anomalies: a systematic literature search
Designs used in published therapeutic studies of rare superficial vascular anomalies: a systematic literature search Open
View article: Cluster randomized trials in nursing homes should better be planned as open-cohort than as closed-cohort
Cluster randomized trials in nursing homes should better be planned as open-cohort than as closed-cohort Open