Agnès Caille

Agnès Caille
University of Tours | UFR · UFR Médecine

MD, PhD

About

107
Publications
10,146
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1,208
Citations

Publications

Publications (107)
Article
Full-text available
Objective We aimed to investigate whether anakinra, an interleukin-1receptor inhibitor, could improve outcome in moderate COVID-19 patients. Methods In this controlled, open-label trial, we enrolled adults with COVID-19 requiring oxygen. We randomly assigned patients to receive intravenous anakinra plus optimized standard of care (oSOC) vs. oSOC a...
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 Dans les essais randomisés contrôlés présentant un critère de jugement de type survie, le risque relatif instantané (ou hazard ratio - HR) est communément utilisé pour mesurer l'effet d'un traitement. Il s'agit d'un indicateur difficile à interpréter sur le plan clinique et ce d'autant plus si l'hypothèse de proportionnalité des risque...
Article
Introduction Dans un essai randomisé en cluster en « stepped-wedge » (ERC-SW), la randomisation ne détermine pas l'intervention reçue par le cluster mais la séquence selon laquelle l'intervention sera implémentée au sein des clusters participants. A la fin de l'essai, tous les clusters reçoivent l'intervention ce qui constitue le principal atout de...
Article
Objective To explore challenges in recruitment and intervention implementation in recent stepped-wedge cluster randomized trials (SW-CRTs). Study design and setting We searched PubMed to identify primary reports of SW-CRTs (2019–2020). Two reviewers independently screened studies and extracted data from each report. Recruitment challenge was defin...
Article
Objective To assess whether meta-analyses include older randomized controlled trials (RCTs) and whether intervention effect differ between older and recent RCTs. Study design and setting In this meta-epidemiological study of 295 meta-analyses (2940 RCTs) published in 2017-2018, we evaluated the difference in intervention effects between older (ie,...
Article
Introduction La pneumopathie interstitielle non spécifique (PINS) a un pronostic sévère. Par analogie avec les pneumopathies interstitielles associées à la sclérodermie, la prise en charge standard de la PINS repose en première ligne sur des immunosuppresseurs tel que le mycophenolate mofetil (MMF). L’infiltration lymphocytaire CD20 pulmonaire au c...
Article
Introduction Le traitement conventionnel du carcinome de Merkel (CCM) métastatique est la chimiothérapie à base de sels de platine, mais l’immunothérapie par inhibiteurs de checkpoints immunitaires (ICI) a montré des résultats encourageants dans des essais ouverts chez ces patients. La place des ICI dans la stratégie thérapeutique reste cependant d...
Article
Background: Innovative therapeutic interventions for post-traumatic stress disorder (PTSD) are required. We opted to facilitate fear extinction by combining trauma script exposure with repetitive transcranial magnetic stimulation (rTMS) to reduce symptoms of PTSD. Objective: The efficacy and safety of 10 Hz rTMS of the right dorsolateral prefron...
Article
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...
Article
Background The management of prosthetic joint infection usually consists of a combination of surgery and antimicrobial therapy. The appropriate duration of antimicrobial therapy for this indication remains unclear. Methods We performed an open-label, randomized, controlled, noninferiority trial to compare 6 weeks with 12 weeks of antibiotic therap...
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
Objectives To estimate the prevalence of time-to-event (TTE) outcomes in cluster randomized trials (CRTs) and to examine their statistical management. Study design and setting We searched PubMed to identify primary reports of CRTs published in six major general medical journals (2013-2018). Nature of outcomes and, for TTE outcomes, statistical met...
Article
Introduction Il est conseillé aux apparentés au 1er degré (AP1D) des patients ayant eu un mélanome (MM) d’adopter des mesures de photoprotection et de détection précoce (auto-examen et consultation d’un dermatologue). Ces conseils sont donnés oralement aux patients qui sont invités à relayer l’information à leurs AP1D. Nous avions évalué l’utilité...
Article
Introduction Le traitement de référence du carcinome de Merkel (CCM) aux stades précoces (I à III AJCC) est la chirurgie élargie. Bien que l’exérèse de la tumeur primitive avec des marges de 1 à 2 cm soit recommandée, certains auteurs préconisent des marges plus étroites dans cette population âgée. En l’absence de données pour conforter cette recom...
Article
Introduction Les malformations capillaires (MC), ou angiomes plans, sont des anomalies vasculaires congénitales, majoritairement situées sur la tête, le cou et les membres. Les MC de membre inférieur peuvent être isolées, l’enjeu étant esthétique, ou plus rarement syndromiques, s’associant à des anomalies sous-jacentes (dilatations veineuses, hyper...
Article
Background Wide local excision constitutes the standard of care for Merkel cell carcinoma, but the optimal margin width remains controversial. Objectives To assess whether narrow margins (0.5 - 1 cm) were associated with outcome. Methods Patients were recruited from a retrospective French multicentric cohort and included if they had had excision...
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
Full-text available
Introduction: Left-sided infective endocarditis (IE) is a serious infection with a heavy burden for patients and healthcare system. Oral switch after initial intravenous antibiotic therapy may reduce costs and improve patients' discomfort without increasing unfavourable outcomes. We describe the methodology of two simultaneously conducted open-lab...
Article
Topical drugs are often used as first-line treatment for dermatological conditions. Depending on the disease and the drug, three main designs can be used for randomized controlled trials assessing topical drugs: the classical individual parallel design, the cluster randomized design, and designs allowing within-individual comparisons, including the...
Article
Introduction: Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being...
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...
Conference Paper
Introduction/Background Standard of care worldwide of locally advanced cancer tend to be non surgical (chemoradiation therapy) with no certainty if this attitude improves survival or not. Therefore, it is important to assess the value of hysterectomy in addition to chemoradiation therapy in this context. The sole randomized controlled trial (Morice...
Article
Background 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 [1]. This association challenges its interpretation. To overcome this situation, Crespi et al. [2] extended a coefficient na...
Article
Résumé Objectif Les cancers du sein triple négatifs, définis par l’absence d’expression des récepteurs hormonaux et de la protéine HER2, sont considérés comme des tumeurs agressives et de mauvais pronostic en comparaison aux tumeurs hormonosensibles. L’objectif de l’étude était d’évaluer les associations entre les facteurs hormonaux et les facteur...
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...
Article
Full-text available
Objectives: Repetitive transcranial magnetic stimulation (rTMS) is an innovative therapeutic option in major depressive disorder (MDD). A complete description of the procedure in reports of randomized controlled trials (RCTs) is a prerequisite for implementation of rTMS in clinical practice. The aim of this study was to evaluate the completeness o...
Article
Full-text available
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...
Article
We thank Fujisawa and colleagues for their nice study demonstrating that baseline NLR level was associated with outcome in patients treated with nivolumab, which was similar to the findings of previous studies of melanoma patients treated with ipilimumab. We agree with their main findings and we wish to comment on some points. Corticosteroids intak...
Article
Introduction Clinical equipoise (i.e., uncertainty within the expert clinical community) is considered as a prerequisite for a randomized controlled trial (RCT). Indeed, a RCT must start with an “honest null hypothesis”, which indicates controversy in the clinical expert community about the superiority of one of the 2 compared interventions. At the...
Article
Full-text available
Some studies have shown that a high neutrophil/lymphocyte ratio (NLR) ≥4 before initiating ipilimumab treatment is an independent prognostic indicator of poor survival in patients with metastatic melanoma (MM). To determine whether the NLR before starting BRAF inhibitor (BRAFi) treatment in patients with (MM) is associated with progression-free sur...
Article
Full-text available
Patients with an inherited autosomal-dominant disorder, capillary malformation-arteriovenous malformation (CM-AVM), frequently have mutations in Ras P21 protein activator 1 (RASA1). The aims of this study were to determine the prevalence of germline RASA1 variants in a French multicentre national cohort of children, age range 2-12 years, with spora...
Article
Background: Genetics discoveries have allowed for better understanding capillary malformations (CMs) with overgrowth syndrome. However, molecular analyses are still not easy to perform or interpret. Other analytical methods are needed. Objective: We aimed to identify clinical and hemodynamic factors associated with leg length discrepancy (LLD) i...
Article
Background and objectives: In developed countries, where omphalitis has become rare and related mortality nil, benefits of antiseptic use in umbilical cord care have not been demonstrated. We aimed to assess the noninferiority of dry care compared with antiseptics in France where antiseptic use is widespread. Methods: We conducted a noninferiori...
Article
Full-text available
Background Anaplastic gangliogliomas (GGGs) are rare tumors whose natural history is poorly documented. We aimed to define their clinical and imaging features and to identify prognostic factors. Methods Consecutive cases of anaplastic GGGs in adults prospectively entered into the French Brain Tumor Database between March 2004 and April 2014 were s...
Article
Full-text available
The biological diagnosis of Pneumocystis jirovecii pneumonia (PjP) is based on the investigation of respiratory fluids by conventional staining methods and/or molecular biology. Diagnostic performance of an in-house technique based on calcofluor-blue brightener for the direct detection of P. jirovecii cysts was prospectively assessed in bronchial-a...
Article
Robust evidence of the effectiveness of interventions relating to policy, practice, and organisation of healthcare often comes from well conducted cluster randomised trials. Such trials are, however, prone to recruitment bias depending on whether participants are recruited before the randomisation of clusters and whether the recruiter is blinded to...
Article
Full-text available
Introduction Postoperative wound seroma is common after mastectomy. This complication is associated with significant impact on patient outcomes and healthcare costs. The optimal closure approach for seroma prevention remains unknown but some evidence suggests that quilting suture of the dead space could lower the incidence of seroma. The aim of thi...
Article
Full-text available
Background: Despite randomization, baseline imbalance and confounding bias may occur in cluster randomized trials (CRTs). Covariate imbalance may jeopardize the validity of statistical inferences if they occur on prognostic factors. Thus, the diagnosis of a such imbalance is essential to adjust statistical analysis if required. Methods: We devel...
Article
Background: There is an unmet need to identify markers predictive of response to ipilimumab in patients with melanoma because the number of responders to ipilimumab is low and its cost is very high. An absolute increase in lymphocytes or low neutrophil/lymphocyte ratio (NLR) just before the third infusion has been reported to be associated with be...
Article
Full-text available
Acute cor pulmonale (ACP) and patent foramen ovale (PFO) remain common in patients under protective ventilation for acute respiratory distress syndrome (ARDS). We sought to describe the hemodynamic profile associated with either ACP or PFO, or both, during the early course of moderate-to-severe ARDS using echocardiography. In this 32-month prospect...
Article
We aimed to assess whether the clinical equipoise principle is satisfied in unbalanced randomized controlled trials (RCTs) (i.e., with an unequal probability of subjects being allocated to one group than another). Observational and comparative study between unbalanced and balanced RCTs. We searched the "core clinical journals" of MEDLINE to identif...
Article
This study was designed to compare conventional closure with a drain and quilting suture of mastectomy dead space for preventing wound seroma. Consecutive patients undergoing mastectomy for breast cancer were included in this retrospective observational study. Patients received conventional closure with drainage or quilting suture for wound closure...
Article
Merkel cell carcinoma (MCC) is a rare high-grade neuroendocrine tumour of the skin. It has been speculated that MCC express somatostatin receptors (SSTRs), but this has never been assessed in a large series of MCCs. The main aim was to assess the expression of SSTR2A and SSTR5 in MCC tumours. The secondary aims were to assess whether expression of...
Article
Late recognition plays an important role in prognosis associated with kidney disease; thus, information transfer at hospital discharge regarding kidney disease is crucial. Whether it is notified in patients' hospital discharge summary (HDS) is presently largely unknown. Cross-sectional. The prevalence of kidney dysfunction [estimated glomerular fil...
Article
Objectives: To assess the reporting of the unequal randomization ratio in reports of trials with this design and to identify the justification for the design. Study design and setting: Systematic review of reports of trials with unequal randomization. We selected all original reports of two parallel-group randomized controlled trials with unequa...
Article
Aim Our study assessed the distribution of physical activity during various typical tasks of daily life in adults with type 2 diabetes (T2D), a population typified by low physical activity. Methods We investigated the duration and intensity of physical activity in four domains (work, leisure, transportation and domestic), and how individual determ...
Article
Despite randomization, selection bias may occur in cluster randomized trials. Classical multivariable regression usually allows for adjusting treatment effect estimates with unbalanced covariates. However, for binary outcomes with low incidence, such a method may fail because of separation problems. This simulation study focused on the performance...
Article
In cluster randomized trials, clusters of subjects are randomized rather than subjects themselves, and missing outcomes are a concern as in individual randomized trials. We assessed strategies for handling missing data when analysing cluster randomized trials with a binary outcome; strategies included complete case, adjusted complete case, and simp...
Article
In cluster randomized trials, clusters of subjects are randomized rather than subjects themselves, and missing outcomes are a concern as in individual randomized trials. We assessed strategies for handling missing data when analysing cluster randomized trials with a binary outcome; strategies included complete case, adjusted complete case, and simp...