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International audience; INTRODUCTION: There is growing evidence on the ethical challenges raised by cluster randomized trials. This specificity is not reflected in the legal texts regulating research, which creates difficulties for researchers implementing these experimental designs. The Ottawa Statement (Weijer et al. 2012) aims to provide detailed guidance on the ethical design, conduct and assessment of cluster trials. More broadly aims to help research stakeholders and decision-makers to make informed ethical decisions regarding the particularity of these experimental designs. It seems that this international statement, written in English, is not sufficiently accessible to all of the French professionals involved in health research. The aim of this article is to provide these professionals with a contextualized and illustrated French translation of the "Ottawa statement". METHOD: . The "complex design" working group of the RECaP network (Research in Clinical Epidemiology and Public Health), carried out this work. A first version was discussed by the authors in several meetings. It was completed by contextual explanations and examples of French studies currently conducted by the authors. The final version was obtained by consensus and validated by the group. RESULTS: . This work reports 15 recommendations grouped into 7 key questions: How to justify cluster design? How to submit an article to an ethics committee? How to identify research participants? How and when to obtain informed consent? Who are the gatekeepers? How to assess benefits and harm? How to protect vulnerable participants? Each of these recommendations is specific to cluster trials. The recommendations are explained and detailed through concrete examples. CONCLUSION: Without interfering with current French laws, this work provides a framework for the organization, conduct and ethical assessment of cluster randomized trials in France. In the present-day context, it is essential that all concerned groups can base their decisions on recommendations in line with the elementary principles of health research ethics.; INTRODUCTION : Il existe une littérature croissante sur les défis éthiques soulevés par les essais randomisés en clusters (ou en grappes). Cette spécificité n'est pas prise en compte dans les textes réglementaires qui régissent la recherche, ce qui est source de difficultés pour les chercheurs utilisant ces schémas expérimentaux. La Déclaration d'Ottawa (Weijer et al. 2012) vise à fournir des conseils détaillés sur l’éthique de la conception, de la conduite et de l’évaluation des essais en clusters. Elle a pour objectif d'aider l'ensemble des acteurs de la recherche (parties prenantes et décideurs) à prendre des décisions éclairées en termes d’éthique relative à la particularité de ces schémas expérimentaux. Il semble que cette déclaration internationale ne soit pas assez accessible auprès de l'ensemble des acteurs français de la recherche en santé. L'objectif de cet article est de proposer à ces professionnels une traduction française de l’« Ottawa Statement », contextualisée et illustrée. METHODE : Le groupe de travail « Design complexe » du réseau RECaP (Recherche en épidémiologie clinique et en santé publique) a réalisé ce travail. Une première version a été discutée par les auteurs au travers de plusieurs réunions. Elle a été complétée par des explications contextuelles et par des exemples d’études françaises actuellement menées par les auteurs. La dernière version a été obtenue par consensus et validée par le groupe. RESULTATS : Ce travail présente les 15 recommandations regroupées en sept grandes questions : quelle justification pour le design en clusters ? Comment soumettre à un comité d’éthique ? Comment identifier les participants à la recherche ? Quand et comment obtenir un consentement éclairé ? Qui sont les personnes référentes ? Comment évaluer les bénéfices et les risques ? Comment protéger les personnes vulnérables ? Chacune de ces recommandations porte spécifiquement sur les essais en clusters. Ces recommandations sont expliquées et détaillées au travers d'exemples. CONCLUSION : Ce travail permet de fournir un cadre pour la mise en place, la conduite et l’évaluation éthique des essais randomisés en clusters en France. Sans ingérence dans les lois actuelles françaises. Dans le contexte actuel, il est indispensable que l'ensemble des groupes concernés puissent appuyer leurs décisions sur des recommandations en accord avec les principes élémentaires de l’éthique de la recherche en santé.

Background HPV vaccine coverage (VC) in France has always been lower than in most high-income countries. The French authorities launched in 2018 the PrevHPV national research program aimed at codeveloping with stakeholders and evaluating the impact of a multicomponent intervention to improve HPV VC among French adolescents. Methods We identified three components to address main barriers to HPV vaccination in France: adolescents’ and parents’ education and motivation (component 1); general practitioners (GPs)’ training (component 2); and access to vaccination at school (component 3). We developed the intervention using the UK Medical Research Council framework for developing complex interventions as a guide. We used (i) findings from published evidence; (ii) primary data on knowledge, attitudes, behavior and preferences collected through a mixed methods approach (quantitative/qualitative studies, discrete choice experiment); (iii) the advice of stakeholders (e.g., adolescents, parents, school nurses, GPs) involved in working groups. We will evaluate the effectiveness, efficiency and implementation of the components (applied alone or in combination) through a pragmatic cluster randomized controlled trial. The primary endpoint is the HPV VC (≥ 1 dose) among adolescents aged 11-14 years, 2 months after the end of the intervention, at the municipality level. Results Primary data highlighted the need to improve adolescents, parents and school staff knowledge on HPV and to help GPs communicate with patients on this topic. They provided guidance on the most effective communication contents. For each component, we codeveloped tools with a participatory approach (e.g., eHealth tools for adolescents, a decision aid tool for GPs). The trial will end in June 2022; 90 middle schools (i.e., about 40,000 adolescents) and 46 GPs accepted to participate. Conclusions Should the intervention prove effective, results from the implementation evaluation will help us refine it before scaling it up. Key messages • The PrevHPV study is supported by the French health authorities and conducted by a multidisciplinary consortium to tackle a long-lasting public health concern in France. • It will add to the small number of studies that compared the effectiveness of various strategies to promote HPV vaccination and will provide key results on cost-effectiveness and implementation.

Introduction Le retard diagnostique est particulierement long dans l’hidradenite suppuree (HS), 7 ans en moyenne, dans de nombreux pays. Les causes de ce delai ont rarement ete explorees. L’objectif de cette etude etait d’evaluer les connaissances des medecins generalistes sur l’HS et d’identifier les raisons du retard diagnostique important dans cette pathologie aupres des medecins generalistes. Materiel et methodes Cette etude a consiste en une enquete realisee au moyen d’un questionnaire compose de 35 items, envoye a 500 medecins generalistes randomises, en France. Le critere de jugement principal etait le taux de reponses correctes a des questions relatives aux connaissances generales sur l’HS, d’une auto-evaluation par les medecins generalistes sur leur aptitude a diagnostiquer, et a traiter l’HS et des donnees sur les freins potentiels au diagnostic precoce de l’HS, identifies par les medecins generalistes. Resultats Sur les 500 questionnaires envoyes, 193 (39,0 %) ont ete retournes et ont pu etre analyses. La moyenne ± deviation-standard du taux de reponses correctes etait de 38,3 %± 10,7 sur 100. Le score global d’auto-evaluation par les medecins generalistes sur leur aptitude a diagnostiquer l’HS etait de 42,8 ± 23,7 sur une echelle de 0 a 100 et sur leur aptitude a la prendre en charge de 41,5 ± 21,9. Le coefficient de correlation de Spearman entre le taux de reponses correctes et les scores d’auto-evaluation etait : rho = 0,13 IC95 % [−0,02 ; 0,26]. La reponse la plus frequente quant aux principaux freins au diagnostic precoce d’HS etait le manque de connaissances sur la pathologie (n = 128, 66,3 %), les difficultes diagnostiques propres a la maladie, comme le caractere aspecifique de certaines lesions (n = 62, 32,1 %) et les difficultes liees aux patients, tardant a consulter (n = 42, 21,8 %). Discussion Le manque de connaissance sur l’HS etait la raison principale identifiee. Ceci est explique par le fait que cette pathologie n’est pas enseignee dans le programme de l’examen classant national, socle de connaissance de tout medecin generaliste francais. Le caractere peu specifique de certaines lesions est un autre ecueil important. La description recente de plusieurs phenotypes distincts permettrait notamment de mieux caracteriser l’HS. Enfin, les patients tardent a consulter. Ceci est explique en partie par des facteurs psychosociaux qu’il convient de combattre, comme la honte ressentie, l’isolement social, la desillusion vis-a-vis de la meconnaissance generale et le peu de therapeutiques efficaces. Le diagnostic correct et la prise en charge precoce de la maladie permettraient probablement d’en limiter la morbidite physique et psychologique. Conclusion Cette enquete souligne la necessite d’ameliorer et d’intensifier la formation sur l’HS, tant pour les etudiants en medecine que pour les medecins generalistes, afin d’aider au mieux les patients atteints de cette pathologie invalidante.

Resume But de l’etude L’entretien predon represente une etape essentielle de la securite transfusionnelle. En France, il est obligatoirement confie a un medecin et conduit sous la forme d’un questionnement methodique guide par un questionnaire standardise. Face a cette evolution, la plus value de l’expertise strictement medicale a progressivement perdu de l’importance. De nombreux pays ont organise la selection des donneurs par des personnels non medicaux formes a cet effet (Quebec, Suisse…). L’arrete du 30 avril 2006 a autorise l’Etablissement francais du sang (EFS) a experimenter un entretien predon par un personnel paramedical habilite sous la forme d’une etude multicentrique prospective en deux phases sur un an. Patients et methodes Phase 1 « situation experimentale » : les six binomes medecin/infirmier de trois etablissements de transfusion sanguine ont recu en entretien 1940 candidats, dont 253 nouveaux donneurs (13 % du total des candidats). Phase 2 « etude observationnelle » : 3222 candidats ont ete recus soit par le medecin selon les modalites habituelles, soit par l’infirmier selon la methode definie et formalisee. Resultats Pour la phase 1, dans 1921 cas, les infirmiers ont ete capables de prendre une decision sans recourir au medecin. Les medecins et les infirmiers ont juge aptes 1678 candidats et ajourne 174, 69 candidats ont ete ajournes par l’un mais pas par l’autre. Pour la phase 2, sur 3222 candidats au don, les taux d’ajournements medians etaient de 12,1 % pour les infirmiers et de 10 % pour les medecins, avec une plus faible variabilite chez les infirmiers. Conclusion Les resultats ont montre que les infirmiers etaient capables de realiser les entretiens predon avec une excellente fiabilite, sans risque supplementaire. La reproductibilite de leurs reponses dans le domaine des risques receveurs etait meilleure.

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 planning stage, randomization may reflect the clinical uncertainty, namely, by the randomization ratio. A 1:1 ratio appears to best fit this state of uncertainty. Objective We aimed to assess whether the clinical equipoise principle is satisfied in unbalanced RCTs (i.e., with an unequal probability of subjects being allocated to one group than another). Method Observational and comparative study between unbalanced and balanced RCTs. We searched the “core clinical journals” of MEDLINE to identify reports of two-parallel–group superiority unbalanced RCTs published between January 2009 and December 2010. For each unbalanced RCT, we identified a maximum of 4 reports (to maximize power) of matched balanced RCTs dealing with the same population. Our primary outcome was the proportion of positive RCTs (i.e., with statistically significant results for the primary outcome [P Results We selected 46 reports of unbalanced RCTs and 164 of balanced RCTs; 65.2% unbalanced RCTs and 43.9% of balanced RCTs were positive [odds ratio 2.38; 95% confidence interval: 1.23, 4.63]. As compared with balanced RCTs, unbalanced RCTs were more often industry-funded and their control treatments were more often inactive. Adjusting for these latter variables did not modify the results. Conclusion This result questions the respect of clinical equipoise in unbalanced RCTs.

Resume Objectif etudier la faisabilite de l’inversion d’un segment colique transverse et evaluer son impact sur le transit intestinal chez le rat Wistar. Methodes sur un groupe test des rats Wistar mâles anesthesies, nous avons isole un segment du colon transverse vascularise par un pedicule nourricier. Ce segment coliqui a ete inverse et anastomose en antiperistaltique sur son site avec du polyglactine 6/0. Pendant la surveillance post-operatoire, nous avons etudie, le poids des rats, le volume des ingestats, le transit intestinal, la survie et les lesions histologiques du segment colique inverse. Sur le groupe controle, nous avons realise l’anastomose d’un segment du colon transverse isole et anastomose en isoperisaltique. Resultats trente rats mâles de 231,5 ± 8,3 g avaient ete operes, 15 dans le groupe test et 15 dans le groupe controle. Le poids moyen des ingestats dans le groupe test etait de 21,87 ± 3 g et de 21,75 ± 4,8 g dans le groupe controle, la difference n’etait pas significative. Le delai moyen de reprise du transit post-operatoire etait de 3 ± 1 jours dans le groupe test et de 2 ± 1 jours pour les rats controles. Un arret des matieres a ete observe dans un delai moyen de 6 ± 2 jours et a entraine une mortalite de 87% dans le groupe test. Deux rats (13%) du groupe test ont survecu et ont eu une prise de poids reguliere par rapport aux rats controles. L’analyse histologique du segment colique inverse a montre des lesions inflammatoires sur sa portion proximale et une paroi normale sans anomalie ischemique sur sa portion distale. Aucun deces n’a ete observe dans le groupe controle. Conclusion l’anastomose antiperistaltique d’un segment colique transverse dans le cadre colique chez le rat Wistar, entraine un arret du transit intestinal par occlusion mecanique sans lesion ischemique du segment colique inverse.

The objective of this study was to assess the performance of seven French laboratories for 16S rRNA gene detection by real-time PCR in the diagnosis of bone and joint infection (BJI) to validate a large multicenter study. External quality control (QC) was required owing to the differences in extraction procedures and the molecular equipment used in the different laboratories. Three proficiency sets were organized, including four bacterial DNA extracts and four bead mill-pretreated osteoarticular specimens. Extraction volumes, 16S rRNA gene primers, and sequencing interpretation rules were standardized. In order to assess each laboratory's ability to achieve the best results, scores were assigned, and each QC series was classified as optimal, acceptable, or to be improved. A total of 168 QCs were sent, and 160 responses were analyzed. The expected results were obtained for 93.8%, with the same proportion for extracts (75/80) and clinical specimens (75/80). For the specimens, there was no significant difference between manual and automated extraction. This QC demonstrated the ability to achieve good and homogeneous results using the same 16S rRNA gene PCR with different equipment and validates the possibility of high-quality multicenter studies using molecular diagnosis for BJI.

Resume Introduction. – Le diagnostic clinique des appendicites aigues de l'enfant reste difficile et les examens biologiques actuellement utilises, la proteine C-reactive et l'hyperleucocytose manquent de sensibilite. Objectif. – Etudier la valeur diagnostique de la procalcitonine (PCT) dans les appendicites de l'enfant et evaluer les variations de son taux serique en fonction des lesions inflammatoires. Patients et methode. – Parmi 101 enfants de 2 a 15 ans hospitalises pour syndrome douloureux abdominal, 70 ont ete operes pour appendicites aigues et peritonites appendiculaires et 31 ne l'ont pas ete. Le dosage quantitatif de PCT a ete effectue chez tous les enfants, son seuil de positivite etait de 0,5 μg/l. Toutes les pieces des appendicectomies ont ete examinees dans le service d'anatomie pathologique pour confirmer le diagnostic et les lesions histologiques ont ete distinguees en trois classes selon leur gravite. Resultats. – Sur les 70 appendices analyses histologiquement, 68 (97 %) etaient malades et 2 (3 %) non malades. La prevalence de l'appendicite aigue dans la population d'etude etait de 67 % : IC 95 % [57–76]. Sur 68 cas d'appendice malade, 19 avaient une PCT superieure a 0,5 μg/l et parmi les 33 cas d'appendice non malade, quatre avaient une PCT superieure a 0,5 μg/l. La sensibilite de la PCT etait de 28 % : IC 95 % [18–40], la specificite de 88 % : IC 95 % [72–97], la valeur predictive positive de 83 : IC 95 % [61–95] et la valeur predictive negative de 37 % : IC 95 % [26–49]. La mediane de PCT ne differe pas significativement entre la population appendice malade et non malade (p = 0,41) mais elle differe significativement en fonction de la gravite des lesions inflammatoires de l'appendice (p = 0,0051). Conclusion. – La PCT n'a pas une bonne valeur diagnostique dans l'appendicite aigue de l'enfant mais est un bon indicateur de gravite de l'appendicite de l'enfant.

STUDY AIM The aim of this retrospective study was to evaluate the 38 month-results of laparoscopic fundoplication for gastroesophageal reflux disease (GERD). PATIENTS AND METHODS Two hundred forty three consecutive patients were operated laparoscopically. The surgical procedures were complete fundoplication with division of short vessels (Nissen: 80 patients), without division of short vessels (Nissen-Rossetti: 68 patients) or partial fundoplication of 270 degrees (Toupet: 95 patients). The mean follow-up was 38 months. Functional results were evaluated in 225 patients (92.5%) using a questionnaire with visual analog scales. RESULTS The morbidity rate was 5%, higher after Nissen procedure (6.5%). With a follow-up of 3 months: a dysphagia coted 5/10, a gas bloat syndrome coted 4/10 and colon distension present in 61% of patients, were significantly more frequent after Nissen procedure. GERD recurred early in 4.5% of patients. With a follow-up of 38 months: dysphagia rate (coted 1/10) was significantly higher after Nissen. Dysphagia still persisted in 8 patients (9%) after Nissen. Colon distension and flatulence were more present after Nissen fundoplication. GERD recurrence rate was 12%. Pyrosis was significantly higher after Toupet fundoplication. Continuous medical treatment was necessary in 19 patients (8%). The satisfaction of patients was coted 7.5/10 without difference between to the three types of fundoplication. CONCLUSION The total laparoscopic fundoplication for GERD seems to be a safe and efficient operation. This procedure proves to be more effective than partial fundoplicature but with a grater morbidity. Whatever the type of fundoplicature, the satisfaction of patients was good.

We lack data on how physicians can instill confidence in patients.We aimed to determine whether dress style (professional white coat or formal, semiformal or casual attire) affects confidence in the physician by patients (children, teenagers, adults) with dermatology complaints consulting in the hospital or private practice.Design. Descriptive prospective cross sectional study carried out from July 1, 2008 to July 1, 2009. Setting. Outpatients in the department of dermatology of a French tertiary care hospital, and two dermatological private consulting rooms. Participants and design. Consulting patients were ≥ 7 years and classified as children 7-11 years old, accompanying parents, teenagers (12-17 years), and adults ≥ 18 years consulting alone. Subjects viewed two iconographic boards containing 4 photographs in a random order of a male physician on 1 board and a female physician on the other board in 4 different dress styles: professional (white coat and stethoscope), formal (shirt and tie for men), semiformal, and casual (T-shirt, jeans). Subjects then completed a questionnaire asking them to rate, on a scale of 0-10, their confidence in the physicians portrayed and answered whether they considered physician dress important. Main outcomes and measures. The main outcome was subjects' ranking of photos of physicians by dress style, according to the confidence they felt. For children 7-11 years old, we considered the frequency of the chosen dress style. The secondary outcome was whether physician dress was important to patients.We included 329 patients. Children at the hospital most frequently chose the photo of the physician, both male (62%) and female (64%), with the white coat. Teenagers' choices were professional dress, then semiformal, formal, and casual attire. Accompanying adults and adults consulting alone had the same ranking.In France, patients of all ages who consult for dermatology complaints in hospital and in private practice have the most confidence in a physician who wears a professional white coat.

Predonation interview accounts for a major step in transfusion safety. In France, it must be performed by a physician, following a methodical questioning and a standardized questionnaire. Faced with this evolution, the value of a strictly medical expertise has been progressively losing importance. In many countries, blood donor selection is being organized by non medical trained staff (Québec, Switzerland, e.g.). A decree of April 30, 2006 allowed the Établissement français du sang to experiment a predonation interview by an authorized paramedical staff in the form of a two-phase prospective multicenter study over a year.Phase I "experimental situation": six physician/nurse teams among three blood transfusion centres interviewed 1940 blood-donation candidates, including 253 new donors (13% out of total). Phase 2 "observational study": 3222 blood-donation candidates were interviewed either by a physician or a nurse.In phase I, nurses were able to make a decision without the physician's help in 1921 cases. A total of 1628 candidates were decided capable of donating blood both by physicians and nurses, 174 donors were rejected both by physicians and nurses and 69 were rejected either by physicians or nurses. In phase 2, out of 3222 blood-donation candidates, an average of 12.1% were rejected by nurses and 10% by physicians.The study reported a weaker variability among nurses. Results show that nurses were able to perform predonation interviews with high reliability, without additional risk. The reproducibility of their answers in the field of recipient-risk evaluation was better than the physicians.

International audience; The recent introduction of high-end ultrasound equipment combined with recent contrast agents provides marked improvements in the characterization of focal liver lesions as previously reported by monocentric studies. The aim of the present study was to evaluate the diagnostic performance of Contrast-Enhanced Ultrasonography (CEUS) using SonoVue as well as its medico-economic value for characterization of focal liver lesions. These nodules were not characterized on previous CT or conventional sonography. This prospective multicentric study conducted in 15 French centres found diagnostic performances similar to those reported for CT and MRI, with a concordance rate of 84.5%, sensitivity greater than 80% and specificity greater than 90% for all types of lesions. Higher acceptance was found for CEUS compared to other imaging modalities. Economical assessment based on examination reimbursment and contrast agent cost showed a lower cost for contrast ultrasound versus CT and MRI. This French multicentric study confirmed the high diagnostic value of CEUS for focal liver lesion characterization and demonstrated a lower economical impact compared to other imaging modalities such as CT and MRI.

Our university hospital serves a population of 300 000 inhabitants. Stroke is the leading cause of admission in our department of neurology. In June 2003, when the Emergency Department (ED) was closed in our institution, was created an acute stroke network (ASN), comprising 2 beds of direct admission and thrombolysis in the intensive care unit, and 4 beds dedicated to stroke care in the department of neurology, in which standardized stroke care protocols were implemented.The aim of this study was to evaluate changes in stroke care related to the creation of the ASN in terms of delays of arrival, imaging, use of intravenous (IV) thrombolysis, and outcome of patients. We conducted a prospective study during 18 months to evaluate characteristics of patients admitted with suspected stroke or transient ischemic attack (TIA) in the newly created ASN and to assess conditions of treatment with IV thrombolysis in terms of safety and efficacy. We also compared the outcome data before and after the creation of the ASN.For each patient admitted in our hospital for suspected stroke or TIA, were prospectively collected clinical and outcome data (age, mode of transport, delay of arrival after the onset of symptoms (OS), treatment with IV thrombolysis, outcome and discharge). This study was conducted in the ED during six months in 2002, and in the ASN during 18 months, for all patients admitted for stroke.Three hundred and sixty four patients were admitted in the ASN. Emergency medical services (EMS) were used in half of cases for transport, and median delay of admission after the OS was 2h and 52 min. Median delay of imaging was 1 h and 45 min. Seventeen patients (8.5 p. 100 of ischemic stroke patients) were treated with IV thrombolysis, with an initial good outcome in 9 patients, 7 with a dramatic recovery). The main reason for therapeutic abstention for untreated patients admitted in the first 3 hours was a mild deficit with a NIHSS6. Compared with the previous management in the ED, patients in the ASN were younger, had more severe neurological symptoms, the EMS transport was the main mode of transport (versus used in 17 p. 100 of cases in 2002), and the delay of admission was significantly lower: 2 h 52 versus 5 h 10 (p0.02). After adjustment on the main predictive factors, only patients with hemorrhagic strokes had a better outcome after the creation of the ASN.Creation of an ASN was associated with a significant decrease of admission and imaging delays, due to a strong collaboration with EMS, and with a better outcome for hemorrhagic stroke patients. Treatment with intravenous thrombolysis in the first 3 hours could be used widely and was efficient and safe. However, the creation of dedicated stroke units for all stroke patients remains necessary to improve quality of care and outcome.

To assess the performance of a power doppler vascularity index in the preoperative diagnosis of ovarian malignancy.Two successive series of adnexal masses (N=101 and N=82) were examined prospectively with power Doppler before surgical treatment. A vascularity index, called Power Doppler Index (PDI), based on the number of colored pixels, was estimated on selected frames (defined region of interest covering the entire tumor) of the tumors using an in house color-quantifying program. The first study was monocentric to test the inter- and intraobserver reproducibilities and the availability of the parameter. The second was multicentric to validate the first results. The sensitivity and specificity of PDI, resistance index (RI) and subjective visual scoring were compared using receiver operating characteristic (ROC) curves.Histology identified 23 malignant and 78 benign lesions in the first study and 34 malignant and 48 benign tumors in the second. PDI was considerably higher in malignant than in benign lesions (0.34+/-0.04 vs 0.12+/-0.06 (P0.001)). Intra-observer and interobserver variability of PDI was low (intraclass correlation coefficients estimated at 0.99 and 0.98, respectively). The PDI cut-off value for differential diagnosis was set at 0.265 (26.5% of the tumor is colored) in the first study and 0.107 in the second. Sensitivity and specificity were 100% (95% CI [87.8; 100.0]) and 97.4% (95% CI [91.0; 99.7]), respectively, for PDI in the first study compared to 75% (95% CI [72.9; 90.7]) and 60% (95% CI [56.3; 92.5]) in the second study. Using logistic regression, visual Doppler scoring performed best.The Power Doppler Index obtained using our color quantifying software has discriminating power for adnexal masses but visual Doppler scoring performs best.

to study the feasibility of the transverse segment colic reversion and to evaluate its impact on the intestinal transit time in the rat Wistar.On a test group of the rats Wistar males anaesthetized, we isolated a segment from the transverse colon vascularized by a feeder pedicle. This segment colic was reversed and anastomosed into antiperistaltic out of termino-terminal on its site with polyglactine 6/0. Into post-operative, we studied, the weight, the volume of the ingestats, the intestinal transit time, the survival and the histological lesions of the reversed segment colic. On the group controls, we carried out the anastomosis of a segment of the transverse colon isolated and anastomosed into isoperisaltic.Thirty rats males of 231.5 +/- 8.3g had been operated, 15 for the test group and 15 for the control group. The average weight of the ingestats of the rats of the test group was of 21.87 +/- 3g and of 21.75 +/- 4.8g in the control group without significant difference. The intestinal transit occured at 3 +/- 1 post-operatives days in the test group and at 2 postoperative days in the control group. A mechanical obstruction of the bowels before the 15th post-operative day involved a mortality of 87% in the test group. Thirteen percent of the rats of the test group survived, with a regular catch of weight. The histological analysis showed inflammatory lesions on the proximal portion of the reversed segment and a normal wall without ischaemic injury on its distal portion. No death was observed in the group controls.The antiperistaltic anastomosis of a transverse segment colic within the colic in the rat Wistar, causes a stop of the intestinal transit time by mechanical occlusion without ischaemic lesion of the segment colic reversed.

A new matrix-based quantitative ultrasound (QUS) device was developed for the assessment of two parameters: BUA (Broadband Ultrasound Attenuation) and SOS (Speed Of Sound). This device, called Beam scanner, is a contact imaging device designed to evaluate the calcaneus. The aim of this preliminary study was to evaluate the reproducibility of results in a sample of patient with heterogeneous age distribution.Seventy-six subjects were included: 18 healthy young males, 18 healthy young women and 40 women aged over 50 years old, including 19 osteoporotic patients according to WHO criteria. Five measurements were made for each patient after foot repositioning. Short-term precision was estimated using the coefficient of variation (CV), standardized CV (SCV) and intra-class correlation coefficient (ICC).SCV varied with the group of subjects between 2.0 and 4.3% for BUA, and between 3.1 and 4.5% for SOS. Mean values of BUA and SOS were statistically lower for osteoporotic women compared with healthy young women or healthy young males (p0.001). For BUA, only SCV and ICC were better for women aged over 50 years old but without statistical difference.This study shows that the heterogeneity of the studied sample population is not a significant factor when assessing precision. This new device has a precision similar to others QUS devices.

Methylphenidate (MPH) is a potential therapeutic tool for Attention Deficit with Hyperactivity Disorders (ADHD). In addition to the immediate-release formulation, Ritalin, two extended-release formulations, Ritalin LA and Concerta are available and allow a once-daily administration. We compared the respective benefits of both formulations for the patients and their family in terms of efficacy, handling and tolerance.This prospective study was based on 30 children aged 6 to 15 years. All patients had a confirmed ADHD and were efficiently treated with Ritalin. The children were consecutively treated with Ritalin LA and Concerta, with a comparable MPH daily dosage, during 2 months for each molecule. The 3 drugs were evaluated individually and comparatively through a battery of questionnaires submitted to the parents and the teachers of each child.Extended-release MPH efficacy was comparable to the immediate-release formulation, Ritalin. For both of them, the once-daily administration appeared beneficial. Concerta was finally prescribed in 18 children, Ritalin LA in 8 cases and Ritalin in 4 cases. In each case the medical choice was consistent with the parents preference. Concerta was appreciated for its persisting efficacy in late afternoon during homework. Concerta and Ritalin LA did not induce significant adverse effects, especially regarding alimentation and sleep.MPH therapy in ADHD carries an excellent risk/benefit ratio without addictive induced behaviours. The extended-release MPH formulations provide an improvement for the patients in keeping with Ritalin efficacy through a once-daily administration. Regardless of its formulation, MPH indications and guidelines must be respected.

Stroke is a leading cause of death and disability. Patients with suspected stroke are usually managed in emergency departments (ED). Stroke units must be created in our country, but only few French epidemiological data are available to define needs in stroke care.A prospective study was planned to evaluate epidemiology and stroke care for patients with suspected stroke admitted in the 22 ED of our region in the center of France during a two-month period.Patients with suspected stroke seen at the 22 ED were prospectively followed until discharge or one month after admission. Data on demographic characteristics, mode of transport, delay of arrival and imaging, clinical findings at arrival, department of admission, diagnosis, Rankin scale at day 7, in-hospital mortality, and outcome at a month were collected. A global statistical analysis and a comparison between rural and urban ED were performed.Five hundred and ninety-eight patients were included. Mean age was 75 years. Median admission delay was 4 hours and 52 minutes. Predominant mode of transport was a private ambulance. A CT scan was obtained in 91 p.cent of cases with a median delay of 2 hours and 30 minutes. Only a third of the patients were admitted in departments of Neurology. Final diagnosis was: ischemic stroke (61 p.cent), transient ischemic attack (16 p.cent), hemorrhagic stroke (10 p.cent), other vascular disease (3 p.cent), non vascular disease (10 p.cent). In-hospital mortality was 20 p.cent, factors significantly associated with death rate were elevated age and a Glasgow coma scale10 at admission. Mean length of stay was 12 days for stroke patients. At one month, 63 percent of patients were discharged to their home, 28 percent were transferred to an institution or in a rehabilitation unit, and 15 percent were still hospitalized. Significant differences in stroke care were found between rural and urban ED.This prospective study provides epidemiological data for our region. Creation of stroke units and definition of acute stroke networks are necessary to improve stroke care.

Limb lymphedema results from incompetence of the lymphatic system, and treatment of both primary and secondary forms involves manual lymphatic drainage and support. The effectiveness of treatment varies from patient to patient and can be unpredictable.To investigate clinical and paraclinical criteria able to predict responses to combined physical treatment (lymphatic drainage and multilayered support) during hospitalization.A retrospective study was performed in 45 patients admitted for one week's intensive treatment of limb lymphedema in the Lymphology Unit of the Department of Dermatology of the University Hospital of Tours. Lymphoscintigraphy was performed for all patients on admission. Loss of volume in affected limbs was studied to evaluate the effectiveness of treatment.Two criteria were predictive of resistance to combined treatment, i.e. venous insufficiency and continuing lymph node evidence of scintigraphic activity four hours after lymphoscintigraphy. The two factors were significantly related.Failure of combined physical treatment for lymphedema appears to be related to venous insufficiency. It is therefore essential to investigate and treat venous insufficiency, particularly in patients with continuing evidence of scintigraphic activity in lymph nodes.

Since benzodiazepines (BZD) are largely prescribed during pregnancy, the Regional Pharmacovigilance Center (RPVC) of Tours regularly deals with questions about the risk of their administration to pregnant women and the monitoring of the newborns exposed in utero to these drugs. During the third trimester, we recommend a switch in the BZD maternal treatment to oxazepam, which has an intermediary half-life and no active metabolite, and a hospitalisation of the newborn in order to monitor his respiratory rate. The purpose of our study was to evaluate the neonatal consequences of BZD used at the end of pregnancy and to analysed if our recommendations were taken into account and if they were appropriate.From 1989 to the end of 2002, we studied the files in which women had received a BZD during the 30 days prior to delivery. We analysed maternal treatments, the outcome of pregnancy and the development of the newborn, the therapeutically attitude recommended and whether or not it was respected.A total of 73 files were selected. Seventy neonates were born to 73 women. The newborns were hospitalised (73%) and they developed adverse reactions possibly related to the use of BZD (51,5%) : an impregnation syndrome (42%) characterized by hypotonia and hypoventilation, and a withdrawal syndrome (20%) with tremulations as the main symptom.Considering the most frequent neonatal manifestations, hospitalization and the respiratory monitoring recommended by the RPVC seemed adequate. However, the switch to oxazepam was seldom done and its advantages should be pointed out.

To analyse neonatal effects after in utero selective serotonin reuptake inhibitors exposure and the pertinence of recommendations delivered by our team.We report a series of 27 pregnancies exposed late in pregnancy including the period of delivery, to the Selective Serotonin Reuptake Inhibitors (SSRI) and having been the subject of a call to the Regional Center of Pharmacovigilance of Tours (CRPV).Twenty-seven children were born without malformation. Twelve children were hospitalized because of prematurity (two), exposure to other drugs imposing particular surveillance (eight) or in view of abnormal neonatal effects (two). Five newborns (18.5%) of which three had also been exposed to other drugs (benzodiazepine, neuroleptic, H1-antagonist) had presented one or more neonatal adverse effects compatible with the role of the SSRI (irritability, agitation, shivering, hypotonia) but with uncertainty about a clear discrimination between withdrawal syndrome and serotonin impregnation. All the symptoms disappeared spontaneously. One of the five children had a described in treated adults but two neonatal observations were published. No child had hemorrhagic symptoms as described in treated adults despite the fact that two neonatal observations were reported.This study confirms the relative benignity of SSRI exposure during late pregnancy. Our recommendations for monitoring the newborns during their stay in maternity wards were well respected. The risk of hemorrhagic symptoms or hyponatremia, not well known by pediatricians, deserves to be recalled to medical teams who take in charge newborns exposed to SSRI.

To analyse neonatal effects after in utero betablockers exposure and the pertinence of recommendations delivered by our team.We report 44 pregnancies exposed to betablockers during the late pregnancy including the period of delivery about which the Regional Pharmacovigilance Center of Tours (CRPV) was questionned.Among the 39 children for whom we know the follow up, 22 had neonatal adverse effects of which 19 could be explained by in utero exposure to betablockers i.e. an hypoglycaemia (11 times), a bradycardia (six times), a bradycardia and hypoglycemia (one time) and an hypotension (one time). A drug-related effect was retained for eleven newborns (27%) and another etiology could be evoked in the eight others. The risk of neonatal adverse effects seems to increase in newborns exposed to labetalol (5/11), to betaxolol (1/2) or to propranolol (2/6) or when the dose is high. The eight newborns who had intrauterine growth retardation were generally more often exposed to atenolol than eutrophic newborns. Four babies had malformations.Our recommendation was an hospitalization 44 times (100%) to monitor heart rate, blood pressure and glycemia. When the follow-up is known, hospitalization was performed in 88% of the cases. Glycemia, heart rate and blood pressure were monitored in all the hospitalized children and in three of the five not hospitalized children. Our recommendation seems particularly justified with regard to hypoglycemia which is often asymptomatic but whose consequences can be severe. Atenolol often provider of intrauterine growth retardation and labetalol more often at the origin of neonatal adverse effects are probably to avoid during pregnancy.

The aim of this study was to assess the usefulness of color Doppler energy in the preoperative diagnosis of ovarian malignancy using multivariate logistic regression analysis.One hundred and thirty adnexal masses were studied with transvaginal B-mode, color energy, and pulsed Doppler ultrasonography before surgery in order to develop a model that could be used to determine malignancy. Each ultrasonographic variable (tumor size, wall thickness, septal structure, echogenicity, papillary projection, density (solid or not)) was included individually or combined together as part of the Sassone ultrasound score. Intratumoral blood flow velocity waveforms were obtained to determine pulsatility index and resistance index and a more subjective parameter, location of tumor vascularity, was also assessed. Menopausal status and serum CA 125 levels were also entered as categorical variables. Sonographic parameters were entered alone, then associated with menopausal status and CA 125 serum levels, and finally with Doppler energy measurements. Our model was then validated in a group of 68 adnexal masses and compared to the model of Alcazar.Eighteen adnexal masses (13.8%) were malignant or of low malignant potential. Multivariate analysis showed that papillary projection of the tumor wall, cyst with solid parts, resistance index with a cut-off value of 0.53, CA 125, and central blood flow location, were the only factors to be independent predictors of malignancy. Menopausal status was not an independent factor. For the final model including the Doppler energy parameter the best sensitivity and specificity were 83% and 93%, respectively, at a cut-off value of 10% probability of malignancy compared to 83% and 87% for the morphological variables alone. Validation of the model showed its diagnostic performance to be as good as that reported in the original population and better than the model of Alcazar.Sonographic analysis of adnexal masses including color Doppler energy shows the best predictive properties according to histological diagnosis, and improves preoperative diagnosis of malignancy.

Reading a clinical trial must not be limited to examining the result. It is essential to analyze the study methodology, the only guarantee of valid results. Among the standard methodological elements required for clinical trials, the notions of a controlled, randomized, double-blind study are of utmost importance. The results should also be interpreted in light of the main outcome, as well as the selection criteria used to establish the study groups. Finally, the results should be interpreted in terms of their clinical relevance, which is not necessarily implied by statistical significance.

The aim of this retrospective study was to evaluate the 38 month-results of laparoscopic fundoplication for gastroesophageal reflux disease (GERD).Two hundred forty three consecutive patients were operated laparoscopically. The surgical procedures were complete fundoplication with division of short vessels (Nissen: 80 patients), without division of short vessels (Nissen-Rossetti: 68 patients) or partial fundoplication of 270 degrees (Toupet: 95 patients). The mean follow-up was 38 months. Functional results were evaluated in 225 patients (92.5%) using a questionnaire with visual analog scales.The morbidity rate was 5%, higher after Nissen procedure (6.5%). With a follow-up of 3 months: a dysphagia coted 5/10, a gas bloat syndrome coted 4/10 and colon distension present in 61% of patients, were significantly more frequent after Nissen procedure. GERD recurred early in 4.5% of patients. With a follow-up of 38 months: dysphagia rate (coted 1/10) was significantly higher after Nissen. Dysphagia still persisted in 8 patients (9%) after Nissen. Colon distension and flatulence were more present after Nissen fundoplication. GERD recurrence rate was 12%. Pyrosis was significantly higher after Toupet fundoplication. Continuous medical treatment was necessary in 19 patients (8%). The satisfaction of patients was coted 7.5/10 without difference between to the three types of fundoplication.The total laparoscopic fundoplication for GERD seems to be a safe and efficient operation. This procedure proves to be more effective than partial fundoplicature but with a grater morbidity. Whatever the type of fundoplicature, the satisfaction of patients was good.

To assess the reliability of body temperature estimated by infrared tympanic thermometry.Prospective study.71 patients in a neurosurgical intensive care unit. 393 triplets of measurements were performed: right ear, left ear and right ear again.Limits of agreements are [-1, +1 degree C] between both ears, and [-0.6, +0.7 degree C] for two consecutive measurements in the right ear. The Bland and Altman diagram show that most of the points responsible for the lack of accuracy are between 36 and 37 degrees C.These values give an estimation of the technique's accuracy. In our point of view, such a reproducibility is adequate for daily clinical practice. The accuracy of infrared tympanic thermometry with the First Temp Genius seems reasonable for the clinical practice when the temperature is over 37 degrees C.

Interpreting changes in continuous structural outcome measures is a common problem in clinical research and in daily practice. We propose a method for estimating whether difference observed between two successive measures in an individual constitutes a statistically relevant change or a change induced by variability. This statistically relevant change is based on an analysis of reproducibility. The continuous structural outcome measure investigated as an example was joint space width (JSW) measurement on standard X-rays, which is known to be the primary end-point for assessing structural osteoarthritis progression. The results of the present study demonstrate that cutoffs are closely dependent on all sources of variabilities in JSW measurement such as joint positioning, radiographic procedure, and the measurement process itself. Therefore, we suggest to determine cutoffs for each study using a representative sample of the population studied and using the procedures and methods of measurement of the specific study. This approach may easily be extended to other continuous structural outcome measures.