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Introduction: COVERAGE is a randomized controlled triaĺ evaluating the safety and efficacy of experimental treatments delivered at home at an early stage, to reduce clinical worsening in at-risk patients with COVID-19, with the intervention of mobile medical teams. Between April and September 2020, due to limited access to PCR tests, these teams offered home testing to patients aged 60 years and over in Gironde. Objectives: to assess the satisfaction of people aged ≥ 60 years screened by RT-PCR at home. A secondary objective was to assess their willingness to participate in the trial and the associated factors. Methods: single-centre cross-sectional survey, conducted by phone between November 3rd and December 10th 2020. Results: 48 persons were interviewed. More than 90% of patients were satisfied with the screening visit at home. 29% of people would not have beeń willing to participate in the trial. This reluctance was associated with lack of knowledge about RCTs (p=0.014), perception of randomization (p

Introduction. Le reflux gastro-œsophagien (RGO), par sa prévalence élevée et son évolution chronique, génère un recours fréquent aux soins primaires. Aucune méta-analyse n’a évalué jusqu’à présent l’efficacité et la sécurité des antiacides chez des patients atteints de RGO. L’objectif de cette étude était d’évaluer la balance bénéfices-risques et le niveau de preuve des antiacides d’alginate de sodium (AlgNa), dans le RGO, sur des critères cliniques directs.Méthodes. Revue systématique des essais cliniques contrôlés randomisés (ECR) évaluant les antiacides d’AlgNa en interrogeant les bases Medline, Cochrane et Embase. Lorsque les données le permettaient, une méta-analyse a été réalisée. Le critère de jugement principal était l’efficacité (évolution symptomatologique perçue ou sur le score du Reflux Disease Questionnaire ou de ses sous-dimensions) et de la sécurité des antiacides. Les critères de jugement secondaires étaient l’évolution de chaque symptôme clinique du RGO, de la sévérité, du délai d’amélioration et de la variation du reflux pH-métrique.Résultats. Nous avons inclus 15 ECR, publiés entre 1974 et 2019, parmi les 258 identifiés, représentants 861 patients participants. La durée de suivi variait d’un jour à 12 semaines. Douze incluaient des adultes, trois des enfants ou nourrissons. L’amélioration des symptômes perçus par le patient, le nombre de reflux pH-métrique et la durée avec un pH < 4 étaient en faveur des antiacides d’AlgNa (respectivement RR=1,57 IC95=[1,38–1,78] ; SMD=-1,46 IC95=[-2,21 – -0,71] ; SMD=-1,19 IC95=[-2,09 – -0,29]). Les effets indésirables déclarés étaient principalement des troubles digestifs sans différence statistiquement significative entre les deux groupes. La qualité des preuves, d’après GRADE, était considérée comme très faible, tant pour l'efficacité que la sécurité.Conclusion. L’utilisation d’antiacides à base d’alginate de sodium chez des patients atteints de RGO semble améliorer les symptômes perçus par le patient, avec un profil de sécurité restant à établir.

This systematic review aims to compare conventional corticotomy with minimally-invasive protocols (MIP). Electronic database, in MEDLINE and CENTRAL, and hand search were performed. Randomized controlled trials (RCTs) and randomized split-mouth designed studies (RSMSs) were selected for inclusion, reporting either the use of a corticotomy procedure or a MIP. The main outcomes were the rate/velocity of tooth movement, type of tooth movement observed, loss of anchorage, periodontal indexes, inflammatory mediators, root resorption, patient's pain experience, impact on the quality of life, and satisfaction. Twenty-two papers were included for the qualitative synthesis, from which ten RCTs and twelve RSMSs. Eighteen of them compared a conventional orthodontic treatment without and with a surgical adjunctive procedure, two with conventional corticotomy and sixteen with a MIP (piezocision, micro-osteoperforations (MOPs) or interseptal bone reduction). Four trials compared a surgical procedure to another one. Corticotomy, piezocision and MOPs are likely to accelerate tooth movement, in decreasing order. Pain is reported to be higher in experimental groups only on the first day after surgery. Patient satisfaction is high after surgical procedures. Loss of anchorage, periodontal indexes, or root resorption occurrence show no differences between groups. Corticotomy stands as the gold-standard procedure for surgically-assisted orthodontics, but piezocision appears as a good compromise solution as well as MOPs, in a lesser extent. MIP are known to accelerate tooth movement only during the first three months.

Le traumatisme craniocérébral léger (TCCL) s'accompagne d'une constellation de symptômes de nature variée, appelés symptômes post-commotionnels (SPC). La majorité des patients se rétablissent complètement et rapidement, à savoir dans le mois qui suit l'accident. Cependant, 10 à 20 % d'entre eux présentent un rétablissement prolongé avec des SPC persistants (SPCP), lesquels entravent la qualité de vie, l'intégration à la communauté et le retour aux activités. Pour la minorité de patients présentant des SPCP, il est donc nécessaire d'intervenir au-delà de la psychoéducation préventive aiguë recommandée par les guides de pratique. Or, il existe très peu d'interventions visant spécifiquement à outiller ces patients afin de diminuer les SPC et ainsi, accélérer le rétablissement. En effet, à l’heure actuelle, les interventions psychologiques et psychoéducatives développées spécifiquement pour la phase post-aiguë, qui prend place entre les phases aiguë (0-1 mois après le TCCL) et chronique (> 6 mois post-accident), sont particulièrement rares. Les quelques études existantes plaident en faveur d'une approche brève de quelques séances de psychoéducation et/ou de soutien. Cependant, il s'agit de données préliminaires et de nombreuses inconnues subsistent encore quant au format idéal (ex. : en personne vs par téléphone, individuel vs en groupe, nombre de séances, contenu précis). En outre, la pauvre qualité méthodologique des études complique significativement les interprétations possibles à ce sujet (ex. : absence de groupe contrôle, groupes non randomisés). L'objectif principal de cette thèse était donc de développer une nouvelle intervention de psychoéducation et de soutien destinée aux personnes en phase post-aiguë du rétablissement post-TCCL, et d’explorer sa faisabilité ainsi que son efficacité. L'objectif du premier article de la thèse (Chapitre 2) était de remédier à la pauvreté de la littérature en ce qui a trait, d'une part, à la description des protocoles d'intervention de psychoéducation et, d'autre part, relativement à leurs assises théoriques. Il avait donc pour objectif de présenter la démarche théorique et méthodologique associée au développement de l'intervention SAAM, un programme de quatre séances d'intervention individuelles d’une heure, données en personne, et visant chacune un type de SPC fréquent en phase post-aiguë : Sommeil/fatigue, Attention, Anxiété/humeur, Mémoire/organisation. Le programme offre de l'information au patient, le rassure sur son rétablissement et l'accompagne vers un retour graduel aux activités, en l'outillant à cet effet. Cette approche est ancrée dans un modèle théorique intégratif de persistance des symptômes (Hou et al., 2012), dont les composantes sont expliquées dans l'article. Celui-ci permet non seulement de mieux saisir les fondements théoriques associés à la création du nouvel outil d'intervention, mais en dévoile également son contenu. Il met donc en lumière une démarche qui s'inscrit parfaitement dans un effort de clarification et de transparence, essentiel au progrès de la recherche interventionnelle. Plus largement, ce travail permettra de faciliter la réplication scientifique et de soutenir le transfert de connaissances vers les milieux cliniques. Le deuxième article de la thèse (Chapitre 3) avait pour objectif d'estimer la faisabilité et d’explorer l'effet de l'intervention SAAM auprès de patients symptomatiques en phase post-aiguë de leur rétablissement. Une étude pilote d’essai contrôlé randomisé à deux groupes parallèles (expérimental, n = 13 et liste d'attente, n = 12) a permis de démontrer la faisabilité et la tolérance à l’intervention SAAM. Les données préliminaires suggèrent un effet de l’intervention sur la diminution des SPC en général. En ce qui a trait plus directement aux SPC visés par l'intervention SAAM, une amélioration des plaintes reliées aux symptômes dépressifs, à la fatigue et à la perception de la qualité du sommeil a été mise en évidence à la suite de l'intervention. Cependant, l’étude n'a pas montré d’effet bénéfique du programme SAAM en termes de plaintes somatiques ni de performance cognitive (attention, mémoire). De plus, aucun effet n'a été observé sur le plan de l'intégration à la communauté. Des analyses supplémentaires (Chapitre 4) suggèrent que l'intervention SAAM pourrait restaurer le besoin de compétence, un besoin psychologique fondamental intimement relié au bien-être des individus. Enfin, des analyses supplémentaires portant sur un questionnaire de satisfaction face à l'intervention confirment un haut taux de satisfaction des participants face à l'intervention, ce qui est de bon augure pour l'implémentation en milieux cliniques. Par son aspect novateur, son format standardisé bref et facilement accessible, ainsi que ses effets objectivés sur plusieurs SPCP particulièrement invalidants à la suite du TCCL, le programme d'intervention SAAM est prometteur. La portée clinique de cette thèse est donc particulièrement importante et est discutée, avec ses limites et les avenues de recherche futures, dans le dernier chapitre. Ces résultats soulignent l'importance de poursuivre la recherche dans le champ des interventions post-TCCL, afin d’outiller les cliniciens et d’offrir les meilleurs soins possibles aux patients ayant subi un TCCL., Mild traumatic brain injury (mTBI) is accompanied by a constellation of manifestations known as post-concussive symptoms (PCS). The majority of patients recover completely and promptly, i.e. within one month of injury. However, 10-20 % experience prolonged recovery with persistent PCS (PPCS), which impact quality of life, community integration and resumption of activities. For the minority of patients who present PPCS, it is necessary to provide them with resources beyond the acute preventive psychoeducation recommended by practice guidelines. However, there are very few interventions available to reduce PCS and thus enhance recovery. To date, psychological and psychoeducational interventions developed specifically for the post-acute phase, which takes place between the acute (0-1 month after mTBI) and the chronic phase (> 6 months post-injury), are particularly rare. The scarce existing evidence suggests that the optimal intervention should be brief, including a few sessions of psychoeducation and/or counseling. Nevertheless, these are preliminary data and many open questions remain regarding the optimal format (e.g., in person vs. on the phone, individual vs. group, number of sessions, specific content). Moreover, the poor methodological quality of previous intervention studies significantly complicate interpretations (e.g., absence of control groups, non-randomized groups). The main objective of this thesis was therefore to develop and explore the feasibility and treatment effect of a novel psychoeducational and counseling intervention program for the post-acute phase after mTBI. The objective of the first article of the thesis (Chapter 2) was to overcome the paucity of work describing psychoeducational intervention protocols and their theoretical underpinnings. The article therefore aimed to present the theoretical and methodological approach associated with the development of the SAAM intervention. SAAM is a program including four 1-hour individual intervention sessions given in person, each targeting a type of common PCS in the post-acute phase: Sleep/fatigue, Attention, Anxiety/mood, Memory/organization. It informs the patient, provides reassurance about recovery, and supports the gradual resumption of activities by giving the patient the tools to do so. This approach is anchored in an integrative theoretical model of symptom persistence (Hou et al., 2012), the components of which are explained in the article. The latter provides a better understanding of the theoretical rationale behind the development of the SAAM intervention, and includes a detailed description of the protocol. The article is meant to align with efforts to clarify the theoretical underpinnings of the intervention program and enhance transparency in scientific reporting, an essential step in the advancement of interventional research. More broadly, this work will facilitate scientific replication and knowledge transfer in clinical settings. The second article (Chapter 3) aimed to estimate feasibility and explore the treatment effect of the SAAM intervention in symptomatic patients during the post-acute phase. A pilot randomized controlled trial with two parallel groups (experimental, n = 13 and wait list, n = 12) demonstrated the feasibility and tolerability of the intervention. Preliminary data suggest an effect of the intervention in reducing overall PCS. More specifically, regarding the PCS targeted by the SAAM intervention, an improvement in complaints related to depressive symptoms, fatigue, and sleep quality perception was observed post-intervention. However, the intervention failed to show a positive effect in addressing anxiety or somatic complaints, nor was it significantly impactful in improving cognitive performance (attention, memory). No effect was observed in terms of community integration either. Nonetheless, additional analyses (Chapter 4) suggest that SAAM intervention might restore the need for competence, a basic psychological need closely related to the individual's well-being. Finally, additional analyses pertaining to an intervention satisfaction questionnaire confirm that participants report a high level of satisfaction with the intervention, which bodes well for clinical implementation. The SAAM intervention holds promise because of its innovative aspect, its brief and easily accessible standardized format, and its demonstrated effects on several disabling PCS. The clinical significance of this thesis is notable and is discussed, along with study limitations and future avenues of research, in the final chapter. This work emphasizes the importance of pursuing research efforts in the field of post-mTBI interventions, in order to provide clinicians with the tools they need to offer the best possible care to patients who have sustained mTBI.

Background: Severe postoperative pain remains a major problem that is seen in 20 to 40% of patients. The Analgesia/Nociception Index (ANI) is a 0-100 index reflecting the relative parasympathetic activity allowing for intraoperative analgesia monitoring. We have previously shown that an ANI value

Spinal fusion surgery induces moderate to severe postoperative painrelief. The lumbar Erector Spinae Plane Block (ESPB) is a recent block. Its diffusion and efficacy remain debated. After anatomical study (dye diffusion), this prospective, randomized, double-blinded, versus placebo, clinical trial evaluated the efficacy of lumbar ESPB on postoperative morphine consumption. Methods: for the anatomical study, three cadavers were injected with color solution using ultrasound approach at the level L3 (20 mL each side). Dissections were performed to describe metameric and spinal diffusion. After CPP approval (Clinical trial: NCT 04473508), 50 patients were randomized from November 2019 to July 2021: saline vs ropivacaïne groups. After standardized general anesthesia, patients were placed in ventral position and a lumbar ESPB was performed under ultrasound approach at L3 (left and right sides). A total dose of 40 mL of ropivacaïne 3.75 mg/mL or saline solution were injected. Similar IV multimodal analgesia was used for both groups: paracetamol (1g), ketoprofene (100mg), nefopam (20mg), ketamine (0.5mg/kg), dexamethasone (8mg). Morphine rescue titration in PACU (VAS pain score >3 on 10) followed by IV PCA morphine (24h) was given to patients. Patients were evaluated (pain scores, side effects) over time until upon discharge and at 3 months (DN4, EQ5SL and VAS pain score). Primary endpoint was morphine consumption at 24H. Results: for anatomical study, we noted a coloration of the dorsal ramus of the spinal nerves at the level of injection. A caudal and rostral diffusion (2-3 metameres) was observed without diffusion in the spinal space. For clinical study, no difference was observed between groups at baseline. Morphine consumption was reduced in Ropivacaïne group, 7.3mg [3.7-19], with no statistical difference with Saline group, 12.5mg [3.5-26] p=0.51 (mean reduction IC (95%): 5mg). In PACU, similar VAS pain scores and morphine titration were recorded between groups. Over time, both groups presented similar VAS pain scores, adverse events (NVPO, urinary retention and confusion), surgical complication and length of stay. At 3 months, VAS pain score at rest and mobilization, DN4 and EQ5D-5L score were not difference between groups. Conclusion: in this study, using multimodal analgesia, lumbar ESPB reduced morphine consumption after spinal fusion surgery without clinical or statistical benefit compared with the saline group, whereas the anatomic study showed the potential benefit of its wide distribution.; La chirurgie rachidienne lombaire induit des douleurs postopératoires modérée à sévère. Le bloc des érecteurs du rachis (ESPB) lombaire est un bloc récent. Sa diffusion et son efficacité restent débattues. Après une étude anatomique (par injection de colorant), cet essai clinique prospectif, randomisé, en double aveugle, versus placebo, a évalué l'efficacité de l'ESPB lombaire sur la consommation postopératoire de morphine. Méthodes : pour l'étude anatomique, trois cadavres ont été injectés avec une solution colorée par une méthode échoguidée au niveau L3 (20 ml de chaque côté). Des dissections ont été réalisées pour décrire la diffusion métamérique et spinale. Après approbation du CPP (essai clinique : NCT 04473508), 50 patients ont été randomisés de novembre 2019 à juillet 2021 : groupes solution salée isotonique (SSI) vs ropivacaïne. Après une anesthésie générale standardisée, les patients ont été placés en décubitus ventral et un ESPB lombaire échoguidé a été réalisé en L3 (côtés gauche et droit). Une dose totale de 40 ml de Ropivacaïne 3,75 mg/mL ou de SSI a été injectée. Une analgésie multimodale IV similaire a été utilisée pour les deux groupes : paracétamol (1g), kétoprofène (100mg), néfopam (20mg), kétamine (0,5mg/kg), dexaméthasone (8mg). Les patients ont reçu une titration de secours de morphine en SSPI (score de douleur EVA>3 sur 10) suivie d'une morphine PCA IV (24h). Les patients ont été évalués (scores de douleur, effets secondaires) au fil du temps jusqu'à la sortie et à 3 mois (DN4, EQ5SL et EVA). Le critère d'évaluation principal était la consommation de morphine à 24H. Résultats : pour l'étude anatomique, nous avons noté une coloration du rameau dorsal des nerfs spinaux au niveau de l'injection. Une diffusion caudale et rostrale (2-3 métamères) a été observée sans diffusion dans l'espace péri-médullaire. Pour l'étude clinique, aucune différence n'a été observée entre les groupes au départ. La consommation de morphine a été réduite dans le groupe Ropivacaïne, 7,3mg [3,7-19], sans différence statistique avec le groupe SSI, 12,5mg [3,5-26] p=0,51 (réduction moyenne : 5mg). En SSPI, des scores de douleur EVA et une titration de morphine similaires ont été enregistrés entre les groupes. Au fil du temps, les deux groupes ont présenté des scores de douleur EVA, des événements indésirables (NVPO, rétention urinaire et confusion), des complications chirurgicales et une durée de séjour similaires. A 3 mois, le score de douleur EVA au repos et à la mobilisation, les scores DN4 et EQ5D-5L n'étaient pas différents entre les groupes. Conclusion : dans cette étude, en utilisant l'analgésie multimodale, l'ESPB lombaire a réduit la consommation de morphine après une chirurgie rachidienne sans bénéfice clinique ou statistique par rapport au groupe SSI, alors que l'étude anatomique avait montré un bénéfice potentiel de sa large diffusion.

Background Bayesian methods, with the predictive probability (PredP), allow multiple interim analyses with interim posterior probability (PostP) computation, without the need to correct for multiple looks at the data. The objective of this paper was to illustrate the use of PredP by simulating a sequential analysis of a clinical trial. Methods We used data from the Laryngobloc trial that planned to include 480 patients to demonstrate the equivalence of success between a laryngoscopy performed with the Laryngobloc® device and a control device. A crossover Bayesian design was used. The success rates of the two laryngoscopy devices were compared. Interim analyses, computed from random numbers of subjects, were simulated. Results The PostP of equivalence rapidly reached the predefined bound of 0.95. The PredP computed with an equivalence margin of 10% reached the efficacy bound between 352 and 409 of the 480 included patients. If a frequentist analysis had been made on the basis of 217 out of 480 subjects, the study would have been prematurely stopped for equivalence. The PredP indicated that this result was nonetheless unstable and that the equivalence was, thus far, not guaranteed. Conclusions Based on these interim analyses, we can conclude with a sufficiently high probability that the equivalence would have been met on the primary outcome before the predetermined end of this particular trial. If a Bayesian approach using PredP had been used, it would have allowed an early termination of the trial by reducing the calculated sample size by 15–20%.

Introduction : La majorité des enfants ayant l’anémie falciforme (AF) sont déficients en vitamine D. Cette déficience causerait ou exacerberait possiblement les complications de l’AF telles que les crises de douleur et les complications osseuses. Nous avons récemment publié que près de 70% des enfants suivis à notre clinique d’AF étaient déficients en vitamine D (250 nmol/L) n’a eu lieu durant l’étude, mais les enfants du groupe bolus ont expérimenté plus de symptômes gastro-intestinaux dans le premier mois suivant l’ingestion du bolus, comparativement au groupe placebo. Le décompte de réticulocytes était plus faible à la fin de l’étude pour les enfants du groupe bolus. Aucun autre effet clinique de l’intervention n’a été observé. Conclusion : L’utilisation d’un bolus de vitamine D à haute dose combiné à une supplémentation quotidienne en vitamine D chez des enfants ayant l’AF était plus efficace à élever les taux de 25(OH)D à des taux supérieurs à 75 nmol/L que la supplémentation quotidienne seule. Des études multicentriques à plus grande échelle et de plus longue durée sont nécessaires afin d’évaluer les effets cliniques d’une telle supplémentation., Background: Most children with sickle cell disease (SCD) are vitamin D deficient. This deficiency could possibly cause or exacerbate SCD complications such as pain crisis and bone complications. We previously showed that nearly 70% of children followed in our SCD Clinic were vitamin D deficient (250 nmol/L). However compared to the placebo group, more children in the bolus group experienced gastro-intestinal symptoms within the first month following the vitamin D bolus. As for the hematology parameters, only a slight difference in reticulocytes counts was observed with lower reticulocytes count the end of the study in children from the bolus group. No other clinical effects of the intervention were observed. Conclusions: High-dose vitamin D bolus combined to daily supplementation in children with SCD is more efficient than daily supplementation alone to raise 25(OH)D levels ≥75 nmol/L. Large-scale multicenter studies of longer duration are needed to assess whether this intervention can improve clinical outcomes of children with SCD.

In France, ‘‘Missions locales’’ are public assistance sites for young people aged 16–25 years who are not in employment, in education or training (NEET). More than 1.4 million NEETs – i.e. ten to fifteen percent of the youth – participate in these sites each year. The main goal of ‘‘Missions locales’’ is to enhance both professional and social insertion – since education, employment, housing and health issues are inseperable. Several international studies have shown that NEETs have poor health status. In France, there were very few quantitative studies on this topic until the PRESAJE survey in 2011, which took place in five ‘’Missions locales’’. Based on data from this survey, we showed that the overall social profile of the NEET population was diverse, with more difficult living conditions than in the general population. Health-related vulnerability factors identified were: low education level; social isolation; insufficient health insurance; low self-esteem; and, low level of trust in institutions. Some of their health indicators were remarkably poor compared to other youth of the same age: more often, they had chronic disease, were overweight or obese, and their mental health status was poor. Despite their poor health, NEETs had less access to health care than the youth of the same age in the general population. This work also has highlighted the importance of having health sites inside ‘‘Missions locales’’. Social and preventive medicine consultations that are fully integrated into the social services for NEETs have an impact on their access to training (and we hope subsequently on their employment), and contribute to changing some of their health-related behaviours.; En France, les Missions locales (ML) accueillent les jeunes en insertion socio-professionnelle – qui ne sont ni en emploi, ni en formation, ni en études – âgés de 16 à 25 ans, soit 10 à 15% des jeunes de cette tranche d’âge. L’objectif des ML est de permettre à ces jeunes de surmonter les difficultés qui font obstacle à leur insertion dans leur transition entre l’école et la vie active – les problématiques de formation, d’emploi, de logement, de santé étant interdépendantes. En France, les études sur la santé des jeunes en insertion restaient exceptionnelles avant la réalisation du projet Presaje conduite dans cinq ML en 2011. Les données de ce travail ont montré que, malgré une certaine hétérogénéité des parcours, ce public nombreux et vulnérable accumule des facteurs de risque vis-à-vis de la santé : peu ou pas diplômé, isolé socialement, ayant une couverture sociale insuffisante, et une faible confiance en soi et dans les institutions. Les jeunes en insertion sont, en effet, en moins bonne santé que les autres jeunes du même âge. Ils sont plus nombreux à présenter une maladie chronique, un mal-être psychique, une obésité ou un surpoids. Malgré des besoins en santé importants, ils ont moins souvent recours aux soins que les autres jeunes en population générale. Cette thèse a aussi permis de souligner l’importance des « points santé » au sein même des ML. La proposition systématique d’une consultation de médecine sociale et préventive auprès de ce public – en plus d’améliorer certains comportements et connaissances en santé – permet d’augmenter leur nombre d’entrées en mesure (participation à une formation ou à un atelier) et nous l’espérons in fine leur taux d’emploi.

In France, ‘‘Missions locales’’ are public assistance sites for young people aged 16–25 years who are not in employment, in education or training (NEET). More than 1.4 million NEETs – i.e. ten to fifteen percent of the youth – participate in these sites each year. The main goal of ‘‘Missions locales’’ is to enhance both professional and social insertion – since education, employment, housing and health issues are inseperable. Several international studies have shown that NEETs have poor health status. In France, there were very few quantitative studies on this topic until the PRESAJE survey in 2011, which took place in five ‘’Missions locales’’. Based on data from this survey, we showed that the overall social profile of the NEET population was diverse, with more difficult living conditions than in the general population. Health-related vulnerability factors identified were: low education level; social isolation; insufficient health insurance; low self-esteem; and, low level of trust in institutions. Some of their health indicators were remarkably poor compared to other youth of the same age: more often, they had chronic disease, were overweight or obese, and their mental health status was poor. Despite their poor health, NEETs had less access to health care than the youth of the same age in the general population. This work also has highlighted the importance of having health sites inside ‘‘Missions locales’’. Social and preventive medicine consultations that are fully integrated into the social services for NEETs have an impact on their access to training (and we hope subsequently on their employment), and contribute to changing some of their health-related behaviours., En France, les Missions locales (ML) accueillent les jeunes en insertion socio-professionnelle – qui ne sont ni en emploi, ni en formation, ni en études – âgés de 16 à 25 ans, soit 10 à 15% des jeunes de cette tranche d’âge. L’objectif des ML est de permettre à ces jeunes de surmonter les difficultés qui font obstacle à leur insertion dans leur transition entre l’école et la vie active – les problématiques de formation, d’emploi, de logement, de santé étant interdépendantes. En France, les études sur la santé des jeunes en insertion restaient exceptionnelles avant la réalisation du projet Presaje conduite dans cinq ML en 2011. Les données de ce travail ont montré que, malgré une certaine hétérogénéité des parcours, ce public nombreux et vulnérable accumule des facteurs de risque vis-à-vis de la santé : peu ou pas diplômé, isolé socialement, ayant une couverture sociale insuffisante, et une faible confiance en soi et dans les institutions. Les jeunes en insertion sont, en effet, en moins bonne santé que les autres jeunes du même âge. Ils sont plus nombreux à présenter une maladie chronique, un mal-être psychique, une obésité ou un surpoids. Malgré des besoins en santé importants, ils ont moins souvent recours aux soins que les autres jeunes en population générale. Cette thèse a aussi permis de souligner l’importance des « points santé » au sein même des ML. La proposition systématique d’une consultation de médecine sociale et préventive auprès de ce public – en plus d’améliorer certains comportements et connaissances en santé – permet d’augmenter leur nombre d’entrées en mesure (participation à une formation ou à un atelier) et nous l’espérons in fine leur taux d’emploi.

CERVOXY CLIN; International audience

ADHD is a common neurodevelopmental disorder, affecting 3-5% of the children. It refers to a variable cluster of inattention, hyperactivity and impulsivity symptoms. Neurofeedback is a rising approach to manage this disorder. This technique aims to enable subjects to learn how to modulate their own brain activity. This thesis aimed at evaluating the effects of a new Neurofeedback training protocol in children with ADHD, exploiting a neurophysiological marker that has never been used in that context, the cortical P300 response. This event-related potential reflects selective and voluntary attention mechanisms and is affected in ADHD. A randomized controlled trial (RCT) has been performed, which entailed a blind comparison with an active control condition based on gaze and a non-blind comparison with a waiting group. This Neurofeedback training was provided through visual Brain-computer Interface (BCI) games. We first demonstrated that typically developing children can control this kind of BCI. This first study also allowed us to build and evaluate a template, corresponding to the evoked responses of these children, that was later used as the neurophysiological target in the Neurofeedback training group. In a second study, we further showed that typically developing children can control, using the template, the three BCI games designed for the RCT and that these games could indeed be used to train the P300 component. Finally, the first analysis of the clinical data shows very few significant differences between the Neurofeedback group and the two control groups. Indeed, despite some differences in favor of the Neurofeedback or both training groups, most indicators showed an improvement of the symptoms regardless of the group. These results suggest that multiple factors may contribute to those changes including nonspecific ones such as time passing, the gaze training that was required in both active groups, or the care given to all children who followed some training. The unique and rich dataset that was collected in this study will continue to teach us and guide future research. Future studies, with a larger sample size and possibly targeting specific subgroups of ADHD children, will need to be carried out in order to further investigate the specific effect of such BCI training onto dimensions such as attention or impulsivity, Le TDAH est un trouble neurodéveloppemental affectant 3-5% des enfants en âge scolaire. Il se caractérise par une triade de symptômes : l'inattention, l'hyperactivité et l'impulsivité. Le Neurofeedback est une approche de plus en plus utilisée pour la prise en charge de ce trouble. Cette technique vise à permettre aux sujets d'apprendre à moduler leur propre activité cérébrale.Cette thèse a pour objectif d’évaluer un nouvel entraînement de l’attention par Neurofeedback pour les enfants TDAH, en exploitant un marqueur neurophysiologique qui n’a encore jamais été utilisé dans ce contexte, la réponse corticale P300. Ce potentiel évoqué reflète des mécanismes d'attention sélective et volontaire et est affecté dans le TDAH. Un essai randomisé et contrôlé (ERC) qui comprenait une comparaison en aveugle avec un groupe contrôle actif basé sur le regard et une comparaison en non aveugle avec un groupe d’attente a été mise en place. Cet entraînement par Neurofeedback a été réalisé par le biais de jeux pilotés par une Interface-Cerveau Machine (ICM). Nous avons tout d'abord démontré que les enfants neurotypiques étaient capables de contrôler ces ICM. Cette première étude nous a également permis de construire et d'évaluer un modèle, correspondant aux réponses évoquées de ces enfants, qui a été utilisé par la suite comme un objectif neurophysiologique pour les enfants réalisant l'entraînement par Neurofeedback. Lors d’une deuxième étude, nous avons montré que les enfants neurotypiques pouvaient contrôler, à l’aide du modèle, les trois jeux en ICM conçus pour l'ERC et que ces jeux pouvaient être utilisés pour entraîner la composante P300. Finalement, à travers les premières analyses des données cliniques, nous n'avons pu montrer que très peu de différences significatives entre le groupe Neurofeedback et les deux groupes contrôles. En effet, nous avons globalement observé une amélioration des symptômes pour tous les enfants, quel que soit le groupe auquel ils appartenaient. Ces résultats suggèrent que de multiples facteurs peuvent contribuer à ces changements, y compris des facteurs non spécifiques comme le temps qui passe, l'entraînement du regard qui était nécessaire dans les deux groupes actifs, ou l'attention particulière portée aux enfants qui suivent un entraînement. Le jeu de données, unique et riche, qui a été recueilli dans le cadre de cette étude doit encore être exploité pour nous guider dans nos futures recherches. Dans l'avenir, des études portant sur un échantillon plus grand et ciblant des sous-groupes plus homogènes pourraient notamment permettre d'étayer davantage l'effet spécifique d'un tel entraînement sur des dimensions comme l'attention ou l'impulsivité

ADHD is a common neurodevelopmental disorder, affecting 3-5% of the children. It refers to a variable cluster of inattention, hyperactivity and impulsivity symptoms. Neurofeedback is a rising approach to manage this disorder. This technique aims to enable subjects to learn how to modulate their own brain activity. This thesis aimed at evaluating the effects of a new Neurofeedback training protocol in children with ADHD, exploiting a neurophysiological marker that has never been used in that context, the cortical P300 response. This event-related potential reflects selective and voluntary attention mechanisms and is affected in ADHD. A randomized controlled trial (RCT) has been performed, which entailed a blind comparison with an active control condition based on gaze and a non-blind comparison with a waiting group. This Neurofeedback training was provided through visual Brain-computer Interface (BCI) games. We first demonstrated that typically developing children can control this kind of BCI. This first study also allowed us to build and evaluate a template, corresponding to the evoked responses of these children, that was later used as the neurophysiological target in the Neurofeedback training group. In a second study, we further showed that typically developing children can control, using the template, the three BCI games designed for the RCT and that these games could indeed be used to train the P300 component. Finally, the first analysis of the clinical data shows very few significant differences between the Neurofeedback group and the two control groups. Indeed, despite some differences in favor of the Neurofeedback or both training groups, most indicators showed an improvement of the symptoms regardless of the group. These results suggest that multiple factors may contribute to those changes including nonspecific ones such as time passing, the gaze training that was required in both active groups, or the care given to all children who followed some training. The unique and rich dataset that was collected in this study will continue to teach us and guide future research. Future studies, with a larger sample size and possibly targeting specific subgroups of ADHD children, will need to be carried out in order to further investigate the specific effect of such BCI training onto dimensions such as attention or impulsivity; Le TDAH est un trouble neurodéveloppemental affectant 3-5% des enfants en âge scolaire. Il se caractérise par une triade de symptômes : l'inattention, l'hyperactivité et l'impulsivité. Le Neurofeedback est une approche de plus en plus utilisée pour la prise en charge de ce trouble. Cette technique vise à permettre aux sujets d'apprendre à moduler leur propre activité cérébrale.Cette thèse a pour objectif d’évaluer un nouvel entraînement de l’attention par Neurofeedback pour les enfants TDAH, en exploitant un marqueur neurophysiologique qui n’a encore jamais été utilisé dans ce contexte, la réponse corticale P300. Ce potentiel évoqué reflète des mécanismes d'attention sélective et volontaire et est affecté dans le TDAH. Un essai randomisé et contrôlé (ERC) qui comprenait une comparaison en aveugle avec un groupe contrôle actif basé sur le regard et une comparaison en non aveugle avec un groupe d’attente a été mise en place. Cet entraînement par Neurofeedback a été réalisé par le biais de jeux pilotés par une Interface-Cerveau Machine (ICM). Nous avons tout d'abord démontré que les enfants neurotypiques étaient capables de contrôler ces ICM. Cette première étude nous a également permis de construire et d'évaluer un modèle, correspondant aux réponses évoquées de ces enfants, qui a été utilisé par la suite comme un objectif neurophysiologique pour les enfants réalisant l'entraînement par Neurofeedback. Lors d’une deuxième étude, nous avons montré que les enfants neurotypiques pouvaient contrôler, à l’aide du modèle, les trois jeux en ICM conçus pour l'ERC et que ces jeux pouvaient être utilisés pour entraîner la composante P300. Finalement, à travers les premières analyses des données cliniques, nous n'avons pu montrer que très peu de différences significatives entre le groupe Neurofeedback et les deux groupes contrôles. En effet, nous avons globalement observé une amélioration des symptômes pour tous les enfants, quel que soit le groupe auquel ils appartenaient. Ces résultats suggèrent que de multiples facteurs peuvent contribuer à ces changements, y compris des facteurs non spécifiques comme le temps qui passe, l'entraînement du regard qui était nécessaire dans les deux groupes actifs, ou l'attention particulière portée aux enfants qui suivent un entraînement. Le jeu de données, unique et riche, qui a été recueilli dans le cadre de cette étude doit encore être exploité pour nous guider dans nos futures recherches. Dans l'avenir, des études portant sur un échantillon plus grand et ciblant des sous-groupes plus homogènes pourraient notamment permettre d'étayer davantage l'effet spécifique d'un tel entraînement sur des dimensions comme l'attention ou l'impulsivité

Since the beginning of the 2000s, Randomized Controlled Trials (RCTs) have returned to center stage, both in the economics of development and in the evaluation of public policy. Despite the fact that RCT promoters claim a filiation with medicine, these economists seem unfamiliar with the literature around clinical trials. This article aims to overcome this limitation, by comparing the use and the limits of RCTs between medicine and economics. I show that while this method is considered to be the “gold standard” of evidence in medicine, some limits exist and have to be taken into account in economics. I also show how the way in which the problem of external validity is addressed in medicine provides arguments to obtain a more nuanced picture of the interest of RCTs in economics.; Depuis le début des années 2000, les essais randomisés contrôlés ont connu un fulgurant retour sur le devant de la scène académique dans le domaine de l’économie du développement et plus généralement dans celui de l’évaluation des politiques publiques. Alors que ses partisans revendiquent une filiation avec les essais cliniques randomisés en médecine, ces derniers demeurent mal connus par les économistes. Cet article vise à combler ce manque en proposant une comparaison de l’usage et des limites des essais contrôlés randomisés entre la médecine et l’économie. Nous montrons ainsi que si cette méthode est bien souvent placée au sommet de la hiérarchie des preuves en médecine, des voix critiques existent et méritent d’être prises en compte pour penser son application en économie. Nous soulignons également que le traitement du problème de la généralisation des résultats, très bien documenté en médecine, permet de nuancer l’intérêt de la méthode en économie.

Objective: Information on risk levels is an essential part of the prevention of colorectal cancer (CRC). The objective of this article is to describe a tailored intervention carried out to inform the protagonists about the high risk of CRC due to family history and then to understand, through an interdisciplinary analysis, the mechanisms implemented during the intervention.Method: A randomized trial design was applied. The primary outcome was the colonoscopy uptake. The intervention concerned firstly the index patients with CRC or adenoma to advise and accompany them in the transmission of information about the elevated risk for their siblings. The siblings received tailored counselling carried out by a preventive nurse, by telephone then by mail. Epidemiological, linguistic and sociological cross-analyzes were carried out to understand the impact of the intervention.Results: Colonoscopy rate was 56.3% in the intervention group, 35.4% in the control group (P = 0.0027; 304 siblings). The linguistic analysis of recorded nurse’s interventions showed that, following the intervention (N = 59), the prevention themes were better assimilated while they remained vague and questioned in the discourse of the control siblings who had carried out the colonoscopy (N = 8). That was confirmed by the sociological analysis (four families) which also revealed the importance of information received from a health professional and of communication within families.Conclusion: The study showed the impact of transmission of information to convince siblings at high risk of CRC to carry out colonoscopy.

En anesthésie pédiatrique, il est courant d'administrer de hautes fractions inspirées d'oxygène (FiO2), mais les répercussions postopératoires de cette hyperoxygénation sur les fonctions pulmonaires sont incertaines. Dans une étude randomisée contrôlée (n=58), nous avons comparé les modifications physiologiques respiratoires d'enfants exposés à une haute FiO2 (80%) versus basse FiO2 (35%) durant leur anesthésie générale. Nos résultats démontrent que dans le groupe FiO2 80%, le volume pulmonaire en fin d'expiration diminue en post-opératoire immédiat (-12.0 [-18.5 à -5.5]%, p=0.01) et l'hétérogénéité ventilatoire reste augmentée à J1 (6.1 [2.5 à 9.8]%, p=0.02). Nous n'avons pas observé de différence entre les deux groupes dans les mesures de mécanique respiratoire (résistance des voies aériennes, élastance tissulaire), ni dans les critères supplémentaires analysés, tels que les complications respiratoires (hypoxémie, pneumonie), la réduction du risque de nausées et vomissements postopératoires ou la survenue d'infection du site opératoire jusqu'à 30 jours.

International audience; Persistant occiput posterior (OP) positions are the commonest malpresentations of the fetal head during labor and their diagnosis remains challenging. They are associated to prolonged second stage of labor, prolonged expulsive efforts, labor augmentation, cesarean sections and instrumental deliveries. On the maternal side, severe perineal tears, post-partum hemorrhage or chorioamnionitis are more frequent. Currently, prevention of persistent OP positions is based on the maintain of precise maternal positions. Several positions have been evaluated but only lateral position on the same side of the fetal spine has proved its effectiveness. Fetal head rotation can also be achieved with extraction instruments though none has ever been evaluated by a randomized controlled trial. Obstetrical forceps seem more efficient than vacuum but are associated with severe perineal tears. Evaluation of rotation with Thierry's spatulas is scarce. Last, manual rotation is of routine use in many wards. This management is associated with a twofold reduction of operative delivery rate and rare adverse outcomes but has never been evaluated through randomized control trial.; Les variétés postérieures sont les malpositions fœtales les plus fréquentes rencontrées au cours du travail. De diagnostic clinique difficile, elles sont associées à de nombreuses situations dystociques (allongement de la durée du deuxième stade, des efforts expulsifs) qui nécessitent un recours plus fréquent à l’oxytocine, aux accouchements instrumentaux ou par césarienne. Sur le versant maternel, les déchirures périnéales graves et la survenue d’une hémorragie du post partum ou d’une chorioamniotite sont plus fréquentes. Les stratégies de prise en charge proposées reposent actuellement sur le maintien de postures maternelles particulières au cours du travail. Plusieurs postures ont fait l’objet d’essais cliniques randomisés : seule celle consistant à positionner la parturiente en décubitus latéral asymétrique du côté homolatéral au dos fœtal semble prometteuse. La rotation de la tête fœtale peut également être obtenue au moyen d’un instrument d’extraction. Bien qu’aucun n’ait été évalué par un essai clinique randomisé, la rotation par forceps semble plus efficace qu’avec l’utilisation d’une ventouse obstétricale mais associée à des traumatismes périnéaux graves plus fréquents. L’utilisation des spatules, peu évaluée, peut sembler intéressante mais les risques maternels et fœtaux en sont mal appréciés. Enfin, la rotation manuelle consiste à appliquer manuellement un mouvement de rotation afin d’amener la tête en variété antérieure. Bien que très utilisée et pouvant permettre de diviser par deux le recours à un accouchement opératoire, son efficacité n’a pas été confirmée et des essais cliniques randomisés sont en cours

La prévalence des problèmes liés à la pharmacothérapie (PRP) chez les patients atteints d’insuffisance rénale chronique (IRC) est élevée. Cependant, leur sévérité et les interventions des pharmaciens communautaires nécessaires pour les gérer sont peu connues. L’objectif de cette thèse était d’évaluer la sévérité des PRP chez les patients avec IRC et mieux comprendre les facteurs influençant leur gestion par les pharmaciens communautaires. Les objectifs des trois projets composant ce programme de recherche étaient 1) développer et valider une grille d’évaluation de la sévérité des PRP en IRC (PROJET 1) ; 2) évaluer la prévalence des PRP en IRC selon leur sévérité; 3) évaluer les retombées d’un Programme de Formation et de Liaison en néphrologie (ProFiL) sur ces PRP (PROJET 2); et 4) identifier les croyances des pharmaciens communautaires, concernant l’identification et la gestion des PRP (PROJET 3). D’abord, une grille existante pour l’évaluation de la sévérité des PRP en milieu hospitalier a été adaptée au contexte de la pharmacie communautaire et validée par un groupe d’experts. Cette nouvelle grille inclut six niveaux de sévérité (I à VI); avec deux niveaux par catégorie (léger, modéré et sévère). Plus la sévérité d’un PRP est élevée, plus les interventions requises pour le gérer sont importantes. La fiabilité de la grille s’est avérée élevée [coefficients kappa : 0,79 (inter-évaluateur) et 0,85 (test-retest)] et les résultats étaient corrélés avec ceux obtenus sur la base d’un jugement implicite. Ensuite, dans le cadre d’un essai clinique, cette grille a été utilisée pour évaluer la prévalence des PRP et les retombées du programme ProFiL sur la qualité de la pharmacothérapie selon le niveau de sévérité. La prévalence des PRP était de 0,39; 0,55 et 1,04 PRP/patient pour les niveaux I (léger), II (léger), et III (modéré), respectivement. Aucune différence statistiquement significative n’a été observée entre les deux groupes d’étude, bien que dans le groupe ProFiL une réduction de la prévalence des PRP de niveau III ait été observée. Finalement, dans le cadre d’une étude qualitative soutenue par la théorie du comportement planifié, quinze pharmaciens ont rapporté ne pas identifier systématiquement les patients avec IRC. Cependant, ils considèrent que leurs interventions sont bénéfiques pour les patients, le système de santé et eux-mêmes. Ils perçoivent l’approbation des patients et des professionnels de la santé, et considèrent la gestion des PRP comme une composante essentielle de leur rôle professionnel. En général, ils se sentent capables de gérer les PRP en IRC. Toutefois, les barrières organisationnelles perçues empêchent leurs interventions. Cette thèse apporte un éclairage nouveau sur plusieurs enjeux touchant le suivi pharmaceutique des patients souffrant d’IRC en première ligne. Mes travaux auront permis de développer un outil pour mieux apprécier la sévérité des PRP et d’identifier plusieurs avenues possibles pour optimiser la qualité des soins pharmaceutiques. La recherche dans ce domaine demeure essentielle pour faire progresser les pratiques pharmaceutiques de première ligne en néphrologie., The prevalence of drug-related problems (DRPs) in chronic kidney disease (CKD) patients is high. However, little is known about their severity and management by community-pharmacists. The purpose of this doctoral thesis was to evaluate the severity of DRPs in CKD patients and provide a better understanding of the factors influencing DRPs management by community pharmacists. This research program is composed of three projects, which aimed to: 1) develop and validate a list of criteria to evaluate the severity of DRPs in CKD patients from a community pharmacy perspective (PROJECT 1); 2) to describe DRPs prevalence by severity level in CKD patients; 3) to assess the impact of a training-and-communication network program in nephrology (ProFiL) on these DRPs (PROJECT 2); and 4) to identify the beliefs of community pharmacists related to DRPs identification and management. (PROJECT 3). As a first step, the criteria were adapted from an existing tool for the evaluation of DRPs severity in hospital settings and were validated by an expert panel. The new criteria include six levels of severity (I to VI); with two levels per category (mild, moderate and severe). More severe DRPs require more intense pharmaceutical interventions. The criteria were reliable [kappa coefficient: 0.79 (inter-rater) and 0.85 (test-retest)] and results were correlated with those based on clinical judgement. Then, as part of a clinical trial, the criteria were used to evaluate the prevalence of DRPs and the impact of the ProFiL program on the quality of medication use, by severity level. The prevalence of DRPs was equal to 0.39, 0.55 and 1.04 DRP/patient for the level I (mild), II (mild) and III (moderate), respectively. No statistically significant difference was observed between the study groups, although the prevalence of level III DRPs was reduced in the ProFiL group. Finally, in a qualitative study guided by the theory of planned behaviour and conducted among fifteen community pharmacists, participants reported that they do not systematically identify CKD patients. However, they thought that their interventions are beneficial to patients, health-systems, and themselves. They felt their interventions are accepted by patients and health-care providers and thought that DRPs identification and management is an essential component of their professional role. Pharmacists generally felt able to manage DRPs in CKD patients. But they felt that significant organisational barriers that impede their ability to intervene. This thesis brings a new perspective on several issues related to pharmaceutical care for CKD patients. My work resulted in the development of a new tool for the assessment of DRPs severity and allowed for the identification of various avenues to optimise the quality of pharmaceutical care. In this context, pharmacy practice research remains crucial to improve pharmaceutical practices for CKD patients in primary care.

In Canada and elsewhere, the case for hiring internationally educated nurses (IENs) has not been adequately made and guidance for employers is lacking. The Web site Internationally Educated Nurses: An Employer's Guide, launched in 2012, is intended to provide healthcare employers in Ontario with comprehensive information on the hiring and integration of IENs. An evaluation framework and mixed methods design were used to determine the usability of the site in relation to its goal. Convenience sampling was employed to select participants representing specified users (i.e., healthcare employers). Overall evaluation of usability was positive. Participants indicated that it raised their awareness of the advantages of hiring and integrating IENs to address shortages, increase workforce diversity, and provide culturally competent care. Future projects should focus on collaboration with employers to increase the uptake of IENs.Au Canada et ailleurs, les avantages de l'embauche des infirmières et infirmiers diplômés à l'étranger (IIDE) n'ont pas été expliqués adéquatement et les employeurs manquent d'orientation à ce propos. Le site Web Internationally Educated Nurses: An Employer's Guide (Infirmières et infirmiers diplômés à l'étranger: Un guide destiné aux employeurs, en anglais seulement), lancé en juin 2012, vise à fournir aux employeurs dans le domaine des soins de santé de l'Ontario des renseignements complets sur l'embauche et l'intégration des IIDE. À partir d'un cadre d'évaluation et de diverses méthodes, le site Web a été soumis à une analyse afin de déterminer sa facilité d'utilisation en fonction de son objectif. Un groupe de participants représentant des utilisateurs précis (les employeurs dans le domaine de la santé) a été constitué au moyen d'un échantillonnage de commodité. Globalement, le résultat de l'évaluation de la facilité d'utilisation du site Web s'est révélé positif. Les participants ont indiqué que le site avait contribué à mieux les sensibiliser aux avantages et à l'importance de l'embauche des IIDE pour résoudre les problèmes de pénurie, pour accroître la diversité de l'effectif et pour offrir des soins adaptés sur le plan culturel. Les projets futurs devraient être axés sur une collaboration avec les employeurs afin d'accroître l'intégration des IIDE.

The serious consequences of school bullying on children’s physical and mental health call for the implementation of effective intervention programs. The goal of this paper is to present the theoretical background, components and effects of the anti-bullying program KiVa, which was designed in Finland in 2006 at the request and with funding from the Ministry of Education. It is currently used in 90 % of Finnish comprehensive schools and in many countries across the world. KiVa is based on the view that students witnessing bullying play a key role in maintaining or stopping it. Therefore, the program targets all students. In Finland, its effectiveness was first demonstrated by a randomized controlled trial (RCT) and then during its nationwide rollout. KiVa significantly reduces bullying and reinforcement of the bullies’ behavior, and increases empathy for the victims. Furthermore, the program has been found to decrease children’s anxiety and depression, and to improve their school motivation, school achievement, and perception of peers. This paper pays special attention to the factors that mediate and moderate the effectiveness of the program.

Sub-saharan Africa (SSA) is characterized by a high population growth and a significant poverty. In addition, this area deals with a burden of disease due to both traditional infection diseases and the emerging chronic diseases. Randomised controlled trials (RCTs) taking into account the local context are needed to strength health policy and to improve the population health. However, because of constraint research capacities, RCTs performed in SSA must investigate relevant research questions, biases must be avoided in methods, and health interventions evaluated must be reported completely for easing implementation in current clinical practice. Such efforts help to avoid waste of research. Our objectives were to describe the epidemiology of SSA RCTs, and then to evaluate the methodological quality as well as the reporting of evaluated interventions. On the one hand, our works highlighted that SSA RCTs mainly focused on diseases of the highest burden in that area, although they were frequently funded by high-income countries, and most of the corresponding authors were affiliated to those countries. In the other hand, we have shown that methods at high risk of bias can be avoided through simple methodological adjustments of minor cost. Improving the methodological quality of SSA RCTs implies a large dissemination of available methods at low risk of bias and guidelines on the complete reporting of interventions. Furthermore, understanding barriers and facilitators to the uptake of those methods and guidelines is equally required.; L’Afrique sub-saharienne (SSA) se caractérise par une croissance démographique rapide et une pauvreté notoire. Cette région du monde fait face à une charge de morbidité causée à la fois par les maladies infectieuses traditionnelles et par l’émergence des maladies chroniques. Les essais contrôlés randomisés (ECR) prenant en compte le contexte local sont nécessaires pour renforcer les politiques de santé publique et améliorer l’état de santé des populations. Toutefois à cause des capacités limitées de recherche, les ECR conduits en ASS doivent répondre à des questions prioritaires, les biais (erreurs systématiques) doivent être évités dans les méthodes, et les interventions de santé évaluées doivent être décrites de manière pour faciliter leur implémentation dans la pratique clinique courante. Ces mesures permettent d’éviter le « gâchis de la recherche ». Nos objectifs étaient de décrire l’épidémiologie des ECR conduits en ASS, et d’évaluer la qualité méthodologique (risque de biais) ainsi que le « reporting » des interventions évaluées. Nos travaux ont montré d’une part qu’en ASS, les ECR portent fréquemment sur les maladies à forte morbi-mortalité dans cette région ; mais que les financements des recherches effectuées proviennent surtout des pays à haut revenu (Europe occidentale et Amérique du Nord), et que les auteurs correspondants sont majoritairement affiliés aux institutions des pays à haut revenu. D’autre part, nous avons montré que les méthodes à haut risque de biais peuvent être évitées au moyen d’ajustements méthodologiques simples au coût mineur. L’amélioration de la qualité méthodologique des ECR conduits en ASS implique une large diffusion des méthodes à faible risque de biais ainsi que celle des recommandations pour la description complète des interventions. En outre, une compréhension des barrières et des facilitateurs à l’adhérence à ces méthodes et à ces recommandations est également nécessaire.

Screening is essential to controlling the HIV epidemic as it ensures early treatment initiation, which limits morbidity, mortality and secondary transmission. In France, thousands of individuals remain unaware of their HIV status and a quarter of diagnoses occur at a late stage of infection. Nurse participation in HIV screening is widely discussed as a means by which to get a greater number of actors involved. Through a systematic review we suggested that, in countries with concentrated epidemics such as France, the United States and the United Kingdom, nurses could increase the number of screening tests being offered and performed. In these countries, Health authorities have recommended non-targeted systematic HIV screening in non-specialized health care settings. While this recommendation has gradually been questioned due to its limited effectiveness and associated increased workload, the DICI-VIH trial was designed to explore a new targeted method of HIV screening, performed by nurses in the Emergency Departments of the Paris metropolitan area, where HIV prevalence is high. A large-scale trial with a cluster-randomized two-period crossover design showed that this screening strategy is a compelling approach. By limiting the use of resources allocated to screening in Emergency Departments and by targeting a limited number of patients, this strategy is shown to be feasible and effective in identifying individuals who are unaware of their HIV status. It is also associated with limited costs. These results contribute new data to the discussion on how to best adapt HIV screening strategies in contexts where the epidemic is concentrated and to the evaluation of the contribution of the nursing profession to screening programs.; Parce qu’il favorise l’initiation précoce du traitement qui limite la morbi-mortalité et les transmissions secondaires, le dépistage du VIH est essentiel au contrôle de l’épidémie. En France, plusieurs milliers de personnes ignorent encore leur séropositivité et un quart des diagnostics du VIH est tardif. La participation infirmière au dépistage du VIH suscite un vif intérêt car elle permet d’élargir les acteurs impliqués. Nous avons suggéré à partir d’une revue de littérature systématique que, dans les pays à épidémie concentrée du VIH comme la France, les Etats Unis ou le Royaume Uni, les infirmiers pouvaient renforcer l’offre et la réalisation du dépistage du VIH. Dans ces pays, les autorités de santé ont préconisé un dépistage généralisé (non ciblé) du VIH dans les structures de santé non spécialisées. En raison de son efficacité modeste et de la charge de travail associée, cette recommandation a progressivement été remise en cause. L’étude DICI-VIH a été conçue pour explorer un nouveau mode, ciblé, de dépistage du VIH par les infirmiers dans les services d’urgences d’Ile-de-France, une région à forte prévalence. Nous avons montré, à l’aide d’un essai à large échelle randomisé en cluster et crossover en deux périodes, que ce mode de dépistage constitue une approche intéressante. En optimisant l’utilisation des ressources consacrées au dépistage dans les services d’urgences, cette stratégie ciblant un nombre limité de patients est réalisable et efficace pour identifier les personnes qui ne connaitraient pas leur séropositivité et, de plus, son coût est limité. Ces résultats fournissent de nouvelles données permettant l’adaptation des stratégies de dépistage du VIH proposées dans les régions où l’épidémie est concentrée. Ils participent également à l’évaluation de l’implication infirmière dans les programmes de dépistage.

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Neonatal seizure related to stroke is a common diagnostic feature. Their treatment, although widely debated even today must be initiated in case of status epilepticus, clinical seizures of more than 5 minutes duration or short (> 30 secondes) and repeated clinical seizures (2 or more per hour). The treatment of neonatal seizures is a challenge that remains only partially solved. It should take into account the etiology of seizures, type of brain lesions and clinical/electrical response to treatment after the first line treatment. It is based on using a single anti-epileptic at its maximum dosage, and if needed, on the association with another anti-epileptic drug with a different mechanism of action. Phenobarbital remains the most commonly used drug for initial treatment of neonatal seizures and for which the most clinical experience has been accumulated. The lack of randomized controlled trials makes difficult recommendations about the optimal duration of treatment, but most experts agree that once arrested seizures, the duration of treatment should be as short as possible because of its potential risk on the developing brain. Novel neuroprotective strategies for reducing impact of neonatal stroke or promoting brain repair remain for the moment the concept stage, pre-clinical or parcel clinical data.

Made available in DSpace on 2018-12-11T17:33:52Z (GMT). No. of bitstreams: 0 Previous issue date: 2017-09-01 Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Aim The aim of this study was to compare the clinical effects of Metronidazole (MTZ) combined with Amoxicillin (AMX) and repeated applications of antimicrobial photodynamic therapy (aPDT) as an adjuvant for the treatment of chronic periodontitis. Methods A double-blind controlled and randomized clinical trial was conducted in 34 patients. All of the patients were treated with scaling and root planing (SRP) and separated into 2 groups: the MTZ + AMX Group (n = 17), who received SRP and the systemic use of MTZ (400 mg 3 × per day for 7 days) and AMX (500 mg 3 × per day for 7 days), and the aPDT Group (n = 17), who received SRP and three aPDT applications at all sites with a probing depth ≥ 5 mm immediately, at 48 and 96 h after scaling and placebo pills over the span of 7 days. Clinical examinations were performed at baseline and 90 days post-therapy. The clinical parameters of bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL) were measured. The aPDT was conducted using methylene blue and a low-level laser (GaAlAs 660 nm, 100 mW, 48 s, and 160 J/cm2) in all sites with a probing depth ≥ 5 mm. A statistical analysis was also performed (α = 5%). Results There was a significant improvement in CAL only in the intermediate pocket in the aPDT group compared to the MTZ + AMX group between baseline and 90 days post-treatment (p = 0.01). There was a reduction of both BOP and the percentage of residual pockets at 90 days after treatment compared with baseline in both groups (p < 0.05). Conclusion Both proposed adjuvant therapies associated with conventional mechanical treatment in patients with chronic periodontitis were equally effective in terms of the gain of clinical insertion, control of inflammation and elimination of residual pockets. Department of Surgery and Integrated Clinic Division of Periodontology São Paulo State University (Unesp) School of Dentistry Departament of Dentistry Children's and Social São Paulo State University (Unesp) School of Dentistry Division of Periodontology School of Dental Medicine University of Geneva Latin American Institute of Dental Research and Education (ILAPEO) Department of Surgery and Integrated Clinic Division of Periodontology São Paulo State University (Unesp) School of Dentistry Departament of Dentistry Children's and Social São Paulo State University (Unesp) School of Dentistry FAPESP: 2014/11637-2 CNPq: 302806/2012-1

Background: Web-based surveys have become a new and popular method for collecting data, but only a few studies have directly compared postal and Web-based surveys among physicians, and none to our knowledge among general practitioners (GPs). Objective: Our aim is to compare two modes of survey delivery (postal and Web-based) in terms of participation rates, response times, and completeness of questionnaires in a study assessing GPs’ preventive practices. Methods: This randomized study was conducted in Western Switzerland (Geneva and Vaud) and in France (Alsace and Pays de la Loire) in 2015. A random selection of community-based GPs (1000 GPs in Switzerland and 2400 GPs in France) were randomly allocated to receive a questionnaire about preventive care activities either by post (n=700 in Switzerland, n=400 in France) or by email (n=300 in Switzerland, n=2000 in France). Reminder messages were sent once in the postal group and twice in the Web-based group. Any GPs practicing only complementary and alternative medicine were excluded from the study. Results: Among the 3400 contacted GPs, 764 (22.47%, 95% CI 21.07%-23.87%) returned the questionnaire. Compared to the postal group, the participation rate in the Web-based group was more than four times lower (246/2300, 10.70% vs 518/1100, 47.09%, P

To correctly interpret the results of a randomised controlled trial (RCT), practitioners have to spot bias and other potential problems present in the trial. Internal as well as external validity of the trial are linked to the presence of such bias. The internal validity is ensured by a clear definition of the objectives of the trial. The number of patients to be included in the trial is calculated on the basis of the main objective of the trial and more precisely on the basis of the primary endpoint selected to assess the efficacy of treatment. This is the best way to ensure that the statistical significance of the result may have a clinical relevance. Internal validity depends also on the process of patients selection, the methods used to ensure comparability of groups and treatments, the criteria employed to assess efficacy, and the methods for the analysis of data. External validity refers to subjects that have been excluded from the trial, limitations of RCTs, as well as the coherence and clinical relevance of the trial. Internal validity has to be fueled by external validity.

Problématique : Les prématurés évoluent dans l’unité néonatale qui présente une intensité lumineuse parfois forte et variable, ce qui a pour effet de provoquer une instabilité physiologique, ainsi qu’une augmentation du niveau d’activité motrice chez ces derniers. Par ailleurs, le contrôle de l’éclairage à l’unité néonatale favorise la stabilité physiologique et réduit le niveau d’activité motrice des prématurés. Deux méthodes de contrôle de l’éclairage ont été étudiées, soit l’éclairage tamisé constant et l’éclairage cyclique. Or, la méthode de contrôle de l’éclairage la plus appropriée au système nerveux immature des prématurés est inconnue et il y a ambivalence en ce qui concerne les résultats des études ayant évalué ces deux modes de contrôle de l’éclairage. But : Le but de cette étude était de mesurer les effets de l’éclairage cyclique versus l’éclairage tamisé constant sur la stabilité physiologique et le niveau d’activité motrice de prématurés nés entre 28 et 32 semaines d’âge gestationnel. Méthode : Un essai clinique randomisé a été réalisé. Les 38 prématurés recrutés dans une unité néonatale de niveaux II et III d’un hôpital universitaire, ont été randomisés dans l’un des deux groupes d’intervention, soit le groupe exposé à l’éclairage tamisé constant ou celui exposé à l’éclairage cyclique. Ces deux types d’éclairage ont été appliqués pendant 24 heures. La stabilité physiologique a été mesurée par le score Stability of the Cardio Respiratory System in Premature Infants (SCRIP) et le niveau d’activité motrice a été mesuré avec un accéléromètre (Actiwatch®). L’intensité lumineuse à laquelle les prématurés ont été exposés a été mesurée de façon continue à l’intérieur de l’incubateur à l’aide d’un photomètre. Résultats : L’analyse des données révèle qu’il n’y aucune différence significative entre les deux groupes d’intervention en ce qui a trait à la stabilité physiologique (valeur-p du score SCRIP de 0,54 à 0,96) et au niveau d’activité motrice (valeur-p de 0,09 à 0,88). Les participants des deux groupes ont manifesté une stabilité physiologique et un niveau d’activité motrice comparables. Conclusion : Des interventions de contrôle de l’éclairage doivent être adoptées à l’unité néonatale, que ce soit des interventions qui permettent la mise en œuvre de l’éclairage cyclique ou de l’éclairage tamisé constant, dans le but de favoriser l’adaptation du prématuré à l’environnement de l’unité néonatale. Des recherches additionnelles sont requises afin d’identifier la méthode de contrôle de l’éclairage (éclairage cyclique ou éclairage tamisé constant) qui doit être implantée à l’unité néonatale., Problem statement: After birth, preterm infants evolve in the neonatal intensive care unit (NICU) characterized by a high and variable lighting which differs significantly from the dimmed intra-uterine environment. Exposure to high or variable NICU lighting can create physiological instability in preterm infants as well as increasing their motor activity level. An appropriate control of the NICU lighting can prevent the adverse effects of exposing infants to inadequate levels of lighting. To date, it appears that two methods of lighting control have been discussed and studied: near dark lighting and cycled lighting. At the same time, it is acknowledged that there is ambiguity about the results of studies which have evaluated these two NICU lighting methods. Therefore, the optimal NICU lighting remains unknown and further research is needed to identify the lighting mode witch promote preterm infant’s adaptation to the NICU environment. Purpose: The objective of this research was to evaluate the effects of cycled lighting versus near dark lighting on the physiological stability and motor activity level of preterm infants born between 28 and 32 weeks of gestation. Methods: A randomized controlled trial (RCT) allowed the assessment of preterm infants' physiological stability and motor activity level. 38 preterm infants born between 28 to 32 weeks of gestational age were recruited from a level II and III NICU university affiliated hospital. Each infant were randomly allocated to one of the following groups for 24 hours: cycled lighting or near dark lighting. Physiological stability was assessed by the SCRIP score, while the motor activity level was evaluated by an accelerometer (Actiwatch®). The light intensity level was continuously measured with a light meter to ensure that the lighting mode assigned was respected. Results: The analysis conducted indicates no significant difference between the two intervention groups in regard to physiological stability (score SCRIP = p-value 0.54 to 0.96) and the motor activity level (p- value 0.09 to 0.88). This lack of significant difference between the two groups indicates that the participants in the two groups demonstrated a comparable physiological stability state and a comparable level of motor activity when exposed to near dark lighting or cycled lighting. Conclusion: Guidelines to decrease bright light, either near dark or cycled light should be adopted in NICUs to control preterm infant’s’ exposure to light. Further research is required to identify the method of lighting control (cycled lighting or near dark lighting) which should be implanted in the neonatal unit.

Background:Promoting regular physical activity (PA) and lessening sedentary behaviors (SB) constitute a public health priority. Recent evidence suggests that PA and SB are not only related to reflective processes (eg, behavioral intentions), but also to impulsive approach-avoidance tendencies (IAAT). This study aims to test the effect of a computerized IAAT intervention on an exercise task.Methods:Participants (N = 115) were randomly assigned to 1 of 3 experimental conditions, in which they were either trained to approach PA and avoid SB (ApPA-AvSB condition), to approach SB and avoid PA (ApSB-AvPA condition), or to approach and avoid PA and SB equally often (active control condition). The main outcome variable was the time spent carrying out a moderate intensity exercise task.Results:IAAT toward PA decreased in the ApSB-AvPA condition, tended to increase in the ApPA-AvSB condition, and remained stable in the control condition. Most importantly, the ApPA-AvSB manipulation led to more time spent exercising than the ApSB-AvPA condition. Sensitivity analyses excluding individuals who were highly physically active further revealed that participants in the ApPA-AvSB condition spent more time exercising than participants in the control condition.Conclusions:These findings provide preliminary evidence that a single intervention session can successfully change impulsive approach tendencies toward PA and can increase the time devoted to an exercise task, especially among individuals who need to be more physically active. Potential implications for health behavior theories and behavior change interventions are outlined.

Background: Randomized controlled trials have shown the efficacy of systemic treatments in moderate-to-severe psoriasis. Clinical outcomes in psoriasis patients under real-world conditions are less well understood. Objective: This study compared Psoriasis Area and Severity Index (PASI) and Dermatological Life Quality Index (DLQI) improvement in all psoriasis patients registered in the Swiss Dermatology Network for Targeted Therapies. We asked whether outcomes differed between 4 treatment strategies, namely biologic monotherapy versus conventional systemic monotherapy, versus combined biologic and conventional systemic drugs, and versus therapy adaptation (switching from one type to another). Methods: PASI and DLQI within 1 year after onset of systemic treatment, measured at 3, 6, and 12 months, were compared among the 4 groups using generalized linear mixed-effects models. Results: Between March 2011 and December 2014, 334 patients were included; 151 received conventional systemic therapeutics, 145 biologics, 13 combined treatment, and 25 had a therapy adaptation. With regard to the absolute PASI, neither the biologic cohort nor the combined treatment cohort significantly differed from the conventional systemic therapeutics cohort. The odds of reaching PASI90 was significantly increased with combined therapy compared to conventional systemic therapeutics (p = 0.043) and decreased with a higher body mass index (p = 0.041). At visits 3 and 4, the PASI was generally lower than at visit 2 (visit 3 vs. visit 2, p = 0.0019; visit 4 vs. visit 2, p < 0.001). After 12 months, patients with biologic treatment had a significantly lower DLQI than those with conventional systemic therapeutics (p = 0.001). Conclusion: This study suggests that after 1 year of treatment, biologics are superior in improving the subjective disease burden compared to conventional systemic drugs.

Given the proposed changes to nutrition labelling in Canada and the dearth of research examining comprehension and use of nutrition facts tables (NFts) by adolescents and young adults, our objective was to experimentally test the efficacy of modifications to NFts on young Canadians' ability to interpret, compare and mathematically manipulate nutrition information in NFts on prepackaged food.An online survey was conducted among 2010 Canadians aged 16 to 24 years drawn from a consumer sample. Participants were randomized to view two NFts according to one of six experimental conditions, using a between-groups 2 x 3 factorial design: serving size (current NFt vs. standardized serving-sizes across similar products) x percent daily value (% DV) (current NFt vs. "low/med/high" descriptors vs. colour coding). The survey included seven performance tasks requiring participants to interpret, compare and mathematically manipulate nutrition information on NFts. Separate modified Poisson regression models were conducted for each of the three outcomes.The ability to compare two similar products was significantly enhanced in NFt conditions that included standardized serving-sizes (p ≤ .001 for all). Adding descriptors or colour coding of % DV next to calories and nutrients on NFts significantly improved participants' ability to correctly interpret % DV information (p ≤ .001 for all). Providing both standardized serving-sizes and descriptors of % DV had a modest effect on participants' ability to mathematically manipulate nutrition information to calculate the nutrient content of multiple servings of a product (relative ratio = 1.19; 95% confidence limit: 1.04-1.37).Standardizing serving-sizes and adding interpretive % DV information on NFts improved young Canadians' comprehension and use of nutrition information. Some caution should be exercised in generalizing these findings to all Canadian youth due to the sampling issues associated with the study population. Further research is needed to replicate this study in a more heterogeneous sample in Canada and across a range of food products and categories.Essai randomisé mesurant l’efficacité des modifications apportées au tableau de la valeur nutritive sur la compréhension et l’utilisation de l'information nutritionnelle par les adolescents et les jeunes adultes au Canada.Compte tenu des changements proposés à l’étiquetage nutritionnel au Canada et de la rareté des travaux de recherche portant sur la compréhension et l’utilisation des tableaux de la valeur nutritive (tVN) chez les adolescents et les jeunes adultes, notre objectif consistait à réaliser un essai expérimental pour déterminer si les modifications apportées au tVN permettaient d’améliorer efficacement la façon dont les jeunes Canadiens interprètent, comparent et manipulent, sur le plan mathématique, l’information nutritionnelle figurant dans le tVN de denrées préemballées.Une enquête en ligne a été menée auprès d’un échantillon de consommateurs composé de 2 010 Canadiens âgés de 16 à 24 ans. Nous avons réparti les participants de façon aléatoire en six groupes d’étude, et nous avons présenté à chacun des groupes deux des six tVN définis comme conditions expérimentales, selon un plan factoriel 2 x 3 : portion de référence (tVN actuel et portions de référence normalisées pour tous les produits similaires) x pourcentage de la valeur quotidienne (% VQ) (tVN actuel, ajout des descripteurs « faible/moyen/élevé » et ajout d’un code de couleurs). L’enquête comprenait sept tâches consistant à interpréter, comparer et manipuler, sur le plan mathématique, l’information nutritionnelle figurant dans les tVN. Des modèles de régression de Poisson modifiés ont été élaborés pour chacun des trois résultats.La capacité à comparer deux produits similaires s’est révélée significativement meilleure quand le tVN incluait une portion de référence normalisée (p ≤ 0,001 dans tous les cas). L’ajout de descripteurs ou d’un code de couleurs indiquant, sur le tVN, le % VQ pour les calories et les nutriments a amélioré de façon significative la capacité des participants à interpréter correctement l’information à propos de ce % VQ (p ≤ 0,001 dans tous les cas). Le fait de présenter aux participants des portions de référence normalisées et des descripteurs du % VQ a eu un effet modeste sur leur capacité à manipuler, sur le plan mathématique, l’information nutritionnelle pour calculer la valeur nutritive de plusieurs portions d’un produit (ratio relatif = 1,19; intervalle de confiance à 95 % : 1,04 à 1,37).La normalisation des portions de référence et l’ajout d’information sur l’interprétation du % VQ dans le tVN ont permis aux jeunes Canadiens de mieux comprendre et utiliser l’information nutritionnelle. Il faut néanmoins faire preuve de prudence avant de généraliser les résultats de l’enquête à l’ensemble des jeunes Canadiens en raison de l’échantillonnage de la population à l’étude. D’autres travaux de recherche sont nécessaires afin de reproduire cette étude au Canada avec un échantillon plus hétérogène, et en utilisant un éventail de produits alimentaires et de catégories d’aliments.

To provide guidelines for health care providers on the use of contraceptive methods to prevent pregnancy and on the promotion of healthy sexuality.Guidance for Canadian practitioners on overall effectiveness, mechanism of action, indications, contraindications, non-contraceptive benefits, side effects and risks, and initiation of cited contraceptive methods; family planning in the context of sexual health and general well-being; contraceptive counselling methods; and access to, and availability of, cited contraceptive methods in Canada.Published literature was retrieved through searches of Medline and The Cochrane Database from January 1994 to January 2015 using appropriate controlled vocabulary (e.g., contraception, sexuality, sexual health) and key words (e.g., contraception, family planning, hormonal contraception, emergency contraception). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English from January 1994 to January 2015. Searches were updated on a regular basis and incorporated in the guideline to June 2015. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.The quality of the evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table). Chapter 1: Contraception in Canada Summary Statements 1. Canadian women spend a significant portion of their lives at risk of an unintended pregnancy. (II-2) 2. Effective contraceptive methods are underutilized in Canada, particularly among vulnerable populations. (II-2) 3. Long-acting reversible contraceptive methods, including contraceptive implants and intrauterine contraception (copper-releasing and levonorgestrel-releasing devices/systems), are the most effective reversible contraceptive methods and have the highest continuation rates. (II-1) 4. Canada currently does not collect reliable data to determine the use of contraceptive methods, abortion rates, and the prevalence of unintended pregnancy among reproductive-age women. (II-2) 5. A universal subsidy for contraceptive methods as provided by many of Canada's peer nations and a few Canadian provinces may produce health system cost-savings. (II-2) 6. Health Canada approval processes for contraceptives have been less efficient than those of other drug approval agencies and Health Canada processes for other classes of pharmaceuticals. (II-2) 7. It is feasible and safe for contraceptives and family planning services to be provided by appropriately trained allied health professionals such as midwives, registered nurses, nurse practitioners, and pharmacists. (II-2) Recommendations 1. Contraceptive counselling should include a discussion of typical use failure rates and the importance of using the contraceptive method consistently and correctly in order to avoid pregnancy. (II-2A) 2. Women seeking contraception should be counselled on the wide range of effective methods of contraception available, including long-acting reversible contraceptive methods (LARCs). LARCs are the most effective methods of reversible contraception, have high continuation rates, and should be considered when presenting contraceptive options to any woman of reproductive age. (II-2A) 3. Family planning counselling should include counselling on the decline of fertility associated with increasing female age. (III-A) 4. Health policy supporting a universal contraception subsidy and strategies to promote the uptake of highly effective methods as cost-saving measures that improve health and health equity should be considered by Canadian health decision makers. (III-B) 5. Canadian health jurisdictions should consider expanding the scope of practice of other trained professionals such as nurses, nurse practitioners, midwives, and pharmacists and promoting task-sharing in family planning. (II-2B) 6. The Canadian Community Health Survey should include adequate reproductive health indicators in order for health care providers and policy makers to make appropriate decisions regarding reproductive health policies and services in Canada. (III-B) 7. Health Canada processes and policies should be reviewed to ensure a wide range of modern contraceptive methods are available to Canadian women. (III-B) Chapter 2: Contraceptive Care and Access Summary Statements 8. Although there are many contraceptive options in Canada, only a narrow range of contraceptive methods are commonly used by those of reproductive age. (II-3) 9. Condom use decreases with longer relationship tenure and when the sexual partner is considered to be the main partner, likely due to a lower perceived risk of sexually transmitted infection in that relationship. Condom use may also decrease markedly as an unintended consequence when an effective non-barrier method, such as hormonal contraception or intrauterine contraception, is initiated. (II-3) 10. Family planning counselling provides a natural segue into screening for concerns about sexual function or intimate partner violence. (III) 11. Well-informed and well-motivated individuals who have developed skills to practise safer sex behaviours are more likely to use contraceptive and safer sex methods effectively and consistently. (II-2) Recommendations 8. Comprehensive family planning services, including abortion services, should be accessible to all Canadians regardless of geographic location. These services should be confidential, non-judgemental, and respectful of individuals' privacy and cultural contexts. (III-A) 9. A contraceptive visit should include history taking, screening for contraindications, dispensing or prescribing a method of contraception, and exploring contraceptive choice and adherence in the broader context of the individual's sexual behaviour, reproductive health risk, social circumstances, and relevant belief systems. (III-B) 10. Health care providers should provide practical information on the wide range of contraceptive options and their potential non-contraceptive benefits and assist women and their partners in determining the best user-method fit. (III-B) 11. Health care providers should assist women and men in developing the skills necessary to negotiate the use of contraception and the correct and consistent use of a chosen method. (III-B) 12. Contraceptive care should include discussion and management of the risk of sexually transmitted infection, including appropriate recommendations for condom use and dual protection, STI screening, post-exposure prophylaxis, and Hepatitis B and human papillomavirus vaccination. (III-B) 13. Health care providers should emphasize the use of condoms not only for protection against sexually transmitted infection, but also as a back-up method when adherence to a hormonal contraceptive may be suboptimal. (I-A) 14. Health care providers should be aware of current media controversies in reproductive health and acquire relevant evidence-based information that can be briefly and directly communicated to their patients. (III-B) 15. Referral resources for intimate partner violence, sexually transmitted infections, sexual dysfunction, induced abortion services, and child protection services should be available to help clinicians provide contraceptive care in the broader context of women's health. (III-B) Chapter 3: Emergency Contraception Summary Statements 12. The copper intrauterine device is the most effective method of emergency contraception. (II-2) 13. A copper intrauterine device can be used for emergency contraception up to 7 days after unprotected intercourse provided that pregnancy has been ruled out and there are no other contraindications to its insertion. (II-2) 14. Levonorgestrel emergency contraception is effective up to 5 days (120 hours) after intercourse; its effectiveness decreases as the time between unprotected intercourse and ingestion increases. (II-2) 15. Ulipristal acetate for emergency contraception is more effective than levonorgestrel emergency contraception up to 5 days after unprotected intercourse. This difference in effectiveness is more pronounced as the time from unprotected intercourse increases, especially after 72 hours. (I) 16. Hormonal emergency contraception (levonorgestrel emergency contraception and ulipristal acetate for emergency contraception) is not effective if taken on the day of ovulation or after ovulation. (II-2) 17. Levonorgestrel emergency contraception may be less effective in women with a body mass index25 kg/m2 and ulipristal acetate for emergency contraception may be less effective in women with a body mass index35 kg/m2. However, hormonal emergency contraception may still retain some effectiveness regardless of a woman's body weight or body mass index. (II-2) 18. Hormonal emergency contraception is associated with higher failure rates when women continue to have subsequent unprotected intercourse. (II-2) 19. Hormonal contraception can be initiated the day of or the day following the use of levonorgestrel emergency contraception, with back-up contraception used for the first 7 days. (III) 20. Hormonal contraception can be initiated 5 days following the use of ulipristal acetate for emergency contraception, with back-up contraception used for the first 14 days. (III) Recommendations 16. All emergency contraception should be initiated as soon as possible after unprotected intercourse. (II-2A) 17. Women should be informed that the copper intrauterine device (IUD) is the most effective method of emergency contraception and can be used by any woman with no contraindications to IUD use. (II-3A) 18.

The incidence of glioblastoma increases with age, with a median age, at diagnosis, of 65 years. Indeed, the optimization of standard of care of elderly glioblastoma patients in an aging population in Western countries becomes crucial. The age remains the main prognostic factor of glioblastoma. Survival among elderly patients is significantly less than among younger patients. The median survival of elderly glioblastoma patients is generally inferior to 6 months. More aggressive tumor behavior, less aggressive treatments, increased toxicity of therapies and more unfavorable clinical factors and comorbidities could explain a higher severity of the disease in the elderly. The balance between treatment efficacy and quality of life is a major focus because of the shorter life expectancy of patients. The standard of care of glioblastoma in elderly patients remains controversial. Large optimal resection, when achievable, should be preferred to biopsy. Survival is longer after adjuvant radiotherapy, either normofractionated over 6-weeks course or hypofractionated over 3-weeks course, for patients with good clinical status. Hypofractionation is often preferred because of shorter procedure. Chemotherapy alone with temozolomide can be proposed to patients with methylated MGMT promoter. A phase III randomized study, testing short-course adjuvant radiotherapy with or without temozolomide in elderly patients with good clinical status, is ongoing.

To review the clinical aspects of ovarian hyperstimulation syndrome and provide recommendations on its prevention.Preventative measures, early recognition, and prompt systematic supportive care will help avoid poor outcomes.Establish guidelines to assist in the prevention of ovarian hyperstimulation syndrome, early recognition of the condition when it occurs, and provision of appropriate supportive measures in the correct setting.Published literature was retrieved through searches of Medline, Embase, and the Cochrane Library from 2011 to 2013 using appropriate controlled vocabulary ([OHSS] ovarian hyperstimulation syndrome and: agonist IVF, antagonist IVF, metformin, HCG, gonadotropin, coasting, freeze all, agonist trigger, progesterone) and key words (ovarian hyperstimulation syndrome, ovarian stimulation, gonadotropin, human chorionic gonadotropin, prevention). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English. There were no date restrictions. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Summary Statements 1. The particular follicle-stimulating hormone formulation used for ovarian stimulation does not affect the incidence of ovarian hyperstimulation syndrome. (I) 2. Coasting may reduce the incidence of severe ovarian hyperstimulation syndrome. (III) 3. Coasting for longer than 3 days reduces in vitro fertilization pregnancy rates. (II-2) 4. The use of either luteinizing hormone or human chorionic gonadotropin for final oocyte maturation does not influence the incidence of ovarian hyperstimulation syndrome. (I) 5. There is no clear published evidence that lowering the human chorionic gonadotropin dose will result in a decrease in the rate of ovarian hyperstimulation syndrome. (III) 6. Cabergoline starting from the day of human chorionic gonadotropin reduces the incidence of ovarian hyperstimulation syndrome in patients at higher risk and does not appear to lower in vitro fertilization pregnancy rates. (II-2) 7. Avoiding pregnancy by freezing all embryos will prevent severe prolonged ovarian hyperstimulation syndrome in patients at high risk. (II-2) 8. Pregnancy rates are not affected when using gonadotropin-releasing hormone (GnRH) agonists in GnRH antagonist protocols for final egg maturation when embryos are frozen by vitrification for later transfer. (II-2) Recommendations 1. The addition of metformin should be considered in patients with polycystic ovarian syndrome who are undergoing in vitro fertilization because it may reduce the incidence of ovarian hyperstimulation syndrome. (I-A) 2. Gonadotropin dosing should be carefully individualized, taking into account the patient's age, body mass, antral follicle count, and previous response to gonadotropins. (II-3B) 3. Cycle cancellation before administration of human chorionic gonadatropin is an effective strategy for the prevention of ovarian hyperstimulation syndrome, but the emotional and financial burden it imposes on patients should be considered before the cycle is cancelled. (III-C) 4. Gonadotropin-releasing hormone (GnRH) antagonist stimulation protocols are recommended in patients at high risk for ovarian hyperstimulation syndrome (OHSS). The risk of severe OHSS in patients on GnRH antagonist protocols who have a very robust ovarian stimulation response can be reduced by using a GnRH agonist as a substitute for human chorionic gonadotropin to trigger final oocyte maturation. (I-B) 5. A gonadotropin-releasing hormone (GnRH) antagonist protocol with a GnRH agonist trigger for final oocyte maturation is recommended for donor oocyte and fertility preservation cycles. (III-C) 6. Albumin or other plasma expanders at the time of egg retrieval are not recommended for the prevention of ovarian hyperstimulation syndrome. (I-E) 7. Elective single embryo transfer is recommended in patients at high risk for ovarian hyperstimulation syndrome. (III-C) 8. Progesterone, rather than human chorionic gonadotropin, should be used for luteal phase support. (I-A) 9. Outpatient culdocentesis should be considered for the prevention of disease progression in severe ovarian hyperstimulation syndrome. (II-2B).

Background Tinnitus is an often disabling condition for which there is no effective therapy. Current research suggests that tinnitus may develop due to maladaptive plastic changes and altered activity in the auditory and prefrontal cortex. Transcranial direct current stimulation (tDCS) modulates brain activity and has been shown to transiently suppress tinnitus in trials. Objective To investigate the efficacy and safety of tDCS in the treatment of chronic subjective tinnitus. Methods In a randomized, parallel, double-blind, sham-controlled study, the efficacy and safety of cathodal tDCS to the auditory cortex with anode over the prefrontal cortex was investigated in five sessions over five consecutive days. Tinnitus was assessed after the last session on day 5, and at follow-up visits 1 and 3 months post stimulation using the Tinnitus Handicap Inventory (THI, primary outcome measure), Subjective Tinnitus Severity Scale, Hospital Anxiety and Depression scale, Visual Analogue Scale, and Clinical Global Impression scale. Results 42 patients were investigated, 21 received tDCS and 21 sham stimulation. There were no beneficial effects of tDCS on tinnitus as assessed by primary and secondary outcome measures. Effect size assessed with Cohen's d amounted to 0.08 (95% CI: −0.52 to 0.69) at 1 month and 0.18 (95% CI: -0.43 to 0.78) at 3 months for the THI. Conclusion tDCS of the auditory and prefrontal cortices is safe, but does not improve tinnitus. Different tDCS protocols might be beneficial.

Background: Induction of labour is common, and cesarean delivery is regarded as its major complication. We conducted a systematic review and meta-analysis to investigate whether the risk of cesarean delivery is higher or lower following labour induction compared with expectant management. Methods: We searched 6 electronic databases for relevant articles published through April 2012 to identify randomized controlled trials (RCTs) in which labour induction was compared with placebo or expectant management among women with a viable singleton pregnancy. We assessed risk of bias and obtained data on rates of cesarean delivery. We used regression analysis techniques to explore the effect of patient characteristics, induction methods and study quality on risk of cesarean delivery. Results: We identified 157 eligible RCTs (n = 31 085). Overall, the risk of cesarean delivery was 12% lower with labour induction than with expectant management (pooled relative risk [RR] 0.88, 95% confidence interval [CI] 0.84-0.93; I2 = 0%). The effect was significant in term and post-term gestations but not in preterm gestations. Meta-regression analysis showed that initial cervical score, indication for induction and method of induction did not alter the main result. There was a reduced risk of fetal death (RR 0.50, 95% CI 0.25-0.99; I2 = 0%) and admission to a neonatal intensive care unit (RR 0.86, 95% CI 0.79-0.94), and no impact on maternal death (RR 1.00, 95% CI 0.10-9.57; I2 = 0%) with labour induction. Interpretation: The risk of cesarean delivery was lower among women whose labour was induced than among those managed expectantly in term and post-term gestations. There were benefits for the fetus and no increased risk of maternal death. © 2014 Canadian Medical Association or its licensors.