Background Due to small iron stores and rapid growth during the first months of life, infants with low birth weight (LBW) are at risk of iron deficiency (ID). ID in infancy is associated with irreversible impaired neurodevelopment. Preventive iron supplementation may reduce the risk of ID and benefit neurodevelopment, but there is also a possible risk of adverse effects. More than 50% of all LBW infants are born with marginally LBW (MLBW, 2000-2500g), and it is not known if they benefit from iron supplementation. Methods We randomized 285 healthy, Swedish, MLBW infants to receive 3 different doses of oral iron supplements; 0 (Placebo), 1, and 2 mg/kg/day from six weeks to six months of age. Iron status, during and after the intervention was assessed and so was the prevalence of ID and ID anemia (IDA), growth, morbidity and the interplay with iron and the erythropoetic hormones hepcidin and erythropoietin (EPO). As a proxy for conduction speed in the developing brain, auditory brainstem response (ABR) was analyzed at six months. In a follow up at 3.5 years of age, the children were assessed with a cognitive test (WPPSI-III) and a validated parental checklist of behavioral problems (CBCL), and compared to a matched reference group of 95 children born with normal birth weight. Results At six months of age, the prevalence of ID and IDA was significantly higher in the placebo group compared to the iron supplemented infants. 36% had ID in the placebo group, compared to 8% and 4 % in the 1 and 2mg/kg/day-groups, respectively. The prevalence of IDA was 10%, 3% and 0%, respectively. ABR-latencies did not correlate with the iron intake and was not increased in infants with ID or IDA. ABR wave V latencies were similar in all three groups. Hepcidin correlated to ferritin and increased in supplemented infants while EPO, which was negatively correlated to iron status indicators, decreased. At follow up there were no differences in cognitive scores between the groups but the prevalence of behavioral problems was significantly higher in the placebo group compared to those supplemented and to controls. The relative risk increase of CBCL-scores above a validated cutoff was 4.5 (1.4 – 14.2) in the placebo-group compared to supplemented children. There was no detected difference in growth or morbidity at any age. Conclusion MLBW infants are at risk of ID in infancy and behavioral problems at 3 years of age. Iron supplementation at a dose of 1-2 mg/kg/day from six weeks to six months of age reduces the risks with no adverse effects, suggesting both short and long term benefit. MLBW infants should be included in general iron supplementation programs during their first six months of life.

Introduction: Les instillations nasales de solution saline isotonique (INSS) chez les enfants sont recommandées par les pédiatres et des oto-rhino-laryngologistes de notre institution dans le but de prévenir les otites moyennes aigues à répétition (OMAr). Cependant, aucune étude dans la littérature ne vient corroborer ou infirmer cette pratique. Objectifs: Déterminer l’efficacité des INSS dans la prévention des OMAr. Méthode: Projet pilote d’un essai clinique randomisé. Les enfants diagnostiqués avec des OMAr étaient éligibles. Les patients recrutés ont été randomisés en 2 groupes. Seul le groupe traitement procède aux INSS. L’issue primaire est l’incidence d’OMAr pendant une période de 3 mois. Résultats: Vingt-neuf patients satisfaisant les critères d’inclusion et d’exclusion ont consenti à participer. Le taux d’OMAr était inférieur dans le groupe traitement (p=0.03, chi-carré) Conclusion: Les INSS semblent efficaces dans la prévention des OMAr. Une étude multicentrique est indiquée pour vérifier la validité externe et confirmer la sécurité. / Introduction: Normal saline nasal cavity irrigations (NSNI) are commonly recommended by pediatricians and otolaryngologists to prevent recurrent acute otitis media (rAOM). However, no published scientific study corroborates or invalidates this practice. Goal: To determine the efficacy of NSNI to prevent rAOM. Method: Pilot randomized controlled clinical trial. All consecutive patients with a diagnosis of rAOM were eligible. Recruited patients were randomized in 2 groups. Only patients in the treatment group proceeded with NSNI. The primary outcome of the study was the incidence of rAOM observed during a 3 month period. Results: Twenty-nine patients met the inclusion and exclusion criteria and agreed to participate. There was a statistically significant lower incidence of rAOM in the treatment group (p=0.003, Fisher exact). Conclusion: Our results suggest that NSNI could effectively prevent rAOM. A larger scale randomized multicentre study is feasible, and it must be done in order to verify for external validity and to properly assess safety issues.

Plusieurs études ont démontré que prés de deux tiers des patients subissant une chirurgie cardiaque souffrent de douleur d’intensité modérée à sévère. Ces niveaux de douleur semblent être partiellement expliqués par la présence de barrières individuelles face au soulagement de la douleur. Le savoir acquis sur les cognitions associées à la douleur ne semble pas avoir été traduit dans de nouvelles approches éducatives face à la douleur aiguë. Le but du projet doctoral était 1) de développer une intervention visant à faciliter l’autogestion de la douleur postopératoire après une chirurgie cardiaque et, 2) d’en évaluer l’acceptabilité et la faisabilité, ainsi que le potentiel d’efficacité sur le soulagement de la douleur de patients subissant une chirurgie cardiaque. Le développement de l’iintervention SOULAGE-TAVIE a inclus quatre étapes fondées sur les savoirs clinique, empirique et théorique et inspirées de plusieurs écrits méthodologiques. SOULAGE-TAVIE consiste en une session préopératoire éducative sur la gestion de la douleur post-chirurgie cardiaque d’approximativement 30 minutes sur un ordinateur, dispensée sur mesure en fonction d’un algorithme. Deux renforcements cliniques en personne sont aussi offerts en phase postopératoire. L’évaluation de l’intervention consistait en un essai clinique pilote à répartition aléatoire incluant 60 participants répartis entre le groupe expérimental (GE : SOULAGE-TAVIE) et le groupe contrôle (GC : soins usuels incluant un feuillet d’information). Les données étaient recueillies au moment de l’admission et dans les sept jours postopératoires. SOULAGE-TAVIE a été jugée comme acceptable et faisable. De plus, les participants du GE n’ont pas expérimenté une douleur de plus faible intensité mais ils ont rapporté significativement moins d’interférence de la douleur avec la toux et la respiration profonde, ont démontré moins de barrières face à la gestion de la douleur et ont consommé plus d’opiacés. Cette étude pilote procure des résultats prometteurs sur les bénéfices potentiels de cette nouvelle approche sur mesure utilisant les technologies de l’information et de la communication (TIC). L’autonomisation des personnes est cruciale et complémentaire pour soutenir le soulagement de la douleur dans le contexte actuel de soins. / Several studies have shown that many patients undergoing a cardiac surgery suffer from moderate to severe pain. These levels of pain may be explained by individual barriers toward pain relief. Knowledge acquired on pain-related cognitions has not been translated into new approaches. The aim of the doctoral project was 1) to develop an intervention to facilitate the self-management of postoperative pain after cardiac surgery and, 2) to assess its the acceptability and feasibility and to investigate its efficacy potential on pain relief in patients undergoing cardiac surgery. The development of SOULAGE-TAVIE included four steps based on clinical, empirical and theoretical knowledge and inspired by diverse methodological considerations. SOULAGE-TAVIE consists in a 30-minute computer-tailored preoperative educational session about postoperative pain management, tailored according to an algorithm. Two short reinforcements are provided in person. The evaluation of SOULAGE-TAVIE consisted in a pilot randomized controlled trial including 60 participants assigned to the experimental group (EG: SOULAGE-TAVIE) and the control group (CG: usual care including educational pamphlet). Data were collected at the time of admission and across Day 1 to 7 after surgery. The results provide preliminary support for the acceptability and feasibility of a tailored and virtual intervention. The results revealed that patients of the EG did not experience less intense pain but they reported significantly less pain interference when breathing/coughing, exhibited fewer pain-related barriers, and consumed more opioid medication. This pilot study provides promising results to support the potential benefits of this new web-tailored approach. Patient empowerment is complementary yet crucial in the current context of care and may contribute to improve pain relief.

Background: Controversy surrounds the questions whether co-occurring depression has negative effects on cognitivebehavioral therapy (CBT) outcomes in patients with panic disorder (PD) and agoraphobia (AG) and whether treatment for PD and AG (PD/AG) also reduces depressive symptomatology. Methods: Post-hoc analyses of randomized clinical trial data of 369 outpatients with primary PD/AG (DSM-IV-TR criteria) treated with a 12-session manualized CBT (n = 301) and a waitlist control group (n = 68). Patients with comorbid depression (DSM-IV-TR major depression, dysthymia, or both: 43.2% CBT, 42.7% controls) were compared to patients without depression regarding anxiety and depression outcomes (Clinical Global Impression Scale [CGI], Hamilton Anxiety Rating Scale [HAM-A], number of panic attacks, Mobility Inventory [MI], Panic and Agoraphobia Scale, Beck Depression Inventory) at post-treatment and follow-up (categorical). Further, the role of severity of depressive symptoms on anxiety/depression outcome measures was examined (dimensional). Results: Comorbid depression did not have a significant overall effect on anxiety outcomes at post-treatment and follow-up, except for slightly diminished post-treatment effect sizes for clinician-rated CGI (p = 0.03) and HAM-A (p = 0.008) when adjusting for baseline anxiety severity. In the dimensional model, higher baseline depression scores were associated with lower effect sizes at post-treatment (except for MI), but not at follow-up (except for HAM-A). Depressive symptoms improved irrespective of the presence of depression. Conclusions: Exposure-based CBT for primary PD/AG effectively reduces anxiety and depressive symptoms, irrespective of comorbid depression or depressive symptomatology. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Background: Evidence-based treatment algorithms, successfully established for asthma, are missing for atopic eczema (AE). Objectives: To investigate whether treatment according to an evidence-based algorithm is an effective and applicable concept for the management of AE. Methods: Based on a systematic literature review, we developed an evidence-based severity-score-oriented treatment algorithm for AE and compared its effectiveness to that of an individualised symptom-oriented treatment (individual therapy) in a randomised controlled trial. Sixty-three participants were randomised to algorithm (n = 32) or individual therapy (n = 31) and treated accordingly for 12 months. Study end points included difference between baseline SCORAD and mean SCORAD under treatment (primary end point), quality of life and treatment utilisation. Analysis was by intention to treat (registration: ClinicalTrials.gov:NCT00148746). Results: No statistically significant differences in clinical or subjective response were observed between groups. Treatment following the algorithm and individual treatment both effectively controlled AE. Mean SCORAD reductions were 47% (95% confidence interval, CI = 38–55; algorithm) and 42% (95% CI = 29–54; individual). Clinical response was paralleled by improved quality of life in both groups. Physicians adhered to the algorithm option in 93% of their treatment decisions. Conclusion: Treatment following an evidence-based algorithm is an effective and applicable concept for the management of AE but does not show clear advantages compared to individualised treatment in a dermatological setting. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

A partir dels anys 90, les alteracions cognitives de l'esquizofrènia han resultat de gran interès per la seva relació amb altres aspectes del funcionament general que posen en relleu el paper nuclear del dèficit cognitiu en aquest trastorn (Kraus i Keefe, 2007; Wykes i Reeder, 2005). Les alteracions de la memòria, la funció executiva i l'atenció han mostrat ser les més rellevants tant per la seva repercussió funcional com per la seva intensitat (Brazo i cols., 2002; Hoff i Kremen, 2003; Medalia i Lim, 2004; Penadés i cols., 1999; Reed i cols., 2002; Sharma i Antonova, 2003; Sponheim i cols., 2003; Wykes i Reeder, 2005; Zandio i cols., 2005). Arran d'aquestes troballes s'ha desenvolupat una eina de rehabilitació coneguda com a remediació cognitiva, que consisteix en un entrenament conductual per a millorar els processos cognitius d'atenció, memòria, funció executiva, cognició social i metacognició (Wykes i cols., 2011). Té com a objectius millorar el funcionament cognitiu de les persones amb esquizofrènia i aconseguir que aquestes millores es traslladin a una major competència en la resolució de problemes quotidians (Medalia i Freilich, 2008). Diversos estudis han trobat que la millora de la funció executiva mitjançant procediments de remediació cognitiva està fortament associada a la millora de l'autonomia personal i del funcionament en la comunitat (Green, 1996; Reeder i cols., 2006; Penadés i cols., 2006 ; Wykes i cols., 2007b; Wykes i Huddy, 2009, Wykes i cols. 2011). Els resultats obtinguts en revisions i metanàlisis han indicat millores consistents en un ampli rang de funcions cognitives, en els símptomes i en el funcionament en la comunitat (Lindenmayer i cols., 2008; McGurk i cols., 2007; Twamley i cols., 2003; Wykes i cols., 2011). En el marc de la Unitat de Recerca i Desenvolupament del Parc Sanitari Sant Joan de Déu (Sant Boi de Llobregat), es va desenvolupar un programa propi de remediació cognitiva i es va dur a terme l'estudi de la seva eficàcia. El programa REPYFLEC és un entrenament de remediació cognitiva en format de paper i llapis, que es realitza en grup (4-6 participants) i es porta a terme dos dies a la setmana durant 4 mesos (32 sessions). Els continguts que es treballen es divideixen en dues àrees principals: Resolució de Problemes i Flexibilitat Cognitiva, i es realitzen 16 sessions de cadascuna. L'objectiu d'aquest tractament és intervenir en les funcions cognitives superiors que estan afectades en l'esquizofrènia, com són la funció executiva i la metacognició. Amb l’objectiu d’avaluar l’entrenament Repyflec es va realitzar un assaig clínic controlat i aleatoritzat, de doble cegament i en comparació a un grup control actiu que realitzava 32 sessions d’un grup d’oci sense objectius específics. Als resultats s'ha trobat que el Repyflec ha produït un canvi superior i estadísticament significatiu a favor del grup experimental en variables cognitives i socials. Més concretament, al post tractament s'han trobat millores a favor del Repyflec en la funció executiva, en les àrees de cura personal, relacions socials -contacte social i en l'ocupació. Els resultats obtinguts al seguiment mostren que les millores en la funció executiva i en el funcionament social es mantenen 6 mesos després d'haver finalitzat el tractament. Així mateix, el Repyflec apunta a influir en la millora d’algunes variables simptomatològiques. El Repyflec és una intervenció de grup, multifunció i restitutiva, que aconsegueix canvis superiors i estadísticament significatius en el funcionament executiu i social de pacients ambulatoris amb esquizofrènia. La intervenció en la funció executiva s'ha mostrat associada a guanys en les àrees de funcionament psicosocial. / "REPYFLEC cognitive remediation group training in schizophrenia. Randomised controlled tria"l TEXT: BACKGROUND: Cognitive difficulties are well known in people with a diagnosis of schizophrenia and are associated with poor long-term functioning. Cognitive remediation trainings are developed to treat cognitive problems that affect functioning. Current international studies about cognitive remediation obtain improvements in cognitive and social functioning and in some psychiatric symptoms. AIMS: To evaluate the efficacy of a cognitive remediation group training program, namely Problem Solving and Cognitive Flexibility training, addressed to improve psicosocial functioning of patients with schizophrenia. METHOD: Participants with a diagnosis of schizophrenia or schizoaffective disorder (n=52) were randomized to 32 -twice a week- group sessions of REPYFLEC training, or to 32 -twice a week- group sessions of activities without specific objectives and focused to leisure. Social functioning, psychiatric symptoms and Theory of Mind (ToM) were measured at weeks 0, 8, 16 and 40. Cognitive function was measured at weeks 0, 16 and 40. Mixed Models were used to estimate statistical differences. RESULTS: Patients in the cognitive remediation training group demonstrated significantly improvements on executive function, social functioning and negative symptoms at post-treatment compared to patients in the control group. At 6 month follow-up assessment, significant improvements in executive function and social functioning remained. CONCLUSIONS: REPYFLEC cognitive training is associated with significant improvements on executive function, social functioning and specific symptoms in outpatients with schizophrenia.

Contexto: A cárie precoce da infância (CPI), definida como a presença de um ou mais dentes decíduos cariados, perdidos por cárie ou restaurados em crianças com menos de 6 anos de idade, é um problema de saúde pública que afeta bebês e crianças pré- escolares em todo o mundo, determinando dor, problemas nas funções da fala e mastigatória, doenças sistêmicas e reflexos psicológicos. O tratamento da CPI é caro, pode requerer anestesia geral e hospitalização e a recidiva é freqüente. Desta forma, a literatura tem recomendado fortemente: (a) estudos de coorte que contribuam para o reconhecimento dos fatores de risco para a ocorrência de CPI; (b) ensaios clínicos que avaliem a efetividade de programas na redução de cárie nos primeiros anos de vida. Objetivos: Avaliar a efetividade a longo prazo de visitas às residências para orientar mães sobre práticas alimentares saudáveis no primeiro ano de vida na ocorrência de CPI e cárie severa da infância (CSI) aos 4 anos de idade. Também foram investigadas práticas alimentares no primeiro ano de vida associadas à ocorrência de CSI nesta população. Métodos: Um ensaio randomizado (grupo intervenção=200; grupo controle=300) foi realizado com mães de crianças que nasceram no Hospital de São Leopoldo, Brasil, no setor do Sistema Único de Saúde (SUS). O grupo intervenção recebeu aconselhamento mensalmente até o 6o. mês e de dois em dois meses até completar o primeiro ano de vida, baseado nos “Dez Passos para uma Alimentação saudável”, uma política nacional para atenção primária baseada nas diretrizes da Organização Mundial da Saúde (OMS). O aconselhamento nutricional foi realizado por estudantes de graduação de nutrição e incluía promoção do aleitamento materno exclusivo, introdução gradual de alimentação complementar, intervalos razoáveis entre as refeições e evitar alimentos com alta 4 densidade de gordura e açúcar. As práticas alimentares foram coletadas aos 6 e 12 meses de idade utilizando metodologia padronizada. As perdas nos 4 anos da coorte compreenderam 160 crianças (32%); 340 foram examinadas para diagnóstico de CPI e CSI na avaliação dos 4 anos de idade. Resultados: As perdas nos 4 anos da coorte compreenderam 160 crianças (32%); 340 foram examinadas para diagnóstico de CPI e CSI na avaliação dos 4 anos de idade; 53,9% (76/141) das crianças do grupo intervenção e 69,3% (138/199) do grupo controle apresentaram CPI, com um risco 22% menor no grupo intervenção (RR 0,78; IC 95% 0,65-0,93; NNT 6,5; IC 95% 3,9-20,0); 29,1% (41/141) das crianças do grupo intervenção e 42,7% (85/199) do grupo controle apresentaram CSI. O risco de ocorrer CSI foi 32% menor para o grupo intervenção (RR 0,68; IC 95% 0,50-0,92; NNT 7,3; IC 95% 4,2-29,4). O número de dentes cariados (lesão com ou sem cavidade), perdidos e restaurados (c1+eo-d) foi menor para o grupo intervenção (3,25) em relação ao grupo controle (4,15) (teste de Mann Whitney; p=0,023). A ocorrência de CSI aos 4 anos de idade (n=126/340; 37%) esteve associada com as seguintes práticas alimentares aos 12 meses, após análise multivariada: aleitamento materno ≥7 vezes ao dia (RR 1,97; IC 95% 1,45-2,68), consumo de alimentos com alta densidade de açúcar (RR 1,43; IC 95% 1,08-1,89), uso da mamadeira para outros líquidos além do leite (RR 1,41; IC 95% 1,08- 1,86), número de refeições por dia >8 (RR 1,42; IC 95% 1,02-1,97). Também estiveram associados à ocorrência de CSI: escolaridade materna ≤8 anos (RR 1,50; IC 95% 1,03- 2,19) e número de dentes erupcionados aos 12 meses. Conclusões: O aconselhamento nutricional nas visitas às residências foi efetivo em reduzir CPI e CSI e estes achados sugerem que a orientação sobre práticas alimentares durante o primeiro ano de vida é uma medida viável para prevenir cárie na infância em comunidades de alto risco. Práticas alimentares no início da vida que representam fatores de risco para severidade de cárie nos anos subseqüentes também foram identificadas. Como estas práticas são reconhecidas como de risco para outras doenças crônicas, estes achados podem contribuir para o desenvolvimento de ações integradas para a prevenção de cárie dentária e outros desfechos de saúde geral. Políticas que promovam as condições socioeconômicas, com ênfase para o nível de escolaridade, poderão contribuir para a diminuição de cárie na infância nesta população. Registro do ensaio clínico: clinicaltrials.gov; número NCT00629629. / Context: Early childhood caries (ECC), defined as the presence of one or more decayed, missing (due to caries lesions) or filled deciduous teeth in children under 6 years of age, is a public health problem that affects infants and preschoolers throughout the world, leading to pain, chewing difficulties, speech problems, general health disorders and psychological problems. The treatment of ECC is expensive, sometimes requiring general anesthesia and hospitalization, and the condition frequently returns a few months later. The literature has strongly emphasized the need for (a) cohort studies in order to recognize the risk factors for the occurrence of childhood caries (b) prospective clinical trials to test alternative methods to prevent caries development in the first years of life. Objectives: To assess the long-term effectiveness of home visits for advising mothers about healthy feeding practices during the first year of life on the occurrence of early childhood caries (ECC) and severe early childhood caries (S-ECC) at the age of 4 years. Feeding practices in the first year of life associated with the occurrence of S-ECC in these children were also investigated. Methods: A randomized trial was carried out in mothers who gave birth within the public health system in Sao Leopoldo, Brazil (intervention group =200; controls = 300). The intervention group received the advice monthly up to 6 months and at 8, 10 and 12 months, based on the "Ten Steps for Healthy Feeding", a Brazilian national health policy for primary care, based on WHO guidelines. Advices were given by nutrition graduate students and included promotion of exclusive breastfeeding, gradual introduction of complementary foods; reasonable intervals between meals; and avoid high fat and sugar foods. Feeding practices were assessed using standardised methods at 6 and 12 months of age. Results: 160 (32%) children were lost in the four-year follow-up; 340 were examined for ECC and S-ECC occurrence at the fourth year assessment. ECC was found in 53.9% (76/141) of the children in the intervention group and 69.3% (138/199) of the controls, being 22% lower for the intervention group (RR 0.78; 95% CI 0.65-0.93; NNT 6.5; 95% CI 3.9-20.0); 29.1% (41/141) of the children in the intervention group and 42.7% (85/199) of the controls had S-ECC. The risk of S-ECC was 32% lower for the intervention group (RR 0.68; 95% CI 0.50-0.92; NNT 7.3; 95% CI 4.2-29.4). The number of decayed (white spots and cavities), missing and filled teeth (d1+mft) was lower for the intervention group (3.25) compared with the control group (4.15) (Mann Whitney U-test; p=0.023). S-ECC occurrence at four years of age (n=126/340; 37%) was significantly associated with the following feeding practices at 12 months: breastfeeding ≥ 7 times daily (RR 1.97; 95% CI 1.45-2.68), high density of sugar (RR 1.43; 95%CI 1.08-1.89), bottle use for liquids other than milk (RR 1.41; 95% CI: 1.08- 1.86), number of meals and snacks >8 (RR 1.42; 95% CI 1.02-1.97). Mother’s education ≤ 8 years (RR 1.50; 95% CI: 1.03-2.19) and number of teeth at 12 months were also associated with S-ECC. Conclusions: The home visits for dietary advice were effective in reducing ECC and S- ECC and our findings suggest that nutritional counseling during the first year of life must be considered as a feasible measure to prevent childhood caries in high-risk communities. Early feeding practices which represent risk factors for caries severity in subsequent years were also identified. Since these practices are recognized as risk factors for other chronic diseases, these findings may contribute to develop integrated interventions to prevent dental caries and general health outcomes. Future childhood caries control in this population is likely to benefit from policies that improve socioeconomic status, with special attention to level of education. Trial registration: site clinicaltrials.gov; registration number NCT00629629.

Introdução: a prevalência de obesidade infantil tem aumentado rapidamente no Brasil nas últimas décadas. Por isso, há uma necessidade urgente de desenvolver estratégias efetivas na prevenção e controle da obesidade infantil. Neste contexto, foi desenvolvido um programa de intervenção com educação nutricional e atividade física no âmbito escolar, com o objetivo de prevenção e controle da obesidade, denominado TriAtiva: educação, alimentação e atividade física. Métodos: trata-se de um estudo controlado randomizado por conglomerado, conduzido em 12 escolas municipais da cidade de Porto Alegre/RS (6 escolas intervenção e 6 escolas controle), do primeiro ao quarto ano do ensino fundamental, durante um ano letivo. O Programa TriAtiva foi implementado nas escolas de intervenção, através de práticas educativas relacionadas à alimentação saudável e à atividade física, visando ao desenvolvimento da saúde do aluno em um ambiente favorável, com o envolvimento da comunidade escolar e dos familiares. Foi considerado desfecho primário o índice de massa corporal e como desfechos secundários o percentual de gordura corporal, circunferência da cintura, além da prevalência, incidência e remissão do excesso de peso e obesidade. Resultados: foram avaliados 600 escolares, com uma perda de 10,3% até o final do estudo. Comparados ao grupo controle, escolares do grupo intervenção apresentaram redução no índice de massa corporal (IMC), com diferença de média padronizada (DMP) de -0,18 (IC95%: -0,27 a -0,08; P=0,002), no peso com DMP de -0,10 (IC95%: - 0,16 a -0,04; P=0,004) e no escore Z do IMC com DMP de -0,19 (IC95%: -0,29 a -0,09; P=0,002), todos com significância estatística. Também houve redução, mas não estatisticamente significativa, na circunferência da cintura com DMP de -0,07 (IC95%: -0,13 a 0,02; P=0,06) e no percentual de gordura corporal com DMP de -0,07 (IC95%: -0,28 a 0,14; P=0,47). O grupo intervenção apresentou mudança com a redução na prevalência de excesso de peso e obesidade com odds ratio (OR) de 0,77 (IC95%:0,61 a 0,97; P=0,02) e OR de 0,54 (IC95%: 0,44 a 0,67; P<0,001), respectivamente. Também houve aumento na remissão do excesso de peso e obesidade, com OR de 3,57 (IC95%: 1,39 a 9,09; P=0,008) e OR de 7,69 (IC95%: 3,94 a 14,28; P<0,001), respectivamente. Mas não houve mudanças na incidência do excesso de peso com OR de 0,57 (IC95%: 0,20 a 1,62; P= 0,29) e na obesidade com OR de 0,89 (IC95%: 0,18 a 4,28; P=0,88). Conclusão: o Programa TriAtiva apresentou efeitos positivos no IMC e mudanças favoráveis na prevalência e remissão da obesidade, após o término do programa, tornando-se um aliado na prevenção e controle da obesidade, no âmbito escolar. Registro Brasileiro de Ensaios Clínicos: RBR- 2xx2z4. / Introduction: The prevalence of childhood obesity has increased rapidly in Brazil in the last decades. Therefore, there is an urgent necessity to develop effective strategies for the prevention and control of childhood obesity. In this context, it was developed an intervention program with nutrition education and physical activity at schools, with objectives to prevent and control obesity, called TriAtiva: education, nutrition and physical activity. Methods: This is a cluster randomized controlled trial, conducted in 12 public schools in Porto Alegre/RS (6 intervention schools and 6 control schools), from first to fourth grade from elementary school during one school year. The TriAtiva Program was implemented in the intervention schools through educational practices associated to healthy eating and physical activity, aimed the development of the health for student in a favorable environment, with the involvement of the school community and family. The body mass index was considered the primary outcome and the secondary outcomes were the percentage of body fat, waist circumference, beyond the prevalence, incidence and remission of overweight and obesity. Results: 600 students were assessed, the loss was 10.3% until the end of the study. Compared to the control group, students in the intervention group showed a reduction in body mass index (BMI), the standardized mean difference (SMD) was -0.18 (95% CI: -0.27 to -0.08; P = 0.002 ), SMD for the weight was -0.10 (95% CI: - 0.16 to -0.04; P = 0.004) and for BMI z-score was -0.19 (95% CI: -0.29 to -0.09; P = 0.002), all with statistical significance. There was a reduction, but not statistically significant, in waist circumference, where SMD was -0.07 (95% CI: -0.13 to 0.02; P = 0.06) and SMD for percentage of body fat was -0.07 (95% CI: -0.28 to 0.14; P = 0.47). The intervention group showed a change with a reduction in the prevalence of overweight and obesity, odds ratio (OR) was 0.77 (95% CI: 0.61 to 0.97; P = 0.02) and 0.54 (95% CI: 0.44 to 0.67; P < 0.001), respectively. Also there was an increase in the remission of overweight and obesity, where OR was 3.57 (95% CI: 1.39 to 9.09; P = 0.008) and 7.69 (95% CI: 3.94 to 14.28; P < 0.001), respectively. Although there were no changes in the incidence of overweight where OR was 0.57 (95% CI: 0.20 to 1.62; P = 0.29) and for obesity OR was 0.89 (95% CI: 0.18 to 4.28; P = 0.88). Conclusion: TriAtiva program showed positive effects on BMI and favorable changes in the prevalence and remission of obesity, after the program ends, becoming an allied in the prevention and control of obesity at schools. Brazilian Clinical Trials Registry (ReBec): RBR- 2xx2z4.

Made available in DSpace on 2015-07-22T20:50:14Z (GMT). No. of bitstreams: 0 Previous issue date: 2011-11-24. Added 1 bitstream(s) on 2015-08-11T03:26:09Z : No. of bitstreams: 1 Publico-12675.pdf: 644045 bytes, checksum: 4760c174c211a52ff1a44e954522d1af (MD5) / A aderência ao tratamento para dependência química é questão preocupante e requer atenção especial dos profissionais que atuam com esta população. OBJETIVO: identificar características dos pacientes usuários de maconha que possam ser consideradas fatores preditivos de abandono do tratamento. METODOLOGIA: foi realizada a análise secundária dos dados de um Ensaio Clínico Randomizado em que foram incluídos 169 dependentes de maconha avaliados no ingresso e reavaliados três vezes nos seguimentos realizados após o tratamento breve ao qual foram submetidos. Os pacientes foram randomizados em três grupos de tratamento: no Grupo 1, os pacientes foram submetidos a quatro sessões de tratamento em um mês, no Grupo 2, as mesmas quatro sessões em três meses e no Grupo 3 ficaram os pacientes em espera, os quais, posteriormente foram randomizados para um dos dois grupos de tratamento. RESULTADOS: Os pacientes alocados no grupo três, ou seja, de espera, apresentaram 3.47 vezes mais chance de abandono do que aqueles inseridos nos outros grupos. Baseado nos dados sócio demográficos, concluiu-se que para cada ano de idade do paciente, as chances de abandono poderiam ser multiplicadas por 0,91, representando riscos mais baixos. Para cada ano de consumo da maconha, as chances também seriam multiplicadas por 0,92 representando menores riscos. CONCLUSÃO: Diante dos dados obtidos, pode-se inferir que quanto mais velho e quanto mais anos de consumo de maconha o sujeito tem, menores são suas chances de desistência do tratamento. Desta forma, pode-se apontar a importância de intervenções específicas para os grupos com riscos mais altos de abandono do tratamento foi discutida bem como a relevância de outros estudos envolvendo usuários de maconha e indicações para os profissionais ajudarem os pacientes a aderirem ao programa proposto. / The present study involved secondary analysis of data from a Randomized Clinical Trial including 169 cannabis-dependents not only dependents assessed at baseline and submitted to brief treatment. Patients were first randomized into three treatment groups. OBJECTIVES: The objective was to identify characteristics which could be considered predictors of treatment dropout. RESULTS: Patients initially allocated into the control group presented a 3.47 greater chance of drop out than those of the treatment groups. Based on the socio-demographic data, it was concluded that for every year of patient age, the chances of drop out would be multiplied by 0.91, representing lower risk. For every year of cannabis use, chances of drop out would be multiplied by 0.92, again representing reduced risk. CONCLUSIONS: The importance of specific interventions for groups with a higher risk of treatment drop out was discussed, along with the relevance of other studies involving cannabis users and possible guidelines for professionals help patient to adhere. / TEDE / BV UNIFESP: Teses e dissertações

Made available in DSpace on 2015-07-22T20:50:15Z (GMT). No. of bitstreams: 0 Previous issue date: 2011-06-29 / Objetivo: Comparar a fotocoagulação focal e em grade de acordo com o protocolo do Early Treatment Diabetic Retinopathy Study modificado (mETDRS) utilizando fotocoagulação com laser diodo 810nm sublimiar em micropulsos e densidade normal (FSM-DN) ou aumentada (FSM-DA) no tratamento do edema macular diabético (EMD). Métodos: Foi conduzido um estudo randomizado, controlado, prospectivo, duplo mascarado com pacientes não tratados com EMD e melhor acuidade visual corrigida (MAVC), pior que 20/40 e melhor que 20/400. Pacientes foram aleatorizados para receber fotocoagulação de acordo com o protocolo mETDRS (42 pacientes), FSM-DN (39 pacientes) ou FSM-DA (42 pacientes). Imediatamente antes do tratamento, 3, 6, bem como 12 meses após ele, todos os pacientes foram submetidos a exame oftalmológico, MAVC, retinografia colorida, angiografia fluorescente e tomografia de coerência óptica (OCT). Efeitos adversos nas diferentes técnicas de fotocoagulação foram observados durante o acompanhamento do estudo. Resultados: Durante o acompanhamento, todos os grupos apresentaram redução da espessura macular central, com diminuição no grupo FSM-DA de 93μm em três meses, 117μm em seis meses e 144μm em nove meses, comparado à redução de 67, 94 e 112μm em três, seis e nove meses respectivamente, no grupo mETDRS. Já o grupo FSM-DN apresentou redução de 20μm em três e seis meses e 34μm em nove meses, significativamente inferior aos grupos FSM-DA e mETDRS. Em relação à acuidade visual, houve melhora da MAVC gradual em três, seis e nove meses nos grupos FSM-DA e mETDRS sem diferenças estatisticamente significativas entre estes grupos, porém ambos superiores ao grupo FSM-DN, que não apresentou mudança na acuidade visual nesses períodos. Em doze meses, o grupo FSM-DA teve o melhor resultado em termos de MAVC (0,25 logMAR), seguido do grupo mETDRS (0,08 logMAR), enquanto o grupo FSM-DN não apresentou melhora significativa na MAVC (0,03 logMAR) (p<0,001). Todos os grupos apresentaram redução estatisticamente significativa da espessura macular central no OCT (p<0,001). O grupo FSM-DA demonstrou a maior redução (154μm), porém não foi estatisticamente significativa em relação ao grupo mETDRS (126μm; p=0,75). Não foram observados efeitos adversos graves nas diferentes formas de tratamento. Conclusão: Em um ano, a resposta clínica do grupo FSM-DA foi superior aos grupos mETDRS e FSM-DN, baseada na medida de espessura central da mácula e acuidade visual. Estes dados sugerem que a técnica de FSM-DA pode ser utilizada como conduta preferível para o tratamento de EMD, porém estudos clínicos multicêntricos são necessários para confirmar estes resultados. / Purpose: To compare modified Early Treatment Diabetic Retinopathy Study (ETDRS) focal/grid laser photocoagulation with normal-density (ND-SDM) or high-density (HD-SDM) subthreshold diode-laser micropulse photocoagulation for the treatment diabetic macular edema (DME). Methods: We conducted a prospective, randomized, controlled, double-masked clinical trial with patients with previously untreated DME and best corrected visual acuity (BCVA) worse than 20/40 and better than 20/400. Patients were randomized to receive either modified ETDRS focal / grid photocoagulation (42 patients), ND-SDM (39 patients) or HD-SDM (42 patients). Before treatment and 3, 6 and 12 months after treatment, all patients underwent ophthalmic examinations, BCVA, color fundus photography, fluorescein angiography and optical coherence tomography (OCT). Results: At 12 months, the HD-SDM group had the best improvement in BCVA (0.25 logMAR), followed by the modified ETDRS group (0.08 logMAR), while no improvements were seen in the ND-SDM group (0.03 logMAR). All groups showed statistically significant progressive reduction of CMT throughout the study (p<0.001). The HD-SDM group exhibited the greatest CMT reduction (154 μm), which was not significantly different from that of the modified ETDRS group (126 μm; p=0.75). Conclusions: At 1 year, the clinical performance of HD-SDM was superior to that of the modified ETDRS photocoagulation technique based on the anatomic and functional measures of improvement used in this investigation. A rationale for this treatment modality as a preferable approach is suggested, and the precise role of sub-threshold micropulse laser treatment may become more defined as experience grows, guided by optimized treatment guidelines and more comprehensive trials. / TEDE / BV UNIFESP: Teses e dissertações