Background: Research suggests that a low omega-3 index may contribute to the low heart rate variability and the increased risk of cardiovascular morbidity and mortality in bipolar disorders. However, so far, no intervention trial with EPA and DHA has been conducted in bipolar patients attempting to increase their heart rate variability. - Methods: 119 patients with bipolar disorder according to DSM-IV were screened, with 55 euthymic bipolar patients—owing to inclusion criteria (e.g. low omega-3 index (< 6%), SDNN < 60 ms.)—being enrolled in a randomized, double-blind, 12-week parallel study design with omega-3 fatty acids (4 capsules of 530 mg EPA, 150 mg DHA) or corn oil as a placebo, in addition to usual treatment. Heart rate variability as well as the omega-3 index were measured at baseline and at the endpoint of the study. - Results: A total of 42 patients (omega-3: n = 23, corn oil: n = 19) successfully completed the study after 12 weeks. There was a significant increase in the omega-3 index (value at endpoint minus value at baseline) in the omega-3 group compared to the corn oil group (p < 0.0001). However, there was no significant difference in the change of the SDNN (value at endpoint minus value at baseline) between the treatment groups (p = 0.22). In addition, no correlation between changes in SDNN and change in the omega-3 index could be detected in the omega-3 group (correlation coefficient = 0.02, p = 0.94) or the corn oil group (correlation coefficient = − 0.11, p = 0.91). Similarly, no significant differences between corn oil and omega-3 group regarding the change of LF (p = 0.19), HF (p = 0.34) and LF/HF ratio (p = 0.84) could be demonstrated. - Conclusions: In our randomized, controlled intervention trial in euthymic bipolar patients with a low omega-3 index and reduced heart rate variability no significant effect of omega-3 fatty acids on SDNN or frequency-domain measures HF, LF and LF/HF ratio could be detected. Possible reasons include, among others, the effect of psychotropic medication present in our trial and/or the genetics of bipolar disorder itself. Further research is needed to test these hypotheses.

Background: In the treatment of diabetes mellitus, the challenge is to integrate adequate self-management into clinical care. Customization including goal setting, monitoring, and feedback could be achieved through digitization. Digital linking between different devices could simplify and promote self-management. The aim of this study is to evaluate the outcome of diabetes treatment assisted by a digital health application compared with standard diabetes therapy. - Methods: The DAVOS study is a 6-month-period prospective, multicentric, randomized controlled trial. In total, 154 diabetes patients (age ≥18; treated with insulin) will be recruited and randomized into control group or intervention group. Both groups will receive standard diabetes care. The intervention group will additionally use a diabetes app. HbA1c value will be monitored on three separate defined visits. Primary endpoint is the overall reduction of HbA1c value. Secondary endpoints (eg, usability of the app) will be determined through patient-reported outcome questionnaires. - Discussion: Through enhanced interaction of health care professionals, providers of the app, and patients, the study aims to demonstrate improvement in the self-management of diabetes. As part of the closure management, all patients will be invited to use the examined application after completion of the study. The DAVOS study will be conducted in accordance with the valid version of the present study protocol and the internationally recognized International Conference on Harmonization–Good Clinical Practice (ICH-GCP) Guidelines. Special attention will be paid to European, national, and regional requirements for the approval, provision, and use of medical devices. The study was registered in the German Register of Clinical Trials (DRKS) with number DRKS00025996.

Introduction: Quality improvement (QI) encompasses a wide range of healthcare studies and activities with the common goal of improving patient outcomes, healthcare system performance, and professional development. QI is characterized by a diversity of definitions, stakeholders, clinical fields and study designs, which creates challenges for rigorous reporting and evaluation of these studies. Understanding and addressing the methodological issues that arise from conducting QI studies from multiple clinical disciplines is critical for generating good evidence for healthcare improvement to tackle health system challenges. Objectives: This thesis addressed three independent objectives: (i) Determine the quality of reporting of QI studies in neonatology. (ii) Compare different statistical methods that can be used to analyze data from a cluster randomized controlled trial with repeated measures data and examine how the estimate of intervention effects varies between these approaches. (iii) Determine the cost-effectiveness of providing timely surgery or timely rehabilitation for patients with hip fracture. Methods: Objective 1: We conducted a systematic survey of quality improvement studies in neonatology to examine the extent to which these publications adhered to SQUIRE 2.0, the guidelines for reporting studies that sought to improve the quality, safety, and value of healthcare. Using the same set of articles, we examined how various methodological attributes, such as stakeholder engagement, outcome measures, and statistical process controls, are reported in these studies. Objective 2: To compare the differences in the statistical estimates of intervention effects between linear mixed models and Generalized Estimating Equations, for the CP@Clinic Program cluster randomized RCT, which contains routinely collected monthly outcome data aggregated at the cluster level. Objective 3: We constructed a Markov cohort model to estimate the cost-effectiveness of receiving timely surgery within 24 hours of admission to the emergency department, receiving immediate admission to inpatient rehabilitation following acute care discharge, receiving both, or none. Results: Objective 1: In our assessment of reporting quality, we found that adherence to SQUIRE 2.0 guidelines was inadequate and that journals should endorse the SQUIRE 2.0 guideline for improvement publications to alleviate this issue. We found that process measures was the most frequently reported methodological attribute (89%), while stakeholder engagement with leadership (32%) or caregivers (10%) were infrequently reported or conducted. Objective 2: In comparing statistical methods for analyzing a cluster randomized controlled trial with correlated data, we found that it was critical to apply a correction to the variance estimator of generalized estimating equations to produce robust estimates of the intervention effects. Objective 3: In our economic evaluation, both timely surgery alone and the combination of timely surgery and timely rehabilitation yielded cost-effective improvements in the quality-adjusted life-years of patients with hip fracture. However, the combination of receiving timely surgery and timely rehabilitation requires a high willingness-to-pay threshold, above $128,000 per quality-adjusted life-years, to be considered cost-effective. Conclusions: Overall, understanding the state of reporting and the broad spectrum of methods and methodologic issues for evaluating quality improvement initiatives will advance its rigorous research, evaluation, reporting, and contribution towards informed decision-making for tackling pressing healthcare issues. / Thesis / Doctor of Philosophy (PhD) / Quality improvement (QI) is a field of healthcare research that can be defined in many ways, and research in this field is conducted by researchers from various medical disciplines. Consequently, challenges may arise in reporting and evaluating QI interventions. Thus, it is important to examine how QI interventions are reported in academic literature and the methods used to evaluate their effectiveness in improving health. The current thesis aims to address these issues through three independent objectives: (1) examine the details reported in QI studies in neonatology, (2) compare different statistical methods that can be used to analyze data from a community paramedicine cluster randomized controlled trial, and (3) investigate whether providing timely surgery and timely hospital-based rehabilitation is a cost-effective way to improve the quality of life of patients who have experienced hip fracture. The findings of these studies will provide insights into the challenges of reporting and evaluating QI interventions, and suggest ways to improve them.

Aim The aim for this present study was to investigate the acute metabolic response from intermittent resistance exercise during hypoxia, with the following research questions: (1) Are blood levels of lactate and glucose different between hypoxia and normoxia? (2) Does hypoxia induce higher lactate accumulation and pH reduction in the human skeletal muscle? (3) Is there a relationship between plasma-, blood- and muscle lactate? Method Eight healthy males (30 ± 2 years) performed 6 sets of unilateral leg extension on each leg (75% of 1RM) with randomized normoxic (20,9% inspired 𝑂2) and normobaric hypoxic (12% inspired 𝑂2) conditions. A total of 5 muscle biopsies was extracted from m. Vastus Lateralis (pre-, post exercise, 90-, 180min and 24h post exercise) during both normoxia and hypoxia trials, separated by one week for all participants. Blood samples were repeatedly taken with 20 min intervals. Heart Rate (HR) and saturation (𝑆𝑝𝑂2) were measured by a pulsoximeter during resistance exercise. Results No significant main effect was observed for blood lactate and glucose levels as well as the muscle lactate accumulation and pH between normoxia and hypoxia. However, pH in muscle showed a trend between the conditions post exercise where hypoxia reached lower levels in total (P=0.08). Significant correlations were observed for blood- and plasma lactate, where hypoxia showed a stronger relationship than normoxia (r=0.98 compared to r=0.87). Equal findings for the correlation of muscle- and plasma lactate showed an even greater coefficient value for hypoxia compared to normoxia (r=0.860 compared to r=0.59). Conclusion Summarized data indicated that no significant difference between hypoxia and normoxia was evident. Nonetheless, tendencies illustrate that hypoxia may alter the metabolic response slightly. However, further research is needed to draw a conclusion between the conditions. / Syftet med denna studie är att undersöka kroppens akuta metabola svar från intermittent styrketräning under hypoxi, med följande frågeställningar: (1) Skiljer sig nivåerna av laktat och glukos i blodet mellan hypoxi och normoxi? (2) Skapar hypoxi större laktatansamling och pH reduktion i människoskelettmuskeln? (3) Finns det en relation mellan plasma-, blod- och muskellaktat? Metod Åtta friska män (30 ± 2 år) deltog där deltagarna utförde 6 set unilateral benextension för varje ben (75% 1RM). Intermittent styrketräning randomiserades med hypoxi som utfördes med 12% syrgas och normoxi som bibehöll normal syrgasnivå (20,9% syrgas). Under två testdagar togs 5 muskelbiopsier från m. Vastus Lateralis (före-, efter träning, 90-, 180min och 24h efter träning) på vartannat ben per testdag. Hjärtfrekvensen och 𝑆𝑝𝑂2 mättes via pulsoximeter under träningen. Resultat Ingen signifikant huvudeffekt påvisades mellan hypoxi och normoxi för blodlaktat samt glukos, såväl som laktatackumulationen och pH värdet i muskeln. Muskel pH visade en trend där hypoxi efter styrketräning nådde lägre totalnivå än normoxi (P=0,08). Vidare observerades hypoxi att ha starka relationer mellan blod- och plasmalaktat jämfört med normoxi (r=0,98 vs. r=0,87). Större skillnad framgick för korrelationen mellan muskel- och plasmalaktat där hypoxi-försöket utgav starkare koefficient jämfört med normoxi (r=0,86 vs. r=0,59). Konklusion Sammanfattad data visar att hypoxi inte skapar större metabolisk respons vid intermittent styrketräning. Trots detta framkom tendenser som illustrerar att hypoxi kan påverka den metabola stressen under styrketräning. Däremot krävs vidare forskning för att kunna säkerställa effekten av hypoxi på kroppens metabola svar. / Ingår i Marcus Mobergs projekt: ”Resistance exercise under hypoxia and the acute molecular effects in human skeletal muscle

Objetivos: O objetivo deste estudo é analisar a perviedade da artéria torácica interna direita (ATID) pediculada, anteroaórtica em anastomose para a região anterior do coração na cirurgia de revascularização do miocárdio (RM), em relação à artéria torácica interna esquerda (ATIE). Métodos: No período de dezembro de 2008 a dezembro de 2011, 100 pacientes foram selecionados para serem submetidos a cirurgia de RM sem circulação extracorpórea (CEC), de forma prospectiva. Eles foram agrupados em Grupo 1 (G-1) e Grupo 2 (G-2), cada um com 50 pacientes, com randomização por computador e conhecimento da técnica no início da cirurgia. No G-1, os pacientes receberam ATIE para a região anterior do coração e complementação da RM com a ATID livre para ramos da circunflexa (CX) e outros enxertos arteriais ou venosos para a coronária direita (CD) e/ou ramos. Os pacientes do G-2 receberam ATID pediculada para a região anterior do coração e complementação da RM com ATIE, pediculada, para ramos da CX e outros enxertos arteriais ou venosos para a CD e/ou ramos. A perviedade das artérias torácicas internas direita e esquerda foi avaliada através de angiotomografia coronária multislice, 64 canais, no 6º mês de pós-operatório. Resultados: Os dois grupos eram semelhantes quanto aos dados clínicos de pré-operatório, como exemplo: diabetes mellitus, hipertensão arterial sistêmica, obesidade. Os dois grupos apresentaram predominância do sexo masculino com 75,6% e 88% nos grupos 1 e 2, respectivamente. Cinco pacientes migraram do G-1 para o G-2 em virtude de doença ateromatosa na aorta ascendente e um deles foi excluído por ter que utilizar enxerto composto. A média de anastomoses distais no G-1 foi de 3,48 (DP=0,72), e no G-2 foi de 3,20 (DP=0,76). Não ocorreu mediastinite em nenhum paciente. Uma paciente do G-1 apresentou osteomielite, e necessitou de intervenção cirúrgica. Dois pacientes do G-1 foram submetidos a reoperação por sangramento. Os resultados das angiotomografias coronarianas com 96 pacientes re-estudados mostram que todas as ATIs, fosse a direita ou a esquerda, utilizadas pediculadas para a região anterior do coração encontravam-se sem oclusões ou estenoses, configurando 100% de perviedade. No G-1, um enxerto livre da ATID para ramos da CX apresentava oclusão total, em dois pacientes havia estenose leve, em um deles havia estenose moderada na anastomose proximal na aorta ascendente e outro apresentava diminuição de calibre na sua porção distal. Em três pacientes o enxerto de segmento de veia safena para ramos da CD se encontravam ocluídos. No G-2, dois pacientes apresentavam oclusão total na ATIE pediculada para ramos da CX, e outro apresentava estenose moderada na porção distal da ATIE utilizada sequencial para dois ramos marginais. Em dois pacientes o enxerto de segmento de veia safena para ramos da CD se encontravam ocluídos. Não houve óbitos em nenhum dos grupos. Conclusão: A cirurgia de RM com utilização da ATID pediculada, anterógrada para o RIA, apresenta resultado semelhante ao da ATIE utilizada para essa mesma coronária. / Objective: To analyze the patency of the pedicled, anteroaortic, right internal mammary artery (RIMA) anastomosed to the left anterior descending (LAD) and branches in coronary artery bypass graft surgery (CABG), in comparison with the left internal mammary artery (LIMA). Methods: From December 2008 to December 2011, 100 patients were selected to undergo a prospective off-pump coronary artery bypass graft surgery and were randomly divided by computer into Group 1 (G-1) and Group 2 (G-2), so that the technique was known at the beginning of the surgery. In each group, with 50 patients, the patency of both right and left internal mammary arteries, which were used pedicled to the LAD, was comparatively studied through coronary computed tomography angiography. G-1 had 50 patients who received the LIMA to the LAD or LAD/diagonal (sequential) and had the CABG complemented with the free RIMA to circumflex branches and other arterial or venous grafts to the right coronary artery (RCA) and/or branches. G-2 had 50 patients who received the pedicled RIMA to the LAD or LAD/diagonal (sequential) and had the CABG complemented with the pedicled LIMA to circumflex branches and other arterial or venous grafts to the RCA and/or branches. Results: Both groups were similar in pre-operative clinical data, such as: diabetes mellitus, systemic arterial hypertension, obesity. Also, there was predominance of males in both groups, with 75,6% and 88% in Groups 1 and 2 respectively. Five patients were switched from G-1 to G-2 owing to atheromatous disease in the ascending aorta, and one of them was dropped for having to use composite graft. The average of distal anastomosis in G-1 was 3,48 (standard deviation (SD=0,72) and in G-2 was 3,20 (SD=0,76). Mediastinitis didn\'t occur in any patient. A patient from G-1 had osteomyelitis that required surgical intervention. Two patients from G-1 underwent reoperation because of bleeding. The 64-slice coronary computed tomography angiography was performed in the 6th postoperative month; 96 patients have been re-studied so far and all pedicled IMAs to the LAD were patent. In G-1 a free RIMA graft to the circumflex branches presented total occlusion, another two had a discreet stenosis and in one moderate at the proximal anastomosis and one more had a string signal at the distal portion. In G-2 two patients had total occlusion of the pedicled LIMA to circumflex artery branches, and another one presented moderate stenosis at its distal portion. In two patients the saphenous vein graft to the RCA branches were occluded. There were no deaths in any of the groups. Conclusion: The CABG surgery using the pedicled, anteroaortic RIMA to the LAD has a similar outcome to that of the LIMA used for this same coronary.

O presente estudo destinou-se a avaliar se os resultados clínicos iniciais da viscossuplementação poderiam ser melhorados com a adição de corticosteróide. As injeções intra-articulares são usadas há muitos anos no tratamento da osteoartrite dos joelhos, principalmente com suspensões cristalinas de corticosteróides. A viscossuplementação é uma intervenção relativamente nova, atualmente recomendada no tratamento da osteoartrite. Trata-se da injeção de ácido hialurônico exógeno em articulações diartrodiais, visando, além de restaurar as propriedades reológicas do líquido sinovial, efeitos modificadores da doença osteoartrite. Revisões sistemáticas mostram que a melhora clínica ocorre em duas a cinco semanas após a viscossuplementação. Comparando-se a viscossuplementação com a injeção intraarticular com corticosteróides, dados recentes sugerem maior eficiência no alívio da dor nas quatro primeiras semanas após a infiltração com corticosteróides, similaridade dos procedimentos ao redor da quarta semana e melhores resultados com a viscossuplementação após a oitava semana. Este inicio de ação mais tardio, associado a relatos de sinovite reacional após a viscossuplementação podem desencorajar médicos e pacientes ao uso desta modalidade de tratamento. No presente estudo foram avaliados 104 pacientes em tratamento para osteoartrite do joelho no grupo de doenças osteometabólicas do Instituto de Ortopedia do Hospital das Clínicas da FMUSP. Os pacientes foram randomizados em dois grupos. Um dos grupos foi denominado VS e recebeu uma única injeção intra-articular de 6ml de Hylan GF-20 (Synvisc One®-Genzyme) no joelho estudado. O segundo grupo foi denominado VS+T e recebeu uma injeção intra-articular de 6ml de Hylan GF-20 (Synvisc One®-Genzyme) mais 1ml (20mg) de Hexacetonido de Triancinolona (Triancil®-Apsen). Foram aplicados a escala visual analógica de dor (EVA) e os questionários de WOMAC e Lequesne uma semana antes da injeção e após uma, quatro, 12 e 24 semanas. Os dois grupos com 52 pacientes cada eram homogêneos. Na primeira semana, o WOMAC e a EVA apresentaram melhores resultados no Grupo VS+T (p < 0,01) em relação ao Grupo VS. Na quarta semana não houve diferença entre os grupos. Ambos apresentaram resultados similares nas semanas 12 e 24. Concluiu-se que a adição de hexacetonido de triancinolona melhorou os resultados clínicos da viscossuplementação no curto prazo, sem interferir nos resultados a longo prazo ou na incidência de efeitos adversos / The present study aims to assess if the initial results of viscosupplementation can be improved by the addition of corticosteroid. Intraarticular injections have been used for many years to treat arthritis and other painful articular disorders, mainly using long-lasting crystalline corticosteroid suspensions. Viscosupplementation is a relatively new intervention that is now widely used and recommended for the treatment of knee osteoarthritis. It is comprised of the injection of exogenous hyaluronic acid in diarthrodial joints, in order to restore the rheological properties of synovial fluid and also to promote osteoarthritis disease-modifying effects. Several placebo-controlled studies reported that clinical improvement began only within two to five weeks after viscosupplementation. When comparing viscosupplementation versus intraarticular injection of corticosteroid, recent data suggest that from baseline to week four, intraarticular steroid were more effective for pain relief. By the fourth week, however, both provided similar relief, but beyond the eighth week, hyaluronic acid provided greater pain reduction. The mechanism of action of hyaluronic acid, with delayed onset of pain/functional improvement, combined with reports of reactional sinovitis may discourage physicians and patients regarding this treatment modality. The present study evaluated 104 patients receiving usual care for knee osteoarthritis at the University of São Paulo Medical Center. Patients were randomized to receive either a single intra-articular injection of 6ml of Hylan GF-20 (Synvisc One®-Genzyme) (Group VS) or a single intra-articular injection of 6ml of Hylan GF-20 (Synvisc One®-Genzyme) plus 1ml (20mg) of Triamcinolone Hexacetonide (Triancil®-Apsen) (Group VS+T). VAS, WOMAC and Lequesne questionnaires were applied one week prior the injection, and after one, four, 12 and 24 weeks. The two groups with 52 patients each were homogeneous. At week one, WOMAC and VAS showed better results for Group VS+T compared to Group VS (p < 0,05). At week four the scores did not show statistically significant differences. The groups showed similar results at weeks 12 and 24. In conclusion, the addition of triamcinolone improved first-week symptom and functional scores of viscosupplementation, but not beyond. It did not seem to alter the likelihood of adverse effects

INTRODUÇÃO: A dependência química engloba alterações comportamentais, cognitivas e fisiológicas. A impulsividade está presente em muitos transtornos psiquiátricos. Sobre a impulsividade na dependência química de cocaína, os estudos existentes são relativamente novos. A Estimulação Magnética Transcraniana de repetição (EMTr) é um método capaz de neuromodular o cérebro. Este estudo avaliou os efeitos da EMTr sobre a impulsividade em dependentes de cocaína. MÉTODOS: Em um estudo randomizado, duplamente encoberto, 25 pacientes diagnosticados pelo DSM-IV-TR foram tratados com EMTr de alta frequência ativa (1250 pulsos/dia) ou EMTr placebo. O tratamento consistiu em 1 mês de aplicação de EMTr seguido de 2 meses em acompanhamento ambulatorial semanal em um grupo de prevenção de recaídas. Os pacientes foram avaliados antes do início do tratamento com EMTr (T0) e após o término das aplicações (T1), através dos instrumentos: The Shorter PROMIS Questionnaire, The Schalling Impulsivity Scale e The Leeds Dependence Questionnaire. RESULTADOS: 25 pacientes foram tratados e a análise dos dados demonstraram redução nos índices de impulsividade em ambos os grupos ao longo do tempo, porém, quando comparados entre si, os valores de interação não se mostraram significativos. CONCLUSÃO: Os efeitos da EMTr não diferiram em eficácia terapêutica na redução da impulsividade em dependentes de cocaína, com o efeito ativo correspondendo com o placebo / INTRODUCTION: Chemical addiction involves behavioral, cognitive and physiological alterations. Impulsivity is present in many psychiatric disorders. Studies about impulsivity and cocaine chemical addiction are relatively new. Transcranial Magnetic Stimulation (EMTr) is a method capable of neuromodulation the brain. This study evaluated the effects of EMTr over impulsivity in cocaine addicts. METHODS: This is a randomized doubly covert study with 25 patients diagnosed by the DSM-IV-TR who were treated with active high frequency EMTr (1250 pulses/day) or placebo. Treatment was consisted of one month of application of EMTr followed by 2 months of clinical follow-up in a relapse prevention group. Patients were evaluated before the treatment with EMTr (T0) and after the end of the applications (T1), through the instruments: The Shorter PROMIS Questionnaire, The Schalling Impulsivity Scale and The Leeds Dependence Questionnaire. RESULTS: 25 patients were treated and data analysis showed a reduction in the levels of impulsivity in both groups throughout the time. However, group comparisons did not show statistical differences. CONCLUSION: EMTr\'s effects did not differ in terms of therapeutical efficacy in the reduction of impulsivity in cocaine addicts

Introdução. A intervenção coronária percutânea (ICP) é um dos tratamentos para pacientes com doença arterial coronária (DAC). Essa intervenção deve ser acompanhada de outras medidas terapêuticas com o intuito de reduzir as incapacidades e o risco de novos eventos coronários; de controlar a progressão da doença; e de melhorar a qualidade de vida. Essas medidas compreendem a prevenção secundária da DAC e estão, principalmente, relacionadas às mudanças no estilo de vida para o manejo de fatores de risco para DAC. O contato por telefone tem sido utilizado por profissionais da área da saúde para o seguimento do paciente e da família no cuidado com diversas condições crônicas, incluindo a DAC. Objetivo. Desenvolver, implementar e avaliar um programa educativo com seguimento por telefone, durante o período de quatro meses após a alta hospitalar, para pacientes submetidos à ICP com o objetivo de melhorar o estado de saúde percebido, a autoeficácia, a adesão aos medicamentos e o estado emocional desses pacientes, bem como comparar desfechos do Programa Educativo com os de serviços de rotina hospitalar. Método. Ensaio clínico controlado e aleatorizado, realizado no Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto. A amostra deste estudo foi constituída pelos pacientes submetidos à primeira ICP, entre agosto de 2011 e junho de 2012. Os participantes foram aleatorizados para o Programa Educativo com Seguimento por Telefone (grupo intervenção [GI]: 30 participantes) ou cuidado conforme a rotina da instituição (grupo controle [GC]: 30 participantes). O referencial teórico que fundamentou o Programa Educativo aplicado neste estudo foi o construto de autoeficácia, presente na Teoria Social Cognitiva de Albert Bandura. O desfecho principal foi o estado de saúde percebido, avaliado pelo Medical Outcomes Survey 36- Item Short Form (SF-36), e os desfechos secundários foram a autoeficácia avaliada pela Escala de Autoeficácia Geral Percebida, a adesão aos medicamentos por meio do instrumento Medida de Adesão aos Tratamentos (MAT) e o estado emocional (ansiedade e depressão) avaliado pela Escala Hospitalar de Ansiedade e Depressão (HADS). Os desfechos foram avaliados antes do procedimento (T0) e seis meses após a ICP (T1). A análise foi por análise descritiva, análise de variância para medidas repetidas, teste de Qui-quadrado e risco relativo com intervalo de confiança de 95%. O nível de significância foi de 0,05. Este ensaio clínico foi registrado sob o número NCT01341093. Resultados. Na avaliação do estado de saúde percebido, com um nível de significância de 0,05, nenhuma interação (tempo e grupo) ou grupo foi estaticamente significante, mas houve interação entre tempo e grupo com valores de nível de significância entre 0,05 e 0,10 no Sumário do Componente Mental (p=0,08) e no domínio Aspectos Emocionais (p=0,07) e melhora no domínio Aspectos Sociais no GI (p=0,10). Na avaliação da autoeficácia, não houve diferenças entre os grupos ou tempos. Houve alta percentagem de participantes que relataram adesão aos medicamentos nos tempos T0 e T1, nos dois grupos (mais de 90% inicial e no seguimento). Na avaliação da ansiedade, seis meses após a ICP, houve aumento de não-caso de ansiedade no GI e diminuição no GC, e a associação entre as variáveis foi estatisticamente significante (p=0,04). Ao final do seguimento, o risco relativo do GI de ser não-caso de ansiedade foi de 1,6 (intervalo de confiança [IC] de 95%=1,0 a 2,4) quando comparado com o GC. Em relação à depressão, não houve evidência de diferenças no percentual de pacientes não- caso de depressão entre os grupos (GI e GC), tanto na internação como no seguimento. Ao final do seguimento, o risco relativo do GI de ser não-caso de depressão foi de 0,8 (intervalo de confiança [IC] de 95%=0,6 a 1,1), quando comparado com o GC. Conclusão. O Programa Educativo com Seguimento por Telefone é uma intervenção promissora para melhorar o estado de saúde percebido e para reduzir a ansiedade de pacientes submetidos à ICP. Pode ser necessário aperfeiçoar a intervenção para que haja efeitos na autoeficácia e na depressão. Os instrumentos para medidas de autoeficácia e de adesão aos medicamentos precisam ser melhorados / Introduction. Percutaneous coronary intervention (PCI) is one of the treatments available for coronary artery disease (CAD) patients. This intervention should be accompanied by other therapeutic interventions with the aim of reducing disabilities and the risk of new coronary events, controlling the progression of the disease, and improving the quality of life. These interventions comprise the secondary prevention of CAD and are mainly related to lifestyle changes, aiming to manage risk factors for CAD. Health professionals have used telephone follow-up to monitor patients and families in the delivery of care to different chronic conditions, including CAD. Objective. To develop, to implement and to assess an educational program with telephone follow-up, during four months after hospital discharge, for patients submitted to PCI, with the aim of improving the perceived health status, self-efficacy, medication adherence and emotional status of these patients, as well as to compare outcomes of the Educational Program with routine hospital services. Method. Randomized controlled clinical trial, developed at the Ribeirão Preto Medical School Hospital das Clínicas, Brazil. The study sample included patients who had been submitted to their first PCI between August 2011 and June 2012. The participants were randomly assigned to the Educational Program with Telephone Follow-up (intervention group [IG]: 30 participants) and routine care (control group [CG]: 30 participants). The theoretical framework that supported the Educational Program applied in this study was the self-efficacy construct in Albert Bandura\'s Social Cognitive Theory. The main outcome was the perceived health status, assessed using the Medical Outcomes Survey 36- Item Short Form (SF-36); and the secondary outcomes were self-efficacy, assessed using the Perceived General Self-Efficacy Scale; medication adherence, assessed using the Medida de Adesão ao Tratamento (MAT); and the emotional status (anxiety and depression), assessed using the Hospital Anxiety and Depression Scale (HADS). The outcomes were evaluated before the procedure (T0) and six months after the PCI (T1). Descriptive analysis was applied, as well as variance analysis for repeated measures, the chi-square test and relative risk, with the confidence interval set at 95%. Significance was set at 0.05. This clinical trial was registered under number NCT01341093. Results. In the assessment of the perceived health status, with significance set at 0.05, no interaction (time and group) or group was statistically significant, but interaction between time and group was verified, with significance levels ranging between 0.05 and 0.10 in the Mental Component Summary (p=0.08) and in the Emotional Aspects domain (p=0.07); as well as improvement in the Social Aspects domain for the IG (p=0.10). In the assessment of self-efficacy, no differences were found between the groups or times. Many participants indicated medication adherence at T0 and T1 in the two groups (more than 90% initially and during the follow-up). In the assessment of anxiety levels six months after the PCI, the number of non-cases of anxiety increased in IG and dropped in CG, with a statistically significant association between the variables (p=0.04). At the end of the monitoring, the relative risk of being a non-case of anxiety in IG corresponded to 1.6 (95% confidence interval [CI]=1.0 - 2.4) when compared to CG. As regards depression, no evidence was found of differences in the percentage of patients non-case of depression between the groups (IG and CG), neither during hospitalization nor during follow-up. At the end of the follow-up, the relative risk of IG being a non-case of depression corresponded to 0.8 (95% confidence interval [CI]= 0.6 - 1.1) when compared to CG. Conclusion. The Educational Program with Telephone Follow-up is a promising intervention to improve the perceived health status and reduce the anxiety of patients submitted to PCI. The intervention may need further development to influence self-efficacy and depression. Self-efficacy and medication adherence instruments need improvements

As complicações biliares mais comuns pós-transplante hepático são as estenoses da anastomose, as estenoses não-anastomóticas e as fístulas biliares e podem ocorrer de diferentes modos, de forma isolada ou associada. A origem do enxerto (doador cadáver ou doador vivo) tem influência na incidência de estenose biliar, bem como na resposta ao tratamento endoscópico. A terapêutica endoscópica utilizando-se esfincterotomia, dilatação balonada da estenose e inserção de próteses biliares através da CPRE é utilizada como método inicial de tratamento dessas complicações. Objetivos: Comparar as diferentes técnicas de tratamento endoscópico das estenoses biliares pós-transplante hepático. Método: Foi realizada uma revisão sistemática da literatura e metanálise sendo a busca conduzida nas bases MEDLINE, EMBASE, Scielo - LILACS e Biblioteca Cochrane até junho de 2015. A metanálise foi executada utilizando-se os softwares Review Manager, 2012 (RevMan) versão 5.2 e OpenMetaAnalyst e os cálculos dos desfechos foram feitos comparando-se os resultados dos estudos incluídos utilizando-se a diferença de risco absoluto e adotando-se um intervalo de confiança (IC) de 95%. Os estudos foram agrupados comparando-se transplantes hepáticos com doador cadáver versus doador vivo; dilatação biliar endoscópica com balão exclusiva versus dilatação biliar endoscópica com balão associada à inserção de próteses plásticas e próteses biliares plásticas comparadas à prótese biliar metálica por endoscopia. Os desfechos clínicos analisados foram incidência da estenose biliar, falha do tratamento endoscópico, resolução da estenose, recorrência da estenose e complicações. Resultados: Foram recuperados 1.110 artigos, sendo motivo de análise dez ensaios clínicos, com apenas um Ensaio Clínico Randomizado e nove Ensaios Clínicos não randomizados, dos quais sete foram incluídos na metanálise. Comparando-se doador cadáver e doador vivo observou-se redução da incidência de estenose biliar (p=0,0001), bem como da falha técnica do tratamento endoscópico (p=0,0009) e da recorrência da estenose biliar (p=0,03) nos transplantes realizados com enxertos provenientes de doador cadáver. Dois estudos compararam o tratamento da estenose da anastomose biliar pós-transplante hepático utilizando dilatação com balão exclusiva versus dilatação com balão associada à inserção próteses plásticas e não foram observadas diferenças estatisticamente significantes em relação aos desfechos falha de tratamento, recorrência da estenose ou complicações. Somente o desfecho clínico complicações teve resultado estatisticamente significante na comparação entre prótese metálica autoexpansível versus prótese plástica no tratamento da estenose da anastomose biliar pós-transplante hepático (p= 0.03). Conclusões: O tratamento da estenose biliar anastomótica pós-transplante hepático com prótese metálica foi igualmente efetivo quando comparado ao uso de prótese plástica, mas associou-se a um menor risco de complicações. A comparação entre dilatação com balão exclusiva e dilatação com balão associada à prótese plástica apresentou resultados semelhantes em relação à falha do tratamento endoscópico, complicações e recorrência da estenose. A utilização de enxerto proveniente de doador cadáver reduziu o risco de estenose biliar pós-transplante hepático e o tratamento endoscópico nesse grupo de pacientes, foi mais efetivo quando comparado com as estenoses biliares após transplante com doador vivo / The most common biliary complications after liver transplantation are anastomotic strictures, non-anastomotic strictures and biliary fistulas and they can occur in different fashions, isolated or in combination. Graft source (cadaveric liver donor or living liver donor) has an influence on the incidence of biliary strictures as well as on the response to endoscopic treatment. The endoscopic treatment using sphincterotomy, balloon dilation and insertion of biliary stents by ERCP (Endoscopic Retrograde Cholangiopancreatography) is used as an initial endoscopic approach to treat these complications. Objectives: To compare different endoscopic techniques to treat post-liver transplantation biliary strictures. Method: It was performed a systematic review of the literature and meta-analysis and the search was carried out on MEDLINE, EMBASE, Scielo-LILACS and Cochrane Library databases until June, 2015. The meta-analysis was made using Review Manager, 2012 (RevMan) version 5.2 and OpenMetaAnalyst software and the calculations of the outcomes were made comparing the results from the included papers by using the difference in absolute risks, adopting a confidence interval of 95%. The studies were grouped comparing cadaveric liver donor versus living liver donor grafts; exclusive balloon dilation versus balloon dilation associated with plastic stents insertion; and plastic stents versus totally covered selfexpandable metal stents. The clinical outcomes were biliary stricture incidence, endoscopic treatment failure, stricture resolution, stricture recurrence and complications. Results: There were retrieved 1,100 articles. Ten clinical trials were analyzed, with just one Randomized Clinical Trial and nine Non-Randomized Clinical Trials, out of which seven were included in the meta-analysis. When comparing cadaveric liver donor transplantation to living liver donor transplantation, it was observed a decrease in the incidence of biliary strictures (p=0.0001), as well as in the technical failure rate of the endoscopic treatment (p=0.0009) and in the biliary stricture recurrence (p=0.03) in the cadaveric liver donor graft group. Two studies have compared the treatment of anastomotic biliary strictures after liver transplantation using balloon dilation exclusive to balloon dilation associated with the insertion of plastic stents, and no statistically significant differences in relation to endoscopic treatment failure, stricture recurrence or complications rates were observed. Only the clinical outcome complications had statistically significant result in a comparison between self-expandable metal stents versus plastic stents in the treatment of post-liver transplantation anastomotic biliary strictures (p=0.03). Conclusions: The treatment of post-liver transplantation anastomotic biliary strictures was equally effective when compared the use of self-expandable metal stents to plastic stents, but the use metallic stents was associated with a lower complication risk. The comparison between exclusive balloon dilation to balloon dilation associated with plastic stents presented similar results in relation to endoscopic treatment failure, complications and stenosis recurrence. The use of graft from cadaveric donor reduced the risk of biliary stenosis after liver transplantation and endoscopic treatment of biliary strictures in these patients were more effective when compared to biliary strictures after living liver donor transplantation

Objetivos: Comparar os efeitos de um mês de tratamento com aparelho de pressão aérea positiva (CPAP) e com placebo sobre a aparência e características objetivas da pele da face de pacientes com apneia obstrutiva do sono (AOS), num estudo randomizado e cruzado. Métodos: Foram incluídos pacientes consecutivos com AOS grave e sonolentos. Os pacientes realizaram três polissonografias (PSG): a primeira para confirmação da AOS e outras duas adicionais com uso de placebo (dilatador nasal) e para titulação de CPAP, antes do início de cada tratamento. Todos os pacientes foram aleatoriamente alocados em dois grupos de tratamento: 1) uso do placebo e 2) uso do CPAP. Após um mês com o primeiro tratamento e 15 dias de washout, houve cruzamento para o segundo tratamento. A face dos pacientes foi fotografada de modo padronizado nos três momentos experimentais. As fotografias foram apresentadas, em ordem aleatória, pelo Qualtrics Survey Software, e avaliadas on-line por 704 observadores para quantificação da aparência saudável (nada saudável até extremamente saudável), atraente (nada atraente até extremamente atraente) e cansada (nada cansada até extremamente cansada). A idade aparente também foi perguntada para cada observador. Foram realizadas avaliações quantitativas das características da pele da face dos pacientes, em cada momento experimental, incluindo a presença de acne, manchas, porosidade, rugas, textura, e uniformidade do tom da pele, por meio da captação de imagens pelo equipamento VISIATM System. Resultados: Foram avaliados 30 pacientes (idade=46±9 anos; 21 homens). Os pacientes utilizaram o placebo em 98% das noites do período de tratamento e a adesão ao CPAP foi de 94% das noites, com média de 6,0 ± 1,7 horas de uso por dia de tratamento. Após o tratamento com CPAP, em comparação ao momento basal e após tratamento placebo, foi observada melhora na qualidade objetiva do sono, sonolência, qualidade de vida e sintomas depressivos (P < 0,05). A avaliação das fotografias pelos observadores mostrou que os pacientes foram identificados como mais jovens após o uso de CPAP (P < 0,001), mas não foram observadas alterações quantitativas das características da pele da face, em comparação com o momento basal e após o uso de placebo. A análise de regressão linear identificou que a quantidade de dias de tratamento com CPAP, o tempo total de sono e a porcentagem do tempo total de sono com saturação de oxihemoglobina abaixo de 90% foram preditores da diminuição da idade atribuída após o uso de CPAP. Conclusão: Os pacientes com AOS graves e sonolentos apresentaram aparência mais jovem após um mês de tratamento com CPAP / Objectives: To compare the effects of one month with continuous positive airway pressure (CPAP) treatment and placebo intervention on the appearance and objective facial skin characteristics of patients with obstructive sleep apnea (OSA) in a randomized crossover study. Methods: Consecutive sleepy patients with severe OSA were included. The patients underwent three polysomnograms (PSG): first one to confirm OSA and two additional ones using placebo (nasal dilator) and for CPAP titration before starting each treatment period. All patients were randomly included into two treatment groups: 1) placebo use and 2) CPAP use. After one month with the first treatment and 15 days of washout, patients were crossed-over for the second treatment. Photographs from the patients\' faces were obtained in the three experimental moments. The photographs were presented in a random order by the Qualtrics Survey Software, and were evaluated online by 704 observers for quantifying healthy appearance (unhealthy to extremely healthy), attractive (unattractive to extremely attractive) and tired (not tired to extremely tired). Apparent age was also rated for each observer. Quantitative evaluations of the skin characteristics of the patients\' faces were also carried out at each experimental moment, including the presence of acne, patches, porosity, wrinkles, texture, and skin tone uniformity, through the capture of images by VISIATM System equipment. Results: 30 patients (age = 46±9 years, 21 men) were evaluated. During treatment period, the patients wearing placebo intervention on 98% of the nights and adherence to CPAP was 94%, with a mean of 6.0 ± 1.7 hours of use per day of treatment. After CPAP treatment, compared to baseline and after placebo treatment, improvement in the objective sleep quality, sleepiness, quality of life and depressive symptoms were observed (P <0.05). Observational assessment of the photographs showed that patients were evaluated as being younger after using CPAP (P < 0.001), but no quantitative changes in face skin characteristics were observed compared to the baseline and after the use of placebo. Linear regression analysis identified the number of days with CPAP treatment, total sleep time and percentage of total sleep time with oxyhemoglobin saturation below 90% were predictors of decreasing of rated age after CPAP treatment. Conclusion: Sleepy patients with severe OSA had a younger appearance after one month of CPAP treatment