L’arrêt cardiaque extra-hospitalier (ACREH) touche environ 30 à 40,000 personnes en France chaque année. Dans près de la moitié des cas, la cause de l’ACREH est une occlusion coronaire aiguë provoquant un trouble du rythme ventriculaire létal. Malgré les progrès réalisés ces dernières années en terme de prise en charge pré et intra-hospitalière, le pronostic de ces patients reste sombre, de par les lésions neurologiques se produisant très rapidement après l’arrêt circulatoire. Alors que le pronostic à court terme est relativement bien décrit, les données sur le devenir à long terme, en termes de survie, mais aussi de devenir fonctionnel, neurologique, et de qualité de vie, restent rares. Objectifs : L’objectif de ce travail est de décrire le devenir à long terme des patients victimes d’un ACREH et admis vivants à l’hôpital (qualité de vie liée à l’état de santé, devenir neurologique et fonctionnel) et d’évaluer les facteurs associés à ce devenir (biomarqueurs, revascularisation coronaire précoce). Patients et méthodes : Ce travail a consisté en l’analyse des données de la cohorte des patients victimes d’un ACREH et admis vivants en réanimation mé- dicale à l’hôpital Cochin. Cette cohorte a été constituée rétrospectivement entre 2000 et 2006 sur dossiers archivés puis prospectivement selon les recommandations internationales d’Utstein depuis 2007. Les données de survie ont été collectées. Le devenir neurologique et fonctionnel et les données de qualité de vie ont été collectées lors d’entretiens téléphoniques réalisés auprès des survivants sortis vivants de l’hôpital. Résultats principaux : La mortalité globale à J30 était de 68,2%. La revascu- larisation coronaire (ATL) immédiate était associée à une mortalité à J30 plus faible (ORcoro sans ATL vs. pas coro 0,79 [0,57;1,08], p=0,14 et ORcoro avec ATL vs. pas coro 0,61 [0,43;0,85], p<0,01). Les 466 patients vivants à J30 ont été suivis pendant une durée médiane de 3,2 ans [IQR : 0,7 ;6,7], avec une durée maximale de suivi de 13,5 ans. En analyse multivariée, la revascularisation coronaire immédiate restait inversement associée à la mortalité à long terme (HRcoro sans ATL vs. pas coro 0,78 [0,45 ;1,33], p=0,35 et HRcoro avec ATL vs. pas coro 0,40 [0,23 ;0,70], p<0,01).
La copeptine a été dosée chez 298/510 patients à l’admission et chez 224 patients à J3. Le taux médian à l’admission était de 261,3 [125,2 ;478,6] pmol/L. Le taux de survie à 1 an était inversement proportionnel au quintile de copeptine à l’admission (38,2, 32,6, 27,7, 31 et 13,6%, respectivement; p<0,01). En analyse multivariée, seul le cinquième quintile de copeptine à l’admission était associé à la mortalité à 1 an (HR5ème vs. 1er 1,64 [1,06;2,58], p=0,03). Après ajustement mutuel des taux de copeptine à l’admission et à J3, le taux de copeptine à l’admission n’était plus associé à la mortalité à 1 an mais le taux de copeptine à J3 restait asso- cié à la mortalité à 1 an par une relation concentration-dépendante (HR2ème vs. 1er 1,60 [0,90-3,17], p=0,10 ; HR3ème vs. 1er 1,94 [1,01 ;3,71], p=0,05 ; HR 4ème vs. 1er 2,01 [1,04 ;3,89], p=0,04 et HR5ème vs. er 2,38 [1,19 ;4,74], p=0,01 ; p de tendance =0,02). Au cours du suivi, 255 patients ont pu être recontactés. Le délai médian de recon- tact après la survenue de l’ACREH était de 50 [22-93] mois. 66% des patients sortis de réanimation avec un score CPC coté à 1 gardaient une performance neurolo- gique préservée au moment de l’interview (n=150/231). Les dimensions physiques et mentales agrégées du SF-36 étaient similaires chez les survivants d’ACREH en comparaison avec les individus de la population générale (47,0 vs. 47,1, p=0,88 et 46,4 vs. 46,9, p=0,45, respectivement). Les patients présentaient une altération plus marquée des dimensions physiques que des dimensions mentales du score SF- 36 en comparaison avec la population générale. L’activité physique (74,1 vs. 78,4, p=0,02) et la vitalité (50,7 vs. 56,2, p<0,01) étaient les dimensions les plus altérées. (...) / Out-of-hospital cardiac arrest (OHCA) occurs in about 30-40,000 people in France each year and is related to a culprit coronary occlusion in half cases. Although pre and in-hospital management of such patients dramatically improved last years, outcome remains poor because of the neurological damage related to brain anoxia. Short-term outcome is well-described but data are lacking on long-term outcome, functionnal and neurological outcome and health-related quality of life (HRQOL). Objectives : The main purpose of this work was to describe the long-term outcome of successfully resuscitated OHCA patients admitted alive at ICU. We aimed at picking up factors associated with HRQOL as well. Patients and methods : Data from the Paris registry were used. Consecutive sucessfully resuscitated OHCA patients admitted alive at Medical ICU of Cochin hospital, Paris, France are included in the database since 2000, January 1st, accor-ding to Utstein style. We also collected survival data. Neurological and functionnal outcome, as well as HRQOL (SF-36 questionnaire) were recorded during phone in- terviews in OHCA patients discharged alive from hospital. Main results : Overall mortality at day-30 was 68.2%. Immediate percutaneous coronary intervention (PCI) was associated with day-30 mortality (ORcoro w/o PCI vs. no coro 0.79 [0.57,1.08], p=0.14 et ORcoro w/ PCI vs. no coro 0.61 [0.43,0.85], p<0.01). The 466 patients alive at day-30 were followed-up for 3.2 years [IQR : 0.7-6.7]. After adjus- tement for cofounders, immediate PCI remained associated with long-term mor-
tality (HRcoro w/o PCI vs. no coro 0.78 [0.45,1.33], p=0.35 et HRcoro w/ PCI vs. no coro 0.40 [0.23,0.70], p<0.01). Copeptin was assessed in 298/510 patients at ICU admission and in 224 patients at day-3. Median admission copeptin level was 261.3 [125.2,478.6] pmol/L. Survival rates were 38.2, 32.6, 27.7, 31 and 13.6% through admission copeptin quintiles (p<0,01). In multivariate analysis, only the fifth quin-
tile was associated with one-year mortality (HR5ème vs. 1st 1.64 [1.06-2.58], p=0.03). After mutual adjustement of admission and day-3 copeptin levels, admission co- peptin level was not associated anymore with one-year mortality whereas day-3 copeptin level remained associated with one-year mortality in a concentration- dependent manner (HR2nd vs. 1st 1.60 [0.90-3.17], p=0.10; HR3th vs. 1st 1.94 [1.01- 3.71], p=0.05; HR 4th vs. 1st 2.01 [1.04-3.89], p=0.04 et HR5th vs. st 2.38 [1.19-4.74], p=0.01 ; p for trend =0.02). During follow-up, 255 OHCA patients dicharged alive from hospital were phone in- terviewed, after a median duration from cardiac arrest of 50 [22-93] months. 66% of patients kept a good cerebral performance after hospital discharge (n=150/231). Overall physical and mental SF-36 dimensions were similar between OHCA pa- tients and age- and gender-matched individuals from French general population (47.0 vs. 47.1,p=0.88 and 46.4 vs. 46.9, p=0.45, respectively). Physical dimensions were more significantly altered in OHCA patients, especially physical functionning (74.1 vs. 78.4, p=0.02) and vitality (50.7 vs. 56.2, p<0.01). In multivariate analysis, age, male gender, initial shockable rhythm were associated with an improvement in most of the SF-36 dimensions. Immediate PCI was associated with a gain in physical functionning (+7.0, p=0.06), general health (+7.3, p=0.02) and vitality (+4.4, p=0.08). Conclusion : Overall survival in this large cohort of successfully resuscitated OHCA patients was about 20%. Immediate PCI was associated with a decrea- sed short and long-term mortality. HRQOL was similar between OHCA patients and age and gender matched individuals from general population but physical di- mensions appeared significantly altered. Age, male gender and initial shockable rhythm were associated with a better HRQOL. (...)

Mit der vorliegenden Arbeit werden aktuelle Anwendungsbereiche der Lebensqualitätsforschung innerhalb der klinischen Medizin dargestellt. Besonderes Gewicht wurde dabei auf die Erläuterung der Grundlagen der Lebensqualitätsforschung und der derzeit verbreiteten Konzepte, die Diskussion aktueller und zukünftiger Messmethoden sowie die Darstellung einiger typischer Anwendungen gelegt. Der letzte Teil der Arbeit weist auf die bereits erkennbaren Grenzen und ethischen Konsequenzen dieser Forschungsrichtung hin. In der Habilitationsschrift werden verschiedene Originalarbeiten zusammengefasst, denen jeweils eine allgemeine Einführung zur leichteren thematische Einordnung vorangestellt ist. / This volume demonstrates the present scope of 'Quality of Life' research within a clinical context. Different chapters describe the foundations and the development of 'Quality of Life' research, presently used concepts, discussions about appropriate measurement models and some perspectives for an improvement of psychometric methods. Further, different applications and purposes to use 'Quality of Life' instruments in a clinical context are demonstrated. The last part discusses particular ethical consequences and other limitations of 'Quality of Life' research. All chapters combine introductory sections with published original works.

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L’étude de la qualité de vie relative à la santé est un objectif prioritaire des essais cliniques en cancérologie pour évaluer l’efficacité d’une prise en charge ; elle est mesurée par le biais d’auto-questionnaire. Dans ce travail, nous proposons différentes modélisations statistiques pour l’analyse longitudinale de ce critère, ainsi que leur application sur des données issues de plusieurs essais cliniques. Une première partie présente les modèles issus de la théorie de réponse à l’item (IRT) pour réaliser une analyse longitudinale directement sur les données brutes (multi-réponses ordinales) et ce par dimension. Une fois replacés dans le contexte des modèles linéaires généralisés mixtes, une sélection conceptuelle de modèles IRT a conclu que le Graded response model semble le mieux adapté. Dans une seconde partie, nous proposons un modèle à équation structurelle permettant de prendre en compte conjointement l’aspect multidimensionnel et longitudinal de la qualité de vie. À l’aide de facteurs reflétés par des ensembles de variables observées, il permet de lier à chaque temps de mesure toutes les observations issues du questionnaire, tout en considérant également des variables explicatives. L’analyse longitudinale est réalisée sur le statut global de santé et les facteurs réduisant ainsi le nombre de tests. Enfin, une approche par mélanges de modèles mixtes est proposée pour obtenir des classes latentes à partir de trajectoires de qualité de vie. Cette approche a permis de caractériser des sous-populations homogènes et d’associer différente évolution de la qualité de vie suivant des profils particuliers de patients. / The health-related quality of life is a major objective in oncology clinical trials to improve patients’ care and better evaluate the impact of the treatments on their everyday life. Auto-questionnaires are usually used to measure this endpoint. In this work, different statistical models for the longitudinal analysis of health-related quality of life in oncology are proposed and applied to clinical trial data. First, we present different models derived from the item response theory (IRT) to achieve a longitudinal analysis directly on raw data (multi-response outcomes) for each dimension. Within the generalized linear mixed model background, a conceptual selection of the IRT models concluded that the graded response model seems to be the most suitable. Then, we propose a structural equation model which allows taking into account the multidimensional nature of data at each time and the longitudinal aspect induced by the repeated measurements. At each measurement time, the model allows to link all the observed variables issued from the questionnaire given explanatory variables. Two factors are estimated, each summarizing a set of observed variables. The longitudinal analysis is performed on the global health status and on the factors, thus reducing the number of tests. Finally, an approach based on a mixture of mixed models is used to obtain latent classes from quality of life trajectories. The approach has resulted in the identification of homogeneous subpopulations and their latent trajectory according to specific patient profiles.

Aims: Coronary Revascularization (CR) has increased patients' survival rate globally. However, the lack of a consensus definition of Health Related Quality of Life (HRQoL) and the different methodological and conceptual approaches adopted by researchers in the cardio-revascularization field create an incomplete picture of the influence of CR on individuals' HRQoL. By using mixed methodology, the current research aimed to explore Greek CHD patients' perspectives of their HRQoL after CR (Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Interventions (PCI)), as well as detect and explain individual disparities. Method: Two studies were conducted with a total sample of 487 individuals: (1) The translation and validation of the Coronary Revascularization Outcome Questionnaire (CROQ) into Greek and (2) The longitudinal mixed methods study, the main study of the thesis, following a sequential explanatory design with two research components: a) the longitudinal quantitative component aimed to detect changes in patients' HRQoL (both overall and its subdomains) following CR over a 12-month period based on individuals' subjective evaluation as captured by the CROQ, detect the influence of CR type on the outcome and to explore potential predictors (individuals' demographic, clinical and behavioural features). Data were analysed using multilevel modelling; b) the qualitative component aimed to capture individuals' lived experience, their view and understanding of themselves and their life approximately 12 months after treatment using Interpretive Phenomenological Analysis (IPA). Results/findings: Based on participants' subjective evaluations as captured by the validated Greek version of the CROQ, one year after CR Greek Coronary Heart Disease (CHD) patients experience an increase in their HRQoL level compared to prior to CR. The pattern of change though is not constant; initially HRQoL increases with time, and then decreases again, however, remaining much greater compared to prior to CR one year after CR. Regarding the influence of the CR type of treatment on patients' HRQoL level, a year after CR mixed findings are revealed. In the symptoms and physical functioning subdomain, patients treated with CABG demonstrate a greater increase compared to patients treated with PCI. In the psychosocial functioning subdomain no difference is found. In the cognitive functioning subdomain, patients treated with CABG demonstrate a decline compared to their cognitive functioning prior to the CR. Various demographic, clinical and behavioural features are demonstrated to be predictors of the outcome though not consistent for all subdomains. The main predictors associated with larger positive changes following CR seem to be sex, BMI and smoking; females with low BMI that do not smoke tend to demonstrate a greater increase in HRQoL after CR. According to individuals' lived experience, participants, reflecting on their experience one year after treatment, perceive CR as a simple process and their negative experience is mostly related to medical care. Many participants with no symptoms or adverse effects tend to misperceive CHD, viewing their health condition as an acute disease treated with CR. Trying to understand disease causality they tend to adopt medical discourse especially in relation to stress as a factor that can be controlled by themselves and reflect on their own responsibility as a causal factor. Feeling grateful for being alive, sensing a different body, a 'revitalized body' as many participants suggest, as well as a fear of re-occurrence or disease progression motivate individuals to work on aspects of the self related to the CHD development in an effort to regain control over their life which has been reduced after the CHD diagnosis. In effect a dramatic change in how the self and life are viewed is reported, highlighting a positive growth; a greater appreciation of life, a personal growth and effort to build more meaningful relationships. Challenges that participants face in modification of their lifestyle are attributed to both external and internal factors. Concerning smoking participants' accounts point to a lack of knowledge regarding the relationship between smoking and CHD, a lack of support (by experts or family members) and conscious denial as a way to cope with every day anxiety and stress, but also a pleasure in everyday life. The findings provide a complementary insight into perceptions of individuals with CHD about their quality of life one year after CR, suggesting that other factors beyond CR may influence their perspectives. Conclusions/implications: This study highlights the benefits of using a mixed methods longitudinal design in exploring HRQoL. Both the quantitative and qualitative findings support the notion that HRQoL is a multidimensional, continuously changing concept, providing support for the Wold Health Organization's definition. Also, the findings suggest that CR has a positive influence on individuals' HRQoL. The effect of the CR type needs further investigation as mixed findings are observed in the present thesis. Moreover, it seems difficult to investigate the pure effect of CR on individuals' HRQoL without taking into consideration individuals' adjustment processes and positive growth triggered by the CR. The self regulation model (SRM) might be considered a useful theoretical framework for developing theory-based interventions aiming to alter patients' false beliefs since individuals' making-meaning process seems to be aligned with it. Finally, the complementary insights concerning smoking may help health care providers to develop smoking cessation interventions tailored to cardiac patients.

Estudo descritivo, correlacional e longitudinal que teve como objetivos estudar a validade e a confiabilidade da Burns Specific Pain Anxiety Scale-BSPAS que avalia ansiedade frente a procedimentos dolorosos e a Impact of Event Scale-IES que avalia o estresse pós-traumático. Participaram do estudo 91 indivíduos maiores de 15 anos de idade, internados na Unidade de Queimados do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto. Seguiramse as seguintes etapas: 1ª etapa: coleta de dados relacionados à internação e ao tratamento. 2ª etapa: seguimento de manifestações dolorosas, durante sete dias, com a aplicação da Escala Visual Analógica para Dor, em três momentos diferentes do dia: a) imediatamente antes do banho e curativo (DIABC); b) imediatamente depois do banho e curativo (DIDBC); e c) dor no período de descanso, por volta das 20 horas (DDPD). 3ª etapa: no oitavo dia, aplicação da BSPAS - Versão Português, da IES - Versão Português e do Inventário de Ansiedade-Estado de Spielberger (IDATE). 4ª etapa (composta por fases A e B): entre o 4º e o 6º meses (fase A) e entre o 9º e o 12º meses, após o acontecimento da queimadura (fase B), aplicação da IES-VP, da Escala de Autoestima de Rosenberg (EAER), do Inventário de Depressão de Beck (IDB) e do SF-36. Nas três primeiras etapas, participaram do estudo 91 pacientes (64 homens e 27 mulheres). A superfície corporal queimada (SCQ) média foi de 18% (1-60%), sendo os locais anatômicos mais atingidos membros superiores (66; 72,5%), tórax (61; 67%) e cabeça/face (43; 47,3%). Os agentes causadores de queimaduras mais comuns foram os líquidos quentes (15,4%) e os agentes inflamáveis, principalmente o álcool, (38,5%). Na 4ª etapa, participaram 77 pacientes, na fase A, e 76, na fase B. Na avaliação da validade de construto convergente, a BSPAS-VP apresentou correlações fortes e positivas com a IES-VP (0,52; p<0,01), fortes e moderadas com as subescalas que avaliam pensamentos intrusivos (0,54; p<0,01) e reações de evitação (0,37; p<0,01) e correlações moderadas com as avaliações de dor: DIABC (0,32; p<0,01), DIDBC (0,31; p<0,01) e DDPD (0,31; <0,01). A IES-VP total apresentou correlações moderadas e positivas com o IDB (0,63; p<0,01), moderadas e negativas com a EAER (-0,58; p<0,01) e moderadas a baixas e negativas com os domínios Dor (r=-0,24; p<0,05), Aspectos Sociais (r=-0,34;p<0,01) e Saúde Mental (r=-0,27; p<0,05), entre o 4º e o 6º meses e baixa e de pouca aplicabilidade para a prática com o domínio Estado Geral de Saúde (r=-0,24; p<0,05), entre o 9º e o 12º meses, do SF-36. Na aplicação da BSPAS-VP e da IES-VP, observaram-se valores médios mais altos para o sexo feminino (55,15 e 63,96, respectivamente), entre os indivíduos com SCQ maior que 20% (54,90 e 62,98, respectivamente) e para os indivíduos que referiam as cicatrizes visíveis (52,53 e 61,40, respectivamente), porém, quando testadas as diferenças por meio do Teste t de Student para amostras independentes, essas não foram estatisticamente significantes. Na análise dos componentes principais por meio da Matrix de Rotação Varimax, a IES-VP apresentou-se como uma escala bidimensional e a BSPAS-VP, unidimensional, conforme a proposta original de cada escala. O Alfa de Cronbach de ambas as escalas foi alto, 0,90 para a BSPAS-VP e 0,87 para a IES-VP, mostrando forte consistência interna entre seus itens. Quando aplicado o Teste t para amostras dependentes, a IES-VP apresentou-se sensível para detectar mudanças no tempo. Conclui-se que a BSPAS-VP e a IES-VP são instrumentos confiáveis e válidos para a avaliação de ansiedade-estado relacionada à dor no paciente queimado e para a avaliação do impacto do evento, respectivamente. / This descriptive, correlation and longitudinal study aimed to study the validity and reliability of the Burns Specific Pain Anxiety Scale-BSPAS, which assesses anxiety about painful procedures, and the Impact of Event Scale-IES, which assesses post-traumatic stress. Study participants were 91 individuals over 15 years of age, hospitalized at the Burns Unity of the Ribeirão Preto Medical School Hospital das Clínicas. The following steps were followed: 1st step: data collection about hospitalization and treatment. 2nd step: follow-up of painful manifestations for seven days, applying the Visual Analogue Scale for Pain at three different times each day: a) immediately before bathing and wound dressing (DIABC); b) immediately after bathing and wound dressing (DIDBC); and c) pain in the rest period, around 20:00h (DDPD). 3rd step: on the eighth day, application of the BSPAS Portuguese Version, IES Portuguese Version and Spielbergers State Anxiety Inventory (SAI). 4th step (including phases A and B): between the 4th and 6th month (phase A) and between the 9th and 12th month after the burn event (phase B), application of the IES-VP, Rosenbergs Self-Esteem Scale (RSES), the Beck Depression Inventory (BDI) and the SF-36. In the first three steps, study participants were 91 patients (64 men and 27 women). The mean burned body surface (BBS) was 18% (1-60%), with upper limbs (66; 72.5%), thorax (61; 67%) and head/face (43; 47.3%) as the most affected anatomical sites. The most common causal agents of the burns were hot fluids (15.4%) and inflammable agents, mainly alcohol (38.5%). In the 4th step, 77 patients participated in phase A and 76 in phase B. In convergent construct validity, the BSPAS-VP presented strong and positive correlations with the IES-VP (0.52; p<0.01), strong and moderate with the subscales that assess intrusive thoughts (0.54; p<0.01) and reactions of avoidance (0.37; p<0.01) and moderate correlations with the pain assessments: DIABC (0.32; p<0.01), DIDBC (0.31; p<0.01) and DDPD (0.31; <0.01). Total IES-VP presented moderate and positive correlations with the BDI (0.63; p<0.01), moderate and negative with the RSES (-0.58; p<0.01) and moderate to low and negative with the Pain (r=-0.24; p<0.05), Social Aspects (r=-0.34;p<0.01) and Mental Health (r=-0.27; p<0.05) domains between the 4th and 6th month, besides low correlation and little applicability to practice with the General Health State (r=-0.24; p<0.05) domain of the SF-36 between the 9th and 12th month. When applying the BSPAS-VP and IES-VP, higher mean scores were observed for women (55.15 and 63.96, respectively), among individuals with a BBS of more than 20% (54.90 and 62.98, respectively) and for people who mentioned visible scars (52.53 and 61.40, respectively). When differences were tested through Students t-test for independent samples, however, these were not statistically significant. In the main components analysis through the Varimax Rotation Matrix, IES-VP appeared as a bidimensional scale and BSPAS-VP as a unidimensional scale, in accordance with each scales original proposal. Both scales obtained a high Cronbachs Alpha, 0.90 for BSPAS-VP and 0.87 for IES-VP, showing strong internal consistency of its items. When the t-test for independent samples was applied, the IES-VP showed sensitivity to detect changes over time. It is concluded that the BSPAS-VP and the IES-VP are reliable and valid instrument to assess state-anxiety related to pain in burned patients and to assess the impact of the event, respectively.

INTRODUÇÃO: Existem dúvidas e controvérsias em relação à falta de controle clínico dos pacientes portadores de asma grave. Neste estudo avaliamos a proporção de asmáticos graves que atingem o controle com seguimento supervisionado e tratamento padronizado. Comparamos a inflamação das vias aéreas através do escarro induzido e do óxido nítrico exalado em pacientes que atingem o controle da asma em comparação aos não controlados. Avaliamos também o impacto do controle sobre o estado de saúde e comparamos o comportamento psicossocial (ansiedade e depressão) entre os pacientes controlados e não controlados. MÉTODOS: Os pacientes foram selecionados no ambulatório de asma da Pneumologia porque apresentavam asma grave não controlada apesar de tratamento de acordo com as diretrizes de tratamento da asma. Avaliamos as características clínicas, funcionais, inflamatórias, controle da asma, qualidade de vida relacionada à saúde e ansiedade e depressão, na condição basal, após as 2 semanas de corticosteróide oral e ao final do tratamento otimizado por via inalatória. RESULTADOS: Cento e vinte e oito pacientes foram elegíveis, 74 incluídos e 54 completaram o protocolo. Destes, 36 (66,7%) pacientes foram classificados em grupo não controlado e 18 (33,3%) controlados. Na inclusão, o grupo que não se controlou apresentou mais mulheres, maior porcentagem de ex-tabagistas, menor porcentagem de dias livres de sintomas e maior porcentagem de mulheres com piora da asma no período menstrual. Os pacientes dos dois grupos apresentavam alta utilização do sistema de saúde e várias comorbidades. Após o tratamento padronizado, não se observou diferença nos parâmetros de função pulmonar, escarro induzido e óxido nítrico exalado entre os grupos. No grupo não controlado, o curso de corticosteróide oral promoveu redução significativa dos eosinófilos no escarro induzido, mas com aumento destes após a retirada da medicação oral, embora sem significância estatística. O óxido nítrico exalado não se alterou com o tratamento, mantendo-se normal nos dois grupos durante todo o acompanhamento. Os pacientes apresentavam baixa qualidade de vida relacionada à saúde, com melhora significativa nos dois grupos. Observamos alta porcentagem de pacientes com ansiedade moderada, que não se alterou com o tratamento da asma. CONCLUSÕES: Pacientes com asma grave não controlada podem atingir o controle clínico quando submetidos à intervenção proposta. Mas 2/3 dos nossos pacientes não atingiram o controle. Apresentaram características semelhantes aos de outras coortes internacionais, grande utilização dos recursos da saúde e baixa qualidade de vida relacionada à saúde. A inflamação eosinofílica responde ao uso de corticosteróide oral. O óxido nítrico exalado pode estar normal em pacientes com asma grave e inflamação eosinofílica persistente. A intervenção proposta melhorou a qualidade de vida relacionada à saúde nestes pacientes, mas não apresentou impacto na ansiedade / INTRODUCTION: There are doubts and open questions about low achieve control in severe asthma patients. In this study we evaluated the proportion of severe asthmatics who achieve control status after a systematic follow-up protocol and standardized treatment. We compared airway inflammation according to induced sputum and exhaled nitric oxide in controlled and non-controlled patients. We also evaluated the impact of control status on health related quality of life and compared the psychosocial behavior (anxiety and depression) between groups. METHODS: Patients were selected on outpatient asthma clinic of Pulmonary Division. They had severe asthma and underwent a systematic follow-up protocol with standardized treatment. We evaluated clinical, functional and inflammatory characteristics, asthma control, health related quality of life and anxiety and depression symptoms in baseline, after two weeks of oral corticosteroid and at the end of the follow-up, with inhaled corticosteroid plus long acting beta 2 agonist. RESULTS: One hundred and twenty eight patients were eligible, 74 included and 54 completed the follow-up period. Among this, 36 (66.7%) patients were classified as non-controlled and 18 (33.3%) controlled. At the inclusion non-controlled group had significantly higher female and ex-smokers prevalence, less percentage of days free of symptoms and higher frequency of females with menstrual worsening of asthma symptoms. Both groups had high health care use and several comobidities. There was not any significant difference in pulmonary function, induced sputum and exhaled nitric oxide between the two groups after standardized treatment. Induced sputum eosinophils had a significant reduction after oral corticosteroid trial in non-controlled patients but there was impairment after oral steroid withdrawn, but without statistic significance. Exhaled nitric oxide did not change with treatment and was normal in both groups during the follow-up period. Patients had low health related quality of life but with significant improvement on two groups. We observed high prevalence of patients with moderate anxiety which did not change with asthma treatment. CONCLUSION: Non-controlled severe asthma patients can achieve clinical control after proposed standardized protocol. But 2/3 of our patients did not achieve clinical control. Our patients share characteristics with others international cohorts, had high health care utilization and low health related quality of life. Induced sputum eosinophilia showed an improvement after oral corticosteroid trial. Exhaled nitric oxide may be normal in severe asthmatics with persistent eosinophilc inflammation. There was an improvement on health related quality of life with asthma treatment but no change was observed on anxiety

O tratamento radioterápico é considerado como uma das modalidades terapêuticas padrão para os cânceres de cabeça e pescoço, cujo objetivo é controlar a evolução do tumor com o menor dano possível aos tecidos e órgãos normais adjacentes, porém, apesar de apresentar a vantagem de preservar a estrutura dos tecidos, pode acarretar reações adversas que se manifestam na cavidade oral, e também efeitos colaterais físicos generalizados, sendo a fadiga o mais comum. Objetivo: avaliar a efetividade da Prática Integrativa e Complementar - Relaxamento com Visualização Guiada, sobre a redução do sintoma de fadiga e melhora da Qualidade de Vida Relacionada à Saúde, durante o tratamento radioterápico. Método: estudo quantitativo, quase-experimental, de corte longitudinal e prospectivo, com a participação de 102 pacientes em início de tratamento radioterápico, com a alocação intencional em dois grupos, o de Intervenção (n=42) e o de Comparação (n=60). Apenas os participantes do Grupo Intervenção realizaram a prática de relaxamento com visualização guiada durante o tratamento radioterápico, porém, todos os participantes responderam aos questionários de avaliação. Foram utilizados os questionários de Qualidade de Vida Relacionada à Saúde (FACT H&N) e a Escala de Fadiga de Piper Revisada. A prática de relaxamento com visualização guiada foi aplicada pela pesquisadora do estudo, por meio de uma gravação de áudio contendo comandos verbais, os quais guiavam o paciente para a realização da prática. Para avaliar o efeito da intervenção entre os grupos intervenção e de controle, foi utilizada a técnica de regressão logística multinomial, estimando razões de chance (odds ratios) por pontos e respectivos erros-padrão (Ep). Resultados: na etapa descritiva dos dados sociodemográficos e clínicos, evidenciou-se a predominância do sexo masculino, faixa etária entre 41 e 60 anos, baixo nível de escolaridade, aposentados, católicos, em uso regular de álcool e tabaco, câncer de orofaringe, em estádio IV. Foram evidenciadas diferenças estatisticamente significativas entre os grupos em relação às variáveis procedência, estado civil e \"tipo de cirurgia\" e os valores-p foram, respectivamente, p=0,000, p= 0,002 e p=0,027. Na etapa analítica evidenciou-se que o relaxamento com visualização guiada mostrou-se efetivo em especial para os domínios global, comportamental e sensorial na segunda aplicação (T2), e afetivo e sensorial na terceira aplicação (T3), levando à redução do sintoma de fadiga, e quanto à Qualidade de Vida Relacionada à Saúde não houve diferença estatisticamente significativa entre os grupos. Conclusão: os resultados demonstraram que o relaxamento com visualização guiada não teve efeito na melhora da Qualidade de Vida Relacionada à Saúde durante o tratamento radioterápico nos pacientes com câncer de cabeça e pescoço, mas reduziu os níveis de fadiga. Trata-se de uma prática de baixo custo, a qual mostrou-se efetiva na redução do sintoma de fadiga, portanto, seu uso deve ser divulgado na prática dos cuidados aos pacientes oncológicos / Radiation therapy is considered to be one of the standard therapeutic modalities for head and neck cancers in order to control tumor evolution with the lowest possible damage to adjacent normal tissues and organs. Although it has the advantage of preserving the structure of tissues, it can lead to adverse reactions occurring in the oral cavity, as well as generalized physical side effects, being fatigue the most common of them. Objective: to evaluate the effectiveness of an Integrative and Complementary Practice - Relaxation with Guided Imagery, on the reduction of fatigue symptom and improvement of Health-Related Quality of Life, during the radiotherapy treatment. METHODS: A quantitative, quasi-experimental, longitudinal and prospective study was carried out with the participation of 102 patients at the beginning of radiotherapy, intentionally allocated in two groups: Intervention (n=42) and Comparison (n = 60). While only the participants of the Intervention Group performed the relaxation practice with guided imagery during the radiotherapy treatment, all the participants answered the evaluation questionnaires. The HealthRelated Quality of Life questionnaires (FACT-H&N) and the revised Piper Fatigue Scale were used. The practice of relaxation with guided imagery was applied by the researcher of the study, through an audio recording containing verbal commands, which guided the patient to perform the practice. To evaluate the effects of the intervention comparing the intervention and control groups, it was used multinomial logistic regression technique in order to estimate odds ratios by points and their respective standard errors (SE). Results: the descriptive stage found in the sociodemographic and clinical data, the prevalence of males, age between 41 and 60 years old, low level of schooling, retirees, Catholics, regular use of alcohol and tobacco, as well as oropharynx cancer in stage IV. There were statistically significant differences between the groups related to the variables place of residence, marital status and \"type of surgery\", while the p-values were respectively, p=0.000, p=0.002 and p = 0.027. In the analytical stage, it was observed that the relaxation with guided imagery was effective for the global, behavioral and sensorial domains in the second application (T2), as well as for the affective and sensorial domains in the third application (T3), leading to the reduction of the fatigue symptoms, while there was no statistically significant difference between the groups related to Health-Related Quality of Life. Conclusion: The results showed that while guided imagery relaxation had no effect on the improvement of the Health-Related Quality of Life during the radiotherapy treatment in patients with head and neck cancer, it still reduced fatigue levels. It is a low-cost practice, which has proved effective in reducing the fatigue symptoms, so its use must be disseminated in caring practices directed to cancer patients

INTRODUÇÃO: Existem dúvidas e controvérsias em relação à falta de controle clínico dos pacientes portadores de asma grave. Neste estudo avaliamos a proporção de asmáticos graves que atingem o controle com seguimento supervisionado e tratamento padronizado. Comparamos a inflamação das vias aéreas através do escarro induzido e do óxido nítrico exalado em pacientes que atingem o controle da asma em comparação aos não controlados. Avaliamos também o impacto do controle sobre o estado de saúde e comparamos o comportamento psicossocial (ansiedade e depressão) entre os pacientes controlados e não controlados. MÉTODOS: Os pacientes foram selecionados no ambulatório de asma da Pneumologia porque apresentavam asma grave não controlada apesar de tratamento de acordo com as diretrizes de tratamento da asma. Avaliamos as características clínicas, funcionais, inflamatórias, controle da asma, qualidade de vida relacionada à saúde e ansiedade e depressão, na condição basal, após as 2 semanas de corticosteróide oral e ao final do tratamento otimizado por via inalatória. RESULTADOS: Cento e vinte e oito pacientes foram elegíveis, 74 incluídos e 54 completaram o protocolo. Destes, 36 (66,7%) pacientes foram classificados em grupo não controlado e 18 (33,3%) controlados. Na inclusão, o grupo que não se controlou apresentou mais mulheres, maior porcentagem de ex-tabagistas, menor porcentagem de dias livres de sintomas e maior porcentagem de mulheres com piora da asma no período menstrual. Os pacientes dos dois grupos apresentavam alta utilização do sistema de saúde e várias comorbidades. Após o tratamento padronizado, não se observou diferença nos parâmetros de função pulmonar, escarro induzido e óxido nítrico exalado entre os grupos. No grupo não controlado, o curso de corticosteróide oral promoveu redução significativa dos eosinófilos no escarro induzido, mas com aumento destes após a retirada da medicação oral, embora sem significância estatística. O óxido nítrico exalado não se alterou com o tratamento, mantendo-se normal nos dois grupos durante todo o acompanhamento. Os pacientes apresentavam baixa qualidade de vida relacionada à saúde, com melhora significativa nos dois grupos. Observamos alta porcentagem de pacientes com ansiedade moderada, que não se alterou com o tratamento da asma. CONCLUSÕES: Pacientes com asma grave não controlada podem atingir o controle clínico quando submetidos à intervenção proposta. Mas 2/3 dos nossos pacientes não atingiram o controle. Apresentaram características semelhantes aos de outras coortes internacionais, grande utilização dos recursos da saúde e baixa qualidade de vida relacionada à saúde. A inflamação eosinofílica responde ao uso de corticosteróide oral. O óxido nítrico exalado pode estar normal em pacientes com asma grave e inflamação eosinofílica persistente. A intervenção proposta melhorou a qualidade de vida relacionada à saúde nestes pacientes, mas não apresentou impacto na ansiedade / INTRODUCTION: There are doubts and open questions about low achieve control in severe asthma patients. In this study we evaluated the proportion of severe asthmatics who achieve control status after a systematic follow-up protocol and standardized treatment. We compared airway inflammation according to induced sputum and exhaled nitric oxide in controlled and non-controlled patients. We also evaluated the impact of control status on health related quality of life and compared the psychosocial behavior (anxiety and depression) between groups. METHODS: Patients were selected on outpatient asthma clinic of Pulmonary Division. They had severe asthma and underwent a systematic follow-up protocol with standardized treatment. We evaluated clinical, functional and inflammatory characteristics, asthma control, health related quality of life and anxiety and depression symptoms in baseline, after two weeks of oral corticosteroid and at the end of the follow-up, with inhaled corticosteroid plus long acting beta 2 agonist. RESULTS: One hundred and twenty eight patients were eligible, 74 included and 54 completed the follow-up period. Among this, 36 (66.7%) patients were classified as non-controlled and 18 (33.3%) controlled. At the inclusion non-controlled group had significantly higher female and ex-smokers prevalence, less percentage of days free of symptoms and higher frequency of females with menstrual worsening of asthma symptoms. Both groups had high health care use and several comobidities. There was not any significant difference in pulmonary function, induced sputum and exhaled nitric oxide between the two groups after standardized treatment. Induced sputum eosinophils had a significant reduction after oral corticosteroid trial in non-controlled patients but there was impairment after oral steroid withdrawn, but without statistic significance. Exhaled nitric oxide did not change with treatment and was normal in both groups during the follow-up period. Patients had low health related quality of life but with significant improvement on two groups. We observed high prevalence of patients with moderate anxiety which did not change with asthma treatment. CONCLUSION: Non-controlled severe asthma patients can achieve clinical control after proposed standardized protocol. But 2/3 of our patients did not achieve clinical control. Our patients share characteristics with others international cohorts, had high health care utilization and low health related quality of life. Induced sputum eosinophilia showed an improvement after oral corticosteroid trial. Exhaled nitric oxide may be normal in severe asthmatics with persistent eosinophilc inflammation. There was an improvement on health related quality of life with asthma treatment but no change was observed on anxiety

Introdução: O tratamento do câncer retal melhorou ao longo das décadas com aprimoramento e surgimento de novas terapêuticas resultando em maior sobrevida. Assim, os resultados e o impacto pós-tratamento sobre a QVRS são cada vez mais considerados e não só a ausência da doença. Objetivo: Avaliar a qualidade de vida imediata e tardia relacionada à saúde em pacientes tratados de câncer retal com intenção curativa. Método: Estudo descritivo-exploratório, com delineamento de coorte prospectivo, de caráter observacional para geração de hipóteses acerca da qualidade de vida de pacientes com câncer de reto. Conduzimos com aplicação de entrevista por questionário específico para dados demográficos; questionário estruturado EORTC QLQ-C30 e EORTC-CR38 para avaliação da QVRS aplicados no início do tratamento, três meses após a cirurgia e 12 meses após. A casuística foi composta de 58 pessoas, totalizando 29 pacientes puderam participar conforme critérios de inclusão e 12 que puderam responder os questionários após 12 meses. Os escores de cada paciente foram comparados - início, após 3 meses de intervenção e 12 meses com ou sem estoma. Os dados foram organizados em planilha Excel e análise dos dados realizada utilizando o software R (R-project) versão 3.1.2. Resultados: Após três meses houve piora da satisfação sexual, Problemas sexuais femininos e Perspectiva futura. Melhoram os Sintomas Gastrointestinais, problemas esfincterianos e perda de peso. Após 12 meses a Perspectiva futura deteriorou, porém houve melhora dos Problemas relacionados ao estoma, Problemas esfincterianos e Imagem Corporal. Conclusão: Apesar de toda complexidade do tratamento multidisciplinar do câncer de reto dentro de um serviço especializado, a qualidade de vida ficou preservada e foi satisfatória na maioria dos quesitos estudados / Introduction: The treatment of rectal cancer has improved over the decades with improvement and emergence of new therapies resulting in greater survival. Thus, the results and post-treatment impact on HRQoL are increasingly considered and not just the absence of the disease. Objective: To evaluate the immediate and late health-related quality of life in patients treated for rectal cancer with curative intent. Method: A descriptive-exploratory study, with a prospective cohort design, with an observational character to generate hypotheses about the quality of life of patients with rectal cancer. We conducted with questionnaire interview application specific to demographic data; structured questionnaire EORTC QLQ-C30 and EORTC-CR38 for the evaluation of HRQoL applied at the beginning of treatment, three months after surgery and 12 months after. The sample consisted of 58 people, totaling 29 patients who could participate according to inclusion criteria and 12 who could answer the questionnaires after 12 months. The scores of each patient were compared - beginning, after 3 months of intervention and 12 months with or without stoma. The data were organized in Excel spreadsheet and data analysis performed using software R (R-project) version 3.1.2. Results: After three months there was worsening of sexual satisfaction, Female sexual problems and Future perspective. Improve Gastrointestinal Symptoms, Sphincter Problems and Weight Loss. After 12 months, the future Perspective deteriorated, but there was improvement of the problems related to the stoma, Sphincter problems and Body Image. Conclusion: Despite the complexity of the multidisciplinary treatment of rectal cancer within a specialized service, the quality of life was preserved and was satisfactory in most of the studied questions