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<p><strong>Background:</strong> Syncope is estimated to account for 1% to 3% of emergency department (ED) annual visits in North America. Although most potential causes of syncope are benign and self-limited, others are associated with serious morbidity and substantial mortality. Recent efforts have focused on prospective identification of ED patients with syncope who are at high risk for early serious adverse outcomes in an attempt to hospitalize them at their first visit to the ED.</p> <p><strong>Objective: </strong>The purpose of this thesis is to describe the methodological issues related to the design of a study to determine whether the Revised Strategy of Syncope Diagnosis in the Emergency Room at the General Hospital Structured Care Pathway (RESASTER-SCP) is superior to usual care in identifying patients at low risk for serious adverse outcomes presenting to the ED who can be safely discharged home. <strong></strong></p> <p><strong>Design and Methods: </strong>A cluster randomized trial will be conducted with EDs (16 teaching and 46 non-teaching general hospitals) as the unit of randomization and patients presenting with syncope (TLOC) as the unit of analysis. Study participants will be followed at 1, 3, 5, and 12 months after the intervention (RESASTER-SCP vs. usual care) has been applied in the ED. Intention to treat analysis will be used. The analysis will be conducted at the individual level using proportions. Alpha level will be set at 0.05 with a power of 0.80 for the primary outcome.<strong></strong></p> <p><strong>Conclusion: </strong>This thesis describes some of the methodological issues concerning the design of a cluster randomized trial to determine whether or not RESASTER-SCP is superior to usual care in identifying patients presenting with syncope to the ED who can be safely discharged home.</p> / Master of Science (MSc)

No / OBJECTIVES: To compare the effects of community hospital care on independence for older people needing rehabilitation with that of general hospital care. DESIGN: Randomized, controlled trial. SETTING: Seven community hospitals and five general hospitals in the midlands and north of England. PARTICIPANTS: Four hundred ninety patients needing rehabilitation after hospital admission with an acute illness. INTERVENTION: Multidisciplinary team care for older people in community hospitals. MEASUREMENTS: The primary outcome was the Nottingham extended activities of daily living scale (NEADL); secondary outcomes were the Barthel Index, Nottingham Health Profile, Hospital Anxiety and Depression Scale, mortality, discharge destination, 6-month residence status, and satisfaction with services. RESULTS: Loss of independence at 6 months was significantly less likely in the community hospital group (mean adjusted NEADL change score group difference 3.27; 95% confidence interval 0.26–6.28; P=.03). The results for the secondary outcome measures were similar for the two groups. CONCLUSION: Postacute community hospital rehabilitation care for older people is associated with greater independence.

Contexte : Etant donné la forte progression de la prévalence du surpoids et de l'obésité à l'adolescence ces dernières décennies, la prévention est devenue une priorité de santé publique internationale. Objectif : L'essai PRALIMAP (PRomotion de l'ALIMentation et de l'Activité Physique) évalue l'impact de trois stratégies de prévention du surpoids et de l'obésité - « Education », « Environnement », « Dépistage » - chez les adolescents en milieu scolaire, sur la corpulence, les connaissances, attitudes et comportements des adolescents vis-à-vis de la nutrition (alimentation et activité physique). Méthode : Les trois stratégies ont été affectées à 24 lycées de la région Lorraine (Nord-est de la France) sur 2 années (en classe de seconde et de première) par randomisation en grappe (=lycée), selon un plan factoriel 2x2x2. La stratégie Éducation consistait en des cours et des travaux de groupe sur la nutrition et une fête nutritionnelle annuelle. La stratégie Environnement consistait à améliorer l'offre nutritionnelle des lycées et organiser une fête nutritionnelle annuelle. La stratégie Dépistage consistait en un repérage des adolescents en surpoids ou obèses suivi d'une prise en charge adaptée collective. Les données ont été recueillies à 3 reprises : à l'entrée en classe de seconde (T0), de première (T1) et de terminale (T2). L'indice de masse corporelle (IMC), son z-score et la proportion d'adolescents en surpoids ou obèses étaient les critères de jugement principaux. Les critères de jugement secondaires étaient les connaissances et comportements nutritionnels. Les différences d'évolution T0-T2 des critères de jugement entre les 12 lycées ayant bénéficié d'une stratégie et les 12 lycées témoins de cette stratégie a été analysée à l'aide de modèles mixtes. Une évaluation du processus a permis d'estimer la dose réelle d'intervention de chaque stratégie dans chacun des lycées. Résultats : La stratégie Dépistage a entrainé une amélioration de la corpulence : augmentation moins importante de l'IMC avec la stratégie Dépistage (+0,6 vs +0,7, p=0,0303), diminution plus importante du z-score de l'IMC (-0,9 vs -0,5, p=0,0173) et de la prévalence du surpoids et de l'obésité (-2,3% vs -0,6%, p=0,0386). La stratégie Education a entrainé une amélioration de certains comportements nutritionnels : augmentation plus importante de la proportion d'adolescent suivant la recommandation nutritionnelle sur les féculents (3,6% vs -0,7%, p=0,0357) et du nombre d'activités physiques pratiquées (+0,02 vs -0,10, p=0,0047). La stratégie Environnement a amélioré les comportements et les connaissances nutritionnels : diminution moins importante de la proportion d'adolescents suivant la recommandation nutritionnelle sur le nombre de repas hebdomadaire (-4,5% vs -8,5%, p=0,0101) et amélioration plus importante du score de connaissances nutritionnelles (+1,9 point vs +1,0 point, p=0,0094). Des différences dans la réalisation des activités et la participation ont été mises en évidence suite à l'estimation de la dose d'intervention et peuvent expliquer certains résultats observés. Conclusion : Une stratégie de dépistage structurée en milieu scolaire apparaît bénéfique sur la réduction du surpoids et de l'obésité. L'addition d'activités d'éducation nutritionnelles dans le cursus n'induit pas d'effets sur la corpulence à court terme. La modification de l'environnement nutritionnel scolaire semble avoir un effet sur les indicateurs intermédiaires de connaissances et comportements nutritionnels / Background: Given the increasing prevalence of youth overweight and obesity in the last decade, prevention as become an international public health priority.Objective: The aim of The PRALIMAP (PRomotion de l'ALIMentation et de l'Activité Physique) trial was to evaluate the 2-year effectiveness of three strategies - « Education », « Screening » et « Environment »- aimed at preventing overweight and obesity among adolescents in high school setting on body size and nutritional knowledge and behaviours. Method: PRALIMAP was a school-based randomized controlled trial beginning in 24 state-run high schools (clusters) in Lorraine (north-eastern France). Each study high school was assigned to receive or not, over a 2-year period (grades 10 and 11), each of the three prevention strategies according to a 2x2x2 factorial school randomization. The prevention strategies were: ?education? (development of nutritional knowledge and skills), "environment" (creation of favourable environment by improving availability of dietary items with a good nutritional quality and physical activity), and "screening" (detection of overweight and obesity and, if necessary, adapted care management). The follow-up consisted of three visits: at the entry of grade 10(T0), grade 11(T1) and grade 12(T2). Body mass index (BMI), BMI z-score and prevalence of overweight and obesity were the main outcomes measures. Secondary outcomes measures were nutritional knowledge and behaviours. Comparisons of changes (T2-T0) of outcomes measures between each strategy schools and their control were carried out using a three-level hierarchical mixed model. A process evaluation allowed estimating an intervention dose really received by adolescents. Results: The 2-year change of anthropometric outcomes was more favourable in the 12 screening high schools as compared with the no-screening ones: a lower increase in BMI (+0,6 vs +0,7, p=0,0303), a greater decrease in BMI z-score (-0,9 vs -0,5, p=0,0173) and a greater decrease in overweight / obesity prevalence (-2,3% vs -0,6%, p=0,0386). The education strategy resulted in improved nutritional behaviours: a greater increase in achievement of starchy food guidelines (3,6% vs -0.7%, p=0.0357) and physical activity practice (+0,02 vs -0,10, p=0,0047). The environment strategy resulted in improved nutritional attitudes: a lower decrease in achievement of number of weekly meals guidelines (-4.5% vs -8.5%, p=0.0101) and greater increase in nutritional knowledge (+1,9 point vs +1,0 point, p=0.0094). Some differences in activity implementation and participation were highlighted and can explain some of the results observed. Conclusions: The screening strategy is an effective way to prevent, at two years, overweight and obesity among adolescents in a high school setting. Nutritional education added to the curriculum is not effective in the short term on body size. The school nutritional environment modification is slightly associated with improved nutritional knowledge and behaviours

Indiana University-Purdue University Indianapolis (IUPUI) / Randomized studies are designed to estimate the average treatment effect (ATE) of an intervention. Individuals may derive quantitatively, or even qualitatively, different effects from the ATE, which is called the heterogeneity of treatment effect. It is important to detect the existence of heterogeneity in the treatment responses, and identify the different sub-populations. Two corresponding statistical methods will be discussed in this talk: a hypothesis testing procedure and a mixture-model based approach. The hypothesis testing procedure was constructed to test for the existence of a treatment effect in sub-populations. The test is nonparametric, and can be applied to all types of outcome measures. A key innovation of this test is to build stochastic search into the test statistic to detect signals that may not be linearly related to the multiple covariates. Simulations were performed to compare the proposed test with existing methods. Power calculation strategy was also developed for the proposed test at the design stage. The mixture-model based approach was developed to identify and study the sub-populations with different treatment effects from an intervention. A latent binary variable was used to indicate whether or not a subject was in a sub-population with average treatment benefit. The mixture-model combines a logistic formulation of the latent variable with proportional hazards models. The parameters in the mixture-model were estimated by the EM algorithm. The properties of the estimators were then studied by the simulations. Finally, all above methods were applied to a real randomized study in a low ejection fraction population that compared the Implantable Cardioverter Defibrillator (ICD) with conventional medical therapy in reducing total mortality.

Background and Objectives: HIV in a major public health problem in many countries of the world. Recent advances in care for people living with HIV such as the use of antiretroviral medication have reduced the mortality and morbidity associated with HIV infection. However, many people receiving antiretroviral therapy do not take it as prescribed and still experience sub-optimal health outcomes. Mobile phone text messaging is emerging as an important tool in health care, and HIV in particular. Our objectives were to explore the determining factors for adherence to antiretroviral therapy, test text messaging as an adherence enhancement tool, develop a framework for community ownership of a text messaging program and describe strategies for transfer of evidence in HIV to other conditions. Methods: This research is primarily based in Yaoundé, Cameroon, and employs a variety of methodologies, including a systematic review, two cross- sectional surveys, a randomized controlled trial, an individual patient data meta-analysis, a mixed methods study and a systematic review of systematic reviews. Results and Conclusions: Two-way weekly text messaging is an effective strategy in improving adherence to antiretroviral therapy and enhancing provider-client communication. People living with HIV in Yaoundé, Cameroon like receiving text messages, and are willing to own and run a text messaging program. Text messaging interventions may be transferred to other conditions by integrating services or by copying what works in HIV. Further research on potential harms, cost effectiveness and text messaging for other chronic conditions is warranted. / Thesis / Doctor of Philosophy (PhD)

Preoperative fasting has been practiced prior to cardiac interventions such as cardiac implantable electronic device (CIED) procedures for 4-6 h since their inceptions. However, there is no data available on safety and efficacy of a non-fasting strategy for these procedures. Strict fasting restrictions may be difficult for patients to abide by, and might even be detrimental to overall patient health and recovery. According to previous studies real fasting times are much longer than 4-6h in clinical practice. Prolonged fasting can lead to patient dissatisfaction as well as affect patient health through increased trauma response or changes in patient medication. Strict fasting regulations also hinder rescheduling patients in case of sudden schedule changes or new patient arrivals . Fasting is practiced before procedures due to a fear of vomiting and aspiration, and the associated aspiration pneumonia. This was first described by Curtis Lester Mendelson as the Mendelson-syndrome in 1946. Since then, fasting protocols have been implemented with varying lengths, and have only been remedied slightly even though modern medicine has improved greatly in regards to treating complications from aspiration. CIED implantations also don’t use regular deep sedation for their procedures, but fasting is still often practiced for 6 hours prior to procedures with very little evidence to support this practice. In our investigator-driven, prospective, parallel-group, and single-arm blinded Fast-CIED trial we randomized 201 patients undergoing elective CIED implantations in a tertiary high-volume center into two groups (NCT04389697). Patients were assigned to a non-fasting strategy (100 patients, solids/fluids allowed up to 1h) or a fasting strategy (101 patients, at least 6h no solids and 2h no fluids) before the procedure and analyzed on an intention-to-treat basis. The co-primary outcomes were patients’ wellbeing scores (based on numeric rating scale, NRS 0-10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration and emergency intubation. Renal, hematologic and metabolic blood parameters and 30-day follow-up data were gathered. The summed pre-procedural patients’ wellbeing score was significantly lower (i.e. better) in the Non-fasting group (Non-fasting: 13.1±9.6 vs. Fasting: 16.5±11.4, 95%CI of Mean Difference (MD) -6.35 - -0.46, P=0.029), which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (Non-fasting versus Fasting; hunger: 0.9±1.9 versus 3.1±3.2, 95% CI of MD -2.86 – -1.42, p < 0.001; tiredness: 1.6±2.3 versus 2.6±2.7, 95% CI of MD -1.68 – -0.29, P=0.023). No intra-procedural food related adverse events were observed. Relevant blood parameters and 30-day follow-up didn’t show significant differences. The study also showed that, in daily practice, fasting times for patients were longer than intended (5.20 ± 4.88 hours and 12.63 ± 6.36 hours for the non-fasting and fasting groups, respectively (P<0.001)) mainly due to standardized meal serving times in hospitals regardless of procedure starting times and short-term schedule changes. The Fast-CIED Study was the first randomized clinical trial to assess the benefits of a non-fasting compared to a fasting strategy before elective cardiac implantable electronic device (CIED) procedures. It showed that a non-fasting strategy is beneficial to a fasting strategy regarding patients’ wellbeing and comparable in terms of safety for CIED-procedures, allowing optimized procedure scheduling with high patient satisfaction. Our Fast-CIED trial made an important step to show that a non-fasting strategy is a viable alternative to a fasting strategy in patients undergoing elective CIED-surgery.:1. Introduction 4 1.1. Purpose of this study 4 1.2. History of preoperative fasting 5 1.3. Modern Practices 7 2. Publication 11 3. Summary/Synopsis 21 4. References 25 5. Spezifizierung des eigenen Beitrags 27 6. Erklärung über die eigenständige Abfassung der Arbeit 29 7. Lebenslauf 30 8. Danksagung 31

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Patients with cancer transitioning from completing their final cancer treatments to survivorship are particularly at risk for experiencing psychosocial stress, and the Institute of Medicine (IOM) has referred to these cancer patients as “lost in transition.” In this study, patients with cancer in their transition phase after completing their final radiation treatment were defined as cancer survivors (CS). CS must deal with chronic stressors such as the fear of cancer recurrence as well as the resumption of their roles in their family and work lives. Chronic stress impacts the nervous system and increases secretion of stress hormones (e.g. cortisol) from the endocrine system, which in turn influences immune function. These systems are particularly relevant for CS since research has shown associations between abnormal cortisol patterns and increased mortality in breast CS and immune dysfunction in CS can increase susceptibility to infections. The theoretical framework of psychoneuroimmunology (PNI), which describes the interactions between the psychosocial, neuroendocrine and immune systems, guided the choice of outcomes for this study. The IOM has identified a lack of theory-driven interventions for managing psychosocial stress in CS. We reviewed the literature and identified two major types of PNI-based psychosocial interventions for cancer patients, namely cognitive-behavioral and complementary medical. One promising brief and inexpensive psychosocial intervention was expressive writing, which involved participants disclosing their deepest thoughts and feelings regarding their cancer in four 20-30 minute writing sessions over four consecutive days. We conducted a two-arm randomized controlled trial to determine the efficacy of an online expressive writing (EW) intervention delivered to CS who were 2-12 months post-radiation treatment completion. The results of this study revealed that EW was effective in regulating stress in our sample of CS over a period of six weeks as measured by lowered salivary cortisol levels and lowered self-reported fear of cancer recurrence. Online EW is a low-cost and convenient approach for delivering stress-management interventions for CS during survivorship. However, coordinated efforts are needed from health researchers, professionals and policy makers to define standardized approaches for testing psychosocial interventions and using PNI biomarkers to help develop evidence-based psychosocial cancer-care for CS during survivorship.