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Das Ziel dieser randomisierten, klinischen 12-Monatsstudie war die Untersuchung der Performance des Universaladhäsivs iBond® Universal an Restaurationen von nicht-kariöse Zahnhalsläsionen (NCCL) sowohl klinisch mittels FDI Kriterien als auch mittels Analyse des Zahn-Komposit-Verbundversagens mittels optischer Kohärenztomografie (OCT). An 50 Patienten wurden je drei bzw. vier NCCLs mit dem Universaladhäsiv iBond Universal (iBU, Kulzer) in den Konditionierungsmodi self-etch (iBU-SE, n = 50), selective-enamel-etch (iBU-SEE, n = 29) und etch-and-rinse (iBU-ER, n = 50) und mittels des Komposit Venus® Diamond Flow restauriert. Als Referenzadhäsiv (Kontrollgruppe) diente das Etch-and-rinse-Adhäsiv OptiBond™ FL (OFL, Kerr, n = 50). Die quantitative Bewertung der interfazialen Spaltformation an Schmelz und Dentin/Zement mittels OCT begann bereits initial (direkt nach Füllungslegung), nach 14 Tagen, nach sechs und zwölf Monaten, während die klinische Bewertung mittels FDI-Kriterien erst nach 14 Tagen begann und dann parallel zur tomografischen Untersuchung erfolgte. Es wurden die kumulativen Fehlerraten (für Randverfärbung, Randadaptation, Frakturen/Retention) berechnet und Kaplan-Meier-Kurven erstellt sowie die gemittelten adhäsiven Defekte pro Gruppe statistisch ausgewertet. Nach zwölf Monaten waren die kumulativen Fehlerraten mit iBU in allen Applikationsmodi signifikant (iBU-SE, iBU-SEE, Fehlerraten je 0,0%) bzw. nicht signifikant (iBU-ER, Fehlerrate 2,1%) geringer als mit OFL. Es ergaben sich für die Randadaptation und Randverfärbung keine signifikanten Gruppenunterschiede, lediglich bei der Gruppe OFL wurden tendentiell beim Kriterium Randadaptation mehr Restaurationen mit Score 2 bewertet als in der Gruppe iBU-SE. Die interfazialen Spalte nahmen innerhalb von 12 Monaten in allen Gruppen signifikant zu. Am Schmelz wurden für iBU-SE von initial bis zwölf Monate signifikant mehr adhäsive Defekte als in der Gruppe OFL und von t1 bis t3 signifikant mehr im Vergleich zu iBU-ER sowie ab t2 bis t3 mehr gegenüber iBU-SEE festgestellt. Am Dentin/Zement wurden mit iBU in allen Modi signifikant weniger adhäsive Defekte als mit OFL sowie ab t2 bis t3 weniger im Modus SE gegenüber ER festgestellt. Das mit dem Referenzadhäsiv OFL im Vergleich zu iBU signifikant häufigere Verbundversagen an der Dentin/Zement-Komposit-Interface (OCT) korrespondiert mit dem nach 12 Monaten signifikant erhöhten Auftreten von Füllungsverlusten in dieser Gruppe. Mit OCT waren die Gruppenunterschiede bereits initial (iBU-SEE, Dentin) bzw. nach 14 Tagen (alle Modi, Dentin und Dentin/Zement) statistisch verifizierbar. Die klinische Bewertung der Restauration lässt diese Aussage erst nach 12 Monaten für die Gruppen iBU-SE und iBU-ER (Trend) zu. Das gesteigerte Verbundversagen an der Dentin-Komposit- bzw. Dentin/Zement-Komposit-Interface in der Gruppe iBU-ER im Vergleich zur Gruppe iBU-SE hat sich hingegen klinisch nach 12 Monaten noch nicht durch eine geringere Retentionsrate in Gruppe iBU-ER manifestiert. Anhand der geringeren Streuung der Messwerte lässt sich vermuten, dass das Universaladhäsiv iBond Universal insbesondere im Modus SEE gegenüber OFL weniger techniksensitiv ist. Die optische Kohärenztomographie ermöglicht das Monitoring von Restaurationen, insbesondere die Progression des interfazialen Zahn-Komposit-Verbundversagens. Die Bewertung des Zahn-Komposit-Verbundversagens könnte geeignet sein, um die klinische Bewährung eines Adhäsivs frühzeitig zu beurteilen.:1. Einführung in die Thematik 1.1 Adhäsivsysteme 1.2 Methoden zur Bewertung des adhäsiven Verbundes in vivo 1.3 Optische Kohärenztomografie 2. Zielsetzungen und Hypothesen 3. Publikationsmanuskript 4. Zusammenfassung 5. Literaturverzeichnis 6. Darstellung des eigenen Beitrags 7. Selbstständigkeitserklärung 8. Wissenschaftliche Veröffentlichung 9. Lebenslauf 34 10. Danksagung 35

<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)

<p><strong>Background: </strong>Walking dysfunction is one of the most disabling and persistent of stroke-related sequela. Theory- and research-derived motor learning principles (MLPs) offer an ideal theoretical framework for the development and evaluation of walking-skill focused interventions.</p> <p><strong>Purpose: </strong>To: 1) appraise the degree of adherence to motor learning principles (MLPs) in current post-stroke walking-skill training research; 2) describe the Motor Learning Walking Program (MLWP), a novel, MLPs-framed walking training program; and 3) compare the MLWP to an alternate theory-framed walking-focused intervention in community-dwelling individuals within one year of stroke.</p> <p><strong>Methods: </strong>A scoping review methodology was used to identify the prevalent theoretical frameworks in current post-stroke walking training literature, and to appraise the adherence to selected MLPs in walking-focused interventions. A randomized controlled trial (n=71) was conducted to compare the MLWP to a body-weight-supported treadmill training (BWSTT) intervention.</p> <p><strong>Results: </strong>In the scoping review of 27 walking-focused studies, a minority of investigators explicitly stated a theoretical-framework. Application of MLPs was inconsistent across interventions. In the randomized controlled trial, both intervention groups improved walking function after 5 weeks of training however, there were no significant between-group differences in the primary and secondary outcomes.</p> <p><strong>Conclusions:</strong> To date, there has been limited integration of MLPs into post-stroke walking-skill training literature. This randomized controlled trial is unique in its comparison of two theoretically divergent, yet equally intense, walking-training interventions. While the results were equivocal, future research should continue to explore the impact of application of MLPs on walking-skill recovery after stroke.</p> / Doctor of Philosophy (PhD)

<p>Upper respiratory tract infection (URTI), which presents clinically as the common cold, is the most common form of respiratory illness experienced by humans and is a major cause of morbidity and hospitalizations. Currently, URTI prevention focuses on hand hygiene with some consideration given to other lifestyle factors such as sleep, nutrition, and exercise. Identifying additional interventions for the prevention of URTI could reduce the burden of this disease.</p> <p>In this thesis, I examine the role of vitamin D3 supplementation and tap water gargling for the prevention of URTI. I employ experimental and observational study designs to assess the effect of these interventions on the risk of URTI in the context of a randomized controlled trial of 600 participants, and a longitudinal cohort of 416 participants. Further, I investigate the association between modifiable lifestyle factors and risk of URTI using data from the longitudinal cohort. Data from this study is also used to explore statistical methods for the analysis of repeated events.</p> <p>When evaluating self-reported, clinical URTI, all analyses supported the use of vitamin D3 supplementation to reduce the risk of URTI. However, this finding was only statistically significant in the analysis of the longitudinal cohort study; results from the RCT indicated that vitamin D3 supplementation statistically significantly reduced the risk of laboratory confirmed infections but had a non-significant benefit for clinical infections. Gargling did not reduce the risk of clinical or laboratory confirmed infections.</p> / Doctor of Philosophy (PhD)

<p><em>Background:</em> There is a shifting culture toward evidence-based plastic surgery. The use of high-quality evidence in patient decision-making is essential. To help achieve this goal the best evidence in the field needs to be identified, and the validity of this evidence verified.</p> <p><em>Objective:</em> This systematic review was designed to evaluate the plastic surgery literature by focusing on the prevalence of, and examining key components of quality of, Randomized Controlled Trials (RCTs) comparing surgical interventions.</p> <p><em>Methods: </em>An electronic search of the pertinent plastic surgery literature identified all RCTs published from 2000 to 2013 that compared one surgical intervention to another surgical intervention. Working in teams of two investigators independently, and in duplicate, assessed each manuscript for potential relevance and performed data extraction. Descriptive statistics, theory-driven multinomial regression, and independent samples t-test were used for data analysis.</p> <p><em>Results:</em> Of the 1664 hits obtained, 173 RCTs were included. These RCTs demonstrated the following data: 35% of RCTs performed and reported randomization properly, and 12% of RCTs reported proper allocation concealment methods. Outcome assessors were blinded in 48 (34%) RCTs, and patients blinded in 45 (26%) RCTs. Multinomial regression demonstrated that trials reporting an a <em>priori</em> sample size are significantly more likely to have a low risk of bias. One-third of trials did not state a primary outcome. The mean and median sample sizes were 73 and 43 patients respectively. Funding and conflict of interest reporting improved over time.</p> <p><em>Conclusions:</em> This systematic review establishes a baseline of the quality of evidence that currently guides practice for surgical interventions in plastic and reconstructive surgery. For the readers of plastic surgery literature to have confidence in the literature, risks of bias should be minimized and transparently reported. This will encourage plastic surgeons to apply the results and findings from published RCTs in their practice, providing patients them with the best possible treatments.</p> / Master of Science (MSc)

PhD thesis assessing the role of non-randomized studies with randomized in evidence syntheses of health interventions. / Randomized studies (RS) are considered the best source of evidence for knowledge syntheses (e.g., systematic reviews, health technology assessments, health guidelines, among others) about healthcare interventions. Historically, non-randomized studies (NRS) have been usually discarded from knowledge syntheses of interventions due to their intrinsic risk of bias and confounding, and they are used only when RS are considered unfeasible or unethical to conduct. With better research methods in observational studies and new tools for the evaluation of risk of bias, NRS are more likely to be a helpful source of information when used as replacement, sequential, or complementary evidence. This, together with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, provide an opportunity for guiding decisions about using RS and NRS in knowledge synthesis and increasing our certainty in a body of evidence. This work aims to improve research synthesis methods by assessing the role and use of RS and NRS in knowledge syntheses using GRADE. This can help health professionals, researchers, guideline developers, and policy-makers build better and more complete healthcare recommendations. / Thesis / Doctor of Philosophy (PhD) / All recommendations about healthcare interventions (from common medicines to strategies to prevent diseases) should ideally come from an adequate synthesis (e.g., systematic reviews) of the least biased studies. Many researchers and authors of health syntheses consider randomized studies (RS), the ‘gold standard’ to demonstrate if an intervention is truly effective. Unfortunately, they are not always available, feasible, or ethical to conduct. Non-randomized studies (NRS), also called observational studies, can potentially provide complementary evidence for a research question. Unfortunately, they are usually considered of poorer quality because of their intrinsic nature of being prone to bias and confounding. In most circumstances, authors of syntheses discard these types of studies from the outset, without considering their potential for providing evidence that could complement or even replace that from randomized studies. This work aims to improve this situation by offering methods for evaluating the appropriateness of integrating both RS and NRS, guiding authors and researchers in cases where this is possible, hence increasing the certainty in a body of evidence and help all stakeholders reach decisions.