Thesis (M. P. H.)--University of Hong Kong, 2007. / Also available in print.

Thesis (M. P. H.)--University of Hong Kong, 2007. / Also available in print.

Thesis (M.D)--Dept. of Clinical and Experimental Pharmacology, University of Adelaide, 1993. / Includes 4 published papers by the author as part of appendix 9. Includes bibliographical references (leaves 1-19 (second sequence)).

Thesis (Ph. D.)--University of Toronto, 2004. / Includes bibliographical references.

Thesis (Ph.D.)--City University of Hong Kong, 2009. / "Submitted to Department of Management Sciences in partial fulfillment of the requirement for the degree of Doctor of Philosophy." Includes bibliographical references (leaves 118-126)

Thesis (Ph.D.)--Duquesne University, 2007. / Title from document title page. Abstract included in electronic submission form. Includes bibliographical references (p. 136-150) and index.

Thesis (M.P.H.)--University of Hong Kong, 2007.

No description available.

Point-of-care clinical trials are randomized clinical trials designed to maximize pragmatic design features. The goal is to integrate research into standard care such that the burden of research is minimized for patient and physician, including recruitment, randomization and study visits. When possible, these studies employ Bayesian adaptive methods and data collection through the medical record. Due to the passive and adaptive nature of these trials, a number of unique challenges may arise over the course of a study. In this dissertation, adaptive methodology for Bayesian time-to-event clinical trials is developed and evaluated for studies with limited censoring. Use of a normal approximation to the study parameter likelihood is proposed for trials in which the likelihood is not normally distributed and assessed with respect to frequentist type I and II errors. A previously developed method for choosing a normal prior distribution for analysis is applied with modifications to allow for adaptive randomization. This method of prior selection in conjunction with the normal parameter likelihood is used to estimate future data for the purpose of prediction of study success. A previously published method for future event estimation is modified to allow for adaptive randomization and inclusion of prior information. Accuracy of this method is evaluated against final study numbers under a range of study designs and parameter likelihood assumptions. With these future estimates, we predict study conclusions by calculating predicted probabilities of study outcome and compare them to actual study conclusions. Reliability of this method is evaluated considering prior distribution choice, study design, and use of an incorrect likelihood for analysis. The normal approximation to non-normally distributed data performs well here and is reliable when the underlying likelihood is known. The choice of analytic prior distribution agrees with previously published results when equal allocation is forced, but changes depending on the severity of adaptive allocation. Performance of event estimation and prediction vary, but can provide reliable estimates after only 25 subjects have been observed. Analysis and prediction can reliably be carried out in point-of-care studies when care is taken to ensure assumptions are reasonable.

Thesis (MCur)--Stellenbosch University, 2012. / ENGLISH ABSTRACT: Background Informed Consent (IC) has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. IC is a vital part of the research process and as such entails more than obtaining a signature on a form. The IC must be given freely, without coercion, and must be based on a clear understanding of what participation involves. Aim The overall aim of this study was to attain an understanding of participants' knowledge regarding informed consent when participating in a research project. Methods The study was conducted at two public hospitals in a city in the Eastern Cape Province of South Africa. The quantitative study used descriptive survey design. A self administered questionnaire was used as a tool for data collection. Results The sample size consisted of 170 women with an average of 25.9 years. The majority had completed secondary level education. More than half of the participants did not have knowledge of the purpose of the original study. The majority of participants did not have knowledge of their responsibilities. Forty-two percent gave uninformative responses and 26% indicated they did not know their responsibilities. None of the participants understood the concept of randomization. The majority (85.9%) of participants indicated that information provided on the IC forms was sufficient for them to decide to participate. Conclusion Despite extensive efforts to ensure that participants understood their participation in the original studies, this study found poor recall of vital information for IC. A signed informed consent does not guarantee that participants understand information given. Recommendations The existing methods of communicating and obtaining of an informed consent seem to be insufficient for participants to make an informed decision. A new approach with more interactive features such as combination of audio-visual techniques might increase the possibilities of the understanding. / AFRIKAANSE OPSOMMING: Agtergrond Ingeligte toestemming (IT) is voorgestel as die optimale metode om die etiese toelating van die pasiënte vir kliniese toetse te verseker. IT is 'n belangrike deel van die navorsingsproses en as sodanig behels dit meer as die verkryging van 'n handtekening op 'n vorm. Die IT moet vrylik gegee word, sonder dwang en moet gebaseer wees op 'n duidelike begrip van wat die deelname behels. Doel Die algemene doel van hierdie studie is om 'n begrip van die deelnemers se kennis met betrekking tot ingeligte toestemming te bepaal, wanneer hulle deelneem aan 'n navorsingsprojek. Metodes Die studie is uitgevoer by twee openbare hospitale in ’n stad in die Oos-Kaap in Suid-Afrika. Die navorsingsontwerp is beskrywend van aard en ’n kwantitatiewe benadering is toegepas. ‘n Self-geadministreerde vraelys is as 'n instrument gebruik om data in te samel. Resultate Die steekproefgrootte het bestaan uit 170 vroue met 'n gemiddelde ouderdom van 25.9 jaar. Die meerderheid van die vroue het opleiding tot op sekondêre vlak. Meer as die helfte van die deelnemers het geen kennis van die doel van die oorspronklike studie gehad nie. Die meerderheid van die deelnemers het ook nie kennis van hul verantwoordelikhede gehad nie. Twee-en-veertig persent het nie toepaslike antwoorde gegee nie en 26% het aangedui dat hulle nie weet wat hul verantwoordelikhede in die studie is nie. Nie een van die deelnemers het die konsep van verewekansiging verstaan nie. Die meerderheid (85.9%) van die deelnemers het aangedui dat die inligting wat deur die IT verskaf word voldoende was om te besluit of hulle aan die studie wou deelneem. Gevolgtrekking Ten spyte van uitgebreide pogings om te verseker dat deelnemers hulle deelname verstaan het in die oorspronklike toetsing, het hierdie studie die swak herroeping van belangrike inligting aangaande IT bewys. ‘n Ondertekende ingeligte toestemming gee geen waarborg dat die deelnemers die inligting waarvoor toestemming geteken is, verstaan nie. Aanbevelings Die bestaande metodes van die kommunikasie en verkryging van ingeligte toestemming blyk onvoldoende te wees om deelnemers ingeligte besluite te laat neem. ‘n Nuwe benadering met meer interaktiewe eienskappe soos ’n kombinasie van oudio-visuele tegnieke mag die moontlikhede om te verstaan, meer duidelik maak.