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Title: Methodology research in clinical studies for Neglected Tropical Diseases (NTDs) of the skin : addressing design, conduct and relevance for context and target population
Author: Erber, Astrid
ISNI:       0000 0004 7430 5413
Awarding Body: University of Oxford
Current Institution: University of Oxford
Date of Award: 2017
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Buruli Ulcer (BU) and Cutaneous Leishmaniasis (CL) are two Neglected Tropical Diseases (NTDs) of the skin. Both are 'diseases of poverty' and can cause long-term disabilities. This work comprises two research methodology studies, suggesting novel approaches to design and conduct of clinical studies in order to make research more relevant for their context, and for patients. The first is a study evaluating a diagnostic test for BU at a point-of-care (PoC) setting in rural Ghana, complemented by interviews and focus group discussions (FGDs) with relevant stakeholders. It reports results from the diagnostics trial and points out roles for a Bayesian statistical framework using existing data on the one hand, and qualitative research in diagnostics development on the other hand, addressing challenges such as those related to the context or small sample sizes. The second, qualitative, study sought to address methodological issues of clinical trials for CL interventions. Semi-structured interviews were conducted with 74 CL patients from seven endemic countries about their disease experiences, and analysed for their preferred outcomes. Patients reported a number of treatment outcomes as important; the majority had only been insufficiently or not included in trials so far. Recommendations made include consideration of a group of outcomes into future trials via suitable outcome measures, and suggest information and/or psychological support for patients to address their fears related to other, undesired ones. The thesis shows a role for qualitative research to enrich clinical studies for skin NTDs. It emphasizes the importance of consulting appropriate stakeholders via suitable methods in order to make trials more relevant and suitable for the context and the intended target population. It also identifies areas that could be addressed with targeted capacity development or further operational research, and seeks to facilitate the conduct of pragmatic trials in low-resource areas.
Supervisor: Olliaro, Piero ; Lambert, Ben ; Marsh, Kevin ; Lang, Trudie Sponsor: Austrian Academy of Sciences
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available