How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials

 

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dc.contributor.author Allen, Elizabeth en_ZA
dc.contributor.author Mushi, Adiel en_ZA
dc.contributor.author Massawe, Isolide en_ZA
dc.contributor.author Vestergaard, Lasse en_ZA
dc.contributor.author Lemnge, Martha en_ZA
dc.contributor.author Staedke, Sarah en_ZA
dc.contributor.author Mehta, Ushma en_ZA
dc.contributor.author Barnes, Karen en_ZA
dc.contributor.author Chandler, Clare en_ZA
dc.date.accessioned 2015-11-04T11:59:10Z
dc.date.available 2015-11-04T11:59:10Z
dc.date.issued 2013 en_ZA
dc.identifier.citation Allen, E. N., Mushi, A. K., Massawe, I. S., Vestergaard, L. S., Lemnge, M., Staedke, S. G., ... & Chandler, C. I. (2013). How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials. BMC medical research methodology, 13(1), 140. en_ZA
dc.identifier.uri http://hdl.handle.net/11427/14686
dc.identifier.uri http://dx.doi.org/10.1186/1471-2288-13-140
dc.description.abstract BACKGROUND:Accurately characterizing a drug's safety profile is essential. Trial harm and tolerability assessments rely, in part, on participants' reports of medical histories, adverse events (AEs), and concomitant medications. Optimal methods for questioning participants are unclear, but different methods giving different results can undermine meta-analyses. This study compared methods for eliciting such data and explored reasons for dissimilar participant responses. METHODS: Participants from open-label antimalarial and antiretroviral interaction trials in two distinct sites (South Africa, n=18 [all HIV positive]; Tanzania, n=80 [86% HIV positive]) were asked about ill health and treatment use by sequential use of (1) general enquiries without reference to particular conditions, body systems or treatments, (2) checklists of potential health issues and treatments, (3) in-depth interviews. Participants' experiences of illness and treatment and their reporting behaviour were explored qualitatively, as were trial clinicians' experiences with obtaining participant reports. Outcomes were the number and nature of data by questioning method, themes from qualitative analyses and a theoretical interpretation of participants' experiences. RESULTS: There was an overall cumulative increase in the number of reports from general enquiry through checklists to in-depth interview; in South Africa, an additional 12 medical histories, 21 AEs and 27 medications; in Tanzania an additional 260 medical histories, 1 AE and 11 medications. Checklists and interviews facilitated recognition of health issues and treatments, and consideration of what to report. Information was sometimes not reported because participants forgot, it was considered irrelevant or insignificant, or they feared reporting. Some medicine names were not known and answers to questions were considered inferior to blood tests for detecting ill health. South African inpatient volunteers exhibited a "trial citizenship", working to achieve researchers' goals, while Tanzanian outpatients sometimes deferred responsibility for identifying items to report to trial clinicians. CONCLUSIONS: Questioning methods and trial contexts influence the detection of adverse events, medical histories and concomitant medications. There should be further methodological work to investigate these influences and find appropriate questioning methods. en_ZA
dc.language.iso eng en_ZA
dc.publisher BioMed Central Ltd en_ZA
dc.rights This is an Open Access article distributed under the terms of the Creative Commons Attribution License en_ZA
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en_ZA
dc.source BMC Medical Research Methodology en_ZA
dc.source.uri http://www.biomedcentral.com/bmcmedresmethodol/ en_ZA
dc.subject.other Clinical trial en_ZA
dc.subject.other Safety en_ZA
dc.subject.other Harm en_ZA
dc.subject.other Pharmacovigilance en_ZA
dc.subject.other Malaria en_ZA
dc.subject.other HIV en_ZA
dc.subject.other Elicitation en_ZA
dc.subject.other Social context en_ZA
dc.title How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials en_ZA
dc.type Journal Article en_ZA
dc.rights.holder 2013 Allen et al.; licensee BioMed Central Ltd en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Division of Clinical Pharmacology en_ZA
uct.type.filetype Text
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This is an Open Access article distributed under the terms of the Creative Commons Attribution License Except where otherwise noted, this item's license is described as This is an Open Access article distributed under the terms of the Creative Commons Attribution License