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.authorAllen, Elizabethen_ZA
dc.contributor.authorMushi, Adielen_ZA
dc.contributor.authorMassawe, Isolideen_ZA
dc.contributor.authorVestergaard, Lasseen_ZA
dc.contributor.authorLemnge, Marthaen_ZA
dc.contributor.authorStaedke, Sarahen_ZA
dc.contributor.authorMehta, Ushmaen_ZA
dc.contributor.authorBarnes, Karenen_ZA
dc.contributor.authorChandler, Clareen_ZA
dc.date.accessioned2015-11-04T11:59:10Z
dc.date.available2015-11-04T11:59:10Z
dc.date.issued2013en_ZA
dc.description.abstractBACKGROUND: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.identifier.apacitationAllen, E., Mushi, A., Massawe, I., Vestergaard, L., Lemnge, M., Staedke, S., ... Chandler, C. (2013). How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials. <i>BMC Medical Research Methodology</i>, http://hdl.handle.net/11427/14686en_ZA
dc.identifier.chicagocitationAllen, Elizabeth, Adiel Mushi, Isolide Massawe, Lasse Vestergaard, Martha Lemnge, Sarah Staedke, Ushma Mehta, Karen Barnes, and Clare Chandler "How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials." <i>BMC Medical Research Methodology</i> (2013) http://hdl.handle.net/11427/14686en_ZA
dc.identifier.citationAllen, 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.ris TY - Journal Article AU - Allen, Elizabeth AU - Mushi, Adiel AU - Massawe, Isolide AU - Vestergaard, Lasse AU - Lemnge, Martha AU - Staedke, Sarah AU - Mehta, Ushma AU - Barnes, Karen AU - Chandler, Clare AB - 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. DA - 2013 DB - OpenUCT DO - 10.1186/1471-2288-13-140 DP - University of Cape Town J1 - BMC Medical Research Methodology LK - https://open.uct.ac.za PB - University of Cape Town PY - 2013 T1 - How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials TI - How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials UR - http://hdl.handle.net/11427/14686 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14686
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2288-13-140
dc.identifier.vancouvercitationAllen E, Mushi A, Massawe I, Vestergaard L, Lemnge M, Staedke S, et al. 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. 2013; http://hdl.handle.net/11427/14686.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDivision of Clinical Pharmacologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2013 Allen et al.; licensee BioMed Central Ltden_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceBMC Medical Research Methodologyen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcmedresmethodol/en_ZA
dc.subject.otherClinical trialen_ZA
dc.subject.otherSafetyen_ZA
dc.subject.otherHarmen_ZA
dc.subject.otherPharmacovigilanceen_ZA
dc.subject.otherMalariaen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherElicitationen_ZA
dc.subject.otherSocial contexten_ZA
dc.titleHow experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trialsen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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