Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report

 

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dc.contributor.author Allen, Elizabeth en_ZA
dc.contributor.author Barnes, Karen en_ZA
dc.contributor.author Mushi, Adiel en_ZA
dc.contributor.author Massawe, Isolide en_ZA
dc.contributor.author Staedke, Sarah en_ZA
dc.contributor.author Mehta, Ushma en_ZA
dc.contributor.author Vestergaard, Lasse en_ZA
dc.contributor.author Lemnge, Martha en_ZA
dc.contributor.author Chandler, Clare en_ZA
dc.date.accessioned 2015-11-11T12:02:06Z
dc.date.available 2015-11-11T12:02:06Z
dc.date.issued 2011 en_ZA
dc.identifier.citation Allen, E. N., Barnes, K. I., Mushi, A., Massawe, I., Staedke, S. G., Mehta, U., ... & Chandler, C. I. (2011). Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report. Trials, 12(Suppl 1), A10. en_ZA
dc.identifier.uri http://hdl.handle.net/11427/14889
dc.identifier.uri http://dx.doi.org/10.1186/1745-6215-12-S1-A10
dc.description.abstract Background: There is no consensus on the ideal methodology for eliciting participant-reported harms, but question methods influence the extent and nature of data detected. This gives potential for measurement error and undermines meta-analyses of adverse effects. We undertook to identify barriers to accurate and complete reporting of harms data, by qualitatively exploring participants’ experiences of illness and treatment, and reporting behaviours; and compared the number and nature of data detected by three enquiry methods. Methods: Participants within antiretroviral/antimalarial interaction trials in South Africa and Tanzania were asked about medical history, treatments and/or adverse events by general enquiries followed by checklists. Those reporting differently between these two question methods were invited to an in-depth interview and focus group discussion. Health narratives were analysed to investigate accuracy and completeness of case record form data and to understand reasons for differential reporting between question methods. Outcomes were the number and nature of data by question method, themes from qualitative analyses and a theoretical interpretation of participants’ experiences. Results: We observed a cumulative increase in sensitivity of detection of all types of reports while progressing from general enquiry, through checklist, to in-depth interview. Questioning detail and terminology influenced participants’ recognition of health issues and treatments. Reporting patterns and vocabulary suggest influence from the relative importance that illnesses and treatments have for participants. Perceptions were often dichotomised (e.g. ‘street’ versus clinic treatments, symptoms experienced versus tests and examinations performed, chronic versus acute illness, persistent versus intermittent symptoms, activity- versus malaria-related symptoms) and this differentiation extended to ideas of relevance to report. South African participants displayed a ‘trial citizenship’, taking responsibility for the impact of their reporting on trial results, and even reaching reporting decisions by consensus. In contrast, Tanzanians perceived their role more as patients than participants; the locus of responsibility for knowing information relevant to the trial fell with trial staff as doctors rather than with themselves. Conclusions: Our observations of how reporting relates to participant perceptions inside and outside trials could help optimise how harms data are elicited. Questions reflecting the different ways that biomedically defined illness and treatment data are perceived by participants may help them understand relevance for reporting. We will theorise how these two disparate trial environments may have influenced how participants understood their role, as this could help researchers achieve empowered participation in similar trials. 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 Trials en_ZA
dc.source.uri http://www.trialsjournal.com/ en_ZA
dc.subject.other Harm Datum en_ZA
dc.subject.other Reporting Decision en_ZA
dc.subject.other Reporting Behaviour en_ZA
dc.subject.other In-depth Interview en_ZA
dc.subject.other Case Record Form en_ZA
dc.title Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report en_ZA
dc.type Journal Article en_ZA
dc.rights.holder 2011 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
uct.type.filetype Image


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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