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.authorAllen, Elizabethen_ZA
dc.contributor.authorBarnes, Karenen_ZA
dc.contributor.authorMushi, Adielen_ZA
dc.contributor.authorMassawe, Isolideen_ZA
dc.contributor.authorStaedke, Sarahen_ZA
dc.contributor.authorMehta, Ushmaen_ZA
dc.contributor.authorVestergaard, Lasseen_ZA
dc.contributor.authorLemnge, Marthaen_ZA
dc.contributor.authorChandler, Clareen_ZA
dc.date.accessioned2015-11-11T12:02:06Z
dc.date.available2015-11-11T12:02:06Z
dc.date.issued2011en_ZA
dc.description.abstractBackground: 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.identifier.apacitationAllen, E., Barnes, K., Mushi, A., Massawe, I., Staedke, S., Mehta, U., ... Chandler, C. (2011). Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report. <i>Trials</i>, http://hdl.handle.net/11427/14889en_ZA
dc.identifier.chicagocitationAllen, Elizabeth, Karen Barnes, Adiel Mushi, Isolide Massawe, Sarah Staedke, Ushma Mehta, Lasse Vestergaard, Martha Lemnge, and Clare Chandler "Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report." <i>Trials</i> (2011) http://hdl.handle.net/11427/14889en_ZA
dc.identifier.citationAllen, 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.ris TY - Journal Article AU - Allen, Elizabeth AU - Barnes, Karen AU - Mushi, Adiel AU - Massawe, Isolide AU - Staedke, Sarah AU - Mehta, Ushma AU - Vestergaard, Lasse AU - Lemnge, Martha AU - Chandler, Clare AB - 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. DA - 2011 DB - OpenUCT DO - 10.1186/1745-6215-12-S1-A10 DP - University of Cape Town J1 - Trials LK - https://open.uct.ac.za PB - University of Cape Town PY - 2011 T1 - Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report TI - Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report UR - http://hdl.handle.net/11427/14889 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14889
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-12-S1-A10
dc.identifier.vancouvercitationAllen E, Barnes K, Mushi A, Massawe I, Staedke S, Mehta U, et al. Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report. Trials. 2011; http://hdl.handle.net/11427/14889.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.holder2011 Allen et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceTrialsen_ZA
dc.source.urihttp://www.trialsjournal.com/en_ZA
dc.subject.otherHarm Datumen_ZA
dc.subject.otherReporting Decisionen_ZA
dc.subject.otherReporting Behaviouren_ZA
dc.subject.otherIn-depth Interviewen_ZA
dc.subject.otherCase Record Formen_ZA
dc.titleEliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to reporten_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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