Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data

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dc.contributor.authorAllen, Elizabethen_ZA
dc.contributor.authorChandler, Clareen_ZA
dc.contributor.authorMandimika, Nyaradzoen_ZA
dc.contributor.authorPace, Cherylen_ZA
dc.contributor.authorMehta, Ushmaen_ZA
dc.contributor.authorBarnes, Karenen_ZA
dc.date.accessioned2015-10-30T09:34:02Z
dc.date.available2015-10-30T09:34:02Z
dc.date.issued2013en_ZA
dc.description.abstractBACKGROUND:Participant reports of medical histories, adverse events (AE) and non-study drugs are integral to evaluating harm in clinical research. However, interpreting or synthesizing results is complicated if studies use different methods for ascertaining and assessing these data. To explore how these data are obtained in malaria drug studies, a descriptive online survey of clinical researchers was conducted during 2012 and 2013. METHODS: The survey was advertised through e-mails, collaborators and at conferences. Questions aimed to capture the detail, rationale and application of methods used to obtain relevant data within various study designs and populations. Closed responses were analysed using proportions, open responses through identifying repeating ideas and underlying concepts. RESULTS: Of fifty-two respondents from 25 counties, 87% worked at an investigational site and 75% reported about an interventional study. Studies employed a range of methods to elicit, assess and record participant-reported AEs and related data. Questioning about AEs in 31% of interventional studies was a combination of general (open questions about health) and structured (reference to specific health-related items), 26% used structured only and 18% general only. No observational studies used general questioning alone. A minority incorporated pictorial tools. Rationales for the questioning approach included: standardization of assessment or data capture, specificity or comprehensiveness of data sought, avoidance of suggestion, feasibility, and understanding participants' perceptions. Most respondents considered the approach they reported was optimal, though several reconsidered this. Four AE grading, and three causality assessment approaches were reported. Combining general and structured questions about non-study drug use were considered useful for revealing and identifying specific medicines, while pictures could enhance reports, particularly in areas of low literacy. CONCLUSIONS: It is critical to evaluate the safety of anti-malarial drugs being deployed in large, diverse populations. Many studies would be suitable for contributing to a larger body of evidence for answering questions on harm. However this survey showed that various methods are used to obtain relevant data, which could influence study results. As the best practices for obtaining such data are unclear, anti-malarial clinical researchers should work towards consensus about the selection and/or design of optimal methods.en_ZA
dc.identifier.apacitationAllen, E., Chandler, C., Mandimika, N., Pace, C., Mehta, U., & Barnes, K. (2013). Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data. <i>Malaria Journal</i>, http://hdl.handle.net/11427/14524en_ZA
dc.identifier.chicagocitationAllen, Elizabeth, Clare Chandler, Nyaradzo Mandimika, Cheryl Pace, Ushma Mehta, and Karen Barnes "Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data." <i>Malaria Journal</i> (2013) http://hdl.handle.net/11427/14524en_ZA
dc.identifier.citationAllen, E. N., Chandler, C. I., Mandimika, N., Pace, C., Mehta, U., & Barnes, K. I. (2013). Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data. Malaria journal, 12(1), 325.en_ZA
dc.identifier.ris TY - Journal Article AU - Allen, Elizabeth AU - Chandler, Clare AU - Mandimika, Nyaradzo AU - Pace, Cheryl AU - Mehta, Ushma AU - Barnes, Karen AB - BACKGROUND:Participant reports of medical histories, adverse events (AE) and non-study drugs are integral to evaluating harm in clinical research. However, interpreting or synthesizing results is complicated if studies use different methods for ascertaining and assessing these data. To explore how these data are obtained in malaria drug studies, a descriptive online survey of clinical researchers was conducted during 2012 and 2013. METHODS: The survey was advertised through e-mails, collaborators and at conferences. Questions aimed to capture the detail, rationale and application of methods used to obtain relevant data within various study designs and populations. Closed responses were analysed using proportions, open responses through identifying repeating ideas and underlying concepts. RESULTS: Of fifty-two respondents from 25 counties, 87% worked at an investigational site and 75% reported about an interventional study. Studies employed a range of methods to elicit, assess and record participant-reported AEs and related data. Questioning about AEs in 31% of interventional studies was a combination of general (open questions about health) and structured (reference to specific health-related items), 26% used structured only and 18% general only. No observational studies used general questioning alone. A minority incorporated pictorial tools. Rationales for the questioning approach included: standardization of assessment or data capture, specificity or comprehensiveness of data sought, avoidance of suggestion, feasibility, and understanding participants' perceptions. Most respondents considered the approach they reported was optimal, though several reconsidered this. Four AE grading, and three causality assessment approaches were reported. Combining general and structured questions about non-study drug use were considered useful for revealing and identifying specific medicines, while pictures could enhance reports, particularly in areas of low literacy. CONCLUSIONS: It is critical to evaluate the safety of anti-malarial drugs being deployed in large, diverse populations. Many studies would be suitable for contributing to a larger body of evidence for answering questions on harm. However this survey showed that various methods are used to obtain relevant data, which could influence study results. As the best practices for obtaining such data are unclear, anti-malarial clinical researchers should work towards consensus about the selection and/or design of optimal methods. DA - 2013 DB - OpenUCT DO - 10.1186/1475-2875-12-325 DP - University of Cape Town J1 - Malaria Journal LK - https://open.uct.ac.za PB - University of Cape Town PY - 2013 T1 - Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data TI - Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data UR - http://hdl.handle.net/11427/14524 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14524
dc.identifier.urihttp://dx.doi.org/10.1186/1475-2875-12-325
dc.identifier.vancouvercitationAllen E, Chandler C, Mandimika N, Pace C, Mehta U, Barnes K. Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data. Malaria Journal. 2013; http://hdl.handle.net/11427/14524.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.sourceMalaria Journalen_ZA
dc.source.urihttp://www.malariajournal.com/en_ZA
dc.subject.otherAnti-malarialen_ZA
dc.subject.otherMalariaen_ZA
dc.subject.otherHarmen_ZA
dc.subject.otherAdverse eventen_ZA
dc.subject.otherConcomitant medicationen_ZA
dc.subject.otherAdherenceen_ZA
dc.subject.otherAssessmenten_ZA
dc.titleEvaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related dataen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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