Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study

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dc.contributor.authorMandimika, Nyaradzo
dc.contributor.authorBarnes, Karen I
dc.contributor.authorChandler, Clare I R
dc.contributor.authorPace, Cheryl
dc.contributor.authorAllen, Elizabeth N
dc.date.accessioned2021-10-08T07:08:19Z
dc.date.available2021-10-08T07:08:19Z
dc.date.issued2017
dc.description.abstractBACKGROUND: Eliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission. METHODS: Experienced and knowledgeable anti-malarial drug clinical researchers were invited to participate in a Delphi technique study, to facilitate consensus on what are considered optimal (relevant, important and feasible) methods, tools, and approaches for detecting participant-reported AE and non-study medication data in uncomplicated malaria treatment studies. RESULTS: Of 72 invited, 25, 16 and 10 panellists responded to the first, second and third rounds of the Delphi, respectively. Overall, 68% (68/100) of all questioning items presented for rating achieved consensus. When asking general questions about health, panellists agreed on the utility of a question/concept about any change in health, taking care to ensure that such questions/concepts do not imply causality. Eighty-nine percent (39/44) of specific signs and symptoms questions were rated as optimal. For non-study medications, a general question and most structured questioning items were considered an optimal approach. The use of mobile phones, patient diaries, rating scales as well as openly engaging with participants to discuss concerns were also considered optimal complementary data-elicitation tools. CONCLUSIONS: This study succeeded in reaching consensus within a section of the anti-malarial drug clinical research community about using a general question concept, and structured questions for eliciting data about AEs and non-study medication reports. The concepts and items considered in this Delphi to be relevant, important and feasible should be further investigated for potential inclusion in a harmonized approach to collect participant-elicited anti-malarial drug safety data. This, in turn, should improve understanding of anti-malarial drug safety.
dc.identifier.apacitationMandimika, N., Barnes, K. I., Chandler, C. I. R., Pace, C., & Allen, E. N. (2017). Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study. <i>Malaria Journal</i>, 16(1), 174 - 177. http://hdl.handle.net/11427/34555en_ZA
dc.identifier.chicagocitationMandimika, Nyaradzo, Karen I Barnes, Clare I R Chandler, Cheryl Pace, and Elizabeth N Allen "Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study." <i>Malaria Journal</i> 16, 1. (2017): 174 - 177. http://hdl.handle.net/11427/34555en_ZA
dc.identifier.citationMandimika, N., Barnes, K.I., Chandler, C.I.R., Pace, C. & Allen, E.N. 2017. Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study. <i>Malaria Journal.</i> 16(1):174 - 177. http://hdl.handle.net/11427/34555en_ZA
dc.identifier.issn1475-2875
dc.identifier.ris TY - Journal Article AU - Mandimika, Nyaradzo AU - Barnes, Karen I AU - Chandler, Clare I R AU - Pace, Cheryl AU - Allen, Elizabeth N AB - BACKGROUND: Eliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission. METHODS: Experienced and knowledgeable anti-malarial drug clinical researchers were invited to participate in a Delphi technique study, to facilitate consensus on what are considered optimal (relevant, important and feasible) methods, tools, and approaches for detecting participant-reported AE and non-study medication data in uncomplicated malaria treatment studies. RESULTS: Of 72 invited, 25, 16 and 10 panellists responded to the first, second and third rounds of the Delphi, respectively. Overall, 68% (68/100) of all questioning items presented for rating achieved consensus. When asking general questions about health, panellists agreed on the utility of a question/concept about any change in health, taking care to ensure that such questions/concepts do not imply causality. Eighty-nine percent (39/44) of specific signs and symptoms questions were rated as optimal. For non-study medications, a general question and most structured questioning items were considered an optimal approach. The use of mobile phones, patient diaries, rating scales as well as openly engaging with participants to discuss concerns were also considered optimal complementary data-elicitation tools. CONCLUSIONS: This study succeeded in reaching consensus within a section of the anti-malarial drug clinical research community about using a general question concept, and structured questions for eliciting data about AEs and non-study medication reports. The concepts and items considered in this Delphi to be relevant, important and feasible should be further investigated for potential inclusion in a harmonized approach to collect participant-elicited anti-malarial drug safety data. This, in turn, should improve understanding of anti-malarial drug safety. DA - 2017 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - Malaria Journal LK - https://open.uct.ac.za PY - 2017 SM - 1475-2875 T1 - Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study TI - Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study UR - http://hdl.handle.net/11427/34555 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/34555
dc.identifier.vancouvercitationMandimika N, Barnes KI, Chandler CIR, Pace C, Allen EN. Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study. Malaria Journal. 2017;16(1):174 - 177. http://hdl.handle.net/11427/34555.en_ZA
dc.language.isoeng
dc.publisher.departmentDepartment of Medicine
dc.publisher.facultyFaculty of Health Sciences
dc.sourceMalaria Journal
dc.source.journalissue1
dc.source.journalvolume16
dc.source.pagination174 - 177
dc.source.urihttps://dx.doi.org/10.1186/s12936-017-1699-x
dc.subject.otherAdverse events
dc.subject.otherClinical trials
dc.subject.otherDelphi
dc.subject.otherElicitation methods
dc.subject.otherNon-study medication
dc.subject.otherSafety
dc.titleWorking towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study
dc.typeJournal Article
uct.type.publicationResearch
uct.type.resourceJournal Article
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