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

Malaria Journal

Research

Cheryl Pace¹  Clare I. R. Chandler²  Elizabeth N. Allen³  Nyaradzo Mandimika³  Karen I. Barnes³ 

[1] Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK;Department of Global Health & Development, London School of Hygiene & Tropical Medicine, London, UK;Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa;

关键词: Elicitation methods;    Clinical trials;    Safety;    Adverse events;    Non-study medication;    Delphi;   

DOI  :  10.1186/s12936-017-1699-x

 received in 2016-06-24, accepted in 2017-01-18,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundEliciting 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.MethodsExperienced 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.ResultsOf 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.ConclusionsThis 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.

【 授权许可】

CC BY   
© The Author(s) 2017