Mandimika Nyaradzo, Barnes Karen I, Chandler Clare I R, Pace Cheryl, Allen Elizabeth N
Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Department of Global Health & Development, London School of Hygiene & Tropical Medicine, London, UK.
Malar J. 2017 Jan 28;16(1):52. doi: 10.1186/s12936-017-1699-x.
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.
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.
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.
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.
从临床研究参与者中获取不良事件（AE）和非研究用药数据报告对于评估药物安全性至关重要。然而，使用不同的方法询问参与者会产生不一致的结果，这会影响跨研究数据的解释、比较和汇总。鉴于抗疟药在弱势群体中的广泛使用，以及它们在健康但有风险的个体中作为预防性治疗或减少疟疾传播的使用日益增加，这一点尤为重要。
邀请经验丰富且知识渊博的抗疟药物临床研究人员参与德尔菲技术研究，以促进就检测单纯性疟疾治疗研究中参与者报告的AE和非研究用药数据的最佳（相关、重要且可行）方法、工具和途径达成共识。
在受邀的72人中，分别有25、16和10名小组成员回复了德尔菲的第一轮、第二轮和第三轮。总体而言，提出供评级的所有询问项目中有68%（68/100）达成了共识。在询问有关健康的一般问题时，小组成员就关于健康任何变化的问题/概念的效用达成了一致，同时注意确保此类问题/概念不暗示因果关系。89%（39/44）的特定体征和症状问题被评为最佳。对于非研究用药，一个一般问题和大多数结构化询问项目被认为是最佳方法。使用手机、患者日记、评分量表以及与参与者公开讨论担忧也被认为是最佳的补充数据获取工具。
本研究成功地在抗疟药物临床研究界的一部分人中就使用一般问题概念和结构化问题来获取有关AE和非研究用药报告的数据达成了共识。应进一步研究本德尔菲中认为相关、重要且可行的概念和项目，以考虑将其纳入收集参与者获取的抗疟药物安全性数据的统一方法中。反过来，这应该会增进对抗疟药物安全性的理解。
