BACKGROUND One important ethical issue in randomised controlled trials (RCTs) is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of randomisation such as equality, fairness, transparency and accountability in community-based trials. The aim of this study was to understand and explore study communities' perspectives of the randomisation process in a cluster RCT in rural Zambia studying the effectiveness of different support packages for adolescent girls on early childbearing. METHODS In this explorative study, in-depth semi-structured interviews were carried out in 2018 with 14 individuals who took part in the randomisation process of the Research Initiative to Support the Empowerment of Girls (RISE) project in 2016 and two traditional leaders. Two of the districts where the trial is implemented were purposively selected. Interviews were audio recorded and fully transcribed. Data were analysed by coding and describing emergent themes. RESULTS The understanding of the randomisation process varied. Some respondents understood that randomisation was conducted for research purposes, but most of them did not. They had trouble distinguishing research and aid. Generally, respondents perceived the randomisation process as transparent and fair. However, people thought that there should not have been a "lottery" because they wanted all schools to receive equal or balanced benefits of the interventions. CONCLUSIONS Randomisation was misunderstood by most respondents. Perceived procedural fairness was easier to realize than substantive fairness. Researchers working on Cluster Randomised Controlled Trials (CRCTs) should consider carefully how to explain randomisation.

中文翻译：

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赞比亚一项整群随机对照试验中社区对随机化和公平性的看法。

背景随机对照试验（RCT）中的一个重要伦理问题是随机化。对于参与的个人和社区如何理解和感知随机化的核心方面（例如基于社区的试验中的平等、公平、透明度和问责制），人们知之甚少。本研究的目的是了解和探索研究群体对赞比亚农村地区随机对照试验中随机化过程的看法，该随机对照试验研究了针对青春期女孩早期生育的不同支持方案的有效性。方法 在这项探索性研究中，2018 年对参与 2016 年支持女孩赋权研究计划 (RISE) 项目随机化过程的 14 名个人和两名传统领导者进行了深入的半结构化访谈。进行试点的两个地区是特意选择的。采访内容均已录音并完全转录。通过编码和描述新兴主题来分析数据。结果 对随机化过程的理解各不相同。一些受访者理解随机化是为了研究目的而进行的，但大多数人不这么认为。他们很难区分研究和援助。一般来说，受访者认为随机化过程是透明和公平的。然而，人们认为不应该有“抽签”，因为他们希望所有学校都能从干预措施中获得平等或平衡的好处。结论 大多数受访者都误解了随机化。感知的程序公平比实质公平更容易实现。从事整群随机对照试验 (CRCT) 的研究人员应仔细考虑如何解释随机化。