PLAIN ENGLISH SUMMARY When designing clinical trials it is important to involve members of the public, who can provide a view on what may encourage or prevent people participating and on what matters to them. This is known as Public and Patient Involvement (PPI). People from minority ethnic groups are often less likely to take part in clinical trials, but it is important to ensure they are able to participate fully so that health research and its findings are relevant to a wide population. We are preparing to conduct a randomised controlled trial (RCT) to test whether taking probiotic capsules can play a role in preventing preterm birth. Women from some minority ethnic groups, for example women from West Africa, and those who are from low-income groups are more likely to suffer preterm births. Preterm birth can lead to extra costs to health services and psychosocial costs for families. In this article we describe how we engaged women in discussion about the design of the planned trial, and how we aim to use our findings to ensure the trial is workable and beneficial to women, as well as to further engage service users in the future development of the trial. Four socially and ethnically diverse groups of women in East London took part in discussions about the trial and contributed their ideas and concerns. These discussions have helped to inform and improve the design of a small practice or 'pilot' trial to test the recruitment in a 'real life' setting, as well as encourage further PPI involvement for the future full-scale trial. ABSTRACT Background Patient and public involvement (PPI) is an important tool in approaching research challenges. However, involvement of socially and ethnically diverse populations remains limited and practitioners need effective methods of involving a broad section of the population in planning and designing research. Methods In preparation for the development of a pilot randomised controlled trial (RCT) on the use of probiotics to prevent preterm birth, we conducted a public consultation exercise in a socially disadvantaged and ethnically diverse community. The consultation aimed to meet and engage local service users in considering the acceptability of the proposed protocol, and to encourage their participation in future and ongoing patient and public involvement activities. Four discussion groups were held in the community with mothers of young children within the proposed trial region, using an inclusive approach that incorporated a modified version of the Nominal Group Technique (NGT). Bringing the consultation to the community supported the involvement of often seldom-heard participants, such as those from minority ethnic groups. Results The women involved expressed a number of concerns about the proposed protocol, including adherence to the probiotic supplement regimen and randomisation. The proposal for the RCT in itself was perceived as confirmation that probiotic supplements had potentially beneficial effects, but also that they had potentially harmful side-effects. The complexity of the women's responses provided greater insights into the challenges of even quite simple trial designs and enabled the research team to take these concerns into account while planning the pilot trial. Conclusions The use of the NGT method allowed for a consultation of a population traditionally less likely to participate in medical research. A carefully facilitated PPI exercise can allow members to express unanticipated concerns that may not have been elicited by a survey method. Findings from such exercises can be utilised to improve clinical trial design, provide insight into the feasibility of trials, and enable engagement of often excluded population groups.

中文翻译：

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让很少听到的群体参与 PPI 流程，为拟定的使用益生菌预防早产的试验的设计提供信息：案例研究。

简单英语摘要 在设计临床试验时，让公众参与进来非常重要，他们可以就什么可能鼓励或阻止人们参与以及什么对他们重要提出意见。这称为公众和患者参与 (PPI)。少数民族群体通常不太可能参加临床试验，但重要的是要确保他们能够充分参与，以便健康研究及其结果与广大人群相关。我们正准备进行一项随机对照试验（RCT），测试服用益生菌胶囊是否能起到预防早产的作用。一些少数民族妇女，例如西非妇女和低收入群体的妇女更容易出现早产。早产可能会导致额外的医疗服务费用和家庭心理社会费用。在本文中，我们描述了我们如何让女性参与有关计划试验设计的讨论，以及我们如何利用我们的研究结果来确保试验可行且对女性有益，并进一步让服务使用者参与未来的发展审判的。东伦敦的四个社会和种族不同的妇女群体参加了有关审判的讨论，并提出了她们的想法和担忧。这些讨论有助于为小型实践或“试点”试验的设计提供信息和改进，以在“现实生活”环境中测试招募情况，并鼓励 PPI 进一步参与未来的全面试验。摘要 背景 患者和公众参与 (PPI) 是应对研究挑战的重要工具。然而，社会和种族多样化人群的参与仍然有限，从业者需要有效的方法让广大人群参与规划和设计研究。方法 为了准备开展一项关于使用益生菌预防早产的随机对照试验 (RCT)，我们在一个社会弱势群体和多元化社区进行了公众咨询活动。此次咨询旨在与当地服务使用者会面并让其参与考虑拟议方案的可接受性，并鼓励他们参与未来和正在进行的患者和公众参与活动。在拟议试验区域内的社区中，与幼儿的母亲一起举行了四个讨论小组，采用包容性方法，其中纳入了名义小组技术（NGT）的修改版本。将咨询带到社区支持了很少被听到的参与者的参与，例如来自少数族裔群体的参与者。结果 参与其中的女性对拟议方案表达了许多担忧，包括遵守益生菌补充剂方案和随机化。RCT 的提议本身被认为证实了益生菌补充剂具有潜在的有益作用，但也有潜在的有害副作用。女性反应的复杂性使我们能够更深入地了解即使是非常简单的试验设计所面临的挑战，并使研究团队能够在规划试点试验时考虑到这些问题。结论 NGT 方法的使用可以为传统上不太可能参与医学研究的人群提供咨询。精心策划的 PPI 练习可以让成员表达调查方法可能未引起的意料之外的担忧。此类练习的结果可用于改进临床试验设计，深入了解试验的可行性，并促进经常被排除的人群的参与。