Context

The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment.

Objective

This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand—and subsequently improve—recruitment and informed consent within a range of clinical trials.

Evidence acquisition

A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review.

Evidence synthesis

The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds.

Conclusions

Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target.

Patient summary

Qualitative research is a term used to describe a range of methods that can be implemented to understand participants’ perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand—and improve—recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.

中文翻译：

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了解和改进随机对照试验的招募：定性研究方法

语境

随机试验证据的重要性现已得到广泛认可，尽管招募通常很困难。定性研究在确定招聘的主要障碍方面显示出希望，并且已经制定了干预措施来减少组织困难并支持临床医生进行招聘。

客观的

本文介绍了定性研究技术，并解释了如何使用这种方法来理解并随后改进一系列临床试验中的招募和知情同意。

取证

使用 Medline、Embase 和 CINAHL 进行文献检索。所有采用定性研究方法侧重于临床医生招募活动的研究均被纳入评价。

证据综合

大多数研究报告说，组织困难和临床工作人员缺乏时间是招聘的主要障碍。然而，定性研究的综合强调了将研究与临床角色相结合时出现的智力和情感挑战，特别是在平衡和患者资格方面。为了支持招聘人员更加适应随机对照试验的设计和原则，已经制定了干预措施，包括 QuinteT 招聘干预措施，其中包括实时深入调查招聘障碍，然后实施量身定制的策略来解决这些问题随着审判的进行而面临挑战。

结论

定性研究可以为试验招募的复杂性提供重要见解，并为干预措施的制定提供信息，并根据需要提供支持和培训计划。研究人员应考虑在预期具有挑战性或招募低于目标的试验中实施此类方法。

患者总结

定性研究是一个术语，用于描述可以实施以了解参与者的观点和行为的一系列方法。数据来自访谈、焦点小组或观察。在这篇综述中，我们展示了如何使用这种方法来理解和改进临床试验的招募。综上所述，我们的审查表明，医疗保健专业人员可能会发现招募试验具有挑战性，并且需要在此过程中获得支持。