Real World Study Delivery, Value Evidence and Outcomes, GlaxoSmithKline plc., Research & Development Ltd., Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK.
RTI Health Solutions, Manchester, M20 2LS, UK.
Trials. 2020 Sep 17;21(1):798. doi: 10.1186/s13063-020-04655-x.
Randomized controlled trials (RCTs) conducted in the routine care setting provide the opportunity to better understand the effectiveness of new medicines but can present recruitment difficulties. An improved understanding of the challenges/opportunities for patient and healthcare professional (HCP) engagement in clinical research is needed to enhance participation and trial experience. In this study, we explored patient and HCP drivers for, and experiences of, participation in the Salford Lung Studies (SLS), and their views on future trial participation and the overall value of such trials.
This was a qualitative study set in Salford, UK, comprising patient telephone interviews (N = 10) and HCP advisory boards (one with general practitioners [GPs], one with practice managers [PMs]); all individuals had participated in the SLS. Semi-structured telephone interviews were recorded, transcribed and analysed thematically. Advisory board meetings were analysed based on transcriptions of audio recordings and field notes.
For patients, key positive aspects of the SLS were the ease/convenience of study assessments and excellent relationships with study nurses. GPs and PMs considered the SLS to be well-organized and highlighted the value of research nurse support; they also described minor challenges relating to trial systems, initial financial strain on practices and staff turnover. All participants indicated that they were very likely to participate in future trials, citing a design closely aligned with routine care practice as essential. Several strategies to encourage trial participation were suggested, such as clearly communicating benefits to patients and ensuring flexible study assessments.
Patients and HCPs had positive experiences of the SLS. The study design, closely aligned with routine care, was considered important to their high likelihood of participating in future trials. The experiences of patients and HCPs in the SLS provide valuable insights that will help inform future best practice in the design and conduct of future real-world effectiveness RCTs in primary care. The detailed first-hand experiences of HCPs will be of significant value to others considering engaging in clinical research and participating in effectiveness RCTs.
在常规护理环境中进行的随机对照试验（RCT）提供了更好地了解新药有效性的机会，但可能会遇到招募困难。为了提高参与度并改善试验体验，需要深入了解患者和医疗保健专业人员（HCP）参与临床研究的挑战/机遇。在这项研究中，我们探讨了患者和 HCP 参与索尔福德肺部研究（SLS）的动机和经验，以及他们对未来试验参与和此类试验整体价值的看法。
这是一项在英国索尔福德进行的定性研究，包括患者电话访谈（N=10）和 HCP 顾问委员会（一个与全科医生[GP]，一个与实践经理[PM]）；所有参与者都参加了 SLS。对电话访谈进行了半结构化记录、转录和主题分析。顾问委员会会议基于音频记录和现场笔记的转录进行了分析。
对于患者而言，SLS 的主要积极方面是研究评估的简便性/便利性以及与研究护士的良好关系。GP 和 PM 认为 SLS 组织得很好，并强调了研究护士支持的价值；他们还描述了与试验系统相关的一些小挑战、最初对实践的财务压力以及员工流失。所有参与者都表示非常有可能参与未来的试验，他们认为试验设计与常规护理紧密结合至关重要。还提出了一些鼓励试验参与的策略，例如向患者清楚地传达益处，并确保灵活的研究评估。
患者和 HCP 对 SLS 有积极的体验。该研究设计与常规护理紧密结合，被认为是他们未来极有可能参与未来试验的重要因素。患者和 HCP 在 SLS 中的经验提供了有价值的见解，这将有助于为未来在初级保健中进行真实世界有效性 RCT 的最佳实践提供信息。HCP 的详细第一手经验对于其他考虑参与临床研究和参与有效性 RCT 的人将具有重要价值。
