Pattison Natalie, Arulkumaran Nishkantha, Humphreys Sally, Walsh Tim
Critical Care, The Royal Marsden NHS Foundation Trust, London, UK.
Critical Care, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK.
J Intensive Care Soc. 2017 Feb;18(1):36-46. doi: 10.1177/1751143716663749. Epub 2016 Aug 22.
Clinical trials in critical care are often resource-intense, with many unique challenges. Barriers to effective recruitment and implementation of study intervention have not been explored in a UK context.
To identify facilitating factors and barriers to enrolling patients into critical care clinical trials within the UK from clinician's perspectives.
A qualitative interview study was undertaken on behalf of the National Institute of Health Research critical care specialty group, in which research active clinicians across different Clinical Research Networks were interviewed. A loosely structured interview schedule was used, based on themes generated from the literature associated with accessing critical care trials. Research teams (critical care doctors, research nurses, and trial coordinators) from hospitals from each Clinical Research Network were contacted to try to achieve representation across the UK.
Interviews were carried out across nine UK Clinical Research Networks with a range of doctors and research nurses. All hospitals were teaching hospitals with varying research nurse numbers and allocated consultant research sessions. There were a range of six to nine ongoing clinical trials in critical care for each centre representative interviewed. Data were analysed using framework analysis, and six final themes were identified related to factors associated with: centre, unit, resources, study, clinician, and patient/family. The most commonly cited barrier to conducting clinical trials was related to resources, namely insufficient human and financial resources, leading to staff and study recruitment difficulties. Clinical uncertainty and equipoise regarding comparative merits of trials were challenging in terms of engaging critical care teams. A number of patient and family factors added complexities in terms of recruitment; however, refusal rates were generally reported as low.
Flexibility in funding and employment by research teams enables continuity of studies and staff. Innovative measures to incentivise research nurses and clinical teams can help recruit more patients into trials. Research teams are highly committed to providing cover to recruit critical care trials, and a significant effort to anticipate barriers is undertaken; these endeavours are summarised to provide guidance for other teams wishing to address any potential difficulties.
重症监护领域的临床试验通常资源需求大，且存在诸多独特挑战。在英国背景下，尚未探讨有效招募患者及实施研究干预的障碍。
从临床医生的角度识别在英国将患者纳入重症监护临床试验的促进因素和障碍。
代表英国国家卫生研究院重症监护专业小组开展了一项定性访谈研究，对不同临床研究网络中积极参与研究的临床医生进行了访谈。基于与参与重症监护试验相关的文献中产生的主题，使用了一个结构松散的访谈提纲。联系了每个临床研究网络中各医院的研究团队（重症监护医生、研究护士和试验协调员），以力求在全英国范围内具有代表性。
在英国九个临床研究网络中对一系列医生和研究护士进行了访谈。所有医院均为教学医院，研究护士数量不同，且分配了顾问研究时段。每位接受访谈的中心代表所在的每个中心都有六至九个正在进行的重症监护临床试验。使用框架分析法对数据进行了分析，确定了六个最终主题，涉及与以下方面相关的因素：中心、科室、资源、研究、临床医生以及患者/家属。开展临床试验最常提到的障碍与资源有关，即人力和财力不足，导致人员配备和研究招募困难。在让重症监护团队参与方面，试验相对优点的临床不确定性和 equipoise 具有挑战性。一些患者和家属因素在招募方面增加了复杂性；然而，总体报告的拒绝率较低。
研究团队在资金和人员聘用方面的灵活性可确保研究和人员的连续性。激励研究护士和临床团队的创新措施有助于招募更多患者参与试验。研究团队高度致力于为招募重症监护试验提供支持，并为预测障碍做出了重大努力；总结这些努力可为其他希望解决任何潜在困难的团队提供指导。
