HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients.
HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients.
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DOI：
10.1186/s13063-017-1933-4
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发表时间：
2017-05-17
期刊：
影响因子：
2.5
通讯作者：
Schuurmans MJ
中科院分区：
文献类型：
--
作者：
Heim N;van Stel HF;Ettema RG;van der Mast RC;Inouye SK;Schuurmans MJ
一个务实的，阶梯式楔形试验设计可以是一个有吸引力的设计，以评估复杂的干预措施在现实生活中的设置。然而，有一些陷阱需要考虑。本文报道了一项随机分组、阶梯式楔形试验的经验和教训，该试验评估了荷兰一家医院老年生活项目（HELP）预防老年患者发生谵妄的效果。我们评估了我们的试验，该试验在两家医院的八个部门进行，在70岁或70岁以上的住院患者中进行，这些患者有谵妄的风险，通过反思我们的假设和我们开始时打算实现的目标，与我们在研究的不同阶段实际实现的目标进行比较。提供了关于设计、时间轴、合格患者入组和常规收集数据使用的经验教训，以及应对挑战的建议。审判推迟开始，造成后来的时间安排问题。质量改进项目需要个人知情同意，这使得纳入更容易产生选择偏差。大多数单位在纳入患者方面遇到了重大困难，导致8个单位中有2个被排除在参与之外。这导致对照条件与干预条件下的患者数量相似。在研究期间无法访问电子患者记录中常规收集的结局数据，并且在分析期间似乎经常缺失。阶梯楔形，集群随机试验在现实生活中的研究设计和执行中带来了特定的风险，研究人员应该意识到这一点，以防止负面后果影响其结果的有效性。在荷兰医院环境中的有效性的HELP的有效性的结论受到我们的务实的试验中的常规临床数据的数量和质量有限。在日常实践环境中使用常规收集的数据执行阶梯式楔形设计需要特别注意伦理审查，灵活性，宽敞的时间表，研究团队的大量能力的可用性以及对数据可用性和质量的早期检查。荷兰试验注册，标识符：NTR3842。2013年1月24日登记。
A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium. We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study. Lessons learned on the design, the timeline, the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges. The start of the trial was delayed which caused subsequent time schedule problems. The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias. Most units experienced major difficulties in including patients, leading to excluding two of the eight units from participation. This resulted in failing to include a similar number of patients in the control condition versus the intervention condition. Data on outcomes routinely collected in the electronic patient records were not accessible during the study, and appeared to be often missing during analyses. The stepped wedge, cluster randomized trial poses specific risks in the design and execution of research in real-life settings of which researchers should be aware to prevent negative consequences impacting the validity of their results. Valid conclusions on the effectiveness of the HELP in the Dutch hospital setting are hampered by the limited quantity and quality of routine clinical data in our pragmatic trial. Executing a stepped wedge design in a daily practice setting using routinely collected data requires specific attention to ethical review, flexibility, a spacious time schedule, the availability of substantial capacity in the research team and early checks on the data availability and quality. Netherlands Trial Register, identifier: NTR3842. Registered on 24 January 2013.