Monash Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia.
Int Wound J. 2019 Apr;16(2):442-458. doi: 10.1111/iwj.13053. Epub 2018 Dec 19.
Evidence translation in wound care relies on the need for evidence generation. Clinical practice may generate evidence only if evidence-generating research projects, such as randomised controlled trials (RCTs), became routinised in clinical settings. The aim of this study was to identify optimal trial-related practices to routinise trial-related activities in Melbourne-located wound clinics as reported by clinicians and researchers. We conducted a secondary analysis of the available data on how to routinise RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face-to-face and telephone interviews. Data were obtained from a qualitative observational study nested within a randomised, double-blinded, placebo-controlled trial on clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers (ASPiVLU). We developed a seven-step Routinisation of Trials in Clinical Care Framework. These steps include: (1) pre-trial clinical site assessment, (2) optimising pre-recruitment arrangements, (3) developing and updating trial-related skills, (4) embedding RCT recruitment as part of routine clinical care, (5) promoting teamwork and trial-related collaboration, (6) addressing trial-related financial issues, and (7) communicating trial results to clinicians.
在伤口护理中进行证据转化依赖于产生证据的需求。只有当产生证据的研究项目（如随机对照试验[RCT]）在临床环境中常规化，临床实践才能产生证据。本研究的目的是确定最佳的试验相关实践，以便在墨尔本的伤口诊所中常规化与试验相关的活动，这是由临床医生和研究人员报告的。我们对如何在临床护理中常规化 RCT 的现有数据进行了二次分析，重点是参与者在面对面和电话访谈中提供的促进因素和建议。数据来自一项嵌套在阿司匹林作为慢性静脉性腿部溃疡（ASPiVLU）辅助治疗的压缩治疗的临床疗效的随机、双盲、安慰剂对照试验中的定性观察性研究。我们制定了一个七步的临床试验常规化框架。这些步骤包括：（1）试验前临床场所评估，（2）优化预招募安排，（3）发展和更新与试验相关的技能，（4）将 RCT 招募纳入常规临床护理的一部分，（5）促进团队合作和与试验相关的协作，（6）解决与试验相关的财务问题，以及（7）向临床医生传达试验结果。
