社区腿部溃疡包扎研究:在一项试点随机对照试验中吸取的经验教训
Community leg ulcer bandaging study: lessons learned in a pilot, randomized controlled trial .
作者信息
Smith Lisa Janette, Harrison Margaret B, Graham Ian D, Lamb Marianne
机构信息
Hotel Dieu Hospital, Kingston, Ontario, Canada.
出版信息
Ostomy Wound Manage. 2010 Sep;56(9):32-42.
Compression is the cornerstone of venous leg ulcer (VLU) care but comparative effectiveness evidence is limited, especially regarding home care. In preparation for a large, community-based randomized controlled clinical trial (RCT), the "Canadian Bandaging Trial" (CBT), a pilot study was conducted to assess the practicality of the CBT study protocol. Nurses who provided home care also performed the research intervention and outcome measurements. All trial procedures were implemented to examine the following aspects of the study protocol: 1) eligibility screening, recruitment, enrollment, and randomization procedures; 2) integration of intervention protocol with usual clinical routines; 3) data collection and management and outcome measures; and 4) database creation and testing. Guided by a Pilot Research Process Framework (PReP), this 6-month pilot RCT was conducted at two community-based sites in Ontario, Canada. Participants included 12 persons with VLUs, 40 nurses providing leg ulcer care, and two site investigators. Individuals with a VLU were randomized to a four-layer or short-stretch compression bandage. Eligibility screening and randomization procedures were found to be efficient but the ratio of screened (49) versus enrolled (12) patients was low and suggested the need for nine additional clinical sites, a change in ulcer size eligibility, and research to evaluate how to incorporate persons with diabetes in leg ulcer trials. Screening practices, data collection form concerns, and wound photo assessment outcomes issues were addressed. The results of this study improved and streamlined the large RCT quality and processes and confirm the value of pilot studies. Research to test the usefulness of the PReP framework for other pilot studies is needed.
压迫疗法是下肢静脉溃疡(VLU)护理的基石,但比较有效性的证据有限,尤其是在家庭护理方面。为筹备一项大型的、基于社区的随机对照临床试验(RCT),即“加拿大绷带试验”(CBT),开展了一项试点研究以评估CBT研究方案的实用性。提供家庭护理的护士同时实施研究干预措施并进行结果测量。所有试验程序均得以实施,以检验研究方案的以下方面:1)资格筛查、招募、入组和随机化程序;2)将干预方案与常规临床流程相结合;3)数据收集与管理以及结果测量;4)数据库创建与测试。在一个试点研究流程框架(PReP)的指导下,这项为期6个月的试点RCT在加拿大安大略省的两个社区地点进行。参与者包括12名患有VLU的患者、40名提供腿部溃疡护理的护士以及两名现场研究者。患有VLU的个体被随机分配至使用四层或短弹力压迫绷带。结果发现资格筛查和随机化程序效率较高,但筛查患者(49名)与入组患者(12名)的比例较低,这表明需要增加9个临床地点,改变溃疡大小的入选标准,并开展研究以评估如何将糖尿病患者纳入腿部溃疡试验。解决了筛查实践、数据收集表相关问题以及伤口照片评估结果相关问题。本研究的结果改进并简化了大型RCT的质量和流程,并证实了试点研究的价值。需要开展研究以测试PReP框架对其他试点研究的有用性。