Hagen Neil A, Stiles Carla, Nekolaichuk Cheryl, Biondo Patricia, Carlson Linda E, Fisher Kim, Fainsinger Robin
Tom Baker Cancer Centre, University of Calgary, Calgary, Canada.
J Pain Symptom Manage. 2008 Feb;35(2):136-52. doi: 10.1016/j.jpainsymman.2007.03.016. Epub 2008 Jan 7.
Breakthrough pain is a prevalent cancer pain syndrome, and research is needed to identify more effective interventions to manage it. A validated tool to assess breakthrough pain in a standard and reliable manner is urgently needed to support the conduct of clinical trials in breakthrough pain. To address this need, we developed a breakthrough pain assessment tool for research purposes. The current study was undertaken to gather validity evidence for this breakthrough pain assessment tool, using a Delphi process involving an expert panel review, followed by a think-aloud process involving patients with cancer-related breakthrough pain. Two expert panels were formed: a national panel (within Canada; n=16) and an international panel (including experts from North America, UK, Europe, the Middle East, Australia, and New Zealand; n=22). Each panel participated in one anonymous survey round. Response rates were 56% (national panel) and 73% (international panel). The Delphi process revealed substantial consensus on the content of the tool, which increased between rounds of review. The overall level of agreement with the tool, averaged over the four evaluated aspects of all items, was 80% among national panelists and 88% among international panelists. Nine patients completed the think-aloud study. They were able to understand and complete the tool and provided specific direction on its improvement. The validity evidence gathered in this study suggests the Alberta Breakthrough Pain Assessment Tool is conceptually grounded and is understandable by patients and clinicians. Further validation of this tool as an assessment measure within clinical trials research is warranted.
爆发性疼痛是一种常见的癌症疼痛综合征,需要开展研究以确定更有效的干预措施来进行管理。迫切需要一种经过验证的工具,以便以标准且可靠的方式评估爆发性疼痛,从而支持爆发性疼痛的临床试验。为满足这一需求,我们开发了一种用于研究目的的爆发性疼痛评估工具。本研究旨在通过德尔菲法收集该爆发性疼痛评估工具的效度证据,首先进行专家小组评审,随后对患有癌症相关性爆发性疼痛的患者进行出声思维过程。组建了两个专家小组:一个是国内小组(加拿大境内;n = 16),另一个是国际小组(包括来自北美、英国、欧洲、中东、澳大利亚和新西兰的专家;n = 22)。每个小组都参与了一轮匿名调查。回复率分别为56%(国内小组)和73%(国际小组)。德尔菲法显示,专家们对该工具的内容达成了高度共识,且在各轮评审之间有所增加。在所有项目的四个评估方面进行平均后,国内小组成员对该工具的总体认同度为80%,国际小组成员为88%。九名患者完成了出声思维研究。他们能够理解并完成该工具,并就其改进提供了具体指导。本研究收集的效度证据表明,艾伯塔爆发性疼痛评估工具在概念上有依据,患者和临床医生都能理解。有必要在临床试验研究中进一步验证该工具作为一种评估手段的有效性。