SMA Clinical Research Center, Columbia University Medical Center, New York, NY, USA.
Neuromuscul Disord. 2010 Mar;20(3):162-5. doi: 10.1016/j.nmd.2009.12.002. Epub 2010 Jan 13.
Clinical research visits are challenging for people with SMA because of limited mobility and intercurrent illnesses. Missing data threaten the validity of research results. Obtaining outcomes remotely would represent a solution. To evaluate reliability of telephone administration of the PedsQL Pediatric Generic Core Quality of Life Inventory 4.0 (Generic) and Neuromuscular Module 3.0 (NM) in SMA, we recruited 21 participants of a Natural History Study for telephone administration of both modules no more than 7 days before or after an in-person study visit. We found excellent reliability between telephone and in-person administration of both modules with the NM slightly better than the Generic. Reliability of the child and parent forms was similar. We concluded that both modules can be administered reliably over the telephone to SMA patients and caregivers, expanding the utility of these tools in clinical trials. Notably, telephone administration is reliable in children as young as 8 years.
临床研究访视对 SMA 患者来说具有挑战性,因为他们活动能力有限且容易并发疾病。数据缺失会威胁研究结果的有效性。远程获取研究结果将是一种解决方案。为了评估电话管理 PedsQL 儿科通用核心生活质量量表 4.0(通用)和神经肌肉模块 3.0(NM)在 SMA 中的可靠性,我们招募了 21 名自然史研究参与者,在面对面研究访视前或后不超过 7 天进行这两个模块的电话管理。我们发现 NM 模块的电话和面对面管理之间具有极好的可靠性,而 NM 模块比通用模块略好。儿童和家长形式的可靠性相似。我们得出结论,这两个模块都可以通过电话可靠地管理 SMA 患者和护理人员,从而扩大这些工具在临床试验中的应用。值得注意的是,电话管理在 8 岁以下的儿童中也是可靠的。