Dias-Barbosa Carla, Matos Rodolfo, Vernon Margaret, Carney Colleen E, Krystal Andrew, Puelles Jorge
Evidera, The Ark, 201 Talgarth Road Hammersmith, London, W6 8BJ, UK.
Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, MA, 20814, USA.
J Patient Rep Outcomes. 2020 Nov 23;4(1):100. doi: 10.1186/s41687-020-00265-y.
The intense itching associated with atopic dermatitis (AD) often causes patients to experience severe sleep disturbance. Here, we describe the results of a two-phase concept elicitation and cognitive interview study to establish the content validity of a sleep disturbance numerical rating scale (SD NRS) and a Consensus Sleep Diary adapted for adults and adolescents with moderate-to-severe AD (CSD-AD©).
In phase I, a concept elicitation conducted in 20 adults and 10 adolescents with moderate-to-severe AD revealed that the following sleep-related issues were important and relevant: nighttime awakening (87%), trouble falling asleep (73%), feeling unrested (53%), daytime fatigue or sleepiness (53%), and feeling as if they did not get enough sleep (33%). The frequency and extent of sleep disturbance varied substantially from day to day due to varying degrees of itching and flares, medication use, and changes in the weather. All participants understood the SD NRS question, with most finding it easy or very easy to understand (100% of adults and 90% of adolescents) and most understanding the anchors as intended (95% of adults, and 100% of adolescents). Most participants (94% of adults, and 90% of adolescents) indicated that they would consider a one- or two-point change meaningful on the SD NRS. The CSD-AD© was revised based on participant feedback, and tested during phase II in a convenience sample of six adults and four adolescents from phase I. The changes made to the CSD-AD© were confirmed to be relevant and understandable. All patients were able to provide an answer to each item in the CSD-AD©, and most were able to estimate the duration of nighttime awakenings, daytime naps, and dozing.
The study supported the content validity of the SD NRS and CSD-AD© in adults and adolescents with moderate-to-severe AD. It also emphasized the importance of using these instruments daily when assessing the benefit of a new treatment on sleep quality in this population.
特应性皮炎（AD）相关的剧烈瘙痒常导致患者出现严重的睡眠障碍。在此，我们描述了一项两阶段的概念激发和认知访谈研究的结果，以确立睡眠障碍数字评定量表（SD NRS）和适用于中重度AD成人及青少年的共识睡眠日记（CSD-AD©）的内容效度。
在第一阶段，对20名中重度AD成人和10名中重度AD青少年进行的概念激发显示，以下与睡眠相关的问题很重要且相关：夜间觉醒（87%）、入睡困难（73%）、感觉未得到充分休息（53%）、白天疲劳或困倦（53%）以及感觉睡眠不足（33%）。由于瘙痒和皮疹程度不同、药物使用以及天气变化，睡眠障碍的频率和程度每天都有很大差异。所有参与者都理解SD NRS问题，大多数人认为很容易或非常容易理解（100%的成人和90%的青少年），并且大多数人按预期理解了评分标准（95%的成人和100%的青少年）。大多数参与者（94%的成人和90%的青少年）表示，他们会认为SD NRS上一分或两分的变化有意义。根据参与者的反馈对CSD-AD©进行了修订，并在第二阶段对来自第一阶段的6名成人和4名青少年的便利样本进行了测试。对CSD-AD©所做的更改被证实是相关且易于理解的。所有患者都能够回答CSD-AD©中的每个项目，并且大多数人能够估计夜间觉醒、白天小睡和打瞌睡的持续时间。
该研究支持了SD NRS和CSD-AD©在中重度AD成人及青少年中的内容效度。它还强调了在评估新治疗对该人群睡眠质量的益处时，每天使用这些工具的重要性。
