Endpoint Outcomes, Boston, MA, USA.
Astellas Pharma B.V., Leiden, Netherlands.
Health Expect. 2018 Aug;21(4):774-786. doi: 10.1111/hex.12673. Epub 2018 Apr 15.
Neuropathic pain (NP) is a complex, chronic pain state initiated by a primary lesion or dysfunction of the nervous system and presents as a variety of symptoms across multiple disease states.
To develop a patient-centred conceptual model of symptoms and impacts in subjects with diabetic peripheral neuropathy (DPN) or post-herpetic neuralgia (PHN) that can inform the measurement strategy in clinical trials.
Thirty subjects with DPN or PHN participated in in-person interviews which were performed until saturation was achieved. Transcripts were analysed in ATLAS.ti.
Interviews were completed with DPN subjects (United States, n = 10; Japan, n = 10) and PHN subjects (United States, n = 5; Japan, n = 5). Numbness and tingling were frequently reported symptoms in the DPN population while itchiness and hypersensitivity were predominant in PHN. Both populations experienced burning and ache/soreness with similar frequency. DPN subjects experienced pain primarily in their lower extremity (eg feet, ankles), while PHN subjects experienced pain primarily in the chest and back. Impacts reported by DPN subjects included difficulty walking, sleep disturbance and climbing stairs. Impacts in PHN subjects included sleep disturbance, avoidance of physical contact, being angry/frustrated and being sad/depressed. Overall, concepts in Japan were not qualitatively different from the United States. Conceptual models of NP were generated based on the concepts elicited.
This research highlights core concepts to measure from the patient's perspective. Moreover, it enables the assessment of existing measures, the possible modification of these measures, or if a new NP measure with improved sensitivity and responsiveness is merited.
神经病理性疼痛（NP）是一种由神经系统的原发性损伤或功能障碍引发的复杂、慢性疼痛状态，表现为多种症状，涉及多种疾病状态。
针对患有糖尿病周围神经病变（DPN）或带状疱疹后神经痛（PHN）的患者，开发一种以患者为中心的症状和影响概念模型，为临床试验中的测量策略提供信息。
30 名 DPN 或 PHN 患者参与了面对面访谈，直到达到饱和状态。使用 ATLAS.ti 对转录本进行分析。
DPN 患者（美国，n=10；日本，n=10）和 PHN 患者（美国，n=5；日本，n=5）完成了访谈。麻木和刺痛是 DPN 人群中经常报告的症状，而瘙痒和超敏是 PHN 的主要症状。两种人群都有相似频率的烧灼感和酸痛/疼痛。DPN 患者主要在下肢（如脚、脚踝）感到疼痛，而 PHN 患者主要在胸部和背部感到疼痛。DPN 患者报告的影响包括行走困难、睡眠障碍和爬楼梯。PHN 患者的影响包括睡眠障碍、避免身体接触、生气/沮丧和悲伤/沮丧。总体而言，日本的概念与美国没有本质上的不同。根据引出的概念生成了 NP 的概念模型。
这项研究从患者的角度强调了需要测量的核心概念。此外，它还可以评估现有的测量方法，对这些方法进行可能的修改，或者是否需要开发一种新的具有更高敏感性和反应性的 NP 测量方法。
