Sachau Juliane, Sendel Manon, Péchard Marie, Schnabel Kathrin, Schmieg Iris, Medkour Terkia, Ecochard Laurent, Woischnik Markus, Liedgens Hiltrud, Pogatzki-Zahn Esther, Baron Ralf, Bouhassira Didier
Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany.
Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany.
J Pain. 2023 Jan;24(1):38-54. doi: 10.1016/j.jpain.2022.09.003. Epub 2022 Oct 8.
In neuropathic pain clinical trials, the patient's perspective is often insufficiently reflected focusing mainly on pain intensity. Comparability of outcome assessment is limited due to heterogenous patient reported outcome measures (PROMs). The MEDLINE, CENTRAL, and Embase databases and reference lists of published meta-analyses were searched. Randomized controlled studies assessing treatment efficacy of drugs for chronic neuropathic pain were included. PROMs were assigned to recommended IMMPACT/NeuPSIG domains: pain intensity, pain other aspects, physical functioning, emotional functioning, global improvement and satisfaction, adverse events, participant disposition. Domains and PROMs were compared regarding the publication year and methodological quality of the studies. Within the 251 included studies 200 PROMs were used with 27 being recommended by IMMPACT/NeuPSIG. The number of domains was higher in high/moderate quality studies. The (sub-) domains 'physical functioning', 'global improvement and satisfaction', and 'neuropathic pain quality' were assessed more frequently in high/moderate quality studies and those published after 2011. Recent studies and those of better quality more often used the recommended PROMs. Although neuropathic assessment via PROMs has improved, there is still a high heterogeneity. A standardized core set of outcome domains and should be defined to improve neuropathic pain treatment and to achieve better comparability of clinical trials. Perspective: This systematic literature review assesses the use of patient reported outcome measures (PROMs) in chronic neuropathic pain. The results show that there is still a high heterogeneity, highlighting the need for a standardized core set of outcome domains and PROMs to improve comparability of clinical trials and neuropathic pain treatment.
在神经性疼痛的临床试验中，患者的观点往往未得到充分体现，主要聚焦于疼痛强度。由于患者报告结局测量指标（PROMs）的异质性，结局评估的可比性有限。检索了MEDLINE、CENTRAL和Embase数据库以及已发表的荟萃分析的参考文献列表。纳入评估慢性神经性疼痛药物治疗疗效的随机对照研究。将PROMs分配到推荐的IMMPACT/NeuPSIG领域：疼痛强度、疼痛其他方面、身体功能、情绪功能、总体改善和满意度、不良事件、参与者处置情况。就研究的发表年份和方法学质量对各领域和PROMs进行比较。在纳入的251项研究中，使用了200种PROMs，其中27种被IMMPACT/NeuPSIG推荐。高质量/中等质量研究中的领域数量更多。在高质量/中等质量研究以及2011年后发表的研究中，“身体功能”“总体改善和满意度”以及“神经性疼痛质量”（子）领域的评估更为频繁。近期研究和质量较好的研究更常使用推荐的PROMs。尽管通过PROMs进行的神经性评估有所改善，但仍存在高度异质性。应定义一套标准化的核心结局领域，以改善神经性疼痛治疗并实现更好的临床试验可比性。观点：本系统文献综述评估了患者报告结局测量指标（PROMs）在慢性神经性疼痛中的应用。结果表明，仍存在高度异质性，凸显了需要一套标准化的核心结局领域和PROMs，以提高临床试验和神经性疼痛治疗的可比性。
