Eli Lilly and Company, Indianapolis, IN, USA.
Evidera, Bethesda, MD, USA.
Curr Med Res Opin. 2024 Apr;40(4):665-676. doi: 10.1080/03007995.2024.2319820. Epub 2024 Feb 29.
Limited real-world evidence exists to better understand the patient experience of living with symptoms and impacts of non-alcoholic steatohepatitis (NASH). This study aimed to (1) describe patient-reported perspectives of NASH symptoms and impacts on patients' daily lives and (2) develop a patient-centered conceptual NASH model.
A cross-sectional study using semi-structured qualitative interviews was conducted among adults (≥18 years) in the United States living with NASH. Eligible participants were diagnosed with NASH, had mild to advanced fibrosis (F1-F3), and no other causes of liver disease. The interview guide was informed by a targeted literature review (TLR) to identify clinical signs, symptoms, impacts, and unmet treatment needs of NASH. Participants described their experiences and perspectives around NASH and the symptoms, symptom severity/bother, and impact of NASH on their daily activities. Interviews were audio-recorded and transcribed verbatim for coding and thematic analysis.
Twenty participants (age: 42.4 years; female: 50.0%) were interviewed. Participants discussed their experience with NASH symptoms (most frequent: fatigue [75.0%]; weakness/lethargy [70.0%]) and impacts (most frequent: physical and psychological/emotional [70.0% each]; dietary [68.4%]). Participants considered most symptoms to be moderately severe or severe and moderately or highly bothersome. Findings from the TLR and qualitative interviews were incorporated into a conceptual model that describes patient-reported symptoms and impacts of NASH, clinical signs, risk factors, and unmet treatment needs.
Our study provides insights into patients' perspectives of NASH symptoms and their impact on their daily lives. These findings may guide patient-physician conversations, supporting patient-centered treatment decisions and disease management.
关于非酒精性脂肪性肝炎(NASH)患者的症状和影响,现有真实世界证据有限,难以深入了解患者的实际体验。本研究旨在:(1)描述患者报告的 NASH 症状和对日常生活的影响;(2)建立以患者为中心的 NASH 概念模型。
采用横断面研究,对美国患有 NASH 的成年人(≥18 岁)进行半结构式定性访谈。合格参与者的诊断为 NASH,存在轻度至晚期纤维化(F1-F3),且无其他肝病病因。访谈指南的制定参考了目标文献综述(TLR),以确定 NASH 的临床体征、症状、影响和未满足的治疗需求。参与者描述了他们对 NASH 及其症状、症状严重程度/困扰、对日常活动的影响的体验和看法。访谈内容进行音频记录并逐字转录,以便进行编码和主题分析。
共对 20 名参与者(年龄:42.4 岁;女性:50.0%)进行了访谈。参与者讨论了他们的 NASH 症状体验(最常见:疲劳[75.0%];乏力/无精打采[70.0%])和影响(最常见:身体和心理/情绪[70.0%],饮食[68.4%])。参与者认为大多数症状为中度至重度,且具有中度至高度困扰性。TLR 和定性访谈的结果被纳入一个概念模型,该模型描述了患者报告的 NASH 症状及其对日常生活的影响、临床体征、危险因素和未满足的治疗需求。
本研究深入了解了患者对 NASH 症状及其对日常生活影响的看法。这些发现可能有助于患者与医生的沟通,支持以患者为中心的治疗决策和疾病管理。