American Institutes for Research, 1400 Crystal Drive, 10th Floor, Arlington, VA, 22202-3289, USA.
Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave, Silver Spring, MD, 20993-0002, USA.
Patient. 2023 May;16(3):265-276. doi: 10.1007/s40271-023-00618-x. Epub 2023 Feb 25.
Understanding symptoms of temporomandibular joint disorders (TMDs) can help doctors and patients document, monitor, and manage the disease and help researchers evaluate interventions. Patients with TMDs experience symptoms ranging from mild to severe, primarily in the head and neck region. This study describes findings from formative patient focus groups to capture, categorize, and prioritize symptoms of TMDs towards the development of a patient-reported outcome measure (PROM).
We conducted ten focus groups with 40 men and women with mild, moderate, and severe TMD. Focus groups elicited descriptions of symptoms and asked participants to review a list of existing patient-reported outcomes (PROs) from the literature and patient advisor input and speak to how those PROs reflect their own experience, including rating their importance.
We identified 52 distinct concepts across six domains: somatic, physical, social, sexual, affective, and sleep. Focus groups identified the ability to chew and eat; clicking, popping, and other jaw noises; jaw pain and headaches; jaw misalignment or dislocation; grinding, clenching, or chewing, including at night; and ear sensations as most important. Participants with severe TMDs more often reported affective concepts like depression and shame than did participants with mild or moderate TMDs.
Findings support PROM item development for TMDs, including selecting existing PROMs or developing new ones that reflect patients' lived experiences, priorities, and preferred terminology. Such measures are needed to increase understanding of TMDs, promote accurate diagnosis and effective treatment, and help advance research on TMDs.
了解颞下颌关节紊乱病（TMD）的症状有助于医生和患者记录、监测和管理疾病，并帮助研究人员评估干预措施。患有 TMD 的患者会出现从轻度到重度的症状，主要集中在头部和颈部区域。本研究描述了形成性患者焦点小组的研究结果，以捕捉、分类和优先考虑 TMD 的症状，从而开发患者报告的结果测量（PROM）。
我们对 40 名轻度、中度和重度 TMD 男性和女性进行了十次焦点小组讨论。焦点小组讨论了症状描述，并要求参与者审查文献和患者顾问输入的现有患者报告结局（PRO）列表，并讨论这些 PRO 如何反映他们自己的体验，包括对其重要性进行评分。
我们在六个领域确定了 52 个不同的概念：躯体、物理、社会、性、情感和睡眠。焦点小组确定了咀嚼和进食能力；咔哒、弹出和其他下颌噪音；下颌疼痛和头痛；下颌错位或脱位；磨牙、咬紧或咀嚼，包括夜间磨牙；以及耳朵感觉是最重要的。患有重度 TMD 的参与者比患有轻度或中度 TMD 的参与者更频繁地报告情感概念，如抑郁和羞耻。
研究结果支持 TMD 的 PROM 项目开发，包括选择现有的 PROM 或开发新的 PROM，以反映患者的生活体验、优先事项和首选术语。这些措施对于增加对 TMD 的理解、促进准确诊断和有效治疗以及帮助推进 TMD 研究是必要的。
