Rosenfeld R M, Goldsmith A J, Tetlus L, Balzano A
Division of Pediatric Otolaryngology, State University of New York, Health Science Center at Brooklyn, and Long Island College Hospital, 11201, USA.
Arch Otolaryngol Head Neck Surg. 1997 Oct;123(10):1049-54. doi: 10.1001/archotol.1997.01900100019002.
To evaluate changes in health-related quality of life for children with otitis media.
Cohort study using a 6-item quality-of-life survey (OM-6) representing the domains of physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns.
Hospital-based pediatric otolaryngology practice in a metropolitan area.
One hundred eighty-six children aged 6 months to 12 years (median age, 3.4 years) with chronic otitis media with effusion or recurrent acute otitis media.
The OM-6 was completed at entry by the child's caregiver and again at least 4 weeks after routine clinical care. Otoscopic findings, static admittance, tympanometric width, audiometric thresholds, and ear-related global quality of life (10-point visual scale) were recorded concurrently.
Test-retest reliability, construct validity, and responsiveness to longitudinal change of the OM-6 survey score (mean value of the 6 items).
Excellent test-retest reliability was obtained for the survey score (R=0.87) and individual survey items (R> or =0.71). The median survey score was 2.8 (95% confidence interval, 2.7-3.0) of a maximum 7.0, with higher values indicating poorer quality of life. Construct validity was shown by significant correlations between the survey score and global ear-related quality of life (R=-0.64), between physical suffering and physician visits in the past month (R=0.47), and between caregiver concerns and antibiotics consumed in the past month (R=0.26). The mean change in survey scores after tympanostomy tubes was 1.7, with a standardized response mean of 1.7 (95% confidence interval, 1.4-2.0), indicating large responsiveness to change. The change score was reliable (R=0.82) and correlated well with the degree of reported clinical change (R=0.66).
The OM-6 is a valid, reliable, and responsive measure of quality of life for children with otitis media. The brevity and ease of administration make the OM-6 ideal for use in outcomes studies, clinical trials, and routine clinical care.
评估中耳炎患儿健康相关生活质量的变化。
采用一项包含6个项目的生活质量调查问卷（OM - 6）的队列研究，该问卷代表身体痛苦、听力丧失、言语障碍、情绪困扰、活动受限和照料者担忧等领域。
大都市地区一家医院的儿科耳鼻喉科诊所。
186名年龄在6个月至12岁（中位年龄3.4岁）的患有慢性中耳积液或复发性急性中耳炎的儿童。
OM - 6由患儿照料者在入组时完成，在常规临床护理至少4周后再次完成。同时记录耳镜检查结果、静态导纳、鼓室图宽度、听力阈值以及与耳朵相关的整体生活质量（10分视觉量表）。
OM - 6调查问卷得分（6个项目的平均值）的重测信度、结构效度以及对纵向变化的反应性。
调查问卷得分（R = 0.87）和各个调查项目（R≥0.71）均获得了出色的重测信度。调查得分中位数为2.8（95%置信区间，2.7 - 3.0），满分7.0，得分越高表明生活质量越差。结构效度通过以下显著相关性得以体现：调查得分与与耳朵相关的整体生活质量之间（R = - 0.64）、身体痛苦与过去一个月内看医生次数之间（R = 0.47）、照料者担忧与过去一个月内使用抗生素情况之间（R = 0.26）。鼓膜置管术后调查得分的平均变化为1.7，标准化反应均值为1.7（95%置信区间，1.4 - 2.0），表明对变化有较大反应性。变化得分可靠（R = 0.82），且与报告的临床变化程度相关性良好（R = 0.66）。
OM - 6是一种用于评估中耳炎患儿生活质量的有效、可靠且具有反应性的测量工具。其简短性和易于实施使其成为结局研究、临床试验和常规临床护理的理想选择。
