Vlastos I M, Kandiloros D, Manolopoulos L, Ferekidis E, Yiotakis I
Department of Otorhinolaryngology, Aghia Sophia Childrens Hospital of Athens, Athens, Greece.
Int J Pediatr Otorhinolaryngol. 2009 Mar;73(3):363-9. doi: 10.1016/j.ijporl.2008.10.030. Epub 2008 Dec 23.
To validate a disease-specific health related quality of life (HRQOL) instrument for children with chronic suppurative otitis media with or without cholesteatoma.
Caregivers of 45 children with chronic suppurative otitis media, who were offered an operation (tympanoplasty or radical mastoidectomy) in a tertiary children's hospital, were administered a 5-item quality of life survey (COM-5) The COM-5, which is a modified version of OM-6, was administered four times: few weeks and few days before operation and six months and one year postoperatively. Psychometric characteristics and more specifically test-retest reliability, internal consistency, construct validity, and responsiveness to clinical change of the COM-5 score were the main outcome measures.
Median COM-5 score was 2.6 (1- to 7-point scale) with higher scores indicating poorer quality of life. Test-retest reliability was good (interclass correlation coefficient=0.73) Construct validity was demonstrated by significant correlations between COM-5 score and global ear-related quality of life (R=-0.485), between physical suffering and ear-related physician visits (R=0.41) and between caregiver concerns vs ear-related physician visits (R=0.44). The mean change in COM-5 score after successful tympanoplasty was 1.1 and correlated well with the change of global ear-related quality of life rating (R=-0.545) as well as with the degree of clinical change reported by the caregiver (R=0.494). The mean standardized response was 1.3 after tympanoplasty indicating the instrument's large responsiveness to clinical change after this procedure, but only 0.7 after radical mastoidectomy.
The COM-5 is a valid, reliable and responsive instrument. Apart from its satisfactory psychometric characteristics, it can be easily administered in caregivers of children who require a tympanoplasty due to chronic suppurative otitis media.
验证一种针对伴有或不伴有胆脂瘤的慢性化脓性中耳炎患儿的疾病特异性健康相关生活质量（HRQOL）评估工具。
在一家三级儿童医院，对45名接受手术（鼓室成形术或根治性乳突切除术）的慢性化脓性中耳炎患儿的照顾者进行了一项包含5个条目的生活质量调查（COM-5）。COM-5是OM-6的修改版本，在术前几周和几天、术后6个月和1年进行了4次调查。主要结局指标为COM-5评分的心理测量特征，更具体地说是重测信度、内部一致性、结构效度以及对临床变化的反应性。
COM-5评分中位数为2.6（1至7分制），分数越高表明生活质量越差。重测信度良好（组内相关系数=0.73）。COM-5评分与整体耳部相关生活质量之间存在显著相关性（R=-0.485），身体痛苦与耳部相关就诊次数之间存在显著相关性（R=0.41），照顾者担忧与耳部相关就诊次数之间存在显著相关性（R=0.44），从而证明了结构效度。鼓室成形术成功后COM-5评分的平均变化为1.1，与整体耳部相关生活质量评分的变化（R=-0.545）以及照顾者报告的临床变化程度（R=0.494）密切相关。鼓室成形术后平均标准化反应为1.3，表明该评估工具对该手术后临床变化的反应性较大，但根治性乳突切除术后仅为0.7。
COM-5是一种有效、可靠且具有反应性的评估工具。除了其令人满意的心理测量特征外，它还可以轻松应用于因慢性化脓性中耳炎而需要进行鼓室成形术的患儿的照顾者。
