Development and validation of disease-specific measures for choroidal melanoma: COMS-QOLS report No. 2.
Development and validation of disease-specific measures for choroidal melanoma: COMS-QOLS report No. 2.
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DOI：
10.1001/archopht.121.7.1010
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发表时间：
2003-07
影响因子：
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通讯作者：
M. Melia;C. Moy;S. Reynolds;D. Cella;T. Murray;K. R. Hovland;J. Hayman;C. Mangione
中科院分区：
文献类型：
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作者：
M. Melia;C. Moy;S. Reynolds;D. Cella;T. Murray;K. R. Hovland;J. Hayman;C. Mangione
目的建立和验证测量脉络膜黑色素瘤患者常见问题的量表：对外观的感知、对癌症复发的担忧以及对需要立体视觉或双眼视觉的视觉依赖活动的困难。设计随机多中心临床试验的横断面研究。方法对参加眼部黑色素瘤协作研究(COMS)的1317例脉络膜黑色素瘤患者中的842例随机接受125I后装治疗或眼球摘除治疗。量表的信度用Cronbach‘s Alpha进行评估，效度通过与现有量表的相关性和COMS临床检查中收集的数据进行调查。结果3个量表均具有较好的内部一致性信度。出现和复发量表与36项简明健康调查心理健康量表(r=0.26和0.31)、医院焦虑和抑郁量表(r=-0.22和-0.19)和焦虑(r=-0.27和-0.42)量表呈低至中度相关。外观评分与外观改变并发症和情况的发生显著相关，复发评分与最近摘除接受近距离放射治疗的眼睛相关，双眼视力良好的患者的立体视/双眼视觉评分高于一侧视力良好的患者和一侧眼球摘除的患者。结论3种量表在被测人群中均具有较好的内部一致性、范围和抑郁自评量表。基于临床数据，有证据表明这三个量表都具有良好的结构效度，尽管也有证据表明立体视觉/双眼视觉量表除了对立体视觉和双眼视觉外，还对视觉的其他方面敏感。外观和复发量表捕捉了标准心理健康量表所不具备的临床相关信息。
OBJECTIVE To develop and validate scales measuring common concerns of patients with choroidal melanoma: perception of appearance, concern about cancer recurrence, and difficulty with vision-dependent activities requiring stereopsis or binocularity. DESIGN Cross-sectional study within a randomized multicenter clinical trial. METHODS Eight-hundred forty-two of 1317 patients with choroidal melanoma enrolled in the Collaborative Ocular Melanoma Study (COMS) for medium-sized tumors and randomized to receive iodine 125 brachytherapy or enucleation were interviewed. Scale reliability was evaluated using Cronbach's alpha, and validity was investigated through correlation with existing scales and with data collected during COMS clinical examinations. RESULTS All 3 proposed scales had good internal consistency reliability. The appearance and recurrence scales had low to moderate correlation with the 36-Item Short-Form Health Survey mental health scale (r = 0.26 and 0.31, respectively) and with the the Hospital Anxiety and Depression Scale depression (r = -0.22 and -0.19) and anxiety (r = -0.27 and -0.42) scales. Appearance scores were significantly associated with occurrence of appearance-altering complications and conditions, recurrence scores were associated with recent removal of the brachytherapy-treated eye, and stereopsis/binocularity scores were higher in patients with good visual acuity in both eyes than in those with good visual acuity in one eye and an enucleated fellow eye. CONCLUSIONS All 3 proposed scales have good internal consistency, range, and SDs of measurement in the tested population. Based on clinical data, there is evidence of good construct validity for all 3 scales, although there also is evidence that the stereopsis/binocularity scale is sensitive to other aspects of vision in addition to stereopsis and binocularity. The appearance and recurrence scales capture clinically relevant information not available from standard mental health scales.