白内障论文：视功能指数量表（Vf-14）的修订及评价
【中文摘要】引进并修订国外视功能指数(Visual Function index-14)量表,形成VF-14中文修订本,并对中文修订本进行信度、效度及可接受性的评价,为探索国内适宜的视功能评价工具提供依据。方法选取经眼科医师确诊的年龄相关性白内障患者440名、眼科专家12名及健康查体者80名作为研究对象。年龄相关性白内障患者的诊断标准采用国家白内障诊断分型标准,年龄40-70岁之间,文化程度小学及以上,其中200名参与量表的修订,240名参与量表的评价;80名健康查体者参与量表的评价;眼科专家为从事眼科临床工作10年以上、职称为副主任医师以上,精通英文,其中一名有留美经历,参与量表的翻译、回译及修订。遵循量表的引进原则,经过眼科专家翻译、回译,与原量表比对,形成VF-14中文本一稿,然后向9名眼科专家及200名患者收集修订意见和建议,对VF-14中文本一稿进行文化适应性修订,最终形成VF-14量表中文修订本。以自行设计的调查问卷为工具向240名年龄相关性白内障患者收集VF-14量表中文修订本评定的资料,内容包括:调查对象的一般情况,眼科检查情况,VF-14量表中文修订本的测评,视功能生存质量量表(VF -QoL)的测评,自评视功能状况及对可接受性信息的评价部分。其中80名患者分别进行2次VF-14中文修订本测评,时间间隔为一周;80名患者同一天内由两名不同调查员分别进行VF-14量表中文修订本的测评;80名患者于术前一天、术后一月分别进行视力、VFQOl、自评视功能状
态及VF-14量表中文修订本的测评,80名健康查体者进行视力、VFQOl、自评视功能状态及VF-14量表中文修订本的测评。全部调查问卷收回后进行统一检查、核对,建立Excel数据库,利用SPSS13.0统计软件进行资料的处理分析,采用t检验、Cronbach’α、ICC值、相关分析、因子分析等对量表的信度、效度、可接受性进行评价。评价的指标:信度评价包括重测信度、内部一致性信度、调查员间信度、分半信度,效度评价包括内容效度、结构效度、效标关联效度、辨别效度,可接受性评价:回答量表的把握度、量表的完成率、每次完成VF-14中文修订本的时间。结果1.VF-14量表的翻译在遵循语义等价性、概念等价性的前提下两名眼科专家各自将原量表翻译成中文,两份译文综合形成中文初译本,另一名眼科专家进行回译,将其与原量表比对,对与原量表不一致的条目,反复进行翻译、回译,直至达成统一,最终形成VF-14中文本一稿。2.分别向眼科专家和年龄相关性白内障患者收集对VF-14中文本一稿的修订意见,专家认为:在我国目前的经济文化生活背景下,VF-14中文本一稿的绝大部分条目能够反映被测量的与视功能相关的生活内容,各条目意思表达清楚,且表达的难易程度对调查对象适宜。100%的专家认为第9项-娱乐活动(bingo,多米诺骨牌,打牌)和第10项-体育活动(保龄球、手球、网球或高尔夫运动)所指内容不符和我国国情、民情,遵循概念等价原则可改为我国大众喜闻乐见的项目,如娱乐活动改为打麻将,扑克牌,下象棋,体育活动改为羽毛球,乒乓球,篮球,门球。95%的
专家认为13、14两项涉及驾车的条目,与我国国情不符且无等价替代条目;患者认为各条目内容通俗易懂,没有读不懂的语句,表达意思清楚,表达的难易程度适宜,1-12项基本符合我国国情、民情,100%的患者认为13、14两项涉及驾车的条目不符合我国国情、民情。综合专家和患者的意见和建议,最终形成VF-14量表中文修订本。3.VF-14量表中文修订本的信度:①重测信度:量表两次评分的各条目和总分的ICC范围值在0.814～0.976 P<0.05,说明量表重测信度较好;②内部一致性信度:量表的Cronbach’α系数为0.916,说明量表的内部一致性较高;③调查员间的信度:各条目和总分的ICC范围值在0.854～0.996 P<0.05,说明量表的调查员间的信度较好;④分半信度:VF-14量表中文修订本的分半信度系数为0.817 P<0.05,说明量表具有较好的分半信度。4.VF-14量表中文修订本的效度:①内容效度:专家一致认为VF-14量表中文修订本的条目既包括了白内障患者基本生存需要的视功能指标,又包括白内障患者更高生活层次需要的指标,内容效度良好;②结构效度:采用因子分析得到4个公因子,这4个公因子共能够解释总方差的88.70%,各条因子载荷均表现为仅在某一因子上较大。其中第一公因子包括:娱乐活动、体育活动、烹饪等条目,反映患者的立体视功能情况;第二公因子包括:阅读小字说明、读书看报、做精细活、填表等条目,反映患者的近视力情况;第三公因子包括:看清楼梯和路缘石、看清各种标识牌、看电视等条目,反映患者的视觉适应情况;第四公因子包括:阅读大体字
、认清楚人等条目,反映患者的主观视觉情况。这与理论构想相吻合,表明结构效度较好。③效标关联效度:采用术前及术后患者视功能生存质量量表(VFQol)与VF-14量表中文修订本得分做相关分析,相关系数分别为0.55和0.67,P <0.01;采用患者术前术后视力与VF-14量表中文修订本的得分做相关分析,相关系数分别为-0.63和-0.72 ,P <0.01,采用患者主观视功能改善程度与VF-14量表中文修订本的得分作相关分析,相关系数为0.65和0.76 ,P <0.01;表明量表的效标关联效度良好。④辨别效度:对患者术前术后VFQOL、视力、自评功能状态的评分进行配对t检验,可知患者术前与术后视功能状况的差异有统计学意义,说明患者术前与术后的视功能状况有变化;对患者术前术后VF-14量表中文修订本测评的得分进行配对t检验,得t=17.18,P<0.01,说明VF-14量表中文修订本能辨别患者视功能状况的变化,对患者术前,及健康查体者的VFQOL、视力、自评功能状态的评分进行t检验,可知患者术前与术后视功能状况的差异有统计学意义,说明患者与健康查体者的视功能状况有变化;对患者及健康查体者的VF-14量表中文修订本测评的得分进行t检验,得t=18.674,P<0.01,说明VF-14量表中文修订本能辨别患者视功能状况的变化,具有较好的辨别效度。5.量表的可接受性:①在560人次的调查中,85.4%的患者认为自己做出的评价“比较准确可靠”,而14.6%的患者则认为“绝对准确可靠”;②在560人次的调查中,量表的完成率达100%;③在全部调查中,量表的完成时间最短5分钟,
最长10分钟;表明VF-14量表中文修订本容易被年龄相关性白内障患者所接受。结论本次研究经过科学严谨的方法形成了视功能(VF-14)量表中文修订本,且经过评价可知其信度、效度良好,可接受性强,适合目前我国经济文化和生活背景的需要,可作为我国眼科患者视功能状况的评价工具。
【英文摘要】To revise the form of Visual Function index-14 from Unite states and introduce to China in Chinese revision, Meanwhile its reliability, validity and acceptability was evaluated to provide evidence to explore the suitable tool of visual function evaluation.Method 440 patients who had been diagnosed with age-related cataract and 12 eye experts and 80 health people were selected as subjects. All patients were diagnosis based on the national standard to diagnose the age-related cataract. The ages of the patients were between 40-70 years old and the levels of all patients’education were finishing primary school at least. Among them 200 patients were selected as subjects to amend of VF-14, and 240-patients and 80 health people served as VF-14 evaluation. The profession title of eye experts was above associate chief physician and with clinical experience more than 10 years. They were proficient in English, and one of them who had t
he experience of studying in U.S.A. took part in translation and amendment of VF.According to the rules of form introduction, VF-14 in Chinese version was formed through the translation, back translation and comparison by the ophthalmologists. After seeking the comments and suggestions from 9 ophthalmologists and 200 patients, the script is amended according the cultural flexibility and the revised Chinese version of VF-14 form is finally formulated.The questionnaire was applied to collected information from 240 age-related cataract patients for evaluating Chinese version of VF-14 including general background of the subjects; conditions of eye examination, evaluation material to the Chinese amendment of VF-14 Scale, evaluation of VF–QoL, condition of self-evaluation, and evaluation of information acceptability. Among them 80 patients are evaluated twice by two different investigators within one day and another 80 patients are checked with eyesight, VFQ01, self-evaluation and Chinese amendment of VF-14 one day before the operation and one month after operation, 80 health people are checked with eyesight, VFQ01, self-evaluation and Chinese amendment of VF-14.All the questionnaires were collected to set an Excel database after double data check. The data were analyzed by SP
SS13.0 statistic software and the credibility, validity, and acceptability of the form were evaluated by“t”test, Cronbach’α, ICC value, relativity analysis, and factor analysis. The indices of the evaluation included credibility evaluation, such as re-test credibility, inner-consistency credibility, inter-investigator credibility, and dichotomy credibility; validity evaluation included content validity, structure validity, criterion-related validity, and discrimination validity. Acceptability evaluation included the credibility of answering the scale, completeness of the scale, the time used in answering the Chinese amendment of VF-14.Result1. The translation of the formIn accordance with the concepts of semantic and concept equivalence, the translation of the form was done by two ophthalmologists separately. The combination of the two translations formed the first Chinese version VF-14 form and then the first version was back-translated by another ophthalmologist. The back-translated version and the first Chinese edition were compared and corrected back until they match each other. Then the finally the VF-14 form Chinese version is formulated.2. Opinions separately form ophthalmologists and age-related cataract patients were collected about the amendment of VF-14 form Chinese edition. The experts suggested that
under the background of current Chinese economical and social life, VF-14 Chinese form reflects largely the content of sight related tests with clear expression and suitable difficulty to the subjects. All the experts thought that the item 8 entertainment (bingo, domino, and poker) and item 10 sports (bowling, handball, tennis or golf) were not suitable to Chinese situation and should be replaced as popular activities in China such as mah-jong, poker, Chinese chess, badminton, table tennis, basketball, and gate ball. 95% of experts suggested that item 13 and 14 and the item related to driving were not suitable in Chinese situation. All the patients believe that all the items were easy to understand in clear expression. Items 1-12 were suitable in China while items 13 and 14 were not. After considering the opinions of experts and patients, the VF-14 Chinese version was finally formulated.3. Credibility of VF-14 Chinese version:①re-test credibility: the value range of two scoring of the scale and the score of ICC was between 0.814～0.976 ( P<0.05) , which indicates a good credibility.②inner-consistency credibility: the coefficient of the form is 0.196, which indicateed a high inner-consistency;③inter-investigator credibility: the value range of all the items and total score of ICC was between 0.854～0.996 (P<0.05), which in
dicated a high inner-investigator credibility.④dichotomy credibility: the coefficient of dichotomy credibility in VF-14 form Chinese version was 0.817 ( P<0.05) ,which indicated a good dichotomy credibility.4. Validity of VF-14 form in Chinese edition.①content validity: experts agreed unanimously that the items in VF-14 form Chinese version included both the sight function of cataract patients for basic living need and the higher living need;②Structure validity: The factor analysis results showed that there were four main factors which accounted for the variance of 88.70% in total. Factor loading of every item was showed that one factor was major. Of them the first main factor included entertainment, sports activities, cooking, etc, which reflect the entries in the patients with three-dimensional visual function. The second main factor included reading the instruction with the small print, reading newspaper, doing fine work, filling out the forms, etc which reflect the patients obtained reflect. The third main factor included seeing the stairs and kerbstone , and all kinds of identification cards, watching TV, etc, which reflect the situation of patients’visual adaption. The fourth main factor included reading general words, recognizing Truman, etc, which reflect the subjective items with visual of patients. This con
sistent with the constructed theory and indicated the well structure validity.③criterion-related validity: The form of survival quality was applied before and after operation to make relevance analysis with the score from VF-14 form Chinese version. the relevant coefficients were 0.55 and 0.67 separately (p<0.01). The sight evaluation score before and after the operation was got and made relevance analysis with the score from VF-14 form Chinese amended version and the relevant coefficients were -0.63 and -0.72 repectively ( p<0.01). The relationship between the improvement of sight reported by the patients and the score from VF-14 form Chinese amended version was made and relevant coefficients were 0.65 and 0.76 separately, p<0.01.④discriminant validity: there were the significant difference between VFQOL, sight, self-evaluation before and after operation, which indicates that the score from VF-14 form Chinese amended version had a good validity in distinguishing the conditions of patients’eyesight. there were the significant difference between VFQOL, sight, self-evaluation patient and health people, which indicates that the score from VF-14 form Chinese amended version had a good validity in distinguishing the conditions of patients’and health people eyesight.5. Acceptability①Through the investigatio
n on 300 patients, 85.4 % of patients thought that their evaluation is relatively reliable. Moreover 14.6 percent of them thought absolutely reliable.②The rate of completion of the VF reached 100 %.③Of all the investigations, the shortest time to complete the VF was 5 minutes, and the longest time was 10 minutes. It indicated that the VF-14 for in Chinese version could be accepted by age-related cataract patients.Conclusion The final VF-14 form Chinese version was finished through scientific and strict research. Study showed that it was with good reliability, validity and strong acceptability. It adapts to the meet of our economy, culture and life background. It can be used as the tool to evaluate the visual function of the ophthalmology patient.
【关键词】白内障 editor evaluating revision视功能 视功能量表 信度 效度 可接受性
【英文关键词】Cataract      Visual function      Visual functional index form      Relia -bility      validity      acceptability
【目录】视功能指数量表（Vf-14）的修订及评价中文摘要5-9英文摘要9-13英文缩写14-15前言15-17对象与方法17-22结果22-36讨论36-44结论44本研究可能存在的问题44-45参考文献
45-49附表49-57综述 视功能相关生存质量量表的应用57-64参考文献62-64致谢64-65个人简历65

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