目的结合校标法和分布法以计算中文版视功能指数量表(VF-11R-CN)用于日常低视力白内障人群围手术期的最小临床意义差异(MCID)，基于MCID值比较不同特点人群术后视觉相关生活质量(VRQol)的改善率。
方法采用横断面研究方法，纳入2018年5月至2019年6月在温州医科大学附属眼视光医院收治的术前日常低视力白内障患者98例，所有患者均接受白内障超声乳化联合人工晶状体植入术，分别于术前和术后1～3个月行VF-11R-CN量表调查，且术后调查时增加校标条目。通过天花板效应和地板效应、术前术后的得分差异和效应值来评估VF-11R-CN量表的适用性。分布法测定MCID值时采用0.5个标准差(SD)和1.96个测量标准误(SEM)进行估算，校标法测定MCID值时采用线性回归分析法进行估算。在应答者分析中计算MCID的敏感性和特异性，对不同特点人群基于MCID值的VRQol提高率进行比较。
结果共85例受试者完成随访。受试者围手术期VF-11R-CN量表得分变化为(399.51±234.92)分，视力变化为(0.65±0.36)。量表术前的天花板和地板效应均为1.18%，术后地板效应为22.35%。受试者术前VF-11R-CN量表总分高于术后，差异有统计学意义( t＝15.68， P<0.001)，VF-11R-CN量表的效应值为1.63。基于0.5个SD和1.96个SEM的MCID估值分别为122.23分和123.10分；校标条目的得分增加1分，围手术期得分变化下降106.17分。平均化分布法和回归分析法得到的MCID值为117.17分。受试者中术后得分超过MCID值者76例，占89.41%，MCID值的灵敏度为96.67%，特异性为46.67%。不同性别间、单种眼病与多种眼病间及手术前视力(以LogMAR 1.3为界)间术后VRQol提高率差异均无统计学意义( P＝0.73、0.88、0.27)。
结论VF-11R-CN量表适用于中国日常低视力白内障手术人群术后生活质量的客观评估，手术的MCID估值为117.17分，MCID估值敏感性高，特异性偏低。
ObjectiveTo assess the applying value of Chinese shorter version of the Visual Function Index questionnaire (VF-11R-CN) for presenting low-vision cataract pre-operation and post-operation by using minimal clinically important difference (MCID) determined by combination of distribution-based with anchor-based methods, and to compare the improvement rate of vision-related quality of life (VRQol).
MethodsA cross-sectional study was performed in this study.Ninety-eight patients with presenting low vision cataract were enrolled at Eye Hospital of Wenzhou Medical University from May 2018 to June 2019.All the patients received a phacoemulsification with intraocular lens implantation.A questionnaire survey was carried out with VF-11R-CN Scale before surgery and 1 month-3 months after surgery, and a complement anchor item was added during the questionnaire after surgery.The applicability of the scale was assessed by floor or ceiling effects, and score difference of the VF-11R-CN over time and effective size was determined.Distribution-based MCID was calculated using 0.5 standard deviation (SD) of score difference and 1.96 standard error of measurement (SEM). Anchor-based MCID was calculated using the slope of the linear regression analysis.In responder analysis, sensitivity and specificity of MCID was reported.The differences of postoperative VRQol improvement rate based-on MCID were compared between male and female, single eye disease and multiple eye diseases, pre-operative and post-operative scores.This study protocol was approved by the Ethics Committee of Eye Hospital of Wenzhou Medical University, and followed the Declaration of Helsinki.Written informed consent was obtained from each patient prior to any medical examination.
ResultsA total of 85 patients completed the following up.The mean score difference was 399.51±234.92, and that of the presenting visual acuity (PVA) was 0.65±0.36.Both the minor floor and ceiling effects were 1.18% before surgery, and the ceiling effects were 22.35% after surgery.The score before surgery was significantly higher than that after surgery ( t=15.68, P<0.001). The effective size for the surgery was 1.63.The MCID was 122.23 and 123.10 according to 0.5 SD and 1.96 SEM.The linearity regression analysis showed that score difference reduced 106.17 if anchor item option increased 1.The average MCID estimate was 117.17.A total of 76 patients (89.41%) reported an improvement of VRQol.The sensitivity of MCID for the assessment of VRQol was 96.67% and specificity was 46.67%.No significant differences were found in VRQol improvement rate between gender, single cataract and multiple eye diseases or PVA (LogMAR 1.3 as cutoff value) ( P=0.73, 0.88, 0.27).
ConclusionsVF-11R-CN scale is available for Chinese presenting low vision cataract patients undergoing surgery.The MCID value for the cataract surgery is 117.17 scores, with a high sensitivity and a relatively low specificity.
陈海丝,黄锦海,高蓉蓉,等. 中文版视功能指数量表在日常低视力白内障手术患者中的应用价值评估[J]. 中华实验眼科杂志,2020,38(04)：342-347.
DOI:10.3760/cma.j.cn115985-20190930-00426版权归中华医学会所有。
未经授权，不得转载、摘编本刊文章，不得使用本刊的版式设计。
除非特别声明，本刊刊出的所有文章不代表中华医学会和本刊编委会的观点。
文档即答
智问智答
机器翻译
你好，我可以帮助您更好的了解本文，请向我提问您关注的问题。
