摘要目的:探讨简体中文版下肢淋巴水肿功能、残疾与健康问卷(Lymph-ICF-LL)的信度和效度。方法:首先对Lymph-ICF-LL进行汉化，形成简体中文版Lymph-ICF-LL。依据纳入和排除标准招募2019年6月至2021年6月在西安交通大学附属西安市中心医院烧伤整形美容外科门诊就诊的61例下肢淋巴水肿患者进行研究。按照筛选流程将纳入患者所填写问卷分别归为样本1~样本4。回收的术前有效简体中文版Lymph-ICF-LL作为样本1(55份)，其填写者包括男1例，女54例，年龄(51.0±9.4)岁(24~70岁)；55例患者中，28例行淋巴管-静脉吻合术(LVA)，抽取其术前及术后半年随访时所填写的简体中文版Lymph-ICF-LL(均为28份)作为样本2和样本3；将样本1患者术前所填写的简体中文版淋巴水肿生活质量问卷(LYMQOL)(55份)作为样本4。采用内部一致性信度和分半信度评估简体中文版Lymph-ICF-LL的信度，Cronbach’s α系数≥0.80表示内部一致性信度良好；Spearman-Brown分半信度系数≥0.70表示分半信度良好。由3名整形外科专家对该问卷与英文原版内容的符合性进行判断，对问卷的内容效度进行认定。采用探索性因子分析和校标关联效度评估简体中文版Lymph-ICF-LL的结构效度。校标关联效度评估时，采用Pearson相关分析检验样本1中Lymph-ICF-LL得分与样本4中LYMQOL得分的相关性。采用配对 t检验对LVA术前和术后半年的简体中文版Lymph-ICF-LL得分进行比较。 结果:(1)简体中文版Lymph-ICF-LL的Cronbach’s α系数为0.937，说明其内部一致性信度良好；该问卷的Spearman-Brown分半信度系数为0.700，提示分半信度良好。(2)通过对简体中文版Lymph-ICF-LL与英文原版问卷内容的符合性作出分析判断，认定此问卷的内容效度良好。采用探索性因子分析提取5个公因子，分别是一般症状、心理症状、日常生活能力、下肢功能和工作/社交生活。简体中文版Lymph-ICF-LL得分与简体中文版LYMQOL得分呈正相关( r＝0.73， P<0.001)，提示校标关联效度良好。(3)LVA术后半年患者简体中文版Lymph-ICF-LL得分明显低于术前，差异有统计学意义[(40.70±15.13)分vs. (54.40±15.70)分， t＝5.96， P<0.001]，提示LVA术后患者的生活质量有明显提高。 结论:简体中文版Lymph-ICF-LL具有较好的信度和效度，可以作为评估我国下肢淋巴水肿患者生活质量的工具。

abstractsObjective:To evaluate the reliability and validity of the simplified Chinese version of Lymphedema function, disability and health questionnaire for lower limb lymphedema (Lymph-ICF-LL).Methods:The original English version was translated into mandarin and modified to accommodate Chinese customs. According to the inclusion and exclusion criteria, 61 patients with lower extremity lymphedema who were treated in the Department of Burn and Plastic Surgery of Xi’an Central Hospital from June 2019 to June 2021 were recruited in this study. The questionnaires filled by the included patients were classified as sample 1 to sample 4 by the screening process. The valid simplified Chinese version of Lymph-ICF-LL was collected as sample 1 ( n=55), including 1 male and 54 females, aged (51.0±9.4) years (24-70 years). Among the 55 patients, 28 patients underwent lymphaticovenular anastomosis (LVA). The simplified Chinese version of Lymph-ICF-LL completed before and follow-up of 6 months after surgery were selected as sample 2 and sample 3( n=28), respectively. The simplified Chinese version of lymphoedema quality of life questionnaire (LYMQOL) filled out by the patients in sample 1 was used as sample 4 ( n=55). The reliability was analyzed by internal consistency test reliability and split-half reliability, Cronbach’s α coefficient ≥0.80 indicated good internal consistency reliability and the Spearman-Brown split-half reliability coefficient ≥0.70 indicated good split-half reliability. The content validity of the Lymph-ICF-LL was determined by three plastic surgery experts who judged the consistency of the questionnaire with the original English content. Exploratory factor analysis and criterion validity were used to analyze construct validity. For criterion validity assessment, Pearson correlation analysis was used to test the correlation between the Lymph-ICF-LL scores in sample 1 and the LYMQOL scores in sample 4. The scores of Lymph-ICF-LL before and half a year after lymphadenectomy were compared by paired t-test. Results:(1) Cronbach’s alpha was 0.937, indicating good internal consistency. The Spearman-Brown split-half reliability coefficient of the total scale was 0.700, indicating good split-half reliability. (2) The content validity of the simplified Chinese version of Lymph-ICF-LL was good. Five factors (physical function, mental function, general tasks/household, mobility and life/social life) were identified by factor analysis. The total score of the simplified Chinese version of Lymph-ICF-LL was positively correlated with the score of the simplified Chinese version of LYMQOL ( r=0.73, P<0.001), and the criterion correlation validity was good. (3) The scores of Lymph-ICF-LL for half a year after LVA was significantly lower than its preoperative counterparts (40.70±15.13 vs. 54.40±15.70, t=5.96, P<0.001). The quality of life of patients after LVA was significantly improved. Conclusion:The simplified Chinese version of Lymph-ICF-LL shows good reliability and validity and can be used to evaluate the quality of daily life regarding patients with lower limb lymphedema.