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肝硬化患者肝性脑病风险评估量表的构建及评价

Development and Evaluation of Risk Assessment Scale for Hepatic Encephalopathy Inpatients with Liver Cirrhosis

【作者】 王娜

【导师】 王小梅;

【作者基本信息】 重庆医科大学 , 护理学, 2019, 硕士

【摘要】 目的:1.构建肝硬化患者肝性脑病风险评估量表并评价其信效度,为探索适合我国护理人员评估肝硬化患者发生肝性脑病风险及预防性治疗、护理提供参考依据。2.初步应用肝硬化患者肝性脑病风险评估量表,分析量表风险状况和预测效果。方法:1.以罗伊的适应模式理论和纽曼的健康系统模式理论为基础,运用文献分析法、临床资料回顾分析法、访谈法、小组讨论等方法初步形成肝硬化患者肝性脑病风险评估指标体系。2.通过两轮德尔菲法对肝硬化患者肝性脑病量表条目池进行专家函询,以筛选、优选量表条目,初步形成肝硬化患者肝性脑病风险评估量表预测试版。3.采用整体抽样法,使用肝硬化患者肝性脑病风险评估量表预测试版对2018年7月至9月就诊于本院肝胆外科、消化内科、感染病科的276例肝硬化住院患者进行调查,依据临界比值、相关系数、因子分析和内部一致性进行项目分析以进一步精简、优化条目,构建肝硬化患者肝性脑病风险评估量表并评价量表信效度。4.采用整体抽样法,以2018年12月至2月就诊于本院本院肝胆外科、消化内科、感染病科的371例肝硬化住院患者为调查对象,初步应用肝硬化患者肝性脑病风险评估量表并通过AMOS进行验证性因素分析,进一步检验该量表的因子结构。5.在第二次调查结果的基础上,采用ROC曲线分析肝硬化患者肝性脑病风险评估量表的预测效能。此外,通过非参数检验分析肝硬化患者肝性脑病风险评估量表比较不同人口学特征对量表风险的影响情况。结果:1.在分析大量文献的基础上初拟条目池,结合临床资料回顾性分析、访谈法的数据结果,初步形成包含8个维度(肝功能情况、门体因素、门体断流术、消化道出血、感染、电解质紊乱、药物饮食习惯、相关疾病因素),44个条目的肝硬化患者肝性脑病风险评估量表条目池。2.两轮专家函询问卷有效率分别为96.3%(26/27)、88.5%(23/26),专家权威系数分别为0.928(0.72~1.00)、0.932(0.79~1.00)。其中,第二轮的均数﹥3.5且变异系数﹤2.5的维度和条目比例分别100%(8/8)、85.7%(30/35),并且,维度和条目的专家意见肯德尔协调系数(Kendall’s W)分别为0.520、0.441(P﹤0.001)。形成包含8个维度(肝功能情况、门体因素、手术因素、消化道出血、感染、电解质紊乱、药物与饮食、合并症),29个条目的肝硬化患者肝性脑病风险评估量表指标。3.经项目分析后,保留3项条目,合并TIPS和外科门体分流术为“门体分流术”,删除5项条目,整理后检验信效度。效度分析结果显示量表内容效度指数为0.984,各条目的内容效度指数范围为0.889~1.000;探索性因子显示肝功能情况、诱发因素累计方差贡献率为63.229%、41.866%,因子载荷范围分别为0.560~0.893、0.400~0.813;维度与总分的相关系数分别为0.859、0.879,条目与总分相关系数范围0.167~0.742;量表与Child-Pugh评分的校标关联效度为0.500、0.455、0.415,呈中度相关;无HE组和HE组的量表总分中位数分别(7,25)分、27(20,36),区分效度较好(Z=-5.302,P﹤0.001);预测版量表、肝功能情况、诱发因素的ROC曲线下面积分别为0.792、0.774、0.757,敏感性和特异性分别是83.9%和59.6%,87.1%和59.2%,90.3%和53.1%,具有较好的预测效度。信度:预测试量表、肝功能情况、诱发因素克朗巴赫系数分别为0.774、0.758、0.614;重测信度分别为0.863、0.996、0.618;量评定者间信度为0.910,各条目之间的评定者间信度为0.447~1.000;折半信度分别为0.834、0.805、0.655。最后形成23个条目、2个维度的肝硬化患者肝性脑病风险评估量表正式版。4.验证性因素分析结果显示,绝对拟合指数指标均达到理想标准,相对拟合指数指标在可接受范围内,这表明正式版肝硬化患者肝性脑病风险评估量表因子结构模型趋于稳定,尚可接受。5.研究结果显示,当量表临界值为18分时,其敏感度为93.0%、特异度为53.8%、正确度为59.8%,量表风险评估结果与肝性脑病实际情况基本符合。此外,量表为18.18±10.04分,说明大多数肝硬化患者肝性脑病风险较高。量表风险评分与Child-Pugh分级、病程、肝性脑病病史、肝癌及文化程度等一般特征明显相关(P﹤0.05)。结论:1.本研究构建的肝硬化患者肝性脑病风险评估量表包括肝功能情况、诱发因素2个维度,共23个条目。2.该量表因子结构趋于稳定,信效度较好,可作为护理人员评估肝硬化患者肝性脑病发生风险的评估工具。3.该量表灵敏度高,预测效能与临床实际结果基本相符。大多数肝硬化患者处于肝性脑病高风险状态,Child-Pugh分级、病程、肝癌、肝性脑病病史及文化程度等因素与肝性脑病风险强相关,所以评估管理肝硬化患者肝性脑病风险,予以健康教育时应适当增加评估频次,重视健康教育反馈评价。

【Abstract】 Objectives:1.To construct a risk assessment scale for hepatic encephalopathy in patients with liver cirrhosis and evaluate the reliability and validity,with the purpose for providing a suitable scale for domestic nurses to assess the risk of hepatic encephalopathy in patients with liver cirrhosis and reference for early treatment and care.2.To preliminarily clinically apply the risk assessment scale for hepatic encephalopathy in patients with liver cirrhosis,and analyze the risk situation and prediction effects.Methods:1.Based on the theory of Roy’s Adaptation model and Newman’s health system model,the initial item-pool of risk assessment scale for hepatic encephalopathy in patients with liver cirrhosis was formed by using literature review,clinical data review,interviewing,group discussion and other methods,.2.Through two Delphi rounds of consultation on dimensions and items of the risk assessment scale for hepatic encephalopathy in patients with liver cirrhosis,these items were selected and optimized.So the pre-trial version of risk assessment scale for hepatic encephalopathy in patients with liver cirrhosis was initially developed.3.Within global sampling method,276 cases with liver cirrhosis from the Department of hepatobiliary surgery,gastroenterology,and infectious diseases from July to September 2018 were investigated using the pre-trial version scale.Four kinds of methods,such as critical ratio,correlation coefficient,factors analysis and internal consistency,were used to further simplify and optimize items,and formed the formal version of liver cirrhosis patients with hepatic encephalopathy risk assessment scale.4.Within global sampling method,371 cases of hospitalized patients with liver cirrhosis from the Department of hepatobiliary surgery,gastroenterology,and infectious diseases were measured by formal version of risk assessment scale of hepatic encephalopathy in patients with liver cirrhosis from December in 2018 to February in 2019.The confirmatory factor analysis was used to further confirmed factor of structure of the scale by AMOS.5.Based on the data of the second survey,analyzing and comparing these effects the risk assessment scale with the risk prediction model by the area under the ROC curve.Moreover,nonparametric test analysis was used to evaluate the risk of hepatic encephalopathy by the risk assessment scale for in cirrhosis patients with different characteristics.Results:1.Based on the results of literature review,retrospective analysis,interviewing and group discussion,the initial draft of scale included forty-four items under eight dimensions: liver function,portal-systemic shunts,gastrointestinal bleeding,electrolyte disorder,infection,drugs and diet,comorbidities and operative factors.2.Twenty-seven experts were contacted,of whom 26(response rate,96.3%)accepted and completed the first round survey and 23(response rate,88.5%)completed the second round.The experts’ authority coefficients for the first and second rounds were 0.928(0.72~1.00)and 0.932(0.79~1.00),respectively,reflecting good content validity.The mean range of all dimensions was both reached mean﹥3.5 scores and CV﹤0.25;among 35 indicators,five factors were removed for failing to achieve a mean >3.5,although all factors achieved CV﹤2.5.Furthermore,Kendall’s coefficient of concordance(Kendall’s W =0.520,0.441,P<0.001)for the group agreement indicated a highly significant level of group consensus.Finally,a 29-item risk assessment scale for hepatic encephalopathy in patients with liver cirrhosis was developed,including 8 dimensions liver function,portal-systemic shunts,gastrointestinal bleeding,electrolyte disorder,infection,drugs and diet,comorbidities and operative factors.3.As a result of the item analysis,the surgical portal-systemic shunts item was merged with the TIPS into portal-systemic shunts.And also,three items were kept and five items was removed.The results of the validity analysis showed that the content validity index of scale was 0.984,and the content validity index of items ranged from 0.889 to 1.000.The cumulative variance contribution rate of exploratory factor displayed liver function and precipitating factors was 63.229% and 41.886%,and the factor loading range was 0.560~0.893,0.400~0.813,respectively.The correlation coefficient of dimensions and the total score of were 0.859 and 0.879,and items and the total scores were 0.167 ~ 0.742.Validity for the scale associated with Child-Pugh score and the predicted model of Overt hepatic encephalopathy respectively were 0.500,0.455,and 0.415,0.600,0.706 and 0.349,showing a moderate relation.Besides,there was a significant difference between HE group and non HE(Z =-5.317,P﹤0.001),reflecting a good distinguishing validity;the results showed that the area under the ROC curve of the scale,two dimensions were 0.792,0.774 and 0.757,and the sensitivity and specificity were 93.5%,and 47.3%,83.9% and 60.8%,58.1% and 79.2%,respectively,showing a well predictive validity.The results of reliability showed the total Cronbach’s alpha for all items on the scale was 0.774,and liver function and precipitating factors were 0.758 and 0.614.Moreover,there were statistically significant degrees of test-retest reliability of the scale,two dimensions were 0.774,0.758 and 0.614.The inter-rater reliability of scale,two subscales were 0.910、0.896、0.773,and the split-half reliability of the scale,dimensions were 0.834、0.805、0.655,showing that this scale had good consistency.Finally,a formal version of hepatic encephalopathy risk assessment scale under 2 dimensions and with 23 items was formed.4.The results of confirmatory factor analysis showed that the absolute fitting index indexes reached the ideal standard and the relative fitting index indexes were within the acceptable range,indicating that the factor structure model of the risk assessment scale for hepatic encephalopathy in patients with liver cirrhosis tended to be stable and acceptable.5.The results showed that when the critical value of the scale was 18 points,its sensitivity,specificity and accuracy was 93.0%,53.8% and 59.8%,respectively,showing the risk assessment results of the scale were basically consistent with the actual situation of hepatic encephalopathy.In addition,the total mean score of patients with hepatic encephalopathy was 18.18±10.04.Among them,the levels of Child-Pugh scores,liver cancer and education,course and previous hepatic encephalopathy have relative correlation with the risk of hepatic encephalopathy(P﹤0.05).Conclusion:1.The risk assessment scale for hepatic encephalopathy patients with liver cirrhosis is developed,which included a total of 23 items under two dimensions covering liver conditions and precipitating factors.2.The results of reliability and validity showed the factor content and factor structure of the scale tends to be stable.The evaluation indexes within content validity index,structure validity,predictive validity,Cronbach’s alpha,test-retest reliability,and inter-rater reliability were acceptable,showing a good reliability and consistency.Thus,the scale could be used to assess the risk levels of hepatic encephalopathy in patients with liver cirrhosis by medical staffs.3.The risk assessment results of the scale were basically consistent with the actual situation of hepatic encephalopathy.Most patients with liver cirrhosis are at a higher risk of hepatic encephalopathy,and Child-Pugh classification,liver cancer,course,education and previous hepatic encephalopathy are strongly correlated with the risk of hepatic encephalopathy.So it is necessary for medical staffs to provide more assessment frequency and counseling.

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