基于患者报告结局用药相关生活质量量表的汉化及其在老年多重用药患者中的信效度研究

Translation of the Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life and Its Validation in Elderly Patients with Polypharmacy

背景老年多重用药人群数量庞大,用药形势严峻,为保证用药患者生命长度与质量最大化,亟需使用特异性测评工具更加全面、客观地评估患者用药后的益处及风险。目的汉化基于患者报告结局用药相关生活质量量表(PROMPT-QoL),并评价该量表在老年多重用药患者中的信度和效度。方法征得原作者的授权,采用Brislin的双人直译-回译法、文化调适、认知性访谈,形成中文版PROMPT-QoL施测稿。于2022年6—8月便利选取延吉市公园街道、北山街道及河南街道社区卫生服务中心、延吉市医院及延边大学附属医院门诊就诊、健康体检、取药的老年多重用药患者作为调查对象。采用条目-维度相关分析法和决断值法进行项目分析;采用条目水平的内容效度指数(I-CVI)、全体一致量表水平的内容效度指数(S-CVI/UA)和平均S-CVI(S-CVI/Ave)评价量表的内容效度;采用探索性因子分析(EFA)和验证性因子分析(CFA)检验结构效度;采用内部一致性(Cronbach'sα系数)和折半信度检验量表的信度。结果共调查590例患者,回收有效资料564份,有效回收率为95.8%。其中234份资料应用于第一阶段的项目分析和EFA,330份资料应用于第二阶段的CFA。各条目得分与各维度得分的相关系数为0.504~0.915(P<0.01),各条目决断值(CR值)均>3.0(P<0.05);I-CVI为0.89~1.00,S-CVI/UA为0.91>0.80,S-CVI/Ave为0.99>0.90;EFA共提取8个公因子,与源问卷结构基本相符,其中条目G34在所属公因子上的载荷量<0.40,故删除条目G34;对剩余41个条目进行CFA,χ^(2)/df=2.160,拟合优度指数(GFI)=0.791,规范拟合指数(NFI)=0.848,增值拟合指数(IFI)=0.912,比较拟合指数(CFI)=0.911,非标准拟合指数(TLI)=0.902,近似误差均方根(RMSEA)=0.059;总量表Cronbach'sα系数为0.839,各维度Cronbach'sα系数为0.823~0.955(P<0.01);各维度的折半信度为0.815~0.957(P<0.01)。结论经汉化和文化调适后的中文版PROMPT-QoL信效度良好,可应用于我国老年多重用药患者的用药相关生活质量水平的评估。

Background There is a high prevalence of polypharmacy among elderly patients with severe situation.There is an urgent need for more comprehensive and objective tools to assess the benefits and risks of medication use in patients to ensure maximum length of life and quality of life for patients.Objective To translate the Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life(PROMPT-QoL)Scale into Chinese and evaluate its reliability and validity among elderly patients with polypharmacy.Methods With the authorization of the original author,Brislin's translation model of forward-back translation,cultural adaptation,and cognitive interviews were used to develop a test draft of the Chinese version of the PROMPT-QoL.Elderly patients with polypharmacy who visited outpatient clinics,received health checkups and took medicine at community health centers of Gongyuan street,Beishan street and Henan street,Yanji Hospital and Yanbian University Hospital from June to August in 2022 were selected as the survey respondents.Item analysis was conducted using the item-dimension correlation analysis and the critical ratio(CR).The content validity of the scale was evaluated using the item-level content validity index(I-CVI),universal agreement scale-level CVI(S-CVI/UA)and average scale-level CVI(S-CVI/AVE).Structural validity was evaluated using exploratory factor analysis(EFA)and confirmatory factor analysis(CFA).Internal consistency tests(Cronbach's alpha coefficient)and the split-half coefficient were used to assess reliability.Results A total of 590 patients were investigated and 564 valid data were recovered,with a recovery rate of 95.8%.Among them,234 data were applied to the item analysis and EFA in the first stage,and 330 data were applied to the CFA in the second stage.The correlation coefficients between the scores of each item and the scores of each dimension ranged from 0.504~0.915(P<0.01),and the CR value of each item was>3.0(P<0.05).The I-CVI ranged from 0.89 to 1.00,the S-CVI/UA was 0.91>0.80,and the S-CVI/Ave was 0.99>0.90.A total of 8 common factors were extracted from EFA,which were basically consistent with the results of the source questionnaire,among which item G34 had a loading of<0.40 on the common factor to which it belonged,so this item was deleted.CFA was performed on the remaining 41 items as follows:χ^(2)/df=2.160,goodness of fit index(GFI)=0.791,normed fit index(NFI)=0.848,incremental fit index(IFI)=0.912,comparative fit idex(CFI)=0.911,Tucker-Lewis index(TLI)=0.902,root mean square error of approximation(RMSEA)=0.059.In the reliability test,Cronbach'sαcoefficient for the scale was 0.839,Cronbach'sαcoefficient for each dimension ranged from 0.823 to 0.955,and the split-half coefficient of each dimension ranged from 0.815 to 0.957.Conclusion The Chinese version of the PROMPT-QoL scale has good reliability and validity,and can be applied to evaluate the pharmaceutical therapy-related quality of life of elderly patients with polypharmacy in China.