【摘要】：目的:將已研制出的慢性阻塞性肺疾病(COPD)“病人報告結(jié)局”(PROs)中醫(yī)評價量表應(yīng)用于慢性阻塞性肺疾病穩(wěn)定期患者及健康人,以對該量表的信度、效度、反應(yīng)度等進行考評。方法:研究中,根據(jù)隨機抽樣、對照、重復(fù)、均衡等原則,嚴(yán)格遵照診斷標(biāo)準(zhǔn)、納入標(biāo)準(zhǔn),共收集慢性阻塞性肺疾病穩(wěn)定期患者病例60例,分中藥組和西藥組(各30例),分別采用中醫(yī)辨證綜合治療和西藥治療,28天為一療程,治療前后均用病人報告結(jié)局量表進行測評,并對患者進行生存質(zhì)量量表的測定。另外,將采用病人報告結(jié)局量表對40例健康人進行測評以了解量表區(qū)分病人與健康人的能力。資料收集完后,采用SPSS17.0統(tǒng)計軟件對資料進行統(tǒng)計處理,并對量表的可行性、效度、信度、反應(yīng)度等進行考評。結(jié)果:1.量表的可行性:量表的接受率100%,回收率100%,問卷完成率為100%,條目完成率為100%,量表平均完成時間平均14.48±5.26分鐘。2.量表的效度:內(nèi)容效度:本量表由有關(guān)各方面人員參與選題與討論,所提出的維度與條目內(nèi)容充分體現(xiàn)了PROs量表的內(nèi)涵及中醫(yī)慢性阻塞性肺疾病穩(wěn)定期有關(guān)病、證、癥特點,并按程序化方式篩選條目,可認(rèn)為具有較好的內(nèi)容效度。結(jié)構(gòu)效度:經(jīng)探索性因子分析,測量結(jié)果與研究時研究者對量表構(gòu)想的結(jié)構(gòu)是相符的。效標(biāo)效度:與WHOQOL-BREF相關(guān)系數(shù)為0.757,具有適度的相關(guān)性(P0.01)。3.量表的信度:總表與各維度的分半信度系數(shù)(R)均在0.66以上�？偙砑案骶S度的Cronbach’s alpha均在0.77以上。4.反應(yīng)度:健康人各維度及總表得分的均數(shù)明顯高于慢性阻塞性肺疾病穩(wěn)定期患者的得分(p0.01)。慢性阻塞性肺疾病穩(wěn)定期患者治前病人報告結(jié)局總表得分均數(shù)與標(biāo)準(zhǔn)差為100.30±12.212,治后為127.95±12.093,p0.01。治后各維度得分均數(shù)均有不同程度增加,提示各維度狀態(tài)提高(p0.01)。治療后各條目得分均數(shù)有不同程度的提高,各條目差異均有統(tǒng)計學(xué)意義(p0.05),其中中醫(yī)證候維度條目變化較大,心理維度條目變化最小。中、西藥組治療前維度得分及總分相近,治后中藥組癥候、生理維度得分明顯高于西藥組(p0.05~0.01);提示中藥在改善慢性阻塞性肺疾病穩(wěn)定期患者的癥候、生理等方面效果優(yōu)于西藥組。結(jié)論:1.本量表的接受率、回收率、完成率較高,完成時間不長,即量表的臨床可行性好。2.本量表能區(qū)分不同人群(健康人與慢阻肺患者)、不同時間(治療前后)生存質(zhì)量的變化、不同干預(yù)措施所致不同療效的能力,甚至能區(qū)分不同組別橫向資料的差異及程度,對各條目資料得分的變化較為敏感,具有較好的反應(yīng)度。3.效度、信度分析結(jié)果表明,本量表具有較好的內(nèi)容效度、結(jié)構(gòu)效度和適度的效標(biāo)效度,維度相關(guān)性高;同時本量表具有較好的分半信度、同質(zhì)性信度。提示本量表具有較好的效度和信度。
[Abstract]:Objective: to evaluate the reliability, validity and responsiveness of (COPD) "patient report outcome" (PROs) scale developed in stable stage of chronic obstructive pulmonary disease (COPD) and healthy people in order to evaluate the reliability, validity and responsiveness of the scale. Methods: according to the principles of random sampling, control, repetition and balance, 60 patients with stable chronic obstructive pulmonary disease (COPD) were collected according to the diagnostic criteria and included in the criteria. They were divided into Chinese medicine group (n = 30) and western medicine group (n = 30). The patients were treated with syndrome differentiation of traditional Chinese medicine (TCM) and western medicine for 28 days as a course of treatment. The quality of life scale was measured. In addition, 40 healthy people will be evaluated with the patient report outcome scale to understand the ability of the scale to distinguish patients from healthy people. After the data were collected, the data were statistically processed by SPSS17.0 statistical software, and the feasibility, validity, reliability and responsiveness of the scale were evaluated. Result: 1. The feasibility of the scale: the acceptance rate of the scale was 100%, the recovery rate was 100%, the completion rate of the questionnaire was 100%, the completion rate of items was 100%, and the average completion time of the scale was 14.48 鹵5.26 minutes. The validity of the scale: content validity: the dimensions and items proposed in this scale fully reflect the connotation of PROs scale and the characteristics of diseases, syndromes and symptoms in the stable stage of chronic obstructive pulmonary disease (COPD), and screen the items according to the programmed way, which can be considered to have better content validity. Structural validity: through exploratory factor analysis, the measured results are consistent with the structure of the scale. Standard validity: the correlation coefficient with WHOQOL-BREF was 0.757, which had a moderate correlation (P01). 3. The reliability of the scale: the split-half reliability coefficient (R) of the total table and each dimension was above 0.66. The Cronbach's alpha of the summary table and each dimension is above 0.77. 4. The mean score of each dimension and total table of healthy people was significantly higher than that of patients with stable chronic obstructive pulmonary disease (p0.01). The average score and standard deviation of the total outcome table of patients with stable chronic obstructive pulmonary disease were 100.30 鹵12.212, 127.95 鹵12.09 3, p0.01. After treatment, the average score of each dimension increased to varying degrees, suggesting that the state of each dimension increased (p0.01). After treatment, the average score of each item was improved to some extent, and the difference of each item was statistically significant (p0.05). The item of TCM syndrome dimension changed greatly, and the change of psychological dimension item was the smallest. The scores of symptoms and physiological dimensions in the traditional Chinese medicine group were significantly higher than those in the western medicine group (p0.05 鈮，

本文編號：2500407