基于中医基础理论的痛经生命质量量表的研制与条目筛选

目的:研制基于中医基础理论的痛经生命质量量表,筛选、优化条目,探索中医药临床产出评价的参考工具。方法:通过文献研究与知情人访谈,构建量表的理论结构模型,进行条目整理,形成包括41个条目的条目池;采用德尔菲法对条目初筛与调整后形成初量表;采用调查统计方法,对纳入的200例受访者数据,采用频数分布法、离散趋势法、因子分析法...     

基于中国文化改良明尼苏达心力衰竭生存质量量表的条目筛选

在明尼苏达心力衰竭生存质量量表(MLHF)21个条目的基础上,加入综合文献和小组专家选出的慢性心力衰竭(心力衰竭)相关中医特色条目16条,形成37个条目的预调查表,选择100例心力衰竭患者进行预调查。在分析总结预调查结果的基础上,再扩大范围征询专家的修订和增补意见,形成包括39个MLHF和中医特色条目的试验调查表的条目池,选择130例心力衰竭患者进行试验调查,经离散趋势法、主观评价法、相关系数法和逐步回归分析法处理,删除相关性较低的条目,初步形成包括28个条目的基于中国文化的改良明尼苏达心力衰竭生存质量量表(C-MLHF)。基于中国文化和中医理论背景,按照国际量表通用的程序化方式研制的符合中国人生活习惯的C-MLHF对我国心力衰竭患者生存质量评价具有更好的适应性。     

结直肠癌术后中医生存质量量表信度和效度评价

目的评价结直肠癌术后中医生存质量量表(QLQ-CMPPCC)的信度和效度。方法 2019年1月-2020年12月对广州中医药大学第二附属医院246例结直肠癌术后患者进行中医生存质量调研,采用克朗巴赫α系数(Cronbach’sα)法评价信度,因子分析法评价效度。结果现场调查收集有效问卷244份。210例非造口患者使用的43个条目总的Cronbach’sα为0.908,去掉某一条目后量表的Cronbach’sα均超过0.70。43个条目共提取10个因子,累计方差贡献率为64.714%;因子分析结果显示,每个条目在其中一个公因子的方差0.4。结论 QLQ-CMPPCC具有良好的信度和效度,可作为结直肠癌术后中医临床疗效评价的工具。     

结直肠癌术后患者中医生存质量量表的研制及条目筛选

目的 研制结直肠癌术后患者中医生存质量量表（quality of life questionnaire of Chinese medicine for postoperative patients with colorectal cancer,QLQ CMPPCC）,以全面、客观地评价中医药在结直肠癌术后的临床疗效。方法 根据WHO生存质量量表制定原则,结合中医基础理论,提出量表的理论结构模型,广泛查阅国内外多种普适性及结直肠癌专用生存质量量表,采用结构化决策的方法,编制初始量表。用调查方式对205例结直肠癌术后患者进行测试,运用专家重要性评分法、条目分布考察法、离散趋势法、 t检验法、相关系数法、因子分析法、克朗巴赫α系数法联合进行条目筛选。结果 研制出含有生理、心理、独立性和社会功能4个领域、 20个方面及54个条目的QLQ CMPPCC。其中,非造口手术患者回答43条,造口手术患者回答46条,生存质量总评价1条。结论 QLQ CMPPCC具有中医特色,全面反映了结直肠癌术后患者生存质量的内涵,可作为结直肠癌术后中医临床疗效评价的工具。     

慢性阻塞性肺疾病稳定期患者报告结局量表的研制及初步考核

目的：初步研制慢性阻塞性肺疾病稳定期患者报告结局量表并进行初步考核。方法：参照量表研制程序规范,选取慢性阻塞性肺疾病稳定期患者为研究对象,成立研究工作小组,在中医理论模型指导下,综合文献研究、专家咨询和工作组讨论等内容,对问卷相关概念进行界定,构建问卷结构领域,组建条目池并进行筛选,并通过100例患者进行预调查,采用Cronbach’sα进行效度评价,领域与其各条目间的相关系数进行内容效度分析,主成分和因子分析法进行结构效度分析。结果：初步研制的慢性阻塞性肺疾病稳定期患者报告结局量表包括3个领域17个条目,问卷预调查信度分析Cronbach＇sα系数0.839,内容效度分析各领域与其包含条目的相关系数在0.5以上,因子分析共提取5个共因子。结论：慢性阻塞性肺疾病稳定患者报告结局量表领域结构和条目设置合理,信度和内容效度良好,结构效度一般。     

中医复发性口腔溃疡患者报告结局量表的研制及条目筛选

目的在中医理论指导下研制中医复发性口腔溃疡患者报告结局(PRO)量表。方法按照PRO量表制作原则与流程,结合中医相关理论,建立复发性口腔溃疡PRO量表的理论框架。通过访谈法、文献法等方式建立条目池,根据专家Delphi法及Likert评定法进行条目筛选和优化,并通过文化适应性调查等形成预调查量表。临床调查复发性口腔溃疡患者,运用离散趋势法、相关系数法、因子分析法、t检验法、克朗巴赫α系数法、专家重要性评分6种统计方法进行条目筛选。结果形成条目池78条症状,经优化得到复发性口腔溃疡PRO预调查量表条目27条。发放量表175份调查表,共回收169份,通过离散趋势法删除标准差0.7的条目2条,因子分析法除去与其他因子接近的条目1条,克朗巴赫α系数法删除Cronbach'sα系数0.7的条目1条,专家重要性评分删除评分8分的条目6条(其中2条与离散趋势法相同),最终筛选出19个条目,形成中医复发性口腔溃疡PRO量表。分为生理、心理、社会、独立性领域4个领域,包括疼痛及不适、体力、睡眠、二便、饮食、出汗、寒热、积极感受、消极感受、日常生活、个人能力、社会关系、社会环境12个方面。结论中医复发性口腔溃疡PRO量表研制流程规范,能够体现中医复发性口腔溃疡发病特色,反映复发性口腔溃疡患者生存质量,尚需对量表的信度、效度及反应度实施进一步的科学性考评。     

中风病患者生存质量量表的研制与考评

目的:对自编的“中风病患者生存质量量表”(QOLISP)进行心理学测评。方法:根据生存质量量表研制原则、方法与步骤,从条目的选择与初筛,专家评议与小范围预试形成粗表,再经过量表预试与条目再筛选,形成QOLISP,包含生理、心理、社会、中医证候4个维度共同36个条目,随后对120例中风患者治疗1个疗程前后的生存质量进行测评。结果:QOLISP的信度、效度、反应度和可行性均达到心理学测评可接受的水平。结论:QOLISP可以作为中风病患者生存质量的评价工具投入临床使用。     

特发性肺间质纤维化患者生活质量评价量表研制

目的研制适合特发性肺间质纤维化(idiopathic pulmonary fibrosis,IPF)生活质量评价量表,客观反映疾病变化。方法根据患者报告临床结局(patient-reported outcome,PRO)量表制定原则,结合中医基础理论,提出量表的理论结构模型,广泛查阅国内外多种呼吸系统疾病生活质量量表,采用结构化决策的方法,编制初始量表。用调查方式对34例确诊IPF患者进行测试,运用专家重要性评分法、因子分析法、相关系数法、克朗巴赫α系数法联合进行条目筛选最终确定IPF生活量表(IPF patient reported outcomes IPF PRO,IP)。结果研制出含有3个领域、38项条目的 IP量表。SGPQ和IP量表临床症状分值相关性分析Pearson相关系数为0.828(P0.01);活动能力分值相关性分析Pearson相关系数为0.929(P0.01);疾病对日常生活影响分值相关性分析Pearson相关系数为0.903(P0.01);总分值相关性分析Pearson相关系数为0.862(P0.01)。对IP量表本身进行信度(reliability)分析,克朗巴赫系数为0.713,用因子分析法对所得数据分析,KMO统计量为0.902。结论 IP量表全面反映了IPF患者生活质量的内涵,可作为IPF患者中医临床疗效评价的工具。     

具有中医特色的溃疡性结肠炎生存质量量表的研制

目的：本研究旨在研制具有中医特色的溃疡性结肠炎患者生存质量量表,进行条目筛选,并对溃疡性结肠炎患者进行问卷调查。方法：以文献回顾结合访谈形式研制具有中医特色的溃疡性结肠炎生存质量初始量表。通过德尔菲2轮专家咨询,进行条目筛选。结果：形成了包含生理、心理、独立性和社会因素4个维度共56个条目的溃疡性结肠炎生存质量量表。结论：具有中医特色的溃疡性结肠炎生存质量量表的研制方法可靠,经检验,专家意见集中,结果科学,可为国内溃疡性结肠炎生存质量的评价提供参考依据。     

维持性血液透析患者生存质量量表的研制与信度效度测评

目的:研制维持性血液透析患者生存质量量表(QLSHPCRF)并进行信度和效度测评。方法:首先建立"QLSHPCRF初表"。由核心工作组建立量表理论模型,提出量表的五维模式结构,筛选45条条目作为条目池,组成"临床信息调查表",运用频数分布法、内部一致性分析法、离散趋势法、相关系数法、逐步回归分析法、专家重要性评价法分别对条目池的45项条目进行筛选,初步确定保留20个条目构成"QLSHPCRF初表"。然后采用重测信度、克朗巴哈a信度系数、分半信度、结构效度、内容效度、标准关联效度进行量表的信度和效度测评。结果:研制出由生理维度、心理维度、社会关系和环境维度、透析相关维度、精神维度组成的"QLSHPCRF",重测信度0.802,各维度Chronbach’sα系数均在0.7以上,分半后相关系数0.831(P0.01),各条目与所属维度的相关系数在0.671~0.879,各条目与所属维度相关系数均大于0.5,与公认的生存质量量表SF-36比较,二者总分相关系数达0.688,各维度之间的相关系数均P0.05。结论:QLSHPCRF具有良好的信度、效度,是可靠、灵敏的,可以应用于维持性血液透析患者生存质量的评价。     

中华生存质量量表对慢性心力衰竭患者的心理测量学评价

目的 探讨中华生存质量量表对慢性心力衰竭患者生存质量评价中的信度、效度和反应度。方法 采用中华生存质量量表、世界卫生组织生存质量测定简表中文版（WHOQOL-BREF）、健康状况调查问卷中文版（SF-36）及明尼苏达州心力衰竭生活质量问卷中文版（MLHF）同时对39例慢性心力衰竭患者的生存质量进行评价和随诊观察。结果 中华生存质量量表具有较好的内部一致性（Cronbach’s α均〉0．7）;因子分析产生的3个因子与量表的理论结构模型一致;同时此量表与WHOQOL-BREF、SF-36和MLHF相比,具有较好的效标效度;4周后共有32例完成随访,根据患者的自我病情评价和医生对患者治疗前后心功能的评价,发现中华生存质量量表的反应度明显优于同样是普适性量表的WHOQOL-BREF和SF-36,略逊于特异性量表MLHF。结论 中华生存质量量表用于心力衰竭患者生存质量评价时具有较好的信度、效度和反应度。     

中华生活质量量表应用于肠易激综合征的信度与效度评价

目的:探讨中华生活质量量表(ChQOL)应用于肠易激综合征(IBS)患者的信度与效度,为临床应用该量表提供依据。方法:选择2015年3月至2017年6月在佛山市中医院门诊和住院部就诊符合罗马Ⅲ诊断标准的IBS患者123例,同时纳入健康受试者123例,使用ChQOL量表测定其生活质量,评价该量表的信度和效度。结果:该量表所有维度的Gronbach’sα系数均 0.7;重测信度 0.7;结构效度分析基本符合量表设计构想;以SF-36作为效标的比较,ChQOL量表各领域具有良好关联性,同时具有良好区分效度。结论:ChQOL量表用于IBS患者的生活质量评价具有良好的信度与效度。     

Development and evaluation of a traditional Chinese medicine syndrome questionnaire for measuring sub-optimal health status in China

[OBJECTIVE]:Sub-optimal health status (SHS),in which a person's mind and body exists in a low-quality state of being between disease and health,has become a public health problem that cannot be ignored...     

基于胸腰椎压缩骨折患者报告的临床结局评价量表的初步构建和统计分析

目的建立基于胸腰椎压缩骨折患者报告的临床结局(PRO)评价量表,从患者报告的角度为胸腰椎压缩骨折临床疗效评价提供一个新的方法。方法采用文献资料查询、专家咨询等方法,参考患者日常就诊时的主诉,结合国内外临床常用量表的条目,进一步完善量表并形成PRO初始量表。结果初步形成一个具有4个域体系(躯体症状、躯体感觉、心理状态和社会交往)、16个条目的量表。该量表总克朗巴赫系数α(Cronbach'sα)为0.878。折半信度(Split-Cronbach'sα)分析为0.783。量表KMO统计量为0.831,通过Bartlett检验,各变量间信息的重叠程度较高(2=1 921.243,P<0.01),适合做因子分析。结论该量表具有较高的信度、效度,可作为胸腰椎压缩骨折患者报告的临床疗效评价的初级量表。     

Reliability and validity of the Tibetan medicine constitution scale: a cross-sectional study of the general population in Beijing,China

Background:The constitutional theory is an important aspect of Tibetan medicine,however a quantitative measurement tool for constitution identification still does not exist.The objective of this study is to evaluate the reliability and validity of a Tibetan medicine constitution scale(TMCS)that consists of three sub-scales and 31 items.Methods:From June to July 2019,622 people from the general population in Beijing,China,aged 18 to 60 were investigated.We employed Cronbach’s alpha(α),split-half reliability,and test-retest reliability to determine the reliability of the scale.The content validity and contract validity of the TMCS were evaluated using factor analysis and correlation analysis based on Tibetan medicine theory.The items were screened according to the reliability test results.Results:After the items were screened,22 items remained in the scale.The Cronbach’s alpha value for the internal consistency reliability of the TMCS was 0.754(95%confidence interval(CI):0.700–0.761).The correlation coefficient for the two-week test-retest of the total score was 0.726(95%CI:0.571–0.834).The split-half coefficient was 0.689(95%CI:0.640–0.734).The scale can be explained by eight potential factors,including morphological structure,physiological function,personality,adaptability,etc.The body mass index was negatively correlated with the score of the sub-rlung scale(r=−0.376),slightly positively correlated with the sub-mkhris pa scale(r=0.099),and positively correlated with the sub-bad kan scale(r=0.362).Conclusion:The TMCS is a reliable and valid instrument that can be used to assess the body constitution of the general population in Beijing,China.Future studies are needed to explore the differences in biological characteristics among the constitutional types and the association between constitution and disease.     

健康亚健康状态社区居民健康教育效果评估问卷的信度和效度研究

旧的]对编制的健康亚健康状态社区居民健康教育效果评估问卷进行信度和效度研究,为社区居民健康教育效果提供科学的、定量的评估工具。[方法]以健康教育知信行理论和健商理念作为问卷编制理论指导,在广泛查阅文献并参考国内外已经开发的相关问卷或量表的基础上,通过专家头脑风暴法形成条目库。采用随机抽样的方法对天津市南开区某社区健康状态或亚健康状态居民（非疾病状态居民）进行调查,用t检验、相关系数、因素分析三种统计方法筛选条目,形成健康教育效果评估问卷。用Cronbaehs’α系数和重测相关系数检验问卷信度;用内容效度、效标效度、结构效度和区分效度检验问卷效度。[结果]探索性因素分析表明,因子载荷值在0．65～0．87之间,健康知识、健康信念和健康行为3个维度可解释总变异的68．80％;Cronbaehs’α系数在0．75～0．89之间;各维度和总分的重测信度在0．79～0．90之间,各维度和总分的相关分析结果显示,各维度间的相关系数小于维度与总分的相关系数;验证性因素分析拟合指标良好,支持3因素模型;效标效度结果显示,各维度及总分和健商量表的效标指数在0．49～0．80之间;区分效度结果显示,女性在各维度和总分上,高于男性,46—55岁年龄组被试的健康知识和健康信念两维度及总分高于45岁以下年龄组（P〈0．01或P〈0．001）。[结论]社区居民健康教育效果评估问卷具有良好的信度、效度,可用作评估社区健康亚健康状态居民的健康教育效果的有效工具。     

Development and validation of Yin-Deficiency Questionnaire

This study describes development and validation of a questionnaire as an adjunct to Traditional Chinese Medicine diagnosis of Yin-Deficiency Syndrome (Yin-DS). The Yin-Deficiency Questionnaire 1 (Yin-DQ1) consists of 10 items. Seventy-nine healthy volunteers and 44 patients diagnosed with Yin-DS were enrolled for the evaluation of discriminant validity and factorial validity. Another group of 83 healthy volunteers participated for test-retest reliability test. Internal consistency was high in both groups (Cronbach's alpha = 0.8615). Test-retest reliability (Spearman's rank correlation coefficient) ranged from 0.54 to 0.79 (p < 0.01). Factor analysis demonstrated that a two factor solution best explained the variance in responses (51.62%). The scores of all items in patients diagnosed with Yin-DS were significantly higher compared with those of healthy volunteers. The data show the internal consistency, test-retest reliability and strong discriminative properties of the Yin-DQ1. Further research determining the optimal cut-off score for Yin-DS and testing its usage as an outcome measure in a clinical trial is needed.     

冠心病心绞痛血瘀证疗效评价标准

由中华中医药学会心血管病分会委托,基于多中心的481例经冠脉造影证实的冠心病心绞痛血瘀证患者,采用多种统计方法,并结合专家意见的集中程度和协调程度,确定了冠心病心绞痛血瘀证疗效评价量表的条目。采用M指数非线性量化等多种方法对量表条目进行了综合量化,最终形成了冠心病心绞痛血瘀证疗效评价量表。本标准(量表)供中医内科、中西医结合内科医生临床使用,适合于冠心病血瘀证患者的临床疗效评价。     

Expectation and experience of ‘nonspecific’ (whole person) feelings elicited by acupuncture: Content validity of a set of questionnaires

Background

Two 32-item questionnaires designed to assess expectation and experience of the relatively nonspecific feelings (whether bodily, emotional or mental) that may arise in response to acupuncture-type interventions have been developed and tested on acupuncture and other complementary health practitioners and students (N = 204).

Objectives

To conduct a survey to assess content validity (CV) for the questionnaires, following two methods popularised by Lawshe and Lynn, and to compare the results. A secondary objective was to reduce questionnaire length from 32 to 20 items.

Methods

Two surveys (Phase 1, 48 items; Phase 2, 18 items) were conducted among 20 experienced acupuncture practitioners and researchers, who scored items as either ‘essential’, ‘useful but not essential’, or ‘not necessary’. Lawshe's and Lynn's methods were applied to the returned data, the former using Wilson's recent modification, the latter with ‘useful but not essential’ rescored as either ‘essential’ or ‘not necessary’. Some subgroup analysis was carried out. In addition, Randolph's multi-rater kappa was used to assess inter-rater reliability as a further measure of content validity.

Results

There were 17 usable responses in Phase 1, 13 in Phase 2. In both surveys, women considered more items as ‘essential’ than men, but fewer as ‘not necessary’, and vice versa (p < 0.001). Lawshe's content validity ratio (CVR) was significant for only 3 items, and the resulting content validity index (CVI) therefore meaningless. When ‘useful’ was rescored as ‘essential’ and Lynn's Scale CVI (S-CVI) calculated as the average of the CVI only for those items considered appropriate for retention (S-CVI_AV-UA), acceptable values were found for subsets of the full list of items, although only for the women respondents. Inter-rater reliability was low for most items, but on the basis of the content validity analysis, together with respondent reservations about particular items and analysis of actual questionnaire usage, a 20-item list was created and circulated to the survey respondents for further feedback.

Discussion

This shorter scale is now being tested on electroacupuncture training courses, and may be useful in determining whether different feelings are elicited by different types of acupuncture, other CAM modalities, or even other, unrelated activities.

Conclusions

A modified content validity assessment method was found to give more usable results than conventional methods. With this new approach, 32-item questionnaires on expectation and experience of nonspecific feelings were shortened to more manageable 20-item instruments. In general, CV was greater among women than among men.     

Reliability and validity of dermatology life quality index: assessment of quality of life in human immunodeficiency virus/acquired immunodeficiency syndrome patients with pruritic papular eruption

Objective

To test the reliability and validity of dermatology life quality index (DLQI) in simplified Chinese language by assessing the quality of life (QoL) in HIV (human immunodeficiency virus)/AIDS (Acquired immunodeficiency syndrome) patients with pruritic papular eruption (PPE).

Methods

A study of simplified-Chinese-version DLQI was carried out in Henan province, China. The reliability and validity were tested by means of statistical method. Data were processed with SPSS 19.0.

Results

One hundred and seven subjects participated in the study and 106 (99.07%) finished the questionnaire. Eighteen patients were mildly affected; 62 were moderately affected, 24 were highly affected, and 2 were extremely affected. Reliability analysis showed that the split-half reliability coefficient of questionnaire was 0.556 and the reliability of the full test estimated with Spearman-Brown. correction was 0.7146. The Cronbach alpha was 0.673. According to validity analysis, the correlation between the scores of items and the total scores ranged from 0.208 to 0.529 (P<0.05). Three factors were abstracted from10 questions with the principal component analysis and the contribution rate of the 3 common factors was 59.95%.

Conclusion

The simplified-Chinese-version DIQL is an acceptable and valid scale for HIV/AIDS patients with PPE. It can be used to evaluate the QoL of HIV/AIDS patients with PPE in China.