【作者】 李文婧；

【导师】 卢祖洵；

【作者基本信息】 华中科技大学 ， 社会医学与卫生事业管理， 2008， 博士

【摘要】 研究目的近二十年来,我国医疗卫生事业处于一个空前活跃和发展的阶段,群众的经济支付能力、自主择医能力不断提高,医院管理也由粗放型经营转向注重内涵建设、构建集约型医院,其中的一个重要特征就是对医疗质量的关注。但是,由于医疗服务领域管理体制、运行机制和补偿机制上的一系列问题,多年来医院之间主要围绕着医疗技术水平而不是医疗质量和医疗服务展开竞争。尽管医疗技术水平有助于改进医疗质量,但在缺乏质量意识和服务意识的情形下,医院医疗质量的持续改进失去了内在的推动力。目前,国家、群众和患者都越来越关注医院的医疗质量,但因为医疗服务的特殊性,特别是医学知识的不对称性,外界难以正确判断医院的医疗质量。这种情形,客观上限制了群众自主择医的权利,国家也没有依据对医院实施相应的监管措施,更无法保证医疗服务系统安全有效运行。为此,急需一整套客观评价、督查医院医疗质量的方法。本次研究,将以上海市已有医疗质量评价督查指标体系和实施方法为基础,通过文献回顾、专家咨询、历史数据分析等方法,检验这套指标体系各个指标的信度和效度,并根据分析结果对指标体系和实施方法提出相应的调整建议。研究内容1、分析各个指标的内容效度、信度、督查整改能力和异常值出现原因,判断指标体系中各个指标的优劣,进而判断哪些指标是否可以直接推广、哪些需要修正指标内容、哪些需要修正督查方法、哪些需要被替换。2、分析已有指标体系中各个维度的结构效度、信度、督查整改能力,判断指标体系维度划分的优劣。3、分析已有指标体系整体的结构效度、信度、督查整改能力,判断指标体系的优劣。研究方法1.1文献回顾方法文献收集来源为中文科技期刊数据库、中国学术期刊全文数据库,Medline,中国、美国等地政府网站和相关研究网站。1.2二次资料统计分析研究报告所使用的指标数据来源于2004年下半年和2005年下半年,上海市卫生局和卫生监督所对69所二级甲等以上医院临床医疗质量和护理质量督察结果确定下来的各项指标的得分。这69所医院包括19所三级综合性医院,12所三级专科医院,30所二级甲等综合性医院,4所职工医院,4所部队医院。由于2005年对各项指标得分上限进行了调整,所以虽然临床医疗质量、护理质量的所有指标之和均为100分,但2004和2005年各指标得分上限有所差异。采用SPSS11.0软件对各项指标分值进行描述性分析、配对T检验、相关分析(信度检验)和因子分析(效度检验)。1.3专家咨询方法选择具有多年医疗质量控制和持续改进工作经验的卫生行政部门领导、医疗机构管理人员、医务人员、临床医生、护理人员为咨询对象,逐一讨论医疗质量评价指标体系维度、指标,以及指标计分方法的合理性、可操作性和改进意见。整个课题先后分四次咨询了33位资深人员,其中20位来自医院,5位来自卫生行政部门,8位来自学术研究机构。研究结果和结论1医院临床医疗工作质量评价指标1.1可以试验性推广的指标各种台帐建立情况、全院质量讲评活动、门急诊人员资质、急诊留观室管理、三级查房、疑难病例讨论、术前小结和术前讨论、术前麻醉访视、术后麻醉访视、术前谈话、输血告知、病情告知委托书、下午下班前查房制度、平均住院日、床位使用率、行政处罚情况等16项指标,具有良好的信度和督查整改效果。这些指标、指标内容和相应的督查方法可以试验性地推广到其他地区使用。1.2修正后可以推广的指标医疗工作规章制度落实程度指标,需要加强信度和抽样样本代表性,措施是增加临床医师抽考人数,至少大于4位。门急诊病历书写指标,需要加强信度和抽样样本代表性,措施是增加抽查病历数,至少大于6份,建议8份以上,并固定评审督查专家。入出院诊断符合率指标,需要加强抽样样本代表性,措施是增加终末病历抽查数,至少大于20份,建议30份以上。1.3需要补充完善后再论证的指标院科二级管理制度及落实情况指标,信度和督查整改效果较不理想。该指标的具体考核内容需要精练,削减医院内部质量管理的考核内容,使考核内容满足外部评价的要求。基本临床技能掌握指标,信度和督查整改效果均不理想。建议增加抽查的医生数量,至少大于4人,建议6人以上。同时对抽查不合格的医院,要求按照1:10的扩大样本原则选派医生参加基本临床技能培训班,即1个医生不合格,则选派10个医生参加基本临床技能培训班,实行考试通过制度,考试不通过者暂停执业资格。落实医疗纠纷登记制度和整改情况指标,信度为,督查整改效果则因为2005年督查内容有变动显示出负向效果,所以该指标应留待下一步研究继续论证。1.4可以考虑作彻底变更的指标医疗事故预防和处理指标,信度、督查整改效果很不理想,建议扩大督查年限范围,把1年时限调整为3年,或者选用其他指标反映医疗安全。1.5临床工作质量指标体系各维度论证结果医院管理评价维度,稳定性很好,复测信度为;督促整改作用不明显,属于;结构效度较好,两个公因子可解释该维度下个指标变化的56.6%。门急诊管理评价维度,稳定性一般,复测信度为;督促整改作用很明显,属于;结构效度很差,维度内四项指标反映的是四个概念。医疗环节质量评价维度,稳定性很好,复测信度为;督促整改作用明显,属于;结构效度很好,两个公因子可解释该维度下个指标变化的66.2%。医疗终末质量评价维度,稳定性非常好,复测信度为;督促整改作用不明显,属于☆;结构效度很差,维度内三项指标反映的是三个概念。医疗安全评价维度,稳定性一般,复测信度为;督促整改作用为负向效果,属于☆☆☆;结构效度很差,维度内两项指标反映的是两个概念。1.6临床医疗工作质量指标体系整体论证结果就临床医疗工作质量指标体系整体而言,稳定性一般,复测信度为;督促整改作用一般,属于;结构效度尚可,各项指标可归结为九个因子,这九个因子可解释各项指标变化的73.5%。2医院护理工作质量评价指标体系研究由于上海市护理工作质量指标体系还在变动完善阶段,缺乏完整的指标体系可供评价和指标择优。2004年和2005年所应用于实践的、名称基本一致的指标只有6个,而在这6个指标中,每个指标的内涵2005年版本比2004年版本又有所变更和改进,由此造成了指标信度和指标督查整改效果分析结果的失真。因此,拟在2006年的研究中完成护理工作质量指标体系的信度和督查整改效果论证。本次研究将侧重于护理工作质量指标体系结构效度的评价。2004年护理工作质量指标体系的八个维度中,除了“补液室工作”维度外,其他七个维度内的指标都不能聚焦于相应的维度内容。可以认为,2004年护理工作质量督查指标体系中的指标存在零乱、重复现象,需要进行精简。所以2005年起,对护理评价指标体系进行了简化处理,由8个维度36个指标精简到6个维度15个指标。2005年护理工作质量指标体系各维度结构效度较2004年版本有所提高。所形成的6个公因子中,有2个可以找到对应维度(特一级护理维度和三基考试维度),但其他维度的指标仍然存在非常明显的交叉分配现象。提示特一级护理维度和三基考试维度下指标可以推广,但其他指标仍需进一步的研究和论证3医疗、护理工作质量能为社会认知的部分医疗质量总体或各维度督查得分与社会对医院医疗质量评价得分无显著相关关系,提示医疗工作质量很难被社会、病人正确认知和比较。社会对医院医疗质量评价得分与医院等级有着密切关系,提示社会、病人主要是通过医院等级来评价医院医疗工作质量。护理工作质量能直接被社会感知的部分主要体现在急救方面,例如抢救车物品的配置。研究的创新点以往制定医疗质量评价标准更侧重于征求专家意见,或各指标能否比较全面的覆盖医疗活动,但是对指标分类的科学性和指标的有效性,缺乏充分的检验和论证。本研究的创新在于用统计的方法对医疗质量指标体系的效度和信度进行了充分的检验和论证,并提出调整意见和建议,这对医疗质量指标体系的科学性构建是一个有特色的探索。不足与需要继续开展的研究(一)不足1、由于时间、经费的局限,调查研究样本限于上海市。鉴于我国地域、经济、文化差异,难以完全代表其他地区医院医疗质量评价指标。2、限于时间和能力,本课题仅对上海市既往医院医疗质量评价现有的指标进行了分析研究,未对指标进行补充,也缺乏对筛选后指标的实际运用和验证,有待今后进一步研究。(二)建议1、扩大调查区域,并且对研究的评价指标进行进一步验证。2、因为已有的部分指标存在重复交叉、有些重要的指标缺失等问题(特别是有关患者医疗安全),所以可以经过专家咨询后,增加一些比较关键的指标然后在实践中进一步论证检验。更多还原

【Abstract】 PurposesIn last 20 years, as the undertaking of medical and health in China is in a unprecedented flourish and development stage, and the abilities of people to pay and to select doctor and hospital were increasing, management model of hospitals also experienced a change from extensive management to intensive management. One symbol about this change was that societies and hospitals paid more and more attention to medical service quality.But,In the medical service market of China, there were a series of serious problems existed in hospital administration system, hospital operation mechanism and hospital reimbursement mechanism, which make the hospitals competition mainly focus on medical techniques rather than on medical service quality.Although the improvement of medical techniques help to improve medical quality, the sustainable amelioration of hospitals’medical quality would lost the internal impetus if there was little stimulation to improving medical quality for hospitals.At present, country, people, and patient pay attention to medical quality for hospitals more and more. Because of the particularity of medical services, especially the asymmetry of medical knowledge, It is difficult to judge medical quality for hospitals for outsideness,which would result in function naturally restricting the hospital-choosing right of the public. State has no the basis of corresponding control measures to supervise hospitals, and cannot guarantee operation of medical services system in a safe and effective status. Therefore, it was urgent to develop a method to evaluate and supervise the hospitals’medical service quality.This study would employ the methods of literature review,expert consultation,historical data analysis to demonstrate the indicator system and its implemental method of medical service quality evaluation and supervision which has been implemented in Shanghai for 2 years. The major demonstrating content was reliability,validity and effectiveness to improve hospital’s medical service quality.Content1. To judge the rationality and feasibility of every indicator in the indicator system by analyzing its content validity,reliability,ability to improve medical service quality and the reason of abnormal data. Every indicator would be argued whether it could be applied in other areas directly,or it’s content should be amended,or its supervising method should be corrected,or it could be substituted.2. To judge the rationality and feasibility of every dimensionality of the indicator system by analyzing its construct validity,reliability and ability to improve medical service quality.3. To judge the rationality and feasibility of the whole indicator system by analyzing its construct validity,reliability and ability to improve medical service quality.Methods1. Data Collecting Method1.1 Literatures ReviewThe related literatures were collected from the Chinese Science and Technology Journal Database,the Chinese Academic Journal(CAJ) Full-text Database,Medine ,r elated research institutions web sites,government web sites of China,USA,etc.1.2 Secondary Data AnalysisThe indicator data in this report come from the supervision activities performed by Shanghai health bureau in 2004 and 2005. In these activities Shanghai health bureau gave score of clinical quality and nursing quality for 69 hospital according to two regulations:“The Basic Contents and Requirements of the Clinical Service Quality Management in Hospitals at and above District or County Level”and“The Basic Contents and Requirements of the Nursing Service Quality Management in Hospitals at and above District or County Level”. These 69 hospitals included 19 comprehensive hospitals and 12 specialized hospitals at municipal level,30 comprehensive hospitals at district or county level,4 enterprise hospitals and 4 military hospitals. SPSS 11.0 was used to do descriptive analysis,correlation analysis (reliability test) and factor analysis (validity analysis) .1.3 Expert ConsultationFour focus group discussions have been organized to discuss dimensionality,indicator, as well as rationality,feasibility and improving suggestions of indicator scoring. 33 experts have been consulted,20 from hospitals,5 from health bureau and 8 from academic institutions.results and conclusion1 Indicators To Evaluate Medical Treatment1.1 Indicators Which Could Be Tentatively Applied In Other Areas Indicator to reflect whether all kinds of record book have been applied in practice, The indicator to reflect the activity of medical quality comment and appraise in terms of whole hospital, Indicator to express the doctors’qualification to serve outpatients, Indicator to express the management of emergency treatment room, Indicator to express the doctor’s activity of three-tier room check, Indicator to express the discussion about specific cases, Indicator to express the brief summary and discussion prior to surgery operation, Indicator to express the visit prior to operation anaesthesia, Indicator to express the visit after operation anaesthesia, Indicator to express the conversation prior to surgery operation, The indicator to express announcement about blood transfusion, Indicator to express proxy file about illness statement announcement, Indicator to express system of room-check prior to off duty in afternoon, Indicator to express average hospitalization days of discharges Indicator to express hospital bed occupancy rate Indicator to express administrative punishment. Above indicators have good reliability and good effectiveness on supervision and behavior change. These indicators,their comment and corresponding supervision methods could be tentatively applied in other areas.1.2 Indicators Which Could Be Applied In Other Areas After Carefully RevisedIndicator to express the implementation of 39 systems about medical works should be carefully revised to improve reliability and sample representation. The major way is to increase number of examined clinic doctors,more than 4 doctors.Indicator to express the writing quality of outpatient’s record should be carefully revised to improve reliability and sample representation. The major way is to increase number of examined outpatient’s records,more than 6 records. 8 records and more would be feasible and the specialists should be fixed for the supervision of every years.Indicator to express the diagnosis consistent rate between charge and discharge should be carefully revised to improve sample representation. The major way is to increase number of examined discharge’s end-records,more than 20 records. 30 records or more would be feasible.1.3 Indicators Which Should Be Argued After Revised Indicator to express medical quality control system in terms of hospital-level and department-level has lower reliability and lower effectiveness on supervision and behavior change. The content of this indicator should be condensed. The content concerning hospital internal quality control should be wiped off and make the residual supervision content satisfy the requirement of external evaluation.Indicator to express the ability which sampled doctor grasp basic clinical techniques has lower reliability and lower effectiveness on supervision and behavior change. It suggested to increase number of examined doctor,more than 4 persons,more than 6 person would be better. Meanwhile,for those unqualified hospital,doctors who are chosen by hospital according to a sampling principle of 1:10 should be sent to attend basic clinic techniques training class. If these doctors can’t pass the class examination,they should be forbidden to practice.Indicator to express the system implementation of medical dissension recording has a reliability of. This indicator’s effect to improve quality showed adverse trend for variation of indicator’s content in 2005. Therefore,this indicator should be demonstrated in next study.1.4 Indicators Which Might Be SubstitutedIndicator to express the prevention and disposal of medical accident had lower reliability and lower effect to improve quality. Some other indicators should be considered to display medical safety.1.5 Dimensionalities of Medical Service Quality Indicator SystemDimensionality of hospital management had good stability(test-retest reliability was evaluated as),show little effect to improve quality(),has good construct validity.Dimensionality of clinic and emergency service management has ordinary stability (test-retest reliability was evaluated as),show strong effect to improve quality(),has bad construct validity.Dimensionality of process quality of medical service has good stability(test-retest reliability was evaluated as),show strong effect to improve quality(),has excellent construct validity.Dimensionality of hospital management had good stability(test-retest reliability was evaluated as),show adverse effect to improve quality(☆),has bad construct validity.Dimensionality of medical safety has ordinary stability (test-retest reliability was evaluated as),show adverse effect to improve quality(☆☆☆) ,has bad construct validity.1.6 Indicator System of Medical Service QualityThe whole indicator system of medical service quality had ordinary stability(test-retest reliability was evaluated as),show ordinary effect to improve quality(),has good construct validity. All the indicators can by reduced into 9 factors which could explain 73.5% of all the indicator’s variation.2 Indicator System To Evaluate Nursing QualityThe indicator system to evaluate nursing quality still stayed at the phase of improvement in the context of Shanghai. Research team couldn’t find integrate indicator system for evaluation and indicator optimization. The number of indicators which had the same name and put into practice in 2004 and 2005 is only 6. The content and supervision ways of 6 indicators varied much between 2004 and 2005. Therefore,there may be some distortions of study results if indicator data of 2004 and 2005 were directly used to calculate reliability and effect to improve quality. The verification of indicator’s reliability and effect to improve quality had to be further studied in 2006. This report would focus on construct validity evaluation.Indicator system of nursing service quality in 2004 had 8 dimensionalities,in which,besides those indicators in dimensionality of“transfusion room service”,indicators in other 7 dimensionalities could not reduce to relative dimensionality. It could be concluded that indicators in nursing service quality indicator system in 2004 were in chaos and should be simplified. In 2005,the indicators of nursing service quality had been condensed,from 8 dimensionalities 36 indicators to 6 dimensionalities 15 indicatorsThe construct validity of indicator system in 2005 was better than that of in indicator system 2004. Among 6 factors reduced from 15 indicators,2 factors could match with relative dimensionalities(first-level nursing service and examination of basic knowledge,basic theory and basic technique). However,indicators in other 4 dimensionalities still show the phenomenon of intercross.3 The Public Was Unable To Give Correct Judgment On A Given Hospital’S Medical And Nursing QualityThe score of all dimensionality or total indicator system had no significant relationship with the score of the public’s subjective evaluation to hospital’s medical quality,which suggested that medical quality of hospital was hard to be correctly recognized and compared for the public. The score of the public’s subjective evaluation to hospital’s medical quality has significant relationship with the level of hospital,which suggested that the public and patients mainly evaluate hospital’s medical quality by hospital’s level. What could be recognized by the public in nursing quality was emergency service,for example,devices equipment in ambulance.Research InnovationIn the past, It focused more on seeking expert advice to constitute the evaluation criteria of medical quality,or whether various indicators were a more comprehensive coverage of medical activities, However, the scientific of indicators’Categories and effective of indicators were not adequate tested and demonstrated. The innovation lies in full testing and demonstrating the validity and reliability of medical quality indicator system by Statistical methods and putting forward adjustments views and suggestions for medical quality indicators. It is a feature exploration for scientific constructing medical quality indicators.Innovative pointsShortcoming and further research neededShortcomings1、Because the time and outlay was limited, The samples of investigation was only in Shanghai. In view of our geographical, economic cultural differences , it is not entirely representative of the evaluation indicators of medical quality in the other areas’hospital.2、Because the time and ability was limited, subject only analyzed the existing evaluation indicators of hospital medical quality in Shanghai in the past, did not complete indicators,not use and validate filtered indicators,It will be researched on the future.Suggestion1、The survey regional would be expanded, and the researched evaluation indicators would be further validated. 2、Because some existed indicators were overlap and some important indicators(especially in relation to patients with medical safety)were lack, etc,after consulting experts, some key indicators would be added and then further validated in practice更多还原