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1、1Alan H. Morris, M.D.减少错误 增加临床试验的严谨性及临床实践的一致性“人不能好于他所使用的工具”中国心衰论坛大连, 中国，2009年8月20-22日2好的科学研究结果应该可以复制(这需要一个详细的可重复的方法)临床工作和科研方法是不可复制的(需要更多变的临床判断)自1987年来，我们一直使用床旁计算机规程作为一个可复制的临床方法随后的3个图表是成人和儿科ICU及常规临床工作中血糖控制的结果血糖 (mg/dl)8 6 4 20 04080 120 160 200 240 280 320床旁计算机规程床旁纸质规程单纯指南P0.0001目标范围 % 血糖测量曲线下面积 = 10
2、0%血糖 (mg/dl)8 6 4 20 04080 120 160 200 240 280 320USA西部USA东南部USA东北部新加坡P=0.18血糖计算机规程% 血糖测量目标范围 6我们想与中国的研究者合作这项研究将把计算机规程应用到研究者的临床工作中研究者将作为出版物的合著者7临床工作中不必要的偏差和错误计算机规程将通过可重复的方法，帮助临床医生做出一致的，循证的决策% 165个诊所,15,381名门诊心衰患者接受了适当的依据指南的治疗最大值90%中数10%最小值说明:临床研究结果的范围%9临床工作中不必要的偏差和错误计算机规程将通过可重复的方法，帮助临床医生做出一致的，循证的决策1
3、0指南: “政策规则或原则的系统声明”- 告诉去哪，而不是怎样去。规程: “准确而详细的计划.医学 .问题和/或. 治疗” 告诉怎样去 。(一个十分明确的规程有充分的细节以便于不同的临床医生对同样的病人特异性的决策- 这就是一个可重复的临床决策方法) 1011王皓在比王皓在比赛中中马琳在比赛中马琳在比赛中12指南“赢得这个球”不十分明确的参数“打左角”十分明确的规程“等待回球高时，左旋用力击球， 转到对手的左侧,落在距离左侧台角1英寸内。”目标: 血压140/90 mmHg，伴最少的或没有副作用 。如果3个月后血压仍未达标，缓慢增加剂量。高血压的控制指南什么是最少的副作用？每周晕倒一次是最少吗
4、？什么是缓慢？每天，每周，每月还是每3个月？不够明确的指南样本将O2降低10%，从90%到80%保持潮气量为 540ml频率从22次/分增加到25次/分15:40采动脉血气机械通气十分明确的建议：可重复的临床决策方法标准化的决策 标准化的工作15每个推荐的参数根据病人的资料至少产生一种标准化决策每个病人有独特的数据患者的治疗 = (随时间推移，由特定患者的数据产生的标准决策)。因而计算机规程是有适应能力的(它根据患者的变化而变化)下面有3个计算机界面样本:标准化的决策 标准化的工作16机械通气参数计算机界面样本17静脉液体 / 血流动力学参数计算机界面样本血糖/胰岛素记录：成人和儿童计算机界面
5、样本我们通过这个血糖计算机规程将研究的结果应用于临床实践血糖 (mg/dl)8 6 4 20 04080 120 160 200 240 280 320ICU研究临床实践(13 个成人ICU)目标范围 % 血糖测量21好的科学需要可重复性方法临床工作中不必要的偏差和错误。计算机规程将通过可重复的方法，帮助临床医生做出一致的，循证的决策。英文版23Alan H. Morris, M.D.Reducing error - Increasing the scientific rigor of clinical experiments and the consistency of clinical c
6、are“Man is only as good as the tools he uses.”GoetheChina Heart Failure SymposiumDalian, Peoples Republic of China 20-22August0924Good science requires replication of study results (this requires a detailed reproducible method)Clinical care and research methods are not reproducible (require much var
7、iable clinician judgment).We have used bedside Computer Protocols to provide a reproducible clinical method since 1987The following 3 graphs are results for Blood Glucose control in adult and pediatric ICUs and in usual clinical careBlood Glucose (mg/dl)8 6 4 20 04080 120 160 200 240 280 320Bedside
8、Computer ProtocolBedside Paper ProtocolSimple GuidelineP0.0001TargetRange % Blood GlucoseMeasurementsArea under curve = 100%Blood Glucose (mg/dl)8 6 4 20 04080 120 160 200 240 280 320Western USASoutheast USANortheast USASingaporeP=0.18TargetRange Blood Glucose Computer Protocol% Blood GlucoseMeasure
9、ments28We seek research collaboration with investigators in the Peoples Republic of ChinaThis research will introduce computer protocols for care in the investigators clinical units.The investigators will be coauthors of publications.29Unnecessary variation and error exists in medical care.Computer
10、protocols help clinicians deliver consistent, evidence-based care with a reproducible method.% of 15,381 Heart Failure Outpatients ReceivingAppropriate Guideline-Based Treatment In 165 clinicsMaximum90% of clinicsMedian10% of clinicsMinimumLegend:Range of results bystudy clinic%31Unnecessary variati
11、on and error exists in medical careComputer protocols help clinicians deliver consistent, evidence-based care with a reproducible method.32Guideline: “A systematic statement of policy rules or principles”- tells where to go, but not how to get there.Protocol: “Precise and detailed plans for .a medic
12、al .problem and/or. therapy.” - tells how to get there.(An adequately explicit protocol has enough detail so different clinicians make the same patient-specific decision - it is a reproducible clinical decision method) 3233王皓在比王皓在比赛中中马琳在比赛中马琳在比赛中34Guideline“Win the point”Inadequately explicit protoc
13、ol“Hit the left corner”Adequately explicit protocol“Wait for a high return and hit the ball hard with a left spin, curving to the opponents left, to land within 1 inch of the left corner of the table.”Goal: Blood Pressure140/90 mmHg with minimal or no adverse effects.If after 3 months, BP not at Goa
14、l, increase dose slowly.Guideline for Controlling High Blood Pressurewhat are minimal adverse effects? Is one episode of fainting a week minimal?what is slowly? Is it an increase daily, weekly, monthly, every 3 months?Inadequately explicit guideline example(不够明确)Reduce O2 by 10% from 90 to 80%Mainta
15、in Tidal Volume at 540mlIncrease Rate from 22 to 25/minuteSample Arterial Blood at 15:40 hoursAdequately Explicit recommendations for Mechanical Ventilation: A Repro-ducible Clinical-Decision MethodStandardized Decisions Standardized Care37Each protocol recommendation produces at least one Standardi
16、zed Decision from patient data.Each patient provides unique data.Patient Care = (Standardized Decisions from unique patient data over time). The computer protocol is therefore adaptive (it responds to changes in the patient).3 computer interface examples follow: Standardized Decisions Standardized C
17、are38Mechanical Ventilation ProtocolComputer Interface Example39IV Fluid / Hemodynamic ProtocolComputerInterface Example血糖/胰岛素记录：成人和儿童ComputerInterface ExampleWe used this Blood Glucose Computer Protocol to translate our research results into Clinical PracticeBlood Glucose (mg/dl)8 6 4 20 04080 120
18、160 200 240 280 320Research ICUClinical Practice(13 Adult ICUs)TargetRange % Blood GlucoseMeasurements43Good science requires reproducible methodsUnnecessary variation and error exists in medical careComputer protocols help clinicians deliver consistent, evidence-based care with a reproducible method.
