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1、1,Alan 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 2 0,0 40 80 120 160 200 240 280 320,床旁计算机规程 床旁纸质规程 单纯指南,P0.0001,
2、目标范围,% 血糖测量,曲线下面积 = 100%,血糖 (mg/dl),8 6 4 2 0,0 40 80 120 160 200 240 280 320,USA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
3、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,10,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),10,11,王皓在比赛中,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
4、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？,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
5、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 2 0,0 40 80 120 160 200 240 280 320,ICU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,23,Alan H. Morris, M.D.,Reduc
6、ing error - Increasing the scientific rigor of clinical experiments and the consistency of clinical care,“Man is only as good as the tools he uses.” Goethe,China Heart Failure Symposium Dalian, Peoples Republic of China 20-22August09,24,Good science requires replication of study results (this requir
7、es a detailed reproducible method) Clinical care and research methods are not reproducible (require much variable clinician judgment).,We have used bedside Computer Protocols to provide a reproducible clinical method since 1987,The following 3 graphs are results for Blood Glucose control in adult an
8、d pediatric ICUs and in usual clinical care,Blood Glucose (mg/dl),8 6 4 2 0,0 40 80 120 160 200 240 280 320,Bedside Computer Protocol Bedside Paper Protocol Simple Guideline,P0.0001, Target Range,% Blood Glucose Measurements,Area under curve = 100%,Blood Glucose (mg/dl),8 6 4 2 0,0 40 80 120 160 200
9、 240 280 320,Western USA Southeast USA Northeast USA Singapore,P=0.18, Target Range,Blood Glucose Computer Protocol,% Blood Glucose Measurements,28,We seek research collaboration with investigators in the Peoples Republic of China This research will introduce computer protocols for care in the inves
10、tigators clinical units. The investigators will be coauthors of publications.,29,Unnecessary variation and error exists in medical care. Computer protocols help clinicians deliver consistent, evidence-based care with a reproducible method.,% of 15,381 Heart Failure Outpatients Receiving Appropriate
11、Guideline- Based Treatment In 165 clinics,Maximum 90% of clinics Median 10% of clinics Minimum,Legend: Range of results by study clinic,%,31,Unnecessary variation and error exists in medical care Computer protocols help clinicians deliver consistent, evidence-based care with a reproducible method.,3
12、2,Guideline: “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 medical problem and/or therapy.” - tells how to get there. (An adequately explicit protocol has enough detail so different clinicians make the
13、 same patient-specific decision - it is a reproducible clinical decision method),32,33,王皓在比赛中,马琳在比赛中,34,Guideline “Win the point”,Inadequately explicit protocol “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
14、 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 Goal, increase dose slowly.,Guideline for Controlling High Blood Pressure,what are minimal adverse effects? Is one episode of fainting a wee
15、k 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% Maintain Tidal Volume at 540ml Increase Rate from 22 to 25/minute Sample Arterial Blood at 15:40 hours,Adequately Explicit recommendatio
16、ns for Mechanical Ventilation: A Repro- ducible Clinical-Decision Method,37,Each protocol recommendation produces at least one Standardized Decision from patient data.,Each patient provides unique data. Patient Care = (Standardized Decisions from unique patient data over time). The computer protocol
17、 is therefore adaptive (it responds to changes in the patient). 3 computer interface examples follow:,Standardized Decisions Standardized Care,38,Mechanical Ventilation Protocol,Computer Interface Example,39,IV Fluid / Hemodynamic Protocol,Computer Interface Example,血糖/胰岛素记录：成人和儿童,Computer Interface
18、 Example,We used this Blood Glucose Computer Protocol to translate our research results into Clinical Practice,Blood Glucose (mg/dl),8 6 4 2 0,0 40 80 120 160 200 240 280 320,Research ICU Clinical Practice (13 Adult ICUs), Target Range,% Blood Glucose Measurements,43,Good science requires reproducible methods,Unnecessary variation and error exists in medical care Computer protocols help clinicians deliver consistent, evidence-based care with a reproducible method.,