Table of Contents
Author's Very Short Introduction: Minimizing Errors in Medicine xv
1 Putting Medical Error in Context: Minimizing Errors in Medicine-Beyond the "Oops!" Factor 1
Executive Summary 1
Thoughts to Think About 2
Introductory Comments: Errors as Part of Advances in Medicine 4
How to View Medical Errors Today 4
What Is Covered in This Book 6
Considering the Medical Error Problem in Light of Recent Experience 6
Medical Error and Patient Safety 9
How This Book Might Contribute to the Present State of Human Error Experience and Patient Safety 10
References 11
2 The Valued Legacy of Error and Harm in General: Error and Harm across General Human Experience in Nonmedical Domains-Welcome to Lathology 15
Executive Summary 15
Thoughts to Think About 16
Introductory Comments 17
A Brief History of Recent Human Error Experience 18
Definition of Human Error and Other Related Terms 19
Note about Heterogeneity of Terms 20
Note about Error versus Accident 20
Note regarding Error versus Adverse Effect 26
Taxonomy of Error 26
Person versus System 27
Planning versus Execution 27
Expertise, Its Quality, and Uses 28
Cognition and Cognitive Process as a Core Source of Error and of Its Understanding and Control 28
Models of Error, Their Development, and Contributing Sites and Entities in Context 30
Person-Oriented Models 30
Rasmussen's Model of Human Activity in Relation to Error 31
Person-Related Errors in the Domain of Skills, Rules, and Knowledge 33
Models of Reasoning and Decision Making Related to Informal Logic and Critical Thinking: Aristotle, Toulmin, Heuristics 33
Argument and Argumentation Models in Optimal Conditions 34
System Functioning-Oriented Models, or "One Thing Goes with and Leads to Another" 40
A Practical Example of an Erroneous Event and of Its Steps as Seen through Their Identification in Various Taxonomies of Error 41
An Epidemiological Approach to the Error Problem 42
A Word about. Root Cause Analysis and Research 44
Beyond Epidemiology: Other Models of Search for Causes 45
Epidemiological Implications of the Error Analysis Problem 46
Thought Experiment: A Complement to Epidemiology? 47
Implications in the Search for Understanding, Control and Prevention of Error Today 47
In the Research Domain 48
In the Control and Prevention Domains 49
Conclusions: Ensuing State of the Human Error Domain Today 49
References 51
3 Error and Harm in Health Sciences: Defining and Classifying Human Error and Its Consequences in Clinical and Community Settings 57
Executive Summary 57
Thoughts to Think About 58
Introductory Comments 59
Overview of Our Understanding of Error Today 60
Overview of Approaches to Error in Medicine 61
Definitions of Medical Error, Associated Entities, Terms 62
Current Definitions of Medical Error and Medical Harm 63
Associated Entities, Terms, and Their Definitions 64
Critical Incident, Error, Harm: Comments on Current Terms Used in Medical Lathology 71
Variables and Their Taxonomy in the Medical Error Domain 73
Migration of Error Taxonomy from Industry to Health Sciences: An Example 74
Medical Error and Related Factors and Variables: Other Approaches 74
Taxonomy by Types, Circumstances and Conditions, Consequences, and Corrections of Medical Error 77
Slips and Mistake-Related Taxonomy 77
Clinical Factors and Specialty-Oriented Taxonomies 80
Exhaustive and Multi-Axial Taxonomies 81
Notes about Related Variables and Contributing and Mitigating Factors 83
Note about Related Variables 84
Note about Contributing and Mitigating Factors 84
Conclusions: Implications of Definitions and Taxonomy for Research and Management of the Medical Error Domain 85
References 88
4 Describing Medical Error and Harm: Their Occurrence and Nature in Clinical and Community Settings 93
Executive Summary 93
Thoughts to Think About 94
Introductory Comments 95
Research, Knowledge Acquisition, and Intervention Strategies in the General Error Domain as Viewed by a Methodologically Minded Physician Epidemiologist 96
Descriptions of Single Cases, Small Sets of Error Cases, and Harm Cases 100
Choosing a Research or Intervention Subject 100
Reporting Unique, Infrequent, or Rare Cases beyond the Customary Methods of Clinical Practice: Case-Based Qualitative Research and Narrative Methods in the Area of Quality Improvement 103
Qualitative Research 103
Case Studies of Medical Error and Harm 105
Two Examples of Qualitative Research in Medicine and in the Domain of Medical Error 107
Reporting Single Cases of Error and Harm the "Medical" Way 108
Reporting Case Series of Error and Harm 110
Back to Epidemiology: What Happens Now? Occurrence Studies, Descriptive Epidemiology, Magnitude, and Distribution ("in Whom, Where, and When") of the Error and Harm Problem 112
A Short Epidemiological Reminder 112
Incident and Incidence 113
Risk and Hazard 114
Error and Harm Reporting in Hospital Care 114
Error and Harm Reporting in Primary Care 115
Guidelines for Describing and Reporting Medical Error and Harm Occurrence 116
Conclusion 119
References 121
5 Analyzing Medical Error and Harm: Searching for Their Causes and Consequences 127
Executive Summary 127
Thoughts to Think About 128
Introductory Comments 130
Searching for "New" (Not Yet Known) Causes and Consequences of Medical Error and Harm: Etiological Research, Analytical Observational Epidemiology 131
Challenge of Deriving Cause-Effect Relationships from One or Very Few Observations: An A Priori Causal Attribution 139
Challenges of Limited Causal Proof or Causes Yet to Be Established 139
Is It Possible to Estimate and Analyze Probabilities of Rare Events? 140
Single-Error Event or Few Error Events Reporting 142
Offbeat Searches for Causes: Siding with Mainstream Epidemiological Experience 142
Root Cause Analysis in the Health Domain 143
Other Approaches to Cause-Effect Studies in Lathology through Observational Methods 149
Causal Trees 149
Probabilistic Risk Analysis 151
Significant-Event Analysis 152
Systems Analysis: Beyond Incident Reports and Root Cause Analysis 153
Experimental Demonstration of Medical Error and Harm Causes and Its Compromises and Alternatives 155
No Experimentation or Observational Research Is Feasible? Thought Experiment ("What If" Reasoning) to the Rescue 155
A Word about Modeling in Epidemiology and Lathology 156
Is the Mainstream Epidemiological Methodology of Causal Research Feasible in the Domain of Medical Error and Harm? 157
Conclusions 158
References 161
6 Flaws in Operator Reasoning and Decision Malting Underlying Medical Error and Harm 167
Executive Summary 167
Thoughts to Think About 168
Introductory Comments 170
Note about Medical Error and Medical Harm 171
System Error versus Individual Human Error 172
Reminder regarding Some Fundamental Considerations 173
Flawed Argumentation and Reasoning as Sites and Generators of Error and Harm: Argumentation and Human Error and Harm Analysis from a Logical Perspective 175
Mistakes and Errors in Medical Lathology 178
Fallacies, Biases, and Cognitive Errors in Medical Lathology 179
Where and When Errors Occur: Cognitive Pathways as Sites of Error 181
Reviewing Diagnoses: Searching for Errors in the Clinimetric Process 182
Reviewing the: Path from Diagnosis to Treatment Decisions and Orders 188
Reviewing Decisions as Sources of Error and Harm 188
Reviewing Actions as Sources of Error and Harm 190
Obtaining Results and Evaluating Their Impact 192
Errors in Making Prognoses 193
Follow-up, Surveillance, Forecasting-Related Errors 194
Conclusions 195
References 199
7 Prevention, Intervention, and Control of Medical Error and Harm: Clinical Epidemiological Considerations of Actions and Their Evaluation 203
Executive Summary 203
Thoughts to Think About 204
Introductory Comments, Interventions in the Medical Error Domain 206
Basic Definitions, Concepts, and Strategies of Intervention in Lathology 207
Two Complementary Strategies: Human Error and System Failures 209
Evaluation of Activities in Lathology 210
Control of Medical Error and Harm 211
Prevention of Medical Error and Harm 211
Protection of Freedom from Medical Error and Harm 212
Promotion of Freedom from Medical Error and Harm 212
Basic Angles of Evaluation in Lathology: Structure, Process, Outcomes, and Other Subjects to Evaluate 212
What Should Be Evaluated at the Individual Level: Knowledge, Attitudes, and Skills 213
Experimental, Quasi-Experimental, and Nonexperimental Evaluation of Interventions to Understand and Better Control Medical Error and Harm Problems 215
Randomized or Otherwise Controlled Clinical Trials 216
Natural Experiment 217
Before-After Studies 219
Case Studies 220
Healthcare Failure Mode and Effect Analysis (HFMEA) 221
Systematic Reviews of Evidence 225
Conclusions and Recommendations 225
References 227
8 Taking Medical Error and Harm to Court: Contributions and Expectations of Physicians in Tort Litigation and Legal Decision Making 231
Executive Summary 231
Thoughts to Think About 232
Introductory Comments 234
Medical, Surgical, and Public Health Malpractice Claims and Litigation 237
Medical and Surgical Malpractice 237
Public Health Malpractice 238
Language of Medicine and Law 239
General Philosophy and Strategies of Medicine and Law 241
Law Process and Its Stages 241
Happenings and Events before the Trial 241
At the Trial 257
After the Trial 258
Cause-Effect Relationships in Medicine and Law 258
Physicians' Roles in the Judicial Search for Causes 260
Is the Causal Link under Review Strong and Specific Enough? 262
What Is Sufficient and Best Proof for Physicians and Lawyers? 262
What Do Physicians Think? 262
What Do Lawyers Think? 263
Disease versus Individual-Case Causes: Error as an Entity (in General) and in Specific Cases 265
Litigating the Argumentative Way 266
Disclosure of Medical Errors: Working in Law and Epidemiology with What Is Available 268
A Difficult Mix: Medicine, Ethics, and Law 270
Conclusions 271
References 273
Conclusions 279
A Brief and (Hopefully) Harmonized Glossary 289
Appendix A List of Cognitive Biases 309
Appendix B List of Fallacies 319
Appendix C Medical Error and Harm-Related Case Report 329
About the Author 333
Index 335