Improving Diagnosis in Health Care (2015)
Chapter: Front Matter
IMPROVING |
Committee on Diagnostic Error in Health Care
Erin P. Balogh, Bryan T. Miller, and John R. Ball, Editors
Board on Health Care Services
Institute of Medicine
THE NATIONAL ACADEMIES PRESS
Washington, DC
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by Contracts HHSH25034020T and 200-2011-38807, TO#20 between the National Academy of Sciences and the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention, respectively. This study was also supported by the American College of Radiology, American Society for Clinical Pathology, Cautious Patient Foundation, College of American Pathologists, The Doctors Company Foundation, Janet and Barry Lang, Kaiser Permanente National Community Benefit Fund at the East Bay Community Foundation, and Robert Wood Johnson Foundation. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
Library of Congress Cataloging-in-Publication Data
Names: Balogh, Erin, editor. | Miller, Bryan T., editor. | Ball, John, 1944- , editor. | Institute of Medicine (U.S.). Committee on Diagnostic Error in Health Care, issuing body.
Title: Improving diagnosis in health care / Committee on Diagnostic Error in Health Care ; Erin P. Balogh, Bryan T. Miller, and John R. Ball, editors ; Board on Health Care Services, Institute of Medicine, The National Academies of Sciences, Engineering, and Medicine.
Description: Washington, DC : The National Academies Press, [2015] | Includes bibliographical references.
Identifiers: LCCN 2015041708|ISBN 9780309377690 (pbk.) | ISBN 9780309377706 (pdf)
DOI: 10.17226/21794
Subjects: | MESH: Diagnostic Errors—prevention & control—United States. | Diagnostic Techniques and Procedures—United States.
Classification: LCC RC71.5 | NLM WB 141 | DDC 616.07/50289—dc23 LC record available at http://lccn.loc.gov/2015041708
Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.
Copyright 2015 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Cover credit: LeAnn Locher & Associates.
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2015. Improving diagnosis in health care. Washington, DC: The National Academies Press.
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COMMITTEE ON DIAGNOSTIC ERROR IN HEALTH CARE
JOHN R. BALL (Chair), Executive Vice President Emeritus, American College of Physicians and American Society for Clinical Pathology
ELISABETH BELMONT, Corporate Counsel, MaineHealth
ROBERT A. BERENSON, Institute Fellow, Urban Institute
PASCALE CARAYON, Procter & Gamble Bascom Professor in Total Quality and Director, Center for Quality and Productivity Improvement, University of Wisconsin–Madison
CHRISTINE K. CASSEL, President and Chief Executive Officer, National Quality Forum
CAROLYN M. CLANCY, Chief Medical Officer, Veterans Health Administration, Department of Veterans Affairs
MICHAEL B. COHEN, Medical Director, Anatomic Pathology and Oncology Division, ARUP Laboratories; Professor and Vice Chair for Faculty Development, Ombudsperson, Health Sciences Center, University of Utah School of Medicine
PATRICK CROSKERRY, Professor of Emergency Medicine and Director, Critical Thinking Program, Dalhousie University Medical School, Dalhousie University
THOMAS H. GALLAGHER, Professor and Associate Chair, Department of Medicine; Director, Hospital Medicine and Center for Scholarship in Patient Care Quality and Safety, University of Washington
CHRISTINE A. GOESCHEL, Assistant Vice President, Quality, MedStar Health
MARK L. GRABER, Senior Fellow, RTI International
HEDVIG HRICAK, Chair, Department of Radiology, Memorial Sloan Kettering Cancer Center
ANUPAM B. JENA, Associate Professor of Health Care Policy and Medicine, Harvard Medical School
ASHISH K. JHA, K.T. Li Professor of International Health and Director, Harvard Global Health Institute, Harvard T.H. Chan School of Public Health
MICHAEL LAPOSATA, Professor and Chair, Department of Pathology, University of Texas Medical Branch at Galveston
KATHRYN McDONALD, Executive Director and Senior Scholar, Center for Health Policy and Center for Primary Care and Outcomes Research, Stanford University
ELIZABETH A. McGLYNN, Director, Center for Effectiveness and Safety Research, Kaiser Permanente
MICHELLE ROGERS, Associate Professor, College of Computing and Informatics, Drexel University
URMIMALA SARKAR, Associate Professor of Medicine, University of California, San Francisco
GEORGE E. THIBAULT, President, Josiah Macy Jr. Foundation
JOHN B. WONG, Chief, Division of Clinical Decision Making, Tufts Medical Center
Study Staff
ERIN BALOGH, Study Director
BRYAN MILLER, Research Associate (from August 2014)
SARAH NAYLOR, Research Associate (until August 2014)
KATHRYN GARNHAM ELLETT, Research Associate (from April 2015 to July 2015)
CELYNNE BALATBAT, Research Assistant (until June 2015)
PATRICK ROSS, Research Assistant (from April 2015)
LAURA ROSEMA, Christine Mirzayan Science and Technology Policy Graduate Fellow (from January to April 2014)
BEATRICE KALISCH, Nurse Scholar in Residence (until August 2014)
PATRICK BURKE, Financial Associate
ROGER HERDMAN, Director, Board on Health Care Services (until June 2014)
SHARYL NASS, Director, Board on Health Care Services (from June 2014); Director, National Cancer Policy Forum
Reviewers
This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:
SUZANNE BAKKEN, Columbia University
DONALD BERWICK, Institute for Healthcare Improvement
PAUL CHANG, University of Chicago Hospitals
JAMES J. CIMINO, University of Alabama at Birmingham
SARA J. CZAJA, University of Miami Miller School of Medicine
GURPREET DHALIWAL, University of California, San Francisco, and San Francisco Veterans Affairs Medical Center
TEJAL GANDHI, National Patient Safety Foundation
HELEN HASKELL, Mothers Against Medical Error
JOHN M. HICKNER, University of Illinois at Chicago
MICHELLE MELLO, Stanford Law School
JEFFREY MEYERS, University of Michigan
MARGARET E. O’KANE, National Committee for Quality Assurance
GORDON SCHIFF, Brigham and Women’s Hospital and Harvard Medical School
SUSAN SHERIDAN, Patient-Centered Outcomes Research Institute
HARDEEP SINGH, Houston Veterans Affairs Health Services Research Center for Innovations, Michael E. DeBakey Veterans Affairs Medical Center, and Baylor College of Medicine
BRIAN R. SMITH, Yale University School of Medicine
LAURA ZWAAN, Erasmus Medical Center
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by BRADFORD H. GRAY, Editor Emeritus, The Milbank Quarterly, Senior Fellow, Urban Institute, and KRISTINE GEBBIE, Flinders University School of Nursing and Midwifery, Adelaide, South Australia. They were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
Acknowledgments
We thank the following individuals who spoke at the committee’s meetings:
Bibb Allen, American College of Radiology
Leonard Berlin, Skokie Hospital, Rush Medical College, University of Illinois
Barbara Brandt, National Center for Interprofessional Practice and Education, University of Minnesota
David Classen, Pascal Metrics and University of Utah School of Medicine
Gurpreet Dhaliwal, University of California, San Francisco, and San Francisco Veterans Affairs Medical Center
Paul Epner, Society to Improve Diagnosis in Medicine
Tejal Gandhi, National Patient Safety Foundation
Emmy Ganos, Robert Wood Johnson Foundation
David Gross, College of American Pathologists
Kerm Henriksen, Agency for Healthcare Research and Quality
Devery Howerton, Centers for Disease Control and Prevention
Heidi Julavits, Columbia University
Allen Kachalia, Brigham and Women’s Hospital, Harvard Medical School, and Harvard School of Public Health
Michael Kanter, Kaiser Permanente
Jerome Kassirer, Tufts University School of Medicine
Steven Kroft, American Society for Clinical Pathology
Michael Millenson, Cautious Patient Foundation
Elizabeth Montgomery, Cautious Patient Foundation
Jeffrey Myers, University of Michigan
David E. Newman-Toker, Johns Hopkins University School of Medicine
Harold Pincus, New York–Presbyterian Hospital, Columbia University, and RAND Corporation
Donald Redelmeier, University of Toronto
Eduardo Salas, University of Central Florida
Nadine Sarter, University of Michigan
Gordon Schiff, Brigham and Women’s Hospital and Harvard Medical School
Hardeep Singh, Houston Veterans Affairs Health Services Research Center for Innovations, Michael E. DeBakey Veterans Affairs Medical Center, and Baylor College of Medicine
Stephen Teret, Johns Hopkins University
Eric Thomas, University of Texas Houston Medical School
Robert Trowbridge, Maine Medical Center and Tufts University School of Medicine
David Troxel, The Doctors Company Foundation
We would also like to thank a number of individuals who submitted written input or provided public comments at the committee meetings that informed the committee’s deliberations. These individuals included:
Melissa Anselmo, OpenNotes
Signall Bell, OpenNotes
Ann Bisantz, University at Buffalo
Dennis Boyle, COPIC
John E. Brush, Jr., Eastern Virginia Medical School and Sentara Healthcare, Norfolk, Virginia
Tom Delbanco, OpenNotes
Gerri Donohue, Physicians’ Reciprocal Insurers
Steven J. Durning, Uniformed Services University of the Health Sciences
Gary Klein, MacroCognition
Alan Lembitz, COPIC
George Lundberg, Medscape
David L. Meyers, American College of Emergency Physicians
Harold Miller, Center for Healthcare Quality and Payment Reform
Geoff Norman, McMaster University
Carolyn Oliver, Cautious Patient Foundation
Frank Papa, University of North Texas Health Science Center
P. Divya Parikh, PIAA
W. Scott Richardson, GRU/UGA Medical Partnership Campus
Meredith Rosenthal, Harvard School of Public Health
Alan Schwartz, University of Illinois, Chicago
Dana Siegal, CRICO
Olle ten Cate, University Medical Center Utrecht
Bill Thatcher, Cautious Patient Foundation
Bill Thorwarth, American College of Radiology
David Troxel, The Doctors Company
Jan Walker, OpenNotes
Saul Weiner, University of Illinois, Chicago, Jesse Brown Veterans Affairs Medical Center
David Wennberg, Northern New England Accountable Care Collaborative
Funding for the study was provided by the Agency for Healthcare Research and Quality, the American College of Radiology, the American Society for Clinical Pathology, the Cautious Patient Foundation, the Centers for Disease Control and Prevention, the College of American Pathologists, The Doctors Company Foundation, Janet and Barry Lang, Kaiser Permanente National Community Benefit Fund at the East Bay Community Foundation, and the Robert Wood Johnson Foundation. The committee appreciates the support extended by these sponsors for the development of this report.
We would also like to thank the individuals who shared their experiences with diagnosis in the dissemination video: Sue, Jeff, and Carolyn.
Finally, many within the National Academies of Sciences, Engineering, and Medicine were helpful to the study staff. We would like to thank Clyde Behney, Chelsea Frakes, Greta Gorman, Laurie Graig, Julie Ische, Nicole Joy, Ellen Kimmel, Katye Magee, Fariha Mahmud, Abbey Meltzer, Jonathan Phillips, and Jennifer Walsh.
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Preface
Fifteen years ago, in its landmark report To Err Is Human: Building a Safer Health System, the Institute of Medicine (IOM) dramatically exposed the issue of patient safety in health care. Stating the obvious—that human beings make errors—but highlighting the theretofore rarely discussed fact that those of us in health care also make errors, the report began a quiet revolution in the way in which health care organizations address the safety and quality of care. This report, Improving Diagnosis in Health Care, is a follow-up to the earlier report and the most recent in the IOM’s Quality Chasm Series. This report has three major themes.
First, Improving Diagnosis in Health Care exposes a critical type of error in health care—diagnostic error—that has received relatively little attention since the release of To Err Is Human. There are several reasons why diagnostic error has been underappreciated, even though the correct diagnosis is a critical aspect of health care. The data on diagnostic error are sparse, few reliable measures exist, and often the error is identified only in retrospect. Yet the best estimates indicate that all of us will likely experience a meaningful diagnostic error in our lifetime. Perhaps the most significant contribution of this report is to highlight the importance of the issue and to direct discussion among patients and health care professionals and organizations on what should be done about this complex challenge.
Second, patients are central to the solution. The report defines diagnostic error from the patient’s viewpoint as “the failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient.” The report’s first goal
centers on the need to establish partnerships with patients and their families to improve diagnosis, and several recommendations aim to facilitate and enhance such partnerships.
Third, diagnosis is a collaborative effort. The stereotype of a single physician contemplating a patient case and discerning a diagnosis is not always true; the diagnostic process often involves intra- and interprofessional teamwork. Nor is diagnostic error always due to human error; often, it occurs because of errors in the health care system. The complexity of health and disease and the increasing complexity of health care demands collaboration and teamwork among and between health care professionals, as well as with patients and their families.
In addition to these major themes, the report highlights several key issues that must be addressed if diagnostic errors are to be reduced:
- Health care professional education and training does not take fully into account advances in the learning sciences. The report emphasizes training in clinical reasoning, teamwork, and communication.
- Health information technology, while potentially a boon to quality health care, is often a barrier to effective clinical care in its current form. The report makes several recommendations to improve the utility of health information technology in the diagnostic process specifically and the clinical process more generally.
- There are few data on diagnostic error. The report recommends, in addition to specified research, the development of approaches to monitor the diagnostic process and to identify, learn from, and reduce diagnostic error.
- The health care work system and culture do not sufficiently support the diagnostic process. Echoing previous IOM work, the report also recommends the development of an organizational culture that values open discussion and feedback on diagnostic performance.
- In addition, the report highlights the increasingly important role of radiologists and pathologists as integral members of the diagnostic team.
There were also areas where the committee that developed the report wished we could go further but found that there are insufficient data currently to support strong recommendations. One of those areas is the payment system, now evolving from fee-for-service to more value- and population-based. Research on the effects of novel payment systems on diagnosis is sorely needed. Another area is that of medical liability. The report recommends the adoption of communication and resolution programs as a key lever to improve the disclosure of diagnostic errors to
patients and to facilitate improved organizational learning from these events. However, other approaches for the resolution of medical injuries, such as safe harbors for the adherence to evidence-based clinical practice guidelines and administrative health courts, hold promise. More needs to be known of their effect on the diagnostic process, and the report recommends demonstration projects to expand the knowledge base in these areas.
A final area of potential controversy is the measurement of diagnostic errors for public reporting and accountability purposes. The committee believed that, given the lack of an agreement on what constitutes a diagnostic error, the paucity of hard data, and the lack of valid measurement approaches, the time was simply not ripe to call for mandatory reporting. Instead, it is appropriate at this time to leverage the intrinsic motivation of health care professionals to improve diagnostic performance and to treat diagnostic error as a key component of quality improvement efforts by health care organizations. Better identification, analysis, and implementation of approaches to improve diagnosis and reduce diagnostic error are needed throughout all settings of care.
As chair of the committee, I thank all of the members of the committee for their individual and group contributions. I am grateful for the time, energy, and diligence, as well as the diversity of experience and expertise, they all brought to the process. When a diverse group of good people with good intent come together for a common purpose, the process is richer and more enjoyable, and the product more likely to be worthwhile. None of the work of the committee would have been possible without the professional IOM staff, led by the study director, Erin Balogh. Both personally and on behalf of the committee, I thank them for a truly collaborative, incredibly responsive, and productive process.
John R. Ball
Chair
Committee on Diagnostic Error in Health Care
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Contents
Origin of Task and Committee Charge
Examples of Diagnosis and Diagnostic Errors
Overview of the Diagnostic Process
Important Considerations in the Diagnostic Process
Clinical Reasoning and Diagnosis
The Diagnostic Evidence Base and Clinical Practice
3 OVERVIEW OF DIAGNOSTIC ERROR IN HEALTH CARE
Definition of Diagnostic Error
Overutilization in the Diagnostic Process and Overdiagnosis
The Diagnostic Process as a Team Endeavor
Patient Engagement in Diagnosis
Health Care Professional Education and Training
5 TECHNOLOGY AND TOOLS IN THE DIAGNOSTIC PROCESS
Design of Health IT for the Diagnostic Process
Safety of Health IT in Diagnosis
Organizational Learning to Improve Diagnosis
Organizational Characteristics for Learning and Improved Diagnosis
A Supportive Work System to Facilitate Diagnosis
7 THE EXTERNAL ENVIRONMENT INFLUENCING DIAGNOSIS: REPORTING, MEDICAL LIABILITY, AND PAYMENT
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Boxes, Figures, and Tables
BOXES
S-1 Goals for Improving Diagnosis and Reducing Diagnostic Error
1-1 Charge to the Committee on Diagnostic Error in Health Care
1-2 Patient and Family Experiences with Diagnosis
2-2 Laboratory Medicine, Anatomic Pathology, and Medical Imaging
2-4 Models of Clinical Reasoning
2-5 Individual Characteristics That Influence Clinical Reasoning
2-6 Examples of Probabilistic (Bayesian) Reasoning
3-1 Types of Errors Described in To Err Is Human: Building a Safer Health System
3-2 Overutilization of Diagnostic Testing
4-1 Principles of Team-Based Health Care
4-2 Suggested Actions for Nurses to Improve Diagnosis and Reduce Diagnostic Error
4-3 Challenges to Effective Patient and Family Engagement in the Diagnostic Process
4-5 Smart Partners About Your Health
4-6 Attributes of Health Literate Health Care Organizations
5-1 Recommendations from Health IT and Patient Safety: Building a Safer Health System
5-4 A Case of Diagnostic Error: Delayed Diagnosis of Ebola Virus Infection
6-1 Characteristics of a Continuously Learning Health Care Organization
6-2 Characteristics of Effective Feedback Interventions
6-3 Important Cultural Values for Continuously Learning Health Care Systems
6-4 A CEO Checklist for High-Value Health Care
7-1 Description of Alternative Approaches to the Medical Liability System
7-2 Payment and Care Delivery Reforms and Their Potential Impact on Diagnosis
8-1 Potential Areas of Research
9-1 Goals for Improving Diagnosis and Reducing Diagnostic Error
FIGURES
S-2 The work system in which the diagnostic process takes place
S-3 The outcomes from the diagnostic process
2-1 The committee’s conceptualization of the diagnostic process
2-2 The dual process model of diagnostic decision making
2-3 Calibration in the diagnostic process
2-4 Number of journal articles published on health care topics per year from 1970 to 2010
3-1 Outcomes from the diagnostic process
3-2 Places in the diagnostic process where failures can occur that contribute to diagnostic errors
4-3 An example of diagnostic teamwork and the potential participants in the diagnostic process
TABLES
2-2 Examples of Heuristics and Biases That Influence Decision Making
3-1 Methods for Estimating the Incidence of Diagnostic Errors
3-2 Methods for Detecting Failures Across the Diagnostic Process
3-3 Methods for Assessing the Effect of the Work System on Diagnostic Errors
5-1 Opportunities to Reduce Diagnostic Error Through Electronic Clinical Documentation
| AAFP | American Academy of Family Physicians |
| ABMS | American Board of Medical Specialties |
| ACGME | Accreditation Council for Graduate Medical Education |
| ACO | accountable care organization |
| ACR | American College of Radiology |
| AHRQ | Agency for Healthcare Research and Quality |
| AMA | American Medical Association |
| ANTS | Anesthetists’ Non-Technical Skills |
| AOA | American Osteopathic Association |
| APN | advanced practice nurse |
| ASCP | American Society for Clinical Pathology |
| CAD | computer-aided detection |
| CAP | College of American Pathologists |
| CBE | competency-based evaluation |
| CCNE | Commission on Collegiate Nursing Education |
| CDC | Centers for Disease Control and Prevention |
| CDS | clinical decision support |
| CEO | chief executive officer |
| CLIA | Clinical Laboratory Improvement Amendments |
| CLIAC | Clinical Laboratory Improvement Advisory Committee |
| CMS | Centers for Medicare & Medicaid Services |
| CPG | clinical practice guideline |
| CPT | current procedural terminology |
| CRP | communication and resolution program |
| CT | computed tomography |
| DMT | diagnostic management team |
| DOD | Department of Defense |
| DRG | diagnosis-related group |
| DSM | Diagnostic and Statistical Manual of Mental Disorders |
| E&M | evaluation and management |
| ED | emergency department |
| EHR | electronic health record |
| EKG | electrocardiogram |
| FDA | Food and Drug Administration |
| FFS | fee-for-service |
| FMEA | failure mode and effects analysis |
| GABHS | Group A β-hemolytic streptococcus |
| GME | graduate medical education |
| health IT | health information technology |
| HFAP | Healthcare Facilities Accreditation Program |
| HHS | Department of Health and Human Services |
| HIMSS | Healthcare Information Management Systems Society |
| HIV | human immunodeficiency virus |
| HRO | high reliability organization |
| ICD | International Classification of Diseases |
| IOM | Institute of Medicine |
| IPU | integrated practice unit |
| IVD | in vitro diagnostic test |
| LCME | Liaison Committee on Medical Education |
| LDT | laboratory developed test |
| LOINC | Logical Observation Identifiers Names and Codes |
| M&M | morbidity and mortality |
| MACRMI | Massachusetts Alliance for Communication and Resolution following Medical Injury |
| MCAT | Medical College Aptitude Test |
| mHealth | mobile health |
| MI | myocardial infarction |
| MIPPA | Medicare Improvements for Patients and Providers Act |
| MOC | maintenance of certification |
| MQSA | Mammography Quality Standards Act |
| MRI | magnetic resonance imaging |
| NCQA | National Committee for Quality Assurance |
| NDC | National Drug Code |
| NIH | National Institutes of Health |
| NLM | National Library of Medicine |
| NLNAC | National League for Nursing Accrediting Commission |
| NPDB | National Practitioner Data Bank |
| NPSD | Network of Patient Safety Databases |
| ONC | Office of the National Coordinator for Health Information Technology |
| PA | physician assistant |
| PCMH | patient-centered medical home |
| PCORI | Patient-Centered Outcomes Research Institute |
| PET | positron emission tomography |
| PRI | Physician Reciprocal Insurers |
| PSO | patient safety organization |
| PSO PPC | PSO Privacy Protection Center |
| PSQIA | Patient Safety and Quality Improvement Act |
| PT | proficiency testing |
| RSNA | Radiological Society of North America |
| TeamSTEPPS | Team Strategies and Tools to Enhance Performance and Patient Safety |
| UDP | Undiagnosed Diseases Program |
| UMHS | University of Michigan Health System |
| VA | Department of Veterans Affairs |
