Making Health Care Safer: a Critical Analysis of Patient Safety Practices
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Evidence Report/Technology Assessment Number 43 Making Health Care Safer: A Critical Analysis of Patient Safety Practices Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 2101 East Jefferson Street Rockville, MD 20852 www.ahrq.gov Contract No. 290-97-0013 Prepared by: University of California at San Francisco (UCSF)–Stanford University Evidence-based Practice Center Editorial Board Kaveh G. Shojania, M.D. (UCSF) Bradford W. Duncan, M.D. (Stanford) Kathryn M. McDonald, M.M. (Stanford) Robert M. Wachter, M.D. (UCSF) Managing Editor Amy J. Markowitz, JD Robert M. Wachter, MD Project Director Kathryn M. McDonald, MM UCSF–Stanford EPC Coordinator AHRQ Publication 01-E058 July 20, 2001 (Revised printing, indexed) ii Preface The Agency for Healthcare Research and Quality (AHRQ), formerly the Agency for Health Care Policy and Research (AHCPR), through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. We welcome written comments on this evidence report. They may be sent to: Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 6010 Executive Blvd., Suite 300, Rockville, MD 20852. John M. Eisenberg, M.D. Douglas B. Kamerow, M.D. Director Director, Center for Practice and Agency for Healthcare Technology Assessment Research and Quality Agency for Healthcare Research and Quality The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service. iv Structured Abstract Objectives: Patient safety has received increased attention in recent years, but mostly with a focus on the epidemiology of errors and adverse events, rather than on practices that reduce such events. This project aimed to collect and critically review the existing evidence on practices relevant to improving patient safety. Search Strategy and Selection Criteria: Patient safety practices were defined as those that reduce the risk of adverse events related to exposure to medical care across a range of diagnoses or conditions. Potential patient safety practices were identified based on preliminary surveys of the literature and expert consultation. This process resulted in the identification of 79 practices for review. The practices focused primarily on hospitalized patients, but some involved nursing home or ambulatory patients. Protocols specified the inclusion criteria for studies and the structure for evaluation of the evidence regarding each practice. Pertinent studies were identified using various bibliographic databases (e.g., MEDLINE, PsycINFO, ABI/INFORM, INSPEC), targeted searches of the Internet, and communication with relevant experts. Data Collection and Analysis: Included literature consisted of controlled observational studies, clinical trials and systematic reviews found in the peer-reviewed medical literature, relevant non-health care literature and “gray literature.” For most practices, the project team required that the primary outcome consist of a clinical endpoint (i.e., some measure of morbidity or mortality) or a surrogate outcome with a clear connection to patient morbidity or mortality. This criterion was relaxed for some practices drawn from the non-health care literature. The evidence supporting each practice was summarized using a prospectively determined format. The project team then used a predefined consensus technique to rank the practices according to the strength of evidence presented in practice summaries. A separate ranking was developed for research priorities. Main Results: Practices with the strongest supporting evidence are generally clinical interventions that decrease the risks associated with hospitalization, critical care, or surgery. Many patient safety practices drawn primarily from nonmedical fields (e.g., use of simulators, bar coding, computerized physician order entry, crew resource management) deserve additional research to elucidate their value in the health care environment. The following 11 practices were rated most highly in terms of strength of the evidence supporting more widespread implementation. • Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk; • Use of perioperative beta-blockers in appropriate patients to prevent perioperative morbidity and mortality; • Use of maximum sterile barriers while placing central intravenous catheters to prevent infections; v • Appropriate use of antibiotic prophylaxis in surgical patients to prevent postoperative infections; • Asking that patients recall and restate what they have been told during the informed consent process; • Continuous aspiration of subglottic secretions (CASS) to prevent ventilator-associated pneumonia; • Use of pressure relieving bedding materials to prevent pressure ulcers; • Use of real-time ultrasound guidance during central line insertion to prevent complications; • Patient self-management for warfarin (Coumadin™) to achieve appropriate outpatient anticoagulation and prevent complications; • Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in critically ill and surgical patients; and • Use of antibiotic-impregnated central venous catheters to prevent catheter-related infections. Conclusions: An evidence-based approach can help identify practices that are likely to improve patient safety. Such practices target a diverse array of safety problems. Further research is needed to fill the substantial gaps in the evidentiary base, particularly with regard to the generalizability of patient safety practices heretofore tested only in limited settings and to promising practices drawn from industries outside of health care. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. Suggested Citation: Shojania KG, Duncan BW, McDonald KM, et al., eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment No. 43 (Prepared by the University of California at San Francisco–Stanford Evidence-based Practice Center under Contract No. 290-97-0013), AHRQ Publication No. 01-E058, Rockville, MD: Agency for Healthcare Research and Quality. July 2001. vi CONTENTS Summary.........................................................................................................................1 Evidence Report .............................................................................................................9 PART I. OVERVIEW ..........................................................................................................11 Chapter 1. An Introduction to the Report..............................................................................13 1.1. General Overview .......................................................................................................13 1.2. How to Use this Report ...............................................................................................18 1.3. Acknowledgments.......................................................................................................20 Chapter 2. Drawing on Safety Practices from Outside Health Care......................................25 Chapter 3. Evidence-based Review Methodology ................................................................29 PART II. REPORTING AND RESPONDING TO PATIENT SAFETY PROBLEMS ...........................39 Chapter 4. Incident Reporting ...............................................................................................41 Chapter 5. Root Cause Analysis............................................................................................51 PART III. PATIENT SAFETY PRACTICES & TARGETS ...........................................................57 Section A. Adverse Drug Events (ADEs).................................................................................58 Chapter 6. Computerized Physician Order Entry (CPOE)