Measures of patient safety in developing and emerging countries: a review of the literature.

CONTEXT: The World Alliance for Patient Safety was formed to accelerate worldwide research progress towards measurably improving patient safety. Although rates of adverse events have been studied in industrialised countries, little is known about the rates of adverse events in developing and emerging countries. PURPOSE: To review the literature on patient safety issues in developing and emerging countries, to identify patient safety measures presently used in these countries and to propose a method of measurably improving patient safety measurement in these countries. METHODS: Using the Medline database for 1998 to 2007, we identified and reviewed 23 English-language articles that examined patient safety measurement in developing and emerging countries. Results Our review included 12 studies that prospectively measured patient safety and 11 studies that retrospectively measured safety. Two studies used measures of structure and the remaining used process measures, outcome measures or both. Whereas a few studies used surveys or direct observation, most studies used chart audits to measure patient safety. Most studies addressed safety at a single facility. CONCLUSIONS: Investigation of patient safety in developing and emerging countries has been infrequent and limited in scope. Establishing fundamental safe patient practices, integrating those processes into routine health services delivery and developing patients' expectations that such processes be present are necessary prerequisites to measuring and monitoring progress towards safe patient care in emerging and developing countries.

Sex differences in operating room care giver perceptions of patient safety: a pilot study from the Veterans Health Administration Medical Team Training Program.

BACKGROUND: Achieving a culture of safety is believed to be an important mechanism for improving patient safety. The Safety Attitudes Questionnaire (SAQ) measures provider perceptions of patient safety culture across six domains; higher scores denote more positive perceptions. Although professional differences on the SAQ have been explored, sex differences have not. METHODS: The SAQ was administered to operating room (OR) care givers at nine Department of Veterans Affairs hospitals. We determined the mean domain scores by care giver profession and sex, used analysis of variance to compare mean scores across professions, used t tests to compare mean scores between sexes and created regression models of the six patient safety domains. RESULTS: The SAQ was completed by 187 OR care givers. Older care givers were significantly more likely to report favourable perceptions of teamwork climate; surgeons were significantly more likely to report favourable perceptions of working conditions; anaesthesia providers were significantly more likely to report favourable perceptions of stress recognition but also less favourable perceptions of safety climate. Women were significantly more likely to report less favourable perceptions of job satisfaction and working conditions. CONCLUSION: This pilot study confirms previously reported profession differences in OR care giver patient safety attitudes. We also found previously unreported sex differences. Educational efforts designed to enhance patient safety should be designed so that they address such differences.

Effective interventions and implementation strategies to reduce adverse drug events in the Veterans Affairs (VA) system.

BACKGROUND: Adverse drug events (ADEs) account for considerable patient morbidity and mortality as well as legal, operational and patient care costs. In Veterans Affairs (VA) hospitals in the USA, all serious adverse events and "potential" adverse events are reviewed using root cause analysis (RCA). This study characterised RCA reports associated with ADEs to determine what actions VA RCA teams took to reduce the number or severity of ADEs, and to evaluate which actions were effective in doing so. METHODS: Every medication-related RCA submitted to the VA National Center for Patient Safety in the fiscal year 2004 (143 reports), and one medication-related aggregated RCA from each facility (111 reports covering 4834 ADEs) were reviewed and coded. Facilities were interviewed about specifics of their reports and the results of their interventions. RESULTS: The commonest classes of medication for which ADEs were reported were narcotics, chemotherapy, and diabetic and cardiovascular medications. The most common types of ADE were "wrong dose", "wrong medication", "failed to give medication", and "wrong patient". 993 actions were taken to address these ADEs, the majority (75.7%) of which were reported to be fully implemented. Improvements in equipment and improving clinical care at the bedside were associated with reports of improved outcomes (p = 0.018, and p = 0.017 respectively), and training and education were negatively correlated with reports of improved outcome (p = 0.005). Improving the process of medication order entry through the use of alerts or forcing functions was positively correlated with reports of improved outcomes (p = 0.022). Leadership support and involving staff were associated with higher implementation rates (p = 0.001 and p = 0.010, respectively). CONCLUSIONS: Changes at the bedside and improvement in equipment and computers are effective at reducing ADEs. Well-organised tracking and support from leadership and staff were characteristics of facilities successful at improving outcomes. Training without action was associated with worse outcomes.

Comparing measures of patient safety for inpatient care provided to veterans within and outside the VA system in New York.

CONTEXT: Previous studies have compared measures of patient safety for veterans using the VA system to the general population. Discrepancies in the results of those studies suggest that the choice of an appropriate comparison group is critical for accurate interpretation of results and for determining whether to take actions to address findings. We explored another method of providing consumer information by comparing the experiences of VA enrolled patients who received care in the VA to those who received care outside the VA system. OBJECTIVE: For male veterans living in New York State and enrolled in the VA healthcare system, to determine (a) whether those who obtain care outside the VA system experience different measures of patient safety than those treated within the VA system, and (b) whether cross-system comparisons of measures of patient safety among older veterans reflect those of the full age spectrum. DESIGN: Retrospective cohort analysis. SETTING: All VA and non-VA hospitals in New York State. PATIENTS: 353,570 male New York State residents who were enrolled in the VA system in 1998, 1999 or 2000. MAIN OUTCOME MEASURES: The Agency for Healthcare Research and Quality (AHRQ) has developed Patient Safety Indicators (PSIs) from hospital discharge data. To standardise these indicators across settings, AHRQ has provided software for risk-adjustment purposes so that the indicators can be compared across settings of care. We used the PSI software to calculate risk-adjusted PSI rates with 95% confidence intervals to compare veterans' inpatient care provided within and outside the VA system. RESULTS: Risk-adjusted rates for nine of 15 PSIs did not differ between care provided within and outside the VA system. However, compared with care provided outside the VA system, risk-adjusted rates of decubitus ulcer, postoperative sepsis, infection due to medical care, postoperative respiratory failure and postoperative metabolic derangement occurred at lower rates within the VA system, while death in low mortality DRGs occurred at a higher rate in the VA system. Findings for patients aged 65 and older were similar to those of the entire age spectrum. CONCLUSIONS: Using AHRQ's PSI software, male veterans in New York who obtain their inpatient care within the VA received care that was comparable with or somewhat better than those who obtained their inpatient care outside the VA. The experiences of older patients reflected those of younger patients. Given that our findings are much more similar to reported comparisons between the VA and Medicare than to comparisons between the VA and the general population, we conclude that, should system comparisons be made, choice of comparison groups will be critical to accurate interpretation of findings; however, prior to such interpretation, the validity of the PSIs must be determined within VA.

Measuring patient safety climate: a review of surveys.

OBJECTIVE: Five years ago the Institute of Medicine recommended improving patient safety by addressing organizational cultural issues. Since then, surveys measuring a patient safety climate considered predictive of health outcomes have begun to emerge. This paper compares the general characteristics, dimensions covered, psychometrics performed, and uses in studies of patient safety climate surveys. METHODS: Systematic literature review. RESULTS: Nine surveys were found that measured the patient safety climate of an organization. All used Likert scales, mostly to measure attitudes of individuals. Nearly all covered five common dimensions of patient safety climate: leadership, policies and procedures, staffing, communication, and reporting. The strength of psychometric testing varied. While all had been used to compare units within or between hospitals, only one had explored the association between organizational climate and patient outcomes. CONCLUSIONS: Patient safety climate surveys vary considerably. Achievement of a culture conducive to patient safety may be an admirable goal in its own right, but more effort should be expended on understanding the relationship between measures of patient safety climate and patient outcomes.

Relationship between tort claims and patient incident reports in the Veterans Health Administration.

OBJECTIVE: The Veterans Health Administration's patient incident reporting system was established to obtain comprehensive data on adverse events that affect patients and to act as a harbinger for risk management. It maintains a dataset of tort claims that are made against Veterans Administration's employees acting within the scope of employment. In an effort to understand the thoroughness of reporting, we examined the relationship between tort claims and patient incident reports (PIRs). METHODS: Using social security and record numbers, we matched 8260 tort claims and 32 207 PIRs from fiscal years 1993-2000. Tort claims and PIRs were considered to be related if the recorded dates of incident were within 1 month of each other. Descriptive statistics, odds ratios, and two sample t tests with unequal variances were used to determine the relationship between PIRs and tort claims. RESULTS: 4.15% of claims had a related PIR. Claim payment (either settlement or judgment for plaintiff) was more likely when associated with a PIR (OR 3.62; 95% CI 2.87 to 4.60). Payment was most likely for medication errors (OR 8.37; 95% CI 2.05 to 73.25) and least likely for suicides (OR 0.25; 95% CI 0.11 to 0.55). CONCLUSIONS: Although few tort claims had a related PIR, if a PIR was present the tort claim was more likely to result in a payment; moreover, the payment was likely to be higher. Underreporting of patient incidents that developed into tort claims was evident. Our findings suggest that, in the Veterans Health Administration, there is a higher propensity to both report and settle PIRs with bad outcomes.

Transfer of risk: "right to sue" legislation and managed care organization stock performance.

We examined whether Congress's consideration of legislation that gave consumers the right to sue managed care organizations impacted the performance of these companies' stocks relative to that of the market. For each company examined, the total return related to such legislation was negative and substantially lower than that expected from the market model; losses in market value were from 17 percent to 48 percent for individual companies and 22 percent for a capitalization-weighted portfolio. The study suggests that equity markets responded to the proposed legislation quickly and that the impact of proposed legislation is felt through loss of market value and increased corporate risk.

The organizational costs of preventable medical errors.

BACKGROUND: Preventable medical errors are associated with additional costs that tend to be borne by patients, but little is known about organizational costs associated with such errors. Two composite case studies (a fall and a delay in diagnosis) were used to identify the organizational costs of preventable medical errors. ANALYSIS: Legal, marketing, and organizational costs--direct, indirect, and long term--were associated with each of the preventable medical errors. A model was generated to examine the theoretical relationship between the costs and four determinants of corporate performance--price, wages, cost of capital, and efficiency. DISCUSSION: Organizations may also have a financial incentive to improve patient safety, for beyond patient and societal costs, preventable medical errors appear to account for significant legal, marketing, and operational costs for the organizations that deliver health care. Some of these costs are not so much the cost of the error but the costs of organizational responses to the error. Three broad areas of inquiry could be used to test the model and improve our understanding of the organizational costs of errors: market response to patient safety interventions, before/after studies of interventions, and case-control studies. SUMMARY AND CONCLUSION: Health care leaders have a moral imperative to implement systems that reduce medical errors and improve patient safety. An understanding of the costs associated with medical errors may help leaders understand the importance of patient safety from a financial perspective, develop measures to evaluate the impact of patient safety initiatives, and efficiently allocate resources to address this important health concern.

The development of a survey instrument for community health improvement.

OBJECTIVE: To develop a survey instrument that could be used both to guide and evaluate community health improvement efforts. DATA SOURCES/STUDY SETTING: A randomized telephone survey was administered to a sample of about 250 residents in two communities in Lehigh Valley, Pennsylvania in the fall of 1997. METHODS: The survey instrument was developed by health professionals representing diverse health care organizations. This group worked collaboratively over a period of two years to (1) select a conceptual model of health as a foundation for the survey; (2) review relevant literature to identify indicators that adequately measured the health constructs within the chosen model; (3) develop new indicators where important constructs lacked specific measures; and (4) pilot test the final survey to assess the reliability and validity of the instrument. PRINCIPAL FINDINGS: The Evans and Stoddart Field Model of the Determinants of Health and Well-Being was chosen as the conceptual model within which to develop the survey. The Field Model depicts nine domains important to the origins and production of health and provides a comprehensive framework from which to launch community health improvement efforts. From more than 500 potential indicators we identified 118 survey questions that reflected the multiple determinants of health as conceptualized by this model. Sources from which indicators were selected include the Behavior Risk Factor Surveillance Survey, the National Health Interview Survey, the Consumer Assessment of Health Plans Survey, and the SF-12 Summary Scales. The work group developed 27 new survey questions for constructs for which we could not locate adequate indicators. Twenty-five questions in the final instrument can be compared to nationally published norms or benchmarks. The final instrument was pilot tested in 1997 in two communities. Administration time averaged 22 minutes with a response rate of 66 percent. Reliability of new survey questions was adequate. Face validity was supported by previous findings from qualitative and quantitative studies. CONCLUSIONS: We developed, pilot tested, and validated a survey instrument designed to provide more comprehensive and timely data to communities for community health assessments. This instrument allows communities to identify and measure critical domains of health that have previously not been captured in a single instrument.

Using an improvement model to reduce adverse drug events in VA facilities.

BACKGROUND: Adverse drug events cause significant morbidity and mortality in health care. Many adverse drug events are due to medication errors and are preventable. In 1999 and 2000 the Patient Safety Center of Inquiry collaborated with the Institute for Healthcare Improvement (IHI) to implement a quality improvement (QI) project designed to reduce medication errors within the Veterans Administration system. METHODS: During a 6- to 9-month period, interdisciplinary teams that want to achieve much higher levels of performance work on a common aim, under the guidance of faculty, and come together for three 2-day educational and planning sessions. Between these sessions, teams implement some of the suggested changes, measure the results of those changes, and report back to the larger group. RESULTS: During the formal project, teams collected allergy information on more than 20,000 veterans and averted 1,833 medication errors that had the potential to cause adverse events. At 6-month follow-up, the majority of teams remained intact, continued to collect data, and maintained their gains, approximately doubling the results obtained during the formal project. Half of the teams expanded their efforts to other settings, and one-third of the teams expanded beyond their original topics. Returns on investment in the QI effort were substantial. CONCLUSIONS: The results suggest that gains made in organized QI efforts can be maintained for 6 months without additional external support or coaching if team structure and leadership support remain intact. Facilitators of QI efforts should focus on teams that are having difficulty learning new techniques. Finally, this effort appeared to generate cost savings.

Thiamine treatment of chronic hepatitis B infection.

OBJECTIVE: Chronic hepatitis B is an international health concern that causes cirrhosis, hepatocellular carcinoma, liver failure, and death. Current treatment options are expensive and associated with side effects; however, indirect evidence suggests a relationship between relative thiamine deficiency and chronic hepatitis B infection. METHODS: The authors present three case studies wherein multiple crossovers of daily thiamine administration were used to evaluate a hypothesized association between thiamine treatment and aminotransferase levels. RESULTS: In each case study, thiamine administration was associated with reduction in aminotransferase levels and the fall of HBV DNA to undetectable levels. Analyses by t test demonstrated a statistically significant reduction in aminotransferase levels in all three cases. CONCLUSIONS: The relationship between thiamine administration and chronic hepatitis B infection warrants further study. If proven effective in reducing liver damage or inducing remission of the hepatitis B virus in larger trials, thiamine will offer obvious advantages over the current treatments for chronic viral hepatitis B infection.

Using the Baldrige management system framework in health care: the Veterans Health Administration experience.

BACKGROUND: In 1998 the Veterans Health Administration (VHA) developed the Quality Achievement Recognition Grant, a competitive grant application open to all Veterans Integrated Service Networks (VISNs) within the VHA system and based on the Baldrige management framework. Eight of the 22 VISNs attended the educational programs and initiated the grant application process; 7 completed applications. Team award experts from VHA and external sources reviewed, scored, and wrote feedback reports to all applicants and conducted four site visits. IDENTIFICATION OF BEST PRACTICES AND RECOMMENDATIONS FOR FUTURE APPLICANTS: Each application was compared to examples of ideal applications to identify areas of excellence and areas for improvement. In general, the best applicants identified and described key processes and articulated the methods used to evaluate and improve processes. For example, they were able to identify the process used to incorporate key constituents into the strategy development process. One applicant developed a series of management advisory committees, the membership of which includes veterans' service organizations, academic affiliates, community members, and congressional delegates, which were tapped to develop a strategic plan. Leading applicants in the future are likely to be able to demonstrate evidence of deployment and constant review of the strategy and to emphasize the human resources plan into the strategic planning and deployment. CONCLUSIONS: The Baldrige management framework is a useful tool for identification of areas of achievement and areas for improvement within the VHA. Potential applicants for the award could benefit from ensuring coherence across the application, placing a greater emphasis on work systems, and incorporating more extensive analysis of market conditions.

Using early clinical experiences to integrate quality-improvement learning into medical education.

Health care providers are delivering care in an increasingly complex environment; this requires that providers develop new competencies to better understand their work and to design changes that can help them succeed. Recognizing these new educational requirements, Dartmouth Medical School created a model two-pronged program for teaching quality improvement to its medical students. The goal of the program is to provide students with an active learning experience as well as an education in the theory and application of continuous quality improvement. The program includes two educational experiences: one curriculum is for all medical students and the other is for selected, highly motivated students. The first curriculum is incorporated in Dartmouth's required "On Doctoring" course, in which students spend time with community-based physician preceptors. The quality-improvement curriculum is designed around an improvement project developed at the students' preceptor sites. The second curriculum for students with a special interest in quality improvement is offered as an elective summer program between the first and second years of medical school. Working in groups of two, students identify an area for improvement within a preceptor's practice, assist the practice in articulating an improvement plan, help implement that plan, and write up their experiences. The authors describe the two curricula, factors associated with their successful implementation, and lessons learned.

Developing a culture of safety in the Veterans Health Administration.

CONTEXT: Weaving patient safety into the fabric of clinical activities is an increasingly important aspect of medical care. OBJECTIVE: To detail the steps taken by the Veterans Health Administration (VHA) to integrate patient safety into its organizational structure. DESIGN: Descriptive study. SETTING: VHA. DATA SOURCES: VHA documents, congressional testimony, the medical literature, the general press, and personal communications. RESULTS: The VHA leadership has taken steps to promote a culture of safety by making public commitments to improving patient safety, allocating resources toward establishment of special centers, enhancing employee education on patient safety, and providing incentives to promote safety. The VHA is also establishing one mandatory and one voluntary adverse event reporting system; in the latter case, the reporter remains anonymous. Examples of nationally mandated initiatives are bar coding of all medications and use of computerized medical record that includes order entry, laboratory and imaging results, and all encounter notes. CONCLUSIONS: The VHA's initial efforts may serve as a template for other health care organizations that wish to engineer a culture of safety. Although progress has been made, patient safety efforts require constant attention to guard against becoming a new bureaucracy or simply window dressing.

Complications of warfarin therapy: causes, costs, and the role of the anticoagulation clinic.

CONTEXT: Anticoagulation with warfarin requires careful management to avoid hemorrhage or thrombosis. The anticoagulation clinic has been suggested as a mechanism to reduce complications related to anticoagulation. OBJECTIVE: To report our experience with anticoagulation complications, the cost of subsequent care, and the role of the anticoagulation clinic. DESIGN: Sequential patients who were receiving warfarin within a period of 4 months were followed to identify warfarin-related adverse events. An independent examiner reviewed medical records to determine whether events were preventable and to identify possible causes. Hospital-based accounting data were used to determine attributable costs. PATIENTS: 306 patients who received warfarin prescriptions at a rural Vermont university-affiliated VA hospital with an established anticoagulation clinic. RESULTS: 91% (278) of patients received follow-up at the anticoagulation clinic, and the remaining 9% (28) were followed by VA physicians without involving the anticoagulation clinic. A total of 12 patients had adverse events associated with either sub- or supratherapeutic international normalized ratios, with an attributable cost of approximately $90,000; 8 of these patients were not enrolled in the anticoagulation clinic. Thus, the estimated relative risk for adverse events for patients not at the clinic, compared with those who were, was almost 20 (95% CI, 6.4 to 61.8). Review of the remaining 4 patients revealed that their problems were attributable either to missed appointments or lack of coordination between other providers and the anticoagulation clinic. CONCLUSIONS: Establishing an anticoagulation clinic is only the first step toward reducing complications related to anticoagulation. The larger challenge is ensuring that patients use the anticoagulation clinic and that providers communicate with it. Our results suggest that our institution could invest considerable resources to meet this challenge and still save money.

This practice is sick: a teaching case.

A case history of a family practice illustrates some of the difficulties of providing health care in an era of changing economic realities. Although some of the problems appear obvious and easily solved, the physicians in the practice may well be hesitant to invest more time in its operation, despite recognition that such an investment would pay off.

Improving patient care in a changing environment: a teaching case.

In previous articles in this issue, other authors have detailed many issues regarding how to improve care for a geriatric population. However, those analyses were done based on survey data that are often difficult to translate into the setting of an actual practice. This article presents a case study of Bob Collins, MD, a practicing geriatrician whose life is altered dramatically as external pressures from the health care system force him to make changes in his practice. It concludes with an analysis of how Dr. Collins could improve his practice life and the care he delivers by considering the perspectives of his patients, his coworkers, and his organization.

Advance directives and the cost of terminal hospitalization.

BACKGROUND: It has been assumed that patients using advance directives would direct terminal care away from the intensive care unit and choose shorter, less costly, less technological terminal hospital stays. METHODS: This retrospective cohort study examined 336 consecutive patients who died in a university tertiary care medical center: 242 without advance directives, 66 with a previously completed advance directive, 13 admitted for the express purpose of terminal care, and 15 who signed an advance directive during their terminal hospitalization. Total charges (hospital and physician) were calculated for all patients and were adjusted using both physician and hospital diagnosis-related group weights. Patient participation in end-of-life decisions was determined by chart review. RESULTS: The group without advance directives had dramatically higher mean total ($49,900 vs $31,200) terminal hospitalization charges than the group with previously completed advance directives, producing a charge ratio of 1.6. After diagnosis-related group adjustment, the charge ratio was 1.35 (95% confidence interval, 1.07 to 1.72) for physician charge, 1.36 (95% confidence interval, 1.06 to 1.74) for hospital charge, and 1.35 (95% confidence interval, 1.08 to 1.73) for total charge. Multiple regression analysis controlling for age, sex, and cancer diagnosis confirmed these findings. Patients with advance directives were significantly more likely to limit treatment and to participate in end-of-life decisions. CONCLUSION: Patients without advance directives have significantly higher terminal hospitalization charges than those with advance directives. Our investigation suggests that the preferences of patients with advance directives are to limit care and these preferences influence the cost of terminal hospitalization.