Patient safety, research, and evidence

Nearly 5 years ago, the Institute of Medicine (IOM) published its highly influential report, To Err Is Human.1 The report brought together existing data and alerted much of the health care establishment, as well as the public, to the harm thousands of patients had experienced as a result of health care. Since then, efforts to understand medical errors and reduce harm have multiplied. Three papers related to patient safety appear in this issue. Plews-Ogan et al. present their initial experience with a voluntary ambulatory error reporting system.2 Although error reports increased 20-fold during the system's second year compared with its first, researchers captured only 100 reports, a number that seems very low in light of the practice's 35,000 annual visits and the frequency of adverse events in the published literature.3,4 The system, however, highlights where the errors and near misses occur and has led to numerous interventions to prevent future errors. A second paper examines the epidemiology of hospital inpatient falls.5 Findings by Hitcho et al. highlight possible causes of falls and ways in which they can be reduced. For example, ambulatory aids were used infrequently even for patients who used them at home and during physical therapy. Higher patient-to-nurse ratios were associated with higher fall rates. While it may not be feasible to decrease the ratios because of cost, different use of staff may reduce falls. For example, increased assistance with elimination-related ambulation at night may be effective. A third paper examines safety for health care workers. Ferguson et al. asked community hospital-based employees about instances of nonadherence with universal precautions and found high rates of nonadherence with hand washing and the use of gloves.6 Remarkably high rates of exposures to needlesticks and body fluids were also documented. While some workers attributed their nonadherence to concern for their patients’ well being, other explanations included feelings that following precautions would interfere with the ability to provide care (such as during insertion of an IV), questions about the necessity for precautions, and a lack of recognition that precautions may be necessary. Less frequent explanations were lack of available equipment, stress leading to hurrying, and simply forgetting. So what do these three very different papers tell us about patient safety as a whole? First, there is still a ways to go until a culture of safety is the norm in health care institutions. Safety culture in a health care organization refers to the commitment and ability of an organization to address issues that could lead to harm for patients as well as employees and may be one of the key drivers to reduce errors rapidly.7 Critical elements of patient safety culture include attitudes supportive of voluntary reporting of adverse events and close calls, and compliance with procedures that ensure safety for both patients and employees. Second, despite considerable effort devoted to medical errors since publication of the IOM report, most of the papers in the literature still largely describe the problem rather than present effective solutions. In part, this is to be expected given that just 5 years ago, little was known about where errors were occurring and why. Establishing a knowledge base is essential for efficient design of interventions. The paucity of work on interventions also has to do with the nature of acceptable evidence. While randomized controlled trials are the gold standard for evidence-based medicine, the paradigm is not necessarily appropriate for assessing interventions to improve patient safety. In the Agency for Healthcare Research and Quality Evidence-based Practice Center report, Making Health Care Safer: A Critical Analysis of Patient Safety Practices, interventions were rated on the strength of evidence, among other criteria.8 A number of practices were not included in the analysis because of a lack of adequate evaluation using traditional assessment methods. These practices include incident reporting, application of human factors principles, and refinement of medical device alarms. In these areas, it is more appropriate to use an engineering model where small changes are implemented and evaluated by looking for their expected effects on surrogate outcomes or indicators. However, papers that look at multiple small-scale changes and their impacts are not traditionally published in the medical literature, reducing one of the prime motivators for research in this area. So, what can be done today to improve patient safety while we are waiting for evidence on effective interventions? First, we need leaders—those at the top of organizational charts as well as leaders at all levels—who are willing to make primum non nocere an active dictum. Second, we need to focus on comprehensive systems of safety rather than attempting to address safety one problem at a time. Three elements comprise comprehensive patient safety: active case finding, methodical analysis, and system redesign.9 Active case finding can be composed of a combination of voluntary reporting, record review, and automated analysis of electronic data. Some triggers, such as the use of naloxone or flumazenil, have a high specificity for adverse events and can identify errors very close to the time of their occurrence, reducing the likelihood of harm and increasing the likelihood of accurate analysis of the event. Methodical analysis entails examination of the events and factors that led to or contributed to an adverse event. While the last error is often the most obvious, usually other errors and factors contributed to the event. For example, a thorough analysis of a case in which the wrong patient underwent an electrophysiologic study identified 17 individual errors.10 System redesign refers to implementation of sustainable changes in processes. While not all change results in improvement, true improvement cannot occur without change. Expectations for safety are rising with greater awareness of the high rates of health care-associated injury and major investments in patient safety research. While we have a much better sense of where errors are occurring and why, we still have inadequate evidence about how to address threats to safety, especially at the level of systems of care. In the next few years, success will be defined by major advances rather than incremental improvements but advances require a whole new set of studies in the medical and health services literature.