As a unified field of scholarship, patient safety dates to the late 20th century. It has its origins in several developmental strands: observational studies demonstrating that the level of avoidable adverse outcomes of care in hospitals was higher than previously realized; the pressure to do something about the high cost of medical litigation; the recognition that the concepts and methods used to assure and improve safety in other high-risk industries were applicable to healthcare but not being used; and the growing public concern that regular media reports of egregious errors suggested that history was repeating itself with no learning taking place. More than many other areas in health, the direction taken by those publishing on, and researching in, patient safety has closely followed the agenda of policy makers, healthcare system leaders, and managers of health organizations who have aimed to reduce the risks of care for patients. The emphasis has been on assessing the burden of unsafe care; establishing effective incident-reporting systems and other ways of assessing harm; understanding why things go wrong; finding effective solutions and interventions to reduce risk; engaging with patients and families; designing models for improvement; and evaluating the potential application of methods developed in other high-risk industries. Much published work expresses ideas, puts forward opinions, describes practical experiences, and makes calls for action. Official reports and other gray literature are an important part of the body of work on patient safety. Studies involving data gathering are generally observational, rather than experimental, in design. They really belong to the family of health-services research. The major journals accept relatively few studies of this genre. Moreover, some of those authors active in patient safety research are from a clinical research background and not formally trained in health-services research. As a result, studies are of variable quality and many are insufficiently interdisciplinary.
The Wider Quality of Care Context
Adverse outcomes have accompanied the delivery of healthcare through the centuries into modern times. Only their frequency and nature have changed. Academic interest in quality of care began to gather pace in the late 1960s after the classic paper Donabedian 1966, in which the author establishes a conceptual framework for considering quality: structure, process, and outcome. Interest in quality in healthcare waxed and waned during the 1970s and 1980s, with most attention being given to measurement, particularly of outcomes. The essay Lohr 1988 is representative of thinking about outcomes and their measurement at that time. It was not until the early 1990s that quality began to hit the mainstream of healthcare organization and delivery; the emphasis by then was on the quality-improvement philosophy and methods that had originally been developed in post-war Japanese industry in Deming 1982. Berwick 2008 is instrumental in setting this earlier work in a healthcare context. Much of the scholarship that accompanied the growth in payer and provider interest in quality improvement was tailored to the payers’ and providers’ needs. There are many more papers dealing with conceptual frameworks, applications, improvement models, and approaches to measurement than with rigorous evaluations of interventions and programs. A number of schools of thought have emerged within the quality of care movement—for example, lean; six sigma; and plan, do, study, act—though most have their roots in the application of Deming’s work to settings outside healthcare. It might be supposed that interest in patient safety arose from study of the outcome dimension of quality. It did not. It emerged largely from need to prevent the events that had led to costly medical litigation. Also, experts in fields of scholarship that were concerned with understanding organizational risk and accident causation began to take an academic interest in adverse events in healthcare. However, the challenge of making care safer has since been embraced by many of the same groups whose interest was in quality measurement and improvement. An essential step in advancing patient safety research and practice was the advocacy of influential medical leaders. Prominent amongst these was Leape, whose paper, Leape 1994, is widely acknowledged to have ignited the debate. So-called thought leaders have played a much more prominent part in the development of patient safety, and indeed healthcare quality more generally, than in clinical medicine. Dixon-Woods, et al. 2011 argue that too often an attitude that some action is better than nothing prompts interventions, rather than the evaluative sciences leading change.
Berwick, D. 2008. The science of improvement. Journal of the American Medical Association 299:1182–1184.
The author is arguably the world leader of quality improvement in healthcare and cofounder of the Institute for Health Improvement in Boston. He sets out the arguments for quality improvement to be a respected and mainstream activity.
Deming, W. E. 1982. Out of the crisis. Cambridge, MA: MIT.
The philosophy of the towering figure in quality improvement. The fourteen principles set out in this book helped transform post-war Japanese industry and then US manufacturing industry. The author’s work is extensively quoted and his speeches and presentations can be viewed on the Internet.
Dixon-Woods, M., R. Amalberti, S. Goodman, B. Bergman, and P. Glasziou. 2011. Problems and promises of innovation: Why health care needs to rethink its love/hate relationship with the new. BMJ Quality and Safety 20:i47–i51.
The authors argue that too often reliance is placed on some action being better than nothing, so that innovations are introduced on the basis of “magical thinking” to justify their benefits.
Donabedian, A. 1966. Evaluating the quality of medical care. Milbank Memorial Fund Quarterly 44:166–206.
A seminal paper by the founding father of healthcare quality, conceptualizing it as a triad of structure, process, and outcome. In subsequent publications, the author went on to shape thinking for several decades afterward, but his original paper is still influential.
Leape, L. L. 1994. Error in medicine. Journal of the American Medical Association 272:1851–1857.
This paper by the “grandfather” of patient safety was a turning point in attitudes in medicine and healthcare. The author argues that traditional approaches to error, using blame and punishment, should be replaced by the approach of other safety-critical industries: “Systems that rely on error-free performance are doomed to failure” (p. 1852).
Lohr, K. N. 1988. Outcome measurement: Concepts and questions. In Special issue: The challenge of quality. Edited by L. Wyszewianski. Inquiry 25:37–50.
Rigorous analysis of the challenges of outcome measurement by one of a group of North American academics who looked in depth at all aspects of healthcare quality in an era when cost containment was the driving force for change. There are many other good essays in this publication. Available online for purchase or by subscription.
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