Patient safety research: an overview of the global evidence A K Jha, 1,2,3 N Prasopa-Plaizier, 4 I Larizgoitia, 4 D W Bates, 1,2 On Behalf of the Research Priority Setting Working Group of the WHO World Alliance for Patient Safety ABSTRACT Background Unsafe medical care may cause substantial morbidity and mortality globally, despite imprecise estimates of the magnitude of the problem. To better understand the extent and nature of the problem of unsafe care, the WHO World Alliance for Patient Safety commissioned an overview of the world’s literature on patient safety research. Methods Major patient safety topics were identified through a consultative and investigative process and were categorised into the framework of structure, process and outcomes of unsafe care. Lead experts examined current evidence and identified major knowledge gaps relating to topics in developing, transitional and developed nations. The report was reviewed by internal and external experts and underwent improvements based on the feedback. Findings Twenty-three major patient safety topics were examined. Much of the evidence of the outcomes of unsafe care is from developed nations, where prevalence studies demonstrate that between 3% and 16% of hospitalised patients suffer harm from medical care. Data from transitional and developing countries also suggest substantial harm from medical care. However, considerable gaps in knowledge about the structural and process factors that underlie unsafe care globally make solutions difficult to identify, especially in resource-poor settings. Interpretation Harm from medical care appears to pose a substantial burden to the world’s population. However, much of the evidence base comes from developed nations. Understanding the scope of and solutions for unsafe care for the rest of the world is a critical component of delivering safe, effective care to all of the world’s citizens. Despite the longstanding principle to “do no harm”, unsafe medical care appears to cause significant morbidity and mortality throughout the world. Although precise estimates are unavailable, preva- lence studies from developed nations suggest that a substantial number of hospitalised patients are injured as a direct result of medical care. 1e4 The evidence for harm in the ambulatory setting is much less robust but is likely to be sizeable. 5 6 Generalising from these figures, tens of millions of people suffer injuries and millions likely die due to unsafe medical care. Injuries can occur in association with many medical interventions, from counterfeit or substandard drugs (due to regulatory and over- sight failures) to healthcare-associated infections (due to unhygienic practices). Many of these injuries are preventable and, therefore, particularly troubling. To better understand the causes and impact of the delivery of unsafe medical care from a global perspective, the World Health Organisation (WHO) Patient Safety team convened an ad hoc expert working group to establish priorities for research on patient safety. To help set priorities, the group commissioned a report on the current evidence available. This assessment was done by identifying topics in patient safety, examining related clinical and organisational issues and distinguishing gaps in current knowledge and directions for future research. This paper highlights the key points of the report. The full report, produced by the working group with the support of leading experts, is far more comprehensive 7 and available on the WHO World Alliance for Patient Safety website (http:// www.who.int/patientsafety/research/en/). METHODS The group began by identifying the types and causes of adverse events that are particularly harmful to patients. Major patient safety issues were identified using a multi-faceted, iterative approach: we first began with a literature search. We identified the major causes of harm and their underlying causes. We then consulted with experts on the committee as well as with external sources, such as the National Patient Safety Foundation, reviews by the Agency for Healthcare Research and Quality 8 (which is the most comprehensive review of its kind) and epidemiologic studies from several nations including the US, 9 Canada 1 and Australia. 10 We went back to the experts on the committee with the preliminary list of harms and their underlying causes for further feedback. After finalising the list, we shared it with external experts to get any final feedback. With the list of harms and their under- lying causes formalised (table 1), we then sought out experts in each individual topic area to write a section of the report on their topic of expertise. While there is some debate about the relationship between quality and safety, the Institute of Medi- cine in the US suggests that safety is one critical component of the delivery of high-quality care. 11 Therefore, the committee chose to categorise the patient safety topics identified into structure, process and outcomes. 12 The Agency for Healthcare Research and Quality (AHRQ) defines “structure” as the resources and organisational arrangements in place to deliver care, “process” as the activities of providers for delivering care and “ outcomes” as the consequences of clinical activities by providers. 13 Each identified topic was then reviewed in detail by lead experts who were asked to describe the basic epidemiology of the topic (eg, frequency, 1 Department of Health Policy and Management, Harvard School of Public Health, Boston, MA, USA 2 Division of General Medicine, Brigham and Women’s Hospital, Boston, MA, USA 3 The VA Boston Healthcare System, Boston, MA, USA 4 WHO World Alliance for Patient Safety, World Health Organization, Geneva, Switzerland Correspondence to Dr Ashish K Jha, Harvard School of Public Health, Boston, Massachusetts, USA; ajha@hsph.harvard.edu Accepted 26 November 2008 42 Qual Saf Health Care 2010;19:42e47. doi:10.1136/qshc.2008.029165 Error management group.bmj.com on September 26, 2016 - Published by http://qualitysafety.bmj.com/ Downloaded from