Study Overview
Objective. To examine the global burden of unsafe medical care and its comparative frequency in low/middle-income vs. high-income countries.
Design. Analytical modeling of aggregated data from observational studies.
Data. Two primary sources of data were used. First, the team conducted a search of over 16,000 articles written in English after 1976 that aimed for a comprehensive exam-ination of both peer-reviewed and non–peer-reviewed studies that focused on 7 inpatient adverse events (see below), and the clinical features of the patients who were injured from them. Two separate literature reviews were conducted in 2007 through early 2008 and then repeated in 2011. Discussions with international experts in each topic area informed the selection process. The second source of data was epidemiological studies commissioned by the World Health Organization (WHO). These aimed to identify inpatient adverse events using a 2-stage medical record review in 26 hospitals across 8 low- and middle-income countries (LMICs) in the Eastern Mediterranean and North Africanregions, and 35 hospitals across 5 countries in Latin America.
Main outcome measures . 7 types of adverse events were evaluated in the analysis: (1) adverse drug events, (2) catheter-related urinary tract infection, (3) catheter-related blood stream infections, (4) nosocomial pneumonia, (5) venous thromboembolism, (6) falls, and (7) pressure ulcers (decubiti). The global burden of disease (GBD) is a standard metric that uses disability-adjusted life years (DALYs) as a proxy measure of morbidity and mortality related to a specific condition. The GBD DALYs model requires several key inputs: the number of people affected, the age at which they are affected, and the clinical consequence of the adverse events. In this study, a single average age per event was used instead of the standard GBD calculations by age and sex. Each input of GBD and DALYs was calculated separately for high-income countries (HICs) versus LMICs. The World Bank sets the income categorization for countries and adjusts the information on an annual basis. Countries in each category share common characteristics of socioeconomic development and epidemiological profiles.
Main results . The rate of hospitalization in HICs was higher than in LMICs: 10.8 vs. 3.7 per 100 citizens per year. There were large variations in the reported incidence of adverse events in both HICs and LMICs. Of the 7 adverse events assessed, adverse drug events were the most common type in HICs, with an incidence rate of 5.0%. In LMICs, venous thromboembolism was most common, with an incidence rate of 3.0%. Catheter-related blood stream infection, venous thromboembolism, and pressure ulcers had comparable rates between HICs and LMIC . The authors estimated that for every 100 hospitalizations, approximately 14.2 adverse events in HICs and 12.7 in LMICs. This is roughly 16.8 million injuries annually among hospitalized patients in HICs. LMICs and experienced approximately 50% more adverse events than HICs. Of note, LMICs had 5 times the population of HICs but the authors did not calculate proportional incidence rates.
The authors estimated 22.6 million DALYs lost due to these adverse events in 2009 globally. Unsurprisingly, the number of DALYs lost were more than twice as high as in LMICs as they were in HICs. This is likely due to the combination of weaker health systems and human resources for health shortages in those countries. In LMICs, venous thromboembolism was the main source of lost DALYs. Although incidences of hospital-acquired infections--such as nosocomial pneumonia, catheter-related blood stream and urinary tract infections--were smaller, they caused a comparable number of DALYs lost. Premature death from adverse events was the primary source of DALYs lost for all countries.
Conclusion. Adverse events from unsafe care is a significant problem across all countries.
Commentary
Globally, the efforts to improve health care delivery for diseases that cause substantial morbidity and mortality have been largely successful. For example, antimalarial drugs and antiretroviral therapies have become more accessible to patients in need [1,2]. However, in order to create more sustainable model, the health care systems of developing countries need sustainable investments to care for their growing populations and increasing medical needs [3,4]. Allengranzi et al [5] concluded from a systemic review that health care–associated infections are ubiquitous and occur at much higher rates in LMICs than in HICs. Findings from this study support those from Allengranzi’s review.
This study helped further our understanding of and explored the impact of unsafe medical care on GBD and DALYs. Several other adverse events related to unsafe care, such as unsafe surgery, harms due to counterfeit drugs, unsafe childbirth and unsafe blood use, were not included in this study due to data limitations. The estimated lost DALYs would be much higher if these events were counted.
This study has several strengths. First, the authors sought out the best available data from a large number of sources. Evidence selected for the analysis came from studies with good quality ratings. The 7 outcome measures used in this study are now standard minimum reporting data internationally. Nonetheless, several limitations are present. As the authors noted, the lack of availability high-quality data is common in international analyses. There can be reporting delays, data collection errors due to a lack of technical capacity, and corruption problems that may influence data quality. Poor reporting practices may exclude or underreport adverse events. Also, the paucity of data for some variables limited the calculation of estimates Second, few studies used standardized approaches in their data collection and analysis, contributing to data inconsistencies that may affect the reliability of the results. Third, the same life expectancy value (the WHO standard) was used for all individuals regardless of their countries’ life expectancy. The authors acknowledged that this approach was controversial and may have resulted in a different number of DALYs lost. Finally, only English-language publications were used, which may have influenced the findings. Latin America, the former Soviet Union states, and many Asian countries have growing bodies of research published in their native languages.
Despite the limitations, the study is one of the first systematic analyses of GBD, the outcomes of unsafe medical care, and associated lost DALYs. The analysis identified that a majority of the harms from adverse events occur in LMICs. Policies addressing, supporting, and enforcing patient safety measures during the health care experience will help ensure reductions in mortality and morbidity in LMICs. Improving the safety of the healthcare system should be a major policy and research emphasis across the globe.
Applications for Clinical Practice
Even though patient safety initiatives have been at the forefront of many organizational policies and health care provider education since the 1999 Institute of Medicine report “Crossing the Quality Chasm,” this study reminds practitioners that safe clinical practice is essential for reducing domestic disease burden. The cost of adverse events from unsafe practice in the United States was estimated to be around $16.6 billion in 2004 alone [6]. With the World Health Organization calling for strengthened research infrastructure across the globe and LMICs now seeing the value of data for health systems policymaking and management, future research will help to further refine the methods developed in this study.
— Jin Jun, MSN, APRN-BC, CCRN, and Allison Squires, PhD, RN