Perspective A Framework to Bridge the Gaps Between Evidence-Based Medicine, Health Outcomes, and Improvement and Implementation Science By Benjamin Djulbegovic, MD, PhD University of South Florida; and H. Lee Moffitt Cancer Center, Tampa, FL Despite spending close to 18% (more than $ 2.7 trillion) of its gross domestic product on health care, 1 it has been well docu- mented that patients in the United States often do not receive high-quality care. It has been estimated that more than 30% of US health care is inappropriate or wasteful, 2 that more than 70,000 deaths occurs annually as a result of medical errors, 3 and that there is 3- to 20-fold variation in delivery of the same health care across the country. 4 At the same time, only 55% of needed health services are delivered. 5,6 There are two fundamental reasons for the suboptimal care in the current US health care systems. First, there is a lack of high-quality evidence related to the (comparative) effects of most health care interventions and a failure to administer those interventions for which there is high-quality evidential support of their beneficial effects. Evidence, however, is necessary but not sufficient for decision making. 7,8 The second reason relates to suboptimal decision making, often affected by the context and system factors (such as time pressure, socioeconomic and cultural issues, financial conflict of interest, and so on). 8 It is estimated that 80% of all health care expenditures are affected by physicians’ decisions 9 and that poor decisions represent the leading cause of death. 10 Based on these considerations, it would appear that an increase in the of application and im- provement of evidence-based decision making should correct at least some deficiencies in the way we deliver health care. Indeed, it is estimated that one third of the leading causes of deaths can be prevented and one third of health care spending can be saved if we were to adhere to evidence-based guidelines. 11 Calls to increase the use of evidence-based interventions have been pe- riodically issued over the last two decades 12,13 with little success. One way to reinvigorate these discussions is to provide a com- mon scientific framework and point to the key factors that underpin delivery and measurements of health care. Conceptual Framework Relating Evidence-Based Medicine, Outcome Research, and Improvement and Implementation Science Table 1 provides the definitions of the seemingly different re- search fields noted above. One way to relate these different concepts is to remember how we evaluate and adopt health care interventions in actual practice. Typically, clinical research is performed to address questions of efficacy (“Can this interven- tion work in the ideal study setting?”), effectiveness (“Does it work; can it be generalized to real-world settings?”), and effi- ciency (“Is it worth it, and should it be paid for?”). Evidence- based medicine (EBM) has developed a substantial body of methodological research to determine whether a study is inter- nally valid (ie, generates reliable results under the ideal study settings). However, more important to practitioners, patients, and policy-makers is whether the intervention will work in the “real world,” that is, in patients who may differ from those enrolled onto clinical trials as a result of age, comorbidities, sex, race/ethnicity, and so on. This is the question of external valid- ity (or directness), 18 which is where EBM informs health out- come research. After an intervention is showed to be both efficacious and effective, the ultimate question of the impor- tance for society at large becomes, “Is the intervention actually worth paying for”? This is the question of efficiency, or cost effectiveness, typically the provenance of health outcome re- search. Once the intervention has been determined to be effi- cacious, effective, and efficient, a monitoring process (ie, assessing the application of the interventions in actual practice) should begin. This is a realm of science of quality improvement (QI), which aims to evaluate whether health care is overused, underused, or misused. Fundamentally, the science of QI mea- sures adherence of clinical practice to evidence-based guide- lines. Computing how many patients received a given intervention (numerator) over the number of patients who should have received the intervention (denominator) according to the EBM guidelines result in the quality indicators and per- Table 1. Definitions of Evidence-Based Medicine, Out- come Research, Improvement Science, and Implemen- tation Research 14-17 Evidence-based medicine: a set of principles and methods to ensure that population-based policies and individual decisions are consistent with totality of the most credible evidence while relying on both type 1 and type 2 cognitive processes to weigh the tradeoffs involved in alternative courses of action. Outcomes research: the study of the end results of health services that people experience and care about, such as change in the ability to function, quality of life, and mortality. By linking the care people get to the outcomes they experience, outcomes research has become the key to developing better ways to monitor and improve the quality of care. Improvement science: a framework for research focused on health care improvement. The primary goal of improvement science is to determine which improvement strategies work as we strive to ensure effective and safe patient care. Implementation research: the scientific inquiry into questions concerning implementation—the act of carrying an intention into effect, which in health research can be policies, programs, or individual practices (collectively called interventions). Special Series: Quality Care Symposium 200 J OURNAL OF O NCOLOGY P RACTICE • V OL . 10, I SSUE 3 Copyright © 2014 by American Society of Clinical Oncology Information downloaded from jop.ascopubs.org and provided by at UNIVERSITY OF SOUTH FLORIDA on May 29, 2014 from 131.247.59.62 Copyright © 2014 American Society of Clinical Oncology. All rights reserved.