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In the past 20 years, outcomes research has proliferated throughout the medical, academic, and health technology communities. But the definitions of outcomes research vary widely depending on who is conducting the research, or using the findings. The origins of outcomes research reach well into the 1960s and are rooted in the evaluation of the quality of medical care. The knowledge gained from outcomes research is critically needed to provide evidence about benefits, risks, and results of treatments to inform decision making by patients, providers, payers, and policy makers.

What is Outcomes Research?

The term outcomes research is a vague, nontechnical term that is used to describe a wide-ranging spectrum of medical care research today. Broadly stated, outcomes research seeks to understand the end results of particular healthcare practices and interventions. Outcomes research has taken on so many different meanings to so many different constituencies or stakeholders in the business model of medicine that a clear definition is thought to be lacking. Depending on who is asked, a different answer will arise. A managed care organization CEO may respond with an economic example related to costs of new technologies that consume limited resources. A physician may be concerned with how well a certain procedure is performed for a certain patient with a given medical problem. A patient, now the consumer of healthcare services, may be equally concerned with how well a procedure or test is performed, but may also want to know if the right thing was done to begin with, or if the best thing was done that takes into account his or her own preferences.

Origins

Arguably, it was Avedis Donabedian who coined the term outcome as a component in his paradigm for quality assessment. His view of outcomes as a means to examine the quality of medical care is a foundation of outcomes research.

Traditionally, outcomes have been classified into three types: economic, clinical, and humanistic, dating to a classification by Kozma and others in the early 1990s. This economic, clinical, or humanistic outcomes (ECHO) model is a useful way to organize a framework around the concept of medical outcome. The model is built on the traditional medical model of an individual that develops disease or symptoms and seeks acute or preventive care. Healthcare professionals assess the needs of the patient, and clinical parameters that are modifiable by treatments can be monitored. Clinical outcomes can be medical events, such as heart attack, stroke, complications, or death, that occur as a result of disease or medical treatment. Recognizing that these concerns alone do not take into account quality-of-life measures such as functional status or patient preferences or the ever-increasing emphasis on costs of care, the model includes humanistic and economic outcomes, respectively. Therefore, depending on whose perspective is engaged, the term outcome can refer to various types of outcomes, but they are all aspects of the same construct: the result of disease or medical care treating the disease. As healthcare systems worldwide become more complex, reflecting the perspectives common to today's environment of the payer, provider, patient, policy maker, or regulating organization, research on these outcomes must necessarily involve a multidisciplinary approach. For example, determination of the value of a new pharmaceutical intervention will require data on all three types of outcomes to conduct cost-effectiveness, – benefit, – utility, or decision analysis.

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