Outcomes research refers to research (usually medically related) which investigates the outcomes of health care practices. It has been defined as the study of the end results of health services that takes patients' experiences, preferences, and values into account—is intended to provide scientific evidence relating to decisions made by all who participate in health care.[1]
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Outcomes research is applied clinical and population based research that seeks to study and optimize the end results of healthcare — that is, the experience of the patient and the impact on society. The intent of this research is to identify shortfalls in practice and to develop strategies to improve care and ultimately prevent disease or mitigate its impact.
By linking healthcare practices and interventions, outcomes research places an emphasis on the patient experience and focuses on the end result. The field is defined by the questions that it addresses and it seeks to provide insight about making efforts more effective, equitable, efficient, timely and patient centered. With thousands of health care decisions made daily, outcomes research focuses on filling gaps in evidence needed by clinicians and patients in making informed decisions. For the most common medical conditions seen by clinicians, healthcare professionals are sometimes unsure of the best treatment due to limited or even a complete lack of evidence comparing treatment options.
Outcomes research seeks to provide evidence about which interventions work best for each patient and under what circumstance. This knowledge is essential because it allows healthcare professionals to make informed decisions based on evidence and allows healthcare professionals to deliver the right treatments to the right patients based on patient demographics/individual patient characteristics at the right time. Outcomes research is increasingly being used by a number of groups concerned with healthcare including clinicians, patients, health care managers and politicians ranging from the insurance sector to drug and medical device companies, major employers, insurance companies and members of legislative bodies. Clinicians are interested in outcomes research because it allows them to deliver the proper treatments; patients want to make informed decisions that affect their health, and policymakers and purchasers are interested in identifying ways to improve the quality and value of care, and reduce costs.
Traditionally outcomes research has been difficult to define because it is the convergence of multiple disciplines applied to generate knowledge about the delivery and organization of healthcare. The term is used to describe a wide variety of fields of research and uses various methodologies that include experimental and non-experimental designs. It combines the basic biological sciences, epidemiological sciences, clinical sciences, social sciences and statistical sciences with an emphasis on cross discipline, national and multi-national collaborations to answer clinically important questions. Outcomes research became increasingly important when it was noted that there were substantial variations in medical practice with identical conditions being treated differently in different regions and communities around the world.
Although the exact origins of the term "outcomes research" is unclear, outcomes research first gained wide attention in the 1850s as a result of the work of Florence Nightingale, a celebrated English nurse, writer and statistician, during the Crimean War. Nightingale studied death as her primary outcome, and the context of her study evaluated the cause of death, including wounds, infections, and other causes. The interventions that she examined were nursing care and how interventions would decrease patient mortality. Additionally she studied variation in childbirth practices at home and at institutions and their effect on maternal mortality.[2] Nightingale later went on to found the first secular nursing school in the world, which is now part of Kings College, London.
Another major advance in outcomes research came with the work of Ernest Amory Codman, a Boston orthopedic surgeon who in 1914 noted that hospitals were reporting the number of patients treated but not how many patients benefited from treatment. At that point he argued that all hospitals should produce a report "showing nearly as possible what are the results of treatment obtained at different institutions." He also suggested that all worthy products and activities of a hospital, from the physicians trained there, to the research conducted, and the care delivered depended on the premise that ill patients were deriving benefit from the therapies that they received. Codman is believed to have developed the "end result" idea that is part of the definition commonly used to define outcomes research.[3]
Around the beginning of the twentieth century, professional organizations and hospital authorities began to adopt a standard form of medical record. In the UK, this was also adopted in primary care. Standardized data recording meant that for the first time medical records could be used as a moderately reliable data base for research.
The unprecedented scale and mechanization of World War I led to intense efforts to improve the outcomes of care for battle casualties. Military medicine has traditionally concentrated on the practical effects of treatment of battle trauma, and during this period, careful attention to outcomes led to major advances in orthopedic surgery, plastic surgery, blood transfusion and the prevention of tetanus and gangrene. There were also major advances in the organization of care and in record keeping.
However, only part of this was carried over into peacetime practice in the interwar period. Codman's ideas on the disclosure of institutional data by hospitals were never widely adopted, and the primary source of outcomes data was usually the case series report of an individual surgeon or physician. The collection of health data in the community was generally sporadic and it was thus impossible to determine the effect on true health outcomes of many widely adopted interventions.
The coming of World War II once again brought with it major advances in military medicine and the organization of medical services to deal with casualties over a huge theatre of war and also with civilian casualties due to the bombing of cities. In the UK, this led directly to the centralization of many medical services and the eventual establishment of a National Health Service in 1948. This model facilitated the establishment of national and local databases and hence the possibility of outcomes research, though it would be a long time before this potential was realized. A key figure in the development of outcomes research in the UK — and subsequently internationally — was Archie Cochrane. His 1971 Rock Carling Fellowship monograph Effectiveness and Efficiency: Random Reflections on Health Services, first published in 1972, clarified a number of key concepts in outcomes research and evidence-based medicine.
The true founder of the present conceptual framework of outcomes research was Avedis Donabedian a Lebanese-born physician and professor of public health. In his classic 1966 paper "Evaluating the Quality of Medical Care" he used the term "outcome," as part of the structure, process and outcome paradigm of quality assessment. This paper, published in the Milbank Quarterly in 1966, subsequently went on to become one of the most frequently-cited papers in public health this century. It stated that "outcomes, by and large, remain the ultimate validation of the effectiveness and quality of medical care."[4]
From the late 1960s onwards, John Wennberg carried out a series of groundbreaking studies mapping variations of healthcare practice in the USA, culminating in the publication of The Dartmouth Atlas of Health Care,[5] a definitive, continuously-updated resource providing a complete picture of healthcare usage and distribution throughout America. Wennberg described his developing methods and insights in his book Tracking Medicine: A Researcher's Quest to Understand Heath Care.[6]
In his 1988 Shattuck Lecture, Paul Ellwood coined the term "outcomes management" and envisioned a future in which patient management would be driven by the experience of how similar patients fared as a consequence of alternative treatments.[7]
In 1998, Carolyn Clancy and John Eisenberg marked the entry of outcomes research into the scientific lexicon with their with a classic article published in Science that stated that outcomes research is "the study of the end results of health services that takes patients experiences, preferences and values into account" and that it is "intended to provide scientific evidence relating to decisions made by all who participate in healthcare."[1] By stating that outcomes research should assist those who participate in healthcare, Clancy and Eisenberg emphasized the needs of those who receive, provide, organize, and pay for healthcare including the public.
A wide variety of outcomes are measured ranging from interventions such as acute clinical events like mortality to measuring the performance of a system. The goal of outcomes research, according to Donabedian, is not only to measure tangible events experienced by the patient such as mortality and morbidity. It should incorporate of the broader definition of health and include how a patient feels as well as his awareness of risk factors.
The common outcomes that are measured can be divided into broad categories of patient and system related.
These outcomes are experienced by the patient and have a more proximal relationship with the healthcare intervention. Examples:
These measures are more distal to the patient experience but are important for assessment of quality of care and influence the patient experience as well. Examples:
Common themes of outcomes research are: