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Overview
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.

With advances in medical research and technology over the last several decades in our ability to prevent, diagnose, and treat disease, questions are increasingly being asked about the dissemination of these strategies, their effectiveness in clinical practice, and their value in society. With the US government’s recent passage of the American Recovery and Reinvestment Act providing $1.1 billion for comparative effectiveness research/outcomes research, outcomes research continues to grow and play an important role in shaping healthcare decisions and policy within the United States and abroad.

The Origins
Although the exact origins of the term "outcomes research" is unclear, outcomes research first gained wide attention in the 1850’s 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. 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 develop the “end result” idea that is part of the definition commonly used to define outcomes research.

The field was stagnant for the next 50 years and then arguably the most important figure in the field, Avedis Donabedian, a Lebanese born physician and public health figure who was exiled to the United States during the second world war emerged with his classic 1966 paper in which he coined the term “outcome,” as part of the structure, process and outcome paradigm of quality assessment. Donabedian, in his 1966 paper published in the Milbank Memorial Fund Quarterly which subsequently went on to become one of the most frequently cited papers in public health this century stated that “outcomes, by and large, remain the ultimate validation of the effectiveness and quality of medical care.”

Twenty years later, Elwood in his 1988 Shattuck lecture coined the term outcomes management in which he envisioned a future in which patient management would be driven by the experience of how similar patients fared as a consequence of alternative treatments.

A decade later, in 1998, Clancy and 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.” They stated that outcomes research is “intended to provide scientific evidence relating to decisions made by all who participate in healthcare.” 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.

The US federal governments flagship program in outcomes research was the Medical Treatment Effectiveness Program administered by the Agency for Health Care Policy and Research.

Examples of Health Outcomes
A wide variety of outcomes are measured ranging from ones proximal to interventions such as acute clinical events like mortality to ones distal from the patient experience measuring the performance of a system. Goal of outcomes research according to Donabedian is not only to measure tangible events experienced by the patient such as mortality, morbidity. It should be incorporative of the broader definition of health and be inclusive of the how a patient feels as well as assessment of his awareness of risk factors. Adding to Donabedian’s broad definition of health care quality assessment, Porter, Mountford and Davis in recent times recognized the importance of cost as an important outcome. Porter defines it as “health outcomes achieved per dollar spent” with outcomes defined as measure of tangible results such as cost, time to recovery or restoration of health and clinical health. It is important to note, that the use of biomarkers or surrogate endpoints such as blood pressure, LDL or glucose level, are not equivalent to patient outcomes because their modification does not effect the patient in predictable ways, and therefore they do not effect the endpoint in predictable ways, and cannot be considered patient outcomes. The common outcomes that are measured can be divided into three broad categories of patient and system related.

A.)Patient

These outcomes are experienced by the patient and have a more proximal relationship with the healthcare intervention. For E.g

•	Mortality rates •	Readmission rates •	Risk-adjusted disease/clinical event rates (e.g. cancer/AMI) •	Patient’s healthcare experiences/health status – via patient questionnaires such as satisfaction •	Costs

B.)System

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. For e.g

•	Waiting times at ED •	Door to balloon times for patients undergoing emergency percutaneous coronary intervention

What are Common Themes in Outcomes Research?
Common themes of outcomes research are reflected in a book published by the Institute of Medicine entitled: Crossing the Quality Chasm: A New Health System for the 21st Century. Common themes of outcomes research are: safety, effectiveness, equity, efficiency, timeliness, and patient centeredness.

Safety: -Misuse of medical therapy and oversight in the course of clinical care – medical mistakes that place patients at risk for adverse events

Effectiveness: -The gap between what can be achieved through medical intervention or policy and what is actually accomplished -Whether policies are adapted by clinicians, the way they are applied, the skill of practioners, the characteristics of the patients receiving interventions and whether patients are adherent to therapy

Equity: Examination of disparity in healthcare delivery that focuses on whether nonclinical factors such as race, sex, and socioeconomic status influence the care of patients

Efficiency: With increasing healthcare costs, outcomes research focuses on ways to maximize efficiency, limit healthcare costs, and reduce waste in the healthcare system.

Timeliness: Patient access to healthcare: barriers to access, and uninsured patients inability to benefit from healthcare.

System responsiveness: Educational efforts amongst the medical community and implementation of healthcare policies that improve patient care.

Patient Centeredness: How medical interventions will affect patients, what patients feel and what they can do to effect medical decision making. The burden of illness, adverse effects of medications, and complication from procedures that affect the quality and quantity of life.

What are the Setting/Common Study Designs/Methodologies Used in Outcomes Research?
The Setting of Outcomes Research: The doctor’s office Health clinic Hospital The patient’s home

Study designs/Methodologies Used: Randomized control trials Cross Sectional Studies Observational Cohort Studies Meta- analysis Systemic Reviews Prepost designs Simulations Controlled perspective studies Economic evaluations Analysis of large administrative data structures – available from Medicare and Medicaid, private insurance companies, and major employers Studies that attempt to affect public policy. Patient questionnaires


 * It is a common myth that outcomes research is primarily associated with secondary data analysis and data mining. This becomes evident when examining the various study designs/methodologies used in outcomes research.

Who Funds Outcomes Research?
Federal Government: Agency of Healthcare Policy and Research (AHPCR) in the Department of Health and Human Services, National Institute of Health, VHA, CDC Private Foundations: Robert Wood Johnson Foundation, Henry J. Kaiser Foundation, Pew Charitable Trusts

What Are the Challenges Faced In Outcomes Research?
Fragmentation of Outcomes Research: Databases and patient registries are fragmented and limited in the number of patients, and many are of unknown data quality. Studies with a small number of patients in health systems limits the use of proper statistical methods and inferences from particular studies. Limited information is available about certain priority populations and sub groups.

Coordination Across Outcomes Research Framework: A number of groups conduct outcomes research within the United States and across the federal government but much of this research effort is not coordinated.

Underrepresentation of Certain Subgroups in Outcome Studies: Efforts must be made to attain information about the elderly, persons with disabilities, and racial and ethnic minorities in clinical and other research studies, as the majority of outcome research studies do not include these subgroups.

Lack of Human and Scientific Capital: Methods for conducting outcomes research need to be developed, and there are limited trained researchers who can conduct outcomes research within the United States and abroad. Increased emphasis must be placed on training outcomes researches both nationally and internationally.

Improper Reporting of Health Related Outcomes: Many hospitals/healthcare providers do not properly report outcomes creating bias in studies.

Lack of Interpretability of Measures/Incorporation Into Clinical Practice: Clinicians must be educated about the usefulness of outcome measures, and outcome measures must be easy to include into daily practice.

The Future of Outcomes Research
With the increasing size of the elderly population, growing knowledge base, broad range of vested interests, increasing sophistication of patients, and the pressures to demonstrate the value of health care to patients and society, outcomes research will expand and assume a more important role in healthcare delivery. Over the last fifty years studies have increased in absolute numbers, in the relative proportion of scientific literature and methodology, and in quality. Outcomes research is no longer performed by a small number of researches, and it has significantly altered the culture of clinical healthcare services research by changing how we evaluate the end result of healthcare delivery. Today, outcomes research is one of the most important tools policymakers, clinicians, managers and payers rely on to provide efficient and effective care. In 2009 the US government’s American Recovery and Reinvestment Act provided $1.1 billion for comparative effectiveness research, further indicating the growing importance of outcomes research within the United States and abroad.

Recent advances in psychometrics (the science of the design, administration and interpretation of questionnaires) has also created an exciting opportunity to measure patient outcomes more efficiently. With the revolution of health information technology, which makes available more patient data, further opportunities exists for analysis on a scale that could not even be imagined decades ago and the breadth of outcomes research will continue to increase. We are entering an era in which we can conduct virtually real time research with expansive and responsive surveillance systems with the ability to evaluate the effects of innovations in care.

As outcomes research expands in its scope it will increasingly be at the forefront of successful efforts to address the daunting challenges of the healthcare environment. It is increasingly being used within many countries around the world to serve as “report cards” that purchasers ad consumers can use to assess the quality of care provide in health plans. To have a lasting impact, outcomes research must reach and affect the behavior of health care providers, institutions, patients and payers. Methods that will increase the presence and effect of outcomes research include conferences, clinical practice guidelines, educational patient videos, and quality improvement initiatives. Efforts must be taken to coordinate outcomes research initiatives, conduct studies focusing on certain subgroups commonly underrepresented in clinical research studies, and developing human and scientific capital to keep up with the rapid growth of this evolving field.