Health outcomes research is essential to align radiology with current standards of high-value patient care, through the assessment of end results of diagnostic tests, interventions, or policy on patient health. To bridge studies of diagnostic test accuracy and health outcomes research, key considerations include: (1) how to determine when a diagnostic test merits evaluation of impact on outcomes, (2) when study of intermediate/surrogate outcomes can be useful, (3) how to consider the possible harms as well as potential benefits of a test, and (4) how to integrate evidence of an imaging test’s efficacy/effectiveness with clinical data to assess outcomes. Due to challenges in conducting studies of long-term outcomes consequent to imaging use, intermediate health outcomes may capture a test’s impact on successful diagnosis and therapy, and can provide readily measurable, incremental insights into the role of imaging in health-care delivery and efficiency. In an era marked by recognition of quality and value of care, outcomes research will provide essential evidence to inform radiologists’ guidance of imaging use toward improved patient care, creation of clinical guidelines, and policy decisions.
Introduction
The development and dissemination of new and improved diagnostic imaging tests have thrived over the past several decades. Disease detection and characterization for medical decision-making increasingly depend upon imaging tests. As in other medical fields, the accumulation of published literature in radiology has become the basis of evidence-based practice or evidence-based radiology. The rapid evolution of imaging technology places unique demands upon this research effort, for re-evaluation of reproducibility, diagnostic test accuracy, and comparative performance against existing imaging tests—in the setting of varying patient populations and techniques for each imaging test. Additionally, the current era of health-care policy, with its emphasis on not only efficacy and effectiveness, but also value, requires evidence about how imaging technology translates into qualitative and quantitative changes in health outcomes and efficiency of clinical care.
Value can be simply defined as the health outcomes achieved per dollar spent . Because of the concern that indiscriminate diagnostic imaging use contributes to high health-care costs and potentially lower quality of care, policies intended to encourage evidence-based use of imaging are being enacted. For example, the Centers for Medicare and Medicaid Services will require ordering physicians to consult appropriate use criteria for imaging tests such as those endorsed by national medical specialty societies, including the American College of Radiology, to avoid reimbursement deductions, and also requires documentation of shared decision-making with patients regarding the benefits and harms of lung cancer screening . In efforts to enhance quality and value in the health-care system, decision-makers from day-to-day practitioners to expert panels and policy-making bodies are evaluating evidence on the impact of diagnostic tests on health outcomes for patients and health-care systems.
The purpose of this article is to provide an overview of some of the methodological issues and approaches that bridge diagnostic test accuracy and health outcomes research: (1) how to determine when a diagnostic test merits further evaluation, (2) when study of surrogate outcomes can be useful, (3) how to consider the possible harms as well as potential benefits of a test, and (4) how to integrate evidence of an imaging test’s efficacy/effectiveness with clinical data to assess outcomes and value.
When Does a Diagnostic Test Merit Further Evaluation through Outcomes Research?
The assessment of imaging tests encompasses several stages, and may be described as a hierarchy of study types, allproviding evidence in support of, and ideally before, a test’s widespread clinical adoption. At the top, patient outcomes (eg life expectancy) and societal impact (eg cost-effectiveness) capture the overarching effect of a diagnostic test on patients and align its use with the ideals of improved population health and sometimes, enhanced value over existing alternatives. In descending order, the study types in the hierarchy include therapeutic and diagnostic impact, diagnostic performance, and technical performance ( Fig 1 ) .
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When Is Study of Intermediate or Surrogate Outcomes Useful?
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Methodological Building Blocks of Outcomes Research: Investigation of Benefits and Harms
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Experimental Studies
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Observational Studies
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Meta-analysis
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Benefits and Harms in Patient-reported Outcomes
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Integration of Efficacy/Effectiveness and Clinical Data to Assess Outcomes: Decision Analysis
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Conclusion
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