Recently created in 2010, the Patient-Centered Outcomes Research Institute (PCORI) supports patient-centered comparative effectiveness research with a focus on prioritizing high-impact studies and improving trial design methodology. The Association of University Radiologists Radiology Research Alliance Task Force on patient-centered outcomes research in Radiology aims to review recently funded imaging-centric projects that adhere to the methodologies established by PCORI. We provide an overview of the successful application of PCORI standards to radiology topics, highlight how these methodologies differ from other forms of radiology research, and identify opportunities for new projects as well as potential barriers for involvement. Our hope is that review of specific case examples in radiology will clarify the use and value of PCORI methods mandated and supported nationally by the Affordable Care Act.
Introduction
Established in 2010, the Patient-Centered Outcomes Research Institute (PCORI) redirects the focus and methodology applied to medical research in the United States toward promoting high-integrity, evidence-based research guided by patients, caregivers, and the broader healthcare community . As the name suggests, patient-centered outcomes research (PCOR) focuses on patients . What are the benefits of this approach? Simply put, patients and their doctors view health and disease from different vantage points. Radiologists and imaging researchers have traditionally studied diagnostic accuracy of various imaging tests or technical success rates of interventional procedures; these end points are radiology-centric. Patients, on the other hand, are primarily concerned with their health status, including the ability to return to work and the quality of life. The PCORI agenda emphasizes patient-centered outcomes, assigning greater value to treatments and diagnostic options in the context of outcomes important to patients. Directly engaging multiple stakeholders, particularly patients, as partners in radiology research promises to bring these two vantage points into a single focus.
The broad research mandate advocated by the PCORI may seem intimidating to radiologists, but clarifying the focus and mission of the institute helps reveal opportunities for radiologists interested in pursuing PCOR. Not only is the institute focused on patient-centered outcomes, but also it holds an intrinsic responsibility to promote research quality with a multipart strategy. Through its Methodologies Committee, the institute has created a prioritization process and methodology standards to identify relevant research questions and ensure that funded research provides high-quality, valid data that aid healthcare decision-making processes.
Radiologists should note that research focusing on patient-centered end points is becoming a critical component of defining value in health care . The metrics devised through such research will help drive national guidelines, inform standards of care, and determine reimbursement. The radiology community must collaborate in this process to help establish our value in this new healthcare paradigm. This paper will present an overview of imaging in PCOR by discussing the national agenda for PCOR, issues specific to imaging, study design and methodology, funding opportunities, current research, and opportunities for PCOR involving medical imaging and radiologists.
National Agenda for PCOR
Vast innovation in medical imaging over the past 40 years has also fostered a concomitant rise in imaging utilization and cost. Annual Medicare expenditures, including part B spending for advanced imaging services are expected to continue growing at a rate that exceeds the overall growth rate of the U.S. economy . In 2007, the Congressional Budget Office identified comparative effectiveness research (CER) as a potential means to stem healthcare cost for both public and private insurers without “adversely affecting health overall” . The national interest for this type of research was bolstered in The American Recovery and Reinvestment Act of 2009, which allocated $1.1 billion for CER and established the Federal Coordinating Council for Comparative Effectiveness Research. The council was created to direct the efforts of all federal agencies conducting CER.
The most recent large-scale effort in the United State to promote CER, arose as part of the Patient Protection and Affordable Care Act (PPACA) of 2010. The PPACA created the mandate and funding to establish PCORI as a nonprofit, nongovernmental organization. The institute was authorized by Congress:
[To] help people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community.
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Defining PCOR and Methodology Standards
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“Given my personal characteristics, conditions, and preferences, what should I expect will happen to me?” “What are my options, and what are the potential benefits and harms of those options?” “What can I do to improve the outcomes that are most important to me?” “How can clinicians and the care delivery systems they work in help me make the best decisions about my health and health care?”
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Prioritization Process
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Translation Framework
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PCOR Trial Design
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Methodology Standards
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Engagement and Collaboration
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Table 1
Principles for Effective Engagement of Stakeholders
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Funding Opportunities and State of Current Research
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Table 2
2012–2015 PCORI Funding Awardees that Include Imaging as an Integral Part of the Research Proposal
Year Awarded Project Title Project Description 2015 Pragmatic trial of more versus less intensive strategies for active surveillance of patients with small pulmonary nodules Compare existing intensive versus less-intensive protocols for CT surveillance. Considers patient-reported outcomes of emotional distress, anxiety, general health status, and satisfaction with the process; resource utilization and radiation exposure; adherence to protocol and use of low-dose technique. 2015 Enabling a paradigm shift: a preference-tolerant RCT of personalized vs. annual screening for breast cancer Targeted approach to breast cancer screening in which patients at higher risk are screened more often and those at lower risk are screened less often. Compare two methods of screening based on personal risk to determine if personalized screening is safe and reduces false-positive test results. Determine if a personalized approach will lead to more of the high-risk patients using strategies to prevent cancer. 2014 Stopping anti-tumor necrosis factor agents in rheumatoid arthritis (STARA) clinical trial Trial examining whether long-term remission RA patients who stop anti-TNF medications have more joint destruction on radiographs and predicting which patients will experience active arthritis during careful analysis for joint inflammation by MRI and ultrasound. 2013 UCSF CT radiation dose registry to ensure a patient-centered approach for imaging Research focusing on developing and implementing strategies to standardize and optimize the protocols and doses used for CT across a large number of institutions and to improve patient safety and lower the risk of future cancers related to CT imaging. 2013 Promoting informed decisions about lung cancer screening Annual screening with low-dose computed tomography has the potential to greatly reduce lung cancer deaths. This trial wants to further recommend that patients be given the opportunity to make a shared decision about lung cancer screening, considering what is important to the patient related to the potential benefits and harms of screening. 2013 Shared decision making in parents of children with head trauma: heat CT choice Head CT choice communicates the risk of traumatic brain injury and the risk of future cancer associated with radiation exposure, informs parents of the advantages and disadvantages of management options, and aligns parents’ choice with values and preferences, thus promoting shared decision-making and enhancing the quality of care. 2013 Comparative effectiveness of surveillance imaging modalities in breast cancer survivors The overall aim is to find out how well MRI works compared to mammography for surveillance in women who have previously had breast cancer. 2013 Post-treatment surveillance in breast cancer: bridging CER to the alliance The project involves the analysis of existing data from a national cancer registry to evaluate whether new imaging technology, beyond mammography, is able to detect recurrence earlier and improve survival. 2013 Improving the effectiveness of routine surveillance following lung cancer resection Aim is to compare patient-centered outcomes for lung cancer resection patients followed by alternative intervals of surveillance imaging. 2013 Patient-centered, risk-stratified surveillance after curative resection of colorectal cancer Hypothesize that by tailoring the strategy for monitoring to the individual CRC survivors—taking into account their risk for recurrence, eligibility for salvage treatment, and personal preferences—the effectiveness of cancer monitoring (periodic CT exams) would be improved and the burden on patients and the healthcare system would be reduced. 2012 Promoting patient-centered counseling to reduce inappropriate diagnostic tests (Pilot project) This trial aims to develop and evaluate a novel intervention using standardized patients (SPs) to enhance physicians’ patient-centered counseling skills regarding two frequently overused services in primary care: magnetic resonance imaging (MRI) for acute low back pain and bone densitometry in women at low risk for osteoporosis. 2012 Measuring patient outcomes from high tech diagnostic imaging studies (Pilot project) This study proposes to evaluate the use of patient surveys, health plan claims data, and medical records information to analyze the care process and outcomes experiences of patients after they have advanced imaging tests for abdominal or low back pain. 2012 A BioScreen for multiple sclerosis (Pilot project) The goal is to develop an effective and secure digital portal named BioScreen to access and display real-time clinical and biomarker information for use by patients and health providers and to integrate multiple dimensions of patient information in a single modular navigation system, including brain imaging.
PCORI, Patient-Centered Outcomes Research Institute.
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Opportunities for Imaging-focused PCOR
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Assessment of Prevention, Diagnosis, and Treatment Options
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Improving Healthcare Systems
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Communication and Dissemination of Research
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Table 3
Strategies for Effective Dissemination of Mixed-method Research
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Accelerating PCOR and Methodological Research
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Conclusion
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