Progressive Pathways

Prepare now to capitalize on new methods and fresh sources of funding for radiology outcomes research.

 By Sarah Howden 

The need for evidence of clinical outcomes and the economic value of health care interventions and approaches is enormous and unlikely to diminish any time soon. This is particularly true given the rapid pace of innovation combined with the ever-present need to reduce costs, improve quality, and increase access for improved health. To fund that research, investigators, clinicians, and other health care professionals apply for research grants from many sources, including foundations, government research agencies, and industry. To be successful, researchers need to be aware of funding opportunities as well as hone their grantsmanship skills. This article is the first in a two-part series to address these topics and stimulate discussion on increased grant-funded outcomes research in radiology.

A majority of physicians surveyed by Harris Interactive stated they either strongly or somewhat support comparative effectiveness research (CER), and the importance of CER for diagnostic imaging is likely to continue to increase with the development and adoption of new testing and treatment options.[i]^,[ii] However, as noted in the “An Eye on Outcomes” article in the March 2012 edition of Axis Imaging News, “To date, little comparative effectiveness data have been available in the diagnostic imaging arena…and in order to best serve the needs of referring physicians and payors, and increase adoption of new technology, radiology should be prepared to demonstrate the value of imaging with comparative effectiveness data.¹

This poses a clear challenge to the radiology community to take up the call to broaden the scope of those engaged in research. Competitive grant funding for outcomes, implementation, and effectiveness research exists in the United States and overseas. Funding sources include, but are not limited to, US government agencies such as the National Institutes of Health, Agency for Healthcare Research and Quality, CMS Innovation Center, and USAID. Additionally, there are private foundations that fund proof of concept and CER studies on specific topics, such as the Bill & Melinda Gates Foundation, Susan G. Komen for the Cure, and Robert Wood Johnson Foundation, as well as international initiatives, such as Grand Challenges: Saving Lives at Birth.

A New Well to Tap                               

Newest on the scene and representing an excellent opportunity for health sector research is the Patient-Centered Outcomes Research Institute (PCORI), which was established by the 2010 Patient Protection and Affordable Care Act as an independent, nonprofit organization. PCORI was created in order to help patients, clinicians, purchasers, and policymakers make better informed health decisions by advancing the quality and relevance of evidence about how to prevent, diagnose, treat, monitor and manage diseases, disorders, and other health conditions. PCORI receives both federal funding as well as a fee assessed on Medicare, private health insurance, and self-insured plans. From these sources, PCORI will have a budget of approximately $250 million in 2013 and $500 million per year from 2014 until 2019, when the current legislative mandate ends.[i]

PCORI defines Patient-Centered Outcomes research that: “Helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. This research answers patient-centered questions such as:

1. 1.‘Given my personal characteristics, conditions, and preferences, what should I expect will happen to me?’
2. 2.‘What are my options and what are the potential benefits and harms of those options?’
3. 3.‘What can I do to improve the outcomes that are most important to me?’
4. 4.‘How can clinicians and the care delivery systems they work in help me make the best decisions about my health and health care?’

 To answer the questions, PCOR:

• Assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative, or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people;
• Is inclusive of an individual’s preferences, autonomy, and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health-related quality of life;
• Incorporates a wide variety of settings and diversity of participants to address individual differences and barriers to implementation and dissemination; and
• Investigates (or may investigate) optimizing outcomes while addressing burden to individuals, availability of services, technology, and personnel, and other stakeholder perspectives.³

A key criterion for PCORI is that the research must involve the active engagement of patients and other stakeholders. This challenges the way that research has been conceived and conducted in the past. A recent Avalere Health research review concluded that only 57% of the abstracts analyzed included patient-centered outcomes, such as survival, function, symptoms, and quality of life. However, “none of the funded CER abstracts indicated that patients were specifically involved in the research proposal or generation of research questions, or otherwise involved in the conduct of the study apart from being research subjects.”[iv] Similarly, a literature review of the use of patient-centered outcome measures in radiology research from 1990 to 2003 found little patient engagement in outcome research in radiology, with only a few studies identified in which patients had been directly involved in the research, largely within the areas of mammography and spinal imaging.[v]

Therefore, while potentially challenging, this PCORI funding criteria for patient and other stakeholder involvement will likely open the door to new ways of doing research. It could promote the formation of creative research collaborations, among academics, clinicians, other health care providers, industry, and patient advocacy groups, as well as directly with patients and/or their caregivers, which could provide useful findings for the field of radiology. For example, Mathers et al⁵ conclude that “patient perspectives on outcome are capable of providing insights that complement or even ‘counterbalance’ those of health care professionals and researchers…. A fruitful route of establishing a patient-defined outcomes program may be by including patients in research teams….” Similarly, recent market research supported by GE Healthcare found that government and private foundation funders of research were generally supportive of innovative research collaborations for outcomes research, such as those between researchers and industry, as long as there is the requisite transparency and compliance applied to the process. The research respondents noted that the potential benefit of these types of collaborations lay in the access to additional expertise, insights, data, and technical and financial resources.

The conduct of CER in radiology faces some additional unique challenges, such as rapidly changing technology, complex care processes, and the difficulty of relating the impact of a diagnostic exam to patient outcome.^2,6 In apparent recognition of the particular issues facing CER in diagnostic imaging, PCORI commissioned, as part of the Methodology Committee’s preparation of Methodology Standards, a report on Standards in the Design, Conduct and Evaluation of Diagnostic Testing for Use in Patient Centered Outcomes Research.⁷ Coming out of that work, the Methodology Committee included five standards for studies of diagnostic tests in its Draft Methodology Standards report, published on the PCORI website on July 23, 2012.

Likewise, PCORI’s inaugural research funding call for the Assessment of Prevention, Diagnosis and Treatment Options notes that “diagnostics continue to evolve in tandem with advances in science and technology that enhance understanding of biological systems and disease. Emerging today are entirely new categories of diagnostics, based on full continuum of care and personalized medicine approaches.  The rapid pace at which these new options are introduced and the diversity of new technologies raise questions about the role and added benefit of these new options for guiding clinical decisions and changing patient outcomes…Some new diagnostic technologies have potential uses for a wide range of conditions, but the evidence base demonstrating benefit for these new indications fails to keep pace with use.”⁸

Important opportunities exist for the radiology community and health care service providers to broaden the scope of those engaged in research and capitalize on external funding opportunities. As Mathers et al indicated, “There will be a significant financial impact on radiology if it fails to respond to the consumer and government agendas regarding patient involvement in health care.”⁵ While those study authors hypothesized that one likely barrier to greater outcome research in radiology was lack of funding, the advent of PCORI in the United States represents an important redress. It also serves as a clear invitation for an expanded cohort of clinicians and other health care professionals to get involved in and seek external funding for patient-centered comparative effectiveness research.

Look for Part 2 in our series on radiology outcomes research grants. The follow-up article will focus on best practices in seeking external funding.

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Sarah Howden is the Grant Development Manager on the GEHC Healthcare Economics and Reimbursement team.