- The PCORI Strategic Plan
- Our Programs
- Our Vision & Mission
- Financial Statements and Reports
- The PCORI Strategic Plan
- Board of Governors
- Methodology Committee
- Authorizing Law
- Evaluating Our Work
- PCORI's Advisory Panels
- Procurement Opportunities
- Draft Key Questions: Systematic Review of Audio Care for the Management of Mental Health and Chronic Conditions (2023)
- Patient-Centered Economic Outcomes Landscape (2023-2024)
Past Opportunities to Provide Input
- Proposed New Methodology Standards for Usual Care as a Comparator (2023)
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
Patients and those who care for them have more options than ever before for managing medical conditions. Making informed choices among different treatment options can be a challenge and, sometimes, frustrating. The decision-making process ideally would take into account the best evidence available about the benefits and harms of any approach, as well as a patient’s individual characteristics, values, and preferences. Most people want to be involved in decisions about their health care, but many patients and their families feel distanced or excluded from choices about which tests they’ll get, which medicines they’ll take, and which procedures they’ll undergo.
Increasingly, shared decision making is being used to address these concerns. In shared decision making, a clinician provides a patient with information about diagnostic or treatment options, including potential benefits and harms, in a form the patient finds easy to understand. The patient is prompted to explain his or her preferences about the potential outcomes that can be expected given those options, concerns about how and where care is delivered and ability to get back to normal activities, and other issues of importance to him or her. The clinician and patient then discuss which diagnostic or treatment plan makes the most sense given the patient’s preferences.
Testing Approaches to Shared Decision Making
At PCORI, we’re interested in the potential for shared decision making to enhance and support patients’ involvement in healthcare decisions. We were established to fund studies that will produce evidence to help patients and those who care for them make better-informed choices about their healthcare options. Those studies compare different clinical options and care approaches to determine which work best, for whom, under which circumstances, with a focus on the health outcomes most important to patients. Part of our research focus considers specific ways to help patients, caregivers, and clinicians to communicate more effectively about their healthcare options, including studies comparing different approaches to shared decision making.
Some Questions That Research on Shared Decision Making May Address
Patient—I’ve had lower back pain for more than a year and am thinking about surgery, but I also want to learn about other options. I don’t like taking painkillers every day, but I worry that surgery will keep me out of work for a long time. How can I let my doctor know what’s important to me, so we can reach the decision that works best?
Clinician—Some of my patients don’t take the medications I prescribe. How can I most effectively understand what issues keep them from taking their medications and talk to them about a medication plan that they will be willing to follow?
Health-System Administrator—I’m convinced that shared decision making leads to better health outcomes and that patients adhere to their medication plans better, but how can I make it easier for our clinicians to follow that approach?
Given that focus, we’re pleased to have supported the latest issue of the journal Health Affairs, which addresses patient and consumer use of evidence in making healthcare decisions. This special theme issue includes research papers and commentaries by several of our awardees and others involved in our work. You can read those articles, and others, free of charge through our website.
To date, we’ve funded 71 patient-centered comparative clinical effectiveness research (CER) studies that have a significant shared decision making component. These projects focus on a wide range of conditions, including cancer, cardiovascular disease, mental and behavioral health, and multiple chronic conditions. The patients included in these studies range from children to those over age 80.
Some of the approaches compared in our studies are designed for patient use, and others target both patients and their clinicians. The projects include materials and activities designed for use in a range of settings, from homes to hospitals to the general community, and in various forms, from print to online. They address different stages health care: prevention, screening, diagnosis, treatment, care transitions, survivorship care, surveillance, and end-of-life care.
Getting People the Information They Need
A first step in encouraging patients and caregivers to participate as full partners in health decisions is to provide them with accessible information they can use. In some cases, such as with reports from genetics labs, the results are complex and presented in technical language that is difficult for many primary care physicians, much less patients and their families, to understand. So in one study we’ve funded, researchers are comparing how well a standard report on children with genetic disorders compares with a new type of personalized report, designed with the parents in mind, in facilitating communication between families and doctors and improving patients’ health.
Some PCORI-funded Projects Addressing Decision Aids
Information also can be provided through decision aids, a specific type of interactive tool for shared decision making. PCORI is funding a variety of projects (see box) that compare the effectiveness of decision aids in presenting understandable evidence about available treatment options, helping patients clarify their values and preferences, and encouraging patients and clinicians to communicate effectively. There’s no question such studies can be useful; past research has shown that patients who use decision aids are better informed about their options, have more accurate perceptions of risk, make decisions better aligned with their goals and preferences, and are more comfortable with their decisions. But we still need better evidence about which kinds of tools might work best for particular patients given their specific concerns and desired outcomes.
PCORI-funded research is designed to address such questions. One study, presented at the 2016 American College of Cardiology (ACC) Scientific Sessions, is particularly intriguing in that it is testing the impact of a simple, one-page decision aid in the high-stress atmosphere of the emergency department. Specifically, it helps people who came in with chest pain—but have not had a heart attack—to decide, after talking to the doctor about their individual circumstances, what, if any, additional tests to undergo. The researchers reported at the ACC meeting that their tool increased patients’ knowledge about their circumstances and options and resulted in a safe reduction in follow-up testing.
Putting Shared Decision Making into Practice
A Presidential commission first used the term shared decision making in 1982 to describe patients’ inclusion in deliberations about healthcare options. Yet even today, although many clinicians agree that the process will improve patient outcomes and satisfaction, they have been slow to incorporate it into their practices because of concerns about how to fit it into the clinical visits. Studies suggest that clinicians are concerned, for example, about the time that shared decision making will take and their patients’ ability to understand medical concepts.
How can healthcare providers be convinced to incorporate shared decision making into their everyday practice and provided with the information and tools they need? One PCORI-funded project introduces clinicians to a toolkit promoting shared decision making in asthma care. The study compares the effectiveness of a traditional dissemination method versus a new method that includes facilitators. Taking advantage of a partnership between a statewide Medicaid network and a consortium of North Carolina research networks, this project will include 30 primary care practices.
The value of shared decision making relies on the availability of reliable evidence to patients, caregivers, and clinicians. We are working to ensure that the results of PCORI-funded projects not only produce that evidence but can help us better get information out to those who need it to improve patient care and outcomes.
What's Happening at PCORI?
The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.