The Latest Published Results from Our Funded Projects
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- About PCORI
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Provide Input
- Draft Key Questions: Systematic Review of the Impact of Doula Support During Pregnancy, Childbirth and Beyond (2024)
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Past Opportunities to Provide Input
- Patient-Centered Economic Outcomes Landscape (2023-2024)
- Systematic Review of Audio Care for the Management of Mental Health and Chronic Conditions (2023) -- Draft Key Questions
- 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)
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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)
- Leadership
When I last updated you on the latest scientific journal articles summarizing results of our funded studies, I told you how excited we were to see this fast-growing body of evidence that can help patients and those who care for them make better-informed healthcare decisions. I’m pleased to tell you that the flow of published papers continues to accelerate and to share with you some of the more-recent publications summarizing results from our awardees that can help improve care and outcomes.
A Decision Aid for Patients with Heart Failure
A report just published in JAMA Internal Medicine describes findings from a study at the University of Colorado School of Medicine on shared decision making for patients with end-stage heart failure. Nearly 6 million Americans are living with heart failure. These patients face complex decisions about their care with big trade-offs, but until now, there was little available to help patients understand the benefits and harms of their choice—a daunting position to be in.
The Colorado research team developed a decision aid intended to help patients who are ineligible for a heart transplant to consider the pros and cons of a left ventricle assist device (LVAD), a surgically implanted pump that attaches to the heart to help it move blood. Patients who choose LVADs tend to live longer than those who decide not to have the device implanted. But LVADs come with serious risks, including infection, stroke, and additional surgeries. Patients with LVADs also must carry a pump with them at all times. And because patients with heart failure often have other serious health problems, an LVAD might make only a small difference in life expectancy.
The research team reported that patients who used the decision aid made more-informed choices about whether to choose an LVAD. Six hospitals and 248 patients tested the decision aid, which asks patients and caregivers about their priorities, presents objective information about outcomes of choosing or opting against an LVAD, and is used along with training for doctors and nurses on how to talk about LVAD. The hospitals switched to the decision aid from existing pre-LVAD education—usually pamphlets from the companies that make the LVADs.
After using the decision aid, patients were more likely to opt not to choose an LVAD. Those willing to undergo risky surgery for a chance to extend their lives were more likely to choose an LVAD; those who didn’t want to be dependent on a machine were more likely to decline.
Previously, patients had reported feeling pressured and helpless when deciding whether to proceed with an LVAD. The results of this study can help alleviate such concerns. It also suggests that when patients receive useful information they can use in making the decision best for them, they will be more confident about choosing not to have a major procedure.
Treatment Options for Inflammatory Bowel Diseases
Nearly 3 million Americans have inflammatory bowel diseases, which can cause long-term diarrhea and stomach pain. Crohn’s disease (CD) and ulcerative colitis (UC) are two of the most common types, and they occur when the immune system attacks the intestines.
Clinicians usually prescribe one of two types of drugs to treat CD and UC: corticosteroids or medications called tumor necrosis factor inhibitors, also known as anti-TNF drugs. Now, a PCORI-funded study gives a sense of which type is better for each of these conditions.
Researchers at the University of Pennsylvania compared insurance claims from more than 13,000 patients with CD and UC who took anti-TNF drugs or long-term steroids. The researchers reported in the American Journal of Gastroenterology that the long-term risk of death was significantly lower for anti-TNF therapy among patients with CD, but not for patients with UC. Among patients with CD, anti-TNF therapy also produced lower rates of serious heart problems and hip fracture.
For patients with UC, the study didn’t find a difference between the two treatments in the risks of death, heart problems, or broken hips. Patients taking anti-TNF drugs had more emergency surgeries and hospital visits for health problems related to UC than patients taking long-term steroids did.
This study provides new data to help clinicians and patients understand the pros and cons of the two common treatments for inflammatory bowel diseases. We think this tailored information can help patients make better, more personalized choices in how to proceed with treatment.
Improving Care for Serious Mental Illness
Compared with the general population, people with serious mental illness often have more health problems—many of which may be undiagnosed—and live shorter lives. A PCORI-funded study compared two ways to help members of this vulnerable population who receive mental health care at behavioral health homes to stay on top of their care.
A behavioral health home—a team-based form of care that incorporates the patient, providers, and caregivers, and integrates primary and behavioral health care—can help patients with severe mental illness manage their health problems. But little evidence exists about whether these homes help patients meet the goals that are most important to them, or whether they work well in rural community mental health centers.
As you can see, we’re getting important results with the potential to change practice and improve patient outcomes.
Researchers at the University of Pittsburgh Medical Center recruited 1,200 adults insured through Medicaid who had serious mental illness and received care at one of 11 rural community health mental centers. All 11 centers participated as behavioral health homes and focused on wellness. In addition to the core parts of the behavioral health home, patients at six of the centers self-directed their health care using a variety of online self-management tools and peer support. Patients at the other five centers used provider-directed care; these patients met with nurses about managing their health care.
After about two years, patients at both types of clinic reported improved mental health, the research team reported in Health Affairs. Participants also had a 36 percent increase in doctor visits after completing the program, suggesting an increased capacity for addressing their healthcare needs.
This project suggests that such patients can improve their outcomes using self-management tools or meeting with nurses, and we’re thrilled more than 40 practices across Pennsylvania have adopted the study’s care model.
Tackling Chronic Pain While Reducing Opioid Use
Chronic pain and opioid overuse are among the nation’s most serious health challenges. Opioid overdoses killed more than 42,000 Americans in 2016, the highest number on record. And 40 percent of all opioid overdoses involved a prescription drug.
PCORI’s research portfolio includes studies that tackle the challenge of chronic pain from many angles. We have funded 65 comparative clinical effectiveness studies addressing chronic noncancer pain management or opioid use.
Researchers at a health plan in Washington State led a study that found that patients who received care at clinics with a dose-reduction and risk-monitoring initiative reported no worse pain than those who attended clinics with no specific dose-reduction efforts. The initiative aimed to lower the highest opioid doses among the clinics’ patients. The study examined patient-reported outcomes among 1,600 patients using opioids for chronic pain and reported results in the Journal of Pain.
To our knowledge, this is the first study to evaluate the effects of a clinical policy initiative that implemented an opioid dose-reduction and risk-monitoring strategy, and its results could inform other health plans’ efforts to combat the opioid epidemic.
Study Finds Usefulness of Pain Education and Therapy for People with Low Incomes
Finally, let me mention another project related to chronic pain with newly published results. In an article in Annals of Internal Medicine last month, a PCORI-funded team at the University of Alabama reported that, compared with standard medical therapy, group sessions providing either cognitive behavioral therapy or pain education helped people dealing with chronic pain. Importantly, the study took place with patients who are economically disadvantaged in western Alabama. Previous studies had found therapy to be effective in treating pain, but these studies hadn’t focused on people with low literacy and low income.
The study involved 290 people randomly assigned to receive medical treatment, medical treatment plus education, or medical treatment plus cognitive behavioral therapy for 10 weeks. Compared with people who received medical treatment only, more people who received group sessions of either type reported lower pain intensity at the end of the sessions. People who attended education or therapy sessions also reported better physical function than people receiving usual care. Depression symptoms eased in people who attended group sessions, but they were not significantly different among the three groups. Most improvements held steady at a follow-up six months later. It is encouraging to note that treatments other than opioids can reduce the symptoms of chronic pain and improve physical function.
Much More to Come
As you can see, we’re getting important results with the potential to change practice and improve patient outcomes. As the uptick in our funded results continue to increase, we’ll have even more exciting updates to share. I hope you’ll check back regularly.