PCORI approves $70M for patient-centered research

What is the most effective way to treat chronic migraines while preventing medication overuse? Would motivational text messages from a doctor’s office help diabetes patients better manage their conditions? What is the optimal dose of aspirin to prevent heart attacks and strokes? The answers to those questions may soon be available, thanks to the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors, which approved $70 million in awards for nine, patient-centered research projects for various conditions ranging from asthma to breast cancer.

PCORI

PCORI is an independent, non-profit organization established by section 6301 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). It funds research to provide patients, caregivers, and clinicians with information to make better-informed health care decisions. PCORI has dedicated over $1.2 billion to research funding.

Pragmatic Clinical Studies

Five of the research projects were awarded funding as part of PCORI’s initiative to support pragmatic clinical studies (pragmatic studies), which are aimed at producing results that are relevant to a broader range of patients and care settings and that are easy to adopt. The studies are conducted in more routine clinical settings rather than in specialized research centers and use study participants that are similar to typical patients.

All of the pragmatic studies work with national advocacy organizations, professional associations, payers, and other key stakeholders to design and implement their studies so as to speed up the dissemination and application of the results.

Breast Cancer

One of the newly approved pragmatic studies will compare treatment options for individuals diagnosed with ductal carcinoma in situ (DCIS), which is an early stage, localized type of breast cancer. The study will examine whether women who undergo active surveillance have the same invasive cancer rate as those who undergo traditional treatments, such as surgery and radiation. It will also compare the mastectomy rate, survival endpoints, and quality of life endpoints between the two groups.

Chronic Migraines

Another study seeks to find an effective treatment for sufferers of chronic migraines who overuse their medication. The study will look at two methods of treatment, and determine whether an early discontinuation of overused medication combined with migraine prophylactic therapy is more effective than continuing the overused medication during the therapy.

“We’re strongly committed to supporting large-scale projects that will provide patients and those who care for them with the useful, authoritative evidence they need to make the better-informed health and health care decisions,” said PCORI Executive Director Joe Selby, MD, MPH.

Clinical Data Research Networks

PCORI also awarded $6.7 million to three Clinical Data Research Networks (CDRNs) that are members of PCORnet, which is the organization’s initiative to establish a national, patient-centered clinical research network. The award will help the CDRNs study how population-targeted health policies and interventions impact complications, risks, and disparities relating to type II diabetes. The projects will be part of the new, Natural Experiments Network (NEN), which is collaboration between PCORI, the Centers for Disease Control and Prevention, and the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The research projects are aimed at assisting policy makers and community leaders prioritize policies so as to prevent diabetes.

Additional Studies

The PCORI Board also approved $5.2 million in funding for a study that will examine whether motivational text messages or diabetes wellness coaches more effectively assist African-American patients in managing uncontrolled diabetes.

A study that seeks to identify the optimal dose of aspirin to prevent heart attacks and strokes in heart disease patients also received $3.8 million. The award will fund expanded trial activities and will recruit patients who have no Internet access. It is estimated that finding optimal aspirin doses could save thousands of lives.

PCORI notes that all of the awards were approved pending review by its staff and the issuance of formal award contracts.