Early this year, we initiated a program to expand our support of patient-centered comparative clinical effectiveness research (CER). We are looking to fund real-world, large-scale trials designed to address critical questions faced by patients, caregivers, clinicians, and delivery systems. We want these studies to provide information that can be directly adopted by healthcare providers. We are now releasing our third PCORI Funding Announcement (PFA) for such large pragmatic studies.

The studies must focus on diverse, representative patient populations and take place within typical clinical care and community settings. The research must compare the effectiveness of two or more alternatives for improving patient-centered outcomes and be large enough to detect small but important differences between alternatives, as well as detect these differences in important patient subgroups.

To ensure that the proposed projects address crucial clinical questions, the PFAs include PCORI Priority Topics. We also remain open to other important CER topics, such as those listed in the Institute of Medicine (IOM) Priorities for CER and the Agency for Health Care Research and Quality (AHRQ) Future Research Needs Projects, in addition to those identified by specific stakeholder organizations, including payers and purchasers of health care.

In this third cycle of large pragmatic trial PFAs, we add to our previous list of PCORI Priority Topics. The topics have been vetted by staff and the PCORI Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options, a 21-member panel that includes caregivers, patient-caregiver advocates, clinicians, researchers, organizational providers, and representatives from payers, industry, and purchasers.

The new topics are:

• Medical versus invasive procedures for asymptomatic carotid artery disease: Compare the effectiveness of aggressive medical treatments with invasive procedures, in patients with asymptomatic carotid artery disease, in terms of stroke rates and other patient-centered outcomes
• Surgical options for hip fracture in the elderly: Compare the effectiveness of different surgical treatments in elderly patients with hip fracture, in terms of functional and other patient-centered outcomes
• Pelvic floor mesh implants: Compare the effectiveness of the use versus non-use of surgical mesh in repair of pelvic floor dysfunction and of different types of mesh using different surgical techniques, in terms of infections, urinary or fecal incontinence, bowel injury, pain, sexual function, and other patient-centered outcomes

We hope that our new, full list of topics will spur creative, powerful ideas for project proposals. Letters of Intent will be screened for their fit with program goals. Only those applicants selected through that screening will be invited to submit full applications. See full details in the PFA.

Ip is a Senior Program Officer in PCORI’s Clinical Effectiveness Research Program
Hickam is Program Director of PCORI’s Clinical Effectiveness Research program