As of November 2019, our Board of Governors has approved about $494 million to fund more than 40 Pragmatic Clinical Studies. Among these large, patient-centered comparative clinical effectiveness research projects are studies that seek to answer critical questions such as:

  • Whether breast cancer screening tailored to women’s individual risks and preferences detects cancer and minimizes “false alarms” as well or better than routine annual screening.
    Laura J. Esserman, MD, MBA; University of California, San Francisco.

  • How well the use of a pair of medicines—roflumilast and azithromycin—work in preventing serious episodes of chronic obstructive pulmonary disease, and to understand the benefits and harms of long-term use.
    Jerry A. Krishnan, MD, PhD; University of Illinois at Chicago

  • The comparative effectiveness of active surveillance of patients diagnosed with ductal carcinoma in situ (DCIS) versus immediate treatment with surgery or radiation.
    Shelley Hwang, MD, MPH; The Alliance for Clinical Trials In Oncology Foundation.

  • The comparative safety and effectiveness of using antibiotics versus surgery to treat patients with uncomplicated appendicitis.
    David Reed Flum, MD, MPH; University of Washington.

  • Whether regional anesthesia in the spine or general anesthesia results in better outcomes and fewer complications among older adults undergoing hip fracture surgery.
    Mark D. Neuman, MD, MS; University of Pennsylvania.

  • The comparative effectiveness of more intensive versus less intensive surveillance via CT scanning to accurately detect lung cancer while minimizing potential harms in patients with potentially cancerous growths detected on their lungs.
    Michael K. Gould, MD, MS; Kaiser Foundation Research Institute.

  • How various breast cancer screening methods—digital mammography alone or with tomosynthesis—compare based on the density of women’s breast tissue and whether preoperative MRI imaging enhances evaluation of an initial cancer.
    Diana Miglioretti, PhD; University of California, Davis.

  • Whether adding the diabetes drug metformin to a healthy lifestyle intervention is more effective than the lifestyle intervention alone in reducing weight gain and metabolic problems associated with certain antipsychotic medications used by youth with bipolar disorders.
    Melissa P. DelBello, MD, MS; University of Cincinnati.

  • Whether children with moderate to severe Crohn’s disease have better outcomes taking a biological therapy that targets tumor necrosis factor (anti-TNF) alone or taking a combination of anti-TNF plus a low dose of the drug methotrexate.
    Michael Kappelman, MD, MPH; The University of North Carolina at Chapel Hill.

  • The effectiveness of different approaches involving community health workers and tailored clinician education to help adults with serious mental illness quit smoking.
    Eden Evins, MD, MPH; Massachusetts General Hospital.

  • The effectiveness of proton beam therapy versus conventional photon radiation therapy in treating breast cancer and minimizing collateral damage to healthy organs and tissue.
    Justin Bekelman, MD; University of Pennsylvania.

  • The comparative effectiveness of routine daily use versus symptom-based use of an asthma medication for reducing symptom exacerbations in African American and Hispanic adults.
    Elliot Israel, MD; Brigham and Women’s Hospital.

  • Whether a comprehensive package of transitional care and in-home support services is more effective than usual care at improving stroke survivors’ functional abilities and preventing hospital readmissions.
    Pamela W. Duncan, PhD, PT; Wake Forest University Health Sciences.

  • The comparative effectiveness of two approaches to help people manage their chronic migraines and reduce the risk of medication overuse.
    Todd Schwedt, MD, MS; Mayo Clinic Arizona.

  • The comparative safety and effectiveness of three blood-thinning drugs commonly used to prevent potentially deadly blood clots in patients undergoing hip and knee replacement.
    Vincent Domenic Pellegrini, MD; Medical University of South Carolina.

  • Whether use of a standing-order entry system advising physicians when to prescribe an infection prevention medication to patients with breast, colorectal, or lung cancer receiving chemotherapy reduces over- and underuse of this medication and reduces rates of potentially serious infections.
    Scott D. Ramsey, MD, PhD; Fred Hutchinson Cancer Research Center.

  • The ability of an exercise coaching program versus usual care to prevent further injuries and improve health for older adults who have experienced a low-impact fracture as a result of a fall.
    Christopher Sciamanna, MD, MPH; Pennsylvania State University Hershey Medical Center.

  • The comparative safety and effectiveness of blood-thinning drugs commonly used to prevent potentially deadly blood clots in patients who have suffered broken bones.
    Robert O’Toole, MD, TRD; University of Maryland Baltimore.

  • Whether increased integration of behavioral health and primary care services or the co-location of providers improve health and mental health outcomes for patients with chronic conditions.
    Benjamin Littenberg, MD; University of Vermont and State Agricultural College.

  • Which intervention is more effective at preventing acute low back pain from progressing to chronic low back pain among at-risk patients: primary care based on clinical guidelines or primary care plus psychologically informed physical therapy.
    Anthony Delitto, PhD, PT; University of Pittsburgh.

  • Which of two approaches involving telemedicine works best to manage post-traumatic stress disorder and bipolar disorder in patients in rural primary care settings.
    John C. Fortney, PhD; University of Washington.

  • Whether surgery or physical therapy for rotator cuff tears better reduces pain and improves function in people age 50 or older.
    Nitin Jain, MD, MS, Vanderbilt University Medical Center.

  • Which of two approaches for transitioning patients who have had traumatic brain injury from the hospital to outpatient care best improves their ability to function and quality of life.
    Jeanne Hoffman, MD, PhD; University of Washington.

  • The comparative effectiveness of two cavity-prevention techniques when delivered in school-based programs to Latino and Hispanic children in areas with a scarcity of dental care providers and clinics.
    PI: Richard Niederman, DMD; New York University College of Dentistry

  • The comparative effectiveness two treatment options for people with psoriasis.
    Joel Mitchell Gelfand, MD, MS; University of Pennsylvania

  • The comparative effectiveness of two types of therapy to lessen problems with swallowing in patients undergoing radiation therapy for head and neck cancer.
    Rosemary Martino, PhD, Katherine Hutcheson, BA, MS, PhD; University Health Network, Toronto, Ontario

  • Which of two commonly available preoperative antiseptic skin solutions is better for reducing hospital-acquired surgical-site infections for patients undergoing surgery to fix a broken bone in a limb.
    Gerard Slobogean, MD, MPH; University of Maryland Baltimore
     

Posted: October 20, 2016; Updated: November 22, 2019

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