The Patient-Centered Outcomes Research Institute (PCORI) is pushing forward with a nearly $66 million effort designed to improve comparative effectiveness for studies tackling topics such as severe obesity, different treatments for appendicitis, and potentially deadly blood clots in patients undergoing hip and knee surgeries.

The nonprofit corporation has approved $56.7 million for four large, patient-centered studies, as well as $9 million for two studies on obesity—one to examine three common types of bariatric (weight-loss) surgery and a second that looks at the relationship between antibiotic use in the first two years of life and weight gain later in childhood.

In addressing questions on the treatment and prevention of obesity, both multiyear studies use the National Patient-Centered Clinical Research Network (PCORnet), an amalgam of patients, clinicians, researchers, health systems and data. The network allows a range of clinical research studies “to be conducted more efficiently and less expensively than traditional research by harnessing the power of clinical data gathered in real-world patient care settings,” according to PCORI.

In May, the first PCORnet study was launched to compare the long-term benefits and harms of a low- and regular-strength daily dose of aspirin in patients diagnosed with heart disease.

“The results of this study, to be conducted in a variety of clinical settings, will help patients and those who care for them make better decisions about how aspirin therapy might be most helpful,” said Adrian F. Hernandez, M.D., director of outcomes and health services research at the Duke Clinical Research Institute and the study’s co-Principal Investigator.
PCORI maintains its network also can conduct observational research studies faster with patient privacy protection and with greater volumes of data than current conventional studies.

“We find that when you have a trial that is attractive to patients—in asking questions that address their needs—you are more likely to find they are willing to participate. Plus we engage the key decision makers early on so they will be inclined to work with us,” said Joe Selby, M.D., MPH, PCORI executive director. “In turn, when the study ends, we see them as disseminating the information, along with our posting findings in both lay language and in scientific publications.”

Selby said four recently approved and funded studies support PCORI’s “pragmatic clinical studies,” which are relevant to a broad range of patients and clinical care settings for easier adoption in routine clinical practice. They will support studies comparing:

The safety and effectiveness of antibiotics versus surgery in treating patients with uncomplicated appendicitis. Although surgical removal of the appendix has been the standard treatment for130 years, recent studies in Europe—five randomized trials involving more than 1,000 patients—have shown that using antibiotics alone to treat appendicitis can result in acceptable outcomes without the need for surgery in most people. While evidence in Europe supports the use of antibiotics alone, studies show that 35% to 50% of people starting antibiotics-first eventually ended up having an appendectomy. The PCORI study is a large-scale, pragmatic, randomized controlled trial comparing appendectomy to antibiotics first for the treatment of uncomplicated appendicitis. Partners in the study include the American College of Surgeons and the American College of Emergency Physicians.

The safety and effectiveness of three blood-thinning drugs used to prevent potentially deadly blood clots in patients undergoing hip and knee replacement, particularly the risk of bleeding from raw, bony surfaces that are created when the joint replacement is done. At issue is whether to use weak or strong blood thinners to reduce the risk of bleeding in that setting. The study’s objective is to combine information about effectiveness in preventing clots in the lungs and legs, and considers how patients recuperate after hip and knee replacements and the opinion of patients about the safety of the most commonly employed blood thinners. The study is expected to have 25,000 patients undergo elective hip or knee replacements.

Different approaches to getting patients with post-traumatic stress disorder and bipolar depression the mental health care they need. Community health centers in rural areas face substantial challenges in managing patients with those two conditions due to the lack of onsite mental health specialists and poor geographical access to specialty mental health services. The central question is whether it’s better for offsite mental health specialists to support primary care providers’ treatment of patients with PTSD or bipolar disorder through an integrated care model, or to use telemedicine technology to facilitate referrals to offsite mental health specialists. PCORI has stated that it will be the largest study of rural Americans with psychiatric disorders ever to be conducted involving 1,000 primary care patients. They will be screened for positive PTSD or bipolar disorder and recruited from 15 community health centers in Washington, Michigan and Arkansas. Telephone surveys will be given to patients at enrollment and at six- and 12-month follow-ups.

Two strategies for getting patients in rural and underserved areas the behavioral healthcare they need to see which works better. Behavioral problems can include tobacco use, diet, physical inactivity, alcohol abuse, drug abuse, sleep treatments, depression and stress. While some patients can be helped, the nation’s current healthcare system doesn’t do a good job of getting the right care to those patients. Some people with behavioral needs may be referred to mental health or substance-abuse specialists, but that method often is unacceptable to patients. Two newer methods involve the use of co-location—in which a behavioral health clinician is located near a physician practice, so a patient will get help—or a behavioral health clinician who is specially trained to work closely with the medical provider as a full member of the primary treatment plan. The aims of the project are to 1) compare the two methods to see which one has better outcomes for patients, 2) see if a structured process to help practices offers a behavioral health clinician help, and 3) explore how the type of practice and the healthcare system influence how well integration works.

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 33, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »