A growing number of our funded research studies are now producing important results that are being summarized in leading medical journals and presented at major scientific meetings. Here are some of those studies and their findings.
Image
Some adults and youth with severe obesity are unable to lose enough weight with diet and exercise to improve their health. There are different types of weight loss, or bariatric, surgeries that may help them lose weight and address other issues related to obesity, such as diabetes. However, such surgeries carry various risks.
A PCORI-funded study led by researchers at Kaiser Permanente Washington Health Research Institute compared two of the most common types of bariatric surgery: (1) Roux-en-Y gastric bypass (RYGB), or gastric bypass, and (2) sleeve gastrectomy (SG), or sleeve surgery. In a January 2020 JAMA Surgery article, the research team detailed five-year outcomes of patients who underwent either RYGB or SG, finding that RYGB patients were significantly more likely than SG patients to end up back in the hospital in the years following surgery. In a March 2020 JAMA Surgery article, the team discussed diabetes remission outcomes among patients who underwent RYGB and SG surgeries.
The research team's PCORI-funded Implementation project is designed to make the results of the original research study part of the decisions patients make with their doctors about weight loss surgery.
Learn more about how this study used vast data from PCORnet®, The National Patient-Centered Clinical Research Network, to study outcomes among the three most common weight-loss surgeries. In addition, find out more in this Q&A with study Principal Investigator David Arterburn, MD, MPH, about the study's findings and bariatric surgery guidelines for patients with type 2 diabetes. Hear more about the research study and Implementation project from Dr. Arterburn through these four videos.
A pair of Evidence Updates is now available that can help clinicians and patients work together to make informed decisions regarding patient care.
Image
African-American children are more likely than other children to have asthma and to get sicker and die from it. For their PCORI-funded study, researchers at Washington University in St. Louis enrolled 206 African American children and teens ages 6-17 with mild persistent asthma.
Results from the study support existing evidence that children with mild asthma can self-manage their condition by using medications when their symptoms occur. This contrasts with the traditional method of taking a medication daily, regardless of symptoms, and using an inhaler when symptoms arise. As reported in The Journal of Allergy and Clinical Immunology, the study focused exclusively on African-American children, who have traditionally been underserved in research and have had worse asthma-related health outcomes than other children.
A pair of Evidence Updates is now available to help support conversations between parents and clinicians about choosing the best option for managing mild persistent asthma in children.
Image
Depression is common among patients with kidney failure and is associated with poor outcomes including higher risk of kidney function decline, hospitalization, and death. A PCORI-funded research team at the University of Washington studied patients with kidney failure undergoing maintenance hemodialysis.
The team found that patients with depression who received the antidepressant medicine sertraline had modestly better depression scores and improvements in other patient-reported outcomes, compared with patients with depression who received cognitive behavioral therapy. However, patients on sertraline also reported more frequent mild to moderate adverse events, according to the findings published in the Annals of Internal Medicine.
A pair of Evidence Updates is now available to help support conversations between patients and/or their caregivers and clinicians about treating depression while receiving maintenance hemodialysis.
Image
People with cardiovascular disease who took aspirin to lower their chances of having a heart attack or stroke experienced similar health benefits, including reduced death and hospitalization, whether they took a high or low dose of the medication, according to findings from the PCORI-funded ADAPTABLE Study, the largest aspirin dosing trial conducted in routine care and clinical settings. The results were presented at ACC.21 – the American College of Cardiology’s 70th Annual Scientific Session – and simultaneously published in the New England Journal of Medicine in May 2021.
The study is also the first randomized controlled trial conducted using PCORnet®, the National Patient-Centered Clinical Research Network. Read more about the study in this blog post and watch a video featuring the study's co-investigator.
In addition, learn more about the findings in this news release, at TheAspirinStudy,org or through these English or Spanish results summaries.
Image
People with serious mental illnesses often struggle to receive care to address common chronic physical health problems. Certain serious mental illnesses may make it hard for people to work or live on their own or to arrange for health care. These problems can be worse if language or cultural issues are barriers to receiving care.
This PCORI-funded study's research team compared two types of care to help these patients: integrated care—physical and mental health care at the same clinic—and integrated care with a peer navigator. Peer navigators have backgrounds similar to patients and help patients find and use healthcare services. Overall, people who worked with peer navigators improved more than people who didn’t, reporting better physical health and empowerment. They also scheduled more appointments with clinicians, which could help them avoid emergency room visits.
In this PCORI Story, read about how this project and three others are testing ways to help people with serious mental illness get the physical health care they need.
Image
Parkinson’s disease is the second most common neurodegenerative condition in the United States, affecting 1 to 2 percent of people over age 60. This disease can cause poor balance; shaking in the hands, legs, or face; and pain, fatigue, dementia, and depression. Progress has been made in treating patients’ motor symptoms. But gaps remain in addressing other patient concerns.
This PCORI-funded project compared the effectiveness of team-based outpatient palliative care to current standards of care for people living with Parkinson’s disease. The palliative care intervention included quarterly visits with a team that included a neurologist, social worker, chaplain, and nurse who used checklists to assess and manage palliative care.
The project team reported in JAMA Neurology that, compared to usual care that used a neurologist and primary care practitioner, patients receiving palliative care at six months had improvements in their quality of life, symptom control, grief, and advance care planning. Caregivers had improved anxiety and spiritual well-being at six months and reduced caregiving burden at 12 months. A related editorial calls palliative care "the next frontier" in treating Parkinson's disease.
Through a Dissemination and Implementation award, the program is now being rolled out as part of standard care at 34 medical centers designated as Centers of Excellence by the Parkinson’s Foundation. The centers vary in size, type, staffing, and resources to support staff, and serve diverse patient populations.
In visits to residents’ homes, community heath representatives provide health education and basic healthcare services. (Courtesy of COPE)
According to the U.S. Department of Health and Human Services, American Indian/Alaska Native adults are almost three times more likely than non-Hispanic white adults to be diagnosed with diabetes.
In response, this PCORI-funded study trained laypeople known as community health representatives to coach and help coordinate care for people in their own Navajo communities. Because many of the communities are rural, there are geographical challenges with access to health clinics.
As reported in International Journal for Equity in Health, compared to those not in the program, people in it lowered blood sugar and cholesterol levels at a greater level, and they also were more likely to make and keep appointments with doctors and other health providers. This blog post provides additional insight into the study and others like it that are focused on the health of people living in the Navajo Nation.
Image
Lung cancer is one of the most common and deadly cancers, causing more deaths than colon, breast, and prostate cancers combined, according to the American Cancer Society. Treatment requires an array of specialists. One promising approach is multidisciplinary care, in which all of the specialists involved in a patient’s care work together to develop a coordinated treatment plan. Leading cancer organizations recommend this approach, but questions remain about its effectiveness and how to best implement it.
Results from a PCORI-funded study suggest patients receiving multidisciplinary care—in which pulmonologists, oncologists, radiologists, and surgeons meet to design a care plan with patients and their families—get more-thorough procedures to pinpoint the stage of their cancer than those who see specialists through a sequence of referrals. As a result, the multidisciplinary treatment that patients receive is more appropriate for their stage of cancer. Finally, patients who received multidisciplinary care and their caregivers also were more satisfied with their overall care.
In this PCORI Story, read about how the research team found that with up-front treatment planning among the different specialists, patients get treatment that is more appropriate for their cancer’s severity
Image
People with a serious mental illness (SMI) may have difficulty with daily activities. In this study, the research team compared two programs to help people with SMI manage their symptoms. In the FOCUS program, people used a smartphone app.
In the Wellness Recovery Action Plan, or WRAP, program, people went to group sessions at a clinic. They wanted to see if one program was more effective at helping patients get the care they need.
As published in Psychiatric Services, participants assigned to the smartphone program were more likely than those assigned to the clinic-based program to start treatment—90 percent versus 58 percent—and remain fully engaged in eight weeks of care—56 percent versus 40 percent.
Participants in both groups improved significantly and did not differ in clinical outcomes. The increased engagement by the telehealth group suggests that the smartphone-based treatment plan may help increase access to care for patients with SMI.
Image
In this study, the research team found that video house calls were an effective way for people with Parkinson’s disease to get care from specialists. Most patients reported being satisfied or very satisfied with care they received during video house calls.
After 12 months, there were no differences between patients who received video house calls and those who didn’t in quality of life, quality of care, or amount of caregiver burden.
Compared with patients who had in-person visits at clinics, patients who used video house calls spent less time traveling to doctor visits. Patients who used video house calls also spent more time talking with specialists during visits.
Now, through a Dissemination and Implementation project, the research team is expanding its telehealth services to include visits with doctors and nurses who specialize in conditions that often accompany Parkinson’s disease, such as dementia and depression.
Read a PCORI Story on the original research study and watch a PCORI Video interview with the study's principal investigator about his D&I project.
Image
More than 70 percent of adults with uncomplicated appendicitis were able to safely delay surgery for at least three months by taking a course of intravenous antibiotics, according to early results from The CODA Study published in the New England Journal of Medicine.
Researchers issued the results early in response to its relevancy to patients and healthcare providers during the coronavirus pandemic.
The study found that health outcomes associated with antibiotics and appendectomy were similar. The majority of patients on antibiotics also missed less time away from work or school. However, nearly 30 percent who received antibiotics ultimately needed surgery and this group experienced more emergency department and hospital visits than the appendectomy group The study was conducted at 25 sites nationwide and involved a wider range of patients than previous studies, making its results more broadly applicable to typical patients with appendicitis.
An accompanying editorial—noting the timing of the release of the results and the American College of Surgeon’s recent guidance on triage of nonemergency surgical procedures during the pandemic—states that “it will be important to ensure that some people, in particular vulnerable populations, are not offered antibiotic therapy preferentially or without adequate education regarding the longer-term implications.”
View a summary of the early findings from the study. In addition, listen to an episode of “Behind the Knife: The Surgery Podcast,” during which members of the research team discussed the early results of the trial. Listen on Apple Podcasts or Spotify.
Image
A PCORI-funded study in Texas has shown that a decision aid delivered through tobacco quitlines effectively reaches a screening-eligible population and results in informed decisions about lung cancer screening.
The researchers devised the patient-centered decision aid to help smokers choose between screening options based on what is most important to them, and then compared its effectiveness versus a traditional brochure that answered common questions about screening.
As the research team reported in JAMA Network Open, compared to the group that received the brochure, patients who used the decision aid were markedly more prepared to make a screening decision.
Because the findings suggest that decision aids about lung cancer screening can reach—and significantly help—large numbers of smokers who are eligible for screening through tobacco quitlines, this project has received a PCORI Dissemination and Implementation Award to spread the decision aid to eight state tobacco quitlines.
Image
Two studies in Tennessee and in North Carolina provide men with robust new evidence about the rates of side effects associated with contemporary treatment options for prostate cancer. These options include robot-assisted surgery and newer forms of radiation therapy, as well as active monitoring instead of immediate treatment. The study’s findings can help men better weigh the benefits and risks of their options in consultation with their clinicians.
Two papers (first paper, second paper), one on each study, appeared in a March 2017 issue of JAMA. A related JAMA editorial states, "To date, men with clinically localized prostate cancer have never been better informed about the trade-off they have to make between oncological outcomes and now clearly defined potential adverse effects of available treatments."
Funding from the Agency for Healthcare Research and Quality extended the follow-up period for study participants to expand the evidence base from this project. JAMA published these results in January 2020.
Find out how men with prostate cancer helped shape one of these studies in a PCORI Story and a PCORI video.
Image
Giving broad-spectrum antibiotics to children with acute respiratory tract infections did not achieve better outcomes than using narrow-spectrum antibiotics, but did increase the rate of harmful effects, a PCORI-funded study found. Earaches, strep throat, and other respiratory tract infections commonly occur in children. Broad-spectrum antibiotics target a wider range of bacteria than narrow-spectrum drugs that target only certain ones, but broad-spectrum carry a somewhat greater risk for creating drug-resistance among bacteria.
The study results published in JAMA support the use of narrow-spectrum antibiotics for most children with these infections. Learn more about this study in a PCORI feature story, and through evidence updates, which are created and disseminated to important stakeholder groups to better present the highlights and context of findings from the study.
Image
Use of antibiotics to treat infections in infants and toddlers was associated with only a small amount of weight gain by age 5—a difference of less than a pound in children of average height and weight who received four or more courses of antibiotics, compared to children who received none, this study found.
This new study is the largest to tackle the issue to date, involving data from more than 360,000 children from 35 health systems nationwide accessed using PCORnet. Because antibiotics are used to promote growth in animals, concerns arose that their use to treat infants’ and toddlers’ infections may be contributing to childhood obesity. Previous studies have had conflicting results. The results appear in Pediatrics.
Although the study alleviates concerns about weight gain as a factor in decision making about antibiotic use in children, other concerns, such as antibiotic resistance, remain important considerations.
Image
Despite ongoing efforts to improve care, medical errors—mistakes that may or may not harm patients—are a leading cause of death nationally. Improving communication in the hospital can help reduce errors.
Past research has focused on how staff communicate with each other, but few studies have focused on how staff communicate with patients and families.
To that end, a PCORI-funded research team tested a program called I-PASS that includes parents as active participants in pediatric unit rounds at eight hospitals to see whether it would improve hospital safety. As The BMJ reports, the program reduced harmful medical errors—preventable adverse events—by 38 percent.
The research team now plans to expand the program to more hospitals through a second PCORI award. In this video, project Principal Investigator Christopher Landrigan, MD, MPH describes his study.
Image
Blood thinning drugs lower patients’ risk of developing a potentially fatal blood clot during their stays in a hospital. Missing prescribed doses, either because patients decline to take the drugs or a healthcare provider skips doses, is associated with an increased risk of blood clots.
This study looked at data from more than 19,600 patients’ hospital stays. It found that prompting healthcare providers not to skip doses resulted in a significant decrease in missed doses. And giving educational information about the drugs to patients—through a conversation with a provider or a video or printed pamphlet—significantly increased the chances that patients took all doses.
The findings have been published in JAMA Network Open.
Image
A randomized trial offered important insights about how to improve advance care planning among people with complex medical situations, especially when language or cultural barriers get in the way.
Researchers developed a culturally tailored, Spanish version of a website, PREPARE, to help Spanish-speaking patients decide what goals are important to them and talk to their providers about those goals.
As the research team reported in JAMA Internal Medicine, their study showed that the website helped Spanish-speaking patients to do advance care planning better than giving them only written forms to state their wishes. The website also enabled them to begin planning on their own without assistance from healthcare staff.
Image
Adults with psoriasis, a chronic skin condition, who used an online program to get care from dermatologists and their primary care providers experienced the same level of improvement as patients who got in-person care in a clinic, this study found. The collaborative online program tested enabled both patients and primary care providers to share and discuss information with the specialists.
In previously studied forms of teledermatology, specialists have not had direct contact with patients. These findings add to evidence about the potential for telehealth to serve as a more widely accessible and convenient addition or alternative to in-person visits with specialty and primary care providers to manage chronic disease. The results appear in JAMA Network Open.
Image
Having a mechanical pump called a left ventricular assist device (LVAD) surgically implanted can prolong the lives of people with end-stage heart failure. But the surgery and the device carry significant risk for harms, such as infections and stroke, making choosing whether to get one very difficult.
Using a shared decision making tool focused on LVAD improved patients’ knowledge about their treatment options’ potential benefits and risks compared to typical educational pamphlets given to patients, this PCORI-funded study found.
The decision aid also helped them make initial decisions better aligned with their values. The results were reported in JAMA Internal Medicine.
Image
Chronic pain disproportionately affects people with less education and low incomes. This PCORI-funded study found that such patients were able to more effectively manage chronic pain after receiving simplified versions of either cognitive behavioral therapy (CBT) or pain education compared to those who got usual pain care. CBT and pain education offer nondrug approaches to help manage chronic pain, a condition that is associated with an alarming surge in opioid use disorders.
CBT and pain education also resulted in improved physical function and lower depression. The study also demonstrated that CBT and education can be simplified to serve patients with limited reading skills without losing their effectiveness.
Results appear in the Annals of Internal Medicine. A related editorial says this study is important because it heeds the call to resolve disparities in pain treatment. Learn more about how these results can help address disparities in pain care in a PCORI feature article.
Image
The finger pricks that many people with type 2 diabetes do daily to check their blood sugar levels confer little value compared with forgoing this self-monitoring, this study concluded.
There has been debate about how much this self-monitoring enhances the health of people with non-insulin-dependent type 2 diabetes, and whether the benefits exceed the inconvenience and discomfort of daily finger pricking, anxiety it can induce, and financial burdens of out-of-pocket costs for the testing equipment. In results that augment findings of previous research, the study found that self-monitoring achieves no significant differences in disease control, hospitalization rates, need to start using insulin, or quality of life.
The results appear in JAMA Internal Medicine. An accompanying editor’s note says, "This important study. . . illustrates how patient-centered clinical research can address clinical problems."
An Evidence Update is now available that can help patients make informed decisions about regular blood sugar-level checks.
Image
Although chest pain sends many people to the ER, a significant percentage are not having a heart attack or other serious heart problems. Using a questionnaire called Chest Pain Choice proved effective in helping such individuals decide whether to forgo unnecessary hospital stays and intensive medical tests.
People who used the questionnaire were more knowledgeable about their risk and care options and more involved in their care decisions than people who didn't use it, this study found. There were no differences in rates of heart-related problems in the following weeks between the two groups.
Results appear in The BMJ. A Medscape commentary describes the tool as a “win-win-win” for patients, providers, and payers. Learn more about how these results can help patients and clinicians make decisions about chest pain in a PCORI feature article.
Image
Long-term use of opioids, particularly in high doses, for treating chronic pain increases the risks for addiction and overdose. Healthcare providers need guidance about what works to help patients manage their pain and to avoid or minimize the risks associated with opioids.
This study in Washington state compared clinics that implemented an initiative focused on more-cautious opioid prescribing to clinics that did not.
Physicians following the initiative prescribed fewer high doses of opioids. The results appear in the Journal of Pain. Learn more about how these results can help advance safer opioid prescribing in a PCORI feature article.
Image
If clinicians routinely collected data about sexual orientation from patients, it would significantly boost our ability to identify and address health disparities among lesbian, gay, and bisexual populations. However, health systems are not regularly collecting this information.
The EQUALITY Study determined that while 80 percent of healthcare professionals believe patients would refuse to provide sexual orientation information if asked, only 10 percent of patients say they would refuse. The researchers also suggested that hospital staff can use these results to design a process to ask patients about sexual orientation and gender identity, adding that regularly asking all patients about SO/GI may make patients feel more comfortable sharing this information.
The results appear in JAMA Internal Medicine and LGBT Health.
The New York Times also has a feature on the study.
A behavioral health home can improve health and wellness for people with mental illness
A behavioral health home, a patient-centered way of coordinating care resources, can help people with serious mental illnesses manage their conditions, potentially enabling them to live longer, healthier lives. This PCORI-funded study showed that two ways of providing a behavioral health home to patients with serious mental illnesses, such as bipolar disorder and schizophrenia, are both effective.
The study compared a patient self-directed approach, in which patients used a variety of online resources to manage their health care, to a provider-supported approach, in which patients met with nurses and other clinical staff about managing their care. Both approaches significantly increased patients’ knowledge and confidence to manage their own care, with provider-supported care doing so more quickly. Both approaches also improved patients’ perceived mental health status and increased their engagement in primary and specialty care.
An article published in Health Affairs highlights the study’s results. The research team is exploring ways to implement the behavioral health home model to people who receive care in residential treatment facilities and who attend opioid treatment programs.
Standing exercises improve older adults’ walking skills better than sitting ones
As people age, they face an elevated risk of losing their independence through increasing difficulty in getting around. Exercise may help preserve mobility, but programs offered to older adults typically involve exercises that they do while sitting down.
This PCORI-funded study compared the effectiveness of a standing exercise program called On the Move with a seated exercise program. It found that On the Move, with its focus on enhancing motor skills and muscle control necessary for walking, was more effective than the seated exercise program at improving older adults’ function and walking ability in the short term.
Although the On the Move group reported a few minor injuries and a somewhat greater discontinuation rate, those in it reported feeling equally safe and satisfied with the more challenging program. The results appear in JAMA Internal Medicine.
Oral antibiotics work as well as IV with fewer costly complications
Children taking antibiotics to prevent recurrence of serious infections could remain infection-free, and their families could face fewer costly complications and daily hassles with medical equipment, if the children took the drugs by mouth rather than receiving them through an intravenous line, according to this study.
The results appear in JAMA Pediatrics, Pediatrics, and Annals of Surgery. A JAMA Pediatrics commentary says, "the investigators have provided very necessary information about how we can best organize and deliver care to children with a relatively common pediatric diagnosis while improving outcomes, reducing costs and untoward effects, and improving patient satisfaction."
Learn more about how these results can inform decisions about treating these infections in a PCORI feature article and a PCORI video.
Blood thinner helps stroke survivors stay in their homes
Using the blood-thinning medicine warfarin enabled stroke survivors, even those over 80, to continue living in their homes longer compared with those who didn’t take the drug, the PROSPER study found. Those taking warfarin stayed in their homes on average 46 more days during the two years after being hospitalized for stroke. Patients advising the researchers said that staying in their homes, rather than being institutionalized in a nursing home or hospital, is the outcome that mattered most.
The findings appear in The BMJ. A related editorial calls the study “a solid example of how to refocus research on questions, outcomes, and approaches that could help patients and clinicians to make better healthcare decisions."
Learn more about how these results can help stroke survivors gain time at home in a PCORI feature article and a PCORI video.
Pinpointing which people with prediabetes will benefit from preventive drug
Using a benefit prediction model, researchers in this study could identify those patients with prediabetes who are most likely to benefit from taking the diabetes drug metformin—and those likely to suffer more harm than good. Although usually safe, metformin causes a potentially serious side effect called lactic acidosis in some people. Knowing which patients won’t benefit from the drug could reduce the number of people who experience this side effect.
The paper appears in The BMJ. The incorporation of this benefit prediction model into an electronic health record is now being tested in 50 clinics via this dissemination project.
Learn more about how these results can help identify who benefits from medicine in a PCORI feature article.
Linking people with community resources to reduce childhood obesity
Two approaches to obesity care helped to reduce body mass index (BMI) scores in children who are overweight or have obesity. Both approaches also improved other key health measures and family satisfaction with the children’s care.
This study's two approaches both enhanced the usual primary care for childhood obesity by linking families to community resources and sending supportive text messages. Some of the families also received bimonthly coaching on healthy behaviors, which resulted in slightly but not significantly greater reductions in their children’s BMI scores.
Results appear in JAMA Pediatrics. Learn more about this study in a PCORI feature article.
What's Happening at PCORI?
The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.
Image
