Children’s Hospital of Philadelphia (CHOP) has been approved for research funding from the Patient-Centered Outcomes Research Institute (PCORI) to study kidney stone surgical intervention. CHOP pediatric urologist Gregory Tasian, MD, MSc, MSCE will serve as one of the principal investigators of the OASIS trial, which will evaluate the benefits of either surgery or observation for patients with asymptomatic, non-obstructive kidney stones.
Once thought of as an adult diagnosis, kidney stones in children have been on the rise for the past few decades. The Divisions of Urology and Nephrology at CHOP manages and treats children with kidney stones daily.
Patients with asymptomatic kidney stones – kidney stones that are present but not causing pain – may experience pain and disruptions in their lives when stones move and obstruct the kidney or when they undergo surgery to remove them. These disruptions, which can include emergency department visits, hospitalizations, and unplanned surgeries, may lead to short-term disability, financial strain, and a decline in physical, emotional, and social health.
Currently, these patients are managed by either observation with periodic CT, ultrasound or x-ray studies and routine clinical visits, or upfront surgical removal. While both options are safe, experts in the medical community disagree about the relative merits of either of these methods, and there is a lack of evidence establishing if one strategy is superior to the other.
CHOP will serve as the data coordinating center for the trial with CHOP’s Tasian and urologist Ryan Hsi, MD, a urologist at University of California-Irvine, co-leading the study. Dr. Tasian is Professor of Surgery and Epidemiology, director for the Center for Outcomes Research in Surgery (CORES), and Co-Associate Director for Clinical Trials at Clinical Futures, a CHOP Research Institute Center of Emphasis. Dr. Tasian and his collaborators are evaluating whether observation, compared with upfront surgery, results in less healthcare-related disruption among children and adults with asymptomatic kidney stones. The study will also identify which groups benefit most from each strategy and the preferences and values that inform the choice between observation and upfront surgery.
The OASIS trial will involve 30 medical centers across the PCORnet clinical research network and aim to enroll patients who are at least 6 years old with asymptomatic, non-obstructive kidney stones between 4 to 10 mm. The three main aims of the OASIS trial are to compare life disruption via both methods, understand variability in treatment effects via both methods, and explore patient preferences as determined through in-depth interviews.
“This study will provide us with valuable insights into the decision-making processes of patients,” Tasian said. “Consequently, researchers and clinicians will be better equipped to guide patients' thought processes while empowering them and their caregivers with knowledge that will help them make more informed treatment decisions. We believe this information will ultimately enhance their health. Our aim is to build trust with patients and caregivers while educating them to make better-informed choices regarding their health and the health of their loved ones.”
The funding for the OASIS study has been approved pending completion of PCORI’s business and programmatic review and issuance of a formal award contract.
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Children’s Hospital of Philadelphia (CHOP) has been approved for research funding from the Patient-Centered Outcomes Research Institute (PCORI) to study kidney stone surgical intervention. CHOP pediatric urologist Gregory Tasian, MD, MSc, MSCE will serve as one of the principal investigators of the OASIS trial, which will evaluate the benefits of either surgery or observation for patients with asymptomatic, non-obstructive kidney stones.
Once thought of as an adult diagnosis, kidney stones in children have been on the rise for the past few decades. The Divisions of Urology and Nephrology at CHOP manages and treats children with kidney stones daily.
Patients with asymptomatic kidney stones – kidney stones that are present but not causing pain – may experience pain and disruptions in their lives when stones move and obstruct the kidney or when they undergo surgery to remove them. These disruptions, which can include emergency department visits, hospitalizations, and unplanned surgeries, may lead to short-term disability, financial strain, and a decline in physical, emotional, and social health.
Currently, these patients are managed by either observation with periodic CT, ultrasound or x-ray studies and routine clinical visits, or upfront surgical removal. While both options are safe, experts in the medical community disagree about the relative merits of either of these methods, and there is a lack of evidence establishing if one strategy is superior to the other.
CHOP will serve as the data coordinating center for the trial with CHOP’s Tasian and urologist Ryan Hsi, MD, a urologist at University of California-Irvine, co-leading the study. Dr. Tasian is Professor of Surgery and Epidemiology, director for the Center for Outcomes Research in Surgery (CORES), and Co-Associate Director for Clinical Trials at Clinical Futures, a CHOP Research Institute Center of Emphasis. Dr. Tasian and his collaborators are evaluating whether observation, compared with upfront surgery, results in less healthcare-related disruption among children and adults with asymptomatic kidney stones. The study will also identify which groups benefit most from each strategy and the preferences and values that inform the choice between observation and upfront surgery.
The OASIS trial will involve 30 medical centers across the PCORnet clinical research network and aim to enroll patients who are at least 6 years old with asymptomatic, non-obstructive kidney stones between 4 to 10 mm. The three main aims of the OASIS trial are to compare life disruption via both methods, understand variability in treatment effects via both methods, and explore patient preferences as determined through in-depth interviews.
“This study will provide us with valuable insights into the decision-making processes of patients,” Tasian said. “Consequently, researchers and clinicians will be better equipped to guide patients' thought processes while empowering them and their caregivers with knowledge that will help them make more informed treatment decisions. We believe this information will ultimately enhance their health. Our aim is to build trust with patients and caregivers while educating them to make better-informed choices regarding their health and the health of their loved ones.”
The funding for the OASIS study has been approved pending completion of PCORI’s business and programmatic review and issuance of a formal award contract.
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Kaila M. Revello
Division of Urology