PCORI-funded study will improve methods used to evaluate the health effects of different sequences of treatments for type 2 diabetes and other chronic conditions
The Kaiser Permanente Division of Research (DOR) will receive $1 million from the Patient-Centered Outcomes Research Institute (PCORI) to improve how investigators use electronic medical records to compare the clinical effectiveness of sequential treatment decisions used to manage type 2 diabetes and other chronic conditions.
The research will be led by Romain Neugebauer, PhD, a DOR research scientist and biostatistician whose work focuses on developing and applying causal and statistical methodologies to evaluate treatment effects in randomized experiments and observational studies. Co-investigators include research scientist Julie Schmittdiel, PhD, associate director of Health Care Delivery and Policy for DOR, and Mark van der Laan, PhD, and Toru Shirakawa, MD, of the University of California, Berkeley.
“The team that is leading this study has extensive experience working together to identify and address methodological gaps in the way we analyze electronic health record data,” said Neugebauer. “We are pleased to have this opportunity to build upon our prior work and develop methods that improve the reliability of evidence used by patients and clinicians to make informed health care decisions.”
This research project is among the latest methodology studies that PCORI has funded to address high-priority gaps in comparative clinical effectiveness research methods. These studies provide results that guide researchers in planning future studies and improve the strength and quality of evidence generated using these research methods.
“This research project was selected for its potential to address a high-priority methodological gap in patient-centered comparative clinical effectiveness research,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “Studies like this one advance the methods used to plan, conduct, and evaluate comparative clinical effectiveness research, strengthening the quality of evidence generated to help patients and those who care for them make better-informed health care decisions. We look forward to following the study’s progress.”
We are pleased to have this opportunity to develop methods that improve the reliability of evidence used by patients and clinicians to make informed health care decisions.
— Romain Neugebauer, PhD
PCORI’s mission is to fund patient-centered research that will help patients make evidence-based health care decisions. The funding award has been approved pending completion of PCORI’s business and programmatic review and issuance of a formal award contract.
The award will enable the investigators to develop and test sophisticated comparative effectiveness methods that provide actionable information to improve patient health outcomes. The new study builds on findings from the research team’s 3 prior PCORI-funded awards, including ON TARGET DM, which compared how well 4 different types of glucose-lowering medications reduce the risk of heart attack and stroke in people with type 2 diabetes.
The investigators will rely on a committee comprised of patients, clinicians, and health care delivery system leaders with diverse perspectives and experiences with the medical system to help guide their research. The framework for community engagement, which was developed by Schmittdiel, was used in the team’s prior PCORI-funded research.
“At DOR, we place the same high value on patient-centered research as PCORI,” said Schmittdiel. “The funding they have provided for this new study will allow us to build on our community’s experience and expertise to ensure that we are asking questions that will be the most relevant and useful to patients and clinicians.”
The investigators will continue to make their methodology available as free and open-source software with detailed online tutorials that will enable the broad adoption by investigators conducting comparative effectiveness analyses.
“Understanding cause and effect is crucial for knowing how to advance evidence-based care,” said Doug Corley, MD, PhD, chief research officer for The Permanente Medical Group. “The tools this team will create will improve outcomes by helping clinicians and patients make informed decisions about which treatments to use, and in what order.”
Added Corley: “Receiving funding from an organization as highly respected as PCORI is an endorsement of our unique ability to contribute to the conversation on how to improve comparative clinical effectiveness research.”
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About the Kaiser Permanente Division of Research
The Kaiser Permanente Division of Research conducts, publishes, and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and society at large. KPDOR seeks to understand the determinants of illness and well-being and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 720-plus staff, including 73 research and staff scientists, are working on nearly 630 epidemiological and health services research projects. For more information, visit divisionofresearch.kp.org.
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