January 16, 2020
John S. Preisser, PhD, professor of biostatistics at the UNC Gillings School of Global Public Health has been approved for a funding award by the Patient-Centered Outcomes Research Institute (PCORI) to study incomplete stepped-wedge designs for pragmatic cluster-randomized trials (CRTs).
This award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
CRTs are commonly used in public health research since they can be more broadly applied to large population samples instead of individual subjects. They are particularly useful for assessing quality of care improvement programs and for evaluating interventions to improve outcomes for vulnerable populations, including prisoners, victims of trauma and violence, people with mental health concerns and the institutionalized elderly. However, the planning of these trials involves carefully balancing logistics and necessary resources with the need to maintain internal validity and reduce bias.
A stepped-wedge design is sometimes chosen for public health CRTs, especially when logistical or financial limitations prevent all participants in the sample from receiving treatment at the same time. Instead, treatment is introduced to clusters over a period of time. Most of the time, study planning methods account for a complete stepped-wedge design, where all clusters have data collected on outcomes in all periods. However, pragmatic CRTs often require intentionally incomplete stepped-wedge designs depending on the limitations of resources.
Preisser’s study plans to “formally quantify trade-offs involved when logistical, resource and patient-centered considerations are balanced against methodological implications” in CRTs that choose to employ an incomplete stepped-wedge design in healthcare intervention research.
“I am very excited to receive this PCORI funding award to work on methodological issues in incomplete stepped wedge designs through a research partnership of the Gillings School with the Duke University School of Medicine, the Dell Medical School of the University of Texas at Austin, and the Yale School of Public Health,” said Preisser.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options,” said PCORI Executive Director Joe Selby, MD, MPH. “We look forward to following the study’s progress and working with the Gillings School to share the results.”
Preisser’s study was selected for PCORI funding through a highly competitive review process in which patients, clinicians and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders and their methodological rigor, among other criteria.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.
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