Project Summary

One of PCORI’s goals is to improve the methods that researchers use for patient-centered outcomes research. PCORI funds methods projects like this one to better understand and advance the use of research methods that improve the strength and quality of comparative effectiveness research.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the project about?

Cluster randomized trials, or CRTs, are research studies that compare treatments among different groups of patients, or clusters. An example of a cluster is a group of people who receive care at a single clinic.  

CRTs often look at patient-centered outcomes, such as quality of life or physical function. Sometimes people with serious illness who are enrolled in CRTs may die during the study. When data are missing due to death, it is hard to measure how the treatment affected patient-centered outcomes. Missing data due to death can also bias results.

In this study, the research team is creating new methods, software, and guidance for researchers on how to analyze CRT data when data are missing due to death.

How can this project help improve research methods?

Methods and software from the project can help researchers accurately measure patient-centered outcomes in CRTs.

What is the research team doing?

In the first part of the study, the research team is creating and testing new methods to account for CRT data that are missing due to death. The team is comparing results from the new methods with those from existing methods. To do so, the team is simulating trials with data that look like data from real-world CRTs. The team is testing the new methods with data from 10 real CRTs.

The research team is reviewing results from the first part of the study with patients, caregivers, researchers, and funders. With their input, the team is creating guidance for addressing CRT data that are missing due to death. Finally, the team is creating software for analyzing patient-centered outcomes in CRTs.

Research methods at a glance

Design ElementsDescription
GoalTo develop and test methods and software for addressing CRT data that are missing due to death
ApproachSimulation analysis, empirical analysis, software development

Project Information

Michael Harhay, PhD, MPH, MA, MS
Trustees of the University of Pennsylvania
Methods to Analyze Patient-Centered Outcomes Missing Due to Death in Cluster-Randomized Trials

Key Dates

November 2020
June 2025


Award Type
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: February 7, 2024