Results Summary

What was the project about?

Patient-reported outcome measures, or PROMs, ask patients how they feel and what activities they can do in daily life. Patients receiving cancer treatment, such as chemotherapy, often have side effects. PROMs can help cancer centers know if patients are getting high-quality care that helps manage their side effects.

In this study, the research team wanted to

  • Learn from patients and clinicians, like doctors and nurses, what side effects are important to track during chemotherapy
  • Create PROMs that can measure important side effects of chemotherapy

The research team also wanted to test the PROMs to see

  • If patients find them easy to complete
  • If the PROMs can detect differences in how well cancer centers control patients’ treatment side effects

What did the research team do?

First, the research team interviewed 124 patients, caregivers, clinicians, and healthcare administrators at six cancer centers. The cancer centers were in California, Connecticut, Florida, Minnesota, North Carolina, and Texas. The team asked which side effects from chemotherapy are most important to track.

Next, the research team reviewed existing PROMs that measure the side effects the group found important. Using PROMs found through the review, the team created 12 new PROMs.

The research team then tested a survey that included the new PROMs. The survey also asked if the PROMs were easy to complete and understand. Patients took the survey at home, online, or by phone after they started chemotherapy.

A total of 607 patients completed the survey. Of these, 73 percent were White, 14 percent were African American, 8 percent were Asian, and 5 percent were another race; 11 percent were Hispanic. Also, 62 percent of patients were under age 65, and 51 percent were women. All patients received care at the six cancer centers.

Patients, clinicians, and PROM researchers helped design the study and analyze results.

What were the results?

From the interviews, the most important side effects were pain, fatigue, and nausea and vomiting.

In filling out the survey

  • Ninety-six percent of patients said that the PROMs were easy to complete
  • Ninety-seven percent said that the PROMs were easy to understand
  • Seventy-two percent completed the survey without a reminder call, and 14 percent completed the survey after a reminder call

The PROMs detected differences between centers. Based on the 12 PROMs, one cancer center performed better than others, and one performed worse. However, not enough patients completed the survey to consistently compare the quality of care across cancer centers.

What were the limits of the project?

The study did not include enough patients to consistently compare quality across cancer centers. Future research could test the PROMS with more patients at different cancer centers.

How can people use the results?

Cancer centers can use these results when considering how to assess patients’ side effects during chemotherapy.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers asked the researchers to provide more information about disease severity among patient participants in the study. One reviewer noted that differences in disease severity among patients could affect the reliability measurements for the patient-reported outcomes measures under investigation. The researchers said that all patients had metastatic cancer and were high risk, but there was no additional information about differences in patient symptoms. The researchers acknowledged that variability in patient symptoms within each clinic site could affect reliability measures and modified their reliability calculations to account for patient-level factors. The researchers also moved their risk adjustment calculations step to occur before the reliability analyses. These changes in methods led to a reduction in the calculated reliability of the patient-reported outcomes measures.
  • The reviewers were concerned that the study did not ask clinicians about treatments for fatigue and loss of appetite, two symptoms that stakeholders identified as important. The researchers explained that clinicians do not have effective treatments for fatigue or loss of appetite related to cancer, although these are important and impactful symptoms in cancer care. The researchers felt that they could not evaluate the quality of cancer care based on these symptoms, however, because clinicians cannot control them.

Conflict of Interest Disclosures

Project Information

Ethan Basch, MD, MS
The University of North Carolina at Chapel Hill
$894,227
10.25302/09.2021.ME.150732079
Development and Evaluation of a Patient-Centered Approach to Assess Quality of Care: Patient-Reported Outcomes-based Performance Measures (PRO-PMs)

Key Dates

April 2016
July 2021
2016
2021

Study Registration Information

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Last updated: January 20, 2023