Results Summary

What was the research about?

Patient-reported outcome measures are surveys that ask patients about their health or well-being. These surveys may include questions about sleep, depression, or pain. Many of the surveys now in use don’t focus on a specific health problem.

The research team wanted to create and test a process for adapting patient-reported outcome measures for specific health problems. To test this process, the team developed surveys for two health problems, one for heart failure and one for knee arthritis.

What were the results?

The survey for heart failure had 86 questions in 18 categories. The new categories based on patient concerns were

  • Health behaviors
  • Illness burden
  • Independence
  • Life satisfaction
  • Symptoms

The survey for knee arthritis had 76 questions in 14 categories. The new categories based on patient concerns were

  • Independence
  • Life satisfaction
  • Symptoms

Testing the surveys with patients showed that

  • Patients understood the questions
  • Patients answered the questions similarly when they retook the surveys a few days later
  • The surveys accurately measured patients’ thoughts and feelings about the health problems and changes over time

Who was in the study?

The study included 847 patients with heart failure. Of these patients, 66 percent were white, 23 percent were African American, and 11 percent were other races. The average patient age was 56, and 44 percent of patients were female.

The study also included 979 patients with knee arthritis. Of these patients, 77 percent were white, 14 percent were African American, and 9 percent were other races. The average patient age was 57, and 63 percent of patients were female.

What did the research team do?

First, the team conducted focus groups with patients living with heart failure or knee arthritis. These patients gave feedback on what concerns related to their specific condition were missing from the general surveys now in use. Then the team wrote questions to fill those gaps. Next, the team interviewed some of these patients about whether the new questions were easy to understand and made changes based on patient recommendations. Finally, the team sent the surveys to patients across the United States. Three to seven days later, the team asked some of the patients to retake the surveys to see if they answered questions similarly. Other patients completed a follow-up survey after three months.

Patient advisors and doctors gave the research team feedback throughout the study.

What were the limits of the study?

The patients in the focus groups didn’t represent all the racial or ethnic backgrounds of people in the United States. People of other races or ethnicities may have different concerns. Future research could test the surveys with patients of different racial and ethnic backgrounds. Researchers could also create shorter versions of the surveys for use in health care.

How can people use the results?

Researchers can use the process developed in this study to create patient-reported outcome measures for other specific health problems.

Final Research Report

View this project's final research report.

More About This Research

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.

Reviewers’ comments and the investigators changes in response included the following:

  • In general, the reviewers found the report to be a comprehensive description of the patient-reported outcomes validation study.
  • The reviewers questioned the limited use of crosswalks, which are tables describing equivalent and differing items within two sets of items such as outcome measures. The reviewers questioned why the investigator used so few crosswalks between existing disease-specific measures and the newly created disease-specific items for PROMIS measures. The investigator explained that such crosswalks were possible only with measures of the same constructs. The investigator also explained that the measures the study developed were not consistently of the same constructs, limiting the use of crosswalks.
  • Some reviewers expressed concern that adding disease-specific items to the widely accepted PROMIS measures would dilute the value of generic measures that span disease and condition areas. The investigator responded by stating that it intended the new items to expand, not limit, the usability of PROMIS measures by including items that would speak to disease-specific experiences.

Conflict of Interest Disclosures

View the COI disclosure form.

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.

Reviewers’ comments and the investigators changes in response included the following:

  • In general, the reviewers found the report to be a comprehensive description of the patient-reported outcomes validation study.
  • The reviewers questioned the limited use of crosswalks, which are tables describing equivalent and differing items within two sets of items such as outcome measures. The reviewers questioned why the investigator used so few crosswalks between existing disease-specific measures and the newly created disease-specific items for PROMIS measures. The investigator explained that such crosswalks were possible only with measures of the same constructs. The investigator also explained that the measures the study developed were not consistently of the same constructs, limiting the use of crosswalks.
  • Some reviewers expressed concern that adding disease-specific items to the widely accepted PROMIS measures would dilute the value of generic measures that span disease and condition areas. The investigator responded by stating that it intended the new items to expand, not limit, the usability of PROMIS measures by including items that would speak to disease-specific experiences.

Conflict of Interest Disclosures

Project Information

Elliott S. Fisher, MD, MPH
Dartmouth College
$1,822,339
10.25302/4.2019.ME.13035928

Key Dates

46 months
September 2013
October 2018
2013
2018

Study Registration Information

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Last updated: October 20, 2021