Results Summary

What was the research about?

Researchers can use data from patient registries to look at which medicines or other treatments work best. Registries store data about people with a specific health problem. The data may include the health care and medicines patients receive over time and patient reports of their health status.

To find out patients’ health status, registries ask patients to fill out surveys at different times during treatment. Researchers can compare survey results from when patients first take the survey with results from surveys taken after treatment. They can then find out how well a medicine works. But patients may not always take the first survey before they start a new medicine. Sometimes, they don’t take the first survey until after starting treatment. When this happens, it is hard to know how well the medicine works.

In this study, the research team looked at different ways to use data from patient surveys in registries. The team wanted to learn which way would give the most accurate understanding of the effects of a new medicine. The study also looked at patients’ views on taking part in registries.

What were the results?

Estimating the effects of medicines. The most accurate understanding of a medicine’s effects came from using surveys completed at the time closest to the start of a new medicine. It didn’t matter if patients completed the survey before or just after they started to take the new medicine. Both ways worked well when used for predicting if the medicine will work.

Patient views on taking part in registries. Patients said they would take part in registries if

  • They knew they were helping others
  • Their own care might benefit
  • Taking the survey was easy

Patients who spoke Spanish reported concerns about taking part in registries. Concerns included being guinea pigs and not trusting the translators.

Patients under age 45 preferred receiving surveys by email, internet, or phone app. Those older than age 65 preferred mailed paper surveys. Patients aged 45–65 had mixed preferences.

What did the research team do?

The research team created a computer program. The program compared 13 different ways to include data from patient surveys in registries. The team wanted to see which way worked best to learn a medicine’s effects. To check the results of the computer program, the team looked at real registry data for patients with rheumatoid arthritis, or RA.

Then, the team gave a survey to 150 registry patients with RA and 169 registry patients with inflammatory bowel disease, or IBD. The survey asked for patients’ views about taking part in registries. In each group, 95 percent of people who took the survey were non-Hispanic white. In addition, 83 percent of patients with RA were women, and 62 percent of patients with IBD were women. The average age of patients with RA was 62; the average age of patients with IBD was 43. Patients lived in Boston, Massachusetts.

What were the limits of the study?

The study only looked at one type of data from patient surveys for two health problems. The results may differ for other types of data. Future studies could look at using patient survey data from patient registries for other health problems.

Most people who took the survey were non-Hispanic white. Results may be different for people of other races and ethnicities. Future research could ask people from other races and ethnicities about taking part in patient registries.

How can people use the results?

The results of this study may help researchers use patient survey data from patient registries to get the most accurate understanding of a medicine’s effects. Researchers may also use the results to encourage people to take part in patient registries.

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 investigator’s changes in response included the following:

  • The awardee restructured the report to more clearly describe the different projects in the study. This included adding an overview section describing how the report’s organization reflects previously published work.
  • The reorganization helped the awardee clarify for reviewers that the projects represented three separate aims. The awardee provided more information on the focus group project. The investigator also indicated to reviewers that the other projects take a novel approach and examine analytic methods directly.

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 investigator’s changes in response included the following:

  • The awardee restructured the report to more clearly describe the different projects in the study. This included adding an overview section describing how the report’s organization reflects previously published work.
  • The reorganization helped the awardee clarify for reviewers that the projects represented three separate aims. The awardee provided more information on the focus group project. The investigator also indicated to reviewers that the other projects take a novel approach and examine analytic methods directly.

Conflict of Interest Disclosures

Project Information

Daniel H. Solomon, MD, MPH
Brigham and Women's Hospital
$888,534
10.25302/9.2019.ME.13035602

Key Dates

56 months
September 2013
June 2018
2013
2018

Study Registration Information

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PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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Last updated: October 20, 2021