Results Summary

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.

Background

Peripheral artery disease (PAD) is a disease in which a fatty material called plaque builds up in arteries. This makes it hard for blood to flow through the body. PAD is most common in the legs, but it can also be found in other parts of the body.

Researchers don’t know much about how PAD might be different for people of different ages, genders, or ethnicities. They also don’t know how different treatments for PAD address what matters most to patients.

Project Purpose

The researchers wanted to build a registry of people with PAD who would be willing to participate in research studies. The registry would track information about patients such as

  • Their disease status, using measures like blood pressure
  • What PAD symptoms they have, such as leg pain
  • How PAD affects their daily activities and their lives in general

The researchers also worked with PAD patients to figure out

  • What types of information to include in the registry
  • How to find patients with PAD, specifically patients who had just been diagnosed with PAD or who had PAD symptoms that were getting worse
  • How to track PAD patients who are getting care from specialty clinics

Methods

The researchers had seven group discussions with a total of 28 patients at specialty outpatient care centers in Missouri and Connecticut. The patients’ ages ranged from 51 to 86 years, and there were 12 women and 16 men. Fourteen participants were African American, three were Hispanic, and 11 were Caucasian. All the patients had been diagnosed with PAD in the past year and were starting treatment at a specialty clinic. People could take part in the focus groups if they were over 21 years old and had signs of new or worsening PAD in their legs. They were asked to join the study before beginning treatment at the clinic. People couldn’t join the study if they had PAD symptoms that were very serious, had leg surgery within the past year, couldn’t speak English well, had a hard time hearing, or did not confirm in writing that they wanted to take part in the study.

The researchers asked about the patients’ experiences with PAD, including how their PAD symptoms affected their daily activities and quality of life. They also asked the patients what information and outcomes were most important to them and what would make patients more or less likely to join a research study.

Based on what the researchers learned, they designed a registry to collect data on patient outcomes, a process to identify eligible patients with PAD, and a process for tracking patients. The researchers tested this registry process at the clinics they regularly partner with for research studies.

Findings

The researchers found three main themes that patients said were important to them when thinking about planning a study on PAD:

  • Patients and doctors sometimes don’t notice or recognize the signs of PAD, which can mean that patients don’t get diagnosed or treated for PAD right away.
  • PAD caused major changes in patients’ daily activities. Patients’ main priorities were getting help with the problems PAD causes, being able to walk better, and improving their quality of life.
  • Patients often had a hard time communicating with doctors, and they didn’t have enough information about their treatment options or what to expect with PAD.
  • Patients felt that getting encouragement from their doctors was helpful when deciding whether or not to join a study. Worries about the cost of transportation and need for family to take time off from work were reasons that they might not join a study. 

The screening process the researchers designed using patient input appeared to be effective at finding patients who could join the PAD registry. The research team also enrolled 80 patients in a study that would track them as they got care, and it was able to follow up with 84 percent of them six months later.  

Limitations

The focus groups included few Hispanic patients. The results might have been different if the researchers had been able to include a more diverse sample of people with PAD.

Importance of Findings

Input from patients helped create a disease registry that focused on what outcomes were most important to patients with PAD. It also helped researchers understand how best to find and include different types of patients in the registry and what types of challenges might come up in designing research studies.

Sharing the Results

The researchers plan to send information about the study’s key findings to the patients who were in the study. The team is writing papers and preparing conference presentations about the research.

Project Information

Kim G. Smolderen, PhD, MSc, BS
St. Luke's Hospital of Kansas City
$639,498
Patient-Centered Outcomes Recovery from Treating PAD: Investigating Trajectories

Key Dates

June 2012
December 2014
2012
2014

Study Registration Information

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State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022