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.

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.

Project Purpose

There are a lack of data on peripheral arterial disease (PAD) to inform patients about how those with similar characteristics have fared and how alternative treatment options can impact the outcomes that they care most about. To address these needs, a detailed, patient-centered registry was built to document patients’ disease-specific health status, symptoms, function, and quality of life.

This study had three objectives: (1) to obtain input from PAD patients to refine the research design and prioritize study outcomes; (2) to develop and test a screening mechanism with which to identify patients with new onset PAD or an exacerbation of PAD symptoms; and (3) to develop and test a centralized follow-up process for PAD patients who enrolled in the study via vascular outpatient clinics.

Study Design

To address Objective 1, researchers conducted focus groups with patients from different backgrounds recruited from PAD specialist clinics. Participants included a cross-sectional sample of patients who underwent treatments or received a diagnosis of PAD in the past year. The researchers partnered with patients to define the data elements, research design, and outcome measures most relevant to them.

To address Objectives 1 and 2, researchers conducted a prospective cohort study. They implemented a screening process and integrated a centralized follow-up process to track patients’ health status over time. Follow-up measurements occurred at 3 and 6 months.

Participants, Interventions, Settings, and Outcomes

Patients were required to have a Doppler resting ankle-brachial index (ABI) ≤0.90 or a significant drop in post-exercise ankle pressure of ≥20 mmHg. Other inclusion criteria were new or recent exacerbations of exertional leg symptoms and age ≥21 years. Exclusion criteria were a non-compressible ABI ≥1.30, critical limb ischemia, having had a lower-limb endovascular or surgical procedure within the last year, lack of fluency in English, hearing impairment, or being unable to provide written informed consent. Patients were asked to participate upon first visiting the PAD clinic, before treatment was started.

Participants were seen in outpatient specialty care settings (cardiology, interventional cardiology, or vascular surgery) at the Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, and Yale University Medical Center, New Haven, Connecticut.

Main outcomes collected in this multicenter registry were focused on patient-centered outcomes related to patients’ PAD—their symptoms, functioning, and quality of life.

Data Sources

Clinical exam data were abstracted from patients’ medical records.

Data Analysis

Focus groups were recorded, and all recordings were transcribed. Members of a multidisciplinary team independently coded the transcribed text and reviewed session notes. A code book was created that defined all of the codes representing key themes from the discussions. A log book was kept to structure all of the responses for each thematic area. After identifying the set of codes, a visual display of key nodes (i.e., terms used to classify the overall themes and subthemes) and attributes was created. Following the individual coding process, researchers reviewed conclusions drawn from qualitative data with the whole team. Conclusions were evaluated in the context of the complete data set and were modified whenever discrepancies were identified.

Findings

A total of 28 patients participated in 7 focus groups (Objective 1). Participants were 12 women and 16 men whose ages ranged from 51 to 86 years. The racial and ethnic backgrounds represented were as follows: 14 African Americans, 3 Hispanics, and 11 Caucasians. Three main themes emerged: (1) PAD symptom unawareness in both patients and doctors caused significant delays in receiving both a diagnosis and treatment; (2) patients reported that PAD had a substantial impact on their daily functioning and prioritized symptom relief, improved walking, and quality of life as key outcomes; and (3) inadequate patient–physician communication and a lack of information about treatment options and outcomes were frequently reported. With regard to study design, facilitators of study participation included encouragement by their doctors to participate in the study and phone follow-up. Barriers to participation included transportation costs and the need for family members to take off time from work.

The screening process (designed based on input from the focus groups) was tested at each participating center and found to be an efficient process to capture patients who were eligible for study participation (Objective 2). For the prospective cohort study (Objective 3), researchers successfully enrolled 80 patients within the proposed deadlines. The follow-up rate was 84% at 6 months follow-up.

Limitations

Although follow-up rates were relatively high, some participants were lost to follow up, suggesting that additional strategies may be necessary to maximize retention. Evaluating case record forms for redundancy and sending out patient newsletters are two additional strategies that might improve retention.

Another limitation was that, despite efforts to identify barriers to enrolling patients with Hispanic ethnicity (e.g., the need for translations, making extra funds available for screening and recruitment), it was difficult to enroll this hard-to-reach group.

Conclusions

Insights from a diverse sample of PAD patients can guide registry development by defining what outcomes PAD patients value most, how best to develop the screening and research design, and how to be maximally inclusive of a wide variety of PAD patients.