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Past Opportunities to Provide Input
- Systematic Review of Audio Care for the Management of Mental Health and Chronic Conditions (2023) -- Draft Key Questions
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- Data Access and Data Sharing Policy: Public Comment (2017)
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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
While the United States has some of the best asthma care in the world, that care is not equally accessible to all children and families. Some communities have historically been left behind as we study what works in asthma care. But we are taking steps to change that through purposeful action to engage diverse communities in asthma studies.
Asthma is a chronic lung disease that affects more than 24 million Americans. It’s a lifelong problem that makes airways narrow, swell, and produce excess mucus. Allergens such as dust, mold, and pollen, which are commonly found in day-to-day life, can trigger asthma, resulting in coughing, wheezing, and difficulty breathing. Asthma attacks can lead to emergency room visits and can be fatal.
While great strides have been made in the asthma care that is available in this country, some communities have historically been left behind as we study what works in asthma care.
Conducting Research Studies with Diverse Participants
Asthma research studies must include diverse participants to ensure treatments will be safe and effective for all communities. New approaches to care can affect people differently based on their age, sex, racial and ethnic group, and health status. It is important for diverse participants to take part in research studies to show how asthma treatments work for different communities.
In 2013, PCORI’s first targeted funding announcement called for research on how to improve adherence to national guidelines for managing asthma, specifically in Black/African-American and Latino communities. Eight studies received funding. (See related blog post, Addressing Disparities in Health Outcomes of People with Asthma.) In a recent paper in the Journal of Allergy and Clinical Immunology, the eight teams behind the studies presented some of the lessons they learned about overcoming barriers to recruiting in a diverse set of communities for asthma research.
Unlike many other chronic diseases, asthma's symptoms can be intermittent or seasonal. So, patients without daily symptoms often do not realize they have asthma.Bradley Kramer and Alex D. Federman
Overcoming Recruitment Challenges
The eight project teams collaborated to better understand how to overcome shared obstacles. We discovered commonality among our patients and the reasons that they did not want to participate in research studies.
Here we highlight strategies to overcome common recruitment challenges:
Diagnosis Is the First Step
Some patients didn’t want to participate in research studies because they didn’t think they had asthma. Unlike many other chronic diseases, asthma’s symptoms can be intermittent or seasonal. So, patients without daily symptoms often do not realize they have asthma. Some do not recognize that the symptoms they have, such as coughing, are related to asthma. And others who know that they have a respiratory disease simply don’t recognize that it’s asthma. (See box below: A Patient Partner’s Report.)
To address this lack of recognition, researchers on our teams used two strategies. First, we changed the language we used in recruiting research participants. Instead of asking prospective participants whether they had asthma, we asked about breathing problems. Second, we asked patients to meet with their clinicians to get clarity on their diagnosis and how to treat it. Once patients recognized that they had asthma, they were more interested in participating in the research.
Linking Asthma to Other Issues
Some patients don’t consider asthma a serious problem, or they consider it secondary to managing other chronic conditions.
To engage these patients, recruiters emphasized other benefits of study participation. For example, some studies assisted with cockroaches or mold in the home, addressed other housing issues, or helped participants navigate the healthcare system. (See box below: Simple Changes Make a Big Difference in a Patient’s Health.)
Flexibility Is Key
Another barrier to study participation is the patient’s everyday life getting in the way. The demands of work, childcare, and transportation made recruitment difficult. This barrier sometimes prevented patients from keeping appointments. It even made it difficult to reach patients by phone.
We realized our projects would require flexibility. Recruitment would require extra time and resources. Study teams tried different times and different days of the week, including weekends, for recruitment calls. We sometimes sent text messages to figure out the best times for calling. Respecting patients’ time, our teams scheduled research appointments along with patients’ regular doctor visits or at convenient locations, such as home or work. Teams provided transportation and parking vouchers to cover costs. Finally, patients could reschedule appointments multiple times.
Understanding and Alleviating Participant Concerns about Research
Researchers from all eight studies encountered patients who didn’t want to participate in any kind of research. Each team tried to understand patients’ reasons, but patients were often not open to sharing. For some patients, the reason was a mistrust of medical research for historical reasons.
To address this barrier, our teams tried to maximize similarity in race and culture between study recruiters and patients. We also tried to build the recruiters’ appreciation of and empathy toward patients’ skepticism and mistrust. Recruiters acknowledged historical institutional racism and intentionally discussed research patients’ rights, confidentiality, and autonomy in research.
We also had success with emphasizing the study’s connection with known and trusted healthcare providers, for instance by sending recruitment letters on community health center letterhead. Finally, we made certain to discuss the study’s potential benefits and emphasize that this was not a pharmaceutical trial, since some patients were averse to being in a study of new medications.
The program has really changed my life. I can breathe better, and I can do so much more physically. It has been a blessing to me.Eugene Ford Study participant
Communication and Gaining Trust
In any recruitment effort, communicating effectively and gaining patients’ trust is a top priority. This is especially important when working with patients from varying socioeconomic backgrounds and with limited health literacy. Our patient advisory boards gave us feedback on how to improve our recruitment language and approach. We learned how to recruit in a way that would resonate with the potential participants and meet them where they are.
The lessons we learned about recruitment in these eight studies can apply beyond asthma. Researchers in other areas have encountered similar challenges in their work, and we hope our experience will help others more easily navigate challenges.
A Patient Partner’s Report
<p><em><a id="PatientPartnersReport" name="PatientPartnersReport"></a>Carol Allen is an asthma patient who is a public health professional at the King County Access to Baby and Child Dentistry Program. As a patient partner, she worked on </em><a href="/node/4305"><em>the PCORI-funded study</em></a> with <em>Bradley Kramer, MPA.</em></p>
<p>I have seen firsthand patients who don’t believe they have asthma. So many people don’t connect the dots to realize that their symptoms are directly related to asthma. I knew a patient who had left the doctor’s office with no idea that she had asthma. She had only been told that she had a cough. Then, a pharmacist handed her the prescribed medication with the word <em>asthma</em> on it.</p>
<p>Stories like this one are really valued by our principal investigators. As a patient partner, I felt my voice and partnership were respected and saw partners’ suggestions included in the study. For example, we thought it was key to have people on the research team who reflect the communities the study is serving. We recommended that we have community health workers who spoke the same language as study participants. The research team listened.</p>
Simple Changes Make a Big Difference in a Patient's Health
<p><em><a id="SimpleChanges" name="SimpleChanges"></a>Eugene Ford knows asthma well. An employee of MV Transportation at Microsoft, he has lived with and been treated for the chronic condition for more than 50 years. His doctor referred him to participate in the </em><a href="/research-results/2013/guidelines-practice-g2p-reducing-asthma-health-disparities-through-guideline"><em>PCORI-funded study</em></a><em> that Bradley Kramer, MPA, helps lead.</em></p>
<p>I have suffered from asthma all my life. I’ve been on every medication and even hospitalized. One time, after spending the night at someone’s house, it got so bad that I didn’t wake up until two weeks later, when I was in the hospital. It turns out the house had black mold that made my lungs so bad, doctors had to put me into a medically induced coma.</p>
<p>In the study, community health workers came into my home and observed. They sat down with me and gave me information that didn’t seem like much at the time, but after trying what they told me, I saw improvement in my breathing. Everything started getting better.</p>
<p>They gave me information on asthma triggers like dust and how often to clean. Before, I would only wash my sheets when they started to smell. Now, I wash them at least once a week and use mattress and pillow covers. They gave me a nice vacuum cleaner with a HEPA filter and showed me how to use it. I used to think that I was cleaning, but I wasn’t cleaning properly. Washing linens, vacuuming, and dusting—it makes a big difference.</p>
<p>The program gives you a complete grip on what’s going to help you. I’ve been to many doctors and specialists, and none of them gave me this. The program has really changed my life. I can breathe better, and I can do so much more physically. It has been a blessing to me.</p>
<p>Before, I couldn’t even get a job, my breathing was so bad. I couldn’t walk stairs. I spent a lot of time lying down. I used to see my doctor every two weeks about my asthma. Now it’s every four months.</p>
<p>It really bothers me that they are finishing up the study. I’m telling you, I would be willing to make donations myself just to help another person because I know the way that it has changed my life. There are other people out there who need the knowledge that the program is providing. This needs to go on.</p>
The views expressed here are those of the authors and not necessarily those of PCORI.
Updated: May 12, 2017
May 10, 2017, 11:32 AM
Comment by VIVAN Life Sciences,
Thanks for sharing this type of post. It's really good. Well done.
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