Results Summary
What was the research about?
Asthma is a common illness that can make it hard for children to breathe. African-American children are more likely to have asthma than children from other racial groups. Inhalers that include daily medicines, such as corticosteroids, can improve asthma symptoms. Doctors usually adjust the patient’s medicine dosage during office visits or by phone. But this approach may not work if parents and children can’t visit the doctor regularly or if they often get care in the emergency room. In addition, some families may prefer an approach that doesn’t require using an inhaler every day or repeated doctor visits.
In this study, the research team compared two ways of controlling symptoms among African-American children with asthma:
- Symptom-based adjustment, or SBA. Patients used an inhaler only when they had asthma symptoms. They used the inhaler along with albuterol, a medicine used during an asthma attack.
- Provider-based adjustment, or PBA. Patients used an inhaler daily no matter what their symptoms were. They met with their doctor if they needed to adjust the dosage.
The research team wanted to learn if SBA was similar to PBA in improving asthma control.
What were the results?
After one year, SBA and PBA had similar results for patients with asthma. Patients receiving SBA and PBA didn’t differ in
- Asthma control
- Number of asthma attacks
- Lung function
- Quality of life, such as being able to complete daily activities
Patients in both groups had better asthma control at the end of the study than at the start. Patients in the SBA group used less inhaled corticosteroids each month compared with those in the PBA group.
Who was in the study?
The study included 206 African-American children ages 6–17 in St. Louis with mild asthma. The average age was 10, and 54 percent were boys.
What did the research team do?
The research team assigned patients by chance to receive either SBA or PBA for one year. In each group, asthma coaches offered patients or their parents two to four asthma education sessions by phone. In these sessions, coaches helped children and parents recognize symptoms and learn how to use asthma medicines.
Parents of children ages 6–11 completed a survey about how often patients had asthma symptoms at the start of the study and again every three months for a year. Children ages 12–17 completed the survey themselves. The research team also tested patients’ lung function at the start of the study and after one year.
Patients, parents, school officials, doctors, and nurse practitioners gave input on the study.
What were the limits of the study?
The research team couldn’t be sure that patients took medicines as directed. The study also didn’t test how well SBA worked for children with severe symptoms.
Future research could test SBA in other groups or locations.
How can people use the results?
Children with asthma, their parents, and healthcare providers can use these results when considering asthma treatments.
| How this project fits under PCORI’s Research Priorities PCORI identified asthma in African American and Hispanic/Latino populations as an important research topic. Patients, clinicians, and others wanted to learn how to encourage care that follows national asthma guidelines and improves patient-centered outcomes for African American and Hispanic/Latino populations. In 2013, PCORI launched an initiative on Treatment Options for African Americans and Hispanics/Latinos with Uncontrolled Asthma. The initiative funded this research project and others. |
Professional Abstract
Objective
To compare the effectiveness of symptom-based adjustment (SBA) versus provider-based adjustment (PBA) of inhaled corticosteroids on asthma control in African-American children with mild persistent asthma
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 206 African-American children ages 6–17 with mild asthma |
| Interventions/ Comparators |
|
| Outcomes | Primary: change in asthma control Secondary: asthma exacerbations, lung function, quality of life, dosage of inhaled corticosteroids |
| Timeframe | 1-year follow-up for primary outcomes |
This randomized controlled trial compared the effectiveness of SBA with PBA in improving pediatric asthma control in African-American children in a primary care setting. Asthma control refers to the frequency of asthma symptoms during the previous four weeks.
Researchers randomized patients receiving care from 12 primary care providers to either SBA or PBA. In each group, asthma coaches offered patients or their parents two to four education sessions by phone to help study participants recognize symptoms and use asthma medications appropriately. In SBA, patients used an inhaled corticosteroid only when they used albuterol, a rescue medication, for asthma symptoms. In PBA, patients used the physician-recommended daily dosage of inhaled corticosteroid, regardless of symptoms.
The study included 206 African-American children in St. Louis who had mild persistent asthma. The average patient age was 10, and 54% were male.
Children ages 12–17 and parents of children ages 6–11 completed a survey to assess asthma symptoms at baseline and again 3, 6, 9, and 12 months later. Researchers also tested patients’ lung function at baseline and again one year later.
Patients, parents, school officials, and clinicians helped design the study, adapt the intervention, and recruit participants.
Results
After one year, children receiving SBA and children receiving PBA did not differ significantly in asthma control, asthma exacerbations, lung function, or quality of life. Patients in both groups had better asthma control at the end of the study than at baseline. Patients receiving SBA used significantly less inhaled corticosteroid per month than patients receiving PBA (p<0.0001).
Limitations
Researchers do not know if participants took medications as recommended, which may have affected study outcomes. The study did not assess the effectiveness of SBA for children with severe symptoms.
Conclusions and Relevance
In this study, SBA worked as well as PBA, and children receiving SBA had a lower average monthly dosage of inhaled corticosteroid.
Future Research Needs
Future research could test SBA in other groups or locations.
| How this project fits under PCORI’s Research Priorities PCORI identified asthma in African American and Hispanic/Latino populations as an important research topic. Patients, clinicians, and others wanted to learn how to encourage care that follows national asthma guidelines and improves patient-centered outcomes for African American and Hispanic/Latino populations. In 2013, PCORI launched an initiative on Treatment Options for African Americans and Hispanics/Latinos with Uncontrolled Asthma. The initiative funded this research project and others. |
Final Research Report
View this project's final research report.
Journal Citations
Article Highlight: Results from this study support existing evidence that children with mild asthma can self-manage their condition by using medications when their symptoms occur. This contrasts with the traditional method of taking a medication daily, regardless of symptoms, and using an inhaler when symptoms arise. As reported in The Journal of Allergy and Clinical Immunology, this study focused exclusively on African-American children, who have traditionally been underserved in research and have had worse asthma-related health outcomes than other children.
Results of This Project
Related Journal Citations
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.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked why the study focused on mild or mild-to-moderate asthma only and asked for clarification on whether the population included only children with mild asthma, or those with mild-to-moderate asthma. The researchers explained that the qualitative portion of the study included participants with mild-to-moderate asthma, but the main quantitative study included only children with mild asthma. The researchers focused on this population because the existing evidence supporting symptom-based adjustment of treatment is in patients with mild asthma only.
- The reviewers noted that the patient and caregiver input section was very important to understanding and justifying the study, and recommended the researchers organize the qualitative themes and comments into tabular form. The reviewers asked the researchers to indicate the frequency of different themes. The researchers explained that the goal of the qualitative interviews, which provided the input in the section the reviewers identified, was meant to obtain broad perspectives. The qualitative analyses did not measure the frequency of different types of comments. The researchers stated they would not be able to quantify the frequency of themes as requested.
- The reviewers noted that the researchers measured the primary outcome, change in asthma control, using one of two different tests: the asthma control test (ACT) and the childhood ACT (cACT). The reviewers asked for more justification for combining the data of these two questionnaires into a single primary outcome measure. The researchers explained that the two measures differed by respondent age group, so they transformed scores into a single, normally distributed outcome measure. This approach provided more power to find an effect of the intervention because it uses a single measure that would be more interpretable for the community.
- The reviewers asked for greater clarity on how the researchers recruited stakeholders. The researchers explained that they asked for referrals from a wide range of people, including patients and community members, for people who are interested in childhood asthma. The researchers explained the role and time commitment to those referred to them. The researchers added that the study did not have specific inclusion criteria for advisory board members and revised the report to describe the recruitment process better.