What was the research about?
Lupus is an illness in which the immune system attacks parts of the body. Lupus can cause a kidney disease called lupus nephritis, a swelling of the kidneys. Lupus nephritis is more common and more severe in minority groups than in other people. Medicines that weaken the immune system’s action, called immune-blocking medicines, are used to treat lupus nephritis. There are many types of immune-blocking medicines. The medicines differ in how well they work, their side effects, and their costs. It can be hard for people with lupus nephritis to choose which medicine to use.
In this study, the research team made an online decision aid for women with lupus nephritis. Decision aids help people use what is most important to them when choosing between two or more treatments. The decision aid shared information about the benefits and side effects of immune-blocking medicines. The research team tailored the information in the decision aid to women’s personal situations, such as their ethnic group and current treatments. The decision aid was available in English and Spanish.
The research team compared use of the decision aid with use of a pamphlet on lupus nephritis. The team wanted to see which was more helpful to patients in making treatment decisions. The team looked at how well the decision aid worked for women of different races and ethnic groups.
What were the results?
Compared with women who read the pamphlet, women who used the decision aid felt less doubt about their medicine choices. This was true for African-American and white women who used the decision aid, but not for Hispanic women.
Women in most races and ethnic groups who used the decision aid didn’t feel more informed than women in those groups who read the pamphlet. The only group of women who felt more informed when they used the decision aid was non-Hispanic white women.
Whether women read the pamphlet or used the decision aid didn’t change how they talked with their doctors. Women who used the decision aid and women who read the pamphlet also had similar feelings of control over making decisions.
Compared with women who used the pamphlet, more women who used the decision aid said that the information source was easy to use. They also rated the information about lupus nephritis and medicines as excellent.
Who was in the study?
The study included 301 women with lupus nephritis. All women in the study were thinking about starting or changing an immune-blocking medicine.
The women were patients at four hospitals across the United States. Of the women, 47 percent were African American, 26 percent were Hispanic, 15 percent were white, 7 percent were Asian, and 5 percent were other races or ethnicities.
What did the research team do?
The research team assigned women to one of two groups by chance. One group received the decision aid. The other group received the pamphlet. Before reading the pamphlet or using the decision aid, the women took a survey. The survey asked the women about feeling doubt and feeling informed when choosing a medicine. The women then took the same survey after they had read the pamphlet or used the decision aid. The second survey also asked how they felt talking with their doctor.
The research team worked with patients with lupus nephritis to design the study and the decision aid.
What were the limits of the study?
There were not enough Asian women in the study to see how the decision aid worked for them. Because lupus is more common in women, the research team didn’t include male patients in the study. The research team surveyed patients shortly after they read the pamphlet or used the decision aid. Patients might feel differently at a later time.
How can people use the results?
Doctors’ offices may want to use the decision aid for women with lupus nephritis who are making a decision about immune-blocking medicines. The decision aid may help patients feel more confident in their treatment choices.
To determine the comparative effectiveness of a computerized decision aid versus a usual-care information pamphlet in helping women from racially and ethnically diverse backgrounds reduce decisional conflict and make informed choices about immunosuppressive medications for lupus nephritis
|Design||Randomized controlled trial|
|Population||301 women with lupus nephritis|
Primary: decisional conflict, informed choice
Secondary: patient-physician communication, patient control over decision making, acceptability and feasibility of the decision aid, patient-centered communication
|Timeframe||Immediate follow-up for primary outcomes|
This multicenter, two-arm, randomized controlled trial assessed a culturally tailored, individualized, computerized decision aid that was available in both English and Spanish. The study tested whether the decision aid improved decision making about taking immunosuppressive drugs among women with lupus nephritis when compared with a lupus information pamphlet from the American College of Rheumatology.
The research team used information from focus groups with patients to tailor the decision aid to ethnicity, health status, and treatment choice. The team worked with patients, advocates, and clinicians to design the study, develop and pilot test the decision aid, refine enrollment criteria, and help recruit study participants.
Patients completed baseline assessments of decisional conflict and informed choice. Questionnaires that patients completed immediately after receiving their assigned interventions measured all primary and secondary outcomes.
Study participants included 301 adult women with lupus nephritis who were considering a change in, or initiation of, immunosuppressive medication. The women were patients at four teaching hospitals across the United States. Of the participants, 47% were African American, 26% were Hispanic, 15% were white, 7% were Asian, and 5% were from other races or ethnicities.
Decisional conflict. Compared with women who read the pamphlet, women who used the decision aid had lower decisional conflict (p=0.005). Reduction in decisional conflict was greater in African-American and white women, but not in Hispanic women (p<0.001, p=0.002, and p=0.07, respectively). The proportion of women whose decisional conflict remained unresolved postintervention was significantly lower among patients who used the decision aid compared with patients who read the pamphlet (p<0.001).
Informed choice. There was no significant difference in informed choice between women who used the decision aid and women who read the pamphlet (p=0.08).
Acceptability and feasibility. Compared with women who read the pamphlet, more women who used the decision aid said the intervention was easy to use (p=0.006). Women who used the decision aid rated its information about the condition, risk factors, medication options, evidence about medications, and studies about other patients as excellent (p≤0.006).
Other secondary outcomes. There were no significant differences between the two groups in patient-physician communication, patient-centered communication, or patient control over decision making, with high rates in both groups.
The sample size for Asian women was too small to determine statistical differences in outcomes. Because lupus occurs predominantly in women, this study excluded male patients. The research team assessed outcomes immediately after patients received the intervention. Changes in decisional conflict and informed choice may not persist over weeks or months.
Conclusions and Relevance
The decision aid reduced decisional conflict about immunosuppressive drug decision making among women with lupus nephritis, particularly among African-American and white women. Compared with the pamphlet, the decision aid was easier to use.
Future Research Needs
Future research could look at the effect of the decision aid on outcomes following treatment decisions, such as medication adherence, quality of life, and satisfaction with medication choice.
Final Research Report
View this project's final research report.
More to Explore...
Informing Patients with a Rare Disease About Their Treatment Options
Around half of all patients with the autoimmune disease lupus develop kidney disease. Because lupus is more common and more severe in minority patients, this PCORI-funded study developed a decision aid to help African-American and Hispanic patients with lupus kidney disease make informed decisions about treatments.
Related PCORI Dissemination and Implementation Project
Article Highlight: Lupus, an illness in which the immune system attacks parts of the body, can cause a kidney disease called lupus nephritis, a swelling of the kidneys. Treatment with immune system-blocking medicines can be effective, but patients must weigh potential benefits and risks with their personal preferences. Researchers in this study developed and tested a decision aid to help these patients. As they report in PLOS Medicine, compared with those who received a standard informational pamphlet, women who used the decision aid felt more confident about their treatment choices.
Results of This Project
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Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not 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 how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.
In response to peer review, Singh made changes including
- Adding more description of the laptop-based intervention tool
- Providing support for the statement that the tool was culturally sensitive
- Revising statements so that the results that were not statistically significant were interpreted accurately
- Providing more detail on why men were excluded, whether incident cases were included, and on the network meta-analysis, in order to better adhere to the PCORI Methodology Standards
Conflict of Interest Disclosures
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