Results Summary
What was the research about?
Rheumatoid arthritis, or RA, is a health problem in which the immune system attacks healthy tissue. RA can cause damage to joints, the heart, and lungs and limit people’s ability to do daily activities. Medicines for RA can control these problems but can also have serious side effects.
In this study, the research team wanted to learn if two programs, used alone or together, helped patients make informed decisions about RA medicines. One program trained patients in gist reasoning. Gist reasoning is making decisions by finding the main idea in complex information. The other program gave patients easy-to-read RA medicine guides. To look at informed decision making, the team studied changes in the number of patients who
- Had high knowledge about RA and treatment options
- Were using a treatment consistent with their values
What were the results?
Among all patients in the study, the gist reasoning program and the easy-to-read guides didn’t affect informed decision making about RA medicines.
The research team also looked at patients who didn’t meet their definition of informed decision making at the start of the study. Among these patients, those in the gist reasoning program were more likely to meet this definition at six months than those who weren’t in the program.
Who was in the study?
The study included 219 patients with RA. The research team enrolled patients online. The team also recruited patients from four large RA clinics across the United States. Of patients, 75 percent were white, and 25 percent were other races. The average age was 55, and 90 percent were women.
What did the research team do?
The research team assigned patients by chance to one of four groups:
- Gist reasoning training program and easy-to-read guides
- Gist reasoning training program and standard guides
- Easy-to-read guides alone
- Standard guides alone
The training program included four 60- to 90-minute online training sessions. The sessions focused on building skills in focusing attention, combining information from many sources, and balancing viewpoints.
The easy-to-read guides covered the 16 most common RA medicines. Each guide summarized the medicine’s benefits and harms. The guides also had links to other information about the medicine. The standard guides provided information patients currently receive with their prescription medicines.
Patients filled out surveys on their knowledge, values, and medicine use at the start of the study and six months later.
Patients with RA and doctors provided input throughout the study.
What were the limits of the study?
In this study, 34 percent of patients in the gist reasoning training program dropped out versus 13 percent of those who weren’t in the program. Also, only 39 percent of patients viewed either type of medicine guide. These factors may have affected the study’s results.
Future research could continue to look at ways to help patients make informed decisions about RA medicines.
How can people use the results?
Health clinics could use these results when considering ways to support patients with RA with medicine choices.
Professional Abstract
Objective
To compare the effectiveness of a gist reasoning training program and plain language medicine guides, used alone and together, versus standard care in helping patients with rheumatoid arthritis (RA) make informed decisions about medicine
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 219 patients with RA |
| Interventions/ Comparators |
|
| Outcomes | Change in the percentage of participants classified as having made an informed decision (knowledge of RA medicines and concordance of medicine use with expressed values) |
| Timeframe | 6-month follow-up for primary outcome |
This 2x2 factorial randomized controlled trial evaluated the effectiveness of two interventions to help patients make informed decisions about RA medicine: a gist reasoning training program called SMART, which taught patients how to get the main idea from complex information, and online plain language medicine guides called DrugFactsBox.
Researchers randomly assigned patients to one of four groups:
- SMART and DrugFactsBox
- SMART and standard medicine guides
- DrugFactsBox alone
- Standard medicine guides alone
SMART included four 60- to 90-minute online training sessions in gist reasoning. The sessions focused on building patient skills in maximizing attention, synthesizing information from multiple sources, and balancing different perspectives. The DrugFactsBox website covered the 16 most common RA medicines. Each guide summarized a medicine’s benefits and harms and included links to additional information about the medicine. The standard medicine guide website presented the information patients currently receive with prescription medicines.
The study included 219 patients with RA. Researchers recruited patients online or from four large academic rheumatology practices across the country. Of these patients, 75% were white and 25% were other races. The average age was 55, and 90% were female.
At baseline and six months later, patients completed surveys on their knowledge of treatment options, values related to RA management, and medicine use. After six months, researchers compared the percentage of patients in each group who went from not meeting the criteria for informed decision making to meeting the criteria. To meet these criteria, patients had to
- Have high knowledge about RA and treatment options
- Be using a treatment consistent with their values
Patients with RA and clinicians helped design the study and provided input throughout.
Results
At six months, among all patients in the study, receiving DrugFactsBox or SMART did not have a significant effect on informed decision making. However, among patients who did not meet the criteria for informed decision making at baseline, patients in the SMART program were more likely to meet these criteria at six months than patients who were not in the program (40% versus 24%, p<0.05).
Limitations
In this study, 34% of patients who received SMART dropped out versus 13% of those who did not receive SMART. In addition, only 39% of patients viewed DrugFactsBox or the standard medicine guides. These factors mays have affected study results.
Conclusions and Relevance
After six months, researchers did not find that SMART or DrugFactsBox, used alone or together, helped patients with RA make informed decisions about medicine. However, the SMART program increased informed decision making among patients with RA who had low knowledge of treatment options or whose medicine use was inconsistent with their values at baseline.
Future Research Needs
Future research could continue to investigate ways to support patients in making informed decisions about RA medicine.
Final Research Report
View this project's final research report.
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 criticized the report for focusing the results on significant secondary outcomes rather than presenting the primary outcome, informed decision making, first. The reviewers noted the importance of starting with the primary outcome in presenting and interpreting results, especially when some secondary outcomes were exploratory. The researchers reorganized to describe the primary outcome results first, even though there were no significant differences between interventions on informed decision making. The researchers also stated that they disagreed that the secondary outcomes were not meaningful even though many were exploratory. They chose to continue to highlight the secondary outcomes but acknowledged that the results should lead to more definitive hypothesis testing for these outcomes.
- The reviewers noted that the number of measurements participants completed at each data collection was quite large and burdensome and may have contributed to the high attrition rate. The number of related outcome measures could also lead to false positive significant tests due to multiple testing and should be acknowledged. The researchers noted that they did not collect all of the outcomes at each time point, but they added a note about the potential for false positives and the importance of viewing the significant secondary analysis results as exploratory, in their limitations section.
- The reviewers noted that the level of attrition differed for different intervention groups, and that there were a number of baseline measures that differed more than 10 percent between groups. Both of these considerations indicated missing data was unlikely to be missing at random, creating an imbalance between treatment groups and affecting the interpretation of available cases analyses. In response the researchers used multiple imputation to account for missing data and found that their results remained robust. Further, the researchers disagreed with the reviewers that a 10 percent difference on baseline characteristics indicated that there was an imbalance in the groups at baseline, before the attrition problems occurred. The researchers stated that they did not find literature defining a 10 percent difference as the threshold for poor balance between groups. They did add a note in their study limitations that the small imbalance at baseline may have affected the study’s power.