Results Summary
What was the research about?
Traumatic brain injury, or TBI, is a change in brain function due to damage caused by a jolt to the head, shaking, or other external forces. TBI can happen from car crashes, sports, falls, violence, or other events. Patients with severe TBI often have a hard time focusing or remembering things. They can also have trouble with walking, dressing, and other daily tasks. Rehabilitation, or rehab, therapy can help patients recover from a TBI.
In this study, the research team looked at two types of rehab therapy:
- Advanced therapy. In advanced therapy, people work on difficult tasks, such as problem solving. The team compared patients who spent more versus less of their therapy time in advanced therapy.
- Therapy with real-life tasks. In this type of therapy, people practice doing tasks of daily life, such as remembering a phone number or calling someone on the phone. The team compared patients who spent more versus less of their therapy time working on real-life tasks.
What were the results?
Advanced therapy. Compared with patients who spent less of their therapy time in advanced therapy, patients who spent more of their therapy time in this type of therapy
- Spent more time in their communities
- Could do more daily tasks without help
- Reported improved well-being
Among those who spent a greater portion of time in advanced therapy, patients with more severe disability improved more on doing daily tasks compared with patients with less severe disability.
Therapy with real-life tasks. Compared with patients who spent less of their therapy time working with real-life tasks, patients who spent more of their therapy time this way
- Spent more time in their communities.
However, the two groups did not differ in their well-being or ability to do daily tasks without help.
Among those who received a greater portion of time in this therapy, patients with more severe disability improved more on doing daily tasks compared with patients with less severe disability.
Who was in the study?
The research team looked at health and research records for 1,843 patients who received rehab therapy while staying in one of nine hospitals across the United States after a TBI. The typical length of patients’ hospital stay was 25 days, with about 15 hours of therapy delivered each week. Of the patients, 82 percent were white, 15 percent were black, and 3 percent were of another race. The average age was 44, and 72 percent were men.
What did the research team do?
The research team reviewed patient records to see
- How much of their therapy was advanced therapy
- How much of their therapy used real-life tasks
- Results from patient surveys about spending time in the community and well-being
The research team used these records to divide people into groups that received a lesser portion of each type of therapy and groups that received a greater portion of each type of therapy. Then they compared the different groups.
Patients with TBI and rehab professionals helped design and conduct the study.
What were the limits of the study?
Although the results suggested that patients with TBI could benefit from spending more time in both types of therapy, the research team can’t be sure it was the amount of time in the two types of therapy that caused the benefits.
Future research could use other study designs and look at the longer term effects of these two types of therapy.
How can people use the results?
Doctors and patients with TBI can use these results when considering what type of therapy patients should get.
Professional Abstract
Objective
To compare the effectiveness of (1) greater versus lesser proportion of time in advanced therapy and (2) greater versus lesser proportion of time in contextualized therapy in improving community participation, functional independence, and well-being in patients with a traumatic brain injury (TBI)
Study Design
| Design Elements | Description |
|---|---|
| Design | Observational: cohort study |
| Population | Medical records and records from a previous research study from 1,843 patients who received inpatient rehabilitation therapy after sustaining a TBI |
| Interventions/ Comparators | Comparison 1: Greater versus lesser proportion of time in advanced therapy Comparison 2: Greater versus lesser proportion of time in contextualized therapy |
| Outcomes | Primary: patient-reported community participation, measured through productivity, being out and about, and social relations Secondary: patient-reported functional independence and well-being |
| Timeframe | 9-month postdischarge follow-up for primary outcome |
The two observational cohort studies compared the effectiveness of
(1) Different proportions of advanced versus nonadvanced therapy. Advanced therapy incorporates activities aimed at high-level abilities and skills, such as executive functions and ambulating over changing surfaces.
(2) Different proportions of contextualized therapy versus decontextualized therapy. Contextualized therapy incorporates activities that patients will use in daily life.
The research team reviewed the medical and research records of 1,843 patients who received inpatient rehabilitation therapy after sustaining a TBI. The typical length of stay was 25 days, with about 15 hours of therapy delivered each week. Patients also completed surveys to obtain information on outcomes nine months after they received therapy.
Of the patients, 82% were white, 15% were black, and 3% were of another race or the race was not known. The average age was 44, and 72% were male.
Based on the amount and type of therapy received, the research team categorized therapy as either advanced or nonadvanced and contextualized or decontextualized. The team then determined the proportion of time that patients received advanced therapy and contextualized therapy. They also classified patients as either having a more or less severe disability from their TBI.
Patients who experienced a TBI and rehabilitation professionals helped design and conduct the study.
Results
Advanced therapy. Patients who received a greater proportion of advanced therapy time reported higher levels of community participation, functional independence, and well-being (all p<0.05) compared with patients who received a lesser proportion of time in advanced therapy. Patients with more severe disability who received a greater proportion of advanced therapy time experienced more gains in functional independence (p<0.05) than patients with less severe disability.
Contextualized therapy. Patients who received a greater proportion of contextualized therapy time reported higher levels of community participation (p<0.05) compared with patients who received a lesser proportion of time in contextualized therapy. Patients did not differ substantially in functional independence or well-being. For patients who received a greater proportion of contextualized therapy time, patients with more severe disability experienced more benefit in terms of functional independence (p<0.05) than patients with less severe disability.
Limitations
The research team used an observational study design. Although the team controlled for factors that may have affected outcomes, there may be other confounding factors for which the team did not control.
Conclusions and Relevance
Patients who received a higher proportion of either advanced therapy or contextualized therapy time reported greater community participation. Patients with more severe disability showed greater benefit in functional independence than patients with less severe disability.
Future Research Needs
Future research could evaluate the long-term effects of advanced or contextualized therapy both during an inpatient stay and postdischarge.
Final Research Report
View this project's final research report.
Journal Citations
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. The comments and responses included the following:
- The reviewers asked that the report include more interpretation of the findings and what they mean practically. In addition, they commented that results need to be written so that they are clear to a general medical research readership. The researchers revised the results section to include more interpretation and to make it more readable to those not accustomed to the types of analyses used in this study.
- Reviewers said it was not clear whether researchers made adjustments in statistical significance for multiple comparisons to reduce the potential for false-positive conclusions. The researchers said they did not adjust for multiple comparisons because they chose the primary outcome and time point of interest before starting the study, and because they were more interested in estimating treatment effects rather than measuring the statistical significance of the effects. By providing all the analyses they conducted and the estimated effect sizes for all comparisons, the researchers said they were providing transparency to allow readers to assess whether the results seem meaningful and whether the conclusions seem valid.
- Reviewers suggested that the two methods for classifying treatments—as advanced or contextualized—are not clearly delineated, and the overlap in these concepts would make analyses difficult to interpret. The researchers argued that the two methods of classification have a minimal relationship with each other. They agreed that a follow-up study could evaluate the effects of therapies with different combinations of contextual and advanced characteristics, but the current study indicates that the most beneficial approach seems to be to provide treatments that target advanced functions in the context of meaningful activities.