When it comes to inpatient rehabilitation interventions for traumatic brain injury (TBI), quality may trump quantity regardless of rehab type, new research shows.
Investigators at Ohio State University compared outcomes for four separate TBI rehab interventions in four separate studies and found intensity of treatment vs time spent in treatment, as well as a greater focus on real-life activities and family involvement, were strong predictors of better outcomes.
“What we were trying to determine was what’s the most effective approach to inpatient rehabilitation,” co-investigator Jennifer Bogner, PhD, vice-chair of research and academic affairs, Ohio State University College of Medicine, Columbus, told Medscape Medical News.
Bogner noted the study might help fill a research gap because there is currently “no evidence that tells us which is the best route to go and which are the most effective interventions to use to improve outcomes from traumatic brain injury.”
TBI can result in mild concussion, posttraumatic amnesia, skull fracture, or neurologic damage. In 2014, the US Centers for Disease Control (CDC) reported 2.87 million TBI-related emergency department visits, hospitalizations, and deaths in the United States.
Determining the most effective rehabilitation approach for TBI is challenging because this patient population is heterogeneous with respect to the type of injury, required therapy, and differences in rates of spontaneous recovery.
In addition, large samples are necessary to balance subgroups. Applying stricter inclusion and exclusion criteria could reduce heterogeneity and the ability to generalize to a larger population, the investigators note. They also point out that randomized trials that withhold treatment to a certain group would be hard to justify ethically.
For the research, investigators used the Comparative Effectiveness of Inpatient Rehabilitation Interventions for Traumatic Brain Injury (TBI-CER) Practice-Based Evidence dataset, a repository of observational data on adult and adolescent inpatients with TBI (n = 1843) who attended one of nine US rehabilitation facilities between 2008 and 2013.
The dataset includes information from each intervention session, medical records, and patient-reported outcomes up to 9 months after discharge.
The four studies assessed:
The effectiveness of different proportions of therapy minutes devoted to real-life activities vs activities in the clinic meant to strengthen skills that underlie real-life tasks
The different proportions of advanced therapy that focused on functions or abilities at the highest level needed for successful community integration, beyond personal self-care
The impact of the patient’s family attending therapy sessions at least 10% of the time
Whether the level of patient engagement in treatment modified the impact of compliance with the 3-hour rule from Centers for Medicare & Medicaid Services (CMS).
The 3-hour rule states that TBI patients receive at least 3 hours daily of occupational or physical therapy plus one additional therapy for 5 of 7 days or 15 hours per week.
Patient outcomes included functional independence and community participation at 3 and 9 months after discharge, social relations, mobility, productivity, life satisfaction, and depressive symptoms.
The researchers used causal inference methods as an alternative to randomized controlled trials (RCTs) in order to measure the effectiveness of rehabilitation practices. Causal inference methods are “a statistical package of tools” that can help with inferring causality when conducting an RCT is not possible, said Bogner.
“We set it up so that we are able to mimic the randomization and the quality between the treatment groups by making the group equal on a number of different potential confounders or variables that could influence the effects of treatment,” she added.
A Good Start
Bogner was the lead author on the study that evaluated family involvement and the study on real-life activities.
Results from the first study showed that involving family in inpatient therapy at least 10% of the time enhanced the effects of rehabilitation, improving outcomes up to 9 months post-discharge, compared with patients who had less family involvement.
Results from the other study led by Bogner showed that patients who received treatment based upon a larger proportion of real-life activities instead of proxy exercises were able to participate more in community activities during the year following discharge.
The primary outcome measure of community participation, as measured by the Participation Assessment with Recombined Tools-Objective, was only significant at 3 months, showing a difference of 0.003 (95% confidence interval [CI], 0.001 – 0.006), P < .01.
However, when measured by an alternative Rasch score, it was significant at both 3 months (difference of 0.079; 95% CI, 0.026 – 0.132; P < .01) and 9 months (difference of 0.057; 95% CI, 0.016 – 0.099; P < .01).
Another study showed that receiving more treatment that targeted advanced functions or complex tasks was associated with better community participation at 3 and 9 months (both, P < .001). There were also positive effects for independence after discharge at 3 and 9 months (both, P < .05).
In addition, patients with the greatest level of cognitive impairment benefited most from challenging tasks.
“What we found is that if you…present patients with these higher level tasks, like tests that are targeting higher executive functions, people do better,” Bogner said.
Finally, the fourth study showed that no strong main effect was identified on treatment compliance with the CMS 3-hour rule. In addition, the level of effort (LOE) did not modify the effect of compliance with the 3-hour rule. However, LOE had a strong positive main effect on all other outcomes, with the exception of depression.
Small effect sizes and potential confounders were a limitation of the research, but offer a good start in evaluating the efficacy of TBI treatments, said Bogner. She also noted that while this research was conducted using a retrospective data set, ideally future research would include a prospective study.
Commenting on the findings for Medscape Medical News, Brionn K. Tonkin, MD, assistant professor, Department of Rehab Medicine, University of Minnesota, Minneapolis, noted that involving an interdisciplinary team enables tailoring the rehabilitation plan to each patient and knowing that each brain injury is quite different.
For research, “ideally you want to do a prospective, blind, randomized trial,” said Tonkin, who was not involved in the current studies. However, “it’s hard to do that in this type of setting because the therapists know, and the patient might know.”
Patients engaging in real-life tasks would be more productive in terms of rehab and recovery than just performing stock tasks, Tonkin noted. More demanding tasks generate a largely better response even in older patients because of brain plasticity, he added.
However, only a certain level of recovery can be achieved before discharge so, “it’s up to the patient and whoever’s supporting them to continue that momentum,” Tonkin said.
Study and/or database funding was provided by the Patient-Centered Outcomes Research Institute; the National Institutes of Health; the National Institute on Disability, Independent Living, and Rehabilitation Research; and the Ontario Neurotrauma Foundation. Tonkin reports being an informal consultant on concussion to the Minnesota Vikings football team.