Applying empirical methods in clinical practice: introducing the model for assessing treatment effect.

BACKGROUND: One challenge in rehabilitation is determining whether improvement in the patient is a treatment-specific effect or due to extraneous factors (eg, the passage of time, spontaneous recovery). DESIGN: Descriptive, model building, and 2 cases illustrating the model. METHOD: The Model for Assessing Treatment Effect (MATE) incorporates the conceptual frameworks of the International Classification of Functioning, Disability, and Health (ICF), along with single-case experimental methodology. RESULTS: The MATE contains 7 levels organized in a hierarchy, representing (i) increasing specificity of evaluation procedures and (ii) control of extraneous variables during therapy. Two illustrative cases of patients with traumatic brain injury undergoing inpatient rehabilitation for, inter alia, cognitive-communication impairments are described to illustrate common clinical practice (level 2 of MATE) and a superior method using a multiple-baseline design across behaviors, enabling rigorous evaluation of treatment effect (level 6 of MATE). CONCLUSIONS: The MATE offers a systematic, evidence-based approach for implementing ICF-informed goals into clinical practice. It also provides a benchmark against which a clinical service can be evaluated in terms of the rigor of its therapy program.

Validity and responsiveness of the care and needs scale for assessing support needs after traumatic brain injury.

OBJECTIVE: To investigate the validity and responsiveness of the Care and Needs Scale (CANS), which was designed to assess support needs of people with traumatic brain injury (TBI). DESIGN: Two samples of community clients (n=38, n=30) were recruited to examine concurrent, convergent/divergent, and discriminant validity. The ability of the CANS to detect change over a 6-month period from the time of inpatient rehabilitation discharge (predictive validity and responsiveness) was investigated in a third sample of 40 rehabilitation inpatients. SETTING: Two Brain Injury Rehabilitation Units in Sydney, Australia. PARTICIPANTS: People (N=108) aged between 16 and 70 years admitted for rehabilitation after TBI. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The CANS, Supervision Rating Scale, FIM, Sydney Psychosocial Reintegration Scale, and Disability Rating Scale. RESULTS: Evidence for concurrent validity was shown with fair to moderate correlation coefficients between the CANS and measures of supervision, functional independence, and psychosocial functioning (absolute value, r(s)=.43-.68; P<.01). Support for convergent and divergent validity was provided by correlation coefficients that were higher for measures tapping similar constructs (absolute value, r(s)=46; P<.01) but lower for measures of dissimilar constructs (absolute value, r(s)=.07-.26; not significant). In addition, the CANS discriminated between levels of injury severity, functional independence, and overall functioning (P<.01). In terms of predictive validity and responsiveness, CANS scores at inpatient rehabilitation discharge predicted the participant's functioning 6 months later. CONCLUSIONS: These results show the CANS is a valid and responsive tool and, together with its previously shown reliability, is suitable for routine application in clinical and research practice.

Reliability of the care and needs scale for assessing support needs after traumatic brain injury.

OBJECTIVE: To investigate the reliability of the Care and Needs Scale (CANS) for measuring the level and types of support needs of people with traumatic brain injury (TBI). METHOD: Interrater reliability was examined in a cohort of 30 community clients with TBI by comparing CANS ratings completed by 2 occupational therapists (OTs) and a case manager. CANS ratings on the same clients were also completed 1 week later to examine test-retest reliability. Reliability of proxy ratings was investigated in a cohort of 40 community clients with TBI by comparing CANS ratings completed by a clinical researcher, multidisciplinary team, relative, and client. RESULTS: Level of support need as measured by the CANS showed excellent interrater reliability both within and across disciplines: ICC = 0.95 between 2 OTs and ICC = 0.93 and 0.96 between OTs and case manager. Test-retest reliability of the CANS over a 1-week period was also excellent (ICC = 0.98). Although the agreement between the clinical researcher and multidisciplinary team was excellent (ICC = 0.92), ICCs with relative and client ratings were variable, ranging from 0.37 to 0.72. CONCLUSIONS: The excellent inter-rater and test-retest reliability findings from this present study, together with the evidence for validity reported previously, indicate that the CANS is a reliable and valid instrument for application in clinical practice.

Sequence of recovery during the course of emergence from the minimally conscious state.

OBJECTIVE: To document and examine recovery profiles of persons during the course of emergence from a minimally conscious state (MCS) after traumatic brain injury (TBI). DESIGN: Case series. SETTING: Participants in an inpatient brain injury rehabilitation program. PARTICIPANTS: Nine people with TBI who emerged from MCS. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The Western Neuro Sensory Stimulation Profile. RESULTS: In all cases, stereotyped (nonreflexive) movement was the first behavior to resolve, yet by itself it was never sufficient to indicate emergence from the MCS. Two of the 9 patients showed consistent object manipulation before all 3 elements of functional communication. Conversely, in 2 patients, all 3 components of functional communication emerged before object manipulation. In the remaining 5 patients, object manipulation occurred along with components of functional communication. CONCLUSIONS: During the course of data collection, issues were raised about differentiation between the MCS and posttraumatic amnesia. The data are also discussed within the context of the work of Giacino et al and the development of their scale to measure duration of the MCS. These data support the theory that functional communication and object manipulation are the 2 key indicators of emergence from MCS.