Prognosis of Individual-Level Mobility and Daily Activities Recovery From Acute Care to Community, Part 2: A Proof-of-Concept Single Group Prospective Cohort Study.

OBJECTIVE: To demonstrate a proof-of-concept for prognostic models of post-stroke recovery on activity level outcomes. DESIGN: Longitudinal cohort with repeated measures from acute care, inpatient rehabilitation, and post-discharge follow-up to 6 months post-stroke. SETTING: Enrollment from a single Midwest USA inpatient rehabilitation facility with community follow-up. PARTICIPANTS: One-hundred fifteen persons recovering from stroke admitted to an acute rehabilitation facility (N=115). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE(S): Activity Measure for Post-Acute Care Basic Mobility and Daily Activities domains administered as 6 Clicks and patient-reported short forms. RESULTS: The final Basic Mobility model defined a group-averaged trajectory rising from a baseline (pseudo-intercept) T score of 35.5 (P<.001) to a plateau (asymptote) T score of 56.4 points (P<.001) at a negative exponential rate of -1.49 (P<.001). Individual baseline scores varied by age, acute care tissue plasminogen activator, and acute care length of stay. Individual plateau scores varied by walking speed, acute care tissue plasminogen activator, and lower extremity Motricity Index scores. The final Daily Activities model defined a group-averaged trajectory rising from a baseline T score of 24.5 (P<.001) to a plateau T score of 41.3 points (P<.001) at a negative exponential rate of -1.75 (P<.001). Individual baseline scores varied by acute care length of stay, and plateau scores varied by self-care, upper extremity Motricity Index, and Berg Balance Scale scores. CONCLUSIONS: As a proof-of-concept, individual activity-level recovery can be predicted as patient-level trajectories generated from electronic medical record data, but models require attention to completeness and accuracy of data elements collected on a fully representative patient sample.

Prognosis of Individual-Level Mobility and Self-Care Stroke Recovery During Inpatient Rehabilitation, Part 1: A Proof-of-Concept Single Group Retrospective Cohort Study.

OBJECTIVE: To demonstrate feasibility of generating predictive short-term individual trajectory recovery models after acute stroke by extracting clinical data from an electronic medical record (EMR) system. DESIGN: Single-group retrospective patient cohort design. SETTING: Stroke rehabilitation unit at an independent inpatient rehabilitation facility (IRF). PARTICIPANTS: Cohort of 1408 inpatients with acute ischemic or hemorrhagic stroke with a mean ± SD age of 66 (14.5) years admitted between April 2014 and October 2019 (N=1408). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: 0-100 Rasch-scaled Functional Independence Measure (FIM) Mobility and Self-Care subscales. RESULTS: Unconditional models were best-fit on FIM Mobility and Self-Care subscales by spline fixed-effect functions with knots at weeks 1 and 2, and random effects on the baseline (FIM 0-100 Rasch score at IRF admission), initial rate (slope at time zero), and second knot (change in slope pre-to-post week 2) parameters. The final Mobility multivariable model had intercept associations with Private/Other Insurance, Ischemic Stroke, Serum Albumin, Motricity Index Lower Extremity, and FIM Cognition; and initial slope associations with Ischemic Stroke, Private/Other and Medicaid Insurance, and FIM Cognition. The final Self-Care multivariable model had intercept associations with Private/Other Insurance, Ischemic Stroke, Living with One or More persons, Serum Albumin, and FIM Cognition; and initial slope associations with Ischemic Stroke, Private/Other and Medicaid Insurance, and FIM Cognition. Final models explained 52% and 27% of the variance compared with unconditional Mobility and Self-Care models. However, some EMR data elements had apparent coding errors or missing data, and desired elements from acute care were not available. Also, unbalanced outcome data may have biased trajectories. CONCLUSIONS: We demonstrate the feasibility of developing individual-level prognostic models from EMR data; however, some data elements were poorly defined, subject to error, or missing for some or all cases. Development of prognostic models from EMR will require improvements in EMR data collection and standardization.

Emulating 3 Clinical Trials That Compare Stroke Rehabilitation at Inpatient Rehabilitation Facilities With Skilled Nursing Facilities.

OBJECTIVE: To inform the design of a potential future randomized controlled trial (RCT), we emulated 3 trials where patient-level outcomes were compared after stroke rehabilitation at inpatient rehabilitation facilities (IRFs) with skilled nursing facilities (SNFs). DESIGN: Trials were emulated using a 1:1 matched propensity score analysis. The 3 trials differed because facilities from rehabilitation networks with different case volumes were compared. Rehabilitation network case volumes were based on the number of patients with stroke that each hospital discharged to each specific IRF or SNF. Trial 1 included 60,529 patients from all networks, trial 2 included 34,444 patients from networks with medium and large case volumes (ie, ≥5 patients), and trial 3 included 19,161 patients from networks with large case volumes (ie, ≥10 patients). The E values were calculated to estimate the minimum strength that an unmeasured confounder would need to be to nullify the results. SETTING: A national sample of IRFs and SNFs from across the United States. PARTICIPANTS: Fee-for-service Medicare patients with acute stroke who received IRF or SNF based rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: One-year successful community discharge (home for >30 consecutive days) and all-cause mortality. RESULTS: Overall, 29,500, 15,156, and 7450 patients were matched for trials 1, 2, and 3. For 1-year successful community discharge, absolute risk differences for IRF patients were 0.21 (95% CI, 0.20-0.22), 0.17 (95% CI, 0.16-0.19), and 0.12 (95% CI, 0.10-0.14) in trials 1, 2, and 3, respectively. For 1-year all-cause mortality, corresponding risk differences were -0.11 (95% CI, -0.12 to -0.11), -0.11 (95% CI, -0.12 to -0.09), and -0.08 (95% CI, -0.10 to -0.06). The E values indicated that a moderately sized unmeasured confounder, with a relative risk of 1.6-2.0 would nullify differences in successful community discharge. CONCLUSIONS: IRF patients had superior outcomes, but differences were attenuated when IRFs and SNFs from larger rehabilitation networks were compared. The vulnerability of the findings to unmeasured confounding supports the need for an RCT.

Rationale for a Clinical Trial That Compares Acute Stroke Rehabilitation at Inpatient Rehabilitation Facilities to Skilled Nursing Facilities: Challenges and Opportunities.

In the United States, approximately 400,000 patients with acute stroke are discharged annually to inpatient rehabilitation facilities (IRFs) or skilled nursing facilities (SNFs). Typically, IRFs provide time-intensive therapy for an average of 2-3 weeks, whereas SNFs provide more moderately intensive therapy for 4-5 weeks. The factors that influence discharge to an IRF or SNF are multifactorial and poorly understood. The complexity of these factors in combination with subjective clinical indications contributes to large variations in the use of IRFs and SNFs. This has significant financial implications for health care expenditure, given that stroke rehabilitation at IRFs costs approximately double that at SNFs. To control health care spending without compromising outcomes, the Institute of Medicine has stated that policy reforms that promote more efficient use of IRFs and SNFs are critically needed. A major barrier to the formulation of such policies is the highly variable and low-quality evidence for the comparative effectiveness of IRF- vs SNF-based stroke rehabilitation. The current evidence is limited by the inability of observational data to control for residual confounding, which contributes to substantial uncertainty around any magnitude of benefit for IRF- vs SNF-based care. Furthermore, it is unclear which specific patients would receive the most benefit from each setting. A randomized controlled trial addresses these issues, because random treatment allocation facilitates an equitable distribution of measured and unmeasured confounders. We discuss several measurement, practical, and ethical issues of a trial and provide our rationale for design suggestions that overcome some of these issues.

Reporting Guideline for RULER: Rasch Reporting Guideline for Rehabilitation Research: Explanation and Elaboration.

The Rasch Reporting Guideline for Rehabilitation Research (RULER) provides peer-reviewed, evidence-based, transparent, and consistent recommendations for reporting studies that apply Rasch Measurement (RM) Theory in a rehabilitation context. The purpose of the guideline is to ensure that authors, reviewers, and editors have uniform guidance about how to write and evaluate research on rehabilitation outcome assessments. The RULER statement includes an organizing framework and a checklist of 59 recommendations. This companion article supports the RULER statement by providing details about the framework, rationale for the domains and recommendations in the checklist and explaining why these considerations are important for improving consistency and transparency in reporting the results of RM studies. This article is not intended to describe how to conduct RM studies but provides rationale for the essential elements that authors should address in each domain. Consistency and transparency in reporting RM studies will advance rehabilitation research if authors consider these issues when planning their study and include the checklist when they submit their manuscript for peer review. A copy of the checklist can be found at [table 2 in https://doi.org/10.1016/j.apmr.2022.03.013].

Rasch Reporting Guideline for Rehabilitation Research (RULER): the RULER Statement.

The application of Rasch Measurement (RM) Theory to rehabilitation assessments has proliferated in recent years. RM Theory helps design and refine assessments so that items reflect a unidimensional construct in an equal interval metric that distinguishes among persons of different abilities in a manner that is consistent with the underlying trait. Rapid growth of RM in rehabilitation assessment studies has led to inconsistent results reporting. Clear, consistent, transparent reporting of RM Theory results is important for advancing rehabilitation science and practice based on precise measures. Precise measures, in turn, provide researchers, practitioners, patients, and other stakeholders with tools for effective decision making. The goal of this Rasch Reporting Guideline for Rehabilitation Research (RULER: Rasch Reporting Guideline for Rehabilitation Research) is to provide peer-reviewed, evidence-based, transparent, and consistent recommendations for reporting studies that apply RM Theory in a rehabilitation context. The purpose of the guideline is to ensure that authors, reviewers, and editors have uniform expectations about how to write and evaluate research on rehabilitation outcome assessments. A task force of rehabilitation researchers, clinicians, and editors met regularly between November 2018 and August 2020 to identify the need for the guideline, develop an organizing framework, identify content areas, and develop the recommendations. This RULER: Rasch Reporting Guideline for Rehabilitation Research statement includes the organizing framework and a checklist of 59 recommendations. The guideline is supported by an Explanation and Elaboration article that provides more detail about the framework and recommendations in the checklist. A glossary of key terms and a recommended iterations table are provided in supplemental online only materials.

Physical Function Recovery Trajectories After Spinal Cord Injury.

OBJECTIVE: To explore trajectories of functional recovery that occur during the first 2 years after spinal cord injury (SCI). DESIGN: Observational cohort study. SETTING: Eight SCI Model System sites. PARTICIPANTS: A total of 479 adults with SCI completed 4 Spinal Cord Injury-Functional Index (SCI-FI) item banks within 4 months of injury and again at 2 weeks, 3, 6, 12, and 24 months after baseline assessment (N=479). INTERVENTION: None. MAIN OUTCOME MEASURES: SCI-FI Basic Mobility/Capacity (C), Fine Motor Function/C, Self-care/C, and Wheelchair Mobility/Assistive Technology (AT) item banks. RESULTS: Growth mixture modeling was used to identify groups with similar trajectory patterns. For the Basic Mobility/C and Wheelchair Mobility/AT domains, models specifying 2 trajectory groups were selected. For both domains, a majority class exhibited average functional levels and gradual improvement, primarily in the first 6 months. A smaller group of individuals made gradual improvements but had greater initial functional limitations. The Self Care/C domain exhibited a similar pattern; however, a third, small class emerged that exhibited substantial improvement in the first 6 months. Finally, for individuals with tetraplegia, trajectories of Fine Motor Function/C scores followed 2 patterns, with individuals reporting generally low initial scores and then making either modest or large improvements. In individual growth curve models, injury/demographic factors predicted initial functional levels but less so regarding rates of recovery. CONCLUSIONS: Trajectories of functional recovery followed a small number of change patterns, although variation around these patterns emerged. During the first 2 years after initial hospitalization, SCI-FI scores showed modest improvements; however, substantial improvements were noted for a small number of individuals with severe limitations in fine motor and self-care function. Future studies should further explore the personal, medical, and environmental characteristics that influence functional trajectories during these first 2 years and beyond.

Measuring Value in Postacute Care.

The value of postacute care (PAC) is unclear. While experienced clinicians understand the appropriateness of each specific site of PAC, clear evidence-based guidelines are not available, and many referrals to PAC today are made based on bed availability rather than patient need. Measuring value (value=outcomes/cost) for the entire episode of care has been proposed as an effective method to both evaluate and enable faster innovation in care. Instituting value-based care will increase patient engagement, improve quality and reduce cost with the potential of unifying the goals for all stakeholders-patients and families, providers, and payers. To achieve a goal of value-based care, rehabilitation researchers will need to measure outcomes and cost for the entire episode of care. Recent laudable efforts by the Centers for Medicare & Medicaid Services (CMS) to standardize data across PAC may not include the entire episode of care since outpatient care and measurement from home are not included. In addition, the true cost of services delivered is rarely measured. To implement value-based care in rehabilitation and facilitate cost-effective care improvements, outcomes research in PAC should focus on 4 areas. First, outcome measures need to reflect the patient's perspective. Second, new methods must be implemented to acquire comparable valid and reliable data from all postacute settings and the home. Third, a predictive model for individual patients should be utilized to guide patient referral from acute care to PAC and monitor progress. And fourth, timely specific measures of true cost (resources consumed) for the outcomes achieved are needed.

Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study.

OBJECTIVE: To examine the feasibility, safety, and secondary benefit potential of exoskeleton-assisted walking with one device for persons with multiple sclerosis (MS). DESIGN: Single-group longitudinal preliminary study with 8-week baseline, 8-week intervention, and 4-week follow-up. SETTING: Outpatient MS clinic, tertiary care hospital. PARTICIPANTS: Participants (N=13; age range, 38-62y) were mostly women with Expanded Disability Status Scale scores ranging from 5.5 to 7.0. INTERVENTION: Exoskeleton-assisted walk training. MAIN OUTCOME MEASURES: Primary outcomes were accessibility (enrollment/screen pass), tolerability (completion/dropout), learnability (time to event for standing, walking, and sitting with little or no assistance), acceptability (satisfaction on the device subscale of the Quebec User Evaluation of Satisfaction with Assistive Technology version 2), and safety (event rates standardized to person-time exposure in the powered exoskeleton). Secondary outcomes were walking without the device (timed 25-foot walk test and 6-minute walk test distance), spasticity (Modified Ashworth Scale), and health-related quality of life (Patient-Reported Outcomes Measurement and Information System pain interference and Quality of Life in Neurological Conditions fatigue, sleep disturbance, depression, and positive affect and well-being). RESULTS: The device was accessible to 11 and tolerated by 5 participants. Learnability was moderate, with 5 to 15 sessions required to walk with minimal assistance. Safety was good; the highest adverse event rate was for skin issues at 151 per 1000 hours' exposure. Acceptability ranged from not very satisfied to very satisfied. Participants who walked routinely improved qualitatively on sitting, standing, or walking posture. Two participants improved and 2 worsened on ≥1 quality of life domain. The pattern of spasticity scores may indicate potential benefit. CONCLUSIONS: The device appeared feasible and safe for about a third of our sample, for whom routine exoskeleton-assisted walking may offer secondary benefits.

Trajectories of Life Satisfaction After Spinal Cord Injury.

OBJECTIVE: To describe individual-level temporal change in life satisfaction after spinal cord injury. DESIGN: Individual growth curve (IGC) analysis of prospectively collected data from the National Institute on Disability, Independent Living, and Rehabilitation Research National Spinal Cord Injury Database (NSCID). SETTING: Multicenter, longitudinal database study. PARTICIPANTS: Participants (N=4846) in the NSCID. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Rasch-transformed Satisfaction With Life Scale scores. RESULTS: Individual-level trajectories reflecting life satisfaction vary extensively and are associated with demographic and injury-related characteristics. Demographic characteristics include race, sex, pre-employment and discharge marital status, and level of education; injury-related factors include days in rehabilitation, neurologic level, age at injury, and injury etiology. Results are displayed graphically by way of a computer-generated interactive tool and represent different trajectories of individual-level changes in life satisfaction. CONCLUSIONS: IGC methodology allows researchers and clinicians to anticipate patient-specific trajectories through use of an automated interactive tool. Projected trajectories hold promise in facilitating planning for inpatient and outpatient services, which could enhance long-term outcomes.

Evaluating Individual Change With the Quality of Life in Neurological Disorders (Neuro-QoL) Short Forms.

OBJECTIVE: To provide a clinically useful means of interpreting change for individual patients on the Quality of Life in Neurological Disorders (Neuro-QoL) adult short forms (SFs) by applying a classical test theory concept for interpreting individual change. DESIGN: Secondary analysis of existing data. SETTING: Community. PARTICIPANTS: Persons with neurologic conditions including stroke, epilepsy, amyotrophic lateral sclerosis, multiple sclerosis, and Parkinson disease residing in community settings. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Neuro-QoL SFs for Applied Cognition-General Concerns, Applied Cognition-Executive Function, Applied Cognition-Combined, Ability to Participate in Social Roles and Activities, Satisfaction With Social Roles and Activities, Positive Affect and Well-Being, Depression, Stigma, Upper Extremity Function (Fine Motor, Activities of Daily Living), Lower Extremity Function (Mobility), Anxiety, Sleep Disturbance, Fatigue, and Emotional and Behavioral Dyscontrol. We estimated conditional minimal detectable change (cMDC) indices from the pooled SEs adjusted for a 95% confidence interval using the average of the SEs for any given pair of scores multiplied by the z score, or ([SE(Score1) + SE(Score2)]/2) * (1.96) * (SQRT(2)). RESULTS: The cMDC indices are generally smallest in the midrange of all scales, ranging from 3.6 to 11.2 T-score points, and higher on the outer quartiles ranging from 3.7 to 21.6 T-score points. The lowest midrange cMDCs were for Satisfaction With Social Roles and Activities (3.6-4.7 T-score points), and the largest were for Sleep Disturbance (9.4-11.2 T-score points). CONCLUSIONS: Change indices can help clinicians and investigators identify differences for individual patients or subjects that are large enough to motivate treatment change. cMDCs can reduce misclassification of magnitudes of change that are near the margins of error across the range of the Neuro-QoL SFs.

Validation of a pain mechanism classification system (PMCS) in physical therapy practice.

The objective of this study was to validate the clinical application of a pain mechanism classification system (PMCS) in clinical practice. We analyzed data abstracted from the medical records of patients who were treated in the outpatient clinics of a large urban rehabilitation hospital in Chicago. We hypothesized that there would be good agreement between the PMCS determined by trained therapists and the PMCS category assigned based on a computer-generated statistical model using patients' signs and symptoms. Using cluster analysis, when we assumed five groups, 97% of patients could be classified. Sensitivity and specificity results with 95% confidence intervals were calculated for the categories using the physical therapist assigned categories (PMCS) as the criterion standard. Sensitivity for four of the five categories (inflammatory, ischemia, peripheral neurogenic, and other ranged from 72·0 to 83·1%). For the central mechanism, sensitivity was much lower at 15%. Specificity for the five categories ranged from 72·4% (ischemia) to 98·8% (central). This study provides empirical support for recent findings in the literature that the peripheral components of a PMCS can be implemented consistently in an outpatient pain clinical practice.

Agreement Between Responses From Community-Dwelling Persons With Stroke and Their Proxies on the NIH Neurological Quality of Life (Neuro-QoL) Short Forms.

OBJECTIVE: To examine agreement between patient and proxy responses on the Quality of Life in Neurological Disorders (Neuro-QoL) instruments after stroke. DESIGN: Cross-sectional observational substudy of the longitudinal, multisite, multicondition Neuro-QoL validation study. SETTING: In-person, interview-guided, patient-reported outcomes. PARTICIPANTS: Convenience sample of dyads (N=86) of community-dwelling persons with stroke and their proxy respondents. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Dyads concurrently completed short forms of 8 or 9 items for the 13 Neuro-QoL adult domains using the patient-proxy perspective. Agreement was examined at the scale-level with difference scores, intraclass correlation coefficients (ICCs), effect size statistics, and Bland-Altman plots, and at the item-level with kappa coefficients. RESULTS: We found no mean differences between patients and proxies on the Applied Cognition-General Concerns, Depression, Satisfaction With Social Roles and Activities, Stigma, and Upper Extremity Function (Fine Motor, activities of daily living) short forms. Patients rated themselves more favorably on the Applied Cognition-Executive Function, Ability to Participate in Social Roles and Activities, Lower Extremity Function (Mobility), Positive Affect and Well-Being, Anxiety, Emotional and Behavioral Dyscontrol, and Fatigue short forms. The largest mean patient-proxy difference observed was 3 T-score points on the Lower Extremity Function (Mobility). ICCs ranged from .34 to .59. However, limits of agreement showed dyad differences exceeding ±20 T-score points, and item-level agreement ranged from not significant to weighted kappa=.34. CONCLUSIONS: Proxy responses on Neuro-QoL short forms can complement responses of moderate- to high-functioning community-dwelling persons with stroke and augment group-level analyses, but do not substitute for individual patient ratings. Validation is needed for other stroke populations.

Self-scoring templates for motor and cognitive subscales of the FIM instrument for persons with spinal cord injury.

OBJECTIVE: To provide self-scoring templates for the FIM instrument's motor and cognitive scales that enable clinicians to monitor progress during rehabilitation using equal-interval Rasch-calibrated measures instead of ordinal raw scores. DESIGN: Secondary analysis of a prospective, observational cohort study. SETTING: Six geographically dispersed hospital-based rehabilitation centers in the United States. PARTICIPANTS: Subset of consecutively enrolled individuals with new traumatic spinal cord injuries discharged from participating rehabilitation centers (N=1146). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Subscores of the FIM instrument, including a 13-item motor scale, a 5-item cognitive scale, an 11-item (without sphincter control items) motor scale, a 3-item transfer scale, a 6-item self-care scale, a 3-item self-care upper extremity scale, and a 3-item self-care lower extremity scale. RESULTS: KeyForms for the FIM instrument scales allow clinicians and investigators to estimate patients' functional status and monitor progress. In cases with no missing data, the look-up tables provide more accurate estimates of patients' functional status. CONCLUSION: Clinicians can use KeyForms and look-up tables for FIM instrument subscales to monitor patients' progress and communicate improvement in equal-interval units.

Functional recovery after severe traumatic brain injury: an individual growth curve approach.

OBJECTIVE: To examine person, injury, and treatment characteristics associated with recovery trajectories of people with severe traumatic brain injury (TBI) during inpatient rehabilitation. DESIGN: Observational prospective longitudinal study. SETTING: TBI rehabilitation units. PARTICIPANTS: Adults (N=206) with severe nonpenetrating TBI admitted directly to inpatient rehabilitation from acute care. Participants were excluded for prior disability and intentional etiology of injury. INTERVENTIONS: Naturally occurring treatments delivered within comprehensive multidisciplinary teams were recorded daily in 15-minute units provided to patients and family members, separately. MAIN OUTCOME MEASURES: Motor and cognitive FIM were measured on admission, discharge, and every 2 weeks in between and were analyzed with individual growth curve methodology. RESULTS: Inpatient recovery was best modeled with linear, cubic, and quadratic components: relatively steep recovery was followed by deceleration of improvement, which attenuated prior to discharge. Slower recovery was associated with older age, longer coma, and interruptions to rehabilitation. Patients admitted at lower functional levels received more treatment, and more treatment was associated with slower recovery, presumably because treatment was allocated according to need. Therefore, effects of treatment on outcome could not be disentangled from effects of case mix factors. CONCLUSIONS: FIM gain during inpatient recovery from severe TBI is not a linear process. In observational studies, the specific effects of treatment on rehabilitation outcomes are difficult to separate from case mix factors that are associated with both outcome and allocation of treatment.

Interpreting Change in Disorders of Consciousness Using the Coma Recovery Scale-Revised.

The purpose of this study was to differentiate clinically meaningful improvement or deterioration from normal fluctuations in patients with disorders of consciousness (DoC) following severe brain injury. We computed indices of responsiveness for the Coma Recovery Scale-Revised (CRS-R) using data from a clinical trial of 180 participants with DoC. We used CRS-R scores from baseline (enrollment in a clinical trial) and a 4-week follow-up assessment period for these calculations. To improve precision, we transformed ordinal CRS-R total scores (0-23 points) to equal-interval measures on a 0-100 unit scale using Rasch Measurement theory. Using the 0-100 unit total Rasch measures, we calculated distribution-based 0.5 standard deviation (SD) minimal clinically important difference, minimal detectable change using 95% confidence intervals, and conditional minimal detectable change using 95% confidence intervals. The distribution-based minimal clinically important difference evaluates group-level changes, whereas the minimal detectable change values evaluate individual-level changes. The minimal clinically important difference and minimal detectable change are derived using the overall variability across total measures at baseline and 4 weeks. The conditional minimal detectable change is generated for each possible pair of CRS-R Rasch person measures and accounts for variation in standard error across the scale. We applied these indices to determine the proportions of participants who made a change beyond measurement error within each of the two subgroups, based on treatment arm (amantadine hydrochloride or placebo) or categorization of baseline Rasch person measure to states of consciousness (i.e., unresponsive wakefulness syndrome and minimally conscious state). We compared the proportion of participants in each treatment arm who made a change according to the minimal detectable change and determined whether they also changed to another state of consciousness. CRS-R indices of responsiveness (using the 0-100 transformed scale) were as follows: 0.5SD minimal clinically important difference = 9 units, minimal detectable change = 11 units, and the conditional minimal detectable change ranged from 11 to 42 units. For the amantadine and placebo groups, 70% and 58% of participants showed change beyond measurement error using the minimal detectable change, respectively. For the unresponsive wakefulness syndrome and minimally conscious state groups, 54% and 69% of participants changed beyond measurement error using the minimal detectable change, respectively. Among 115 participants (64% of the total sample) who made a change beyond measurement error, 29 participants (25%) did not change state of consciousness. CRS-R indices of responsiveness can support clinicians and researchers in discerning when behavioral changes in patients with DoC exceed measurement error. Notably, the minimal detectable change can support the detection of patients who make a "true" change within or across states of consciousness. Our findings highlight that the continued use of ordinal scores may result in incorrect inferences about the degree and relevance of a change score.

Using individual growth curve models to predict recovery and activities of daily living after spinal cord injury: an SCIRehab project study.

OBJECTIVE: To evaluate change in functional outcomes over 1 year after spinal cord injury (SCI). DESIGN: Observational longitudinal secondary analysis. SETTING: Six rehabilitation facilities participating in the SCIRehab project. PARTICIPANTS: Patients (N=1146) with SCI enrolled from 2007 to 2010. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: FIM instrument 13-item and 11-item motor, 3-item transfer, 6-item self-care, 3-item self-care upper-extremity, and 3-item self-care lower-extremity subscores modeled as trajectories of change. RESULTS: Patients were on average 37 years old, non-Hispanic white, with high school or higher education, a body mass index of 25, and a Comprehensive Severity Index score of 20. Most were men with paraplegia (37%) or high tetraplegia (27%). Median time frames were 22 days from injury to admission, 46 days from admission to discharge, 407 days from admission to follow-up, and 44 days for rehabilitation length of stay. The motor subscores were higher on admission for paraplegia and American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade D groups, and recovered faster for the AIS grade D group. Lower function at admission was associated with older age, higher Comprehensive Severity Index score, longer length of stay, fewer physical therapy and therapeutic recreation hours, and more occupational therapy hours. Slower recovery rates were associated with older age, more days from injury to admission, and fewer physical therapy hours per week. CONCLUSIONS: Longitudinal outcomes modeled as individual trajectories of change are clinically meaningful. Individual growth curve models could facilitate recovery prediction and outcome evaluation at individual and group levels. However, assessment of the effects of treatment on outcome trajectories will require the addition of outcome measures at time points during intervention and may require the use of outcome measures specific to aspects of rehabilitation, such as mobility and self-care.

An introduction to applying individual growth curve models to evaluate change in rehabilitation: a National Institute on Disability and Rehabilitation Research Traumatic Brain Injury Model Systems report.

The abundance of time-dependent information contained in the Spinal Cord Injury and the Traumatic Brain Injury Model Systems National Databases, and the increased prevalence of repeated-measures designs in clinical trials highlight the need for more powerful longitudinal analytic methodologies in rehabilitation research. This article describes the particularly versatile analytic technique of individual growth curve (IGC) analysis. A defining characteristic of IGC analysis is that change in outcome such as functional recovery can be described at both the patient and group levels, such that it is possible to contrast 1 patient with other patients, subgroups of patients, or a group as a whole. Other appealing characteristics of IGC analysis include its flexibility in describing how outcomes progress over time (whether in linear, curvilinear, cyclical, or other fashion), its ability to accommodate covariates at multiple levels of analyses to better describe change, and its ability to accommodate cases with partially missing outcome data. These features make IGC analysis an ideal tool for investigating longitudinal outcome data and to better equip researchers and clinicians to explore a multitude of hypotheses. The goal of this special communication is to familiarize the rehabilitation community with IGC analysis and encourage the use of this sophisticated research tool to better understand temporal change in outcomes.

Descriptive modeling of longitudinal outcome measures in traumatic brain injury: a National Institute on Disability and Rehabilitation Research Traumatic Brain Injury Model Systems study.

Establishing accurate mathematical models of outcome measures is essential in understanding change throughout the rehabilitation process. The goal of this study is to identify the best-fitting descriptive models for a set of commonly adopted outcome measures found within the Traumatic Brain Injury Model Systems National Database where the modeling is based on data submission through 2011 and the complete range of recorded time points since injury for each individual, where time points range from admission to rehabilitation to 20 years postinjury. The statistical methodology and the application of the methodology contained herein may be used to assist researchers and clinicians in (1) modeling the outcome measures considered, (2) modeling various portions of these outcomes by stratification and/or truncating time periods, (3) modeling longitudinal outcome measures not considered, and (4) establishing models as a necessary precursor in conducting individual growth curve analysis.

Randomized Trial of Two Exercise Programs to Increase Physical Activity and Health-Related Quality of Life for Persons With Spinal Cord Injury.

Objectives: To compare the effectiveness of two different interventions that promote physical activity in individuals with traumatic spinal cord injury (SCI) and determine the effect of relapse prevention. Methods: A sequential, multiple assignment, randomized trial was conducted at a universally designed community-based exercise facility. Participants were individuals with traumatic SCI, >3 months post injury, levels C5 to T12, age ≥18 years (N = 79). After randomization, Bridge Program participants completed an 8-week personalized, less intense, exercise program informed by American College of Sports Medicine (ACSM) guidelines and supported with hands-on peer mentoring, exercise of choice, and caregiver training. Structured Exercise participants completed an 8-week program in a group format based on ACSM guidelines. After intervention, participants were randomized to receive or not receive relapse prevention for 6 months. The time and intensity of physical activity and psychological change in depression, anxiety, self-efficacy, and function were assessed with self-reported measures. Results: Compared to baseline, physical activity increased post intervention for both the Bridge and Structured Exercise programs. Compared to baseline, participants in the Bridge Program recorded fewer anxiety symptoms. No significant changes were noted for either program in depressive symptoms, self-efficacy, or function. There was no difference in relapse prevention between the two groups at 6 months. Conclusions: The Bridge Program, a novel personalized exercise program with peer support, exercise of choice, and caregiver training, and a structured exercise program both improved self-reported physical activity, but the Bridge Program also reduced anxiety symptoms. This study provides important insight into the limitations of commonly used measures of physical activity and psychosocial domains in people with SCI.