Assessing Clinically Important Differences During Rehabilitation for Stroke: A Pilot Study Evaluating Anchor and Distribution Derived Estimates of Physical Function Change in Classically Summed and Rasch Models of Section GG of the Inpatient Rehabilitation Facility Patient Assessment Instrument.

OBJECTIVE

To determine clinically important differences (CIDs) on Section GG physical functioning scores on the Centers for Medicare and Medicaid Services (CMS) Inpatient Rehabilitation Facility Assessment Instrument (IRF-PAI) for patients with stroke, using anchor and distribution-based approaches.

DESIGN

Pilot prospective observational cohort study.

SETTING

Inpatient rehabilitation facility.

PARTICIPANTS

Patients with stroke (N=208).

INTERVENTIONS

Physicians assessed improvements during rehabilitation using the modified Rankin scale (mRS). Improvements (≥1 point) on the mRS were used as the anchor for establishing CIDs.

MAIN OUTCOME MEASURES

Classically summed and Rasch transformed Section GG change scores associated with clinically important improvements on the mRS.

RESULTS

A total of 166 patients (79.8%) improved ≥1 point on the mRS. Change scores of 27, 9, and 16 on Section GG total physical functioning (self-care + mobility), self-care, and mobility/walk scales, respectively, had high sensitivity (0.82-0.85) but low specificity (0.52-0.69) in identifying patients improving on the mRS. Positive predictive values ranged from 0.87 to 0.91, and negative predictive values ranged from 0.42 to 0.52. Total physical functioning and selfcare anchor-derived change scores were similar to the reliable change index (RCI [2.77 × SEM]), calculated as 28 and 10 points, respectively, whereas anchor-derived mobility/walk scale change scores were equivalent to 1.96 × SEM. Exploratory Rasch modeling identified 3 Section GG subscales (R-Self-Care, R-Mobility, and R-Walking). Improvements on the R-Walking subscale were most correlated with mRS improvements (ρ=-0.47); however, accuracy of CID estimates was not improved.

CONCLUSIONS

Cut-off scores obtained using the mRS anchor aligned with more robust estimates of change, as estimated by distribution-based measures. While patients achieving anchor-derived cut-offs have a high probability of mRS improvement, change scores may fail to detect clinically meaningful improvements at these same thresholds. Alternative criteria for determining MCID/CIDs, should be explored. Rasch models require further validation.