Baseline dependency of minimal clinically important improvement

Abstract

Background: Minimal clinically important improvement (MCII) is the smallest outcome measure change important to patients. Research suggests that MCII is dependent on patients' baseline functional status measures.

Objective: The purposes of this study were: (1) to confirm whether MCII is dependent on patients' admission scores and (2) to test whether MCII is dependent on selected demographic characteristics.

Study design and setting: This was a prospective, longitudinal, observational cohort study of 6,651 patients with orthopedic knee impairments treated in 332 outpatient rehabilitation clinics in 27 states in the United States.

Outcome measures: Patient self-reports of functional status (FS) from the Lower Extremity Functional Scale were assessed using a computerized adaptive testing application (0-100 scale).

Methods: An anchored-based longitudinal method, with a 15-point Likert-type scale (-7 to +7), was used to provide a global rating of change (GROC). The MCII threshold for the GROC was defined at a cut-score of +3 or greater and was determined using nonparametric receiver operating characteristic curve analysis for each of the following variables: sex, symptom acuity, age group, and quartile of baseline FS scores.

Results: The results showed that MCII was dependent on patient baseline and demographic characteristics. Patients who were male, were younger, had more-acute symptoms, or had lower FS scores at admission required more FS change to report meaningful change.

Limitations: As this study was a secondary analysis, how the length of treatment mediated the relationship between the independent and dependent variables was unclear.

Conclusions: Although a single MCII index may provide a standard cut-score defining the smallest FS change that is meaningful to patients, researchers and clinicians should be aware that MCII is context specific and not a fixed attribute. Current results may help researchers, clinicians, and policy makers to interpret FS change related to the importance of the change to the patient.