Posts Tagged clinically important change
[ARTICLE] Minimal Clinically Important Difference of the 6-Minute Walk Test in People With Stroke – Full Text
Background and Purpose: The 6-minute walk test (6MWT) is commonly used in people with stroke. The purpose of this study was to estimate the minimal clinically important difference (MCID) of the 6MWT 2 months poststroke.
Methods: We performed a secondary analysis of data from a rehabilitation trial. Participants underwent physical therapy between 2 and 6 months poststroke and the 6MWT was measured before and after. Two anchors of important change were used: the modified Rankin Scale (mRS) and the Stroke Impact Scale (SIS). The MCID for the 6MWT was estimated using receiver operating characteristic curves for the entire sample and for 2 subgroups: initial gait speed (IGS) <0.40 m/s and ≥0.40 m/s.
Results: For the entire sample, the estimated MCID of the 6MWT was 71 m with the mRS as the anchor (area under the curve [AUC] = 0.66) and 65 m with the SIS as the anchor (AUC = 0.59). For participants with IGS <0.40 m/s, the estimated MCID was 44 m with the mRS as the anchor (AUC = 0.72) and 34 m with the SIS as the anchor (AUC = 0.62). For participants with IGS ≥0.40 m/s, the estimated MCID was 71 m with the mRS as the anchor (AUC = 0.59) and 130 m with the SIS as the anchor (AUC = 0.56).
Discussion and Conclusions: Between 2 and 6 months poststroke, people whose IGS is <0.40 m/s and experience a 44-m improvement in the 6MWT may exhibit meaningful improvement in disability. However, we were not able to estimate an accurate MCID for the 6MWT in people whose IGS was ≥0.40 m/s. MCID values should be estimated across different levels of function and anchors of importance.
Video Abstract available for more insights from the authors (see Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A232).
The 6-minute walk test (6MWT) is commonly used in people with stroke undergoing rehabilitation.1–3 Although originally developed and validated as a submaximal oxygen consumption test for individuals with cardiac or pulmonary disease,4 , 5 the 6MWT is a valid6–11and reliable12 , 13 measure of walking endurance and is highly recommended by the Academy of Neurologic Physical Therapy for use with people with stroke and other neurologic conditions across the continuum of care.14 More recently, the 6MWT has been used to predict community walking activity.15
An important psychometric property of any outcome measure is its sensitivity to change and responsiveness. Liang and colleagues16 , 17 define sensitivity to change as the ability of an instrument to measure change regardless of whether or not that change is important; it is the amount of change that exceeds measurement error and patient variability. Responsiveness is the ability of an instrument to measure important change. In particular, the minimal detectable change ([MDC] an index of sensitivity to change) and the minimal clinically important difference ([MCID] an index of responsiveness) are useful for clinicians and researchers when interpreting scores and/or change on an outcome measure. The MDC is an estimate of the measurement error and random fluctuation in the test score in patients who are stable.18 , 19
Although MDC is useful for interpreting change scores, it is not ideal, as it provides only the information that the change has exceeded measurement error and variability in patients who are stable. Conversely, the MCID is more useful clinically as it provides an index of important change. The MCID involves an anchor-based approach to estimating how much change in an outcome measure is clinically important and meaningful. The anchor is some external variable that is judged to be important.20 External anchors can be patients’ perception of important change, clinicians’ perception of important change, or an objective marker of important change (eg, discharge home).20 For example, Fulk and colleagues21 used patient and therapist’s perception of important change measured with a Global Rating of Change Scale as an anchor to estimate clinically important change in the Arm Motor Ability Test. When estimating the MCID of gait speed, Tilson and colleagues22 used a 1-point improvement on the modified Rankin Scale (mRS) as the anchor of important improvement in disability.
Unfortunately, there is limited research on the sensitivity to change and responsiveness of the 6MWT in people with stroke. In people with chronic stroke, the MDC is estimated to be 29 m,12 ,23 while in people with stroke undergoing inpatient rehabilitation 30 days poststroke, the MDC is estimated to be 54 m.10 To the best of our knowledge, the MCID of the 6MWT has been reported for people with stroke in only 1 other study. Using data from a completed rehabilitation trial, Perera and colleagues24 estimated meaningful change in the 6MWT using 3 different methodologies. They used an anchor-based approach using decline on 2 items of the 36-Item Short Form Health Survey (walking 1 block and climbing a flight of stairs) as the anchors. Using a distribution-based approach, they calculated standard error of measurement, and they multiplied mean baseline 6MWT distance by a small (0.2) and medium effect size (0.5). Limitations in their findings are that the anchor-based approach used was in relation to decline in performance on the anchor and so should not be applied when trying to interpret improvement. The distribution-based methods Perera and colleagues24 used to estimate change in the 6MWT were based on patients whose condition was stable and are indices of sensitivity to change not responsiveness (ie, important change). However, the MCID of the 6MWT has been reported for other patient populations and has been estimated to be between 14.0 m and 156 m in people with chronic obstructive pulmonary disease, lung disease (lung disease), coronary artery disease, fibromyalgia, and older adults.25–28
The purpose of this research study was to estimate the MCID of the 6MWT in people with stroke undergoing outpatient rehabilitation 2 months poststroke using an anchor-based approach. Based on the MDC values reported in the literature, we hypothesized that the MCID would be greater than the reported MDC values.[…]