Establishing the Minimal Clinically Important Difference of the Barthel Index in Stroke Patients

Abstract

Background. The interpretation of the change scores of the Barthel Index (BI) in follow-up or outcome studies has been hampered by the fact that its minimal clinically important difference (MCID) has not been determined. Objective. This article was written to establish the MCID of the BI in stroke patients. Methods. Both anchor-based and distribution-based methods were used to establish the MCID. In the anchorbased method, 43 stroke inpatients participated in a follow-up study designed to determine the MCID of the BI using patients' global ratings of the activities of daily living function on a 15-point Likert-type scale. The mean change scores on the 20-point scale of the BI of the MCID group, based on the patients' ratings on the Likert-type scale, served as the first estimate of the MCID. In the distribution-based method, 56 chronic stroke patients participated in the test-retest reliability study to determine the MCID of the BI. One standard error of measurement (SEM) served as the second estimate for the MCID. The larger MCID value of the 2 estimates was chosen as the MCID of the BI. Results. In the anchor-based study, there were 20 patients in the MCID group, with a mean change score of 1.85 points (ie, the first MCID estimate). In the distribution-based study, the SEM based on test-retest agreement was 1.45 points (ie, the second MCID estimate). The MCID of the BI in stroke patients was estimated to be 1.85 points. Conclusion. The authors' results, within the limitations of their design, suggest that if the mean BI change score within a stroke group has reached 1.85 points in a study, the change score on the BI can be perceived by patients as

Does physical exercise improve ADL capacities in people over 65 years with moderate or severe dementia hospitalized in an acute psychiatric setting? A multisite randomized clinical trial

“…Hsieh et al (2007) estimating the minimal clinically important difference of the BI to be 1.85 points. We estimated the effect size at 0.2 using a mean difference of two points between groups and a standard deviation of five in each group.…”

An Occupational Therapy intervention for residents with stroke-related disabilities in UK Care Homes (OTCH): cluster randomised controlled trial with economic evaluation

“…This difference did not represent a significant impact clinically. 82 The composite BI outcome analysis revealed that in the intervention arm 54% had a poor outcome (BI score change of zero or below) and 15% had a good outcome (BI score increase of two or above), compared with 52% and 14%, respectively, in the control arm. The odds of improvement in outcome were not significantly different between the groups (OR 0.96, CI 0.70 to 1.33) ( Table 21).…”

“…The potential pitfalls of the cluster design associated with the provision of informed consent, identification of the unit of inference and methods of stratification were addressed in the trial protocol. 71,104 The trial was sufficiently powered to detect a clinically significant change in the BI measure following a 3-month course of individualised OT, 82 involving task-related ADL practice, provision of adaptive equipment, adaptations to the individual's environment and caregiver training. The unadjusted ICC for BI scores was 0.36 at baseline; however, for the change in scores from baseline to 3 months, allowing for the effect of treatment, TACs and type of care home, it decreased to 0.09.…”

“…A 2-point change in score is widely accepted as having clinical meaning. 82 It equates to a change that is perceived by stroke survivors and clinicians as a step change in function. For example, a patient may change from being unable to dress and feed to being able to manage with some help or from being able to manage the toilet with some help to being able to manage alone.…”

“…82 In order to detect a difference of this magnitude between the treatment arms, a sample of 72 participants in each arm was required, based on an estimate of standard deviation (SD) of 3.7 points, 47,48,49 90% power and 5% significance level. However, residents in this trial were cluster randomised by care home and, therefore, the sample size was inflated by a factor of 4.6, resulting in an increase to 330 residents per randomisation arm.…”