We don't need meaningful measurements or assessments. Doing lazy crapola like this means we never get the only goal in stroke solved. 100% RECOVERY.
Minimal clinically important difference for the Fugl-Meyer assessment of the upper extremity in convalescent stroke patients with moderate to severe hemiparesis
Shogo hiragami, OTR, PhD1)*, Yu inoue, RPT, PhD2), Kazuhiro harada, RPT, PhD3)
1) Faculty of Rehabilitation, Hyogo University of Health Sciences: 1-3-6 Minatojima, Chuo-ku, Kobe-shi, Hyogo 650-8530, Japan 2) Department of Rehabilitation, Kurashiki Heisei Hospital, Japan 3) Department of Physical Therapy, School of Health Sciences and Social Welfare, Kibi International University, Japan
1) Faculty of Rehabilitation, Hyogo University of Health Sciences: 1-3-6 Minatojima, Chuo-ku, Kobe-shi, Hyogo 650-8530, Japan 2) Department of Rehabilitation, Kurashiki Heisei Hospital, Japan 3) Department of Physical Therapy, School of Health Sciences and Social Welfare, Kibi International University, Japan
Abstract.
[Purpose]
To estimate the minimal clinically important difference for the Fugl-Meyer assessment of the upper extremity by using anchor-based methods in stroke patients with moderate to severe hemiparesis.
[Participants and Methods]
Fourteen patients who were hospitalized in a convalescent phase rehabilitation ward were included in this study. Fugl-Meyer assessment of the upper extremity was used to assess the impairment prior to intervention and at follow-up (six weeks later). Participants were asked to evaluate the degree of improvement of paresis of the upper extremity using the global rating of change scale at follow-up. The mean change in Fugl-Meyer assessment scores in the group of patients who answered “a little better, meaningful in daily life” in the global rating of change scale was considered as the minimal clinically important difference.
[Results]
The mean post-onset period of participants for analysis was 49.4 days. The minimal clinically important difference of the Fugl-Meyer assessment scores were 12.4 (upper extremity), 5.6 (upper arm), and 4.9 (wrist/hand).
[Conclusion]
A score of 12.4 in the Fugl-Meyer assessment of the upper extremity is likely to be perceived as meaningful in stroke patients with moderate to severe hemiparesis. Key words: Fugl-Meyer assessment, Minimal clinically important difference, Stroke (This article was submitted Jun. 21, 2019, and was accepted Aug. 7, 2019)
INTRODUCTION
The most common deficit after stroke is hemiparesis of the upper limb1). The upper-extremity (UE) portion of the Fugl Meyer assessment (FMA-UE) is the most frequently used outcome scales to measure post stroke motor recovery of the UE2, 3). Due to severe impact on quality of life, there are a great deal of clinical trials related to hemiparesis of the upper limb1). This means that there is high demand and utility for clinically valid metrics which can be ascertained using outcome measures such as the FMA-UE. A newer focus within outcome measures is the concept of the minimal clinically important difference (MCID). MCID is defined as “the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effect and excessive cost, a change in the patient’s management”4). The use of MCID as an index allows clinicians and researchers to determine whether the change in the scores of outcomes due to intervention indicates meaningful and clinically important improvement for patients5, 6). Traditional usage of statistical
J. Phys. Ther. Sci. 31: 917–921, 2019
*Corresponding author. Shogo Hiragami (E-mail: hiragami@huhs.ac.jp) ©2019 The Society of Physical Therapy Science. Published by IPEC Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (by-nc-nd) License. (CC-BY-NC-ND 4.0: https://creativecommons.org/licenses/by-nc-nd/4.0/)
The Journal of Physical Therapy Science
J. Phys. Ther. Sci. Vol. 31, No. 11, 2019 918
significance (e.g., p<0.05) to determine whether an intervention is effective is influenced not only by the extent of change but also the sample size and group variance of the study5, 7). Thus, if a study observing a stroke group yields a smaller change score than the MCID, this should not be viewed as a significant change to the participants, even if the change in experimental outcome reaches a statistically significant level7). MCID of an instrument can be determined via distribution-based or anchor-based methods5, 6). Distribution-based methods estimate MCID values based on the statistical characteristics of scores within a sample5, 6). A limitation of the distribution based method is that derived values do not typically indicate the perception of change of the score by patients. Anchor-based methods estimate MCID values by comparing change scores with the external criteria, usually either the report of a patient or a clinician5, 6). Page et al. reported that in stroke patients with minimal to moderate chronic paresis (baseline FMA-UE scores of ≥28 to ≤50), the estimated MCID scores in the FMA-UE were 4.25 (grasping ability), 5.25 (releasing ability), and 7.25 (ability to move arm)8). Arya et al. reported that in stroke patients with severe subacute paresis (baseline FMA-UE scores of 14.4), the estimated MCID score of the FMA-UE was 9 to 109). There is often a range in MCID estimates that varies across patient population (e.g., baseline levels of the disability) and clinical study context5, 6). Thus, a single MCID value may be insufficient across all patient samples. Since levels of UE hemiparesis in stroke patients are diverse10), accumulating evidence of MCID in the FMA-UE at each post-onset period and level of paresis is necessary. Increased knowledge about MCID based on FMA-UE would improve the interpretation of treatment effects in interventional research, thereby improving the clinical management of hemiplegic stroke patients. Therefore, the present study aimed to estimate the MCID of the FMA-UE in stroke patients with moderate to severe hemiparesis in the convalescent phase.
INTRODUCTION
The most common deficit after stroke is hemiparesis of the upper limb1). The upper-extremity (UE) portion of the Fugl Meyer assessment (FMA-UE) is the most frequently used outcome scales to measure post stroke motor recovery of the UE2, 3). Due to severe impact on quality of life, there are a great deal of clinical trials related to hemiparesis of the upper limb1). This means that there is high demand and utility for clinically valid metrics which can be ascertained using outcome measures such as the FMA-UE. A newer focus within outcome measures is the concept of the minimal clinically important difference (MCID). MCID is defined as “the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effect and excessive cost, a change in the patient’s management”4). The use of MCID as an index allows clinicians and researchers to determine whether the change in the scores of outcomes due to intervention indicates meaningful and clinically important improvement for patients5, 6). Traditional usage of statistical
J. Phys. Ther. Sci. 31: 917–921, 2019
*Corresponding author. Shogo Hiragami (E-mail: hiragami@huhs.ac.jp) ©2019 The Society of Physical Therapy Science. Published by IPEC Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (by-nc-nd) License. (CC-BY-NC-ND 4.0: https://creativecommons.org/licenses/by-nc-nd/4.0/)
The Journal of Physical Therapy Science
J. Phys. Ther. Sci. Vol. 31, No. 11, 2019 918
significance (e.g., p<0.05) to determine whether an intervention is effective is influenced not only by the extent of change but also the sample size and group variance of the study5, 7). Thus, if a study observing a stroke group yields a smaller change score than the MCID, this should not be viewed as a significant change to the participants, even if the change in experimental outcome reaches a statistically significant level7). MCID of an instrument can be determined via distribution-based or anchor-based methods5, 6). Distribution-based methods estimate MCID values based on the statistical characteristics of scores within a sample5, 6). A limitation of the distribution based method is that derived values do not typically indicate the perception of change of the score by patients. Anchor-based methods estimate MCID values by comparing change scores with the external criteria, usually either the report of a patient or a clinician5, 6). Page et al. reported that in stroke patients with minimal to moderate chronic paresis (baseline FMA-UE scores of ≥28 to ≤50), the estimated MCID scores in the FMA-UE were 4.25 (grasping ability), 5.25 (releasing ability), and 7.25 (ability to move arm)8). Arya et al. reported that in stroke patients with severe subacute paresis (baseline FMA-UE scores of 14.4), the estimated MCID score of the FMA-UE was 9 to 109). There is often a range in MCID estimates that varies across patient population (e.g., baseline levels of the disability) and clinical study context5, 6). Thus, a single MCID value may be insufficient across all patient samples. Since levels of UE hemiparesis in stroke patients are diverse10), accumulating evidence of MCID in the FMA-UE at each post-onset period and level of paresis is necessary. Increased knowledge about MCID based on FMA-UE would improve the interpretation of treatment effects in interventional research, thereby improving the clinical management of hemiplegic stroke patients. Therefore, the present study aimed to estimate the MCID of the FMA-UE in stroke patients with moderate to severe hemiparesis in the convalescent phase.
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