The Stroke Impairment Assessment Set: Its Internal Consistency and Predictive Validity

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1 863 The Stroke Impairment Assessment Set: Its Internal Consistency and Predictive Validity Tetsuya Tsuji, MD, Meigen Liu, MD, DMSc, Shigeru Sonoda, MD, DMSc, Kazuhisa Domen, MD, DMSc, Naoichi Chino, MD, DMSc A FUNCTIONAL ASSESSMENT and rehabilitation regimen should be carefully devised for each patient based on ABSTRACT. Tsuji T, Liu M, Sonoda S, Domen K, Chino N. The Stroke Impairment Assessment Set: its internal consistency and predictive validity. Arch Phys Med Rehabil 2000;81: Objective: To study the scale quality and predictive validity of the Stroke Impairment Assessment Set (SIAS) developed for stroke outcome research. Design: Rasch analysis of the SIAS; stepwise multiple regression analysis to predict discharge functional independence measure (FIM) raw scores from demographic data, the SIAS scores, and the admission FIM scores; cross-validation of the prediction rule. Setting: Tertiary rehabilitation center in Japan. Patients: One hundred ninety stroke inpatients for the study of the scale quality and the predictive validity; a second sample of 116 stroke inpatients for the cross-validation study. Main Outcome Measures: Mean square fit statistics to study the degree of fit to the unidimensional model; logits to express item difficulties; discharge FIM scores for the study of predictive validity. Results: The degree of misfit was acceptable except for the shoulder range of motion (ROM), pain, visuospatial function, and speech items; and the SIAS items could be arranged on a common unidimensional scale. The difficulty patterns were identical at admission and at discharge except for the deep tendon reflexes, ROM, and pain items. They were also similar for the right- and left-sided brain lesion groups except for the speech and visuospatial items. For the prediction of the discharge FIM scores, the independent variables selected were age, the SIAS total scores, and the admission FIM scores; and the adjusted R 2 was.64 ( p.0001). Stability of the predictive equation was confirmed in the cross-validation sample (R 2.68, p.001). Conclusions: The unidimensionality of the SIAS was confirmed, and the SIAS total scores proved useful for stroke outcome prediction. Key Words: Cerebrovascular disorders; Rehabilitation; Functional assessment; Outcome assessment by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation From the Department of Rehabilitation Medicine, Keio University School of Medicine (Tsuji, Sonoda, Domen, Chino), Tokyo, Saitama Prefecture General Rehabilitation Center (Liu), Saitama, Japan. Submitted June 18, Accepted for publication November 24, No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the authors or upon any organization with which the authors are associated. Reprint requests to Tetsuya Tsuji, MD, Department of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan /00/ $3.00/0 doi: /apmr the International Classification of Impairment, Disability, and Handicaps, developed by the World Health Organization in A reliable and valid measure of the impairment resulting from stroke is needed in medical rehabilitation to describe the consequences of neurologic deficits, to monitor the effects of treatment and natural recovery, and to understand how reductions in disability are related to improvements in impairment. 2 There are a host of measures of stroke impairment, 3 either comprehensive (Canadian neurological scale, 4 National Institutes of Health stroke scale, 5 and Fugl-Meyer assessment 6 )or specific (motricity index 7 and Brunnstrom stage 8 for motor impairment, the modified Ashworth scale 9 for spasticity, and trunk control test for trunk function 10 ). Based on the recommendations of a symposium on methodologic issues in stroke outcome research, 11 we recently developed a new evaluation tool for stroke patients called the Stroke Impairment Assessment Set (SIAS). The SIAS assesses various aspects of impairment in hemiplegic patients, including motor function, tone, sensory function, range of motion (ROM), pain, trunk function, visuospatial function, speech, and sound side function. 12,13 The interrater reliability, concurrent and predictive validity, and sensitivity of the SIAS have already been reported, but its scale quality has not been fully examined. Our first purpose, therefore, is to evaluate the scale quality and to determine the difficulty pattern of the SIAS using Rasch analysis, 17 which is a statistical method to convert an ordinal scale to an interval scale, assuming unidimensionality of the measurement items. The second purpose is to test the predictive validity of the SIAS and to cross-validate the prediction rule in another sample of stroke patients. METHODS Subjects The subjects for the Rasch analysis 17 and the predictive validity were 190 stroke patients who had been admitted within 4 months after the onset of stroke to a university hospital and its eight affiliated hospitals and discharged. The second set of subjects, for the cross-validation study, consisted of 116 stroke patients who had been admitted within 4 months after the onset of stroke to a university hospital and its seven affiliated hospitals and discharged. Daily rehabilitation therapy was given to all patients by the nursing staffs, physical therapists, occupational therapists, speech therapists, or psychologists as indicated. Patients who were transferred to acute care hospitals were excluded. The average age at admission was 61 (34 to 92) years old. Of the 190 patients, 116 (61.1%) were men. There were 110 with cerebral infarction, 70 with cerebral hemorrhage, and 10 with subarachnoid hemorrhage. Ninety-five (50%) of the patients had right-sided brain lesion and the remaining 95 (50%) had left-sided lesion. The average number of days from stroke onset

2 864 CONSISTENCY AND VALIDITY OF THE SIAS, Tsuji to admission and the mean length of hospital stay were 47.3 and 90.9 days, respectively. Data acquisition. A structured form was used to prospectively collect information on demographic data, primary pathology, impairment as assessed with the SIAS, as well as admission and discharge functional independence measure (FIM) 18 raw scores. Before data collection, the purposes and procedures were fully explained, and informed consent was obtained from the patients and their family members. Instruments. The SIAS was scored by physiatrists in charge of the patients. It is a standardized measure of stroke impairment consisting of the subcategories of motor function, tone, sensory function, ROM, pain, trunk function, visuospatial function, speech, and sound side function. As shown in table 1, there are altogether 22 items, and each item is rated from 0 (severely impaired) to 3 (normal) for muscle tone, sensory, ROM, pain, trunk, higher cortical function, and unaffected side function or to 5 (normal) for motor function. Figure 1 illustrates how the motor items are scored. The total scores are cumulative across the items. The FIM, which was developed to ensure uniformity in assessing the activities of daily living, was scored by physiatrists, nurses, or therapists. The Rasch analysis. The Rasch analysis 17 was used in our study to calibrate the scale structure and place the items on a linear scale. It is based on the relative difficulty of the items and the persons abilities to perform the task items. The SIAS instrument was converted to an interval scale by use of a Rasch analysis computer program BIGSTEPS a that computes estimates of the item difficulty, associated standard errors of the measurement, and each item s fit to the Rasch measurement model. We analyzed the pattern of the item difficulty and the misfit to the unidimensional model. Estimated SIAS scores values for individuals or items, standard errors, and fit statistics were calculated. The mean square fit statistics (MNSQ), which measures each item s adherence to the Rasch model, denotes scale unidimensionality. A MNSQ near 1.0 indicates satisfactory functioning of the item. A MNSQ above 1.3 indicates that Motor function Proximal Table 1: Stroke Impairment Assessment Set Upper Extremity Lower Extremity 0-5 (Finger function) 0-5 (Hip flexion) 0-5 (Knee extension) Distal 0-5 (Knee-mouth) 0-5 (Foot tap) Muscle tone DTR Tone Sensory function Touch Position Range of motion 0-3 (shoulder abd) 0-3 (ankle df) Pain 0-3 Trunk Verticality 0-3 Abdominal MMT 0-3 Higher cortical function Visuospatial 0-3 Speech 0-3 Unaffected side function Grip strength 0-3 Quadriceps MMT 0-3 Total score 76 Abbreviations: DTR, deep tendon reflex; shoulder abd, shoulder abduction; ankle df, ankle dorsiflexion; MMT, manual muscle testing. the item fits poorly to the Rasch model, or means a lack of coherence between ratings on the item and the overall levels of performance of stroke patients. Item difficulties are expressed in logits. Predictive validity. To investigate the predictive validity of the SIAS, or, the degree to which a measure relates to a logically important outcome criterion, we analyzed in the subjects described above how the SIAS total scores contributed to the prediction of the discharge FIM raw scores with a stepwise multiple regression analysis. 19 In another sample, we cross-validated the predictive equation developed in the first sample. We analyzed the correlation coefficient between the observed and the predicted total FIM scores calculated with the predictive equation. The average age at admission was 59.9 (24 to 86) years old. Of the 116 patients, 80 (68.9%) were men. There were 63 with cerebral infarction, 52 with cerebral hemorrhage, and 1 with subarachnoid hemorrhage. Fifty-nine (50.9%) of the patients had a right-sided brain lesion, and the remaining 57 (49.1%) had a left-sided lesion. The average number of days from stroke onset and the mean length of hospital stay were 69.1 and days, respectively. The above statistical analyses were performed with a Stat- View 4 software b developed for a Macintosh computer. c RESULTS Fit statistics of the SIAS. The fit statistics of the SIAS items at admission and at discharge are shown in table 2. The MNSQ was within 1.3 logits except for the shoulder ROM, pain, visuospatial function, and speech items. When the leftand right-sided brain lesion groups were analyzed separately, the results of the fit statistics were almost identical both at admission and at discharge except for speech and visuospatial items (table 3). The speech item for the right-sided and the visuospatial item for the left-sided brain lesion group fitted poorly. As shown in table 2 and figure 2, the logits intervals between the more difficult and the easier items for the SIAS items were wide enough to describe fine impairment changes. The intervals of difficulty among the items varied. The touch and position sense items of the upper extremity and lower extremity items showed similar difficulties both at admission and at discharge. The other items had inter-item differences of from 0.1 to 0.6 logits. Item difficulties for the SIAS items. Figure 2 shows that the difficulty patterns were identical at admission and at discharge except for the deep tendon reflex (upper extremity), deep tendon reflex (lower extremity), ROM (shoulder and ankle), pain, and verticality items. The verticality and the quadriceps manual muscle testing items were the easier items, whereas the finger function, knee mouth, and foot pat items were the more difficult. The difficulty patterns at admission for the left- and rightsided brain lesion groups are illustrated separately in figure 3. They were almost identical except for the speech item. The results were identical at discharge as well. Predictive validity. Table 4 summarizes the results of the multiple stepwise regression analysis to predict discharge FIM scores. When we excluded the SIAS total scores, the independent variables selected were age, and the admission FIM scores (motor and cognitive FIM scores); adjusted R 2 was.61 ( p.0001). Adding the SIAS total scores increased the R 2 to.64 ( p.0001). Figure 4 shows the result of the crossvalidation of the predictive equation in the second sample (n 116). The adjusted R 2 was.68 ( p.0001).

3 CONSISTENCY AND VALIDITY OF THE SIAS, Tsuji 865 Fig 1. Illustration for the SIAS motor items (knee mouth, finger function, hip flexion, knee extension, and foot tap). DISCUSSION Fit statistics of the SIAS. Scale reliability is usually analyzed as internal consistency or unidimensionality. 3 To determine the scale quality, we performed Rasch analysis 17 on the SIAS instrument and analyzed the fit statistics with all the 22 items. The fit statistics were acceptable, except for the shoulder ROM, pain, visuospatial function, and speech. Why do these four SIAS items fit poorly to the Rasch model? The first reason may be the different characteristics of the patients with right- and left-sided brain lesions. Patients with right-sided brain lesion often suffer from unilateral spatial neglect, while patients with left-sided brain lesion are more likely to have aphasia. The distribution of the visuospatial deficit and speech scores were actually different between the two groups (fig 5). Second, the shoulder ROM and pain items fit poorly because they are affected not only by the stroke per se but also by the occurrence of a shoulder-hand syndrome, osteoarthritic changes, and other comorbidities. 20 The larger misfit was found for the pain item at admission, which was the easiest item. Items with extreme scale calibrations often misfit because their scale extremes are less well defined and thus fit less well than do items with intermediate difficulties. 21 Another problem is concerned with the inter-item differences, or the magnitude of the interval between the items on the difficulty scale. The touch and position sense for both upper and lower extremity items showed similar difficulties (fig 2). Because the number of items with similar difficulties is better reduced, they can be scored together as sensory function, for example. Item difficulties for the SIAS items. We performed Rasch analysis to analyze the item difficulties of the SIAS. 17 It allows one to position the items according to the difficulty, and persons according to their ability, with regard to the items on a common unidimensional and additive scale. In our longitudinal study, identical difficulty patterns were observed at admission and at discharge except for the deep tendon reflex (both extremities), ROM (shoulder and ankle), and pain items. The more limited ankle ROM at discharge might be caused by the resistance brought about by the increased tone. The shoulder ROM improved at discharge, possibly as a result of the intensive ROM exercises. The pattern of item difficulty was the same except for the speech item when the right- and left-sided brain lesion groups were analyzed separately. This is because the patients with left-sided brain lesion suffer from aphasia more frequently. Predictive validity. In this study, we investigated whether the sum of the raw SIAS item scores contributes to the stroke outcome prediction with a multiple regression analysis. The predictive validity of the SIAS was evidenced because it was selected as one of the independent variables to predict discharge

4 866 CONSISTENCY AND VALIDITY OF THE SIAS, Tsuji Table 2: Item Difficulties (By Logits) and Fit Statistics for the SIAS Items Items Item Difficulties (Logits) Fit Statistics (MNSQ) Admission Discharge Admission Discharge Finger function Knee mouth Hip flexion Knee extention Foot pat DTR (U/E) DTR (L/E) Tone (U/E) Tone (L/E) Touch (U/E) Touch (L/E) Position (U/E) Position (L/E) ROM (shoulder) * ROM (ankle) Pain * 1.00 Verticality Abdominal MMT Visuospatial * 1.99* Speech * Grip strength Quadriceps MMT Abbreviations: DTR, deep tendon reflex; U/E, upper extremity; L/E: lower extremity; ROM, range of motion; MMT, manual muscle testing. * Misfit: MNSQ 1.3. Table 3: Comparison Between the Right- and Left-Sided Brain Lesion Groups at Admission Items Item Difficulties (Logits) Fit Statistics (MNSQ) Right- Sided Left- Sided Right- Sided Left- Sided Finger function Knee mouth Hip flexion Knee extention Foot pat DTR (U/E) DTR (L/E) Tone (U/E) Tone (L/E) Touch (U/E) Touch (L/E) Position (U/E) Position (L/E) ROM (shoulder) ROM (ankle) Pain * 1.38* Verticality * Abdominal MMT Visuospatial * Speech * 1.01 Grip strength Quadriceps MMT Abbreviations: Right-Sided, right-sided brain lesion group; Left- Sided, left-sided brain lesion group; DTR, deep tendon reflex; U/E, upper extremity; L/E, lower extremity; ROM, range of motion; MMT, manual muscle test. * Misfit: MNSQ 1.3. Fig 2. Item difficulties for the SIAS items (by logits) for stroke patients at admission and at discharge. DTR, deep tendon reflex; U/E, upper extremity; L/E, lower extremity; ROM, range of motion; MMT, manual muscle testing.

5 CONSISTENCY AND VALIDITY OF THE SIAS, Tsuji 867 Fig 3. Item difficulties for the SIAS items (by logits) for patients with left- and right-sided brain lesions at admission. DTR, deep tendon reflex; U/E, upper extremity; L/E, lower extremity; ROM, range of motion; MMT, manual muscle testing. FIM scores together with age and admission FIM scores (table 4). We could confirm the cross-validity of the predictive equation in a different sample. We used a multiple regression analysis for ordinal scales and, theoretically, this could be misleading. 22,23 But Kleinbaum et al 24 contend that although regression analysis is classically considered to accommodate continuous variables best, in practice any type of variables can be used. Because we could demonstrate the cross-validity of our predictive equation, we believe that the use of a stepwise multiple regression analysis in this study can be justified. Future study. Our study showed, using Rasch analysis, that the SIAS instrument was a valid linear measure for stroke patients at admission and at discharge. However, we still need to enhance its scale quality further. To improve some of the poor Table 4: Result of Stepwise Multiple Regression Analysis (n 190)* Independent Variables Analyzed Adjusted R 2 p Variables in Model Std Coeff Age Age Admission motor FIM score Mot FIM Admission cognitive FIM score Cog FIM Intercept SIAS total score Age Mot FIM Cog FIM SIAS Intercept Abbreviations: FIM, functional independence measure; Mot FIM, FIM motor score; Cog FIM, FIM cognitive score. * Dependent variable: Discharge FIM score. F Fig 4. Cross-validation of the predictive equation. In the second sample (n 116), the predictive equation developed from the first sample (n 190) was cross-validated. The predictive accuracy was acceptable (adjusted R 2.68; p F.0001).

6 868 CONSISTENCY AND VALIDITY OF THE SIAS, Tsuji Fig 5. Comparison of the histograms of the speech and visuospatial item scores at admission between the right- and left-sided brain lesion groups., right-sided brain lesion group;, left-sided brain lesion group. fitting items, the SIAS instrument might be better divided into two or three subsets, or the number of items might be reduced by combining them. CONCLUSION We confirmed the scale quality of the SIAS instrument with the Rasch analysis, and the SIAS total scores proved useful for stroke outcome prediction. The SIAS is a valid scale assessing impairment severity resulting from stroke undergoing medical rehabilitation. References 1. World Health Organization. Classification of impairments, disabilities, and handicaps. Geneva: World Health Organization; Heinemann AW, Harvey RL, McGuire JR, Ingberman D, Lovell L, Semik P, et al. Measurement properties of the NIH stroke scale during acute rehabilitation. Stroke 1997;28: Liu M, Ishigami S. Toward future research. In: Chino N, Melvin JL, editors. Functional evaluation of stroke patients. Tokyo: Springer-Verlag; p Cote R, Battista RN, Wolfson C, Boucher J, Adam J, Hachinski V. The Canadian neurological scale: validation and reliability assessment. Neurology 1989;39: Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke 1989;20: Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. A method for evaluation of physical performance. Scand J Rehabil Med 1975;7: Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol 1980;19: Brunnstrom S. Movement therapy in hemiplegia; a neurophysiological approach. New York: Harper & Row; Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987;67: Collin C, Wade D. Assessing motor impairment after stroke: a pilot reliability study. J Neurol Neurosurg Psychiatry 1990;53: Gresham GE. Methodologic issues in stroke outcome research. Stroke 1990;21 Suppl 2: Chino N, Sonoda S, Domen K, Saitoh E, Kimura A. Stroke impairment assessment set (SIAS): a new evaluation instrument for stroke patients. Jpn J Rehabil Med 1994;31: Chino N, Sonoda S, Domen K, Saitoh E, Kimura A. Stroke impairment assessment set (SIAS). In: Chino N, Melvin JL, editors. Functional evaluation of stroke patients. Tokyo: Springer- Verlag; p Domen K, Sonoda S, Chino N, Saitoh E, Kimura A. Evaluation of motor function in stroke patients using the stroke impairment assessment set (SIAS). In: Chino N, Melvin JL, editors. Functional evaluation of stroke patients. Tokyo: Springer-Verlag; p Sonoda S, Saitoh E, Domen K, Chino N. Prognostication of stroke patients using the stroke impairment assessment set and the functional independence measure. In: Chino N, Melvin JL, editors. Functional evaluation of stroke patients. Tokyo: Springer-Verlag, p Seki M, Hase K, Domen K, Sonoda S, Saitoh E, Chino N. Longitudinal study of recovery from hemiplegia using the stroke impairment assessment set (SIAS) [abstract]. Nosocchu 1995;17: 630 (in Japanese). 17. Wright BD, Masters GN. Rating scale analysis: Rasch measurement. Chicago: MESA; Data Management Service of the Uniform Data System for Medical Rehabilitation and the Center for Functional Assessment Research. Guide for use of the uniform data set for medical rehabilitation including the functional independence measure (FIM). version 3.0. Buffalo: State University of New York; Armitage P, Berry G. Statistical methods in medical research. 3rd ed. Oxford: Blackwell Scientific Publications; Liu M, Domen K, Chino N. Comorbidity measures for stroke outcome research: a preliminary study. Arch Phys Med Rehabil 1997;78: Linacre JM, Heinemann AW, Wright BD, Granger CV, Hamilton BB. The structure and stability of the functional independence measure. Arch Phys Med Rehabil 1994;75: Merbitz C, Morris J, Grip JC. Ordinal scales and foundations of misinference. Arch Phys Med Rehabil 1989;70: Wright BD, Linacre JM. Observations are always ordinal; measurements, however, must be interval. Arch Phys Med Rehabil 1989;70: Kleinbaum DG, Kupper LL, Muller KE, Nizam AZ. Applied regression analysis and other multivariable methods. 2nd ed. Boston: PWS-Kent; Suppliers a. MESA Press, 5835 S Kimbark, Chicago, IL b. SAS Institute, SAS Campus Dr, Cary, NC c. Apple Computer, Inc, 1 Infinite Loop, Cupertino, CA

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