(Stroke. 1999;30:1357-1361.)
© 1999 American Heart Association, Inc.
Original Contributions |
From North Tyneside General Hospital (C.I.M.P., R.H.C., H.R.), and the Departments of Medicine (Geriatrics) (H.R.) and Epidemiology & Public Health (H.R.), University of Newcastle, Newcastle Upon Tyne, UK.
Correspondence to Dr. Christopher Price, Academic Department, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear NE29 8NH, UK. E-mail C.I.M.PRICE{at}NCL.AC.UK
| Abstract |
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MethodsConsent was obtained from 96 subjects with a clinical stroke (mean age, 72.5 years; 50 men) and 48 control subjects without cerebrovascular disease (mean age, 71.5 years; 29 men). Patients with reduced conscious level or severe dysphasia were excluded. Subjects were asked to rate the tightness that they could feel on the (unaffected) upper arm after 3 low-pressure inflations with a standard sphygmomanometer cuff, which followed a predetermined sequence (20 mm Hg, 40 mm Hg, 0 mm Hg). Immediately after each change, they rated the perceived tightness on 5 scales presented in a random order: 4-point rating scale (none, mild, moderate, severe), 0 to 10 numerical rating scale, mechanical VAS, horizontal VAS, and vertical VAS. Standard tests recorded deficits in language, cognition, and visuospatial awareness.
ResultsInability to complete scales with the correct pattern was associated with any stroke (P<0.001). There was a significant association between success using scales and milder clinical stroke subtype (P<0.01). Within the stroke group, logistic regression analysis identified significant associations (P<0.05) between impairments (cognitive and visuospatial) and inability to complete individual scales correctly.
ConclusionsMany patients after a stroke are unable to successfully complete self-report measurement scales, including VAS.
Key Words: neuropsychological tests outcome measurement rehabilitation stroke validity
| Introduction |
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Researchers have already anticipated that stroke-related impairments such as hemianopia, inattention, and limited manual dexterity could theoretically invalidate the traditional horizontal VAS. To overcome these problems, vertical and mechanical "slide-rule" versions have been used to investigate pain,15 16 17 mood,18 and health status19 after stroke. In the assessment of mood, it was reported that even stroke patients without cognitive impairment were bewildered by the visual analogue mood scale.18 In contrast, the Euroquol vertical VAS with numbers has shown a high level of test-retest reliability.19 Despite this good evidence that a modified VAS can have intrasubject reliability, there has been no work to examine the actual validity and sensitivity to change of the VAS concept in stroke populations. Our study examined the influence of stroke and the resulting higher cortical impairments on the validity of the VAS, and compared it with 2 less-sensitive scales that are common alternatives.
| Subjects and Methods |
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A single observer (C.I.M.P.) who was not involved in the care of any study subjects conducted a structured interview with each individual between 9 AM and noon and 2 and 5 PM on weekdays. Most interviews took place in a consulting room without an accompanying carer. Several inpatients were assessed on the main ward because of immobility, but efforts were made to prevent any other potential subjects from witnessing the interview. Subjects did not receive prior warning that they would be approached, and all denied having previously received instruction about any of the scales under examination. All were able to give informed consent.
Scale Examination
Subjects were asked to demonstrate their understanding of 5
scales by asking them to report the changes of a controlled stimulus:
low-pressure inflations of a sphygmomanometer cuff. A standard
sphygmomanometer cuff was placed around 1 arm of each subject (the
unaffected arm in those in the stroke group) and inflated slowly until
the individual could start to feel the cuff tighten (20 to 30
mm Hg). It was then inflated by an additional 5 mm Hg, and
subjects were asked to rate this initial tightness on the 5 scales
(Figure
and Table 1
).
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These were presented in a predetermined, computer-generated random order. Instructions for each scale were typed clearly on a laminated A4-size card and read aloud to the subjects before they rated the tightness. Subjects who could not hold a pen were all able to point to the scales to indicate the position of their answer. The rating on each scale was recorded by the observer. The Mechanical, Horizontal, and Vertical VAS results were measured in millimeters from the lowest end.
The cuff was further inflated to twice the initial pressure (40 to 60 mm Hg), and subjects were asked to indicate the level of tightness on the scales presented to them in a random sequence. Finally, the cuff was deflated to 0 mm Hg before subjects were asked to rate perceived cuff tightness for a third time. To report on the scales at each level of tightness took less than 1 minute, and there were no complaints of discomfort.
To confirm that subjects were correctly sensing the cuff tightness, they were also asked after the second and final changes to indicate whether the pressure that they felt on their arm was the "same, more, or less" (SML) than before. This SML scale was used to check that the change was correctly perceived in simple terms and that inaccuracies in the use of the more complex scales was not simply due to perceptual problems in the upper limb.
Scale Definitions
These scales recorded subjective perceptions of cuff
tightness, and so no attempt was made to assign "correct" values
for the level of tightness reported each time. Subjects who understood
how to use a scale were defined as those whose answers were compatible
with the direction of cuff inflations. Due to the subjective
nature of the measurement, individuals were not required to score the
lowest point of each scale for the final rating (although many did),
but to be defined as correct it was essential that the final rating was
below the initial rating. Because the scales were treated as ordinal
rather than ratio measures, subjects were required to demonstrate the
appropriate pattern of cuff tightness only.
Each type of scale possesses a different degree of sensitivity, according to the number of options available to record the degree of tightness.20 21 22 The following criteria for correct scale completion were defined in advance: (1) The SML scale was scored correctly if subjects indicated an increase and decrease as the first and second changes from the initial tightness level. (2) The 4 categories of the 4-point rating scale (FPRS) were judged to be broad enough so that the increase in cuff tightness would not necessarily trigger a movement up to a more intense category, eg, from mild to moderate. Subjects were defined as using the scale correctly if the decrease to 0 mm Hg resulted in a decrease on the scale to below the initial level. (3) The numerical rating scale was considered sensitive enough with its 11 points (0 to 10) that the increase and decrease in tightness could be reflected by a change of at least 1 point. (4) The VAS in its mechanical, vertical, and horizontal forms was the most sensitive scale used. We defined that correct use of the scale required subjects to mark at least a 5-mm change from the chosen starting mark for both the cuff increase and decrease.
Assessment of Stroke Impairment
After the examination of scales, all stroke subjects underwent a
structured examination of stroke-related impairments in the following
sequence: language (the comprehension and expression sections of the
Frenchay Aphasia Screening Test [FAST]23 ), cognition
(Abbreviated Mental Test Score [AMTS]24 ), visuospatial
impairment (the Star Cancellation Test [SCT]25 ), visual
field defect by confrontation, tactile inattention by perception of
bilateral light touch,26 presence of clinically obvious
hemineglect if inattention was not assessable, and limb power
(Motricity Score27 ). When it was not possible to determine
the absence of an impairment in subjects with aphasia (eg, cognitive
deficit), it was assumed to be present. The clinical stroke
subtype28 at time of maximal impairment was extracted from
the hospital records.
Although they were not formally assessed with the above tests, the records of the control subjects were examined to exclude any history of cerebrovascular disease or any undeclared sensory and cognitive impairment that could affect their ability to understand the instructions on completion of the scales.
Data Analysis
The results were analyzed by SPSS for Windows, version
7.5 (SPSS Inc.), by the
2 test and ANOVA to compare the
proportions of subjects who completed each scale correctly and logistic
regression with forward stepwise conditioning to separate the
influences of the higher cortical impairments upon success in scale
completion. The level of statistical significance was set in advance at
P<0.05.
| Results |
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The number of stroke and control subjects who successfully completed
each scale are given in Table 3
. It can
be seen that apart from the SML scale, stroke was associated with a
significantly lower proportion of subjects using each of the rating
scales correctly. Within the stroke group, successful scale completion
varied significantly with stroke subtype (Table 4
).
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To examine the relative influence of stroke-related impairments on
failure to use each scale correctly, the following factors were used
simultaneously in a logistic regression analysis:
sex, age, clinical stroke subtype, first or recurrent stroke, left or
right handedness, limb side affected, days since stroke, overall limb
power (Motricity Score), FAST status, AMTS status, SCT status, presence
of tactile inattention or clear hemineglect, and presence of visual
field defect. Those factors significantly associated with incorrect
completion of the rating scales and their odds ratios are
described in Table 5
.
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| Discussion |
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Clinical stroke subtype influenced scale completion. After posterior circulation stroke, subjects were likely to be successful in all scales. The lacunar circulation stroke group demonstrated a high level of competency for the FPRS. The partial and total anterior circulation stroke groups showed low levels of correct scale use beyond the SML measure. This would suggest that the ability to use these scales is impaired by loss of higher cortical function.
Plausible associations between stroke impairments and the correct use of individual scales were identified when possible dependent factors were entered into the regression analysis. The dominant factor for the FPRS, NRS, and Mechanical VAS was cognitive, whereas the Horizontal and Vertical VAS showed a greater reliance on visuospatial factors. It is possible that the former require greater cognitive competence in view of their linguistic, mathematical, and mechanical basis, while the latter need an intact appreciation of a 10-cm line arranged horizontally or vertically.
Aphasia was not significantly associated with mistakes using these
scales, although impairment of language is also likely to be an
important factor determining their comprehension. Aphasia has been
associated with a reduction in the amount of pain medication received
by patients,29 and a recent review examining the
definition of pain30 emphasized the need to develop scales
that allow for limitations in expression. However, in this study it
should be noted that patients with aphasia which prevented them from
understanding a simple command were excluded. In addition, subjects who
were unable to answer the questions of the AMTS or complete the SCT for
any reason were scored accordingly (Table 2
). This simple pragmatic
approach may explain the lack of additional value of the FAST score in
the regression analysis.
This study did not include a comparison of higher cortical impairments found in the stroke and nonstroke populations, because the control group was not formally assessed with the AMTS, FAST, and SCT. This should not undermine the validity of these results, as our intention was to examine the overall influence of stroke on scale performance and then further investigate the impact of higher cortical deficits within the stroke population alone. A careful survey of medical records excluded control subjects with any undeclared cognitive and sensory deficits. It would require a more complicated design to include subjects with similar higher cortical impairments not due to cerebrovascular disease, and so it is currently unknown whether the difficulties in using these scales extend beyond the stroke population.
Subjective states such as pain and quality of life cannot be measured objectively in a reliable fashion. In the absence of a clear gold standard, there are difficulties in evaluating scale validity. It is a minimum requirement that measurement scales be ordinal if they are to have any practical value. Studies using thermal electrodes to produce a controlled temperature stimulus suggest that the VAS is valid as a ratio scale,9 but other researchers have not confirmed this.3 26 We defined correct usage of the VAS when subjects indicated the correct directional change in tightness. Thus, we were examining the validity of these scales as ordinal measures only. The majority of the control group were able to use the various formats of the VAS correctly according to these criteria (Mechanical, 85%; Vertical, 88%; and Horizontal, 81%). This concurs with results from previous studies which have suggested that older subjects can use VAS formats as competently as their younger counterparts.31 The horizontal VAS was the least successful scale used by the control group, supporting a previous report that it is the least suitable design for general use in the elderly.32
The cuff tightness test used in this study is a low-pressure alternative to the Submaximal Effort Tourniquet Test,33 in which the sphygmomanometer cuff is used to occlude the arterial supply to the hand for a set time, while repeated flexion/extension movements cause lactic acidosis to occur in the forearm muscles. The time for which occlusion is maintained has been found to reliably agree with the amount of discomfort that subjects report on the VAS. Our painless alternative requires subjects to rate the perceived sensation of tightness on the upper arm to validate the self-report scales as ordinal measures. The property of tightness does not necessarily reflect the difficulties faced by subjects rating pain intensity but has allowed an exploration of how stroke affects scale comprehension.
Because of the obvious nature of many stroke impairments, it is important to acknowledge that it was not possible for the observer to be completely blinded to which subjects had suffered a stroke. However, to minimize sources of observer error, the data collection was carried out by a single researcher who was not involved in the care of the subjects, the scale performance was always recorded before the stroke impairments were formally measured, and the predetermined definitions for correct scale use were strictly adhered to. Whenever possible, attempts were made to standardize other factors during the assessments, such as setting and timing. To minimize a carry-over effect between scales, these were presented in a predetermined random order each time.
This study suggests that caution is needed when using traditional scales to obtain subjective health status data from stroke patients with higher cortical deficits. Scales that have been designed and validated in the nonstroke population will not necessarily be either valid or useful for stroke patients. We do not recommend that the VAS in any format is generally employed as a self-report measurement tool after stroke. Accurate assessments of subjective health states after stroke, such as pain, are still needed in both clinical and research settings.
| Acknowledgments |
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Received February 23, 1999; revision received April 12, 1999; accepted April 12, 1999.
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