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JM Fritz, PT, PhD, ATC, is Assistant Professor, Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, 6035 Forbes Tower, Pittsburgh, PA 15260 (USA) (jfritz{at}pitt.edu). Address all correspondence to Dr Fritz
JJ Irrgang, PT, PhD, ATC, is Assistant Professor, Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, and Vice President of Quality Improvement and Outcomes, Center for Rehabilitation Services, Pittsburgh, Pa
Submitted June 17, 1999;
Accepted June 29, 2000
 | Abstract |
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Key Words: Disability • Low back pain • Measurement • Responsiveness • Standard error of measurement
| Introduction |
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 TopAbstract Introduction MethodResultsDiscussionConclusionAppendix 1Appendix 2References |
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Two of the most commonly used disability scales for people with LBP are the Roland-Morris Disability Scale and the Oswestry Low Back Pain Disability Questionnaire (OSW).3 The measurement properties of both of these scales have been studied extensively, and a recent report of the International Forum for Primary Care Research in Low Back Pain contended that both scales are acceptable for measuring disability related to LBP.2 Kopec et al4,5 described the development of the Quebec Back Pain Disability Scale (QUE). The developers of the QUE proposed that instruments such as the OSW or the Roland-Morris Disability Scale lack a strong conceptual basis and are of uncertain content validity.4 In their original description of the QUE, the developers presented data indicating that this instrument may have advantages over older scales such as the OSW,5 but further direct comparisons of the competing scales have not been reported.
Scales designed to assess the magnitude of change in patients over time are expected to possess high levels of reliability and responsiveness.6–8 Reliability requires that scales show little variability in repeated measurements of patients whose clinical status has not changed. Responsiveness may be considered an aspect of validity9 and describes a scale's ability to detect change over time that is clinically meaningful.10 Deyo and Centor11 made the analogy to a diagnostic test, in which the disability scale is used to detect the presence of clinically meaningful change in the patient's status. From this perspective, responsiveness consists of 2 properties: sensitivity (the ability to detect clinically meaningful change when it has occurred) and specificity (the ability to remain stable when no clinically meaningful change has occurred).11
Although disability scales were developed to make comparisons among groups, many experts believe that they may also be used to make decisions about individual patients.12 In order to be used for individual patient decision making, we believe that the clinician should know how much change must occur before the change may be considered meaningful. Meaningful change may be considered from 1 of 2 perspectives: statistical or clinical.13–15 From a statistical perspective, meaningful change is based on the measurement error associated with a scale and can be defined as the amount of change needed to be certain, within a defined level of statistical confidence, that "true change" has occurred. Numerous terms have been used to describe statistically meaningful change, including "minimum detectable change,"13 "smallest detectable difference,"16 "minimum reliable change,"17 and "minimal metrically important change."18 The presence of a statistically meaningful change does not attest to the clinical importance of the change. The minimum clinically important change (MCID) has been defined as the smallest change in a scale that is important to patients.13,19 Knowledge of the MCID allows clinicians to examine pre- and post-treatment scores and to determine whether the patient has actually improved an amount that is likely to be perceived as important to the patient. Therefore, some authors19,20 contend that the MCID is the most important measurement property to consider when evaluating a scale's ability to be used in making individual patient decisions. Furthermore, the MCID is useful for determining sample size requirements for clinical trials and for distinguishing between statistical significance and clinical significance in published research.21–23
Several methods have been described for evaluating responsiveness and determining an MCID. Many commonly used methods make a comparison between a scale's change score and an external standard of clinically meaningful change.9,24 A true measure of clinically meaningful change is not available for people with LBP.25–27 Therefore, we believe that researchers should use a construct to represent change. Many authors13,24,28–33 have used a global rating of change as the external standard of meaningful change.
The use of a global rating of change as an external standard of meaningful change has been questioned. Norman et al26 raised 3 concerns regarding the use of global ratings: (1) the reliability and validity of global ratings are unknown, (2) global ratings typically are highly correlated with the patient's present status and are not an unbiased measure of change, and (3) bias in the patient's judgment of change also will be reflected in the final disability scale score, making the errors of measurement on the global rating and the disability scale correlated. Other authors,13 however, have argued that comparisons of scales designed for the same purpose with a global rating are a valid way to assess responsiveness.
The purpose of our study was two-fold. First, we tested the construct validity of the use of a global rating of change as an external standard of meaningful change to compare competing disability scales in a cohort of patients with acute LBP. Second, we compared the measurement properties of 2 disability scales for patients with LBP: the OSW and the QUE. Reliability, responsiveness, and statistically and clinically meaningful levels of change for each scale were determined.
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1Appendix 2References |
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Measurements
The subjects completed a series of self-reports and underwent a physical examination lasting approximately 20 minutes at the time of the initial and final evaluations. Data for the following measures were collected:
Modified Oswestry Low Back Disability Questionnaire.
The OSW was originally described in 1980.34 Individual items included in the OSW were selected based on the experience of the scale's developers and were pilot tested in a sample of 25 patients.34 The questionnaire consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage. The version of the OSW used in this study was modified by the authors (Appendix 1). The modified OSW used in this study was similar to the modified OSW used by Hudson-Cook et al,35 who replaced the sex life section with a question related to fluctuations in pain intensity. Hudson-Cook et al reported levels of test-retest reliability and internal consistency for the modified version similar to those of the original OSW. The measurement characteristics of the version used in our study have not been previously reported. A section regarding employment and home-making ability was substituted for the section related to sex life because the sex life item is frequently found to be left blank.
Quebec Back Pain Disability Scale.
The QUE is a condition-specific measure of disability that was described by Kopec et al in 1995.5 The final set of items of the QUE were selected from a larger pool of items by examining the test-retest reliability, item-total correlations, and responsiveness of individual items and by using techniques of factor analysis and item response theory.4 The developers believed this method was likely to produce a scale with measurement properties superior to those of scales developed with a more intuitive approach to item selection.4,5 For example, items on the OSW were selected based on the developers' opinion that each item was relevant to patients with LBP.34 The final scale contains 20 daily activities and asks the patient to rate his or her degree of difficulty in performing each activity from 0 ("not difficult at all") to 5 ("unable to do") (Appendix 2). The item scores were summed for a total score between 0 and 100, with higher numbers representing greater levels of disability.
Physical Impairment Index.
Waddell et al36 described a method of evaluating physical impairment in patients with LBP. The index consists of 7 individual tests—4 range of motion tests (total lumbar flexion, lumbar extension, average lumbar side bending, and average straight leg raise) and 3 other tests (bilateral active straight leg raise, active sit-up, and spinal tenderness). Each test is scored as positive (1) or negative (0) based on published cutoff values, resulting in a total score ranging from 0 to 7. Higher values represent increased levels of physical impairment. Waddell et al found the impairment index yielded reliable results (intraclass correlation coefficient [ICC] values between .86 and .95 and kappa values between .48 and .60 for individual tests), distinguished between patients with LBP and individuals without symptoms (specificity=86%, sensitivity=76%), and was correlated with disability (r=.51).36 The impairment index was measured at the initial evaluation, after 2 weeks, and at the time of the final evaluation.
At the time of the final evaluation, the physical therapists and the subjects completed a global rating of change survey instrument. The therapists and the subjects were asked to rate the overall change in the subject's low back condition since the beginning of physical therapy intervention using a 15-point rating scale described by Jaeschke et al.29 The scale ranges from –7 ("a very great deal worse") to 0 ("about the same") to +7 ("a very great deal better"). Intermittent descriptors of worsening or improving are assigned values from –1 to –6 and from +1 to +6, respectively. The therapists and the subjects were blinded to each others' ratings. The ratings of the therapists and the subjects were averaged in order to balance the input of both the therapist and the patient. Jaeschke et al29 recommended that changes of –3 to –1 or +1 to +3 would represent small alterations in function, changes of –4 to –5 or +4 to +5 would represent moderate changes, and changes of –6 to –7 or +6 to +7 would represent large changes. Subjects with an average rating greater than +3 were considered to have experienced a clinically meaningful improvement, subjects with average ratings between +3 and –3 were considered as stable, and subjects with average ratings less than –3 were categorized as experiencing a deterioration in their clinical status.
Data Analysis
Construct validation of global rating of change.
The use of global ratings of change has been criticized.21 The ability of these scales to reflect a patient's status and whether they can be used to accurately depict changes occurring between initial and final assessments have been questioned.21 We compared changes in Physical Impairment Index scores between patient groups defined as stable or improved based on a global rating of change using a 2-way analysis of variance (ANOVA) for repeated measures on the impairment index scores measured initially and at 2- and 4-week follow-up examinations. We hypothesized that the improved group would show a progressive decrease in physical impairment at each measurement interval, whereas the impairment level of the stable group would not change. This finding would be indicated by a group x time interaction, with the group of patients defined as improved showing a greater improvement in Physical Impairment Index scores than the group defined as stable.
Reliability.
Test-retest reliability was assessed in subjects defined as stable over the treatment period based on the average global rating of change. An ICC (2,1) and a 95% confidence interval (CI) were calculated for the QUE and the modified OSW using the methods recommended by Shrout and Fleiss.37 Variance components were calculated for the sources of variation involving a random factor using the methods described by Eliasziw et al.38
Responsiveness.
Responsiveness was first evaluated using a receiver operating characteristic (ROC) curve. An ROC curve was constructed by calculating the sensitivity (true positive rate) and specificity (true negative rate) as the cutoff change score defining clinically meaningful change varied.11 For example, sensitivity and specificity values were calculated using a change score of 1 or more points of change defining a clinically meaningful change, then 2 or more points, and so on. Sensitivity was calculated by dividing the number of subjects identified by the scale as having improved based on the selected cutoff score by the total number of subjects identified as having undergone meaningful change based on the average global rating. Specificity was calculated by dividing the total number of subjects identified by the scale as remaining stable by the total number of subjects identified as having a stable condition based on the average global rating. Confidence intervals for the sensitivity and specificity values were calculated using the method of Simel et al.39 The ROC curve was constructed by plotting the sensitivity values on the y-axis and 1 minus the specificity values on the x-axis for different values of the change scores. The area under the curve (AUC) can be used as a quantitative method for assessing a scale's ability to distinguish patients who have undergone true change from those who remain stable. The AUC can be interpreted as the probability of correctly identifying the improved patient from randomly selected pairs of improved and unimproved patients40 and ranges between 0.5 (no diagnostic accuracy beyond chance) to 1.0 (perfect diagnostic accuracy). The AUC for the modified OSW and the QUE were compared using the method described by Hanley and McNeil.41 The nonparametric method was used for estimating the AUC and the standard error of the area, which does not require normal distributions of change scores for improved and stable patients.40
The second method for assessing responsiveness was the calculation of Guyatt's Responsiveness Index (GRI)10 for the OSW and QUE. The GRI is defined as the ratio of the average change in patients identified as improved divided by the standard deviation of the change in patients identified as remaining stable. A large GRI indicates greater responsiveness. The GRIs and 95% CIs were calculated,42 and the difference between the GRIs obtained for the modified OSW and the QUE was computed. The significance of the difference was determined using the method described by Tuley et al.42 A 95% CI of the difference score between the GRIs obtained for the modified OSW and the QUE that did not contain zero indicated that the difference between GRIs was significant.
The third method used to assess responsiveness was a comparison of the correlations between the change scores of the disability scales and the average global ratings. The correlations were compared using a Fisher r to Z-transformation for comparing correlated correlation coefficients.43
Statistically meaningful change.
Statistically meaningful change was determined by calculating the standard error of measurement (SEM) between the initial and final scores for subjects identified as stable based on the global rating of change. The SEM was calculated as (sd x [1–r]
), where r is the test-retest reliability coefficient and sd is the square root of the total variance. Numerous authorities16,38,44,45 have argued that the SEM is the most appropriate statistic for determining statistically meaningful change in health status questionnaires. The SEM has several properties that make it an attractive statistic for determining clinically meaningful change. First, the SEM accounts for the possibility that some of the change observed with a particular measure may be attributable to random error.12 Second, the SEM is considered to be a fixed characteristic of a measure, independent of the sample under investigation.46,47 That is, the SEM is expected to remain relatively constant for all samples taken from a given population.48 In addition, the SEM in expressed in the original metric of the measure, aiding its interpretations.48,49 There is currently no consensus regarding the number of SEMs required to define statistically meaningful change. Previous researchers46,48 have reported one SEM as the best measure of meaningful change on health-related quality-of-life measures. Other researchers18,50 have recommended 1.96 x SEM to correspond with the 95% CI. We calculated statistically meaningful change by multiplying the SEM by 1.65 to correspond to the 90% CI. This value was then multiplied by 
to adjust for the error associated with taking 2 measurements.47
Minimum clinically important difference.
The ROC curve was used to provide an estimate of the MCID. The point on the curve nearest the upper left-hand corner of the graph represents the cutoff score that best discriminates between patients who have improved and those who are stable. If the consequences of a false-positive or false-negative result are judged to be equally important, this cutoff score can be used as an estimate of the MCID for the scale.25
| Results |
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1Appendix 2References |
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The Pearson correlation between the change score of the modified OSW and the mean global rating was .78, and the Pearson correlation between the change score of the QUE and the mean global rating was .67. The correlation between the change scores of the modified OSW and the QUE was .82. There was a difference between the correlations of the change scores and the mean global rating (P=.03).
Statistically Meaningful Change
The SEM values were 5.40 (95% CI=4.35–7.22) for the modified OSW and 13.08 (95% CI=10.54–17.47) for the QUE. Based on these SEM values, the threshold for statistically meaningful change was 12.68 for the modified OSW and 30.52 for the QUE.
Minimum Clinically Important Difference
The MCID calculated from the ROC curve using the cutoff point nearest the upper left-hand corner of the graph was 6 points for the modified OSW (sensitivity=91% [95% CI=82%–99%], specificity=83% [95% CI=67%–98%]) and 15 points for the QUE (sensitivity=82% [95% CI=70%–93%], specificity=83% [95% CI=67%–98%]).
| Discussion |
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1Appendix 2References |
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We assessed the construct validity of the global rating of change by comparing the Physical Impairment Index scores over the study period in the groups defined as stable and improved based on a global rating of change. Proponents of physical disablement models propose a relationship between impairments and disability,53,54 and the Physical Impairment Index has been shown to be correlated with disability in patients with LBP (r=.51 with the Roland-Morris Disability Scale).36 The group defined as stable based on the global rating of change showed little variation in impairment scores over time, whereas the group defined as improved demonstrated a steady reduction in impairment (Fig. 1). Although a one-to-one correlation between impairment and disability does not exist, this finding indicates that the clinical status of the group defined as stable remained fairly constant, not only at the time of the final evaluation, but throughout the study period.
The differences in impairment index scores indicate to us that the global rating of change could be used to separate those subjects whose clinical status improved from those remaining stable in one dimension of disablement: physical impairment. The improved group appeared to experience a steady decline in physical impairment during the study period, whereas the stable group did not experience a change in impairment. We believe this finding supports the construct validity of the use of a global rating of change as an external standard of meaningful change. One criticism offered against the use of a global rating of change is that the global rating offered by the patient at one point in time reflects only the patient's present status and not the clinical course of the condition.26 Our results indicate that the group defined as stable based on the global rating of change did not experience any change in physical impairment at the time the global rating was assessed, and also at a measurement taken 2 weeks prior to assessment of the global rating of change.
Reliability estimates of clinical measures attest to a measure's stability in patients whose clinical status is unchanged. These estimates are typically accomplished by repeated administrations of an instrument in a time frame short enough to ensure that clinical change is unlikely to have occurred. If time frames are too short, however, patient recall may inflate reliability.3,8 A measure with a high degree of test-retest reliability should also remain stable in patients whose clinical status is unchanged over a more extended period of time. In our study, reliability was determined in patients judged to be stable across a 4-week period.
The ICC value calculated in this study for the modified OSW (ICC=.90) was consistent with reliability coefficients found in some other studies using shorter follow-up times. Fairbank et al34 found a correlation coefficient of .99 for repeated administrations of the OSW on consecutive days in 22 patients. A correlation coefficient of .94 was reported by Triano et al55 when administrations of the OSW were separated by 2 hours. Kopec et al5 reported an ICC value of .91 for the OSW given 1 to 14 days (median=3.8 days) apart. In the same study, an ICC of .92 was found for the QUE.5 Schoppink et al56 found an ICC of .90 for a Dutch adaptation of the QUE given 1 week apart. We did not replicate the high degree of reliability reported in these studies. Our findings suggest that the QUE may not remain stable in patients who do not undergo change over an extended period of time. Because clinical trials typically look for treatment effects occurring over a period of weeks, months, or years instead of days, this finding may mean the use of the QUE as a measure of treatment outcome has some drawbacks. In addition, we evaluated only patients with acute LBP. Previous studies have focused on patients with chronic conditions.5,55,56 The diminished reliability of the QUE may reflect instability in the scale when applied in patients with acute LBP. The QUE may lack specificity in patients with acute LBP (ie, it detects change where no clinically meaningful change has occurred based on the external standard). The sample size of stable patients on whom the ICC was based was small (n=23), however, which may have had an impact on our reliability estimates. The CIs, particularly for the QUE, were wide, indicating a lack of precision for the ICC statistic.
The ANOVA tables for the modified OSW and the QUE (Tabs. 2 and 3) can be used to provide further insight into potential sources of error. The F test for a difference between initial and follow-up measurements was not significant for either measure. This finding indicates the lack of a systematic difference between measures due to time, as would be expected in a group of patients whose status remains stable. For the modified OSW, the variance component between subjects (257.87) was much larger than the variance component for the error term (29.21). However, for the QUE, the variance component due to error was much larger (171.26), approaching the magnitude of the variance component between subjects (211.90), indicating a large degree of nonsystematic, or random, error. We plotted a histogram of the change scores for each scale to further examine the pattern of errors in the measurements (Fig. 3). The change scores for the modified OSW tended to cluster around 0 to a greater extent than the QUE change scores, as indicated by the smaller standard deviation for the modified OSW change scores (Tab. 1). One subject in the stable group showed a 58-point improvement on the QUE. The modified OSW change score for this subject was 19 points. Because this score may represent an outlier, we recalculated the ICC values with the subject's scores removed. This recalculation resulted in ICCs of .92 (95% CI=.82–.97) for the modified OSW and .70 (95% CI=.40–.86) for the QUE. The corresponding SEM values would be changed to 4.99 and 10.27 for the modified OSW and the QUE, respectively. Even with the potential outlier removed, the results favor the superior reliability of the modified OSW; however, the 95% CIs for the ICC values would overlap somewhat.
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The second method for studying responsiveness was the difference between the GRI statistics. This difference was statistically significant, with the modified OSW demonstrating the greater responsiveness. The third method was computing correlation coefficients between the change scores of the disability scales and the mean global rating. The correlations calculated in this study (.78 for the modified OSW, .67 for the QUE) are larger than correlations reported by other authors. Kopec et al5 found correlations of .35 for the OSW and .42 for the QUE over a 4-month period. Stratford et al31 reported a correlation of .57 for the OSW and a global rating of change over a 4- to 6-week period. We believe the larger coefficients we found are a reflection of the shorter follow-up time (4 weeks) and the use of patients with acute LBP. Weaker relationships between patient-reported disability and improvement in patients with chronic LBP may be related to the increased influence of psychosocial factors in these individuals. In our study, the correlation was larger for the modified OSW, indicating a greater relationship between the change scores of the modified OSW and an external criterion of change. Scales with greater responsiveness will require smaller sample sizes to achieve a given level of statistical power in experimental studies,10 making the modified OSW more attractive for use as an outcome measure.
We examined the meaningfulness of change from both statistical and clinical perspectives. There is general agreement that statistically meaningful change is best assessed by calculating the SEM, because it is expressed in the same metric as the measurement being used and because it represents the standard error in an observed score that obscures the true score.16,49 However, the threshold defining statistically meaningful change based on the SEM has varied. Some authors12,18 have recommended multiplying the SEM by 1.96 to construct a 95% CI to define statistically meaningful change. Other authors have corrected the SEM for errors in the 2 measurements taken by multiplying by , then multiplying by either 1.65 for a 90% CI57 or 1.96 for a 95% CI.16,45 We used the correction method and a 90% CI as advocated by Stratford et al57 to compute statistically meaningful change thresholds of 13 and 31 points for the modified OSW and the QUE, respectively.
We believe it is reasonable to expect that the minimum level of statistical change would be less than or equal to the MCID. Other researchers46,57,58 have speculated that this may not necessarily be the case. Using the ROC curves, we calculated MCID values of 6 and 15 points for the modified OSW and the QUE, respectively. Both values are less than the corresponding values for statistically meaningful change as defined in our study. This may be a result of the small sample size (n=23) on which the SEM confidence interval was based. Alternatively, this result may reflect the stringency of the definition of statistically meaningful change used in this and other studies. Two recent reports46,48 have indicated that a 1–SEM criterion best approximated the MCID using the Chronic Respiratory Disease Questionnaire in samples of subjects with chronic obstructive pulmonary disease. Although tested only with one questionnaire, the authors speculated that the 1–SEM criterion may most closely approximate the MCID in other valid and reliable quality-of-life questionnaires.46,48 If this hypothesis were to hold true, the MCID would always be smaller than statistically meaningful change when the latter is calculated in the manner done in our study. We found general concordance between the SEM and MCID values for the modified OSW (5.4 versus 6 points) and the QUE (13.1 versus 15 points). Our finding supports the hypothesis that a 1–SEM criterion may be most closely related to the MCID. We contend that further research is needed to identify the optimal methods for calculation of statistical and clinical meaningfulness and to explore the relationship between the 2 concepts.
Beurskens et al25 used the ROC curve method and found the MCID for the OSW to be 4 to 6 points, consistent with the value calculated in our study. The MCID of the QUE has not been reported previously. Our results suggest that the MCID is within approximately 15 points. The QUE demonstrated greater variability in subjects whose status remained stable, deflating the ICC value and reflecting a lack of specificity. Low specificity occurs when false-positive results are relatively common (ie, assuming important change has occurred when it has not). Knowledge of the high MCID of the QUE is important for researchers when determining sample sizes for clinical trials and for interpretation of clinical significance of results of clinical trials using the QUE as an outcome measure.
The increased variability of the QUE in the subjects with stable LBP may be related to the response format of this instrument. The modified OSW asks the patient to rate his or her perceived level of disability for several fundamental tasks of daily living (eg, walking, sitting, standing, lifting). The QUE asks the patient to rate his or her perceived disability for more specific functional tasks (eg, walking several miles, throwing a ball, moving a chair). Patients may have more difficulty in accurately judging their level of disability for tasks when these tasks are not performed on a regular basis. Another difference between the scales is the time frame that the patient is asked to use as a reference. The QUE asks the patient to rate his or her ability to perform tasks today, whereas the modified OSW does not specify a time frame reference. It is possible that restricting patients to the consideration of their condition on the day of completing the questionnaire may increase the variability of the measurements. However, we believe that this is unlikely because, in our experience, most patients tend to reference their current status whether or not they are specifically directed to do so.
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1Appendix 2References |
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| Appendix 1 |
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1Appendix 2References |
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| Appendix 2 |
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1Appendix 2References |
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| Footnotes |
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This study was approved by the Institutional Review Board at the University of Pittsburgh.
This study was partially funded by a grant from the Foundation for Physical Therapy.
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1Appendix 2References |
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