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Results of the Scoliosis Research Society Instrument for Evaluation of Surgical Outcome in Adolescent Idiopathic Scoliosis: A Multicenter Study of 244 Patients

Haher, Thomas R. MD*; Gorup, John M. MD; Shin, Tae M. MD; Homel, Peter PhD; Merola, Andrew A. MD; Grogan, Dennis P. MD§; Pugh, Linda RN§; Lowe, Thomas G. MD; Murray, Michael MD*

Deformity

Study Design. An outcome questionnaire was constructed to evaluate patient satisfaction and performance and to discriminate among patients with adolescent idiopathic scoliosis.

Objectives. To determine reliability and validity in a new quality-of-life instrument for measuring progress among scoliosis patients.

Summary of Background Data. Meta-analysis of the surgical treatment of adolescent idiopathic scoliosis determined that a uniform assessment of outcome did not exist. In addition, patient measures of well-being as opposed to process measures (e.g., radiographs) were not consistently reported. This established the need for a standardized questionnaire to assess patient measures in conjunction with process measures.

Methods. The instrument consists of 24 questions divided into seven equally weighted domains as determined by factor analysis: pain, general self-image, postoperative self-image, general function, overall level of activity, postoperative function, and satisfaction. The questionnaire takes approximately 5 minutes to complete and is taken at predetermined time intervals. A total of 244 of patients from three different sites responded to the questionnaire.

Results. The reliability based on internal consistency was confirmed with a Cronbach’s alpha coefficient greater than 0.6 for each domain. In addition, acceptable correlation coefficient values greater than 0.68 were obtained for each domain by the test-retest method on normal controls. Similarly, to establish validity of the questionnaire, responses of normal high school students were compared with that of the patients. Consistent differences were noted in the domains between the two groups with P < 0.003. The largest differences were in pain (control, 29.96 ± 0.20; patient, 13.23 ± 5.55) and general level of activity (control, 14.96 ± 0.20; patient, 12.16 ± 3.23). Examination of the relationship between the domains and patient satisfaction showed that pain correlates with satisfaction to the greatest degree (Pearson’s correlation coefficient, r = −0.511; P < 0.001), followed by self-image(r = 0.412; P < 0.001).

Conclusions. This questionnaire addresses patient measures for evaluation of outcome in adolescent idiopathic scoliosis surgery by examining several domains. It also allows for dynamic monitoring of scoliosis patients as they become adults. This is a validated instrument with good reliability measures.

From the *Department of Orthopaedics, St. Vincent’s Hospital Medical Center, New York; †Department of Orthopaedic Surgery and ‡Scientific Computing Academic Center, State University of New York Health Science Center at Brooklyn, New York; §Department of Orthopaedics, Shriner’s Hospital, Tampa, Florida; and ∥Department of Orthopaedics, University of Colorado Hospital and Medical Center, Denver, Colorado.

Acknowledgment date: December 19, 1997.

First revision date: May 14, 1998.

Second revision date: October 1, 1998.

Acceptance date: January 11, 1999.

Address reprint requests to

Thomas R. Haher, MD

Department of Orthopaedic Surgery

St. Vincent’s Hospital Medical Center

203 W. 12th Street, OTB 2056

New York, NY, 10011

Device status category: 1.

Despite the existence of a variety of quality-of-life instruments, there is none available to assess patient outcome after the operative treatment of adolescent idiopathic scoliosis. Traditionally, patient outcome has been equated to process measures, a straight spine and good sagittal balance, and has not addressed the issue of patient satisfaction. 4,17,19,20 Numerous investigators have attempted to develop questionnaires to correlate patient measures with process measures. 9,10,15,22,23,24,25 In a meta-analysis of 11,000 patients, Haher et al 16 found a statistically significant correlation between patient satisfaction and degree of curve correction. However, measures of satisfaction were not standardized, and approaches of measurement varied widely among studies. Their study highlighted the need for a standardized outcome measure to evaluate and monitor patients with idiopathic scoliosis.

The purpose of this study was to construct and evaluate an outcome questionnaire as a tool to assess and discriminate among patients. It also allowed us to determine which variables accounted for patient satisfaction after scoliosis surgery. In addition, we present our questionnaire as a model against which other outcome questionnaires can be compared and tested.

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Materials and Methods

The Scoliosis Research Society (SRS) instrument was developed by incorporating questions from previously validated questionnaires 24,26 and including additional questions piloted and tested at the authors’ institutions. Among the questions added were some that dealt with patients’ self-image, an issue not previously addressed by other researchers. 7,12,21

An original set of 55 items was developed for the purpose of pretesting and evaluating item suitability and usefulness. These items were intended to cover the following areas of interest: (1) the degree of pain endured by the patient; (2) the level of functioning of the patient; (3) the patient’s evaluation of his or her self-image and attractiveness to others; and (4) the degree of the patient’s satisfaction with surgery.

Items varied in format; 29 items required the patient to respond relative to a Likert-style or ordinal scale (e.g., Has your surgery changed your self-image? Increased, Not changed, Decreased). Others simply required the patient to answer either yes or no (e.g., Have you taken any sick days because of back pain?). The full set of 55 items was administered to 108 patients who were sampled from three different sites. There were no significant differences for any items as a function of site.

Initial evaluation of the response rate led to the elimination of 30 items because of high rates of nonresponse and item redundancy. Items with similar responses were deleted to improve efficiency of the questionnaire. The remaining 25 items were submitted to factor analysis to determine whether the they could be organized into clinically meaningful factors that could be used as subscales. A factor analysis using principal components extraction followed by varimax rotation indicated that the 25 items tended to load onto seven orthogonal factors. These factors accounted for 71% of the original variance. Moreover, the factor loading of the items agreed fairly well with the original constants they were intended to measure. One item that asked whether the patient was sexually active did not load highly on any factor and was dropped from the survey.

The final version of the questionnaire is provided in the Appendix. Each factor can be used as a separate subscale to measure a specific aspect of the patient’s state or quality of life. There is a pain scale consisting of seven items that deal with the patient’s experience of pain (questions 1 to 3, 6, 8, 11, and 18). The general evaluation of self-image scale consists of three items (questions 5, 14, and 15). The scale for self-image after surgery consists of three items (questions 19 to 21). Function after surgery is measured by two items (questions 16 and 17). The general function scale deals with the patient’s ability to function as a result of his or her general back condition (questions 7, 12, and 13). Function in terms of level of activity is measured by three items (questions 4, 9, and 10). Finally, patient satisfaction with surgery is measured by three items (questions 22 to 24).

The questions were developed to maximize responsiveness. The questionnaire is comprised of Likert-type questions of varying ranges on the part of the patient (three to nine response options), as well as two choice, yes-and-no–type questions. It was believed that intermixing different question types resulted in a more interesting questionnaire for the patient. There is also an alternation in terms of the valence of the item choices. This method encourages the patients to read the questions for an appropriate response.

A scoring system has been provided to cast each item into a five-point scale. For example, for item 9, which is a two-option question measuring pain, “yes” is equivalent to 1 and “no” is equivalent to 5 (see scoring scale in Appendix). For all items, a score of 5 represents a “good” outcome. Items within a subscale can be summed to obtain an overall score for each domain, with higher scores representing better outcome. Likewise, a total score can be calculated by summing the subtest scores.

Further data for determining reliability and validity of the questionnaire were obtained from several sites across the country. Completed questionnaires were compiled by the senior authors, and the data were analyzed using a multistatistical approach. Cronbach’s alpha coefficient was established for each subscale to measure the degree of internal consistency of the subscale as well as the reliability. Additional reliability analysis was conducted for normal patients with the test-retest correlation coefficient. Further analyses using multiple regression were conducted to determine which subscales best correlated with patient satisfaction. Construct validity was determined by comparing mean responses of scoliotic patients with a nonsymptomatic control group, using two-tailed Mann-Whitney tests. Differences were regarded as significant at P ≤ 0.0125 (using a Bonferroni adjustment for the number of comparisons). All analyses were performed using SPSS for Windows 8.0 (SPSS, Inc., Chicago, IL).

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Results

One hundred thirty-six patients with adolescent idiopathic scoliosis responded to the 24-item questionnaire. These results were combined with 108 patients who had participated in the standardization sample. The responding patients were from three geographic centers over a 2-year period. Information pertaining to surgical procedure, instrumentation, preoperative and postoperative bracing, age at operative intervention, and degree/percentage of curve correction were not available from all sites.

Using the final set of 24 questions, estimates of the reliability, based on internal consistency for the items making up each of the seven factors, were performed using Cronbach’s alpha coefficient. In general, the internal consistency measures for the scales were fairly high, with an average coefficient of 0.73 (Table 1). An alpha coefficient ≥ 0.70 is usually considered acceptable.

Table 1

Table 1

An additional measure of reliability was performed using the test-retest method. The 24-question survey was administered to 26 high school students who reported no evidence of back pathology. After a 2-week interval, the same students completed the questionnaire again. Reliability was then estimated by calculating the intraclass correlation coefficient. Factors involving postoperative questions were not analyzed because the “normal” students were instructed not to respond to those questions. The correlation coefficients were high, with values ranging from 0.68 to 1.00 (Table 1), consistent with the results of Cronbach’s alpha coefficient. A partial limitation of this method is that retesting was not performed in the patient population. However, high coefficients were obtained from the nonsymptomatic group to show sufficient reliability. In addition, analysis from the Cronbach’s alpha data confirmed acceptable reliability.

To establish validity of the questionnaire, the responses of the 26 nonsymptomatic high school students were compared with that of 244 patients from three different centers using Mann-Whitney nonparametric tests. Before administering the questionnaire, the adolescent high school volunteers were questioned to determine that back pathology did not exist. Only the four subscales that did not involve postoperative evaluations were used for the comparison: pain, general self-image, function from back condition, and level of activity. As shown in Table 2, the “normal” respondents had significantly better scores for all four measures. The effect sizes for each comparison ranged from moderate (0.50 for general self-image) to very high (2.99 for pain). This, in effect, measures the ability of the instrument to discriminate between adolescents with and without back pathology. High school students were chosen as the control group to simulate the patient population with adolescent idiopathic scoliosis. Unfortunately, the two groups were not exactly matched for age and sex because complete demographic data were not available from all sites. Some sites did not initially collect this type of data. Although the variables of age and sex could have influenced questions regarding self-image, matching patient demographic variables is not as critical because the purpose of this comparison is not to compare the two population groups, but to establish that the instrument is able to distinguish between the two groups.

Table 2

Table 2

Correlational analysis involving the patient samples showed that the satisfaction subscale is significantly related to all the other subscales (Table 3). The strongest correlation factor was pain (r = −0.51) followed by postoperative self-image (r = 0.41) and general level of self-image (r = 0.40). The function subscales were the least predictive. However, the postoperative function level was the strongest correlation factor from the three function subscales.

Table 3

Table 3

Stepwise regression analysis showed that three subscale factors accounted for 37% of the variance observed in the satisfaction subscale (Table 4). The significant predictive factors for patient satisfaction were pain, postoperative self-image, and general evaluation of self-image, in that order. The pain domain explained most of the variance noted in the satisfaction subscale.

Table 4

Table 4

When patients were asked if surgery had changed the way others viewed them, 35% of the patients believed that surgery improved the way others viewed them, whereas only 2% believed the opposite. Similarly, 31% of the patients responded that surgery increased their self-image, whereas only 4% stated that surgery decreased their self-image. Sixty-three percent of the patients were aesthetically pleased with the results of their surgery, 16% believed that there was no difference, and only 3% believed that their appearance was worse after surgery.

The majority of patients (74%) were satisfied with the outcome of their surgery. Only 4% were dissatisfied with their surgical outcome, and 16% were neither satisfied nor dissatisfied. When asked whether they would undergo the procedure again, 86% said they would, whereas 6% said they would not. As another way of assessing satisfaction, patients were asked how they would feel about spending the rest of lives with their current back condition. Sixty-one percent were very or somewhat happy, and 22% were somewhat to very unhappy. Similar results were obtained by Cherkin et al 5 when patients with low back pain at 1 year from their initial episode were asked how they would feel if they had their current back condition for the rest of their lives. Likewise, 60% of surgically treated patients with sciatica and 67% of surgically treated patients with lumbar spinal stenosis indicated that they would be satisfied to spend the rest of their lives in their current state at 1-year follow-up. 1,2

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Discussion

New questionnaires should not be generated unless a careful literature review indicates the need for them. 3,8 The meta-analysis performed by Haher et al 16 highlighted the need for a standardized questionnaire to address patient outcome after the surgical treatment of adolescent idiopathic scoliosis. In recent years, the determination of success regarding the care of adolescent idiopathic scoliosis has become a multifactorial equation, with both subjective and objective variables being incorporated into studies to judge the efficacy of a particular treatment modality.

The mechanics of designing a new questionnaire are complex. It is necessary to use a number of outcome measures (domains) when testing the overall satisfaction of a particular treatment. 14,18,27 The initial questionnaire containing 55 questions underwent multifactorial analysis to establish statistically significant domains. These domains consisted of both physical and psychological aspects of quality of life. Statistically unreliable questions were eliminated, and a final questionnaire was developed with 24 questions consisting of seven major domains.

There are two categories of instruments based on their clinical purpose. 11,13 The purpose of a discriminative instrument is to detect cross-sectional differences between patients at a point in time. For a discriminative instrument to be clinically useful, it must satisfy two essential attributes. First, reproducibility is substantiated when a measure provides the same result when repeated. Second, validity is confirmed when it is established that the instrument is actually measuring the characteristic that one wants to measure. This means that the instrument is able to distinguish between different clinical populations. A second type of questionnaire is an evaluative instrument. An evaluative instrument, which measures longitudinal changes within people over time, requires an additional property. The instrument must show sensitivity to change by being able to detect clinically important alterations in a patient’s quality of life over time.

The SRS instrument satisfies most of these criteria. The reproducibility of the SRS instrument is demonstrated by the high test-retest reliabilities shown in the domains of pain, self-image, and function. This was also shown by the fair to high coefficients of internal consistency shown by the items in all domains. The criterion of validity has been demonstrated by the difference in SRS instrument scores shown by scoliosis patients versus nonpatients. Therefore, the instrument satisfies the required properties to discriminate between people at a point in time. This allows for a useful method of measuring outcome and thus comparing outcomes between patients.

Responsiveness, or the sensitivity to change over time, was not examined. More research needs to be conducted to determine the sensitivity of the SRS instrument to change. A longitudinal study is currently underway in patients undergoing surgery to measure whether changes in patients before versus after surgery are associated with concomitant changes in the domains of the SRS instrument. These data were not included because complete information was not available from all sites. Another study is planned to determine whether the instrument is responsive to changes associated with regression of the Cobb angle with long-term follow-up in postoperative scoliotic patients.

Although sensitivity to change over time was not directly determined, as previously stated, the instrument is able to gauge changes in patients’ postoperative status compared with their preoperative condition. To assess change over time, the postoperative section of the instrument contains questions about current self-image, function, and pain compared with the status of these items before the scoliosis correction surgery. Although this is a reasonable technique to contrast current status to previous status, it is not flawless. It is important to note that the patients may not accurately recall the self-image, function, or level of pain they experienced before the operation.

A report by Climent et al 6 measured quality of life in adolescents with spine deformities. Although dimensions of physical and psychosocial domains were measured, patient satisfaction was not determined. Inclusion of the patient satisfaction domain in the SRS instrument allows for description of an effective intervention. In addition, patient status after surgery was not included in the previous report. With the addition of specific questions pertaining to postoperative conditions, the SRS instrument again allows for better assessment of the operative intervention, whether it is effective or ineffectual. Thus, in addition to its ability to discriminate among individuals along a continuum of health, the SRS instrument is better able to evaluate changes with an effective intervention to serve as an outcome tool. Another goal in designing the SRS instrument was to provide a practical means to determine outcome. Unlike other available quality-of-life questionnaires, the SRS instrument contains only 24 questions, allowing minimal time for completion and evaluation. This is especially important in the adolescent population, where interest is quickly lost. The SRS instrument is a simple and practical disease-specific questionnaire that provides valid and reliable measures of pain, self-image, function, and satisfaction in scoliotic patients. This information can be used in the clinical practice to improve the quality of patient care and offers individual assessment of patient status. In addition, the questionnaire attempts to address the magnitude of longitudinal change over time, thereby allowing for monitoring of scoliosis patients as they become adults.

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References

1. Atlas SJ, Deyo RA, Keller RB, et al. The maine lumbar spine study, part II. One-year outcomes of surgical and nonsurgical management of sciatica. Spine 1996; 21: 1777–86.
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3. Bombardier C, Tugwell P. Methodological considerations in functional assessment. J Rheumatol 1987; 15(Suppl): 6–10.
4. Bonnett C, Brown JC, Cross B, Barron R. Posterior spinal fusion with Harrington rod instrumentation in 100 consecutive patients. Contemp Orthop 1980; 2: 396–9.
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7. Cochran T, Irstam L, Nachemson A. Long-term anatomic and functional changes in patients with adolescent idiopathic scoliosis treated by Harrington rod fusion. Spine 1983; 8: 576–84.
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18. Kirshner B, Guyatt GH. A methodological framework for assessing health indices. J Chron Dis 1985; 38: 27–36.
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Appendix.

Scoliosis Patient Questionnaire With Answer Key (scores are given as numbers next to corresponding responses)

Section 1: All patients complete this section

  • 1. On a scale of 1 to 9, with 1 meaning “no pain” and 9 meaning “severe pain,” indicate the degree of pain you experience regularly.
  • 1 2 3 4 5 6 7 8 9
  • \ / \ / ‖ \ / \ /
  • 5 4 3 2 1 = SCORE
  • 2. Using the same scale, indicate the most severe degree of pain you have experienced over the last month.
  • 1 2 3 4 5 6 7 8 9
  • \ / \ / ‖ \ / \ /
  • 5 4 3 2 1 = SCORE
  • 3. If you had to spend the rest of your life with your back as it is right now, how would you feel about it?
  • 5 Very happy
  • 4 Somewhat happy
  • 3 Neither happy nor unhappy
  • 2 Somewhat unhappy
  • 1 Very unhappy
  • 4. What is your current level of activity?
  • 1 Bedridden/wheelchair
  • 2 Primarily no activity
  • 3 Light labor, such as household chores
  • 4 Moderate manual labor and moderate sports, such as walking and biking
  • 5 Full activities without restriction
  • 5. How do you look in clothes?
  • 5 Very good
  • 4 Good
  • 3 Fair
  • 2 Bad
  • 1 Very bad
  • 6. Do you experience back pain at rest?
  • 1 Very often
  • 2 Often
  • 3 Sometimes
  • 4 Rarely
  • 5 Never
  • 7. What is your current level of work/school activity?
  • 5 100% normal
  • 4 75% normal
  • 3 50% normal
  • 2 25% normal
  • 1 0% normal
  • 8. What medications, if any, are you currently taking for your back? (circle all that apply)
  • 5 None
  • 4 Nonsteroidal drugs (i.e., ibuprophen, indomethacin, etc.)
  • 3 Steroids (i.e., cortisone, prednisone, solumedrol, etc.)
  • 2 Muscle relaxants
  • 1 Narcotics (i.e., Morphine, Codeine, Oxycontin, oxycodone, etc.)
  • 9. Does your back limit your ability to do things around the house?
  • 1 Yes
  • 5 No
  • 10. Have you taken any sick days from work/school because of back pain?
  • 1 Yes
  • 5 No
  • 11. Do you feel that your condition negatively affects your personal relationships?
  • 1 Yes
  • 5 No
  • 12. Are you or your family experiencing financial difficulties because of your back?
  • 5 None
  • 3 Some
  • 1 A lot
  • 13. Do you go out more or less than your friends?
  • 5 More
  • 3 Same
  • 1 Less
  • 14. Do you feel attractive?
  • 5 Yes, very
  • 4 Yes, somewhat
  • 3 Neither attractive nor unattractive
  • 2 No, not very much
  • 1 No, not at all
  • 15. On a scale of 1 to 9, with 1 being very low and 9 being extremely high, how would you rate your self-image?
  • 1 2 3 4 5 6 7 8 9
  • \ / \ / ‖ \ / \ /
  • 5 4 3 2 1 = SCORE
  • Section 2: Posttreatment patients only
  • 16. Has your back treatment changed your function and daily activity?
  • 5 Increased
  • 3 Not changed
  • 1 Decreased
  • 17. Has your back treatment changed your ability to enjoy sports/hobbies?
  • 5 Increased
  • 3 Not changed
  • 1 Decreased
  • 18. Has your back treatment ________________ your back pain?
  • 1 Increased
  • 3 Not changed
  • 5 Decreased
  • 19. Has your treatment changed your confidence in personal relationships with others?
  • 5 Increased
  • 3 Not changed
  • 1 Decreased
  • 20. Has your treatment changed the way others view you?
  • 5 Much Better
  • 4 Better
  • 3 Same
  • 2 Worse
  • 1 Much Worse
  • 21. Has your treatment changed your self-image?
  • 5 Increased
  • 3 Not changed
  • 1 Decreased
  • 22. Are you satisfied with the results of your back treatment?
  • 5 Extremely satisfied
  • 4 Somewhat satisfied
  • 3 Neither satisfied nor dissatisfied
  • 2 Somewhat dissatisfied
  • 1 Extremely dissatisfied
  • 23. Compared with before your treatment, how do you feel you now look?
  • 5 Much better
  • 4 Better
  • 3 Same
  • 2 Worse
  • 1 Much Worse
  • 24. Would you have the same treatment again if you had the same condition?
  • 5 Definitely yes
  • 4 Probably yes
  • 3 Not sure
  • 2 Probably not
  • 1 Definitely not
Keywords:

adolescent; outcome assessment; quality of life; scoliosis; spine

Copyright © 1999 Wolters Kluwer Health, Inc. All rights reserved.