The Journal of Bone and Joint Surgery 79:1323-35 (1997)
© 1997 The Journal of Bone and Joint Surgery, Inc.
Comparison of the Musculoskeletal Function Assessment Questionnaire with the Short Form-36, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Sickness Impact Profile Health-Status Measures*
DIANE P. MARTIN, PH.D. ,
RUTH ENGELBERG, PH.D. ,
JULIE AGEL, M.A. and
MARC F. SWIONTKOWSKI, M.D. , SEATTLE, WASHINGTON
Investigation performed at Harborview Medical Center, Seattle, Valley Orthopedics Associates, Renton, and Northwest Orthopedics and Fracture Clinic, Spokane
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Abstract
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We compared the reliability, validity, and responsiveness of the Musculoskeletal Function Assessment (MFA) questionnaire with those of three commonly used health-status measures: the Short Form-36 (SF-36), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Sickness Impact Profile (SIP).
The MFA, like the other health-status measures, demonstrated good reliability (intraclass correlation coefficients of more than 0.70), good sensitivity and specificity (more than 70 per cent), good criterion validity that correlated with physicians' ratings (p < 0.01), and good construct validity that correlated with the characteristics of the patients (p < 0.01). It also demonstrated better content validity than the other questionnaires, with no ceiling or floor effects for the total score. In addition, it was more responsive than the SF-36; for eight of the eleven comparisons, it was more efficient (relative efficiency of more than 2.00) in measuring changes in function between the baseline values and the values determined at the latest follow-up evaluation.
These findings suggest that the MFA can be used to assess the health status of patients who have a musculoskeletal disorder.
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Introduction
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The Musculoskeletal Function Assessment (MFA), a new health-status questionnaire, is a tool for the evaluation of patients' perceptions about their physical, psychological, and social well-being67. It was designed for use by patients who have disorders of the musculoskeletal system, such as fractures, soft-tissue injuries, repetitive-motion injuries, and osteoarthrosis. The stability, internal consistency, content validity, and criterion validity of the MFA have been reported previously25,47.
We performed the current study in two parts. First, we compared the reliability, validity, and responsiveness of the MFA with those of the Short Form-36 (SF-36)45,46,56,57,63,64, a generic health-status measure, and we compared the validity of the MFA with that of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)6,7, a disease-specific health-status measure for patients who have osteoarthrosis. Second, we compared the validity of the MFA with that of the Sickness Impact Profile (SIP), a generic health-status measure used in many studies to assess the function of the musculoskeletal system13-15,18,55.
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Part I: Comparison of the MFA with the SF-36 and the WOMAC
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Materials and Methods
Health-Status Instruments
The MFA comprises 101 items grouped into ten categories: self-care; sleep and rest; hand and fine motor skills; mobility; housework; employment and work; leisure and recreational activities; family relationships; cognition and thinking; and emotional adjustment, coping, and adaptation25,47. Earlier versions of the questionnaire used in its developmental phase comprised 100 items. (There was one less item in the employment and work category.) Patients assess their function by answering "yes" or "no" to each item of the questionnaire. A score is calculated for each category and for the entire questionnaire, with each "yes" response assigned 1 point and each "no" response or unanswered question assigned 0 points. Scores range from 0 to 100 points, with high scores indicating poor function. The total score is not considered as one of the 101 items. The questionnaire can be completed in about fifteen minutes. The validity analyses require supplemental questions about sociodemographic characteristics such as race, education, income, marital status, health insurance, work status, comorbid conditions, health habits, and changes in life and health status.
The SF-36, which is the most frequently used health-status measure in the United States, is self-administered and can be completed in about ten minutes. It comprises thirty-six multiple-choice items grouped into eight subscales: physical functioning, role limitations due to physical health problems (physical role functioning), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (emotional role functioning), and mental health. The term subscales as used in the SF-36 is synonymous with the term categories as used in the MFA, the WOMAC, and the SIP. The questionnaire provides eight subscale scores but not a total score. The subscale scores are standardized and range from 0 to 100 points, with high scores indicating better function. The SF-36 has one item, reported health transition, that is not included in any of the subscales. This item is administered as a supplemental question with the instrument and may be used to measure changes in health status.
The WOMAC, a self-administered test for the evaluation of patients who have osteoarthrosis, comprises twenty-four multiple-choice items grouped into three categories: stiffness, pain, and physical function. This questionnaire is widely used to evaluate the effectiveness of operative and non-operative treatment of osteoarthrosis3-10, and it can be completed in about ten minutes. The questions that were answered are ranked on a 5-point scale (with 1 point indicating the best function and 5 points, the worst), and the scores then are added together for each category. Use of a summary score is not recommended9.
Characteristics of the Patients
Of an eligible pool of 637 patients, 444 completed the MFA at both the baseline and the follow-up evaluation. Eighty patients (13 per cent) did not participate in the study: fifty-seven refused, and twenty-three either returned an incomplete survey or completed the survey after the baseline study period. An additional 113 patients (18 per cent) did not complete the follow-up survey: eighty-three could not be contacted because of an incorrect address or phone number, seven refused to complete the follow-up survey, and twenty-three either returned an incomplete survey or completed the survey after the follow-up administration period.
The 444 patients who were included in the study were at least eighteen years old and had a traumatic fracture or soft-tissue injury of the extremities, a history of a repetitive-motion disorder, osteoarthrosis, or rheumatoid arthritis. Patients were excluded if they had a head injury or a fracture of the spine with a residual neurological deficit; a neuromuscular disease; an amputation secondary to a systemic disease; a history of a stroke or cardiovascular disease with an acute episode in the preceding six months; end-stage renal disease, cancer, or acquired immunodeficiency syndrome; a serious psychiatric or cognitive limitation; or an inability to speak or understand English. All patients were selected from a level-I trauma center (Harborview Medical Center), a private orthopaedic clinic in the Seattle area (Valley Orthopedics Associates), or another such clinic located in eastern Washington (Northwest Orthopedics and Fracture Clinic). Consecutive patients who had a traumatic injury were recruited either during hospitalization or at the time of the first office visit after the injury. Consecutive patients who had a repetitive-motion disorder or osteoarthrosis were recruited at the time of the office visit.
The MFA and the SF-36 were administered by an interviewer (at the Harborview Medical Center) or were mailed to the patients (from the two private orthopaedic clinics) at two points in time. Only patients who completed both the baseline and the follow-up questionnaires were included in the analyses. To assess the test-retest reliability of the MFA and the SF-36, 268 patients (193 who had a traumatic injury and seventy-five from other categories) were mailed an additional MFA and SF-36 one week after the baseline evaluation.
The 327 patients who had a traumatic injury completed the surveys six months apart. Of these patients, fifty-seven (17 per cent) who visited their physician at the same time as the questionnaire was administered also were evaluated by their physician with use of a form designed specifically for this study. The physicians rated function of the lower and upper extremities, ability to carry out activities of daily living as well as recreational and leisure activities, and emotional coping and adjustment. Scores were assigned on the basis of an 11-point scale, with 0 points indicating the best function and 11 points, the poorest function.
The 117 patients who had a non-traumatic disorder (fifty-four who had a history of a repetitive-motion disorder, forty-four who had osteoarthrosis, and nineteen who had rheumatoid arthritis) completed the surveys at the time of the baseline office visit and three months later. At the follow-up visit, the sixty-three patients who had osteoarthrosis or rheumatoid arthritis also were asked to complete the WOMAC. Fifty-nine of these patients accurately completed the WOMAC, the MFA, and the SF-36, and they were included in the analysis of the WOMAC.
Criteria for Analysis
To facilitate comparison of the questionnaires, the category scores for each were standardized to range from 0 to 100 points, with 0 points indicating the best function and 100 points, the poorest function. The scores for the SF-36 were reversed to correspond with the scoring systems used for the MFA and the WOMAC. Many scores were not distributed normally; therefore, non-parametric statistics were used when appropriate.
Reliability was evaluated for both the MFA and the SF-36. Stability of the test-retest data was assessed with use of Spearman correlations and intraclass correlation coefficients23,27. Because the Spearman correlations and the intraclass correlation coefficients were equivalent, only the latter are reported. We expected correlations between the test-retest data for the MFA and the SF-36 categories to be more than 0.70, the standard for adequate reliability for questionnaire development and group comparisons31,51.
Validity was examined in terms of content, criteria, and construct11,54. Questionnaires with good content validity are expected to have fewer categories or fewer categories with ceiling or floor effects36,43,59,60. The lack of ceiling or floor effects demonstrates the appropriateness and comprehensiveness of a questionnaire. A floor effect occurs when the patient reports the poorest function for all or almost all items and receives the worst possible score (100 points), making it impossible to demonstrate deterioration in function over time for such a patient with use of the questionnaire. A ceiling effect occurs when the patient reports excellent function and receives the best score (0 points), making it impossible to show improvement in function over time.
Criterion validity is present when the scores correlate with an accepted measure of the condition being evaluated12,52. We selected ratings by physicians as the accepted measure because they have been used effectively in clinical trials as well as for validation of health-status instruments1,4,24,48,61. Scores for categories of the MFA and the SF-36 that were identified as conceptually similar to categories rated by the physicians were compared with the physicians' ratings. Because the physicians tended to use end points rather than the entire rating scale, we used non-parametric Spearman correlations. According to a standard suggested by Stewart and Ware56 for the definition of meaningful correlations that support criterion validity, the categories for the MFA and the SF-36 were expected to correlate with the physicians' ratings at rho > 0.40 and p < 0.001.
Construct validity is present when a questionnaire can be used to accurately differentiate patients who are expected to vary with regard to important characteristics, such as limited function as opposed to few limitations. The construct validity of all three questionnaires was evaluated with use of a receiver operating characteristic curve analysis16,17,21,23,28,29,49,50,62,66. This analysis shows the accuracy of an instrument with regard to correctly differentiating, across the full range of scores, patients who have a condition such as depression or insomnia from those who do not have the condition. The probability that an instrument will correctly identify patients who have a disease is defined as its sensitivity, and the probability that it will correctly identify those who do not have the disease is defined as its specificity. A curve is created by plotting the number of patients correctly identified as having the condition on the y axis and the number of patients incorrectly identified as having the condition on the x axis for each possible score. If a questionnaire allows correct classification of the patients, the line runs parallel to the y axis and then curves to the right. If a questionnaire is uninformative, the curve is drawn at a 45-degree angle. Values in the area under the curve range from 0.5 to 1.00, with 0.5 indicating that a questionnaire is not better than chance for the differentiation of patients and a value of 1.0 indicating that all patients are differentiated accurately. The values in the area under the curve, and the accompanying standard deviations, are useful for testing the differences between questionnaires.
For the receiver operating characteristic curve analysis, we divided the patients into groups on the basis of their responses to the question: "How much has your injury/arthritis changed your life?" Patients who answered "quite a bit" or "completely" on the 5-point scale were classified as having poor function, and those who answered "somewhat," "a little," or "not at all" were classified as having good function. We compared the specificity, sensitivity, and areas under the curve among the questionnaires with use of the baseline total score for the MFA and the physical function category scores for the SF-36 and the WOMAC. We expected the sensitivity and specificity of the questionnaires to be more than 0.70, and we evaluated the areas under the curve with use of a chi-square test to detect any significant differences62.
We also evaluated construct validity by correlating the questionnaire scores with the characteristics of the patients (number of comorbid conditions, perceived over-all health status, and changes in activities) identified from answers to supplemental questions included with the MFA. Comorbid conditions were presented in a checklist format, and patients indicated the conditions that applied to them. The perception of over-all health status was evaluated on the basis of the response to the question: "In general, would you say your health is excellent/very good/good/fair/poor?" Changes in activities were measured on the basis of the answer to the question: "Are your daily activities or work the same/different?" We expected patients who had more comorbid conditions, poorer perceived over-all health status, or changes in activities to receive poorer scores. With use of Pearson correlations, we correlated the total score for the MFA and the physical function category scores for the SF-36 and the WOMAC with the selected characteristics of the patients. We expected the correlations to be significant at p < 0.01.
Responsiveness, or the ability of the questionnaire to detect important clinical changes26,27,37, was evaluated with use of the MFA and SF-36 categories that had similar items, at r > 0.60. Because the content of the two instruments was similar, we expected their responsiveness to change to be the same. For the MFA, we used the total score and the category scores for mobility; housework; leisure and recreational activities; emotional adjustment, coping, and adaptation; and family relationships. For the SF-36, we used the category scores for physical functioning, physical role functioning, bodily pain, and social functioning. We evaluated responsiveness with use of standardized response means (mean change in score/standard deviation of individuals' changes in score)32,33,38,39 and relative efficiency statistics ([(instrument 1 t test)/(instrument 2 t test)]2)17,39. We compared the magnitude of the standardized response means with use of the Cohen standard for the description of small effects (more than 0.2), moderate effects (more than 0.5), and large effects (more than 0.8)19. Because there are no standards for the comparison of health-status measures with use of relative efficiency statistics9, we considered a relative efficiency statistic of more than 2.00 as showing a difference in the efficiency of the questionnaire in detecting change.
Results
Characteristics of the Patients
The mean age of the 444 patients was forty-six years (range, eighteen to ninety-one years). Two hundred and twenty-two patients (50 per cent) were women, thirty-two (7 per cent) were non-white, and 151 (34 per cent) had completed twelve years of education or less (Table I). One hundred and seventy-three patients (39 per cent) were not working outside the home. Thirty patients (7 per cent) earned $5000 or less per year, and 124 (28 per cent) earned more than $50,000. One hundred and seventeen patients (26 per cent) had a non-traumatic musculoskeletal disorder. Of the 401 injuries in the remaining 327 patients, seven were arterial injuries, twenty-two were nerve injuries, and thirty-four were open fractures; the remaining 338 injuries were closed fractures. Two hundred and thirty-two injuries (58 per cent) were treated operatively. Of the 327 patients who had a traumatic injury, fifty-one (11 per cent of the series) were involved in litigation and eighty-five (19 per cent of the series) were receiving disability compensation.
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TABLE I
DEMOGRAPHIC CHARACTERISTICS OF THE PATIENTS FOR WHOM RESPONSES TO THE MFA, SF-36, AND WOMAC WERE COMPARED*
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The 193 non-respondents were not different from the 444 respondents in terms of gender, number of injuries, type of wound, number of operations, number of complications, or severity of the disorder. However, the non-respondents were older than the respondents (mean age [and standard deviation], 55 ± 19 years compared with 46 ± 17 years) and were more likely to have a repetitive-motion disorder (forty-four [23 per cent]) compared with fifty-four [12 per cent]) or osteoarthrosis (fifty [26 per cent]) compared with forty-four [10 per cent]). The non-respondents had fewer type-C fractures (fourteen [7 per cent]) compared with eighty-four [19 per cent]) and more type-B fractures (eighty-five [44 per cent]) compared with 120 [27 per cent]), according to the AO/Orthopaedic Trauma Association classification52.
Reliability
The MFA was slightly more reliable than the SF-36. Intraclass correlation coefficients ranged from 0.75 (for leisure and recreational activities) to 0.92 (for the total score) for the MFA and from 0.66 (for emotional role functioning) to 0.90 (for physical functioning) for the SF-36. The intraclass correlation coefficients were more than 0.80 for 65 per cent of the categories of both the MFA and the SF-36. Only one category in each questionnaire had an intraclass correlation coefficient of more than 0.90. Both questionnaires demonstrated sufficient test-retest reliability to support their use for monitoring and evaluating clinical interventions in groups of patients. With a single exception in each instrumentthe total score of the MFA and the physical functioning score of the SF-36neither questionnaire demonstrated sufficient reliability to support its use for comparisons or monitoring of individual patients56.
Content Validity
The ceiling and floor effects were examined for the total score and the category scores of the MFA and the category scores of the SF-36 for all 444 patients (Table II). The total score of the MFA performed better than any of the category scores of the SF-36; no patient received a floor score of 100 points, and only one (0.2 per cent) received a ceiling score of 0 points. The best-performing categories of the SF-36 were mental health (no patient had a score of 100 points and thirteen [2.9 per cent] had a score of 0 points) and vitality (four patients [0.9 per cent] had a score of 100 points and five [1.1 per cent] had a score of 0 points).
There were fewer floor effects and more ceiling effects for the MFA than for the SF-36. The number of patients who received a floor score of 100 points ranged from none (for self-care; mobility; and emotional adjustment, coping, and adaptation) to ninety-eight (22 per cent) (for employment and work) for the MFA and from none (for mental health) to 168 (38 per cent) (for physical role functioning) for the SF-36. The large number of patients who scored at the floor level suggests that the latter category had an important floor effect. None of the categories of the MFA had such a strong floor effect.
The number of patients who received a ceiling score of 0 points ranged from three (0.7 per cent) (for emotional adjustment, coping, and adaptation) to 310 (70 per cent) (for cognition and thinking) for the MFA and from five (1.1 per cent) (for vitality) to 260 (59 per cent) (for emotional role functioning) for the SF-36. Despite the similar ranges of the number of patients who received a ceiling score, at least one-third of the patients had a score of 0 points for five of the ten categories of the MFA compared with only two of the eight categories of the SF-36.
The ceiling effects (indicating best function) and the floor effects (indicating poorest function) were analyzed for the MFA and the WOMAC for fifty-nine patients (Table II). The total score for the MFA, in contrast to the category scores for the WOMAC, had no ceiling or floor effects. The category scores for the WOMAC had fewer ceiling and floor effects than did those for the MFA. The number of patients who had a floor score of 100 ranged from none (for self-care; sleep and rest; family relationships; and emotional adjustment, coping, and adaptation) to eight (14 per cent) (for cognition and thinking) for the MFA and from none (for pain and physical function) to one (2 per cent) (for stiffness) for the WOMAC. The number of patients who had a ceiling score of 0 ranged from none (for emotional adjustment, coping, and adaptation) to thirty-eight (64 per cent) (for employment and work) for the MFA and from one (2 per cent) (for stiffness) to five (9 per cent) (for pain) for the WOMAC.
Criterion Validity
A larger number of category scores of the MFA correlated with the physicians' ratings than did those of the SF-36 (Table III); this difference was significant (p < 0.001). Eight of the twelve comparisons for the MFA and three of the eleven for the SF-36 correlated at rho > 0.40, a standard recommended for the testing of criterion validity56. As might be expected, the physicians' ratings of emotional function did not correlate with the patients' assessments of emotional health on either the MFA or the SF-36.
Construct Validity
All of the questionnaires demonstrated good sensitivity and specificity, but the MFA performed the best (a sensitivity of 80 per cent and a specificity of 79 per cent compared with 76 and 69 per cent for the SF-36, and a sensitivity of 86 per cent and a specificity of 85 per cent compared with 77 and 76 per cent for the WOMAC); however, we could not detect a significant difference (p > 0.05, chi-square test) with the numbers available. These findings suggest that the questionnaires can be used to differentiate between patients who have poor function and those who have good function (area under the curve, more than 0.81).
The correlational analyses showed that the scores on all three questionnaires were related to the characteristics of comorbid conditions, changes in activities, and perceived over-all health status (Table IV). This finding was significant (p < 0.01) for all categories except the physical function score of the WOMAC, which did not correlate with perceived over-all health status but did correlate with comorbid conditions and changes in activities.
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TABLE IV
CORRELATIONS BETWEEN CHARACTERISTICS OF THE PATIENTS, MFA TOTAL SCORE, SF-36 PHYSICAL FUNCTIONING SCORE, AND WOMAC PHYSICAL FUNCTION SCORE*
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Responsiveness
The analysis of the standardized response means and the relative efficiency statistics showed the MFA to be more responsive to changes, between the time of the baseline evaluation and the time of the latest follow-up, in self-reported physical functioning than the SF-36 (Table V). On the basis of standardized response means, the total score and three of the categories of the MFA (housework; leisure and recreational activities; and emotional adjustment, coping, and adaptation) were moderately responsive (range, 0.56 to 0.74). The remaining two categories (mobility and family relationships) showed small effects (0.26 and 0.45). The four categories of the SF-36 were not as responsive, as demonstrated by small effects ranging from 0.32 (for social functioning) to 0.45 (for physical role functioning). The analyses of relative efficiency showed that the total and category scores of the MFA were more efficient (relative efficiency of more than 2.00) than the SF-36 for eight of the eleven comparisons. The MFA and the SF-36 were equally efficient for the three remaining comparisons.
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TABLE V
COMPARISON OF THE RESPONSIVENESS OF THE MFA AND SF-36 ACCORDING TO STANDARDIZED RESPONSE MEANS AND RELATIVE EFFICIENCY STATISTICS*
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Part II: Comparison of the MFA and the SIP
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Materials and Methods
Health-Status Instruments
The MFA was described in Part I of this paper.
The SIP13-15,18,55 is a general health-status questionnaire used to evaluate patients who have a musculoskeletal disorder2,20,22,35,40-42,65. It can be completed in thirty minutes. It comprises 136 questions grouped into twelve categories: walking, body care and movement, mobility, social interaction, alertness behavior, emotional behavior, communication, sleep and rest, eating, home management, recreational activities, and work. As with the MFA, the questions are answered as either "yes" or "no." Each item is weighted, and the scores of all answered questions are combined. There are twelve category scores, two summary scores (physical and psychosocial), and a total score. The scores are standardized and range from 0 to 100 points, with 100 indicating the poorest function.
We evaluated the content, criteria, and construct validity for the MFA and the SIP with use of total and category scores. Non-parametric statistics were used whenever the scores were not normally distributed. The statistical methods used to evaluate the data were the same as for Part I.
Characteristics of the Patients
We recruited sixty-six patients who had sustained a traumatic injury of the upper or lower extremity, or both, and who were seen at a level-I trauma center (Harborview Medical Center) or at one of two private orthopaedic clinics (Valley Orthopedics Associates or Northwest Orthopedics and Fracture Clinic). The criteria for inclusion were the same as for Part I. Sixty (91 per cent) of the sixty-six patients agreed to participate in the study. The MFA and the SIP were administered once by an interviewer three months after the date of the injury. Twenty-seven patients (45 per cent) had visited their physician at the time of the study interview and were evaluated by the physician with use of the physician-rating form.
Results
Characteristics of the Patients
The sixty patients had a mean age of thirty-eight years (range, nineteen to seventy-one years). Twenty-seven patients (45 per cent) were women, nine (15 per cent) were non-white, and twenty-five (42 per cent) had completed twelve years of education or less (Table VI). Twenty-six patients (43 per cent) were not working outside of the home. Three patients (5 per cent) earned $5000 or less per year, and thirteen (22 per cent) earned more than $50,000. Ten patients (17 per cent) were involved in litigation, and fifteen (25 per cent) were receiving disability compensation. Of the eighty-seven injuries, two were nerve injuries, none were arterial injuries, and two were open fractures; the remaining eighty-three injuries were closed fractures. Fifty-one injuries (59 per cent) were treated operatively. The six non-respondents were similar to the respondents in terms of age, type of injury, and number of operations.
Content Validity
The total score of the MFA had no ceiling or floor effects (Table VII). The total score of the SIP also had no floor effects, but it did have ceiling effects (six patients [10 per cent] had a score of 0 points). For the category scores, the MFA had fewer ceiling effects and the SIP had fewer floor effects. Six of the ten categories of the MFA had a ceiling effect (more than one-third of the patients had a score of 0 points) compared with ten of the twelve categories of the SIP. In contrast, the categories of the SIP provided fewer floor effects, with patients receiving a score of 100 points for only two of the twelve categories compared with six of the ten categories of the MFA.
Criterion Validity
The correlations between the MFA and SIP responses and the physicians' ratings were similar, with six of the twelve comparisons revealing a significant association (p < 0.001 and p < 0.01; Table VIII). The physicians' ratings for mobility of the lower extremities, mobility of the upper extremities, and the ability to carry out recreational and leisure activities correlated with conceptually similar categories of both questionnaires. The physicians' ratings for activities of daily living and emotional function did not correlate with selected categories of either questionnaire.
Construct Validity
The receiver operating characteristic curve analysis demonstrated that the sensitivity and specificity of the total scores of the MFA and the SIP were 82 and 79 per cent compared with 77 and 76 per cent. Areas under the curve showed that the two questionnaires discriminated equally well between patients who had good function and those who had poor function; with the numbers available, we did not detect a significant difference between the areas under the curve (0.83 for the MFA compared with 0.82 for the SIP).
Correlations between the total scores of the MFA and the SIP and selected characteristics of the patients showed that both instruments were responsive to changes in activities and the number of operations (Table IX); this finding was significant (p < 0.001). Neither instrument was altered by the number of comorbid conditions.
Discussion
New questionnaires should be evaluated relative to existing ones with use of direct comparisons performed in the same patient population30,33,38,39,53,59,60,65. The findings from these comparisons should help to clarify the strengths and weaknesses of each questionnaire for various types of patients, and they should help clinicians and researchers to make informed choices among health-status measures. The criteria used in direct comparisons include reliability, validity, and responsiveness12,34,36. We compared the MFA with three health-status measuresthe SF-36, the WOMAC, and the SIPthat are used to evaluate patients who have a musculoskeletal disorder3,6,7,17,21,24,58. To be useful, the MFA must perform as well as or better than other questionnaires according to these criteria.
The SF-36 and the SIP are generic questionnaires designed for the assessment of functional outcomes in populations of patients. The WOMAC is a disease-specific health-status questionnaire designed for patients who have osteoarthrosis. The questionnaires have varying response formats: the SF-36 and the WOMAC employ multiple-choice items, and the SIP and the MFA require yes-or-no responses. Each questionnaire includes items from a number of domains, some of which are shared with other instruments and others of which are unique to that instrument. For example, the SIP, SF-36, and MFA all have categories for mobility, emotional adjustment, social adjustment, and work, while the WOMAC and the SF-36 both have categories for mobility and pain. However, only the SIP has categories for eating and alertness, only the WOMAC has a category for stiffness, only the SF-36 has a category for vitality, and only the MFA has categories for coping and fine motor skills. All of these questionnaires have been carefully tested and have been found to have good reliability, validity, and, to a lesser degree, responsiveness7,13,14,39,45,46,56.
Our results show that the MFA is as reliable, valid, and responsive to changes in the functional status of patients who have a musculoskeletal disorder as are the SF-36, the WOMAC, and the SIP. In some categories, the MFA demonstrated better validity and responsiveness than the other questionnaires. The MFA and the SF-36 displayed equal reliability, with intraclass correlation coefficients consistently greater than 0.70 (the standard required for instruments used in group-level applications)44. The total score of the MFA demonstrated better content validity than the SF-36, the SIP, or the WOMAC, with the fewest patients scoring at either the ceiling or the floor level. With regard to category scores, the WOMAC displayed the best content validity, with the fewest ceiling or floor effects for patients who had osteoarthrosis.
The criterion validity of the MFA was similar to that of the SIP, and the same number of category scores (six of twelve) correlated with the physicians' ratings (Table VIII). The criterion validity was better for the MFA than for the SF-36; more category scores of the MFA correlated with the physicians' ratings (eight of twelve compared with three of eleven) (Table III). All of the questionnaires displayed good construct validity, allowing differentiation of patients who had poor function from those who had good function. Category scores correlated (p < 0.01) with the patients' perception of their over-all health status, changes in activity, and number of operations. The MFA was more responsive than the SF-36 for measuring changes in function from the time of the baseline evaluation to the follow-up administration of the questionnaires. The total score and the category scores of the MFA were more efficient (relative efficiency of more than 2.00) than those of the SF-36 in eight of eleven comparisons. With use of standardized response means, the total score and three of the five categories of the MFA showed moderate effects, whereas all four of the SF-36 categories showed small effects.
On the basis of the findings in this study, we believe that the MFA is an appropriate questionnaire for evaluating the outcomes of patients who have a broad range of musculoskeletal disorders. It is reliable, it provides a wide range of relevant items, it correlates well with physicians' ratings of the functional status of the patient, it differentiates between groups of patients with and without dysfunction, and it is responsive to changes in function over time. The MFA, like the SF-36, the WOMAC, and the SIP, has been validated for use for groups rather than individuals44.
The decision to use the MFA rather than another questionnaire depends on the goals of the investigator, the clinical setting, the population of patients, and the outcomes being measured. Investigators studying patients who have osteoarthrosis may be better served by the WOMAC, which has been validated for use for patients with this disease3-10. Those seeking to compare the general health status of patients who have musculoskeletal disorders with that of patients who have asthma might select the SF-36 or the SIP because of the broad applicability and generalizability of these instruments to many patients who have a variety of conditions45,46,56-58. However, the MFA may be the questionnaire of choice for the assessment of patients who have musculoskeletal disorders and are seen in the offices of orthopaedic or primary-care physicians.
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Footnotes
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*No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. Funds were received in total or partial support of the research or clinical study presented in this article. The funding sources were the National Institutes of Health and the National Institute of Child Health and Human Development.
Departments of Health Services (D.P.M.) and Orthopaedics (R.E. and J.A.), Harborview Medical Center, University of Washington, Box 359798, 325 Ninth Avenue, Seattle, Washington 98104-2499.
Department of Orthopaedics and Surgery, University of Minnesota, 420 Delaware Street, Minneapolis, Minnesota 55455.
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