Joan C. Rogers and James J. Irrgang. AMERICAN ACADEMY OF ORTHOPEDIC SURGEONS LOWER LIMB QUESTIONNAIRE General Description. Administration.

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1 Arthritis & Rheumatism (Arthritis Care & Research) Vol. 49, No. 5S, October 15, 2003, pp S67-S84 DOI /art , American College of Rheumatology MEASURES OF FUNCTION Measures of Adult Lower Extremity Function The American Academy of Orthopedic Surgeons Lower Limb Questionnaire, The Activities of Daily Living Scale of the Knee Outcome Survey (ADLS), Foot Function Index (FFI), Functional Assessment System (FAS), Harris Hip Score (HHS), Index of Severity for Hip Osteoarthritis (ISH), Index of Severity for Knee Osteoarthritis (ISK), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC TM ) Joan C. Rogers and James J. Irrgang AMERICAN ACADEMY OF ORTHOPEDIC SURGEONS LOWER LIMB QUESTIONNAIRE General Description Purpose. Assess overall generalized pain and disability in the lower limbs over the past week or since injury (1). Content. Items cover degree of stiffness and swelling and pain severity walking on a flat surface, going up or down stairs, and lying in bed; overall ability to get around; and difficulty taking off socks or stockings. Developer/contact information. Outcomes Studies Committee of the American Academy of Orthopedic Surgeons (AAOS), in collaboration with multiple musculoskeletal health specialty societies, accessed March 23, Versions. Baseline and follow-up versions are identical, except for the title. Similar questionnaires are available for the foot and ankle, hip and knee, and sports-related conditions. Translated versions are available (sports knee) or Joan C. Rogers, PhD, OTR/L, James J. Irrgang, PhD, PT, ATC: University of Pittsburgh School of Health and Rehabilitation Sciences, Pittsburgh, Pennsylvania. Address correspondence to Joan C. Rogers, PhD, OTR/L, University of Pittsburgh School of Health and Rehabilitation Sciences, 5017 Forbes Tower, Pittsburgh, PA Submitted for publication April 23, 2003; accepted April 24, under development (hip, knee) (1). A computer adaptive test is being explored (1). Number of items in scale. 7 items. Subscales. None. Populations. Developmental/target. Patients in the United States being treated for general lower limb problems or injuries. Other uses. Not reported. WHO ICF Components. Impairment, Activity limitation, Participation restriction, Environmental factor. Administration Method. Patient-report by questionnaire. Training. None. Time to administer/complete. Less than 5 minutes. Equipment needed. Photocopy of instrument. Cost/availability. Instrument, scoring instructions, and psychometric information are available at Scoring Responses. Scale. Items have 5 to 7 ordinally scaled response options; each option has a verbal anchor. If both lower limbs are problematic, only the worse side is rated. Degree of stiffness and S67

2 S68 Rogers and Irrgang swelling is rated on 5-point scales (not at all to extremely). Pain severity while walking, using the stairs and lying are rated on 6-point scales, with a 7th option for being unable to do for reasons other than pain. Support or assistance needed for general mobility is rated on a 7-point scale and sock donning on a 6-point difficulty scale. Score range. To calculate a score, at least 4 items must have a response; the mean value is assigned to missing items. Raw scores are computed by taking the mean score of the 7 items. Formulas are provided in the scoring documentation to transform raw scores to standardized (raw scores rescaled from 0 100) and normative (mean 50; SD 10) scores. Interpretation of scores. Lower scores indicate greater disability. Patients with a normative score below the population mean of 50 (SD 10) have a higher disability level than the overall general population. A normative score greater than 50 indicates a lower degree of disability than the general population. The population mean of the standardized score is (SD 13.78) (1). Method of scoring. By hand. Time to score. About 15 minutes to calculate standardized and normative scores. Training to score. Self-study of the scoring documentation. Training to interpret. A fundamental understanding of classic test theory is needed. Norms available. Norms are representative of the general US population stratified by sex, age categories (19 34, 35 44, 45 54, 55 64, 65 74, 75 years), ethnicity (White, African American, Hispanic, Asian, Native American, Other), and comorbid conditions (heart, high blood pressure, lung, diabetes, ulcer/stomach, kidney, liver, anemia/blood, cancer, depression, osteoarthritis, back, rheumatoid arthritis, other) (1). Psychometric Information Reliability. Internal consistency. The range of Cronbach s alpha coefficients was 0.89 to 0.94, indicating satisfactory internal consistency. Pearson item-to-scale correlation coefficients ranged from r 0.49 to 0.54 (1,2). Test-retest. 24 hour interval, r 0.91 (3). Validity. Content. Established through literature reviews and consensus judgment of AAOS Outcomes Committee (3). Criterion (concurrent). The Lower Limb was the best predictor of physicians ratings of patients global pain and function (3). Construct (known groups). The Lower Limb discriminated diagnostic groups (e.g., amputation, osteoarthritis, rheumatoid arthritis) (3). Construct (convergent and divergent). The Lower Limb was moderately correlated with physicians ratings of patients function (0.60) and pain (r 0.49), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) global score (r 0.42) and the Short Form-36 (SF-36) physical health score (r 0.60) (3). The correlations were higher for the physicians ratings and the SF-36 when the Lower Limb was completed for hip and knee problem (3). The Lower Limb was less strongly correlated with SF- 36 physical components summary score (r 0.24) and mental health (r 0.08) scale than with the physical health, function and pain measures. Construct (convergent and item discriminant). Multitrait scaling analysis indicated that the itemto-scale scores, across all 11 AAOS questionnaires, had higher correlations with their hypothesized scales than with other scales, except for 4 items on the Pediatric Parent-Child Survey (1,2). Item internal consistency indicated that 100% of itemto-scale correlations (corrected for overlap) were 0.40 (item internal consistency of 90% accepted as satisfactory); 100% of item-to-scale correlations were 2 standard errors than the correlation of that item to other scales ( 80% item-to-scale correlations in the total data set and within each scale reflects scaling success) (1,2). Sensitivity/responsiveness to change. At 6- month followup, the mean change score was 8.8 (SD 16.2). The Lower Limb correlated moderately with the combined physician/patient global transition score (r 0.53) and discriminated well between patients who improved and those who did not improve (3). Comments and Critique The Lower Limb is to be used with the SF-36, which provides a measure of global physical and mental health. In testing, AAOS items overlapping with SF-36 items were eliminated (3).

3 Adult Lower Extremity Function S69 References 1. (Original) American Academy of Orthopedic Surgeons, accessed March 12, Hunsaker FG, Cioffi DA, Amadio PC, Wright JG, Caughlin B. The American Academy of Orthopedic Surgeons outcome instruments: Normative values from the general population. J Bone Joint Surg Am 2002;84: Daltroy LH, Johanson MD, Fossel AH, Liang MH. American Academy of Orthopedic Surgeons lower limb outcomes scales: validity, reliability, and sensitivity to change. 1997;Unpublished manuscript. WHO ICF Components. Impairment, Activity limitation, Participation restriction, Environmental factor. Administration Method. Patient-report by questionnaire. Training. No formal training; review of the ADLS to become familiar with the items. Time to administer/complete. 5 to 10 minutes. Equipment needed. Photocopy of Scale. THE ACTIVITIES OF DAILY LIVING SCALE OF THE KNEE OUTCOME SURVEY (ADLS) General Description Purpose. Evaluate symptoms and functional limitations in daily living activities caused by knee pathologies and impairments (1). Content. The ADLS includes symptoms (pain, crepitus, stiffness, swelling, instability/slipping, buckling, and weakness) and functional limitations (difficulty walking on level surfaces, including use of walking aids, and limping; going up and down stairs, standing, kneeling, squatting, sitting, and rising from a sitting position). Developer/contact information. James J. Irrgang, Department of Physical Therapy, University of Pittsburgh School of Health and Rehabilitation Sciences, Room 6058, Forbes Tower, Pittsburgh PA in collaboration with Lynn Snyder-Mackler, Robert S. Wainner, Freddie H. Fu, and Christopher D. Harner. irrgangjj@upmc.edu. Versions. A version using a Likert response scale is available from the author. Validated in English only. Number of items in scale. There are 17 items, 7 symptoms and 10 functional limitations. Subscales. None. Populations. Developmental/target. Physical therapy patients in the United States with various knee disorders, including ligamentous and meniscal injuries, patello-femoral pain, and osteoarthritis. Other uses. Validated for athletic patients (2). Cost/availability. Available in appendix to original article (1). Scoring Responses. Scale. Patients rate items using descriptive responses, which are translated to a numerical ordinal scale for scoring. The number of scoring points ranges from 0 to 5 on the symptom items but varies (0 5; 0 3; 0 2) on the functional disability items. Score range. The scores across all items are summed and then divided by 80 and multiplied by 100 to transform to a scale that ranges from 0 to 100. Interpretation of scores. Higher scores represent the absence of symptoms and a higher level of function. Method of scoring. Scored by hand. Time to score. Less than 5 minutes. Training to score. No formal training. Training to interpret. No formal training. Norms available. Norms are not available. Psychometric Information Reliability. Internal consistency. Cronbach s coefficient alpha was 0.92 at baseline and 0.93 at the 1, 4, and 8 week assessments (1). Test-retest. Intraclass correlation coefficient (ICC), with data collected before and after treatment within the same day, was 0.97 (1). Validity. Content. Items were based on a review of instruments and expert professional opinion. Factor analysis yielded two factors-one reflecting

4 S70 Rogers and Irrgang symptoms and functional limitations and one reflecting only symptoms (1). Construct (known groups). Smaller change on the ADLS was evidenced in patients whose knee improved somewhat than those whose knee improved greatly at both 4 and 8 weeks (1). Construct (convergent). Moderately strong correlations were obtained at baseline, 1, 4, and 8 weeks between the ADLS and the Lysholm Knee Scale (r 0.78 to 0.86) and a global functional rating made by patients (r 0.66 to 0.75) (1). Sensitivity/responsiveness to change. Over 8 weeks of physical therapy, scores on the ADLS improved significantly, with the change at 8 weeks greater than the change at 4 weeks, and the change at 4 weeks greater than the change at 1 week (P for both). The effect sizes for the score changes were 0.44, 0.94, and 1.26 at 1, 4, and 8 weeks, respectively (1). Comments and Critique There were no floor effects at the baseline, 1-, 4-, or 8-week assessments. Ceiling effects were detected at 1 (1.5%), 4 (0.9%) and 8 (5.6%) weeks (1). The construct validity and responsiveness of the ADLS was found to be slightly better than that of the Lysholm Scale, the subjective components of the Cincinnati knee-rating system, and the American Academy of Orthopedic Surgeons (AAOS) Sports Knee Scale in a sample of athletic patients (2). References 1. (Original) Irrgang JJ, Snyder-Mackler L, Wainner RS, Fu FH, Harner CD. Development of a patient-reported measure of function of the knee. J Bone Joint Surg Am 1998;80: Marx RG, Jones EC, Allen AA, Altchek D, O Brien SJ, Rodeo SA, et al. Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am 2001;83: FOOT FUNCTION INDEX (FFI) General Description Purpose. Measure the effect of foot pathology on pain, disability, and activity restriction (1). Content. Pain severity is evaluated at its worst, in the morning, and at the end of the day, and walking and standing (barefoot, with shoes, and with orthotics). Disability is evaluated in walking, stair use, rising from a chair, standing on tip-toes, and climbing curbs. Activity limitation is evaluated for limiting activities, staying in bed, staying inside, and the use of assistive devices. Developer/contact information. Elly Budiman- Mak, VA Hines Hospital, Hines, IL 60141, in collaboration with Kendon J. Conrad and Kathryn E. Roach. Versions. The Dutch FFI uses 5-point verbal rating scales rather than the visual analog scales (2). The FFI was modified to measure symptoms and disability from osteoarthritis of the ankle, by deleting the activity limitations subscale and relating the anatomic descriptors to the ankle (3). Number of items in scale. There are 23 items. Subscales. There are 3 subscales: pain (9 items), disability (9 items), and activity limitation (5 items). Populations. Developmental/target. Adults in the US with definitive or classical active rheumatoid arthritis. Other uses. Validated in patients with ankle osteoarthritis (3), nontraumatic forefoot complaints (2), and the pain subscale for clinical investigations in orthopedic surgery (4). WHO ICF Components. Impairment, Activity limitation, Participation restriction, and Environmental factor. Administration Method. Patient-report by questionnaire. Training. Short period of instruction the first time the FFI is completed. Time to administer/complete. 5 to 10 minutes. Equipment needed. Copy of instrument. Cost/availability. Available from author. Scoring Responses. Scale. Items are rated on horizontal visual analog scales, with verbal anchors: no to worst imaginable for pain; no difficulty to so difficult unable for disability; none of the time to all of the time for activity limitations. Score range. The horizontal line is divided into 10 equal segments; each segment is assigned a

5 Adult Lower Extremity Function S71 number from 0 to 9. Subscale scores are calculated by adding the item scores and dividing by the maximum total score for the items that the patient indicated were applicable. Subscale scores are multiplied by 100 to eliminate the decimal point. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores range from 0 to 100. Interpretation of scores. Higher scores indicate greater dysfunction. Method of scoring. Scored by hand. Time to score. 2 to 3 minutes. Training to score. No formal training. Training to interpret. No formal training. Norms available. Norms are not available. Psychometric Information Reliability. Internal consistency. Cronbach s alpha: Total FFI 0.96; pain 0.93; disability 0.95; activity limitation 0.73 (1). Test-retest. One week test-retest interval; ICC: Total FFI 0.87; pain 0.69; disability 0.84; activity limitation 0.81 (1). Validity. Content. Except for 2 items, the content validity of the FFI total and subscale scores was supported by factor analysis (1). Construct (convergent). Moderate Pearson correlation coefficients were obtained between the FFI total score and foot joint count (0.53) and walking time (0.48) and the pain, disability, and activity limitation subscales scores for foot joint count (0.54, 0.43, 0.43) and walking time (0.34, 0.51, 0.42), respectively (1). Construct (divergent). Lower, but still significant correlations, were obtained between hand joint count, a non-foot function measure, and the total (0.33), pain (0,30), disability (0.31), and activity limitation (0.25) scores (1). Sensitivity/responsiveness to change. Over 6 months, changes in painful foot joint count correlated significantly with changes in the total FFI (r 0.45) and pain subscale (r 0.47) scores and significantly, although less strongly, with the activity limitation subscale ( r 0.34) scores (1). Comments and Critique As an outcome measure, the FFI found no effect on rheumatoid arthritis-related disability and pain in a double-blind clinical trial of foot orthoses over placebo (5), and found evidence suggesting that a firm molded insole was as effective as the insole plus magnetic foil in treating heel pain (6). References 1. (Original) Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol 1991;44: Kuyvenhoven MM, Gorter KJ, Zuithoff P, Budiman- Mak E, Conrad KJ, Post MWM. J Rheumatol 2002;29: Domsic RT, Saltzman CL. Ankle Osteoarthritis Scale. Foot Ankle Int 1998;19: Saag KG, Saltzman, CL, Brown CK, Budiman-Mak E. The Foot Function Index for measuring rheumatoid arthritis pain: evaluating side-to-side reliability. Foot Ankle Int 1996;17: Conrad KJ, Budiman-Mak E, Roach KE, Hedeker D. Impacts of foot orthoses on pain and disability in rheumatoid arthritis. J Clin Epidemiol 1996;49: Caselli MA, Clark N, Lazarus S, Velez Z, Venegas L. Evaluation of magnetic foil and PPT insoles in the treatment of heel pain. J Am Podiatr Med Assoc 1997; 87:11 6. FUNCTIONAL ASSESSMENT SYSTEM (FAS) General Description Purpose. Evaluate lower extremity dysfunction (1). Content. Five domains are evaluated: hip impairment, knee impairment, physical disability, social disability, and pain. Hip impairment involves active flexion, extension, abduction and adduction. Knee impairment involves active flexion and extension, and quadriceps and hamstring muscle strength. Physical disability is operationalized as rising from half standing, raising up and sitting down, step height, one leg standing, stair climbing, gait speed, and use of a walking aid. Social disability includes communication and transportation, work and housekeeping, activities of daily living functions, and leisure involvement. Pain examines pain at load and rest. Developer/contact information. Öberg U, Department of Physical Therapy, County Hospital of Eksjö-Nässjö, S Eksjö, Sweden, in collaboration with Öberg B, Öberg T. ulrika.oberg@hoegland.ltjkpg.se.

6 S72 Rogers and Irrgang Versions. Swedish, Finnish, Danish, Norwegian, Icelandic, Polish, and Spanish language versions are available. Number of items in scale. There are 20 items in 5 domains. Subscales. There are 5 subscales: hip impairment (4 items), knee impairment (4 items), physical disability (7 items), social disability (4 items), and pain (1 item). Populations. Developmental/target. Adult patients in Sweden with osteoarthritis of the hip and knee accepted for joint replacement arthroplasty. Other uses. Patients with unspecified lower extremity problems, those accepted for tibial osteotomy and healthy people. WHO ICF Components. Impairment, Activity limitation, Participation restriction, Environmental factor. Administration Method. Observer administered. Hip and knee impairment involves active range of motion evaluation; physical disability involves performance tests; social disability and pain are assessed by patient interview. Training. Designed for use by physical therapists; no formal training required. Time to administer/complete. 30 minutes. Equipment needed. Copy of instrument, goniometer, stop watch, strain gauge dynamometer, adjustable chair, adjustable step heights, bench. Cost/availability. Costs of any unavailable equipment. FAS is available from the primary author. Scoring Responses. Scale. Each item is scored on a 5- point Likert scale according to descriptors unique to each item. Score range. All items are treated independently and each item score can range from 0 to 4, with 0 indicating no reduced function and 4 severe or total lack of function. Interpretation of scores. Scores are presented in a profile illustrating the functional reduction for each variable. Method of scoring. Scored by hand. Time to score. Scoring is included in administration time. Training to score. No formal training. Training to interpret. No formal training. Norms available. Norms are not available. Psychometric Information Reliability. Internal consistency. Not available. Test-retest. Not available. Interrater. Goodman-Kruskal gamma correlations between two physical therapists indicated perfect agreement (1.00) for all variables, except communication/transport which was 0.9 (1). Validity. Content. Factor analysis yielded 5 factors, with 17 of 20 variables loading according to the hypothesized domains; extension deficits of the hip and knee loaded together with pain rather than in the hip and knee impairment domains (1). Construct (known groups). The FAS discriminated well between healthy people and those with osteoarthritis of the hip and knee. Except for the knee flexion and extension variables in the hip group and the hip abduction and adduction variables in the knee group, it also discriminated well between healthy people and those with osteoarthritis when the two groups were divided. When the hip and knee groups were compared, the hip group had significantly higher scores on the hip variables, and the knee group had significantly higher scores on the knee variables. Most variables, except for the knee and hip variables, discriminated well between patients with different degrees of osteoarthritis, including those without osteoarthritis (2). Older adults admitted for hip or knee arthroplasty had significantly lower functioning (muscle force and most physical and social disability variables) than younger adults. This age difference was not observed in the healthy control group, suggesting that the difference was more likely due to osteoarthritis disease than age alone (3).

7 Adult Lower Extremity Function S73 Construct (convergent). For the mobility, physical activity, household activity, activities of daily living, and pain variables of the Arthritis Impact Measurement Scales, there was moderate to high agreement (Goodman-Kruskal gamma coefficients) with all FAS variables, except knee flexion and extension (4). A high agreement was also observed between quality of life (Rosser-Kind Index) and lower extremity dysfunction (4). Construct (discriminant). All physical and social disability variables showed high sensitivity (disease detection), while the sensitivity of the impairment variables was low, except for those involving muscle strength. Specificity (correct identification of those not having the disease) approached 1.0, except for the muscle strength variables, gait speed and standing on one leg (2). For the depression, anxiety, and social contacts variables of the Arthritis Impact Measurement Scales, there was low agreement (Goodman- Kruskal gamma coefficients) with all FAS variables (4). Low agreement was observed between radiographic evidence and lower extremity dysfunction (4). Sensitivity/responsiveness to change. Responsiveness, calculated as the standardized response mean, for impairment was 0.3 and 1.0; for disability 0.4 and 0.7; and for interview questions 0.8 and 0.9 at 3 and 6 months respectively after total hip replacement (5). In patients with high tibial osteotomy, significant improvement was observed in 6/20 variables and 10/20 variables at 6 and 12 months, respectively (6). Following arthroplasty, patients with hip osteoarthritis FAS scores improved significantly, except for knee flexion and extension variables; those with knee osteoarthritis improved significantly except for hip abduction, knee flexion and walking aid variables (perhaps because these scores were low preoperatively) (7). Comments and Critique The pain and function variables of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Short Form-36 exhibited greater responsiveness than the FAS at 3 months after hip replacement and these differences were retained at 6 and 12 months (5). References 1. (Original) Öberg U, Öberg B, Öberg T. Validity and reliability of a new assessment of lower-extremity dysfunction. Phys Ther 1994;74: Öberg U, Öberg T. Discriminatory power, sensitivity and specificity of a new assessment system (FAS). Physiother Can 1997;49: Öberg U, Öberg T. Worse functional status among old people when admitted for arthroplasty. Scand J Caring Sci 1996;10: Öberg U, Öberg B, Öberg T. Concurrent validity of a new assessment of lower extremity dysfunction. Eur J Phys Med Rehabil 1996;6: Nilsdotter A, Roos EM, Westerlund JP, Roos HP, Lohmander LS. Comparative responsiveness of measures of pain and function after total hip replacement. Arthritis Rheum (Arthritis Care Res) 2002;45: Öberg U, Öberg T. Functional outcome after high tibial osteotomy: a study using individual goal achievement as the primary outcome variable. J Rehabil Res Dev 2000;37: Öberg U, Öberg T. Hagstedt B. Functional improvement after hip and knee arthroplasty. Physiother Theory Pract 1996;12:3 13. HARRIS HIP SCORE (HHS) General Description Purpose. Evaluate various hip impairments and methods of treatment (1). Content. Domains cover pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities. The function domain is divided into gait (limp, support needed) and activities (stair use, managing shoes and socks, sitting, using public transportation). Deformity takes into account hip flexion, adduction, internal rotation and limblength discrepancy and range of motion measures flexion, abduction, external and internal rotation, and adduction. The Trendelenburg test is recorded but not rated as a part of the HHS. Developer/contact information. William H. Harris, Department of Orthopedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA. Versions. The HHS is completed by a qualified healthcare professional. A patient-report, 7-item version is available consisting of all HHS items except those on hip range of motion and deformity and public transportation (2). Number of items in scale. There are 10 items in 4 domains. Subscales. None. Populations. Developmental/target. Adults in the US with hip problems and before and after

8 S74 Rogers and Irrgang treatment (1); most psychometric data from Swedish patients (2). Other uses. None. WHO ICF Components. Body function, Impairment, Activity limitation, Participation restriction, Environmental factor. Administration Method. Administered by a qualified health care professional, such as a physician or rehabilitation therapist. Training. The assessor must be familiar with the content and rating system of the instrument and trained to measure range of motion. Time to administer/complete. 15 to 30 minutes. Equipment needed. Copy of instrument, goniometer. Cost/availability. Available in original article (1). doc_ch20.04.html#a Scoring Responses. Scale. Each item has a unique numerical scale, which is anchored to descriptive response options. The number of response options varies by item, as does the number of points assigned to each response option. The range of motion item is comprised of 6 motions (e.g., flexion, abduction), which are graded based on the arc of motion possible. Each range of motion gradation is assigned an index factor and a maximum possible value, which are used to calculate arc of motion points. Points for the individual arcs of motions are added and multiplied by 0.05 to obtain the total points for range of motion. The total score is calculated by summing the scores for the 4 domains. The Trendelenburg test is recorded as positive, level, or neutral. Score range. Total of 100 points. Pain receives 44 points; function, 47 points (activities of daily living receives 14 points; gait 33 points), range of motion, 5 points; and deformity, 4 points. Interpretation of scores. The higher the HHS, the less dysfunction. A total HHS score below 70 points is considered a poor result; 70 to 80 a fair result; and 90 to 100 an excellent result (1). Method of scoring. Scored by hand or using computer based algorithms. Time to score. About 5 minutes. Training to score. No formal training; must learn how to calculate index values for range of motion items. Training to interpret. No formal training. Norms available. Norms are not available. Psychometric Information Reliability. Internal consistency. Cronbach s alpha coefficients exhibited high internal consistency for the domains, except for deformity, which could not be computed; specific coefficients were not reported (3). Test-retest. The retest interval was 3 to 4 weeks. Total score reliability was excellent for both physicians (r 0.94) and physical therapists (r 0.95). Similar results were obtained for physicians and therapists, respectively for pain (r 0.98, r 0.93) and function (r 0.93, r 0.95). Correlations for deformity could not be calculated because all patients received the highest score. Correlations for the Trendelenberg test and bone length evaluation were 0.58 and 0.49 for physicians, respectively, and 0.37 and 0.55 for therapists, respectively (3). Interrater. Interrater correlations for the domain scores were good to excellent, ranging from 0.74 to The lowest item correlation was 0.67 for sitting (in the function domain). Significant correlations between physicians and therapists scores were achieved for the flexion and abduction items. Correlations in the deformity domain were not computed because deformity did not vary (3). Validity. Content. The content is based on expert judgment and spans factors significant for surgery, with pain and function being the two basic considerations and receiving the most weight in scoring (1). Construct (convergent/divergent). In a comparison of the HHS, WOMAC, the SF-36, and the Nottingham Health Profile, correlations (Spearman rho) between similar constructs on these instruments [pain ( ), function ( )] were typically higher than those between different constructs [pain and function ( )] (4). In another study, in Cohort I, Spearman rho correlations within pain ranged from 0.41 to 0.60 and within function from 0.63 to 0.76, and between pain and function ranged from 0.10 to 0.49; comparable results were obtained from

9 Adult Lower Extremity Function S75 Cohort II (3). Comparisons between the HHS and SF-36 provided convergent/divergent evidence in that the strongest HHS correlations (Kendall Tau) were in physical function (0.51) and weakest in mental health (0.18) (5). A strong correlation was found between the HHS and the Nottingham Health Profile (Spearman 0.82) (6). Sensitivity/responsiveness to change. In a study of hip arthroplasty patients, the HHS yielded an effect size of 2.5 and a standardized response mean of 1.8 (7). Comments and Critique The HHS is the most widely used scoring system for evaluating hip arthroplasty (3). In patients with total hip replacement, the HHS domains showed high ceiling effects, with the mean score for deformity achieving the maximum points (3). Its responsiveness, quantified according to several methods, was found to be equivalent to or better than the WOMAC pain and function subscales (7). Evidence suggests that HHS scores are influenced by age and comorbidities (8). agreement (r 0.99) was demonstrated between patient-report HHS and surgeon-assessed HHS for evaluating total hip arthroplasty outcomes (2). A telephone call following patient completion of a mailed HHS questionnaire was found to be useful for improving the quality and quantity of responses (9). References 1. (Original) Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. J Bone Joint Surg Am 1969;51: Mahomed NN, Arndt DC, McGrory BJ, Harris WH. The Harris Hip Score: comparison of patient selfreport with surgeon assessment. J Arthroplasty 2001; 16: Söderman P, Malchau H. Is the Harris Hip Score system useful to study the outcome of total hip replacement? Clin Orthop Rel Res 2001;384: Söderman P, Malchau H, Herberts P. Outcome of total hip replacement: a comparison of different measurement methods. Clin Orthop Rel Res 2001;390: Lieberman JR, Dorey F, Shekelle P, Schumacher L, Kilgus DJ, Thomas BJ, et al. Outcomes after total hip arthroplasty: comparison of a traditional diseasespecific and a quality-of-life measurement of outcome. J Arthroplasty 1997;12: Garellick G, Malchau H, Herberts P. Specific or general health outcome measures in the evaluation of total hip replacement: a comparison between the Harris Hip Score and the Nottingham Health Profile. J Bone Joint Surg Br 1998;80: Wright JG, Young NL. A comparison of different indices of responsiveness. J Clin Epidemiol 1997;50: Brinker MR, Lund PJ, Cox DD, Barrack RL. Demographic biases found in scoring instruments of total hip arthroplasty. J Anthroplasty 1996;11: McGrory BJ, Shinar AA, Freiberg AA, Harris WH. Enhancement of the value of hip questionnaires by telephone follow-up evaluation. J Arthroplasty 1997; 12: INDEX OF SEVERITY FOR HIP OSTEOARTHRITIS (ISH) General Description Purpose. Evaluate the severity of osteoarthritis of the hip (1 4). Content. Three domains are covered: pain or discomfort, distance walked, and activities of daily living. The pain domain measures pain at night, during standing, when walking, and while sitting, and stiffness. Distance walked takes into account distance and use of walking aids. Activities of daily living assessed are donning socks, picking up an object from the floor, using stairs, and car transfers. Developer/contact information. Michel Lequesne, Hôpital Léopold Bellan, 19 rue Vercingétorix; Paris, France, in collaboration with C. Méry and M. Samson. Versions. A self-administered version is available (4). One version has an additional question on sexual activity, which is to be rated for sexually active women when a hip prosthesis is being considered (4). Available in French, German (5), and Korean (6). Number of items in scale. There are 11 items in 3 domains: 5 items relate to pain; 2 items to distance walked, and 4 items to activities of daily living. Subscales. None. Populations. Developmental/target. Adults in France with hip osteoarthritis. Other uses. None. WHO ICF Components. Impairment, Activity limitation, Participation restriction, Environmental factor. Administration Method. Interview by trained interviewers.

10 S76 Rogers and Irrgang Training. About 20 to 30 interviews to reach criterion consistently with a trained investigator (2,3). Time to administer/complete. 3 to 4 minutes. Equipment needed. Copy of instrument. Cost/availability. Available in articles (1 4). Also available at: doc_ch20.04.html#a Scoring Responses. Scale. Within each domain the scale is created by descriptive phrases to which points are assigned. Pain or discomfort during night time bed rest, with morning stiffness, and while walking are assigned 0 to 2 points. Pain while standing and during prolonged sitting 0 to 1 points. Walking is given 0 to 6 points based on distance walked; an additional point is given if one walking aid is used and 2 points if two walking aids are used. Activities of daily living are given 0 to 2 points, with 0 indicating without difficulty and 2 indicating unable. Lower points imply less dysfunction. Score range. The possible score range is 0 24, with 8 points allocated for each domain pain, maximum distance walked, and activities of daily living. Interpretation of scores. Lower scores reflect better function. The suggested interpretation of level of participation restriction (handicap) is: a score 14 reflects extremely severe handicap; 11 13, very severe; 8 10, severe; 5 7 moderate; and 1 4, minor. A score of points after appropriate medical treatment indicates the need for surgery (2 4). Method of scoring. Scored by hand. Time to score. Less than 1 minute. Training to score. Training to score is inherent in training to administer. Training to interpret. No formal training. Norms available. No norms are available. Psychometric Information Reliability. Internal consistency. Not available. Test-retest. Not available. Interobserver. The mean deviation in the scores recorded by two observers was 0.55 points (not significant) (2 4). Validity. Content. Not addressed. Criterion (Predictive). In patients with hip osteoarthritis, an ISH score 10 carried a relative risk of 2.59 for total hip arthroplasty (7). Construct. The ISH discriminated the time patients were on nonsteroidal antiinflammatory drugs (NSAIDs) from the time on placebo. Sensitivity/responsiveness to change. Active drug treatment reduces the score by 30 40%, with effect sizes of (4). Patients recruited for clinical trials generally score between 9 and 11 points at baseline (SD 2.3 to 3.8). After a short trial ( 2 weeks) of NSAIDs and a longer trial with SYSADOA ( 6 8 weeks), ISH tends to decrease 2.5 to 4 points or about 25 40% (4). Effect sizes in drug trials ranging from 1.07 to 1.86 were reported (4). Comments and Critique The correlation between the self-administered version and the investigator-version ranged from 0.70 at baseline to 0.82 at the 5th visit (4). References 1. (Original) Lequesne M, Méry C. European guidelines for clinical trails of new antirheumatic drugs. EULAR Bull 1980;9: Lequesne M, Méry C, Samson M, Gerard P. Indices of severity for osteoarthritis of the hip and knee. Scan J Rheumatol 1987;65 Suppl: Lequesne M. Indices of severity and disease activity for osteoarthritis. Semin Arthritis Rheum 1991;20 Suppl 2: Lequesne MG. The algofunctional indices for hip and knee. J Rheumatol 1997;24: Lesquesne M. Klinishe und röntgenologische verlaufsbeobachtung bei hüft und kniearthrosen methoden und ergebnisse. Z Rheumatol 1994;53: Bae SC, Lee HS, Yun HR, Kim TH, Yoo DH, Kim SY. Cross-cultural adaptation and validation of Korean Western Ontario and McMaster Universities (WOMAC) and Lequesne Osteoarthritis Indices for clinical research. Osteoarthritis Cartilage 2001;9: Dougados M, Gueguen A, Nguyen M, Berdah L, Lequesne M, Mazieres B, et al. Requirement for total hip arthroplasty: an outcome measure of hip osteoarthritis. J Rheumatol 1999;26:

11 Adult Lower Extremity Function S77 INDEX OF SEVERITY FOR KNEE OSTEOARTHRITIS (ISK) General Description Purpose. Evaluate the severity of osteoarthritis of the knee (1 3). Content. Three domains are covered: pain or discomfort, distance walked, and activities of daily living. The pain domain measures pain at night, during standing, when walking, and when getting up from a sitting position, and stiffness. Distance walked takes into account distance and use of walking aids. Activities of daily living tested are going up and down stairs, squatting, and walking on uneven ground. Developer/contact information. Michel Lequesne, Hôpital Léopold Bellan, 19 rue Vercingétorix; Paris, France, in collaboration with C. Méry and M. Samson. Versions. Self-administered (3) and French, German (3), and Korean (4) versions are available. Number of items in scale. There are 11 items in 3 domains: 5 items relate to pain; 2 items to distance walked, 4 items to activities of daily living. Subscales. None. Populations. Developmental/target. Adults in France with knee osteoarthritis. Other uses. None. WHO ICF Components. Impairment, Activity limitation, Participation restriction, Environmental factor. Administration Method. Interview by trained interviewer. Training. About 20 to 30 interviews to reach criterion consistently with a trained investigator is recommended (1,2). Time to administer/complete. 3 to 4 minutes. Equipment needed. Copy of instrument. Cost/availability. Available in articles (1 3). Also available at doc_ch20.04.html#a Scoring Responses. Scale. Within each domain, the scale is created by descriptive phrases to which points are assigned. Pain or discomfort during nighttime bed rest, with morning stiffness, and while walking are assigned 0 to 2 points. Pain while standing and rising from prolonged sitting 0 to 1 points. Walking is given 0 to 6 points based on distance walked; an additional point is given if one walking aid is used and 2 points if two walking aids are used. Activities of daily living are given 0 to 2 points, with 0 indicating without difficulty and 2 indicating unable. Lower points imply less dysfunction. Score range. The possible score range is 0 24, with 8 points allocated for each domain pain, maximum distance walked, and activities of daily living. Interpretation of scores. Suggested interpretation of level of participation restriction (handicap): 1 4, minor; 5 7, moderate; 8 10, severe; 11 13, very severe; 14, extremely severe; a score of 8 12 is suggestive of the need for a knee replacement (1 3). Method of scoring. Scored by hand. Time to score. Less than 1 minute. Training to score. Training to score is inherent in training to administer. Training to interpret. No formal training. Norms available. No norms are available. Psychometric Information Reliability. Internal consistency. Not available. Test-retest. Not available. Interobserver. The maximum difference between two blind observers was 1.5 points, which was not significant (1 3). Validity. Content. Not addressed. Construct. The ISK discriminated the time patients were on NSAIDs and a placebo (1 4). Sensitivity/responsiveness to change. Patients recruited for clinical trials generally score between 9 and 11 points at baseline (SD ). After a short trial ( 2 weeks) of NSAID and a longer trial with SYSADOA ( 6 8 weeks), scores usually

12 S78 Rogers and Irrgang decrease from 2.5 to 4 points or about 25 40% (3). In a knee OA trial of acupuncture, the ISK effect size was greater than that of the WOMAC at 8 (2.0 versus 1.0) and 12 (1.3 versus 0.7) weeks (5). Significant differences between knee OA patients treated with orgotein versus betamethasone were demonstrated on the ISK at 1 and 2 weeks (6). Comments and Critique The correlation between the self-administered version and the investigator-version ranged from 0.70 at baseline to 0.82 at the 5th visit (3). References 1. (Original) Lequesne M, Méry C, Samson M, Gerard P. Indices of severity for osteoarthritis of the hip and knee. Scand J Rheumatol 1987;65 Suppl: Lequesne M. Indices of severity and disease activity for osteoarthritis. Semin Arthritis Rheum 1991;20 Suppl 2: Lequesne MG. The algofunctional indices for hip and knee. J Rheumatol 1997;24: Bae SC, Lee HS, Yun HR, Kim TH, Yoo DH, Kim SY. Cross-cultural adaptation and validation of Korean Western Ontario and McMaster Universities (WOMAC) and Lequesne Osteoarthritis Indices for clinical research. Osteoarthritis Cartilage 2001;9: Berman BM, Lao L, Green M, Anderson RW, Wong RH, Langenberg P. Efficacy of traditional Chinese acupuncture in the treatment of symptomatic knee osteoarthritis: a pilot study. Osteoarthritis Cartilage 1995;3: Mazieres B, Masquelier A, Capron M. A French controlled multicenter study of intrarticular orgotein versus intrarticular corticosteroids in the treatment of knee osteoarthritis: a one-year followup. J Rheumatol 18(Suppl 27): KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) General Description Purpose. Evaluate the short-term (week to week) and long-term (over years) patient-relevant outcomes of knee injury that can result from posttraumatic osteoarthritis, such as anterior cruciate ligament injury, meniscus injury, chondral injury (1,2). Content. Five outcomes are considered: pain, other symptoms, activities of daily living function, sport and recreation function, and knee-related quality of life. Overall pain frequency is measured and pain severity is measured for 8 actions (e.g., pivoting, lying in bed at night). Symptoms (presence, severity) cover stiffness, swelling, grinding, catching, and the ability to straighten and bend the knee. Activities of daily living span difficulty with functional movements (sitting, standing, car transfers), personal care (putting on and taking off stockings/socks), and home management (e.g., shopping, heavy and light domestic duties). Sport and recreation involves difficulty squatting, running, jumping, kneeling and turning or twisting the knee. Quality of life addresses awareness of knee problems, interference with lifestyle, confidence in knee function, and overall difficulty with the knee. Developer/contact information. Ewa M. Roos, Department of Orthopedics, Lund University, University Hospital, S Lund, Sweden; ; ewa.roos@ort.lu.se, in collaboration with Harald P. Roos, L. Stefan Lohmander, Charlotte Ekdahl, and Bruce D. Beynnon; accessed March 21, Versions. There are American-English, Swedish, and Danish versions. German and Italian versions are under development. Number of items in scale. There are 42 items. Subscales. Five scales: pain (9 items), symptoms (7 items), activities of daily living (17 items), sport and recreation function (5 items), and knee-related quality of life (4 items). Populations. Developmental/target. Young and middle-aged persons in America with anterior cruciate ligament injury, meniscus injury, or post traumatic osteoarthritis. Other uses. Not reported. WHO ICF Components. Impairment, Activity limitation, Participation restriction. Administration Method. Patient-report by questionnaire. Training. No formal training Time to administer/complete. About 10 minutes. Equipment needed. Copy of instrument. Cost/availability. Available at nu. Scoring Responses. Scale. All items are rated on a 5- point Likert scale created by adjective descriptors. Items on the pain scale related to degree of pain;

13 Adult Lower Extremity Function S79 the symptoms scale related to knee stiffness severity; the quality of life scale related to difficulty; and all items on the activities of daily living and sport and recreation scales are rated as none, mild, moderate, severe or extreme. Items on the quality of life scale related to lifestyle modifications and lack of confidence in the knee are rated as not at all, mildly, moderately, severely and totally/extremely. All other items are rated for frequency but the scale varies from never, monthly, daily or always; to never, rarely, sometimes, often, or always; to always, often, sometimes, rarely, or never. Items are answered for the previous week. Score range. All items are scored from 0 to 4. Scores received on each item are summed to obtain scale scores; there is no total score. For the pain scale, the possible raw score range is 0 36; for symptoms, 0 28; for activities of daily living, 0 68; for sport and recreation, 0 20; for knee-related quality of life Scale scores are transformed to a scale, by multiplying the raw score by 100, dividing by the highest possible raw score, and, subtracting from 100. Interpretation of scores. Scale scores range between 0 and 100, with 0 extreme knee problems and 100 no knee problems. The 5 scores are presented as an outcome profile. Method of scoring. Scored by hand. Time to score. Less than 5 minutes. Training to score. No formal training. Training to interpret. No formal training. Norms available. No norms are available. Psychometric Information Reliability. Internal consistency. Not available. Test-retest. Administered twice preoperatively (anterior cruciate ligament reconstruction) with an average interval of 3.6 days ( 2.6). High ICC values: pain 0.85; symptoms 0.93; activities of daily living 0.75; sports and recreation function 0.81; knee-related quality of life 0.86 (1). Validity. Content. Outcomes were identified through literature review, expert panel (from Sweden and the United States) and a pilot study of patients with post-traumatic osteoarthritis. Items on the sports and recreational and knee-related quality of life subscales were borrowed or adapted from other instruments (1). Construct (known groups). Significant differences between post-traumatic osteoarthritis group and age- and sex-matched control group without osteoarthritis on all 5 subscales (2 4). Construct (convergent). Evidenced in the significant correlations (Spearman) between SF-36 physical function and KOOS activities of daily living (r s 0.57) and sport and recreation (r s 0.47) scales; and SF-36 bodily pain and KOOS pain (r s 0.46) scales (1). Construct (discriminant). Demonstrated in lower correlations between the SF-36 mental health and KOOS activities of daily living (r s 0.22), sports/ recreation (r s 0.23), and pain (r s 0.09) scales than between comparable physical function and pain scales on the SF-36 and KOOS scales (1). Sensitivity/responsiveness to change. By 3 months post-surgery and rehabilitation, significant change was evident in the pain, activities of daily living, and knee-related quality of life scores. By 6 months post-surgery, all scores improved significantly and by 12 months post-surgery, improvement beyond that achieved at 6 months, occurred in sport and recreation and knee-related quality of life. Effect sizes 6 months after surgery were: pain 0.84, symptoms 0.87, activities of daily living 0.94, sport and recreation 1.16, and quality of life 1.65 (1). Comments and Critique The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is included on the KOOS (2). The Foot and Ankle Survey (FAOS), which is based on the KOOS, assesses foot and ankle problems, such as lateral ankle instability, Achilles tendinosis, and plantar fasciitis (2). References 1. (Original) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon, BD. Knee Injury and Osteoarthritis Outcome Score (KOOS): development of a selfadministered outcome measure. J Orthop Sports Phys Ther 1998;78: A User s Guide to Knee Injury and Osteoarthritis Outcome Score, KOOS, accessed March 12, Roos E, Roos H, Lohmander LS. WOMAC Osteoarthritis Index: additional dimensions for use in post-traumatic osteoarthritis of the knee. Osteoarthritis Cartilage 1999;7: Roos E, Roos H, Ekdahl C, Lohmander LS. Knee injury and osteoarthritis outcome score (KOOS): validation of a Swedish version. Scand J Med Sci Sports 1998;8: