- Email: [email protected]
A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients
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Lynch TS, Cole BJ, Ahmad CS. The role of functional sports assessment in the return to sport after ACL reconstruction. Sports Medicine Weekly. Jan/Feb 2015. Page 5–6. Mascarenhas R, Erickson BJ, Sayegh ET, et al. Is there a higher failure rate of allografts compared with autografts in anterior cruciate ligament reconstruction: a systematic review of overlapping meta-analyses. Arthroscopy. 2015;31(2):364–372. Myer GD, Paterno MV, Ford KR, Quatman CE, Hewett TE. Rehabilitation after anterior cruciate ligament reconstruction: criteria-based progression through the return-to-sport phase. J Orthop Sports Phys Ther. 2006;36(6):385–402.
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Risberg MA, Holm I. The long-term effect of 2 postoperative rehabilitation programs after anterior cruciate ligament reconstruction: a randomized controlled clinical trial with 2 years of follow-up. Am J Sports Med. 2009;37(10):1958–1966. Shelbourne KD, Patel DV. Timing of surgery in anterior cruciate ligament-injured knees. Knee Surg Sports Traumatol Arthrosc. 1995;3(3):148–156.
A complete reference list can be found online at ExpertConsult.com.
A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients Belle L. van Meer, MD, PhD, Duncan E. Meuffels, MD, PhD, Max Reijman, PhD
INTRODUCTION It is important to monitor patients after anterior cruciate ligament (ACL) injury over time to evaluate their recovery after nonoperative or operative treatment so that the rehabilitation program can be monitored and adjusted if necessary. Furthermore, monitoring is essential to determine the effectiveness of different interventions during clinical studies. Mid- and long-term evaluation is also important for assessing the mid- and long-term consequences after an ACL rupture, and these outcomes can be used for development of new treatment strategies. One way to monitor a patient’s recovery is periodic assessment by the treating physician, including a physical examination that incorporates range of motion and stability tests of the knee. However, it is equally important to record the patient’s perception of the knee during daily living and sports activities. This can be done using self-administered patient reported outcome measures (PROMs) that ask about complaints and symptoms, how the knee functions during daily activities and sports, and quality of life (QOL). PROMs can be used for different purposes: as feedback for the patient self, for the clinician to identify which patient experiences improved or deteriorated health outcome over time, in clinical research, and as an indicator in healthcare systems for assessing the performance of hospitals and clinics. The PROMs should be relevant for patients with ACL rupture or reconstruction and should cover the whole domain of symptoms and complaints specific for this group. In the acute phase, pain and functional limitations are the main complaints, followed by knee instability and limitations in sport and leisure participation. For monitoring patient’s perception of the long-term consequences after ACL rupture, the domain of knee osteoarthritis (OA) should be assessed. Furthermore, the PROM should be reliable—that is, it should evoke similar answers on repeated measurements if the complaints and symptoms do not alter. Finally, if the complaints change over time, the PROM should be able to detect these changes over time. Therefore the following properties of a PROM are important: 1. The PROM should be validated in the population of interest. The domain validity consists of three measurement properties: content validity, construct validity, and criterion validity.1
a. Content validity evaluates the degree to which the content of a PROM is relevant and comprehensive for patients with ACL rupture.1,2 Content validity should be assessed by the target population and by experts of the field. b. Construct validity evaluates the degree to which the scores of a PROM are consistent with predefined hypotheses based on the assumptions that the PROM validly measures the construct to be measured. Predefined hypotheses are tested about expected direction and magnitude of the correlation coefficients between the PROM and other test scores. In other words, does the PROM assess the specific symptoms and complaints of a patient with an ACL rupture? An aspect of construct validity is cross-cultural validity; this should only be assessed for translated PROMs.1,2 c. Criterion validity evaluates the degree to which the scores of a PROM adequately relate to a “gold standard.” This is not applicable to PROMs of constructs for which no “gold standard” test exists. Criterion validity can be used when testing a short-form version of a PROM against the original version.1,2 2. The test should be reliable. The reliability should be evaluated by the test-retest reliability and measurement error. The test-retest reliability assesses if the PROM provides similar answers on repeated measurements under the assumption that the symptoms and complaints are similar. Intraclass correlation coefficient (ICC) is commonly reported, and the reliability is considered to be good if the ICC is at least 0.70. Measurement error should be assessed to determine the agreement between repeated measurements in one patient. This is the systematic and random error of a patient’s score that is not attributed to true changes.1,2 3. The PROM should be able to detect changes over time; this is called responsiveness. It can be considered as the validity of the change scores of the PROM over time, or as longitudinal construct validity. Predefined hypotheses should be tested concerning the magnitude and direction of the correlation coefficients between the PROM change scores and the anchor question (the change according to the patient’s own experience) and between the PROM change scores and change
CHAPTER 120 A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients
scores of other tests, which measure the same construct. Furthermore, hypotheses about the expected effect size could be formulated.1–3 4. Evaluation of the presence of floor (minimal score) and ceiling (maximal score) effects at baseline are also important because they can influence the content validity and responsiveness. Floor and ceiling effects were considered present if more than 15% of the patients achieved the minimal or maximal score.2
PATIENT REPORTED OUTCOME MEASURES There are many generic PROMs of health status; however, these will not be discussed in this chapter. The focus of this chapter lies on ACL specific PROMs. Table 120.1 shows an overview of frequently used PROMs in ACL injured patients, with the different domains intended to be measured. We have ordered them as frequently used in literature, as we have perceived at present. Table 120.2 shows an overview of the PROMs and their properties. The measurement properties were evaluated, and it is shown for which PROM the measurement properties were assessed according the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) criteria.1,3
International Knee Documentation Committee Subjective Knee Form The International Knee Documentation Committee (IKDC) subjective is a knee-specific instrument, developed to measure symptoms, function, and sport activities in patients with a variety of knee problems. The IKDC subjective has been validated in patients who visited orthopaedic sports medicine practices with the preceding injuries.4 The IKDC subjective has also been validated in a specific population of ACL injured patients.6 This PROM consists of 18 items and is scored by summing the scores of the individual items (raw score) and then transforming the summed score to a scale ranging from 0 to 100. Higher scores represent lower levels of symptoms, and higher levels of function and participation in sports activity.
Knee Injury and Osteoarthritis Outcome Score The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument developed to evaluate functioning in daily living, sport, and recreation, as well as the knee-related QOL in patients with knee injuries who are at risk of OA developing (ACL, meniscus, or chondral injury). This questionnaire
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is intended to monitor the short- and long-term consequences (i.e., OA) of these injuries.8 It has been validated in several populations—for example, patients after ACL injury,6,8 total knee arthroplasty,34 and meniscectomy.35 The KOOS has five subscales, each scored separately: Pain (9 items), Symptoms (7 items), Activities of Daily Living (ADL; 17 items), Sport and Recreation Function (Sport/Rec; 5 items), and knee-related QOL (4 items). All items are scored 0–4; for each subscale the scores are transformed to a 0–100 scale (0 representing extreme knee problems and 100 representing no knee problems). A validation study during short-term follow-up after ACL injury showed that the subscales Pain and Activities of Daily Living were assessed as nonrelevant; only the subscale Sport and Recreation Function had acceptable construct validity, and none of the subscales had sufficient score for responsiveness.6 However, these clinimetric properties were assessed in patients with recent ACL ruptures and those in the first year after ACL reconstruction.
Lysholm Rating Scale The Lysholm scale was initially designed for physician administration and was validated in patients with ACL injuries and meniscal injuries.10,14 It has also been validated as a patientadministered instrument to measure symptoms and function in patients with a variety of knee injuries.11,36–38,59 The Lysholm scale does measure the domains of symptoms and complaints and does measure functioning in daily activities slightly, but does not measure the domain of functioning in sports and recreational activities. This scale consists of eight items. It is scored on a scale of 0 to 100, with higher scores indicating fewer symptoms and higher levels of functioning.
Tegner Activity Score The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries.14 To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. However, few studies documented the clinimetric properties of this score.11,37,38,59 The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. A disadvantage of this score is that the scale is related to sports instead of functional activities. Thus the generalizability of this scale is debatable because cultural differences
TABLE 120.1 Overview of Patient Reported Outcome Measures and the Domains of Assessment Symptoms/ Pain
Function Activities of Daily Living
Function Sport and/or Recreation Activity Scale
Quality of Life
Return to Sport Type Score
International Knee Documentation Committee Subjective Knee Form (IKDC subjective) Knee Injury Osteoarthritis Outcome Score (KOOS) Lysholm score Tegner activity score Cincinnati knee rating system
x
x
x
—
—
—
Total score
x
x
x
—
x
—
x — x
x — x
— — x
x x
— — —
— — —
Marx activity rating scale Anterior cruciate ligament—Quality of life (ACL-QOL) Anterior Cruciate Ligament—Return to Sport after Injury (ACL-RSI)
— x
— x
— x
— x
— —
Score per subscales Total score 1 score Score per subscales Total score Total score
x
Total score
Patient Reported Outcome Measure
x
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TABLE 120.2 Properties of the Patient Reported Outcome Measures
CHAPTER 120 A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients
Patient Reported Outcome Measures
Developed by
Number of Questions
Available in the Following Languages*
Developed for Following Population
Irrgang et al. (2001)4
n = 18
19 languages§5
Roos et al. (1998)8
Total, n = 42 Pain, n = 9 Symptoms, n = 7 ADL, n = 17 Sport/ Rec., n = 5 QOL, n = 4
49 languages**9 Short- and long-term consequences after traumatic knee injuries (ACL-, meniscus-, and chondral injuries); post-traumatic knee OA.
Lysholm et al. (1982)10
n=8
English11 German12 Turkish13 Dutch59 Chinese60
Tegner activity Scale Tegner et al. (1985)14
n=1
English11 German15 Persian16 Dutch59 Chinese61
Cincinnati knee rating system
Noyes et al. (1983)17,18
Marx activity rating scale Anterior cruciate ligament—Quality of life(ACL-QOL) Anterior cruciate ligament—Return to Sport after Injury(ACL-RSI)
Marx et al. (2001)20 Mohtadi et al. (1998)21
English19 Total, n = 13 Symptoms, n = 4 Overall condition of the knee, n = 1 Daily living functional scales, n = 3 Sport activities function scale, n = 3 Sports activity scale, n = 1 Occupational scale, n=1 English20 n=4 Persian16 English21 n = 32 Turkish22
International Knee Documentation Committee Subjective Knee Form (IKDC subjective) Knee Injury Osteoarthritis Outcome Score (KOOS)
Variety of knee problems (ligament and meniscal injuries, articular cartilage lesions, and patellofemoral pain)
Lysholm score
Webster et al. (2008)23
n = 12
English23 French24 Swedish25
Initially as physician administration for ACL and meniscal injuries. To date as patient administration for variety of knee problems (acute patellar dislocation, chondral injuries, meniscal- and ACL injuries). Initially as physician administration for ACL and meniscus injuries. To date as patient administration for variety of knee problems (acute patellar dislocation, chondral injuries, meniscaland ACL injuries). Variety of knee operations (ACL, PCL, MCL, LCL, and posterolateral injuries, meniscal injury, high tibial osteotomy
Assessment Validity According to COSMIN Irrgang et al. (2001)4: Yes Irrgang et al. van Meer et al. (2013)6: (2001)4: Yes No van Meer et al. (2013)6: Yes Roos et al. Pain (1998)8: No Roos et al. (1998)8: Yes van Meer et al. (2013)6: No van Meer et al. (2013)6: Yes Symptoms Roos et al. (1998)8: Yes van Meer et al. (2013)6: No ADL Roos et al. (1998)8: Yes van Meer et al. (2013)6: No Sport/Rec. Roos et al. (1998)8: Yes van Meer et al. (2013)6:Yes QOL Roos et al. (1998)8: Yes van Meer et al. (2013)6: No Yes No
Yes
No
Yes
No
Variety of knee disorders.
Yes
No
ACL injury
NA
NA
ACL injury
Yes
No
*Availability of the patient reported outcome measures (PROMs) in different languages is shown if there is an online link or if it has a Medline registration. Because some translation/validity studies are not published, it is possible that the PROMs in some other languages, which are not presented in in this table, are available. †Presence of predefined hypotheses concerning the direction and magnitude of the correlation coefficients. ‡Presence of assessment of test-retest reliability (ICC) and assessment of measurement error. §Brazilian,26 simplified Chinese (People’s Republic of China, Singapore), traditional Chinese (Taiwan, Hong Kong),27 Czech, Dutch.6,28 English (UK), English (US),4 French, German, Greek, Italian,29 Japanese, Korean,30 Norwegian, Polish,31 Spanish, Swedish,62 Thai,32 Turkish.33 **Arabic (Egypt), Arabic (Saudi Arabia), Austria-German, Bengali (India), Czech, Chinese (Hong Kong), Chinese (Singapore), Croatian, Danish, Dutch, Estonian, English, Filipino (Philippines), French, German, Greek, Hindi (India), Icelandic, Italian, Japanese, Kannada (India), Korean, Latvian, Lithuanian, Malayalam (India), Malay, Marathi (India), Norwegian, Persian, Portuguese, Portuguese (Brazil), Polish, Romanian, Russian, Singapore English, Slovakian, Slovenian, Spanish, Spanish (US), Spanish (Peru), Swedish, Tamil (India), Telugu (India), Thai, Turkish, Ukrainian, Urdu (India), Vietnamese, Zulu. ††The development of the anterior cruciate ligament—quality of life and item reductions was done in an anterior cruciate ligament injured population. ‡‡Assessment of clinimetric properties in the translation and validation study by Kvist et al.25 ACL, Anterior cruciate ligament; ADL, activities of daily living; COSMIN, consensus-based standards for the selection of health status measurement instruments; LCL, lateral collateral ligament; MCL, medial collateral ligament; NA, not applicable; PCL, posterior cruciate ligament; QOL, quality of life; RSI, return to sport after injury.
Assessment Responsiveness
Presence of Floor and Ceiling Effects
Validation in Anterior Cruciate Ligament Patients or Anterior Cruciate Ligament Patients Part of the Study Group (Yes / No)
According to COSMIN‡
—
—
Irrgang et al. (2001)4: Yes van Meer et al. (2013)6: Yes
Irrgang et al. (2001)4: Yes No van Meer et al. (2013)6: No
Assessment Reliability
—
According to COSMIN†
Irrgang et al. (2006)7: Yes van Meer et al. (2013)6: Yes
Irrgang et al. (2006)7: Irrgang et al. (2001)4: Yes No van Meer et al. (2013)6: Yes van Meer et al. (2013)6: Yes
—
Roos et al. 19988: No Pain van Meer et al. 20136: Yes Roos et al. (1998)8: Yes van Meer et al. (2013)6: No Symptoms Roos et al. (1998)8: Yes van Meer et al. (2013)6: No ADL Roos et al. (1998)8: Yes van Meer et al. (2013)6: No Sport/Rec. Roos et al. (1998)8: Yes van Meer et al. (2013)6:No QOL Roos et al. (1998)8: Yes van Meer et al. (2013)6: No
Pain Roos et al. (1998)8: Yes van Meer et al. (2013)6: Yes Symptoms Roos et al. (1998)8: Yes van Meer et al. (2013)6: Yes ADL Roos et al. (1998)8: Yes van Meer et al. (2013)6: Yes Sport/Rec. Roos et al. (1998)8: Yes van Meer et al. (2013)6:Yes QOL Roos et al. (1998)8: Yes van Meer et al. (2013)6: Yes
Roos et al. (1998)8: No van Meer et al. (2013)6: Yes
Roos et al. (1998)8: Yes NA van Meer et al. (2013)6: Pain Yes (Ceiling) Symptoms No ADL Yes (ceiling) Sport/Rec. No QOL No
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
No
NA
Yes
NA
NA
Yes
No
NA
Yes
NA
NA
NA
NA
NA
Yes††
NA
NA
Yes
Yes
No
Yes‡‡
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determine which sports are widely practiced in different countries. Therefore validation in different languages is important.
Cincinnati Knee Rating System The first version of the Cincinnati Knee Rating System was published in 1983.17,18 Modifications and additional scales were added for occupational activities, athletic activities, symptoms, and functional limitations regarding daily activities and sports.39,40 The Cincinnati Knee Rating System has been used for evaluation of different knee related operations, such as knee ligament reconstructions (ACL, posterior cruciate ligament [PCL], medial collateral ligament [MCL], lateral and posterolateral ligaments), meniscal repairs, and for high tibial osteotomy. In 1999 the Cincinnati Knee Rating System was validated in patients after ACL reconstruction.19 This rating system consists of 13 scales in different domains: 1. Four symptoms rating scales (pain, swelling, partial giving way, and full giving way); a minimal score of 0 represents severe symptoms and maximal score of 10 represents a normal knee. 2. A patient perception rating scale of the overall condition of the knee; a minimal score is 1 and maximal score is 10, representing normal/ excellent condition of the knee. 3. Three ADL function scales (walking, stair climbing, and squatting); it is scored on a scale of 0–40, in which 40 represents normal/unlimited. 4. Three sports activities function scales (running, jumping, and twisting/cutting/pivoting), with a score between 40 (not able to do) and 100 (fully competitive). 5. A sports activity scale; the scale is based on frequency of participation in sports and specific knee function. Frequency of participation is assessed on four levels: level I sports (participation in sports 4–7 days/week), level II sports (participation 1–3 days/week), level III sports (participation 1–3 times/ month), and level IV (no sports). Each level is categorized by specific knee function: category 1 represents jumping, hard pivoting, and cutting; category 2 represents running, twisting, and turning; and category 3 represents no running, twisting, or jumping (e.g., cycling, swimming). The total scale ranges from 0 (level IV activities with severe problems) to 100 (level I pivoting sports).19 Regarding clinimetric properties, there is adequate evidence only for reliability.41 6. An occupational rating scale; the severity of work is divided into six factors ranging from sitting to lifting/carrying. Besides this, the amount of hours per day performing the work and amount of pounds carried is scored. The overall ratings scale of the Cincinnati Knee Rating System will not be discussed, because objective measurements, such as functional and stability tests and assessment of radiographs, are also included in the overall rating scale. In the past years the Cincinnati Knee Rating System is further modified by others with a range of score between 6 and 100 (best function). This modified version provided similar results as the IDC subjective in a population with complex knee disorders.42
Marx Activity Rating Scale The Marx Activity Rating Scale is based on specific knee functions and frequency of participation. Each of four knee functions (running, cutting, decelerating, and pivoting) are rated on a fivepoint scale of frequency (<1 time in a month, 1 time/month, 1 time in a week, 2 or 3 times in a week, or 4 or more times a week) and scored between 0 and 4. The scale is scored by adding the scores to give a total out of a possible 16 points, with a higher score indicating more frequent participation.20 Regarding clinimetric properties there is adequate evidence for reliability and validity; however, responsiveness was not studied.41
Anterior Cruciate Ligament—Quality of Life The ACL-QOL was published in 1998 and developed as a QOL measure in chronic ACL deficient patients.21 The score comprises 32 items in five domains: symptoms and physical complaints (5 items), work-related concerns (4 items), recreational activities and sport participation or competition (12 items), related to lifestyle (6 items), and social and emotional function (5 items). Each item is assessed using a visual analogue scale. The raw score is transformed to a 0- to 100-point scale, with each item weighted equally.
Anterior Cruciate Ligament—Return to Sport After Injury The ACL—Return to Sport After Injury (RSI) measure was published in 2008. The rationale for the development of this PROM was the low rate of returning to sports after ACL reconstruction and no available scales that measured the athlete’s emotions, confidence, and risk appraisal. These domains might be important among athletes for returning to sport.23 The scale consists of three domains: Emotions (5 items), Confidence in Performance (5 items), and Risk Appraisal (2 items). For scoring each item, a 10 cm visual analogue scale is used with the description of “extremely” and “not at all” at the opposite ends. All raw scores are converted to a 0 (extremely negative psychological responses) to 100 (no negative psychological responses) scale. For a single score of the ACLRSI scale, all 12 items are summed and averaged.
Miscellaneous The Knee Outcome Survey—Activities of Daily Living Scale (KOS-ADLS) is a knee-specific PROM measuring functional limitation experienced by patients with a wide variety of knee disorders.43 There are more newly constructed PROMs. However, there are no sufficient studies available for assessment of these PROMs. The Knee Self-Efficacy Scale (K-SES) was developed in 2006 for measuring perceived self-efficacy in patients with an ACL injury.44 In 2013 the Knee Numeric-Entity Evaluation Score (KNEES-ACL) was developed. The KNEES-ACL is a newly constructed PROM created specifically for patients pre- and post-ACL reconstruction, for use in longitudinal clinical studies. It measures the following constructs: symptoms, activity, and psychosocial consequences in patients with ACL deficiency, and after nonoperative or operative treatment.45,46
GENDER DIFFERENCES The literature is contradictory regarding the influence of gender on patient-reported outcomes after ACL injury.6,47,48 A recently published systematic review and meta-analysis showed that subjective outcomes and functional scores including the Lysholm score, Tegner Activity Scale, and Ability to Return to Sports were poorer in females.49 However, validation studies of PROMs do not distinguish between male and female gender. Thus for clinical research our advice would be to analyze if patient gender has an effect on the scores of the PROMs.
PATIENT REPORTED OUTCOME MEASURES IN CHILDREN It seems that the incidence of ACL injury increases in children and adolescents. To date, there is no consensus on the optimal treatment strategy of ACL injuries in immature skeletal children.50–53 For monitoring pediatric ACL patients, PROMs are also important measures for evaluating the patient’s perception of their knee function, sports-related, and knee-related QOL. Original PROMs may not be appropriate in children; therefore
CHAPTER 120 A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients
existing PROMs should be modified and validated in children. Two knee-specific PROMs were modified and validated in children with knee injuries: KOOS-Child9,54,55 and IKDC Subjective Knee Evaluation Form in Children.5,56 Recently, an activity rating scale for athletically active children and adolescents (aged between 10 and 18 years) was developed for assessment of activity: The Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS).57 This eightitem scale showed good clinimetric properties and could be used in clinical outcome studies in the field of orthopaedic surgery, sports medicine, and rehabilitation. However, this scale is not sport or joint specific.
CONCLUSION PROMs are important and valuable for monitoring patients after ACL injury. For assessment of patients’ perception of the knee after ACL injury we recommend using the IKDC subjective for short-term follow-up and the KOOS for long-term follow-up.6 To evaluate the activity level of patients after ACL injury, our advice is to use the best available and in Europe the frequently used Tegner activity score, although we have noticed that the Marx activity rating scale is frequently used in the United States. Online registration of monthly sports participations showed promising results for a detailed overview of changes in sport participation after ACL injury.58 This kind of activity registration might be valuable for collecting detailed data of sports participation after ACL injury in longitudinal studies. SELECTED READINGS
Barber-Westin SD, Noyes FR, McCloskey JW. Rigorous statistical reliability, validity, and responsiveness testing of the Cincinnati knee rating system in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed knees. Am J Sports Med. 1999;27:402–416. Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kocher MS, Steadman JR. The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med. 2009;37:890–897.
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Irrgang JJ, Anderson AF, Boland AL, et al. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001;29:600–613. Knee Injury and Osteoarthritis Outcome Score (KOOS).; 2015. Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am J Sports Med. 2001;29:213–218. Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med. 1998;26:350–359. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010;63:737–745. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee injury and osteoarthritis outcome score (KOOS)—development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;28: 88–96. Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985;198:43–49. Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60:34–42. The American Orthopaedic Sociaty for Sports Medicine. IKDC forms.
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22. Kinikli GI, Celik D, Yuksel I, Atay OA. Turkish version of the anterior cruciate ligament quality of life questionnaire. Knee Surg Sports Traumatol Arthrosc. 2015;23:2367–2375. 23. Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008;9:9–15. 24. Bohu Y, Klouche S, Lefevre N, Webster K, Herman S. Translation, cross-cultural adaptation and validation of the French version of the anterior cruciate ligament-return to sport after injury (ACL-RSI) scale. Knee Surg Sports Traumatol Arthrosc. 2015;23:1192–1196. 25. Kvist J, Osterberg A, Gauffin H, Tagesson S, Webster K, Ardern C. Translation and measurement properties of the Swedish version of ACL-return to sports after injury questionnaire. Scand J Med Sci Sports. 2013;23:568–575. 26. Metsavaht L, Leporace G, Riberto M, de Mello Sposito MM, Batista LA. Translation and cross-cultural adaptation of the Brazilian version of the International Knee Documentation Committee Subjective Knee Form: validity and reproducibility. Am J Sports Med. 2010;38:1894–1899. 27. Fu SN, Chan YH. Translation and validation of Chinese version of International Knee Documentation Committee Subjective Knee Form. Disabil Rehabil. 2011;33:1186–1189. 28. Haverkamp D, Sierevelt IN, Breugem SJ, Lohuis K, Blankevoort L, van Dijk CN. Translation and validation of the Dutch version of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006;34:1680–1684. 29. Padua R, Bondi R, Ceccarelli E, et al. Italian version of the International Knee Documentation Committee Subjective Knee Form: crosscultural adaptation and validation. Arthroscopy. 2004;20:819–823. 30. Kim JG, Ha JK, Lee JY, Seo SS, Choi CH, Lee MC. Translation and validation of the Korean version of the international knee documentation committee subjective knee form. Knee Surg Relat Res. 2013;25:106–111. 31. Piontek T, Ciemniewska-Gorzela K, Naczk J, Cichy K, Szulc A. Linguistic and cultural adaptation into Polish of the IKDC 2000 subjective knee evaluation form and the Lysholm scale. Pol Orthop Traumatol. 2012;77:115–119. 32. Lertwanich P, Praphruetkit T, Keyurapan E, Lamsam C, Kulthanan T. Validity and reliability of Thai version of the International Knee Documentation Committee Subjective Knee Form. J Med Assoc Thai. 2008;91:1218–1225. 33. Celik D, Coskunsu D, KiliCoglu O, Ergonul O, Irrgang JJ. Translation and cross-cultural adaptation of the international knee documentation committee subjective knee form into Turkish. J Orthop Sports Phys Ther. 2014;44:899–909. 34. Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS)—validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003;1:17. 35. Roos EM, Roos HP, Lohmander LS. WOMAC Osteoarthritis Index—additional dimensions for use in subjects with post-traumatic osteoarthritis of the knee. Western Ontario and MacMaster Universities. Osteoarthritis Cartilage. 1999;7:216–221. 36. Kocher MS, Steadman JR, Briggs KK, Sterett WI, Hawkins RJ. Reliability, validity, and responsiveness of the Lysholm knee scale for various chondral disorders of the knee. J Bone Joint Surg Am. 2004;86-A:1139–1145. 37. Briggs KK, Kocher MS, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am. 2006;88:698–705. 38. Paxton EW, Fithian DC, Stone ML, Silva P. The reliability and validity of knee-specific and general health instruments in assessing acute patellar dislocation outcomes. Am J Sports Med. 2003;31:487– 492. 39. Noyes FR, Mooar LA, Barber SD. The assessment of work-related activities and limitations in knee disorders. Am J Sports Med. 1991;19:178–188. 40. Noyes FR, Barber SD, Mooar LA. A rationale for assessing sports activity levels and limitations in knee disorders. Clin Orthop Relat Res. 1989:238–249. 41. Letchford R, Button K, Sparkes V, van Deursen RWM. Assessing activity participation in the ACL injured population: a systematic review of activity rating scale measurement properties. Phys Ther Rev. 2012;17:99–109.
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42. Agel J, LaPrade RF. Assessment of differences between the modified Cincinnati and International Knee Documentation Committee patient outcome scores: a prospective study. Am J Sports Med. 2009; 37:2151–2157. 43. 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;80:1132–1145. 44. Thomee P, Wahrborg P, Borjesson M, Thomee R, Eriksson BI, Karlsson J. A new instrument for measuring self-efficacy in patients with an anterior cruciate ligament injury. Scand J Med Sci Sports. 2006;16:181–187. 45. Comins JD, Krogsgaard MR, Brodersen J. Development of the Knee Numeric-Entity Evaluation Score (KNEES-ACL): a condition-specific questionnaire. Scand J Med Sci Sports. 2013;23:e293–e301. 46. Comins JD, Krogsgaard MR, Kreiner S, Brodersen J. Dimensionality of the Knee Numeric-Entity Evaluation Score (KNEES-ACL): a condition-specific questionnaire. Scand J Med Sci Sports. 2013; 23:e302–e312. 47. Ryan J, Magnussen RA, Cox CL, Hurbanek JG, Flanigan DC, Kaeding CC. ACL reconstruction: do outcomes differ by sex? A systematic review. J Bone Joint Surg Am. 2014;96:507–512. 48. Ageberg E, Forssblad M, Herbertsson P, Roos EM. Sex differences in patient-reported outcomes after anterior cruciate ligament reconstruction: data from the Swedish knee ligament register. Am J Sports Med. 2010;38:1334–1342. 49. Tan SH, Lau BP, Khin LW, Lingaraj K. The importance of patient sex in the outcomes of anterior cruciate ligament reconstructions: a systematic review and meta-analysis. Am J Sports Med. 2016;44: 242–254. 50. Moksnes H, Engebretsen L, Risberg MA. The current evidence for treatment of ACL injuries in children is low: a systematic review. J Bone Joint Surg Am. 2012;94:1112–1119. 51. Mohtadi N, Grant J. Managing anterior cruciate ligament deficiency in the skeletally immature individual: a systematic review of the literature. Clin J Sport Med. 2006;16:457–464. 52. Moksnes H, Engebretsen L, Eitzen I, Risberg MA. Functional outcomes following a non-operative treatment algorithm for anterior cruciate ligament injuries in skeletally immature children 12 years and younger. A prospective cohort with 2 years follow-up. Br J Sports Med. 2013;47:488–494.
53. Ramski DE, Kanj WW, Franklin CC, Baldwin KD, Ganley TJ. Anterior cruciate ligament tears in children and adolescents: a metaanalysis of nonoperative versus operative treatment. Am J Sports Med. 2014;42:2769–2776. 54. Ortqvist M, Roos EM, Brostrom EW, Janarv PM, Iversen MD. Development of the Knee Injury and Osteoarthritis Outcome Score for children (KOOS-Child): comprehensibility and content validity. Acta Orthopaedica. 2012;83:666–673. 55. Ortqvist M, Iversen MD, Janarv PM, Brostrom EW, Roos EM. Psychometric properties of the Knee injury and Osteoarthritis Outcome Score for Children (KOOS-Child) in children with knee disorders. Br J Sports Med. 2014;48:1437–1446. 56. Iversen MD, Lee B, Connell P, Andersen J, Anderson AF, Kocher MS. Validity and comprehensibility of the International Knee Documentation Committee Subjective Knee Evaluation form in Children. Scand J Med Sci Sports. 2010;20:e87–e95. 57. Fabricant PD, Robles A, Downey-Zayas T, et al. Development and validation of a pediatric sports activity rating scale: the Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS PediFABS). Am J Sports Med. 2013;41:2421–2429. 58. Grindem H, Eitzen I, Snyder-Mackler L, Risberg MA. Online registration of monthly sports participation after anterior cruciate ligament injury: a reliability and validity study. Br J Sports Med. 2014;48:748–753. 59. Eshuis R, Lentjes GW, Tegner Y, Wolterbeek N, Veen MR. Dutch translation and cross-cultural adaptation of the Lysholm Score and Tegner Activity Scale for patients with anterior cruciate ligament injuries. J Orthop Sports Phys Ther. 2016;46(11):976–983. 60. Wang W, Liu L, Chang X, Jia ZY, Zhao JZ, Xu WD. Cross-cultural translation of the Lysholm knee score in Chinese and its validation in patients with anterior cruciate ligament injury. BMC Musculoskelet Disord. 2016;17(1):436. 61. Huang H, Zhang D, Jiang Y, Yang J, Feng T, Gong X, Wang J, Ao Y. Translation, validation and cross-cultural adaptation of a simplifiedChinese version of the Tegner activity score in Chinese patients with anterior cruciate ligament injury. PLoS One. 2016;11(5):e0155463. 62. Tigerstrand Grevnerts H, Gravare Silbernagel K, Sonesson S, Ardern C, Osterberg A, Gauffin H, Kvist J. Translation and testing of measurement properties of the Swedich version of the IKDC subjective knee form. Scand J Med Sci Sports. 2017 Feb 16. doi: 10.1111/ sms.12861. [Epub ahead of print].
SECTION XXIV Outcomes After Anterior Cruciate Ligament Reconstruction
Lynch TS, Cole BJ, Ahmad CS. The role of functional sports assessment in the return to sport after ACL reconstruction. Sports Medicine Weekly. Jan/Feb 2015. Page 5–6. Mascarenhas R, Erickson BJ, Sayegh ET, et al. Is there a higher failure rate of allografts compared with autografts in anterior cruciate ligament reconstruction: a systematic review of overlapping meta-analyses. Arthroscopy. 2015;31(2):364–372. Myer GD, Paterno MV, Ford KR, Quatman CE, Hewett TE. Rehabilitation after anterior cruciate ligament reconstruction: criteria-based progression through the return-to-sport phase. J Orthop Sports Phys Ther. 2006;36(6):385–402.
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Risberg MA, Holm I. The long-term effect of 2 postoperative rehabilitation programs after anterior cruciate ligament reconstruction: a randomized controlled clinical trial with 2 years of follow-up. Am J Sports Med. 2009;37(10):1958–1966. Shelbourne KD, Patel DV. Timing of surgery in anterior cruciate ligament-injured knees. Knee Surg Sports Traumatol Arthrosc. 1995;3(3):148–156.
A complete reference list can be found online at ExpertConsult.com.
A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients Belle L. van Meer, MD, PhD, Duncan E. Meuffels, MD, PhD, Max Reijman, PhD
INTRODUCTION It is important to monitor patients after anterior cruciate ligament (ACL) injury over time to evaluate their recovery after nonoperative or operative treatment so that the rehabilitation program can be monitored and adjusted if necessary. Furthermore, monitoring is essential to determine the effectiveness of different interventions during clinical studies. Mid- and long-term evaluation is also important for assessing the mid- and long-term consequences after an ACL rupture, and these outcomes can be used for development of new treatment strategies. One way to monitor a patient’s recovery is periodic assessment by the treating physician, including a physical examination that incorporates range of motion and stability tests of the knee. However, it is equally important to record the patient’s perception of the knee during daily living and sports activities. This can be done using self-administered patient reported outcome measures (PROMs) that ask about complaints and symptoms, how the knee functions during daily activities and sports, and quality of life (QOL). PROMs can be used for different purposes: as feedback for the patient self, for the clinician to identify which patient experiences improved or deteriorated health outcome over time, in clinical research, and as an indicator in healthcare systems for assessing the performance of hospitals and clinics. The PROMs should be relevant for patients with ACL rupture or reconstruction and should cover the whole domain of symptoms and complaints specific for this group. In the acute phase, pain and functional limitations are the main complaints, followed by knee instability and limitations in sport and leisure participation. For monitoring patient’s perception of the long-term consequences after ACL rupture, the domain of knee osteoarthritis (OA) should be assessed. Furthermore, the PROM should be reliable—that is, it should evoke similar answers on repeated measurements if the complaints and symptoms do not alter. Finally, if the complaints change over time, the PROM should be able to detect these changes over time. Therefore the following properties of a PROM are important: 1. The PROM should be validated in the population of interest. The domain validity consists of three measurement properties: content validity, construct validity, and criterion validity.1
a. Content validity evaluates the degree to which the content of a PROM is relevant and comprehensive for patients with ACL rupture.1,2 Content validity should be assessed by the target population and by experts of the field. b. Construct validity evaluates the degree to which the scores of a PROM are consistent with predefined hypotheses based on the assumptions that the PROM validly measures the construct to be measured. Predefined hypotheses are tested about expected direction and magnitude of the correlation coefficients between the PROM and other test scores. In other words, does the PROM assess the specific symptoms and complaints of a patient with an ACL rupture? An aspect of construct validity is cross-cultural validity; this should only be assessed for translated PROMs.1,2 c. Criterion validity evaluates the degree to which the scores of a PROM adequately relate to a “gold standard.” This is not applicable to PROMs of constructs for which no “gold standard” test exists. Criterion validity can be used when testing a short-form version of a PROM against the original version.1,2 2. The test should be reliable. The reliability should be evaluated by the test-retest reliability and measurement error. The test-retest reliability assesses if the PROM provides similar answers on repeated measurements under the assumption that the symptoms and complaints are similar. Intraclass correlation coefficient (ICC) is commonly reported, and the reliability is considered to be good if the ICC is at least 0.70. Measurement error should be assessed to determine the agreement between repeated measurements in one patient. This is the systematic and random error of a patient’s score that is not attributed to true changes.1,2 3. The PROM should be able to detect changes over time; this is called responsiveness. It can be considered as the validity of the change scores of the PROM over time, or as longitudinal construct validity. Predefined hypotheses should be tested concerning the magnitude and direction of the correlation coefficients between the PROM change scores and the anchor question (the change according to the patient’s own experience) and between the PROM change scores and change
CHAPTER 120 A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients
scores of other tests, which measure the same construct. Furthermore, hypotheses about the expected effect size could be formulated.1–3 4. Evaluation of the presence of floor (minimal score) and ceiling (maximal score) effects at baseline are also important because they can influence the content validity and responsiveness. Floor and ceiling effects were considered present if more than 15% of the patients achieved the minimal or maximal score.2
PATIENT REPORTED OUTCOME MEASURES There are many generic PROMs of health status; however, these will not be discussed in this chapter. The focus of this chapter lies on ACL specific PROMs. Table 120.1 shows an overview of frequently used PROMs in ACL injured patients, with the different domains intended to be measured. We have ordered them as frequently used in literature, as we have perceived at present. Table 120.2 shows an overview of the PROMs and their properties. The measurement properties were evaluated, and it is shown for which PROM the measurement properties were assessed according the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) criteria.1,3
International Knee Documentation Committee Subjective Knee Form The International Knee Documentation Committee (IKDC) subjective is a knee-specific instrument, developed to measure symptoms, function, and sport activities in patients with a variety of knee problems. The IKDC subjective has been validated in patients who visited orthopaedic sports medicine practices with the preceding injuries.4 The IKDC subjective has also been validated in a specific population of ACL injured patients.6 This PROM consists of 18 items and is scored by summing the scores of the individual items (raw score) and then transforming the summed score to a scale ranging from 0 to 100. Higher scores represent lower levels of symptoms, and higher levels of function and participation in sports activity.
Knee Injury and Osteoarthritis Outcome Score The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument developed to evaluate functioning in daily living, sport, and recreation, as well as the knee-related QOL in patients with knee injuries who are at risk of OA developing (ACL, meniscus, or chondral injury). This questionnaire
485
is intended to monitor the short- and long-term consequences (i.e., OA) of these injuries.8 It has been validated in several populations—for example, patients after ACL injury,6,8 total knee arthroplasty,34 and meniscectomy.35 The KOOS has five subscales, each scored separately: Pain (9 items), Symptoms (7 items), Activities of Daily Living (ADL; 17 items), Sport and Recreation Function (Sport/Rec; 5 items), and knee-related QOL (4 items). All items are scored 0–4; for each subscale the scores are transformed to a 0–100 scale (0 representing extreme knee problems and 100 representing no knee problems). A validation study during short-term follow-up after ACL injury showed that the subscales Pain and Activities of Daily Living were assessed as nonrelevant; only the subscale Sport and Recreation Function had acceptable construct validity, and none of the subscales had sufficient score for responsiveness.6 However, these clinimetric properties were assessed in patients with recent ACL ruptures and those in the first year after ACL reconstruction.
Lysholm Rating Scale The Lysholm scale was initially designed for physician administration and was validated in patients with ACL injuries and meniscal injuries.10,14 It has also been validated as a patientadministered instrument to measure symptoms and function in patients with a variety of knee injuries.11,36–38,59 The Lysholm scale does measure the domains of symptoms and complaints and does measure functioning in daily activities slightly, but does not measure the domain of functioning in sports and recreational activities. This scale consists of eight items. It is scored on a scale of 0 to 100, with higher scores indicating fewer symptoms and higher levels of functioning.
Tegner Activity Score The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries.14 To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. However, few studies documented the clinimetric properties of this score.11,37,38,59 The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. A disadvantage of this score is that the scale is related to sports instead of functional activities. Thus the generalizability of this scale is debatable because cultural differences
TABLE 120.1 Overview of Patient Reported Outcome Measures and the Domains of Assessment Symptoms/ Pain
Function Activities of Daily Living
Function Sport and/or Recreation Activity Scale
Quality of Life
Return to Sport Type Score
International Knee Documentation Committee Subjective Knee Form (IKDC subjective) Knee Injury Osteoarthritis Outcome Score (KOOS) Lysholm score Tegner activity score Cincinnati knee rating system
x
x
x
—
—
—
Total score
x
x
x
—
x
—
x — x
x — x
— — x
x x
— — —
— — —
Marx activity rating scale Anterior cruciate ligament—Quality of life (ACL-QOL) Anterior Cruciate Ligament—Return to Sport after Injury (ACL-RSI)
— x
— x
— x
— x
— —
Score per subscales Total score 1 score Score per subscales Total score Total score
x
Total score
Patient Reported Outcome Measure
x
120
TABLE 120.2 Properties of the Patient Reported Outcome Measures
CHAPTER 120 A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients
Patient Reported Outcome Measures
Developed by
Number of Questions
Available in the Following Languages*
Developed for Following Population
Irrgang et al. (2001)4
n = 18
19 languages§5
Roos et al. (1998)8
Total, n = 42 Pain, n = 9 Symptoms, n = 7 ADL, n = 17 Sport/ Rec., n = 5 QOL, n = 4
49 languages**9 Short- and long-term consequences after traumatic knee injuries (ACL-, meniscus-, and chondral injuries); post-traumatic knee OA.
Lysholm et al. (1982)10
n=8
English11 German12 Turkish13 Dutch59 Chinese60
Tegner activity Scale Tegner et al. (1985)14
n=1
English11 German15 Persian16 Dutch59 Chinese61
Cincinnati knee rating system
Noyes et al. (1983)17,18
Marx activity rating scale Anterior cruciate ligament—Quality of life(ACL-QOL) Anterior cruciate ligament—Return to Sport after Injury(ACL-RSI)
Marx et al. (2001)20 Mohtadi et al. (1998)21
English19 Total, n = 13 Symptoms, n = 4 Overall condition of the knee, n = 1 Daily living functional scales, n = 3 Sport activities function scale, n = 3 Sports activity scale, n = 1 Occupational scale, n=1 English20 n=4 Persian16 English21 n = 32 Turkish22
International Knee Documentation Committee Subjective Knee Form (IKDC subjective) Knee Injury Osteoarthritis Outcome Score (KOOS)
Variety of knee problems (ligament and meniscal injuries, articular cartilage lesions, and patellofemoral pain)
Lysholm score
Webster et al. (2008)23
n = 12
English23 French24 Swedish25
Initially as physician administration for ACL and meniscal injuries. To date as patient administration for variety of knee problems (acute patellar dislocation, chondral injuries, meniscal- and ACL injuries). Initially as physician administration for ACL and meniscus injuries. To date as patient administration for variety of knee problems (acute patellar dislocation, chondral injuries, meniscaland ACL injuries). Variety of knee operations (ACL, PCL, MCL, LCL, and posterolateral injuries, meniscal injury, high tibial osteotomy
Assessment Validity According to COSMIN Irrgang et al. (2001)4: Yes Irrgang et al. van Meer et al. (2013)6: (2001)4: Yes No van Meer et al. (2013)6: Yes Roos et al. Pain (1998)8: No Roos et al. (1998)8: Yes van Meer et al. (2013)6: No van Meer et al. (2013)6: Yes Symptoms Roos et al. (1998)8: Yes van Meer et al. (2013)6: No ADL Roos et al. (1998)8: Yes van Meer et al. (2013)6: No Sport/Rec. Roos et al. (1998)8: Yes van Meer et al. (2013)6:Yes QOL Roos et al. (1998)8: Yes van Meer et al. (2013)6: No Yes No
Yes
No
Yes
No
Variety of knee disorders.
Yes
No
ACL injury
NA
NA
ACL injury
Yes
No
*Availability of the patient reported outcome measures (PROMs) in different languages is shown if there is an online link or if it has a Medline registration. Because some translation/validity studies are not published, it is possible that the PROMs in some other languages, which are not presented in in this table, are available. †Presence of predefined hypotheses concerning the direction and magnitude of the correlation coefficients. ‡Presence of assessment of test-retest reliability (ICC) and assessment of measurement error. §Brazilian,26 simplified Chinese (People’s Republic of China, Singapore), traditional Chinese (Taiwan, Hong Kong),27 Czech, Dutch.6,28 English (UK), English (US),4 French, German, Greek, Italian,29 Japanese, Korean,30 Norwegian, Polish,31 Spanish, Swedish,62 Thai,32 Turkish.33 **Arabic (Egypt), Arabic (Saudi Arabia), Austria-German, Bengali (India), Czech, Chinese (Hong Kong), Chinese (Singapore), Croatian, Danish, Dutch, Estonian, English, Filipino (Philippines), French, German, Greek, Hindi (India), Icelandic, Italian, Japanese, Kannada (India), Korean, Latvian, Lithuanian, Malayalam (India), Malay, Marathi (India), Norwegian, Persian, Portuguese, Portuguese (Brazil), Polish, Romanian, Russian, Singapore English, Slovakian, Slovenian, Spanish, Spanish (US), Spanish (Peru), Swedish, Tamil (India), Telugu (India), Thai, Turkish, Ukrainian, Urdu (India), Vietnamese, Zulu. ††The development of the anterior cruciate ligament—quality of life and item reductions was done in an anterior cruciate ligament injured population. ‡‡Assessment of clinimetric properties in the translation and validation study by Kvist et al.25 ACL, Anterior cruciate ligament; ADL, activities of daily living; COSMIN, consensus-based standards for the selection of health status measurement instruments; LCL, lateral collateral ligament; MCL, medial collateral ligament; NA, not applicable; PCL, posterior cruciate ligament; QOL, quality of life; RSI, return to sport after injury.
Assessment Responsiveness
Presence of Floor and Ceiling Effects
Validation in Anterior Cruciate Ligament Patients or Anterior Cruciate Ligament Patients Part of the Study Group (Yes / No)
According to COSMIN‡
—
—
Irrgang et al. (2001)4: Yes van Meer et al. (2013)6: Yes
Irrgang et al. (2001)4: Yes No van Meer et al. (2013)6: No
Assessment Reliability
—
According to COSMIN†
Irrgang et al. (2006)7: Yes van Meer et al. (2013)6: Yes
Irrgang et al. (2006)7: Irrgang et al. (2001)4: Yes No van Meer et al. (2013)6: Yes van Meer et al. (2013)6: Yes
—
Roos et al. 19988: No Pain van Meer et al. 20136: Yes Roos et al. (1998)8: Yes van Meer et al. (2013)6: No Symptoms Roos et al. (1998)8: Yes van Meer et al. (2013)6: No ADL Roos et al. (1998)8: Yes van Meer et al. (2013)6: No Sport/Rec. Roos et al. (1998)8: Yes van Meer et al. (2013)6:No QOL Roos et al. (1998)8: Yes van Meer et al. (2013)6: No
Pain Roos et al. (1998)8: Yes van Meer et al. (2013)6: Yes Symptoms Roos et al. (1998)8: Yes van Meer et al. (2013)6: Yes ADL Roos et al. (1998)8: Yes van Meer et al. (2013)6: Yes Sport/Rec. Roos et al. (1998)8: Yes van Meer et al. (2013)6:Yes QOL Roos et al. (1998)8: Yes van Meer et al. (2013)6: Yes
Roos et al. (1998)8: No van Meer et al. (2013)6: Yes
Roos et al. (1998)8: Yes NA van Meer et al. (2013)6: Pain Yes (Ceiling) Symptoms No ADL Yes (ceiling) Sport/Rec. No QOL No
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
No
NA
Yes
NA
NA
Yes
No
NA
Yes
NA
NA
NA
NA
NA
Yes††
NA
NA
Yes
Yes
No
Yes‡‡
488
SECTION XXIV Outcomes After Anterior Cruciate Ligament Reconstruction
determine which sports are widely practiced in different countries. Therefore validation in different languages is important.
Cincinnati Knee Rating System The first version of the Cincinnati Knee Rating System was published in 1983.17,18 Modifications and additional scales were added for occupational activities, athletic activities, symptoms, and functional limitations regarding daily activities and sports.39,40 The Cincinnati Knee Rating System has been used for evaluation of different knee related operations, such as knee ligament reconstructions (ACL, posterior cruciate ligament [PCL], medial collateral ligament [MCL], lateral and posterolateral ligaments), meniscal repairs, and for high tibial osteotomy. In 1999 the Cincinnati Knee Rating System was validated in patients after ACL reconstruction.19 This rating system consists of 13 scales in different domains: 1. Four symptoms rating scales (pain, swelling, partial giving way, and full giving way); a minimal score of 0 represents severe symptoms and maximal score of 10 represents a normal knee. 2. A patient perception rating scale of the overall condition of the knee; a minimal score is 1 and maximal score is 10, representing normal/ excellent condition of the knee. 3. Three ADL function scales (walking, stair climbing, and squatting); it is scored on a scale of 0–40, in which 40 represents normal/unlimited. 4. Three sports activities function scales (running, jumping, and twisting/cutting/pivoting), with a score between 40 (not able to do) and 100 (fully competitive). 5. A sports activity scale; the scale is based on frequency of participation in sports and specific knee function. Frequency of participation is assessed on four levels: level I sports (participation in sports 4–7 days/week), level II sports (participation 1–3 days/week), level III sports (participation 1–3 times/ month), and level IV (no sports). Each level is categorized by specific knee function: category 1 represents jumping, hard pivoting, and cutting; category 2 represents running, twisting, and turning; and category 3 represents no running, twisting, or jumping (e.g., cycling, swimming). The total scale ranges from 0 (level IV activities with severe problems) to 100 (level I pivoting sports).19 Regarding clinimetric properties, there is adequate evidence only for reliability.41 6. An occupational rating scale; the severity of work is divided into six factors ranging from sitting to lifting/carrying. Besides this, the amount of hours per day performing the work and amount of pounds carried is scored. The overall ratings scale of the Cincinnati Knee Rating System will not be discussed, because objective measurements, such as functional and stability tests and assessment of radiographs, are also included in the overall rating scale. In the past years the Cincinnati Knee Rating System is further modified by others with a range of score between 6 and 100 (best function). This modified version provided similar results as the IDC subjective in a population with complex knee disorders.42
Marx Activity Rating Scale The Marx Activity Rating Scale is based on specific knee functions and frequency of participation. Each of four knee functions (running, cutting, decelerating, and pivoting) are rated on a fivepoint scale of frequency (<1 time in a month, 1 time/month, 1 time in a week, 2 or 3 times in a week, or 4 or more times a week) and scored between 0 and 4. The scale is scored by adding the scores to give a total out of a possible 16 points, with a higher score indicating more frequent participation.20 Regarding clinimetric properties there is adequate evidence for reliability and validity; however, responsiveness was not studied.41
Anterior Cruciate Ligament—Quality of Life The ACL-QOL was published in 1998 and developed as a QOL measure in chronic ACL deficient patients.21 The score comprises 32 items in five domains: symptoms and physical complaints (5 items), work-related concerns (4 items), recreational activities and sport participation or competition (12 items), related to lifestyle (6 items), and social and emotional function (5 items). Each item is assessed using a visual analogue scale. The raw score is transformed to a 0- to 100-point scale, with each item weighted equally.
Anterior Cruciate Ligament—Return to Sport After Injury The ACL—Return to Sport After Injury (RSI) measure was published in 2008. The rationale for the development of this PROM was the low rate of returning to sports after ACL reconstruction and no available scales that measured the athlete’s emotions, confidence, and risk appraisal. These domains might be important among athletes for returning to sport.23 The scale consists of three domains: Emotions (5 items), Confidence in Performance (5 items), and Risk Appraisal (2 items). For scoring each item, a 10 cm visual analogue scale is used with the description of “extremely” and “not at all” at the opposite ends. All raw scores are converted to a 0 (extremely negative psychological responses) to 100 (no negative psychological responses) scale. For a single score of the ACLRSI scale, all 12 items are summed and averaged.
Miscellaneous The Knee Outcome Survey—Activities of Daily Living Scale (KOS-ADLS) is a knee-specific PROM measuring functional limitation experienced by patients with a wide variety of knee disorders.43 There are more newly constructed PROMs. However, there are no sufficient studies available for assessment of these PROMs. The Knee Self-Efficacy Scale (K-SES) was developed in 2006 for measuring perceived self-efficacy in patients with an ACL injury.44 In 2013 the Knee Numeric-Entity Evaluation Score (KNEES-ACL) was developed. The KNEES-ACL is a newly constructed PROM created specifically for patients pre- and post-ACL reconstruction, for use in longitudinal clinical studies. It measures the following constructs: symptoms, activity, and psychosocial consequences in patients with ACL deficiency, and after nonoperative or operative treatment.45,46
GENDER DIFFERENCES The literature is contradictory regarding the influence of gender on patient-reported outcomes after ACL injury.6,47,48 A recently published systematic review and meta-analysis showed that subjective outcomes and functional scores including the Lysholm score, Tegner Activity Scale, and Ability to Return to Sports were poorer in females.49 However, validation studies of PROMs do not distinguish between male and female gender. Thus for clinical research our advice would be to analyze if patient gender has an effect on the scores of the PROMs.
PATIENT REPORTED OUTCOME MEASURES IN CHILDREN It seems that the incidence of ACL injury increases in children and adolescents. To date, there is no consensus on the optimal treatment strategy of ACL injuries in immature skeletal children.50–53 For monitoring pediatric ACL patients, PROMs are also important measures for evaluating the patient’s perception of their knee function, sports-related, and knee-related QOL. Original PROMs may not be appropriate in children; therefore
CHAPTER 120 A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients
existing PROMs should be modified and validated in children. Two knee-specific PROMs were modified and validated in children with knee injuries: KOOS-Child9,54,55 and IKDC Subjective Knee Evaluation Form in Children.5,56 Recently, an activity rating scale for athletically active children and adolescents (aged between 10 and 18 years) was developed for assessment of activity: The Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS).57 This eightitem scale showed good clinimetric properties and could be used in clinical outcome studies in the field of orthopaedic surgery, sports medicine, and rehabilitation. However, this scale is not sport or joint specific.
CONCLUSION PROMs are important and valuable for monitoring patients after ACL injury. For assessment of patients’ perception of the knee after ACL injury we recommend using the IKDC subjective for short-term follow-up and the KOOS for long-term follow-up.6 To evaluate the activity level of patients after ACL injury, our advice is to use the best available and in Europe the frequently used Tegner activity score, although we have noticed that the Marx activity rating scale is frequently used in the United States. Online registration of monthly sports participations showed promising results for a detailed overview of changes in sport participation after ACL injury.58 This kind of activity registration might be valuable for collecting detailed data of sports participation after ACL injury in longitudinal studies. SELECTED READINGS
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