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A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate Ligament Injured or Reconstructed Patients
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.
- a.
Content validity evaluates the degree to which the content of a PROM is relevant and comprehensive for patients with ACL rupture. 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.
- 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.
- a.
- 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.
- 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 scores of other tests, which measure the same construct. Furthermore, hypotheses about the expected effect size could be formulated.
- 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.
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 120.1
Overview of Patient Reported Outcome Measures and the Domains of Assessment
| Patient Reported Outcome Measure | 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) | x | x | x | — | — | — | Total score |
| Knee Injury Osteoarthritis Outcome Score (KOOS) | x | x | x | — | x | — | Score per subscales |
| Lysholm score | x | x | — | — | — | Total score | |
| Tegner activity score | — | — | — | x | — | — | 1 score |
| Cincinnati knee rating system | x | x | x | x | — | — | Score per subscales |
| Marx activity rating scale | — | — | — | x | — | — | Total score |
| Anterior cruciate ligament—Quality of life (ACL-QOL) | x | x | x | x | — | Total score | |
| Anterior Cruciate Ligament—Return to Sport after Injury (ACL-RSI) | x | Total score |
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.
TABLE 120.2
Properties of the Patient Reported Outcome Measures
| Patient Reported Outcome Measures | Developed by | Number of Questions | Available in the Following Languages ∗ | Developed for Following Population | Assessment Validity | Assessment Responsiveness | Assessment Reliability | 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 | — | According to COSMIN † | — | According to COSMIN ‡ | — | — | ||||||
| International Knee Documentation Committee Subjective Knee Form (IKDC subjective) | Irrgang et al. (2001) | n = 18 | 19 languages § | Variety of knee problems (ligament and meniscal injuries, articular cartilage lesions, and patellofemoral pain) | Irrgang et al. (2001) : Yes van Meer et al. (2013) : Yes |
Irrgang et al. (2001) : No van Meer et al. (2013) : Yes |
Irrgang et al. (2006) : Yes van Meer et al. (2013) : Yes |
Irrgang et al. (2006) : No van Meer et al. (2013) : Yes |
Irrgang et al. (2001) : Yes van Meer et al. (2013) : Yes |
Irrgang et al. (2001) : Yes van Meer et al. (2013) : Yes |
Irrgang et al. (2001) : No van Meer et al. (2013) : No |
Yes |
| Knee Injury Osteoarthritis Outcome Score (KOOS) | Roos et al. (1998) | Total, n = 42 Pain, n = 9 Symptoms, n = 7 ADL, n = 17 Sport/ Rec., n = 5 QOL, n = 4 |
49 languages ∗∗ | Short- and long-term consequences after traumatic knee injuries (ACL-, meniscus-, and chondral injuries); post-traumatic knee OA. | Pain Roos et al. (1998) : Yes van Meer et al. (2013) : No Symptoms Roos et al. (1998) : Yes van Meer et al. (2013) : No ADL Roos et al. (1998) : Yes van Meer et al. (2013) : No Sport/Rec. Roos et al. (1998) : Yes van Meer et al. (2013) :Yes QOL Roos et al. (1998) : Yes van Meer et al. (2013) : No |
Roos et al. (1998) : No van Meer et al. (2013) : Yes |
Pain Roos et al. (1998) : Yes van Meer et al. (2013) : No Symptoms Roos et al. (1998) : Yes van Meer et al. (2013) : No ADL Roos et al. (1998) : Yes van Meer et al. (2013) : No Sport/Rec. Roos et al. (1998) : Yes van Meer et al. (2013) :No QOL Roos et al. (1998) : Yes van Meer et al. (2013) : No |
Roos et al. 1998 : No van Meer et al. 2013 : Yes |
Pain Roos et al. (1998) : Yes van Meer et al. (2013) : Yes Symptoms Roos et al. (1998) : Yes van Meer et al. (2013) : Yes ADL Roos et al. (1998) : Yes van Meer et al. (2013) : Yes Sport/Rec. Roos et al. (1998) : Yes van Meer et al. (2013) :Yes QOL Roos et al. (1998) : Yes van Meer et al. (2013) : Yes |
Roos et al. (1998) : No van Meer et al. (2013) : Yes |
Roos et al. (1998) : NA van Meer et al. (2013) : Pain Yes (Ceiling) Symptoms No ADL Yes (ceiling) Sport/Rec. No QOL No |
Yes |
| Lysholm score | Lysholm et al. (1982) | n = 8 | English German Turkish Dutch Chinese |
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). | Yes | No | Yes | No | Yes | Yes | No | Yes |
| Tegner activity Scale | Tegner et al. (1985) | n = 1 | English German Persian Dutch Chinese |
Initially as physician administration for ACL and meniscus injuries. To date as patient administration for variety of knee problems (acute patellar dislocation, chondral injuries, meniscal- and ACL injuries). | Yes | No | Yes | No | Yes | Yes | No | Yes |
| Cincinnati knee rating system | Noyes et al. (1983) | 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 |
English | Variety of knee operations (ACL, PCL, MCL, LCL, and posterolateral injuries, meniscal injury, high tibial osteotomy |
Yes | No | Yes | No | Yes | No | NA | Yes |
| Marx activity rating scale | Marx et al. (2001) | n = 4 | English Persian |
Variety of knee disorders. | Yes | No | NA | NA | Yes | No | NA | Yes |
| Anterior cruciate ligament—Quality of life(ACL-QOL) | Mohtadi et al. (1998) | n = 32 | English Turkish |
ACL injury | NA | NA | NA | NA | NA | NA | NA | Yes †† |
| Anterior cruciate ligament—Return to Sport after Injury(ACL-RSI) | Webster et al. (2008) | n = 12 | English French Swedish |
ACL injury | Yes | No | NA | NA | Yes | Yes | No | Yes ‡‡ |
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.
∗ 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, simplified Chinese (People’s Republic of China, Singapore), traditional Chinese (Taiwan, Hong Kong), Czech, Dutch. English (UK), English (US), French, German, Greek, Italian, Japanese, Korean, Norwegian, Polish, Spanish, Swedish, Thai, Turkish.
∗∗ 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.
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. The IKDC subjective has also been validated in a specific population of ACL injured patients. 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 is intended to monitor the short- and long-term consequences (i.e., OA) of these injuries. It has been validated in several populations—for example, patients after ACL injury, total knee arthroplasty, and meniscectomy. 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. However, these clinimetric properties were assessed in patients with recent ACL ruptures and those in the first year after ACL reconstruction.
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