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Address correspondence to Austin V. Stone, M.D., Ph.D., Department of Orthopaedic Surgery and Sports Medicine, University of Kentucky, 2195 Harrodsburg Rd, Lexington, KY 40504.
To report the variability in outcome measures after meniscal surgery and to compare responsiveness between patient-reported outcome measures (PROMs).
Methods
A systematic search of the PubMed/MEDLINE and Web of Science databases was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A total of 257 studies met inclusion criteria. Patient and study attributes were extracted, including pre- and postoperative means for PROMs. Of the studies that met inclusion criteria for responsiveness analysis (2+ PROMs reported, 1-year minimum follow-up; n = 172), we compared the responsiveness between PROM instruments using effect size and relative efficiency (RE) if a PROM could be compared with another in at least 10 articles.
Results
In total, 18,612 patients (18,690 menisci, mean age = 38.6 years, mean body mass index = 26.3) were included in this study. Radiographic measures were reported in 167 (65.0%) studies, range of motion was reported in 53 (20.6%) studies, and 35 different PROM instruments were identified. The mean number of PROMs in each article was 3.6 and 83.8% reported 2 or more PROMs. The most used PROMs were Lysholm (74.5%) and IKDC (51.0%). IKDC was found to be more responsive than other PROMs, which include Lysholm (RE = 1.03), Tegner (RE = 3.90), and Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) (RE = 1.12). KOOS Quality of Life (QoL) was also more responsive than other PROMs, such as IKDC (RE = 1.45) and KOOS ADL (RE = 1.48). Lysholm was more responsive compared with KOOS QoL (RE = 1.14), KOOS ADL (RE = 1.96), and Tegner (RE = 3.53).
Conclusions
Our study found that IKDC, KOOS QoL, and Lysholm were the most responsive PROMs. However, because of the previously reported risks of either floor effects (KOOS QoL) or ceiling effects (Lysholm), the IKDC may offer a more complete psychometric profile when quantifying outcomes after meniscus procedures.
Clinical Relevance
To improve clinical outcomes, surgical decision-making, and research methodology, it is important to determine which PROMs are the most responsive after meniscal surgery.
The treatment of meniscal pathology is a rapidly expanding area in the field of orthopaedic surgery.
Despite expanding meniscal studies in the literature, a standardized, reliable metric to assess outcomes after meniscal procedures has not been established. Multiple patient-reported outcome measures (PROMs) have been used to assess the efficacy of treatment
; however, the most effective measures remain unclear. Effective outcomes are needed to standardize the reporting of various meniscal pathologies to better assist not only patient satisfaction, but the surgeon’s decision-making as well. The use of unnecessary PROMs can increase health care costs, time, and clinical inefficiency. The absence of guidelines on which pre- and postoperative outcomes to report also can lead to increased bias in the literature, as the variability of reporting methodology has not been quantified in a systematic manner and there are no comparisons performed between PROMs to determine responsiveness.
have demonstrated similar variability. As a result, this makes analysis of multiple studies difficult, limiting the ability to draw definitive conclusions from pooled data. With meniscal pathology being a common reason for surgery,
consistent reporting is critical to determine how to best follow these patients throughout their recovery. To identify patients at risk for inferior outcomes, pooled data from multiple studies are needed to assess risk; however, because of highly variable reporting measures, the ability to do so is limited. PROM instruments need to be compared within the same patient population before and after surgery to measure responsiveness.
Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III.
The purposes of this systematic review were to report the variability in outcome measures after meniscal surgery and to compare responsiveness between PROMs. We hypothesized that the International Knee Documentation Committee (IKDC) would be the most responsive and commonly used PROM.
Methods
This project did not require review by the institutional review board. A comprehensive literature review by 2 authors (A.K. and L.S.) was conducted in PubMed/MEDLINE and Web of Science databases using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines to identify all articles referring to meniscal repair published between January 1989 and April 2022. The key words “meniscal,” “menisci,” “patient reported outcomes,” “PROs,” and “outcomes” were used to identify articles. Cross-referencing was performed to identify articles that were potentially missed. Inclusion criteria were both English-language publications, as well as any study examining subjective and/or objective clinical outcomes after meniscal surgery for any presenting pathology. Exclusion criteria included systematic reviews, meta-analyses, nonhuman subject testing, nonmeniscal studies, multiligament studies, studies in pediatric patients with an average age ≤14 years, and foreign-language publications (Fig 1).
Fig 1Preferred Reporting Items for Systematic Reviews and Meta-Analyses diagram.
Information extracted from each article included year and journal of publication, number of patients, number of knees, Level of Evidence, mean patient demographics, mean follow-up, and pathology treated. Outcome measures documented were as follows: range of motion, revision rate, PROMs, and patient satisfaction. Pre- and postoperative means and standard deviations of PROMs from all studies that used 1 or more PROMs were recorded. From these articles, we were able to compare responsiveness between the PROM instruments via calculating the effect size and relative efficiency if a PROM could be compared with another in at least 10 articles. A previously published methodology was used to evaluate responsiveness.
Effect size measures the change from pre- to postoperative scores while also accounting for variability within a specific PROM tool. An effect size between 0.2 and 0.49 is described as small, those between 0.5 and 0.79 are moderate, and those greater than or equal to 0.8 are large. Relative efficiency was then calculated to compare responsiveness between 2 individual PROM instruments used in the same study and population of patients. A relative efficiency value of <1 signals that the first patient-reported outcome has less responsiveness than the other tool, and a value >1 indicates that the first PROM has greater responsiveness.
Each article included in this study was assigned a level of evidence based on the Oxford Centre for Evidence-Based Medicine. The Methodological Index for Nonrandomized Studies tool
score as used to assess randomized studies. It uses a scoring system between 0 and 100, where 100 indicates a high-quality study without chances, bias, and other confounding factors.
We identified 257 studies that met inclusion criteria. These articles included 18,612 patients (18,690 menisci, mean age = 38.6 years, mean body mass index = 26.3). The mean number of menisci per article was 65.2 (range, 4-1,090 menisci). The mean follow-up was 48.5 months (range, 2-240 months). A total of 167 of 257 studies (65.0%) reported radiographic measures. The Kellgren–Lawrence classification (53/167) and meniscal extrusion (in millimeters) (37/167) were the most commonly reported variables. Range of motion was reported in 53 of 257 studies (20.6%), with the overall mean duration between the onset of symptoms and surgery being 16.3 months (range, 0.8-72 months). There were 104 articles (40.5%) that reported revision arthroscopy. The mean Methodological Index for Non-Randomized Studies score was 12.3 and the mean Coleman score was 65.2 (Table 1). The median Level of Evidence was III, with 55 of 257 (21.4%) being classified as Level I or II evidence (Fig 2). The Knee Surgery, Sports Traumatology, Arthroscopy journal had the greatest number of Level I and II studies. Journals that published the greatest number of articles are reported in Table 2.
Thirty-five different PROM instruments were identified in this study. The mean number of PROMs in each study was 3.6 (range, 1-13), and 217 of 257 (84.4%) used 2 or more PROMs. The most used PROM was the Lysholm Score (n = 193, 75.1%), followed by IKDC (n = 132, 51.4%), Tegner Activity Scale (n = 111, 43.2%), Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain (n = 79, 30.7%), KOOS Sport and Recreation (Sport/Recreation) (n = 75, 29.2%), KOOS Quality of Life (QoL) (n = 75, 29.2%), KOOS Symptoms (n = 75, 29.2%), and visual analog scale (n = 67, 26.1%) (Table 3). A total of 66 of 257 articles (25.7%) reported patient satisfaction.
Table 3The Most Commonly Used Patient-Reported Outcome Measures
Patient-Reported Outcome Measure
No. of Articles (%)
Lysholm
193 (75.1)
International Knee Documentation Committee
132 (51.4)
Tegner Activity Scale
111 (43.2)
Knee Injury and Osteoarthritis Outcome Score – Pain
79 (30.7)
Knee Injury and Osteoarthritis Outcome Score – Sport and Recreation
75 (29.2)
Knee Injury and Osteoarthritis Outcome Score – Quality of Life
75 (29.2)
Knee Injury and Osteoarthritis Outcome Score – Symptoms
75 (29.2)
Visual analog scale
67 (26.1)
Knee Injury and Osteoarthritis Outcome Score – Activities of Daily Living
59 (23.0)
Knee Injury and Osteoarthritis Outcome Score – Overall
35 (13.6)
Western Ontario and McMaster Universities Osteoarthritis Index
From the full set of 257 articles, 172 articles were identified that met inclusion criteria for responsiveness analyses (used 2 or more PROMs, minimum follow-up time was 1 year, and both pre- and postoperative means and standard deviations were reported). The majority of articles used either Lysholm or IKDC with additional PROMs. The 3 PROMs with the greatest positive effect sizes were IKDC (1.94), KOOS Overall (1.64) and KOOS QoL (1.62) (Table 4). The 3 PROMs with the highest relative efficiencies were IKDC, Knee Injury and Osteoarthritis Outcome Score Quality of Life, and Lysholm (Table 5).
Table 4Pooled Pre- and Postoperative Means and ES of PROMs
PROM
No. of Studies
No. of Menisci
Preoperative Score
Postoperative Score
ES
IKDC
66
3,261
46.7 ± 15.2
76.2 ± 18.3
1.94
KOOS Overall
10
912
43.1 ± 17.3
71.4 ± 20.8
1.64
KOOS QoL
31
2,110
32.8 ± 18.6
63.0 ± 24.5
1.62
Lysholm
100
5,025
55.8 ± 17.7
83.4 ± 16.1
1.56
KOOS Pain
33
2,168
54.9 ± 18.6
79.4 ± 17.8
1.32
KOOS Sport/Recreation
31
2,110
34.6 ± 23.8
61.7 ± 26.3
1.14
KOOS ADL
31
2,110
65.3 ± 20.3
86.2 ± 15.1
1.03
KOOS Symptoms
31
2,110
55.7 ± 19.0
74.5 ± 17.7
0.99
Tegner
38
1,654
3.6 ± 2.2
4.8 ± 2.1
0.57
VAS
35
2,010
5.4 ± 2.5
1.9 ± 1.9
−1.38
ADL, activities of daily living; ES, effect size; IKDC, International Knee Documentation Committee; KOOS, Knee Injury and Osteoarthritis Outcome Score; PROM, Patient-Reported Outcome Measure; QoL, Quality of Life; VAS, visual analog scale.
Values >1 suggest that the PROM tool in the top row is more responsive than the corresponding PROM tool in the left column. A dash indicates that there were not 10 comparisons to be made between PROMs to calculate relative efficiency.
Lysholm
IKDC
Tegner
VAS
KOOS Pain
KOOS ADL
KOOS Symptoms
KOOS Sport/Recreation
KOOS QoL
Lysholm
1.03
0.28
0.79
0.70
0.51
0.41
0.38
0.88
IKDC
0.97
0.26
0.12
1.12
0.89
0.72
0.73
1.45
Tegner
3.53
3.90
1.49
–
–
–
–
–
VAS
1.27
8.36
0.67
1.00
0.69
0.72
0.84
1.15
KOOS Pain
1.44
0.89
–
1.00
0.74
0.60
0.65
1.07
KOOS ADL
1.96
1.12
–
1.46
1.34
0.87
0.89
1.48
KOOS Symptoms
2.47
1.38
–
1.39
1.67
1.15
1.10
1.83
KOOS Sport/Recreation
2.62
1.37
–
1.19
1.54
1.12
0.91
1.66
KOOS QoL
1.14
0.69
–
0.87
0.93
0.68
0.55
0.60
ADL, Activities of Daily Living; IKDC, International Knee Documentation Committee; KOOS, Knee Injury and Osteoarthritis Outcome Score; PROM, patient-reported outcome measure; QoL, Quality of Life; VAS, visual analog scale.
∗ Values >1 suggest that the PROM tool in the top row is more responsive than the corresponding PROM tool in the left column. A dash indicates that there were not 10 comparisons to be made between PROMs to calculate relative efficiency.
The most important finding of this study was that the IKDC, KOOS QoL, and Lysholm were the most responsive instruments when compared with other PROMs used to assess outcomes after meniscal procedures. The Lysholm was the most commonly used instrument.
With the knee being a very common site of injury, outcome measures have been developed and validated to measure patient status postsurgery.
The IKDC was used in 132 of 257 studies (51%), which was originally developed as a knee-specific outcome measure of patient symptoms, sport activity, and function for multiple knee pathologies. It consists of 18 questions to measure pain, stiffness, swelling, joint locking, joint instability, and the ability to perform activities of daily living.
Reliability, validity, and responsiveness of a modified International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC) in children with knee disorders.
assessed the floor and ceiling effects of IKDC in meniscal injuries, finding the overall score (0-100) has both a 0% floor effect and 0% ceiling effect. Floor and ceiling effects are defined as the proportion of respondents that score the lowest (floor) or highest (ceiling) score on a questionnaire.
Floor and ceiling effects, time to completion, and question burden of PROMIS CAT domains among shoulder and knee patients undergoing nonoperative and operative treatment.
For example, having a 0% floor effect means that no respondent scored the lowest possible score on a questionnaire. There was an acceptable test–retest reliability with an interclass correlation of 0.95.
assessed IKDC scores in meniscal allograft transplant outcomes with patient satisfaction, finding that IKDC outcome scores reflect patient satisfaction well before and after a multivariable logistic regression, whereas Lysholm only showed a significant association on univariate analysis.
The KOOS was developed in 1995 as an extension of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) to assess short- and long-term symptoms in patients with knee injury and osteoarthritis. It is composed of 42 items in 5 subsections: Pain (9 items), Activities of Daily Living (17 items), Sport/Recreation (5 items), QoL (4 items), and other Symptoms (7 items).
Scores are then transformed to a scale of 0-100, with 100 being no knee problems. Overall scores are usually not reported, as it is more desirable to analyze the 5 separate subscales individually.
assessed the reliability and validity of Dutch-language IKDC, KOOS, and WOMAC in patients with meniscal injuries. Cronbach alpha scores were 0.90, 0.72-0.95, and 0.84-0.95, with an intraclass correlation coefficient of 0.93, 0.84-0.89, and 0.77-0.89 respectively. Floor effects within the smallest detectable difference from a minimum score was found for KOOS Sports/Recreation and QoL. Ceiling effects within the smallest detectable difference from the maximum score was found in KOOS Activities of Daily Living and WOMAC. They recommended IKDC to be used in assessing functional outcomes in patients with meniscal tears,
Comparison of second-look arthroscopic findings and clinical results according to the amount of preserved remnant in anterior cruciate ligament reconstruction.
The adaptation for multiple knee pathologies may be due to its familiarity with clinicians and researchers. Lysholm measures outcomes in 8 categories: limp, locking, pain, stair-climbing, support, instability, swelling, and squatting.
The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later.
compared the ceiling effects of Lysholm and IKDC in patients undergoing ACLR, finding no significant difference between IKDC subjective and Lysholm scores in terms of ceiling effects. However, there was a concern that the ceiling effect of Lysholm was greater than IKDC subjective score. The Lysholm was shown to be one of the most responsive instruments in the current results; however, the potential for ceiling effects minimizes enthusiasm for using the Lysholm to quantify outcomes after meniscal procedures when compared to the IKDC.
Outcome reporting in meniscal literature is highly variable and guidelines should be constructed on how to best measure outcomes, allowing for better interpretation of studies to draw conclusions. Although each PROM has its role in orthopaedic literature, the results of this systematic review showcase that IKDC, KOOS QoL, and Lysholm were the most responsive instruments. However, because of the risks of either floor effects (KOOS QoL) or ceiling effects (Lysholm), the IKDC may offer a more complete psychometric profile when quantifying outcomes after meniscus procedures.
Limitations
This study was not without limitations. We did not review the included studies for treatment efficacy, only to report and assess responsiveness of the PROM they used. Several articles were excluded from responsiveness analysis due to not meeting inclusion criteria for analysis. Even though not every article was included in responsiveness analysis, we believe that the inclusion criteria was important to preserve the integrity and validity of our study. Finally, only studies written in English were included in this review.
Conclusions
Our study found that IKDC, KOOS QoL, and Lysholm were the most responsive PROMs. However, because of the previously reported risks of either floor effects (KOOS QoL) or ceiling effects (Lysholm), the IKDC may offer a more complete psychometric profile when quantifying outcomes after meniscus procedures.
Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III.
Reliability, validity, and responsiveness of a modified International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC) in children with knee disorders.
Floor and ceiling effects, time to completion, and question burden of PROMIS CAT domains among shoulder and knee patients undergoing nonoperative and operative treatment.
Comparison of second-look arthroscopic findings and clinical results according to the amount of preserved remnant in anterior cruciate ligament reconstruction.
The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later.
The authors report that they have no conflicts of interest in the authorship and publication of this article. Full ICMJE author disclosure forms are available for this article online, as supplementary material.
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