International Knee Documentation Committee Knee Survey Use After Anterior Cruciate Ligament Reconstruction: A 2005-2012 Systematic Review and World Region Comparison Jeffrey C. Wera, B.S., John Nyland, Ed.D., D.P.T., Cameron Ghazi, B.S., Kenneth G. W. MacKinlay, M.S., R. Cameron Henzman, B.S., Justin Givens, B.S., and Jefferson C. Brand, M.D.
Purpose: The purpose of this review was to evaluate International Knee Documentation Committee (IKDC) survey use after anterior cruciate ligament reconstruction compared with other surveys and determine evidence levels and methodologic study quality by world region. Methods: The Medline database was searched from January 2005 through December 2012. Results: We identiﬁed 421 studies and 33 surveys. Europe and Australia had more objective and subjective IKDC form use (c2 ¼ 9.6, P ¼ .047). Europe and Asia had more objective IKDC form use (c2 ¼ 19.4, P ¼ .001). Asia had more Lysholm knee scale use (c2 ¼ 29.9, P < .0001). Europe had more Tegner Activity Level scale (c2 ¼ 31.7, P < .0001) and Knee Injury and Osteoarthritis Outcome Score (c2 ¼ 20.5, P < .0001) use. North America and Australia had more Cincinnati or Noyes knee rating scale use (c2 ¼ 21, P < .0001). Asia and Australia had more studies with greater than 60 subjects (c2 ¼ 24.4, P ¼ .018). Europe had more studies with greater than 24 months’ follow-up (c2 ¼ 18.4, P ¼ .018). Asia had more studies with adequate surgical descriptions (c2 ¼ 33.2, P < .0001). North America had more studies with welldescribed rehabilitation (c2 ¼ 18.2, P ¼ .02). Europe had more studies with conﬁrmed recruitment (c2 ¼ 12.9, P ¼ .012). Australia and North America had more studies with conﬁrmed independent investigators (c2 ¼ 11.1, P ¼ .026). Europe had more studies with greater than 80% recruitment (c2 ¼ 16.0, P ¼ .04). Methodologically stronger studies used the objective IKDC survey (P < .0001), the objective and subjective IKDC survey (P ¼ .002), or the Cincinnati or Noyes scale (P ¼ .002). This group also made greater use of the Tegner scale (P ¼ .013). Conclusions: Objective and subjective IKDC form use is comparable with Lysholm and Tegner scale use. Objective and subjective IKDC form use in combination with the Tegner Activity Level scale is recommended. Level of Evidence: Level IV, systematic review of Level I-IV studies.
From the Division of Sports Medicine, Department of Orthopaedic Surgery, University of Louisville (J.C.W., J.N., C.G., K.G.W.M., R.C.H., J.G.); Athletic Training Program, Kosair Charities College of Health and Natural Sciences, Spalding University (J.N.), Louisville, Kentucky; and Heartland Orthopedic Specialists (J.C.B.), Alexandria, Minnesota, U.S.A. The authors report the following potential conﬂict of interest or source of funding: J.N. receives support as follows: Journal of Orthopaedic and Sports Physical Therapy Board President but non-funded. J.C.B. receives support as follows: Associate Editor, Arthroscopy Journal. Received March 6, 2014; accepted May 20, 2014. Address correspondence to John Nyland, Athletic Training Program, Kosair Charities College of Health and Natural Sciences, Spalding University, 901 S Fourth St, Louisville, KY 40203-2188, U.S.A. E-mail: [email protected]
Ó 2014 by the Arthroscopy Association of North America 0749-8063/14232/$36.00 http://dx.doi.org/10.1016/j.arthro.2014.05.043 Note: To access the supplementary material accompanying this report, visit the November issue of Arthroscopy at www. arthroscopyjournal.org.
n 1983 Feagin and Blake1 proposed that comparing the results of different treatments after anterior cruciate ligament (ACL) reconstruction was impossible without a standard evaluation method. Because most early knee evaluation systems attributed points to non-quantiﬁable factors, followed by the addition of arbitrary scores, few gained worldwide acceptance. Discrepancies among existing knee scales have long been considered an impediment to the evolution of knee surgery and rehabilitation. The International Knee Documentation Committee (IKDC) knee survey was developed to provide a standardized, worldwide knee evaluation system with sufﬁcient validity, reliability, and responsiveness to measure improvement or deterioration of knee symptoms, function, and sports activity for a variety of knee conditions including ligament and meniscal injuries, articular cartilage lesions, and patellofemoral pain.2,3 An important early
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step was agreeing on a common interpretation of basic terminology, documentation, and evaluation.4 Our purpose for IKDC survey development was to establish a minimum requirement for all major journals regarding publication of results related to knee injury treatment. The committee suggested minimum (not average) follow-up times for publication results to be respected: 2 years for short-term results, 5 years for midterm results, and 10 years for long-term results.3 Use of other evaluations in addition to the minimum standard IKDC knee survey was encouraged particularly regarding those that provided more comprehensive information about other factors of speciﬁc interest.3 The objective component of the IKDC knee survey system was developed in 1993.2,3 After committee work and pilot testing,5 the subjective IKDC knee form was published in 2001.6 The subjective IKDC knee form is an 18-item region-speciﬁc instrument designed to measure symptoms, function, and sports activities. The subjective IKDC knee form was created by a committee of international knee experts from the American Orthopaedic Society for Sports Medicine and the European Society of Sports Traumatology, Knee Surgery & Arthroscopy. These groups formed the IKDC with the goal of standardizing an international documentation system for assessing patient outcomes after knee surgery or treatment.6 Though more recently introduced than other surveys, the subjective IKDC knee form is gaining recognition. The instrument contains 18 selected items designed to measure symptoms and assess pain, stiffness, swelling, joint locking, and joint instability, whereas other items designed to measure knee function assessed the ability to perform activities of daily living. Items purported to measure activity levels assess the respondent’s ability to run, jump, and land; stop and start quickly; ascend and descend stairs; stand; kneel on the front of the knee; squat; sit with the knee bent; and rise from a chair. Examples of questions include the following: “What is the highest level of activity that you can perform without signiﬁcant knee pain?” “What is the highest level of activity that you can participate in on a regular basis?” “How does your knee affect your ability to go up stairs?” Response types include 5-point Likert scales, 11-point Likert scales, and dichotomous yes or no answers. More recent studies have determined normative data for the subjective IKDC form,7 as well as its sensitivity and responsiveness to changes over time,8-10 its capacity for assessing symptoms and disabilities most signiﬁcant to patients after ACL reconstruction,11 its reliability and validity,12 its utility for evaluating children with knee conditions,13-15 and its usefulness for evaluating patients with recent ACL ruptures and during the ﬁrst year after ACL reconstruction.16 The IKDC forms are currently available in Brazilian Portuguese, simpliﬁed and traditional Chinese, English, French,
Fig 1. Systematic literature review search results. (PCL, posterior cruciate ligament.)
German, Greek, Italian, Japanese, Korean, Spanish, and Swedish languages.17 The purpose of this systematic review was to evaluate IKDC knee survey use for reporting patient outcomes after ACL reconstruction, compare it with use of other surveys, and determine the evidence level of studies18 and methodologic study quality19 by world region. The study hypothesis was that the IKDC knee survey would display use frequency comparable with that of the more traditional Lysholm knee score and Tegner Activity Level scale.
Methods A systematic literature review was performed using Ovid to search the Medline database from January 2005 through December 2012. This 8-year period was considered representative of a period during which both the objective and subjective IKDC knee survey components were widely available. The key search term “anterior cruciate ligament” was combined with other terms including “reconstructive surgical procedures or reconstruction” and “outcome assessment (health care) or outcome and process assessment (health care) or outcome measurement” (Fig 1). Inclusion Criteria Only human studies reported in the English language were included. Studies that focused on patient outcomes
SYSTEMATIC REVIEW OF IKDC SURVEY USE
Fig 2. Survey use frequency from January 2005 through December 2012. (ACL_RSI, ACL Return to Sport after Injury Scale; ADL, activities of daily living; Cincinnati System, Cincinnati Knee Rating System; HSS, Hospital for Special Surgery; KOOS, Knee Injury and Osteoarthritis Outcome Score; Noyes Scale, Noyes sports activity scale; OAK, Orthopadische Arbeitsgruppe Knie Scoring System; QOL, quality of life; SPORTS, Subjective Patient Outcome for Return to Sports; UCLA, University of California, Los Angeles; VISA, Victorian Institute Sport Assessment; WOMAC, Western Ontario and McMaster Universities Arthritis Index.)
after primary or revision ACL reconstruction with or without concomitant knee joint procedures were included. Case reports were included if their primary focus was patient outcome after ACL reconstruction. Exclusion Criteria We excluded studies not available in full text, studies with an English-language abstract but noneEnglishlanguage full text, studies lacking a knee- or ACLfocused patient outcome measure, review articles, editorial comments or letters, review or meta-analysis studies, studies lacking postsurgical outcome measurement, studies lacking surgical intervention for ACL reconstruction, literature reviews, technique articles, dissertations, and nonepeer-reviewed publications. Assessment of Methodologic Study Quality Included studies were initially evaluated for research methodologic quality using the Modiﬁed Coleman Methodology Score (MCMS) and for study evidence level by 3 investigators (C.G., R.C.H., K.G.W.M.) working independently. After this, a second review was performed by another group of 3 investigators (J.G., J.N., J.C.W.) including the primary investigator (J.C.W.) working collaboratively to achieve ﬁnal consensus. Multiple factors contributed to a given study displaying a higher MCMS. These include the following: a larger number of study subjects; a longer follow-up period; use of only 1 surgical procedure per reported outcome; use of a randomized controlled study design; adequate surgical procedure details such as tunnel
placement, drilling, and graft ﬁxation methods; adequate description of postsurgical rehabilitation, including primary criteria for program advancement to sport-speciﬁc training and return to unrestricted sports participation; clear statements regarding the outcome measures that were used, as well as the timing of their administration; use of outcome measurement criteria with good reliability and sensitivity; subject recruitment rather than extraction of data from surgeons’ ﬁles; use of an investigator independent of the surgeon; use of a valid written survey that subjects were allowed sufﬁcient time to complete by themselves with minimal investigator assistance; a clear description of an unbiased subject selection process; a subject recruitment rate of greater than 80% of eligible subjects; and adequate accounting for eligible subjects not included in the study sample.19 Table 1. MCMS and Evidence Level Study Evidence Level I
MCMS (Mean [95% Conﬁdence Interval]) 84.1 (81.1 to 87.0)
78.8 (76.2 to 81.3)
68.5 (66.6 to 70.4) 68.9 (67.3 to 70.6)
Statistical Findings I > II (P ¼ .03) I > III (P < .0001) I > IV (P < .0001) II > III (P < .0001) II > IV (P < .0001)
NOTE. Evidence Level I studies had higher MCMSs than Level II, III, or IV studies. Evidence Level III and IV studies did not show signiﬁcant group differences (P ¼ .99).
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Table 2. MCMS Quartile and Evidence Level MCMS Quartile Study Evidence Level I II III IV Total
High (75th Percentile) 44 (18.1)* 36 (21.9)* 2 (18.6) 24 (47.3) 106 (106)
Moderate ( .99), use of outcome criteria with good sensitivity (P > .99), use of a written assessment method (P ¼ .28), completion of assessment by subjects themselves with minimal investigator assistance (P ¼ .07), use of selection criteria that were reported and unbiased (P ¼ .50), and eligible subjects not included in the study being satisfactorily accounted for (P ¼ .24). Statistically signiﬁcant differences were observed for study size. Asia and Australia had more studies with greater than 60 subjects (c2 ¼ 24.4, P ¼ .018) (Table 3). Europe had more studies with greater than 24 months’ follow-up (c2 ¼ 18.4, P ¼ .018) (Table 4). Asia had more studies that provided an adequate surgical procedure description (c2 ¼ 33.2, P < .0001) (Table 5). North America had more studies with a well-described rehabilitation protocol (c2 ¼ 18.2, P ¼ .02) (Table 6). Europe and Australia had more studies with conﬁrmed subject recruitment (results not taken from surgeons’ ﬁles) (c2 ¼ 12.9, P ¼ .012) (Table 7). Australia and North America had more studies with a conﬁrmed investigator independent of the surgeon (c2 ¼ 11.1, P ¼ .026) (Table 8). Europe had more studies with a greater than 80% recruitment rate (c2 ¼ 16.0, P ¼ .04) (Table 9). Studies in the ﬁrst quartile for MCMS made greater use of the objective IKDC criteria alone (P < .0001), made greater use of both the objective and subjective IKDC forms in combination (P ¼ .002), or made greater use of the Cincinnati knee rating scale (P ¼ .002) than studies that scored in the lower quartiles. Studies that scored in the ﬁrst quartile also made greater use of the Tegner Activity Level scale (P ¼ .013) than studies that scored in the lower quartiles.
Table 6. Adequacy of Rehabilitation Protocol Description by Region Rehabilitation protocol not reported Rehabilitation not adequately described Rehabilitation well described Total
Asia 18 (31.4) 81 (65.7) 12 (14) 111 (111)
Europe 64 (54) 103 (113) 24 (24) 191 (191)
North America 24 (23.2) 44 (48.5) 14 (10.3)* 82 (82)
Australia 9 (8.5) 19 (17.7) 2 (3.8) 30 (30)
NOTE. Data are presented as actual observation (expected observation). *North America had more studies with well-described rehabilitation protocols (c2 ¼ 18.2, P ¼ .02).
South America 4 (2) 19 (17.7) 1 (0.9) 7 (7)
Total 119 (119) 249 (249) 53 (53) 421 (421)
SYSTEMATIC REVIEW OF IKDC SURVEY USE Table 7. Conﬁrmed Subject Recruitment Status by Region Results may have been taken from surgeons’ ﬁles Subjects recruited Total
Asia 37 (26.6) 74 (84.4) 111 (111)
Europe 42 (45.8) 149 (145.2)* 191 (191)
North America 20 (19.7) 62 (62.3) 82 (82)
Australia 2 (7.2) 28 (22.8)* 30 (30)
South America 0 (1.7) 7 (5.3) 7 (7)
Total 101 (101) 320 (320) 421 (421)
NOTE. Data are presented as actual observation (expected observation). *Europe and Australia had more studies with conﬁrmed subject recruitment (i.e. results not taken from surgeons’ ﬁles) (c2 ¼ 12.9, P ¼ .012).
Discussion As expected, the MCMS differed among studies of varying evidence levels. This validates the review procedures we used to score studies. A total of 33 different survey types were identiﬁed in the studies included in this systematic review. Among the surveys used by at least 5% of the studies, signiﬁcant use pattern differences were observed among different world regions. Europe and Australia showed greater use of both the objective and subjective IKDC forms. Europe and Asia displayed greater use of the objective IKDC form and the Lysholm knee scale. Europe showed greater use of the Tegner Activity Level scale and Knee Injury and Osteoarthritis Outcome Score. North America and Australia displayed greater use of the Cincinnati knee rating system or Noyes sports activity scale. Of considerable interest are the differences observed for MCMS comparisons among different world regions. Asia and Australia had more studies with greater than 60 subjects. Europe had more studies with greater than 24 months’ follow-up. Asia had more studies that provided an adequate surgical procedure description. North America had more studies that provided an adequate postsurgical rehabilitation description. Europe had more studies with subject recruitment (results not taken from surgeons’ ﬁles). Australia and North America had more studies with a conﬁrmed investigator independent of the surgeon. Europe had more studies with reported recruitment rates of greater than 80% of the available study population. This review identiﬁed only 7 studies from South America and no studies from the African continent. Current International Society of Arthroscopy, Knee Surgery & Orthopaedic Sports Medicine (ISAKOS) membership numbers are as follows: South America, 1,468; Asia-Paciﬁc Region (including Australia), 1,023; North America, 691; Europe, 660; and Africa, 119 (K. Anderson, B.A., oral communication, February 28, 2014). Given that South America (n ¼ 1,468) currently represents 37%
of the total ISAKOS members (total of 3,961), the number of studies identiﬁed from this region seems low. Perhaps more could be done to facilitate research development among South American knee surgeons. In contrast, given its expanse, a population of over 1 billion persons, and likely, few knee surgeons, the African continent represents a world region that might beneﬁt from both orthopaedic knee surgery and research training. Outcome studies of patients after ACL reconstruction between 2005 and 2012 that showed higher research methodology scores used either the objective IKDC criteria alone, the combined objective and subjective IKDC criteria, or the Cincinnati knee rating scale as the primary outcome measurement survey. The Tegner Activity Level scale was the most prevalent secondary survey. We recommend use of the combined objective and subjective IKDC criteria in combination with the Tegner Activity Level scale on the basis of research methodology study ﬁndings and the greater worldwide use of these criteria. Limitations A main study limitation was that only Englishlanguage studies were evaluated. Another limitation was having the reviews performed primarily by secondand third-year medical students interested in pursuing orthopaedic surgery as a career. Ideally, a cohort of orthopaedic surgery experts in ACL reconstruction would have evaluated all studies. However, an expert group would be more likely to have inherent biases regarding their own ACL reconstruction preferences. Pre-study meetings were held to orient all investigators to the scoring criteria. This helped establish an early level of consensus. Use of a second, collaborative review performed by 3 investigators (J.G., J.N., J.C.W.) including the primary investigator (J.C.W.) both conﬁrmed the initial MCMS and proved to be an effective method to achieve ﬁnal consensus. Lastly, for study purposes, Turkey was categorized as an Asian
Table 8. Independent Investigator Status by Region Independent investigator not reported Use of investigator independent of surgeon Total
Asia 56 (47.5) 55 (63.5) 111 (111)
Europe 82 (81.7) 109 (109.3) 191 (191)
North America 34 (35.1) 48 (46.9)* 82 (82)
Australia 5 (12.8) 25 (17.2)* 30 (30)
South America 3 (3) 4 (4) 7 (7)
NOTE. Data are presented as actual observation (expected observation). *Australia and North America had more studies with a conﬁrmed investigator independent of the surgeon (c2 ¼ 11.1, P ¼ .026).
Total 180 (180) 241 (241) 421 (421)
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Table 9. Recruitment Rate by Region Not reported 80% Total
Asia 8 (8.7) 20 (17.9) 83 (84.4) 111 (111)
Europe 12 (15) 24 (30.9) 155 (145.2)* 191 (191)
North America 6 (6.4) 18 (13.2) 58 (62.3) 82 (82)
Australia 7 (2.4) 5 (4.8) 18 (22.8) 30 (30)
South America 0 (0.5) 1 (1.1) 6 (5.3) 7 (7)
Total 33 (33) 68 (68) 320 (320) 421 (421)
NOTE. Data are presented as actual observation (expected observation). *Europe had more studies with a recruitment rate greater than 80% (c2 ¼ 16.0, P ¼ .04).
country. The nation of Turkey traverses both the European and Asian continents. 8.
Conclusions Objective and subjective IKDC form use is comparable with Lysholm knee score and Tegner Activity Level scale use. The strengths and weaknesses of methodologic ACL patient outcome research study quality differed by world region. Information such as this should help improve the quality of knee research in both established and developing areas. We recommend use of the combined objective and subjective IKDC criteria in combination with the Tegner Activity Level scale on the basis of research methodology study ﬁndings and the greater worldwide use of these criteria.
Acknowledgment The authors thank Dr. James Jay Irrgang of the University of Pittsburgh for his generous assistance during study development.
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