ICRS Recommendation Document

Objective: The purpose of this article is to describe and recommend patient-reported outcome instruments for use in patients with articular cartilage lesions undergoing cartilage repair interventions. Methods: Nonsystematic literature search identifying measures addressing pain and function evaluated for validity and psychometric properties in patients with articular cartilage lesions. Results: The knee-specific instruments, titled the International Knee Documentation Committee Subjective Knee Form and the Knee injury and Osteoarthritis and Outcome Score, both fulfill the basic requirements for reliability, validity, and responsiveness in cartilage repair patients. A major difference between them is that the former results in a single score and the latter results in 5 subscores. A single score is preferred for simplicity’s sake, whereas subscores allow for evaluation of separate constructs at all levels according to the International Classification of Functioning. Conclusions: Because there is no obvious superiority of either instrument at this time, both outcome measures are recommended for use in cartilage repair. Rescaling of the Lysholm Scoring Scale has been suggested, and confirmatory longitudinal studies are needed prior to recommending this scale for use in cartilage repair. Inclusion of a generic measure is feasible in cartilage repair studies and allows analysis of health-related quality of life and health economic outcomes. The Marx or Tegner Activity Rating Scales are feasible and have been evaluated in patients with knee injuries. However, activity measures require age and sex adjustment, and data are lacking in people with cartilage repair.

[1]  R. Sitgreaves.  Psychometric theory (2nd ed.). , 1979 .

[2]  A. Anderson,et al.  Validity and comprehensibility of the International Knee Documentation Committee Subjective Knee Evaluation form in Children , 2010, Scandinavian journal of medicine & science in sports.

[3]  The intention-to-treat principle: a primer for the orthopaedic surgeon. , 2006, The Journal of bone and joint surgery. American volume.

[4]  J. Karlsson,et al.  Sports Activity Level after Surgical Treatment for Chronic Anterolateral Ankle Instability , 2002, The American journal of sports medicine.

[5]  D. Rubin,et al.  Statistical Analysis with Missing Data. , 1989 .

[6]  Lars Engebretsen,et al.  A randomized trial comparing autologous chondrocyte implantation with microfracture. Findings at five years. , 2007, The Journal of bone and joint surgery. American volume.

[7]  G. Chard.  International Classification of Functioning, Disability and Health , 2004 .

[8]  D. Saris,et al.  Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions. , 2009, Osteoarthritis and cartilage.

[9]  P. Lachenbruch.  Statistical Power Analysis for the Behavioral Sciences (2nd ed.) , 1989 .

[10]  E. Roos,et al.  Bmc Musculoskeletal Disorders Knee Complaints Vary with Age and Gender in the Adult Population. Population-based Reference Data for the Knee Injury and Osteoarthritis Outcome Score (koos) , 2022 .

[11]  C. Sherbourne,et al.  The MOS 36-Item Short-Form Health Survey (SF-36) , 1992 .

[12]  R. Brooks.  EuroQol: the current state of play. , 1996, Health policy.

[13]  J. Brazier,et al.  The estimation of a preference-based measure of health from the SF-36. , 2002, Journal of health economics.

[14]  R. Raman,et al.  Efficacy of Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee -- a prospective randomized clinical trial. , 2008, The Knee.

[15]  G H Guyatt,et al.  Determining a minimal important change in a disease-specific Quality of Life Questionnaire. , 1994, Journal of clinical epidemiology.

[16]  F. Lord.  Applications of Item Response Theory To Practical Testing Problems , 1980 .

[17]  Douglas G. Altman,et al.  Practical statistics for medical research , 1990 .

[18]  P. Stratford,et al.  Defining the minimum level of detectable change for the Roland-Morris questionnaire. , 1996, Physical therapy.

[19]  Ware J.E.Jr.,et al.  THE MOS 36- ITEM SHORT FORM HEALTH SURVEY (SF- 36) CONCEPTUAL FRAMEWORK AND ITEM SELECTION , 1992 .

[20]  J. R. Landis,et al.  The measurement of observer agreement for categorical data. , 1977, Biometrics.

[21]  C. Probst,et al.  Autologous Chondrocyte Implantation for Joint Preservation in Patients with Early Osteoarthritis , 2010, Clinical orthopaedics and related research.

[22]  Georg Rasch,et al.  Probabilistic Models for Some Intelligence and Attainment Tests , 1981, The SAGE Encyclopedia of Research Design.

[23]  R. Rabin,et al.  EQ-SD: a measure of health status from the EuroQol Group , 2001, Annals of medicine.

[24]  M. Lind,et al.  The first results from the Danish ACL reconstruction registry: epidemiologic and 2 year follow-up results from 5,818 knee ligament reconstructions , 2009, Knee Surgery, Sports Traumatology, Arthroscopy.

[25]  B. Beynnon,et al.  IKDC or KOOS? Which measures symptoms and disabilities most important to postoperative articular cartilage repair patients? , 2009, The American journal of sports medicine.

[26]  J. Farr,et al.  A Prospective Study of Autologous Chondrocyte Implantation in Patients with Failed Prior Treatment for Articular Cartilage Defect of the Knee , 2009, The American journal of sports medicine.

[27]  B. Mazières,et al.  Effect of chondroitin sulphate in symptomatic knee osteoarthritis: a multicentre, randomised, double-blind, placebo-controlled study , 2007, Annals of the rheumatic diseases.

[28]  森川 敏彦,et al.  COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS ( CPMP ) POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS , 2002 .

[29]  L. Engebretsen,et al.  Development of a National Cruciate Ligament Surgery Registry , 2008, The American journal of sports medicine.

[30]  D. Streiner,et al.  Health measurement scales , 2008 .

[31]  T. Ackland,et al.  MRI and clinical evaluation of collagen-covered autologous chondrocyte implantation (CACI) at two years. , 2007, The Knee.

[32]  D. Heisey,et al.  The Abuse of Power , 2001 .

[33]  Michael Sittinger,et al.  Treatment of posttraumatic and focal osteoarthritic cartilage defects of the knee with autologous polymer-based three-dimensional chondrocyte grafts: 2-year clinical results , 2007, Arthritis research & therapy.

[34]  Jacob Cohen.  Statistical Power Analysis for the Behavioral Sciences , 1969, The SAGE Encyclopedia of Research Design.

[35]  J. Reginster,et al.  A naturalistic study of the determinants of health related quality of life improvement in osteoarthritic patients treated with non-specific non-steroidal anti-inflammatory drugs , 2004, Annals of the rheumatic diseases.

[36]  C. Bombardier,et al.  Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders. , 2007, The Journal of rheumatology.

[37]  K. Bruynesteyn,et al.  Robustness and generalizability of smallest detectable difference in radiological progression. , 2001, The Journal of rheumatology.

[38]  E. Roos,et al.  The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis , 2003, Health and quality of life outcomes.

[39]  J. Richmond,et al.  Development and Validation of the International Knee Documentation Committee Subjective Knee Form * , 2001, The American journal of sports medicine.

[40]  B. Beynnon,et al.  Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. , 1998, The Journal of orthopaedic and sports physical therapy.

[41]  C. Kaps,et al.  Treatment of focal degenerative cartilage defects with polymer-based autologous chondrocyte grafts: four-year clinical results , 2009, Arthritis research & therapy.

[42]  J. Ware,et al.  A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. , 1996, Medical care.

[43]  Stuart Guterman,et al.  Bending the Curve: Options for Achieving Savings and Improving Value in U.S. Health Spending , 2007 .

[44]  G. Scuderi**,et al.  Proximal Tibial Osteotomy. A Subjective Outcome Study*† , 1996, The Journal of bone and joint surgery. American volume.

[45]  C. Terwee,et al.  On assessing responsiveness of health-related quality of life instruments: Guidelines for instrument evaluation , 2003, Quality of Life Research.

[46]  Maurilio Marcacci,et al.  Articular Cartilage Engineering with Hyalograft® C: 3-Year Clinical Results , 2005, Clinical orthopaedics and related research.

[47]  C. Sherbourne,et al.  The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. , 1994 .

[48]  G. Guyatt,et al.  Measurement of health status. Ascertaining the minimal clinically important difference. , 1989, Controlled clinical trials.

[49]  R. Marx.  Evaluating Outcome Following Cartilage Procedures , 2007 .

[50]  A. Anderson,et al.  The International Knee Documentation Committee Subjective Knee Evaluation Form , 2006, The American journal of sports medicine.

[51]  D. Rosenbaum,et al.  Clinical and functional comparison of uni- and bicondylar sledge prostheses , 2005, Knee Surgery, Sports Traumatology, Arthroscopy.

[52]  J. Brodersen,et al.  Rasch analysis of the Knee injury and Osteoarthritis Outcome Score (KOOS): a statistical re‐evaluation , 2008, Scandinavian journal of medicine & science in sports.

[53]  K. Briggs,et al.  Lysholm Score and Tegner Activity Level in Individuals with Normal Knees , 2009, The American journal of sports medicine.

[54]  A. Tennant,et al.  Modification and validation of the Lysholm Knee Scale to assess articular cartilage damage. , 2009, Osteoarthritis and cartilage.

[55]  J. Ware,et al.  The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: relative validity of scales in relation to clinical measures of arthritis severity. , 1999, Medical care.

[56]  J. Ware,et al.  The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: tests of data quality, scaling assumptions and score reliability. , 1999, Medical care.

[57]  Maurilio Marcacci,et al.  Patellofemoral Full-Thickness Chondral Defects Treated with Hyalograft-C , 2006, The American journal of sports medicine.

[58]  Amir Herman,et al.  Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials. , 2009, Journal of Bone and Joint Surgery. American volume.

[59]  M. Kocher,et al.  Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. , 2006, The Journal of bone and joint surgery. American volume.

[60]  J. Lysholm,et al.  Rating systems in the evaluation of knee ligament injuries. , 1985, Clinical orthopaedics and related research.

[61]  K. Shelbourne,et al.  Responsiveness of the International Knee Documentation Committee Subjective Knee Form , 2006, The American journal of sports medicine.

[62]  R. Marx,et al.  Knee-Specific Quality-of-Life Instruments , 2007, The American journal of sports medicine.

[63]  H. Watanabe,et al.  Points to Consider on Multiplicity Issues in Clinical Trials , 2006 .

[64]  Edward C. Jones,et al.  The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. , 2005, The Journal of bone and joint surgery. American volume.

[65]  Lewis E. Kazis,et al.  Effect Sizes for Interpreting Changes in Health Status , 1989, Medical care.

[66]  E. Roos,et al.  Sex Differences in Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction , 2010, The American journal of sports medicine.

[67]  M. Liang,et al.  Comparisons of Five Health Status Instruments for Orthopedic Evaluation , 1990, Medical care.

[68]  Richard J Hawkins,et al.  Reliability, validity, and responsiveness of the Lysholm knee scale for various chondral disorders of the knee. , 2004, The Journal of bone and joint surgery. American volume.

[69]  J. Brazier,et al.  The Estimation of a Preference-Based Measure of Health From the SF-12 , 2004, Medical care.

[70]  C. McHorney,et al.  The MOS 36‐Item Short‐Form Health Survey (SF‐36): II. Psychometric and Clinical Tests of Validity in Measuring Physical and Mental Health Constructs , 1993, Medical care.

[71]  F. Noyes,et al.  Prospective evaluation of allograft meniscus transplantation: a minimum 2-year follow-up. , 2006, The American journal of sports medicine.

[72]  S. Fruensgaard,et al.  Conservative treatment for acute rupture of the Achilles tendon , 2004, International Orthopaedics.

[73]  J. Fleiss.  The design and analysis of clinical experiments , 1987 .

[74]  Finn Børlum Kristensen,et al.  European network for Health Technology Assessment, EUnetHTA: Planning, development, and implementation of a sustainable European network for Health Technology Assessment , 2009, International Journal of Technology Assessment in Health Care.

[75]  A. Anderson,et al.  Responsiveness of the International Knee Documentation Committee Subjective Knee Form in Comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects , 2010, The American journal of sports medicine.

[76]  Nicole A. Lazar,et al.  Statistical Analysis With Missing Data , 2003, Technometrics.

[77]  A. Boonen,et al.  The international classification for functioning, disability and health , 2007, Clinical Rheumatology.

[78]  J. Mulder,et al.  Health-related quality of life in patients with osteoarthritis in a family practice setting. , 1995, Arthritis care and research : the official journal of the Arthritis Health Professions Association.

[79]  P. Dexter,et al.  Distribution and predictors of depressive symptoms in osteoarthritis. , 1994, The Journal of rheumatology.

[80]  C. Ekdahl,et al.  Knee injury and Osteoarthritis Outcome Score (KOOS) ‐ validation of a Swedish version , 1998, Scandinavian journal of medicine & science in sports.

[81]  Edward C. Jones,et al.  Development and Evaluation of an Activity Rating Scale for Disorders of the Knee , 2001, The American journal of sports medicine.

[82]  A. Yanke,et al.  Outcomes of Autologous Chondrocyte Implantation in a Diverse Patient Population , 2009, The American journal of sports medicine.

[83]  S. Toksvig-Larsen,et al.  Knee injury and Osteoarthritis Outcome Score (KOOS) – validation and comparison to the WOMAC in total knee replacement , 2003, Health and quality of life outcomes.

[84]  P. Stratford,et al.  Applying the results of self-report measures to individual patients: an example using the Roland-Morris Questionnaire. , 1999, The Journal of orthopaedic and sports physical therapy.

[85]  D. Beaton,et al.  Understanding the relevance of measured change through studies of responsiveness. , 2000, Spine.

[86]  E. Roos,et al.  Self-reported activity level and knee function in amateur football players: the influence of age, gender, history of knee injury and level of competition , 2008, Knee Surgery, Sports Traumatology, Arthroscopy.