A Comparison of Treatment Effects for Nonsurgical Therapies and the Minimum Clinically Important Difference in Knee Osteoarthritis: A Systematic Review.

BACKGROUND The minimum clinically important difference (MCID) was developed to ascertain the smallest change in an outcome that patients perceive as beneficial. The objectives of the present review were (1) to compare the MCIDs for pain assessments used among guidelines and meta-analyses investigating different nonsurgical therapies for knee osteoarthritis and (2) to compare the effect estimates of different nonsurgical interventions against a single commonly-utilized MCID threshold. METHODS Systematic and manual searches were conducted to identify guidelines and meta-analyses evaluating pain outcomes for nonsurgical knee osteoarthritis interventions. Individual treatment effects for pain were presented on a common scale (the standardized mean difference [SMD]). To evaluate the perception of the relative benefit of each nonsurgical treatment, the variation in MCIDs selected from the published MCID literature was assessed. RESULTS Thirty-seven guidelines and meta-analyses were included. MCIDs were often presented as an SMD or a mean difference (MD) on a validated scale and varied in magnitude across sources. This analysis demonstrated that intra-articular hyaluronic acid, intra-articular corticosteroids, and acetaminophen all had relatively larger effect sizes than topical nonsteroidal anti-inflammatory drugs (NSAIDs). Higher-molecular-weight intra-articular hyaluronic acid had a greater relative effect compared with both non-selective and cyclooxygenase-2-selective oral NSAIDs. Evaluating the treatment effect estimates against a commonly utilized MCID revealed similarities in which observations attained clinical significance among treatments; however, this observation varied across the range of reported MCIDs. CONCLUSIONS The present review confirmed the variability in the MCIDs for pain assessments that are used across guidelines and meta-analyses evaluating nonsurgical interventions for knee osteoarthritis. This variability may yield conflicting treatment recommendations, ranging from rejecting treatments that are indeed efficacious to accepting treatments that may not be beneficial. Additional research is required to determine why some nonsurgical therapies are more consistently recommended in knee osteoarthritis guidelines than others as these findings suggest similarities in their effect estimates for pain. Relevant stakeholders need to reach a consensus on a standard approach to determining the MCIDs for these therapies to ensure that appropriate and effective treatment options are available to patients prior to invasive surgical intervention. LEVEL OF EVIDENCE Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

[1]  A. Bendele,et al.  Viscosupplementation may preserve tibial cartilage and collagen in osteoarthritis: findings from a preclinical model of osteoarthritis , 2020, Journal of Experimental Orthopaedics.

[2]  H. Liszka NICE (National Institute for Health and Care Excellence) recommendations in the treatment of osteoarthritis , 2020 .

[3]  G. Guyatt,et al.  An overview of the GRADE approach and a peek at the future , 2018, The Medical journal of Australia.

[4]  Gregory A. Brown,et al.  Mixed Treatment Comparisons for Nonsurgical Treatment of Knee Osteoarthritis: A Network Meta-analysis , 2018, The Journal of the American Academy of Orthopaedic Surgeons.

[5]  Jian Zhang,et al.  Efficacy of Platelet-Rich Plasma in Pain and Self-Report Function in Knee Osteoarthritis: A Best-Evidence Synthesis , 2017, American journal of physical medicine & rehabilitation.

[6]  G. Guyatt,et al.  Application of minimal important differences in degenerative knee disease outcomes: a systematic review and case study to inform BMJ Rapid Recommendations , 2017, BMJ Open.

[7]  Hua Zhang,et al.  Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. , 2017, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[8]  R. Altman,et al.  Product Differences in Intra-articular Hyaluronic Acids for Osteoarthritis of the Knee , 2016, The American journal of sports medicine.

[9]  G. Guyatt,et al.  A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. , 2016, Journal of clinical epidemiology.

[10]  John R. Hatzenbuehler,et al.  AMSSM scientific statement concerning viscosupplementation injections for knee osteoarthritis: importance for individual patient outcomes , 2016, British Journal of Sports Medicine.

[11]  Gregory A. Brown,et al.  Viscosupplementation for Osteoarthritis of the Knee: A Systematic Review of the Evidence. , 2015, The Journal of bone and joint surgery. American volume.

[12]  Shu-guang Gao,et al.  Effectiveness and safety of Glucosamine, chondroitin, the two in combination, or celecoxib in the treatment of osteoarthritis of the knee , 2015, Scientific Reports.

[13]  A. Rutjes,et al.  Intra-articular corticosteroid for knee osteoarthritis. , 2015, The Cochrane database of systematic reviews.

[14]  R. Altman,et al.  Assessment of clinical practice guideline methodology for the treatment of knee osteoarthritis with intra-articular hyaluronic acid. , 2015, Seminars in arthritis and rheumatism.

[15]  Raveendhara R. Bannuru,et al.  Effectiveness and Implications of Alternative Placebo Treatments , 2015, Annals of Internal Medicine.

[16]  F. Chen,et al.  Efficacy and Safety of Duloxetine on Osteoarthritis Knee Pain: A Meta-Analysis of Randomized Controlled Trials. , 2015, Pain medicine.

[17]  V. Strand,et al.  Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials , 2015, Journal of pain research.

[18]  Y. Henrotin,et al.  Hyaluronan for knee osteoarthritis: an updated meta-analysis of trials with low risk of bias , 2015, RMD Open.

[19]  Jaume Puig-Junoy,et al.  Socio-economic costs of osteoarthritis: a systematic review of cost-of-illness studies. , 2015, Seminars in arthritis and rheumatism.

[20]  T. Birmingham,et al.  Valgus Bracing for Knee Osteoarthritis: A Meta‐Analysis of Randomized Trials , 2015, Arthritis care & research.

[21]  S. Mcconnell,et al.  Exercise for osteoarthritis of the knee. , 2015, The Cochrane database of systematic reviews.

[22]  C. Schmid,et al.  Comparative Effectiveness of Pharmacologic Interventions for Knee Osteoarthritis , 2015, Annals of Internal Medicine.

[23]  J. Higgins,et al.  Evaluating the Quality of Evidence from a Network Meta-Analysis. , 2014, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[24]  Anna Chaimani,et al.  Evaluating the Quality of Evidence from a Network Meta-Analysis , 2014, PloS one.

[25]  J. Jordan,et al.  A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. , 2014, Seminars in arthritis and rheumatism.

[26]  C. Juhl,et al.  Impact of Exercise Type and Dose on Pain and Disability in Knee Osteoarthritis: A Systematic Review and Meta‐Regression Analysis of Randomized Controlled Trials , 2014, Arthritis & rheumatology.

[27]  Gregory A. Brown,et al.  The American Academy of Orthopaedic Surgeons evidence-based guideline on: treatment of osteoarthritis of the knee, 2nd edition. , 2013, The Journal of bone and joint surgery. American volume.

[28]  A. Sutton,et al.  Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis☆ , 2013, Osteoarthritis and cartilage.

[29]  J. Jordan,et al.  Lifetime Risk and Age at Diagnosis of Symptomatic Knee Osteoarthritis in the US , 2013, Arthritis care & research.

[30]  D. Haverkamp,et al.  Hyaluronic Acid in the Treatment of Knee Osteoarthritis , 2012, BioDrugs.

[31]  A. Rutjes,et al.  Viscosupplementation for Osteoarthritis of the Knee , 2012, Annals of Internal Medicine.

[32]  M. Cucherat,et al.  Symptom-Modifying Effect of Chondroitin Sulfate in Knee Osteoarthritis: A Meta-Analysis of Randomized Placebo-Controlled Trials Performed with Structum® , 2012, The open rheumatology journal.

[33]  P. Tugwell,et al.  Ottawa panel evidence-based clinical practice guidelines for aerobic walking programs in the management of osteoarthritis. , 2012, Archives of physical medicine and rehabilitation.

[34]  C. Juhl,et al.  A Hierarchy of Patient-Reported Outcomes for Meta-Analysis of Knee Osteoarthritis Trials: Empirical Evidence from a Survey of High Impact Journals , 2012, Arthritis.

[35]  G. Guyatt,et al.  GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. , 2011, Journal of clinical epidemiology.

[36]  M. King A point of minimal important difference (MID): a critique of terminology and methods , 2011, Expert review of pharmacoeconomics & outcomes research.

[37]  G. Lewith,et al.  Meta-Analysis of the Related Nutritional Supplements Dimethyl Sulfoxide and Methylsulfonylmethane in the Treatment of Osteoarthritis of the Knee , 2011, Evidence-based complementary and alternative medicine : eCAM.

[38]  C. Gerlinger,et al.  Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials , 2010, Health and quality of life outcomes.

[39]  Philip B. Stark,et al.  A Primer of Frequentist and Bayesian Inference in Inverse Problems , 2010 .

[40]  Raveendhara R. Bannuru,et al.  Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis--meta-analysis. , 2010, Osteoarthritis and cartilage.

[41]  Christopher G. Maher,et al.  Exercise for Osteoarthritis of the Knee , 2010, Physical Therapy.

[42]  A. Rutjes,et al.  Therapeutic ultrasound for osteoarthritis of the knee or hip. , 2010, The Cochrane database of systematic reviews.

[43]  R. Tashjian,et al.  Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. , 2009, Journal of shoulder and elbow surgery.

[44]  E. Hendriks,et al.  Transcutaneous electrostimulation for osteoarthritis of the knee. , 2009, The Cochrane database of systematic reviews.

[45]  David Cella,et al.  Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. , 2008, The journal of pain : official journal of the American Pain Society.

[46]  S. Gabriel,et al.  Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. , 2008, Arthritis and rheumatism.

[47]  Mark I. Johnson,et al.  Short-term efficacy of physical interventions in osteoarthritic knee pain. A systematic review and meta-analysis of randomised placebo-controlled trials , 2007, BMC musculoskeletal disorders.

[48]  Klaus Linde,et al.  Meta-analysis: Acupuncture for Osteoarthritis of the Knee , 2007, Annals of Internal Medicine.

[49]  G. Guyatt,et al.  How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure , 2006, Health and quality of life outcomes.

[50]  A. Astrup,et al.  Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis , 2006, Annals of the rheumatic diseases.

[51]  M. Callaghan,et al.  Pulsed electromagnetic energy treatment offers no clinical benefit in reducing the pain of knee osteoarthritis: a systematic review , 2006, BMC musculoskeletal disorders.

[52]  M. Müllner,et al.  Intra-articular hyaluronic acid for the treatment of osteoarthritis of the knee: systematic review and meta-analysis , 2005, Canadian Medical Association Journal.

[53]  A. Klovning,et al.  Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials , 2004, BMJ : British Medical Journal.

[54]  Walter Grassi,et al.  Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale , 2004, European journal of pain.

[55]  C. Bombardier,et al.  Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement , 2004, Annals of the rheumatic diseases.

[56]  M. Dougados,et al.  OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. , 2004, Osteoarthritis and cartilage.

[57]  K. Bennell,et al.  Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? , 2004, Archives of physical medicine and rehabilitation.

[58]  Arden,et al.  EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT) , 2003, Annals of the rheumatic diseases.

[59]  I. Stiell,et al.  Clinically important change in the visual analog scale after adequate pain control. , 2003, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.

[60]  G. Norman,et al.  Interpretation of Changes in Health-related Quality of Life: The Remarkable Universality of Half a Standard Deviation , 2003, Medical care.

[61]  J. Farrar,et al.  Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale , 2001, PAIN.

[62]  M. Rowbotham What is a ‘clinically meaningful’ reduction in pain? , 2001, PAIN.

[63]  F Angst,et al.  Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. , 2001, Arthritis and rheumatism.

[64]  P. Tugwell,et al.  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. , 1997, The Journal of rheumatology.

[65]  K. Todd,et al.  Clinical significance of reported changes in pain severity. , 1996, Annals of emergency medicine.

[66]  P. Tugwell,et al.  Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. , 1993, The Journal of rheumatology.

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

[68]  N. Foster OF ACUPUNCTURE FOR PERIPHERAL JOINT OSTEOARTHRITIS , 2015 .

[69]  R. Bannuru,et al.  Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark? , 2014, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[70]  J. Higgins,et al.  Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0. The Cochrane Collaboration , 2013 .

[71]  K. Avin,et al.  Patellar taping and bracing for the treatment of chronic knee pain: a systematic review and meta-analysis. , 2008, Arthritis and rheumatism.

[72]  G. Guyatt,et al.  Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force. , 2006, Chest.

[73]  Medical Advisory Secretariat Intra-articular viscosupplementation with hylan g-f 20 to treat osteoarthritis of the knee: an evidence-based analysis. , 2005, Ontario health technology assessment series.

[74]  G. Stucki,et al.  Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities. , 2002, The Journal of rheumatology.

[75]  N. Bellamy,et al.  Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. , 2000, The Journal of rheumatology.