658
LETTERS TO THE EDITOR
References 1. Bannuru RR, Vaysbrot EE, McIntyre LF. Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark? Arthroscopy 2014;30:86-89. 2. Lubowitz JH, Provencher MT, Poehling GG. Congratulations and condemnations: Level I evidence prize for femoral tunnel position in ACL reconstruction, and AAOS Clinical Practice Guidelines miss the markdAgain. Arthroscopy 2014;30:2-5. 3. Eden J, Levit L, Berg A, Morton S, eds. Finding what works in health care: Standards for systematic review. Washington, DC: National Academies Press, 2011. 4. Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E, eds. Clinical practice guidelines we can trust. Washington, DC: National Academies Press, 2011. 5. Wright JG, Swiontkowski MF, Heckman JD. Introducing levels of evidence to the journal. J Bone Joint Surg Am 2003;85:1-3. 6. Rutjes AW, Juni P, da Costa BR, Trelle S, Nuesch E, Reichenbach S. Viscosupplementation for osteoarthritis of the knee: A systematic review and meta-analysis. Ann Intern Med 2012;157:180-191. 7. Jevsevar DS, Brown GA, Jones DL, et al. The American Academy of Orthopaedic Surgeons evidence-based guideline on: Treatment of osteoarthritis of the knee, 2nd edition. J Bone Joint Surg Am 2013;95:1885-1886. 8. National Institute for Health and Clinical Excellence (NICE) 2008. Osteoarthritis: The care and management of osteoarthritis in adults. Available from: URL: www. guidance.nice.org.uk/cg59. Accessed March 11, 2014. 9. Altman RD, Rosen JE, Bloch DA, Hatoum HT, Korner P. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). Semin Arthritis Rheum 2009;39:1-9. 10. Chevalier X, Jerosch J, Goupille P, et al. Single, intraarticular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: A randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis 2010;69:113-119. 11. Huang TL, Chang CC, Lee CH, Chen SC, Lai CH, Tsai CL. Intra-articular injections of sodium hyaluronate (Hyalgan(R)) in osteoarthritis of the knee. A randomized, controlled, double-blind, multicenter trial in the Asian population. BMC Musculoskelet Disord 2011;12:221. 12. Jorgensen A, Stengaard-Pedersen K, Simonsen O, et al. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: A multicentre, randomised, placebocontrolled, double-blind study of 337 patients followed for 1 year. Ann Rheum Dis 2010;69:1097-1102. 13. Maheu E, Zaim M, Appelboom T, et al. Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F20 in symptomatic osteoarthritis of the knee (KOA). Results of a non inferiority, prospective, randomized, controlled trial. Clin Exp Rheumatol 2011;29:527-535. 14. Navarro-Sarabia F, Coronel P, Collantes E, et al. A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated
15.
16.
17.
18.
19.
20.
intra-articular injections of hyaluronic acid in knee osteoarthritis: The AMELIA project. Ann Rheum Dis 2011;70: 1957-1962. Pavelka K, Uebelhart D. Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial((R))) vs hylan G-F20 (Synvisc((R))) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. Osteoarthritis Cartilage 2011;19:1294-1300. Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomised trials. BMJ 1998;316:690-693. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002;77:371-383. Deeks J, Higgins J, Altman D. Analyzing data and undertaking meta-analyses. In: Higgins J, Green S, eds. Cochrane handbook for systematic reviews of interventions. Hoboken, NJ: John Wiley & Sons, 2008. Johnston BC, Thorlund K, Schunemann HJ, et al. Improving the interpretation of quality of life evidence in meta-analyses: The application of minimal important difference units. Health Qual Life Outcomes 2010;8:116. Thorlund K, Walter SD, Johnston BC, Furukawa, Guyatt GH. Pooling health-related quality of life outcomes in meta-analysisdA tutorial and review of methods for enhancing interpretability. Res Synth Methods 2011;3: 188-203.
Authors’ Reply Drs. Jacobs, Jevsevar, Brown, and Cummins have responded to our article, “Did the American Academy of Orthopaedic Surgeons Osteoarthritis Guidelines Miss the Mark?,”1 with a letter defending the CPG process. We welcome this debate because their letter is an important illustration that the best way to assess the orthopaedic literature to provide guidance to surgeons, patients, and other interested parties is not settled. Just because a process comports well with Institute of Medicine guidelines does not mean it is applicable or relevant to every setting in medicine. It certainly does not mean that the process is beyond legitimate criticism despite such comportment. We have studied the CPG methodology for over 4 years and think it could be improved significantly. We have made recommendations to the Academy in meetings and in writing as to how this might be accomplished.2,3 Our article was an integral part of that effort. We will let readers of the Journal decide the value of our efforts. Our goal in publishing the article was to educate orthopaedic surgeons on aspects of the CPG process so that they can critically examine these documents and provide meaningful input in their localities as these guidelines begin to affect the way they make treatment recommendations to their patients. Orthopaedic surgeons are the musculoskeletal disease experts and are in the best
LETTERS TO THE EDITOR
position as patient advocates to ensure access to safe and effective treatments. Surgeons need to be aware of evidence-based methodologies such as MCII (meaningful clinical important improvement). They need to know that even when treatment effects do not reach an MCII cutoff value, there could still be a significant proportion of patients who cross that threshold and for whom clinically significant improvement can be achieved. Informed expert opinion on the CPG process itself is absolutely necessary to make sure these analyses are a reasonable assessment of the available medical evidence to ensure patients are cared for with both evidence and access in mind. A flawed process will lead to decreased access to safe and effective treatments. Indeed, as a result of the AAOS CPG process, there are insurers who have decided not to cover viscosupplementation for patients with osteoarthritis. How can a process not be flawed that includes Level I studies that show a statistically significant treatment response and good safety profiles for viscosupplementation injections but then recommends strongly against such a treatment? As stated by Lubowitz et al.,4 “it is not in the interests of all patients to recommend against a treatment that is of significant benefit for some patients, especially when that treatment is for a disease (knee OA) that is not preventable, and for which there is no cure. In our opinion, it does not serve AAOS members and our profession to recommend against a treatment that AAOS members provide their own patients, many of whom demand such treatment because viscosupplementation decreases their knee OA pain and limitations of function with a risk-to-benefit profile they prefer to alternative treatments, including no treatment at all.” We could not state it better than that. All human endeavor is potentially flawed and open to both criticism and improvement; the CPG process is not immune to this reality. We think the Academy is to be applauded for initiating and supporting such an effort. Now would be a good time to improve it to make sure it adheres to the AAOS mission, which is to “champion the interests of all patients, serve our members and the profession, and advance the highest quality musculoskeletal health.”5 Louis F. McIntyre, M.D. White Plains, NY Raveendhara R. Bannuru, M.D. Elizaveta E. Vaysbrot, M.D., M.S. White Plains, New York Ó 2014 by the Arthroscopy Association of North America http://dx.doi.org/10.1016/j.arthro.2014.03.001
References 1. Bannuru RR, Vaysbrot EE, McIntyre LF. Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark? Arthroscopy 2014;30:86-89.
659
2. McIntyre LF, Beach WR, Higgins LD, et al. Evidence-based medicine, appropriate-use criteria, and sports medicine: How best to develop meaningful treatment guidelines. Arthroscopy 2013;29:1224-1229. 3. Lubowitz LH, McIntyre LF, Provencher MT, Poehling GG. AAOS rotator cuff clinical practice guideline misses the mark. Arthroscopy 2012;28:589-592. 4. Lubowitz LH, Provencher MT, Poehling GG. Congratulations and condemnations: Level I evidence prize for femoral tunnel position in ACL reconstruction, and AAOS clinical practice guidelines miss the markdAgain. Arthroscopy 2014;30:2-5. 5. American Academy of Orthopaedic Surgeons. Mission statement. Available from: URL: http://www.aaos.org/ about/mission.asp. Accessed November 5, 2013.
New England Journal of Medicine Article Evaluating the Usefulness of Meniscectomy Is Flawed To the Editor: ElAttrache et al.1 have raised concerns regarding the New England Journal of Medicine (NEJM) article by Sihvonen et al.2 and we want to further underline their impression. The NEJM article describes the efficacy of arthroscopic partial meniscectomy in patients with a degenerative tear of the medial meniscus without knee osteoarthritis in a randomized double-blind, shamcontrolled trial and found no significant benefit of partial medial meniscectomy over sham surgery. However, to assess the benefits of an intervention aimed at restoring meniscal function and relieving knee pain, a detailed analysis of the meniscal tear is important but was not included in the stratification process. Differentiation of the meniscus tears with respect to the tear depth, tear location, the radial location, the tear pattern (longitudinal, horizontal, radial, vertical flap, horizontal flap, or complex), and the quality of the tissue might lead to another outcome than described.3 Sihvonen et al.2 show that 2 patients underwent meniscal repair, which indicates that the tear pattern had an impact on the way of treatment. It is possible that some patients with complex degenerative meniscus tears, vertical flaps, or horizontal flaps without osteoarthritis would benefit from surgery but were not appropriately addressed in this study. Patrick Sadoghi, M.D., Ph.D. Graz, Austria Andreas H. Gomoll, M.D. Boston, Massachusetts Ó 2014 by the Arthroscopy Association of North America http://dx.doi.org/10.1016/j.arthro.2014.03.016
LETTERS TO THE EDITOR
References 1. Bannuru RR, Vaysbrot EE, McIntyre LF. Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark? Arthroscopy 2014;30:86-89. 2. Lubowitz JH, Provencher MT, Poehling GG. Congratulations and condemnations: Level I evidence prize for femoral tunnel position in ACL reconstruction, and AAOS Clinical Practice Guidelines miss the markdAgain. Arthroscopy 2014;30:2-5. 3. Eden J, Levit L, Berg A, Morton S, eds. Finding what works in health care: Standards for systematic review. Washington, DC: National Academies Press, 2011. 4. Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E, eds. Clinical practice guidelines we can trust. Washington, DC: National Academies Press, 2011. 5. Wright JG, Swiontkowski MF, Heckman JD. Introducing levels of evidence to the journal. J Bone Joint Surg Am 2003;85:1-3. 6. Rutjes AW, Juni P, da Costa BR, Trelle S, Nuesch E, Reichenbach S. Viscosupplementation for osteoarthritis of the knee: A systematic review and meta-analysis. Ann Intern Med 2012;157:180-191. 7. Jevsevar DS, Brown GA, Jones DL, et al. The American Academy of Orthopaedic Surgeons evidence-based guideline on: Treatment of osteoarthritis of the knee, 2nd edition. J Bone Joint Surg Am 2013;95:1885-1886. 8. National Institute for Health and Clinical Excellence (NICE) 2008. Osteoarthritis: The care and management of osteoarthritis in adults. Available from: URL: www. guidance.nice.org.uk/cg59. Accessed March 11, 2014. 9. Altman RD, Rosen JE, Bloch DA, Hatoum HT, Korner P. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). Semin Arthritis Rheum 2009;39:1-9. 10. Chevalier X, Jerosch J, Goupille P, et al. Single, intraarticular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: A randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis 2010;69:113-119. 11. Huang TL, Chang CC, Lee CH, Chen SC, Lai CH, Tsai CL. Intra-articular injections of sodium hyaluronate (Hyalgan(R)) in osteoarthritis of the knee. A randomized, controlled, double-blind, multicenter trial in the Asian population. BMC Musculoskelet Disord 2011;12:221. 12. Jorgensen A, Stengaard-Pedersen K, Simonsen O, et al. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: A multicentre, randomised, placebocontrolled, double-blind study of 337 patients followed for 1 year. Ann Rheum Dis 2010;69:1097-1102. 13. Maheu E, Zaim M, Appelboom T, et al. Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F20 in symptomatic osteoarthritis of the knee (KOA). Results of a non inferiority, prospective, randomized, controlled trial. Clin Exp Rheumatol 2011;29:527-535. 14. Navarro-Sarabia F, Coronel P, Collantes E, et al. A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated
15.
16.
17.
18.
19.
20.
intra-articular injections of hyaluronic acid in knee osteoarthritis: The AMELIA project. Ann Rheum Dis 2011;70: 1957-1962. Pavelka K, Uebelhart D. Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial((R))) vs hylan G-F20 (Synvisc((R))) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. Osteoarthritis Cartilage 2011;19:1294-1300. Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomised trials. BMJ 1998;316:690-693. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002;77:371-383. Deeks J, Higgins J, Altman D. Analyzing data and undertaking meta-analyses. In: Higgins J, Green S, eds. Cochrane handbook for systematic reviews of interventions. Hoboken, NJ: John Wiley & Sons, 2008. Johnston BC, Thorlund K, Schunemann HJ, et al. Improving the interpretation of quality of life evidence in meta-analyses: The application of minimal important difference units. Health Qual Life Outcomes 2010;8:116. Thorlund K, Walter SD, Johnston BC, Furukawa, Guyatt GH. Pooling health-related quality of life outcomes in meta-analysisdA tutorial and review of methods for enhancing interpretability. Res Synth Methods 2011;3: 188-203.
Authors’ Reply Drs. Jacobs, Jevsevar, Brown, and Cummins have responded to our article, “Did the American Academy of Orthopaedic Surgeons Osteoarthritis Guidelines Miss the Mark?,”1 with a letter defending the CPG process. We welcome this debate because their letter is an important illustration that the best way to assess the orthopaedic literature to provide guidance to surgeons, patients, and other interested parties is not settled. Just because a process comports well with Institute of Medicine guidelines does not mean it is applicable or relevant to every setting in medicine. It certainly does not mean that the process is beyond legitimate criticism despite such comportment. We have studied the CPG methodology for over 4 years and think it could be improved significantly. We have made recommendations to the Academy in meetings and in writing as to how this might be accomplished.2,3 Our article was an integral part of that effort. We will let readers of the Journal decide the value of our efforts. Our goal in publishing the article was to educate orthopaedic surgeons on aspects of the CPG process so that they can critically examine these documents and provide meaningful input in their localities as these guidelines begin to affect the way they make treatment recommendations to their patients. Orthopaedic surgeons are the musculoskeletal disease experts and are in the best
LETTERS TO THE EDITOR
position as patient advocates to ensure access to safe and effective treatments. Surgeons need to be aware of evidence-based methodologies such as MCII (meaningful clinical important improvement). They need to know that even when treatment effects do not reach an MCII cutoff value, there could still be a significant proportion of patients who cross that threshold and for whom clinically significant improvement can be achieved. Informed expert opinion on the CPG process itself is absolutely necessary to make sure these analyses are a reasonable assessment of the available medical evidence to ensure patients are cared for with both evidence and access in mind. A flawed process will lead to decreased access to safe and effective treatments. Indeed, as a result of the AAOS CPG process, there are insurers who have decided not to cover viscosupplementation for patients with osteoarthritis. How can a process not be flawed that includes Level I studies that show a statistically significant treatment response and good safety profiles for viscosupplementation injections but then recommends strongly against such a treatment? As stated by Lubowitz et al.,4 “it is not in the interests of all patients to recommend against a treatment that is of significant benefit for some patients, especially when that treatment is for a disease (knee OA) that is not preventable, and for which there is no cure. In our opinion, it does not serve AAOS members and our profession to recommend against a treatment that AAOS members provide their own patients, many of whom demand such treatment because viscosupplementation decreases their knee OA pain and limitations of function with a risk-to-benefit profile they prefer to alternative treatments, including no treatment at all.” We could not state it better than that. All human endeavor is potentially flawed and open to both criticism and improvement; the CPG process is not immune to this reality. We think the Academy is to be applauded for initiating and supporting such an effort. Now would be a good time to improve it to make sure it adheres to the AAOS mission, which is to “champion the interests of all patients, serve our members and the profession, and advance the highest quality musculoskeletal health.”5 Louis F. McIntyre, M.D. White Plains, NY Raveendhara R. Bannuru, M.D. Elizaveta E. Vaysbrot, M.D., M.S. White Plains, New York Ó 2014 by the Arthroscopy Association of North America http://dx.doi.org/10.1016/j.arthro.2014.03.001
References 1. Bannuru RR, Vaysbrot EE, McIntyre LF. Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark? Arthroscopy 2014;30:86-89.
659
2. McIntyre LF, Beach WR, Higgins LD, et al. Evidence-based medicine, appropriate-use criteria, and sports medicine: How best to develop meaningful treatment guidelines. Arthroscopy 2013;29:1224-1229. 3. Lubowitz LH, McIntyre LF, Provencher MT, Poehling GG. AAOS rotator cuff clinical practice guideline misses the mark. Arthroscopy 2012;28:589-592. 4. Lubowitz LH, Provencher MT, Poehling GG. Congratulations and condemnations: Level I evidence prize for femoral tunnel position in ACL reconstruction, and AAOS clinical practice guidelines miss the markdAgain. Arthroscopy 2014;30:2-5. 5. American Academy of Orthopaedic Surgeons. Mission statement. Available from: URL: http://www.aaos.org/ about/mission.asp. Accessed November 5, 2013.
New England Journal of Medicine Article Evaluating the Usefulness of Meniscectomy Is Flawed To the Editor: ElAttrache et al.1 have raised concerns regarding the New England Journal of Medicine (NEJM) article by Sihvonen et al.2 and we want to further underline their impression. The NEJM article describes the efficacy of arthroscopic partial meniscectomy in patients with a degenerative tear of the medial meniscus without knee osteoarthritis in a randomized double-blind, shamcontrolled trial and found no significant benefit of partial medial meniscectomy over sham surgery. However, to assess the benefits of an intervention aimed at restoring meniscal function and relieving knee pain, a detailed analysis of the meniscal tear is important but was not included in the stratification process. Differentiation of the meniscus tears with respect to the tear depth, tear location, the radial location, the tear pattern (longitudinal, horizontal, radial, vertical flap, horizontal flap, or complex), and the quality of the tissue might lead to another outcome than described.3 Sihvonen et al.2 show that 2 patients underwent meniscal repair, which indicates that the tear pattern had an impact on the way of treatment. It is possible that some patients with complex degenerative meniscus tears, vertical flaps, or horizontal flaps without osteoarthritis would benefit from surgery but were not appropriately addressed in this study. Patrick Sadoghi, M.D., Ph.D. Graz, Austria Andreas H. Gomoll, M.D. Boston, Massachusetts Ó 2014 by the Arthroscopy Association of North America http://dx.doi.org/10.1016/j.arthro.2014.03.016
