Letters to the Editor
Sham Surgery Studies
To the Editor: We read with interest the recent Arthroscopy editorial on potential bias in the New England Journal of Medicine (NEJM).1 We have a significant interest in the field of sham surgery trials and also have some issues with the NEJM publication of the FIDELITY (Finnish Degenerative Meniscal Lesion Study) trial.2 We wrote to the NEJM to raise these issues but were told that we could only comment within 3 weeks of publication of the FIDELITY study. In our previously published work (which included extensive consultation with surgeons, anesthetists, patients, and ethics committee chairs),3 we explored the development of placebo (sham) operations and concluded that entering a joint with instruments and saline solution introduced the potential of confounding effects. Our sham knee arthroscopy procedure included 2 skin incisions to mimic the normal skin incisions without joint penetration. To call a diagnostic arthroscopy a placebo procedure is, we believe, overly stretching the definition of “placebo.” We would also question the use of spinal anesthesia in the study. For sham surgery, we would advocate an anesthetic that is the same as that used for routine practice, usually a general anesthetic by an experienced anesthetist. We do not, however, agree with Lubowitz et al.1 that these issues mean that “sham surgery trials may themselves be a sham.” The process is challenging, but there is a debate on the subject of arthroscopic treatment of knee degeneration that demands clear answers. Patients either are being denied surgery that actually works or are being exposed to unnecessary danger for an intervention that has no value beyond placebo, depending on your viewpoint. To suggest that patients who participate in sham surgery trials “may not be of entirely sound mind”1 and that those recommending such trials are “not ethical surgeons”1 is inflammatory and not conducive to open scientific and informed debate. The Declaration of Helsinki is, of course, essential in protecting patients involved in research and must be considered, but there are many potentially harmful interventions in routine use that are of questionable value and have an inadequate evidence basedfor example, large-head metalon-metal hip replacements or platelet-rich plasma injections. Before we become overly fixated on the
potential harm of a carefully conducted and highly regulated sham operation study, we should consider the potential harm of a treatment that is in continued use despite lack of evidence that it actually works. Alasdair G. Sutherland, M.B.Ch.B., M.D.(Hons), F.R.C.S.Ed.(Tr&Orth), F.R.A.C.S.(Orth), F.A.Orth.A. Warrnambool, Victoria, Australia Brian H. Cuthbertson, M.B.Ch.B., M.D., F.R.C.A. Toronto, Ontario, Canada Marion Campbell, Ph.D. Aberdeen, Scotland Note: The authors report the following potential conflict of interest or source of funding: A.G.S., B.H.C., and M.C. receive support from UK National Institute of Health Research Health Technology Assessment Programme (grant number 03/48/01). Crown Copyright Ó 2014 Published by Elsevier Inc. on behalf of the Arthroscopy Association of North America. All rights reserved. http://dx.doi.org/10.1016/j.arthro.2014.08.004
References 1. Lubowitz JH, Provencher MT, Rossi MJ. Could the New England Journal of Medicine be biased against arthroscopic knee surgery? Part 2. Arthroscopy 2014;30:654-655. 2. Sihvonen R, Paavola M, Malmivaara A, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscus tear. N Engl J Med 2013;369:2515-2524. 3. Campbell MK, Entwistle VA, Cuthbertson BH, et al. Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility. Trials 2011;12:50.
Editors’ Reply The editors appreciate this thoughtful letter, and we have many points in common. We too find the New England Journal of Medicine censorship of letters to the editor limiting.1 We also agree that true sham arthroscopy stops after the skin incisions, and does not include lavage. We agree that lavage is not sham. We believe you understate the case, politely, when you
Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 30, No 11 (November), 2014: pp 1389-1391
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LETTERS TO THE EDITOR
describe lavage as “overly stretching the definition of placebo.” In our opinion, the title “Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscus tear” is misleading, and Sihvonen et al. and the New England Journal of Medicine editors are guilty of suboptimal research methods and bias, respectively.2 With regard to the ethics of sham surgery, we admire that you are published experts,3 and acknowledge its use is controversial, but we humbly distinguish sham surgery from the more acceptable form of placebo control in nonsurgical research. Strictly defined, sham is “something that is not what it appears to be and that is meant to trick or deceive people.”4 Although we agree the debate should be open, the word “sham” itself ruffles our feathers as deception. We respectfully challenge the statement that “patients are either being denied surgery that actually works, or are being exposed to unnecessary danger for an intervention that has no value beyond placebo.” This description paints a black and white picture of the gray reality. When proper indications for surgical treatment of meniscus pathology are chosen, partial meniscectomy works.5-7 And until proven otherwise, “sham” does not. James H. Lubowitz, M.D. Editor-in-Chief Matthew T. Provencher, M.D. Assistant Editor-in-Chief Michael J. Rossi, M.D. Deputy Editor Ó 2014 by the Arthroscopy Association of North America http://dx.doi.org/10.1016/j.arthro.2014.08.003
References 1. Rossi MJ, D’Agostino RB Jr, Provencher MT, Lubowitz JH. Could the New England Journal of Medicine be biased against arthroscopic knee surgery? Arthroscopy 2014;30:536-537. 2. Lubowitz JH, Provencher MT, Rossi MJ. Could the New England Journal of Medicine be biased against arthroscopic knee surgery? Part 2. Arthroscopy 2014;30:654-655. 3. Campbell MK, Entwistle VA, Cuthbertson BH, Skea Z, Sutherland AG, McDonald AM, et al. Developing a placebo controlled trial in surgery: Issues of design, acceptability and feasibility. Trials 2011;12:50. 4. Sham [Def 1]. In Merriam Webster Online. Available at http:// www.merriam-webster.com/dictionary/sham. Accessed 14 August 2014. 5. Lubowitz JH, Poehling GG. Save the meniscus. Arthroscopy 2011;27:301-302. 6. Petty CA, Lubowitz JH. Does arthroscopic partial meniscectomy result in knee osteoarthritis? A systematic review with a minimum of 8 years’ follow-up. Arthroscopy 2011;27:419-424. 7. Lubowitz JH, Appleby D. Cost-effectiveness analysis of the most common orthopaedic surgery procedures: Knee
arthroscopy and knee anterior cruciate ligament reconstruction. Arthroscopy 2011;27:1317-1322.
The Incidence of DVT To the Editor: I read with interest the article entitled “Incidence of symptomatic and asymptomatic venous thromboembolism after elective knee arthroscopic surgery: A retrospective study with routinely applied venography” by Sun et al. in the July 2014 issue. I was quite frankly surprised by the high incidence of asymptomatic DVT. Going into the specifics of the “Methods” section, it seems that Sun et al. mentioned that they started mobilization on day 4. If so, it could explain the high incidence of DVT they report. If they had started earlier, it is not obvious from the methodology. My group has published 2 studies in which there was no significant difference in DVT rates when early mobilization was begun,2,3 irrespective of DVT prophylaxis. On the basis of the numbers mentioned in the study by Sun et al.,1 could these numbers be reflective of a racial/ regional variation? Second, have they started using DVT prophylaxis routinely following these observations? Ashish Anand, M.D. Jackson, Mississippi Note: The author reports that he has no conflicts of interest in the authorship and publication of this letter. Published by Elsevier Inc. on behalf of the Arthroscopy Association of North America http://dx.doi.org/10.1016/j.arthro.2014.08.005
References 1. Sun Y, Chen D, Xu Z, et al. Incidence of symptomatic and asymptomatic venous thromboembolism after elective knee arthroscopic surgery: A retrospective study with routinely applied venography. Arthroscopy 2014;30: 818-822. 2. Raviraj A, Anand A, Kodikal G, Chandrashekar M, Pai S. A comparison of early and delayed arthroscopically assisted reconstruction of the anterior cruciate ligament using hamstring autograft. J Bone Joint Surg Br 2010;92:521-526. 3. Raviraj A, Anand A, Kodikal G. Incidence of deep vein thrombosis and thromboprophylaxis in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Indian J Orthop 2011;5:450-453.
Authors’ Reply We appreciate the concerns Dr. Anand raised in his letter on our latest study published in the July 2014 issue.
Sham Surgery Studies
To the Editor: We read with interest the recent Arthroscopy editorial on potential bias in the New England Journal of Medicine (NEJM).1 We have a significant interest in the field of sham surgery trials and also have some issues with the NEJM publication of the FIDELITY (Finnish Degenerative Meniscal Lesion Study) trial.2 We wrote to the NEJM to raise these issues but were told that we could only comment within 3 weeks of publication of the FIDELITY study. In our previously published work (which included extensive consultation with surgeons, anesthetists, patients, and ethics committee chairs),3 we explored the development of placebo (sham) operations and concluded that entering a joint with instruments and saline solution introduced the potential of confounding effects. Our sham knee arthroscopy procedure included 2 skin incisions to mimic the normal skin incisions without joint penetration. To call a diagnostic arthroscopy a placebo procedure is, we believe, overly stretching the definition of “placebo.” We would also question the use of spinal anesthesia in the study. For sham surgery, we would advocate an anesthetic that is the same as that used for routine practice, usually a general anesthetic by an experienced anesthetist. We do not, however, agree with Lubowitz et al.1 that these issues mean that “sham surgery trials may themselves be a sham.” The process is challenging, but there is a debate on the subject of arthroscopic treatment of knee degeneration that demands clear answers. Patients either are being denied surgery that actually works or are being exposed to unnecessary danger for an intervention that has no value beyond placebo, depending on your viewpoint. To suggest that patients who participate in sham surgery trials “may not be of entirely sound mind”1 and that those recommending such trials are “not ethical surgeons”1 is inflammatory and not conducive to open scientific and informed debate. The Declaration of Helsinki is, of course, essential in protecting patients involved in research and must be considered, but there are many potentially harmful interventions in routine use that are of questionable value and have an inadequate evidence basedfor example, large-head metalon-metal hip replacements or platelet-rich plasma injections. Before we become overly fixated on the
potential harm of a carefully conducted and highly regulated sham operation study, we should consider the potential harm of a treatment that is in continued use despite lack of evidence that it actually works. Alasdair G. Sutherland, M.B.Ch.B., M.D.(Hons), F.R.C.S.Ed.(Tr&Orth), F.R.A.C.S.(Orth), F.A.Orth.A. Warrnambool, Victoria, Australia Brian H. Cuthbertson, M.B.Ch.B., M.D., F.R.C.A. Toronto, Ontario, Canada Marion Campbell, Ph.D. Aberdeen, Scotland Note: The authors report the following potential conflict of interest or source of funding: A.G.S., B.H.C., and M.C. receive support from UK National Institute of Health Research Health Technology Assessment Programme (grant number 03/48/01). Crown Copyright Ó 2014 Published by Elsevier Inc. on behalf of the Arthroscopy Association of North America. All rights reserved. http://dx.doi.org/10.1016/j.arthro.2014.08.004
References 1. Lubowitz JH, Provencher MT, Rossi MJ. Could the New England Journal of Medicine be biased against arthroscopic knee surgery? Part 2. Arthroscopy 2014;30:654-655. 2. Sihvonen R, Paavola M, Malmivaara A, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscus tear. N Engl J Med 2013;369:2515-2524. 3. Campbell MK, Entwistle VA, Cuthbertson BH, et al. Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility. Trials 2011;12:50.
Editors’ Reply The editors appreciate this thoughtful letter, and we have many points in common. We too find the New England Journal of Medicine censorship of letters to the editor limiting.1 We also agree that true sham arthroscopy stops after the skin incisions, and does not include lavage. We agree that lavage is not sham. We believe you understate the case, politely, when you
Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 30, No 11 (November), 2014: pp 1389-1391
1389
1390
LETTERS TO THE EDITOR
describe lavage as “overly stretching the definition of placebo.” In our opinion, the title “Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscus tear” is misleading, and Sihvonen et al. and the New England Journal of Medicine editors are guilty of suboptimal research methods and bias, respectively.2 With regard to the ethics of sham surgery, we admire that you are published experts,3 and acknowledge its use is controversial, but we humbly distinguish sham surgery from the more acceptable form of placebo control in nonsurgical research. Strictly defined, sham is “something that is not what it appears to be and that is meant to trick or deceive people.”4 Although we agree the debate should be open, the word “sham” itself ruffles our feathers as deception. We respectfully challenge the statement that “patients are either being denied surgery that actually works, or are being exposed to unnecessary danger for an intervention that has no value beyond placebo.” This description paints a black and white picture of the gray reality. When proper indications for surgical treatment of meniscus pathology are chosen, partial meniscectomy works.5-7 And until proven otherwise, “sham” does not. James H. Lubowitz, M.D. Editor-in-Chief Matthew T. Provencher, M.D. Assistant Editor-in-Chief Michael J. Rossi, M.D. Deputy Editor Ó 2014 by the Arthroscopy Association of North America http://dx.doi.org/10.1016/j.arthro.2014.08.003
References 1. Rossi MJ, D’Agostino RB Jr, Provencher MT, Lubowitz JH. Could the New England Journal of Medicine be biased against arthroscopic knee surgery? Arthroscopy 2014;30:536-537. 2. Lubowitz JH, Provencher MT, Rossi MJ. Could the New England Journal of Medicine be biased against arthroscopic knee surgery? Part 2. Arthroscopy 2014;30:654-655. 3. Campbell MK, Entwistle VA, Cuthbertson BH, Skea Z, Sutherland AG, McDonald AM, et al. Developing a placebo controlled trial in surgery: Issues of design, acceptability and feasibility. Trials 2011;12:50. 4. Sham [Def 1]. In Merriam Webster Online. Available at http:// www.merriam-webster.com/dictionary/sham. Accessed 14 August 2014. 5. Lubowitz JH, Poehling GG. Save the meniscus. Arthroscopy 2011;27:301-302. 6. Petty CA, Lubowitz JH. Does arthroscopic partial meniscectomy result in knee osteoarthritis? A systematic review with a minimum of 8 years’ follow-up. Arthroscopy 2011;27:419-424. 7. Lubowitz JH, Appleby D. Cost-effectiveness analysis of the most common orthopaedic surgery procedures: Knee
arthroscopy and knee anterior cruciate ligament reconstruction. Arthroscopy 2011;27:1317-1322.
The Incidence of DVT To the Editor: I read with interest the article entitled “Incidence of symptomatic and asymptomatic venous thromboembolism after elective knee arthroscopic surgery: A retrospective study with routinely applied venography” by Sun et al. in the July 2014 issue. I was quite frankly surprised by the high incidence of asymptomatic DVT. Going into the specifics of the “Methods” section, it seems that Sun et al. mentioned that they started mobilization on day 4. If so, it could explain the high incidence of DVT they report. If they had started earlier, it is not obvious from the methodology. My group has published 2 studies in which there was no significant difference in DVT rates when early mobilization was begun,2,3 irrespective of DVT prophylaxis. On the basis of the numbers mentioned in the study by Sun et al.,1 could these numbers be reflective of a racial/ regional variation? Second, have they started using DVT prophylaxis routinely following these observations? Ashish Anand, M.D. Jackson, Mississippi Note: The author reports that he has no conflicts of interest in the authorship and publication of this letter. Published by Elsevier Inc. on behalf of the Arthroscopy Association of North America http://dx.doi.org/10.1016/j.arthro.2014.08.005
References 1. Sun Y, Chen D, Xu Z, et al. Incidence of symptomatic and asymptomatic venous thromboembolism after elective knee arthroscopic surgery: A retrospective study with routinely applied venography. Arthroscopy 2014;30: 818-822. 2. Raviraj A, Anand A, Kodikal G, Chandrashekar M, Pai S. A comparison of early and delayed arthroscopically assisted reconstruction of the anterior cruciate ligament using hamstring autograft. J Bone Joint Surg Br 2010;92:521-526. 3. Raviraj A, Anand A, Kodikal G. Incidence of deep vein thrombosis and thromboprophylaxis in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Indian J Orthop 2011;5:450-453.
Authors’ Reply We appreciate the concerns Dr. Anand raised in his letter on our latest study published in the July 2014 issue.
