Treatments should always incur the least potential harm to the patient
Hans-Rudolf Weiss, Private Practice
18 September 2013
We appreciate the response by Dr. Shay Bess [1] regarding "Indication for surgical treatment in patients with adolescent Idiopathic Scoliosis - a critical appraisal," May 24, 2013[2]. To be clear, it was a letter to the editor, not a review.
Obviously, there is substantial disagreement regarding treatment for scoliosis. Our concerns are regarding surgeries and when they are warranted. The results of recent long-term studies referenced [3] or lack thereof are another concern. It is essential to stimulate dialogue for the benefit of the long-term health and awareness for patients with AIS.
The overzealous use of surgery as a treatment for scoliosis is a concern because of potential complications in the short and long term. Surgery for scoliosis is routinely carried out primarily to address cosmetic appearance and prevent progression. It is not performed to improve ventilatory function [4].
In treating AIS, we find it problematic that many in the surgical community have chosen to ignore the general conclusions in studies on natural history. In their conclusion, Weinstein et al specifically state, "Untreated adults with LIS are productive and functional at a high level at 50-year follow-up. Untreated LIS causes little physical impairment other than back pain and cosmetic concerns [5]."
Incidentally, these conclusions are why the term "relatively benign" was chosen to describe AIS, as others preceding us have also referred to it [6]. Our terminology is in no way meant to downplay the very real effect of scoliosis.
Dr. Bess objects to citations authored by HRW [7] as anti-surgery in tone and content, yet conclusions drawn are from current literature. In fact, Hawes was the first author to have pointed out a lack of evidence for surgery [8]. The sad reality is, few have ever challenged surgery for AIS in a field which surgeons dominate and manage. Most patients and parents naturally have an aversion to surgery for scoliosis yet most spinal surgeons lead patients to believe there is no other choice.
We agree with Dr. Bess' statement calling for an "open minded view" regarding treatment options for scoliosis. It is a position we have been advocating for years.
We contend that any "open minded view" should include full disclosure about the potential unknowns of surgery in the short and long term so families may weigh the myriad of unknowns against the perceived benefits. Examples include, but are not limited to: pain, hardware failure including breakage, corrosion [9], advanced degeneration, late infections [7], and the potential for one or more revision surgeries.
Dr. Bess takes issue with our interpretation from Mueller and Gluch calling the study an outlier perhaps because the conclusions do not satisfy his agenda or those of his cited affiliates. Outlier or not, at minimum, their article raises the point that additional long-term follow-ups are necessary before subjecting patients to potential risk. Risks must be disclosed so patients are aware that after two, three four or five decades' unintended consequences or additional surgeries could be their fate.
Dr. Bess states we have a "single-sided view," implying bias referring to a "zealous rejection of surgery for AIS." A similar counter-accusation can be made with equal justification on our part. Our purpose as conservative care physicians is to empower patients to manage scoliosis non-surgically. If that results in a bias, we are guilty as charged. Although our methods differ from surgeons, our ultimate goals are the same: to help patients lead the highest quality of life possible while living with scoliosis. We recognize there are a few exceptions when surgery may be warranted.
Avoiding bias is indeed a challenge for all physicians who are passionate and dedicated to their field, or niche within that field. We must constantly strive to that end for the benefit of the patient. Unfortunately, many prominent spinal surgeons have affiliations with medical device companies, as Dr. Bess reveals of himself. His current relationships with Depuy Spine, Medtronic, K2M, Allosource and Pioneer Spine could lead a reasonable person to believe that perhaps those relationships create a bias. In the recent decade, questionable relationships between other spinal surgeons and medical device companies have been reported in the Wall Street Journal [10] and the New York Times [11].
Also, there are hundreds, probably thousands of published works by SRS surgeons, and others, with stated conflicts of interest in regard to device patents and affiliations, also raising the question of bias.
Spinal fusion surgery is a very lucrative procedure. Patient testimonials in the online forum of the National Scoliosis Foundation report surgeon fees which could be considered astronomical. As a result, Martha Hawes devotes a chapter of her book to, "The appearance of a conflict of interest [6]." We understand that our "zeal" for treating scoliosis conservatively puts us in the minority and in direct opposition with surgeons. Dr. Bess refers to our beliefs as jaded, however, one could surmise that certain surgeons also have a jaded view. How is it responsible to inform patients with little remaining growth and balanced curves that nothing can be done short of surgery? From our perspective, this certainly indicates a bias for surgery in light of natural history studies which seem to have been ignored by many.
As advocates for patients and families, we merely want informed consent - in every sense - to ensure that patients understand the potential long-term complications of surgery and revision surgery or surgeries. These complications may result in consequences far worse than living with scoliosis itself. Anecdotally, clinical experience has revealed those living with negative long-term effects of surgery are perhaps underestimated due to doctor hopping by patients desperately trying to solve the problems of scoliosis post-surgically, two, three, four, or more decades later - also the subject of frequent discussion on the NSF online forum.
Post-surgical patients have presented with descriptions of lives spent in pain with x-ray images confirming advanced degeneration. Few long-term studies exist, but one cites the likelihood of early disc degeneration post-surgically in the non-fused segments due to hypermobility [12].
It is well understood that surgical procedures are constantly evolving but this underscores our point that patients should be made aware that the long-term is unknown.
Dr. Bess cites several HRQOL (health-related quality of life) studies as support for the necessity of surgery. HRQOL's are a virtuous effort, but we posit at best they are subjective measures. As stated in our original publication, they fail to take the effects of cognitive dissonance into account. No one will argue against wanting to improve health-related quality of life scores when possible, or that HRQOL for adolescents with AIS differs from those who are unaffected by the condition. The latest information states that self-image is the sole area that differs from a clinical perspective [13]. However, the larger question is whether a procedure as invasive as spinal fusion is necessary for improved HRQOL's, or will the long term outcomes actually result in improved HRQOL's should post-surgical complications occur after a period of time?
The HRQOL studies cited by Bess do little to assuage our concerns about surgery and contribute little to a discussion about evidence based medicine on behalf of the patient in the long term. For example, one of the studies presented as evidence about the benefits of surgery is a parent -patient questionnaire. The study states, "Based on SRS-24 data, parents typically scored higher than their children in the operative treatment of idiopathic scoliosis in total score, self-image, and overall satisfaction [14]." In the end, does matter what the parents' perceptions are? Our concern is with the patients in the long term. Using this type of evidence to support claims for surgery does little to strengthen the argument for surgery.
One last note on HRQOL, perhaps Dr. Bess has missed the point of our submission indicating concerns about the long term since his citations are for HRQOL's of mostly 6 - 12 months post-surgery, with the longest having a mean of 24 months [1]. This evidence only serves to emphasize how few studies exist on long-term follow-up. For the patient, this ultimately raises the question, are minimal statistical changes in HRQOL a reason to expose oneself or a child to the unknown risks and their effects over a lifetime for a surgical procedure not supported by any prospective controlled trial [7,8]?
Indeed, it is a fact that surgery for AIS is the only treatment option not supported by any prospective controlled study. Cochrane reviews of physical methods exist concluding there is a lack of high quality evidence, and on bracing admittedly, low quality evidence [16]. Furthermore, it should be noted, there is a Cochrane review of surgery, not for AIS, but for neuromuscular scoliosis [17]. This review fails to show necessity of surgery.
Dr. Bess takes issue with our citing of Westrick and Ward, and their statement, "no long term, prospective controlled studies exist to support the hypothesis that surgical intervention for AIS is superior to natural history [18]." His response: to cite limitations in the literature, which is exactly our point - limitations exist. He also claims the natural history studies are "poorly performed historical studies with incomplete follow-up and poor metrics."
Let us agree to disagree, but foremost to consider the long-term safety of patients. In the field of AIS, certainly most physicians will agree there are still many unknowns. There are few ideal treatment protocols available for scoliotics, especially from a patients' perspective. This is why dialogue must be in keeping with the goal that treatments should always incur the least potential harm to the patient.
[1] Bess Shay. Response to Weiss HR, Moramarco M: Indication for surgical treatment in patients with adolescent idiopathic scoliosis - a critical appraisal. Patient Safety in Surgery, 2013, 7:26. Published online 2013 July 18. doi: 10.1186/1754-9493-7-26.
[2] Weiss HR, Moramarco M. Indication for surgical treatment in patients with adolescent Idiopathic Scoliosis - a critical appraisal. Patient Safety in Surgery, 2013, 7:17.
[3] Mueller FJ, Gluch H. Cotrel-dubousset instrumentation for the correction of adolescent idiopathic scoliosis. Long-term results with an unexpected high revision rate. Scoliosis, 2012, 7:13. doi: 10.1186/1748-7161-7-13.
[4] Alpert Richard K, Spiro Stephen G BSC MD, Jett James R, MD, eds. Clinical Respiratory Medicine. 3rd Ed. Philadelphia: Mosby, Inc; 2008. 898. Online and in print.
[5] Weinstein Stuart L, Dolan Lori A, Spratt Kevin F, Peterson Kirk K, Spoonamore Mark J, Ponseti Ignacio V. Health and Function of Patients with Untreated Idiopathic Scoliosis: A 50 Year Natural History Study. JAMA 2003;289(5):559-567. doi: 10.1001/jama.289.5.559.
[6] Hawes, Martha C. Scoliosis and the Human Spine. 2nd Edition: West Tucson Press: 2003.
[7] Weiss HR, Moramarco M: Scoliosis - treatment indications according to current evidence.
OA Musculoskeletal Med, 2013, 1(1):1.
[8] Hawes M: Impact of spine surgery on signs and symptoms of spinal deformity. Pediatric Rehabilitation. 2006;9(4):318-39.
[9] Akazawa T, Minami S, Takahashi K, Kotani T, Hanawa T, Moriya H. Corrosion of spinal implants retrieved from patients with scoliosis. J Orthop Sci. 2005;10(2):200-5.
[12] Luk KD, Lee FB, Leong JC, Hsu LC. The effect on the lumbosacral spine of long spinal fusion for idiopathic scoliosis. A minimum 10-year follow-up. Spine. 1987 Dec;12(10):996-1000.
[13] Rushton, Paul R, Grevitt, Michael P. Comparison of Untreated Adolescent Idiopathic Scoliosis With Normal Controls: A Review and Statistical Analysis of the Literature. Spine. 2013;38(9):778-785. doi: 10.1097/BRS.0b013e31827db418.
[14]Rinella A, Lenke L, Peelle M. et al. Comparison of SRS questionnaire results submitted by both parents and patients in the operative treatment of idiopathic scoliosis. Spine. 2004;7:303-310. doi: 10.1097/01.BRS.0000106489.03355.C5.
[15] Romano, M, Minozzi S, Zaina F, Saltikov JB, Chockalingam N, Kotwicki T, Hennes AM, Negrini S. Exercises for adolescent idiopathic scoliosis: a Cochrane systematic review. Spine. 2013;38(14):E883-93. doi: 10.1097/BRS.0b013e31829459f8.
[16] Negrini, S, Minozzi, S, Bettany-Saltikov J, Zaina F, Chockalingam N, Grivas T, Kotwicki T, Maruyama T, Romano M, Vasiliadis E. Braces for idiopathic scoliosis in adolescents. A cochrane review. Scoliosis, 2012, 5(Suppl 1):O58. Published online 2010 September 10. doi: 10.1186/1748-7161-5-S1-O58.
[17] Cheuk DKL, Wong V, Wraige E, Baxter P, Cole A, N'Diaye T. Surgery for scoliosis in Duchenne muscular dystrophy. Editorial Group: Cochrane Neuromuscular Disease Group. Cochrane Database Syst Rev 2013 Feb.
[18] Westrick ER, Ward WT. Adolescent idiopathic scoliosis: 5-year to 20-year evidence-based surgical results. J Pediatr Orthop. 2011;7:S61-S68.
K. Moramarco, HR Weiss, M Moramarco
Competing interests
KM and MM declare that they have no competing interest, HRW is advisor of Koob GmbH, Germany.
Patient Safety in Surgery
Treatments should always incur the least potential harm to the patient
18 September 2013
We appreciate the response by Dr. Shay Bess [1] regarding "Indication for surgical treatment in patients with adolescent Idiopathic Scoliosis - a critical appraisal," May 24, 2013[2]. To be clear, it was a letter to the editor, not a review.
Obviously, there is substantial disagreement regarding treatment for scoliosis. Our concerns are regarding surgeries and when they are warranted. The results of recent long-term studies referenced [3] or lack thereof are another concern. It is essential to stimulate dialogue for the benefit of the long-term health and awareness for patients with AIS.
The overzealous use of surgery as a treatment for scoliosis is a concern because of potential complications in the short and long term. Surgery for scoliosis is routinely carried out primarily to address cosmetic appearance and prevent progression. It is not performed to improve ventilatory function [4].
In treating AIS, we find it problematic that many in the surgical community have chosen to ignore the general conclusions in studies on natural history. In their conclusion, Weinstein et al specifically state, "Untreated adults with LIS are productive and functional at a high level at 50-year follow-up. Untreated LIS causes little physical impairment other than back pain and cosmetic concerns [5]."
Incidentally, these conclusions are why the term "relatively benign" was chosen to describe AIS, as others preceding us have also referred to it [6]. Our terminology is in no way meant to downplay the very real effect of scoliosis.
Dr. Bess objects to citations authored by HRW [7] as anti-surgery in tone and content, yet conclusions drawn are from current literature. In fact, Hawes was the first author to have pointed out a lack of evidence for surgery [8]. The sad reality is, few have ever challenged surgery for AIS in a field which surgeons dominate and manage. Most patients and parents naturally have an aversion to surgery for scoliosis yet most spinal surgeons lead patients to believe there is no other choice.
We agree with Dr. Bess' statement calling for an "open minded view" regarding treatment options for scoliosis. It is a position we have been advocating for years.
We contend that any "open minded view" should include full disclosure about the potential unknowns of surgery in the short and long term so families may weigh the myriad of unknowns against the perceived benefits. Examples include, but are not limited to: pain, hardware failure including breakage, corrosion [9], advanced degeneration, late infections [7], and the potential for one or more revision surgeries.
Dr. Bess takes issue with our interpretation from Mueller and Gluch calling the study an outlier perhaps because the conclusions do not satisfy his agenda or those of his cited affiliates. Outlier or not, at minimum, their article raises the point that additional long-term follow-ups are necessary before subjecting patients to potential risk. Risks must be disclosed so patients are aware that after two, three four or five decades' unintended consequences or additional surgeries could be their fate.
Dr. Bess states we have a "single-sided view," implying bias referring to a "zealous rejection of surgery for AIS." A similar counter-accusation can be made with equal justification on our part. Our purpose as conservative care physicians is to empower patients to manage scoliosis non-surgically. If that results in a bias, we are guilty as charged. Although our methods differ from surgeons, our ultimate goals are the same: to help patients lead the highest quality of life possible while living with scoliosis. We recognize there are a few exceptions when surgery may be warranted.
Avoiding bias is indeed a challenge for all physicians who are passionate and dedicated to their field, or niche within that field. We must constantly strive to that end for the benefit of the patient. Unfortunately, many prominent spinal surgeons have affiliations with medical device companies, as Dr. Bess reveals of himself. His current relationships with Depuy Spine, Medtronic, K2M, Allosource and Pioneer Spine could lead a reasonable person to believe that perhaps those relationships create a bias. In the recent decade, questionable relationships between other spinal surgeons and medical device companies have been reported in the Wall Street Journal [10] and the New York Times [11].
Also, there are hundreds, probably thousands of published works by SRS surgeons, and others, with stated conflicts of interest in regard to device patents and affiliations, also raising the question of bias.
Spinal fusion surgery is a very lucrative procedure. Patient testimonials in the online forum of the National Scoliosis Foundation report surgeon fees which could be considered astronomical. As a result, Martha Hawes devotes a chapter of her book to, "The appearance of a conflict of interest [6]." We understand that our "zeal" for treating scoliosis conservatively puts us in the minority and in direct opposition with surgeons. Dr. Bess refers to our beliefs as jaded, however, one could surmise that certain surgeons also have a jaded view. How is it responsible to inform patients with little remaining growth and balanced curves that nothing can be done short of surgery? From our perspective, this certainly indicates a bias for surgery in light of natural history studies which seem to have been ignored by many.
As advocates for patients and families, we merely want informed consent - in every sense - to ensure that patients understand the potential long-term complications of surgery and revision surgery or surgeries. These complications may result in consequences far worse than living with scoliosis itself. Anecdotally, clinical experience has revealed those living with negative long-term effects of surgery are perhaps underestimated due to doctor hopping by patients desperately trying to solve the problems of scoliosis post-surgically, two, three, four, or more decades later - also the subject of frequent discussion on the NSF online forum.
Post-surgical patients have presented with descriptions of lives spent in pain with x-ray images confirming advanced degeneration. Few long-term studies exist, but one cites the likelihood of early disc degeneration post-surgically in the non-fused segments due to hypermobility [12].
It is well understood that surgical procedures are constantly evolving but this underscores our point that patients should be made aware that the long-term is unknown.
Dr. Bess cites several HRQOL (health-related quality of life) studies as support for the necessity of surgery. HRQOL's are a virtuous effort, but we posit at best they are subjective measures. As stated in our original publication, they fail to take the effects of cognitive dissonance into account. No one will argue against wanting to improve health-related quality of life scores when possible, or that HRQOL for adolescents with AIS differs from those who are unaffected by the condition. The latest information states that self-image is the sole area that differs from a clinical perspective [13]. However, the larger question is whether a procedure as invasive as spinal fusion is necessary for improved HRQOL's, or will the long term outcomes actually result in improved HRQOL's should post-surgical complications occur after a period of time?
The HRQOL studies cited by Bess do little to assuage our concerns about surgery and contribute little to a discussion about evidence based medicine on behalf of the patient in the long term. For example, one of the studies presented as evidence about the benefits of surgery is a parent -patient questionnaire. The study states, "Based on SRS-24 data, parents typically scored higher than their children in the operative treatment of idiopathic scoliosis in total score, self-image, and overall satisfaction [14]." In the end, does matter what the parents' perceptions are? Our concern is with the patients in the long term. Using this type of evidence to support claims for surgery does little to strengthen the argument for surgery.
One last note on HRQOL, perhaps Dr. Bess has missed the point of our submission indicating concerns about the long term since his citations are for HRQOL's of mostly 6 - 12 months post-surgery, with the longest having a mean of 24 months [1]. This evidence only serves to emphasize how few studies exist on long-term follow-up. For the patient, this ultimately raises the question, are minimal statistical changes in HRQOL a reason to expose oneself or a child to the unknown risks and their effects over a lifetime for a surgical procedure not supported by any prospective controlled trial [7,8]?
Indeed, it is a fact that surgery for AIS is the only treatment option not supported by any prospective controlled study. Cochrane reviews of physical methods exist concluding there is a lack of high quality evidence, and on bracing admittedly, low quality evidence [16]. Furthermore, it should be noted, there is a Cochrane review of surgery, not for AIS, but for neuromuscular scoliosis [17]. This review fails to show necessity of surgery.
Dr. Bess takes issue with our citing of Westrick and Ward, and their statement, "no long term, prospective controlled studies exist to support the hypothesis that surgical intervention for AIS is superior to natural history [18]." His response: to cite limitations in the literature, which is exactly our point - limitations exist. He also claims the natural history studies are "poorly performed historical studies with incomplete follow-up and poor metrics."
Let us agree to disagree, but foremost to consider the long-term safety of patients. In the field of AIS, certainly most physicians will agree there are still many unknowns. There are few ideal treatment protocols available for scoliotics, especially from a patients' perspective. This is why dialogue must be in keeping with the goal that treatments should always incur the least potential harm to the patient.
[1] Bess Shay. Response to Weiss HR, Moramarco M: Indication for surgical treatment in patients with adolescent idiopathic scoliosis - a critical appraisal. Patient Safety in Surgery, 2013, 7:26. Published online 2013 July 18. doi: 10.1186/1754-9493-7-26.
[2] Weiss HR, Moramarco M. Indication for surgical treatment in patients with adolescent Idiopathic Scoliosis - a critical appraisal. Patient Safety in Surgery, 2013, 7:17.
[3] Mueller FJ, Gluch H. Cotrel-dubousset instrumentation for the correction of adolescent idiopathic scoliosis. Long-term results with an unexpected high revision rate. Scoliosis, 2012, 7:13. doi: 10.1186/1748-7161-7-13.
[4] Alpert Richard K, Spiro Stephen G BSC MD, Jett James R, MD, eds. Clinical Respiratory Medicine. 3rd Ed. Philadelphia: Mosby, Inc; 2008. 898. Online and in print.
[5] Weinstein Stuart L, Dolan Lori A, Spratt Kevin F, Peterson Kirk K, Spoonamore Mark J, Ponseti Ignacio V. Health and Function of Patients with Untreated Idiopathic Scoliosis: A 50 Year Natural History Study. JAMA 2003;289(5):559-567. doi: 10.1001/jama.289.5.559.
[6] Hawes, Martha C. Scoliosis and the Human Spine. 2nd Edition: West Tucson Press: 2003.
[7] Weiss HR, Moramarco M: Scoliosis - treatment indications according to current evidence.
OA Musculoskeletal Med, 2013, 1(1):1.
[8] Hawes M: Impact of spine surgery on signs and symptoms of spinal deformity. Pediatric Rehabilitation. 2006;9(4):318-39.
[9] Akazawa T, Minami S, Takahashi K, Kotani T, Hanawa T, Moriya H. Corrosion of spinal implants retrieved from patients with scoliosis. J Orthop Sci. 2005;10(2):200-5.
[10] http://online.wsj.com/article/SB10001424052748703395204576024023361023138.html
[11] http://www.nytimes.com/2006/12/30/business/30spine.html?pagewanted=all
[12] Luk KD, Lee FB, Leong JC, Hsu LC. The effect on the lumbosacral spine of long spinal fusion for idiopathic scoliosis. A minimum 10-year follow-up. Spine. 1987 Dec;12(10):996-1000.
[13] Rushton, Paul R, Grevitt, Michael P. Comparison of Untreated Adolescent Idiopathic Scoliosis With Normal Controls: A Review and Statistical Analysis of the Literature. Spine. 2013;38(9):778-785. doi: 10.1097/BRS.0b013e31827db418.
[14]Rinella A, Lenke L, Peelle M. et al. Comparison of SRS questionnaire results submitted by both parents and patients in the operative treatment of idiopathic scoliosis. Spine. 2004;7:303-310. doi: 10.1097/01.BRS.0000106489.03355.C5.
[15] Romano, M, Minozzi S, Zaina F, Saltikov JB, Chockalingam N, Kotwicki T, Hennes AM, Negrini S. Exercises for adolescent idiopathic scoliosis: a Cochrane systematic review. Spine. 2013;38(14):E883-93. doi: 10.1097/BRS.0b013e31829459f8.
[16] Negrini, S, Minozzi, S, Bettany-Saltikov J, Zaina F, Chockalingam N, Grivas T, Kotwicki T, Maruyama T, Romano M, Vasiliadis E. Braces for idiopathic scoliosis in adolescents. A cochrane review. Scoliosis, 2012, 5(Suppl 1):O58. Published online 2010 September 10. doi: 10.1186/1748-7161-5-S1-O58.
[17] Cheuk DKL, Wong V, Wraige E, Baxter P, Cole A, N'Diaye T. Surgery for scoliosis in Duchenne muscular dystrophy. Editorial Group: Cochrane Neuromuscular Disease Group. Cochrane Database Syst Rev 2013 Feb.
[18] Westrick ER, Ward WT. Adolescent idiopathic scoliosis: 5-year to 20-year evidence-based surgical results. J Pediatr Orthop. 2011;7:S61-S68.
K. Moramarco, HR Weiss, M Moramarco
Competing interests
KM and MM declare that they have no competing interest, HRW is advisor of Koob GmbH, Germany.