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      “Evidence of Overuse of Medical Services Around the World” By Brownlee et al., Lancet, 2017: Does This Apply to Transforaminal Lumbar Interbody Fusions (TLIF)?

      Surgical Neurology International

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          Abstract

          INTRODUCTION In 2017, Brownlee et al. published a paper in Lancet entitled: “Evidence for overuse of medical services around the world.” In this article they discussed the overdiagnosis of “disease,” the overuse of medical devices, and resultant unnecessary treatments being performed in medicine/surgery. Here we reviewed Brownlee’s key points, and offer direct parallels to the present overuse of transforaminal lumbar interbody fusion (TLIF) to treat degenerative lumbar disc disease and stenosis with/without degenerative spondylolisthesis. Over Diagnosis, Overuse, and Overmedicalization of Medical Devices/Services Overdiagnosis Brownlee described overdiagnosis as the “…diagnostic labeling of abnormalities or symptoms that are indolent, nonprogressive or regressive, and that if left untreated or treated later will not cause significant distress or shorten the person’s life.”[2] They further discussed overdiagnosis as including “…the provision of medical services that are more likely to cause harm than good...”[2] Overuse Brownlee et al. (2017) defined: “…overuse in the form of aggressive treatment of clinically insignificant findings.”[2] In the US, they estimated overuse occurs in 6-8% of all cases, while in Medicare patients, the frequency was 29%.[2] Ausman provided yet another definition of overuse (personal communication, James I. Ausman, M.D.): “Overuse is the use of a tool or management of a problem unnecessarily.” Through a personal communication, Dr. Koo Van OverBeeke made the following comments regarding the overuse of spine instrumentation. He stated “We all know this is a money driven overuse. In the Netherlands the use of spinal instrumentation is restricted by rules from the insurance companies. Patients are not allowed to pay more by themselves; we do not have private practices for these surgeries. In other countries, such rules are known. Spinal instrumentation is much more common. Is it really necessary? It is something that we always wanted to know, but we are afraid to ask.” He also stated: “Because of the enormous rise of medical costs in the Netherlands, the ministry of health asked for a survey in order to see what is useful in the daily practice of all doctors working in Dutch hospitals. The preliminary result was that 50% of medical care was not proven to be of any effect compared with no medical treatment. Of course, medical treatment should be tailored to any individual patient , which means that a medical treatment can be useful for one patient and not for the other”. Overmedicalization Overmedicalization, according to Brownlee et al. consisted of: “…disease or abnormality…leading to populations previously considered “normal” or health being labeled as diseased.”[2] For example, degenerative findings attributed to the normal aging process in the spine should not necessarily be considered “disease” warranting any intervention; e.g. epidural injections, and surgery. Promoting such treatment options in the absence of significant “pathology” would, therefore, fall under their definition of overmedicalization. Further, Brownlee et al. described providing such services as those “… that are unnecessary in any way and for any reason…” for which there was no “… evidence or consensus-based guidelines….”[2] Application of Browlnee et al. Overuse, Overdiagnosis, and Overmedicalization As It Could Be Applied to TLIF (Transforaminal Lumbar Interbody Fusion) Certainly, overuse, overdiagnosis, and overmedicalization would apply to many of the transforaminal lumbar interbody fusions (TLIF) vs. decompression alone performed to treat lumbar disc disease, stenosis, with/without degenerative spondylolisthesis (DS). In 2018, Epstein reviewed the outcomes/complications of performing laminectomy alone for patients with 2-3 level (58 patients; stenosis/disc disease) and 4-6 level lumbar disease (79-disc disease/ stenosis/26 DS).[4] Postoperatively, patients experienced: no new neurological deficits, no infections, no adjacent segment disease (ASD), no readmissions, 1 reoperation (seroma; in-house postoperative day 7), and 4 (2.9%) cerebrospinal fluid fistulas.[4] These results were better than those complications cited in the literature associated with TLIF/MI TLIF that ranged from 7.7% to 23.0%. For example, for TLIF/MI TLIF, the following complication rates were reported; wound infections (8.3% vs. 0% for laminectomies alone), durotomies (6.1% vs. 2.9%), permanent neurological deficits (9.7% vs. 0%), new sensory deficits (20.2% vs. 0%), and reoperation rates (1.6-6% vs. 0.7%). The following additional complications were unique to TLIF/MI TLIF; 2.3% instrumentation failure, 1.26-2.4% cage migration, 0.8% cage extrusions, and 1.6% misplaced screws (1.6%), for an additional total complication rate of 7.1% not observed for laminectomy alone. SPORT Trial Documented Efficacy of Laminectomy (With or Without Fusion) For Lumbar Degenerative Spondylolisthesis (DS) Abdu et al. in their 2018 randomized controlled Spine Patient Outcomes Research Trial (SPORT) evaluated the 8-year outcomes for patients from 13 centers treated for DS utilizing “decompressive laminectomy (with or without fusion) versus standard nonoperative care.”[1] They found that DS treated surgically resulted in better 8-year outcomes vs. those managed non surgically. However, outcomes for all fusion groups were comparable; laminectomy with non- instrumented PLF (posterolateral fusion), instrumented PLF, and 360 instrumented fusions (e.g. including TLIF).[1] Not only should spinal surgeons reassess whether they are overdiagnosing and overmedicalizing DS, but they should also recognize and reemphasize the efficacy of laminectomy without fusion to avoid overusing medical devices. Failure of Industry-Supported Studies to Report Complications of TLIF/MI TLIF In 2011, the Carraggee et al. article “A Critical Review of Recombinant Human Bone Morphogenetic Protein-2 Trials in Spinal Surgery” reviewed the results of 13 Medtronic- funded studies in which they found skewed results favoring the product rhBMP-2.[3] They noted: “In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, particularly TLIF, adverse events …were either not reported at all, or not reported to be associated with rhBMP-2 use.”[3] In the 13 industry-sponsored rhBMP-2 publications, analyzing 80 patients receiving rhBMP-2 (e.g. in prospective controlled studies) they found: “No rhBMP-2-associated adverse events (0%).” Furthermore, the study designs were found to be heavily biased in favor of surgical RhBMP-2 use. Reviewing “FDA documents and subsequent publications” they found “originally unpublished adverse events and internal inconsistencies.” The result was the discovery of a previously unreported 10%-50% incidence of adverse events when using rhBMP-2 use in spine fusion (i.e. especially TLIF/MI TLIF), while a 40% risk of complications (e.g. including life-threatening events) occurred in patients undergoing anterior cervical fusion with rhBMP-2. CONCLUSION As so aptly described by Brownlee et al. (2017), today’s practice of spine surgery, particularly as it concerns TLIF/ MI TLIF, is overshadowed by the overdiagnosis, overuse, and performance of unnecessary operations.[2]

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          Most cited references 4

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          A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned.

          Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight. To compare the conclusions regarding the safety and related efficacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases. Systematic review. Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efficacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses. There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2-associated adverse events (0%) were reported in any of these studies (99% confidence interval of adverse event rate <0.5%). The study designs of the industry-sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects reported early back pain and leg pain adverse events; higher doses of rhBMP-2 were also associated with a greater apparent risk of new malignancy. Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications. Copyright © 2011 Elsevier Inc. All rights reserved.
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            Evidence for overuse of medical services around the world.

            Overuse, which is defined as the provision of medical services that are more likely to cause harm than good, is a pervasive problem. Direct measurement of overuse through documentation of delivery of inappropriate services is challenging given the difficulty of defining appropriate care for patients with individual preferences and needs; overuse can also be measured indirectly through examination of unwarranted geographical variations in prevalence of procedures and care intensity. Despite the challenges, the high prevalence of overuse is well documented in high-income countries across a wide range of services and is increasingly recognised in low-income countries. Overuse of unneeded services can harm patients physically and psychologically, and can harm health systems by wasting resources and deflecting investments in both public health and social spending, which is known to contribute to health. Although harms from overuse have not been well quantified and trends have not been well described, overuse is likely to be increasing worldwide.
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              Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT).

              Randomized trial with a concurrent observational cohort study.
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                Author and article information

                Contributors
                Journal
                Surg Neurol Int
                Surg Neurol Int
                Surgical Neurology International
                Scientific Scholar (USA )
                2229-5097
                2152-7806
                2019
                02 August 2019
                : 10
                Affiliations
                Professor of Clinical Neurosurgery, School of Medicine, State University of New York at Stony Brook, New York, and Chief of Neurosurgical Spine and Education, NYU Winthrop Hospital, NYU Winthrop NeuroScience/Neurosurgery, Mineola, New York 11501, United States.
                Author notes
                [* ] Corresponding author: Nancy E. Epstein, M.D., NYU Winthrop Hospital, NYU Winthrop NeuroScience/Neurosurgery, 200 Old Country Rd. Suite 485, Mineola, NY 11501, United States. nancy.epsteinmd@ 123456gmail.com
                SNI-10-154
                10.25259/SNI_386_2019
                6744801
                Copyright: © 2019 Surgical Neurology International

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

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