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Letter to the Editor in response to: “A critical appraisal of the North American Spine Society guidelines with the Appraisal of Guidelines for Research and Evaluation II instrument”
2300
Letters to the Editor / The Spine Journal 15 (2015) 2297–2301
fails. The three-column fixation of the pedicle screw system can provide good stability and mechanical strength [5]. The implants are far from the lesions. Thus, posterior pedicle screw system is the first choice for fixation and correction of thoracolumbar spinal TB. The focuses can be debrided through the anterior approach. Comparatively speaking, our novel technique through different muscle windows via a posterior midline approach and debridement through a cross-window allowed debridement, decompression of the anterior spine, bone graft fusion, orthopedic internal fixation, and thorough drainage. The procedure is characterized by focus debridement. It decomposes multisegmental lesions into cross adjacent single unit to debridement and bone graft. It simplifies the procedure and reduces surgical trauma. But it needs a deep surgical field and requires a long learning curve. The classic finding of spinal TB is mainly characterized by destruction of disc. This can identify with malignancy or metastasis through preoperative imaging data. There are large paravertebral abscesses (gravitation abscess) in the multisegmental spinal TB. Less often, posterior elements of the spine may be involved in Pott disease [6]. In laboratory tests, the change of erythrocyte sedimentation rate, CRP, and TB-specific indicators (eg, interferon gamma release assay (IGRA), t cells spot detection (T-SPOT)) also serves as reference to identify preoperative diagnosis. If the aforementioned evidences were supported, we had not biopsied conventionally. We admitted that biopsy from the lesions is the gold standard for diagnosis. For the suspected cases (central vertebral TB, intervertebral atypical destroyed, no paraspinal abscess, and so forth), biopsy do have a higher clinical value for diagnosis.
References [1] Gao Z, Wang M, Zhu W, Zheng G, Meng Y. Tuberculosis of ultralong segmental thoracic and lumbar vertebrae treated by posterior fixation and cleaning of the infection center through a cross-window. Spine J 2015;15:71–8. [2] Oguz E, Sehirlioglu A, Altinmakas M, Ozturk C, Komurcu M, Solakoglu C. A new classification and guide for surgical treatment of spinal tuberculosis. Int Orthop 2008;32:127–33. [3] Jin DD, Qu DB, Chen JT, Zhang H. One-stage anterior interbody autografting and instrumentation in primary surgical management of thoracolumbar spinal tuberculosis. Eur Spine J 2004;13:114–21. [4] Li L, Xu J, Ma Y. Surgical strategy and management outcomes for adjacent multisegmental spinal tuberculosis: a retrospective study of forty-eight patients. Spine (Phila Pa 1976) 2014;39:E40–8. [5] Moran JM, Berg WS, Berry JL. Transpedicular screw fixation. J Orthop Res 1989;107–14. [6] De Backer AI, Mortele KJ, Vanschoubroeck IJ. Tuberculosis of the spine: CT and MR imaging features. JBR-BTR 2005;92–7.
Zhichao Gao Department of Orthopedics Yuhang Hospital Affiliated to Medical College of Hangzhou Normal University
Hangzhou 311100 Zhejiang Province, China FDA device/drug status: Not applicable. Author disclosures: ZG: Nothing to disclose. 1529-9430 Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.spinee.2015.07.434
Letter to the Editor in response to: ‘‘A critical appraisal of the North American Spine Society guidelines with the Appraisal of Guidelines for Research and Evaluation II instrument’’ To the Editors: We thank the authors for their interest in NASS guidelines and appreciate the opportunity to reply. The authors applied the AGREE II [1] instrument in evaluation of NASS guidelines and suggest that ‘‘NASS guidelines seem good overall, but individual qualities still need improvement.’’ [2] It should be stated that while widely used for the assessment of guidelines, the AGREE II instrument has documented limitations, including the inability to evaluate the clinical appropriateness or validity of guideline recommendations and the need to improve certain instrument concepts, such as representation of patient-public engagement and the items related to applicability and implementability of the guideline [3]. In addition, the authors suggest that AGREE was found to be the most effective system for guideline assessment in a review of 24 appraisal tools [4]. This is misleading as the purpose of this study was to identify critical appraisal tools for guidelines that would serve in developing a critical appraisal tool for clinical pathways, not to validate these tools for guidelines. In response to specific criticism, the NASS guidelines scored the lowest under ‘‘Domain 2: Stakeholder Involvement.’’ NASS does agree that increasing stakeholder input may improve the overall guideline quality. This has been a topic of internal discussion for the past couple years, and has resulted in change in our methodology to include multiple stakeholders beyond our multidisciplinary panel. This is being implemented as of our current guideline in progress. Of note, however, the purpose of this domain in AGREE II is to evaluate the composition of the work group and intended audience [1], not to assess nor recommend the testing or piloting of guidelines by target users before publication, as suggested by the authors. The NASS Guidelines also received low scores in ‘‘Domain 5: Applicability.’’ The application of Domain 5 is an area under debate by the AGREE Consortium and is being slated for future research [3]; therefore, its validity is uncertain. Regardless, our recent guideline processes have placed greater emphasis on cost-effectiveness and value of
Letters to the Editor / The Spine Journal 15 (2015) 2297–2301
treatments, although we have found that to date available evidence to make recommendations of this sort is generally poor or absent. NASS guidelines scored a median of 71.8% in ‘‘Domain 6: Editorial Independence.’’ While it was stated that there was consensus on editorial independence, the authors provided low scores for ‘‘poor statement of disclosures.’’ This is simply inaccurate. All guideline participants disclose all conflicts of interest in accordance with NASS’ Disclosure Policy for Committee Members and these are clearly documented at the beginning of each document [5]. In addition, members with any conflicts relevant to the subject matter are asked to recuse themselves from deliberation. NASS has been a leader in managing conflicts of interest, and continues to uphold itself to the highest standards for ethics and disclosure. In closing, we appreciate this feedback. NASS is committed to the highest quality, ethical, value and evidencebased spine care for patients, and we will continue to evaluate and modify our processes to ensure the publication of high quality guidelines. References [1] The AGREE II Instrument [Electronic version]. Available at: http:// www.agreetrust.org. Accessed May 7, 2015. [2] Yaman ME, Gudeloglu A, Senturk S, Yaman ND, Tolunay T, Ozturk Y, et al. A critical appraisal of the North American Spine Society guidelines with the Appraisal of Guidelines for Research and Evaluation II instrument. Spine J 2015;15:777–81. [3] Brouwers M, Kho ME, Browman GP, Cluzeau F, feder G, Fervers B, et al. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J 2010;182: E839–42. [4] Vlayen J, Aertgeerts B, Hannes K, Sermeus W, Ramaekers D. A systematic review of appraisal tools for clinical practice guidelines: multiple similarities and one common deficit. Int J Qual Health Care 2005;17:235–42. [5] North American Spine Society. Disclosure Policy. Adopted January 13, 2006. Revised March 2012. Burr Ridge, IL: North American Spine Society. Available at: https://www.spine. org/Documents/WhoWeAre/DisclosurePolicy.pdf. Accessed May 7, 2015.
Charles H. Cho, MD, MBA NASS Evidence Compilation and Analysis Chair Department of Radiology Brigham and Women’s Hospital
2301
Harvard Medical School 75 Francis St, Boston MA 02115, USA Zoher Ghogawala, MD NASS Clinical Research Development Chair Department of Neurosurgery Lahey Hospital & Medical Center Burlington, MA, USA Paul Matz, MD NASS Evidence-Based Guideline Development Committee Co-Chair Neurosurgery & Neurology LLC, Chesterfield MO, USA D. Scott Kreiner, MD NASS Evidence-Based Guideline Development Committee Co-Chair Ahwatukee Sports & Spine Phoenix, AZ, USA Charles Reitman, MD NASS Research Council Director Department of Orthopedic Surgery Medical University of South Carolina Charleston, SC, USA FDA device/drug status: Not applicable. Author disclosures: CHC: Board of Directors: North American Spine Society (Non-Financial, travel expenses); ZG: Board of Directors: Congress of Neurological Surgeons (Vice-President) (Non-Financial), North American Spine Society (Non-Financial), Research Support (Investigator Salary, Staff/Materials): Stuart Foundation (F, Private Research Foundation, Paid directly to institution/employer, Paid directly to institution); Grants: NIH/PCORI (H, Paid directly to institution/employer, Paid directly to institution); PM: Speaking and/or Teaching Arrangements: AO Spine North America (B), North American Spine Society (A); DSK: Stock Ownership: LDR Holdings (B); Speaking and/or Teaching Arrangements: North American Spine Society (A, travel reimbursement), International Spine Intervention Society (Non financial); CR: Board of Directors: North American Spine Society (B); Clinical Orthopedics And Related Research Deputy Editor (B, Paid directly to institution). The disclosure key can be found on the Table of Contents and at www. TheSpineJournalOnline.com.
1529-9430 Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.spinee.2015.06.022
Letters to the Editor / The Spine Journal 15 (2015) 2297–2301
fails. The three-column fixation of the pedicle screw system can provide good stability and mechanical strength [5]. The implants are far from the lesions. Thus, posterior pedicle screw system is the first choice for fixation and correction of thoracolumbar spinal TB. The focuses can be debrided through the anterior approach. Comparatively speaking, our novel technique through different muscle windows via a posterior midline approach and debridement through a cross-window allowed debridement, decompression of the anterior spine, bone graft fusion, orthopedic internal fixation, and thorough drainage. The procedure is characterized by focus debridement. It decomposes multisegmental lesions into cross adjacent single unit to debridement and bone graft. It simplifies the procedure and reduces surgical trauma. But it needs a deep surgical field and requires a long learning curve. The classic finding of spinal TB is mainly characterized by destruction of disc. This can identify with malignancy or metastasis through preoperative imaging data. There are large paravertebral abscesses (gravitation abscess) in the multisegmental spinal TB. Less often, posterior elements of the spine may be involved in Pott disease [6]. In laboratory tests, the change of erythrocyte sedimentation rate, CRP, and TB-specific indicators (eg, interferon gamma release assay (IGRA), t cells spot detection (T-SPOT)) also serves as reference to identify preoperative diagnosis. If the aforementioned evidences were supported, we had not biopsied conventionally. We admitted that biopsy from the lesions is the gold standard for diagnosis. For the suspected cases (central vertebral TB, intervertebral atypical destroyed, no paraspinal abscess, and so forth), biopsy do have a higher clinical value for diagnosis.
References [1] Gao Z, Wang M, Zhu W, Zheng G, Meng Y. Tuberculosis of ultralong segmental thoracic and lumbar vertebrae treated by posterior fixation and cleaning of the infection center through a cross-window. Spine J 2015;15:71–8. [2] Oguz E, Sehirlioglu A, Altinmakas M, Ozturk C, Komurcu M, Solakoglu C. A new classification and guide for surgical treatment of spinal tuberculosis. Int Orthop 2008;32:127–33. [3] Jin DD, Qu DB, Chen JT, Zhang H. One-stage anterior interbody autografting and instrumentation in primary surgical management of thoracolumbar spinal tuberculosis. Eur Spine J 2004;13:114–21. [4] Li L, Xu J, Ma Y. Surgical strategy and management outcomes for adjacent multisegmental spinal tuberculosis: a retrospective study of forty-eight patients. Spine (Phila Pa 1976) 2014;39:E40–8. [5] Moran JM, Berg WS, Berry JL. Transpedicular screw fixation. J Orthop Res 1989;107–14. [6] De Backer AI, Mortele KJ, Vanschoubroeck IJ. Tuberculosis of the spine: CT and MR imaging features. JBR-BTR 2005;92–7.
Zhichao Gao Department of Orthopedics Yuhang Hospital Affiliated to Medical College of Hangzhou Normal University
Hangzhou 311100 Zhejiang Province, China FDA device/drug status: Not applicable. Author disclosures: ZG: Nothing to disclose. 1529-9430 Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.spinee.2015.07.434
Letter to the Editor in response to: ‘‘A critical appraisal of the North American Spine Society guidelines with the Appraisal of Guidelines for Research and Evaluation II instrument’’ To the Editors: We thank the authors for their interest in NASS guidelines and appreciate the opportunity to reply. The authors applied the AGREE II [1] instrument in evaluation of NASS guidelines and suggest that ‘‘NASS guidelines seem good overall, but individual qualities still need improvement.’’ [2] It should be stated that while widely used for the assessment of guidelines, the AGREE II instrument has documented limitations, including the inability to evaluate the clinical appropriateness or validity of guideline recommendations and the need to improve certain instrument concepts, such as representation of patient-public engagement and the items related to applicability and implementability of the guideline [3]. In addition, the authors suggest that AGREE was found to be the most effective system for guideline assessment in a review of 24 appraisal tools [4]. This is misleading as the purpose of this study was to identify critical appraisal tools for guidelines that would serve in developing a critical appraisal tool for clinical pathways, not to validate these tools for guidelines. In response to specific criticism, the NASS guidelines scored the lowest under ‘‘Domain 2: Stakeholder Involvement.’’ NASS does agree that increasing stakeholder input may improve the overall guideline quality. This has been a topic of internal discussion for the past couple years, and has resulted in change in our methodology to include multiple stakeholders beyond our multidisciplinary panel. This is being implemented as of our current guideline in progress. Of note, however, the purpose of this domain in AGREE II is to evaluate the composition of the work group and intended audience [1], not to assess nor recommend the testing or piloting of guidelines by target users before publication, as suggested by the authors. The NASS Guidelines also received low scores in ‘‘Domain 5: Applicability.’’ The application of Domain 5 is an area under debate by the AGREE Consortium and is being slated for future research [3]; therefore, its validity is uncertain. Regardless, our recent guideline processes have placed greater emphasis on cost-effectiveness and value of
Letters to the Editor / The Spine Journal 15 (2015) 2297–2301
treatments, although we have found that to date available evidence to make recommendations of this sort is generally poor or absent. NASS guidelines scored a median of 71.8% in ‘‘Domain 6: Editorial Independence.’’ While it was stated that there was consensus on editorial independence, the authors provided low scores for ‘‘poor statement of disclosures.’’ This is simply inaccurate. All guideline participants disclose all conflicts of interest in accordance with NASS’ Disclosure Policy for Committee Members and these are clearly documented at the beginning of each document [5]. In addition, members with any conflicts relevant to the subject matter are asked to recuse themselves from deliberation. NASS has been a leader in managing conflicts of interest, and continues to uphold itself to the highest standards for ethics and disclosure. In closing, we appreciate this feedback. NASS is committed to the highest quality, ethical, value and evidencebased spine care for patients, and we will continue to evaluate and modify our processes to ensure the publication of high quality guidelines. References [1] The AGREE II Instrument [Electronic version]. Available at: http:// www.agreetrust.org. Accessed May 7, 2015. [2] Yaman ME, Gudeloglu A, Senturk S, Yaman ND, Tolunay T, Ozturk Y, et al. A critical appraisal of the North American Spine Society guidelines with the Appraisal of Guidelines for Research and Evaluation II instrument. Spine J 2015;15:777–81. [3] Brouwers M, Kho ME, Browman GP, Cluzeau F, feder G, Fervers B, et al. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J 2010;182: E839–42. [4] Vlayen J, Aertgeerts B, Hannes K, Sermeus W, Ramaekers D. A systematic review of appraisal tools for clinical practice guidelines: multiple similarities and one common deficit. Int J Qual Health Care 2005;17:235–42. [5] North American Spine Society. Disclosure Policy. Adopted January 13, 2006. Revised March 2012. Burr Ridge, IL: North American Spine Society. Available at: https://www.spine. org/Documents/WhoWeAre/DisclosurePolicy.pdf. Accessed May 7, 2015.
Charles H. Cho, MD, MBA NASS Evidence Compilation and Analysis Chair Department of Radiology Brigham and Women’s Hospital
2301
Harvard Medical School 75 Francis St, Boston MA 02115, USA Zoher Ghogawala, MD NASS Clinical Research Development Chair Department of Neurosurgery Lahey Hospital & Medical Center Burlington, MA, USA Paul Matz, MD NASS Evidence-Based Guideline Development Committee Co-Chair Neurosurgery & Neurology LLC, Chesterfield MO, USA D. Scott Kreiner, MD NASS Evidence-Based Guideline Development Committee Co-Chair Ahwatukee Sports & Spine Phoenix, AZ, USA Charles Reitman, MD NASS Research Council Director Department of Orthopedic Surgery Medical University of South Carolina Charleston, SC, USA FDA device/drug status: Not applicable. Author disclosures: CHC: Board of Directors: North American Spine Society (Non-Financial, travel expenses); ZG: Board of Directors: Congress of Neurological Surgeons (Vice-President) (Non-Financial), North American Spine Society (Non-Financial), Research Support (Investigator Salary, Staff/Materials): Stuart Foundation (F, Private Research Foundation, Paid directly to institution/employer, Paid directly to institution); Grants: NIH/PCORI (H, Paid directly to institution/employer, Paid directly to institution); PM: Speaking and/or Teaching Arrangements: AO Spine North America (B), North American Spine Society (A); DSK: Stock Ownership: LDR Holdings (B); Speaking and/or Teaching Arrangements: North American Spine Society (A, travel reimbursement), International Spine Intervention Society (Non financial); CR: Board of Directors: North American Spine Society (B); Clinical Orthopedics And Related Research Deputy Editor (B, Paid directly to institution). The disclosure key can be found on the Table of Contents and at www. TheSpineJournalOnline.com.
1529-9430 Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.spinee.2015.06.022