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Abstract：
METHODS: Methodological study for guideline development.
OBJECTIVE: AO Spine Guideline for Using Osteobiologics (AO-GO) project for spine degenerative pathologies was an international, multidisciplinary collaborative initiative to identify and evaluate evidence on existing use of osteobiologics in Anterior Cervical Fusion and Decompression (ACDF). The aim was to formulate precisely defined, clinically relevant and internationally applicable guidelines ensuring evidence-based, safe and effective use of osteobiologics, considering regional preferences and cost-effectiveness.
METHODS: Guideline was completed in two phases: Phase 1- evidence synthesis; Phase 2- recommendation development based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. In Phase 1, key questions identified by a panel of experts were addressed in a series of systematic reviews of randomized and non-randomized studies. In Phase 2, the GRADE approach was used to formulate a series of recommendations, including expert panel discussions via web calls and face-to-face meetings.
CONCLUSIONS: AO-GO aims to bridge an important gap between evidence and use of osteobiologics in spine fusion surgeries. Owing to differences in osteobiologics preparation and functional characteristics, regulatory requirements for approval may vary, therefore it is highly likely that these products enter market without quality clinical trials. With a holistic approach the guideline aims to facilitate evidence-based, patient-oriented decision-making processes in clinical practice, thus stimulating further evidence-based studies regarding osteobiologics usage in spine surgeries. In Phase 3, the guideline will be disseminated and validated using prospectively collected clinical data in a separate effort of the AO Spine Knowledge Forum Degenerative in a global multicenter clinical study.
OBJECTIVE: AO Spine Guideline for Using Osteobiologics (AO-GO) project for spine degenerative pathologies was an international, multidisciplinary collaborative initiative to identify and evaluate evidence on existing use of osteobiologics in Anterior Cervical Fusion and Decompression (ACDF). The aim was to formulate precisely defined, clinically relevant and internationally applicable guidelines ensuring evidence-based, safe and effective use of osteobiologics, considering regional preferences and cost-effectiveness.
METHODS: Guideline was completed in two phases: Phase 1- evidence synthesis; Phase 2- recommendation development based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. In Phase 1, key questions identified by a panel of experts were addressed in a series of systematic reviews of randomized and non-randomized studies. In Phase 2, the GRADE approach was used to formulate a series of recommendations, including expert panel discussions via web calls and face-to-face meetings.
CONCLUSIONS: AO-GO aims to bridge an important gap between evidence and use of osteobiologics in spine fusion surgeries. Owing to differences in osteobiologics preparation and functional characteristics, regulatory requirements for approval may vary, therefore it is highly likely that these products enter market without quality clinical trials. With a holistic approach the guideline aims to facilitate evidence-based, patient-oriented decision-making processes in clinical practice, thus stimulating further evidence-based studies regarding osteobiologics usage in spine surgeries. In Phase 3, the guideline will be disseminated and validated using prospectively collected clinical data in a separate effort of the AO Spine Knowledge Forum Degenerative in a global multicenter clinical study.
摘要：
方法：制定指南的方法学研究。
目的：AO脊柱退行性病变使用骨生物学指南（AO-GO）项目是一项国际性的，多学科协作倡议，以确定和评估在颈椎前路融合减压术（ACDF）中使用骨生物制剂的现有证据。目的是制定精确的定义，临床相关和国际适用的指南，确保以证据为基础，安全有效地使用骨生物制剂，考虑区域偏好和成本效益。
方法：指南分两个阶段完成：第1阶段证据综合；第2阶段基于建议分级的建议开发，评估,开发和评估(等级)方法。在第一阶段，专家小组确定的关键问题在一系列随机和非随机研究的系统评价中得到了解决。在第二阶段中，使用了GRADE方法来制定一系列建议，包括通过网络通话和面对面会议进行专家小组讨论。
结论：AO-GO旨在弥合骨生物制剂在脊柱融合手术中的证据和使用之间的重要差距。由于骨生物制剂的制备和功能特性的差异，批准的监管要求可能会有所不同，因此，这些产品很有可能在没有高质量临床试验的情况下进入市场。通过整体方法，该指南旨在促进基于证据的，临床实践中面向患者的决策过程，因此刺激了关于骨生物学在脊柱手术中使用的进一步循证研究。在第3阶段，该指南将在AO脊柱知识论坛的一项全球多中心临床研究中使用前瞻性收集的临床数据进行传播和验证。
目的：AO脊柱退行性病变使用骨生物学指南（AO-GO）项目是一项国际性的，多学科协作倡议，以确定和评估在颈椎前路融合减压术（ACDF）中使用骨生物制剂的现有证据。目的是制定精确的定义，临床相关和国际适用的指南，确保以证据为基础，安全有效地使用骨生物制剂，考虑区域偏好和成本效益。
方法：指南分两个阶段完成：第1阶段证据综合；第2阶段基于建议分级的建议开发，评估,开发和评估(等级)方法。在第一阶段，专家小组确定的关键问题在一系列随机和非随机研究的系统评价中得到了解决。在第二阶段中，使用了GRADE方法来制定一系列建议，包括通过网络通话和面对面会议进行专家小组讨论。
结论：AO-GO旨在弥合骨生物制剂在脊柱融合手术中的证据和使用之间的重要差距。由于骨生物制剂的制备和功能特性的差异，批准的监管要求可能会有所不同，因此，这些产品很有可能在没有高质量临床试验的情况下进入市场。通过整体方法，该指南旨在促进基于证据的，临床实践中面向患者的决策过程，因此刺激了关于骨生物学在脊柱手术中使用的进一步循证研究。在第3阶段，该指南将在AO脊柱知识论坛的一项全球多中心临床研究中使用前瞻性收集的临床数据进行传播和验证。
