The Global Spine Care Initiative: a consensus process to develop and validate a stratification scheme for surgical care of spinal disorders as a guide for improved resource utilization in low- and middle-income communities.

PURPOSE: The purpose of this study was to develop a stratification scheme for surgical spinal care to serve as a framework for referrals and distribution of patients with spinal disorders. METHODS: We used a modified Delphi process. A literature search identified experts for the consensus panel and the panel was expanded by inviting spine surgeons known to be global opinion leaders. After creating a seed document of five hierarchical levels of surgical care, a four-step modified Delphi process (question validation, collection of factors, evaluation of factors, re-evaluation of factors) was performed. RESULTS: Of 78 invited experts, 19 participated in round 1, and of the 19, 14 participated in 2, and 12 in 3 and 4. Consensus was fairly heterogeneous for levels of care 2-4 (moderate resources). Only simple assessment methods based on the clinical skills of the medical personnel were considered feasible and safe in low-resource settings. Diagnosis, staging, and treatment were deemed feasible and safe in a specialized spine center. Accurate diagnostic workup was deemed feasible and safe for lower levels of care complexity (from level 3 upwards) compared to non-invasive procedures (level 4) and the full range of invasive procedures (level 5). CONCLUSION: This study introduces a five-level stratification scheme for the surgical care of spinal disorders. This stratification may provide input into the Global Spine Care Initiative care pathway that will be applied in medically underserved areas and low- and middle-income countries. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: a summary of guidelines on invasive interventions for the management of persistent and disabling spinal pain in low- and middle-income communities.

PURPOSE: The purpose of this study was to synthesize recommendations on the use of common elective surgical and interventional procedures for individuals with persistent and disabling non-radicular/axial with or without myelopathy, radicular back pain, cervical myelopathy, symptomatic spinal stenosis, and fractures due to osteoporosis. This review was to inform a clinical care pathway on the patient presentations where surgical interventions could reasonably be considered. METHODS: We synthesized recommendations from six evidence-based clinical practice guidelines and one appropriate use criteria guidance for the surgical and interventional management of persistent and disabling spine pain. RESULTS: Lower priority surgery/conditions include fusion for lumbar/non-radicular neck pain and higher priority surgery/conditions include discectomy/decompressive surgery for cervical or lumbar radiculopathy, cervical myelopathy, and lumbar spinal stenosis. Epidural steroid injections are less expensive than most surgeries with fewer harms; however, benefits are small and short lived. Vertebroplasty should be considered over kyphoplasty as an option for patients with severe pain and disability due to osteoporotic vertebral compression fracture. CONCLUSION: Elective surgery and interventional procedures could be limited in medically underserved areas and low- and middle-income countries due to a lack of resources and surgeons and thus surgical and interventional procedures should be prioritized within these settings. There are non-invasive alternatives that produce similar outcomes and are a recommended option where surgical procedures are not available. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: classification system for spine-related concerns.

PURPOSE: The purpose of this report is to describe the development of a classification system that would apply to anyone with a spine-related concern and that can be used in an evidence-based spine care pathway. METHODS: Existing classification systems for spinal disorders were assembled. A seed document was developed through round-table discussions followed by a modified Delphi process. International and interprofessional clinicians and scientists with expertise in spine-related conditions were invited to participate. RESULTS: Thirty-six experts from 15 countries participated. After the second round, there was 95% agreement of the proposed classification system. The six major classifications included: no or minimal symptoms (class 0); mild symptoms (i.e., neck or back pain) but no interference with activities (class I); moderate or severe symptoms with interference of activities (class II); spine-related neurological signs or symptoms (class III); severe bony spine deformity, trauma or pathology (class IV); and spine-related symptoms or destructive lesions associated with systemic pathology (class V). Subclasses for each major class included chronicity and severity when different interventions were anticipated or recommended. CONCLUSIONS: An international and interprofessional group developed a comprehensive classification system for all potential presentations of people who may seek care or advice at a spine care program. This classification can be used in the development of a spine care pathway, in clinical practice, and for research purposes. This classification needs to be tested for validity, reliability, and consistency among clinicians from different specialties and in different communities and cultures. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: model of care and implementation.

PURPOSE: Spine-related disorders are a leading cause of global disability and are a burden on society and to public health. Currently, there is no comprehensive, evidence-based model of care for spine-related disorders, which includes back and neck pain, deformity, spine injury, neurological conditions, spinal diseases, and pathology, that could be applied in global health care settings. The purposes of this paper are to propose: (1) principles to transform the delivery of spine care; (2) an evidence-based model that could be applied globally; and (3) implementation suggestions. METHODS: The Global Spine Care Initiative (GSCI) meetings and literature reviews were synthesized into a seed document and distributed to spine care experts. After three rounds of a modified Delphi process, all participants reached consensus on the final model of care and implementation steps. RESULTS: Sixty-six experts representing 24 countries participated. The GSCI model of care has eight core principles: person-centered, people-centered, biopsychosocial, proactive, evidence-based, integrative, collaborative, and self-sustaining. The model of care includes a classification system and care pathway, levels of care, and a focus on the patient's journey. The six steps for implementation are initiation and preparation; assessment of the current situation; planning and designing solutions; implementation; assessment and evaluation of program; and sustain program and scale up. CONCLUSION: The GSCI proposes an evidence-based, practical, sustainable, and scalable model of care representing eight core principles with a six-step implementation plan. The aim of this model is to help transform spine care globally, especially in low- and middle-income countries and underserved communities. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: methodology, contributors, and disclosures.

PURPOSE: The purpose of this report is to describe the Global Spine Care Initiative (GSCI) contributors, disclosures, and methods for reporting transparency on the development of the recommendations. METHODS: World Spine Care convened the GSCI to develop an evidence-based, practical, and sustainable healthcare model for spinal care. The initiative aims to improve the management, prevention, and public health for spine-related disorders worldwide; thus, global representation was essential. A series of meetings established the initiative's mission and goals. Electronic surveys collected contributorship and demographic information, and experiences with spinal conditions to better understand perceptions and potential biases that were contributing to the model of care. RESULTS: Sixty-eight clinicians and scientists participated in the deliberations and are authors of one or more of the GSCI articles. Of these experts, 57 reported providing spine care in 34 countries, (i.e., low-, middle-, and high-income countries, as well as underserved communities in high-income countries.) The majority reported personally experiencing or having a close family member with one or more spinal concerns including: spine-related trauma or injury, spinal problems that required emergency or surgical intervention, spinal pain referred from non-spine sources, spinal deformity, spinal pathology or disease, neurological problems, and/or mild, moderate, or severe back or neck pain. There were no substantial reported conflicts of interest. CONCLUSION: The GSCI participants have broad professional experience and wide international distribution with no discipline dominating the deliberations. The GSCI believes this set of papers has the potential to inform and improve spine care globally. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: World Spine Care executive summary on reducing spine-related disability in low- and middle-income communities.

PURPOSE: Spinal disorders, including back and neck pain, are major causes of disability, economic hardship, and morbidity, especially in underserved communities and low- and middle-income countries. Currently, there is no model of care to address this issue. This paper provides an overview of the papers from the Global Spine Care Initiative (GSCI), which was convened to develop an evidence-based, practical, and sustainable, spinal healthcare model for communities around the world with various levels of resources. METHODS: Leading spine clinicians and scientists around the world were invited to participate. The interprofessional, international team consisted of 68 members from 24 countries, representing most disciplines that study or care for patients with spinal symptoms, including family physicians, spine surgeons, rheumatologists, chiropractors, physical therapists, epidemiologists, research methodologists, and other stakeholders. RESULTS: Literature reviews on the burden of spinal disorders and six categories of evidence-based interventions for spinal disorders (assessment, public health, psychosocial, noninvasive, invasive, and the management of osteoporosis) were completed. In addition, participants developed a stratification system for surgical intervention, a classification system for spinal disorders, an evidence-based care pathway, and lists of resources and recommendations to implement the GSCI model of care. CONCLUSION: The GSCI proposes an evidence-based model that is consistent with recent calls for action to reduce the global burden of spinal disorders. The model requires testing to determine feasibility. If it proves to be implementable, this model holds great promise to reduce the tremendous global burden of spinal disorders. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: care pathway for people with spine-related concerns.

PURPOSE: The purpose of this report is to describe the development of an evidence-based care pathway that can be implemented globally. METHODS: The Global Spine Care Initiative (GSCI) care pathway development team extracted interventions recommended for the management of spinal disorders from six GSCI articles that synthesized the available evidence from guidelines and relevant literature. Sixty-eight international and interprofessional clinicians and scientists with expertise in spine-related conditions were invited to participate. An iterative consensus process was used. RESULTS: After three rounds of review, 46 experts from 16 countries reached consensus for the care pathway that includes five decision steps: awareness, initial triage, provider assessment, interventions (e.g., non-invasive treatment; invasive treatment; psychological and social intervention; prevention and public health; specialty care and interprofessional management), and outcomes. The care pathway can be used to guide the management of patients with any spine-related concern (e.g., back and neck pain, deformity, spinal injury, neurological conditions, pathology, spinal diseases). The pathway is simple and can be incorporated into educational tools, decision-making trees, and electronic medical records. CONCLUSION: A care pathway for the management of individuals presenting with spine-related concerns includes evidence-based recommendations to guide health care providers in the management of common spinal disorders. The proposed pathway is person-centered and evidence-based. The acceptability and utility of this care pathway will need to be evaluated in various communities, especially in low- and middle-income countries, with different cultural background and resources. These slides can be retrieved under Electronic Supplementary Material.

A migrated knitting needle in a paediatric spine: case report.

PURPOSE: The aims of this study were to present migration of a sharp metal material into the spinal canal in a paediatric patient and to discuss the management of metallic foreign bodies in the spinal canal. METHODS: Patient's medical reports, radiological tests, review of intraoperative findings, and literature search were examined. RESULTS: The migration and penetration of a knitting needle in a 7-year-old-boy are presented. CONCLUSIONS: There is a significant risk of migration of penetrating foreign materials into the spinal canal. Early identification and removal of these foreign bodies retained in the spinal canal may be important even when the patient is asymptomatic.

Analysis of factors affecting baseline SF-36 Mental Component Summary in Adult Spinal Deformity and its impact on surgical outcomes.

OBJECTIVES: To identify the factors that affect SF-36 mental component summary (MCS) in patients with adult spinal deformity (ASD) at the time of presentation, and to analyse the effect of SF-36 MCS on clinical outcomes in surgically treated patients. METHODS: Prospectively collected data from a multicentric ASD database was analysed for baseline parameters. Then, the same database for surgically treated patients with a minimum of 1-year follow-up was analysed to see the effect of baseline SF-36 MCS on treatment results. A clinically useful SF-36 MCS was determined by ROC Curve analysis. RESULTS: A total of 229 patients with the baseline parameters were analysed. A strong correlation between SF-36 MCS and SRS-22, ODI, gender, and diagnosis were found (p < 0.05). For the second part of the study, a total of 186 surgically treated patients were analysed. Only for SF-36 PCS, the un-improved cohort based on minimum clinically important differences had significantly lower mean baseline SF-36 MCS (p < 0.001). SF-36 MCS was found to have an odds ratio of 0.914 in improving SF-36 PCS score (unit by unit) (p < 0.001). A cut-off point of 43.97 for SF-36 MCS was found to be predictive of SF-36 PCS (AUC = 0.631; p < 0.001). CONCLUSIONS: The factors effective on the baseline SF-36 MCS in an ASD population are other HRQOL parameters such as SRS-22 and ODI as well as the baseline thoracic kyphosis and gender. This study has also demonstrated that baseline SF-36 MCS does not necessarily have any effect on the treatment results by surgery as assessed by SRS-22 or ODI. LEVEL OF EVIDENCE: Level III, prognostic study.

Does Surgery for Adult Spinal Deformity Affect the Cognitive Abilities in Patients over 50 Years of Age?

AIM: To analyze the cognitive abilities of older patients undergoing spinal deformity surgery so as to understand whether adult spinal deformity (ASD) surgery is associated with postoperative cognitive malfunction. MATERIAL AND METHODS: A prospective longitudinal study was performed on surgical patients older than 50 years, enrolled in a prospective multicenter database. Mini-mental state examination (MMSE) was performed to assess cognitive function in addition to the health-related quality of life (HRQOL) tests; (SF-36, ODI and SRS-22) at the pre-operative, post-operative 6 weeks and 6 months points. Demographics, preoperative health status, co-morbidities and surgical characteristics were also analyzed. Descriptive statistics and repeated measures of variance analysis were performed. RESULTS: A total of 90 patients with a mean age of 67.4±8.2 years were enrolled in the study; all had MMSE evaluations at 6 weeks follow-up and 58 patients had both 6 weeks and 6 months follow-up. Average (SD) surgical time, estimated blood loss, number of levels fused and hospital stay were 240.1 (111.9) minutes, 1621.2 (1058.7) ml, 11.2 (4.4) levels and 14.2 (11.45) days, respectively. On analysis, a slight increase in mean MMSE score (p > 0.05) between time points was found despite decreases of > 2 points (3 or 4) in 6 patients (6.7%) at both time points. CONCLUSION: Although ASD surgery in older patients is recognized as challenging, this study suggests that it is not necessarily associated with a significant deterioration in the cognitive abilities of patients undergoing surgery. This may be due to the relatively minor influence of ASD itself on the cognitive abilities of the patients involved as well as to the relatively stable hemodynamic conditions obtainable during modern ASD surgery.

Global Forum: Spine Research and Training in Underserved, Low and Middle-Income, Culturally Unique Communities: The World Spine Care Charity Research Program's Challenges and Facilitators.

The World Spine Care (WSC), established by volunteers from 5 continents, is dedicated to providing sustainable, evidence-based spine care to individuals and communities in low and middle-income countries consistent with available health-care resources and integrated within the local culture. The research committee approves and oversees the WSC's collaborative research and training projects worldwide and serves to create a sustainable research community for underserved populations focused on preventing disability from spinal disorders. The purpose of this article is to describe 4 projects overseen by the WSC research committee and to discuss several challenges and specific facilitators that allowed successful completion of initiatives. These novel projects, which involved establishing spine surgery expertise and data collection in the WSC clinics and surrounding communities, all met their aims. This was achieved by overcoming language and resource challenges, adapting to local customs, and taking time to build mutual respect and to nurture relationships with local investigators and stakeholders.