A Critical Appraisal of the Congress of Neurological Surgeons Evidence-Based Guidelines on the Evaluation and Treatment of Patients With Thoracolumbar Spine Trauma.

Background and objective Thoracolumbar spine trauma (TST) is frequently associated with spinal cord injury and other soft tissue and bony injuries. The management of such injuries requires an evidence-based approach. This study used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument to assess the methodological quality of clinical guidelines for the management of TST published by the Congress of Neurological Surgeons (CNS). Methods All clinical guidelines on TST published by CNS until 2020 were assessed. Five appraisers from three international centers evaluated the quality of eligible clinical guidelines by using AGREE II. Mean AGREE II scores for each domain were determined. In higher-quality domains, the scores for individual items were analyzed. Results A total of 12 guidelines published by CNS on TST were assessed. Mean scores for all six domains were as follows: Scope and Purpose (75.2%), Stakeholder Involvement (45.4%), Rigor of Development (57.0%), Clarity of Presentation (58.7%), Applicability (16.9%), and Editorial Independence (64.1%). The mean score for the overall quality of all CNS guidelines was 52.9% [95% confidence interval (CI): 52.2-53.5%]. The overall agreement among appraisers was excellent [intra-class correlation coefficients (ICCs) for each guideline ranged from 0.903 to 0.963]. Conclusions CNS guidelines for the management of TST demonstrated acceptable quality across most domains; however, the domains of Applicability and Stakeholder Involvement could be further improved in future guideline updates. The assessors concluded that all guidelines could still be recommended for clinical practice with or without modifications.

Low back pain patients' experience and expectations: A qualitative study focusing on physiotherapist and physician care.

BACKGROUND: Low back pain (LBP) is a common and disabling musculoskeletal disorder. LBP experiences and expectations can vary from one person to another and influence their clinical outcomes. Despite the existence of numerous evidence-based treatment recommendations, LBP management in primary care remains challenging. This study aims to investigate the experiences and expectations of patients with LPB in primary care settings. METHODS: A qualitative study with an inductive thematic analysis was conducted. Semi-structured interviews were performed using individuals who had experienced LBP in the past year and had consulted a family physician (FP) or a physiotherapist (PT). RESULTS: Ten participants with LBP were interviewed (5 women, 5 men, mean age 49 ± 17). Five themes were identified: (1) I am always upset because I can't do anything; (2) I waited to consult; I thought it would go away; (3) I want to see what is going on with my LBP; (4) I want to see the person that will provide the right treatment; (5) I need support to get over it. Participants consulted when their pain was severe and disabling. They expected an imaging test to explain the cause of their LBP and placed more importance on the imaging test results than the FP's or PT's evaluation. Their opinions on care selection and being listened to were important for the participants. CONCLUSION: This study has highlighted the importance of the patient's point of view in their care. This consideration is important to ensure a comprehensive and collaborative approach with evidence-based practice care.

Is there any difference between Eastern and Western clinical practice guidelines in management of gastric cancer?

BACKGROUND AND RECENT FINDINGS: Gastric cancer (GC) has been known as one of the most common causes of cancer mortality both in Western and Eastern countries. However, there might be differences between how it is managed in different countries. Thus, we aimed to investigate these differences. MATERIALS AND METHODS: The most well-known clinical guidelines in field of GC management including Korean GC Association (KGCA), Japanese GC Association (JGCA), National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO), British Society of Gastroenterology (BSG), and National Institute for health and Care Excellence (NICE) have been reviewed. RESULTS: The contents of these guidelines were categorized under eight headings including (1) genetic predisposition, (2) prevention, (3) management of gastric polyp, atrophy, dysplasia and metaplasia, (4) diagnosis, (5) pathology and molecular biology, (6) treatment, (7) supportive and palliative care, and (8) follow up. Difference in each section was discussed. CONCLUSION: Considering KGCA and JGCA as Eastern and NCCN, ESMO, BSG, and NICE as Western guidelines, it is revealed that both sets of guidelines share common practices such as prioritizing comprehensive diagnostic evaluations, personalizing treatment plans, and palliative care. However, main differences can be seen in treatment regimens, the adoption of newer therapies like immunotherapy, and the utilization of emerging techniques such as HIPEC. These differences reflect the diverse clinical landscapes, research focuses, and healthcare systems within these regions.

Critical appraisal of Australian and New Zealand paediatric vision screening clinical practice guidelines using the AGREE II tool.

CLINICAL RELEVANCE: Vision disorders in children impact health-related quality of life, with early detection and intervention improving outcomes and educational performance. Eye health professionals should be aware of paediatric vision screening guidelines and their development to understand the components of local programmes and the differences in sensitivity and specificity between protocols. BACKGROUND: High-quality clinical practice guidelines (CPGs) for vision screening enable the early detection of common vision disorders; however, they require rigorous development to ensure optimal accuracy in detecting vision disorders, enabling timely interventions. This study evaluated the quality of available vision screening CPGs on vision screening of children in Australia and New Zealand. METHODS: A systematic search of academic databases, guideline databases, professional associations and Google search engines was conducted to identify relevant paediatric vision screening CPGs. Four independent reviewers used the Appraisal of Guidelines, Research and Evaluation (AGREE II) instrument to assess the quality of individual guidelines and scores were aggregated and reported as the percentage of the total possible score across the six AGREE II domains: scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability, and editorial independence. RESULTS: Initial 2,999 items were evaluated, with seven guidelines included. AGREE-II quality score agreement ranged from 43.3% to 95.8%. All guidelines scored >60.0% in the scope and purpose, however, most had poor scores of <26.5% in the rigour of development and <3.3% in editorial independence domains. All guidelines recommended screening using measures of habitual distance vision. CONCLUSION: Of the guidelines developed for use in Australia and New Zealand, most guidelines scored poorly when assessed against the AGREE II tool, because of lack of editorial independence and rigour of development. Paediatric vision screening guidelines should prioritise systematic review of literature to inform practice and include statements regarding competing interests.

Development of palliative care clinical practice guidelines and referral care pathways for primary care practitioners in Pakistan.

BACKGROUND: Despite a large burden of life-limitingillness, there exists a dearth of services of palliative care in Pakistan. International guidelines have questionable applicability in Pakistan due to the socioeconomic differences. We generated a protocol describing the process of developing comprehensive palliative care guidelines and palliative care referral pathways for primary care practitioners to adopt in Pakistan. METHODS: A GRADE-ADOLOPMENT approach with modification has been employed to create guidelines for a Pakistani context. The "National Comprehensive Cancer Network Guidelines Insights: Palliative Care, Version 2.2021" was used as the source guideline. Recommendations from the source guideline were reviewed by two local palliative care specialists to either "Adopt," "Adapt" or "Exclude". The finalized recommendations were incorporated into the local palliative care guideline. Clinical diagnosis and referral pathways were made from the finalized guideline. Any gaps in management found in the pathways were filled by taking existing recommendations from other credible guidelines. RESULTS: Twenty-seven recommendations were adopted without modification. No recommendations were deemed to be adapted and 15 were excluded. The referral care pathways created were reflective of the local guideline and included elements of initial assessment, preliminary management, reassessment, and referral. 6 additional recommendations were made. CONCLUSION: The described clinical practice guidelines and primary care clinical referral pathways will aid to standardize palliative care provision in Pakistan. These can be used by other resource constrained settings to develop guidelines within their own local context.

Tracheostomy care of non-ventilated patients and COVID considerations: A scoping review of clinical practice guidelines and consensus statements.

BACKGROUND: The purpose of this study is to examine and evaluate the existing clinical practice guidelines and consensus statements regarding tracheostomy care for non-mechanically ventilated patients. METHODS: A systematic search of databases, and professional organisations was conducted from inception to 19 March 2023. Two appraisers evaluated each guideline using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) and the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Text and Opinion Papers. RESULTS: No specific clinical guidelines exist on airway management in non-mechanically ventilated patients. Of 6318 articles identified, we included 12 clinical practice guidelines, and 9 consensus statements, which were from China, the US, the UK, South Korea, Australia, France and Belgium. The AGREE II scores in six domains are (1) the scope and purpose, 70.30%; (2) stakeholder involvement, 37.61%; (3) rigor of development, 33.97%; (4) clarity of presentation, 68.16%; (5) applicability, 44.23% and (6) editorial independence, 40.06%. The overall quality of evidence was level B. The summarised recommendations for clinical practice encompass the following six areas: airway humidification, management of the trach cuff, management of inner cannula, tracheostoma care, tracheostomy suctioning and management and prevention of common post-operative complications. CONCLUSIONS: The overall quality of the clinical guidelines on non-ventilated tracheostomy care was moderate, and further improvements are needed in domains of stakeholder involvement, applicability, clarity of presentation and editorial independence. Recommendations on non-ventilated tracheostomy care are often embedded in the guidelines on ventilated tracheostomy. Specific clinical guidelines are needed to provide a standardised approach to tracheostomy care for non-ventilated patients. RELEVANCE TO CLINICAL PRACTICE: Patients with non-ventilated tracheostomy need specialised airway management. Improving patient outcomes requires standardised protocols, patient involvement, quality evaluation, and interdisciplinary approaches. NO PATIENT OR PUBLIC CONTRIBUTION: The study reviewed clinical practice guidelines and consensus statements, therefore patient or public input was not needed.

The Japanese breast cancer society clinical practice guidelines for radiation treatment of breast cancer, 2022 edition.

The Breast Cancer Clinical Practice Guidelines, organized by the Japanese Breast Cancer Society (JBCS), were published in 2022. We present the English version of the Radiation Therapy (RT) section of the guidelines. The JBCS formed a task force to update the 2018 version of the JBCS Clinical Practice Guidelines. The Background Questions (BQs) contain the standard treatments for breast cancer in clinical practice, whereas the Clinical Questions (CQs) address daily clinical questions that remain controversial. Future Research Questions (FRQs) explore the subjects that are considered important issues, despite there being insufficient data for inclusion as CQs. The task force selected the 12 BQs, 8 CQs, and 6 FRQs for the RT section. For each CQ, systematic literature reviews and meta-analyses were conducted according to the Minds Manual for Guideline Development 2020, version 3.0. The recommendations, strength of recommendation, and strength of evidence for each CQ were determined based on systematic reviews and meta-analyses, and finalized by voting at the recommendation decision meeting.

The real-world clinical decisions of physicians in the management of Takayasu arteritis and giant cell arteritis in Japan: A cross-sectional web-questionnaire survey.

OBJECTIVES: To access the real-world clinical management of physicians who treat Takayasu arteritis (TAK) and giant cell arteritis (GCA) after the publication of the Japanese Circulation Society (JCS) 2017 Guidelines for the Management of Vasculitis Syndrome. METHODS: This descriptive, cross-sectional study utilized self-administered electronic questionnaires, which were answered in February 2022 by physicians treating TAK or GCA and registered with Macromill Inc. RESULTS: The 329 survey respondents comprised 110 cardiologists, 110 rheumatologists, 34 cardiovascular surgeons, 24 surgeons, 35 internal medicine physicians, 13 nephrologists, and 7 pediatricians. The 2017 JCS Guidelines were the most commonly referenced information source for resolving clinical questions, accessed by 70% of respondents. Ophthalmoscopy was performed in only 50% of patients with TAK, and in 70% for GCA. The median percentages of patients who underwent 18F-fluorodeoxyglucose-positron emission tomography/computed tomography for TAK and GCA patients were 23% and 20% at diagnosis, respectively, and 10% each at follow-up within 12 months. Tocilizumab was the most frequently used medication in combination with glucocorticoids for both TAK and GCA, especially in remission induction therapy for relapsed patients. CONCLUSIONS: The majority of physician treating TAK and GCA referred to the 2017 JCS guidelines. This report clarified the current clinical practice for large vessel vasculitis in Japan, providing information for the next revision of the guidelines.

Consensus on lipoprotein(a) of the Spanish Society of Arteriosclerosis. Literature review and recommendations for clinical practice. / Consenso sobre lipoproteína (a) de la Sociedad Española de Arteriosclerosis. Revisión bibliográfica y recomendaciones para la práctica clínica.

The irruption of lipoprotein(a) (Lp(a)) in the study of cardiovascular risk factors is perhaps, together with the discovery and use of proprotein convertase subtilisin/kexin type 9 (iPCSK9) inhibitor drugs, the greatest novelty in the field for decades. Lp(a) concentration (especially very high levels) has an undeniable association with certain cardiovascular complications, such as atherosclerotic vascular disease (AVD) and aortic stenosis. However, there are several current limitations to both establishing epidemiological associations and specific pharmacological treatment. Firstly, the measurement of Lp(a) is highly dependent on the test used, mainly because of the characteristics of the molecule. Secondly, Lp(a) concentration is more than 80% genetically determined, so that, unlike other cardiovascular risk factors, it cannot be regulated by lifestyle changes. Finally, although there are many promising clinical trials with specific drugs to reduce Lp(a), currently only iPCSK9 (limited for use because of its cost) significantly reduces Lp(a). However, and in line with other scientific societies, the SEA considers that, with the aim of increasing knowledge about the contribution of Lp(a) to cardiovascular risk, it is relevant to produce a document containing the current status of the subject, recommendations for the control of global cardiovascular risk in people with elevated Lp(a) and recommendations on the therapeutic approach to patients with elevated Lp(a).

Clinical practice guideline for acupuncture and moxibustion: Allergic rhinitis.

Acupuncture is one of the most effective complementary therapies for allergic rhinitis (AR) and has been recommended by several clinical practice guidelines (CPGs) for AR. However, these CPGs mentioned acupuncture without making recommendations for clinical implementation and therapeutic protocols, therefore limiting the applicability of acupuncture therapies for AR. Hence, for the benefit of acupuncture practitioners around the world, the World Federation of Acupuncture-moxibustion Societies have initiated a project to develop the CPG for the use of acupuncture and moxibustion to treat AR. This CPG was developed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, referring to the principles of the World Health Organization Handbook for Guideline Development. During the development of the CPG, the guideline development group (GDG) played an important role. The clinical questions, recommendations and therapeutic protocols were all formulated by the GDG using the modified Delphi method. The CPG contains recommendations for 15 clinical questions about the use of acupuncture and moxibustion interventions. These include one strong recommendation for the intervention based on high-quality evidence, three conditional recommendations for either the intervention or standard care, and 11 conditional recommendations for the intervention based on very low quality of evidence. The CPG also provides one filiform needle acupuncture protocol and five moxibustion protocols extracted based on the protocols presented in randomized controlled trials reviewed by the GDG. Please cite this article as: Du SH, Chen S, Wang SZ, Wang GQ, Du S, Guo W, Xie XL, Peng BH, Yang C, Zhao JP. Clinical practice guideline for acupuncture and moxibustion: Allergic rhinitis. J Integr Med. 2024; Epub ahead of print.

Prediction and prevention of preterm birth: Quality assessment and systematic review of clinical practice guidelines using the AGREE II framework.

BACKGROUND: Prediction of pregnancies at risk of preterm birth (PTB) may allow targeted prevention strategies. OBJECTIVES: To assess quality of clinical practice guidelines (CPGs) and identify areas of agreement and contention in prediction and prevention of spontaneous PTB. SEARCH STRATEGY: We searched for CPGs regarding PTB prediction and prevention in asymptomatic singleton pregnancies without language restriction in January 2024. SELECTION CRITERIA: CPGs included were published between July 2017 and December 2023 and contained statements intended to direct clinical practice. DATA COLLECTION AND ANALYSIS: CPG quality was assessed using the AGREE-II tool. Recommendations were extracted and grouped under domains of prediction and prevention, in general populations and high-risk groups. MAIN RESULTS: We included 37 CPGs from 20 organizations; all were of moderate or high quality overall. There was consensus in prediction of PTB by identification of risk factors and cervical length screening in high-risk pregnancies and prevention of PTB by universal screening and treatment for asymptomatic bacteriuria, screening and treatment for BV in high-risk pregnancies, and use of preventative progesterone and cerclage. Areas of contention or limited consensus were the role of PTB clinics, universal cervical length measurement, biomarkers and cervical pessaries. CONCLUSIONS: This review identified strengths and limitations of current PTB CPGs, and areas for future research.

The Role of Blood Testing in Prevention, Diagnosis, and Management of Chronic Diseases: A Review.

Blood tests are vital to prevention, diagnosis, and management of chronic diseases. Despite this, it can be challenging to construct a comprehensive view of the clinical importance of blood testing because relevant literature is typically fragmented across different disease areas and patient populations. This lack of collated evidence can also make it difficult for primary care providers to adhere to best practices for blood testing across different diseases and guidelines. Thus, this review article synthesizes the recommendations for, and importance of, blood testing across several common chronic conditions encountered in primary care and internal medicine, including cardiovascular diseases, diabetes mellitus, chronic kidney disease, vitamin D deficiency, iron deficiency, and rheumatoid arthritis. Future research is needed to continue improving chronic disease management through clearer dissemination and awareness of clinical guidelines among providers, and better access to blood testing for patients (e.g., via pre-visit laboratory testing).

Conflicts of Interest Among Cardiology Clinical Practice Guideline Authors in Japan.

BACKGROUND: Clinical practice guidelines (CPGs) offer disease management recommendations based on scientific evidence. However, financial conflicts of interest between CPG developers and the pharmaceutical industry could bias these recommendations, potentially affecting patient care. Proper management of these conflicts of interest is particularly crucial for maintaining the integrity of CPGs. The study aimed to evaluate the extent of financial relationships between the pharmaceutical industry and authors of CPGs for cardiovascular diseases in Japan. METHODS AND RESULTS: The study analyzed personal payments from the pharmaceutical industry to authors of cardiovascular disease CPGs published by the Japanese Circulation Society from January 2015 to December 2022. Payment data, including speaking, consultancy, and writing fees from 2016 to 2020, were extracted from a publicly available database containing personal payments disclosed by all major pharmaceutical companies. A total of 929 unique authors from 37 eligible Japanese Circulation Society CPGs were identified. Notably, 94.4% of these authors received personal payments from pharmaceutical companies, totaling >US $70.8 million. The mean±SD payment per author was US $76 314±138 663) and the median payment per author was US $20 792 (interquartile range: US $4262-US $76 998) over the 5-year period. Chairs of CPGs received significantly higher payments than other authors. More than 80% of authors in each CPG received personal payments. CONCLUSIONS: The study elucidated that there were considerable financial relationships between pharmaceutical companies and cardiology CPG authors in Japan. This finding deviates from international conflict of interest management policies, suggesting the need for more stringent conflict of interest management strategies by the Japanese Circulation Society to ensure the development of trustworthy and evidence-based CPGs.

Knowledge Translation Task Force for core measures clinical practice guideline: a short report on the process and utilization.

BACKGROUND: As part of the 2018 Clinical Practice Guideline (CPG): A Core Set of Outcome Measures for Adults with Neurologic Conditions Undergoing Rehabilitation, a Knowledge Translation (KT) Task Force was convened. The purpose of this short report was to (1) demonstrate the potential impact of a CPG KT Task Force through a practical example of efforts to implement a CPG into neurologic physical therapy practice and (2) describe the process to convene a KT Task Force and develop products (KT Toolkit) to facilitate implementation of the CPG. METHODS: To describe the process used by the KT Task Force to develop and review a KT Toolkit for implementation of the CPG. RESULTS: Utilizing the Knowledge-To-Action Cycle framework, eight tools were developed as part of the KT Toolkit and are available with open access to the public. Findings indicate that the Core Outcome Measures Homepage, which houses the KT Toolkit, has had greater than 70,000 views since its publication. CONCLUSIONS: This short report serves as an example of the efforts made to implement a CPG into physical therapy practice. The processes to facilitate KT and the tools developed can inform future implementation efforts and underscore the importance of having a KT Task Force to implement a CPG. Moving forward, KT Task Forces should be convened to implement new or revised guidelines. TRIAL REGISTRATION: N/A.

Clinical practice guideline for acupuncture and moxibustion: Female urinary incontinence.

Urinary incontinence (UI) is a common problem worldwide. It has a major impact on physical and social activities and interpersonal relationships. UI is common in women, but is under-reported and under-treated. It affects the quality of life of female patients severely. Acupuncture and moxibustion have been proposed as potentially effective interventions for female UI. Hence, for the benefit of acupuncture practitioners around the world, the World Federation of Acupuncture-moxibustion Societies initiated a project to develop a clinical practice guideline (CPG) for the use of acupuncture and moxibustion to treat female UI. This CPG was developed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, referring to the principles of the World Health Organization Handbook for Guideline Development. During the development of the CPG, the guideline development group (GDG) played an important role. The clinical questions, recommendations and therapeutic protocols were all formulated by GDG using the modified Delphi method. This CPG contains ten recommendations about the use of acupuncture and moxibustion interventions for ten clinical questions, which include nine conditional recommendations for the intervention and one conditional recommendation for either the intervention or the comparison. This CPG also provides one protocol for conventional filiform needle therapy, two therapy protocols for deep needling stimulation on lumbosacral acupoints, and four moxibustion therapy protocols, based on the protocols presented in randomized controlled trials reviewed by the GDG. Please cite this article as: Yang C, Wang SZ, Chen S, Du S, Wang GQ, Guo W, et al. Clinical practice guideline for acupuncture and moxibustion: Female urinary incontinence. J Integr Med. 2024; Epub ahead of print.

Australian and New Zealand Living Guideline cholesterol-lowering therapy for people with chronic kidney disease (CARI Guidelines): Reducing the evidence-practice gap.

AIM: People with chronic kidney disease experience high rates of cardiovascular disease. Cholesterol-lowering therapy is a mainstay in the management but there is uncertainty in the treatment effects on patient-important outcomes, such as fatigue and rhabdomyolysis. Here, we summarise the updated CARI Australian and New Zealand Living Guidelines on cholesterol-lowering therapy in chronic kidney disease. METHODS: We updated a Cochrane review and monitored newly published studies weekly to inform guideline development according to international standards. The Working Group included expertise from nephrology, cardiology, Indigenous Health, guideline development and people with lived experience of chronic kidney disease. RESULTS: The guideline recommends people with chronic kidney disease (eGFR ≥15 mL/min/1.73 m2) and an absolute cardiovascular risk of 10% or higher should receive statin therapy (with or without ezetimibe) to reduce the risk of cardiovascular events and death (strong recommendation, moderate certainty evidence). The guidelines also recommends a lower absolute cardiovascular risk threshold (≥5%) for Aboriginal and Torres Strait Islander Peoples and Maori with chronic kidney disease to receive statin therapy (with or without ezetimibe) (strong recommendation, low certainty evidence). The evidence was actively surveyed from 2020-2023 and updated as required. No changes to guideline recommendations were made, with no new data on the balance and benefits of harms. CONCLUSIONS: The development of living guidelines was feasible and provided the opportunity to update recommendations to improve clinical decision-making in real-time. Living guidelines provide the opportunity to transform chronic kidney disease guidelines.

Acute heart failure - an EFIM guideline critical appraisal and adaptation for internists.

BACKGROUND: Over the past two decades, several studies have been conducted that have tried to answer questions on management of patients with acute heart failure (AHF) in terms of diagnosis and treatment. Updated international clinical practice guidelines (CPGs) have endorsed the findings of these studies. The aim of this document was to adapt recommendations of existing guidelines to help internists make decisions about specific and complex scenarios related to AHF. METHODS: The adaptation procedure was to identify firstly unresolved clinical problems in patients with AHF in accordance with the PICO (Population, Intervention, Comparison and Outcomes) process, then conduct a critical assessment of existing CPGs and choose recommendations that are most applicable to these specific scenarios. RESULTS: Seven PICOs were identified and CPGs were assessed. There is no single test that can help clinicians in discriminating patients with acute dyspnoea, congestion or hypoxaemia. Performing of echocardiography and natriuretic peptide evaluation is recommended, and chest X-ray and lung ultrasound may be considered. Treatment strategies to manage arterial hypotension and low cardiac output include short-term continuous intravenous inotropic support, vasopressors, renal replacement therapy, and temporary mechanical circulatory support. The most updated recommendations on how to treat specific patients with AHF and certain comorbidities and for reducing post-discharge rehospitalization and mortality are provided. Overall, 51 recommendations were endorsed and the rationale for the selection is provided in the main text. CONCLUSION: Through the use of appropriate tailoring process methodology, this document provides a simple and updated guide for internists dealing with AHF patients.

An Update of a Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Role and Timing of Decompressive Surgery.

STUDY DESIGN: Clinical practice guideline development. OBJECTIVES: Acute spinal cord injury (SCI) can result in devastating motor, sensory, and autonomic impairment; loss of independence; and reduced quality of life. Preclinical evidence suggests that early decompression of the spinal cord may help to limit secondary injury, reduce damage to the neural tissue, and improve functional outcomes. Emerging evidence indicates that "early" surgical decompression completed within 24 hours of injury also improves neurological recovery in patients with acute SCI. The objective of this clinical practice guideline (CPG) is to update the 2017 recommendations on the timing of surgical decompression and to evaluate the evidence with respect to ultra-early surgery (in particular, but not limited to, <12 hours after acute SCI). METHODS: A multidisciplinary, international, guideline development group (GDG) was formed that consisted of spine surgeons, neurologists, critical care specialists, emergency medicine doctors, physical medicine and rehabilitation professionals, as well as individuals living with SCI. A systematic review was conducted based on accepted methodological standards to evaluate the impact of early (within 24 hours of acute SCI) or ultra-early (in particular, but not limited to, within 12 hours of acute SCI) surgery on neurological recovery, functional outcomes, administrative outcomes, safety, and cost-effectiveness. The GRADE approach was used to rate the overall strength of evidence across studies for each primary outcome. Using the "evidence-to-recommendation" framework, recommendations were then developed that considered the balance of benefits and harms, financial impact, patient values, acceptability, and feasibility. The guideline was internally appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. RESULTS: The GDG recommended that early surgery (≤24 hours after injury) be offered as the preferred option for adult patients with acute SCI regardless of level. This recommendation was based on moderate evidence suggesting that patients were 2 times more likely to recover by ≥ 2 ASIA Impairment Score (AIS) grades at 6 months (RR: 2.76, 95% CI 1.60 to 4.98) and 12 months (RR: 1.95, 95% CI 1.26 to 3.18) if they were decompressed within 24 hours compared to after 24 hours. Furthermore, patients undergoing early surgery improved by an additional 4.50 (95% 1.70 to 7.29) points on the ASIA Motor Score compared to patients undergoing surgery after 24 hours post-injury. The GDG also agreed that a recommendation for ultra-early surgery could not be made on the basis of the current evidence because of the small sample sizes, variable definitions of what constituted ultra-early in the literature, and the inconsistency of the evidence. CONCLUSIONS: It is recommended that patients with an acute SCI, regardless of level, undergo surgery within 24 hours after injury when medically feasible. Future research is required to determine the differential effectiveness of early surgery in different subpopulations and the impact of ultra-early surgery on neurological recovery. Moreover, further work is required to define what constitutes effective spinal cord decompression and to individualize care. It is also recognized that a concerted international effort will be required to translate these recommendations into policy.

A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on Hemodynamic Management.

STUDY DESIGN: Clinical practice guideline development following the GRADE process. OBJECTIVES: Hemodynamic management is one of the only available treatment options that likely improves neurologic outcomes in patients with acute traumatic spinal cord injury (SCI). Augmenting mean arterial pressure (MAP) aims to improve blood perfusion and oxygen delivery to the injured spinal cord in order to minimize secondary ischemic damage to neural tissue. The objective of this guideline was to update the 2013 AANS/CNS recommendations on the hemodynamic management of patients with acute traumatic SCI, acknowledging that much has been published in this area since its publication. Specifically, we sought to make recommendations on 1. The range of mean arterial pressure (MAP) to be maintained by identifying an upper and lower MAP limit; 2. The duration of such MAP augmentation; and 3. The choice of vasopressor. Additionally, we sought to make a recommendation on spinal cord perfusion pressure (SCPP) targets. METHODS: A multidisciplinary guideline development group (GDG) was formed that included health care professionals from a wide range of clinical specialities, patient advocates, and individuals living with SCI. The GDG reviewed the 2013 AANS/CNS guidelines and voted on whether each recommendation should be endorsed or updated. A systematic review of the literature, following PRISMA standards and registered in PROSPERO, was conducted to inform the guideline development process and address the following key questions: (i) what are the effects of goal-directed interventions to optimize spinal cord perfusion on extent of neurological recovery and rates of adverse events at any time point of follow-up? and (ii) what are the effects of particular monitoring techniques, perfusion ranges, pharmacological agents, and durations of treatment on extent of neurological recovery and rates of adverse events at any time point of follow-up? The GDG combined the information from this systematic review with their clinical expertise in order to develop recommendations on a MAP target range (specifically an upper and lower limit to target), the optimal duration for MAP augmentation, and the use of vasopressors or inotropes. Using methods outlined by the GRADE working group, recommendations were formulated that considered the balance of benefits and harms, financial impact, acceptability, feasibility and patient preferences. RESULTS: The GDG suggested that MAP should be augmented to at least 75-80 mmHg as the "lower limit," but not actively augmented beyond an "upper limit" of 90-95 mmHg in order to optimize spinal cord perfusion in acute traumatic SCI. The quality of the evidence around the "target MAP" was very low, and thus the strength of this recommendation is weak. For duration of hemodynamic management, the GDG "suggested" that MAP be augmented for a duration of 3-7 days. Again, the quality of the evidence around the duration of MAP support was very low, and thus the strength of this recommendation is also weak. The GDG felt that a recommendation on the choice of vasopressor or the use of SCPP targets was not warranted, given the dearth of available evidence. CONCLUSION: We provide new recommendations for blood pressure management after acute SCI that acknowledge the limitations of the current evidence on the relationship between MAP and neurologic recovery. It was felt that the low quality of existing evidence and uncertainty around the relationship between MAP and neurologic recovery justified a greater range of MAP to target, and for a broader range of days post-injury than recommended in previous guidelines. While important knowledge gaps still remain regarding hemodynamic management, these recommendations represent current perspectives on the role of MAP augmentation for acute SCI.

AO Spine/Praxis Clinical Practice Guidelines for the Management of Acute Spinal Cord Injury: An Introduction to a Focus Issue.

STUDY DESIGN: Narrative overview and summary. OBJECTIVES: The objective of this introductory manuscript is to provide an overview of the effort that was undertaken to establish clinical practice guidelines for a number of important topics in spinal cord injury (SCI). These topics included: 1. The role and timing of surgical decompression after acute traumatic SCI; 2. The hemodynamic management of acute traumatic SCI; and 3. The definition, diagnosis, and management of intra-operative SCI. Here, we introduce the rationale for the guidelines, the methodology utilized, and summarize how the topics are addressed within various manuscripts of this Focus Issue. METHODS: The key clinical questions were defined using the PICO format for treatment reviews (patient; intervention; comparison; outcomes) or PPO format (patient, prognostic factor, outcomes) for risk factor review. Multi-disciplinary, international guideline development groups (GDGs) were established to evaluate and collate the available evidence in a rigorous, systematic manner, followed by a review of systematically obtained evidence within the framework of the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) criteria and application of the Evidence to Decision process. Consensus meetings, using a modified Delphi approach, were held with the multidisciplinary, international GDGs using online video-conferencing technology and anonymous voting to develop the final recommendations for each of the topics addressed. All systematic review protocols followed PRISMA standards and were registered on PROSPERO; all potential conflicts were vetted in an open and transparent manner. The funders (AO Spine and Praxis Spinal Cord Institute) had no influence over editorial content or the guidelines process). RESULTS: Updated guidelines were established for the timing of surgical decompression after acute SCI, with surgical decompression within 24 hours of injury now "recommended" as a treatment option. Updated guidelines were also established for hemodynamic management, with an expanded target range for mean arterial pressure (MAP) of 75-80 to 90-95 mmHg for between 3 to 7 days post-injury now "suggested" as a treatment option. The available literature mandated scoping and systematic reviews on the topic of intra-operative SCI, and this resulted in manuscripts to address the definition, frequency, and risk factors, to define the role of intra-operative neuromonitoring, and to suggest an evidence-based care pathway for management. CONCLUSION: A rigorous process following GRADE standards was undertaken to review the available evidence and establish guideline recommendations around the role and timing of surgery in acute SCI, optimal hemodynamic management of acute SCI and the prevention, diagnosis and management of intraoperative SCI. This effort also identified key knowledge gaps and future directions for study, which will serve to refine these recommendations in the future.