Development Of Clinical Practice Guidelines Research Articles

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

BackgroundDespite 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.MethodsA 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.ResultsTwenty-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.ConclusionThe 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.

Axial spondyloarthritis guidelines - aiming for maximum impact.

This review discusses international clinical practice guidelines (CPGs) for axial spondyloarthritis (axSpA) focusing on methodology, guideline quality, and implementation. The Assessment of SpondyloArthritis International Society/European Alliance of Associations for Rheumatology (ASAS/EULAR) and Pan-American League of Associations for Rheumatology (PANLAR) recently published axSpA CPGs and updates of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network (ACR/SAA/SPARTAN) and Asia-Pacific League of Associations for Rheumatology (APLAR) CPGs are expected. GRADE has emerged as the dominant framework for CPG development and has been used by three of the four international axSpA guidelines. Notable differences exist among these guidelines in the way that the recommendations are presented. Two of the four acknowledge the need for implementation strategies, but little detail about this is provided. The few studies that have evaluated the implementation of axSpA CPGs have identified poor adherence to recommendations on physical therapy/exercise and disease activity monitoring. Implementation science has identified many barriers and facilitators affecting guideline uptake, including those related to healthcare professionals and to the guidelines themselves. Creation of a tailored implementation plan simultaneously with the CPG is recommended. While methodological rigor in the creation of evidence-based recommendations is the focus of CPG development, recommendations must be presented in a user-friendly format that makes them easy to apply. 'Living guidelines' could facilitate keeping content up to date. Implementation is critical for the success of a CPG and should be emphasized in future axSpA guideline updates. Further research is needed to better understand the factors impacting the successful implementation of axSpA CPGs.

Suicide Behavior Among Indigenous and Non-Indigenous Living with HIV: A Cross-Sectional Study in Indonesia.

Suicide remains a major public health problem, with nearly 1million deaths per year. The number tends to increase over time and factors leading to suicide suicidal behaviors are complex. However, there is a paucity of evidence on suicidal behaviors and the associated factors among people living with HIV (PLWH) in Indonesia. Therefore, this study aimed to estimate the prevalence and associated factors of suicidal behavior between indigenous and non-indigenous living with HIV who were on Dolutegravir and Efavirenz therapies. The cross-sectional data were collected using questionnaires. Participants completed the Suicidal Behaviors Questionnaire-Revised (SBQ-R), Depression Anxiety Stress Scale-42 (DASS-42), HIV Stigma-Sowell Scale, and demographic information questions. The outcome was low and high self-reported suicidal behaviors, while logistic regression analyses were used to estimate adjusted odds ratios (aOR) for associated factors of high suicidal behaviors. A total of 200 PLWH were enrolled and 8.5% of the participants had high levels of suicidal behaviors. The majority of participants were Efavirenz users (84.0%), and Papuans as Indigenous (75.5%). More than half had a high school education (60.5%), were female (58%), married (54%), and unpaid (59%). The multiple logistic regression model showed that indigenous (aOR = 0.122; 95% CI = 0.029-0.514), and people who had children (aOR = 0.221; 95% CI = 0.051-0.957) were more likely to have low suicidal behaviors. Participants who were aged 18-27 years (aOR = 5.894; 95% CI = 1.336-30.579), had high self-blame (aOR = 1.342; 95% CI) = 1.004-1.792), and detectable HIV viral load (aOR = 6.177; 95%CI = 1.118-34.119) had high suicidal behavior. This study identified the risk of suicidality among PLWHs is high and routine suicide assessment is prioritized. The findings are also useful for intervention design and the development of clinical practice guidelines to manage the well-being of PLWH such as using digital intervention to cope with hindrances.

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

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. 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. 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.

Quality appraisal of clinical guidelines for Helicobacter pylori infection and systematic analysis of the level of evidence for recommendations.

To systematically assess the quality of clinical practice guidelines (CPGs) for Helicobacter pylori (HP) infection and identify gaps that limit their development. CPGs for HP infection were systematically collected from PubMed, Embase, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature, and six online guideline repositories. Three researchers independently used the AGREE Ⅱ tool to evaluate the methodological quality of the eligible CPGs. In addition, the reporting and recommendation qualities were appraised by using the RIGHT and AGREE-REX tools, respectively. The distribution of the level of evidence and strength of recommendation among evidence-based CPGs was determined. A total of 7,019 records were identified, and 24 CPGs met the eligibility criteria. Of the eligible CPGs, 19 were evidence-based and 5 were consensus-based. The mean overall rating score of AGREE II was 50.7% (SD = 17.2%). Among six domains, the highest mean score was for scope and purpose (74.4%, SD = 17.7%) and the lowest mean score was for applicability (24.3%, SD = 8.9). Only three of 24 CPGs were high-quality. The mean overall score of recommendation quality was 35.5% (SD = 12.2%), and the mean scores in each domain of AGREE-REX and RIGHT were all ≤ 60%, with values and preferences scoring the lowest (16.6%, SD = 11.9%). A total of 505 recommendations were identified. Strong recommendations accounted for 64.1%, and only 34.3% of strong recommendations were based on high-quality evidence. The overall quality of CPGs for HP infection is poor, and CPG developers tend to neglect some domains, resulting in a wide variability in the quality of the CPGs. Additionally, CPGs for HP infection lack sufficient high-quality evidence, and the grading of recommendation strength should be based on the quality of evidence. The CPGs for HP infection have much room for improvement and further researches are required to minimize the evidence gap.

Impact of antithrombotic agents on outcomes in patients requiring surgery for chronic subdural haematoma: a systematic review and meta-analysis.

A chronic subdural haematoma (CSDH) is a collection of aged blood between the dura and the brain, typically treated with surgical evacuation. Many patients with CSDH have comorbidities requiring the use of antithrombotic medications. The optimal management of these medications in the context of CSDH remains unknown, as the risk of recurrence must be carefully weighed against the risk of vaso-occlusive events. To better understand these risks and inform the development of clinical practice guidelines, we conducted a systematic review and meta-analysis. A systematic review was conducted in accordance with the PRISMA guidelines, searching Medline and Embase databases. The study was registered with PROSPERO (CRD42023397061). A total of 44 studies were included, encompassing 1 prospective cohort study and 43 retrospective cohort studies. Pooled odds ratios (ORs) were calculated for CSDH recurrence and vaso-occlusive events in patients taking anticoagulant or antiplatelet medications compared to patients not receiving antithrombotic therapy. GRADE was used to assess the quality of evidence. In patients on anticoagulant therapy at CSDH diagnosis, the pooled OR for CSDH recurrence was 1.41 (95% CI 1.11 to 1.79; I2 = 28%). For patients on antiplatelet therapy, the pooled OR was 1.31 (95% CI 1.08 to 1.58; I2 = 32%). Patients taking antithrombotic medications had a significantly higher risk of vaso-occlusive events, with a pooled OR of 3.74 (95% CI 2.12 to 6.60; I2 = 0%). There was insufficient evidence to assess the impact of time to recommence antithrombotic medication on CSDH outcomes. We found that baseline antithrombotic use is associated with the risk of CSDH recurrence and vaso-occlusive events following surgical evacuation. The evidence base is of low quality, and decisions regarding antithrombotic therapy should be individualised for each patient. Further high-quality, prospective studies or registry-based designs are needed to better inform clinical decision-making and establish evidence-based guidelines.

Addressing Differences in Knowledge and Experience in Trauma Care Capabilities Among an International Team of Military Medical Care Providers in a Deployed Setting.

Military medical personnel are crucial in providing life-saving care at the point of injury (POI) in challenging environments such as combat zones and disaster areas. This article examines the specialized training US Military medical personnel undergo before deployment and the increasing trend of deploying as part of multinational forces in operations like those in Afghanistan with NATO and non-NATO countries. Integrating medical teams from diverse backgrounds poses significant challenges in maintaining a cohesive and efficient team due to varying trauma management training standards and medical practices among the allied forces. Tactical Combat Casualty Care (TCCC) training and the development of clinical practice guidelines (CPG) by the US Joint Trauma Service have been key strategies by the US Military to standardize care. However, the variation in trauma management training among NATO allies and the differences in medical subspecialties and approaches can lead to inefficiencies and reduced effectiveness in a multinational trauma center setting. For instance, the approach to trauma care can significantly differ between the US and European countries, impacting the interoperability and teamwork in multinational medical teams. To address these challenges, the article highlights the importance of standardized medical training programs that include cultural awareness to enhance the effectiveness of multidisciplinary, multinational medical teams. It also underscores the necessity for standardized international trauma training in the face of increasing global conflicts and the potential for large-scale combat operations. The article discusses the "Trauma Tuesday" program implemented in Kabul, Afghanistan, as an example of how intensive training and simulation exercises can improve team dynamics, knowledge, and skills in trauma management among a diverse team from various nations. The need for ongoing education and developing a standard for managing trauma patients in international teams is emphasized to ensure effective communication and coordination. The article suggests that multinational trauma training can significantly improve team cohesion and critical life-saving skills, essential for future battlefields where access to definitive care may be delayed. Further research is recommended to explore the best methods for achieving effective multinational medical team integration and training standardization.

Is it too early to recommend local treatment in oligometastatic non-small cell lung cancer: a plea for equipoise.

Oligometastatic non-small cell lung cancer (OMD NSCLC) has been proposed to bridge the spectrum between non-metastatic and widely metastatic states and is perceived as an opportunity for potential cure if removed. Twelve clinical trials on local treatment have been reported, yet none are conclusive. These trials informed the development of a joint clinical practice guideline by the American & European Societies for Radiation Oncology, which endorses local treatment for OMD NSCLC. However, the heterogeneity between prognostic factors within these trials likely influenced outcomes and can only support guidance at this time. Caution against an uncritical acceptance of the guideline is discussed, as strong recommendations are offered based on expert opinion and inconclusive evidence. The guideline is also examined by a patient's caregiver, who emphasizes that uncertain evidence impedes shared decision making.

Optimal timing of prophylactic pegylated G-CSF after chemotherapy administration for patients with cancer: a systematic review and meta-analysis from Clinical Practice Guidelines for the use of G-CSF 2022.

The timing of prophylactic pegylated granulocyte colony-stimulating factor (G-CSF) administration during cancer chemotherapy varies, with Day 2 and Days 3-5 being the most common schedules. Optimal timing remains uncertain, affecting efficacy and adverse events. This systematic review sought to evaluate the available evidence on the timing of prophylactic pegylated G-CSF administration. Based on the Minds Handbook for Clinical Practice Guideline Development, we searched the PubMed, Ichushi-Web, and Cochrane Library databases for literature published from January 1990 to December 2019. The inclusion criteria included studies among the adult population using pegfilgrastim. The search strategy focused on timing-related keywords. Two reviewers independently extracted and assessed the data. Among 300 initial search results, only four articles met the inclusion criteria. A meta-analysis for febrile neutropenia incidence suggested a potential higher incidence when pegylated G-CSF was administered on Days 3-5 than on Day 2 (odds ratio: 1.27, 95% CI 0.66-2.46, p = 0.47), with a moderate certainty of evidence. No significant difference in overall survival or mortality due to infections was observed. The trend of severe adverse events was lower on Days 3-5, without statistical significance (odds ratio: 0.72, 95% CI 0.14-3.67, p = 0.69) and with a moderate certainty of evidence. Data on pain were inconclusive. Both Day 2 and Days 3-5 were weakly recommended for pegylated G-CSF administration post-chemotherapy in patients with cancer. The limited evidence highlights the need for further research to refine recommendations.

Chinese national clinical practice guidelines on the prevention, diagnosis, and treatment of early gastric cancer.

Gastric cancer is one of the most common malignant tumors in the digestive system in China. Few comprehensive practice guidelines for early gastric cancer in China are currently available. Therefore, we created the Chinese national clinical practice guideline for the prevention, diagnosis, and treatment of early gastric cancer. This clinical practice guideline (CPG) was developed in accordance with the World Health Organization's recommended process and with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) in assessing evidence quality. We used the Evidence to Decision framework to formulate clinical recommendations to minimize bias and increase transparency in the CPG development process. We used the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement and the Appraisal of Guidelines for Research and Evaluation II (AGREE II) as reporting and conduct guidelines to ensure completeness and transparency of the CPG. This CPG contains 40 recommendations regarding the prevention, screening, diagnosis, treatment, and follow-up of early gastric cancer based on available clinical studies and guidelines. We provide recommendations for the timing of Helicobacter pylori eradication, screening populations for early gastric cancer, indications for endoscopic resection and surgical gastrectomy, follow-up interval after treatment, and other recommendations. This CPG can lead to optimum care for patients and populations by providing up-to-date medical information. We intend this CPG for widespread adoption to increase the standard of prevention, screening, diagnosis, treatment, and follow-up of early gastric cancer; thereby, contributing to improving national health care and patient quality of life.

Systematic review of clinical practice guidelines for the diagnosis and management of retinal vein occlusion.

To assess the methodological quality of Clinical Practice Guidelines (CPG) for the diagnosis and management of Retinal Vein Occlusion (RVO). A systematic review of CPGs for the diagnosis and management of RVO was carried out with a search in databases, metasearch engines, CPG development institutions, ophthalmology associations and CPG repositories until April 2022. Search update was performed on April 2023, with no new record available. Five CPGs published in the last 10 years in English/Spanish were selected, and 5 authors evaluated them independently, using the Appraisal of Guidelines for Research and Evaluation (AGREE-II) instrument. An individual assessment of each CPG by domain (AGREE-II), an overall assessment of the guide, and its use with or without modifications were performed. Additionally, a meta-synthesis of the recommendations for the most relevant outcomes was carried out. The lowest score (mean 18.8%) was for domain 5 'applicability', and the highest score (mean 62%) was for domain 4 'clarity of presentation'. The 2019 American guideline (PPP) presented the best score (40.4%) in domain 3 'rigour of development'. When evaluating the overall quality of the CPGs analysed, all CPGs could be recommended with modifications. In the meta-synthesis, anti-VEGF therapy is the first-choice therapy for macular oedema associated with RVO, but there is no clear recommendation about the type of anti-VEGF therapy to choose. Recommendations for diagnosis and follow-up are similar among the CPGs appraised. Most CPGs for the diagnosis and management of RVO have a low methodological quality assessed according to the AGREE-II. PPP has the higher score in the domain 'rigour of development'. Among the CPGs appraised, there is no clear recommendation on the type of anti-VEGF therapy to choose.

The Musculoskeletal Tumor Society Clinical Practice Guideline on the Management of Metastatic Humeral Disease.

Management of Metastatic Humeral Disease is based on a systematic review of published studies surrounding the management of metastatic disease, multiple myeloma, and lymphoma limited to the humerus. This guideline contains seven action statements to assist orthopaedic surgeons, orthopaedic oncologists, physicians, and any other qualified healthcare professionals involved in the surgical management of metastatic disease of the humerus. It is also intended to serve as an information resource for decision makers, researchers, and developers of clinical practice guidelines. In addition to providing pragmatic practice recommendations, this guideline also highlights gaps in the literature and informs areas for future research and quality measure development. This guideline has been endorsed by the American Academy of Orthopaedic Surgeons.

A Clinical Practice Guideline on the Timing of Surgical Decompression and Hemodynamic Management of Acute Spinal Cord Injury and the Prevention, Diagnosis, and Management of Intraoperative Spinal Cord Injury: Introduction, Rationale, and Scope.

Protocol for the development of clinical practice guidelines following the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) standards. Acute SCI or intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. The treatment of SCI has dramatically evolved over the last century as a result of preclinical and clinical research that has addressed important knowledge gaps, including injury mechanisms, disease pathophysiology, medical management, and the role of surgery. In an acute setting, clinicians are faced with critical decisions on how to optimize neurological recovery in patients with SCI that include the role and timing of surgical decompression and the best strategies for hemodynamic management. The lack of consensus surrounding these treatments has prevented standardization of care across centers and has created uncertainty with respect to how to best manage patients with SCI. ISCI is a feared complication that can occur in the best of hands. Unfortunately, there are no systematic reviews or clinical practice guidelines to assist spine surgeons in the assessment and management of ISCI in adult patients undergoing spinal surgery. Given these limitations, it is the objective of this initiative to develop evidence-based recommendations that will inform the management of both SCI and ISCI. This protocol describes the rationale for developing clinical practice guidelines on (i) the timing of surgical decompression in acute SCI; (ii) the hemodynamic management of acute SCI; and (iii) the prevention, identification, and management of ISCI in patients undergoing surgery for spine-related pathology. Systematic reviews were conducted according to PRISMA standards in order to summarize the current body of evidence and inform the guideline development process. The guideline development process followed the approach proposed by the GRADE working group. Separate multidisciplinary, international groups were created to perform the systematic reviews and formulate the guidelines. All potential conflicts of interest were vetted in advance. The sponsors exerted no influence over the editorial process or the development of the guidelines. This process resulted in both systematic reviews and clinical practice guidelines/care pathways related to the role and timing of surgery in acute SCI; the optimal hemodynamic management of acute SCI; and the prevention, diagnosis and management of ISCI. The ultimate goal of this clinical practice guideline initiative was to develop evidence-based recommendations for important areas of controversy in SCI and ISCI in hopes of improving neurological outcomes, reducing morbidity, and standardizing care across settings. Throughout this process, critical knowledge gaps and future directions were also defined.

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

Clinical practice guideline development following the GRADE process. 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. 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. 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 90-95mmHg 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 3-7days. 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. 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.

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.

Clinical practice guideline development. 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 24hours 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, <12hours after acute SCI). 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 24hours of acute SCI) or ultra-early (in particular, but not limited to, within 12hours 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. The GDG recommended that early surgery (≤24hours 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 2times 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 12months (RR: 1.95, 95% CI 1.26 to 3.18) if they were decompressed within 24hours compared to after 24hours. 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 24hours 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. It is recommended that patients with an acute SCI, regardless of level, undergo surgery within 24hours 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.

Interventions to Optimize Spinal Cord Perfusion in Patients With Acute Traumatic Spinal Cord Injury: An Updated Systematic Review.

Systematic review update. Interventions that aim to optimize spinal cord perfusion are thought to play an important role in minimizing secondary ischemic damage and improving outcomes in patients with acute traumatic spinal cord injuries (SCIs). However, exactly how to optimize spinal cord perfusion and enhance neurologic recovery remains controversial. We performed an update of a recent systematic review (Evaniew et al, J. Neurotrauma 2020) to evaluate the effects of Mean Arterial Pressure (MAP) support or Spinal Cord Perfusion Pressure (SCPP) support on neurological recovery and rates of adverse events among patients with acute traumatic SCI. We searched PubMed/MEDLINE, EMBASE and ClinicalTrials.gov for new published reports. Two reviewers independently screened articles, extracted data, and evaluated risk of bias. We implemented the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach to rate confidence in the quality of the evidence. From 569 potentially relevant new citations since 2019, we identified 9 new studies for inclusion, which were combined with 19 studies from a prior review to give a total of 28 studies. According to low or very low quality evidence, the effect of MAP support on neurological recovery is uncertain, and increased SCPP may be associated with improved neurological recovery. Both approaches may involve risks for specific adverse events, but the importance of these adverse events to patients remains unclear. Very low quality evidence failed to yield reliable guidance about particular monitoring techniques, perfusion ranges, pharmacological agents, or durations of treatment. This update provides an evidence base to support the development of a new clinical practice guideline for the hemodynamic management of patients with acute traumatic SCI. While avoidance of hypotension and maintenance of spinal cord perfusion are important principles in the management of an acute SCI, the literature does not provide high quality evidence in support of a particular protocol. Further prospective, controlled research studies with objective validated outcome assessments are required to examine interventions to optimize spinal cord perfusion in this setting.

Improving meta-analyses of suicide prevention programs to inform the development of actionable clinical practice guidelines.

Improving meta-analyses of suicide prevention programs to inform the development of actionable clinical practice guidelines.

GRADE pearls and pitfalls-Part 2: Clinical practice guidelines.

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach is the de facto standard framework for summarising evidence in systematic reviews and developing recommendations in clinical practice guidelines. We describe how the GRADE approach is used in clinical practice guidelines, including key points and examples. The intended audience of this overview of GRADE is clinicians and researchers who are, or plan to be, involved in the development or assessment of clinical practice guidelines. We cover guideline endorsement and adaptation; guideline panels and sponsors; conflicts of interest; guideline questions and outcome prioritisation; systematic review creation, updating and re-use; rating the overall certainty of evidence; development of recommendations and implications; and peer review, publication, implementation and updating of guidelines. This overview aims to help developers, assessors and users of clinical practice guidelines understand how trustworthy, high-quality guidelines are developed using the GRADE approach.

The clinical practice guideline for the management of amyotrophic lateral sclerosis in Japan-update 2023.

Amyotrophic lateral sclerosis (ALS) is an adult-onset intractable motor neuron disease characterized by selective degeneration of cortical neurons in the frontotemporal lobe and motor neurons in the brainstem and spinal cord. Impairment of these neural networks causes progressive muscle atrophy and weakness that spreads throughout the body, resulting in life-threatening bulbar palsy and respiratory muscle paralysis. However, no therapeutic strategy has yet been established to halt ALS progression. Although evidence for clinical practice in ALS remains insufficient, novel research findings have steadily accumulated in recent years. To provide updated evidence-based or expert consensus recommendations for the diagnosis and management of ALS, the ALS Clinical Practice Guideline Development Committee, approved by the Japanese Society of Neurology, revised and published the Japanese clinical practice guidelines for the management of ALS in 2023. In this guideline, disease-modifying therapies that have accumulated evidence from randomized controlled trials were defined as "Clinical Questions," in which the level of evidence was determined by systematic reviews. In contrast, "Questions and Answers" were defined as issues of clinically important but insufficient evidence, according to reports of a small number of cases, observational studies, and expert opinions. Based on a literature search performed in February 2022, recommendations were reached by consensus, determined by an independent panel, reviewed by external reviewers, and submitted for public comments by Japanese Society of Neurology members before publication. In this article, we summarize the revised Japanese guidelines for ALS, highlighting the regional and cultural diversity of care processes and decision-making. The guidelines cover a broad range of essential topics such as etiology, diagnostic criteria, disease monitoring and treatments, management of symptoms, respiration, rehabilitation, nutrition, metabolism, patient instructions, and various types of care support. We believe that this summary will help improve the daily clinical practice for individuals living with ALS and their caregivers.

Does Sex Matter to the Biomedical Approach in Clinical Practice Guidelines (CPGs)?: A Systematic Review of Methodology Documents Used in the Spanish National Health System.

Sex and gender are important variables in health, although their incorporation in medicine has been very slow. If research is sensitive and yields fruitful sex and gender evidence, these results should be included in the guidelines for clinical practices. However, literature claims that clinical practice guidelines devote very little space to these categories. The present systematic review addresses the relevance of sex and gender dimensions through methodology documents for the development of clinical practice guidelines based on three sources: the AGREE Reporting Checklist, the GRADE Handbook, and the Spanish GuíaSalud NHS Clinical Guideline Program. Findings suggest that neglecting sex and gender issues in the biomedical approach may lead to continuing to ignore relevant evidence on biological and social dimensions that do indeed influence people's health and diseases.