Population, Intervention, Comparator, Outcome Questions Research Articles

American Burn Association Clinical Practice Guidelines on Burn Shock Resuscitation.

This Clinical Practice Guideline (CPG) addresses the topic of acute fluid resuscitation during the first 48 hours following a burn injury for adults with burns ≥20% of the total body surface area (%TBSA). The listed authors formed an investigation panel and developed clinically relevant PICO (Population, Intervention, Comparator, Outcome) questions. A systematic literature search returned 5978 titles related to this topic and after 3 levels of screening, 24 studies met criteria to address the PICO questions and were critically reviewed. We recommend that clinicians consider the use of human albumin solution, especially in patients with larger burns, to lower resuscitation volumes and improve urine output. We recommend initiating resuscitation based on providing 2 mL/kg/% TBSA burn in order to reduce resuscitation fluid volumes. We recommend selective monitoring of intra-abdominal and intraocular pressure during burn shock resuscitation. We make a weak recommendation for clinicians to consider the use of computer decision support software to guide fluid titration and lower resuscitation fluid volumes. We do not recommend the use of transpulmonary thermodilution-derived variables to guide burn shock resuscitation. We are unable to make any recommendations on the use of high-dose vitamin C (ascorbic acid), fresh frozen plasma (FFP), early continuous renal replacement therapy, or vasopressors as adjuncts during acute burn shock resuscitation. Mortality is an important outcome in burn shock resuscitation, but it was not formally included as a PICO outcome because the available scientific literature is missing studies of sufficient population size and quality to allow us to confidently make recommendations related to the outcome of survival at this time.

Evidence-Based Guideline for Prehospital Airway Management

Airway management is a cornerstone of emergency medical care. This project aimed to create evidence-based guidelines based on the systematic review recently conducted by the Agency for Healthcare Research and Quality (AHRQ). A technical expert panel was assembled to review the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. The panel made specific recommendations on the different PICO (population, intervention, comparison, outcome) questions reviewed in the AHRQ review and created good practice statements that summarize and operationalize these recommendations. The recommendations address the use of ventilation with bag-valve mask ventilation alone vs. supraglottic airways vs. endotracheal intubation for adults and children with cardiac arrest, medical emergencies, and trauma. Additional recommendations address the use of video laryngoscopy and drug-assisted airway management. These recommendations, and the associated good practice statements, offer EMS agencies and clinicians an opportunity to review the available evidence and incorporate it into their airway management strategies.

European Academy of Neurology/Peripheral Nerve Society Guideline on diagnosis and treatment of Guillain-Barré syndrome.

Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy. Symptoms may vary greatly in presentation and severity. Besides weakness and sensory disturbances, patients may have cranial nerve involvement, respiratory insufficiency, autonomic dysfunction and pain. To develop an evidence-based guideline for the diagnosis and treatment of GBS, using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology, a Task Force (TF) of the European Academy of Neurology (EAN) and the Peripheral Nerve Society (PNS) constructed 14 Population/Intervention/Comparison/Outcome questions (PICOs) covering diagnosis, treatment and prognosis of GBS, which guided the literature search. Data were extracted and summarised in GRADE Summaries of Findings (for treatment PICOs) or Evidence Tables (for diagnostic and prognostic PICOs). Statements were prepared according to GRADE Evidence-to-Decision (EtD) frameworks. For the six intervention PICOs, evidence-based recommendations are made. For other PICOs, good practice points (GPPs) are formulated. For diagnosis, the principal GPPs are: GBS is more likely if there is a history of recent diarrhoea or respiratory infection; CSF examination is valuable, particularly when the diagnosis is less certain; electrodiagnostic testing is advised to support the diagnosis; testing for anti-ganglioside antibodies is of limited clinical value in most patients with typical motor-sensory GBS, but anti-GQ1b antibody testing should be considered when Miller Fisher syndrome (MFS) is suspected; nodal-paranodal antibodies should be tested when autoimmune nodopathy is suspected; MRI or ultrasound imaging should be considered in atypical cases; and changing the diagnosis to acute-onset chronic inflammatory demyelinating polyradiculoneuropathy (A-CIDP) should be considered if progression continues after 8 weeks from onset, which occurs in around 5% of patients initially diagnosed with GBS. For treatment, the TF recommends intravenous immunoglobulin (IVIg) 0.4 g/kg for 5 days, in patients within 2 weeks (GPP also within 2-4 weeks) after onset of weakness if unable to walk unaided, or a course of plasma exchange (PE) 12-15 L in four to five exchanges over 1-2 weeks, in patients within 4 weeks after onset of weakness if unable to walk unaided. The TF recommends against a second IVIg course in GBS patients with a poor prognosis; recommends against using oral corticosteroids, and weakly recommends against using IV corticosteroids; does not recommend PE followed immediately by IVIg; weakly recommends gabapentinoids, tricyclic antidepressants or carbamazepine for treatment of pain; does not recommend a specific treatment for fatigue. To estimate the prognosis of individual patients, the TF advises using the modified Erasmus GBS outcome score (mEGOS) to assess outcome, and the modified Erasmus GBS Respiratory Insufficiency Score (mEGRIS) to assess the risk of requiring artificial ventilation. Based on the PICOs, available literature and additional discussions, we provide flow charts to assist making clinical decisions on diagnosis, treatment and the need for intensive care unit admission.

European Academy of Neurology/Peripheral Nerve Society Guideline on diagnosis and treatment of Guillain-Barré syndrome.

Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy. Symptoms may vary greatly in presentation and severity. Besides weakness and sensory disturbances, patients may have cranial nerve involvement, respiratory insufficiency, autonomic dysfunction and pain. To develop an evidence-based guideline for the diagnosis and treatment of GBS, using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology a Task Force (TF) of the European Academy of Neurology (EAN) and the Peripheral Nerve Society (PNS) constructed 14 Population/Intervention/Comparison/Outcome questions (PICOs) covering diagnosis, treatment and prognosis of GBS, which guided the literature search. Data were extracted and summarised in GRADE Summaries of Findings (for treatment PICOs) or Evidence Tables (for diagnostic and prognostic PICOs). Statements were prepared according to GRADE Evidence-to-Decision (EtD) frameworks. For the six intervention PICOs, evidence-based recommendations are made. For other PICOs, good practice points (GPPs) are formulated. For diagnosis, the principal GPPs are: GBS is more likely if there is a history of recent diarrhoea or respiratory infection; CSF examination is valuable, particularly when the diagnosis is less certain; electrodiagnostic testing is advised to support the diagnosis; testing for anti-ganglioside antibodies is of limited clinical value in most patients with typical motor-sensory GBS, but anti-GQ1b antibody testing should be considered when Miller Fisher syndrome (MFS) is suspected; nodal-paranodal antibodies should be tested when autoimmune nodopathy is suspected; MRI or ultrasound imaging should be considered in atypical cases; and changing the diagnosis to acute-onset chronic inflammatory demyelinating polyradiculoneuropathy (A-CIDP) should be considered if progression continues after 8 weeks from onset, which occurs in around 5% of patients initially diagnosed with GBS. For treatment, the TF recommends intravenous immunoglobulin (IVIg) 0.4 g/kg for 5 days, in patients within 2 weeks (GPP also within 2-4 weeks) after onset of weakness if unable to walk unaided, or a course of plasma exchange (PE) 12-15 L in four to five exchanges over 1-2 weeks, in patients within 4 weeks after onset of weakness if unable to walk unaided. The TF recommends against a second IVIg course in GBS patients with a poor prognosis; recommends against using oral corticosteroids, and weakly recommends against using IV corticosteroids; does not recommend PE followed immediately by IVIg; weakly recommends gabapentinoids, tricyclic antidepressants or carbamazepine for treatment of pain; does not recommend a specific treatment for fatigue. To estimate the prognosis of individual patients, the TF advises using the modified Erasmus GBS outcome score (mEGOS) to assess outcome, and the modified Erasmus GBS Respiratory Insufficiency Score (mEGRIS) to assess the risk of requiring artificial ventilation. Based on the PICOs, available literature and additional discussions, we provide flow charts to assist making clinical decisions on diagnosis, treatment and the need for intensive care unit admission.

Polymerization Cycle and Occlusal Vertical Dimension of Complete Dentures: Systematic Review and Meta-Analysis

The aim of this systematic review and meta-analysis was to assess the influence of the polymerization cycle on the occlusal vertical dimension (OVD) of complete dentures. This review was based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The PICO (Population, Intervention, Comparison, Outcome) question evaluated was “Does the microwave polymerization cycle influence the occlusal vertical dimension of complete dentures when compared to conventional water bath polymerization?”. The literature search was conducted in the PubMed/MEDLINE, Web of Science, and Scopus databases for relevant articles published up to March 2023. In vitro studies involving OVD measurement from complete dentures polymerized with different polymerization methods were included. The risk of bias was analyzed using the Critical Appraisal Checklist for Quasi-Experimental Studies (non-randomized experimental studies) from the Joanna Briggs Institute (JBI). The meta-analysis was based on the inverse variance (IV) methods with mean difference (MD) for OVD evaluation between techniques. Five articles were included in the qualitative and quantitative analysis. A total of 222 complete dentures were evaluated. In the polymerization cycles, microwave cycles with 90 W to 810 W between 3-5 minutes and conventional water bath cycles between 9-12 hours (long cycles) and 3-4 hours (short cycles) were used. In a quantitative analysis of polymerization methods, no statistically significant difference was found between water bath and microwave techniques [p = 0.99; MD: -0.00; CI = -0,26-0,26]. The current meta-analysis can be concluded that both techniques can be used to polymerization of complete dentures without significant clinical changes in the OVD.

Guidelines for the Neurocritical Care Management of Aneurysmal Subarachnoid Hemorrhage.

The neurointensive care management of patients with aneurysmal subarachnoid hemorrhage (aSAH) is one of the most critical components contributing to short-term and long-term patient outcomes. Previous recommendations for the medical management of aSAH comprehensively summarized the evidence based on consensus conference held in 2011. In this report, we provide updated recommendations based on appraisal of the literature using the Grading of Recommendations Assessment, Development, and Evaluation methodology. The Population/Intervention/Comparator/Outcome (PICO) questions relevant to the medical management of aSAH were prioritized by consensus from the panel members. The panel used a custom-designed survey instrument to prioritize clinically relevant outcomes specific to each PICO question. To be included, the study design qualifying criteria were as follows: prospective randomized controlled trials (RCTs), prospective or retrospective observational studies, case-control studies, case series with a sample larger than 20 patients, meta-analyses, restricted to human study participants. Panel members first screened titles and abstracts, and subsequently full text review of selected reports. Data were abstracted in duplicate from reports meeting inclusion criteria. Panelists used the Grading of Recommendations Assessment, Development, and Evaluation Risk of Bias tool for assessment of RCTs and the "Risk of Bias In Nonrandomized Studies - of Interventions" tool for assessment of observational studies. The summary of the evidence for each PICO was presented to the full panel, and then the panel voted on the recommendations. The initial search retrieved 15,107 unique publications, and 74 were included for data abstraction. Several RCTs were conducted to test pharmacological interventions, and we found that the quality of evidence for nonpharmacological questions was consistently poor. Five PICO questions were supported by strong recommendations, one PICO question was supported by conditional recommendations, and six PICO questions did not have sufficient evidence to provide a recommendation. These guidelines provide recommendations for or against interventions proven to be effective, ineffective, or harmful in the medical management of patients with aSAH based on a rigorous review of the available literature. They also serve to highlight gaps in knowledge that should guide future research priorities. Despite improvements in the outcomes of patients with aSAH over time, many important clinical questions remain unanswered.

Executive Summary: Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Neurology, Peri-Transplant Medicine, Infectious Disease, and Gastroenterology Considerations.

Executive Summary: Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Neurology, Peri-Transplant Medicine, Infectious Disease, and Gastroenterology Considerations.

Management of adult renal trauma: a practice management guideline from the eastern association for the surgery of trauma

BackgroundThe kidney is the most frequently injured component of the genitourinary system, accounting for 5% of all trauma cases. Several guidelines by different societies address the management of urological trauma. However, unanswered questions remain regarding optimal use of angioembolization in hemodynamically stable patients, indications for operative exploration of stable retroperitoneal hematomas and renal salvage techniques in the setting of hemodynamic instability, and imaging practices for patients undergoing non-operative management. We performed a systematic review, meta-analysis, and developed evidence-based recommendations to answer these questions in both blunt and penetrating renal trauma.MethodsThe working group formulated four population, intervention, comparator, outcome (PICO) questions regarding the following topics: (1) angioembolization (AE) usage in hemodynamically stable patients with evidence of ongoing bleeding; (2) surgical approach to stable zone II hematomas (exploration vs. no exploration) in hemodynamically unstable patients and (3) surgical technique (nephrectomy vs. kidney preservation) for expanding zone II hematomas in hemodynamically unstable patients; (4) frequency of repeat imaging (routine or symptom based) in high-grade traumatic renal injuries. A systematic review and meta-analysis of currently available evidence was performed. RevMan 5 (Cochran Collaboration) and GRADEpro (Grade Working Group) software were used. Recommendations were voted on by working group members and concurrence was obtained for each final recommendation.ResultsA total of 20 articles were identified and analyzed. Two prospective studies were encountered; the majority were retrospective, single-institution studies. Not all outcomes projected by PICO questions were reported in all studies. Meta-analysis was performed for all PICO questions except PICO 3 secondary to the discrepant patient populations included in those studies. PICO 1 had the greatest number of articles included in the meta-analysis with nine studies; yet, due to differences in study design, no critical outcomes emerged; similar differences among a smaller set of articles prevented observation of critical outcomes for PICO 4. Analyses of PICOs 2 and 3 favored a non-invasive or minimally invasive approach in-line with current international practice trends.ConclusionIn hemodynamically stable adult patients with clinical or radiographic evidence of ongoing bleeding, no recommendation could be made regarding the role of AE vs. observation. In hemodynamically unstable adult patients, we conditionally recommend no renal exploration vs. renal exploration in stable zone II hematomas. In hemodynamically unstable adult patients, we conditionally recommend kidney preserving techniques vs. nephrectomy in expanding zone II hematomas. No recommendation could be made for the optimal timing of repeat imaging in high grade renal injury.Level of evidence: Guideline; systematic review, level III.

Need for Training in Research Methodology Prior to Conducting Systematic Reviews and Meta-Analyses, and the Effectiveness of an Online Training Program: The Global Andrology Forum Model.

Systematic reviews and meta-analyses (SRMAs) are used to generate evidence-based guidelines. Although the number of SRMAs published in the literature has increased dramatically in the last decade, the training and the experience of the researchers performing the SRMAs are usually not explained in the SRMAs' methodology, and this may be a source of bias. Although some studies pointed out the need for quality control of SRMAs and training in proper statistical methods, to the best of our knowledge, no study has reported the importance of training the researchers that conduct the SRMAs. The aim of this study is to describe a training program designed to impart the essential knowledge and skills required for the conduct of an SRMA and to assess the need for, and outcome of, such a training. Researchers were trained for use of Scopus, study eligibility, assessment of the quality of evidence (QoE) through the Cambridge Quality Checklist for observational studies, as well as the Cochrane Risk of Bias tool, the Consolidated Standards of Reporting Trials (CONSORT) guidelines, and the Jadad score for randomized controlled trials (RCTs), Population, Intervention, Comparison, Outcome (PICO) questions and data extraction. A total of 35 of them were approved to join a planned SRMA. At the end of the SRMA, they were administered 43 multiple-choice questions (MCQs) on demographics, motivation for participation in the SRMA, self-perceived change in knowledge before and after conducting the SRMA, and self-assessment of performance. The senior researchers then revised the spreadsheet of the SRMA and, based on the mistakes found, organized a training focused on the correct assessment of the study design, where 43 researchers (9 joined midway) and 11 trainees with no experience in conducting SRMA attended. They all were tested through a 5 MCQ assessment that was administered before and after the training. Those scoring poorly were re-trained and re-tested, and only those scoring satisfactorily were admitted to further SRMAs. Approximately 54.3% of the participants were medical doctors (MD), 31.4% were urologists and 48.6% had previous experience with SRMAs. Joining an international collaborative study was the main motivation, chosen by 19.7% of researchers. The results of the self-perceived change in knowledge showed a significant improvement in the use of Scopus, checklists for QoE, PICO questions, data required to perform a meta-analysis, and critical reading of scientific articles. Also, the majority of the researchers ranked the quality of their work as high. The pre-test results of the 5 MCQ showed a low score, which was not different from that achieved by a group of fresh trainees (median, 2; IQR 1-3 vs. median, 1; IQR, 1-2; p=0.3). Post-training there was significant improvement in both groups (researchers: median, 4; IQR, 3-5 vs. median, 2; IQR, 1-3; p<0.001; trainees: median, 4; IQR, 3-4 vs. median, 1; IQR, 1-2; p=0.02). Out of the 44 researchers, 12 (27.3%) scored poorly (≤3). After re-training, all of them scored satisfactorily (>3) and were admitted to subsequent SRMAs. At the end of our model, 100% of researchers participating in this study were validated to be included in a meta-analysis. This validation required the involvement of the MT, two meetings, a self-evaluation survey, and one or two sets of objective tests with explanations and corrections. Our results indicate that even well-trained clinicians are naïve when it comes to the methodology of SRMA. All the researchers performing an SRMA need comprehensive training that must cover each aspect of the SRMA methodology. This paper provides a replicable training program that could be used by other investigators to train the researchers to perform high-quality SRMAs.

Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE)

The objective of these Guidelines was to revise and update the previous 2016 Italian Guidelines on Abdominal Aortic Aneurysm Disease, in accordance with the National Guidelines System (SNLG), to guide every practitioner toward the most correct management pathway for this pathology. The methodology applied in this update was the GRADE-SIGN version methodology, following the instructions of the AGREE quality of reporting checklist as well. The first methodological step was the formulation of clinical questions structured according to the PICO (Population, Intervention, Comparison, Outcome) model according to which the Recommendations were issued. Then, systematic reviews of the Literature were carried out for each PICO question or for homogeneous groups of questions, followed by the selection of the articles and the assessment of the methodological quality for each of them using qualitative checklists. Finally, a Considered Judgment form was filled in for each clinical question, in which the features of the evidence as a whole are assessed to establish the transition from the level of evidence to the direction and strength of the recommendations. These guidelines outline the correct management of patients with abdominal aortic aneurysm in terms of screening and surveillance. Medical management and indication for surgery are discussed, as well as preoperative assessment regarding patients' background and surgical risk evaluation. Once the indication for surgery has been established, the options for traditional open and endovascular surgery are described and compared, focusing specifically on patients with ruptured abdominal aortic aneurysms as well. Finally, indications for early and late postoperative follow-up are explained. The most recent evidence in the Literature has been able to confirm and possibly modify the previous recommendations updating them, likewise to propose new recommendations on prospectively relevant topics.

POS0830 SYSTEMATIC LITERATURE REVIEW INFORMING THE 2022 UPDATE OF THE EULAR RECOMMENDATIONS FOR THE MANAGEMENT OF ANCA-ASSOCIATED VASCULITIS: FOCUS ON TREATMENT STRATEGIES

BackgroundThe 2008 and 2016 European Alliance of Associations for Rheumatology (EULAR) recommendations for the management of ANCA-associated vasculitis (AAV)1,2 have supported clinicians with comprehensive recommendations for the treatment of patients with AAV in daily practice. During the past 5 years, the publication of several high-impact randomized-controlled studies have further improved the standard of care of AAV.ObjectivesThe aim of this systematic review was to collect evidence supporting the 2022 update the AAV management recommendations.MethodsThe recommendations were developed based on an evidence-based approach as outlined in the 2014 EULAR standardized operating procedures (SOP)3. Areas of interest were adopted from the 2016 recommendations and updated by identifying additional topics through a Delphi process. Key questions were framed in the PICO (Population, Intervention, Comparator, Outcome) format and a search strategy consisting of keywords identifying treatment-related topics of interest was created based on the PICO questions. Aspects of drug treatment and other therapeutic interventions in AAV were included in the search, with a focus on remission induction, maintenance treatment and steroid sparing protocols. Outcomes such as survival, remission/relapses, infectious complications and malignancies were also covered. PubMed (Medline), Embase and the Cochrane Library databases were searched for articles providing data on the search questions. Abstracts of the annual meetings of EULAR, ACR, ERA-EDTA, ASN and the Vasculitis and ANCA Workshops were also screened, but restricted to randomized controlled clinical trials (RCTs).After deduplication publications were sorted by title and abstract first. There was full text review for articles eligible after title/abstract screening. The data were extracted from included articles and grouped according to the PICO questions. Data extraction results were collected in evidence tables.The Cochrane revised tool for assessing risk of bias for RCTs (RoB2), ROBINS-1 for observational studies and AMSTAR II for meta-analyses were used for bias assessment. Evidence was categorized based on the GRADE system as per EULAR SOP3.ResultsBased on the results of the Delphi, 11 topics related to therapeutic interventions were identified that were transformed into PICO questions (Table 1). Other items that received lower scores were added in the format of subquestions. Based on these research questions, search strings for the SLR were created.Table 1.Key topics of interest for treatment strategies identified in the Delphi exercise grouped according to the PICO formatPatientsIntervention &amp; ComparatorsOutcomeDiagnosisCyclophosphamideDisease-related outcomesGranulomatosis with PolyangiitisRituximabTreatment-related adverse eventsMicroscopic PolyangiitisMycophenolateEosinophilic Granulomatosis with PolyangiitisMethotrexateDisease severityAzathioprineNew-onset diseaseGlucocorticoidsRelapsing diseaseAvacopanOrgan- or life-threatening diseaseMepolizumabNot organ- or life-threatening diseasePlasma exchangeThe SLR was still ongoing at the time this abstract has been written and results of the SLR will be presented at the meeting.ConclusionThis SLR identified recent developments affecting key areas of AAV treatment, that provide systematic evidence to inform the 2022 update of the EULAR recommendations for the management of AAV, which will also be presented at this meeting.

ESCMID COVID-19 guidelines: diagnostic testing for SARS-CoV-2

ScopeThe objective of these guidelines is to identify the most appropriate diagnostic test and/or diagnostic approach for SARS-CoV-2. The recommendations are intended to provide guidance to clinicians, clinical microbiologists, other health care personnel, and decision makers. MethodsAn ESCMID COVID-19 guidelines task force was established by the ESCMID Executive Committee. A small group was established, half appointed by the chair and the remaining selected with an open call. Each panel met virtually once a week. For all decisions, a simple majority vote was used. A list of clinical questions using the PICO (population, intervention, comparison, outcome) format was developed at the beginning of the process. For each PICO, two panel members performed a literature search focusing on systematic reviews, with a third panellist involved in case of inconsistent results. Quality of evidence assessment was based on the GRADE-ADOLOPMENT (Grading of Recommendations Assessment, Development and Evaluation - adoption, adaptation, and de novo development of recommendations) approach. RecommendationsA total of 43 PICO questions were selected that involve the following types of populations: (a) patients with signs and symptoms of COVID-19; (b) travellers, healthcare workers, and other individuals at risk for exposure to SARS-CoV-2; (c) asymptomatic individuals, and (d) close contacts of patients infected with SARS-CoV-2. The type of diagnostic test (commercial rapid nucleic acid amplification tests and rapid antigen detection), biomaterial, time since onset of symptoms/contact with an infectious case, age, disease severity, and risk of developing severe disease are also taken into consideration.

Dental Implants Survival After Nasal Floor Elevation: A Systematic Review.

The aim of this work is to assess the clinical outcomes of implants placed after a nasal floor elevation procedure. A systematic review was conducted using 4 electronic databases: MEDLINE (PubMed), Cochrane Library, Directory of Open Access Journals, and Scopus, following the PRISMA (Preferred Reporting Items for Systematic Reviews) statement recommendations to answer the PICO (Population, Intervention, Comparison, Outcome) question: "In patients undergoing dental implant placement in the maxillary anterior region (P), Do implants placed after nasal floor elevation (I) have a different survival (O) from those implants placed without grafting procedures (C)? The study was pre-registered in PROSPERO (CRD42021229479). Included article quality was assessed using the "NIH quality assessment tool", "The Newcastle-Ottawa scale," and "JBI critical appraisal tools for case reports." Twelve articles were finally selected, including 151 patients and 460 implants. The weighted mean follow-up was 32.2 months, and the weighted survival rate after this period was 97.64% (range: 89.2%-100%). No statistical differences could be inferred between the treatments performed in 1- or 2-stage, following a lateral approach or a transcrestal approach or using different grafting materials. A great heterogeneity was found in study design and methodological aspects. For this reason, a quantitative analysis followed by meta-analysis was not possible. Within the limitations of this study, implants placed after a nasal floor elevation present a good survival and a low range of complications. In absence of randomized studies, the level of evidence was low, attending the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) system and based on the study quality level, the strength of evidence attending the SORT (Strength Of Recommendation Taxonomy) was B.

Multiple Sclerosis International Federation guideline methodology for off-label treatments for multiple sclerosis.

BackgroundA total of 2.8 million people are living with multiple sclerosis and due to disparities in access to medicines, the ability to treat this condition varies widely. Off-label disease-modifying therapies are sometimes more available or affordable in different health systems. Appropriate methodology is integral in creating high-quality and trustworthy guidelines. In this article, we outline Multiple Sclerosis International Federation’s (MSIF) approach to creating guidelines for off-label treatments for multiple sclerosis.MethodsWe use the Guidelines International Network (GIN)-McMaster Guideline Development Checklist and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Evidence-to-Decision (EtD) framework. We developed detailed health descriptors for health outcomes and the panel drafted PICO (Population, Intervention, Comparator, Outcome) questions and prioritised outcomes. We collaborate with independent organisations, which systematically review and collate the information. We are actively engaging stakeholders and consulting with relevant organisations, boards, working groups and individuals.ResultsThe draft guideline recommendations will be published for open comment and stakeholders will be encouraged to endorse and disseminate the guidelines. Our methodology ensures integrity and transparency in the criteria, evidence and judgement used to make recommendations.ConclusionsThis approach will facilitate transparent creation of high-quality and trustworthy guidelines, and allow the global guidelines to be adopted or adapted into national settings.

Patient blood management – recommendations from the International Consensus Conference, Frankfurt/Main, Germany

An International Consensus Conference (ICC) on PBM was held in 2018 to develop evidence‐based clinical and research recommendations for preoperative anaemia, red blood cell (RBC) transfusion thresholds for adults and implementation of PBM programmes. An international scientific committee (SC) defined 17 Population‐Intervention‐Comparison‐Outcome (PICO) questions for the three topics preoperative anaemia, red blood cell (RBC) transfusion thresholds for adults and PBM implementation. Based on these questions, an extensive literature search was conducted in four biomedical databases. The GRADE framework (= grading of recommendations, assessment, development and evaluation) was used to develop a systematic approach to the presentation of evidence summaries and for making clinical recommendations. Three expert panels (EP) consisting of clinicians, scientists, nurses, patient representatives and methodologists were established and used these methods to develop recommendations driven by published evidence. Out of more than 17 500 literature citations, data from 145 studies were incorporated. The expert panel for preoperative anaemia developed 4 clinical and 3 research recommendations. A strong recommendation advices early detection and management of preoperative anaemia before major elective surgery. For RBC transfusion thresholds, 4 clinical and 6 research recommendations have been formulated. Two strong clinical recommendations for RBC transfusion thresholds comprise a haemoglobin concentration of &lt;7 g/dl for critically ill, but clinical stable adult intensive care patients independent of septic shock and &lt;7·5 g/dl for adults undergoing cardiac surgery. For the implementation of PBM programmes, 2 clinical and 3 research recommendations were developed. Research recommendations were formulated as encouragement of new studies to answer open questions. Due to the relative paucity of strong evidence‐based answers in current publications to the 17 PICO questions, additional research, an international consensus for accepted definitions and Hb thresholds as well as clinically meaningful end‐points for clinical studies are necessary. The 2018 PBM ICC defined the current status of PBM evidence and established 10 clinical and 12 research recommendations for preoperative anaemia, RBC transfusion thresholds for adults and implementation of PBM programmes.

Association of Veterinary Hematology and Transfusion Medicine (AVHTM) transfusion reaction small animal consensus statement (TRACS). Part 3: Diagnosis and treatment

To systematically review available evidence to develop guidelines for diagnosis and treatment of transfusion-associated reactions in dogs and cats. Standardized and systemic evaluation of the literature (identified through Medline via PubMed and Google Scholar searches) was carried out for identified transfusion reaction types in dogs and cats. The available evidence was evaluated using PICO (Population, Intervention, Comparison, Outcome) questions generated for each reaction type. The evidence was categorized by level of evidence (LOE) and quality (Good, Fair, or Poor). Guidelines, diagnostic, and treatment algorithms were generated based on the evaluation of the evidence. Consensus on the final guidelines was achieved through Delphi-style surveys. Draft recommendations were disseminated through veterinary specialty listservs for review and comments, which were evaluated and integrated prior to final publication. Medline via PubMed and Google Scholar databases were searched. There were 14 Population Intervention Comparison Outcome questions identified and corresponding worksheets were developed focusing on the diagnosis and treatment of transfusion-associated reactions in dogs and cats. Fourteen guidelines and four algorithms were developed with a high degree of consensus. This systematic evidence evaluation process yielded recommended diagnostic and treatment algorithms for use in practice. However, significant knowledge gaps were identified, demonstrating the need for additional research in veterinary transfusion medicine.

Diagnostic yield of sentinel lymph node biopsy in oral squamous cell carcinoma T1/T2-N0: systematic review and meta-analysis

The objective of this study was to conduct a systematic review and meta-analysis on the efficacy of sentinel lymph node biopsy (SLNB) in T1/T2-N0 oral squamous cell carcinoma (OSCC). A systematic review of the literature on SLNB until March 2019 was conducted. The review was organized according to the PRISMA protocol, considering the following PICO (population, intervention, comparison, outcome) question: What is the sensitivity of sentinel lymph node biopsy in OSCC? ‘P’ was patients with head and neck squamous cell carcinoma T1/2-N0; ‘I’ was SLNB; ‘C’ was neck treated with elective neck dissection and haematoxylin–eosin histopathology; ‘O’ was sensitivity and specificity. A meta-analysis and meta-regression were performed on the selected studies. The sensitivity of SLNB was up to 88% (95% confidence interval (CI) 72–96%) and specificity was up to 99% (95% CI 96–100%). The area under the summary receiver operating characteristic curve was 0.99 (95% CI 0.98–1.00). In the four studies where immunohistochemistry was performed, both the sensitivity and specificity were higher than in the studies without immunohistochemistry: 93% (95% CI 88–97%) and 98% (95% CI 96–100%), respectively. In conclusion, SLNB is an effective technique for treating patients with some types of stage T1/2-N0 OSCC. Some parameters such as immunohistochemistry could determine the level of diagnostic accuracy.

Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline.

Nontuberculous mycobacteria (NTM) represent over 190 species and subspecies, some of which can produce disease in humans of all ages and can affect both pulmonary and extrapulmonary sites. This guideline focuses on pulmonary disease in adults (without cystic fibrosis or human immunodeficiency virus infection) caused by the most common NTM pathogens such as Mycobacterium avium complex, Mycobacterium kansasii, and Mycobacterium xenopi among the slowly growing NTM and Mycobacterium abscessus among the rapidly growing NTM. A panel of experts was carefully selected by leading international respiratory medicine and infectious diseases societies (ATS, ERS, ESCMID, IDSA) and included specialists in pulmonary medicine, infectious diseases and clinical microbiology, laboratory medicine, and patient advocacy. Systematic reviews were conducted around each of 22 PICO (Population, Intervention, Comparator, Outcome) questions and the recommendations were formulated, written, and graded using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Thirty-one evidence-based recommendations about treatment of NTM pulmonary disease are provided. This guideline is intended for use by healthcare professionals who care for patients with NTM pulmonary disease, including specialists in infectious diseases and pulmonary diseases.

Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline.

Nontuberculous mycobacteria (NTM) represent over 190 species and subspecies, some of which can produce disease in humans of all ages and can affect both pulmonary and extrapulmonary sites. This guideline focuses on pulmonary disease in adults (without cystic fibrosis or human immunodeficiency virus infection) caused by the most common NTM pathogens such as Mycobacterium avium complex, Mycobacterium kansasii, and Mycobacterium xenopi among the slowly growing NTM and Mycobacterium abscessus among the rapidly growing NTM. A panel of experts was carefully selected by leading international respiratory medicine and infectious diseases societies (ATS, ERS, ESCMID, IDSA) and included specialists in pulmonary medicine, infectious diseases and clinical microbiology, laboratory medicine, and patient advocacy. Systematic reviews were conducted around each of 22 PICO (Population, Intervention, Comparator, Outcome) questions and the recommendations were formulated, written, and graded using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Thirty-one evidence-based recommendations about treatment of NTM pulmonary disease are provided. This guideline is intended for use by healthcare professionals who care for patients with NTM pulmonary disease, including specialists in infectious diseases and pulmonary diseases.

Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline.

Nontuberculous mycobacteria (NTM) represent over 190 species and subspecies, some of which can produce disease in humans of all ages and can affect both pulmonary and extrapulmonary sites. This guideline focuses on pulmonary disease in adults (without cystic fibrosis or human immunodeficiency virus infection) caused by the most common NTM pathogens such as Mycobacterium avium complex, Mycobacterium kansasii, and Mycobacterium xenopi among the slowly growing NTM and Mycobacterium abscessus among the rapidly growing NTM. A panel of experts was carefully selected by leading international respiratory medicine and infectious diseases societies (ATS, ERS, ESCMID, IDSA) and included specialists in pulmonary medicine, infectious diseases and clinical microbiology, laboratory medicine, and patient advocacy. Systematic reviews were conducted around each of 22 PICO (Population, Intervention, Comparator, Outcome) questions and the recommendations were formulated, written, and graded using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Thirty-one evidence-based recommendations about treatment of NTM pulmonary disease are provided. This guideline is intended for use by healthcare professionals who care for patients with NTM pulmonary disease, including specialists in infectious diseases and pulmonary diseases.