BackgroundCare bundles (CBs) are structured sets of evidence-based interventions designed to enhance the quality and safety of care. Despite increasing diffusion, a lack of uniformity in development and implementation processes underscores the need for a standardised approach to evaluating methodological quality. To our knowledge, no widely accepted and standardised instrument is currently available to assess the methodological quality of CBs. To address this gap, we developed the Care Bundle Quality Assessment Tool (CBQuAT). It consists of 20 items grouped into five key dimensions.MethodsThe development of the tool was informed by the IHI guidelines published in 2001 and by evidence identified through a previously published systematic review. The preliminary checklist was subjected to content validation in two rounds by a panel of 12 experts, and the Content Validity Index (CVI) and Ratio (CVR) were then calculated. Subsequently, two reviewers applied CB-QuAT to the 20 CBs obtained through a systematic literature search to assess their reliability. The inter-rater reliability (IRR) was calculated using Cohen's weighted kappa and the intra-class correlation coefficient (ICC). All analyses were conducted using SPSS and RStudio.ResultsA total of 20 items were included in the final checklist, organised into five analytical domains that reflect key aspects of bundle quality. The analysis highlighted excellent reliability and strong content validity. Construct validity was not evaluated, as it was not necessary for the specific purpose of the instrument. The average weighted Cohen’s kappa was 0.860 (95% CI: 0.828–0.892), and the mean ICC was 0.918 (95% CI: 0.872–0.964), indicating almost perfect agreement between reviewers. Internal consistency was exceptional, with a Cronbach’s Alpha of 0.957 (95% CI: 0.936–0.979). Specific examples include the bundle for preventing viral infections in paediatrics (USA, 2018), which showed the highest reliability (ICC = 0.997), while some bundles for surgical site infections had lower but still substantial agreement.ConclusionsThe CB-QuAT has proven to be a valid and reliable tool for evaluating the methodological quality of CBs and for guiding their development across different clinical settings.

Background and Objectives Health guidelines play a central role in informing clinical practice, public health measures and health policy. But their trustworthiness may be undermined by factors such as insufficient methodological rigor, lack of transparency, conflicts of interest, and inconsistent application of established standards. Existing appraisal tools address selected aspects of guideline quality but do not comprehensively assess the trustworthiness of individual recommendations, nor do they adequately reflect recent advances in guideline methodology, including living guidelines, Grading of Recommendations, Assessment, Development, and Evaluation, adaptation, and the use of artificial intelligence (AI). This study aims to develop and validate Transparent, Rigorous, Useable, Standardized, and Trustworthy Guide (TRUSTGUIDES), a globally applicable, flexible set of tools to assess the trustworthiness of health guideline recommendations. We define trustworthiness as distinct from methodological quality: it encompasses not only rigorous methods but also transparency, independence, and applicability, which together determine whether a recommendation merits user confidence. Methods TRUSTGUIDES will be developed through a multistep, mixed-methods process. First, a scoping review and expert consultation will identify existing guideline appraisal tools and inform domains and items generation. Using deductive and inductive approaches, domains and items will be generated and may be refined through focus groups and selected through iterative Delphi surveys involving an international, multidisciplinary working group. TRUSTGUIDES will be validated by assessing internal consistency, inter-rater reliability, content validity, and construct validity, including comparisons with established instruments such as the Grading of Recommendations, Assessment, Development, and Evaluation certainty domains, AGREE II, and PANELVIEW. Psychometric properties will be examined using factor analysis and, as necessary, item response theory models. AI will be integrated both as an object of assessment and as methodological support for tool application, with large language models evaluated against a human reference standard. Conclusion TRUSTGUIDES will be designed to evaluate the trustworthiness of individual guideline recommendations across key factors, including transparency and credibility, and to address relevant domains such as the certainty of evidence, strength of recommendations, conflicts of interest, applicability, adaptability, currency, certification, and the appropriate use of AI. TRUSTGUIDES addresses critical gaps in current guideline appraisal by offering a comprehensive, recommendation-level assessment of trustworthiness aligned with the World Health Organization guideline standard methodology. By integrating AI, our tools will support efficient, transparent, and future-ready guideline evaluation within an evolving health evidence ecosystem.

Trauma remains a principal cause of mortality across all age groups, particularly in cases of major abdominal trauma and hemorrhage, which can lead to the 'lethal triad' of coagulopathy, metabolic acidosis, and hypothermia. This systematic review explores the efficacy of Damage Control Laparotomy (DCL) compared to definitive surgery (DEF) in major abdominal trauma. A systematic literature search following PRISMA and MOOSE guidelines was conducted across Medline, Cochrane Library, and Embase databases. Seven studies were found, including one randomized controlled trial (RCT) and six observational studies (OS). Mortality rates varied, with one observational study indicating higher 24-h mortality in the DCS group (OR 1.49, 95

BACKGROUND:Healthcare-associated infections (HAIs) are a global concern, with Italy reporting a 7.5% prevalence. The World Health Organization recommends infection prevention strategies, including care bundles (CBs), evidence-based interventions to improve patient safety. Despite their effectiveness, adoption of CBs in Italy remains low (20-25%). AIM:This pilot survey aimed to test the feasibility of a large-scale study on healthcare workers' knowledge and use of CBs in high-risk wards. METHODS:The study took place from October to November 2024. An anonymous online questionnaire, developed according to the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) and the Consensus-Based Checklist for Reporting of Survey Studies (CROSS), investigated demographics, knowledge, use, and barriers/facilitators to CB implementation, as well as feedback on the tool. Participants - physicians and nursing/obstetric staff from various specialties - were recruited through Scientific Societies and Professional Associations. FINDINGS:A total of 753 healthcare professionals completed the questionnaire (73.5% response rate). Most respondents were from northern regions (43.6%). Nearly half of physicians (49%) were unfamiliar with CBs, though 90% of them expressed interest in training. Among those familiar with CBs, only 57% reported applying them. Anaesthetists and surgeons showed greater awareness than orthopaedists. While 64% of nurses noticed CBs, 53% of obstetricians were unaware, and only 23% of the latter group used them in practice. CONCLUSION:The survey highlights gaps in the knowledge and application of CBs across professional groups, emphasizing the need for targeted strategies to enhance adoption in clinical practice.

BACKGROUND:Distal radio-cephalic arteriovenous fistula (RCAVF) is the gold standard vascular access for haemodialysis (HD). A rare complication of RCAVF is high blood flow (defined as flow (Qa) >1.5 L/min). In order to reduce high flow in such RCAVF, we conceived a novel banding technique of the proximal radial artery (PRAB), as a variant of the Bourquelot's proximal radial artery ligation (PRAL). We describe our experience, which began in 2016. METHODS:We retrospectively examinated prospectively collected data from 20 consecutive patients treated from 2016 to 2023 in a single centre.All patients were referred because of high-flow RCAVF and evaluated systematically by colour Doppler ultrasound (CDU) examination preoperatively and 1, 6 and 12 months postoperatively (Qa0, Qa1, Qa6 and Qa12), with flow measurements and verification of ulnar artery and palmar arches patency.The procedure consisted in the ligation of the juxta-juxtaanastomotic proximal radial artery over a 2 mm external tutor (proximal radial artery banding), therefore - compared to classic PRAL - preserving continuity of the proximal radial artery. The aim of this variant was to prevent involution of the radial artery proximally to ligation.Patient characteristics (means): age 69 years, comorbidities (hypertension 85%, diabetes 0%), HD vintage 21 months, AVF vintage 31.5 months, Qa0 2650 mL/min.Primary and secondary patency following PRAB were calculated at 6 and 12 months (PP6, PP12, SP6, SP12). RESULTS:At T1, T6 and T12, AVF mean flow reduction rates were 52%, 52% and 51%, respectively, proximal radial artery patency was verified in all patients by CDU. Primary and secondary patency rates at 6 and 12 months were 100%, 83.3%, 100% and 100%, respectively. Three patients (16.6%) necessitated of iuxta-anastomotic vein revision because of low flow within 12 months after flow reduction, one patient died 5 months postoperatively unrelated to the procedure, one patient was lost to follow-up. No thrombosis or hand ischaemia occurred postoperatively. CONCLUSIONS:PRAB is as safe and effective as PRAL for surgical reduction of high-flow RCAVF with satisfying mid- and long-term patency results. The potential of preserving the patency of radial artery could represent an added value especially in younger patient. Further studies are needed to better define these results.

INTRODUCTION:The management of patients with major trauma is complex and encompasses the entire clinical pathway. The trauma coordinator role has been introduced to enhance communication and coordination. Despite the clinical benefits of trauma coordinators, their implementation in Italy is currently limited. METHODS:We conducted a national online survey from May to July 2023 consisting of 6 sections: (1) the trauma centers, (2) the knowledge of the trauma coordinator, (3a) trauma coordinator characteristics, (3b) characteristics that the trauma coordinator should have, (4) trauma coordinator's role and duties, (5) trauma coordinator organizational characteristics, and (6) barriers and opportunities. We performed a descriptive statistics and tested the agreement among raters for sections 2 and 6 using Cohen's or Fleiss' kappa. RESULTS:Fifty-five respondents from 26 trauma centers participated in the survey. Sixty percent of respondents indicated that a trauma coordinator exists in their trauma center, but only 31% reported that the trauma coordinator is formally recognized. Most trauma coordinators had experience in critical care (69%), but 45% of respondents noted that no rewards were provided for their function. The barriers to trauma coordinator implementation were the absence of a job description (40%) and a lack of human resources (45%). For opportunities, enhanced communication among providers was the most reported benefit. Full agreement on the knowledge of trauma coordinators was found in only 3 centers. CONCLUSION:This survey highlights the need for a more structured integration of trauma coordinators into trauma care teams. Emphasizing clear role descriptions, formal recognition, and appropriate compensation is essential to maximize the impact of trauma coordinators on patient outcomes.

INTRODUCTION:Orthoplastic surgery, which combines orthopedic and plastic surgery principles, plays a crucial role in the treatment of open fractures of the lower limb. Clinical Practice Guidelines (CPGs) are valuable tools for standardizing and improving patient care. OBJECTIVE:To assess the availability and quality of international CPGs for orthoplastic treatment of open fractures of the lower limb. A secondary objective was to provide a detailed analysis of the specific recommendations by comparing them among different CPGs. METHODS:A systematic review was conducted in 2023 according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines across major medical databases and gray literature. Inclusion criteria focused on guidelines specific to orthoplastic surgery for lower limb open fractures. The Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool, a widely accepted instrument for guideline assessment, was utilized to evaluate the methodological rigor and transparency of the selected guidelines. RESULTS:Three orthoplasty CPGs have been identified, 2 of which were judged reliable according to the AGREE II methodology. Orthoplastic recommendations are no more than 7 per CPG. Consistent agreement was observed on the timing of debridement, the importance of early fixation, and definitive coverage. CONCLUSION:CPGs are critical to set up clinical pathways that are safe and evidence-based. Only 3 international CPGs address orthoplastic treatment of open lower limb fractures, 2 of which are judged reliable according to methodology. Therefore, it becomes essential to develop and disseminate high-quality, evidence-based guidelines, which are critical to improving patient outcomes and standardizing clinical practice worldwide.

Abstract Background The application of non-invasive pelvic circumferential compression devices (PCCDs), including pelvic binders, has shown to improve the position and stability of some types of pelvic fractures. To date the clinical efficacy of PCCDs application is still scarce and of poor quality. We assessed the clinical efficacy of pelvic binder pre-hospital in the management of pelvic fracture. Methods We systematically searched MEDLINE (PubMed), EMBASE and Cochrane CENTRAL up to June 2022. Two authors independently extracted data and appraised risk of bias using the Newcastle Ottawa Scale for observational studies. The quality of evidence was assessed using the Grading of Recommendations Assessment (GRADE) approach. Results We included ten studies with a total of 2770 participants. None of the included studies showed a statistically significant difference in overall mortality, 48h or 30-day mortality in PCCD group compared to no PCCD, whereas a reduction of mortality was observed in favour of the group with early PCCD when compared to PCCD placement after diagnosis (adjusted OR 0.00326; p = 0.039). Adjusted estimates did not show a clear indication of the benefits of PCCDs application vs no-PCCDs on the need for massive transfusion. Patients who received early PCCD vs PCCD after diagnosis had significantly less blood transfusion requirements (p = 0.009). The main reported complication was skin necrosis related to the comparison early PCCD vs late PCCD placement. Conclusions Our results suggest a positive effect of the early application of PCCDs on overall mortality, however, randomized controlled trials are needed in order to confirm preliminary results observed in observational studies.

BACKGROUND:The use of intravenous fluid therapy in patients with major trauma in prehospital settings is still controversial. We conducted an umbrella review to evaluate which is the best volume expansion in the resuscitation of a hemorrhagic shock to support the development of major trauma guideline recommendations.METHODS:We searched PubMed, Embase, and CENTRAL up to September 2022 for systematic reviews (SRs) investigating the use of volume expansion fluid on mortality and/or survival. Quality assessment was performed using AMSTAR 2 and the Certainty of the evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.RESULTS:We included 14 SRs investigating the effects on mortality with the comparisons: use of crystalloids, blood components, and whole blood. Most SRs were judged as critically low with slight overlapping of primary studies and high consistency of results. For crystalloids, inconsistent evidence of effectiveness in 28- to 30-day survival (primary endpoint) was found for the hypertonic saline/dextran group compared with isotonic fluid solutions with moderate certainty of evidence. Pre-hospital blood component infusion seems to reduce mortality, however, as the certainty of evidence ranges from very low to moderate, we are unable to provide evidence to support or reject its use. The blood component ratio was in favor of higher ratios among all comparisons considered with moderate to very low certainty of evidence. Results about the effects of whole blood are very uncertain due to limited and heterogeneous interventions in studies included in SRs.CONCLUSION:Hypertonic crystalloid use did not result in superior 28- to 30-day survival. Increasing evidence supports the scientific rationale for early use of high-ratio blood components, but their use requires careful consideration. Preliminary evidence is very uncertain about the effects of whole blood and further high-quality studies are required.

A structured approach involves systematic management of trauma patients. We aim to conduct an overview of reviews about the clinical efficacy and safety of structured approach (i.e., primary and secondary survey) by guideline checklist compared to non-structured approach (i.e. clinical examination); moreover, routine screening whole-body computer tomography (WBCT) was compared to non-routine WBCT in patients with suspected major trauma. We systematically searched MEDLINE (PubMed), EMBASE and Cochrane Database of Systematic Reviews up to 3 May 2022. Systematic reviews (SRs) that investigated the use of a structured approach compared to a non-structured approach were eligible. Two authors independently extracted data, managed the overlapping of primary studies belonging to the included SRs and calculated the corrected covered area (CCA). The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. We included nine SRs investigating two comparisons in stable trauma patients: structured approach vs non-structured approach (n = 1) and routine WBCT vs non-routine WBCT (n = 8). The overlap of included primary studies was generally high across outcomes (CCA ranged between 20.85 and 42.86 The application of structured approach by checklist during trauma resuscitation may improve patient- and process-related outcomes. Including non-routine WBCT seems to offer the best trade-offs between benefits and harm. Clinicians should consider these findings in the light of their clinical context, the volume of patients in their facilities, the need for time management, and costs.

OBJECTIVE:This review will map and define the terminology used in health care literature for "best practice" as well as its underpinning framework/methodology. INTRODUCTION:Numerous international organizations and institutions have sought to develop models or frameworks to guide health care providers to integrate the best evidence into clinical practice. However, different concepts related to best practice have been used, both in the biomedical literature and by public institutions, leading to a lack of consistency in definitions of the term. This poses a potential difficulty for clinical professionals in applying evidence effectively to achieve desired patient outcomes. INCLUSION CRITERIA:This review will adopt the following inclusion criteria: i) the study must contain a definition of the term "best practice" or its related concepts; ii) the concept of best practice must refer to clinical activities and not have organizational features; and iii) any study design can be included. Studies will be excluded if they describe a definition of best practice that is not directly related to clinical practice (eg, business). METHODS:The review will follow the JBI methodology for scoping reviews. An initial search of MEDLINE identified keywords and MeSH terms. MEDLINE (PubMed), Embase, CINAHL (EBSCOhost), and Google Scholar will be searched from 2001 until the present, the year in which the first definition of best practice appeared in the literature. Four pairs of reviewers will independently select studies and perform data extraction and data synthesis. Data will be presented in figures or tables, accompanied by a narrative summary. Searches will be limited to articles in English, Italian, German, French, and Spanish. REVIEW REGISTRATION:Open Science Framework: https://osf.io/52vxe/.

reports of data from original research.• Policy Case Studies -brief articles on policy development at a regional or national level.• Study Protocols -Articles describing a research protocol of a study.• Methodology Papers -Papers that present different methodological approaches that can be used to investigate problems in a relevant scientific field and to encourage innovation.• Tobacco Industry Monitoring Letters -brief articles on tobacco industry tactics.

BACKGROUNDMajor trauma describes serious injuries requiring lifesaving interventions or resulting in long-term disability; it represents about 8% of all deaths worldwide. Specific guidelines can help reduce deaths and disabilities, provided they adhere to high quality and trustworthiness standards. This article aims at introducing the development process of the Istituto Superiore di Sanità, ISS (Italian National Institute of Health) guideline for major trauma integrated management.METHODSWe applied the ISS methodological standards including the GRADE-ADOLOPMENT approach for adoption, adaptation, and de novo development of trustworthy guidelines.RESULTSThe scope was formulated by the multidisciplinary panel with stakeholders' involvement; two guidelines were identified as appropriate sources for adolopment. Forty questions from the two source guidelines were prioritised and five new ones formulated. New systematic reviews or updates were conducted for each clinical question, Evidence to Decision frameworks developed or re-assessed and the recommendations formulated after public consultations and external review. The policy on conflicts of interest was applied throughout the process.CONCLUSIONSThrough a broad expertise representation, the early and wide stakeholders' participation, a continual process for disclosure and management of conflict of interests and the transparency of the process, ISS standards are proving to be an efficient model for developing trustworthy clinical guidance.

Aim To investigate whether and how ten ethical principles are mentioned within documents on critical care resources allocation during public health emergencies. Materials and Methods We conducted a search of documents con-cerning critical resources allocation during public emergencies publicly available from Google and two specific international websites, up to November 2020. Each document was analyzed by two independent reviewers to assess whether a reference to any of the 10 key ethical principles indicated by the Northern Italy Ethical Committee could be found in the documents. Cohen's K statistic was used. Results We obtained 34 documents, of which 19 were allocation frameworks, 15 crisis standards of care, 4 clinical triage protocol, 3 clinical guidelines and 2 public health emergency response plans. The principles most frequently mentioned as important for decision-making was "number of lives saved", followed by "transparency", "equity", "respect of person and their autonomy". The most cited tiebreakers were "younger first/life cycle" and "lottery". Conclusions All documents aim to protect the life and health of the largest number of people and should be objective, ethical, transparent, applied equitably, and be publicly disclosed. It is plausible that short- and long-term prognostic tools can help allocate critical resources, but it remains strong that the decision-making process must be guided by a multi-principle ethical model that is not always easy to apply.

BACKGROUND:Early detection of critical bleeding by accurate tools can help ensure rapid delivery of blood products to improve outcomes in major trauma patients. We conducted a systematic review to evaluate the accuracy of risk tools to predict critical bleeding in patients with major trauma.METHODS:PubMed, Embase, and CENTRAL were searched up to February 2021 for studies investigating risk tools to predict critical bleeding for major trauma people in prehospital and emergency department. We followed the Preferred Reporting Items for Systematic Review and Meta-Analysis of Diagnostic Test Accuracy study guidelines. Two independent authors included studies, extracted data, appraised the quality using the Quality Assessment of Diagnostic Accuracy Studies 2 and assessed the certainty of evidence (CoE) using the Grading of Recommendations Assessment, Development and Evaluation methodology. Sensitivity, specificity, and the receiver operating characteristics curve for all selected triage tools.RESULTS:Eighty-nine observational studies for adults and 12 observational studies for children met our inclusion criteria. In adults, we found 23 externally validated and 28 unvalidated tools; in children, 3 externally validated tools and 5 unvalidated. In the externally validated tools, we identified those including clinical, laboratory, and ultrasound assessments. Among tools including only a clinical assessment, the Shock Index showed high sensitivity and specificity with the CoE ranging from very low to moderate in adults, as well as Shock Index Pediatric Age adjusted with a moderate CoE. We found that tools using clinical, laboratory, and ultrasound assessments were overall more accurate than those tools without all three components.CONCLUSION:Clinicians should consider risk tools to predict critical bleeding in a time-sensitive setting like major life-threatening trauma. The Shock Index and Shock Index Pediatric Age adjusted are easy and handy tools to predict critical bleeding in the prehospital setting. In the emergency department, however, many other tools can be used, which include laboratory and ultrasound assessments, depending on staff experience and resources.LEVEL OF EVIDENCE:Systematic Review and Meta-Analysis; Level III.

BACKGROUND:To explore knowledge, attitude, and barriers of the Italian National Guidelines System (SNLG) for the development of clinical practice guidelines (CPG) among scientific-technical societies (STS) of health care professional.METHODS:A cross-sectional survey was distributed to the STS registered in the Italian Ministry of Health (n = 336). The questionnaire consisted of three sections: Respondent characteristics; Perception, knowledge, attitude, and use of CPGs; Knowledge of the SNLG.RESULTS:The survey sample was 194 (57.7%) STS: 69% STS members stated they "often consulted CPGs". Two out of three STS perceived scientific activities as extremely important. Additionally, 20.6% STS had submitted at least one CPG to the SNLG platform after the Gelli-Bianco Law went into effect (median 1 CPG; interquartile range, IQR, 1-4). The most often cited barrier (62.7%) to CPG submission was limited economic resources.CONCLUSIONS:STS members hold a positive attitude towards CPGs despite barriers to CPG development.

Background Guideline adaptation provides an important alternative to de novo guideline development by making the process more efficient and reducing unnecessary duplication. The quality evaluation of international guidelines is an essential part of the adaptation process. The study aims at describing the development and validation of a new tool to screen trustworthy Clinical Practice Guidelines (CPGs) for their adoption/adaption: the International Guideline Evaluation Screening Tool (IGEST). Methods The process of developing the IGEST involved two main phases: 1) tool development and 2) content validation. The tool development phase comprised three stages, where the scope of the IGEST was defined and the item pool was generated and refined. The content validation was performed through the computation of a content validity index (CVI) based on the opinions of an expert panel. Results All the items obtained a CVI >0.78, which resulted in the validation of the instrument. The final instrument comprised four preliminary conditions and 12 criteria organised into three dimensions: (i) the management of conflict of interest; (ii) the quality of evidence and the coherence between evidence and recommendations; and (iii) the panel composition. Conclusion The IGEST showed good content validity for assessing the quality of international guidelines. Using the new tool to select trustworthy guidelines might increase the likelihood that international clinical practice guidelines will be adopted/adapted to the local context by allowing a quick screening of existing guidelines trustworthiness and providing an acceptability threshold that supports the decision-making process.

The effect of systemic hemostatic agents initiated during pre-hospital care of severely injured patients with ongoing bleeding or traumatic brain injury (TBI) remains controversial. A systematic review and meta-analysis was therefore conducted to assess the effectiveness and safety of systemic hemostatic agents as an adjunctive therapy in people with major trauma and hemorrhage or TBI in the context of developing the Italian National Institute of Health guidelines on major trauma integrated management. PubMed, Embase, and Cochrane Library databases were searched up to October 2021 for studies that investigated pre-hospital initiated treatment with systemic hemostatic agents. The certainty of evidence was evaluated with the Grading of Recommendations Assessment, Development, and Evaluation approach, and the quality of each study was determined with the Cochrane risk-of-bias tool. The primary outcome was overall mortality, and secondary outcomes included cause-specific mortality, health-related quality of life, any adverse effects and blood product use, hemorrhage expansion, and patient-reported outcomes. Five trials of tranexamic acid (TXA) met the inclusion criteria for this meta-analysis. With a high certainty of evidence, when compared to placebo TXA reduced mortality at 24 h (relative risk = 0.83, 95

Background We conducted a systematic review to evaluate and compare the accuracy of pre-hospital triage tools for major trauma in the context of the development of the Italian National Institute of Health guidelines on major trauma integrated management. Methods PubMed, Embase, and CENTRAL were searched up to November 2019 for studies investigating pre-hospital triage tools. The ROC (receiver operating characteristics) curve and net clinical benefit for all selected triage tools were performed. Quality assessment was performed using the Quality Assessment of Diagnostic Accuracy Studies–2. Certainty of the evidence was judged with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results We found 15 observational studies of 13 triage tools for adults and 11 for children. In adults, according to the ROC curve and the net clinical benefit, the most reliable tool was the Northern French Alps Trauma System (TRENAU), adopting injury severity score (ISS) > 15 as reference (sensitivity (Sn), 0.92; specificity (Sp), 0.41; 1 study; sample size, 2572; high certainty of the evidence). When mortality as reference was considered, the pre-hospital triage tool with the best net clinical benefit trajectory was the New Trauma Score (NTS) < 18 (Sn, 0.82; Sp, 0.86; 1 study; sample size, 1001; moderate certainty of the evidence). In children, high variability among all triage tools for sensitivity and specificity was found. Conclusion Sensitivity and specificity varied across all available pre-hospital trauma triage tools. TRENAU and NTS are the best accurate triage tools for adults, whereas in the pediatric area a large variability prevents any firm conclusion.