Systemic hemostatic agents initiated in trauma patients in the pre-hospital setting: a systematic review.

PURPOSE: 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. METHODS: 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. RESULTS: 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% confidence interval = 0.73-0.94) and at 1 month among trauma patients (0.91, 0.85-0.97). These results depend on the subgroup of patients with significant hemorrhage because in the subgroup of TBI there are no difference between TXA and placebo. TXA also reduced bleeding death and multiple organ failure whereas no difference in health-related quality of life. CONCLUSION: Balancing benefits and harms, TXA initiated in the pre-hospital setting can be used for patients experiencing major trauma with significant hemorrhage since it reduces the risk of mortality at 24 h and one month with no difference in terms of adverse effects when compared to placebo. Considering the subgroup of severe TBI, no difference in mortality rate was found at 24 h and one month. These results highlight the need to conduct future studies to investigate the role of other systemic hemostatic agents in the pre-hospital settings.

Accuracy of risk tools to predict critical bleeding in major trauma: A systematic review with meta-analysis.

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.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) in patients with major trauma and uncontrolled haemorrhagic shock: a systematic review with meta-analysis.

BACKGROUND: Multiple studies regarding the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in patients with non-compressible torso injuries and uncontrolled haemorrhagic shock were recently published. To date, the clinical evidence of the efficacy of REBOA is still debated. We aimed to conduct a systematic review assessing the clinical efficacy and safety of REBOA in patients with major trauma and uncontrolled haemorrhagic shock. METHODS: We systematically searched MEDLINE (PubMed), EMBASE and CENTRAL up to June 2020. All randomized controlled trials and observational studies that investigated the use of REBOA compared to resuscitative thoracotomy (RT) with/without REBOA or no-REBOA were eligible. We followed the PRISMA and MOOSE guidelines. Two authors independently extracted data and appraised the risk of bias of included studies. Effect sizes were pooled in a meta-analysis using random-effects models. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Primary outcomes were mortality, volume of infused blood components, health-related quality of life, time to haemorrhage control and any adverse effects. Secondary outcomes were improvement in haemodynamic status and failure/success of REBOA technique. RESULTS: We included 11 studies (5866 participants) ranging from fair to good quality. REBOA was associated with lower mortality when compared to RT (aOR 0.38; 95% CI 0.20-0.74), whereas no difference was observed when REBOA was compared to no-REBOA (aOR 1.40; 95% CI 0.79-2.46). No significant difference in health-related quality of life between REBOA and RT (p = 0.766). The most commonly reported complications were amputation, haematoma and pseudoaneurysm. Sparse data and heterogeneity of reporting for all other outcomes prevented any estimate. CONCLUSIONS: Our findings on overall mortality suggest a positive effect of REBOA among non-compressible torso injuries when compared to RT but no differences compared to no-REBOA. Variability in indications and patient characteristics prevents any conclusion deserving further investigation. REBOA should be promoted in specific training programs in an experimental setting in order to test its effectiveness and a randomized trial should be planned.

Accuracy of pre-hospital triage tools for major trauma: a systematic review with meta-analysis and net clinical benefit.

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.

The efficacy of balneotherapy, mud therapy and spa therapy in patients with osteoarthritis: an overview of reviews.

Osteoarthritis is a degenerative disease considered a leading cause of functional disability. Its treatment is based on a combination of pharmacological and non-pharmacological interventions, but the role of these latter is still debated. This overview of systematic reviews aimed at evaluating the short-term efficacy of different thermal modalities in patients with osteoarthritis. We searched PubMed, Scopus, CINHAL, Web of Science, ProQuest and the Cochrane Database of Systematic Reviews from inception until October 2020, with no language restrictions. We selected the following outcomes a priori: pain, stiffness and quality of life. Seventeen systematic reviews containing 27 unique relevant studies were included. The quality of the reviews ranged from low to critically low. Substantial variations in terms of interventions studied, comparison groups, population, outcomes and follow-up between the included SRs were found. From a re-analysis of primary data, emerged that balneotherapy was effective in reducing pain and improving stiffness and quality of life, mud therapy significantly reduced pain and stiffness, and spa therapy showed pain relief. However, the evidence supporting the efficacy of different thermal modalities could be seriously flawed due to methodological quality and sample size, to the presence of important treatment variations, and to the high level of heterogeneity and the absence of a double-blind design. There is some encouraging evidence that deserves clinicians' consideration, suggesting that thermal modalities are effective on a short-term basis for treating patients with AO.

Clinical practice guideline for the integrated management of major trauma by the Italian National Institute of Health: process and methods.

BACKGROUND: Major 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. METHODS: We applied the ISS methodological standards including the GRADE-ADOLOPMENT approach for adoption, adaptation, and de novo development of trustworthy guidelines. RESULTS: The 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. CONCLUSIONS: Through 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.

Strategies to exiting the COVID-19 lockdown for workplace and school: A scoping review.

In an attempt to curb the COVID-19 pandemic, several countries have implemented various social restrictions, such as closing schools and asking people to work from home. Nevertheless, after months of strict quarantine, a reopening of society is required. Many countries are planning exit strategies to progressively lift the lockdown without leading to an increase in the number of COVID-19 cases. Identifying exit strategies for a safe reopening of schools and places of work is critical in informing decision-makers on the management of the COVID-19 health crisis. This scoping review describes multiple population-wide strategies, including social distancing, testing, and contact tracing. It highlights how each strategy needs to be based on both the epidemiological situation and contextualize at local circumstances to anticipate the possibility of COVID-19 resurgence. However, the retrieved evidence lacks operational solutions and are mainly based on mathematical models and derived from grey literature. There is a need to report the impact of the implementation of country-tailored strategies and assess their effectiveness through high-quality experimental studies.

Towards a New System for the Assessment of the Quality in Care Pathways: An Overview of Systematic Reviews.

Clinical or care pathways are developed by a multidisciplinary team of healthcare practitioners, based on clinical evidence, and standardized processes. The evaluation of their framework/content quality is unclear. The aim of this study was to describe which tools and domains are able to critically evaluate the quality of clinical/care pathways. An overview of systematic reviews was conducted, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, using Medline, Embase, Science Citation Index, PsychInfo, CINAHL, and Cochrane Library, from 2015 to 2020, and with snowballing methods. The quality of the reviews was assessed with Assessment the Methodology of Systematic Review (AMSTAR-2) and categorized with The Leuven Clinical Pathway Compass for the definition of the five domains: processes, service, clinical, team, and financial. We found nine reviews. Three achieved a high level of quality with AMSTAR-2. The areas classified according to The Leuven Clinical Pathway Compass were: 9.7% team multidisciplinary involvement, 13.2% clinical (morbidity/mortality), 44.3% process (continuity-clinical integration, transitional), 5.6% financial (length of stay), and 27.0% service (patient-/family-centered care). Overall, none of the 300 instruments retrieved could be considered a gold standard mainly because they did not cover all the critical pathway domains outlined by Leuven and Health Technology Assessment. This overview shows important insights for the definition of a multiprinciple framework of core domains for assessing the quality of pathways. The core domains should consider general critical aspects common to all pathways, but it is necessary to define specific domains for specific diseases, fast pathways, and adapting the tool to the cultural and organizational characteristics of the health system of each country.

Triage protocol for allocation of critical health resources during Covid-19 pandemic and public health emergencies. A narrative review.

BACKGROUND AND AIM OF THE WORK: Triage during the Covid-19 pandemic can impose difficult allocation decisions when demand for mechanical ventilation or intensive care beds greatly exceeds available resources. Triage criteria should be objective, ethical, transparent, applied equitably and publically disclosed. The aim of this review is to describe the triage tools and process for critical care resources in a pandemic health emergency. METHODS: A narrative review was conducted of the literature on five electronic databases, namely PubMed, CINHAL, Web of Science, Cochrane and Embase, searching for studies published from 2006 to June 2020. RESULTS: The results describe different triage tools. A gold standard of triage does not exist for the adult or paediatric population. Using probability of short-term survival as the sole allocation principle is problematic. In general, each triage protocol should be applied with a specific ethical justification, including transparency, duty to care, duty to steward resources, duty to plan, and distributive justice. CONCLUSIONS: Clinical triage decisions based on clinical judgment alone are prone to inconsistent application by triage officers in a pandemic. An ethical framework can inform decision-making and improve accountability. It remains difficult to connect clinical criteria and ethical criteria, because of the models on offer for health services.