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2. Volume replacement in the resuscitation of trauma patients with acute hemorrhage: an umbrella review

Author

Gianola, S, Castellini, G, Biffi, A, Porcu, G, Napoletano, A, Coclite, D, D'Angelo, D, Di Nitto, M, Fauci, A, Punzo, O, Iannone, P, Chiara, O, Gianola S., Castellini G., Biffi A., Porcu G., Napoletano A., Coclite D., D'Angelo D., Di Nitto M., Fauci A. J., Punzo O., Iannone P., Chiara O., Gianola, S, Castellini, G, Biffi, A, Porcu, G, Napoletano, A, Coclite, D, D'Angelo, D, Di Nitto, M, Fauci, A, Punzo, O, Iannone, P, Chiara, O, Gianola S., Castellini G., Biffi A., Porcu G., Napoletano A., Coclite D., D'Angelo D., Di Nitto M., Fauci A. J., Punzo O., Iannone P., and Chiara O.

Abstract

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 require

Published
2023

8. Allocation of scarce critical care resources during public health emergencies: which ethical principles support decision making

Author

Fauci A. J., Latina R., Iacorossi L., Coclite D., D'Angelo D., Napoletano A., Terrenato I., Iannone P., Fauci A.J., Latina R., Iacorossi L., Coclite D., D'Angelo D., Napoletano A., Terrenato I., and Iannone P.

Subjects
Ethics, Health Care Rationing, Pandemic, Critical Care, Decision Making, Nursing, Settore MED/45 - Scienze Infermieristiche Generali, Cliniche E Pediatriche, Public Health Emergency, Humans, Critical resources, Public Health, Emergencies, Triage, Covid-19, Pandemics
Abstract

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.

Published
2022

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

Author

Gianola, S, Castellini, G, Biffi, A, Porcu, G, Napoletano, A, Coclite, D, D'Angelo, D, Fauci, A, Iacorossi, L, Latina, R, Salomone, K, Gupta, S, Iannone, P, Chiara, O, Gianola S., Castellini G., Biffi A., Porcu G., Napoletano A., Coclite D., D'angelo D., Fauci A. J., Iacorossi L., Latina R., Salomone K., Gupta S., Iannone P., Chiara O., Gianola, S, Castellini, G, Biffi, A, Porcu, G, Napoletano, A, Coclite, D, D'Angelo, D, Fauci, A, Iacorossi, L, Latina, R, Salomone, K, Gupta, S, Iannone, P, Chiara, O, Gianola S., Castellini G., Biffi A., Porcu G., Napoletano A., Coclite D., D'angelo D., Fauci A. J., Iacorossi L., Latina R., Salomone K., Gupta S., Iannone P., and Chiara O.

Abstract

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 bleed

Published
2022

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

Author

Fauci A. J., Coclite D., Napoletano A., D'Angelo D., Biffi A., Castellini G., Gianola S., Iacorossi L., Latina R., Porcu G., Salomone K., Chiara O., Iannone P., Coniglio C., de Blasio E. -V., Fabbri A., Flego G., Geraci M., Maccauro G., Rampoldi A., Ruggieri M. P., Santolini F., Stocchetti N., Tacconi C., Tugnoli G., Fauci A.J., Coclite D., Napoletano A., D'Angelo D., Biffi A., Castellini G., Gianola S., Iacorossi L., Latina R., Porcu G., Salomone K., Chiara O., Iannone P., Coniglio C., de Blasio E.-V., Fabbri A., Flego G., Geraci M., Maccauro G., Rampoldi A., Ruggieri M.P., Santolini F., Stocchetti N., Tacconi C., Tugnoli G., Fauci, A, Coclite, D, Napoletano, A, D'Angelo, D, Biffi, A, Castellini, G, Gianola, S, Iacorossi, L, Latina, R, Porcu, G, Salomone, K, Chiara, O, Iannone, P, Coniglio, C, de Blasio, E, Fabbri, A, Flego, G, Geraci, M, Maccauro, G, Rampoldi, A, Ruggieri, M, Santolini, F, Stocchetti, N, Tacconi, C, and Tugnoli, G

Subjects
Major trauma, Italy, Delivery of Health Care, Integrated, Healthcare decision-making, Practice Guidelines as Topic, Humans, Wounds and Injuries, Clinical Practice Guideline, GRADE approach, Settore MED/45 - Scienze Infermieristiche Generali, Cliniche E Pediatriche, Italian National Guidelines System
Abstract

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.

Published
2021

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

Author

Gianola S., Castellini G., Biffi A., Porcu G., Fabbri A., Ruggieri M. P., Stocchetti N., Napoletano A., Coclite D., D'Angelo D., Fauci A. J., Iacorossi L., Latina R., Salomone K., Gupta S., Iannone P., Chiara O., Coniglio C., De Blasio E., Flego G., Geraci M., Maccauro G., Rampoldi A., Santolini F., Tacconi C., Tugnoli G., Gianola, S, Castellini, G, Biffi, A, Porcu, G, Fabbri, A, Ruggieri, M, Stocchetti, N, Napoletano, A, Coclite, D, D'Angelo, D, Fauci, A, Iacorossi, L, Latina, R, Salomone, K, Gupta, S, Iannone, P, Chiara, O, Coniglio, C, De Blasio, E, Flego, G, Geraci, M, Maccauro, G, Rampoldi, A, Santolini, F, Tacconi, C, Tugnoli, G, Gianola S, Castellini G, Biffi A, Porcu G, Fabbri A, Ruggieri MP, Stocchetti N, Napoletano A, Coclite D, D'Angelo D, Fauci AJ, Iacorossi L, Latina R, Salomone K, Gupta S, Iannone P, Chiara O, and Italian National Institute of Health guideline working group

Subjects
medicine.medical_specialty, Emergency Medical Services, RD1-811, Major trauma, Context (language use), Review, Pre-hospital, Accuracy, 03 medical and health sciences, 0302 clinical medicine, nursing, Medicine, Humans, 030212 general & internal medicine, Receiver operating characteristic, business.industry, RC86-88.9, pre-hospital, 030208 emergency & critical care medicine, Medical emergencies. Critical care. Intensive care. First aid, medicine.disease, Settore MED/45 - Scienze Infermieristiche Generali, Cliniche E Pediatriche, Triage, Sample size determination, Meta-analysis, Emergency medicine, Emergency Medicine, Systematic review, Injury Severity Score, Wounds and Injuries, Observational study, Surgery, business
Abstract

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.

Published
2021

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

Author

Fauci, A, Coclite, D, Napoletano, A, D'Angelo, D, Biffi, A, Castellini, G, Gianola, S, Iacorossi, L, Latina, R, Porcu, G, Salomone, K, Chiara, O, Iannone, P, Coniglio, C, de Blasio, E, Fabbri, A, Flego, G, Geraci, M, Maccauro, G, Rampoldi, A, Ruggieri, M, Santolini, F, Stocchetti, N, Tacconi, C, Tugnoli, G, Fauci A. J., Coclite D., Napoletano A., D'Angelo D., Biffi A., Castellini G., Gianola S., Iacorossi L., Latina R., Porcu G., Salomone K., Chiara O., Iannone P., Coniglio C., de Blasio E. -V., Fabbri A., Flego G., Geraci M., Maccauro G., Rampoldi A., Ruggieri M. P., Santolini F., Stocchetti N., Tacconi C., Tugnoli G., Fauci, A, Coclite, D, Napoletano, A, D'Angelo, D, Biffi, A, Castellini, G, Gianola, S, Iacorossi, L, Latina, R, Porcu, G, Salomone, K, Chiara, O, Iannone, P, Coniglio, C, de Blasio, E, Fabbri, A, Flego, G, Geraci, M, Maccauro, G, Rampoldi, A, Ruggieri, M, Santolini, F, Stocchetti, N, Tacconi, C, Tugnoli, G, Fauci A. J., Coclite D., Napoletano A., D'Angelo D., Biffi A., Castellini G., Gianola S., Iacorossi L., Latina R., Porcu G., Salomone K., Chiara O., Iannone P., Coniglio C., de Blasio E. -V., Fabbri A., Flego G., Geraci M., Maccauro G., Rampoldi A., Ruggieri M. P., Santolini F., Stocchetti N., Tacconi C., and Tugnoli G.

Abstract

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.

Published
2021

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

Author

Gianola, S, Castellini, G, Biffi, A, Porcu, G, Fabbri, A, Ruggieri, M, Stocchetti, N, Napoletano, A, Coclite, D, D'Angelo, D, Fauci, A, Iacorossi, L, Latina, R, Salomone, K, Gupta, S, Iannone, P, Chiara, O, Coniglio, C, De Blasio, E, Flego, G, Geraci, M, Maccauro, G, Rampoldi, A, Santolini, F, Tacconi, C, Tugnoli, G, Gianola S., Castellini G., Biffi A., Porcu G., Fabbri A., Ruggieri M. P., Stocchetti N., Napoletano A., Coclite D., D'Angelo D., Fauci A. J., Iacorossi L., Latina R., Salomone K., Gupta S., Iannone P., Chiara O., Coniglio C., De Blasio E., Flego G., Geraci M., Maccauro G., Rampoldi A., Santolini F., Tacconi C., Tugnoli G., Gianola, S, Castellini, G, Biffi, A, Porcu, G, Fabbri, A, Ruggieri, M, Stocchetti, N, Napoletano, A, Coclite, D, D'Angelo, D, Fauci, A, Iacorossi, L, Latina, R, Salomone, K, Gupta, S, Iannone, P, Chiara, O, Coniglio, C, De Blasio, E, Flego, G, Geraci, M, Maccauro, G, Rampoldi, A, Santolini, F, Tacconi, C, Tugnoli, G, Gianola S., Castellini G., Biffi A., Porcu G., Fabbri A., Ruggieri M. P., Stocchetti N., Napoletano A., Coclite D., D'Angelo D., Fauci A. J., Iacorossi L., Latina R., Salomone K., Gupta S., Iannone P., Chiara O., Coniglio C., De Blasio E., Flego G., Geraci M., Maccauro G., Rampoldi A., Santolini F., Tacconi C., and Tugnoli G.

Abstract

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.

Published
2021

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

Author

Castellini, G, Gianola, S, Biffi, A, Porcu, G, Fabbri, A, Ruggieri, M, Coniglio, C, Napoletano, A, Coclite, D, D'Angelo, D, Fauci, A, Iacorossi, L, Latina, R, Salomone, K, Gupta, S, Iannone, P, Chiara, O, Stocchetti, N, De Blasio, E, Flego, G, Geraci, M, Maccauro, G, Rampoldi, A, Santolini, F, Tacconi, C, Tugnoli, G, Castellini G., Gianola S., Biffi A., Porcu G., Fabbri A., Ruggieri M. P., Coniglio C., Napoletano A., Coclite D., D'Angelo D., Fauci A. J., Iacorossi L., Latina R., Salomone K., Gupta S., Iannone P., Chiara O., Stocchetti N., De Blasio E., Flego G., Geraci M., Maccauro G., Rampoldi A., Santolini F., Tacconi C., Tugnoli G., Castellini, G, Gianola, S, Biffi, A, Porcu, G, Fabbri, A, Ruggieri, M, Coniglio, C, Napoletano, A, Coclite, D, D'Angelo, D, Fauci, A, Iacorossi, L, Latina, R, Salomone, K, Gupta, S, Iannone, P, Chiara, O, Stocchetti, N, De Blasio, E, Flego, G, Geraci, M, Maccauro, G, Rampoldi, A, Santolini, F, Tacconi, C, Tugnoli, G, Castellini G., Gianola S., Biffi A., Porcu G., Fabbri A., Ruggieri M. P., Coniglio C., Napoletano A., Coclite D., D'Angelo D., Fauci A. J., Iacorossi L., Latina R., Salomone K., Gupta S., Iannone P., Chiara O., Stocchetti N., De Blasio E., Flego G., Geraci M., Maccauro G., Rampoldi A., Santolini F., Tacconi C., and Tugnoli G.

Abstract

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 c

Published
2021

20. Effectiveness of pre-hospital tourniquet in emergency patients with major trauma and uncontrolled Haemorrhage: A systematic review and meta-analysis

Author

Latina, R, Iacorossi, L, Fauci, A, Biffi, A, Castellini, G, Coclite, D, D'Angelo, D, Gianola, S, Mari, V, Napoletano, A, Porcu, G, Ruggeri, M, Iannone, P, Chiara, O, Latina R., Iacorossi L., Fauci A. J., Biffi A., Castellini G., Coclite D., D'Angelo D., Gianola S., Mari V., Napoletano A., Porcu G., Ruggeri M., Iannone P., Chiara O., Latina, R, Iacorossi, L, Fauci, A, Biffi, A, Castellini, G, Coclite, D, D'Angelo, D, Gianola, S, Mari, V, Napoletano, A, Porcu, G, Ruggeri, M, Iannone, P, Chiara, O, Latina R., Iacorossi L., Fauci A. J., Biffi A., Castellini G., Coclite D., D'Angelo D., Gianola S., Mari V., Napoletano A., Porcu G., Ruggeri M., Iannone P., and Chiara O.

Abstract

Trauma is one of the leading causes of uncontrolled haemorrhage, death, and disability. Use of a tourniquet can be considered an optimal anti-haemorrhagic resource, in pre-hospital and emergency settings, and its lifesaving effect is clinically contradictory. This review aims to assess the clinical efficacy of the tourniquet in the emergency pre-hospital care setting for the management of haemorrhage. We conducted the systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, the PRISMA statement. We searched the following electronic databases: EMBASE, MEDLINE, and Cochrane-CENTRAL. All studies included were appraised for risk of bias. Prevalent primary outcomes were mortality and use of blood products. Secondary outcomes were related to adverse effects. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE). Four studies were involved (1762 trauma patients). The adjusted odds ratio (aOR) of 0.47 (95% confidence Interval (CI) 0.19-1.16; three studies; 377 patients) for overall mortality estimates did not give a clear indication of the benefits of emergency pre-hospital tourniquets (PH-TQ) versus no pre-hospital tourniquet (NO PH-TQ) placement. The adjusted mean difference for blood product use was −3.28 (95% CI −11.22, 4.66) for packed red blood cells (pRBC) and −4.80 (95% CI −5.61, −3.99) for plasma, respectively. The certainty of evidence was downgraded to very low for all outcomes. Our results suggest an unclear effect of emergency pre-hospital tourniquet placement on overall mortality and blood product use. However, this systematic review highlights the availability of only observational studies and the absence of high quality RCTs assessing the efficacy of PH-TQs. Randomized controlled trials are needed.

Published
2021

22. Allocation of scarce critical care resources during public health emergencies: which ethical principles support decision making.

Author

Fauci, A. J., Latina, R., Iacorossi, L., Coclite, D., D’Angelo, D., Napoletano, A., Terrenato, I., and Iannone, P.

Subjects
DECISION making, PUBLIC health, MEDICAL emergencies, COVID-19 pandemic, CRITICAL care medicine
Abstract

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 concerning 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. [ABSTRACT FROM AUTHOR]

Published
2022
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26. Introduction and methods of the evidence-based guidelines for the diagnosis and management of autism spectrum disorder by the Italian National Institute of Health

Author

Morgano, G. P., Fulceri, F., Nardocci, F., Barbui, C., Ostuzzi, G., Papola, D., Fatta, L. M., Fauci, A. J., Coclite, D., Napoletano, A., De Crescenzo, F., D'Alo, G. L., Amato, L., Cinquini, M., Iannone, P., Schunemann, H. J., Scattoni, M. L., Arduino, M., Bellosio, C., Biasci, S., Buono, S., Cappa, C., Cordo, C., Di Tommaso, E., Duff, C. M., Felici, C., Massagli, A., Molteni, M., Reali, L., Tancredi, R., Valeri, G., Venturini, L., Zuddas, A., Andreoli, M., Bergamin, C., Bertelli, M., Catania, D., Cavagnola, R., Cirrincione, P., Corti, S., Crognale, M., Faggioli, R., Giogoli, A. M., Grittani, S., Keller, R., Pace, P., Politi, P., Starace, F., Valenti, M., Balduzzi, S., Basile, M., Cruciani, F., D'Amico, R., Davoli, M., Lorenzo, M. G., Minozzi, S., Mitrova, Z., Moschetti, I., Pistotti, V., Saulle, R., and Vecchi, S.

Subjects
Adult, Male, Evidence-based practice, Adolescent, Autism Spectrum Disorder, Psychological intervention, Guideline, Recommendations, lcsh:Computer applications to medicine. Medical informatics, 03 medical and health sciences, 0302 clinical medicine, Diagnosis, medicine, Humans, 030212 general & internal medicine, Patient Reported Outcome Measures, Autism Spectrum disorder, GRADE approach, Healthcare decision, Italian National Institute of health, Italian national guidelines system, Treatment, Grading (education), Child, Medical education, Evidence-Based Medicine, Research, Public Health, Environmental and Occupational Health, Conflict of interest, Stakeholder, Italy, Quality of Life, Practice Guidelines as Topic, General Medicine, Evidence-based medicine, medicine.disease, Autism spectrum disorder, ComputingMilieux_COMPUTERSANDSOCIETY, lcsh:R858-859.7, Psychology, 030217 neurology & neurosurgery
Abstract

Background Autism Spectrum Disorder (ASD) is a neuro-developmental disorder that affects communication and behavior with a prevalence of approximately 1% worldwide. Health outcomes of interventions for ASD are largely Participant Reported Outcomes (PROs). Specific guidelines can help support the best care for people with ASD to optimize these health outcomes but they have to adhere to standards for their development to be trustworthy. Objective The goal of this article is to describe the new methodological standards of the Italian National Institute of Health and novel aspects of this guideline development process. This article will serve as a reference standard for future guideline development in the Italian setting. Methods We applied the new standards of the Italian National Institute of Health to the two guidelines on diagnosis and management of children/adolescents and adults with ASD, with a focus on the scoping, panel composition, management of conflict of interest, generation and prioritization of research questions, early stakeholders’ involvement, and PROs. Recommendations are based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence-to-Decision frameworks. Results Following a public application process, the ISS established two multidisciplinary panels including people with ASD and/or their caregivers. Seventy-nine research questions were identified as potentially relevant for the guideline on children and adolescents with ASD and 31 for the one on adults with ASD. Questions deemed to have the highest priority were selected for inclusion in the guidelines. Other stakeholders valued their early involvement in the process which will largely focus on PROs. The panels then successfully piloted the development of recommendations using the methodological standards and process set by the ISS with a focus on PROs. Conclusions In this article, we describe the development of practice guidelines that focus on PROs for the diagnosis and management of ASD based on novel methods for question prioritization and stakeholder involvement. The recommendations allow for the adoption or adaptation to international settings.

Published
2020

31. A computational model of the fluid dynamics of undulatory and flagellar swimming

Author

Fauci, Lisa J.

Subjects
Fluid dynamics -- Models, Animal swimming -- Research, Microorganisms -- Motility, Spermatozoa -- Motility
Abstract

We present a mathematical model and numerical method designed to study the fluid dynamics of swimming organisms. The full Navier-Stokes equations are solved in a domain of fluid within which an organism undergoing time-dependent motions is immersed. Of interest are both the dynamics of a single organism and the relationship of its morphology to its motility properties, as well as the collective hydrodynamic interactions of groups of swimmers with each other and their environment. Biological applications include spermatozoa motility in the reproductive tract, swimming of non-smooth filaments, and collective swimming of algal cells.

Published
1996

37. Testify first, know why later: responding to civil investigative demands for testimony in false claims act cases

Author

Green, Karen F. and Fauci, James J.

Subjects
United States. Department of Justice, Banking, finance and accounting industries
Abstract

This article outlines the rules governing Civil Investigative Demands for oral testimony and how they differ from the rules governing depositions. It then discusses issues a company should consider when the government demands that its employees (or former employees) testify early in an investigation., The Department of Justice's use of Civil Investigative Demands ('CIDs') in False Claims Act ('FCA') investigations has dramatically increased during the past four years. CIDs allow the government, prior to [...]

Published
2014

45. A Grid-Free Method for High Reynolds Number Flow Around an Immersed Elastic Structure.

Author

TULANE UNIV NEW ORLEANS LA DEPT OF MATHEMATICS, Fauci, Lisa J., TULANE UNIV NEW ORLEANS LA DEPT OF MATHEMATICS, and Fauci, Lisa J.

Abstract

This report is concerned with the computational modeling of problems in biological fluid mechanics. Typically, these problems involve the study of flow about highly flexible, moving boundaries; for instance, distensible vessels, moving heart walls, and valves. The fluid along with the boundary constitutes a coupled mechanical system in the sense that the motion of the boundary is determined by that of the fluid, but at the same time the boundary exerts force on the fluid and alters its motion. Finite difference schemes do not perform well in simulations of high Reynolds number flow because a restrictive number of grid points must be used to resolve boundary layers. In this report we present a grid-free numerical method which may be used to calculate flows around an immersed elastic structure. Numerical results are presented in 2 simple cases: flow past a circular cylinder and flow past a flat plate. The boundary motion is specified and is not time dependent. however, this algorithm can be used to simulate more complicated, time dependent problems in biological fluid mechanics.

Published
1991

46. A Grid-Free Method for High Reynolds Number Flow Around an Immersed Elastic Structure

Author

TULANE UNIV NEW ORLEANS LA DEPT OF MATHEMATICS, Fauci, Lisa J., TULANE UNIV NEW ORLEANS LA DEPT OF MATHEMATICS, and Fauci, Lisa J.

Abstract

Finite difference schemes do not perform well in simulations of high Reynolds number flow because a restrictive number of grid points must be used to resolve boundary layers. In this report we present a grid-free numerical method which may be used to calculate flows around an immersed elastic structure. Numerical results are presented in two simple cases: flow past a circular cylinder and flow past a flat past a flat plate. Here the boundary motion is specified and is not time dependent. However, this algorithm can be used to simulate more complicated, time dependent problems in biological fluid mechanics.

Published
1990

50. ERROR ESTIMATION FOR IMMERSED INTERFACE SOLUTIONS.

Author

Vanderlei, Ben A., Hopkins, Matthew M., and Fauci, Lisa J.

Subjects
ESTIMATION theory, ERRORS, BOUNDARY value problems, COMPUTER simulation, ELLIPTIC equations
Abstract

We present an error estimation method for immersed interface solutions of elliptic boundary value problems. As opposed to an asymptotic rate that indicates how the errors in the numerical method converge to zero, we seek a posteriori estimates of the errors, and their spatial distribution, for a given solution. Our estimate is based upon the classical idea of defect corrections, which requires the application of a higher-order discretization operator to a solution achieved with a lower-order discretization. Our model problem will be an elliptic boundary value problem in which the coefficients are discontinuous across an internal boundary. [ABSTRACT FROM AUTHOR]

Published
2012
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