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Objective: With the modernization of traditional Chinese medicine (TCM) industry, the investment in research and development of new commercial Chinese polyherbal preparations (CCPPs) is increasing, and the varieties of CCPPs are growing. CCPPs play an increasingly important role in the TCM industry. This study has comprehensively summarized and analyzed the current situation of CCPPs that has been on the market in China, and provided suggestions for the research and promotion of CCPPs., Methods: This study took the CCPPs approved for marketing in domestic drug database of the National Medical Products Administration (NMPA) as the research object, and combined with the publication of related randomized controlled trials (RCTs) of CCPPs in 2020-2022 and the sales of CCPPs in domestic chain pharmacies, statistical analysis was carried out on the drug name, pharmaceutical companies, dosage form, number of flavors, CBDs, ICD-11 classification of diseases treated, etc., Results: Currently, 58,409 approvals for CCPPs have been issued in China, involving 9,986 varieties of CCPPs, 2,896 pharmaceutical companies and 39 dosage forms. The number of flavors of prescriptions of CCPPs varies from 1 to 90, among which Glycyrrhiza glabra L. [Fabaceae; Glycyrrhizae radix et rhizoma] and Angelica sinensis (Oliv.) Diels [Apiaceae; Angelicae sinensis radix] are the most widely used. The study found that the CCPPs with the most diverse variety is CCPPs for the treatment of respiratory diseases, some CCPPs can treat multiple system diseases. According to the survey, the sales of CCPPs for respiratory diseases in the chain pharmacies account for more than 1/3 of the total sales of the chain pharmacies, while the number of published randomized controlled trials (RCTs) on CCPPs for circulatory diseases was the largest., Conclusion: The approval process of CCPPs should be further standardized, and the transformation of TCM prescriptions into CCPPs should be promoted. In the approval process of CCPPs, it is suggested to strengthen the supervision of drug names to clarify the differences between the CCPPs of same name but different prescriptions. Improve the effectiveness and safety of CCPPs by improving the quality of CBDs. It is suggested to optimize the design of new drug research program of CCPPs to avoid waste of research resources., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Chenyao, Haiyin, Menglong, Yucong, Fauci, Lee, Xiaolei, Junhua and Zhaochen.)

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., (© 2023. The Author(s).)

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/., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 JBI.)

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., (© 2022. The Author(s).)

Background: 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., Methods: 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., Results: 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%) with some discrepancies in the directions of effects across reviews. The application of a structured approach by checklist may improve adherence to guidelines (e.g. Advanced Trauma Life Support) during resuscitation and might lead to a reduction in mortality among severely injured patients as compared to clinical examination (Adjusted OR 0.51; 95% CI 0.30-0.89; p = 0.018; low certainty of evidence). The use of routine WBCT seems to offer little to no effects in reducing mortality and time spent in emergency room or department, whereas non-routine WBCT seems to offer little to no effects in reducing radiation dose, intensive care unit length of stay (LOS) and hospital LOS (low-to-moderate certainty of evidence)., Conclusions: 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., (© 2023. The Author(s).)

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.

This study aimed to systematically review and depict the current studies of traditional Chinese medicine for the mental health of patients with coronavirus disease 2019 (COVID-19)., Methods: A scoping review was conducted by searching PubMed, Web of Science, CNKI, Wanfang database, VIP database, and SinoMed, with the retrieval time being from the establishment of the database to April 18, 2022. The basic information of the included studies, objective, design, types of patients, interventions, outcomes, etc., was reviewed and summarized narratively. Methodological quality was assessed using the Cochrane Risk of Bias assessment tool, the methodological index for non-randomized studies or the Newcastle-Ottawa scale., Results: We identified 30 traditional Chinese medicine (TCM) studies from six databases. Among them, finished randomized controlled trials ( n = 16) accounted for most of the studies, followed by single-arm studies (n = 9). In terms of study theme, 20 studies defined the mental health of patients with COVID-19 as the research theme. Psychological assessment was included in the inclusion criteria (performed before participation) of nine studies, whereas the other studies only mentioned the mental outcomes. TCM interventions included TCM exercises (Yijinjing, Baduanjin, Liuzijue, Taichi), acupoint stimulation (auricular and body points), moxibustion, decoction, or granules based on TCM syndrome differentiation, decoction, or granules with fixed formulae (Baidu Jieduan granules, Xuanfei Baidu decoction, and Qingfei Paidu decoction), Chinese patent medicine (Jinhua Qinggan granules), TCM psychological therapy (TCM ideological therapy, TCM five-tone therapy, and TCM psychological sand table), and TCM nursing (dialectical care, dialectical diet, and psychological counseling). Anxiety and depression were the main outcomes evaluated in regard to mental health in patients with COVID-19. The limitations of methodological quality were predominantly from follow-up, blinding, and registration. Positive results were reported by 27 studies (90%, n = 30)., Conclusion: We summarized the existing literature about the impact of TCM on mental health in patients with COVID-19. The number of studies evaluating the impact of TCM on mental health is encouraging, but overall methodological quality was low. Several TCM interventions warrant further evaluation, particularly among populations outside of China, for the purpose of establishing supporting evidence. More importantly, research with stronger methodological quality needs to be developed., Graphical Abstract: http://links.lww.com/AHM/A36., Competing Interests: This article only represents the authors’ personal opinions, and does not represent any involvement of the bodies or authorities of affiliation. All authors have not received any fee or reimbursement for participating in the study and writing this article., (Copyright © 2022 Tianjin University of Traditional Chinese Medicine.)

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., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

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., (© 2022. The Author(s).)

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.

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.

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., (© 2021. The Author(s).)

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.

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.

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., (© 2020 Elsevier Ltd. All rights reserved.)

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.

Background: Many systematic reviews of clinical trials on acupuncture were performed within the Cochrane Collaboration, the evidence-based medicine (EBM) most recognized organization. Objective of the article was to systematically collect and identify systematic reviews of acupuncture published in the Cochrane Library and assess their quality from a methodological perspective., Methods: A comprehensive literature search was performed in the Cochrane Database of Systematic Reviews to identify the reviews of acupuncture conducted until June 2019. The methodological quality of the included reviews was assessed using the AMSTAR 2 checklist, an evaluation tool for systematic reviews., Results: Out of a total of 126 eligible reviews, 50 systematic reviews were included. According to the AMSTAR 2, 52% of Cochrane Systematic Reviews (CSRs) were of low quality, due to the presence of one or more weaknesses in at least one of the domains defined as critical for the methodological quality assessment. The less satisfied critical domain was inadequate investigation and discussion of publication bias. Declaration of potential sources of conflict of interest, and funding of the authors of the review and of the included studies were other important weaknesses., Conclusions: The main methodological flaws in the included CSRs were related to topics of relatively new concern in the conduction of systematic reviews of the literature. However, both, lack of attention about retrieval of negative studies, and statements about conflict of interests are crucial point for the evaluation of therapeutic interventions according to EBM methodology.

Protecting Health Care Workers (HCWs) during routine care of suspected or confirmed COVID-19 patients is of paramount importance to halt the SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2) pandemic. The WHO, ECDC and CDC have issued conflicting guidelines on the use of respiratory filters (N95) by HCWs. We searched PubMed, Embase and The Cochrane Library from the inception to March 21, 2020 to identify randomized controlled trials (RCTs) comparing N95 respirators versus surgical masks for prevention of COVID-19 or any other respiratory infection among HCWs. The grading of recommendations, assessment, development, and evaluation (GRADE) was used to evaluate the quality of evidence. Four RCTs involving 8736 HCWs were included. We did not find any trial specifically on prevention of COVID-19. However, wearing N95 respirators can prevent 73 more (95% CI 46-91) clinical respiratory infections per 1000 HCWs compared to surgical masks (2 RCTs; 2594 patients; low quality of evidence). A protective effect of N95 respirators in laboratory-confirmed bacterial colonization (RR = 0.41; 95%CI 0.28-0.61) was also found. A trend in favour of N95 respirators was observed in preventing laboratory-confirmed respiratory viral infections, laboratory-confirmed respiratory infection, and influenza like illness. We found no direct high quality evidence on whether N95 respirators are better than surgical masks for HCWs protection from SARS-CoV-2. However, low quality evidence suggests that N95 respirators protect HCWs from clinical respiratory infections. This finding should be contemplated to decide the best strategy to support the resilience of healthcare systems facing the potentially catastrophic SARS-CoV-2 pandemic., Competing Interests: The authors have declared that no competing interests exist.

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.

Law No. 24/2017 on professional responsibility has assigned a fundamental role to the guidelines, giving the Istituto Superiore di Sanità, through the new Centro Nazionale per l'Eccellenza Clinica, la Qualità e la Sicurezza delle Cure (CNEC), the role of methodological guarantor and of national governance of the guidelines production process. In a scenario marked by the increasing use of defensive medicine, the adherence to guidelines recognized as reliable by an institutional body can lead to the desired reduction of the malpractice claim, as well as to considerable clinical advantages, with the improvement of the quality of healthcare and of health outcomes and the reduction of unjustified variability of clinical practices in the national territory. If the opportunity that the new National Guidelines System (SNLG) offers is great and must be seized, at the same time the connection between guidelines and health responsibility presents some critical issues. In this context, it is of utmost importance to promote an efficient production mechanism of good quality national guidelines, informed by the best evidence available and responding to the population health needs, based on the criteria of relevance and clinical, economic and social impact, as well as to make the SNLG the pivotal instrument to achieve that alignment of clinical efficacy, professional and organizational appropriateness, fairness, security and humanization of care that can guarantee the sustainability of our National Health Service and its capacity to face the difficult challenges of the future.

Background: The pharmacologic treatment of migraine still remains below the expectations. The aim of this study is to compare the effectiveness of traditional acupuncture and valproic acid in migraine prophylaxis., Methods: A prospective, controlled study was performed in 100 patients affected by migraine without aura lasting for over one year. The patients were stratified for sex and randomly divided into two groups of 50 patients each. Patients belonging to Group A (acupuncture) were submitted to 20 sessions of acupuncture, while patients belonging to Group V valproate) were administered Valproic acid (Depakin Chrono®) at a dose of 600 mg/day; 10 mg Rizatriptan wafers were allowed as needed to treat the attacks. The Midas Index (MI) and pain intensity (PI, by VAS) were recorded before treatment (T0), at three (T1) and six (T2) months; a six-point scale Pain Relief score (PRS), the Rizatriptan intake and adverse events were recorded at T1 and T2., Results: Eighty-two out of 100 patients completed the study (9 dropouts in each group). In both groups the MI improved at T1 and T2 (P<0.0001). Pain intensity was better at T1 in group V (P<0.0001), but PI and PRS (P=0.02) as well as rizatriptan intake (P=0.001) were better in group A at T2. The rate of adverse events was 47.8% in group V and 0% in group A., Conclusion: Our data show a lower pain intensity and lower Rizatriptan intake at six-months follow-up with no adverse events in acupuncture patients compared to those treated with valproic acid.

Aim: This qualitative study is aimed at analysing the impact of the 2004 tsunami on the Quality of Life of the Sri Lankan population. It focused on the factors that have contributed to an increase in the people's susceptibility to the impact of hazards - their vulnerability - as well as of the natural ability to cope of the populations affected - their resilience., Methodology: The study is based on the conduction of 10 Focus Group discussions and 18 In-depth Interviews, then analysed through a qualitative analysis software., Results and Conclusions: The analysis shows that each factor involved in the interplay among the different processes that produced the changes in the affected people's quality of life is at the same time a damaged asset, a vulnerability factor and a resource to draw upon for coping. The complexity of this situation opens further speculation as to how disasters and relief interventions influence relationships and dynamics in society. This should thus be further investigated, together with the effects of individual and group trauma on society.