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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.

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.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.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.STS members hold a positive attitude towards CPGs despite barriers to CPG development.

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

Highlights • Epidemiological conditions should be monitored and enforced. • COVID-19 must be under control below thresholds of safeguards. • Testing, contact tracing, and isolation strategies are essential components to ease the lockdown. • The maintenance of social distancing measures is an overarching mitigation strategy. • The benefit gained from the implementation of social distancing was evident., 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.

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.

ObjectivesThis study aimed to identify the guiding ethical principles that should be considered for critical resource allocation during pandemic emergency situations, and especially for the COVID-19 outbreak. The secondary objective was to define the priority to be assigned to each principle.SettingThe study was conducted from March to June 2020 within the context of an ethical committee (EC) in Northern Italy.ParticipantsEleven EC members and five additional external healthcare and bioethical professionals, forming a multidisciplinary panel, took part in the study.Primary and secondary outcome measuresThe compilation of a list of ethical principles (maximum of 10 items) and their priority ranking and application within an emergency pandemic context was established as the expected outcome of this work.ResultsA consensus on 10 guiding ethical principles was reached by the multidisciplinary panel. Transparency ranked first on the priority list as the most frequently voted principle, followed by the number of lives saved, life-years saved, respect for individuals’ autonomy and equity. Other principles including life cycle, ‘sickest first’, reciprocity, instrumental value and lottery were also considered appropriate as potential tiebreakers. These principles were discussed and made consistent with the current Italian pandemic context by producing an explanatory document.ConclusionsThe identified principles could be used in preparedness plans to guide resource allocation during pandemic events. By combining their rank and relevance in relation to disease, health system organisations, social and economic settings, and critical resources at risk of scarcity, these principles could help to maximise the benefit of resource use for the community, thus reducing inequalities for individuals.

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.

ObjectiveThe main objectives of this review are to summarise the existing literature and to identify strategies for exiting lockdown during the COVID-19 pandemic, with a focus on reopening schools and returning to work.IntroductionAfter months of strict quarantine, several countries are planning exit strategies to progressively lift social restrictions without giving rise to an increase in the number of COVID-19 cases. Although several strategies have been studied in terms of how and when to relax such stringent constraints, there is a lack of consensus on the optimal strategy for managing the pandemic beyond lockdown. The risks posed by delaying return to work and school openings are real and sizeable, particularly for relevant working sectors and for students from low-income familiesInclusion criteriaThis review will consider studies that focussed on relaxation strategies for lockdown exit among workers and students facing an epidemic /pandemic crisis.MethodsThe searches will be conducted across four databases (MEDLINE, EMBASE, SciSearch, Google Scholar), and the bibliography of all selected studies will be hand-searched. In addition, because the topic is new, relevant literature will be checked using daily, updated COVID-19 collections from NCBI (LitCovid) and MedRxiv servers. Studies published in English, German, Spanish, Italian and French will be included, with no limits on publication dates. This review will consider all study designs, regardless of their rigor. The review method will be based on a two-phase approach: a title and abstract screening, and a full-text review performed by two independent researchers. Data will be summarised and categorised, and results will be presented in a tabular/diagrammatic form.

Background There is emerging interest in integrating Patient Reported Outcome Measures (PROMs) into the assessment of care quality. This study protocol aims at testing the collection and use of PROMs for evaluating and comparing health outcomes by patients with colorectal cancer. This is part of a project of the Istituto Superiore di Sanità and Gruppo Italiano di Reti Oncologiche (GIRO) aimed at promoting Value-Based Healthcare (VBHC) for performance evaluation of oncological healthcare providers. Methods A multicentric prospective observational study will be conducted at the seven GIRO oncological hospitals. For each hospital, 40 colorectal cancer patients undergoing either surgery or surgery plus neoadjuvant therapy, will be recruited (20 colon; 20 rectum) over 12 months. The data will be collected twice (before and after surgery) or three times for patients undergoing neoadjuvant therapy, by using EORTC-C30, a generic module for cancer patients and EORTC-CR29, a specific module for colorectal cancer patients. Collected data will be analyzed descriptively and the scores of each hospital will be compared to the overall scores of all the centers. Additional medical information will be used to adjust for the center casemix. Feedback from health professionals and patients will be collected through structured questionnaires and focus groups. Results The results will be interpreted to assess and compare the health outcomes reported by the patients among the GIRO hospitals. Feedback from health professionals and patients will help identify barriers and facilitators of implementation of PROs collection. Conclusions PROMs have the potential to systematically incorporate the patient perspective into the health outcome measurements for performance evaluation and benchmarking, which is essential to delivering high-value patient-centered care. The PROMs collected in this study will be integrated in a set of process and outcome indicators previously defined within same project. Key messages Patient-Reported Outcome Measures (PROMs) have the potential to systematically incorporate the patient perspective, which is essential to delivering high-value patient-centered care. It is critical to integrate PROMs in performance evaluation and comparison among oncological healthcare providers for improving the quality of care in a Value-Based Healthcare perspective.

Background An ongoing project, promoted by “Gruppo Italiano di Reti Oncologiche” (GIRO) network and coordinated by the “Istituto Superiore di Sanità”, aims to apply Value Based Healthcare (VBH) for evaluating the performance of oncological healthcare providers. In this framework, the aim of this study was to define a set of indicators for assessing the overall clinical pathway for patients with colorectal cancer receiving healthcare in one of the seven GIRO referral centers. Methods A 2-round Delphi study was conducted involving experts from GIRO centers. A list of preliminary indicators, identified from national and international agencies, was firstly evaluated according to four criteria (relevance, evidence-based, measurability, actionability) using a 5-point Likert scale. Indicators receiving ≥50% of judgements ≥3 in 3/4 criteria went to selection process of the second round. The second survey firstly asked whether the indicator was to be included in the final set and, if yes, it was then evaluated on a balancing criterion. Indicators receiving ≥75% of agreement for inclusion and ≥50% of judgements ≥3 for balancing were confirmed for the final set. During the face-to-face meeting, a subset of indicators was prioritized for a pilot collection. Results After 1st-round consultation, all the 34 indicators in the preliminary list passed to the 2nd-round and 32 (94%) of these were included in the final set (16 colon;16 rectum). During the face-to face meeting, critical issues highlighted during the process (e.g. events occurring outside the referral center) were discussed and 16 (50%) indicators were prioritized for the pilot collection (8 colon;8 rectum). Conclusions Evaluating the overall clinical pathway for oncological patients is very important for achieving high-quality healthcare. Enhancing collaboration and networking among oncological referral centers is a main tool for the continuous improvement of healthcare outcomes in a VBH perspective. Key messages Evaluating the overall clinical pathway for oncological patients is very important for achieving high-quality healthcare. Enhancing collaboration and networking among oncological referral centers is a main tool for the continuous improvement of healthcare outcomes in a VBH perspective.

BackgroundEvidence is needed on the effectiveness of wearing face masks in the community to prevent SARS-CoV-2 transmission.MethodsSystematic review and meta-analysis to investigate the efficacy and effectiveness of face mask use in a community setting and to predict the effectiveness of wearing a mask. We searched MEDLINE, EMBASE, SCISEARCH, The Cochrane Library and pre-prints from inception to 22 April 2020 without restriction by language. We rated the certainty of evidence according to Cochrane and GRADE approach.FindingsOur search identified 35 studies, including 3 randomised controlled trials (RCTs) (4017 patients), 10 comparative studies (18984 patients), 13 predictive models, 9 laboratory experimental studies. For reducing infection rates, the estimates of cluster-RCTs were in favour of wearing face masks versus no mask, but not at statistically significant levels (adjusted OR 0.90, 95%CI 0.78-1.05). Similar findings were reported in observational studies. Mathematical models indicated an important decrease in mortality when the population mask coverage is near-universal, regardless of mask efficacy. In the best-case scenario, when the mask efficacy is at 95%, the R0 can fall to 0.99 from an initial value of 16.90. Levels of mask filtration efficiency were heterogeneous, depending on the materials used (surgical mask: 45-97%). One laboratory study suggested a viral load reduction of 0.25 (95%CI 0.09-0.67) in favour of mask versus no mask.InterpretationThe findings of this systematic review and meta-analysis support the use of face masks in a community setting. Robust randomised trials on face mask effectiveness are needed to inform evidence-based policies.Fundingnone.PROSPERO registrationCRD42020184963.Contribution to the fieldGuidelines by various organizations provide conflicting evidence about the effectiveness of face mask use in the community. We performed a systematic review of the available evidence, including 35 studies, across 41 countries and six continents. Previous systematic reviews on the effectiveness of face mask use mainly focused on healthcare and household setting including only randomized controlled trials and observational studies with most of them of low quality. In our review, we included randomized controlled trials, observational studies, laboratory experimental studies as well as mathematical modelling studies in order to answer different questions and provide quantitative estimates for planning pandemic response efforts.Our review supports the use of surgical masks in the community for providing protection during the COVID-19 pandemic. However, the infection rate, mortality, spread of transmission (R0), filtering capacity of masks and viral load reduction are highly dependent on the type of face mask worn and on the adherence of the population wearing masks. Policy makers should promote face mask use in the community.

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 January 2006 to July 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. (www.actabiomedica.it)

Patient engagement is receiving a growing attention in the healthcare context. However, although worldwide healthcare stakeholders agree that patient engagement is a priority for quality and effective care, no shared recommendations on how to promote patient engagement are currently available. Based on these premises, a Consensus Conference (CC) was promoted to address four main issues: What is the definition of Patient Engagement? How measuring Patient Engagement? What are the most recommended methodologies and the tools to promote Patient Engagement? What is the role of new technologies in promoting of Patient Engagement? The consensus was obtained through an iterative process that began with a systematic synthesis of the available literature in each domain followed by plenary expert discussions. This CC - including the systematic analysis of internationals scientific evidences (2749 sources across the major international scientific databases) together with experiences of a multi-disciplinary consortium of investigators and key stakeholders - attempted to provide the first evidence-based Expert Consensus Statement for the promotion of Patient Engagement in chronic care. These recommendations should be envisaged as inspirational principles to promote a real eco-system of engagement and might orient health services research and interventions.

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.

Any evidence-based recommendation needs careful assessment of its methodological background as well as of its content trustworthiness, especially given that following it will not necessarily produce the intended clinical outcomes. There are no established instruments to evaluate guidelines for their content, while useful tools assessing the quality of methods followed are well recognised and adopted. We suggest a 'safety bundle' considering methodological aspects and content trustworthiness of guidelines, by adopting the GRADE method in a backward fashion. Sharing the critical analysis of the guidelines with patients, including any eventual uncertainty about them, is of key importance in order to avoid the possible adverse effects derived from following the wrong guidelines. Such critical approach is also helpful and beneficial in producing better care pathways, health policy decisions and more relevant and ethical research.

The so-called Gelli-Bianco Law (L 24/2017) recognizes the central role of Guidelines as far as decision-making in the health sector is concerned and establishes the Italian National Guidelines System (SNLG) as a "safe harbor", notwithstanding the specificities of each real-world case. The Italian National Center for Clinical Excellence, Quality and Security (CNEC) is responsible for the creation and the development of the SNLG. After considering the many issues revolving around the creation of shared Guidelines, both on the national and international level, we present here the activities of the SNLG to date, together with an evaluation of how the new rules and practices around the creation of National Guidelines have been received. We also provide a series of recommendations for scientific societies on how best to produce Guidelines in their own field and how to submit them to the SNLG.

Patient engagement has been recognized as a key priority in chronic care. However, scholars agree that guidelines are needed to ensure effective patient engagement strategies. To this end, a Consensus Conference process was promoted with the following methodological steps: (1) extensive literature review about patient engagement initiatives in chronic care, (2) a stakeholders survey to collect best practices and (3) workshops with experts. On the basis of the information collected, a consensus statement was drafted, revised, and finalized by a panel of select renowned experts. These experts agreed in defining engagement as an eco-systemic concept involving multiple actors all of which contribute to influence patients&rsquo, willingness and ability to engage in chronic care. Moreover, experts recommended, whenever possible, to adopt standardized instruments to assess engagement levels and related unmet needs. Then, experts strongly advised appropriate trainings for healthcare professionals about patient engagement strategies. Furthermore, the importance of promoting healthcare professionals&rsquo, wellbeing has been advocated. Family caregivers, as well as patients&rsquo, organizations - should be trained and engaged to increase the effectiveness of interventions dedicated to patients. Finally, experts agreed that digital technologies should be considered as a crucial enhancer for patient engagement in chronic care.

Evidence-based guidelines are considered an essential tool in assisting physicians, policymakers and patients when choosing among alternative care options and are considered unbiased standards of care. Unfortunately, depending on how their reliability is measured, up to 50% of guidelines can be considered untrustworthy. This carries serious consequences for patients' safety, resource use and health economics burden. Although conflict of interests, panel composition and methodological flaws are traditionally thought to be the main reasons undermining their untrustworthiness, corruption and waste of biomedical research also contribute. We discuss these issues in the hope for a wider awareness of the limits of guidelines.

In the first article in this series we described the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision (EtD) frameworks and their rationale for different types of decisions. In this second article, we describe the use of EtD frameworks for clinical recommendations and how it can help clinicians and patients who use those recommendations. EtD frameworks for clinical practice recommendations provide a structured and transparent approach for guideline panels. The framework helps ensure consideration of key criteria that determine whether an intervention should be recommended and that judgments are informed by the best available evidence. Frameworks are also a way for panels to make guideline users aware of the rationale (justification) for their recommendations.

The concept of patient engagement is receiving a growing attention in the healthcare field. The last decades have seen a deep revision of care models in the aim of a greater acknowledge of the patient role, seen as an expert actor, in the healthcare process. On the other side, healthcare systems are facing a growing request for participation expressed by citizens and patients. People claim for being more involved in all the crucial turning point of their healthcare journey and of being better aware of their right and duties. They require a deeper knowledge about all the different therapeutic options with the related risks and advantages. However, although all the different stakeholders agree in considering patient engagement a pragmatic further then ethical priority, a shared consensus related to the strategies and instrument to promote has still to come. Patients and healthcare professional perspective about the factors that may hinder or sustain patient engagement still need to be further studied and at shared recommendations - about the programs better effective and efficient in promoting patient engagement - are still missed. Based on these premises, Università Cattolica of Milano and DG Welfare of Regione Lombardia, under the methodological supervision of the Istituto Superiore di Sanità, promoted a consesus conference entitled "Recommendation for promoting patient engagement in healthcare for chronic conditions". This consensus conferences constituted the occasion of sharing and discussion among experts belonging to different clinical and institutional contexts as well as with representative of patients associations in order to identify good practices and effective tools to promote patient engagement in the care and cure process for chronic conditions.

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.

Introduction:In Italy, the central government sets the health benefit package (denominated “Livelli Essenziali di Assistenza” - LEAs) of the National Health System (NHS), which must be provided to all residents. In 2004, the Italian Ministry of Health established a new technical body, the National LEA Commission, responsible for updating LEAs.Methods:Recently, the Ministry has commissioned to the National Institute of Health (NIH) the development of a new value-based procedure for updating the health benefit package for the Italian NHS, supporting the National LEA Commission. A review and comparison of value frameworks and decisional models was performed in order to select a framework and a model that can be applied to the Italian context, design an administrative process for the update procedure, and propose approaches for: (i) the assessment of services currently included in the health benefit basket and of those planned to be incorporated, (ii) the process of appraisal and decision-making to be adopted by the Commission.Results:The NIH outlined an evidence and value-based three-step (i.e. priority setting, assessment and appraisal) administrative process that integrates roles and responsibilities of the different Italian healthcare institutions involved in LEA updating and HTA.Conclusions:The NIH is proposing to the Ministry of Health and to the National LEA Commission a new evidence and value-based procedure for updating the health benefit package for the Italian NHS. This procedure is entering a pilot phase in which potential gaps can be identified and minimized for its subsequent implementation.

Concerns have been expressed about the reliability of clinical practice guidelines. We analyzed 3 guidelines from medical specialty societies about dronedarone hydrochloride, an antiarrhythmic drug related to amiodarone hydrochloride, for treatment of patients with atrial fibrillation. We compared the recommendations in these guidelines with the conclusions about dronedarone that we reached by applying the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Method to the same evidence base. In our analysis, as a rate control drug, dronedarone was better than placebo only for a surrogate outcome (heart rate). As a rhythm control drug, dronedarone was associated with 13 (95% CI, −15 to 61) excess deaths per 1000 patients treated as compared with placebo. Compared with amiodarone, dronedarone was less effective (214 [95% CI, 130 to 294] more recurrences of atrial fibrillation per 1000 patients treated) and similarly tolerated (−28 [95% CI, −69 to 33] more serious adverse events requiring drug suspension per 1000 patients treated). Despite the limits of the evidence, all 3 guidelines recommended dronedarone for prevention of recurrences of atrial fibrillation; 2 of the guidelines recommended it as a rate control agent. Our findings raise questions about the reliability of these clinical practice guidelines, as well as the financial associations between many of the panel members and the manufacturer of dronedarone.

Objective To conduct a systematic review to check the level of validity and reliability of the Manchester Triage System and the quality of reporting of literature on this topic. Design This is a systematic review based on the PRISMA guideline on reporting systematic reviews. Data sources The systematic search of the international literature published from 1997 through 30 November 2012 in the PubMed, Embase, Cochrane Library, Cinahl, Web of Knowledge, and Scopus databases. Review methods This review included quantitative and qualitative research investigating the reliability and validity of the Manchester Triage System for the broad population of adults and children visiting the emergency department. After a systematic selection process, included studies were assessed on their quality by three researchers using the STARD guidelines. Results Twelve studies were included in the review. The studies investigated the inter- and intra-rater reliability using the “kappa” statistic; the validity was tested with many measures: validity in predicting mortality, hospital admission, under- and overtriage, used resources, and length of stay in the emergency department, as well as a reference standard rating. Conclusions In this review, the Manchester Triage System shows a wide inter-rater agreement range with a prevalence of good and very good agreement. Its safety was low because of the high rate of undertriage and the low sensitivity in predicting higher urgency levels. The high rate of overtriage could cause unnecessarily high use of resources in the emergency department. The quality of the reporting in studies of the reliability and validity of the Manchester Triage System is good.

Direct current cardioversion (DCC) has been shown to be effective for the management of atrial fibrillation (AF) in the emergency department (ED). Pharmacological cardioversion was compared with a strategy including DCC on patients with uncomplicated, recent-onset (48emsp14;h) AF managed in a short observation unit (SOU).A prospective observational study was undertaken over a period of 13 months in two institutions. A DCC-centred protocol was applied to 171 AF cases in a hospital (DCC-cohort) and pharmacological cardioversion to 151 AF cases in another hospital (P-cohort). Patients remaining in AF after 24 h were admitted. The outcomes were rate of discharge in sinus rhythm, length of stay in the ED-SOU, rate of hospitalisation and complications of treatment. Data collected were analysed according to Student t test and χ(2) statistics.Discharge in sinus rhythm was achieved in 159/171 cases in the DCC-cohort and 77/151 cases in the P-cohort (93% vs 51%; number needed to treat (NNT) 2.4; 95% CI 2.0 to 3.1, p0.001), whereas mean length of stay was 7+7 h in the DCC-cohort and 9+6 h in the P-cohort (p=0.43). Eleven cases from the DCC-cohort and 67 from the P-cohort were admitted (admission rate 6% vs 44%; NNT 2.6; 95% CI 2.2 to 3.5, p0.001). Three short-term complications occurred in the DCC-cohort and five in the P-cohort (2% vs 3%, p=0.59). Two strokes were registered in the DCC-cohort during 6-month follow-up (p undefined).Electrical cardioversion of recent-onset AF in the SOU is safe, effective and reduces hospitalisations. Further studies are needed to identify the most cost-effective strategy for the management of AF patients in emergency settings.

Acute abdominal pain is a medical challenge for emergency physician due to the variety of possible diagnosis, lack of diagnostic and treatment standard in emergency department and the need of a rapid patient management. It is of paramount importance to quickly rule out or diagnose life threatening clinical conditions as acute myocardial infarction or aortic abdominal aneurism rupture. A few more time is allowed to confirm other diseases that lead to major complications if left untreated as acute appendicitis, testicular torsion and acute pyelonefritis. While acute abdominal pain in the elderly reflect often surgical conditions, it has a benign origin in the majority of young patients who can be generally managed as out patient, after a short clinical observation, with a diagnosis at discharge of non specific abdominal pain. The reason for the development of practical clinical pathways for patient with acute abdominal pain is to facilitate physician in differentiating patient who need hospital admission or a short intensive observation from those who can be safely discharged home.