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Human activities often drive landscape degradation and the associated loss of value. This paper describes a method that, by integrating multiple factors, characterize landscape value to establish relevant and effective management practices. The new integrated method for landscape assessment (IMLA) is a four-step model that includes: (i) establishment of a general theoretical basis for sustainability relevant metrics, (ii) characterization of the landscape, (iii) landscape valuation, (iv) recommendations for landscape value management. Each step includes different interactive components of analysis. The new IMLA considers the potential range of values associated with each landscape unit and facilitates sustainable landscape management. The method is systematic and includes both inductive and deductive reasoning. Its articulation is represented in the conjunction and overlapping of all factors and variables considered. IMLA was tested in Santiago de Cuba Bay (Cuba) and used to determine five landscape scopes, eight first-order landscape units and 29 s-order units. It proved to be a useful tool to establish landscape values and sound management strategies. Application of IMLA in Cuba will help local authorities institute land-use plans and to establish decision-making processes that include valuation of cultural landscapes.

Background Direct oral anticoagulants (DOACs) are replacing warfarin for stroke prevention in patients with atrial fibrillation (AF). Objective To assess the effectiveness and safety of concomitant treatment with antiplatelet-DOAC compared to antiplatelet-warfarin in patients with acute coronary syndrome (ACS) and AF. Design Retrospective propensity score-matched cohort study using United States-based commercial healthcare database from January 2016 to June 2019. Participants New-users of antiplatelet-DOAC and antiplatelet-warfarin who initiated the combined therapy within 30 days following incident ACS diagnosis. Measurements Primary study outcomes were recurrent cardiovascular diseases (CVD) (ie, a composite of stroke and myocardial infarction) and major bleeding events identified via discharge diagnoses. We controlled for potential confounders via propensity score matching (PSM). We generated marginal hazard ratios (HRs) via Cox proportional hazards regression using a robust variance estimator while adjusting for calendar time. Results After PSM, a total of 2,472 persons were included (1,236 users of antiplatelet-DOAC and 1,236 users of antiplatelet-warfarin). The use of antiplatelet-DOAC (vs. antiplatelet-warfarin) was associated with a reduced rate of recurrent CVD (adjusted HR 0.72, 95% confidence interval [CI], 0.56-0.92) and major bleeding events (adjusted HR, 0.49, 95% CI 0.33-0.72). Limitations Residual confounding. Conclusions In real-world data of AF patients with concurrent ACS, the use of antiplatelet-DOAC following ACS diagnosis was associated with a lower rate of recurrent CVD and major bleeding events compared with antiplatelet-warfarin. These findings highlight a potential promising role for DOACs in patients with ACS and AF requiring combined antiplatelet therapy.

Este artículo contiene 10 páginas, 3 figuras, 2 tablas., Defining impact significance is the main technical task that influences decision-making during the Environmental Licensing Procedure (ELP). The ELP begins with screening to determine potentially significant impacts of the proposed project. Scoping then follows to address any interventions deemed worthy of attention in the production of an Environmental Impact Assessment (EIA). This will include consideration of relevant landforms and geomorphological processes. However, preliminary assessments of environmental impacts often lack the scientific robustness to procure substantive and transactive effectiveness. This review presents an examination of the established practices of screening and scoping while highlighting the foremost challenges to improve the technical grounds of the ELP. The analysis of screening and scoping practices stresses the need for novel methods that ensure the sequential reasoning between their criteria while improving the preliminary evaluation of impact significance. Reducing the inherent subjectivity of discretionary judgment requires scientific methodologies that acknowledge the interaction between the natural system and human interventions, which has been addressed by geomorphological research. The knowledge consolidated in this review opens the gate to explore the compatibility between the United Nations strategy of Ecosystem Approach (EA) with the ELP through a novel geomorphological interpretation of the EIA. Therefore, this diagnosis demonstrate that screening and scoping practices would benefit from reliable methods that balance the precautionary principle with the efficient character required in the ELP., This contribution is a product of the post-doctoral research No 80740-103-2020, financed by the National Financing Fund ‘‘FRANCISCO JOSÉ DE CALDAS” and the Ministry of Science, Technology and Innovation of Colombia. The authors would like to thank PROPLAYAS Network, of which they are members, and to the Project INDEX No. INV.1106-01-002-15 ‘‘Cultural practices and environmental certification of beaches: a contribution for the sustainable development in the insular states” of Universidad de la Costa of Barranquilla, Colombia.

Objective: Stakeholders involved in developing recommendations need to have a common understanding of health outcomes and the perspective of affected individuals. In this paper we report on the development and application of health outcome descriptors (HODs) to inform decision-making by panels developing guideline recommendations. Study Design and Setting: Ten American Society of Hematology guideline panels addressing the management of venous thromboembolism developed HODs, rated their importance and health utility, applied them to prioritize outcomes, and to balance potential benefits and harms to formulate recommendations. Results: It was feasible to involve 18 panelists in developing 127 HODs. There was high agreement (82%) across the ten panels about outcomes perceived as critical or important for decision-making. Panelists' utility ratings of the outcomes were strongly correlated with panelists' outcome importance ratings (Pearson's r =-0.88). HODs were incorporated into Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence-to-decision (EtD) frameworks to support a shared understanding of health outcomes in panel deliberations. Conclusion: HODs serve as a valuable tool to promote an explicit, common understanding of health outcomes during clinical guideline development and across different stakeholders. They are helpful across multiple steps of guideline development to facilitate panels' judgements, aiming to avoid variable implicit interpretations of health outcomes. (C) 2021 Elsevier Inc. All rights reserved.

Immune-mediated thrombotic thrombocytopenic purpura (iTTP) is a potentially fatal thrombotic microangiopathy caused by autoantibody-mediated severe deficiency of ADAMTS13. Standardized definitions of response, exacerbation, remission and relapse were initially proposed in 2003 and modified by the International Working Group (IWG) for TTP in 2017. These definitions, which have been widely used in clinical practice and research, are based primarily on the platelet count and are benchmarked against the timing of discontinuation of therapeutic plasma exchange (TPE). They do not incorporate ADAMTS13 activity or the temporizing effects of caplacizumab, a novel anti-von Willebrand factor (VWF) nanobody, on the platelet count. In light of these limitations, the IWG aimed to develop revised consensus outcome definitions that incorporate ADAMTS13 activity and the effects of anti-VWF therapy using an estimate-talk-estimate approach. The updated definitions distinguish clinical remission and clinical relapse (defined primarily by platelet count) from ADAMTS13 remission and ADAMTS13 relapse (defined by ADAMTS13 activity). The revised definitions of exacerbation and remission are benchmarked against not only the timing of discontinuation of TPE, but also of anti-VWF therapy. Retrospective validation of the revised definitions is described, though they remain to be prospectively validated. Clinical implications of the updated outcome definitions are also discussed and an example of their application to clinical practice is provided in order to highlight their clinical relevance.

Key Points The proposed guideline manuscript template is the first detailed template for transparent and complete reporting of guidelines.Consistent application of the template may simplify preparing an evidence-based guideline manuscript and facilitate its use., Visual Abstract, Trustworthy health guidelines should provide recommendations, document the development process, and highlight implementation information. Our objective was to develop a guideline manuscript template to help authors write a complete and useful report. The McMaster Grading of Recommendations Assessment, Development and Evaluation Centre collaborated with the American Society of Hematology (ASH) to develop guidelines for the management of venous thromboembolism. A template for reporting the guidelines was developed based on prior approaches and refined using input from other key stakeholders. The proposed guideline manuscript template includes: (1) title for guideline identification, (2) abstract, including a summary of key recommendations, (3) overview of all recommendations (executive summary), and (4) the main text, providing sufficient detail about the entire process, including objectives, background, and methodological decisions from panel selection and conflict-of-interest management to criteria for updating, as well as supporting information, such as links to online (interactive) tables. The template further allows for tailoring to the specific topic, using examples. Initial experience with the ASH guideline manuscript template was positive, and challenges included drafting descriptions of recommendations involving multiple management pathways, tailoring the template for a specific guideline, and choosing key recommendations to highlight. Feedback from a larger group of guideline authors and users will be needed to evaluate its usefulness and refine. The proposed guideline manuscript template is the first detailed template for transparent and complete reporting of guidelines. Consistent application of the template may simplify the preparation of an evidence-based guideline manuscript and facilitate its use.

The new blue economy (NBE) will require a workforce educated in new ways. The old blue economy (OBE) is built of a legacy of labor relationships shaped by centuries of profit-motivated exploitation of workers and aquatic resources. This toll of exploitation falls hardest on people of color. Education of the workforce of the NBE must reject the tradition of exploitation for a new vision of shared ownership that places high value on human diversity and sustainable use of marine resources. This means educating all participants in the workforce, from laborers to managers, about alternative business models and the value of diversity and equity.

Objective Many factors are postulated to affect guidelines developments. We set out to identify the key determinants. Study design and setting a) Web-based survey of 12 panels of 153 “voting” members who issued 2941 recommendations; b) qualitative analysis of 13 panels of 311 attendees (panel members, systematic review teams and observers). Results Compared with “no recommendations”, when intervention's benefit outweigh harms (BH-balance), probability of issuing strong recommendations in favor of intervention was 0.22 (95%CI: 0.08 to 0.36) when certainty of evidence (CoE) was very low; 0.5 (95%CI:0.36 to 0.63) when low; 0.74 (95%CI 0.61 to 0.87) when moderate and 0.85 (95%CI:0.71 to 1.00) when high. No other postulated factor significantly affected recommendations. The findings are consistent with a J- curve model when recommendations are issued in favor but not against an intervention. Panelists often changed their judgments as a result of the meeting discussion (67% for CoE to 92% for balance between benefits and harms). The panels spent over 50% of their time debating CoE; the chairs and co-chairs dominated discussion. Conclusions CoE and BH-balance are key determinants of recommendations in favor of an intervention. Chairs and co-chairs dominate discussion. Panelists often change their judgments as a result of panel deliberation.

Background: Coronavirus disease 2019 (COVID-19)–related critical illness and acute illness are associated with a risk of venous thromboembolism (VTE). Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in decisions about the use of anticoagulation for thromboprophylaxis for patients with COVID-19–related critical illness and acute illness who do not have confirmed or suspected VTE. Methods: ASH formed a multidisciplinary guideline panel and applied strict management strategies to minimize potential bias from conflicts of interest. The panel included 3 patient representatives. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic evidence reviews (up to 19 August 2020). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, including GRADE Evidence-to-Decision frameworks, to assess evidence and make recommendations, which were subject to public comment. Results: The panel agreed on 2 recommendations. The panel issued conditional recommendations in favor of prophylactic-intensity anticoagulation over intermediate-intensity or therapeutic-intensity anticoagulation for patients with COVID-19–related critical illness or acute illness who do not have confirmed or suspected VTE. Conclusions: These recommendations were based on very low certainty in the evidence, underscoring the need for high-quality, randomized controlled trials comparing different intensities of anticoagulation. They will be updated using a living recommendation approach as new evidence becomes available., Visual Abstract

Coronavirus disease 2019 (COVID-19) is a viral infection that can, in severe cases, result in cytokine storm, systemic inflammatory response and coagulopathy that is prognostic of poor outcomes. While some, but not all, laboratory findings appear similar to sepsis-associated disseminated intravascular coagulopathy (DIC), COVID-19- induced coagulopathy (CIC) appears to be more prothrombotic than hemorrhagic. It has been postulated that CIC may be an uncontrolled immunothrombotic response to COVID-19, and there is growing evidence of venous and arterial thromboembolic events in these critically ill patients. Clinicians around the globe are challenged with rapidly identifying reasonable diagnostic, monitoring and anticoagulant strategies to safely and effectively manage these patients. Thoughtful use of proven, evidence-based approaches must be carefully balanced with integration of rapidly emerging evidence and growing experience. The goal of this document is to provide guidance from the Anticoagulation Forum, a North American organization of anticoagulation providers, regarding use of anticoagulant therapies in patients with COVID-19. We discuss in-hospital and post-discharge venous thromboembolism (VTE) prevention, treatment of suspected but unconfirmed VTE, laboratory monitoring of COVID-19, associated anticoagulant therapies, and essential elements for optimized transitions of care specific to patients with COVID-19.

The indicated dose of 4-factor prothrombin complex concentrate (4F-PCC) for urgent vitamin K antagonist (VKA) reversal in patients with an international normalized ratio (INR) of 2 to 4 is 25 IU/kg, but there is no indicated dose for INR

Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy characterized by severe congenital or immune‐mediated deficiency in ADAMTS13, the enzyme that cleaves von Willebrand factor multimers. This rare condition leads invariably and rapidly to a fatal outcome in the absence of treatment, and therefore raises multiple diagnostic and therapeutic challenges. The novel concepts and mechanisms identified in the laboratory for this disease have been rapidly and successfully translated into the clinic for the benefit of patients, making TTP an archetypal disease that has benefited from targeted therapies. After decades of empirical treatment with plasma exchange, identification of ADAMTS13 as the key enzyme involved in TTP pathophysiology provided an explanation for the remarkable efficacy of plasma administration, in which the missing enzyme is replenished, and paved the way for development of a recombinant form of the enzyme. Similarly, the demonstration of a major role of anti‐ADAMTS13 antibodies through models of passive transfer of autoimmunity spurred development of immunomodulatory strategies based on B‐cell depletion. More recently, an inhibitor of the platelet‐von Willebrand factor interaction demonstrated efficacy in large clinical trials through prevention of formation of further microthrombi and protection of organs from ischemia. These translational breakthroughs in TTP are described in our review.

BACKGROUND The PLASMIC score was developed to identify patients with thrombotic microangiopathy who are most likely to have immune thrombotic thrombocytopenic purpura (TTP) and benefit from therapeutic plasma exchange (TPE). PLASMIC scores of 0-4, 5, and 6-7 are said to correspond to low, intermediate, and high probability of TTP, respectively. STUDY DESIGN AND METHODS We conducted a systematic review and meta-analysis on the diagnostic accuracy of the PLASMIC score in adults with suspected TTP. We evaluated the sensitivity, specificity, positive predictive value, and negative predictive value (NPV) of PLASMIC score thresholds of ≥5 and ≥6. Study quality was appraised using the QUADAS-2 tool. RESULTS We identified 13 eligible studies, which collectively enrolled 970 patients. The median prevalence of TTP among eligible studies was 35%. The sensitivity and specificity of a PLASMIC score ≥5 was 0.99 (95% confidence interval [CI], 0.91-1.00) and 0.57 (95% CI, 0.41-0.72), respectively. At a prevalence of 35%, the NPV of a PLASMIC score ≥5 was 0.99 (95% CI, 0.92-1.00). A PLASMIC score ≥6 was associated with a sensitivity and specificity of 0.85 (95% CI, 0.67-0.94) and 0.89 (95% CI, 0.81-0.94), respectively. The NPV of a PLASMIC score ≥6 at a prevalence of 35% was 0.92 (95% CI, 0.82-0.97). CONCLUSION A PLASMIC score threshold of ≥5 is associated with high sensitivity and NPV and may be a useful screening tool for identifying patients who are unlikely to have TTP and do not require TPE, though prospective assessment is required. A PLASMIC score

Although arterial and venous thromboembolic disorders are among the most frequent causes of mortality and morbidity, there has been little description of how the composition of thrombi and emboli depends on their vascular origin and age. We quantified the structure and composition of arterial and venous thrombi and pulmonary emboli using high-resolution scanning electron microscopy. Arterial thrombi contained a surprisingly large amount of fibrin, in addition to platelets. The composition of pulmonary emboli mirrored the most distal part of venous thrombi from which they originated, which differed from the structure of the body and head of the same thrombi. All thrombi and emboli contained few biconcave red blood cells but many polyhedrocytes or related forms of compressed red blood cells, demonstrating that these structures are a signature of clot contraction in vivo. Polyhedrocytes and intermediate forms comprised the major constituents of venous thrombi and pulmonary emboli. The structures within all of the thrombi and emboli were very tightly packed, in contrast to clots formed in vitro. There are distinctive, reproducible differences among arterial and venous thrombi and emboli related to their origin, destination and duration, which may have clinical implications for the understanding and treatment of thrombotic disorders.

Background:Methods for the development of clinical guidelines have advanced dramatically over the past 2 decades to strive for trustworthiness, transparency, user-friendliness, and rigor. The American Society of Hematology (ASH) guidelines on venous thromboembolism (VTE) have followed these advances, together with application of methodological innovations.Objective:In this article, we describe methods and methodological innovations as a model to inform future guideline enterprises by ASH and others to achieve guideline standards. Methodological innovations introduced in the development of the guidelines aim to address current challenges in guideline development.Methods:We followed ASH policy for guideline development, which is based on the Guideline International Network (GIN)-McMaster Guideline Development Checklist and current best practices. Central coordination, specialist working groups, and expert panels were established for the development of 10 VTE guidelines. Methodological guidance resources were developed to guide the process across guidelines panels. A methods advisory group guided the development and implementation of methodological innovations to address emerging challenges and needs.Results:The complete set of VTE guidelines will include >250 recommendations. Methodological innovations include the use of health-outcome descriptors, online voting with guideline development software, modeling of pathways for diagnostic questions, application of expert evidence, and a template manuscript for publication of ASH guidelines. These methods advance guideline development standards and have already informed other ASH guideline projects.Conclusions:The development of the ASH VTE guidelines followed rigorous methods and introduced methodological innovations during guideline development, striving for the highest possible level of trustworthiness, transparency, user-friendliness, and rigor.

Venous thromboembolism (VTE) is a common disorder associated with substantial morbidity and mortality. It may be encountered by clinicians in virtually all medical specialties and healthcare settings. A large number of clinical practice guidelines (CPGs) on VTE have been published in recent years to support clinicians in delivering high-quality care for the prevention, diagnosis, and management of VTE. Essential elements of CPGs include a guideline panel composed of content experts from multiple disciplines, methodologists, and representatives from key affected groups; a systematic review of evidence; consideration of patient subgroups and patient values and preferences; management of conflicts of interest; an explanation of the relationship between alternative care options and health outcomes; and rating of the quality of evidence and strength of recommendations. These elements enhance the transparency and trustworthiness of CPGs and set them apart from other types of clinical guidance documents. The objectives of this narrative review are to summarize methods used to develop CPGs and to provide guidance to end-users on how to interpret recommendations and apply them in clinical practice. While much of the content of this review applies to CPGs in general, irrespective of disease focus, a number of examples specific to VTE are included.

In 2009, a network of scholars identified the legal framework associated with coastal management in eleven Latin American countries. They found an important lag in several countries, including Colombia. According to many scholars, a clear regulatory framework is of the utmost importance for integrated coastal management; however, the hurdles to reaching this goal have been poorly analyzed. This article aims to illustrate the challenges and barriers to legislate on coastal and marine issues in Colombia. The methodology and analysis used in this study can serve as an example to other Latin American countries. We combined comparative, documentary, and analytical research techniques to describe the current Latin American state-of-the-art legal framework. Additionally, from 16,224 gazettes (official records of the Congress of Colombia) we identified 80 bills concerning coastal and marine activities for a period of 17 years. However, only 2.1% of those bills addressed marine or coastal issues from the perspective of planning and management procedures. Instead the majority focused on social uses and economic activities. This research identified the difficulties that could be faced by a country in regulating its coast from an integrated perspective. These findings could support future procedures to approve coastal laws in Latin America and other countries on the world.