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semenology the semen bartenders handbookHandbook of Oral Anticoagulation aims to provide an accessible overview of the exciting new developments in this field. Incorporating numerous quick-reference tables and figures and fully referenced throughout to key papers and the latest reviews, it will be a useful resource for all healthcare professionals involved in thromboprophylaxis. Presented in a concise format Authored by a well-known expert Provides a user-friendly overview of the most important clinical trials Professor Lip is a member of the scientific documents committee of the European Heart Rhythm Association (EHRA), and serves on the board of the Working Group on Hypertension of the Heart of the European Society of Cardiology (ESC). He is also a member of the Working Groups of Thrombosis and Cardiovascular Pharmacology of the ESC. Professor Lip has acted as Clinical Adviser for the UK National Institute for Health and Clinical Excellence (NICE) guidelines on atrial fibrillation (AF) management. He is also on the writing committee for the 2010 ESC Guidelines on Atrial Fibrillation and will be Deputy Editor for the 9th ACCP guidelines on antithrombotic therapy for AF. He has published and lectured extensively on thrombosis and antithrombotic disease in cardiovascular disease. Dr Shantsila worked in the Republican Research and Practical Centre 'Cardiology', insk, Belarus, as a researcher and a cardiologist from 1998 and completed his MD thesis in 2002. From 2005 to 2008 he was a head of the Department of Urgent Cardiology in this centre, where he was actively involved in research work on the problems of cardiovascular diagnostics, endothelial dysfunction and thrombosis. He is a member of the Working Group of Thrombosis of the European Society of Cardiology. Dr Shantsila has published extensively on these topics, and is a peer reviewer of major journals in thrombosis.http://www.asianstar-tech.net/upload/hp-2420-manual.xml

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Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians and other health care professionals in their decisions about the use of anticoagulants in the management of VTE. These guidelines assume the choice of anticoagulant has already been made. Methods: ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment. Results: The panel agreed on 25 recommendations and 2 good practice statements to optimize management of patients receiving anticoagulants. Conclusions: Strong recommendations included using patient self-management of international normalized ratio (INR) with home point-of-care INR monitoring for vitamin K antagonist therapy and against using periprocedural low-molecular-weight heparin (LMWH) bridging therapy.The panel followed best practice for guideline development recommended by the Institute of Medicine and the Guidelines International Network. 2-5 The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach 6-12 to assess certainty in evidence and formulate recommendations. For clinicians: Most individuals should follow the recommended course of action. Formal decision aids are not likely to be needed to help individual patients make decisions consistent with their values and preferences. For policy makers: The recommendation can be adopted as policy in most situations.http://chemtron-vostok.ru/media/hp-2420dn-service-manual.xml Adherence to this recommendation according to the guideline could be used as a quality criterion or performance indicator. For researchers: The recommendation is supported by credible research or other convincing judgments that make additional research unlikely to alter the recommendation. On occasion, a strong recommendation is based on low or very low certainty in the evidence. In such instances, further research may provide important information that alters the recommendations. Decision aids may be useful in helping patients to make decisions consistent with their individual risks, values, and preferences. For clinicians: Different choices will be appropriate for individual patients, and clinicians must help each patient arrive at a management decision consistent with the patient’s values and preferences. Decision aids may be useful in helping individuals to make decisions consistent with their individual risks, values, and preferences. For policy makers: Policy-making will require substantial debate and involvement of various stakeholders. Performance measures should assess whether decision-making is duly documented. For researchers: This recommendation is likely to be strengthened (for future updates or adaptation) by additional research. An evaluation of the conditions and criteria (and the related judgments, research evidence, and additional considerations) that determined the conditional (rather than strong) recommendation will help identify possible research gaps. The guideline panel offers no recommendation for 1 approach over the other. The guideline panel offers no recommendation for 1 approach over the other. Other aspects of VTE treatment (such as choice and duration of anticoagulant treatment, inpatient or outpatient management, treatment of cancer-associated VTE, indications for advanced therapies, and treatment of superficial vein thrombosis, calf vein thrombosis, and subsegmental PE) are addressed in other guidelines.http://gbb.global/blog/howa-chucks-manual Recommendations focus on commonly used anticoagulant medications, including UFH, LMWH, fondaparinux, VKA, and the DOACs apixaban, dabigatran, edoxaban, and rivaroxaban (betrixaban was not available during panel deliberations and is not currently approved for treatment of VTE; thus, it was not considered in any of the evidence). The specific objectives of the recommendations are to improve patient-important outcomes, including overall mortality, recurrent VTE, major bleeding, and quality of life. For specific recommendations, the panel considered time in the therapeutic INR range (TTR) as a surrogate for bleeding and thrombosis. For all recommendations, the panel considered resource use, cost-effectiveness, potential impact on health care equity, acceptability, and feasibility when such information was available. Policy makers interested in these guidelines include those involved in developing local, national, or international plans aimed at reducing the incidence and improving the management of VTE and evaluating direct and indirect harms and costs related to VTE and associated treatments. This document may also serve as the basis for adaptation by local, regional, or national guideline panels. Project oversight was provided initially by a coordination panel, which reported to the ASH Committee on Quality, and then by the coordination panel chair (Adam Cuker) and vice chair (Holger J. Schunemann). ASH vetted and appointed individuals to the guideline panel. The McMaster GRADE Centre vetted and retained researchers to conduct systematic reviews of evidence and coordinate the guideline development process, including the use of the GRADE approach. The membership of the panel and the GRADE center team is described in supplement 1. The panel chair was a practicing anticoagulation pharmacist and content expert. The vice chair was a practicing internist and methodologist with experience in guideline development processes. The panel’s work was done using web-based tools ( www.surveymonkey.com and www.gradepro.org ) and face-to-face and online meetings. Most members of the guideline panel were members of ASH. ASH staff supported panel appointments and coordinated meetings but had no role in choosing the guideline questions or determining the recommendations. Through the McMaster GRADE Centre, some researchers who contributed to the systematic evidence reviews received salary or grant support. Other researchers participated to fulfill requirements of an academic degree or program. Some panelists disclosed new interests or relationships during the development process, but the balance of the majority was maintained. Members of the VTE Guideline Coordination Panel reviewed the disclosures and judged which interests were conflicts and should be managed. Supplement 2 provides the complete “Disclosure of Interests” forms of all panel members. In part A of the forms, individuals disclosed material interests for 2 years prior to appointment. In part B, they disclosed interests that were not mainly financial. Part C summarizes ASH decisions about which interests were judged to be conflicts. Part D describes new interests disclosed by individuals after appointment. During all deliberations, panel members with a current, direct financial interest in a commercial entity with any product that could be affected by the guidelines were recused from making judgments about relevant recommendations. 5,18-20 The Evidence-to-Decision (EtD) framework for each recommendation describes which individuals were recused from making judgments about each recommendation. On a recommendation-by-recommendation basis, none of the researchers who contributed to the systematic evidence reviews informing a recommendation had any current, material interest in a commercial entity with any product that could be affected by the recommendation. Supplement 3 provides the complete disclosure of interest forms of researchers who contributed to these guidelines. Rating outcomes by their relative importance helps focus attention on those outcomes that are most important and helps resolve or clarify potential disagreements. The panel rated the following outcomes as critical for decision-making across questions: mortality, PE, DVT in the upper leg, DVT in the upper arm, and major bleeding. For specific questions, other outcomes were included to inform decision-making, including TTR as a surrogate for bleeding and thrombosis, impairment of quality of life, critical INR as a surrogate for bleeding and thrombosis, increased duration of hospitalization, medication adherence as a surrogate for bleeding and thrombosis, and delay of intervention. Some studies reported outcomes differently from what the panel determined to be critical or important for decision-making. Typically, outcomes are reported as “any VTE,” “any PE,” “any DVT,” “any proximal DVT,” or “any distal DVT,” sometimes preceded by “asymptomatic” or “symptomatic.” Reporting of outcomes was inconsistent across studies. Some studies assessed thromboembolic and bleeding outcomes for indications other than VTE; in these cases, those results were extrapolated to PE and DVT outcomes and used to estimate the relative effects on prioritized outcomes. In such instances, the panel rated down certainty for indirectness. The EtD table addressed desirable and undesirable effects of interventions, certainty in the evidence, values and preferences (relative importance of outcomes), resource use, health equity, acceptability, and feasibility. The guideline panel reviewed draft EtD tables before, during, or after the guideline panel meeting and made suggestions for improvement. To ensure that recent studies were not missed, searches (presented in supplement 4) were updated during February and March 2017, and panel members remained alert for new eligible studies and could bring these to the panel for potential inclusion. When existing reviews were used, judgments of the original authors regarding risk of bias were accepted and checked for accuracy or conducted de novo. For new reviews, risk of bias was assessed at the outcome level using the Cochrane Collaboration’s risk-of-bias tools for randomized trials or nonrandomized studies. In addition to conducting systematic reviews of intervention effects, the researchers searched for evidence related to baseline risks, values and preferences, and costs and summarized findings within the EtD frameworks. 6,7,12 Subsequently, the certainty in the body of evidence (also known as quality of the evidence or confidence in the estimated effects) was assessed for each of the effects estimate of the outcomes of interest, test accuracy, and the importance of outcomes following the GRADE approach based on the following domains: risk of bias, precision, consistency and magnitude of the estimates of effects, directness of the evidence, risk of publication bias, presence of a dose-effect relationship, and an assessment of the effect of residual, opposing confounding. The certainty was categorized into 4 levels from very low to high. 8-10 For each recommendation, the panel took a population perspective and agreed on the following: the certainty in the evidence, the balance of benefits and harms of the compared management options, and inferences regarding the values and preferences associated with the decision. The guideline panel explicitly considered the extent of resource use associated with alternative management options. The guideline panel agreed on the recommendations (including direction and strength), remarks, and qualifications on the basis of consensus or, in rare instances, by voting, based on the balance of all desirable and undesirable consequences. All panel members reviewed and approved the final recommendations. The words “the guideline panel recommends ” are used for strong recommendations and “the guideline panel suggests ” for conditional recommendations. Table 2 provides the suggested interpretation of strong and conditional recommendations by patients, clinicians, and health care policy makers. The majority of individuals in this situation would want the suggested course of action, but many would not. Decision aids may be useful in helping patients to make decisions consistent with their individual risks, values, and preferences. Clinicians Most individuals should follow the recommended course of action. Different choices will be appropriate for individual patients; clinicians must help each patient arrive at a management decision consistent with the patient’s values and preferences. Policy makers The recommendation can be adopted as policy in most situations. Policy-making will require substantial debate and involvement of various stakeholders. Performance measures should assess whether decision-making is appropriate. Researchers The recommendation is supported by credible research or other convincing judgments that make additional research unlikely to alter the recommendation. In such instances, further research may provide important information that alters the recommendations. The recommendation is likely to be strengthened (for future updates or adaptation) by additional research. An evaluation of the conditions and criteria (and the related judgments, research evidence, and additional considerations) that determined the conditional (rather than strong) recommendation will help identify possible research gaps. Implications for The majority of individuals in this situation would want the suggested course of action, but many would not. View Large Ten individuals or organizations submitted comments. The document was revised to address pertinent comments. On 30 June 2018, the ASH Guideline Oversight Subcommittee and the ASH Committee on Quality approved that the defined guideline development process was followed, and on 3 August 2018, the officers of the ASH Executive Committee approved submission of the guidelines for publication under the imprimatur of ASH. The guidelines were then subjected to peer review by Blood Advances. Other purposes are to inform policy, education, and advocacy and to state future research needs. They may also be used by patients. These guidelines are not intended to serve or be construed as a standard of care. Clinicians must make decisions on the basis of the clinical presentation of each individual patient, ideally through a shared process that considers the patient’s values and preferences with respect to the anticipated outcomes of the chosen option. Decisions may be constrained by the realities of a specific clinical setting and local resources, including but not limited to institutional policies, time limitations, and availability of treatments. These guidelines may not include all appropriate methods of care for the clinical scenarios described. As science advances and new evidence becomes available, recommendations may become outdated. Following these guidelines cannot guarantee successful outcomes. ASH does not warrant or guarantee any products described in these guidelines. They should never be omitted when recommendations from these guidelines are quoted or translated. Implementation of the guidelines will be facilitated by the related interactive forthcoming decision aids. The use of these guidelines is also facilitated by the links to the EtD frameworks and interactive summary-of-findings tables in each section. Two studies included mortality as an outcome, 23,24 5 studies reported development of VTE, 23-27 and 5 studies reported major bleeding outcomes. 23-27 The EtD framework is shown online at. There was no effect of the intervention on mortality, as no deaths were reported in the included studies. There is very low certainty in the available evidence. Furthermore, CYP3A4 enzymes are involved in the metabolism of oral direct Xa inhibitors, but not dabigatran, and strong inhibitors of CYP3A4 enzymes potentially decrease the metabolism and increase direct Xa inhibitor effect, whereas inducers of CYP3A4 enzymes potentially increase the metabolism and decrease direct Xa inhibitor effect. It is uncertain whether patients who require coadministration of potentially interacting drugs (see Table 3 ) and DOACs would have better outcomes if instead of a DOAC they received another anticoagulant. We found no systematic reviews that addressed this question. There were no randomized trials that addressed the outcomes prioritized for this question. Available evidence was very limited and consisted of pharmacokinetic studies with small sample sizes, subgroup analysis of clinical trials, 28 information from product labeling, and drug-interaction reference texts. The EtD framework is shown online at. In general, these parameters are increased by P-gp or CYP3A4 inhibitors and decreased by inducers. No studies have reported different rates of bleeding, thromboembolism, or mortality between DOACs and a comparator (eg, VKA). Reference texts on tertiary drug interaction generally suggested observing patients for symptoms of bleeding or thromboembolism and to consider adjusting DOAC doses. Depending on the specific DOAC, product labeling in some cases suggested modification of DOAC dosing (eg, apixaban) or recommended avoiding the use of DOACs when interacting drugs were coprescribed (eg, rivaroxaban). View Large Theoretically, the concurrent use of P-gp or CYP3A4 inducers could decrease DOAC benefits, but the panel was unable to estimate the magnitude of decrease, if any. The panel was unable to identify any evidence regarding other considerations. Given the lack of evidence, we suggest that clinicians consider using an alternative anticoagulant (such as VKA or LMWH) rather than DOACs for patients requiring administration of P-gp inhibitors or inducers or strong inhibitors or inducers of CYP enzymes (conditional recommendation based on very low certainty in the evidence about effects). The recommendation places a high value on avoiding the uncertainty in DOAC anticoagulant response associated with coadministration of the interacting drug and a low value on avoiding the burden of warfarin or LMWH therapy.For this specific question, we were interested only in PST and performed meta-analysis on this subset of studies. We included 11 studies measuring outcomes relevant to this question for patients performing PST. 30-40 Studies included patients requiring VKA therapy for various indications, mainly for indications other than VTE treatment. The effect of PST on recurrent PE and DVT was estimated by applying the RR estimate for thromboembolic events to baseline recurrence rates of PE and DVT.The likelihood of PST being cost-effective varied, with 1 review, 1 RCT, and 1 modeling study indicating that PST is likely to be cost-effective compared with usual care, 43-45 whereas 2 other reviews concluded that PST is unlikely to be cost-effective within accepted standards 46,47 and that PST implementation would probably result in reduced health equity for patients in lower socioeconomic classes and those with cognitive problems and poor manual dexterity. Because some patients are unwilling to perform PST, the panel determined that the acceptability of PST to major stakeholders varies, but the intervention is probably feasible to implement, though a substantial investment in patient training and testing equipment is necessary. This benefit is conditional upon patients and health care systems being able to afford and manage the self-testing equipment. In settings in which resources are limited or when patients are not willing or able to perform PST, deviation from this suggestion is appropriate. Furthermore, systems using PST should be able to perform regular external quality assessment of the testing equipment and patient’s ability to obtain accurate INR results. The panel calls upon payers, including the Centers for Medicare and Medicaid Services, to carefully evaluate current reimbursement regulations and make changes as necessary to ensure that unnecessary testing is not incentivized, that providers and patients are aware of this testing option, and that funding is available for those who would like to use PST. Two studies evaluated the effect of PSM on quality of life. 52,59 The EtD framework is shown online at. General treatment satisfaction and daily hassles scores improved with PSM and remained unchanged in the control group. 59 Self-efficacy and distress scores improved in both groups but improved significantly more with PSM. PSM had no significant effect on the strained social network scores. 59 After 4 months, treatment satisfaction significantly improved and daily hassles, psychological distress, and a strained social network all significantly decreased with PSM compared with the control group. 52 The likelihood of PSM being cost-effective varied, with 1 modeling study indicating that PSM is likely to be cost-effective compared with usual care, 74 whereas 1 RCT concluded that PSM is unlikely to be cost-effective. 75 Most panel members also believed that PSM implementation would result in reduced health equity for patients in lower socioeconomic classes and those with cognitive problems and poor manual dexterity. The acceptability of PSM to major stakeholders varies but is probably feasible to implement. However, a substantial investment in patient training (even more so than with PST) and testing equipment is necessary. This benefit is conditional upon patients and health care systems being able to afford and manage the self-testing equipment and patients being able to make independent decisions about VKA dosing based on INR results. The panel determined that PSM was superior to PST, as it has shown reduction in mortality. Although the panel agreed that a strong recommendation in favor of PSM was warranted based on the available evidence, in settings where resources are limited or when patients are not willing or able to perform PSM, system decision-makers or individual patients may choose against PSM. Furthermore, systems using PSM should be able to perform regular external quality assessment of the testing equipment and patients’ ability to obtain accurate INR results and make rational VKA dosing decisions using instructions from their health care providers. The panel calls upon payers, including the Centers for Medicare and Medicaid Services, to carefully evaluate current reimbursement regulations and make changes as necessary to ensure that unnecessary testing is not incentivized, that providers and patients are aware of this testing option, and that funding is available for those who wish to use PSM. Three observational studies have evaluated the impact of INR recall interval on surrogate outcomes such as site-level TTR performance and TTR below 75. 76-78 No studies reported the risks of mortality, recurrent VTE, or bleeding. The EtD framework is shown online at. The panel was unable to estimate the magnitude of benefit for clinically important outcomes such as mortality, recurrent VTE, and bleeding. The study population was different from patients receiving INR monitoring and VKA dose adjustments from their anticoagulation providers. Another study evaluated the association between center next-visit INR interval ratio (the mean number of days after a visit with an INR outside the therapeutic range, divided by the number of days after a visit with an INR within the therapeutic range) and site-level TTR. 78 The results suggested that site-level TTR increased with shorter INR recall intervals. Most patients are adverse to frequent INR monitoring yet will return for INRs as directed by their anticoagulation provider. How much the INR is out of range should guide the choice for the INR recall interval, as well as the etiology of the out-of-range INR. For example, a recall interval between 2 and 4 weeks might be reasonable following a VKA dose adjustment for an INR of 3.3 in a patient with generally stable INR control, whereas a recall interval not exceeding a few days might be needed after temporary interruption of VKA following an INR of 8.2 in a patient who recently started taking antibiotics. All studies included patients receiving VKA anticoagulation therapy but were not limited to patients being treated for VTE. No studies reported the impact of INR recall interval on quality of life. The EtD framework is shown online at. The 12-week INR recall interval was associated with a reduced risk for PE and DVT, but the estimates were based on only 1 event, and the CIs therefore include both important benefit and harm. The thromboembolic event rate from the other study was not used as it only included patients receiving anticoagulants for mechanical heart valves.The panel determined that longer INR recall intervals would increase health equity, would be acceptable to key stakeholders, and are feasible. The panel did not specify a definition of stable INR control and agreed that this should be defined according to local standards. The panel also determined that this recommendation should not be used for patients engaging in PST or PSM, as these patients were not included in the RCTs for longer INR recall intervals and are usually monitored more frequently than the 4-week INR recall interval comparator used for this recommendation.Given the low risk of adverse events in stable patients, a very large patient sample will likely be required to answer this question. (2) What is the cost-effectiveness of 6- to 12-week INR recall intervals compared with a 4-week recall interval from the societal perspective? Most included studies were single-arm cohort studies in which patients receiving LMWH with renal dysfunction had anti-Xa concentrations monitored. Included studies grouped patients with varying indications for LMWH, most commonly patients with acute VTE, atrial fibrillation, and acute coronary syndrome. The panel agreed that studies with grouped indications would be used for the outcome of major bleeding and the evidence rated down for indirectness. Studies with grouped indications were also combined for the outcome of percentage of anti-Xa concentrations in the therapeutic range. Studies with grouped indications were not used for the outcome of PE, DVT, or mortality. Combined studies administered different LMWHs (enoxaparin and tinzaparin) and used different dosing regimens (once daily and twice daily). The EtD framework is shown in online at. Studies with grouped indications were not used for PE or DVT. No studies reported the outcome of mortality. When multiple studies reported the prioritized outcomes, the number of events was added across all studies and reported over the total sample. The EtD framework is shown online at.