The panel assumed that avoidance of death, PE, DVT, and major bleeding was critical to patients. The certainty in these estimated effects was moderate owing to imprecision of the estimates when the small possible benefits are balanced against the harms. The guideline panel determined that there is low certainty in the evidence for net health harm from using extended compared with in-hospital prophylaxis. Critically ill patients were defined as suffering from an immediately life-threatening condition admitted to an intensive or critical care unit. In acutely or critically ill medical patients who do not receive pharmacological VTE prophylaxis, the ASH guideline panel suggests using mechanical VTE prophylaxis over no VTE prophylaxis (conditional recommendation, moderate certainty in the evidence of effects ⊕⊕⊕◯). 0000030576 00000 n The guideline panel determined that there was a paucity of evidence, as well as very low certainty in the evidence. In critically ill medical patients, the ASH guideline panel recommends using UFH or LMWH over no UFH or LMWH (strong recommendation, moderate certainty in the evidence of effects ⊕⊕⊕◯) and suggests using LMWH over UFH (conditional recommendation, moderate certainty in the evidence of effects ⊕⊕⊕◯). Overall, the panel judged that, for all interventions, the undesirable consequences were greater than the desirable consequences and made recommendations against their use, with the exception of patients with VTE risk factors. The recommendations are labeled as “strong” or “conditional” according to the GRADE approach. The 2017 Asian Venous Thrombosis Forum updated guidelines for medically ill patients concluded that, if prophylaxis was used, pharmacological prophylaxis was preferred in the absence of bleeding risk; otherwise, intermittent pneumatic compression, but not graduated compression stockings, were recommended.171. 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. For PE, the ARR was 11 fewer per 1 000 000 (95% CI, 9-12 fewer per 1 000 000), for proximal DVT, the ARR was 540 fewer per 1 000 000 (95% CI, 450-576 fewer per 1 000 000), and for distal DVT, the ARR was 2112 fewer per 1 000 000 (95% CI, 1760-2253 fewer per 1 000 000). In addition to synthesizing evidence systematically, the McMaster GRADE Centre supported the guideline-development process, including determining methods, preparing agendas and meeting materials, and facilitating panel discussions. They may also be used by patients. Like the ACCP and unlike the IUA, the ASH panel recommended against extending prophylaxis after discharge with a DOAC or other agent (with only enoxaparin being evaluated by the ACCP and the IUA). Patient populations and interventions for the prevention of VTE and the corresponding recommendations. The panel assumed that avoidance of death, PE, DVT, and major bleeding was critical to patients and judged that the benefits clearly favored prophylaxis. Extended duration of pharmacological prophylaxis (LMWH or DOAC) appeared to have no effect on mortality (RR, 1.00; 95% CI, 0.89-1.12; ARR, 0 per 1000; 95% CI, 5 fewer to 5 more per 1000). Proper use of graduated compression stockings might require support in the elderly and people with disabilities, but stockings on a population level were considered probably feasible. We identified 1 systematic review that addressed this question in critically ill medical patients.114  Three RCTs in this review fulfilled our inclusion criteria and measured outcomes relevant to this context (eg, mortality, PE, DVT, major bleeding, and thrombocytopenia).115-117  Our update of this systematic review did not identify any additional studies that fulfilled the inclusion criteria. The guideline panel determined that, although the health effects may suggest net benefit for the use of graduated compression stockings, cost would be moderate, and use of stockings would not be cost-effective. Five of 6 panelists without conflicts voted in favor of a strong recommendation over a conditional recommendation. On occasion, a strong recommendation is based on low or very low certainty in the evidence. Overall, the certainty in these estimated effects was very low owing to very serious imprecision and serious indirectness of the estimates (see evidence profile and online EtD framework). Two RCTs reported an increase in gastrointestinal bleeding (RR, 2.61; 95% CI, 0.36-18.86; ARR, 50 more per 1000; 95% CI, from 20 fewer to 558 more per 1000), and 3 reported little impact on thrombocytopenia (RR, 0.95; 95% CI, 0.47-1.92; ARR, 0 per 1000; 95% CI, from 1 fewer to 2 more per 1000), with 1 of the studies specifically reporting no HIT in either group. ASH vetted and appointed individuals to the guideline panel. More information on the optimal dosing of parenteral anticoagulation to prevent VTE in acutely or critically ill medical inpatients is needed. The panel used the GRADEpro Guideline Development Tool (https://gradepro.org)49  and SurveyMonkey (https://www.surveymonkey.com) to brainstorm and then prioritize the questions described in Table 2. The panel did not identify high-priority future research questions. We did not identify trials that directly addressed this question. [Guideline] Witt DM, Nieuwlaat R, Clark NP, et al. Based on enhanced understanding of these issues, a paradigm shift in VTE risk assessment and prevention is underway that prompts clinicians to strive for individualized prophylaxis based on VTE and bleeding risk. However, the effect estimates all favored LMWH and, thus, the overall certainty was moderate for the critical outcomes.120. In absolute and relative terms, mechanical prophylaxis may reduce mortality, PE, and DVT, but the estimates are very uncertain (for mortality the RR was 0.50; 95% CI, 0.05-5.30; ARR, 4 fewer per 1000; 95% CI, from 8 fewer to 34 more per 1000; for PE the RR was 0.35; 95% CI, 0.05-2.22; ARR, 1 fewer per 1000; 95% CI, from 1 fewer to 1 more per 1000; for proximal DVT the RR was 0.13; 95% CI, 0.04-0.40; ARR, 2 fewer per 1000; 95% CI, 1-2 fewer per 1000; for distal DVT the RR was 0.21; 95% CI, 0.02-1.76; ARR, 6 fewer per 1000; 95% CI, from 7 fewer to 5 more per 1000). 0000015303 00000 n 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. Diagnostic strategies were evaluated for pulmonary embolism (PE), deep vein thrombosis (DVT) of the lower and upper extremity, and recurrent VTE. Overall, the certainty in the estimated effects was very low owing to very serious imprecision and serious indirectness of the estimates (see evidence profile and online EtD framework). These associations were no longer evident by 12 weeks after travel. For this recommendation, there was only 1 RCT with 43 participants and very few events (1 death, 1 PE, 3 DVTs). The panel rated adverse effects of mechanical prophylaxis, such as risk of falls, ischemia, and limb ulceration, as important, but not critical, for decision making. ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. With regard to research, the panel felt that: A systematic review of observational studies and a large comparative RCT are needed to increase the evidence available comparing pneumatic compression devices to graduated compression stockings in acutely or critically ill medical patients. In long-distance (>4 hours) travelers without risk factors for VTE, the ASH guideline panel suggests not using graduated compression stockings, LMWH, or aspirin for VTE prophylaxis (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). Four studies utilizing enoxaparin (1 study) or a DOAC (3 studies) for extended prophylaxis reported the effect of extended vs in-hospital–only pharmacological prophylaxis on the development of nonfatal PE, symptomatic proximal DVT, major bleeding, and mortality42,140,141,145 ; 3 studies reported the development of symptomatic distal DVT,42,140,141  and 1 study145  assessed the risk of developing HIT. In acutely or critically ill medical patients, the ASH guideline panel suggests pharmacological VTE prophylaxis alone over mechanical combined with pharmacological VTE prophylaxis (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). These evidence-based guidelines from the American Society of Hematology (ASH) intend to support patients, clinicians, and others in decisions about preventing VTE in these groups. All authors approved the content. This recommendation includes stroke patients, despite a slightly higher bleeding risk with LMWH compared with UFH among stroke patients in our systematic review. Adherence to this recommendation according to the guideline could be used as a quality criterion or performance indicator. The panel felt that the following research areas would be helpful: Development of risk-assessment methods to determine absolute risk of VTE in outpatients with minor provoking VTE risk factors and. Among these anticoagulants, the panel suggests using LMWH (low certainty in the evidence of effects ⊕⊕◯◯) or fondaparinux (very low certainty in the evidence of effects ⊕◯◯◯) rather than UFH (conditional recommendation). Blood Adv. We also considered long-distance travelers, as those traveling by air for >4 hours, and outpatients with minor provoking risk factors for VTE. 0000059740 00000 n Question: Should mechanical combined with pharmacological VTE prophylaxis vs pharmacological VTE prophylaxis alone be used in acutely or critically ill medical patients? The final guidelines, including recommendations, were reviewed and approved by all members of the panel. The panel assumed that avoidance of PE, DVT, and bleeding events was critical or important for decision making to patients. The panel chair was a content expert. For distal DVT, this extrapolated to an ARI of 7 more per 1000 (95% CI, 3 fewer to 40 more per 1000) using a baseline risk of 0.7%. Brien L. Anticoagulant medications for the prevention and treatment of thromboembolism. The panel assumed that avoidance of death, PE, and DVT was critical for decision making for patients. In absolute terms, use of a DOAC compared with LMWH probably had no impact on VTE-related mortality (RR, 0.64; 95% CI, 0.21-1.98; ARR, 0 fewer deaths per 1000; 95% CI, 1 fewer to 1 more per 1000) and little impact on VTE (for nonfatal PE: RR, 1.01; 95% CI, 0.29-3.53; ARR, 0 fewer per 1000; 95% CI, 1 fewer to 3 more per 1000; for symptomatic DVT: RR, 1.03; 95% CI, 0.34-3.08; ARR, 0 fewer per 1000; 95% CI, 1 fewer to 2 more per 1000). The panel identified the following additional research questions: Better information on baseline risk assessment of thrombosis and bleeding in medical inpatients is needed, in particular whether risk varies over the course of admission; and. contributed to drafting and critical revisions of the manuscript and contributed to further drafts; guideline panel members (H.J.S., M.C., J.B.-W., A.E.B., F.A.S., F.D., S.R.K., J.L., S.M.R., N.A.Z., K.A.B.) Equity would probably be reduced because graduated compression stockings would likely be an out-of-pocket cost, and acceptability would vary because insurance companies may not be willing to cover the cost. For VTE, the RR was 1.98 (95% CI, 0.60-6.58). The ASH panel also specifically recommended against prophylaxis in outpatients with minor provoking factors for VTE. Agency for Healthcare Research and Quality. The study reported an increase in thrombocytopenia (RR, 4.89; 95% CI, 0.24-98.96), but this increase was very imprecise, and the panel considered thrombocytopenia an important, but not critical, outcome for decision making. The words “the guideline panel recommends” are used for strong recommendations, and “the guideline panel suggests” for conditional recommendations. The panel suggested future research: Studies on identification of high-risk subgroups of chronically ill medical patients who could benefit from VTE prophylaxis, with consideration given to those who are immobilized; Studies of low-dose anticoagulant approaches, including use of DOACs or aspirin in chronically ill medical patients; and. The panel judged that the cost or savings were negligible, and LMWH was probably acceptable and feasible given that fewer injections would be required compared with UFH. The DVT RR was 0.86 (95% CI, 0.59-1.25), and ARR was 1 fewer per 1000 (95% CI, 8 fewer to 5 more per 1000) for distal DVT, for a baseline risk of 2.0%. The recommendation is likely to be strengthened (for future updates or adaptation) by additional research. M.C. Leg falls to bed by 5 seconds but has some effort against gravity using the National Institutes of Health stroke scale. The panel made a strong recommendation for using pharmacological prophylaxis, although the exact magnitude of the mortality benefit is still in question. The panel agreed on 19 recommendations for acutely ill and critically ill medical inpatients, people in long-term care facilities, outpatients with minor injuries, and long-distance travelers. However, inclusion of asymptomatic VTE in our analysis would not have changed interpretation of the relative effects of treatment. and H.J.S. 2018 Nov 27. For long-distance travelers at increased risk for VTE, the ACCP recommended 15- to 30-mm Hg below-knee graduated compression stockings, frequent ambulation, calf muscle exercise, or sitting in an aisle seat. Holger J. Schünemann, Mary Cushman, Allison E. Burnett, Susan R. Kahn, Jan Beyer-Westendorf, Frederick A. Spencer, Suely M. Rezende, Neil A. Zakai, Kenneth A. Bauer, Francesco Dentali, Jill Lansing, Sara Balduzzi, Andrea Darzi, Gian Paolo Morgano, Ignacio Neumann, Robby Nieuwlaat, Juan J. Yepes-Nuñez, Yuan Zhang, Wojtek Wiercioch; American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients. 0000007147 00000 n 0000003680 00000 n For symptomatic DVT, the RR was 2.20 (95% CI, 0.22-22.1). Two available studies assessed the risk of VTE in total joint arthroplasty patients, finding no association between preoperative or postoperative air travel and VTE risk.154,156  However, findings might be biased if travelers took precautions to reduce their risk of VTE, and studies might have been underpowered to detect associations. A systematic review, Venous thrombosis risk assessment in medical inpatients: the medical inpatients and thrombosis (MITH) study, A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score, Predictive and associative models to identify hospitalized medical patients at risk for VTE, Multicentre validation of the Geneva Risk Score for hospitalised medical patients at risk of venous thromboembolism. Both have been externally validated and showed fair discrimination in identifying medical inpatients who are and are not at increased risk for VTE.32,37,38  The IMPROVE investigators also developed an externally validated bleeding risk RAM (Table 1) that may aid in identifying acutely ill medical inpatients at increased risk for bleeding.39-41  The footnote of Table 1 provides data on how these RAMs may be applied for clinical decision making. For scores ≥ 2, VTE prophylaxis is indicated. Decision aids may be useful in helping individuals to make decisions consistent with their individual risks, values, and preferences. In acutely ill hospitalized medical patients, the ASH guideline panel recommends using LMWH over DOACs for VTE prophylaxis (strong recommendation, moderate certainty in the evidence of effects ⊕⊕⊕◯). For several outcomes, the studies reported outcomes differently from what the panel determined to be critical or important for decision making. The panel selected outcomes of interest for each question a priori, following the approach described in detail elsewhere.50  In brief, the panel brainstormed all possible outcomes before rating their relative importance for decision making following the GRADE approach.50  During this rating process, the panel used definitions of the outcomes (“marker states”) that were developed for these guidelines. In general, mechanical prophylaxis was considered acceptable, and, among options, graduated compression stockings were considered more feasible than pneumatic compression devices. For new reviews, risk for bias was assessed at the health outcome level using the Cochrane Collaboration’s risk for bias tool for randomized trials or nonrandomized studies. For each guideline question, the McMaster GRADE Centre prepared a GRADE Evidence-to-Decision (EtD) framework, using the GRADEpro Guideline Development Tool (https://gradepro.org).12,13,18  The EtD table summarized the results of systematic reviews of the literature that were updated or performed for these guidelines. In acutely or critically ill medical patients, the ASH guideline panel suggests pharmacological or mechanical VTE prophylaxis alone over mechanical combined with pharmacological VTE prophylaxis (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). 0000033190 00000 n The panel assumed no impact on health equity and that the use of fondaparinux was acceptable and probably feasible. 0000009067 00000 n 0000004341 00000 n The panel included hematologists, internists, other physicians, and a pharmacist who all had clinical and research expertise on the guideline topic; methodologists with expertise in evidence appraisal and guideline development; and 1 patient representative. One trial,28  which was included in 9 identified systematic reviews,55,56,58-61,63,66,67  addressed the use of fondaparinux compared with no prophylaxis in acutely ill medical patients. The guideline panel reviewed draft EtD tables before, during, or after the guideline panel meeting and made suggestions for corrections and identified missing evidence. Interpretation of strong and conditional recommendations. Using a baseline risk of 0.2% for proximal DVT, the ARI was 2 more per 1000 (95% CI, 1 fewer to 38 more per 1000), and with a baseline risk of 0.7% for distal DVT, this extrapolated to an ARI of 9 more per 1000 (95% CI, 6 fewer to 152 more per 1000). These patients may be referred to the KPWA Anticoagulation/Anemia Management Service (AMS). The ASH panel addressed use of DOACs for inpatient and postdischarge prophylaxis in medical patients using data not available to other guideline groups and recommended against the use of DOACs over other treatments in the hospital. For each recommendation, the panel took a population perspective and came to consensus on the following: the certainty in the evidence, the balance of benefits and harms of the compared management options, and the assumptions about the values and preferences associated with the decision. Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism. Chronically ill medical patients were defined as those with medical conditions who may be cared for in long-term care facilities. Although optimal strategies for VTE risk assessment and decision making on prophylaxis are yet to be identified, when clinicians and health care systems use these ASH VTE guidelines, they should integrate VTE and bleeding risk assessments into clinical decision-making processes. These guidelines are based on updated and original systematic reviews of evidence conducted under the direction of the McMaster University GRADE Centre with international collaborators. People without known VTE risk factors who place a high value on prevention of VTE may choose to use graduated compression stockings. 0000050562 00000 n Over the last decade, several quantitative VTE risk-assessment models (RAMs) were developed for medical inpatients.32-34  The 2 most extensively studied are the empirically derived Padua score35  and the database-derived IMPROVE score36  (Table 1). LMWH compared with UFH had little impact on mortality (RR, 0.99; 95% CI, 0.82-1.19; ARR, 1 fewer per 1000; 95% CI, 9 fewer to 10 more per 1000). None of the 5 trials reported serious adverse effects of wearing the stockings, but in 1 trial, 4 patients developed varicose vein thrombosis, possibly as a result of the stockings.165  The panel was concerned about potential allergy to the stocking material, but this adverse effect was not reported in the trials. Distal DVT’s are not usually treated, but GPs can use discretion , ideally involving the patient in the decision -making on management, and may choose either A or B: A: No initial anticoagulation treatment but a repeat funded Acute Demand scan after 5 - 8 days. 0000008168 00000 n For LMWH and aspirin, people with substantially increased risk for VTE (eg, recent surgery, history of VTE, hormone replacement therapy, pregnant or postpartum women, active malignancy, or ≥2 VTE risk factors) may experience more health benefits than harms. The American Society of Hematology (ASH), the world’s largest professional society concerned with the causes and treatment of blood disorders, has long recognized the need for a comprehensive set of guidelines on the treatment of VTE to help the medical community better manage this serious condition. The panel assumed that avoidance of PE, DVT, and bleeding events was critical or important to patients for decision making. Guidelines aim to present all the relevant evidence on a particular clinical issue in order to help physicians to weigh the benefits and risks of a particular diagnostic or therapeutic procedure. The guideline panel determined that there is very low certainty in the balance between desirable and undesirable health effects of combined mechanical and pharmacological prophylaxis compared with mechanical prophylaxis alone in acutely or critically ill medical patients. One study117  reported on development of DVT assessed as symptomatic DVT, which was used to extrapolate data for proximal DVT and distal DVT representing the moderate marker state. The vice-chair was an internist and expert in guideline-development methodology. This trial was used to indirectly compare the effect of fondaparinux with LMWH and UFH through a calculation of the ratio of risk ratios based on the 25 identified RCTs that compared these agents vs no prophylaxis. Overall, the panel judged the certainty in these estimated effects as moderate owing to serious imprecision of the estimates, although the certainty was judged as low for mortality and PE. However, the panel considered thrombocytopenia an important, but not critical, outcome for decision making. Remark: People without known risk factors who place a high value on prevention of VTE may choose to use graduated compression stockings (also reduces edema). Unlike ACCP, the ASH panel addressed combination mechanical and pharmacological prophylaxis over either alone and suggested against the combination. 1,2. Although the panel judged that extending prophylaxis with a DOAC was probably acceptable and feasible, it could increase inequity because of access to and cost of extended out-of-hospital use. Active malignancy, surgery (especially orthopedic), immobilization, and estrogen use/pregnancy are common transient provoking factors. While there Conditional recommendations included not to use VTE prophylaxis routinely in long-term care patients or outpatients with minor VTE risk factors. The ACCP advised not to use prophylaxis in medical patients at low risk of VTE, based on the Padua Prediction Score, or at high risk of bleeding. We found 17 systematic reviews that addressed this question,51-54,54-67  with 25 studies29,30,68-89  (H. Vissinger and S. Husted, unpublished data, 1995) in these reviews evaluating outcomes relevant to this question. In Part A of the forms, individuals disclosed material interests for 2 years prior to appointment. The same RR was used for distal DVT, resulting in an ARR of 0 fewer per 1000 (95% CI, 1 fewer to 20 more per 1000) for a low-risk population and 0 fewer per 1000 (95% CI, 4 fewer to 61 more per 1000) for a high-risk population. 0000027396 00000 n Remark: This recommendation applies to heparin and DOACs. With regard to future research, the panel suggests: Studies of risk assessment tools for guidance on defining high-risk status for VTE and bleeding at discharge; Trials of pharmacological or nonpharmacological interventions in selected high-risk medical patients for VTE at discharge143 ; and. The resulting ARR for symptomatic proximal DVT was 0 fewer per 1000 (95% CI, 0-1 fewer per 1000) for a baseline risk of 0.2%, and the ARR for symptomatic distal DVT was 2 fewer per 1000 (95% CI, 0-4 fewer per 1000) for a baseline risk of 0.6%. Therefore, we extrapolated the effects to representative baseline risks for PE and proximal and distal VTE to estimate the potential benefits and harms but rated down for indirectness because information for symptomatic VTE was not available. Evidence on effectiveness and safety of DOACs to prevent VTE in travelers at risk of VTE. The limitations of these guidelines are inherent in the low or very low certainty in the evidence we identified for many of the questions. 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