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%. 0000050562 00000 n In critically ill medical patients, the ASH guideline panel recommends inpatient over inpatient plus extended-duration outpatient VTE prophylaxis (strong recommendation, moderate certainty in the evidence of effects ⊕⊕⊕◯). EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study, Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial, Rivaroxaban for thromboprophylaxis after hospitalization for medical illness, Can home prophylaxis for venous thromboembolism reduce mortality rates in patients with chronic obstructive pulmonary disease? 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. A total of 69% of patients in this study37  were low risk for VTE (score 0 or 1). 0000003485 00000 n 0000025510 00000 n Overall, the certainty in these estimated effects is very low owing to very serious indirectness and serious risk of bias for the estimates (see evidence profile and online EtD framework). The panel rated the following outcomes as critical for clinical decision making across questions: mortality, PE, proximal DVT, distal DVT, major bleeding including gastrointestinal bleeding, and heparin-induced thrombocytopenia (HIT). We identified 1 randomized trial of LMWH vs placebo with 87 patients147  that fulfilled our inclusion criteria and measured outcomes relevant to this question (mortality, PE, proximal and distal DVT). Conflict-of-interest disclosure: All authors were members of the guideline panel, members of the systematic review team, or both. The panel made a conditional recommendation because of remaining uncertainty about the exact magnitude of the effect and because critically ill medical patients with renal failure and hepatic failure may require alternative options. The panel judged that costs were negligible, and heparin prophylaxis was acceptable and feasible. Other EtD criteria were generally in favor of using LMWH so that the desirable consequences were greater than the undesirable consequences. They may also be used by patients. The guideline panel developed and graded the recommendations and assessed the certainty in the supporting evidence following the GRADE approach.12-18  The overall guideline-development process, including funding of the work, panel formation, management of conflicts of interest, internal and external review, and organizational approval, was guided by ASH policies and procedures derived from the GIN–McMaster Guideline Development Checklist (http://cebgrade.mcmaster.ca/guidecheck.html) and was intended to meet recommendations for trustworthy guidelines by the Institute of Medicine and GIN.8-11  An article detailing the methods used to develop these guidelines is forthcoming. ASH does not warrant or guarantee any products described in these guidelines. Brien L. Anticoagulant medications for the prevention and treatment of thromboembolism. In acutely or critically ill medical patients, the ASH guideline panel suggests using mechanical alone over mechanical combined with pharmacological VTE prophylaxis (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). 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. Importantly, none of the existing validated quantitative RAMs proposed for clinical use in this setting have undergone extensive impact analyses that shows their use leads to a reduction in clinical outcomes. Project oversight was provided initially by a coordination panel, which reported to the ASH Committee on Quality, and then by the coordination panel chair (Dr. Adam Cuker) and vice-chair (H.J.S.). The panel assumed that avoidance of death, VTE-related death, PE, DVT, and bleeding was critical or important to patients for decision making. LMWH showed reductions in PE, symptomatic DVT, major bleeding, and HIT compared with UFH, but the estimates were imprecise, with small ARRs (see evidence profile in the online EtD framework). We excluded studies that addressed this question in critically ill patients who underwent surgery or those with trauma. Decision aids may be useful in helping patients to make decisions consistent with their individual risks, values, and preferences. 0000005553 00000 n In acutely ill medical patients, the American Society of Hematology (ASH) guideline panel suggests using UFH, LMWH, or fondaparinux rather than no parenteral anticoagulant (conditional recommendation, low certainty in the evidence of effects ⊕⊕◯◯). These guidelines are not intended to serve or be construed as a standard of care. 0000037185 00000 n Question: Should mechanical combined with pharmacological VTE prophylaxis vs mechanical VTE prophylaxis alone be used in acutely or critically ill medical patients? Statements about the underlying values and preferences, as well as qualifying remarks accompanying each recommendation, are its integral parts and serve to facilitate more accurate interpretation. In Part B, they disclosed interests that were not mainly financial. The EtD framework is shown at https://dbep.gradepro.org/profile/92523320-6D45-1BCA-9311-C750EB428BCB. The ultimate judgment regarding any specific clinical procedure or treatment must be made by the physician in light of the circumstances presented by the patient. Patients with peripheral vascular disease may experience higher rates of adverse events, including leg ulceration, ischemia, and amputations. A relevant trial was published after the guideline panel finalized this recommendation and during revision of this manuscript.146  The study did not find that rivaroxaban was superior to placebo when given to medical patients at increased predicted VTE risk for 45 days after hospital discharge.146  This finding is consistent with the conclusions of the systematic review conducted for this recommendation. Figure 2. 0000003899 00000 n Recent studies among hospitalized medically ill patients suggest that a universal approach to prevention has minimal impact on reducing VTE.26,27  This may be due, in part, to (1) shorter lengths of stay and truncated thromboprophylaxis regimens compared with older studies that showed significant reductions in thromboembolic events with prophylaxis or insufficient duration of follow-up in research studies28-30 ; (2) overprophylaxis of low-risk patients and underprophylaxis of high-risk patients, resulting in an unfavorable risk–harm balance for these patients; or (3) underutilization of appropriate prophylaxis in hospitalized medical patients due to clinician concern for bleeding or perception that patients are not at sufficiently high risk for VTE to warrant prophylaxis.31. 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 ⊕◯◯◯). 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. Some researchers who contributed to the systematic evidence reviews received salary or grant support through the McMaster GRADE Centre. On occasion, a strong recommendation is based on low or very low certainty in the evidence. The panel assumed that avoidance of PE, DVT, and bleeding events was critical or important for decision making to patients. In comparing these 1 alternatives the panel believed felt it could not judge the balance of health effects based on this RCT. The certainty was categorized into 4 levels ranging from very low to high.14-16. The study included outpatients with chronic obstructive pulmonary disease requiring home oxygen and who also had restricted physical activity. They also recommended, with moderate certainty, the use of graduated compression stockings plus intermittent pneumatic compression in ischemic or hemorrhagic stroke patients in whom risks of anticoagulant prophylaxis were deemed unacceptable. The guideline panel determined that there is very low certainty in the evidence that the undesirable consequences of pharmacological thromboprophylaxis in chronically ill medical patients outweigh the desirable consequences. The guideline panel determined that, in acutely or critically ill medical patients, there is very low certainty in the evidence that, compared with pharmacological prophylaxis the undesirable consequences of mechanical combined with pharmacological prophylaxis outweigh the desirable consequences of the 2 approaches combined. 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. It aims to support rapid diagnosis and effective treatment for people who develop deep vein thrombosis (DVT) or pulmonary embolism (PE). Overall, the certainty in these estimated effects was very low owing to the risk of bias, the indirect comparison, and imprecision of the estimates. Pharmacological thromboprophylaxis was deemed to be of high cost and probably not acceptable to stakeholders. 0000005999 00000 n The EtD framework is shown at https://dbep.gradepro.org/profile/B7E7908E-FFD0-19C4-862E-16561BEC51FE. Research questions are listed in under recommendation 13. In 2014, in response to long-standing member interest, ASH initiated an effort to develop evidence-based clinical practice guidelines for hematology that meet the highest standards of development, rigor and trustworthiness. The recommendation is likely to be strengthened (for future updates or adaptation) by additional research. Overall, the certainty in these estimated effects is very low owing to very serious imprecision and serious indirectness of the estimates (see evidence profile and online EtD framework). For scores ≥ 2, VTE prophylaxis is indicated. and one third will have a recurrent DVT or PE within 10 years. In Part A of the forms, individuals disclosed material interests for 2 years prior to appointment. Decision aids may be useful in helping individuals to make decisions consistent with their individual risks, values, and preferences. Remark: This recommendation applies to heparin and DOACs. The panel determined that there is low certainty in the evidence for a net health benefit from using any parenteral anticoagulant in acutely ill medical patients. In people who are at substantially increased VTE risk (eg, recent surgery, prior history of VTE, postpartum women, active malignancy, or ≥2 risk factors, including combinations of the above with hormone replacement therapy, obesity, or pregnancy), the ASH guideline panel suggests using graduated compression stockings or prophylactic LMWH for long-distance (>4 hours) travel (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). 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. The National Institute for Health and Care Excellence guidelines released in 2018 addressed VTE prevention in all hospitalized patients.172  For medical patients, they addressed specific subgroups separately: acute coronary syndrome, stroke, medical, renal impairment, cancer, palliative care, critically ill, and psychiatry patients. These guidelines should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. 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. 0000026415 00000 n 0000004216 00000 n 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 ⊕⊕⊕◯). In such instances, further research may provide important information that alters the recommendations. 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. During a 2-day in-person meeting, followed by online communication and conference calls, the panel developed clinical recommendations based on the evidence summarized in the EtD tables. On 30 April 2018, the ASH Guideline Oversight Subcommittee and the ASH Committee on Quality approved that the defined guideline-development process was followed; on 4 May 2018, the officers of the ASH Executive Committee approved submission of the guidelines for publication under the imprimatur of ASH. DEEP VEIN THROMBOSIS (DVT): TREATMENT . 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 ⊕◯◯◯). 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. 0000026861 00000 n 0000042209 00000 n Design, rationale, and clinical implications. For example, patients given mechanical prophylaxis must be observed to reduce the risk of falls and other complications. Other EtD criteria were generally in favor of using in-hospital prophylaxis only, because the undesirable consequences were greater than the desirable consequences in acutely ill medical patients, leading to a recommendation for shorter prophylaxis. 0000004089 00000 n Interpretation of strong and conditional recommendations. The guideline panel determined that there was moderate certainty in the evidence that the desirable effects of heparin (UFH or LMWH) outweigh the undesirable effects in critically ill medical patients. Our systematic search for RCTs identified 1 study131  conducted in critically ill medical patients, which provided limited evidence. Mechanical vs pharmacological prophylaxis, 8. The overall certainty in these estimated effects was moderate owing to imprecision of the estimates for the VTE outcomes (see evidence profile in the online EtD framework). Table 3 provides GRADE’s interpretation of strong and conditional recommendations by patients, clinicians, health care policy makers, and researchers. The certainty in these estimated effects was moderate owing to imprecision of the estimates when the small possible benefits are balanced against the harms. 0000003680 00000 n 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 to identify possible research gaps. 0000063517 00000 n The ASH panel recommended LMWH or graduated compression stockings and the use of aspirin if these were not feasible or available. 0000004341 00000 n We did not identify any systematic review that addressed this question, but our systematic search for RCTs identified 1 RCT122  in acutely ill medical patients that provided limited evidence for this question. The panel assumed that avoidance of death, PE, and DVT was critical or important for decision making to patients. The panel agreed on the recommendations (including direction and strength), remarks, and qualifications by consensus or, in rare instances, by voting (an 80% majority was required for a strong recommendation), based on the balance of all desirable and undesirable consequences. Question: Should pneumatic compression devices vs graduated compression stockings be used for VTE prophylaxis in acutely or critically ill medical patients? trailer <]/Prev 264436/XRefStm 2896>> startxref 0 %%EOF 1027 0 obj <>stream The 3 RCTs reported the effects of DOAC vs LMWH on mortality, VTE-related mortality, PE, symptomatic DVT, and major bleeding. VTE in hospitalized and nonhospitalized medical patients and long-distance travelers confers an important disease burden and can be fatal. 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. Members of the guideline panel received travel reimbursement for attendance at in-person meetings, and the patient representative was offered, but declined, an honorarium of $200. 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.11,46-48  The Evidence-to-Decision framework for each recommendation describes which individuals were recused from making judgments about each recommendation. CI, confidence interval; CCU, Coronary Care Unit; GFR, glomerular filtration rate; ICU, Intensive Care Unit; INR, international normalized ratio. DVT AND PE ANTICOAGULATION MANAGEMENT thromboembolism (VTE) in patients with acute deep vein thrombosis (DVT) and/or CHEST guidelines support the use of the PE severity index (PESI) to identify These guidelines were issued in 2013 and will be reviewed in 2017 or sooner if new evidence To provide guidance in preventing venous thromboembolism. The guideline panel determined that there was a paucity of evidence, as well as very low certainty in the evidence. 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. form of treatment. Overall, the certainty in these estimated effects was low owing to imprecision of the estimates and indirect comparisons (see evidence profile in the online EtD framework). The panel felt that the very low certainty about the effect estimates suggests that there is a research gap with regard to effectiveness. The panel assumed that avoidance of death, PE, and DVT was critical or important for decision making to patients. 0000001916 00000 n In absolute and relative terms, combined mechanical and pharmacological prophylaxis compared with mechanical prophylaxis alone appeared to have no impact on mortality (RR, 1.0; 95% CI, 0.8-1.2; ARR, 0 fewer per 1000; 95% CI, from 10 fewer to 10 more per 1000). 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. In people who are at substantially increased VTE risk (eg, recent surgery, history of VTE, postpartum women, active malignancy, or ≥2 risk factors, including combinations of the above with hormone replacement therapy, obesity, or pregnancy) and in whom LMWH or graduated compression stockings is not feasible (eg, resource-constrained setting or aversion to other indicated anticoagulants), the ASH guideline panel suggests using aspirin rather than no VTE prophylaxis (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). The panel felt that more research should be conducted to: Provide more direct evidence on combined mechanical and pharmacological prophylaxis compared with mechanical prophylaxis alone via clinical trials on efficacy, harms, and adherence to the intervention, particularly in high-risk medical inpatients in whom the balance of potential benefits vs harms might be more favorable than among lower-risk patients; Obtain patient preferences for mechanical or pharmacological prophylaxis by studying feasibility, equity, and acceptability; Determine current utilization rate of combined mechanical and pharmacological prophylaxis in practice; and. While there The guidelines favor shorter courses of anticoagulation (3-6 months) for acute DVT/PE associated with a transient risk factor. The document was revised to address pertinent comments, but no changes were made to the recommendations. Intermittent pneumatic compression stockings vs graduated compression stockings, 12. Some panelists disclosed new interests or relationships during the development process, but the balance of the majority was maintained. Unlike ACCP, the ASH panel addressed combination mechanical and pharmacological prophylaxis over either alone and suggested against the combination. American Society of Hematology 2018 guidelines for management of venous thromboembolism: optimal management of anticoagulation therapy. The panel made a conditional recommendation for using pharmacological prophylaxis over mechanical prophylaxis and determined that the recommendation would not apply to groups in whom the risk of VTE would be too small to justify the downsides or burden of any prophylaxis. In acutely ill medical patients, the ASH guideline panel suggests using UFH, LMWH, or fondaparinux rather than no parenteral anticoagulant (conditional recommendation, low certainty in the evidence of effects ⊕⊕◯◯). [Guideline] Witt DM, Nieuwlaat R, Clark NP, et al. For VTE, there were important relative effects but small absolute effects. 0000006088 00000 n Worldwide, 3.4 billion passengers traveled by air in 2015 (http://data.worldbank.org/indicator/IS.AIR.PSGR). 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). 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. In acutely ill medical patients, the ASH guideline panel recommends inpatient over inpatient plus extended-duration outpatient VTE prophylaxis (strong recommendation, moderate certainty in the evidence of effects ⊕⊕⊕◯). sion of DVT on serial imaging for two weeks.8,10,11 Evidence supports outpatient treatment of PE if the risk of nonadherence is low and the patient is clinically We did not identify any systematic review that addressed this question or any RCT addressing this question in acutely or critically ill medical patients. Venous thromboembolism (VTE) is the third most common vascular disease. In particular, can lower or higher doses be used in different settings (perhaps dependent on baseline risk), and should dosing be adjusted in obese patients, underweight patients, and patients with renal disease? PDF | The review article ... 10th edition of the ACCP guidelines for diagnosis and treatment of venous thromboembolism. 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. The EtD framework is shown at https://dbep.gradepro.org/profile/481D40D6-31CD-153A-BB3F-1CF50F1A7B23. None of the studies reported whether the symptomatic DVTs were proximal or distal; therefore, we estimated the absolute effect on proximal and distal DVT by applying results to a representative baseline risk. and H.J.S. Rating outcomes by their relative importance can help to focus attention on those outcomes that are considered most important for clinicians and patients and help to resolve or clarify potential disagreements. The EtD framework is shown at https://dbep.gradepro.org/profile/783DCF1B-50FC-72D0-A1E1-3C31011E9471. For proximal DVT, the RR was 0.98 (95% CI, 0.06-15.1), with an ARR of 0 fewer per 1000 (95% CI, 22 fewer to 329 more per 1000 using the study baseline risk of 2.3%). This study compared intermittent pneumatic compression with graduated compression stockings. Correspondence: Holger J. Schünemann, Department of Health Research Methods, Evidence and Impact, McMaster University, HSC-2C16, 1280 Main St West; Hamilton, ON L8N 3Z5, Canada; e-mail: schuneh@mcmaster.ca. The EtD framework is shown at https://dbep.gradepro.org/profile/FDD22673-C5BB-8A63-A715-5D225B808EA2. 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. We did not address whether twice or thrice daily unfractionated heparin should be used when unfractionated heparin is chosen, because we did not develop a guideline question for this, there are little data, and there are no recent data. 0000004189 00000 n Parenteral anticoagulants (UFH, LMWH, or fondaparinux) had no impact on mortality based on a meta-analysis of 21 RCTs (relative risk [RR], 0.97; 95% confidence interval [CI], 0.91-1.04; absolute risk reduction [ARR], 2 fewer per 1000; 95% CI, from 6 fewer to 3 more per 1000), but we estimated that heparins reduced the risk for developing PE (RR, 0.59; 95% CI, 0.45-0.78; ARR, 4 fewer per 1000; 95% CI, from 6-2 fewer per 1000), symptomatic proximal DVT (RR, 0.28; 95% CI, 0.06-1.37; ARR, 3 fewer per 1000; 95% CI, from 4 fewer to 1 more per 1000), and symptomatic distal DVT (RR, 0.75; 95% CI, 0.17-3.34; ARR, 1 fewer per 1000; 95% CI, from 2 fewer to 5 more per 1000). 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