Structured benefit-risk assessment for enoxaparin, in the context of its label extension, for the extended treatment of deep vein thrombosis and pulmonary embolism, and prevention of its recurrence in patients with active cancer.

PURPOSE: Guidelines recommend low-molecular-weight heparins (LMWHs) for patients with cancer-associated thrombosis. However, until recently, only dalteparin and tinzaparin were approved in the European Economic Area (EEA) for these patients. This study compares the benefit-risk profile of enoxaparin with dalteparin and tinzaparin for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence in adult patients with active cancer. METHODS: A semi-quantitative structured benefit-risk assessment was conducted for the label-extension application of enoxaparin based on the benefit-risk action team descriptive framework: define decision context; determine key benefit and risk outcomes; identify data sources; extract data; interpret results. RESULTS: The key benefits were defined as reduced all-cause mortality and venous thromboembolism (VTE) recurrence (including symptomatic DVT, fatal PE or non-fatal PE); the key risks were major and non-major bleeding of clinical significance, and heparin-induced thrombocytopenia (HIT). Enoxaparin demonstrated comparable effects for the reduction of VTE recurrence and all-cause mortality versus other EEA-approved LMWHs (dalteparin, tinzaparin). There was no evidence of a significant difference between enoxaparin and the comparator groups with regard to incidence of major and non-major bleeding. The data on HIT were too limited to assess the difference between the two groups. CONCLUSIONS: The assessment demonstrated a favourable benefit-risk profile for enoxaparin similar to that of other EEA-approved LMWHs for the treatment of DVT and PE and the prevention of recurrence in patients with active cancer and thus supported the label-extension approval.

Apixaban for Extended Thromboprophylaxis After Oncologic Resection: Outcomes and Cost Analysis.

BACKGROUND: Patients undergoing oncologic resection are at risk of developing venous thromboembolism (VTE), and this can lead to increased morbidity and hospital costs. Low-molecular weight heparin (LMWH) is recommended as extended thromboprophylaxis (ETP) in high-risk patients and has been shown to reduce rates of VTE. METHODS: This is a retrospective review of consecutive patients undergoing resection for oncologic indications at a single institution from May 2016 to May 2019. This study evaluated the use of apixaban as ETP at discharge. The primary outcomes were deep vein thrombosis (DVT), pulmonary embolism (PE), or mesenteric/portal venous thromboembolism at 30, 60, and 90 days postoperatively. RESULTS: A total of 600 patients were included; 449 patients received no ETP, and 151 patients received apixaban. PE occurred in 1.1, 1.6, and 2.3% of patients without ETP and 0, 0, and .7% of patients in the apixaban group (at 30, 60, and 90 days; P = .338, P = .201, and P = .306, respectively). DVT occurred in 1.8, 2.1, and 2.8% of patients without ETP and 0, 0, and 1.4% in the apixaban group (P = .211, P = .121, and P = .535, respectively). The total cost, including ETP and readmission for VTE, per patient was US $5.51 more in the apixaban group. CONCLUSION: Apixaban therapy for ETP did not produce a statistically significant reduction in VTE events in our patients. Future studies should include more patients in a prospective multicenter trial.

Thromboembolic events in hospitalised patients with COVID-19: ecological assessment with a scoping review.

OBJECTIVES: Thrombosis is a common complication of the novel COVID-19. Pre-COVID-19 studies reported racial differences in the risk of developing thrombosis. This study aimed to describe the geographical variations in the reported incidences and outcomes of thromboembolic events and thromboprophylaxis in hospitalised patients with COVID-19. The final search for randomised clinical trials was carried out in January 2022. Screening eligible articles and data extraction were independently performed in duplicate by multiple reviewers. DESIGN: Scoping review. MEDLINE, Embase, Cochrane Libraries were searched using terms related to COVID-19 and thromboembolism. SETTING: Hospitals all over the world. PARTICIPANTS: In-hospital patients with COVID-19. OUTCOME MEASURES: The incidence of deep venous thrombosis (DVT) and pulmonary embolism (PE), and the prophylactic anticoagulation therapy. RESULTS: In total, 283 studies were eligible, representing (239 observational studies, 39 case series and 7 interventional studies). The incidence of DVT was the highest in Asia (40.8%) and hospital mortality was high (22.7%). However, the incidence of PE was not very high in Asia (3.2%). On the contrary, the incidence of PE was the highest in the Middle East (16.2%) and Europe (14. 6%). Prophylactic anticoagulation therapy with low-molecular-weight heparin was the main treatment provided in all areas. Four of the seven randomised clinical trials were conducted internationally. CONCLUSIONS: The incidence of DVT was the highest in Asia. The incidence of PE was higher in the Middle East and Europe; however, detection bias during the pandemic cannot be ruled out. There were no major differences in the type or dose of prophylactic anticoagulants used for thromboprophylaxis among the regions.

Reducing Surgical Complications in Spine Patients Through a Medication Management Support Program.

STUDY DESIGN: A hospital-wide medication management program was implemented to ensure that high-risk patients would systematically pause antiplatelet and anticoagulant medications. We analyzed complications before and during the implementation of this program. OBJECTIVE: The goal of the study was to determine if a medication management support program was effective for reducing perioperative complications, including hemorrhage, myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis. DATA AND METHODS: Using data from the National Surgical Quality Improvement Program database, we examined the presence of 5 complications before and during the implementation of a medication management support program. There were 9732 patients in the clinic population who underwent elective spine surgery between 2011 and 2020 and were included in this analysis. Of those 9732 patients, 7205 had surgery before the introduction of the program, whereas 2527 had surgery at some point after the program was introduced. We conducted a series of Pearson's χ 2 tests to determine the relative frequencies of the complications before and during the program. RESULTS: Results showed that during the implementation of the program, patients were relatively less likely to experience hemorrhage (3.16% vs. 1.11%; P <0.001). The reductions in thrombotic complications were clinically significant: myocardial infarction (0.12% vs. 0.00%), stroke (0.10% vs. 0.04%), pulmonary embolism (0.33% vs. 0.28%), and deep vein thrombosis (0.36% vs. 0.28%). These P values ranged from P =0.08 for myocardial infarction to P =0.67 for pulmonary embolism. CONCLUSIONS: The use of this medication management support program appears effective for reducing the need for blood transfusions and thrombotic complications. While promising, the results should be interpreted with caution as we do not know whether this type of program will be effective for other hospital systems.

Comparison of real-world clinical and economic outcomes in patients receiving oral anticoagulants: A retrospective claims analysis.

BACKGROUND: Direct oral anticoagulants (DOACs) have become widely used for the prevention of stroke in nonvalvular atrial fibrillation (AF) and for the treatment of venous thromboembolism (VTE). Warfarin, the standard of care prior to DOACs, requires monitoring and dose adjustment to ensure patients remain appropriately anticoagulated. DOACs do not require monitoring but are significantly more expensive. We sought to examine real-world effectiveness and costs of DOACs and warfarin in patients with AF and VTE. OBJECTIVE: To examine clinical and economic outcomes. The clinical objectives were to determine the bleeding and thrombotic event rates associated with DOACs vs warfarin. The economic objectives were to determine the cost associated with these events, as well as the all-cause medical and pharmacy costs associated with DOACs vs warfarin. METHODS: This analysis was an observational, propensity-matched comparison of retrospective medical and pharmacy claims data for members enrolled in an integrated health plan between October 1, 2015, and September 30, 2020. Members who were older than 18 years of age with at least 1 30-day supply of warfarin or a DOAC filled within 30 days of a new diagnosis of VTE or nonvalvular AF were eligible for the analysis. Cox hazard ratios were used to compare differences in clinical outcomes, where paired t-tests were used to evaluate economic outcomes. RESULTS: After matching, there were 893 patients in each group. Among matched members, warfarin was associated with increased risk of nonmajor bleeds relative to apixaban (hazard ratio [HR] = 1.526; P = 0.0048) and increased risk of pulmonary embolism relative to both DOACs (apixaban: HR = 1.941 [P = 0.0328]; rivaroxaban: HR = 1.833 [P = 0.0489]). No statistically significant difference was observed in hospitalizations or in length of stay between warfarin and either DOAC. The difference-in-difference (DID) in total costs of care per member per month for apixaban and rivaroxaban relative to warfarin were $801.64 (P = 0.0178) and $534.23 (P = 0.0998) more, respectively. DID in VTE-related cost for apixaban was $177.09 less, relative to warfarin (P = 0.0098). DID in all-cause pharmacy costs for apixaban and rivaroxaban relative to warfarin were $342.47 (P < 0.0001) and $386.42 (P < 0.001) more, respectively. CONCLUSIONS: Warfarin use was associated with a significant decrease in total cost of care despite a significant increase in VTE-related costs vs apixaban. Warfarin was also associated with a significant increase in other nonmajor bleeds relative to apixaban, as well as a significant increase in pulmonary embolism relative to both DOACs. Warfarin was associated with a significant reduction in all-cause pharmacy cost compared with either DOAC. DISCLOSURES: The authors of this study have nothing to disclose.

Evaluation of the Effectiveness and Safety of Direct Oral Anticoagulants in Elderly Patients With Nonvalvular Atrial Fibrillation Who Are Not Candidates for Warfarin in Real-World Setting.

ABSTRACT: Limited literature has established the role of direct oral anticoagulants (DOAC) for elderly patients with nonvalvular atrial fibrillation who are unsuited for warfarin. Therefore, the objectives of this study were to assess the effectiveness and safety of DOAC use in this vulnerable patient population. This was a retrospective propensity score matching cohort study. Among all patients aged 75+ years who were not candidates for warfarin, we matched those who initiated DOAC between September 2017 and September 2018 with those who did not receive DOAC or warfarin in a 1:1 ratio. Effectiveness outcome was a composite measure of stroke, transient ischemic attack, and pulmonary embolism. Safety outcome was a composite measure of non-trauma-related intracranial hemorrhage and gastrointestinal bleed. Unless patients died or lost membership, follow-up period for the effectiveness outcome was until the end of 2019, whereas the safety outcome was for a period up to 1 year. Conditional logistic regression was used to analyze both outcomes. We identified 7818 patients who met the inclusion criteria and started DOAC, which matched to 7818 patients who did not receive anticoagulants. The mean age was 82.3 ± 5.1 years, and 51.5% male. The DOAC group had a lower hazard ratio of 0.37 (confidence interval, 0.24-0.57; P < 0.01) for composite effectiveness outcomes, whereas no difference in the composite safety outcome (hazard ratio, 0.91; confidence interval, 0.65-1.25; P = 0.55) when compared with matched control. In conclusion, DOAC was found to be effective in preventing thromboembolic events in patients aged 75+ years with nonvalvular atrial fibrillation who were not eligible for warfarin.

Cost-effectiveness of early placement of vena cava filters to prevent symptomatic pulmonary embolism in patients with contraindications to prophylactic anticoagulant.

INTRODUCTION: Vena cava filters have been used as a primary means to prevent symptomatic pulmonary embolism (PE) in trauma patients who cannot be anticoagulated after severe injury, but the economic implications for this practice remain unclear. METHODS: Using a healthcare system perspective to analyze the a priori primary outcome of the da Vinci trial, we report the cost-effectiveness of using vena cava filters as a primary means to prevent PE in patients who have contraindications to prophylactic anticoagulation after major trauma. RESULTS: Of the 240 patients enrolled, complete, prospectively collected, hospital cost data during the entire hospital stay - including costs for the filter, medical/nursing/allied health staff, medical supplies, pathology tests, and radiological imaging - were available in 223 patients (93%). Patients allocated to the filter group (n = 114) were associated with a reduced risk of PE (0.9%) compared to those in the control group (n = 109, 5.5%; p = 0.048); and the filter's benefit was more pronounced among those who could not be anticoagulated within 7 days (filter: 0% vs control: 16%, Bonferroni-corrected p = 0.02). Overall, the cost needed to prevent one PE was high (AUD $379,760), but among those who could not be anticoagulated within 7 days, the costs to prevent one PE (AUD $36,156; ~ USD $26,032) and gain one quality-adjusted life-year (AUD $30,903; ~ USD $22,250) were substantially lower. CONCLUSION: The cost of using a vena cava filter to prevent PE for those who have contraindications to prophylactic anticoagulation within 3 days of injury is prohibitive, unless such contraindications remain for longer than 7 days. (Australian New Zealand Clinical Trials Registry no.: ACTRN12614000963628).

A tale of two centers: Is low-molecular-weight heparin really superior for prevention of posttraumatic venous thromboembolism?

BACKGROUND: Low-molecular-weight heparin (LMWH) is widely used for venous thromboembolism chemoprophylaxis following injury. However, unfractionated heparin (UFH) is a less expensive option. We compared LMWH and UFH for prevention of posttraumatic deep venous thrombosis (DVT) and pulmonary embolism (PE). METHODS: Trauma patients 15 years or older with at least one administration of venous thromboembolism chemoprophylaxis at two level I trauma centers with similar DVT-screening protocols were identified. Center 1 administered UFH every 8 hours for chemoprophylaxis, and center 2 used twice-daily antifactor Xa-adjusted LMWH. Clinical characteristics and primary chemoprophylaxis agent were evaluated in a two-level logistic regression model. Primary outcome was incidence of DVT and PE. RESULTS: There were 3,654 patients: 1,155 at center 1 and 2,499 at center 2. The unadjusted DVT rate at center 1 was lower than at center 2 (3.5% vs. 5.0%; p = 0.04); PE rates did not significantly differ (0.4% vs. 0.6%; p = 0.64). Patients at center 2 were older (mean, 50.3 vs. 47.3 years; p < 0.001) and had higher Injury Severity Scores (median, 10 vs. 9; p < 0.001), longer stays in the hospital (mean, 9.4 vs. 7.0 days; p < 0.001) and intensive care unit (mean, 3.0 vs. 1.3 days; p < 0.001), and a higher mortality rate (1.6% vs. 0.6%, p = 0.02) than patients at center 1. Center 1's patients received their first dose of chemoprophylaxis earlier than patients at center 2 (median, 1.0 vs. 1.7 days; p < 0.001). After risk adjustment and accounting for center effects, primary chemoprophylaxis agent was not associated with risk of DVT (odds ratio, 1.01; 95% confidence interval, 0.69-1.48; p = 0.949). Cost calculations showed that UFH was less expensive than LMWH. CONCLUSION: Primary utilization of UFH is not inferior to LMWH for posttraumatic DVT chemoprophylaxis and rates of PE are similar. Given that UFH is lower in cost, the choice of this chemoprophylaxis agent may have major economic implications. LEVEL OF EVIDENCE: Prognostic and epidemiological, level II; Therapeutic, level III.

Avaliação do risco de sangramento na profilaxia do tromboembolismo venoso / Bleeding risk assessment for venous thromboembolism prophylaxis

Resumo O tromboembolismo venoso (TEV) é uma das principais causas preveníveis de morbimortalidade em pacientes hospitalizados, sendo a embolia pulmonar (EP) fatal possivelmente a sua primeira manifestação. Diretrizes nacionais e internacionais recomendam o uso de modelos de avaliação de risco para a prescrição de profilaxia do TEV em pacientes hospitalizados. Apesar das evidências e diretrizes de apoio, o uso da tromboprofilaxia permanece abaixo do ideal, o que pode resultar da baixa conscientização dos benefícios da profilaxia, mas também pode refletir o medo de complicações hemorrágicas, justificando a subutilização da tromboprofilaxia em todo o mundo. A avaliação do risco de sangramento é, portanto, necessária para a adequação de profilaxia e deve ser realizada de forma concomitante à avaliação do risco de trombose. O objetivo desta revisão é salientar a importância da avaliação conjunta do risco de TEV e do risco de sangramento em pacientes hospitalizados.

Abstract Venous thromboembolism (VTE) is one of the main preventable causes of morbidity and mortality in hospitalized patients and fatal pulmonary embolism (PE) may be its first manifestation. Several national and international guidelines recommend using risk assessment models for prescription of VTE prophylaxis in hospitalized patients. Despite evidence and guidelines supporting VTE prevention, use of VTE prophylaxis in hospitalized patients remains suboptimal, which may be because of low awareness of the benefits of VTE prophylaxis, but might also reflect fear of bleeding complications in these patients, since this constitutes one of the main reasons for underutilization of thromboprophylaxis worldwide. Bleeding risk assessment is therefore necessary for adequate prophylaxis prescription and should be carried out concurrently with assessment of the risk of thrombosis. The purpose of this review is to highlight the importance of jointly assessing risk of VTE and risk of bleeding in hospitalized patients.

Time Trends in Pulmonary Embolism Mortality Rates in the United States, 1999 to 2018.

Background Although historical trends before 1998 demonstrated improvements in mortality caused by pulmonary embolism (PE), contemporary estimates of mortality trends are unknown. Therefore, our objective is to describe trends in death rates caused by PE in the United States, overall and by sex-race, regional, and age subgroups. Methods and Results We used nationwide death certificate data from Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research to calculate age-adjusted mortality rates for PE as underlying cause of death from 1999 to 2018. We used the Joinpoint regression program to examine statistical trends and average annual percent change. Trends in PE mortality rates reversed after an inflection point in 2008, with an average annual percent change before 2008 of -4.4% (-5.7, -3.0, P<0.001), indicating reduction in age-adjusted mortality rates of 4.4% per year between 1999 and 2008, versus average annual percent change after 2008 of +0.6% (0.2, 0.9, P<0.001). Black men and women had approximately 2-fold higher age-adjusted mortality rates compared with White men and women, respectively, before and after the inflection point. Similar trends were seen in geographical regions. Age-adjusted mortality rates for younger adults (25-64 years) increased during the study period (average annual percent change 2.1% [1.6, 2.6]) and remained stable for older adults (>65 years). Conclusions Our study findings demonstrate that PE mortality has increased over the past decade and racial and geographic disparities persist. Identifying the underlying drivers of these changing mortality trends and persistently observed disparities is necessary to mitigate the burden of PE-related mortality, particularly premature preventable PE deaths among younger adults (<65 years).

Improving VTE risk assessment and prophylaxis prescribing rate in medical patients: integrating risk assessment tool into the workflow.

Medical inpatients often have important risk factors for venous thromboembolism (VTE). In our institution, VTE prophylaxis in this group was underused. The main barriers identified were inattention to VTE prophylaxis, competing priorities and lack of confidence in the decision-making. We aimed to improve the rate of VTE prophylaxis use by introducing a paper-based risk assessment tool, with actionable management recommendations within the prescription chart. The rationale was that an assessment tool at the point of prescribing can reduce steps between decision-making and prescribing process, thus promoting confidence and acting as a reminder. A total of 552 prescription charts completed over a period of 29 weeks were examined during the baseline period. In the postintervention period, 871 charts completed over 40 weeks period were examined. The risk assessment tool was completed in 51% of the cases examined in the postintervention period. The introduction of the risk assessment tool was associated with a significant change in the pattern of VTE pharmacological prophylaxis use. The change occurred when the form was made highly visible and enclosed in the prescription chart. The pharmacological prophylaxis use was higher with a completed assessment form than without (mean (SD) 97.5% (7.6%) vs 70.1% (19.4%); p<0.0001). The rate of appropriate prophylaxis decision was 98.2% (SD 5.2%) with a completed assessment form, and 80.7% (SD 17.9%) when it was not used. The qualitative interviews revealed positive themes; many users found it useful, easy and convenient to use. Our data have shown that a paper-based VTE risk assessment tool placed within the prescription chart could substantially improve the rate of appropriate assessment and VTE prophylaxis implementation. This suggests that tool clearly needs to be a seamless integration into the workflow to capture users' attention and mitigate the influence of time perception.

Practice Variation in Vena Cava Filter Use Among Trauma Centers in the National Trauma Database.

BACKGROUND: Agreement regarding indications for vena cava filter (VCF) utilization in trauma patients has been in flux since the filter's introduction. As VCF technology and practice guidelines have evolved, the use of VCF in trauma patients has changed. This study examines variation in VCF placement among trauma centers. MATERIALS AND METHODS: A retrospective study was performed using data from the National Trauma Data Bank (2005-2014). Trauma centers were grouped according to whether they placed VCFs during the study period (VCF+/VCF-). A multivariable probit regression model was fit to predict the number of VCFs used among the VCF+ centers (the expected [E] number of VCF per center). The ratio of observed VCF placement (O) to expected VCFs (O:E) was computed and rank ordered to compare interfacility practice variation. RESULTS: In total, 65,482 VCFs were placed by 448 centers. Twenty centers (4.3%) placed no VCFs. The greatest predictors of VCF placement were deep vein thrombosis, spinal cord paralysis, and major procedure. The strongest negative predictor of VCF placement was admission during the year 2014. Among the VCF+ centers, O:E varied by nearly 500%. One hundred fifty centers had an O:E greater than one. One hundred sixty-nine centers had an O:E less than one. CONCLUSIONS: Substantial variation in practice is present in VCF placement. This variation cannot be explained only by the characteristics of the patients treated at these centers but could be also due to conflicting guidelines, changing evidence, decreasing reimbursement rates, or the culture of trauma centers.

A Review of Two Heparin Prophylaxes for Trauma.

Venous thromboembolism (VTE) prophylaxis has a significant impact on mortality and morbidity in trauma patients. This article reviews 9 published studies that investigate and compare low-dose unfractionated heparin (LDUH) with low-molecular-weight heparin (LMWH) for prophylaxis of VTE in the trauma patient population in terms of efficacy, safety, and cost. There is no difference between LDUH and LMWH for VTE prophylaxis. Four databases were utilized to find 9 relevant studies whose patient population was adult trauma patients: PubMed, CINAHL, EMBASE and Scopus. Two studies found statistically significant differences in deep venous thrombosis, and 3 found differences in pulmonary embolism between LDUH and LMWH. Only 1 study demonstrated a significant difference in bleeding complications between the 2 treatment regimens. Two statedthat using LDUH resulted in remarkable cost savings versus LMWH. The 9 studies all came to different conclusions. Contrary findings may have been affected by population variety, different dosing regimens, various applications of mechanical VTE prophylaxis, and/or different VTE-screening tools. All of the studies had major variances leading to conflicting results, which made this review unable to draw concrete conclusions. Limitations of each study, population variety, and disparity of dosing regimens made it difficult for this review to make recommendations for practice.

Venous Thromboembolism Prophylaxis Strategies for People Undergoing Elective Total Hip Replacement: A Systematic Review and Network Meta-Analysis.

OBJECTIVES: To assess the efficacy and safety of venous thromboembolism prophylaxis in people undergoing elective total hip replacement. METHODS: Systematic review and Bayesian network meta-analyses of randomized controlled trials were conducted for 3 outcomes: deep vein thrombosis (DVT), pulmonary embolism (PE), and major bleeding (MB). MEDLINE, EMBASE, and Cochrane Library (CENTRAL) databases were searched. Study quality was assessed using the Cochrane risk-of-bias checklist. Fixed- and random-effects models were fitted and compared. The median relative risk (RR) and odds ratio (OR) compared with no prophylaxis, with their 95% credible intervals (CrIs), rank, and probability of being the best, were calculated. RESULTS: Forty-two (n = 24 374, 26 interventions), 30 (n = 28 842, 23 interventions), and 24 (n = 31 792, 15 interventions) randomized controlled trials were included in the DVT, PE, and MB networks, respectively. Rivaroxaban had the highest probability of being the most effective intervention for DVT (RR 0.06 [95% CrI 0.01-0.29]). Strategy of low-molecular-weight heparin followed by aspirin had the highest probability of reducing the risk of PE and MB (RR 0.0011 [95% CrI 0.00-0.096] and OR 0.37 [95% CrI 0.00-26.96], respectively). The ranking of efficacy estimates across the 3 networks, particularly PE and MB, had very wide CrIs, indicating high degree of uncertainty. CONCLUSIONS: A strategy of low-molecular-weight heparin given for 10 days followed by aspirin for 28 days had the best benefit-risk balance, with the highest probability of being the best on the basis of the results of the PE and MB network meta-analyses. Nevertheless, there is considerable uncertainty around the median ranks of the interventions.

[Quality assessment of the clinical practice guideline for diagnosis, treatment and prevention of pulmonary thromboembolism, 2018].

Objective: To assess the quality of the clinical practice guideline for diagnosis, treatment and prevention of pulmonary thromboembolism, 2018 in China, providing the references for updating and developing clinical practice guidelines of this field in the future. Methods: The quality of the clinical practice guideline for diagnosis, treatment and prevention of pulmonary thromboembolism, 2018 in China was assessed using the internationally recognized instrument Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ). AGREE Ⅱ instrument consisted of 23 items in six domains, followed by two overall assessment items. Each item was scored from 1 to 7. The final overall guideline quality considered all domain items. Results: The scores of the six AGREE Ⅱ domains were: Scope and purpose 76.4%, Stakeholder involvement 55.6%, Rigor of development 78.1%, Clarity and presentation 83.3%, Applicability 55.2%, and Editorial independence 66.7%. The guideline was recommended for clinical use. Among the 101 recommendations, recommendations based on Levels High, Moderate and Low evidence accounted for 7 (6.9%), 31 (30.7%) and 63 (62.4%), respectively. Conclusion: The methodological quality of the clinical practice guideline for diagnosis, treatment and prevention of pulmonary thromboembolism, 2018 in China was great, but the levels of evidence were not high. More efforts were urgently required to improve in Stakeholder involvement and applicability. Especially corresponding economic research evidence, as well as preferences of patients and the public should be considered in the future development of clinical practice guidelines.

The case of Patient Safety Indicator 12 (PSI12): use of administrative data to estimate the incidence of "Postoperative Pulmonary Embolism or Deep Vein Thrombosis". A pilot study in a General Hospital.

INTRODUCTION: The AHRQ Quality Indicators (QIs) were created in order to both identify the performance and to track the improvement of patient safety. Patient Safety Indicator 12 (PSI12) is relative to the risk of Post Operatory Pulmonary Embolism or Deep Venous Thrombosis (PO DVT/PE). This pilot study has three main objectives. Firstly, to perform an analysis of the performance of different hospital wards by using administrative data; secondly, to analyze defects in the process that led to the occurrence of the adverse event; thirdly, reviewing the single PO DVT/PE. METHODS: Data were extracted from a Hospital Information data flow (SIO) and compared to Clinical Discharge Record. PSI12 estimates were computed before and after the screening. Control Charts allowed the static analysis of performance between different hospital wards in 2014. The Ishikawa diagram was drawn for the analysis of the underlying causal process. RESULTS: The number of PSI12 cases provided by DRGs through SIO data flow decreased from 45 to six after the comparison with the correspondent clinical records. Four clinical records provided full information allowing the analysis of process. The Ishikawa Diagram identified the defects in the process of prophylaxis that resulted into a PO DVT/PE. DISCUSSIONS: The clinical records screening revealed a lower incidence of PO DVT/PE with respect to the DRGs statistics. Overall the PO DVT/PE occurrence in 2014 fell into the control limits, although the result could be undermined by the low quality of clinical records compilation. The failure in the prophylaxis procedure was imputable to pitfalls in the health care management and to the individual attitude towards patient safety procedures. In conclusion, the reliability and validity of administrative data in monitoring quality and safety are worthy to be explored in the context of further validation studies.

Obstructive sleep apnea affects complication rates following knee arthroscopy but use of continuous positive airway pressure is not protective against complications.

PURPOSE: Obstructive sleep apnea (OSA) has not been studied as a risk factor for complications following knee arthroscopy. The goals of this study were to: (1) compare complication rates after knee arthroscopy between patients with and without OSA and (2) evaluate whether continuous positive airway pressure (CPAP) mitigated complication rates. METHODS: A national private insurance database was queried for patients undergoing simple knee arthroscopy from 2007 to 2016. Patients with a diagnosis of OSA were then identified using ICD-9/10 codes. Patients with OSA were then subdivided into cohorts with and without a billing code for a CPAP device. Adverse events within 30 days postoperatively related to OSA were then assessed in all groups: (1) emergency room (ER) visit, (2) hospital admission, (3) pulmonary embolism (PE), (4) myocardial infarction, (5) respiratory arrest and (6) in-hospital mortality within 6 months postoperatively. Adverse event rates were compared between the control and study groups using a multivariable regression analysis. RESULTS: 97,036 patients underwent simple knee arthroscopy with 8656 patients having a diagnosis of OSA. Of these, 3820 (44%) had orders for CPAP machines. After controlling for confounders, patients with OSA had significantly higher risk of ER visits, PE and respiratory arrest compared to controls (p < 0.05). The majority of these significant findings persisted regardless of CPAP use. There were no significant differences in complication rates between OSA patients with and without CPAP orders. CONCLUSIONS: OSA appears to be independently associated with a higher risk for ER visits, PE and respiratory arrest following knee arthroscopy after controlling for demographic and comorbidity confounders. An order for CPAP was not associated with a significant reduction the risk for these complications. CPAP noncompliance may not be as important a factor when risk stratifying patients undergoing ambulatory knee arthroscopy compared to more significant medical comorbidities. LEVEL OF EVIDENCE: III.

Health-care Cost Impact of Continued Anticoagulation With Rivaroxaban vs Aspirin for Prevention of Recurrent Symptomatic VTE in the EINSTEIN-CHOICE Trial Population.

BACKGROUND: Using data from the Reduced-Dose Rivaroxaban in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism (EINSTEIN-CHOICE) trial, this study assessed cost impact of continued anticoagulation therapy with rivaroxaban vs aspirin. METHODS: Total health-care costs (2016 USD) associated with rivaroxaban and aspirin were calculated as the sum of clinical event costs and drug costs from a US managed care perspective. Clinical event costs were calculated by multiplying event rate by cost of care. One-year Kaplan-Meier clinical event rates for recurrent pulmonary embolism, recurrent DVT, all-cause mortality, and bleeding were obtained from EINSTEIN-CHOICE. Cost of care was determined by literature review. Drug costs were the product of drug price (wholesale acquisition cost) and treatment duration. A one-way sensitivity analysis was conducted. RESULTS: Rivaroxaban users had lower per patient per month (PPPM) clinical event costs compared with aspirin users ($123, $243, and $381 for rivaroxaban 10 mg, rivaroxaban 20 mg, and aspirin, respectively). However, vs aspirin, PPPM total health-care costs were $24 higher for patients treated with rivaroxaban 10 mg ($143 higher for rivaroxaban 20 mg) due to higher cost of rivaroxaban. With a 15% discount for rivaroxaban 10 mg, the lower cost of clinical events for the rivaroxaban-treated patients more than fully offset the higher drug costs, and yielded a $19 lower total health-care cost. CONCLUSIONS: Continued therapy with rivaroxaban 10 and 20 mg vs aspirin was associated with lower clinical event costs but higher total health-care costs; with a 15% drug discount rivaroxaban 10 mg had lower total health-care costs than aspirin.