Evaluation of surrogacy in the multi-trial setting based on information theory: an extension to ordinal outcomes.

In clinical trials, surrogate outcomes are early measures of treatment effect that are used to predict treatment effect on a later primary outcome of interest: the primary outcome therefore does not need to be observed and trials can be shortened. Evaluating surrogates is a complex area as a given treatment can act through multiple pathways, some of which may circumvent the surrogate. One of the best established and practically sound approaches to surrogacy evaluation is based on information theory. We have extended this approach to the case of ordinal outcomes, which are used as primary outcomes in many medical areas. This extension provides researchers with the means of evaluating surrogates in this setting, which expands the usefulness of the information theory approach while also demonstrating its versatility.

Multicenter Review of Current Practices Associated With Venous Thromboembolism Prophylaxis in Pediatric Patients After Trauma.

OBJECTIVES: Frequency of venous thromboembolism in pediatric trauma patients admitted to PICUs is not insignificant, ranging up to 6%. Risk factors have been identified in this population. However, there is little consensus of actual venous thromboembolism prophylaxis practice. We examined factors associated with venous thromboembolism prophylaxis in PICUs. DESIGN: A retrospective study evaluating associations with mechanical venous thromboembolism prophylaxis, pharmacologic venous thromboembolism prophylaxis, or dual therapy (DUAL) prophylaxis compared with no venous thromboembolism prophylaxis. Multivariable logistic regression explored the relationship between prophylaxis type and selected covariates with stepwise selection method to identify the independent predictors of venous thromboembolism prophylaxis utilization. SETTING: Five level I/II pediatric trauma centers in the United States. PATIENTS: Children less than 18 years from January 1, 2013, to December 31, 2013, admitted to the PICU after a trauma, identified through combined trauma registry and Virtual Pediatric Systems database. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Six hundred ninety-two patients were included in the database, with 55 excluded for missing data. Of the remaining 637 patients, 538 (84.5%) had no venous thromboembolism prophylaxis by 48 hours, 77 (12.1%) had only mechanical venous thromboembolism prophylaxis, 11 (1.7%) had DUAL, and 11 (1.7%) had pharmacologic venous thromboembolism prophylaxis alone. Multivariable analysis showed increased age, and orthopedic procedure was associated with all forms of prophylaxis. Orthopedic procedures were associated with higher utilization of dual prophylaxis use (odds ratio, 5.2; 95% CI, 1.2-21.8), pharmacologic venous thromboembolism prophylaxis (odds ratio, 8.5; 95% CI, 2.3-31.7), and mechanical venous thromboembolism prophylaxis (odds ratio, 2.2; 95% CI, 1.1-4.2) alone. Brain/spinal cord procedures (odds ratio, 3.7; 95% CI, 1.9-7.3) and abdominal procedures (odds ratio, 6.6; 95% CI, 2.5-17.1) were associated with mechanical venous thromboembolism prophylaxis. Head injury was associated with a decreased use of any prophylaxis (odds ratio, 0.5; 95% CI, 0.3-0.9). Patient comorbidities were associated with decreased use of mechanical venous thromboembolism prophylaxis (odds ratio, 0.5; 95% CI, 0.3-1.0). CONCLUSIONS: Pharmacologic venous thromboembolism prophylaxis is not common in critically ill children after trauma. Patient age, orthopedic and vascular procedures, and higher injury severity are associated with pharmacologic venous thromboembolism prophylaxis.

Effect of Intermittent Pneumatic Compression on Preventing Deep Vein Thrombosis Among Stroke Patients: A Systematic Review and Meta-Analysis.

BACKGROUND: Deep vein thrombosis (DVT) and subsequent pulmonary embolism (PE) are common complications of stroke. However, the effect of intermittent pneumatic compression (IPC) for patients after stroke is uncertain. OBJECTIVES: To assess the effectiveness and safety of IPC in reducing the risk of DVT, PE, and mortality in stroke patients. METHODS: We searched leading medical databases including Medline, EMBASE, Cochrane Library, Wanfang, CNKI, and CBM, from inception to June 2, 2017. Studies comparing IPC with no IPC in stroke patients were included. Agreement was measured using simple agreement and kappa statistics. The rates of PE, DVT, and mortality were compared. The results were pooled using a fixed effects model to evaluate the differences between the IPC and control groups. If there was significant heterogeneity in the pooled result, a random effect model was used. RESULTS: We identified seven randomized controlled trials that included 3,551 stroke patients. The average calculated κ for the various parameters was κ = 0.96 (0.70-1). Overall, IPC significantly reduced the incidence of DVT in stroke patients (risk ratio [RR] = 0.50; 95% confidence interval [CI 0.27, 0.94]). At the same time, IPC increased IPC-related adverse events (RR = 5.71; 95% CI [3.40, 9.58]). Though IPC was associated with a significant increase in survival by 4.5 days during 6 months of follow-up (148-152 days; 95% CI [-0.2, 9.1]), there was a mean gain of only 0.9 days (26.7-27.6 days; 95% CI [2.1, 3.9]) in quality-adjusted survival during the 6-month follow-up. Overall, sensitivity analyses did not alter these findings. LINKING EVIDENCE TO ACTION: This review provides an important basis for preventing DVT in stroke patients, especially in hemorrhagic stroke patients. IPC significantly reduces the risk of DVT and significantly improves survival in a wide variety of patients who are immobile after stroke. However, IPC does not significantly improve quality-adjusted survival. Clinicians should take functional status and quality of life into consideration when making decisions for stroke patients.

Postpartum Thromboembolism Prophylaxis during Delivery Hospitalizations.

OBJECTIVE: This article evaluates trends in venous thromboembolism (VTE) prophylaxis during delivery hospitalizations in the United States. METHODS: We utilized an administrative database to determine if women hospitalized for vaginal or cesarean delivery received pharmacologic VTE prophylaxis, mechanical VTE prophylaxis, or both from January 2011 through March 2015. Mechanical prophylaxis included sequential compression devices, graduated compression stockings, and other pneumatic devices. Pharmacologic prophylaxis included unfractionated heparin, low molecular weight heparin, or fondaparinux. Probability of use of thromboprophylaxis for individual hospitals was estimated in an adjusted model. RESULTS: A total of 956,428 women who underwent cesarean and 1,914,142 women who underwent vaginal delivery were included in the analysis. Cesarean VTE prophylaxis declined between 2011 (50.3%) and 2015 (47.7%; p < 0.01). Of women undergoing vaginal delivery, 2.9% received prophylaxis. Delivery hospital was an important determinant of cesarean prophylaxis: in the adjusted model, one-third of hospitals used prophylaxis for less than 20% of deliveries, one-third of hospitals used prophylaxis for 20 to 80% of deliveries, and the final third of hospitals used prophylaxis in greater than 80% of deliveries. CONCLUSION: While many hospitals appear to be following best clinical practices, some do not provide routine cesarean VTE prophylaxis. Minimizing care quality variation may improve maternal safety.

"Keep Calm and Stop the Clot".

The impact of a nurse-driven change project.

What Factors Influence Compliance With Sequential Compression Devices in an Orthopaedic Unit: A Quality Assurance Observational Study.

The purpose of this study was to determine the compliance rate with sequential suppression devices (SCDs) of patients admitted to an orthopaedic unit of a level I trauma center. A quality assurance observational study was conducted over a 4-week period (June/July 2015). Three observations were performed per 24-hour period (0700, 1300, 1900 hours). ``Full SCD compliance'' was defined as the SCD ordered, on and functioning properly at the time of observation. Of the 1356 observations in 109 patients, 434 (32%) were fully compliant with SCD prophylaxis. SCD compliance in trauma patients was higher (21%) as compared with elective surgical patients (10%) (p < .0001). Morning observations had the highest compliance rate (38.3%), whereas the afternoon (23.5%) and evening observations (33.1%) had less compliance rates (p < .0001). There was a significantly higher compliance rate on weekdays (33.9%) as compared with weekends (28%) (p < .03). The overall low compliance level (32%) indicates compliance challenges and not the modality of the prophylaxis as the cause (Journal of Surgical Orthopaedic Advances 27(4):307-311, 2018).

Usability of advanced pneumatic compression to treat cancer-related head and neck lymphedema: A feasibility study.

BACKGROUND: This functional usability study assessed ease of use, fit, comfort, and potential clinical benefits of advanced pneumatic compression treatment of cancer-related head and neck lymphedema. METHODS: Patient-reported comfort and other treatment aspects were evaluated and multiple face and neck measurements were obtained on 44 patients with head and neck lymphedema before and after 1 treatment session to assess usability and treatment-related lymphedema changes. RESULTS: A majority of the patients (82%) reported the treatment was comfortable; most patients (61%) reported feeling better after treatment, and 93% reported that they would be likely to use this therapy at home. One treatment produced overall small but highly statistically significant reductions in composite metrics (mean ± SD) of the face (82.5 ± 4.3 cm vs 80.9 ± 4.1 cm; P < .001) and neck (120.4 ± 12.2 cm vs 119.2 ± 12.1 cm; P < .001) with no adverse events. CONCLUSION: Results found the treatment to be safe, easy to use, and well tolerated while demonstrating edema reduction after a single initial treatment.

A survey of knowledge and application of mechanical thromboprophylaxis among the medical staff of intensive care units in North China.

INTRODUCTION: Mechanical prophylaxis with graduated compression stockings (GCS) or intermittent pneumatic compression (IPC) is suggested for patients who are bleeding or at high risk for major bleeding. OBJECTIVES: To explore how intensive care unit (ICU) medical staff in North China comprehend and practice mechanical thromboprophylaxis. METHODS: Questionnaires comprising 39 questions including 4 dimensions of thromboprophylaxis were administered in ICUs in North China. RESULTS: Fifty-two ICUs were surveyed from September 2014 to January 2015. A total of 2500 questionnaires were sent and 1861 were returned, corresponding to approximately 74.4%. Approximately 52.30% of all surveyed medical staff indicated they often practiced mechanical thromboprophylaxis. Twenty-five percentage of them never used or had never heard of mechanical thromboprophylaxis. Thirty-eight percent and twenty-four percent of them doubted the effectiveness of GCS and IPC respectively. Regarding the use of GCS, 50.2% of them were concerned about skin injury, 57.4% were concerned about difficulty with removal and 57.6% were anxious about discomfort. Thirty-five percent of the medical staff feared the ease of thrombus release during IPC thromboprophylaxis. CONCLUSIONS: A wide gap exists with regards to the knowledge and application of mechanical thromboprophylaxis for venous thromboembolism (VTE) between the medical staff of our country and abroad. Strengthened standardized training may help medical staff improve their understanding and application of mechanical thromboprophylaxis. Amelioration of concerns regarding IPC and GCS could help increase the rate of mechanical thromboprophylaxis for VTE, reduce the occurrence of VTE in ICUs and improve the prognosis of these critically ill patients.

Radiobiological analysis of stereotactic body radiation therapy for an evidence-based planning target volume of the lung using multiphase CT images obtained with a pneumatic abdominal compression apparatus: a case study.

This study evaluated the efficiency of stereotactic body radiation therapy of lung (SBRT-Lung) in generating a treatment volume using conventional multiple-phase three-dimensional computed tomography (3D-CT) of a patient immobilized with pneumatic abdominal compression. The institutional protocol for SBRT-Lung using the RapidArc technique relied on a planning target volume (PTV) delineated using 3D-CT and accounted for linear and angular displacement of the tumor during respiratory movements. The efficiency of the institutional protocol was compared with that of a conventional method for PTV delineation based on radiobiological estimates, such as tumor control probability (TCP) and normal tissue complication probability (NTCP), evaluated using dose-volume parameters. Pneumatic abdominal compression improved the TCP by 15%. This novel protocol improved the TCP by 0.5% but reduced the NTCP for lung pneumonitis (0.2%) and rib fracture (1.0%). Beyond the observed variations in the patient's treatment setup, the institutional protocol yielded a significantly consistent TCP (p < 0.005). The successful clinical outcome of this case study corroborates predictions based on radiobiological evaluation and deserves validation through an increased number of patients.

Can intermittent pneumatic compression (IPC) reduce time to surgery for malleolar fractures?

BACKGROUND: Surgery of malleolar fractures are often delayed due to oedema of the ankle. The use of intermittent pneumatic compression (IPC) is thought to reduce oedema of the fracture site and thereby time to surgery in patients with malleolar fractures. PURPOSE: To investigate the influence of IPC on the time from admission to surgery in adult patients with internal fixated primary malleolar fractures. METHODS: February 1st 2013 IPC was introduced as a standard treatment for all patients admitted with a malleolar fracture. Data was retrieved from the hospital database 2 years prior and after the introduction date. The patients were found using ICD-10 diagnoses codes (DS825-8) in combination with NOMESCO procedure codes (KNHJ40-3, KNHJ60-3, KNHJ70-3, KNHJ80-3). One reviewer examined all the journals and classified the x-ray images by the AO classification. The primary outcome measure was time from diagnosis to surgery. RESULTS: 74 patients in the IPC cohort and 113 in the non-IPC cohort were included in the study. Time from admission to surgery was 21.9 (10.8-45.0) hours in the control group and 22.1 (8.9-41.2) hours in the IPC group. The difference is not statistically significant (p=0.420). A subgroup analysis divided the patients operated before and after 24h from admission. The median (IQR) time to surgery for patients operated before 24h was 10.9 (6.4-16.9) hours for the control group and 9.9 (5.8-20.1) hours in the IPC group (p=0.989). The median (IQR) time to surgery for patients operated after 24h was 21.5 (4.1-57.0) hours for the control group and 18.4 (7.4-32.3) hours in the IPC group (p=0.353). INTERPRETATION: There was no benefit from IPC on time to surgery in patients with acute primary malleolar fracture in a cohort with a mean surgical delay less than 24h.

The use of foot pumps compression devices in the perioperative management of ankle fractures: Systematic review of the current literature.

BACKGROUND: Ankle fractures account for 9% of all fractures seen in the United Kingdom. 15,000 of these fractures undergo operative fixation each year. Soft tissue swelling impacts on timing of fixation due to fears of infection and wound dehiscence. The use of arterio-venous foot pumps (AVFP) is increasing in this population although the evidence for their efficacy is unclear. In order to address this, we present an overview of the evidence for AVFP device use following ankle fracture. METHODS: In September 2015 an electronic literature search was undertaken of studies comparing two or more methods of swelling reduction in patients with ankle fractures. Of 326 screened, 5 papers ultimately were included. RESULTS: Two studies reported a statistically significant reduction in swelling (p=0.03) and (p=0.03 at 24 hours, p=0.05 at 48 hours) after using AVFP devices compared to the controls (leg elevation +/ ice therapy). Stockle et al. reported a greater reduction in the preoperative ankle, midfoot and forefoot circumference at 24 hours in their AVFP group (53% versus 32% and 10% in their continuous cryotherapy and cool pack cryotherapy groups respectively). Whereas, Rohner-Spengler et al. observed improved preoperative swelling reduction in patients treated with a multilayer compression bandage when compared to their AVFP group. Keehan et al. reported that time to surgery was considerably reduced in patients treated with an AVFP device, (2.3 days) compared to those treated with leg elevation (4.6 days) (p=0.02). Length of stay (LOS) was not influenced by any of the tested interventions. CONCLUSIONS: AVFP devices have been shown to reduce time to surgery and degree of swelling before operative intervention better than other methods but the strength of evidence to support this remains poor.

Intermittent pneumatic compression in combination with low-molecular weight heparin in the prevention of venous thromboembolic events in esophageal cancer surgery.

INTRODUCTION: Aim of this study was to evaluate the use of Intermittent Pneumatic Compression (IPC) in the prevention of symptomatic venous thromboembolic events (VTE) in patients undergoing esophagectomy for cancer. METHODS: From a prospective database, all patients operated between 2010 and 2014 received IPC in addition to LMWH and were compared to a historical cohort of patients treated LMWH only (2004-2009). RESULTS: Of the 313 included patients, 195 (62%) received IPC. Patients with IPC received neoadjuvant chemoradiation more often (45% vs. 3%, P < 0.001), whereas, neoadjuvant chemotherapy was equally distributed (31% vs. 34%, P = 0.631). There were no differences with regard to surgical approach, operative time, blood loss, and ICU stay. Patients treated without IPC had a longer hospital stay (18 vs. 15 days, P = 0.014). Overall, 12 clinical VTE's occurred in 11 patients, which consisted of two deep venous thromboses and 10 pulmonary embolisms. In the group of patients, who received IPC 1.5% developed a symptomatic VTE compared to 6.8% in patients without IPC (OR = 0.215; 95% CI = 0.06-0.83). Multivariate analysis identified IPC as the only independent prognostic factor correlated with a reduction in postoperative VTE's (OR = 0.225; 95% CI = 0.06-0.88). CONCLUSION: The addition of IPC in patients undergoing esophagectomy for cancer was associated with a reduction in symptomatic VTE's. J. Surg. Oncol. 2017;115:181-185. © 2017 Wiley Periodicals, Inc.

Perioperative thromboprophylaxis in severely obese patients undergoing bariatric surgery: insights from a French national survey.

BACKGROUND: Venous thromboembolism (VTE) is a leading cause of death in obese patients undergoing bariatric surgery (BS), but there is neither consensus nor high-level guidelines yet on VTE prophylaxis in this specific population. OBJECTIVE: We aimed to evaluate patterns of BS perioperative thromboprophylaxis practices. SETTING: French obesity specialized care centers (CSO), which are tertiary care referral hospitals for the most severe cases of obesity METHODS: A detailed questionnaire survey (11 opened, 15 closed questions) investigating their prophylactic schemes of anticoagulation (molecule, dose, weight-adjustment, duration, associated measures, follow-up) was sent to the 37 CSO. RESULTS: Completion rate was 92%. Over 90% of respondents indicated using low molecular weight heparin. Enoxaparin was the most commonly used molecule (89%), twice daily (71%), started mostly 6 hours after BS (74%), whereas fondaparinux (9%), dalteparin (6%), and tinzaparin (6%) were less often prescribed. Dosing varied significantly according to centers from 4000 to 12,000 IU/d, with the most commonly used dose being 8000 IU once daily, 83%, as well as treatment duration (1 week, 9%; 3 weeks, 47%). Half CSO adjusted low molecular weight heparin dose to weight. Biological monitoring was performed in 88%. Only 1 center followed systematically anti-Xa activity. Associated measures such as elastic stoking or intermittent pneumatic compression were used in 32% and 26%, respectively, and both were used in 39%. CONCLUSION: This study finds significant discrepancies in thromboprophylaxis practices in obese patients undergoing BS, particularly with respect to treatment duration and dose adjustment, highlighting the urgent need for improved implementation of existing clinical practice guidelines in this VTE high-risk population.

Mechanical Prophylaxis after Lower Extremity Total Joint Arthroplasty: A Review.

Venous thromboembolism (VTE) is a serious complication that can occur after total hip and knee arthroplasty, and can potentially lead to significant morbidity and even mortality. While various modalities have been used to prevent VTE development, the medications can be associated with a number of adverse events. Therefore, mechanical prophylaxis with pumps and compressive devices has been used more frequently alone, or in combination, with medications. Therefore, the purpose of this study was to review the current literature on mechanical prophylaxis for VTEs after lower extremity total joint arthroplasty. Specifically, we reviewed mechanical prophylaxis after: 1) total hip arthroplasty and 2) total knee arthroplasty.

Compression therapy - current practice of care: level of knowledge in patients with venous leg ulcers.

BACKGROUND AND OBJECTIVES: Compression therapy is a mainstay in the causal treatment of patients with venous leg ulcers. It facilitates healing, reduces pain and recurrences, and increases quality of life. Up until now, there is a scarcity of scientific data with respect to the level of care and the specific knowledge of patients with venous leg ulcers. PATIENTS AND METHODS: At first presentation, patients with venous leg ulcers anonymously answered a standardized questionnaire. Participating facilities nationwide included 55 outpatient care services, 32 medical practices, four wound centers, and one specialized care center. RESULTS: Overall, 177 patients (mean age of 69.4; 75.1 % women) participated in the study. The average duration of florid venous leg ulcers was 17 months. With regard to compression therapy, 31.1 % of patients received none; 40.1 % used bandages; 28.8 % used stockings. Of the latter, 13.7 % were treated with compression class III; 67.4 %, with compression class II; and 19.6 %; with compression class I. While 70.6 % put on their stockings after getting out of bed in the morning, 21.1 % wore them day and night. In 39.2 % of individuals, the stockings caused them discomfort. Merely 11.7 % owned a donning device. On average, bandages were worn for 40.7 weeks, and 69 % were used without underpadding. In 2.8 % of patients, ankle and calf circumference was measured to monitor therapeutic success. 45.9 % reported doing leg exercises. CONCLUSIONS: Although it is considered a basic therapeutic measure in venous leg ulcers, one-third of all patients received no compression treatment. Moreover, given the long duration of ulcers, adequate product selection and correct use have to be questioned, too. Our findings indicate that improvements in the level of knowledge among users and prescribers as well as patient training are required.

Venous thromboembolism after lower limb arthroplasty: is chemical prophylaxis still needed?

BACKGROUND: Venous thromboembolism (VTE) is a significant complication of lower limb arthroplasty. The National Institute for Health and Care Excellence recommends routine use of chemical and mechanical prophylaxis to prevent VTE. Our high-volume, elective, arthroplasty unit adopted this guidance in 2008. PURPOSE: We examined our incidence of VTE before and after introduction of chemical thromboprophylaxis to determine whether the incidence of VTE reduced. METHODS: We retrospectively gathered data on 2 cohorts of patients-from January 2004 to August 2007 (Group 1) and January 2010 to December 2012 (Group 2). Patients in Group 1 received mechanical prophylaxis only (unless particularly high risk for VTE), and patients in Group 2 received mechanical and chemical prophylaxis. We recorded VTE occurring within 6 months of surgery. Patients in Group 1 receiving chemical prophylaxis were excluded. RESULTS: Group 1 had 2320 cases of primary and revision lower limb arthroplasty, and Group 2 had 1430 cases. VTE occurred in 37 cases in Group 1 (1.6 %), and in 17 cases in Group 2 (1.2 %). This difference was not statistically significant (p = 0.26). In Group 1, 1 patient died within 6 months due to pulmonary embolism (0.04 %); there were no VTE-related deaths in Group 2 (0 %). This was also not statistically significant (p = 0.06). CONCLUSIONS: Although our VTE rate reduced by 0.4 % and our VTE-related mortality reduced by 0.04 % after introduction of chemical thromboprophylaxis, these differences were not statistically significant. Chemical thromboprophylaxis may not be required in all patients undergoing arthroplasty providing appropriate mechanical prophylaxis is used.

The Use of Intermittent Pneumatic Compression in Orthopedic and Neurosurgical Postoperative Patients: A Systematic Review and Meta-analysis.

OBJECTIVE: The objective of this systematic review and meta-analysis was to carry out an up-to-date evaluation on the use of compression devices as deep vein thrombosis (DVT) prophylaxis methods in orthopedic and neurological patients. SUMMARY OF BACKGROUND DATA: There is an increased risk of DVT with surgery, particularly in patients who are not expected to mobilize soon after their procedures, such as orthopedic and neurosurgical patients. Compression devices are often employed for DVT prophylaxis in these patients. However, the true efficacy of these devices and the standardization of use with these devices are yet to be established. METHODS: Medline, CINAHL, Embase, Google Scholar, and the Cochrane library electronic databases were searched to identify randomized controlled trials and observational studies reporting on the use of compression devices for DVT prevention. RESULTS: Nine studies were included for review and meta-analysis. Use of an intermittent pneumatic compression device alone is neither superior nor inferior to chemoprophylaxis. CONCLUSIONS: In the absence of large randomized multicenter trials comparing the use of intermittent pneumatic compression or chemoprophylaxis alone to a combination of both treatments, the current evidence supports the use of a combined approach in high-risk surgical patients.

Venous thromboembolism prophylaxis during and following caesarean section: a survey of clinical practice.

BACKGROUND: Caesarean section (CS) is a significant risk factor for venous thromboembolism; however, the optimal method of thromboprophylaxis around the time of CS is unknown. AIMS: To examine current thromboprophylaxis practice during and following CS in Australia and New Zealand, and the willingness of obstetricians to participate in a randomised controlled trial (RCT) comparing different methods of thromboprophylaxis after CS. MATERIALS AND METHODS: An online survey was sent to fellows and trainees of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. RESULTS: There were 488 responses from currently practising obstetricians (response rate 23.4%). During CS, 48% and 80% of obstetricians recommended intermittent pneumatic compression (IPC) and elastic stockings (ES), respectively. Following CS, 96-97% of obstetricians recommended early ambulation, 87-90% recommended ES, 23-36% recommended IPC, and 42-65% recommended low molecular weight heparin (LMWH) depending on clinical factors. Increased BMI (OR 3.42; 95% CI 2.87-4.06), emergency CS (OR 1.88; 95% CI 1.67-2.16) and older maternal age (OR 1.37; 95% CI 1.26-1.49) were associated with more frequent LMWH use. Of obstetricians who prescribed LMWH, 70% adjusted the dose depending on maternal weight. LMWH therapy was most commonly recommended until discharge from hospital (31%), <5 days (24%) and 5-7 days (15%). Most obstetricians (58-79%) were willing to enrol women in a RCT, but less likely if the woman had an increased BMI or emergency CS. CONCLUSIONS: There is considerable variation in clinical practice regarding thromboprophylaxis during and following CS. Obstetricians support a RCT to assess different methods of thromboprophylaxis following CS.

Development of a Novel Composite Process Measure for Venous Thromboembolism Prophylaxis.

BACKGROUND: Postoperative venous thromboembolism (VTE) is important clinically, and VTE quality metrics are used in public reporting and pay-for-performance programs. However, current VTE outcome measures are not valid due to surveillance bias, and the Surgical Care Improvement Project (SCIP-VTE-2) process measure only requires prophylaxis within 24 hours of surgery. OBJECTIVES: We sought to (1) develop a novel measure of VTE prophylaxis that requires early ambulation, mechanical prophylaxis, and chemoprophylaxis throughout the hospitalization, and (2) compare hospital performance on the SCIP-VTE-2 process measure to this novel measure. RESEARCH DESIGN: A new composite measure of ambulation, sequential compression device (SCD), and chemoprophylaxis component measures was developed. The ambulation component required daily ambulation, the SCD component required documentation of continuous use, and the chemoprophylaxis component required patient-appropriate and medication-appropriate dosing and administration. Requirements could also be met with component-specific exceptions. Surgical patients at an academic center from 2012 to 2013 were assessed for SCIP-VTE-2 and composite measure adherence. RESULTS: Of 786 patients, 589 (74.9%) passed the ambulation measure, 494 (62.8%) passed the SCD measure, and 678 (86.3%) passed the chemoprophylaxis measure. A total of 268 (91.8%) SCD failures and 46 (42.6%) chemoprophylaxis failures were ordered but not administered. When comparing the 2 measures, 784 (99.7%) passed SCIP-VTE-2, whereas only 364 (46.3%) passed the composite measure (P<0.001). CONCLUSIONS: This new measure incorporates the critical aspects of VTE prevention to ensure defect-free care. After additional evaluation, this composite VTE prophylaxis measure with appropriate exclusion criteria may be a better alternative to existing VTE process and outcome measures.