Health Economic Analysis of Rivaroxaban and Warfarin for Venous Thromboembolism Management in Chinese Patients.

PURPOSE: Rivaroxaban, a direct oral anticoagulant, has demonstrated non-inferiority to warfarin for venous thromboembolism (VTE) treatment in clinical trials. This study aimed to analyze the direct medical costs for VTE management with rivaroxaban versus warfarin in Hong Kong Chinese patients. METHODS: In this retrospective observational study, VTE patients admitted to the Princess Margaret Hospital from March 2012 to February 2017 who were initiated and discharged with either rivaroxaban or warfarin were included. Patient demographic and clinical data, and healthcare resource utilization for VTE management were collected for the VTE index admission and 1-year post-discharge period. RESULTS: A total of 181 patients (90 in the rivaroxaban group; 91 in the warfarin group) were included. The mean (± SD) length of stay (LOS) was 4.8 ± 2.7 days and 8.0 ± 3.0 days in the rivaroxaban and warfarin groups, respectively (p > 0.001). The total cost for VTE index admission in the rivaroxaban group was significantly lower than that of the warfarin group (USD 5473 ± 1914 versus USD 3457 ± 1796; p < 0.001) (USD 1 = HKD 7.8). Recurrent VTE and bleeding rates in 1-year post-discharge period were not significantly different between the two groups. The direct total cost of the rivaroxaban group (USD 1271 ± 767) was significantly lower than that of the warfarin group (USD 1739 ± 1045) in 1-year post-discharge period (p < 0.001). CONCLUSIONS: Total direct cost and LOS for VTE admission and total cost in 1-year post-discharge period were significantly lower in patients initiated and discharged with rivaroxaban than those of warfarin.

The measurement properties of modified Rivermead mobility index and modified functional ambulation classification as outcome measures for Chinese stroke patients.

Valid, reliable, responsive and practical outcome measures are essential for treatment planning and outcome assessment. This study aimed to examine the measurement properties of Modified Rivermead Mobility Index (MRMI) and Modified Functional Ambulation Classification (MFAC) in Chinese stroke patients. The content validity, responsiveness, predictive validity, test-retest reliability, internal consistency and factor structure of the MRMI were examined. The content validity, discriminative power and inter-rater agreement of the MFAC were investigated. A total of 456 Chinese stroke patients were recruited. Evidence of good content validity, high responsiveness, adequate predictive validity, excellent test-retest reliability with 1.3-point as minimum detectable change in 95% confidence interval, high internal consistency and unidimensionality was obtained for the MRMI. Good content validity, sufficient discriminative power and excellent inter-rater agreement were demonstrated for the MFAC. Both the MRMI and MFAC have good to excellent measurement properties and are recommended as routine outcome measures for Chinese stroke patients.

Risk stratification of patients with early breast cancer.

BACKGROUND: Sentinel lymph node biopsy (SLNB) is the standard procedure performed to stage the axillae, and axillary node clearance (ANC) or radiotherapy is the treatment for nodal involvement. The aims of this study were to assess (1) the role of preoperative axillary ultrasonography (US), (2) the number of positive lymph nodes on ANC after either positive SLNB results or preoperative ultrasonographically guided nodal biopsy, and (3) the role of ANC in patients with node-positive breast cancer. PATIENTS AND METHODS: All patients with invasive breast cancer and axillary node involvement (but clinically negative nodes on presentation) who underwent ANC between January 2008 and December 2009 were identified, and information regarding clinicopathologic parameters and the nodal yield was collected. ANC was performed for 3 groups: patients with micrometastasis seen in SLNB specimens, macrometastasis seen in SLNB specimens, and positive axillary nodes detected on US biopsy. RESULTS: ANC was performed 141 times over the 2-year period. Forty-two percent of axillary node involvement was diagnosed by biopsy or preoperative US, and 40% of these patients received neoadjuvant chemotherapy. The remainder of cases were diagnosed by SLNB: 30% had micrometastases and 70% had macrometastases. Fifty percent of cancers with an ultrasonographic diagnosis of lymph node involvement were high grade and 56% had 4 or more positive nodes on ANC; this was significantly higher than in patients with positive SLNB results (P = .0001). Only 20% of patients with macrometastases on SLNB had 4 or more positive nodes in comparison with 56% with positive axillary lymph nodes by US (P < .0001). CONCLUSION: The routine use of preoperative axillary US and biopsy of abnormal nodes helps in identifying high-risk patients and thus aids in planning treatment.

The use of one step nucleic-acid amplification (OSNA) in clinical practice: a single-centre study.

BACKGROUND: The development of intraoperative sentinel node biopsy (SLNB) analysis methods, such as One-Step Nucleic Acid Amplification (OSNA), has made single-stage procedures possible. AIMS: We investigated the incidence of OSNA-detected lymph node positivity, comparing it to conventional histopathology, the incidence of non-SLNB node disease for the OSNA positive patients, and the breast re-operation rate, to assess the benefit from single-stage procedures. METHODS: This was a single-centre series of 573 consecutive patients undergoing SLNB (173 histopathology and 400 OSNA). RESULTS: OSNA-detected SLNB macrometastasis was similar to routine histopathology, with more micrometastasis detected (p < 0.001). Non-SLNB involvement in the OSNA group was similar to documented histopathological series. 27.6% of OSNA patients avoided further surgery because of OSNA. The median time for OSNA results was 42 min. CONCLUSIONS: OSNA is an effective method for detecting SLNB-metastasis. It is easily used in clinical practice, providing reliable results and negating the need for a second axillary operation.

Laparoscopic anti-reflux surgery is effective in obese patients with gastro-oesophageal reflux disease.

INTRODUCTION: Obesity has long been regarded as a risk factor for the development of gastro-oesophageal reflux disease (GORD). It has been claimed that surgical efficacy of laparoscopic anti-reflux operations is decreased in obese patients. The aim of this study was to assess whether laparoscopic anti-reflux surgery is effective in obese patients with GORD compared to non-obese patients. PATIENTS AND METHODS: A total of 366 patients (mean age 44 years; range, 12-86 years) underwent laparoscopic anti-reflux surgery between 1997-2003. Of these, 74 patients were considered obese; 58 patients had a body mass index (BMI) of 30-34 kg/m(2) and 16 were classified as morbidly obese with a BMI >or= 35 kg/m(2). Pre-operative symptomatic scoring, indications for surgery, pH studies, operative times and complications were compared between obese and non-obese patients. Symptomatic outcome and Visick score between the two groups were assessed at 6 weeks, 6 months and 1 year following surgery. RESULTS: Failure of medical treatment was the main reason for surgery in all groups. Operative time was longer in obese patients (mean time 93 min compared to 81 min; P = 0.0007), the main difficulty being gaining access because of their body habitus. All groups found the procedure to be effective in symptomatic outcome, 91% of obese patients compared to 92% of non-obese patients scored Visick I or II at 6 weeks' postoperatively. Similar Visick scoring was shown between the two groups at 6 months and 1 year, and in the morbidly obese group. CONCLUSIONS: The outcome of laparoscopic anti-reflux surgery is similar between obese and non-obese patients with no trend towards a worse outcome in the obese or morbidly obese. Obesity should not be seen as a contra-indication, although it may be more technically challenging in this group of patients. Good results can be achieved in obese patients.

Manipulating the self-assembling process to obtain control over the morphologies of copper oxide in hydrothermal synthesis and creating pores in the oxide architecture.

Copper oxide with various morphologies was synthesized by the hydrolysis of Cu(ac)2 with urea under mild hydrothermal conditions. In the synthesis, a series of organic amines with one or two amine groups (monoamine and diamine), including isobutylamine, octylamine (OLA), dodecylamine, octadecylamine (monoamines), ethylenediamine dihydrochloride, and hexamethylenediamine (diamines), was used as the "structure-directing agent". The monoamines led to the formation of one-dimensional (1D) aggregates of the copper oxide precursor particles (Pre-CuO), while the diamines led to the formation of two-dimensional (2D) aggregates. In both cases, the shorter carbon-chain amine molecules showed a stronger structure-directing function than that of the longer carbon-chain amine molecules. Next, in a series of syntheses, OLA was selected for further study, and the experimental parameters were systematically manipulated. When the hydrolysis was adjusted to a very slow rate by coupling the hydrolysis reaction with an esterification reaction, 1D aggregates of Pre-CuO were formed; when the hydrolysis rate was in the middle range, spherical Pre-CuO architectures composed of smaller linear aggregates were formed. However, under the high hydrolysis rates achieved by increasing the precipitation agent (urea) or by conducting the reaction at high temperatures (>/=120 degrees C), only Pre-CuO nanoparticles with a featureless morphology were formed. The formed spherical Pre-CuO architectures can be converted to a porous structure (CuOx) after removing the OLA molecules via calcination. Compared to the 1D and 2D aggregates, this porous architecture is highly thermally stable and did not collapse even after calcination at 500 degrees C. Preliminary results showed that the porous structure can be used both as a catalyst support and as a catalyst for the oxidation of CO at low temperatures.

Multihospital surveillance of nosocomial methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococcus, and Clostridium difficile: analysis of a 4-year data-sharing project, 1999-2002.

BACKGROUND: This study sought to establish a benchmark of resistant organism rates among a cohort of regional hospitals. METHODS: The Centers for Disease Control and Prevention (CDC) definitions were used to standardize the methodology for obtaining rates per 1000 patient days of nosocomial infection and colonization with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE), and nosocomial infection with Clostridium difficile (CDIF). Only newly acquired nosocomial cases were counted. Data were reported as individual hospital control charts and as cohorted aggregate data. VHA East Coast Infection Control Professionals from 32 hospitals in New Jersey and Pennsylvania were involved. RESULTS: Benchmarks were established with pooled mean rates for each cohort. During the observational period, a statistically significant downward trend was observed for VRE and MRSA (P = .02 and .0007, respectively), and an upward trend was observed for CDIF (P = .0256). CONCLUSION: Benchmarks were established to compare nosocomial MRSA, VRE, and CDIF rates. Although significant changes in rates were observed, no attempt was made to establish a causal relationship between infection control practices and observed rates. However, a secondary gain was achieved through sharing best practices.

Subspecialisation and its effect on the management of rectal cancer.

INTRODUCTION: To assess the impact of subspecialisation on surgical and oncological outcomes after rectal cancer surgery in a single surgical unit within a district general hospital. PATIENTS AND METHODS: A total of 207 patients with rectal cancer treated surgically by two colorectal surgeons and four experienced general surgeons at the Royal Berkshire Hospital, Reading, England between January 1995 and December 1999 were studied. A retrospective case-note review of each patient's personal details, operative and histological findings, their subsequent clinical progress and oncological outcomes, including 5-year survival were recorded. RESULTS: In the study group, 127 patients were treated by a colorectal surgeon and 80 by general surgeons. Pre-operative radiotherapy was more likely to be given to patients treated by a colorectal surgeon. Fewer permanent stomas were performed by colorectal surgeons. Postoperative morbidity, transfusion requirements, anastomotic leak rates and 30-day mortality were not significantly different. Tumour-involved circumferential resection margins, local recurrence rates and risk of distant metastases were similar between the two groups of surgeons. CONCLUSIONS: Colorectal subspecialisation has resulted in an increased use of pre-operative radiotherapy and fewer permanent stomas. No significant improvement in surgical or oncological outcomes after rectal cancer surgery have been observed.

A comparison of POSSUM, P-POSSUM and colorectal POSSUM for the prediction of postoperative mortality in patients undergoing colorectal resection.

PURPOSE: POSSUM (Physiologic and Operative Severity Score for enUmeration of Morbidity & Mortality) and P-POSSUM have been validated as scoring tools for the prediction of postoperative complications in general surgical patients. More recently a colorectal-specific POSSUM has been developed for mortality prediction. This study was designed to evaluate and compare the accuracy for mortality prediction of POSSUM, P-POSSUM, and colorectal POSSUM after major and complex major colorectal procedures. METHODS: The relationship between the observed and expected morbidity and mortality was examined in 347 consecutive patients (321 elective, 26 urgent) undergoing a major or complex major colorectal resection using POSSUM, P-POSSUM, and Colorectal POSSUM. The accuracy of using these scoring tools to predict mortality was assessed using Receiver Operator Characteristic curve analysis. RESULTS: A total of 347 consecutive patients (median age, 69 (range, 34-92) years) were assessed. Seventy-one patients (20.5 percent) suffered a postoperative complication and 15 patients (4.3 percent) died. The observed: expected POSSUM ratio for morbidity was 0.71 and mortality 0.68. The area under curve from Receiver Operator Characteristic curve analysis for POSSUM was 0.752. The observed:expected mortality ratio for P-POSSUM was 0.71, and the area under curve from Receiver Operator Characteristic curve analysis was 0.749. The observed:expected mortality ratio for colorectal POSSUM was 0.75, and the area under the curve from Receiver Operator Characteristic curve analysis was 0.781. CONCLUSIONS: Colorectal POSSUM provides comparable prediction of mortality risk after colorectal resection compared with POSSUM and P-POSSUM.

Twenty months' routine use of a new percutaneous tracheostomy set using controlled rotating dilation.

After a favorable trial period, we introduced the new percutaneous tracheostomy set, PercuTwist, in February of 2002 for our routine procedures. Over the next 20 mo, 90 procedures were performed with minimal complications. To prospectively evaluate this experience, we collected information on reasons for unit admission, operators' previous experience, the duration of prior tracheal intubation, the time needed for the procedure, the grading of the difficulty, the amount of bleeding, and the complications of the procedure. Twenty-two of 90 (24.4%) procedures were performed by senior consultants with experience; 68 of 90 (75.6%) were safely performed by intensive care residents under close bedside supervision. The mean time needed for the procedure was 13 min 7 s. In only one procedure during the entire study was any difficulty observed during the insertion process. This occurred because the initial skin incision was too small. However, no major bleeding or complications were encountered.