BMT CTN 1101 is a Phase III randomized controlled trial evaluating the comparative effectiveness of double unrelated umbilical cord blood (dUCB) versus HLA-haploidentical related donor bone marrow ...(haplo-BM) donor cell sources for blood or bone marrow transplantation (BMT) in patients with hematologic malignancies. Herein, we present the rationale, design and methods of the first cost-effectiveness analysis to be conducted alongside a BMT trial.
Consenting patients will provide health insurance information to allow calculation of direct medical costs from reimbursement records, and will provide out-of-pocket costs, time costs and health-related quality of life measures through an online survey. These outcomes will inform a cost-effectiveness analysis comparing dUCB and haplo-BM donor cell sources from patient, payer and societal perspectives.
Novel approaches may significantly change the cost, outcomes or availability of BMT. The results of this analysis will be the first to provide a comprehensive evaluation of the comparative effectiveness of these approaches from multiple perspectives.
Background Laparoscopic resection for colon cancer has been proven to have a similar oncological efficacy compared to open resection. Despite this, it is performed by a minority of colorectal ...surgeons. The aim of our study was to evaluate the short-term clinical, oncological and survival outcomes in all patients undergoing laparoscopic resection for colon cancer. Methods From July 2005 to December 2008, 202 consecutive patients underwent laparoscopic resection for colon cancer. Surgery was analysed on an intention to treat basis. The mean follow-up was 24.3 months. Results Two hundred twenty-two patients underwent resection for colon cancer. Two hundred two underwent laparoscopic resection (91%). One hundred sixteen were male patients. Mean age was 65.9 years (range = 24-91). The median length of stay was 6.6 days (mean = 7.1 days). One hundred eighty-eight of 202 (93.1%) were completed laparoscopically. Fourteen (6.9%) were converted. The overall morbidity rate was 15.8%. There were three clinically apparent anastomotic leaks. The 30-day mortality was 1 (0.5%). The mean nodal yield was 13.4 (range = 8-37) nodes. There were no positive margins detected. Overall survival in laparoscopically treated colon cancer was 88.1%. In those patients with non-metastatic disease, the overall survival was 90.7% (165/182). Conclusion Laparoscopic resection for colon cancer is achievable in 85% (188/222) of patients. This facilitates adequate oncological clearance. It is associated with a low morbidity rate and favourable short-term survival outcomes. This data reflects the potential outcomes dedicated MIS colorectal units will have to offer colon cancer patients once laparoscopic colorectal surgery becomes the de facto surgical approach.
Background Enhanced recovery programmes (ERPs) have demonstrated reduced morbidity and length of hospital stay in patients undergoing open elective colorectal resections. The application of ...laparoscopic techniques to colorectal surgery is associated with shorter length of stay and morbidity compared to open resections. In the setting of laparoscopic surgery, it is unclear whether there is an additive effect on length of stay and morbidity by combining these. The current study addresses the benefit of an ERP (RAPID protocol) in a cohort of matched patients undergoing laparoscopic sigmoid colon resection Materials and methods Consecutive patients over a 40-month period who underwent laparoscopic sigmoid colon resection were assigned either to the RAPID protocol (group 1) or traditional post operative care (group 2) in a non-randomised manner. Analysis was on an “intention to treat” basis. Primary and secondary endpoints were identified; primary endpoints included length of hospital stay and readmission rate. Secondary endpoints included morbidity and mortality rate. Results Seventy-three consecutive patients were included. Group 1 included 37 patients. Group 2 included 36 patients. Median length of hospital stay in groups 1 and 2 was 5 and 8 days, respectively (p = 0.01). Readmission rate in groups 1 and 2 was 8.1% and 8.3%, respectively (p = 0.98). Morbidity rate in groups 1 and 2 was 30% and 22%, respectively (p = 0.61); there was one mortality in each group. Conclusion The application of the ERP (RAPID) to patients undergoing laparoscopic sigmoid colon resection results in a significant improvement in length of hospital stay, with comparable morbidity and readmission rates.
Dose intense chemotherapy may improve efficacy with acceptable toxicity. A phase II study was conducted to determine the feasibility of a dose-intense two weekly schedule of capecitabine, ...oxaliplatin, and bevacizumab in metastatic colorectal cancer (mCRC).
49 patients with previously untreated mCRC were recruited. Nineteen received capecitabine (1750 mg/m(2) oral BD days 1-7)oxaliplatin (85 mg/m(2)i.v. day 1) and bevacizumab (5 mg/kg i.v. day 1) using a 14-day cycle (C1750). Following toxicity concerns capecitabine was reduced to 1500 mg/m2oral BD (C1500) and 30 further patients recruited.
Over 80% of patients received at least 75% of planned chemotherapy doses over the first two cycles. At C1750 Grade 3 or higher toxicity occurred in 74% (95% CI 49% to 91%) and on C1500 in 70% (95% CI 51% to 85%). The median progression-free survival was 6.9 months (95% CI 4.7 to 8.7) for C1750 dose and 8.9 months (95% CI 4.1 to 12.4) for C1500. 3 treatment-related deaths occurred.
Dose intense capecitabine and oxaliplatin with bevacizumab does not show additional efficacy and has potentially significant toxicity. Its use outside of clinical trials is not recommended.
ISRCTN41540878.
Few studies have evaluated the parietal lobe in schizophrenia despite the fact that it has an important role in attention, memory, and language-all functions that have been reported to be abnormal in ...schizophrenia. The inferior parietal lobule, in particular, is of interest because it is not only part of the heteromodal association cortex but also is part of the semantic-lexical network, which also includes the planum temporale. Both the inferior parietal lobule, particularly the angular gyrus of the inferior parietal lobule, and the planum temporale are brain regions that play a critical role as biological substrates of language and thought. The authors compared volume and asymmetry measures of the individual gyri of the parietal lobe by means of magnetic resonance imaging (MRI) scans.
MRI scans with a 1. 5-Tesla magnet were obtained from 15 male chronic schizophrenic and 15 comparison subjects matched for age, gender, and parental socioeconomic status.
Inferior parietal lobule volumes showed a leftward asymmetry (left 7.0% larger than right) in comparison subjects and a reversed asymmetry (left 6.3% smaller than right) in schizophrenic subjects. The angular gyrus accounted for this difference in asymmetry, with the left angular gyrus being significantly larger (18.7%) than the right in comparison subjects, a finding that was not observed in schizophrenic patients. A further test of angular gyrus asymmetry showed a reversal of the normal left-greater-than-right asymmetry in the schizophrenic patients.
Patients with schizophrenia showed a reversed asymmetry in the inferior parietal lobule that was localized to the angular gyrus, a structure belonging to the heteromodal association cortex as well as being part of the semantic-lexical network. This finding contributes to a more comprehensive understanding of the neural substrates of language and thought disorder in schizophrenia.
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