ABSTRACT
Cost data caliber governance is key to fine cost management. To tackle the troubles in cost data management at multiple campuses of one hospital, the authors built a multi-campus cost data caliber governance mode. By means of enhanced top-level design, the mode carried out data governance by such measures as the establishment of data dictionary mapping library, standardizing department names and caliber, classification of charging items of medical services, precisely matching between fixed assets and charging items, interconnecting the management system of charging library and the procurement library of consumables, as well as precisely matching surgical disease types and charging items. These measures accomplished the consistency and comparability of cost data across campuses, building an automated, streamlined, standardized and integrated data governance mode for reference of hospitals with multiple campuses in need of cost management.
ABSTRACT
Background@#In China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence. @*Methods@#SOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography–computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cyclesof platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate.
ABSTRACT
Background@#Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice. @*Methods@#The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC).The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.
ABSTRACT
Background@#Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice. @*Methods@#The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC).The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.
ABSTRACT
Objective:To explore the influence of organizational management mode and regional medical resource allocation on thrombolysis rate of stroke.Methods:A cross-sectional study was carried out in 61 thrombolytic units distributed at 16 administrative districts of Shanghai to collect information including the number of imaging equipment, neurologists and nurses, hospital organization and management mode, thrombolytic rate, etc. Using SPSS 19.0 statistical software, simple linear regression analysis and chi square test were used to analyze the correlation between related indexes and thrombolysis rate.Results:There was no linear correlation between imaging equipment, human resources and regional thrombolysis rate. The key factor to improve thrombolysis rate was the organizational management of stroke( OR=1.488, 95% CI=1.357-1.631, P<0.001). Conclusions:An effective hospital organization and management model, including the establishment of multi department cooperation, stroke emergency team, stroke green channel, can significantly improve the thrombolysis rate of stroke.
ABSTRACT
Objective@#To analyze the causes of preoperative miscarriage of pancreatic serous cystadenoma (SCN) and find the ways to improve it.@*Methods@#Clinical data of 425 pancreatic cystic neoplasm patients who underwent surgical resection from January 2006 to December 2016 in Department of Pancreatic Surgery in Huashan Hospital were retrospectively analyzed.Excel database was created which covered 128 fields of 7 fields: general information of patients, preoperative blood biochemical indexes, tumor markers, surgical related data, postoperative complications, imaging findings and pathology.One hundred and sixty-one cases of SCN were analyzed in depth, mainly in three aspects: surgical benefit, preoperative imaging diagnostic value and interference factors in preoperative judgement.The classification data were analyzed by χ2 test and the quantitative data were analyzed by t test.The Logistic regression model was used for multiple factor analysis.@*Results@#Of the 425 PCN cases surgically removed, 161 cases (37.9%) were SCN, the incidence of operative complications was 40.4%(65/161), the hospitalization days was (20.7±12.1)days and the medical cost was (75 267±37 866) yuan.Only 3 of 161 cases of SCN were accurately diagnosed by preoperative imaging methods, 61 cases were diagnosed as "cystic lesions of pancreas" (37.9%) and 52 cases were diagnosed as "pancreatic cystadenoma" (32.3%). SCN was misdiagnosed as MCN(32.3%) and IPMN(28%) before operation.25.5% of them were diagnosed as SCN before operation, but still underwent radical operation.The rate of preoperative imaging diagnosis for identifying SCN was 62.8%.The lack of preoperative endoscopy and the lack of understanding of the image characteristics and biological behavior of SCN were the most important factors affecting the accuracy of preoperative judgment.Statistics found that gender, age, CA125 and tumor location can be used as independent factors contribute to the clinical identification(χ2=8.995, P=0.003; χ2=10.019, P=0.007; t=3.157, P=0.002; χ2=6.790, P=0.009). Logistic analysis showed that women, older than 60 years old, the tumors located in the pancreatic body and tail were the independent factors of SCN classification and diagnosis (OR=0.481, 0.376, 0.577, 0.666, 95% CI: 0.305-0.759, 0.199-0.710, 0.361-0.924, 0.433-1.024, P=0.002, 0.003, 0.022, 0.064).@*Conclusions@#SCN has more benign biological behavior.Although surgical excision is acceptable for clinical safety, the corresponding benefit is very limited.It is possible to improve the rationality of SCN clinical operation decisions to some extent by performing endoscopic examination, imaging doctors to improve the SCN feature recognition and surgeons to enhance the awareness of SCN.
ABSTRACT
Objective To investigate the relationship between cytoreduction outcome and staging of ovarian cancer with preoperative blood cell count.Methods The data of 148 ovarian cancer patients from January 2007 to June 2012 were analyzed retrospectively.Clinicopathological and blood cell count data were collected,and benign ovarian tumor group (n =96) as controls.Results Compared to the control group,there were significant differences in the number of white blood cells,neutrophils,lymphocytes,monocytes,platelets,neutrophil to lymphocyte ratio,and platelets to lymphocyte ratio in patients with ovarian cancer (P ＜ 0.05).The same results were also observed in advanced groups and early groups.While between optimal cytoreduction and suboptimal cytoreduction,there were significant differences in platelets,monocytes,neutrophil to lymphocyte ratio,and platelets to lymphocyte ratio (P ＜ 0.05).Conclusions The cytoreduction outcome and pathological staging of ovarian cancer are closely related to the preoperative blood cell count.Blood cell count is important for the identification of benign and malignant ovarian tumors,cytoreduction outcome and the prediction of pathological staging,and may be of significance to the monitoring and prognosis of the disease.
ABSTRACT
Despite multimodel chemotherapy after successful surgical cytoreduction for ovarian cancer,disease recurrence continues to be problematic.Therefore,exploring new treatment strategy has already become urgent matter of the moment. Biological targeted therapies have been studied to overcome chemotherapy resistance.The most promising one at this time is bevacizumab.Results from phase Ⅱ and phase Ⅲ trials were excited.Deeper understanding of biologic pathway in ovarian cancer,and more biologic targets undergoing clinical trial will develop a new world for the treatment of ovarian cancer.
ABSTRACT
Objective To evaluate the strategies and effect of surgical treatment for concomitant abdominal aortic aneurysm (AAA) and colorectal cancer (CRC). Methods Literatures on concomitant AAA and CRC published from January 1988 to December 2008 were retrieved from Pubmed, Sciencedirect, Ovid, CBMdisc, CNKI and et al, and correlated indexes were extracted for analysis. Differences among the groups were analyzed using the t test, chi-square test and fisher's exact test. Results A total of 367 cases of concomitant AAA and CRC treated by operation were retrieved. The length of operation delay of patients who received radical resection of CRC first was (115 ± 21 )days, which was significantly longer than (42 ± 8 )days of patients who received open abdominal aortic aneurysm repair (OAAR) first (t = 18. 9, P <0.05). The 30-day complication rate and accumulative length of hospital stay of patients who received one-stage radical resection of CRC + OAAR were 10.5% ( 12/114 )and (23 ±6) days, and 26.0% (47/181) and ( 16 ±4)days of patients who received two-stage radical resection of CRC + OAAR, with a significant difference ( χ2 = 10.42, t = 12. 01, P <0.05 ). The accumulative length of hospital stay of patients who received radical resection of CRC + endovascular aneurysm repair (EVAR) was (12 ±4) days, which was significantly shorter than that of patients who received radical resection of CRC + OAAR [ ( 19 ±5 ) days ] ( t = 9.48, P < 0. 05 ). The 4-year survival rate of patients who received two-stage radical resection of CRC + OAAR was 43.5% (27/62), which was significantly lower than that of patients who received two-stage radical resection of CRC + EVAR [69.2% (18/26) ] or one-stage radical resection of CRC + OAAR [73.7%(14/19) ] (χ2 =4.83, 5.28, P<0.05). Conclusions If the diameter of AAA is under 5 cm, radical resection of CRC should be firstly carried out; but if the diameter of AAA is above 5 cm, OAAR should be firstly carried out to prevent the rapture of tumors. One-stage surgery is better than two-stage surgery if patients could tolerate it.
ABSTRACT
Purpose:To evaluate the efficacy and toxicities of gemcitabine plus cisplatin for patients with relapsed ovarian cancer. Methods:Twenty-eight patients with recurrent ovarian carcinoma received gemcitabine (1000 mg/m~(2)) plus cisplatin (35 mg/m~(2)) on days 1 and 8 of each 21-day cycle. Of 28 patients, sixteen who relapsed within six months of previously platinum-based regimen were platinum-resistant and the other twelve were platinum-sensitive. Results:Of 28 patients, there were 5 (17.9%) complete and 12 (42.9%) partial responses, for an overall response rate of 60.7% (95%CI: 41.7%–79.6%). The median time to progression for objective responders was 5.5 months with a range of 2.5 to 20 months. Median overall survival for all 28 patients was 12.5 months. Among 16 platinum-resistant patients, a 56.3% response rate occurred. The median survival time was 10.5 months. Among 12 platinum-sensitive patients, a 66.7% response rate occurred. The median survival time was 14.5 months. There were leukopenia grade Ⅲ in 35.7%, grade Ⅳ in 17.9%; thrombocytopenia grade Ⅲ in 28.6 %, grade Ⅳ in 14.3% of patients. Conclusions:Cisplatin plus gemcitabine is active in patients with relapsed ovarian cancer. The adverse effects are tolerable. Hematologic toxicities are manageable with dose modifications.