Objective:To conduct a quantitative and qualitative analysis of the issues found in quality management, establish a risk-based whole-process quality management model, and improve the quality of clinical trials.Methods:Based on the risk-based quality management theory, the issues found in the quality control of drug clinical trials in Beijing Cancer Hospital in 2020 were structured and classified by severity (mild to moderate to severe) and 10 categories, and the risk matrix was graded by a semi-quantitative method. Targeted quality control strategies for different levels of risk were carried out according to visual analysis of the informative quality analysis platform. Chi-square tests of the severity of quality control issues in our hospital in 2020 and 2021 and non-parametric tests of the number of issues per capita in each category were used to evaluate the effectiveness of the management model.Results:A risk matrix was established according to the severity and frequency of the issues found in the quality control in 2020. The issues with severe risks were categorized as protocol compliance and serious adverse events, and categories with moderate risks included informed consent, biological sample related, original records, and investigator folders. After using visual analysis and adopting the risk-based quality control strategy, the proportion of severe issues found in quality control in our hospital in 2021 was 0.92%, lower than that of 1.39% in 2020, and the difference was statistically significant. The average number of issues detected per capita in each category for each trial in 2021 was lower than that in 2020 with a statistical difference, indicating that the management model was effective.Conclusions:Using information technology to adopt risk-based quality management is helpful to improve the quality of hospital clinical trials.

Objective:To evaluate 5-years breast cancer-specific survival (CCS) by age, and the relationship of age at diagnosis and the risk of breast cancer mortality.Methods:Medical records of 3 470 resident patients diagnosed with primary, invasive female breast cancer between January 1, 2006 and December 31, 2010 in four hospitals in Beijing were reviewed and collected. All patients were followed up until December 31, 2018 to acquire survival outcome. Five-years breast CCS of the five subgroups was estimated by the life-table method. Cox proportional hazard regression models were used to estimate hazard ratios ( HRs) and 95% confidence intervals (CIs) of different levels of age stratification and breast cancer mortality, and restricted cubic spline (RCS) model was used to detect the dose-response relationship. Results:The median diagnosis age among 3 470 female breast cancer patients was 53.2 years. There were 1 289 patients in the age-group of 45~54 years, with the highest proportion of 37.15%. However, only 126 patients occurred in the age-group of less than 35 years, with the lowest proportion of 3.63%. A total of 528 (15.22%) patients died of breast cancer during the study period. Overall 5-year CCS was 90.72% (95% CI: 89.74%~91.70%), 88.68% (95% CI: 83.09%~94.27%) and 87.05% (95% CI: 84.27%~89.82%) for all of the patients, aged less than 35 years and those aged 65 years and older. Compared with patients with diagnosis age of 45~54 years, the multivariate-adjusted HRs for breast cancer mortality associated with patients in age-group of <35 years and those in the age-group of ≥65 years were 1.72 (95% CI: 1.06~2.81) and 1.89 (95% CI: 1.43~2.49), respectively. In addition, patients aged ≥65 years had significantly higher risk of breast cancer mortality in Luminal subtypes, with HR of 1.70 (95% CI: 1.17~2.46) for Luminal A breast cancer and HR of 3.84 (95% CI: 1.74~8.49) for Luminal B breast cancer. RCS analysis exhibited a non-linear ( "J-shaped" ) relationship between diagnosis age of female breast cancer and the risk of breast cancer mortality (nonlinear P<0.000 1). In addition, patients aged ≥65 years had significantly higher risk of breast cancer mortality in Luminal subtypes, with HR of 1.70 (95% CI: 1.17~2.46) for Luminal A breast cancer and HR of 3.84 (95% CI: 1.74~8.49) for Luminal B breast cancer. RCS analysis exhibited a non-linear ( "J-shaped" ) relationship between diagnosis age of female breast cancer and the risk of breast cancer mortality (nonlinear P<0.000 1). Conclusion:Age at diagnosis is an important prognostic factor for female breast cancer, with worse outcome for both young and old patients.

Objective:To evaluate 5-years breast cancer-specific survival (CCS) by age, and the relationship of age at diagnosis and the risk of breast cancer mortality.Methods:Medical records of 3 470 resident patients diagnosed with primary, invasive female breast cancer between January 1, 2006 and December 31, 2010 in four hospitals in Beijing were reviewed and collected. All patients were followed up until December 31, 2018 to acquire survival outcome. Five-years breast CCS of the five subgroups was estimated by the life-table method. Cox proportional hazard regression models were used to estimate hazard ratios ( HRs) and 95% confidence intervals (CIs) of different levels of age stratification and breast cancer mortality, and restricted cubic spline (RCS) model was used to detect the dose-response relationship. Results:The median diagnosis age among 3 470 female breast cancer patients was 53.2 years. There were 1 289 patients in the age-group of 45~54 years, with the highest proportion of 37.15%. However, only 126 patients occurred in the age-group of less than 35 years, with the lowest proportion of 3.63%. A total of 528 (15.22%) patients died of breast cancer during the study period. Overall 5-year CCS was 90.72% (95% CI: 89.74%~91.70%), 88.68% (95% CI: 83.09%~94.27%) and 87.05% (95% CI: 84.27%~89.82%) for all of the patients, aged less than 35 years and those aged 65 years and older. Compared with patients with diagnosis age of 45~54 years, the multivariate-adjusted HRs for breast cancer mortality associated with patients in age-group of <35 years and those in the age-group of ≥65 years were 1.72 (95% CI: 1.06~2.81) and 1.89 (95% CI: 1.43~2.49), respectively. In addition, patients aged ≥65 years had significantly higher risk of breast cancer mortality in Luminal subtypes, with HR of 1.70 (95% CI: 1.17~2.46) for Luminal A breast cancer and HR of 3.84 (95% CI: 1.74~8.49) for Luminal B breast cancer. RCS analysis exhibited a non-linear ( "J-shaped" ) relationship between diagnosis age of female breast cancer and the risk of breast cancer mortality (nonlinear P<0.000 1). In addition, patients aged ≥65 years had significantly higher risk of breast cancer mortality in Luminal subtypes, with HR of 1.70 (95% CI: 1.17~2.46) for Luminal A breast cancer and HR of 3.84 (95% CI: 1.74~8.49) for Luminal B breast cancer. RCS analysis exhibited a non-linear ( "J-shaped" ) relationship between diagnosis age of female breast cancer and the risk of breast cancer mortality (nonlinear P<0.000 1). Conclusion:Age at diagnosis is an important prognostic factor for female breast cancer, with worse outcome for both young and old patients.

Objective: To understand the consciousness of the cancer early treatment and its demographic and socioeconomic factors. Methods: A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China (CanSPUC) from 2015 to 2017. A total of 32 257 local residents aged ≥18 years old who could understand the investigation procedure were included in the study by using the cluster sampling method and convenient sampling method. All local residents were categorized into four groups, which contained 15 524 community residents, 8 016 cancer risk assessment/screening population, 2 289 cancer patients and 6 428 occupational population, respectively. The questionnaire collected personal information, the consciousness of the cancer early treatment and relevant factors. The Chi square test was used to compare the difference between the consciousness of the cancer early treatment and relevant factors among the four groups. The logistic regression model was used to analyze the influencing factors related to the consciousness of the cancer early treatment. Results: With the assumption of being diagnosed as precancer or cancer, 89.97% of community residents, 91.84% of cancer risk assessment/screening population, 93.00% of cancer patients and 91.52% of occupational population would accept active treatments (P<0.001). If the immediate family members were diagnosed as precancer or cancer, people who would encourage their family members to receive early treatment in the four groups accounted for 91.96%, 91.94%, 92.44% and 91.55%, respectively (P<0.001). The company employees, annual household income with 40 000 yuan and more and other three groups had a relatively better consciousness of the cancer early treatment (P<0.05). Male, widowed, unemployed and from the central and western regions had a relatively worse consciousness of the cancer early treatment (P<0.05). Conclusion Residents in urban China participants had a good consciousness of the cancer early treatment. The marital status, occupation, annual household income and residential regions were major factors related to the consciousness of the cancer early treatment.

Objective: To analyze the temporal trends of lung cancer incidence between age, gender (male and female) and areas (urban and rural) in Beijing during 2000-2012. Methods: The lung cancer cases were collected by Beijing cancer registry between 2000 and 2012. We calculated the incidence and world age-standardized incidence rates (ASR) which standardized by World Segi's population. Also, the average age and median age of lung cancer incidence were calculated. The annual percent changes (APC) for the whole period, for the gender ratio and for the area ratio were evaluated with Joinpoint analysis. Result: Totally, 81 378 new cases of lung cancer were diagnosed in 2000-2012 with the average incidence rate of 52.67/100 000. The incidence rate increased by 4.84% per year from 38.99/100 000 to 65.33/100 000, but the APC of ASR was 1.69% (P<0.001) . The ASR increased 0.54% (P=0.029) per year in urban from 29.71/100 000 to 30.55/100 000 and 3.93% (P<0.001) in rural areas from 24.02/100 000 to 35.79/100 000. The incidence ratio of urban to rural decreased from 1.24 to 0.85 (APC=-3.29%, P<0.001). The incidence ratio of male to female decreased from 1.84 to 1.69 (APC=-0.45%, P=0.019).The average age of lung cancer incidence of male and female increased from 66.27 and 66.00 to 68.97 and 69.11 (P<0.001), respectively. Conclusion The incidence rate of lung cancer increased slightly in urban areas but increased significantly in rural areas during 2000-2012, the area ratio trend was declined. The average age of lung cancer occurrence gradually increased, but the temporal trends varied with age group. The gender ratio decreased from 2000 to 2012.

Objective To investigate the efficacy and safety of low-dose ammonia sulfur-sulfur-resistant treatment.Methods 120 patients with initial depression were randomly divided into a group(40 cases), the estercalyptrin group(40)and the drug group(40).The treatment was treated by the treatment of the ammonia sulfonate, 20 mg/d, 20 mg/d, and 20 mg/d of escitaloplan tablet.The clinical efficacy and response scale(TESS)was evaluated with the Hamilton depression scale(TESS)in the treatment of 1, 2, 4 and 8 over the weekend.Results Three groups showed significant improvement(P<0.01)during the 8th weekend of treatment of the HAMD scores.Grade 1 and 2 weekend, combined treatment group compared with single drug group score had significant difference(P<0.01), and the contrast between the single drug groups had no significant difference, 4 score over the weekend, and comparison between the three way were significant differences(P<0.05), 8 scores over the weekend, and share with escitalopram phthalein general group is no difference, but tolbutamide will benefit group compared with the other two groups had significant difference(P<0.01).Conclusion Small doses of tolbutamide will benefit has antidepressant effect, but the long-term curative effect of treatment is better than the amount of escitalopram citalopram, and share small doses of escitalopram citalopram tolbutamide will benefit can obviously accelerate the antidepressant treatment work.

Objective: To analyze the incidence trends and to describe the characteristics of soft tissue sarcoma (STS) among residents in Beijing from 1999 to 2013. Methods: Medical information of the cases diagnosed as STS(ICD10: C47&C49) from 1999 to 2013 in Beijing was extracted from the population-based database of Beijing Cancer Registry.Crude incidence rate, age-standardized incidence rates to Chinese population (ASRC)and the world population(ASRW) were calculated. The characteristics of the STS cases in different gender and age groups from urban and rural areas were respectively analyzed.The incidence trends and annual percentage changes (APC) during last 15 years were analyzed by using JoinPoint 3.4.3 software. Results: A total of 2 048 cases were diagnosed as STS during the study period and the incidence rate of STS was 1.15 per 100 000 person-years. The ASRC was 0.74 per 100 000 person-years and ASRW was 0.86 per 100 000 person-years, respectively. Except for the impact of changes in the age composition, the APC of ASRW from 1999 to 2013 was 3.95%. For males, the incidence rate was increased from 0.65 per 100 000 in 1999 to 1.51 per 100 000 in 2013, and the APC was 4.27% (P<0.05); For females, the incidence rate was increased from 0.61 per 100 000 in 1999 to 0.91 per 100 000 in 2013, and the APC was 3.38% (P<0.05). In urban area, the incidence rate increased from 1.14 per 100 000 in 2000 to 1.35 per 100 000 in 2013, and the APC was 2.70% (P=0.05); In rural area, the incidence rate increased from 0.57 per 100 000 in 2000 to 0.98 per 100 000 in 2013, and the APC was 4.66% (P=0.04). 85.89%cases were pathologically diagnosed.Among them, undifferentiated pleomorphic sarcoma was the most common subtype, which accounting for 19.22%, followed by liposarcoma (19.04%), malignantnerve sheath tumor (10.18%), fibrosarcoma (10.06%)and sarcoma without definite type(7.22%). Conclusions The incidence rate of STS is still increasing, especially in the rural area of Beijing. The most common subtypes of STS in different age-groups were different. Further study is needed to explore the high risks of STS in the population with specific characteristics.

Objective: To evaluate the incidence and mortality status of thyroid cancer in China, 2013. Methods: Incidence and mortality data of thyroid cancer were derived from 255 population-based cancer registries in China. Age-specific and age standardized incidence and mortality rates of thyroid cancer in different areas (urban and rural) with different gender were calculated based on the stratification of area (urban and rural), gender, age and tumor position. Chinese census in 2000 and the world Segi′s population were used for age-standardized incidence/mortality rates. The incident cases and deaths were estimated using age-specific rates and national population data in 2013. Results: The estimates of new cancer incident cases and deaths were 143.9 thousand and 6 500, respectively. The crude incidence rate was 10.58/100 000 (Male 5.12/100 000, Female 16.32/100 000). Age-standardized incidence rates by Chinese standard population (ASIRC, 2000) and by world standard population (ASIRW) were 8.82/100 000 and 7.67/100 000, respectively. Male to female ratio was 1∶3.2. The crude incidence rate in urban and rural areas were 15.03/100 000 and 5.41/100 000, respectively. After adjustment by China standard population, the rate in urban areas was 2.57 times higher than that of rural areas. The crude mortality rate of thyroid cancer was 0.48/100 000 (Male 0.33/100 000, Female 0.63/100 000). Age-standardized mortality rates by Chinese standard population (ASIRC, 2000) and by world standard population (ASIRW) were 0.33/100 000 and 0.32/100 000, respectively. The crude mortality rate in urban and rural areas were 0.57/100 000 and 0.38/100 000, respectively. After adjustment by China standard population, the rate in urban areas was 1.41 times higher than that of rural areas. The cumulative incidence and mortality rates (0-74 years old) were 0.74% and 0.03%, respectively. According to the data from 255 cancer registries, papillary carcinoma is the main pathology type, which accounted for 89.9% of all malignant tumors. Conclusions The disease burden of thyroid cancer in urban areas is higher than that in rural areas. Females have the higher incidence rate than that of males. The reasons related to the higher incidence rate of thyroid cancer should be further investigated to provide evidence for appropriate cancer control strategies and policies to be made in China.

OBJECTIVETo explore the relationship between female breast cancer incidence and the socioeconomic status in Beijing.

METHODSThe data of female breast cancer patients of Beijing residents diagnosed between 2001 and 2010 were sorted from the population-based surveillance database of Beijing Cancer Registry.28, 184 cases were included, covering 58, 427, 396 female person-years. Incidence rates, rates adjusted by world population in each year, mean and median age at diagnosis and the peak age group were calculated. JoinPoint software was applied to calculate the incidence trend and the annual percentage of changing (APC). Using the data from the Beijing Statistical Yearbook in 1991-2000, we calculated the gross output value of industry, the average wage of Beijing residents, the food expenditure level and the average wage in different districts in Beijing. The relationship between female breast cancer incidence, the average age (mean, median and the peak age groups) at diagnosis and the socioeconomic status in the last 10 years was also calculated.

RESULTSFrom 2001 to 2010, the incidence rate of female breast cancer in Beijing rose from 32.03/100 000 to 58.10/100 000, a total increase of 81.39% over the last 10 years and the annual percentage change was 5.76%, after adjusted by world population (APC = 5.76%, P < 0.05). The relationships between female breast cancer incidence from 2001-2010 and the gross output value of industry, the average wage of Beijing residents, the food expenditure level in 1991-2000 were significant (P < 0.05). The Pearson correlation coefficients were 0.928, 0.957, and 0.982, respectively. In terms of the data in different districts in Beijing, the relationships between the average age (mean, median and the peak age group) in 2001-2010 and the average wage of Beijing residence in 1991-2000 were also significant with a correlation coefficient of 0.806,0.785 and 0.754, respectively (P < 0.05).

CONCLUSIONSThe increase of female breast cancer incidence rate in Beijing is positively correlated with the socioeconomic status, especially with the food expenditure level of Beijing residents over the last 10 years. The higher the economic development, the peak age of onset of female breast cancer is more postponed.

Breast Neoplasms ; epidemiology ; Cell Movement ; China ; epidemiology ; Female ; Humans ; Incidence ; Menopause ; Social Class ; Socioeconomic Factors

OBJECTIVETo analyze the incidence trends and characteristics of lymphoma in Beijing, 1998-2010.

METHODSTotal of 9 763 new cases diagnosed as lymphoma in 1998-2010 were extracted from the population-based database of Beijing Cancer Registry, covering population of 151 601 066 person-years. Incidence, age-adjusted incidence, cumulative incidence, truncated incidence and annual percentage change (APC) were calculated. The gender-specific, age-specific and pathology-specific incidence trends were analyzed.

RESULTThe incidence rate of lymphoma was 6.48/100 000 (9 763/150 720 187) during the period of 1998-2010, increased from 3.78/100 000 (410/10 850 626) in 1998 to 8.88/100 000 (1 111/12 518 114) in 2010 with an increasing rate of 136.17% (APC = 5.21%, P < 0.05). The incidence rate of Hodgkin lymphoma increased from 0.25/100 000 (27/10 850 626) in 1998 to 0.47/100 000 (59/12 518 114) in 2010 with an increasing rate of 88.00% (APC = 4.33%, P < 0.05). The incidence rate of non-Hodgkin lymphoma was increased from 2.89/100 000 (314/10 850 626) in 1998 to 5.93/100 000 (742/12 518 114) in 2010 with an increasing rate of 105.19% (APC = 4.19%, P < 0.05) . During the period of 1998-2010, the incidence of lymphoma was 7.78/100 000 (7 125/91 621 898) in urban areas and 4.47/100 000 (2 638/59 098 289) in rural areas, 7.40/100 000 (5 632/76 121 672) in males and 5.54/100 000 (4 131/74 598 518) in females.

CONCLUSIONThe incidence of lymphoma keeps increasing in 1998-2010, and the incidence was higher in males than females, urban areas than rural areas. The incidence patterns of Hodgkin lymphoma and non-Hodgkin lymphoma were different.

Aged ; China ; epidemiology ; Female ; Humans ; Incidence ; Lymphoma ; Male ; Rural Population ; Urban Population