AIM: To investigate the design significance, method and content of the oncology clinical trial case report form (CRF) based on the clinical data acquisition standards harmonization (CDASH). METHODS: Compared with CDASH v 2.2, the characteristics of oncology clinical trial data were analyzed, and a standardized CRF was designed to meet the actual needs of oncology clinical trials. RESULTS: The CDASH was applied to the design of the CRF of the oncology clinical trial, and the data collection of the oncology clinical trial was standardized, so that the CRF design of the oncology clinical trial was relatively standardized and the data quality was improved. CONCLUSION: The implementation of oncology CRF design based on CDASH can promote the exchange and sharing of oncology clinical research data, which is conducive to improving the reliability of oncology clinical research results.

Objective To analyze the prevalence of visual acuity disorder among children aged 4-18 in Xuhui District of Shanghai from 2015 to 2019, and analyze its influencing factors, and to provide a scientific basis for the prevention and control of visual acuity disorder in Xuhui District of Shanghai. Methods Using random cluster sampling, students from 10 kindergartens, 3 primary schools and 2 middle schools were randomly selected as the investigation subjects. Visual acuity examinations and demographic survey were conducted, and chi-square test was used to describe the development trend of poor visual acuity. Results A total of 29 613 people were screened in five years, and the detection rate of poor vision in Xuhui District of Shanghai from 2015 to 2019 was 41.08% in 2015 and 50.59% in 2018, showing an increasing trend year by year (χ²=127.45, P<0.05). The detection rate of poor vision was 86.72% in high school and 11.95% in kindergarten. The detection rate of poor vision increased with the grade, and the difference was statistically significant (χ²=7237.84, P<0.05). The overall detection rate of poor vision in children aged 4-18 was higher in girls than in boys, and the difference was statistically significant (χ²=80.93, P<0.05). The detection rate of poor vision among students of 4-6 years old born in autumn was 9.29%, which was lower than that in the other three seasons, and the difference was statistically significant (χ²=12.91, P<0.05). Conclusion In Xuhui District, the detection rate of poor vision among children and adolescents aged 4-18 years old was relatively high, and the development trend of visual problems was severe. In order to prevent the occurrence and development of poor eyesight, education departments, health departments and parents should strengthen the cultivation of good eye use habits and awareness among students, and take reasonable measures to control the development of poor vision.

Objective:To evaluate the efficacy and safety of tazarotene/betamethasone dipropionate cream at different concentration ratios in the treatment of psoriasis vulgaris, and to determine the optimal drug concentration ratio for clinical use.Methods:A multicenter, randomized, double-blinded, multi-dose controlled study was conducted. From December 2008 to April 2009, a total of 180 patients with psoriasis vulgaris were enrolled from 7 research centers, such as Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College. These patients were randomly and equally divided into 5 groups: treatment groups 1, 2, 3, 4 treated with tazarotene/betamethasone dipropionate cream at concentration ratios of 0.025%/0.025%, 0.05%/0.025%, 0.025%/0.05% and 0.05%/0.05% respectively once a day, and control group treated with the cream vehicle once a day. The treatment lasted 4 weeks. Efficacy and safety were evaluated after 1, 2 and 4 weeks of treatment. One-way analysis of variance and least significant difference (LSD)- t test were used to compare measurement data among several groups, chi-square test and Fisher′s exact test to compare categorical data among groups, and Cochran-Mantel-Haenszel (CMH) test to compare psoriasis area severity index (PASI) response rates between groups. Results:After 4 weeks of treatment, 11 patients (30.56%) , 12 (33.33%) , 12 (33.33%) , 19 (52.78%) and 2 (5.56%) in the treatment groups 1, 2, 3, 4 and control group respectively achieved a 75% reduction in PASI (PASI75) , and the proportions of patients achieving PASI75 were significantly higher in the treatment groups than in the control group (all P < 0.012 7) . Additionally, the proportions of patients achieving PASI90 were also significantly higher in the treatment groups 1, 2 and 4 than in the control group (all P < 0.012 7) . After 4 weeks of treatment, the rates of reduction in PASI scores were 59.52% ± 26.79%, 57.19% ± 31.98%, 56.85% ± 30.46% and 68.21% ± 37.20% in treatment groups 1, 2, 3, and 4 respectively, which were all significantly higher than the rate of reduction in the control group (20.07% ± 28.55%; LSD- t = 5.36, 5.05, 5.00, 6.55, all P < 0.001) . The treatment group 4 showed marked comprehensive efficacy. All the tested drugs were well tolerated in the patients, and adverse reactions occurred in 11 (30.56%) , 8 (22.22%) , 2 (5.56%) , 4 (11.11%) and 2 (5.56%) cases in the treatment groups 1, 2, 3, 4 and control group respectively. The incidence rate of adverse reactions was significantly higher in the treatment group 1 than in the control group ( P = 0.012) , and there was no significant difference among the treatment groups 2, 3, 4 and control group (all P > 0.05) . Conclusion:The tazarotene 0.05%/betamethasone dipropionate 0.05% cream can be recommended for subsequent clinical trials in psoriasis vulgaris.

Objective:To preliminarily evaluate clinical efficacy and safety of tazarotene 0.05%/betamethasone dipropionate 0.05% cream in the treatment of psoriasis vulgaris.Methods:A multicenter, randomized, double-blinded, single-dummy, parallel-controlled clinical trial was conducted. Subjects with mild to moderate psoriasis vulgaris were randomized into 4 groups at a ratio of 2∶1∶1∶1, including tazarotene 0.05%/betamethasone dipropionate 0.05% cream (Taz/Bp) group, betamethasone dipropionate 0.05% cream (Bp) group, tazarotene 0.05% gel (Taz) group and cream vehicle control (Plb) group. The treatment lasted 4 weeks. After 1, 2 and 4 weeks of treatment, efficacy and safety of drugs were evaluated in the above groups. Two-way analysis of variance model with main effects was used to compare continuous indices, least significant difference t-test was used for multiple comparisons, and chi-square test or Fisher′s exact test for comparisons of categorical data. Results:A total of 300 subjects were enrolled from 7 research centers, including 120 in the Taz/Bp group, 60 in the Bp group, 60 in the Taz group and 60 in the Plb group. After 4 weeks of treatment, proportions of patients achieving a 75% reduction in PASI (PASI75) were 35.83%, 20.00%, 18.33% and 6.67% in the Taz/Bp, Bp, Taz and Plb groups respectively, and there was a significant difference among the 4 groups ( P < 0.05) ; the proportion of patients achieving PASI75 was significantly higher in the Taz/Bp group than in the Plb group (α = 0.05, P < 0.05) and Taz group (α = 0.025, P < 0.025) , but there was no significant difference between the Taz/Bp group and Bp group (α = 0.016 7, P > 0.016 7) ; the proportions of patients achieving PASI90 were 25.00%, 8.33%, 5.00% and 1.67% in the Taz/Bp, Bp, Taz and Plb groups respectively, which significantly differed among the 4 groups ( P < 0.05) , and the Taz/Bp group showed a significantly increased proportion of patients achieving PASI90 compared with the Plb group ( P < 0.05) , Taz group ( P < 0.025) and Bp group ( P < 0.016 7) . All the tested drugs were well tolerated in the 4 groups. Adverse drug reactions occurred in 15 (12.50%) , 5 (8.33%) , 19 (31.67%) and 9 (15.00%) patients in the Taz/Bp, Bp, Taz and Plb groups respectively. The incidence rate of adverse drug reactions significantly differed among the 4 groups ( P = 0.004) , and was significantly lower in the Taz/Bp group than in the Taz group ( P < 0.05) , but insignificantly different between the Taz/Bp group and Bp or Plb group (both P > 0.05) . Conclusion:Tazarotene 0.05%/betamethasone dipropionate 0.05% cream is effective and safe for the treatment of psoriasis vulgaris.

Objective: To understand the health literacy and relevant factors of cancer prevention consciousness in Chinese urban residents from 2015 to 2017. Methods: A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China 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 self-designed questionnaire was used to collect the information of demographic characteristics and cancer prevention consciousness focusing on nine common risk factors, including smoking, alcohol, fiber food, food in hot temperature or pickled food, chewing betel nut, helicobacter pylori, moldy food, hepatitis B infection, estrogen, and exercise. The logistic regression model was adopted to identify the influencing factors. Results: The overall health literacy of the cancer prevention consciousness was 77.4% (24 980 participants), with 77.4% (12 018 participants), 79.9% (6 406 participants), 77.2% (1 766 participants) and 74.5% (4 709 participants) in each group (P<0.001). The correct response rates for nine risk factors ranged from 55.2% to 93.0%. The multivariate logistic regression analysis showed that compared with community residents, people with primary school level education or below, and the number of people living together in the family <3, the cancer risk assessment/screening intervention population, cancer patients, those with junior high school level educationor above and the number of people living in the family ≥3 had better health literacy of the cancer prevention consciousness (all P values <0.05). Compared with females, 39 years old and below, government-affiliated institutions or civil servants, from the eastern region, males, older than 40 years, company or enterprise employees, and from the middle or western region had worse health literacy of the cancer prevention consciousness (all P values <0.05). Conclusion The health literacy of the cancer prevention consciousness in Chinese urban residents should be improved. The cancer screening intervention, gender, age, education, occupation, the number of people co-living in the family, and residential region were associated with the health literacy of the cancer prevention consciousness.

Objective: To understand the consciousness of the cancer early detection among urban residents and identify the influencing factors from 2015 to 2017. Methods: A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China 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. Self-designed questionnaires were used to collect population, socioeconomic indicators, self-cancer risk assessment, regular participation in physical examination and other information. The multivariate logistic regression model was used to identify the factors of people who had not regularly participated in the regular physical examination in the past five years. Results: The self-assessment results of 32 357 residents showed that there were 27.54% (8 882) of total study population with self-reported cancer risk, 45.48% (14 671) without cancer risk and 26.98% (8 704) with unclear judgement on their own cancer risk. Among population with cancer risk, 79.84% (7 091) considered physical examination accounted. In the past five years, there were 21 105 (65.43%) residents participated in regular physical examination and 11 148 (34.56%) participated in non-scheduled one, respectively. The multivariate logistic regression analysis showed that compared with unmarried and western region residents, divorced, middle and eastern region residents had a stronger consciousness to participate in the regular physical examination (P<0.05). Compare with residents with annual household income less than 20 000 CNY in 2014, cancer risk assessment/screening intervention population, and self-assessment with cancer risk, residents with annual household income between 20 000 CNY and 59 000 CNY in 2014, occupational population, community residents, cancer patients, self-reported cancer-free risk, and self-assessment with unclear judgement of cancer risk were less likely to participate in the regular physical examination (all P values <0.05). Conclusion From 2015 to 2017, the Chinese urban residents had a acceptable consciousness of the cancer early detection. The marital status, annual household income, population group and self-assessment of cancer risk were related to the consciousness of the cancer early detection of people who had not participated in the regular physical examination in the past five years.

Objective: To understand the consciousness of the cancer early diagnosis among urban residents and identify the related factors from 2015 to 2017. Methods: A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China 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 general demographic characteristics, the consciousness of the cancer early diagnosis (whether people would have a willingness or encourage their relatives/friends to confirm the abnormal results once which were detected from the physical examination) and other information were collected by using the self-designed questionnaire. The non-conditional logistic regression model was used to identify the relateol factors related to the consciousness of the cancer early diagnosis. Results: As for residents with abnormal result from the physical examination, 89.29% (28 802) of residents would choose to seek medical treatment for further diagnosis. If their relatives/friends had abnormal results from the physical examination, 89.55% (28 886) of residents would encourage their relatives/friends to confirm the diagnosis in time. The non-conditional logistic regression model analysis showed that compared with the public institution staff/civil servants, annual household income less than 20 000 CNY, the western region and the cancer risk assessment/screening intervention population, the company staff, annual household income about 40 000 CNY and more, and the residents from the middle and eastern region had a stronger consciousness to seek further diagnosis; while the unemployed residents and community residents were less likely to seek further diagnosis (P<0.05). Conclusions From 2015 to 2017, the Chinese urban residents had a good consciousness of the cancer early diagnosis. Occupation, annual household income, residential region and population group were related to the consciousness of the cancer early diagnosis.

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 understand the health literacy of the cancer prevention and treatment among urban residents of China, and explore the related 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 health literacy of the cancer prevention, early discovery, early diagnosis, early treatment and the demands of cancer prevention and treatment knowledge was analyzed. The level of health literacy among different groups were calculated and compared. The binary logistic regression model was used to analyze the influencing factors of the health literacy of the cancer prevention and treatment. Results: The level of health literacy of the cancer prevention and treatment was 56.97% among all study population; in each group it was 55.01% for community residents, 59.08% for cancer risk assessment/screening population, 61.99% for cancer patients and 57.31% for occupational population, respectively (P<0.001). The level of health literacy of the cancer prevention and treatment of residents aged 50 to 69 years old, other occupational groups, unmarried, the central and western region residents and the group with unclear self-assessment of cancer risk was significantly lower than that of residents younger than 40 years old, personnel of public institutions/civil servants, married, the eastern region residents and the group whose self-assessment without cancer risk (P<0.05) . The level of health literacy of cancer prevention and treatment of females, people who went to high school or over, cancer risk assessment/screening population, cancer patients and occupational population was significantly higher than that of males, people who had an education level of primary school or below and community residents (P<0.05) . Conclusion The health literacy of the cancer prevention and treatment of urban residents in China was relatively high, but there was still room for improvement. Gender, age, educational level, occupation, region, marital status, self-assessment of cancer risk, and type of respondents were the key influencing factors of the health literacy of the cancer prevention and treatment. Male, 50-69 years old, lower educational level, central and western regions, unclear cancer risk self-assessment, and without specific environmental exposure to cancer prevention and treatment knowledge or related risk factors were the characteristics of the key intervention group of the health literacy of the cancer prevention and treatment.

Objective: To investigate the demand and access to the cancer prevention and treatment knowledge and related factors among urban residents in China from 2015 to 2017. Methods: A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China 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 self-designed questionnaire was used to collect the information of general demographic characteristics, the demand and access to cancer prevention and treatment knowledge, and the influencing factors of the attitude. The Chi-square test was used to analyze the difference of the demand of the cancer prevention knowledge among different groups and the corresponding factors of the cancer prevention and treatment knowledge were analyzed by using the logistic regression model. Results: The proportion of residents who need the cancer prevention and treatment knowledge was 79.5%. The demand rate of the inducement, symptom and diagnosis methods of cancer in the occupational population was highest, about 66.8%, 71.0% and 20.8%, respectively. The demand rate of treatment methods and cost in current cancer patients was the highest, about the 45.9% and 21.9%, respectively. The top three sources to acquire the cancer prevention and treatment knowledge were "broadcast or television" (69.5%), "books, newspapers, posters or brochures" (44.7%) and "family and friends" (33.8%). The multivariate analysis showed that compared with public institution personnel/civil servants, unmarried/cohabiting/divorced/widowed and others, annual household income less than 20 000 CNY, from the eastern region, people without cancer diagnosis and people with self-assessment of cancer risk, the demand rate of cancer prevention and treatment knowledge was higher in enterprise personnel/workers, married, annual household income between 60 000 CNY and 150 000 CNY, from the central region, people with cancer and people with unclear cancer risk (all P values <0.05). Conclusion There was a high demand for the cancer prevention and treatment knowledge among urban residents in China from 2015 to 2017. The main access to the knowledge is from the radio or television. The occupation, marital status, annual household income, residential region, health status and risk of disease were the main factors of the demand of the cancer prevention and treatment knowledge.